topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 10.0-75.0, Mycobacterium Infections, Atypical Granulomatous Disease, Chronic Job's Syndrome Influenza, Human FOR to 75 years of age Enrolled without regard to gender, race, or ethnicity NIH employees or non-employees eligible Able to provide proof of identity Able and willing to complete the informed consent process Able and willing to arrange to have another person drive them home after the procedure Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure Willing to donate blood and respiratory tract samples for storage to be used for future research In good general health without clinically significant medical history FOR AND Less than 18 or greater than 75 years old A smoking history of 10 pack-years or more, a current smoker, or tobacco free for less than a year Positive HIV status. Subjects must have a negative FDA-approved HIV blood test Acute or chronic hepatitis based on viral hepatitis serologies Pregnancy or breastfeeding Any active medical problems especially bleeding disorders, significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws, use of anticoagulants, or pulmonary disorders including asthma History of allergic reaction to lidocaine, sedative medications like Valium Trademark or Versed Trademark, or narcotic medications like morphine or fentanyl Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics is not excluded) Use of platelet inhibitors including aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days of procedure | 2 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-12.0, Ventilator Associated Pneumonia Children on mechanical ventilation for more than 72 hours and having simplified clinical pulmonary infection score more than 6 were included in study Age less than 1 month | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Cytomegalovirus Infections Orthotopic liver transplant recipient Donor CMV seropositive / Recipient CMV seronegative Enrolled within 10 days after liver transplant Able to swallow tablets Multiple organ transplant HIV infection CMV disease Use of other anti-CMV therapy at time of enrollment | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-1.0, Infection Precancerous/Nonmalignant Condition Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs) CMV interstitial pneumonia based on the constellation of clinical and radiological findings Female Oxygen desaturation (pulse oximetry 85% on room air) Abnormal chest radiograph No CMV retinitis Prior ganciclovir and foscarnet sodium | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Leishmaniasis DoD healthcare beneficiary of any age and gender Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection Able to provide informed consent or assent (children) All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period History of hypersensitivity to pentavalent antimonials Any of the following on screening examination QTc interval greater or equal to 0.5 sec Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias) History of recurrent pancreatitis Liver failure or active hepatitis with transaminases > 3x upper limit of normal Renal failure or creatinine > 2.5 mg/dL Thrombocytopenia (platelets <100,000/mm3) White blood cell count < 2000 / mm3 | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Cytomegalovirus Infections Prior to receiving treatment, some patients may undergo diagnostic and/or other testing of their tissue, if available, to determine if their CMV infected cells are likely to respond to treatment with CMV specific T cells. Alternatively, blood samples may be required for research tests to ascertain that the CMV-specific T-cells do not contain any cells that could react against the patient. These patients will sign a separate pre-treatment consent. If it is determined that a patient will qualify for and might benefit from infusions of CMV CTLs, he/she will go on to sign the standard treatment consent for MSKCC IRB # 05-065 and be enrolled and treated on trial, if all other are met Each patient must satisfy at least one of the following The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis) or The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids consistent with CMV infection The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV antigenemia or CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs The patient has developed CMV viremia as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant. or the patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC < 1000 ul/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance < than or equal to 60ml/min/1.73m2 or creatinine >2 mg/dl]) Because CMV infections are life-threatening and may involve the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems, and antiviral drugs may also compromise renal and hematopoietic function, dysfunctions of these organs will not affect for this protocol However, to be eligible, the patients should meet the following clinical They must have a stable blood pressure and circulation, not requiring pressor support Patients requiring high doses of glucocorticosteroids (>0.5 mg/kg prednisone or its equivalent) as treatment for active (grade 2-4) acute graft vs. host disease (GVHD) or chronic GVHD Patients who are moribund Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T cell infusion Donor for Donation of Blood Lymphocytes for Generation of Donor-Derived CMV-Specific T cells Adequate health for donation as determined by institutional (related donor) or NMDP (unrelated donor) guidelines. Normal donors will be evaluated for evidence of prior sensitization to CMV by CMV serology. They will also be typed for HLA A, B, C and DR. For allogeneic hematopoietic progenitor cell transplant (HSCT) recipients, the marrow transplant donor will constitute the donor of choice, since those T-cells will grow and persist in a patient who has already engrafted with a transplant from that donor. However, if the HSCT donor is CMV seronegative or not available (e.g. a cord blood transplant or an unrelated donor who has not already donated T-cells for adoptive therapy), CMV-specific T-cells generated from a seropositive donor matched for at least 2 HLA alleles shared by the patient may be used Normal donors fulfilling these who consent to donate blood for the generation of CMV-specific T-cells for adoptive therapeutic purposes will receive a detailed clinical evaluation, including a medical history, physical examination, and serologic testing for transmissible diseases within 1 week of donation including hepBs Ag and hepatitis C antibody, HIV-1 and 2, HTLV-1 and 2, CMV (only if previously negative), VDRL, WNV, and Chagas An HIV+ donor will be rejected on medical grounds. Donors must have Hgb value > 10 gm/dl and must be capable of undergoing a single 3-6 unit leukapheresis (preferable) or a single unit of blood for T cells (for pediatric donors, no more than 5 ml/kg at any one blood draw) A prospective donor will be informed of the purposes of this study, and its requirements. If he/she consents, the donor will be requested to provide two blood samples i. An initial donation of 25ml blood anticoagulated with heparin or ACD. This blood is used to establish a B cell line transformed with the B95.8 laboratory strain of EBV. This EBV+ B cell line/ (EBVBLCL) will be used as an antigen-presenting cell. When loaded with the pool of CMVpp65 pentadecapeptides, the efficiently sensitize T cells from the same donors against CMV as well as EBV Because the establishment and testing of an EBV transformed B cell line suitable for use or as an antigen-presenting cell require 4-5 weeks of in vitro culture, it is important that this sample be obtained as early as possible for patients at risk for a CMV infection. Because patients receiving HSCT from unrelated or HLA disparate donors are particularly at risk for severe CMV infections in the first 2-3 months after transplant, this blood sample should be obtained from the donor prior to donation of the hematopoietic progenitor cell transplant whenever possible | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Cytomegalovirus Infection Age more than 18-year-old Informed consent minors pregnant or lactating women adults under guardianship immunosuppression at the entrance to resuscitation AIDS | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Men or women 40 years or above FEV1 between 40 and 80% of predicted normal value post-bronchodilator Clinical diagnosis of COPD Other clinically relevant disease or disorders Exacerbation of COPD within 30 days | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Cytomegalovirus Infection Male or female patients who fulfill the following are eligible for inclusion CMV D+/R liver, kidney, heart, pancreas, lungor combined transplant recipients All eligible patients must be scheduled to receive 3 months of either valganciclovir, oral ganciclovir, or intravenous ganciclovir prophylaxis Able to give written informed consent Are willing and able to comply with the protocol Age >=18 years Patient unwilling or unable to give informed consent | 2 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-18.0, Asthma years of age or younger Scheduled for bronchoscopy at National Jewish Health for persistent asthma, persistent, poorly controlled wheezing, chronic cough, GERD, atelectasis, bronchopulmonary dysplasia, infection Consent and assent from parent and patient [if appropriate] Unwillingness to consent/assent to retrieval of BAL fluid for research analysis | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-0.014, Cytomegalovirus Disease All LBWIs whose weight is ≤ 1500 grams at birth LBWI is within first five days of life LBWI not expected to live past first seven days of life LBWI has a severe congenital abnormality LBWI has received a RBC or platelet transfusion at another institution prior to transfer LBWI has received an in-utero transfusion LBWI is clinically suspected of having toxoplasmosis, rubella, herpes infection(s) at birth Refusal by the mother to grant consent for herself and/or refusal to grant consent for her LBWI If the mother of the child has previously participated in this study | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-12.0, Post Bronchoscopy Fever under twelve years of age all patients undergoing bronchoscopy and bronchoalveolar lavage children with immune deficiency allergy to previous exacerbation of asthma due to fever on the day of the examination current antibiotic treatment | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-80.0, Chronic Beryllium Disease Diagnosis of chronic beryllium disease based on the below History of beryllium exposure, and Positive blood and/or bronchoalveolar lavage Beryllium Lymphocyte Proliferation Tests (BeLPT), and Biopsy-proven pathologic changes consistent with CBD-non-caseating granulomas and/or mononuclear cell interstitial infiltrates, and Positive bronchoalveolar lavage (BAL) BeLPT and > 15% lymphocytes in BAL fluid History of Hepatic disease History of Renal disease Hypersensitivity to Pentasa (5-ASA) or salicylates Pregnancy Presence of another disease that may be expected to significantly affect patient mortality (e.g., HIV), severe cor pulmonale) The use of blood thinners Current use of tobacco (smoking or otherwise) in the past 6 months Patient inability to participate in the study, such as inability to undergo venipuncture and BAL procedures (if undergoing bronchoscopy) that form part of the inclusion/ or part of the outcome measure If undergoing bronchoscopy | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Invasive Aspergillosis BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason Patients without fulfilling criteria Patients with some contraindication to perform a bronchoscopy | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 16.0-999.0, Cytomegalovirus Infection Age 16 years or older cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor Patient Informed consent Prepared to undergo additional study procedures as per study schedule Patient has undergone counselling about risk Donor engraftment (neutrophils > 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein Healthy, Cytomegalovirus (CMV)seropositive donor Pregnant or lactating women Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae Human immunodeficiency virus infection Active acute Graft versus Host Disease (GVHD) > Grade I (to be assessed prior to CMV-specific T cell infusion ) Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion ) Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by creatinine > 200 uM/l bilirubin > 50 uM/l alanine transferase > 3x upper limit of normal Donor pregnant or lactating | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Infections, Cytomegalovirus Subjects who the investigator believes that they can and will comply with the requirements of the protocol A pregnant female, 18 years of age or older at the time of study enrolment Women with confirmed primary CMV infection Written informed consent obtained from the subject Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product Previous vaccination against CMV infection Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination Major congenital defects, serious chronic illness or organ transplantation Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy Documented Human immunodeficiency virus (HIV)-positive subject Gestational age of more than 34 weeks, as determined by foetal ultrasound | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-60.0, Mycoplasma Pneumonia Confirmed community acquired pneumonia 60ys≥age≥18 ys Respiratory symptom (cough accompanied by little or no sputum) New infiltration showed by chest radiology(x-ray or CT) Lung signs was not obvious White blood cell<10,000/mm3 Without underlying diseases or mild Age<18ys or >60ys Pregnancy or breast-feeding Over one week after the onset of symptoms HIV infection Recent 90-day hospitalized history(length of stay greater than 2 days) Live in nursing homes or rehabilitation hospitals Taken macrolides or quinolones medicines before enrollment | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.5-6.0, Infections, Respiratory Tract Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol A male or female child between, and including, six to 72 months of age at the time of enrolment Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject No antibiotic therapy within four weeks prior to the visit No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome No documented evidence or suspicion of gastroesophageal reflux disease No evidence of an upper viral respiratory infection four weeks prior to the visit In addition, all subjects regarded as 'cases' must satisfy all the following at study entry Persistent cough greater than eight weeks No response to five-day prednisolone treatment Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Child in care | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Drug Safety Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC ≤ 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Congenital Cytomegalovirus Infection Maternal Cytomegalovirus Infection Diagnosis of primary maternal CMV infection on the basis of one of the following A positive CMV Immunoglobulin M (IgM) antibody and low-avidity maternal CMV Immunoglobulin G (IgG) antibody screen Evidence of maternal seroconversion with development of CMV IgG antibody following a prior negative CMV screen Gestational age at randomization no later than 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound; or no later than 27 weeks 6 days for women with a positive IgM, negative IgG initially screened before 23 weeks who are rescreened after 2-4 weeks and have evidence of IgG seroconversion Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 14 weeks by project gestational age is acceptable Maternal CMV infection pre-dating pregnancy as defined by a high IgG avidity index or a positive IgG in the presence of a negative IgM Known hypersensitivity to plasma or plasma derived products Planned termination of pregnancy Known major fetal anomalies or demise Maternal Immunoglobulin A (IgA) deficiency Planned use of immune globulin, ganciclovir, or valganciclovir Maternal renal disease (most recent pre-randomization serum creatinine ≥ 1.4 mg/dL; all women must have serum creatinine measured during the pregnancy and prior to randomization) Maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications) Findings on pre-randomization ultrasound suggestive of established fetal CMV infection (cerebral ventriculomegaly, microcephaly, cerebral or intra-abdominal calcifications, abnormalities of amniotic fluid volume, echogenic bowel or ascites). Abnormally low amniotic fluid volume is defined as no fluid prior to 14 weeks or maximum vertical pocket < 2 cm on or after 14 weeks gestation. Abnormally high amniotic fluid volume is defined as > 10 cm Positive fetal CMV findings from culture (amniotic fluid) or PCR | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Patients Scheduled for Bronchoscopy Patients undergoing Fiberoptic Bronchoscopy for any indication and signing an informed consent form Hypoxemia < 90% at Room air | 2 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-55.0, Respiratory Disorders Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests nd cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The investigator may discuss with GSK medical monitor as required Male or female between 18 and 55 years of age inclusive: A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit Normal creatinine clearance values at screening (calculated from serum creatinine by a predicting equation using Cockcroft-Gault formula), normal serum creatinine value as defined by the local reference laboratory, normal urine microscopy and no significant proteinuria on dipstick testing Body weight greater than and equal to 50 kg and BMI within the range 19 9 kg/m2 (inclusive) No evidence of previous or active TB infection and a negative QuantiFERON TB Gold test taken within 7 days of dosing, and negative medical history with respect to active or latent mycobacterium tuberculosis complex infection Normal spirometry (FEV1 greater than and equal to 85% of predicted, FEV1/FVC ratio greater than and equal to 70%) at screening. Predictions should be according to ECCS equations, and race corrections should be made for non-caucasians Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Available to complete all study assessments Subjects who are able to use the inhaler device correctly A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones) A positive pre-study drug/alcohol screen History of and/or a positive test for toxoplasmosis consistent with active toxoplasmosis infection at the time of enrollment A positive RT-PCR test for influenza A/B Current evidence or history of an influenza-like illness as defined by fever (greater than 380C) and two or more of the following symptoms within the last 7 days: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhoea in the absence of a known cause, other than influenza Corrected QT interval (QTc) >450msec History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits Subjects with a smoking history of greater than 5 cigarettes per day in the last 3 months (Part 1); smokers are not eligible to take part in Part 2 | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Cytomegalovirus Each patient must satisfy at least one of the following The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection Patient must also satisfy at least one of the following The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant Or c. The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000μl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance ≤ 60 ml/min/1.73 m2 or serum creatinine > 2 mg/dl]) Patient has CMV specific T-cells from the donor of his/her HSCT available. CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect for this protocol Patients must meet the following clinical to receive CMVpp65-CTL infusions Stable blood pressure and circulation, not requiring pressor support Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography A life expectancy of at least 3 weeks, even if requiring artificial ventilation Patients requiring high doses of glucocorticosteroids (≥ 0.3 mg/kg prednisone or its equivalent) 2. Patients who are moribund 3. Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion 4. Patients who are pregnant 6.1.3 Donor 6.1.3a Donors in Group 1 (Historical Donors) Donors in Group 1 (Section 5.1) would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 11-130. There are no additional requirements for these donors 1.3b Donors in Groups 2 & 3 (Prospective and Volunteer Donors) Transplant donors and healthy HLA typed volunteers who agree to provide T-cells for Third-party donation (section 5.1, Groups 2 and 3) will need to meet the following requirements prior to donation Donors must satisfy the specified in FDA 21 CFR 1271 Donors must be typed for HLA-A, B, C and DR Donors must have a hemoglobin value > 10g/dl Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood 1.4 Donor HTLV/HIV(+) or Hepatitis B or C antigen(+) donors | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 13.0-49.0, Influenza, Human HIV Malaria Tetanus Polio Resident of HDSS village Singleton pregnancy Second or third trimester (after quickening) but before 33 weeks of gestation by fundal height Does not plan to relocate out of the HDSS area or population-based surveillance site in the next 12 months and agrees to all follow-up visits/contact by phone Is not currently enrolled in another intervention study Provides informed consent by signature or thumb print Consents to HIV testing and counseling as required Willing to deliver in the labor ward of the study hospital No history of chronic illness requiring multiple hospitalizations or prolonged medical therapy (except HIV on ART) History of allergic reaction to any component of the study vaccines Residence outside the study area or planning to relocate out in the 9 months following enrollment Received immunoglobulin or blood products within 45 days of study entry Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted) High risk pregnancy including any pre-existing condition likely to cause complications of pregnancy (hypertension, diabetes, current asthma, eclampsia or pre-eclampsia, epilepsy, heart disease, renal disease, liver disease, fistula repair, leg or spine deformity) Unable to give informed consent (for example due to mental disability) Previous enrollment in a study with similar interventions Gestational age >32 weeks by last menstrual period or fundal height Acutely ill with temperature ≥37.5°C on the day of randomization/vaccination Hemoglobin <7.0 g/dL | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Aplastic Anemia Main diagnosis: aplastic anemia Absence of severe and/or uncontrolled comorbidities Confirmed iron overload (serum ferritin ≥ 1000 mkg/L) Serum creatinine is not higher than the upper limit of normal for the given age Absence of severe proteinuria. Protein/Creatinine ratio should be < 0.5 mg/mg Liver enzymes are < 5 ULN Completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications WHO (ECOG) performance status ≤ 2 No signed informed consent form Patient is under 18 years old Severe concomitant condition Severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment History of increased sensitivity to active substance and any other ingredient of the medicinal product Creatinine clearance (CC) < 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at Visits 1 and 2 Severe liver disorders (class C by Child-Pugh scale) Patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease Significant proteinuria basing on protein creatinine ratio > 1.0 mg/ml in urine sample from second urination at Visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening) Rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Infection in Solid Organ Transplant Recipients Informed consent Male/female patients at least 18 years old who will be followed at our outpatient clinic for at least one year Recipients of first or repeat kidney transplants from living or deceased donors Recipients of any combined transplant (kidney/pancreas, kidney liver) Unlikely to comply with the requirements of the study | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-80.0, Postoperative Complications Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded Lost to follow up | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 20.0-999.0, Allogeneic Hematopoietic Cell Transplant Subject is planned to undergo either of the following Sibling Donor Transplant 8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing Unrelated Donor Transplant 8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS) Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3 Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA) Subject has received any of the following substances or treatments T-cell depletion of donor cell product Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial Administration of a CMV vaccine, including any prior exposure to ASP0113 Subject has received an allogeneic stem cell transplant within one year prior to transplant Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, EBV Infection CMV Infection Adenoviral Infection Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or single or double umbilical cord blood CMV, adenovirus or EBV infection persistent despite standard therapy For CMV infection Patients with CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates OR Failure of antiviral therapy: defined as the continued presence of pp65 antigenemia (>1+ cell/100,000 cells) or DNAemia (as defined by reference lab performing PCR assay but usually >400 copies/ml) after at least 7 days of antiviral therapy OR Relapse after antiviral therapy defined as recurrence of either pp65 antigenemia or DNAemia after at least 2 weeks of antiviral therapy For CMV infection, standard therapy is defined as 7 days therapy with Ganciclovir, Foscarnet or Cidofovir for patients with disease or recurrence after 14 days therapy For EBV infection EBV infection is defined as Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR OR Received ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment Uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection Received donor lymphocyte infusion (DLI) within 28 days Active acute GVHD grades II-IV Active and uncontrolled relapse of malignancy Pregnant or lactating in female patients, if applicable (childbearing potential who have received a reduced intensity conditioning regimen) | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 16.0-90.0, Kidney Transplantation Recipients age 16 or more agree with written informed consent donor CMV IgG (+) and recipient CMV IgG (-) | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 16.0-99.0, Bone Marrow Transplantation age 16 or more agree with written informed consent | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Cytomegalovirus Kidney Transplantation CMV Specific Immune Response Patient receiving a kidney graft Recipient being CMV-seropositive prior transplantation and receiving a graft from either a CMV-seropositive or from a seronegative donor (intermediate risk groups, D+/R+; D-/R+,) Patient scheduled to follow the preemptive antiviral strategy with oral valganciclovir or intravenous ganciclovir after transplantation Patient receiving the standard triple immunosuppressive regimen (CNI, MMF/MPA or mTOR inhibitors, steroids), with or without induction therapy (except ATG) as start therapy after transplantation Male or female patient at least 18 years of age Written informed consent Patient is scheduled for the optional visit 1, but requires ongoing treatment with a systemic immunosuppressive drug already prior to kidney transplantation (except induction therapy other than ATG) Patient receiving ATG as induction therapy Patient is known to be positive for HIV or suffering from chronic hepatitis infections Patient has significant uncontrolled concomitant infections or other unstable medical conditions before transplantation that could interfere with the study objectives Patient is unable to comply with the visit schedule in the protocol Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, CMV Infection Persistent CMV Viremia Each patient must satisfy at least one of the following The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection Patient must also satisfy at least one of the following The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant Or c. The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000μl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance ≤ 60 ml/min/1.73 m2 or serum creatinine > 2 mg/dl]) CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect for this protocol Patients must meet the following clinical to receive CMVpp65-CTL infusions Stable blood pressure and circulation, not requiring pressor support Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography Patients requiring high doses of glucocorticosteroids (≥ 0.3 mg/kg prednisone or its equivalent) Patients who are moribund Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion Patients who are pregnant Donors in Group 1 (Historical Donors) Donors in Group 1 would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 11-130. There are no additional requirements for these donors Donor (Prospective Donors) Transplant donors and healthy HLA typed volunteers who give written consent to provide Tcells for Third-party donation (section 5.1, Groups 2 and 3), will need to meet the following requirements prior to donation Donors must satisfy the specified in FDA 21 CFR 1271 Donors must be typed for HLA-A, B, C and DR at high resolution Donors must have a hemoglobin value > 10g/dl Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Viral Pneumonia mechanical ventilation > 96 hrs and expected duration of mechanical ventilation of at least 2 days positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR age > 18 years informed consent negative pregnancy test < 18 years Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV Had received antiviral agent active against HSV/CMV during the previous month Hypersensitivity to aciclovir/ganciclovir Pregnancy Breast feeding Bone marrow failure Solid organ recipients Bone marrow recipients HIV positive patients | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-80.0, HIV COPD Pulmonary Disease Aging Pregnancy or breast-feeding Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.) Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry Hospitalization within 4 weeks prior to study entry Uncontrolled hypertension at screening visit (systolic > 160 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled Active cancer requiring systemic chemotherapy or radiation Active infection of lungs, brain, or abdomen Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator HIV+ young HIV-1 infection, documented in medical record at any time prior to study entry Men and women age 45 years and below Ability and willingness to complete all tests Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community HIV+ old HIV-1 infection, documented in medical record at any time prior to study entry Men and women age 50 years and above Ability and willingness to complete all tests Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Cytomegalovirus Infection GVHD Patients receiving an allogeneic hematopoietic stem cell transplantation being either CMV seropositive or receiving a graft from a CMV seropositive donor or both, donor and recipient are CMV seropositive (D+/R-, D-/R+, D+/R+) Patients receiving a first allogeneic hematopoietic stem cell graft Patient at least 18 years of age Written informed consent Seronegativity for CMV both for patient and donor (D-/R-) Patients receiving standard anti-CMV prophylaxis Patients receiving a haploidentical allogeneic hematopoietic stem cell graft Patients receiving an umbilical cord blood graft Patients treated with Alemtuzumab (e.g. Campath) Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator Lack or withdrawal of informed consent Patient is unable to comply with the visit schedule in the protocol | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Transplantation Infection Cytomegalovirus Infection Age ≥ 18 years End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug Total ischemia time below 36 hours Capable of understanding the purpose and risks of the study Fully informed and having given written informed consent (signed Informed Consent has been obtained) Affiliation to the social security regimen CMV seronegative patient Historical or current TGI (French equivalence of calculated PRA) > 85 % Presence of historical or current anti-HLA donor specific antibodies Patient who received anti-CMV therapy within the past 30 days prior to screening Receiving or having previously received an organ transplant other than a kidney Receiving a graft from a non-heart-beating donor Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients Severe hyperlipidemia defined by: total cholestérol ≥ 9,1 mmol/L (≥ 350 mg/dL) et/ou triglycérides ≥ 8,5 mmol/l (≥ 750 mg/dL) in spite an adequate medication | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Cytomegalovirus Viraemia Adult solid organ transplant (SOT) recipient on at least one immunosuppressive medication Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new onset CMV disease CMV viral load ≥ 1000 IU/mL Known ganciclovir-resistant CMV Known intolerance to valganciclovir or ganciclovir Unable to comply with protocol | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 2.0-59.0, Dengue Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age Agree with periodic contacts, either/or by phone, electronic means, and home visits Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study History of asplenia Use of any investigational product within 28 days before or after receiving this study vaccination Has participated in another clinical trial six months prior to in the study or planning to participate in another clinical trial within 2 years following inclusion Use of immunosupressant drugs such as: antineoplastic chemotherapy, radiation therapy, imunossupressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for use of corticosteroids 3 months prior to the in the study and 6 months prior to the for the other therapies mentioned, and planned use of any immunesupressant therapy within 2 years following in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥20 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 2.0-25.0, Quadrivalent Live Attenuated Influenza Vaccine Age 2-25 Only supposed to get one dose of vaccine for upcoming influenza season No viral respiratory symptoms at time of immunization HIV-infected group: must have HIV-infection documented by 2 tests such as positive serology, positive HIV DNA or positive HIV RNA; must thave a CD4>25% or 500 OR must have CD4>15% or 200 and be on HAART Healthy controls:no major medical problems affecting the immune system Recruited among HIV-unifected clients of the Children's Immunodeficiency Program(CHIP), Children's Hospital Colorado Child Health Clinic and Adolescent Clinics History of reactive airway disease, recurrent wheezing, or asthma Active wheezing at time of immunization On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir, oseltamivir)at time of immunization or planned over 21 days of shedding collection Receipt of IVIG within 3 months prior to enrollment Plan to receive IVIG during the 4 weeks after immunization Moderate to severely immunocompromised individual living in the home Pregnant Breastfeeding Plan to start immunosupressive medications or stop HAART over the 4 weeks following immmunization Temperature > 100F or 37.8C | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 20.0-70.0, CYCLOSPORINE/TACROLIMUS Patients who received a kidney transplant at least 12 months ago prior to enrollment Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial Patients who are considered clinically stable by observer's judgment Patients must understand the purpose and risk of participating the the trial and signed on the written consent Patients who have previously received an organ transplant other than a kidney Patients diagnosed with congestive heart failure within 6 months (EF <35%) Patients with untreated ischemic heart disease Patients whose hemoglobin is in the level of <7.0 g/dL Patients who have a known hypersensitivity to tacrolimus Patients taking potassium sparing diuretics Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer Patients who are pregnant or lactating | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-80.0, Bronchiectasis Age≥18 years and ≤80 years Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT Are sensitive to amikacin Acute exacerbation of bronchiectasis Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc Willing to join in and sign the informed consent form Active bleeding without control； Receiving nasal or facial surgery recently； With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc Be allergic to amikacin | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Cardiac Surgery Patients admitted for cardiac surgery Age 18 and above Immunosuppressed patients including: HIV, active cancer, biological chemotherapy, steroid use equivalent to prednisone dosage above 1 mg/Kg a day, post organ transplantation | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 0.0-999.0, Viral Infection Viral Reactivation Infection in an Immunocompromised Host Immunocompromised patient with evidence of viral infection or reactivation Age >1 day Recipients who have had a stem cell transplant must be greater than 28 days after stem cell infusion Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent Must be able to receive CTL infusion at CCHMC Informed consent obtained by PI or sub-investigator at CCHMC Active acute GVHD grades II-IV Uncontrolled bacterial or fungal infection Uncontrolled relapse of malignancy Infusion of ATG or alemtuzumab within 2 weeks of CTL infusion | 1 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 51.0-76.0, HRV and RSV Presence in the Lungs of Stable COPD Patients. stable COPD,indication for bronchoscopic procedure atopic history, asthma, extensive pleural effusions, bronchiectasis, immunosuppression due to chemotherapy or systemic corticosteroids and all the contraindications of the bronchoscopic procedures | 0 |
A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. | eligible ages (years): 18.0-999.0, Renal Failure Chronic Requiring Dialysis Patient being hemodialysis-dependent due to end-stage kidney disease Male or female patient at least 18 years of age Written informed consent Patient requires ongoing dosing with a systemic immunosuppressive drug Patient has received immunosuppressive therapy within the last three month Patient is known to be positive for HIV or suffering from chronic hepatitis infections Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-999.0, Cancer The patient must be at least 18 years of age (because of the nature of "Dignity Psychotherapy," which presumes a relatively advanced level of social and psychological development) Have a terminal illness (Stage IV with a prognosis of less than 6 months, but expected to live at least 7 to 10 days, i.e. the average length of the protocol) Must be able to identify a family member/significant other who agrees to participate in the study (in the case of "Dignity Psychotherapy," this family member/significant other will receive the generativity document) Be able to communicate with an English-speaking therapist (patients who are visually impaired will be offered assistance with the consent forms and surveys) In the investigator's judgement, participant is cognitively able to provide valid, informed consent Significant psychiatric disturbance sufficient to preclude participation in a psychotherapeutic intervention (e.g. acute, severe psychiatric symptoms which would require individual treatment and medication management rather than a psychotherapy intervention) Active psychotic mental disorder (e.g. schizophrenia, acute mania), or marked paranoid ideation. Patients who are on stable regimens of psychotropic medications (e.g. antidepressants for clinical depression) or who are in concurrent individual or group psychotherapy will not be excluded. This information regarding concurrent psychiatric treatment will be collected and utilized as a co-variate in data analysis Presence of a cognitive disturbance (i.e. delirium or dementia) sufficient to preclude participation in psychotherapy, and/or data collection Physical limitations or illness severity sufficient to preclude participation in psychotherapy | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 12.0-65.0, Generalized Convulsive Epilepsy Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic clonic seizures on awakening must be included Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1 Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit 1 Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1 Previous exposure to levetiracetam History of partial seizures History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1 Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet Subject taking any drug (except the concomitant AEDs) with possible CNS effects | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Cognitive Impairment Delirium years of age or older Hospitalized in a medical ward Able to speak English Cognitive impairment based on screening at time of hospital admission Previously enrolled in the study during prior hospitalization (for multiple admissions; only data from the first admission will be used) Enrolled in another clinical trial Does not have cognitive impairment based on screening at time of hospital admission | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-999.0, Creutzfeldt-Jakob Disease Diagnosis of probable or definite sCJD: Definite--biopsy confirmed sCJD; Probable--a progressive dementia with either a typical EEG or a typical MRI consistent with sCJD, and at least two of the following clinical features: myoclonus, pyramidal or extrapyramidal signs, visual symptoms, cerebellar signs, akinetic mutism, other focal higher cortical neurologic signs (e.g. neglect, apraxia, aphasia) years of age or older Able to swallow Able to follow simple one-step commands Have had a brain MRI within 6 months and an EEG within 3 months ruling out other etiologies such as masses, strokes, or non-convulsive status epilepticus Consent to autopsy in the event of their death during or after the study History of other significant or life-threatening disease, including: cancer; end-stage liver or renal disease; severe heart disease History of other disease requiring regular supportive care Liver disease Active alcoholism Bone marrow suppression Severe hypotension Severe psoriasis Poorly controlled diabetes Women who are pregnant or breast-feeding Men, or women of childbearing age, not practicing reliable contraception | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Alzheimer's Disease Dementia Alzheimers Disease Inability to understand English No telephone | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 1.0-18.0, Congenital Disorders Any patient between 1 – 18 years of age (inclusive) Any patient with end stage heart disease Treated at Egleston Hospital, Children's Healthcare of Atlanta Followed by Sibley Heart Center Cardiology Those who do not meet | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Depression Meets Diagnostic and Statistical Manual for Mental Disorders(DSM)IV for unipolar major depression Severity of depression greater than or equal to 17 on MADRS Disability as determined by at least 1 impairment in instrumental activities of daily living Evidence of executive dysfunction or impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory ([scaled score less than 7] adjusted for age and race based on Mayo's older participants normative data) Family member or caregiver able and willing to participate in treatment Not currently taking antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 8 weeks prior to study entry with no medical recommendation for change of these agents in the near future High suicide risk Axis I psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression Axis II diagnosis of antisocial personality Moderate to severe dementia: DRS total score corresponding to moderate or more severe impairment (scaled score less than or equal to 5) Acute or severe medical illness (e.g., delirium; metastatic cancer; decompensated cardiac; liver or kidney failure; major surgery; stroke; myocardial infarction during the 3 months prior to entry) Currently taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids) Currently receiving psychotherapy Aphasia Sensory problems Inability to speak English | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 40.0-83.0, Alzheimer's Disease Memory Decline Alzheimer's disease other neurologic disease | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 50.0-85.0, Alzheimer Disease Diagnosis of AD Age 50-85 MMSE 14-26 Other Apply Significant Neurological Disease Major Psychiatric Disorder Clinically Significant Systemic Illness Other Apply | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 30.0-80.0, Frontotemporal Dementia Pick Complex Outpatients with a clinical diagnosis of Frontotemporal Dementia or Pick Complex (PC/FTD) documented for at least 1 year with either primary progressive aphasia or frontotemporal dementia recent MRI or CT confirming frontotemporal lobar atrophy consistent with Frontotemporal Dementia or Pick Complex PC/FTD opportunity to perform certain activities of daily living as described in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory living with or having regular visits (least 4 days/week) from a responsible caregiver Mini Mental State Examination score > 5 and the ability to complete baseline neuropsychometric testing able to see, hear, and communicate sufficiently, and willing to complete serial neuropsychometric tests female subjects of childbearing age must be surgically sterile or practicing an effective method of birth control before entry and throughout the study No neurodegenerative disorders and other causes of dementia or cognitive impairment from acute cerebral injuries, cerebrovascular disease or hypoxic cerebral damage, vitamin deficiency states, infection cerebral neoplasia no primary memory disturbance or an amnestic syndrome more compatible with Alzheimer's disease or other primary degenerative dementia no uncontrolled epilepsy or clinically significant psychiatric disease, cardiovascular disease, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, active peptic ulcer and urinary outflow obstruction no use of any agent used for the treatment of dementia or other cognitive impairment no history of severe drug allergy or hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Dementia 65 years of age or older Diagnosed with dementia by a physician Mini-Mental State Examination score of 23 points or less Capable of participating at least once a week for 6 weeks in succession Management of a medical risk required Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis Never having been on a bicycle, and incapable of pedaling well | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 0.0-999.0, Dementia GP and practice or district nurse must participate as a duo | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 60.0-999.0, Dementia Behavioral Symptoms Mental Health All probable cases will be examined by a trained clinician (AD) to confirm the diagnosis of dementia according to DSM IV and graded using the Clinical Dementia Rating (CDR) Scale CDR mild and moderate dementia The principal caregiver, as identified by the family, was enrolled for the trial. The principal caregiver was generally the spouse, although in some instances another family member was the principal caregiver, particularly when the spouse was not in a position to care CDR severe dementia or severe co-morbid physical health conditions | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 50.0-999.0, Alzheimer's Disease Patients in the mild to moderate stages of Alzheimer's Disease : MMSE score between 16 and 26 ; and stages 3 to 5 of the Global Deterioration Scale Patients over 50 years of age Patients with social security affiliation Patients suffering other type of dementia Institutionalized patients Patients with psychiatric disorder Patients with severe pathology in the terminal stages Patients receiving non pharmacological therapies other than that proposed in the study Enrollment in a pharmacological trial in the first 6 months | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Dementia Participated in the WHIMS study Non-English speaking Hearing Impaired | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 0.0-999.0, Dementia Patients with memory or other cognitive impairments suggestive of dementia syndrome those with a formal diagnosis of dementia, of any type Patients and carers who are already involved in concurrent research If the key professional feels that an approach to the person with dementia or their carer would be inappropriate, for example the dementia is very severe, or that an approach may increase distress and any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 40.0-999.0, Alzheimer's Disease Dementia AD group Male or female patient, aged ≥ 40 years old included at entry Patients having a clinical diagnosis of probable AD according to DSM-IV TR [F00.xx] and National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the AD diagnosis, and that the results are compatible with AD diagnosis Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD Patient compliant with study procedures Non AD demented group Male or female patient, aged ≥ 40 years old included at entry Patients having a clinical diagnosis of dementia which can be one of the following AD group Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of probable AD, or that may rend the initial diagnosis of probable AD doubtful at entry, according to the opinion of the investigator Current or recent history of drug or alcohol abuse or dependence Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting AD diagnostic and not affecting daily living activities Current diagnosis of brain tumour Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator Pregnancy Patient who is not registered at "Sécurité Sociale" Current participation in another study using an investigational non-marketed product Non-AD demented group | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 51.0-999.0, Alzheimer Disease Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease Mini-Mental Status Examination (MMSE) >=10 at screening Caregiver able to attend all clinic visits with subject Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response Any significant brain MRI abnormality Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Dementia dementia diagnosis advanced cognitive impairment feeding problem age >= 65 surrogate decision maker feeding tube decision made hospice BMI > 26 major psychosis or developmental delay | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 52.0-87.0, Alzheimer's Disease Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all and non of the Screening brain MRI scan is consistent with the diagnosis of AD MMSE score 10 and above Significant neurological diseases other than AD Brain MRI evidence of vasogenic edema during the preceding studies Clinically significant illness | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-999.0, Advanced Cancer FOR Able to speak and understand English Over age 18 NEW diagnosis, recurrence, or progression of an advanced stage cancer within days of the date the patient was informed of the diagnosis by his/her oncology clinician Estimated survival of 2 years or less Diagnosed with an advanced stage cancer such as one of the following Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell Breast Cancer: Stage IV with poor prognostic indicators including but not limited to: a) >2 cytotoxic regimens for MBC; b) diagnosis of MBC less then or equal to 12 months since completion of adjuvant or neoadjuvant treatment; c) triple negative disease (ER/PR and Her 2-);d) parenchymal brain mets and/or carcinomatous meningitis Gastrointestinal (GI) Cancers: Unresectable stage III or IV Dementia or significant confusion (Impaired cognitive status as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool 18) Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder) Patients will not be excluded if they do not identify a caregiver Prior involvement with palliative care service within the last year Minimum predicted survival of less than 12 weeks (3 months) Receiving chronic steroid hormones or unable to schedule specimen collection distant from chemotherapy from steroid pre-medications Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times Unwilling to participate in study | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Gait Apraxia Alzheimer Disease Impaired Cognition Diagnosis of Alzheimer's disease (AD) (DSM-IV/NINCDS-ADRDA criteria) Age ≥ 65 years old Mild AD (Mini-Mental State Examination score between 21 and 25), moderate AD (Mini-Mental State Examination score between 10 and 20) and severe AD (Mini-Mental State Examination score between 3 and 9) Able to walk without any aid on 15 meters Near visual acuity ≥ 2 Absence of severe depression (score of the 15-item Geriatric Depression Scale ≤ 10) Written consent form to participate in the study (or trustworthy person or legal representative for severe AD) Being affiliated to a social security regime Musculoskeletal disorders not related to Alzheimer's disease Near visual acuity < 2 History of cerebrovascular accident or other cerebro-spinal pathology Poor workmanship of the written or oral French language Refusal to be informed on possible hanging bare anomaly during study Score of Mini-Mental State Examination < 3 Presence of severe depression (score of the 15-item Geriatric Depression scale > 10) Use of walking aid Subject suffering from pre-existing impellent disturbances Refusal to participate (or trustworthy person or legal representative) | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 60.0-999.0, Alzheimer's Disease Clinical diagnosis of Alzheimer's Disease MMSE score of 14-26 Visual impairment Auditory impairment Psychiatric disorders | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 70.0-75.0, Dementia Alzheimer Disease Vascular Dementia to be resident in Abbiategrasso to be born between 1935 and 1939 to refuse to participate te be not contactable in any way (mail, telephone) to be legally resident, but actually living somewhere else | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Depression Dementia Geriatrics Age: >64 (65 years and older) Diagnosis: Major depression, unipolar as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID), using Diagnostic and Statistical Manual for Mental Disorders (DSM)IV criteria Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18 Disability, i.e. impairment in at least 1 Instrumental Activity of Daily Living as measured by Philadelphia Multilevel Assessment Instrument Instrumental Activities of Daily Living subscale (MAI-IADL) Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive) Caregiver (family member or professional) able and willing to participate in treatment Off antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 12 weeks and no medical recommendation for change of these agents in the near future Command of English sufficient to participate in therapy and research assessments High suicide risk, i.e. intent or plan to attempt suicide in near future Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria) Moderate to Severe Dementia: We will participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total <=90) Acute or severe medical illness (i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry); drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids); or chronic addictive drug use Current involvement in psychotherapy Aphasia | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-999.0, Dementia for Veterans with dementia English speaking diagnosed with dementia as above able to participate in at least two activities of daily living ADLs bathing dressing grooming toileting transferring from bed to chair Non English speaking Non-Veteran No caregiver No diagnosis of dementia | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 0.0-999.0, Mild Cognitive Impairment Clinical diagnosis of Mild Cognitive Impairment Clinical diagnosis of dementia History of neurological conditions known to impair cognition History of alcohol or drug abuse History of chronic psychiatric illness Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15) | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Dementia Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia Non-related legal surrogate without personal knowledge of resident | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-999.0, Alzheimer's Disease Dementia Family Caregivers to be a family caregiver of an person diagnosed with possible or probable Alzheimer's disease or other advanced stage dementia show interest in participating Sign informed consent Alzheimer's or dementia person to have a probable or possible Alzheimer type dementia or other advanced dementia according to a diagnosis done by a Specialized Evaluation Unit GDS 5-6 and a minimental equal or lower than 12 to preserve a verbal comprehension of basic instructions to preserve the mobility of the arms, as well as the visual and auditive capacities that allow to conduct the activities Caregivers to have a negative attitude towards the emotional interaction with his/her Alzheimer or dementia family member Unavailability to participate in other socio-educative interventions during the study period Any other situation that makes the caregiver as not suitable according to investigator's Alzheimer's or dementia person Do not have the sensorial or motor capacities needed for the interaction Serious impairment of the verbal comprehension Disabling health conditions | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 50.0-999.0, Alzheimer's Disease, Mild to Moderately Severe Stages of AD Community Dwelling Patients With Family Caregiver Quality of Life patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26) in community dwelling with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week) is informed and has given his/her consent whom caregiver is informed and has given his/her consent patient with other type of dementia living in nursing home or long term care with no caregiver not informed or has not given his/her consent whom caregiver is not informed or has not given his/her consent | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-999.0, Critical Illness Chronic Disease Terminal Care Palliative Care Communication Advance Care Planning Neoplasm Metastasis Lung Neoplasms Pulmonary Disease, Chronic Obstructive Heart Failure End Stage Liver Disease Kidney Failure, Chronic Eligible primary clinicians will all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also nurse practitioners and physician assistants playing a "primary role" with eligible patients. A "primary role" denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated Eligible interprofessional team members will nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values <35% predicted or oxygen dependence or restrictive lung disease with a TLC < 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of >17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of < 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness. Additional PAH w. 6MWD <250m, restrictive lung disease (IPF, ILD) w/ TLC <50%, and cystic fibrosis with FEV1 < 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, "family member" is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires Reasons for for all subject groups legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 0.0-69.0, Frontotemporal Dementia Alzheimer's Disease. Debut of dementia symptoms before the age of 65 years, but age at time of may be up to 70 years FTD (Neary et al 1998 criteria) Primary progressive aphasia (Mesulam 2003 criteria) AD (DSM-IV) Community living, excl. dementia-specific living facilities manned 24/7 Family member with regular contact at least x 1/week Lack of informed consent No close or appropriate family member Frontal lobe dysfunction due to non-progressive injury, i.e. cerebral infarction Frontal lobe dysfunction due to motor neuron disease (ALS) Other dementia specific condition with frontal lobe dysfunction (Huntington, HIV, Down syndrome, alcoholic dementia) Mental retardation Current substance abuse, incl. excessive alcohol consumption for the past 12 months | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 55.0-999.0, Family Member Men and women ages 55 years and over English or Spanish speaking Interest in participating in a novel nutritional supplement program Willingness to follow recommendations, including going off of all vitamin-D and calcium containing supplements, multivitamins, or OTC medications (e.g., Tums) 2 weeks before starting the study and during the intervention Scoring 0-2 errors on the Short Portable Mental Status Questionnaire Less than 55 years of age Currently enrolled in another research trial for vitamin D dietary supplements or other bone disease treatments Unable to consent to the study Living in a skilled or intermediate care level nursing facility Women who are pregnant, during their period, or less than 2 days before or after their period at the time of the assessment Psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence Bleeding disorders Aphasia or sensory, motor, and/or visual disturbances that could interfere with assessments, including inability to walk 10 feet without a walking aid Gastrointestinal disorders that could lead to uncertain resorption of the study supplements Major conditions such as neurologic, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint that could interfere with vitamin D metabolism, psychometric tests, or body composition assessment (especially renal and heart failure) | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 0.0-999.0, End Stage Heart Disease Heart Failure Ability to speak Cantonese Living within the hospital service area Ability to be contacted by phone Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below (i) Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy Discharged to nursing home or other institution Inability to communicate Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 1.0-16.0, Dravet Syndrome Onset of seizures in the first year of life History of fever-induced prolonged seizures as determined by the Investigator These may prolonged (approximately 15 minutes or longer) hemi-clonic seizures Multiple seizure types which may generalised tonic-clonic (required for inclusion) clonic (required for inclusion) myoclonic jerks/seizures history of normal development prior to seizure onset followed by development delay or regression after seizure onset abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy Other protocol-defined and | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 1.0-16.0, Dravet Syndrome The and for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below The patient has a diagnosis of Dravet Syndrome supported by onset of seizures in the first year of life history of fever-induced prolonged seizures as determined by the Investigator these may prolonged (approximately 15 minutes or longer) hemi-clonic seizures multiple seizure types which may generalised tonic-clonic (required for inclusion) clonic (required for inclusion) myoclonic jerks/seizures history of normal development prior to seizure onset followed by development delay or regression after seizure onset | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 50.0-90.0, Memory Disorders Mild Cognitive Impairment Aging Age > 50 years old Medical conditions that compromise survival or limit physical activity Geriatric Depression Scale-15 score of 6 or higher Alcohol intake > 4 units/day Mini Mental State Examination < 24 Clinical Dementia Rating score of 1 or more | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-100.0, Dementia dementia, controls(lumbar puncture at our department) <18år other CNS disease | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-80.0, Parkinson Disease for Parkinson disease (PD) subjects with freezing of gait (FOG) Diagnosis of PD by United Kingdom Brain bank Hoehn & Yahr stage I-IV Levodopa treated and responsive Able to manage 12 hours off dopaminergic medication Age 18-80 years Presence of FOG by history and seen by examiner at their clinical office visit or in a video taken at home Able sign a consent document and willing to participate in all aspects of the study Able to have an MRI scan (no pacemakers or history of claustrophobia) for Parkinson disease (PD) subjects with freezing of gait (FOG) Dementia that precludes completing study protocol Stage V PD unable to walk independently when "off" History of FOG without ever being seen to have it Atypical parkinsonism: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD), Vascular Parkinsonism Treatment with medications that cause parkinsonism: drug-induced parkinsonism Any neurological or orthopedic disorders that interfere with gait Treatment with medications that will interfere with NET-PET (norepinephrine transporter-positron emission tomography) ligand binding a. Noradrenergic drugs: methylphenidate, atomoxetine, serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine) | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 30.0-80.0, Alzheimer's Disease Dementia 80years old Caregivers who spend their own time with dementia patients over 4 hours a day caregiver distress scores >= 2 caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10~26) illiterate severe hearing/visual acuity difficulty cognitive impairment | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 65.0-999.0, Dementia Alzheimer Disease dementia known comorbid cognitive or neurological impairments | 2 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-75.0, Long QT Syndrome All Individuals Be a nonsmoker or consume < 20 cigarettes per day Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at study screening Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator Screening labs within defined thresholds Individuals with mild, moderate, or severe renal impairment must also meet the following additional to be eligible for participation in this study Must have diagnosis of chronic (> 6 months), stable renal impairment with no clinically significant changes within 3 months (90 days) prior to study drug administration (Day 1) Individuals with severe renal impairment, creatinine clearance (CLcr) must be 15-29 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification Individuals with moderate renal impairment, CLcr must be 30-59 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification Individuals with mild renal impairment , CLcr must be 60-89, inclusive mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors, myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries or a family history of seizures Presence or history of cardiovascular disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection fraction < 40%), cardiac conduction abnormalities, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years Syncope, palpitations, or unexplained dizziness Implanted defibrillator or pacemaker Medical history of renal carcinoma or hepatorenal syndrome Individuals receiving or anticipating use of hemodialysis, peritoneal dialysis, or any other renal replacement therapy or other medical procedure that serves as a surrogate for renal function during the study Individuals with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the individual's renal function will be determined by the investigator Renal allograft recipients Experienced hypertensive crisis, required the addition of ≥1 antihypertensive drug, or required more intensive antihypertensive therapy (eg, addition of a new drug class) in the last 3 months | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 45.0-999.0, COPD ESRD Dementia Age 45 years or older Current hospitalization of at least 3 calendar days Diagnosis of one or more of the following End-stage renal disease (ESRD) on dialysis Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months Patients younger than 45 years old are excluded. The additional workload to screen patients younger than 45 years old is not justifiable given that only an extremely small percentage of people in this age range will have one of the three diagnoses of interest (ESRD, home oxygen dependent COPD, advanced dementia) | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 60.0-999.0, Cognitive Deterioration Subjects with a diagnosis of Alzheimer's disease according to (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007) Score at Mini Mental Test (MMSE) ≥16 Subjects residing in nursing homes Subjects beneficiaries of a social security scheme Signature of free and informed consent Failure to pass the neuropsychological tests because of a sensory or motor deficit Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation Persons deprived of liberty (administrative or judicial) | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 6.0-12.0, Duarte Galactosemia Healthy Children/Children with Duarte Galactosemia Age between 6-12 years Parents/Caregivers Primary caregiver to a child age between 6-12 years of age with/without Duarte Galactosemia Chronic illness Any condition unrelated to Duarte Galactosemia but known to cause developmental problems Children who did not have the current parent/guardian as the primary caregiver when the child was an infant | 0 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 50.0-90.0, Memory Disorders Mild Cognitive Impairment Alzheimer's Disease A diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI due to AD) by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association (Albert et al., 2011) A diagnosis of mild Alzheimer's disease by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association (McKhann et al., 2011) 90 years of age Younger than the age of 50 or older than the age of 90 Any self-reported history of substance abuse or alcohol abuse Any self-reported history of prior head trauma (e.g., stroke, traumatic brain injury) Any prior self-reported history of significant depression or other mood disorder | 1 |
An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word "world" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in | eligible ages (years): 18.0-999.0, Dementia Patients aged 18 years and over Registered with a participating general practice during the study period Minimum one year of records prior to study entry meeting CPRD data quality Followed on or after 1 January 1997 Patients without recorded gender Less than 1 year of follow-up between study entry and date of administrative censoring | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 13.0-999.0, Cryptosporidiosis HIV Infections Patients must have Documented HIV infection Intestinal cryptosporidiosis Willingness to undergo a 1 week washout phase of all anticryptosporidial medications and stabilization on a protocol directed, antidiarrheal regimen Greater than or equal to 4 stools per day, on average, for a minimum of 21 out of 28 days prior to study entry, secondary to cryptosporidiosis AS PER 2/10/97 Four or more stools per day, on average, during the 5-day screening period prior to baseline Co-existing Condition Patients with the following symptoms and conditions are excluded Inability to tolerate oral medications Life expectancy less than 3 months in the opinion of the investigator Active CMV colitis, C. difficile colitis, giardiasis, salmonellosis, shigellosis, campylobacteriosis, inflammatory bowel disease, diarrhea secondary to another documented intestinal pathogen, or active or uncontrolled MAC disease, defined as symptomatic MAC disease and/or a patient who is not on appropriate anti-MAC therapy in the presence of MAC disease NOTE Patients who have been treated for MAC disease for at least 4 weeks and have resolved their symptoms may be enrolled. Patients dually infected with microsporidiosis may be randomized to the study but will not count toward the sample size AS PER 2/10/97 Failure to record a minimum of four days of information on the use of antidiarrheal medication and the frequency of bowel movements in the daily diary during the screening period Allergy to corn or corn products | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, HIV Infections Cytopenias Concurrent Treatment Allowed Minimal local irradiation for tumors Patients must have Diagnosis of AIDS or AIDS related complex (ARC) Neutropenia, due either to zidovudine (AZT) or HIV infection Life expectancy = or > 6 months Co-existing Condition Patients with the following conditions or symptoms are excluded Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following Serum carotene less than 75 IU/ml Vitamin A level less than 75 IU/ml More than 4 foul-smelling or greasy stools per day Other of malabsorption Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection Concurrent Medication | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, HIV Infections Cytopenias Patients must have Serum antibody to HIV with or without evidence of HIV antigenemia White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week Qualifying indications for AZT therapy Life expectancy = or > 6 months Co-existing Condition Patients with the following conditions or symptoms are excluded Current or past history of malignancy including Kaposi's sarcoma Excessive diarrhea or significant malabsorption If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO) Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP) Active OI requiring systemic treatment Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia Concurrent Medication | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Protozoan Infections HIV Infections Concurrent Medication Required If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks Allowed Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization Patients must have HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization Average of > 3 liquid bowel movements per day over 7 consecutive days immediately prior to randomization, with an average volume > 500 ml per day over three or more consecutive days immediately prior to randomization, as documented by data collected in a daily diary. NOTE Co-existing Condition Patients with the following symptoms or conditions are excluded Grade 4 neutropenia Decompensated liver disease Positive toxin analysis for C. difficile Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter Positive fluorescent antibody test for Cryptosporidium Evidence of CMV on small bowel biopsy, flexible sigmoidoscopic or colonoscopic biopsies within 90 days of randomization Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study entry | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Cryptosporidiosis HIV Infections Concurrent Medication Allowed Antidiarrheal compounds (if dose remains stable) Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry) Patients must have AIDS Cryptosporidium parvum enteritis Chronic diarrhea Life expectancy of at least 4 weeks Ability to tolerate food by mouth Co-existing Condition Patients with the following symptoms or conditions are excluded Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis Grossly bloody diarrhea Known allergy to milk or milk products (other than lactose intolerance) Prior Medication Excluded Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-65.0, HIV Infections Patients must have AIDS diagnosis according to CDC criteria CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks Cryptosporidial diarrhea as defined by (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks) Life expectancy of at least 1 month Ability to tolerate food by mouth Prior Medication Required Any anti-diarrheal or anti-emetic medication for which the dosage regimen has been stable for at least 1 week prior to enrollment Co-existing Condition Patients with the following symptoms or conditions are excluded Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.) Patients with the following prior conditions are excluded Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay) History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis Prior Medication Excluded Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 55.0-999.0, Diarrhea Gastrointestinal Diseases years or older primary source of drinking water used at home is supplied by Sonoma County Water Agency without use of home filtration device or bottled water all individuals living in the home must sign informed consent and agree to have the water treatment device installed no known immunocompromising conditions (including HIV/AIDS, active cancer, or transplant recipients) persons with immunocompromising condition (including HIV/AIDS, active cancer, or transplant recipients) employees and family members of the Sonoma County Water Agency or a Sonoma County Water District | 0 |
Subsets and Splits