cyrilzakka/clinical-trials huggingface dataset:
The Primary Care - Dementia Assessment and Treatment Algorithm

Alzheimer's disease (AD) and related forms of dementia currently affect over 400,000 individuals in Canada and the numbers of community dwelling older adults with AD is rapidly growing. AD is associated with over $15 billion annually in care costs. Most individuals with AD are under the care of primary care providers (PCPs) including family physicians and primary care nurses. The evaluation and management of AD is challenging for PCPs and the quality of care provided to older adults with AD by PCP could be improved which would optimize outcomes for this vulnerable population. Provision of quality care to older adults with AD involves implementation of best practices as outlined in guidelines such as the Canadian Consensus Conference Guidelines on the Diagnosis and Treatment of Dementia. Utilizing a group of dementia researchers, PCPs, other knowledge users, and individuals affected by AD, this project will develop practical, clinically relevant resources for primary care physicians and nurses to aid in the evaluation of older adults with AD. A knowledge tool, the Primary Care - Dementia Assessment and Treatment Algorithm (DATA Tool) will be introduced into several primary care settings in Ontario using educational sessions with PCP with additional support from internet resource and a dementia care manager. The quality of dementia care provided to older adults newly diagnosed with AD will be assessed in the three years preceding the intervention compared to the year following the implementation. This project will also describe the process of knowledge exchange with PCPs, including potential barriers and facilitators of knowledge uptake and examine if the care provided during the intervention was patient-centred through interviews with patients and caregivers.

Research Objectives:

1. Develop knowledge tools to facilitate assessment and treatment of AD by PCPs based on best evidence;
2. Transfer these knowledge tools into a variety of primary care settings in Ontario; and,
3. Evaluate the effects of this intervention on dementia quality of care, PCP application of knowledge, and the patient-centeredness of care.


Eligibility Criteria:
Primary Care Provider Inclusion Criteria:

* Primary care provider at participating sites

Primary Care Provider Exclusion Criteria:

* primary care provider at non-participating site

Patient Inclusion Criteria:

* Community-dwelling at time of initial presentation to primary care provider
* Age 60 years or older at time of initial assessment by primary care provider
* Presenting to primary care providers with cognitive or functional symptoms suggestive of Alzheimer's disease or other form of dementia
* Patient must have a caregiver or substitute decision maker

Patient Exclusion Criteria:

* Prevalent cases of dementia will be excluded from study population
* Individuals with dementia residing in long-term care or nursing homes
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease

The researchers are trying to determine whether ovarian hormones are associated with aging processes and with the risk of developing Alzheimer's disease in women.

The proposed project will enroll 200 women. Each women will have one clinic visit consisting of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451.

Eligibility Criteria:
Inclusion Criteria:

* Women who lived in Olmsted County, Minnesota between 1988 and 2007
* Currently aged 55 years and older
* More than six months post chemotherapy or major surgery requiring general anesthesia
* Willing and able to sign informed consent

Exclusion Criteria:

* Not able to read and speak English
* In hospice
* Claustrophobic
* If undergoing Tau imaging, cannot have QT Prolongation
Longitudinal Study of HAART, Social Networks, & Adherence

Our study is a randomized controlled trial that aims to evaluate the effectiveness of modified directly observed therapy (mDOT) to (1) increase both short and long term adherence to HAART treatment, and (2) improve clinical outcomes associated with HAART therapy.

Our hypothesis is that modified directly observed therapy (mDOT) during the initial 6 weeks of HAART, supervised primarily by HIV-positive lay activists, will improve adherence and clinical outcomes compared with those that do not have supervised mDOT. We also hypothesize that the benefits of mDOT will be achieved through a variety of mediators that will result from the social interactions the patients will have with the activists. These mediators include improved social support, improved knowledge about HAART, reduced stigma, and improved self-efficacy.

To test this hypothesis, we intend to randomize 350 ARV naïve patients starting HAART to either receive mDOT for the initial 6 weeks of treatment or standard adherence support. Both intervention and control groups will receive standard HIV care that includes HAART medications free of charge, clinical and laboratory follow-up, psychosocial adherence support by a trained social worker, and referral to community-based peer support groups. Patients in the intervention group will in addition to stand care, receive their morning weekday dose of a twice-daily HAART regimen under DOT in clinic for 6 weeks. Nighttime and weekend doses are self-administered. A group of HIV-positive DOT activists, who are trained and paid lay-clinic personnel, will be primarily responsible for the direct observation of treatment in the mDOT group. In addition to observing treatment, DOT activists will provide counseling, education, and emotional support to patients, and will also locate patients not presenting for DOT on the same day. Although the HIV activists may also provide psychosocial and adherence support to specific patients in the control group, this support will only be a daily and formalized part of care in the group randomized to mDOT.

Eligibility Criteria:
Inclusion Criteria:

* HIV+ persons initiating HAART
* Adults and children over the age of 18
* Reside in or around Beira Mozambique
* Willing and able to provide consent to participate

Exclusion Criteria:

* Physically or mental incapable to make daily clinic visits
* Psychotic or demented
An End to the Yom Kippur (and Ramadan) Headache

Fasting is a known trigger for headache. People who fast to comply with religious edict have been shown to be prone to headache which becomes more likely to occur with increasing length of fasting, and in people prone to headache. This has been documented as 'Yom Kippur Headache' and 'First of Ramadan Headache.' We performed a study to test the hypothesis that Rofecoxib, a pain medicine and anti-inflammatory, with a prolonged duration of action would prevent or attenuate headache when taken just prior to the complete (no food or drink) 25 hour fast of Yom Kippur.

Introduction: Religious fasting is associated with headache. This has been documented as 'Yom Kippur Headache' and ' First- of - Ramadan Headache.' The Cox2 inhibitor, rofecoxib, has been reported effective in preventing perimenstrual migraine and in preventing recurrence of migraine. Given its 17 hour half-life, we undertook this study to see whether 50mg rofecoxib taken just prior to the 25 hour Yom Kippur fast would be effective in preventing headache.

Methods: We performed a double blind randomized prospective trial of rofecoxib 50mg vs placebo, taken just prior to the onset of fasting, Yom Kippur 2004. Healthy adults aged 18 - 65 were enrolled from the community and from hospital staff. Subjects completed a demographic data form and questions regarding headache history and a post-fast survey on headache during the fast, headache intensity, general ease of fasting and side effects.

Results: We sent out 170 forms of which 105 were completed and returned. Of those subjects receiving rofecoxib (n=53), ten or 18.9% vs 34 or 65.4 % of the placebo group (n=52) had headache at some point during the fast (p\<.0001). Severity of headache in the treatment group was significantly less for the treatment group (3.45 vs 6.29 on a visual analog scale of 10 (p = .009)). None of those receiving rofecoxib reported a 'more difficult than usual fast' whereas the distribution of difficult to easy fast among the placebo group was more even.

Conclusion: Rofecoxib 50mg taken prior to a twenty five hour ritual fast prevents and attenuates fasting headache.

Eligibility Criteria:
Inclusion Criteria:

* History of fasting headache
* Age 18-65
* Intention to fast on Yom Kippur
* History of Fasting on Yom Kippur

Exclusion Criteria:

* Pregnant or Nursing Women
* Known allergy to NSAID type medication
* History of chronic illness including heart, kidney, liver or peptic ulcer disease, hypertension, diabetes, lung disease including asthma, or a history of gastrointestinal bleeding.
The Effects of Self-monitoring With a Mobile Application in Heart Failure

In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.

HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management.

All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* 45 years old or older
* Left ventricular ejection fraction \</= 40% or an LVEF \> 40% (with left atrial size \>40mm or BNP \> 200 pg/ml or NT-proBNP \> 800 pg/ml)
* Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks.
* Smartphone (iOS or Android) with home wifi

Exclusion Criteria:

* Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI)
* Primary valvular heart disease
* Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus)
* Uncorrected thyroid disease
* Advanced renal disease (dialysis or creatinine \>4.0 mg/dL)
* End-stage HF (hospice candidate, home milrinone or dobutamine)
* Active cancer
* Pulmonary fibrosis
* Discharge to a setting other than home
Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adults age \> 18 years
* Patients with stable coronary disease, stable angina, and/or objective evidence of myocardial ischemia OR
* Target vessel lesion with \> 50% stenosis treated by PCI

Exclusion Criteria:

* Patients presenting with ST elevation myocardial infarction
* Complete total occlusion of the vessel
* Unprotected left main disease
* Presentation with acute coronary syndrome and actively rising troponin
* Contraindication to adenosine (advanced heart blocks, bronchospasm, HSN to the drug)
* Known hypersensitivity to nicardipine
* Severe aortic stenosis
* Left Ventricular dysfunction with ejection fraction less than 30%
* Hemodynamically unstable defined as systolic blood pressure \< 90 mmHg and not responding to IV fluids
* Significant chronic renal insufficiency (Glomerular filtration rate \[GFR\] \<30)
* Unwilling or unable to provide informed consent
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers

Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes.

The objective of this study is to evaluate the safety, tolerability and pK profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers.

In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years.
* Weight within normal ranges (Quetelet index between 21 and 26) (weight (kg)/height (m2).
* Adequate physical examination and clinical history
* No organic and psychiatric disorder
* Normal Blood pressure, Pulse Rate, temperature and ECG.
* Lab test within normal values according to reference lab values of Biochemistry lab of Hospital Santa Creu I Sant Pau. It will be allowed changes according to clinical criteria of the clinical staff of ICIM-SANT PAU
* Females of childbearing potential with adequate contraceptive precautions, other than oral contraceptives and negative urine pregnancy test.
* No participation in any other clinical trial within the previous two months before the initiation of this study.
* No blood donation within the previous four weeks before the initiation of this study.
* Signed informed consent.

Exclusion Criteria:

* Drugs or alcohol abuse.
* Consumer of stimulant drinks (\> 5 coffees, teas, cola drinks).
* Smokers (\> 10 cigars).
* Precedents of drugs allergy or hypersensitivity
* Intake of any other medication within the previous 15 days before this study.
* Positive HIV, HBV or HCV.
* Chronic disease (cardiovascular, respiratory, endocrine, gastrointestinal, hematologic, neurologic or others).
* Prior surgery within the previous six months before the initiation of this study.
* Pregnant women or breastfeeding or females of childbearing potential with no adequate contraceptive precautions, other than oral contraceptives.
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery

Standard Heparin management, based on total body weight, is not well established for obese patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM) to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.


Eligibility Criteria:
Inclusion Criteria:

* Obese patients (BMI ≥ 30kg/m2)
* Planned cardiac surgery
* Age ≥ 18 years

Exclusion Criteria:

* Permanent pacemaker
* Known intolerance to protamine
* Known or suspected allergy to the used antifibrinolytic agent
* Refusal to receive blood products
* Planned off pump coronary artery bypass
* Planned peri-operative use of desmopressin
* Known Heparin-induced thrombocytopenia
* Known deficiency in protein C, protein S, antithrombin or homozygous factor V Leiden
* Known congenital bleeding disorders
* Current endocarditis
* Planned hypothermic circulatory arrest (\<28C)
* Two or more cardiac surgery procedures
* Emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms)
* Planned CPB priming with red blood cells
* Any known autoimmune disease
* Any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism
* Significant (≥50%) carotid artery stenosis
* Patient dosed with low molecular weight Heparin less than 24h before surgery
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* Confirmed ST elevation myocardial infarction (STEMI) within 7 days
* Pre-operative platelet count \<100,000/microliter
* Anaemia (Hematocrit \<32% for females, \<35%for males)
* Dosed with clopidogrel or ticagrelor within the last 5 days prior to surgery, or prasugrel within 7 days
* Dosed with GPIIb/IIIa receptor blockers (Abciximab, Tirofiban, Eptifibatide) ≤ 24 hours prior to surgery
* International ratio (INR) \>1.5 on the day of surgery in patients treated with vitamin K antagonist
* Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
* Renal failure (creatinine ≥ 175 micromol/L or dialysis)
* Current thromboembolic disease other than myocardial infarct
* Patients who have pre-donated autologous blood
* Patient presenting with a resistance to Heparin
Trial of Meditation for Cardiometabolic Disease in Older Black Women

This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-the Transcendental Meditation (TM) program or a health education (HE) program. Participants were recruited, tested, and instructed at two clinical sites: Howard University Hospital, Washington, DC and Morehouse (School of Medicine) Healthcare, Atlanta, GA. Main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.

This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women \>55 years with CVD or at high CVD risk over a one-year intervention and follow-up period.

All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima-media thickness (IMT), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use).

Eligibility Criteria:
Inclusion Criteria:

* African American women,
* 55 years or older with at least one of the five cardiovascular conditions (below):

Either/or:

* coronary heart disease or
* positive coronary angiography or
* previous MI or
* coronary revascularization or
* percutaneous transluminal coronary angioplasty (PTCA).

OR a risk factor assessment score of at least two points based on the Framingham study/ATP III report. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking.

Exclusion Criteria:

Recent (last 3 months):

* myocardial infarction
* unstable angina
* coronary artery by-pass grafting (CABG)
* percutaneous transluminal coronary angioplasty (PTCA)
* stroke within the preceding three months
* carotid artery endarterectomy
* atrial fibrillation
* second or third degree AV block
* heart failure
* clinically significant valvular heart disease
* major psychiatric disorders,
* current alcohol/dependency disorder
* other drug abuse dependency disorder
* non-cardiac life-threatening illness
* participating in a formal stress management program
* plans to move out of the study area or travel extensively
* unwillingness to accept randomization into any study group.
Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients

Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis.

The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.


Eligibility Criteria:
Inclusion Criteria:

* persons who have provided written informed consent
* persons aged between 18 and 70 years
* persons waiting for a liver transplantation (group LT)
* persons with stable liver damage
* persons waiting for a kidney transplantation (KT)
* healthy subjects (control group) no known disease

Exclusion Criteria:

* persons without national health insurance cover
* persons with chronic infection,
* persons with acute infection,
* persons with progressive cancer,
* persons with an antibiotic treatment,
* persons who drink alcohol,
* pregnant or breast-feeding women,
* persons with an aversion to the foods proposed in the study,
* persons taking treatments known to interfere with gustatory and olfactory performance,
* adults under guardianship
A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index ( BMI )20.0 - 45.0kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
* Proliferative diabetic retinopathy