cyrilzakka/clinical-trials huggingface dataset:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Propranolol/Carvedilol Versus Atenolol/Bisoprolol/Sotalol

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1ltZHHv6AvMkPBbSp_9c0dtQ0XMmBc00d4jaRId5ovaA/edit?usp=sharing or Appendix A (https://drive.google.com/drive/folders/1a-1uRt73kVywEoV8L0cEmDNgaqYEIudT?usp=sharing) for full code and algorithm definitions.

Medicare timeframe: 2008 to 2019 (end of data availability).

Inclusion Criteria:

* 1. Aged \>/= 65 years on the index date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 3. At least 1 inpatient claim or 2 outpatient claims with hypertension diagnosis recorded in 365 days prior to drug initiation

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
* 3. Prior use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol
* 4. Use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol concomitantly on index date
Monitoring Glucose Levels in Patients With Myocardial Infarction

To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes

Methodology Part a) Explorative Part b) Randomised, parallel-group design

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome according to the joint recommendations by the European Society of Cardiology (48, 49)
* Signed written informed consent consistent with Helsinki declaration and local legislations prior to participation in the trial.

Exclusion Criteria:

* \<18 years old.
* Congestive heart failure.
* Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).
Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment (CT-CTO Trial)

The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Recently, the success rate of the recanalization of CTOs has been raised in several studies.

Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from CTO intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. We suggest that success rates and clinical outcome of intervention of CTO lesion can be improved by pre-procedural CCTA.


Eligibility Criteria:
Inclusion Criteria:

* Patients (age \>19 years) with CTO (TIMI = 0 and estimated duration of occlusion at least 3 months)
* Typical symptomatic angina or positive stress test in various functional studies evaluating ischemia
* Eligible patients for pre-procedural CT scan and coronary angiogram

Exclusion Criteria:

* Cardiogenic shock or ejection fraction \< 25%
* CTO lesions at DES restenosis or graft occlusion lesion
* Significant left main stenosis
* Retry of same CTO lesion within 2 weeks
* Acute myocardial infarction within 48 hours
* Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
* Severe hepatic dysfunction (≥3 times normal reference values)
* Life expectancy \< 1 years
* Pregnant women or women with potential childbearing
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream

The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

The purpose of this study is to test a new noninvasive topical cream, AIJP (Arnebia Indigo Jade Pearl), for treatment of precancerous anal lesions in order to prevent their progression to anal cancer. AIJP is a topical Chinese herbal cream that has been specifically designed to treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In general, HPV infection is a key factor in development of cervical, anal and vulvar cancers. People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is known that prior to development of anal cancer a person develops a precancerous condition known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high impact on prevention of anal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Anal HSIL confirmed by biopsy no more than 30 days prior to entry
* Anal HSIL deemed not amenable to therapy or participant declines routine ablative therapy
* HIV positive
* Stable HIV treatment regimen for at least 8 weeks prior to entry
* At least 18 years of age
* Women of childbearing potential must use contraception
* Platelet count above 70,000/mm3 within 30 days prior to entry
* ANC greater or equal to 1000/mm3 within 30 days prior to entry
* Creatinine less then or equal to 1.5 times ULN within 30 days prior to entry
* AST and ALT less than or equal to 3 times ULN within 30 days prior to entry

Exclusion Criteria:

* Prior history of invasive anal, cervical, vaginal, or vulvar cancer
* Pregnancy or lactation and breast-feeding
* Must not participate in a conception process including sperm donation
* Medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with ability to comply with protocol
* Known allergy to any topical cream components
* Patients with lesions clinically suspicious per HRA examiner for early progression (less than one year) to anal cancer
Consequences of Temporomandibular Disorder on Balance Control

To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.

Primary objective: to evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Patient group: TMD patients, care: occlusal splint therapy, behavioral advices
* Control group: matched with TMD patients (age, sex, lifestyle).

Exclusion Criteria:

* Patient group: treatment generating secondary effects in postural control (psychotrop, antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma (\< 4 months); vertigo and dysequilibrium (\< 6 months), whiplash
* Control group: id. and TMD.
Randomized Study for Patients With Follicular Lymphoma Needing Treatment

2 parallel studies.

* For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
* For elderly patients (\>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

2 parallel studies.

* For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
* For elderly patients (\>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

Eligibility Criteria:
Inclusion Criteria:

* study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node \>7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
* study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node \>7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)

Exclusion Criteria:

* contra-indication to anthracycline or interferon
* transformation into large cell lymphoma
* previous treatment
* localized stage without criteria of large tumor mass
* patients HIV+
Changing Lifestyles for Better Health

The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style intervention (ILI) program that has been developed and implemented at the FHCHC to prevent the development of diabetes.

This project is a clinical outcome study that merges the expertise of a senior Yale clinical investigator, the clinical and translational research resources of YCCI, the clinical and community expertise of the FHCHC Diabetes Team, and the high-need patient population of FHCHC. In addition to determining the efficacy and cost-effectiveness of an ILI for diabetes prevention in an inner-city community health center setting, this project will evaluate the effectiveness of pooling academic expertise with direct clinical services to disadvantaged, at-risk populations.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible for this study, the following criteria must be met:

* Subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ILI (the John Martinez School).
* Subjects must have had a 2 hour 75 gram Oral Glucose Tolerance Test (OGTT) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
* Willingness to undergo fasting blood testing: HOMA-IR, fasting lipid profile (including total cholesterol, HDL, LDL cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the OGTT) and repeated at 12 months.
* Subjects must have no medical contraindications to exercise or dieting.

Exclusion Criteria:

* Subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ILI program.
* Subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
* Women who are pregnant or planning to become pregnant will not be enrolled in this study.
* Any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
* Subjects cannot participate if they have concurrent membership in a comprehensive weight management program.
Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.

Eligibility Criteria:
Inclusion Criteria:

* Met MGH transplant center criteria and already listed for kidney transplant
* No available living kidney donor
* Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
* On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate \<15mL/min/1.73m2 at the time of screening
* Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
* Weigh at least 50kg
* Serum ALT within normal limits with no history of liver disease
* Able to sign informed consent

Exclusion Criteria:

* AB blood type
* BMI \> 35
* Any liver disease in recipient
* Pregnant or nursing (lactating) women
* Known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and Mavyret
* Cardiomyopathy (LV ejection fraction \< 50%)
* Albumin \< 3g/dl or platelet count \< 75 x 103/mL
* Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
* Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
* HCV RNA positive
* Hepatitis B surface antigen positive
* Any known liver disease or elevated liver transaminases
* Patients with primary focal segmental glomerulosclerosis (FSGS), FSGS recurring after previous transplant, or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or the investigator team
* Any contra-indication to kidney transplantation per MGH center protocol
* Patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy

The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.

In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* Having been diagnosed with Type 2 diabetes for at least one year,
* Diagnosed with diabetic peripheral neuropathy for at least 6 months by EMG by a neurologist,
* Individuals with diabetes mellitus with neuropathic pain who score 12 or higher on the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) pain scale,
* Visual Analogue Scale (VAS) value to be at least 1,
* Receiving medical treatment for diabetic neuropathy,
* Did not receive physical therapy and non-pharmacological treatment during the research period,
* Having no physical and mental problems that will prevent communication,
* Having blood glucose meters at home,
* Individuals with smart device use,

Exclusion Criteria:

* Peripheral vascular complications due to diabetes or another etiology,
* Having a history of surgery on the knee, ankle and hip and indication for surgery during the intervention period,
* Those who cannot communicate on the phone (with hearing problems),
* Having nephropathy, retinopathy and diabetic foot,
* Neurological diseases (stroke, cerebrovascular diseases, epilepsy) and serious musculoskeletal problems (rheumatoid arthritis, osteoarthritis)
* Neurocognitive disorder (Alzheimer's disease, dementia),
* Not taking any physical therapy during the intervention period,
* Patients with deep vein thrombosis, femur fractures, surgical conditions, open wounds
Steroid Eyedrop Adherence After Trabeculectomy

The study will monitor how often persons use eye drops that are prescribed after glaucoma surgery and will compare the adherence with drop use to the success rate of the surgery.

Trabeculectomy is the most common operation performed for all forms of glaucoma. The procedure depends upon appropriately modulated healing of the conjunctiva and sclera, a major component of which is delivery of frequent topical corticosteroid eye drops (prednisolone acetate 1%) by the patient, initially every 2 hours when awake for 1-2 weeks, then in tapering frequency over the 6 weeks after surgery. While the initial success of trabeculectomy at one year varies from 55-80% depending upon the criteria chosen to measure outcome, improvements in success would benefit hundreds of thousands of patients in the USA yearly. There is reasonable evidence that steroid drops benefit success, but there is essentially no data on how successfully patients remember to take the drops. In previous research, investigators have shown that glaucoma patients take only half to two-thirds of prescribed drops. An electronic monitoring device is now available that can fit the eye drop bottle used in steroid drops, accurately measuring the time and date of each drop taken. The investigators can further assess the accuracy with which each patient can deliver a drop from the bottle being monitored in a clinic session directly onto the eye's surface by observing their performance. The proposal's hypothesis is that the one year success rate of the procedure will be related to the adherence to steroid drop taking by patients. The outcome will have two important benefits. First, if adherence is less than ideal (which is very likely), then those with greater adherence will have more successful surgery, confirming that steroid treatment is effective. This has only been measured once, 30 years ago, at a time when trabeculectomy was being performed quite differently. If steroid treatment is not related to success, a change in preferred practice patterns is in order. If steroid treatment is related to success and adherence is variable, the investigation will have proven means to increase adherence through reminder systems, which have shown in past randomized clinical trial to be effective.

Eligibility Criteria:
Inclusion Criteria:

* Persons having glaucoma surgery

Exclusion Criteria:

* Persons not eligible for glaucoma surgery, including pregnant females persons allergic to standard postoperative eye drops
Impact of LA-CEAL HALT COVID-19 Ambassador Program on Likelihood to Vaccinate

The purpose of the study is to assess the effectiveness of the HALT COVID Ambassador educational outreach program on increasing likelihood to vaccinate against COVID-19

Investigators will use a randomized controlled trial to test the effectiveness of HALT COVID educational outreach by HALT COVID Ambassadors. HALT COVID Ambassadors will receive training to answer common vaccine questions \& address misconceptions; conduct motivational interviewing; and implement basic behavioral economics and related strategies to remove barriers to vaccination. A random sample of FQHC patients will be identified in EHR data downloads of adult patients seen in the last year and contacted by telephone to gain consent and assess eligibility. A total of 100 individuals will be enrolled into the trial and randomized to intervention (engagement with the HALT COVID Ambassador over a 1 month period via in-person or virtual sessions exploring their own questions and concerns about vaccines) or usual care (no extra engagement). Baseline, 1-month, and 2-month follow-up surveys will assess for vaccine likelihood.

Eligibility Criteria:
Inclusion Criteria:

* Unlikely to vaccinate in next month
* Age \>=18 years
* Self-identification as Black or African American
* Ability to understand and speak English
* Willingness to engage with HALT COVID Ambassador via in-person or virtual sessions exploring questions and concerns about vaccines

Exclusion Criteria:

* Unable or unwilling to give informed consent