cyrilzakka/clinical-trials huggingface dataset:
Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"

The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.

The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000.

This multi-center observational trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

-Patients with Parkinson's disease should be surveyed.

Exclusion Criteria:

-Participants who have contraindications on package insert of rasagiline.
Efficacy of Neuro-HAART in Patients With HIV

Patients infected with Human Immunodeficiency Virus (HIV) are at risk of brain related complications despite the use of highly active antiretroviral therapy (HAART). Such complications are termed HIV neurocognitive disorders (HAND) and comprise a spectrum from asymptomatic neurocognitive impairment (ANI), through mild cognitive impairment (MCI) to severe HIV dementia (HAD).

Prior to HAART approximately 30% of patients with advanced HIV disease had cognitive impairment; with HAART the incidence of HAND has decreased but its prevalence increased. The reasons for the ongoing development of cognitive impairment in HAART treated patients are not clear. They might relate to virus induced brain injury prior to starting HAART, the onset of a separate neurological process, toxicity related to HAART, or ongoing viral infection in the brain.

It is clear that the ability of different antiretroviral drugs to penetrate the brain varies but what is not established is whether these differences between drugs lead to different neurological outcomes. The investigators propose to study HIV infected patients stable on HAART for 12 months; subdividing the groups according to the brain penetrance of their drug combination. Patients would undergo neuropsychological assessment and MRI brain scan at the start of the study and after 12 months.

Differences in neuropsychological tests and MRI would be sought between treatment groups to establish whether HAART with better CNS penetration is associated with better outcome and fewer MRI changes.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive with nadir cluster of differentiation 4 (CD4) count \<350 /microlitre (uL)
* Taking HAART with CNS Penetration Effectiveness (CPE) score of either ≤7.0 or ≥7.5 for 1 year or more. Changes in antiretrovirals (ARVs) within the last 12 months are allowed so long as the CPE score does not lead to a change groups
* Plasma HIV viral load \<50 copies / mL for preceding 12 months or longer
* Informed consent given by participant or legally appointed guardian

Exclusion Criteria:

* Non-HIV related neurological disorders and active CNS opportunistic infection as assessed by full blood count, electrolytes, creatinine, glucose, liver function tests, cryptococcal antigen, venereal disease reaction level (VDRL), MRI brain scan and cerebrospinal fluid analyses for cell count, protein, glucose, culture, VDRL and cryptococcal antigen.
* Psychiatric disorders on the psychotic axis, current major depression, and current substance use disorder as assessed by the Study Enrolment Questionnaire for Eligibility
* Severe substance use disorders (within 12 months of study entry)
* Active Hepatitis C virus (HCV) (detectable HCV RNA because HCV per se can cause cognitive impairment)
* History of loss of consciousness \>1 hour
* Non-proficient in English as assessed by the "English as a second language questionnaire"
* Medications known pharmacologically to interact with ARVs
* Pregnancy as assessed by the urinary pregnancy test
Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)

This Phase IV, multicenter trial is designed to assess the efficacy of prasugrel in preventing the formation of blood clots in Taiwanese patients with ACS who have been treated with PCI.


Eligibility Criteria:
Inclusion Criteria:

* Is within the age limits and has signed informed consent
* Weighs at least 50 kg
* Had a previous diagnosis of ACS (UA, STEMI, or NSTEMI), underwent PCI, and received one of the following treatments:

  * Clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-8 weeks following clopidogrel loading dose (LD) of 300 mg or 600 mg at the time of PCI
  * Ticagrelor MD of 90 mg twice daily (BID) and aspirin 81-100 mg for 1-4 weeks and switching to clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-4 weeks following ticagrelor LD of 180 mg at the time of PCI
  * Clopidogrel MD 75 mg and aspirin 81-100 mg for 2-8 weeks following ticagrelor LD of 180 mg at the time of PCI
  * Or based on investigator's judgment with at least 2 weeks continued use of clopidogrel MD and aspirin 81-100 mg per day before switching to prasugrel and maximum 8 weeks P2Y12 inhibitors MD treatment (prasugrel is not allowed)
* Is willing and able to abide by the rules of the research unit and study restrictions
* If a woman of child-bearing potential, has a negative serum pregnancy test at screening
* Agrees to use at least one method of contraception during the study

Exclusion Criteria:

* Has active bleeding, significant risk of hemorrhage, or unusual susceptibility to bleed
* Had previous hemorrhagic stroke at any time, or transient ischemic attack (TIA) or ischemic stroke within 3 months before the informed consent date
* Has known allergies or hypersensitivity to prasugrel, aspirin, or any of their excipients
* Has significant hypertension at screening or baseline assessment
* Has hemoglobin levels \<10.5 g/dL or hematocrit levels \<30%
* Has severe left ventricular systolic dysfunction, ejection fraction \<30%
* Is currently undergoing hemodialysis
* Has evidence of severe hepatic disease or any of the following: serum alanine transaminase or aspartate transaminase ≥3 times the upper limit of normal (ULN); or bilirubin ≥2 times the ULN at screening
* Has any clinical laboratory result performed at screening that is determined to be detrimental to the patient or could compromise the study as determined the Investigator
* Has previously participated in this study or in another interventional trial that is not compatible with this study
* Has evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse as determined by the Investigator
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Ability to remain hospitalized for at least first 4 weeks of study
* Needs hospitalization due to worsening of schizophrenia

Exclusion Criteria:

* Type 1 or 2 diabetes
* Previous use of clozapine
* Serious medical illness other than schizophrenia
A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life

Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.

This is a non-interventional, multi-site, ambispective, national follow-up study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017. This represents approximately 150 patients to date, who are therefore the first patients to have received treatment with Ocaliva® in France outside of pre-approval clinical trials.

All patients who received treatment within the context of the ATU (conditional marketing authorization in France) or after EU marketing authorization approval for the product will be followed up for 18 months (this follow-up will be partly retrospective and partly prospective). The study therefore involves retrospective recruitment with retrospective and prospective data collection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PBC treated with Ocaliva® 5 mg or 10 mg according to the terms of Ocaliva® approved SmPC: in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA (over the age of 18 years at the time of treatment introduction).
* Patients with PBC with a suboptimal response to UDCA who received at least one dose of Ocaliva®.
* Patients with or without an overlap syndrome (Nguyen-Khac E, 2004)
* Prior to any follow-up and inclusion in this cohort, the attending physician must give the patient or his or her legal representative or designated healthcare proxy information on the drug, a side effect report and notice of his or her inclusion in the cohort (patient information sheet in writing).
* The patient (or his or her legal representative or designated healthcare proxy) must have read the information sheet and agreed verbally to take part, and must show the sheet to any doctor who is consulted.

Exclusion Criteria:

* Diseases triggering a non-hepatic elevation of alkaline phosphatases (ALP) (for example Paget's disease or fractures within the previous three months).
* Participation in another investigational study on a product, biological material or medical device within the 30 days prior to selection.
* Inability to comply with the study follow-up procedures.
Well-Child Visit Trial

This project will use Twilio as a platform for a text messaging campaign to implement timely follow up with parents/guardians of children ages 0 to 17 years who have missed Well Child Visits (WCVs). The first phase of this project was an open trial. This second phase of the study will be a randomized controlled trial (RCT) to randomly assign parents/guardians of children who missed a WCV to an intervention condition or no intervention, and assess reasons for missed visits and experiences at last visit. Parents/guardians will receive text messages notifying them of missed visits and prompting them to reschedule, as well as inviting them to complete an online survey. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal. Outcomes of the follow-up campaign will be evaluated, including rescheduled visits within 6 weeks of missed visit and attendance at rescheduled visit. This aim will incorporate patient Electronic Health Record (EHR) data into mixed effects logistic regressions for the primary study outcomes.

Well-Child visits (WCV) are an opportunity to maximize the health and future well-being and development of children. Missed visits, however, can result in negative outcomes for patients and families and for the healthcare system. For patients, missed primary care visits can result in greater Emergency Department (ED) visits and hospitalizations, and in delays in diagnosing a variety of medical conditions, including identification of child abuse and neglect. For healthcare systems, missed visits result in decreased efficiency, lower quality measures, decreased provider productivity, and loss in revenue. Although smart phones are nearly ubiquitous, even among more economically disadvantaged populations, literature to date has reported only on using text messages for pre-visit reminders. There is a tremendous opportunity to study use of text messaging to engage families in follow-up for missed WCV. Even more so, testing the use of text messages with different content is missing, as well as using text messages to invite patients to share reasons for missing the last WCV.

Eligibility Criteria:
Inclusion Criteria:

Patients included in text messaging campaign (caregivers receive text messages):

* Are 0-17 years
* No-showed for a well-child visit scheduled at one of five locations: Pediatrics-Downtown Health Plaza, Family Medicine-Piedmont Plaza, Pediatrics-Winston East, Family Medicine-Peace Haven, or Pediatrics-Clemmons
* Have a phone number on record for a primary caregiver
* With primary language for contact that is English or Spanish

Caregivers must be 18 years or older

Exclusion Criteria:

Patients who:

* Are 18+ years old
* No-showed for a different type of visit, or no-showed for a WCV at a different practice location
* Already rescheduled their appointment by the time the sample list was generated
* Have primary language specified that is not English or Spanish.

Caregivers who are under 18 years old
Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection

To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.

Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.

Eligibility Criteria:
Inclusion Criteria:

* all patients who candidate for receiving intravitreal bevacizumab

Exclusion Criteria:

* patients who had advanced glaucoma
* patients who received antiglaucoma agents in the past
* patients who had corneal scar which affect IOP measurement
Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in general good health, home delivery
* Must live in one of 78 study villages

Exclusion Criteria:

* Hypertension
* Non-cephalic presentation
* Polyhydramnios
* Previous cesarean section
* Suspected multiple pregnancy
* Suspected still birth
* Antepartum hemorrhage
* Previous complication in 3rd trimester
* Anemia of \<8 g/dl
Apprehension-based Training Compared with Standard Physical Therapy for Military Personnel Following Anterior Shoulder Dislocation - a Randomized Clinical Trial

The goal of this clinical trial is to determine if a new rehabilitation protocol (apprehension-based training), leads to better recovery after shoulder dislocation among military personnel.

Participants will be randomly allocated to apprehension-based training or standard physical therapy. In apprehension-based training participants will train to control their shoulder under progressively more unstable conditions. Standard physical therapy will be provided based on the clinical judgment of the treating physical therapist The primary hypothesis is that participants undergoing apprehension-based training will experience a more complete recovery of function, better shoulder-related quality of life, and incur less recurrent dislocations.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-39 years
* Shoulder dislocation (primary or recurrent) documented by a medical practitioner (physician, military medic)
* Positive anterior apprehension test
* Gross shoulder muscle strength 3/5 or greater

Exclusion Criteria:

* Previous shoulder fracture, tendon tear, or shoulder surgery
* Voluntary shoulder dislocation
* Functional (Stanmore polar III) shoulder instability
* Dislocation associated with a motor vehicle accident.
* Diagnosis of rheumatoid arthritis, cancer (current), fibromyalgia, psychiatric disease)
* Current pregnancy
* Inability to attend at least one physical therapy session every 2 weeks.
Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.

Cancer related fatigue (CRF) is a common and debilitating side effect of radiotherapy in breast cancer patients. Physical activity interventions can attenuate CRF. The proposed study is a randomized, controlled trial (RCT) of exercise of structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce CRF and improve health-related quality of life among breast cancer patients. Eighty women with breast cancer scheduled to receive radiation therapy at Hackensack University Medical Center (HUMC) will be randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; or 2) a control group. Intervention arm participants will exercise at the hospital either before or after their radiation treatment. Assessments will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit. The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life (QOL). The study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing CRF in women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. women between the ages of 18 and 75 years
2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
3. radiation therapy naïve
4. sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire
5. ambulatory
6. negative serum pregnancy test and not planning to become pregnant in the next three months
7. able to provide meaningful consent.
8. Patients must have been deemed by their medical oncologist or internist that they "may participate in \[this\] exercise trial." Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program.

Exclusion Criteria:

1. younger than 18 or older than 75 years
2. no histological confirmation of breast cancer
3. prior breast, chest, or pelvic radiotherapy
4. concurrent chemotherapy
5. distant metastases
6. physical limitations that contraindicate participation in low to moderate intensity exercise
7. positive pregnancy test
8. currently engaged in moderate to vigorous physical activity
9. psychiatric disorder which would render the participant unable to provide informed consent.
Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD

Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease.

Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)


Eligibility Criteria:
Inclusion Criteria: (Main)

* 1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.

AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):

* Progression on prednisone 7 mg/kg/week for 2 weeks, or
* Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
* Inability to taper prednisone below 3.5 mg/kg/week.

Exclusion Criteria: (Main)

* 1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.

OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.

OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.

OR 4. Time from allogeneic transplantation \> 2 years. OR 5. Lymphocyte count \< 0.2 x 109/L on two last consecutive CBCs before inclusion
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily).

Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.

Eligibility Criteria:
KEY INCLUSION CRITERIA:

1. Prior completion of Study E3810-G000-302 or -303. Subjects will need to have healed erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-302 or -303.

KEY EXCLUSION CRITERIA:

1. Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
2. Barrett's esophagus or esophageal stricture.
3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs with significant anticholinergic effects throughout the study.
4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>= 20 mg/day prednisone or equivalent), or aspirin (-\>; 325 mg/day).
5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would be likely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study.
6. Any condition that would make the subject, in the opinion of the Investigator or Sponsor, unsuitable for the study.