bioihbjkbjnl/mcl2 huggingface dataset:
Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination
Condition: HIV; Rabies
MeSH terms: Rabies
Study type: Interventional

Summary: 
      Booster rabies vaccination in HIV - infected patients who have ever received rabies primary
      vaccination could improve their immune response to this kind of vaccine.
    

Detailed description: 
      The investigators have learned from the previous studies that some HIV-infected patients
      especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies
      vaccination. Because of the role of the memory B cell, the investigators hypothesized that
      primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody
      response to ones after booster vaccination in case of re-exposure of rabies occur despite of
      their immunocompromised state.
    

Intervention name(s): rabies vaccines on day 0 and 3
Intervention type(s): Biological
Intervention description(s): All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; booster; rabies; immune response
The Effect of Telerehabilitation-Based Structured Exercise Program in Video Game-Addicted Adults
Condition: Video Game Addiction
MeSH terms: Technology Addiction
Study type: Interventional

Summary: 
      The increasing use of computers and mobile devices due to advancing technology has brought
      with it some negative consequences such as video game addiction. Research has shown that
      playing video games for too long can lead to a number of acute and chronic serious
      musculoskeletal problems that can negatively affect health. The aim of the present study is
      to investigate the effect of telerehabilitation-based structured exercise program in video
      game-addicted adults and compare these effects with the effect of brochure-based exercise.
      Postural assessments, pain assessments, fine motor skill assessments, grip strength
      measurements, and reaction time assessments were performed. All assessments were repeated
      before and after the 8-week program for both groups. Participants in the EG were given a
      telerehabilitation-based structured exercise program for an average of 40 minutes three days
      a week for 8 weeks. Participants in the CG were given brochure-based exercises three days a
      week for 8 weeks.
    


Intervention name(s): Brochure-Based Exercise Program; Telerehabilitation-Based Structured Exercise Program
Intervention type(s): Other; Other
Intervention description(s): Simple posture exercises; Progressive physical fitness and posture exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Prognostic Impact of Sleep Disorders in Patients : Pro-TSIC Study
Condition: Heart Failure; Sleep Disorder; Insomnia
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Observational

Summary: 
      Heart failure (HF) is a common and progressive condition associated with significant
      morbidity and mortality. Only 25-35% of patients survive 5 years after diagnosis.Sleep
      disorders are frequently found in this population with up to 94% of patients complaining of
      sleep disorders. Of these, insomnia and sleep disorders are the most common. The frequency of
      restless legs syndrome (RLS) varies between 4 and 40% depending on the studies. Patients with
      HF frequently experience poor sleep quality which is associated with deterioration in quality
      of life, alertness, and mood.

      Few studies have examined the prognostic impact of sleep disturbances in this population. A
      greater morbidity and mortality is observed in the event of poor quality sleep or in the
      presence of sleep breathing disorders .

      The investigators therefore propose to evaluate the sleep disorders of patients with HF by
      self-administered questionnaires, hypothesizing that complaints of poor sleep are linked to a
      poorer cardiovascular prognosis.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients included in this study are the patients followed in the Cardiology Department
        of the Montpellier University Hospital and diagnosed with heart failure according to the
        2016 criteria of the European Society of Cardiology.
Modulation of Visually Evoked Potentials by an Antidepressant
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks.
      Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and
      statistically compared. This study aims to examine a putative modulation of synaptic
      transmission and plasticity by an antidepressant and is part of a series of studies in
      healthy individuals and depressed patients.
    


Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; SSRI; Sertraline; synaptic plasticity; visually evoked potentials
Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of the study is to quantitatively evaluate pituitary hormone response, follicle
      stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate in
      normally fertile women.
    

Detailed description: 
      Empirical use low-dose clomiphene citrate has been advocated by some practitioners to enhance
      fecundity in women with unexplained infertility. No clinical trials have examined the
      efficacy of such treatment in the patient population, although certain studies have shown
      that active ovulation induction can be effective in women with unexplained infertility, and
      that cycle fecundity is improved for normally cycling women with active ovulation management
      in a program of artificial insemination. Since clomiphene citrate can have paradoxical
      effects on fertility through its anti-estrogenic mode of action, the benefit or lack of
      benefit from treatment with clomiphene citrate in this patient group needs to be evaluated.
      We aim to establish a dose response of FSH and LH to various low doses of clomiphene citrate
      in normally cycling women of known fertility, that is women with an intact
      hypothalamic-pituitary-ovarian-axis. The significance of this information is that it may help
      to elucidate the mechanism by which low-dose clomiphene citrate may improve fecundity in
      patients with unexplained infertility as it is currently being used empirically.
    

Intervention name(s): Clomiphene Citrate
Intervention type(s): Drug
Intervention description(s): 0, 25, 50 or 100 milligrams daily. Will be taken orally days five through nine of the menstrual cycle.
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pituitary Hormone Response; Clomiphene Citrate; Follicle Stimulating Hormone; Luteinizing Hormone
Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      The overall goal of the proposed project is to improve the treatment of individuals with
      Alcohol Use Disorder (AUD). We will conduct a pilot feasibility trial of Approach Bias
      Modification (AABM) training of heavy-drinking non-treatment seeking individuals with AUD. We
      will measure feasibility with respect to recruitment, retention and tolerability of AABM
      training and the Alcohol Drinking Paradigm (ADP). We will also assess changes in alcohol
      craving and alcohol consumption during ADP sessions conducted before and after 2 weeks of
      AABM training.
    

Detailed description: 
      Twelve heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD
      will receive 2 weeks of AABM training preceded and followed by a 1-day ADP session.

      AABM training is a computer training program that participants interact with by pushing and
      pulling a joystick. Participants are asked to respond to the format of a presented picture,
      irrespective of the pictures' content. Training effect is achieved by presenting alcohol
      pictures in push format only and non-alcoholic drinks in pull format only. Training is
      conducted in 3 sessions per week for 2 weeks, for a total of 6 sessions.

      The ADP session is a one day human laboratory session taking place at the SFVA Medical
      Center. This human laboratory session involves the self-administration of alcoholic beverages
      by research participants under highly structured, observed conditions in order to evaluate
      the effects of the study intervention (AABM training) on alcohol craving and alcohol
      consumption.
    

Intervention name(s): Alcohol Approach Bias Modification
Intervention type(s): Device
Intervention description(s): Computerized training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: human laboratory; alcohol approach bias modification; alcohol use disorder; non-treatment seeking
Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat)
      have provided conflicting results with some in vitro and ex vivo studies consistent with non
      toxicity and other suggestive of toxicity. We recently reported results of a single
      administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while
      assessing symptoms and changes of intestinal permeability. Although results of intestinal
      permeability were inconclusive Tm, but not other type of gluten, was clinically well
      tolerated.

      The aim of the present study was to assess safety of 60 days of administration of Tm (100
      grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on
      clinical, serological and histological parameters in Celiac Disease patients on remission
      after 1 year of GFD.
    


Intervention name(s): Triticum monococcum
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Celiac Disease; Gluten; Gluten free diet; Triticum monococcum
Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's
Condition: Parkinson's Disease; Parkinson Disease; Dyskinesias
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates how effective a new formulation of a marketed drug is in increasing the
      time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with
      Parkinson's Disease who have been taking levodopa for less than 2 years.
    


Intervention name(s): ropinirole controlled-release (REQUIP CR) for RLS
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: dyskinesia; SINEMET; Parkinson's disease; controlled release ropinirole
Comparing Unimanual and Bimanual Mirror Therapy for Upper Limb Recovery Post Stroke
Condition: Cerebral Vascular Accident (CVA); Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The purpose of this randomized controlled study is to

        1. Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan
           area;

        2. Evaluate the effectiveness of home MT versus traditional home exercise program; and

        3. Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic
           stroke subjects with moderate hand deficits. Subjects from occupational therapy at the
           Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular
           accident (CVA) or stroke will be divided into three (3) groups:

             -  Control Group subjects will participate in standard occupational therapy
                rehabilitation protocol plus a traditional home based exercise program.

             -  Experimental group 1 subjects will participate in standard rehabilitation protocol
                plus unimanual home based mirror therapy program

             -  Experimental group 2 subjects will participate in standard rehabilitation protocol
                plus bimanual home based mirror therapy program.
    


Intervention name(s): Traditional Home Based Exercise Program; Unimanual Home Based Mirror Therapy Program; Bimanual Home Based Mirror Therapy Program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects in the control group will receive a traditional home Occupational Training exercise program as per conventional OT guidelines with the same home program duration.; The affected hand will remain still in the mirror box, the unaffected hand will perform the exercises while the subject watches the mirror reflection.; The affected hand in the mirror box will best mimic the unaffected hand, while also watching the mirror reflection.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants included in the study will be those referred to outpatient occupational
        therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral
        vascular accident (CVA) or stroke.
      
Keywords: Post Stroke Recovery; Mirror Therapy; Unimanual mirror therapy; Bimanual mirror therapy; Stroke
Bioavailability of Prochlorperazine Suppositories, 25 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare prochlorperazine plasma concentrations produced after
      administration of the test formulation with those produced after administration of a marketed
      reference product.
    


Intervention name(s): Prochlorperazine suppositories, 25mg; Compazine® suppositories, 25mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Prochlorperazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare
Condition: Days Absent From Daycare; Respiratory Tract Infections; Gastrointestinal Infections; Allergy
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Hypersensitivity
Study type: Interventional

Summary: 
      The aim of the intervention is to examine the effect of a combination of the two bacterial
      strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic
      manifestations in small children, and how a combination of BB-12 and LGG affects the immune
      system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter
      seasons.
    


Intervention name(s): Probiotic (2 * 10^9 cfu/day); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months; Placebo for 6 months
Other intervention name(s): bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day; Lactobacillus Rhamnosus GG (LGG), 10^9 cfu/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Infections; Allergy; Immune function; Microbiota; Infant
Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there is a difference between the result of
      treatment of shoulder osteoarthritis with two different shoulder prostheses.
    

Detailed description: 
      In this randomized study, we wish to investigate with the use of clinical and radiological
      parameters whether there is a difference between the result of treatment of shoulder
      osteoarthritis with the Copeland resurfacing prosthesis and the Global CAP resurfacing
      prosthesis.

      Clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario
      Osteoarthritis of the Shoulder Index (WOOS):

        1. Pain

        2. Activities of Daily Living (ADL)

        3. Range of Motion (ROM)

        4. Muscle strength

      Radiologic parameters:

        1. Migration of resurfacing prostheses with use of MB-RSA

        2. Bone density around the prosthesis measured with Dual Energy X-ray Absorptiometry (DEXA)

        3. Correlation between bone density and prosthesis migration
    

Intervention name(s): Copeland or Global CAP resurfacing prosthesis
Intervention type(s): Procedure
Intervention description(s): Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: osteoarthritis; shoulder; resurfacing; prosthesis
Levosimendan in Congenital Cardiac Surgery
Condition: Congenital Cardiovascular Defects; Low Cardiac Output Syndrome
MeSH terms: Cardiac Output, Low
Study type: Interventional

Summary: 
      Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of
      complex congenital malformations, require inotropic support for low cardiac output syndrome.
      Milrinone through its positive inotropic and vasodilatory effects is widely used for this
      purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with
      calcium-sensitizing properties. We hypothesized that using Levosimendan would result in
      reduced serum lactate through a higher cardiac index.
    


Intervention name(s): Levosimendan; Milrinone
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection; Intravenous injection
Intervention MeSH terms: Simendan; Milrinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cardiac surgery with cardiopulmonary bypass
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
Condition: Breast Cancer; Hereditary Breast and Ovarian Cancer Syndrome
MeSH terms: Hereditary Breast and Ovarian Cancer Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized controlled trial to look at early complications, cosmetic outcome, patient
      satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate
      implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a
      mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer
      centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
    


Intervention name(s): TiLoop Bra; Protexa
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: breast; reconstruction; mesh; acellular dermal matrix
The Effect of Dietary Strawberry Supplementation on Older Adults
Condition: Aging; Age-related Memory Disorders
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      This study is being conducted to assess the effect of dietary strawberry supplementation on
      cognition and mobility in older adults. It is hypothesized that plant compounds, present in
      strawberries, may improve cognition and mobility by protecting against oxidative stress and
      inflammation.
    

Detailed description: 
      This study is being conducted to assess the effect of dietary strawberry supplementation vs.
      placebo on measures of cognition and mobility in older adults. Participants will visit the
      HNRCA on 4 occasions. During the first visit, participants will complete a dietary assessment
      and familiarize themselves with some of the cognitive tests used in the study. After a period
      of up to 45 days participants will return for the second visit. Participants will be
      randomized to consume either freeze dried strawberry powder or a placebo powder that tastes
      like strawberry. At visits 2, 3 and 4, participants will undergo tests of cognition, memory,
      gait and balance. In addition, blood samples and 24-hour urine will be collected at these
      visits. Tests include balance and gait assessment using a treadmill instrumented with
      pressure sensors which will measure postural sway and a variety of spatial/temporal gait
      parameters. Participants will also be affixed with surface electrodes to measure the
      activation of muscles in their legs during these balance and gait measurements. Participants
      will complete a battery of cognitive tests on paper and by computer. In the time between
      participants' visit 2 and visit 4, participants will receive a weekly telephone call to check
      in with them and remind them to continue taking the study powder. At the very end of the
      study, when all participants are finished, participants will receive a telephone call to
      debrief them and notify them which group they were randomized into. An optional tissue
      banking protocol will be offered for collection of additional blood to be banked at visits
      2-4.
    

Intervention name(s): Freeze-dried Strawberry; Strawberry Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 12g freeze-dried strawberry (powder), twice daily with water, for 90 days; 12g blue, strawberry-flavored powder, twice daily with water, for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postural Balance; Walking; Giat; Cognition; Learning; Memory; Antioxidants; Anti-Inflammatory Agents; Brain; Strawberry