bioihbjkbjnl/mcl2 huggingface dataset:
Buspirone Treatment of Anxiety in Williams Syndrome
Condition: Williams Syndrome; Anxiety
MeSH terms: Williams Syndrome; Syndrome; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to do a preliminary assessment of whether buspirone is
      effective, safe, and tolerable in the treatment of anxiety in children, adolescents, and
      adults with Williams syndrome.
    

Detailed description: 
      After being informed about the study and potential risks, all patients or their legal
      guardians giving written informed consent will be screened for study eligibility. Patients
      who meet the eligibility requirements will participate in a 16-week, flexibly-dosed,
      open-label trial of buspirone. The dose of buspirone will be adjusted over the first 12 weeks
      of the study and a stable dose will be maintained for the final four weeks of the trial.
      Adverse effects will be reviewed at each visit and standardized measures of anxiety will be
      conducted at weeks 4, 8, 12, and 16.
    

Intervention name(s): Buspirone
Intervention type(s): Drug
Intervention description(s): All participants in the study will receive open-label treatment with orally administered buspirone for the full duration of the 16-week trial. Buspirone has high affinity for serotonin 5-HT1A and 5-HT2 receptors and moderate affinity for dopamine D2 receptors. It is approved for the management of generalized anxiety disorder in adults.
Intervention MeSH terms: Buspirone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identification of the Cranberry Juice Compounds That Prevent Urinary Tract Infections
Condition: Urinary Tract Infections
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional

Summary: 
      The purpose of this study is to identify the substances in cranberry juice that make it
      effective in reducing urinary tract infections (UTIs) in women.
    

Detailed description: 
      Urinary tract infections (UTIs) are a significant health issue, with one fourth of all women
      experiencing symptoms during their lifetimes. Cranberry juice has been shown to reduce the
      incidence of UTIs by preventing bacteria from adhering to the bladder. However, the compounds
      that direct this activity have not been identified. This study will identify and examine
      UTI-reducing compounds in cranberry juice.

      Participants in this study will drink a specified amount of water following an overnight
      fast. Their urine will be collected 1 to 3 hours after the water is consumed. Several days
      later, the women will be provided with cranberry juice to replace the water in the regimen.
      Urine samples will be analyzed for compounds that have antibacterial or antiadhesion activity
      against the bacteria that cause UTIs.
    

Intervention name(s): Cranberry juice cocktail
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Vaccinium macrocarpon
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
Condition: HIV Infections; Mycobacterium Infections; Tuberculosis
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Tuberculosis; Mycobacterium Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in
      patients receiving antitubercular therapy.

      II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of
      HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.

      III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or
      mycobacterial infections.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type
      of infection.

      Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily
      for up to 8 weeks, beginning the night before antitubercular treatment is initiated.
    

Intervention name(s): thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: bacterial infection; human immunodeficiency virus infection; immunologic disorders and infectious disorders; mycobacterium infection; mycobacterium tuberculosis infection; rare disease; viral infection
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected
      pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.
    


Intervention name(s): BI 1015550; BI 1015550; BI 1015550; BI 1015550; BI 1015550; Placebo; BI 101550; BI 1015550; BI 1015550; BI 1015550
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): High dose powder for oral solution; Medium dose powder for oral solution; Low dose powder for oral solution; Low dose powder for oral solution; Low dose powder for oral solution; Solution for oral administration; High dose powder for oral solution; Low dose powder for oral solution; Medium dose powder for oral solution; Medium dose powder for oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the single-dose pharmacokinetics (PK) of
      A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy
      adult subjects.
    

Detailed description: 
      This is an open-label, randomized, 3-way crossover, food-effect and sprinkle study. On Day 1
      of each period, subjects will receive a single oral dose of A4250 under 1 of 3 conditions:
      fasting, following a high-fat, high-calorie breakfast, or sprinkled on applesauce. Subjects
      will receive A4250 under each condition on one occasion. Blood samples for PK analysis will
      be collected for 18 hours following each study drug administration. There will be a washout
      period of at least 7 days between doses. Study participants will be contacted approximately
      14 days after the last study drug administration to determine if any adverse event (AE) has
      occurred since the last study visit.
    

Intervention name(s): A4250
Intervention type(s): Drug
Intervention description(s): 9.6 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3-Way Crossover Design
Masking: None (Open Label)
Primary purpose: Treatment
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
Condition: Myeloid Leukemia, Chronic, Chronic-Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia
      chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant
      to imatinib mesylate (Gleevec).
    


Intervention name(s): dasatinib; dasatinib; dasatinib; dasatinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 50 mg BID, indefinitely, survival study; Tablets, Oral, 70 mg BID, indefinitely, survival study; Tablets, Oral, 100 mg QD, indefinitely, survival study; Tablets, Oral, 140 mg QD, indefinitely, survival study
Other intervention name(s): Sprycel; BMS-354825; Sprycel; BMS-354825; Sprycel; BMS-354825; Sprycel; BMS-354825
Intervention MeSH terms: Dasatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Phase Chronic Myelogenous Leukemia
Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The main objective is to know if the transcranial static magnetic field stimulation (tSMS)
      reduces the perception of pain in patients with fibromyalgia and its effect on health-related
      quality of life. In addition, it will seek to limit the parameters necessary to achieve
      efficiency with the technique.
    

Detailed description: 
      Background:

      Various non-invasive brain stimulation techniques have been successfully tested in
      fibromyalgia syndrome (FMS). Transcranial static magnetic field stimulation (tSMS) is a new,
      portable and inexpensive non invasive brain stimulation (NIBS) technique that has shown
      security, biological effects, and therapeutical effects in some pathologies. Some studies
      have studied its effect in pain central processing, our aim is to study its effect on FMS.
      The safety that tSMS has demonstrated in several clinical trials opens doors to future
      clinical trials that will extend its clinical utility.

      Objectives:

      To investigate the effect of tSMS on pain in patients with FMS, using subjective and
      objective assessment measures. Identify dose response to the treatment to limit the
      parameters required to achieve effectiveness with the technique.
    

Intervention name(s): transcranial static magnetic field stimulation (tSMS); Sham transcranial static magnetic field stimulation
Intervention type(s): Procedure; Procedure
Intervention description(s): The intervention group will receive a treatment of tSMS in the primary motor cortex.; The placebo group will receive a dummy treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial static magnetic field stimulation; fibromyalgia; pain
Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the
      Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.
    

Detailed description: 
      a randomized, controlled, double-blind study and we will be evaluated and compared the
      clinical and radiological results of concentrated autologous bone marrow against the
      hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee
      will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid,
      then every patient is considered both in control and treatment group, limiting the
      heterogenity between groups and will not be informed of the knee assigned to the treatment
      group.
    

Intervention name(s): injection of autologous bone marrow concentrate; injection of hyaluronic acid.
Intervention type(s): Biological; Biological
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: autologous bone marrow concentrate vs. hyaluronic acid.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; autologous bone marrow concentrate
A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      This study aims to establish a novel approach assisting the rational development of analgesic
      and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether
      proteins mediating inflammation and pain can be detected in an experimentally induced
      inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected
      from the inflamed skin site via small porous catheters. We wish to establish the expression
      pattern of different proteins and correlate it with various tests assessing pain.
    


Intervention name(s): Micro-plasmapheresis
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology
Condition: Bacterial Vaginosis; HIV Infections
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Disease Susceptibility
Study type: Interventional
Phase: Phase 1

Summary: 
      A non-randomized, interventional, longitudinal clinical study to quantify the impact of
      bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.
    

Detailed description: 
      Bacterial Vaginosis (BV), defined as an alteration in the normal vaginal bacteria
      ("microbiome"), is characterized by a reduction of hydrogen peroxide-producing gram-positive
      lactobacilli and overgrowth of gram-negative and anaerobic bacteria. BV is more prevalent in
      SSA and usually recurs soon after treatment. BV is associated with vaginal inflammation, an
      increased HIV acquisition risk among uninfected women, and increased HIV transmission to the
      male sexual partner of a co-infected woman. Therefore, BV may be responsible for up to 17% of
      HIV transmission events in SSA.

      There are several hypotheses for the mechanisms by which BV may increase the risk of HIV
      acquisition. These include the disruption of mucosal barrier, alteration of protective innate
      immunity, and increased number and/or susceptibility of HIV target cells in the genital
      mucosa. Longitudinal studies that address the mechanisms by which the vaginal microbiota
      alters host mucosal immunology and HIV risk will help us better understand the impact of BV
      and it's treatment on mucosal immunology and HIV susceptibility. The goal of this
      non-randomized, interventional, longitudinal clinical study is to use a novel ex vivo HIV
      infectivity assay developed in the Kaul lab to quantify the effect of BV and its treatment on
      HIV susceptibility and genital immunology in HIV-uninfected women from Nairobi, Kenya. Fifty
      HIV, STI-uninfected women with bacterial vaginosis on Nugent scoring will be provided with
      one week of metronidazole 400mg po three times daily (as per Kenyan National Guidelines).
      Cytobrush and vaginal SoftCup sampling will be performed at baseline and 4 weeks after
      treatment initiation, at the same stage of the menstrual cycle. The primary endpoint will be
      pseudovirus entry into cervix-derived CD4+ T cells. Secondary endpoints will include a
      pre-defined cervico-vaginal inflammation score; genital CD4+ T cell immune characteristics;
      the genital microbiome; the genital proteome.
    

Intervention name(s): Metronidazole
Intervention type(s): Drug
Intervention description(s): Participants will be provided with oral metronidazole 400mg po tid for one week, and followed up one month after treatment initiation.
Other intervention name(s): flagyl
Intervention MeSH terms: Metronidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Genital immunology; HIV susceptibility; Microbiome; Bacterial vaginosis; Virus entry assay
Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
Condition: Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine any significant differences in the efficacy and
      acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of
      gastrointestinal subjects undergoing a colon examination.
    

Detailed description: 
      The composite principal objective of the current study will therefore be, to determine any
      significant differences in the joint variable of efficacy and acceptability between
      CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of subjects undergoing a
      colon examination.

      The evaluation will be carried out by two blinded assessors, independent of the investigator
      who performed the procedure (endoscopist investigator). It will be assessed from images of
      different sections of the colon: cecum, ascending, transverse, descending and rectum and
      subsequent confirmation by Principal Investigator if an agreement has been reached between
      the two blinded assessors or whether it is necessary to reach consensus.

      The evaluation of the subject's acceptability will be assessed using a 5 point scale which
      assesses the difficulty of taking the product, the degree of discomfort caused by it, and the
      taste of the drug.

      The secondary objective is to evaluate the safety of CitraFleet.

      In addition a second exploratory arm of CitraFleet was included in this study (CitraFleet
      Exploratory arm). The study is not powered to make formal statistical comparisons for this
      arm. Exploratory assessment of this arm against the main CitraFleet regimen and Klean-Prep
      will be made in order to run future trials design with this schedule.
    

Intervention name(s): Sodium picosulphate, light magnesium oxide and anhydride citric acid.; Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
Intervention type(s): Drug; Drug
Intervention description(s): 2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).; 4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr).
Other intervention name(s): Citrafleet; KleanPrep PEG 4l
Intervention MeSH terms: Picosulfate sodium; Sodium sulfate; Magnesium Oxide; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Colonoscopy, Preparation, Evacuating, Bowel Cleansing.
A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.
Condition: Perioperative Hypotension; Prevention; Child
MeSH terms: Hypotension; Hypothermia
Study type: Interventional

Summary: 
      Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during
      anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing
      general anesthesia is very important. However, there is very little information about
      effectiveness of various insulating materials used in the operating room.

      Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative
      hypothermia in pediatric patients.
    

Detailed description: 
      A randomized controlled trial was conducted in 42 pediatric patients (age 1 month-3 years,
      ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary
      surgery. The patients were randomly allocated into 2 groups. The patient's arms, legs and
      bodies were wrapped with either plastic (study group) or cotton (control group). All patients
      received standard general anesthesia with endotracheal tube and control ventilation with a
      fresh gas flow at 1 l/min. The core temperature (rectal temperature) was recorded every 10
      minutes for 60 minutes.
    

Intervention name(s): Plastic wrap (study group) and cotton (control group) wrap.
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Prevention of Hypothermia; Pediatric Patient; Cotton; Plastic wrap
Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux
Condition: Gastroesophageal Reflux; Obesity
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to
      laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the
      relationship between LSG and GER the majority reported only changes in symptoms and
      manometric data, while assessment of GER using 24-hour pH monitoring is lacking.

      The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.
    

Detailed description: 
      Consecutive morbidly obese patients selected for LSG are included in a prospective clinical
      study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper
      endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive morbidly obese patients selected for LSG
      
Keywords: Obesity; Gastroesophageal reflux; sleeve gastrectomy; pH-monitoring; manometry
Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      This study looks at whether niacin improves reverse cholesterol transport (RCT) in healthy
      volunteers. 3H-Cholesterol will be used to measure RCT by analyzing changes in the tracer
      activity in total plasma, lipoproteins, red blood cells (RBCs) and stool. The hypothesis is
      that niacin augments reverse cholesterol transport.
    

Detailed description: 
      The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the
      ability of high density lipoprotein (HDL) to transport cholesterol to the liver to be
      eliminated. This process is called Reverse Cholesterol transport and is one of the main
      mechanisms by which HDL protect against atherosclerotic cardiovascular disease. The
      availability of a method to assess RCT is important for the development of new drugs which
      affect RCT and may result in useful treatments for atherosclerosis.

      This study will evaluate the use of radiolabeled particulate cholesterol administered
      intravenously in association with albumin, as a method to study reverse cholesterol transport
      (RCT) in humans before and after treatment by niacin by analyzing changes in the tracer
      activity in total plasma and lipoproteins. The study population is healthy volunteers.
    

Intervention name(s): Niacin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.; Placebo
Other intervention name(s): Niacor and Niaspan
Intervention MeSH terms: Niacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Niacin; HDL; Reverse cholesterol transport