bioihbjkbjnl/mcl2 huggingface dataset:
Intimate Partner Violence (IPV)Screening in Health Care Clinics in Rural South Carolina
Condition: Partner Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to implement universal screening for intimate partner violence
      (IPV) and to test two clinic-based interventions for women who screen positive for current or
      recent IPV. The study population will be implemented in Pee Dee region of the state of South
      Carolina and will include primarily low-income women who seek care at selected primary health
      care clinics in the region.

      In this study, all women 18 and older receiving care at selected primary care clinics will be
      offered screening for IPV annually. Clinicians will use a structured screening tool to assess
      physical, sexual, and psychological IPV in a current relationship (IPV+) or IPV experienced
      by the woman in the past five years (Recent IPV). Clinics will be randomly assigned to
      implement a clinic-based intervention for women who screen positive for current or recent
      IPV. Two interventions will be implemented using a factorial design. In the
      Empowerment-Focused Patient Education Intervention, clinicians will conduct a 7-session
      intervention focusing on the health and well-being of the woman and attempt to link women's
      IPV experience with their health. In the IPV Services Intervention, IPV Specialists who are
      trained advocates from the Pee Dee Coalition Against Domestic and Sexual Assault (PDC) will
      be based in the clinic to (a) counsel women about IPV including safety planning, (b) provide
      linkages to PDC services, and (c) link women to clinic-based support groups developed
      specifically for this project.

      We hypothesize the intervention(s) will change (a) clinician screening, referral, and IPV
      documentation patterns, (b) clinician IPV knowledge and perceived skills in working with
      women who have experienced IPV and their children (c) women's help-seeking behaviors, risk of
      poor mental and physical health, and (d) women's risk of subsequent IPV victimization. To
      evaluate these outcomes, we will survey clinicians and prospectively follow a group of
      consenting IPV+ women (N=300 in each intervention arm) to assess changes in their
      help-seeking, health behavior and status, IPV experience over two-years of follow-up.
    


Intervention name(s): Onsite IPV specialist; Empowerment focused intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: partner abuse; screening; intimate partner violence
Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks
Condition: Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin
      with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in
      subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..
    


Intervention name(s): Rosuvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 40mg; 80mg
Other intervention name(s): Crestor; Lipitor
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cholesterol; low density lipoproteins; Hypercholesterolemia; Coronary Heart Disease; Rosuvastatin; Crestor; Atorvastatin; Lipitor
Psychotherapy of Anxiety Disorders With Noninvasive Brain Stimulation - Using Virtual Reality
Condition: Phobia
Study type: Interventional

Summary: 
      The aim of the study is to transfer the rTMS stimulation protocol by Raij et al. (2018) into
      a therapeutic setting to improve exposure therapy in acrophobic patients. The
      quasi-randomized, placebo-controlled and double-blinded study will include 88 patients with
      height phobia (according to DSM 5). All participants will perform two exposure sessions in
      virtual reality (VR). Before exposure therapy, one group will receive verum rTMS of the left
      frontal cortex, which is indirectly functionally linked to the ventromedial prefrontal cortex
      (Raij et al., 2018). The control group will receive sham stimulation. A structural MRI and a
      TMS navigation system will be used for precise localization of the left FC. Anxiety symptoms
      will be measured using subjective ratings (e.g. Acrophobia Questionnaire) and the behavioural
      approach task (BAT) in VR and in real life before and after the treatment, and at 6 months
      follow-up. Furthermore, blood samples will be collected before rTMS and after exposure
      treatment to assess epigenetic and gene expression based changes.
    

Detailed description: 
      The following hypotheses are derived:

        1. Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a
           significantly stronger reduction of phobic symptoms immediately after exposure therapy,
           compared to the sham stimulation group.

        2. Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a
           significantly greater increase in approach behavior and significantly less distress
           during the BAT immediately after exposure therapy, compared to the sham stimulation
           group.

        3. The postulated differences in hypotheses 1 and 2 are still detectable at follow-up after
           6 months.
    

Intervention name(s): Verum TMS; Sham TMS
Intervention type(s): Device; Device
Intervention description(s): Intensity of 100% of the resting motor threshold with iTBS. 600 stimuli applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s.; Sham stimulation with same protocol, but without magnetic stimulation
Other intervention name(s): Cool-B70 A/P, MagPro X100, MagVenture®, Denmark; Cool-B70 A/P, MagPro X100,, MagVenture®, Denmark
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: VR; Exposure therapy; Acrophobia; rTMS; PFC
Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women
Condition: Sexual Functions and Problems in the Adult
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.
    

Detailed description: 
      Sexuality is an integral part of every personality, influence thoughts, feelings, actions,
      integrations, and therefore the physical and mental health. It is estimated that 43% of women
      have at least one complaint of sexual problem. Disorders of desire and arousal are among the
      most common problems found in gynecologic practice. Medicinal plants have been used for
      therapeutic purposes for thousands of years, and aphrodisiac properties described in several
      plants. Tribulus terrestris is a plant indigenous to India, recommended in the treatment of
      infertility, low libido and impotence, and its main active ingredient protodioscin (PTN).
    

Intervention name(s): Placebo; Tribulus terrestris
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet/ oral/ 3 times a day for 90 days; 1 tablet of 250mg/ oral/ 3 times a day for 90 days
Other intervention name(s): lot 168159; lot 168059
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Menopause; Sexual dysfunction; Tribulus; Sexuality; Phytotherapeutic Drugs
A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability, safety, and
      tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
    


Intervention name(s): telaprevir formulation A; telaprevir Formulation B; telaprevir Formulation C; telaprevir Formulation D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single 1125-mg dose administered orally; A single 1125-mg dose administered orally; A single 1125-mg dose administered orally; A single 1125-mg dose administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Relative bioavailability; telaprevir formulations
CC-42344 Safety Study in Healthy Participants
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD)
      parts.
    

Detailed description: 
      This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study
      drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between
      18-55 are planned to be enrolled in this study in two parts.

      Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4
      groups of 8) will be assigned randomly to receive a single oral dose of the study drug or
      placebo. The placebo will look the same as the study drug but will not contain any medicine.
      An additional 6 participants will receive a single oral dose of CC-42344 to help further
      understand the effect of food on the uptake of the drug.

      Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8)
      will be randomized to receive an oral dose of study drug or placebo given once a day for 14
      days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the
      study drug but will not contain any medicine.
    

Intervention name(s): CC-42344; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CC-42344 capsules; Placebo capsules
Other intervention name(s): Active
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 4 cohorts for SAD, with food cohort; 5 cohorts for MAD; 6 active and 2 placebo per cohort; 6 additional active in food cohort
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Synbiotic on Immune Response, Gut Permeability and Microbiota in Patient With Connective Tissue Disease
Condition: Connective Tissue Diseases
MeSH terms: Connective Tissue Diseases
Study type: Interventional

Summary: 
      This is a double blind randomized placebo controlled trial to determine the effect of
      synbiotic to FOXP3 regulatory T cells, IL-17, gut permeability and gut microbiota in patients
      with connective tissue disease. Synbiotic can increase FOXP3 regulatory T cells, decrease
      IL-17 and improve gut permeability and gut microbiota in patients with connective tissue
      disease.
    

Detailed description: 
      Study showed gut microbiota has a role in the pathogenesis of autoimmune diseases. Gut
      microbiota which can increase gut permeability affect the antigen presentation to the immune
      system. Synbiotic supplementation is expected to improve immune system, gut permeability, and
      gut microbiota in patients with connective tissue disease.

      The subjects who fulfill inclusion criteria, willing to participate and sign informed consent
      will be randomized into two groups: the group receiving synbiotic containing probiotic
      (Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, dan Bifidobacterium
      bifidum R0071 20%) and 80 mg fructooligosaccharide (group I, n=23) and the group receiving
      placebo (group II, n=23). Both groups receive intervention for two months. Patients continue
      to receive their immunosuppressive drugs (corticosteroids, hydroxychloroquine, mycophenolate
      mofetil, azathioprine, or cyclosporine).

      Percentage of FOXP3 Regulatory T-cells, serum IL-17, zonulin, high sensitivity C-reactive
      protein, and gut microbiota are evaluated at the beginning and at the end of the study. FOXP3
      regulatory T-cell is evaluated by flowcytometry. Serum IL-17 and zonulin are measured by
      ELISA. Gut microbiota is evaluated using 16s ribosomal RNA gene next generation sequencing.
      The DNA from the stool is isolated by DNA stool mini kit (QIAamp).

      The results are presented in mean ± standard deviation, median (IQR 25-75%) and n (%). The
      Kolmogorov-Smirnov test is used to determine the normality of the data, assuming the
      normality of the data is fulfilled if p> 0.05. Bivariate analysis uses paired T test if the
      data has normal distribution. If the distribution is not normal, Wilcoxon test will be used.
      Differences are said to be significant when the value of p <0.05.
    

Intervention name(s): Synbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsule; capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: synbiotic; probiotic; lupus; connective tissue disease
A Pilot Study of Terazosin for Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The TZ-PD trial will be a 1:1 (active:placebo) randomized, double-blind, placebo-controlled
      Phase II trial to evaluate the safety and tolerability of terazosin for the treatment of PD.
    

Detailed description: 
      This will be a single center, randomized, double-blind, controlled, pilot study to assess the
      safety and tolerability of terazosin (TZ) at a dose of 5 milligrams (MG) daily for patients
      with PD. The primary goal of this study is to assess the safety and tolerability of TZ in
      patients with PD. This is a pilot study and is not powered to assess efficacy of this
      medication. Our hope is that this study will guide future studies of this (and similar)
      medications for the disease modification of PD. This study is also aimed to learn more about
      how patients with produce and use energy and if TZ can help to reverse energy deficits that
      appear in PD.
    

Intervention name(s): Terazosin 5 MG; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): 5 milligrams by mouth daily at bedtime; 1 capsule by mouth daily at bedtime
Other intervention name(s): Hytrin; Placebo
Intervention MeSH terms: Terazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: terazosin
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Condition: Advanced Hematologic Malignancies; Leukemia; Preleukemia
MeSH terms: Neoplasms; Hematologic Neoplasms; Preleukemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a clinical research study designed to evaluate whether a conditioning regimen
      consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine
      supported by donor blood cells will result in rapid recovery and a high rate of long-lasting
      remissions in patients with leukemia, lymphoma and myeloma.
    


Intervention name(s): Clofarabine; Melphalan; Campath; Stem Cell Transplant
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).; Doses ranging from 100 to 140 mg/m2; 20mg/d x5; Infusion of donor, bone marrow and auto.
Intervention MeSH terms: Melphalan; Alemtuzumab; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melphalan; Alemtuzumab; Clofarabine
Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Study type: Observational

Summary: 
      The purpose of this study is to examine whether patients can use the AliveCor case to record
      their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm
    

Detailed description: 
      AliveCor is a new monitoring technology used with a smart phone which allows patients to
      record their rhythm. The study will compare AliveCor recordings and automated interpretation
      of the rhythm with the interpretation by an Electrophysiologist.
    

Intervention name(s): Record and transmit heart rhythm
Intervention type(s): Device
Intervention description(s): The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the hospital for your atrial fibrillation or atrial flutter
Optimization of Antiviral Therapy of Chronic HBV Infection
Condition: Australia Antigen Positive; Hepatitis B; Adverse Effects
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      Along with the improvement of the accuracy of detection of HBV serological markers, the
      optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection
      becomes feasible. Currently, the recommendation of optimized treatment especially interferon
      therapy are mainly based on retrospective studies, it still lacks prospective evidence. This
      study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks
      optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg
      positive CHB with inadequate response to 24 weeks interferon treatment.
    

Detailed description: 
      Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this
      study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these
      patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were
      observed. Safety and the economic effect of the two optimized therapy methods also were
      observed.
    

Intervention name(s): Interferon Alfa-2a add on ADV
Intervention type(s): Drug
Intervention description(s): Interferon add on ADV for 48 weeks
Other intervention name(s): Response guild treatment; optimized therapy; Chronic HBV infection
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a
        were enrolled.
      
Biospecimen description: 
      Blood samples were retented at 12w,24w and 48w after optimized therapy
    
Keywords: HBeAg seroconversion; Peginterferon alfa-2a; chronic hepatitis B(CHB; Optimal therapy; Response guild treatment(RGT);
The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors
Condition: Diabetes; Cardiovascular Risk
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The investigators propose to perform a double-blind, randomized placebo-controlled trial to
      examine the hypothesis that soy protein with isoflavones could improve glycemic control,
      insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with
      prediabetes.
    


Intervention name(s): soy protein; isoflavones; milk protein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Caseins
Plaster Cast Versus DJO Walker in Paediatric Ankle Injuries
Condition: Ankle Sprain Strain
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      Present treatment of children with stable ankle and foot injuries very often involves a
      period in plaster cast(s). In the last decade in adult patients this has been superceded in
      many instances by the use of a removable foot brace/splint.

      There are many benefits to this approach including progressive rehabilitation, reduced costs
      in materials and personnel, improved hygiene and adaptability of fit. The use of such a
      splint has not been investigated in children and this project aims to assess the value of
      introducing this as a treatment mode through the analysis of outcomes between traditional
      cast treatment and the newer removable brace/splint treatment. The outcomes will include
      patients' preferences, clinical results and relative costings.
    

Detailed description: 
      The study is a longitudinal cohort study of all eligible ankle injuries per the eligibility
      criteria presenting to Sheffield Children's NHS Fountain Trust. These children and their
      parents/carers are presented with an information sheet regarding the study and are then
      invited to enter the study.

      Once consented - by appropriately trained research and/or clinical staff - those recruited
      are treated in either cast or boot on the basis of block randomisation.

      Patients are followed up per protocol and outcomes completed by patients and clinicians.

      Study information is kept securely for future analysis and write up.
    

Intervention name(s): DJO Walker; Traditional plaster cast
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is meant to assess the effectiveness of idebenone on neurological outcome measures
      in patients with Friedreich's Ataxia over a 6 months period.
    

Detailed description: 
      The study involves 6 clinic visits and upon completion the possibility to join a 12 months
      extension study where all patients will receive high dose Idebenone.
    

Intervention name(s): Idebenone; Idebenone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients > 45 kg/99 lbs: idebenone 900 mg/day; Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients > 45 kg/99 lbs: idebenone 2250 mg/day; Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
Intervention MeSH terms: Ubiquinone; Idebenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Friedreich's Ataxia; Idebenone; ICARS