bioihbjkbjnl/mcl2 huggingface dataset:
Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women
Condition: Hiv
Study type: Interventional

Summary: 
      Young pregnant and postpartum women living with HIV are at the greatest risk of disengagement
      from HIV services and suboptimal adherence to antiretroviral therapy (ART). Among young
      women, stigma is a major barrier to retention in services and adherence to ART, and
      interventions are needed to combat stigma and improve ART outcomes. The investigators are
      conducting a pilot study of a peer support intervention to mitigate the negative effects of
      stigma in this population.
    

Detailed description: 
      Despite major reductions in mother-to-child HIV transmission (MTCT), young pregnant and
      postpartum women living with HIV remain a vulnerable group and experience the greatest risk
      of disengagement from services and suboptimal adherence to antiretroviral therapy (ART).
      HIV-related and intersectional stigmas are major barriers to uptake and retention in
      prevention of mother-to-child transmission (PMTCT) services and drive suboptimal adherence,
      and young women experience unique stigmas. Despite this, there are no evidence-based
      interventions to combat stigma and improve ART outcomes in this group. Peer support group
      interventions have shown promise in other populations, but have not been examined in young
      pregnant and postpartum women living with HIV. The investigators are conducting a pilot study
      of a peer support intervention to mitigate the negative effects of stigma in young pregnant
      and postpartum women living with HIV in South Africa. Participants will be allocated to the
      standard of care, in which no standardized peer support groups exist for this patient
      population, or to a peer support intervention.
    

Intervention name(s): Peer support intervention
Intervention type(s): Behavioral
Intervention description(s): Peer support groups will meet monthly for the duration of follow-up, with separate groups for pregnant and postpartum women. Groups will be facilitated by women who are living with HIV and have experience of PMTCT services in this setting. Group sessions will include brief information and a structured discussion about a relevant topic, followed by opportunities for unstructured discussion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia
Condition: Oral Leukoplakia
MeSH terms: Leukoplakia; Leukoplakia, Oral
Study type: Interventional
Phase: Phase 4

Summary: 
      Photodynamic therapy for oral leukoplakia and erythroleukoplakia
    

Detailed description: 
      Photodynamic therapy for oral leukoplakia and erythroleukoplakia
    

Intervention name(s): photodynamic therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: leukoplakia; erythroleukoplakia; photodynamic therapy
Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      the current study was conducted to assess efficacy of vaginal misoprostol before IUD
      insertion following previous insertion failure
    


Intervention name(s): Misoprostol; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): vaginal misoprostol prior IUD insertion; vaginal placebo tablet prior IUD insertion
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Acupuncture Compared With "Sham" Acupuncture for Treatment of Chronic Neck Myofascial Pain
Condition: Chronic Neck Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      In order to investigate the therapeutic effect of acupuncture on chronic neck myofacial pain
      syndrome, the investigaotrs designed a pilot study of a single-blind randomized controlled
      trial. A total of 34 chronic neck myofacial pain syndrome patients were selected from
      Department of Neurology of Nantou Hospital, Department of Health. The age ranged from 18 to
      85, and all subjects were full informed consent and volunteers. They were divided into two
      groups of 17 subjects randomly as follows: acupuncture group, acupuncture stainless needles
      were inserted into bilateral Fenhchi, Jianliao and Houxi acupoints, respectively. The
      acupuncture needles then were manual twist and de Qi, and remain for 20 min; sham acupuncture
      group, the methods were identical the acupuncture group, but acupuncture stainless needles
      were inserted into subcutaneous tissue only. All the subjects were treated with acupuncture
      two times per week and continuously three weeks, i.e. Six times acupuncture treatment. The
      therapeutic effect of acupuncture was assessed before and finishing six times acupuncture
      treatment, and four weeks and twelve weeks after stopping acupuncture, respectively. The
      index of acupuncture therapeutic effect was according to the range of motion (ROM) of the
      cervical spine, the intensity of pain (Short-Form McGill Pain Questionnaire; SF-MPQ) and
      quality of life (SF-36). The investigators expect acupuncture apply to bilateral Fenhchi,
      Jianliao and Houxi acupoints may relief the pain and motion of chronic neck facial pain
      syndrome patient, and also improves the life quality.
    


Intervention name(s): acupuncture
Intervention type(s): Device
Implementing OSCE in Team Based Learning Format for Teaching Clinical Skills to Undergraduate Medical Students
Condition: OSCE (Objective Structured Clinical Examination); TBL (Team Based Learning); Teaching Clinical Skills to Undergraduate Medical Students
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the effectiveness of using OSCE(objective
      structured clinical exam) on principles of TBL (team based learning) in teaching clinical
      skills to undergraduate medical students. The main question it aims to answer is whether
      using OSCE on TBL format is an effective role for teaching clinical skills in undergraduate
      medical students.

      4th year MBBS students included in study after informed written consent. By simple random
      sampling students divided into two groups i.e. Experimental and control group.

      Control group was named Group A while the interventional group was Group B. Control group
      (Group A) underwent traditional teaching of skills as routinely carried out in gynecology
      department during clinical clerkship of three weeks. Group B underwent intervention in the
      form of learning session where OSCE was implemented on principles of Team-based learning.
      Both groups had pre-test at start of study in the form of two OSCE stations with
      pre-validated checklists, to check their baseline knowledge. Post-test on same stations was
      taken after traditional teaching for group A and intervention for group B. The groups were
      later crossed over so no student was devoid of the learning experience.
    


Intervention name(s): modification of OSCE using TBL format
Intervention type(s): Other
Intervention description(s): Modification of Team-based learning format and implementing OSCE using that modified format to teach clinical skills to medical students.To teach clinical skills this structure of TBL was modified and with use of OSCE following strategy was planned as intervention. First of all, the students were provided with the resource material regarding the skills to be taught. Then a formative OSCE session was organized where students were divided into groups each with 5 students. They were rotated in two OSCE stations. First each student one by one was supposed to perform the task that was clearly documented and was evaluated by peers and facilitator. Immediate feedback from peers and facilitators was given to each student. Students were also instructed to discuss among themselves and designate roles also to make a plan and act like team in performing task on OSCE station 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Condition: Allogeneic Hematopoietic Stem Cell Transplantation
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects
      in many body tissues, organs and systems such as immune, cardiovascular, pulmonary,
      gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and
      skin.Available limited numbers of studies showed that inspiratory muscle weakness in
      allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies
      demonstrated beneficial effects of inspiratory muscle training on several outcomes in
      different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart
      failure, no published paper reported the effects of IMT in allo-HSC recipients.
    

Detailed description: 
      Thirty-eight allo-HSCT recipients (˃100 days past post-transplant status) were included.
      Before and after 6-week IMT, maximal and submaximal exercise capacity, respiratory and
      peripheral muscle strength, pulmonary functions, dyspnea and fatigue perception, depression
      and quality of life were evaluated. Primary outcome measurement was respiratory muscle
      strength, secondary outcomes were exercise capacity, dyspnea, peripheral muscle strength,
      quality of life, fatigue and depression.
    

Intervention name(s): Inspiratory muscle training; Sham inspiratory muscle training
Intervention type(s): Device; Device
Intervention description(s): Treatment group received inspiratory muscle training using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP).
The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload.
The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.; Control group received sham inspiratory muscle training using threshold loading device (POWERbreathe Classic IMT Technologies Ltd. Birmingham, England) at fixed workload, 5% of MIP.
The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180
      mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on skin wheals
      and flares induced by seasonal allergen.
    


Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The safety and efficacy of a chewable formulation of extended-release methylphenidate will be
      studied in children with ADHD
    


Intervention name(s): NWP09; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Methylphenidate, variable dose, daily dosing, 1 week duration; Placebo
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; methylphenidate extended-release
A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis
Condition: Bronchitis, Chronic
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compared the clinical efficacy and safety of azithromycin with that of
      amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with
      an exacerbation of chronic bronchitis.
    


Intervention name(s): Amoxicillin/clavulinic acid; Azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days; Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
Intervention MeSH terms: Amoxicillin; Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the effect of CK-2127107 relative to placebo on cycle
      ergometer exercise tolerance, assessed as change from period baseline in constant work rate
      (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with
      integrated electrocardiogram (ECG). The time to intolerance was assessed by a stopwatch and
      verified from electronic recordings of the cycle ergometer.

      This study assessed cardiopulmonary and neuromuscular effects of CK-2127107 relative to
      placebo; the effect of CK-2127107 on resting spirometry relative to placebo; the safety and
      tolerability of CK-2127107 as well as the pharmacokinetics of CK-2127107.
    

Detailed description: 
      Enrolled participants were randomly assigned to 1 of 2 treatment sequences and received both
      CK-2127107 and matching placebo over 2 treatment periods.
    

Intervention name(s): Reldesemtiv; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Other intervention name(s): CK-2127107
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; CK-2127107; COPD
Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      ALS is a debilitating disease with varied etiology characterized by rapidly progressive
      weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking
      (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is
      the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment
      that has been found to improve survival but only to a modest extent. It lengthens survival by
      several months, and may have a greater survival benefit for those with a bulbar onset. It
      also extends the time before a person needs ventilation support.Stem cell transplantation is
      a new hopeful way to improve the patients conditions and reduce the period of disabilities.
    

Detailed description: 
      In this study our purpose is to evaluate the safety of intraventricular injection of bone
      marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow
      aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell
      intraventricular injection by stereotaxis.after injection he will be under observed in ICU to
      monitor the adverse events(allergic and neurological side effects).patients are followed
      1th,3th ,6th and 12 months after injection and each time these parameters are
      checked:ALS-FRS,EMG-NCV,FVC,side effect check list.
    

Intervention name(s): intrathecal injection
Intervention type(s): Biological
Intervention description(s): Intrathecal injection of mesenchymal stem cells in patients with ALS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS intrathecal injection bone marrow mesenchymal stem cell
Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on
      vision-specific quality of life. This study attempts to confirm this statement and assess
      whether cross-linking and cross-linking combined with photorefractive keratectomy improve
      vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.
    


Intervention name(s): Corneal Cross Linking; Corneal Cross Linking combined with topoguided PRK
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Keratoconus; Corneal cross Linking; Topo guided PRK; Quality of Life
Coached, Coordinated, Enhanced Neonatal Transition (CCENT)
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study will evaluate a new neonatal follow-up model that offers additional support and
      coping resources for parents during their child's NICU admission as well as during their
      transition home. The Coached, Coordinated, Enhanced Neonatal Transition (CCENT) model
      involves a key worker who will be the primary support for families during the first year of
      their child's life. The key worker's role involves 1) parental coaching using an Acceptance
      and Commitment Therapy approach, 2) coordinating care across various levels of care as well
      as supporting families in system and resource navigation, and 3) provided proactive education
      targeting normal challenges in caring for a child who required intensive care support. The
      goal is to improve the psychosocial support and medical care coordination beyond the neonatal
      intensive care unit as many of the medical and social concerns do not end at the time of
      discharge. Primary objective is parent stress at 12 months.
    


Intervention name(s): CCENT Intervention
Intervention type(s): Other
Intervention description(s): Acceptance and Commitment Therapy approach: engaging families through structured individual or group sessions within the NICU and continue this support once discharged.
Care coordination: supporting providers in clear communication when liaising across various levels of care as well as supporting families in system and resource navigation.
Anticipatory guidance: proactive education targeting normal challenges in caring for a child who required intensive care support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Neonatal Intensive Care Unit; Mindfulness; Care coordination; Anticipatory guidance; Parental support; Neonatal follow-up; Acceptance and Commitment Therapy
A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
Condition: Alzheimer's Disease; Huntington's Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the absorption, safety, and tolerability of a dimebon transdermal solution
      relative to the dimebon immediate release oral formulation.
    


Intervention name(s): Dimebon IR; Dimebon Transdermal; Dimebon Transdermal; Dimebon IR; Dimebon Transdermal
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.; A single, transdermal 5 mg dose of dimebon free base solution will be applied to the back over a 24 hour period. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.; A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.; A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.; A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose in Cohort 1. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: percutaneous transcutaneous dimebon transdermal pharmacokinetics
Shivering and Glucose Homeostasis
Condition: Healthy Overweight/Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of prolonged shivering thermogenesis
      on glucose homeostasis in overweight/obese humans.
    


Intervention name(s): Cold exposure
Intervention type(s): Other
Intervention description(s): Subjects will be exposed to shivering thermogenesis for at least 1 hour for 10 days
Intervention model: Single Group Assignment
Intervention model description: a single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Shivering thermogenesis; skeletal muscle