bioihbjkbjnl/mcl2 huggingface dataset:
An Evaluation of a Customized Insole to Provide Relief From Heel Pain Due to Plantar Fasciitis or General Heel Pain When Used in Footwear Over a Period of Four Weeks
Condition: Foot Orthoses
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      The primary objective of this trial will be to demonstrate the ability of a 3/4 length foam
      insole to provide relief from pain due to plantar fasciitis or general heel pain when used in
      footwear over a 4-week period of time
    


Intervention name(s): BPI1000013
Intervention type(s): Device
Intervention description(s): Foam insole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health
Condition: Obesity
Study type: Interventional

Summary: 
      Obesity- related diseases are linked to elevated levels of inflammation, oxidative stress,
      and metabolic dysfunction. Methylsulfonylmethane (MSM) is a naturally occurring compound that
      demonstrates antioxidant and anti-inflammatory effects. Improvements in measures of metabolic
      health have been observed in mouse models of obesity and type 2 diabetes following MSM
      treatment. However, the effect of MSM on obesity-related risk factors for disease in humans
      has not been investigated. Therefore, the purpose of this investigation will be to determine
      whether MSM supplementation improves metabolic health, and markers of inflammation and
      oxidative status.
    


Intervention name(s): methylsulfonylmethane; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3g per day; white rice flour
Other intervention name(s): MSM
Intervention MeSH terms: Dimethyl sulfone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind placebo controlled randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and
      coadministered lesinurad and allopurinol tablets in the fasted state based on the
      pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.
    


Intervention name(s): lesinurad/allopurinol 200/300 FDC tablets; lesinurad 200 mg; allopurinol 300 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Test Drug; Comparator 1; Comparator 2
Intervention MeSH terms: Allopurinol; Lesinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS
Condition: Gulf War Syndrome; Headache
MeSH terms: Headache; Persian Gulf Syndrome
Study type: Interventional

Summary: 
      This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS)
      on Gulf War illness related headaches and pain.
    

Detailed description: 
      Headaches (HA) and wide spread pain are some of the most common debilitating symptoms in Gulf
      War Veterans (GWV) with Gulf War Illness (GWI). Migraine like HA and diffuse body pain were
      detected in 64% of GWV with GWI. This high prevalence of chronic HA and diffuse body pain
      conditions are often associated with neuropsychological dysfunction in mood, attention,
      memory and other systemic symptoms, which cast a profound negative impact on patients'
      quality of life. Unfortunately, conventional pharmacological treatments for GWI related
      headaches and pain (GWI-HAP) has not been shown to be effective and drugs such as narcotics
      contain many long term untoward psychosomatic and abusive side effects. Therefore, developing
      and validating non-invasive and low risk innovative treatment for this patient population is
      warranted. Transcranial Magnetic Stimulation (TMS) is currently a US FDA approved treatment
      for major depression and migraine HA.
    

Intervention name(s): Repetitive transcranial magnetic stimulation; Repetitive transcranial magnetic stimulation (sham)
Intervention type(s): Device; Device
Intervention description(s): A non-invasive method of brain stimulation that emits a magnetic pulse.; No brain stimulation will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gulf War Illness; Headache; Muscle Pain; Joint Pain; TMS
Folate Supplementation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to examine factors potentially contributing to differences in blood folate,
      homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low
      folate is associated with negative symptoms, and to examine the efficacy of folate
      supplementation for reducing negative symptoms.
    

Detailed description: 
      This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia
      patients who score at least a 3 (moderate or greater severity) on at least one of the SANS
      global assessment subscales, with the exception of the attention global assessment subscale.
      The specific aims of this study are:

        -  To examine factors potentially contributing to differences in blood folate, homocysteine
           or B12 levels between patients at baseline, including dietary intake and cigarette
           smoking.

        -  To test the hypothesis that low folate is associated with negative symptoms by examining
           correlations between red blood cell folate concentrations and clinical ratings of
           negative symptoms and by comparing folate concentrations in deficit syndrome versus
           non-deficit syndrome patients. We will also control for dietary intake cigarettes
           smoking, gender, and age.

        -  To examine the efficacy of folate supplementation for reducing negative symptoms
    

Intervention name(s): Folate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Folic acid taken as 2, 1mg capsule daily for 12 weeks; Placebo taken as 2, 1mg capsule daily for 12 weeks
Other intervention name(s): Folate or folic acid
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Negative Symptoms; Folate
The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index
Condition: Asthenozoospermia
MeSH terms: Asthenozoospermia
Study type: Interventional
Phase: Phase 2

Summary: 
      Although several studies have considered the relationship between infertility and semen thiol
      compounds levels, no study on the effects of asthenospermia treatments such as oral zinc
      supplementation on thiol related enzymes activity which are important in fertility of the
      individual has been reported.
    

Detailed description: 
      The present study was conducted to study the effect of zinc supplementation on the
      quantitative and qualitative characteristics of semen along with reduced thiol, oxidized
      thiol and thiol related enzymes in the seminal plasma of asthenospermic patients.
    

Intervention name(s): zinc sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
Intervention MeSH terms: Zinc Sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zinc supplementation; Thiol; Glutathione peroxidase; Sulfhydryl oxidase
Assessment of Two Point Discrimination
Condition: Assessment, Self
Study type: Interventional

Summary: 
      When the studies in the literature are examined, no study has been reached to examine whether
      median nerve mobilization causes changes in two-point discriminatory values in healthy
      individuals. This study aimed to investigate the effect of median nerve mobilization exercise
      on two-point discrimination in healthy adult male and female participants. Secondly, it was
      aimed to determine the role of variables such as gender, age, BMI (weight in kilograms,
      height in meters and weight and height will be combined to report BMI in kg/m^2), smoking,
      dominant extremity and physical activity level in 2-point discrimination.
    

Detailed description: 
      Two-point discrimination is one of the most important cortical senses that require strong
      tactile sensitivity and the ability to distinguish two points from one point on the skin.
      Neural mobilization has been reported to be effective in the nerve-related waist, leg, neck,
      arm, and plantar heel pain, but there is still insufficient evidence for other
      neuromusculoskeletal problems. It has been stated that factors such as application technique,
      type and patient characteristics of mobilization are effective in the treatment and more
      comprehensive studies should be done on this subject. This study aimed to investigate the
      effect of median nerve mobilization exercise on two-point discrimination in healthy adult
      male and female participants.

      120 healthy female and male adult individuals (60 females, 60 males) will be included in the
      study. Individuals will be divided into two groups as female and male (n = 60), and a
      two-point discrimination test will be performed on the palmar face of both hands from the
      distal phalanx, forefinger, middle finger and palm. After the evaluation, the participants in
      both groups were randomly divided into two groups as the exercise group (n = 30) and control
      group (n = 30). Participants in the exercise group will perform 2 sets of 5 repetitive Median
      nerve mobilization exercises (total of 20 sessions) per day for 10 days. After the exercise
      program, the two-point discrimination measures will be repeated in all groups.
    

Intervention name(s): Mobilization of median nerve
Intervention type(s): Device
Intervention description(s): Neural mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: two-point discrimination; neural mobilization; tactile sensation; median nerve
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
Condition: KNEE OSTEOARTHRITIS
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomized, double-blind clinical trial in a Chinese population
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-positive, phase iii study evaluating
      the efficacy and safety of brothamine hydrochloride spray in patients with knee
      osteoarthritis
    

Intervention name(s): X0002 Spray; Celecoxib capsules; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day; X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day; X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day
Other intervention name(s): Test drug; Active comparator; Placebo Spray
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Complex and chronified pain syndromes requires a specialized therapeutic concept. From
      patients with chronic low back pain the investigators know, that an interdisciplinary
      multi-modal approach may improve the therapeutic success. In this observational study the
      investigators investigated if the multi-modal pain therapy is also effective in patients with
      mixed chronic pain syndromes.
    

Detailed description: 
      The multi-modal pain therapy includes:

        -  specific drug therapy

        -  pain education

        -  psychological therapy

        -  physical therapy

        -  behavioral therapy

        -  work hardening

        -  bio-feedback

        -  ergotherapy
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        260 consecutive patients with chronic pain syndromes
      
Keywords: multi-modal pain therapy, chronic pain
Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions
Condition: Schizophrenia
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To verify the efficacy of a group cognitive-behavioral therapy approach to lessening
      psychotic symptoms of individuals with a first episode of psychosis, and to compare its
      effects to a known skills training approach and a control group. Our primary hypotheses were
      that CBT would do better than the control group at all points in time, and better than the
      skills training approach, though only at follow-ups
    

Detailed description: 
      The study's protocol has the following objectives: to verify the efficacy of a group CBT
      approach; to compare the effects of CBT to those of the symptom management module and to a
      control group on psychotic symptoms and subjective experiences (e.g., depression, anxiety,
      self-esteem, social support, insight, and coping); and to assess what the effects are related
      to, via measuring client variables, therapist variables, and intervention variables that
      might explain the results. This study follows a randomized controlled trial design where
      participants are randomly assigned to one of the three groups at each recruiting wave. Both
      treatment modalities hold the same number of group meetings as well as similar formats,
      lengths of treatment and operational structures, each operationalized in detailed manuals.
      Interviewers are blind to group allocation. Symptoms, both psychotic and otherwise,
      depression, self-esteem, social adaptation, anxiety, insight, social support, and coping are
      all measured before the beginning of treatment, three months follow-up, nine-months
      follow-up, and 15-months follow-up
    

Intervention name(s): Cognitive-Behavioral therapy and Symptom Management
Intervention type(s): Behavioral
Intervention description(s): A group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and comparison its effects to a known skills training approach and a control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cognitive-behavioral therapy; symptom management; first psychotic episode
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the functional mobility and self-reported satisfaction
      with the Xavier electromyography hands-free wheelchair control system in comparison with a
      standard joystick.
    


Intervention name(s): Xavier wheelchair controller
Intervention type(s): Device
Intervention description(s): Controlling a wheelchair using the Xavier surface EMG system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Asthma Link: A Real World Application of School Supervised Asthma Therapy
Condition: Childhood Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this study is to assess the feasibility of a clinical trial to evaluate the
      impact and process of deploying school-supervised asthma therapy in a real-world setting for
      children with poorly controlled asthma (aged 6-17 years).
    

Detailed description: 
      The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of
      conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy
      program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites
      versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads
      enrolled per site (N=72 dyads).

      Primary trial outcomes will be participant recruitment, retention, and intervention fidelity.
      Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency
      department visits, hospital admissions, courses of oral corticosteroids, spirometry values,
      medication adherence and school absences between intervention and enhanced usual care sites
      at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability,
      adoption, costs, sustainability).
    

Intervention name(s): Asthma Link; Enhanced Usual Care
Intervention type(s): Other; Other
Intervention description(s): Providers enroll patients in school nurse supervised daily controller asthma medication delivery; Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: asthma; childhood asthma; stakeholder engagement; medication adherence; school-supervised asthma therapy; real-world; pragmatic trial
DNA Analysis in Influencing Response to Rituximab in Samples From Patients With Follicular Lymphoma Treated on ECOG-E4402
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors predict how well patients will respond to treatment.

      PURPOSE: This research study is studying DNA isolated from blood samples to see how well it
      influences response to rituximab in patients with follicular lymphoma treated on clinical
      trial ECOG-E4402.
    

Detailed description: 
      OBJECTIVES:

        -  To test the influence of killer immunoglobulin-like receptor (KIR) and human lymphocyte
           antigen (HLA) genotype on response to anti-CD20 antibody lymphoma immunotherapy.

      OUTLINE: DNA samples are analyzed for killer immunoglobulin-like receptor (KIR) and human
      lymphocyte antigen (HLA) genotyping with sequence-specific primers (SSP) by real-time PCR.
      KIR and HLA typing are analyzed according to KIR-HLA matched vs mismatched, KIR B haplotype
      content, and the number of inhibitory KIR-HLA pairs. Results are then correlated to each
      patient's overall response and duration of response to rituximab.
    

Intervention name(s): rituximab; DNA analysis; gene expression analysis; polymerase chain reaction; laboratory biomarker analysis
Intervention type(s): Biological; Genetic; Genetic; Genetic; Other
Intervention MeSH terms: Rituximab
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E4402 from whom samples were submitted for research
      
Keywords: stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Hot Flashes
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri-
      and postmenopausal women who are experiencing sleep difficulties related to nighttime hot
      flashes.
    


Intervention name(s): suvorexant; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10-20 mg taken at bedtime for four weeks; placebo taken at bedtime for four weeks
Other intervention name(s): Belsomra
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insomnia; hot flashes; menopause; suvorexant; belsomra
Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers
Condition: Gastroduodenal Ulcer
MeSH terms: Peptic Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      Gastroduodenal ulcers are extremely common in the community today. Though much has been
      written and observed concerning how ulcers form, not much has been described in the human
      model concerning how these ulcers heal. As numerous patients already suffer from
      gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the
      treatment and management of these patients. The goal of this study is to investigate the
      effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal
      lesions in order to elucidate the mechanisms of ulcer healing. This single site,
      single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer
      healing through endoscopic, immunohistologic, and molecular PCR modalities.
    

Detailed description: 
      In order to assess the extent of healing of the biopsy sites, a 12-point scale was developed
      and validated.

      After all of the procedures were complete, this scale was used to measure the effects of the
      study drugs on the healing of the biopsy-induced ulcers.
    

Intervention name(s): Naproxen; Aspirin; Celecoxib; Clopidogrel; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet 500mg BID for 8 days; 1 tablet 81mg QD for 8 days; 1 capsule 200mg QD for 8 days; Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days; 1 capsule BID for 8 days
Other intervention name(s): naprosyn; naproxen sodium; Aleve; Anaprox; Miranax; Naprogesic; Naprelan; Proxen; Synflex; ASA; Bayer; Celebrex; Plavix; sugar pill
Intervention MeSH terms: Aspirin; Celecoxib; Naproxen; Clopidogrel
Keywords: NSAID; ulcer; gastroduodenal ulcer; naproxen; aspirin; ASA; celecoxib; clopidogrel; healing; Cyclooxygenase 2 Inhibitors; Anti-Inflammatory Agents, Non-Steroidal; Platelet Aggregation Inhibitors; Wound Healing