bioihbjkbjnl/mcl2 huggingface dataset:
Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Condition: Joint Pain; Breast Cancer
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors,
      aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong
      disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness
      (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an
      evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease
      (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them
      maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness,
      and 3) thereby enable them to remain on AI therapy as prescribed.
    


Intervention name(s): Walk with Ease
Intervention type(s): Behavioral
Intervention description(s): An evidence-based walking program
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: breast cancer; aromatase inhibitors; physical activity; joint pain
Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures
Condition: Facial Rhytidectomy (Face-lift)
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant
      with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to
      reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).
    


Intervention name(s): Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
Intervention type(s): Biological
Intervention description(s): Each subject received fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face. The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2. The study product will be applied to the subcutaneous plane in both the neck and the face area. The product will be applied using the spray device provided by the sponsor. (The other side of the face will be treated using standard of care.)
Other intervention name(s): Fibrin Sealant; TISSEEL
Intervention MeSH terms: Thrombin; Fibrin Tissue Adhesive; Aprotinin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
Condition: Colonic Polyps
MeSH terms: Colonic Polyps
Study type: Interventional

Summary: 
      The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic
      imaging technique. Specifically, topographical surface contrast reconstructed from the PSE
      data will be compared to conventional imaging contrast to assess if PSE provides enhanced
      contrast of abnormal tissue.
    


Intervention name(s): PSE
Intervention type(s): Device
Other intervention name(s): photometric stereo endoscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colonoscopy
The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
Condition: Obesity; Type 2 Diabetes Prevention; Executive Function (Cognition)
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a behavioral clinical trial of aerobic exercise to determine dose-response
      effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other
      cardiovascular risk factors in overweight elementary schoolchildren.

      The hypothesis is that the more exercise a child does, the more benefit he or she will gain
      in reducing the risk of diabetes and other cardiovascular diseases.

      An ancillary study examined effects on cognition and achievement.
    

Detailed description: 
      The study is a behavioral clinical trial of aerobic exercise to determine dose-response
      effects on insulin response to the oral glucose tolerance test, body composition, fitness,
      lipid profile, inflammation and other metabolic syndrome components in overweight elementary
      schoolchildren.

      Blinded psychological assessments of cognition and achievement were obtained.
    

Intervention name(s): Aerobic exercise program
Intervention type(s): Behavioral
Intervention description(s): Vigorous intermittent physical activity in group format conducted in research gymnasium after school by research staff. Heart rate monitors documented each child's average heart rate on a daily basis. Small incentives were offered for achieving goal of >150 bpm average HR each day and attending at least 80% of sessions (4 days/week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; children; diabetes; overweight; obesity; metabolic syndrome; exercise; insulin resistance; female; male; black, African-American; white, Caucasian; cognition; executive function
Contraception Perspectives in Adolescents in Haiti
Condition: Contraception
Study type: Observational

Summary: 
      The overall goal of this study is to assess facilitators and barriers to contraception with a
      focus on long-acting reversible contraception (LARC) among adolescents and health care
      providers (HCPs) in rural Haiti. The investigator plans to accomplish the following
      objectives:
    

Detailed description: 
      Objective 1: Develop locally-informed surveys and in-depth interview guides, based on the
      ecologically-expanded Theory of Planned Behavior, to assess attitudes, social norms,
      perceived behavioral control, and intentions regarding contraception, with a focus on LARC,
      among adolescents and HCPs in rural Haiti.

      Objective 2: Conduct a formative mixed methods study of attitudes, social norms, perceived
      behavioral control, and intentions regarding contraception, with a focus on LARC, among
      female adolescents (N=150 survey, 25-50 in-depth interviews) and HCPs (N=15; survey and
      in-depth interviews) in rural Haiti.
    

Intervention name(s): Interviews/Surveys
Intervention type(s): Other
Intervention description(s): This is a cross sectional survey and interviews of adolescents 14- 18 years old and HCPs living in rural Haiti
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents 14-24 years old and health care providers in rural Haiti
Recurrent Carotid Stenosis
Condition: Cardiovascular Diseases; Carotid Stenosis; Cerebrovascular Disorders; Heart Diseases; Vascular Diseases
MeSH terms: Carotid Stenosis; Cerebrovascular Disorders; Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Constriction, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether recurrent stenosis following carotid endarterectomy could be reduced by
      pre- and post-operative oral administration of platelet-inhibiting drugs.
    

Detailed description: 
      BACKGROUND:

      Following endarterectomy, platelets adhere and aggregate on the endarterectomized surface and
      release platelet-derived growth factor which induces smooth muscle cell migration and
      proliferation which may result in restenosis. Many patients had been treated with aspirin and
      dipyridamole, but not in a controlled trial. The Recurrent Carotid Stenosis Study established
      whether antiplatelet therapy was beneficial in the prevention of recurrent carotid artery
      stenosis.

      DESIGN NARRATIVE:

      Randomized, double-blind. Eighty-three patients (90 endarterectomies) were randomly assigned
      to receive 325 mg of oral aspirin plus 75 mg of dipyridamole, beginning 12 hours
      pre-operatively, followed by a second dose administered within eight hours after the
      operation, and given three times daily thereafter for one year. Eighty patients (85
      endarterectomies) received placebo. After the adequacy of the surgical procedure was
      confirmed by intraoperative angiography, restenosis at the endarterectomy sites was evaluated
      using serial duplex ultrasound before hospital discharge and at three-month intervals
      postoperatively for one year.
    

Intervention name(s): aspirin; dipyridamole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Dipyridamole
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Activation Technique in cVEMPs
Condition: Activation Technique in cVEMP Testing
Study type: Interventional

Summary: 
      This study will investigate two different techniques used for eliciting sternocleidomastoid
      (SCM) muscle contraction. Sustained contraction of the SCM muscle is necessary for accurate
      recording of cervical vestibular evoked myogenic potentials (cVEMPs). These responses are
      used clinically to assess the function of structures within the vestibular system.

      The British Society of Audiology (BSA) guidelines recommend the head turn and head raise
      techniques as effective methods for eliciting SCM contraction. However, they do not recommend
      which technique to employ, leaving that to the discretion of the clinician. The purpose of
      this study is to determine which activation technique to recommend in the local standard
      operating procedure on cVEMP testing developed by the Audiology and Vestibular Function
      Testing service based at the Royal Liverpool University Hospital.

      Healthy volunteers will be recruited to the study. The study will be conducted at the Royal
      Liverpool University Hospital, Liverpool, UK.

      The participants will each be invited to attend one appointment in which they will undergo
      cVEMP testing, performed using each activation technique in turn. After testing the
      participants will be asked to complete a questionnaire in which they will comment on their
      experience of performing each technique and assign each a tolerability rating.
    


Intervention name(s): Head Turn Activation Technique; Head Raise Activation Technique
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Participant sat upright with head turned to the side through 45 degrees. They are presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.; Participant assumes caloric test position (30 degrees from horizontal) with head raised. Participant is presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered
      intravenously as a single dose in participants with mild to moderate COVID-19
    


Intervention name(s): BGB-DXP593; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm; Placebo to match BGB-DXP593 administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      The purpose of this research study is to assess whether seeing other people itch affects itch
      perception in patients with atopic dermatitis and healthy subjects.
    

Detailed description: 
      The objectives of this study are to quantitatively assess the effect of visual stimuli on
      perception of itch and to assess if visual stimuli affect individuals with atopic dermatitis
      differently than healthy people.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        general community population
Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle
      training with that of placebo in patients with moderate to severe stress urinary incontinence
    


Intervention name(s): Duloxetine; Pelvic Floor Muscle Training (PFMT); Imitation PFMT; placebo
Intervention type(s): Drug; Procedure; Procedure; Drug
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioequivalence Study of Montelukast 5 mg Chewable
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of montelukast tablets are
      bioequivalent.

      Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product
      Singulair (5 mg chewable tablets; Merck Sharp & Dohme). The single dosage was one tablet.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 32 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Montelukast 5 mg chewable tablets; Montelukast 5 mg chewable tablets
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Singulair; Merck Sharp & Dohme de Mexico SA de CV
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Mexico; Asthma; Montelukast; Chewable
Intravenous Thyroxine for Heart-Eligible Organ Donors
Condition: Brain Death; Heart Failure
MeSH terms: Brain Death
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized controlled trial will evaluate whether intravenous thyroxine infusion given
      to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more
      hearts transplanted than saline placebo
    

Detailed description: 
      Background: Brain death frequently induces hemodynamic instability and cardiac stunning.
      Impairments in cardiac performance are major contributors to hearts from otherwise eligible
      organ donors not being transplanted. Deficiencies in pituitary hormones (including thyroid
      stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid
      hormone has been proposed as a means of improving stability and increasing hearts available
      for transplantation. Intravenous thyroxine is commonly used in donor management. However,
      small controlled trials have not been able to demonstrate efficacy.

      Methods: This multicenter study will involve organ procurement organizations (OPOs) across
      the country. A total of 800 heart-eligible brain dead organ donors who require vasopressor
      support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline
      placebo. The primary study hypothesis is that thyroxine treatment results in more hearts
      transplanted. Additional outcome measures are time to achieve hemodynamic stability (weaning
      off vasopressors) and improvement in cardiac ejection fraction on echocardiography.

      Discussion: This will be the largest randomized controlled study to evaluate the efficacy of
      thyroid hormone treatment for organ donor management. By collaborating across multiple OPOs,
      it will be able to enroll an adequate number of donors and be powered to definitively answer
      the critical question of whether treatment increases hearts transplanted and/or provides
      other hemodynamic benefits.
    

Intervention name(s): Thyroxine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.; The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Organ donor
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Condition: Suspected or Confirmed COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label, randomized, and controlled clinical trial aims to determine the feasibility
      and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to
      modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19
      patients.
    


Intervention name(s): NBT-NM108; Usual Care Only
Intervention type(s): Drug; Other
Intervention description(s): Taken in the form of drinks four times a day (before each main meal and 2 hours after dinner) for 28 days. Each drink is prepared by mixing one sachet (30 g) with 500 ml of water.; Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; NBT-NM108; Notitia Biotechnologies Company; Notitia Biotechnologies; Microbiome; Microbiota; Gut microbiome; Gut microbiota; Corona Virus; Novel Corona Virus; SARS-CoV-2
Non-Pharmacological Nursing Pain Management for Preterm Infants
Condition: Pain Management
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      A randomized controlled trial will be conducted to examine the effect of non-pharmacological
      nursing pain management strategies in alleviating pain among preterm infants. The study
      includes a simple random sample of 105 preterm infants with CGA 32- < 37 weeks were randomly
      assigned into five groups: routine care (n = 21), breast milk (n = 21), oral sucrose (n =
      21), KMC (n = 21), nesting position (n = 21). PIPP-R will be used to subjectively assess the
      pain intensity after heel stick, and salivary cortisol measures will be used to objectively
      assess the pain intensity in NICU at Children Welfare Teaching Hospital/ Medical City Complex
      in Baghdad City.
    


Intervention name(s): Non-pharmacological pain management strategies
Intervention type(s): Procedure
Intervention description(s): Non-pharmacological pain management strategies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Non-pharmacological Pain Management Strategies; Preterm Infants; NICU
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
Condition: Systemic Sclerosis; Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the
      connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis
      causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis
      eventually causes the involved skin to harden, limiting mobility, and can also damage other
      organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the
      abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may
      modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is
      currently investigating a human monoclonal antibody (CAT-192) that neutralizes active
      TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety,
      tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early
      stage diffuse Systemic Sclerosis.
    


Intervention name(s): Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
Intervention type(s): Drug
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal; Mitogens
Primary purpose: Treatment