bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Grape Juice Consumption on the Parameters of Oxidative Stress and Muscle Fatigue in Judo Athletes
Condition: Oxidative Stress; Muscle Fatigue; Polyphenol; Free Radical Oxidation of Tissue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This project aims to evaluate if after 14 days of grape juice ingestion there is improvement
      of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will
      be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling
      simulations will be performed on 3 different days.
    

Detailed description: 
      Grape juice has a high concentration of phenolic compounds and is capable of modulating
      biochemical parameters and oxidative stress. By naturally containing carbohydrates grape
      juice can help acutely minimize fatigue during exercise as well as long-term oxidative stress
      parameters in athletes. This project aims to evaluate if after 14 days of grape juice
      ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in
      judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo
      athletes. Judo wrestling simulations will be performed on 3 different days. Each exercise
      session will consist of four 7-minute bouts, with 14-minute rest between them. The athletes
      will perform a first fight simulation without ingestion of any beverage (control group 1),
      and then will be randomized to determine the order of participation in the groups:
      maltodextrin (group 2 placebo) and grape juice (intervention group 3). Analyzes of oxidative
      stress; Muscle strength and fatigue; Perceived effort rate; Lactate; Heart rate; Analysis of
      food consumption and body composition.Two-way ANOVA will be used to evaluate the relation of
      the intervention and physical exercise, besides parameters of strength and fatigue. The level
      of significance adopted will be 5% and for the analysis, the SPSS summer 23 statistical
      program will be used.
    

Intervention name(s): Grape juice; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400ml diary of grape juice; 400ml diary of maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Affective Responses in Mountain Hiking
Condition: Affect
Study type: Interventional

Summary: 
      Using a within-subject design, 42 healthy participants were randomly exposed to three
      different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary
      control situation (3.5 hours each). Measures included the Feeling Scale, Felt Arousal Scale
      and a Mood Survey Scale. Univariate ANOVAs were used to analyse differences between the
      conditions.
    


Intervention name(s): walking; Treadmill
Intervention type(s): Behavioral; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bone Status and Insulin Resistance in Hirsutism
Condition: Hirsutism
MeSH terms: Hirsutism
Study type: Observational

Summary: 
      The purpose of this study is to investigate how the bones of hirsute women are different from
      bones of healthy women. The change in hormone content in the blood will also be investigated.
      The study can be used to evaluate whether it will be relevant to bone scan all newly referred
      hirsute women.

      Hirsute women are often over-weight and often have an increased amount of the male sex
      hormone in their blood. Their blood tests often show changes reminding of the ones seen in
      diabetic patients.

      All hirsute women referred to the department will undergo an investigation revealing the
      reason for the increased hair growth. The investigation includes clinical investigation
      (height, weight and degree of hair growth), blood tests (for hormone status and bone status
      analysis) and bone scanning of the abdomen (body composition).

      The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women
      with normal hair growth. They are matched by body weight, since weight has great importance
      for the bone mineral content and thereby for osteoporosis in the long run.
    


Observational model: Case-Control
Time perspective: Prospective
Study population: 
        hirsute patients vs. controls
      
Keywords: Hirsutism; Bone status; Androgens; insulin
A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or
      twice daily in female subjects with rosacea.
    


Intervention name(s): tretinoin gel 0.05%; vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea; Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tretinoin, efficacy, safety, rosacea
Bringing What Works to Youth in Corrections: A Trauma Intervention
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Youth with mental illnesses are disproportionately represented in juvenile correctional
      facilities and limited evidence exists about effective treatments in this setting. This study
      will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be
      efficacious in community settings, to the correctional setting and study the feasibility of
      its implementation. Conducted within Texas youth correctional facilities, the findings will
      be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the
      unique needs of incarcerated youth and the correctional system, one of the priorities
      outlined in the National Institute of Mental Health Strategic Plan.
    


Intervention name(s): Trauma-Focused Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Individual psychotherapeutic approach occurring once per week for 12 to 20 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post Traumatic Stress Disorder; Major Depressive Disorder; Dysthymia; Generalized Anxiety Disorder; Social Phobia; Panic Disorder
Breath Analysis in Lung Fibrosis
Condition: Idiopathic Lung Fibrosis; Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The aim of the study is to answer the question whether a disease specific profile of breath
      in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study
      using exhaled breath analysis by mass spectrometry.
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Confirmed diagnosis of idiopathic pulmonary fibrosis based on clinical, radiologic and/or
        pathologic data without evidence or suspicion of an alternative diagnosis that may
        contribute to their interstitial lung disease. Patients must fulfill all of the following
        criteria:
      
Biospecimen description: 
      Exhaled breath
    
Keywords: Mass spectrometry; Exhaled breath analysis
The Effectiveness of Vestibulectomy
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Interventional

Summary: 
      Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination
      before and 6 months after vestibulectomy. The investigators hypothesize that pain will
      decrease.
    


Intervention name(s): vestibulectomy
Intervention type(s): Procedure
Intervention description(s): Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vulvodynia; vestibulectomy; surgery; vestibulitis
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, single-blind, placebo-controlled, multiple
      ascending dose study of SM04755 solution applied topically once daily for 14 days to intact
      skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of
      80 cm^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1
      (SM04755:placebo).
    


Intervention name(s): SM04755; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): SM04755 is a small molecule inhibitor of the Wnt pathway.; Same formulation as topical SM04755 solution, without SM04755 included.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SM04755; topical; Samumed; Wnt inhibitor
Carotid Ultrasound in the Evaluation of Heart Failure
Condition: Coronary Artery Disease; Cardiomyopathy; Heart Failure
MeSH terms: Heart Failure; Coronary Artery Disease; Cardiomyopathies
Study type: Interventional

Summary: 
      Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most
      common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The
      standard test to find coronary artery disease is coronary angiography. This test is highly
      accurate but is invasive and carries a small risk of complications. This study investigates
      ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery
      disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid
      ultrasound will have excellent negative predictive value for severe CAD.
    

Detailed description: 
      Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most
      common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The
      standard test to find coronary artery disease is coronary angiography. This test is highly
      accurate but is invasive and carries a small risk of complications. This study investigates
      ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery
      disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid
      ultrasound will have excellent negative predictive value for severe CAD.
    

Intervention name(s): Carotid ultrasound
Intervention type(s): Other
Intervention description(s): Measurement of intima-media thickness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have
      been approved for the treatment of three anxiety indications in China. This bioequivalence
      study will evaluate Paroxetine IR tablets manufactured in GSKT (A) and Mississauga (B) sites
      in healthy Chinese subjects under fasting and fed conditions to support the quality
      consistency evaluation. This is a single dose, open-label, randomized, two-period crossover
      study and will include a screening period (up to 7 days), two open-label treatment periods
      (up to 16 days) and a follow-up phase (up to 14 days after last-dose). The whole study will
      be divided into two groups, one for fasting condition enrolling approximately 36 subjects and
      another for fed condition for which approximately 44 subjects will be enrolled. In both
      groups, eligible subjects will be randomized to receive single dose of Paroxetine IR tablets
      A or B in a cross-over manner.
    


Intervention name(s): Paroxetine IR tablets A; Paroxetine IR tablets B
Intervention type(s): Drug; Drug
Intervention description(s): Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.; Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In this study, each subject will receive paroxetine IR 40mg A or B in a cross-over manner
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cross-over; Chinese; GSKT; Mississauga; Healthy; Bioequivalence; Paroxetine
Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules
      relative to four 25 mg capsules under fed condition in adult healthy participants and to
      estimate the effect of a high-fat, high-calorie meal on the bioavailability of a single 100
      mg capsule of bosutinib relative to fasted condition in adults healthy participants. The
      comparisons will be performed using the pharmacokinetic parameters that define the rate and
      extend of absorption (Cmax, AUC). Statistical analyses will be performed after the
      administration of a single 100 mg dose under fed condition as the Reference treatment and the
      four 25 mg capsules as the Test treatment for the first comparison, and after administration
      of a single 100 mg dose under fasted condition as the Reference treatment and the 100 mg
      capsule under fed condition as the Test treatment for the second comparison.
    


Intervention name(s): Bosutinib capsule; Bosutinib capsule; Bosutinib; Bosutinib capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast; Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast; Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours; Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Phase 1, open-label, randomized, single dose, 3-period, 4 sequence, crossover study in healthy participants
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Food Effect; Bosutinib; Maximum Observed Plasma Concentration (Cmax); Area Under the Curve (AUC)
Infrared Photomodulation Therapy for Seasonal Affective Disorder
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

Summary: 
      During winter months in northern latitudes use of Joovv device on self-reported non-clinical
      mental health (aka mood), sleep and energy levels. Participants will also submit Withings and
      Oura activity and sleep data.
    


Intervention name(s): Joovv Mini
Intervention type(s): Device
Intervention description(s): the smallest photomodulation device in the Joovv infrared light product line.
Intervention model: Single Group Assignment
Intervention model description: Single arm pilot study
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine
Condition: Morphine; Histamine; Cowhage; Isotonic Saline
Study type: Interventional

Summary: 
      The aim of this study is to the effect of opioid (morphine) intradermal application on
      histaminergic and non-histaminergic itch. In particular, we would like to demonstrate that
      also peripheral administration of morphine may affect mast cell release of histamine.
    

Detailed description: 
      Opioids (i.e. substances extracted from opium poppies, e.g. morphine) are used for treatment
      of both acute and chronic pain conditions as well as in surgical procedures. Opioids render
      effective pain relief, however, they may cause bothersome itch as a side effect. With this
      series of experiments, we wish to clarify how an injection with morphine in the skin layer
      called dermis (located right below the upper skin) will affect itch.
    

Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): During the 1st session, each of the middle forearms of the subject will be divided into two squared areas (4x4 cm) located 3 cm apart. Two areas will be treated with an intradermal injection of morphine (0.05 ml, 0.1 mg/ml), and two areas with an intradermal injection of isotonic saline.
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer
Condition: Healthy; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to assess the impact of a decision aid leaflet on the participation
      of women invited to participate in the French national breast cancer screening program.
    


Intervention name(s): decision aid group
Intervention type(s): Device
Intervention description(s): The paper-based leaflet DECIDEO is a 12-page pocket leaflet providing scientific information about the advantages and disadvantages of participating in the national breast screening program, understandable by all, constructed to conform with the International Patient Decision Aid Standards
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer screening; patient decision aids; informed decision; empowerment; randomized control trial; From 50 to 74 years old; invited to national breast cancer screening
Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The goal of the study is to evaluate how cannabis use affects memory and thinking skills and
      response to stress in older adults. The study will also relate cannabis use to Alzheimer's
      Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test
      whether sex and hormones play a role in these effects. The study is recruiting adults between
      the ages of 50 and 80 who use cannabis products on a regular basis. Study participation will
      last about two weeks.
    


Intervention name(s): Trier Social Stress Task (TSST)
Intervention type(s): Behavioral
Intervention description(s): The TSST is a standardized psychological stress challenge which provokes a stress response in a laboratory setting. During the task, saliva samples will be collected for hormone testing along with physiological and subjective measures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)
Condition: Hepatitis C; HIV Coinfection
MeSH terms: Hepatitis C; Coinfection; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the
      pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide
      (TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving
      tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate [TDF]),
      and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to
      participate.

      The study will consist of five visits: a screening visit, three abbreviated 4-hour
      pharmacokinetic visits, and one end-of-study follow-up visit.

      Subjects will also be asked to use a Wisepill device, which will track medication adherence
      throughout the study.
    


Intervention name(s): TDF with a boosted protease inhibitor; TAF with a boosted protease inhibitor; TAF with a boosted protease inhibitor and LDV/SOF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted protease inhibitor for HIV treatment will continue to take their prescribed treatment for 12 weeks after enrollment.
Other: Blood draws for tenofovir PK, renal function assessment; Participants will be switched from tenofovir disoproxil fumarate to tenofovir alafenamide 25 mg/emtricitabine 200 mg with a boosted protease inhibitor.
Other: Blood draws for tenofovir PK, renal function assessment; After taking tenofovir alafenamide/emtricitabine for 12 weeks, participants will then start taking ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) in combination with the tenofovir alafenamide 25 mg/emtricitabine 200 mg (Descovy) and a boosted protease inhibitor for 4 weeks. Subjects will then return to taking tenofovir alafenamide 25 mg/emtricitabine 200 mg (Descovy) and a boosted protease inhibitor for the final 12 weeks.
Other: Blood draws for tenofovir PK, renal function assessment
Other intervention name(s): Viread or Truvada with a boosted protease inhibitor; Descovy with a boosted protease inhibitor; Descovy with a boosted protease inhibitor and Harvoni
Intervention MeSH terms: Emtricitabine tenofovir alafenamide; Emtricitabine; Tenofovir; HIV Protease Inhibitors; Protease Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Arm Ergometry on Children With Down Syndrome
Condition: EFFECT OF ARM ERGOMETRY ON RESPIRATION
MeSH terms: Down Syndrome
Study type: Interventional

Summary: 
      Cardiopulmonary issues are the major cause of sickness and hospitalisation in children with
      Down syndrome . Down syndrome children are also more likely to develop chronic lung
      infections, middle ear infections, and persistent tonsillitis.
    

Detailed description: 
      30 Down's syndrome children (boys and girls). randomly separated into two groups of equal
      size. Both groups received traditional chest physical therapy, with the addition of arm
      ergometry training in Group B
    

Intervention name(s): ARMEROMTERY
Intervention type(s): Other
Intervention description(s): ARMERGOMTERY TRAINING FOR UPPERLIMB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment