bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis
Condition: Diabetic Gastroparesis; Idiopathic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of treatment with 2 dose
      levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12
      weeks of treatment.
    

Detailed description: 
      The drug being tested in this study is called TAK-906. TAK-906 is being tested to treat
      people who have symptomatic idiopathic or diabetic gastroparesis.

      The study will enroll approximately 205 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the three treatment groups (in 1:1:1:1 ratio) which
      will remain undisclosed to the patient and study doctor during the study (unless there is an
      urgent medical need):

        -  TAK-906 Maleate 5 mg (After implementation of Amendment 8, participants will not be
           further randomized to this arm)

        -  TAK-906 Maleate 25 mg

        -  TAK-906 Maleate 50 mg Placebo (dummy inactive pill) - this is a capsule that looks like
           the study drug but has no active ingredient

      Prior to Amendment 8, participants were randomized to receive TAK-906 5 mg. After
      implementation of Amendment 8, participants will not be further randomized to this dose arm.
      All participants will be asked to take one capsule twice daily, at approximately the same
      time each day throughout the study.

      This multi-center trial will be conducted worldwide. The overall study duration is
      approximately 17 weeks. Participants will make multiple visits to the clinic, and will be
      contacted by telephone 30 days after receiving their last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): TAK-906 Maleate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-906 maleate capsules.; TAK-906 maleate placebo-matching capsules.
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
Consumer Engagement to Increase Advance Care Planning: Patient Randomization
Condition: Advance Care Planning
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a study of the effect of consumer-directed financial incentives on completion of
      advance care planning among Medi-Cal patients.
    

Detailed description: 
      Older adults receiving primary care from one of three clinics contracting with Partnership
      HealthPlan of California, a multi-county Medi-Cal managed care plan will be mass randomized
      to receiving educational materials regarding advance care planning with or without a
      financial reward for completing advance care planning.
    

Intervention name(s): Financial incentive; Educational website
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Offer of money designed to overcome barriers to advance care planning.; Research-verson of the "Prepare for your care" website (www.prepareforyourcare.org)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
WP1066 in Children With Refractory and Progressive or Recurrent Malignant Brain Tumors
Condition: Brain Tumor; Medulloblastoma; Brain Metastases
MeSH terms: Brain Neoplasms; Medulloblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      In this Phase I clinical study, the investigators plan to offer investigational treatment
      with the novel JAK2/STAT3 inhibitor WP1066 (Moleculin Biotech, Inc.) to pediatric patients
      with any progressive or recurrent malignant brain tumor that is refractory to standard
      treatment and is without known cure.
    

Detailed description: 
      The goal of this clinical research study is to find the highest tolerable dose of WP1066 that
      can be given to pediatric patients with recurrent (has returned after treatment) cancerous
      brain tumors or melanoma that has gotten worse and spread to the brain. The safety of this
      drug will also be studied.

      WP1066 is designed to target the STAT3 pathway in cancer cells, which makes these cells
      divide, increases new blood vessels to the tumor, causes the cancer cells to move throughout
      the body and brain, and avoids them being detected by the immune system. Targeting this
      pathway may cause the immune system to kill the cancer cells. The investigators will
      administer five escalating doses of WP1066, starting at lowest dose currently found to be
      safe and tolerable in adults.

      WP1066 is not FDA approved or commercially available. It is currently being used for research
      purposes only.

      Up to 36 participants will be enrolled in this study. All will take part at Children's
      Healthcare of Atlanta (CHOA).
    

Intervention name(s): WP1066
Intervention type(s): Drug
Intervention description(s): WP1066 is an analogue of caffeic acid that is a potent inhibitor of p-STAT3.
It will be taken by mouth 2 times per day on Monday, Wednesday, and Friday of Weeks 1 and 2 of each 28-day cycle.
Other intervention name(s): STAT3 Inhibitor WP1066
Intervention MeSH terms: Tyrphostins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain Tumor
Influence of FSH/LH Ratio in Controlled Ovarian Stimulation
Condition: Sub-Fertility
MeSH terms: Infertility
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation
    


Intervention name(s): FSH/LH
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FSH; LH; IVF
Effect of Kinesiotaping on Elbow Joint Proprioception
Condition: Healthy
Study type: Interventional

Summary: 
      assessing the effects of kinesiotape application on elbow joint proprioception
    

Detailed description: 
      assessing the effects of kinesiotape application on elbow joint proprioception by evaluating
      joint position sense
    

Intervention name(s): kinesiotape; sham taping
Intervention type(s): Procedure; Procedure
Intervention description(s): an elastic adhesive tape; a sham taping without the tension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode
      according to DSM IV (APA 1994) over a 12 weeks period of treatment.

      To evaluate the clinical safety of Di-valproate.
    


Intervention name(s): depakine chrono
Intervention type(s): Drug
Intervention description(s): Depakine Chrono 500 mg
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
Condition: Skin Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to
      severe glabellar lines.
    


Intervention name(s): Botulinum toxin type A(Botulax®); Botulinum toxin type A(Botox®)
Intervention type(s): Drug; Drug
Intervention description(s): Single administration, Day 0, 20 units; Single administration, Day 0, 20units
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions
Condition: Energy Metabolism; Hypoxia; Metabolism and Nutrition Disorder
MeSH terms: Nutrition Disorders; Hypoxia
Study type: Interventional

Summary: 
      The aim is to define in detail metabolic pathways at rest and during aerobic exercise in
      normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions,
      using metabolomics technologies based on minimally invasive sampling relying on gas
      chromatography and mass spectrometry.
    


Intervention name(s): 30-minute movement activity; Hypoxia
Intervention type(s): Behavioral; Other
Intervention description(s): The subjects arrive in the CRU after a 12 hours overnight fast to perform a 30-minute movement activity with individually adapted exercise intensity on the treadmill.; The 30-minute movement activity on the treadmill will be completed by each subject once under normobaric normoxic and once under normobaric hypoxic conditions (equivalent to approximately 3000 meters above sea level) in a randomized episode.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
The Clinical and Biochemical Characteristics in Women With Different Menstrual Pattern
Condition: Regular Menstrual Cycle; Irregular Menstrual Cycle
Study type: Observational

Summary: 
      Background: Menstrual disturbance is the major complain in reproductive age women, the
      clinical and biochemical characteristics of women with different menstrual disturbance had
      not been well-understood. Objective: To study the clinical and biochemical characteristics of
      women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method: Retrospective
      study, medical records reviewed in patients who visited to outpatient clinic of Reproductive
      Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1 to 2011 Nov. 31.
      Including criteria: Patients had sufficient medical records (anthropometric, endocrine,
      metabolic, lipid parameters) and age less than 45. Excluding criteria: (1) Women who
      experienced menarche <3 years before the beginning of the study; (2) Women who received
      hormones or drugs for major medical diseases; (3) Women who presented ovarian cysts or
      ovarian tumors, uterine abnormality; (4) Women who were >45 years old.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid
        parameters) and age less than 45.
Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the potential antiviral efficacy of triple-combination
      therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype
      3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).
    

Detailed description: 
      i) Obtain preliminary information on the association between important baseline and
      on-treatment factors and SVR in this patient population. Variables to be examined may include
      gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral
      load, RVR, wk 8 viral load, end-of-treatment viral response.

      ii) Evaluate adverse events. iii) Evaluate viral resistance.
    

Intervention name(s): Boceprevir
Intervention type(s): Drug
Intervention description(s): All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).
Other intervention name(s): VICTRELIS™; boceprevir capsules, 200 mg; Hepatitis C Virus (HCV) Protease Inhibitor
Intervention MeSH terms: Protease Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Boceprevir; Hepatitis C Genotype 3
Intrapulmonary Pharmacokinetics of ME1100 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, single-dose study. The primary objective is to determine
      Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The
      secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess
      tolerability and safety of a single dose of ME1100 inhalation solution.
    


Intervention name(s): ME1100 inhalation solution
Intervention type(s): Drug
Other intervention name(s): arbekacin
Intervention MeSH terms: Arbekacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trim Tots Pre-school Obesity Prevention Programme
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Randomised controlled trial of a lifestyle intervention programme for mothers and children
      aged 1-5 years aimed at prevention of overweight and obesity.
    


Intervention name(s): Lifestyle intervention; waiting list control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Lifestyle intervention with Trim Tots pre-school programme.; waiting list control
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Obesity; overweight; BMI; ifestyle; diet; nutrition; physical activity; pre-school; toddlers; children; Prevention of overweight and obesity in pre-school children
Effects of Cannabis Abstinence on Symptoms and Cognition in Depression
Condition: Cannabis Use Disorder; Major Depressive Disorder; Cognition
MeSH terms: Marijuana Abuse; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The objective of this study is to assess the changes in symptoms and cognition that occur
      after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and
      Major Depression (MDD). This study employs a 28-day abstinence paradigm a total of 8 visits
      to the CAMH Russell site (screening, training, baseline, week 1, week 2, week 3, week 4,
      follow-up). Participants should be between the ages of 18-55, meet criteria for moderate
      depression and CUD, be non-treatment seeking, and be on a stable dose of antidepressant
      medication. The study visits will take up a total of approximately 22.5 hours with
      compensation for time provided. These visits will involve multiple clinical, substance use,
      and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching
      sessions and contingency reinforcement.
    


Intervention name(s): Weekly Behavioral Coaching Session; Contingency Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days of abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.; If the participant's weekly abstinence is successful as determined by the urine results on day 28, the participant will receive an additional $300.00 cash bonus on top of their hourly $10 compensation for attending all visits. We predict that this cash bonus is enough incentive to allow for the behavioural change of abstinence in this patient population.
Intervention model: Single Group Assignment
Intervention model description: This is an open label intervention of contingent reinforcement and behavioral support to try to enhance cannabis abstinence for 28 days with people with Major Depressive Disorder. We will analyze data post hoc from this study as a function of subjects who attain abstinence versus those who do not.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Cognitive Functioning; Cannabis Use Disorder
A Novel Objective Diagnostic Test for Otitis Media With Effusion
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Observational

Summary: 
      Otitis media with effusion (OME) cases refer to a clinically silent condition. Otoscopic
      findings are subjective and not always reliable. As an objective test tympanometric
      evaluation is imperfect for diagnosis of OME. The objective of our study was to investigate,
      in OME cases, the correlation of tympanic membrane color changes with the presence and
      viscosity of effusion in the middle ear. The study aimed to provide objective diagnostic and
      therapeutic criteria for patients scheduled for surgery by 2 means: measuring the viscosity
      of the fluid and evaluating color changes objectively with red-green-blue (RGB) measurements.
    

Detailed description: 
      Endoscopic images of the tympanic membranes of 52 patients (Group 1) and 52 healthy controls
      (Group 2) were taken during their otologic examinations. All patients in Group 1 had hearing
      loss and were diagnosed with OME after audiological evaluation. Specific points were
      designated at certain areas on each tympanic membrane, and RGB values of those specific
      points were measured on the tympanic membrane images of both groups. Additionally, in Group 1
      viscosity of each effusion taken by paracentesis during surgery was also measured
      intraoperatively with a viscometer. Patients with viscosity values lower than 450 cP
      (centipoise) were subdivided into Group 1a, and those with values higher than 450 cP into
      Group 1b.
    

Intervention name(s): RGB
Intervention type(s): Other
Intervention description(s): When a circular area of 30 surrounding pixels are placed exactly upon the above-mentioned standardized points, the Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in that area. The RGB values of the same points on the tympanic membrane images of the two groups were obtained and compared. Diagnostic significance of objectively assessed color changes at the tympanic membrane in OME patients was evaluated.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Endoscopic images of the tympanic membranes of 52 patients (Group 1) and 52 healthy
        controls (Group 2) were taken during their otologic examinations. RGB values of specific
        points were measured on the tympanic membrane images of both groups. Additionally, in Group
        1 viscosity of each effusion taken by paracentesis during surgery was also measured
        intraoperatively with a viscometer. Patients with viscosity values lower than 450 cP
        (centipoise) were subdivided into Group 1a, and those with values higher than 450 cP into
        Group 1b.
      
Keywords: Otitis media with effusion, viscosity, RGB (red-green-blue).
Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
Condition: Menopause; Cognitive Deficits, Mild
MeSH terms: Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The goal of this quasi-experimental study is to test effect of time-restricted eating on
      cognitive function and other biopsychosocial factors in menopausal women undertaking a
      12-week exercise programme. The main questions to answer are:

        1. What is effect of time-restricted eating on cognitive function in menopausal women
           undertaking a 12-week exercise programme?

        2. What is effect of time-restricted eating on menopausal symptoms in menopausal women
           undertaking a 12-weeks exercise programme?

        3. What is effect of time-restricted eating on metabolic health parameters in menopausal
           women undertaking a 12-weeks exercise programme?

      Participants of both groups will have moderate intensity circuit mixed endurance and
      resistance exercise programme two times per week for 55 minutes for 12 weeks. Participants of
      one of two groups will not only exercise but also have a time-restricted eating following
      16:8 protocol for 12 weeks.

      Participants will have pre-tests and post-tests:

        -  blood samples collection (to measure level of brain-derived neurotrophic factor, glial
           cell derived neurotrophic factor, insulin, glucose, lipid profile),

        -  body composition analysis,

        -  Stroop test and N-back test,

        -  electroencephalography using Emotiv Epic X devices,

        -  One-repetition maximum test, Ruffier test,

        -  Questionnaire assessment (using Menopause Rating Scale and The Menopause-Specific
           Quality of Life Questionnaire).

      Researchers will compare two groups - exercise group and combination group which will do both
      time-restricted eating and exercise to see if there is a modulating effect of time-restricted
      eating in participants undertaking exercise.
    


Intervention name(s): Exercise and Time-Restricted Eating; Exercise only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks and a time-restricted eating following 16:8 protocol for 12 weeks.; Moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks only.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Kinesio Taping in Archery
Condition: Sports Physical Therapy
Study type: Observational

Summary: 
      The aim of the study is to investigate the effects of KT on archery athletes' performance.
    

Detailed description: 
      Archery is a sport that requires strength, endurance, stabilization, and coordination of the
      upper body and shoulder girdle muscles. Kinesio taping (KT), which increased in popularity
      with the use in the athletes in the 2008 summer Olympics, is commonly investigated in the
      literature. KT is claimed to reduce pain and edema, increase functional performance, joint
      position sense, and blood-lymph flow, provide stability, and improve range of motion,
      flexibility, and strength. The aim of the study is to investigate the effects of KT on
      archery athletes' performance.
    

Intervention name(s): Kinesiotaping
Intervention type(s): Other
Intervention description(s): Kinesio taping will be applied on the lower part of the trapezius.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Archery athletes