bioihbjkbjnl/mcl2 huggingface dataset:
Telerehabilitation Program Based on Yoga Training in Tennis Players
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      Although there are frequent studies on core strength in tennis players in the literature,
      studies on exercise applications targeting the development of physical fitness parameters are
      limited. In this context, it was aimed to investigate the effect of telerehabilitation method
      and yoga exercise practice on core stabilization and physical fitness.
    

Detailed description: 
      Core training is mostly used to improve balance, strength, functional alignment and
      flexibility. Core training can be a good option to improve physical fitness parameters. It
      has been observed that core stability training improves core function and trunk control, and
      positively affects functional and trunk flexibility.

      It has been shown that the flexibility of people who practice yoga regularly increases, their
      posture improves, the mobility of the joints increases, the muscles become stronger, the
      stability of the ligaments increase, the kinetic chain load transfer is more effective, the
      breath control is formed, and the person feels more free and dynamic. The target areas of
      poses such as downward facing dog, plank, boat, shoulder pose, bakasana, which are among the
      yoga poses, are the core region of the body and are movements that develop core muscles with
      core activation. Many of the yoga poses require body physical fitness parameters to maintain
      the pose.

      In order for individuals to continue their rehabilitation processes in their own environment
      and to participate in their training, the telerehabilitation system was frequently used, and
      according to the results of the study, the effectiveness of the practices performed with
      telerehabilitation was found to be at a high level.

      In this study, it was aimed to investigate the effect of telerehabilitation method and yoga
      exercise practice on core stabilization and physical fitness.
    

Intervention name(s): Control; Yoga training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An informative presentation; Yoga exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tennis; Yoga; Core stabilization; Physical fitness; Telerehabilitation
Ramanspectroscopy in Barrett's Esophagus
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      This study is being done to see if a new device, called near-infrared Raman spectroscopy, can
      provide similar information as that obtained from taking biopsies of the lining of your
      Barrett's esophagus
    

Detailed description: 
      In the search for means to enhance the surveillance of BE, optical spectroscopy is emerging
      as a candidate with high potential. Optical spectroscopic techniques measure specific
      light-tissue interactions, such as fluorescence, elastic scattering, and Raman (inelastic)
      scattering, which provide objective and quantitative diagnostic information about the
      molecular and/or structural status of tissue. Moreover, optical spectroscopy has the capacity
      to identify tissue pathology in situ in a rapid and non-destructive fashion. Among the
      optical spectroscopic techniques, near-infrared Raman spectroscopy (NIRS) is particularly
      promising because of the wealth of molecular-specific information contained in its spectra
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Barrett's esophagus surveillance
      
Biospecimen description: 
      esophageal biopsy
    
Keywords: Barrett's Esophagus
A Study of Soticlestat and Rifampin in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this study is to check how rifampin affects the way soticlestat is processed
      by the body.

      Participants will be required to stay at the study clinic for 18 consecutive days. On the
      first full day and 15th day, participants will take a single dose of soticlestat. Rifampin
      will be taken each day starting on the 5th day for 13 consecutive days.

      Clinic staff will follow up with each participant about 15 days after the last soticlestat
      dose to check for any side effects.
    

Detailed description: 
      The drug being tested in this study is called soticlestat (TAK-935). The study will evaluate
      the safety and tolerability of soticlestat when co-administered with rifampin in healthy
      participants.

      The study will enroll 14 participants. The participants will be assigned to treatment group
      to receive following therapies:

      • Soticlestat 300 milligram (mg) + Rifampin 600 mg

      The study will have two periods: Period 1 and Period 2. In Period 1, participants will
      receive soticlestat in fasted condition while in Period 2 participants will receive
      soticlestat along with rifampin. The data will be collected and stored in electronic case
      report form (eCRF).

      This single-center trial will be conducted in the United Kingdom. The overall study duration
      of the study will be approximately 58 days including 28 days screening and follow up
      duration. There will be a follow up contact required for all participants approximately 15
      days after the last dose of soticlestat.
    

Intervention name(s): Soticlestat; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Soticlestat tablets.; Rifampin capsules.
Other intervention name(s): TAK-935
Intervention MeSH terms: Rifampin
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug therapy
A Study of LY3016859 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of LY3016859
      administered as single doses, and to determine how long LY3016859 remains in the body
    


Intervention name(s): LY3016859 intravenous; Placebo intravenous; LY3016859 subcutaneous; Placebo subcutaneous
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered intravenously; Administered intravenously; Administered subcutaneously; Administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cephalic Vascular Recording Upon SPG Stimulation
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Observational

Summary: 
      Hypothesis:

      Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological
      parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter.

      Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological
      parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel
      diameter.
    

Detailed description: 
      Efferent
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Chronic Cluster Headache
Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2
      Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150
      mg/1,000 mg each) following once-daily oral dosing in healthy participants.
    

Detailed description: 
      This is an open-label (physicians and participants know the identity of the assigned
      treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination
      (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The
      study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label
      Treatment Phase, (when the participants will be confined to the study center for 11 days),
      and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days
      for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult
      participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days
      after a provided dinner. Participants will be required to fast from the end of lunch until
      the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.
    

Intervention name(s): CANA/MET XR FDC
Intervention type(s): Drug
Intervention description(s): Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Canagliflozin; Metformin; INVOKANA®; Type 2 Diabetes Mellitus
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Condition: Non-melanomatous Skin Cancer
MeSH terms: Basal Cell Nevus Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development of cancer. The use of celecoxib may be an effective way to prevent the
      development of basal cell carcinoma.

      PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing
      basal cell carcinoma in patients who have basal cell nevus syndrome.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether celecoxib prevents the development of basal cell carcinoma in patients
           with basal cell nevus syndrome.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are randomized to 1 of 2 arms.

        -  Arm I: Patients receive oral celecoxib twice daily.

        -  Arm II: Patients receive oral placebo twice daily. Treatment continues for 2 years in
           the absence of unacceptable toxicity.

      Patients are followed every 3 months for 3 years.

      PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.
    

Intervention name(s): celecoxib
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: basal cell carcinoma of the skin
Efficacy of Motilitone on Gastric Accommodation in Healthy Adult Patients: Evaluation Using MRI Method
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal
      pain or discomfort in the absence of a specific structural cause. Improving gastric
      accommodation and prokinetic effect seem to be an attractive physiological target in patients
      with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in
      December 2011 in Korea for treating patients with FD. The current study aims to evaluate
      effects of motilitone on gastric accommodation and emptying after a meal in a group of
      healthy volunteers using three-dimensional gastric volume measurements by magnetic resonance
      imaging (MRI). Healthy volunteers are randomly allocated to receive either motilitone or
      placebo in a double blinded manner. After 5 days of treatment, subjects undergo gastric MRI.
      The primary endpoint is gastric accommodation.
    


Intervention name(s): Placebo (for Motilitone); Motilitone
Intervention type(s): Drug; Drug
Intervention description(s): Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).; Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).
Other intervention name(s): Sugar pill manufactured to mimic Motilitone 60mg tablet; DA-9701
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: accommodation, emptying, motilitone
Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First in human (FIH) single ascending dose study to evaluate the safety,
      tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy
      human subjects
    

Detailed description: 
      This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was
      transferred to Biogen.
    

Intervention name(s): BIIB118; BIIB118; BIIB118
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo; Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo; Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension
Other intervention name(s): PF-05251749; PF-05251749; PF-05251749
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: First in human; Single Ascending Dose Study; Safety and Tolerability; Pharmacokinetics; Plasma; Cerebrospinal Fluid
Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum
      prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade,
      low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10;
      clinical stage T1C or T2a), who elect to have their disease monitored through active
      surveillance for at least one year.
    


Intervention name(s): cholecalciferol; cholecalciferol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4,000 I.U. softgel daily orally for 48 weeks; cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks
Other intervention name(s): vitamin D3; vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate; cancer; vitamin D3; early stage; active surveillance
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet
      containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets
      containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet
      with respect to the analytes, ibuprofen and pseudoephedrine.

      Secondary objective To assess the bioequivalence of a fixed dose combination tablet
      containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets
      containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet
      with respect to R- and S-ibuprofen (enantiomers of ibuprofen).
    


Intervention name(s): Ibuprofen; Pseudoephedrine-HCl
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose combination; Fixed dose combination
Intervention MeSH terms: Ibuprofen; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Sublingual Microcirculation of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope
Condition: Healthy
Study type: Observational

Summary: 
      This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39
      (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males
      and 15 females). The sublingual microcirculation will be examined with the incident dark
      field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims to
      compare the differences of microcirculation among the three groups and between genders.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy Volunteers
A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body
Condition: Fibrosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and the effects two
      ND-L02-s0201 have on the body
    


Intervention name(s): ND-L02-s0201
Intervention type(s): Drug
Intervention description(s): Specified dose on specified day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor
      (NNI) in healthy volunteers and HCV infected individuals
    

Detailed description: 
      This is a single center, double-blind, placebo-controlled, randomized, single ascending oral
      dose and multiple oral dose design, incorporating fed/fasted comparisons.

      The study will include two groups: Group A - single ascending dose (SAD) including a food
      effect cohort, and multiple dose (MD) in healthy volunteers (HV), and Group B MD in Hepatitis
      C Virus (HCV) infected individuals divided in two parts.

      Five single-dose cohort are planned. For the five single-dose cohorts, a sentinel group of 2
      subjects will be dosed at least one day prior to enrolling remaining subjects.

      Six multiple-dose cohorts are planned. Three multiple dose cohorts in healthy volunteers and
      three cohorts in HCV-infected individuals.

      The dosing of Group B will be conducted following safety and pharmacokinetic (PK) review of
      Group A. The dosing of Group B, Part 2 will be conducted only if Part 1 shows acceptable
      safety and efficacy results.
    

Intervention name(s): CDI-31244; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NNI; no active ingredients
Other intervention name(s): CC-31244; CDI-31244 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: non-nucleoside inhibitor; NNI; HCV; DAA
Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)
Condition: Controlled Ovarian Stimulation; Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study
      to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human
      chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in
      normogonadotrophic women.
    


Intervention name(s): recombinant luteinizing hormone (r-LH); recombinant human chorionic gonadotropin (r-hCG)
Intervention type(s): Drug; Drug
Intervention description(s): administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14); administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Intervention MeSH terms: Chorionic Gonadotropin; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COS; ART; Infertility
Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy
Condition: PTSD; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Study examining the effectiveness of 16 weeks of Internal Family Systems (IFS) therapy for
      adults with posttraumatic stress disorder (PTSD).
    

Detailed description: 
      Evaluation study of IFS therapy among trauma-impacted adults in order to explore the
      applicability of IFS with this population, ensure fidelity of treatment administration, and
      examine initial efficacy. Evaluate the utility of IFS in reducing symptoms of PTSD,
      dissociation and depression and increasing self-regulatory capacity, self-awareness and
      self-compassion. 15 subjects between the ages of 18 and 56 who are receiving 16, 90-minute
      sessions of IFS therapy by certified IFS practitioners in the community will be recruited for
      this evaluation study. Blind evaluators will assess treatment effects at pre-treatment,
      mid-treatment, post-treatment and at one-month follow-up, measuring change in symptoms of
      PTSD, dissociation and depression, as well as self-regulation, self-compassion, and
      interoceptive awareness.
    

Intervention name(s): Internal Family Systems (IFS)
Intervention type(s): Behavioral
Intervention description(s): Weekly individual psychotherapy
Intervention model: Single Group Assignment
Intervention model description: The Internal Family Systems (IFS) model of psychotherapy is a trauma-informed promising practice that has shown promise for individuals who struggle with trauma related symptoms including PTSD, dissociation and depression, as well as disruptions in self-concept and self-regulation. IFS places a heavy emphasis on aiding individuals in building an internalized sense of self-efficacy and self-compassion that may then support the development of self-regulatory capacity and reductions in trauma-related symptoms.
Masking: None (Open Label)
Primary purpose: Treatment