bioihbjkbjnl/mcl2 huggingface dataset:
A Itraconazole Effect Study of SHR2554 on Healthy Chinese Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of Itraconazole on
      pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR2554
      tablets.

      The secondary objective of the study is to evaluate the safety of single dose of SHR2554
      orally in healthy subjects.
    

Detailed description: 
      SHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 -
      12
    

Intervention name(s): SHR2554 and Itraconazole
Intervention type(s): Drug
Intervention description(s): Single dose of oral administration of SHR2554 and Multiple dose of oral of Itraconazole Capsules
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
Condition: Chronic Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm
      trials to determine the safety and efficacy of two different dose levels of SEL-212 compared
      to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were
      randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two
      dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial
      respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were
      performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
    

Detailed description: 
      This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm
      trials to determine the safety and efficacy of two different dose levels of SEL-212 compared
      to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were
      randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two
      dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial
      respectively (SEL-212/301 and SEL-212/302). The SEL-212 doses differed as to the SEL-110.36
      component. Participants received SEL-037 administered at a dose of 0.2 mg/kg via intravenous
      (IV) infusion immediately after receiving SEL-110.36 at a dose of either 0.1 mg/kg (SEL-212
      low-dose) or 0.15 mg/kg (SEL-212 high-dose) via IV infusion. The placebo consisted of normal
      saline.

      Placebo subjects who completed the study will be offered enrollment in an open-label
      extension study for treatment with SEL-212 (SEL-212/303).

      Efficacy assessments were conducted at intervals that are appropriate to determine treatment
      effect with samples for the primary endpoint drawn during Treatment Period 6. Safety was
      monitored throughout the study with an independent data safety monitoring board (DSMB).
    

Intervention name(s): SEL-212 low-dose; SEL-212 high-dose; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): SEL-212 low-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase
Drug: SEL-110.36 (0.1 mg/kg) Other Names: SEL-110, ImmTOR; SEL-212 high-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase
Drug: SEL-110.36 (0.15 mg/kg) Other Names: SEL-110, ImmTOR; Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Anterior Cruciate Ligament Reconstruction and Plyometric Exercise
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional

Summary: 
      This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled patients
      had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced
      rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or
      high-intensity plyometric exercise. The objective of the study was to determine the effect of
      plyometric exercise intensity on knee function and knee cartilage in patients with ACL
      reconstruction.
    

Detailed description: 
      As part of the study, investigators will insure patients meet the criteria for advanced
      rehabilitation based on knee motion, pain levels and quadriceps strength.

      Participants will be asked to review the informed consent and consent to the study prior to
      any study procedures. The study will consist of 2 testing sessions and an 8 week intervention
      (2 visits per week) at the UF&Shands Orthopaedics and Sports Medicine Institute. The testing
      sessions will include clinical measures of knee impairments, questionnaires, biomechanical
      analysis and functional performance testing.
    

Intervention name(s): Plyometric Exercise
Intervention type(s): Behavioral
Intervention description(s): Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; plyometric
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Study objectives:

        1. generate local clinical, health-related quality-of-life and health economic data to
           evaluate the benefits of two types of minimally invasive weight-loss surgery

        2. support multi-disciplinary bariatric sites in Germany by providing structured procedure
           guidelines and training, therefore facilitating procedural adoption, increasing safety
           and shortening the learning curve for weight-loss surgery.
    

Detailed description: 
      The objectives of this study are the following: to generate local clinical, health-related
      quality-of-life and health economic data to evaluate the benefits of two types of minimally
      invasive weight-loss surgery; and to support multi-disciplinary bariatric sites in Germany by
      providing structured procedure guidelines and training, therefore facilitating procedural
      adoption, increasing safety and shortening the learning curve for weight-loss surgery.
    

Intervention name(s): Gastric Sleeve Resection; Roux-en-Y Gastric Bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Gastric Sleeve Resection; Laparoscopic Roux-en-Y Gastric Bypass
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed as obese and eligible for weight loss surgery (BMI>40; or BMI>35 with
        co-morbidities) and the following insurance approval status (Kostenubernahmeantrag):
        approved.
      
Keywords: Gastric Sleeve; Gastric Bypass; Roux en Y; Morbid Obesity; Laparoscopy
Paracervical Block Before Intrauterine Device (IUD) Insertion
Condition: Pain Control for Intrauterine Device Insertions
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine
      administered prior to IUD insertion reduces insertion pain. The hypothesis is that women
      receiving paracervical analgesia will experience less pain during IUD insertion than those
      who do not receive such analgesia.
    


Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): 1% Lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intrauterine device; local anesthetic
Sun Protection Factor Assay (SPF Assay 19008)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z12-034)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and bioequivalence of
      isotretinoin formulations after administration of single doses to normal, non-smoking,healthy
      males under fasting conditions
    

Detailed description: 
      An open label, randomized, two-treatment, single dose, oral bioequivalence study of
      Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fasting conditions
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): Isotretinoin Capsules,40 mg
Other intervention name(s): ACCUTANE
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-67953964 in Healthy Japanese Adult Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      after single- and multiple-dose oral administration of JNJ-67953964 in healthy Japanese adult
      male participants.
    


Intervention name(s): JNJ-67953964; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-67953964 capsule will be administered orally.; Matching placebo will be administered orally.
Intervention MeSH terms: Aticaprant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.
    


Intervention name(s): ISU302; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: gaucher disease, imiglucerase, ISU302
Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is a leading cause of disability worldwide affecting both male and female especially
      in older people. Functional independence and locomotion are hampered in stroke, therefore,
      affecting their quality of life. Objective: To find the comparative effects of activity base
      therapy vs strength training on gait performance in chronic stroke patients.
    

Detailed description: 
      It was a randomized controlled trial, conducted in physical therapy department of Sir Ganga
      Ram Hospital. 20 chronic stroke patients were equally divided into two groups. In group-A
      patients were treated with activity base therapy and in group-B patients were treated with
      strength training. Patients were treated for a total of 6 weeks (12 sessions), 1 hour in a
      day, 3 times per week. Patients were assessed using Timed Up and Go (TUG) test and Fugl Meyer
      Examination-Lower Extremity (FME-LE). SPSS 25 was used toanalyze the dat
    

Intervention name(s): activity based therapy; Strength Training
Intervention type(s): Other; Other
Intervention description(s): Standing and reaching (2) Sit-to-stand (3) Stepping forward and backward onto blocks (4) Stepping sideways onto blocks (5) Forward step up onto blocks (6) Raising and lowering of heel (7) Standing with the base of support constrained with feet in parallel and tandem conditions Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill; (11) Walking over various surfaces and obstacles;; Strength training included for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Activity based therapy; Chronic stroke; Gait; strength training; exercises
A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
Condition: Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be a prospective, randomized, double-blind, placebo-controlled, parallel
      group, multicenter trial of postmenopausal subjects with an intact uterus.
    

Detailed description: 
      Postmenopausal subjects with an intact uterus who meet the study entry criteria will be
      randomized to one of five treatment arms (four active and one placebo) and followed for 12
      months. During the Screening period all subjects will be provided with a diary to self-assess
      the frequency and severity of their vasomotor symptoms. Subjects experiencing a minimum daily
      frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will participate in a VMS
      Substudy during the first 12 weeks of treatment. The Substudy subjects will be stratified by
      treatment arm within the sites, and only Substudy subjects have the possibility of being
      randomized to placebo. Subjects who qualify for the study except for experiencing a minimum
      daily frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will be stratified
      within sites to one of the four active treatment arms and followed for 12 months, but will
      not participate in the VMS Substudy. (However, VMS information will be collected from all
      subjects during the first 12 weeks of treatment.) All Study Subjects: Postmenopausal women
      with an intact uterus who seek relief from hot flushes and meet all other inclusion/exclusion
      criteria are eligible for 12 months of study treatment.

      VMS Substudy Subjects: A subset of All Study Subjects who have ≥7 per day or ≥50 per week
      moderate to severe hot flushes (as determined during Screening) are eligible for the 12-week
      VMS Substudy and for a total of 12 months of study treatment.

      Clinical evaluations will be performed at the following time points:

        -  Screening Period (Week: - 8.5) (up to -60 Days)

        -  Visit 1 Randomization (Week 0) (Day 1)

        -  Visit 2 Interim (Week 4)

        -  Visit 3 Interim (Week 8)

        -  Visit 4 Interim (Week 12)

        -  Visit 5 Interim (Month 6)

        -  Visit 6 Interim (Month 9)

        -  Visit 7 End of Treatment (Month 12)
    

Intervention name(s): Estradiol; Progesterone; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): 17B-estradiol; Estrace; Prometrium
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vasomotor symptoms; Hot flashes; Endometrial protection
The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients
Condition: Renal Replacement Therapy; Hemodialysis
Study type: Interventional
Phase: Phase 4

Summary: 
      Adequacy of solute clearance makes a profound impact on clinical outcome in maintenance
      hemodialysis patients. Thus far, guidelines on the target of solute clearance (Kt/V or URR)
      are based on patients with three dialysis sessions per week. However, quite a few patients
      have their dialysis sessions twice per week in China. The dialysis target of solute clearance
      in this population remains to be elucidated. The aim of this study was to explore the optimum
      target solute clearance (Kt/V or URR) in maintenance hemodialysis patients with two dialysis
      sessions per week. Two groups of hemodialysis patients with different Kt/V (1.2 ≤ Kt/V < 1.7
      versus Kt/V ≥ 1.7) will be followed until 96 weeks in this prospective, randomized,
      multi-center, interventional study.
    

Detailed description: 
      This is a prospective, randomized, multi-center intervention study. 400 maintenance
      hemodialysis patients with twice dialysis sessions per week will be enrolled into the study.
      All the patients have their baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V < 1.7). After
      treatment intervention, the patients will be randomized to two groups according to their
      different Kt/V (1.2 ≤ Kt/V < 1.7 vs. Kt/V ≥ 1.7), then the patients will be regularly
      followed up at baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks and 96 weeks. Clinical
      outcomes such as mortality, complications and life quality between the two groups will be
      investigated.
    

Intervention name(s): modification of hemodialysis parameters on dialysis machine
Intervention type(s): Procedure
Intervention description(s): Modification of hemodialysis parameters such as dialysis time, blood flow rate and dialysate flow rate to reach a Kt/V ≥ 1.7.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Breathing for Adolescent Stress Reduction Feasibility RCT
Condition: Anxiety; Stress
Study type: Interventional

Summary: 
      The purpose of this study was to test a simple slow breathing curriculum for reducing stress
      among high school students. The curriculum was developed by the Health and Human Performance
      Foundation and implemented for this study at a public high school in Colorado, United States.
    

Detailed description: 
      Nearly 1 in 3 US adolescents meet the criteria for anxiety, an issue worsened by the COVID-19
      pandemic. Untreated adolescent stress and anxiety can adversely affect teenagers'
      development, education, and physical and mental health. Although stress-management strategies
      may seem abundant, many are unscalable or inaccessible for today's youth. Slow diaphragmatic
      breathing reduces stress and anxiety by downregulating the body's stress response, and is a
      recommended adolescent stress management strategy. Schools are under pressure to support
      students in reducing stress, yet diaphragmatic breathing practices are rarely used in school
      settings. The investigators developed and implemented a 5-week curriculum during COVID-era
      hybrid learning to conduct the first randomized controlled trial of slow diaphragmatic
      breathing for stress reduction in a US high school setting.
    

Intervention name(s): Slow diaphragmatic breathing
Intervention type(s): Behavioral
Intervention description(s): The curriculum was based on three key breathing components that have been shown to reduce stress in adolescents: slow breathing; diaphragmatic breathing; and extended exhale breathing. Slow breathing entails breathing at a pace slower than normal breathing. Diaphragmatic breathing focuses on breaths starting from the diaphragm or abdominal areas, with abdominal, then lung, then chest expansion during the inhale and a slow, gradual, full release of air in the reverse direction on the exhale. Extended exhale breathing comprises breathing with the exhalation duration longer, often twice as long, as the inhalation.
Two versions of slow diaphragmatic extended exhale breathing were included in this study. For both, participants did the practice while seated comfortably and breathing through the nose, and were guided to increase the inhale and exhale durations over the 5 weeks. Students followed 5-minute videos for each session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants
Condition: Premature Infants; Apnea
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      Doxapram is used to stimulate respiration. For a given dose, the fluctuations in
      concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy
      or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of
      this study is to compare a dosage regimen based only on patient's weight, to another one
      using a dosing chart taking into account weight, age and gender.
    

Detailed description: 
      Doxapram is a drug used to stimulate respiration in neonates prematurely born and failing to
      breathe. For a given dose, the fluctuations in concentrations of drug observed in infants'
      blood might be wide, leading to a risk of lack of efficacy of the treatment or of toxic
      effects. Two factors are linked to these fluctuations: age and gender. The aim of our study
      is to compare a dosage regimen based only on patient's weight, and another one using a dosing
      chart taking into account not only weight but also age and gender to prescribe the initial
      dose of doxapram. The final goal of this trial is to improve efficacy and tolerance of
      doxapram by minimizing the fluctuations in blood drug levels in premature neonates.
    

Intervention name(s): Doxapram
Intervention type(s): Drug
Intervention description(s): Dosing comparison between fixed scheduled and sex related dosage.
Dosing related to weight only versus chart taking into account weight, age and gender.
Other intervention name(s): Dopram
Intervention MeSH terms: Doxapram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premature infants; Apnea; Doxapram; pharmacokinetics
Cardiovascular Treatment
Condition: Obesity
Study type: Interventional

Summary: 
      Exercise training is proved to protect against premature cardiovascular mortality.
      Additionally there is evidence that relatively high exercise intensity may be an important
      factor for improving aerobic capacity and endothelial function in patients with
      post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in
      overweight and obese individuals.

      The aim of this study is to investigate the amount of high-intensity exercise needed to
      improve aerobic capacity and endothelial function.
    


Intervention name(s): 1x4 min interval
Intervention type(s): Other
Intervention description(s): Aerobic interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: slightly overweight; males 35-45 years