bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body
Condition: Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open label, 2 period, fixed sequence study in healthy male subjects,
      performed at a single study center in the Unites States of America. The purpose of this study
      is to evaluate the effect of savolitinib on the PK of midazolam, a known cytochrome P450
      (CYP) 3A substrate.
    

Detailed description: 
      This study is designed as an open-label, 2 treatment period, fixed sequence study in healthy
      male subjects, performed at a single study center.

      The study will comprise:

        -  A screening period of maximum 28 days;

        -  Two treatment periods:

      Treatment Period 1 consists of 5 days (Study Days -1 to 4), starting with admission to the
      Study Center on Study Day -1, dosing of midazolam alone on Study Day 1 and ending on Study
      Day 4, after a 3 day washout period.

      Treatment Period 2 consists of 2 days (Study Days 5 and 6), with administration of midazolam
      in combination with savolitinib on Study Day 5. Subjects will be discharged from the Study
      Center on Study Day 6, after the last PK sample is collected.

        -  The Follow up Visit will occur at least 14 days (Study Day 19 or after) after the
           administration of savolitinib in Treatment Period 2.

        -  Subjects will be admitted to the Study Center on Study Day -1, prior to the evening meal
           the night before dosing with midazolam alone (Study Day 1) and will stay in house until
           at least 24 hours after dosing with midazolam in combination with savolitinib (Study Day
           5). Subjects will thus be discharged on Study Day 6, after the last PK sample has been
           collected.

      Each subject will be involved in the study between 21 and approximately 48 days.
    

Intervention name(s): Savolitinib; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Single dose (together with midazolam) on Study Day 5 after a high fat, high calorie breakfast.; Single dose (alone) on Study Day 1 and single dose (together with savolitinib) on Study Day 5, both after a high fat, high calorie breakfast.
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Small molecule kinase inhibitor; Open-label
Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Postoperative rehabilitation following rotator cuff repair is important to promote tendon
      healing, restore strength, and recover normal function. The aim of this study is to assess
      whether aquatic rehabilitation is more efficient than classical rehabilitation (land-based
      session) in term of range of motion, function, and pain than classical rehabilitation
      (land-based session) after an arthroscopic repair of the rotator cuff.
    

Detailed description: 
      Introduction:

      Postoperative rehabilitation following rotator cuff repair is important to promote tendon
      healing, restore strength, and recover normal function. Aquatic rehabilitation in hot water
      allows body relaxation and well-being that promote patient conditioning for efficient
      rehabilitation and is appreciated by patients. The aim of this study is to assess whether
      aquatic rehabilitation is more efficient than classical rehabilitation (land-based session)
      in term of range of motion, function, and pain after an arthroscopic repair of the rotator
      cuff.

      Methods:

      This prospective case-control clinical study is randomized 1:1 between rehabilitation with
      hydrotherapy and land-based (standard) rehabilitation. This superiority trial that included
      84 patients that have benefited from an arthroscopic superior cuff repair. Patients were
      evaluated clinically at 6 weeks, 3, 6 and 24 months and using ultrasound at 6 months.
      Multivariable linear regressions were performed to determine if 2-year postoperative scores
      were associated with gender, body mass index (BMI), age at index operation, rehabilitation
      group (Hydrotherapy vs Standard), and baseline passive range of motion (PROM) Active range of
      motion (AROM).
    

Intervention name(s): Hydrotherapy; Land-based Therapy
Intervention type(s): Other; Other
Intervention description(s): Aquatic therapy was performed in a swimming pool (depth 125-140 cm, temperature 28-31°C) supervised by a physiotherapist. Patients were asked to kneel or sit to submerge both shoulders to perform exercises consisting of progressive passive and active motion of the shoulder for 4-6 weeks, then strengthening exercises in a swimming pool for 2-4 months.; Land-based therapy was performed at a rehabilitation center supervised by a physiotherapist. Patients performed progressive passive and active-assisted motion of the shoulder for 4-6 weeks, then strengthening exercises for 2-4 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based rehabilitation.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Preoperative Antiseptic in Newborn Circumcision Comparison of Povidone Iodine and Hypochlorous Acid Used
Condition: Newborn; Infection; Disinfection; Circumcision
Study type: Interventional

Summary: 
      Comparison of Povidone iodine and Hypochlorous acid used as a Preoperative Antiseptic in
      Newborn Circumcision abstract

      Aim:

      Circumcision is one of the most common surgical procedures in all age groups. Before the
      circumcision procedure, asepsis is provided with a surface disinfectant. Various methods can
      be used for this process. Povidone iodine, which has been used for years during the
      transition from traditional circumcision methods to surgical circumcision methods; tissue
      damage, allergic reactions and increase in pain level. For this reason, the investigators
      aimed to compare it with Hypochlorous acid (Crystalin), which is a less toxic and more
      physiological antiseptic solution.

      Material and Method:

      Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and
      Povidone iodine group. At the beginning of the circumcision procedure, a culture was taken in
      the form of a prepucial swab 1 minute after the cleaning of the local area and the inner
      surface of the prepuce. Then circumcision was performed. Culture results and complications
      were compared.
    

Detailed description: 
      It is aimed to compare two solutions used for cleaning the operation area in newborn
      circumcision.It was conducted to compare the antibacterial activity of povidone iodine and
      hypochlorous.
    

Intervention name(s): hypochlorous acid
Intervention type(s): Drug
Intervention description(s): Randomize
Other intervention name(s): povidone iodine
Intervention MeSH terms: Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Two models:Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: circumcision,; wound; antibacterial
Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
Condition: COPD; OSA; Lung Function Decreased
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA
      Overlap Syndrome
    

Detailed description: 
      To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA
      Overlap Syndrome by 6 minute walking distance and oxygen consumption.
    

Intervention name(s): CPAP therapy; Control
Intervention type(s): Device; Other
Intervention description(s): Continous positive airway pressure therapy; No CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To compare pulmonary function of COPD-OSA overlap subjects who using and not using (waiting list for PAP therapy) in the period of 2 months.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD-OSA overlap syndrome; Pulmonary function test
Cardiovascular Contrast-enhanced Magnetic Resonance Imaging Using Polysaccharide Superparamagnetic Iron Oxide Injection in Diabetic Patients
Condition: Diabetes; Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label, single-center, single-dose study aims to evaluate the effect and
      safety of polymeric superparamagnetic iron oxide in cardiovascular magnetic resonance imaging
      for diabetic patients with concomitant chronic kidney disease.
    


Intervention name(s): Polysaccharide superparamagnetic iron oxide injection
Intervention type(s): Drug
Intervention description(s): Polysaccharide superparamagnetic iron oxide injection can be used for the treatment of iron-deficiency anemia and for magnetic resonance imaging enhancement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm birth refers to a delivery that occurs before 37 weeks of gestation. Identification
      of those who will eventually deliver in the preterm period is very important. However, few
      interventions have been proven to prolong pregnancy in women at risk such as cervicovaginal
      fetal fibronectin (fFN) level or transvaginal cervical length measurements. In a
      meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level or
      transvaginal cervical length measurements, absence of fetal breathing was superior to other
      methods for prediction of preterm birth in 48 hours or 7 days. In this study, the
      investigators hypothesized that if a fetus holds its breath in case of preterm birth, then
      there may be specific fetal breathing patterns during preterm labor, which may be detected by
      ultrasonography
    

Detailed description: 
      Preterm birth refers to a delivery that occurs before 37 weeks of gestation and it is the
      leading cause of neonatal morbidity and mortality. 33% of prenatal hospital admissions are
      due to preterm labor but almost 50% of patients receiving tocolytics in order to prevent
      birth deliver in the term period. Therefore, identification of those who will eventually
      deliver in the preterm period is very important. Ideally, identification of modifiable and
      nonmodifiable risk factors for preterm birth in will lead to interventions that help prevent
      this complication. However, few interventions have been proven to prolong pregnancy in women
      at risk such as cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length
      measurements. Another method for preterm birth prediction is presence of fetal breathing. In
      a meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level
      or transvaginal cervical length measurements, absence of fetal breathing was superior to
      other methods for prediction of preterm birth in 48 hours or 7 days. In this study, the
      investigators hypothesized that if a fetus holds its breath in case of preterm birth, then
      there may be specific fetal breathing patterns during preterm labor, which may be detected by
      ultrasonography
    

Intervention name(s): Fetal nasal Doppler by ultrasonography
Intervention type(s): Device
Intervention description(s): Pregnant patients who present with preterm labor will be evaluated with ultrasonography and fetal nasal Doppler will be used to detect specific fetal breathing patterns and measurements will be performed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Preterm birth; Fetal nasal Doppler; Fetal breathing
Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
Condition: PTSD
Study type: Interventional

Summary: 
      Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
    

Detailed description: 
      This study compared exposure to one of two web-based treatments in self-reported improvement
      of posttraumatic stress disorder (PTSD) symptoms in adults with at least one lifetime
      traumatic event and elevated posttraumatic stress symptoms.
    

Intervention name(s): Safety Behavior Elimination for Traumatic Stress (SBETS); Modifiable Behavior Intervention (MoBI)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention took 30 minutes to complete. At the end of the intervention, participants were instructed to select two of their most commonly-used trauma-related safety behaviors to reduce or eliminate over the coming month.; The intervention took 30 minutes to complete. At the end of the intervention, participants were instructed to select two of their most commonly-used unhealthy behaviors to reduce or eliminate over the coming month.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to complete one of two web based interventions
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Psychoeducation; Online Intervention
Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effects of steady-state TPV/r (500 mg/100 mg BID) on the single-dose
      and steady-state pharmacokinetics of Atazanavir (300 mg QD) co-administered with Ritonavir
      (100 mg). To investigate the effects of single-dose and steady-state Atazanavir (300 mg) on
      the steady-state pharmacokinetics of Tipranavir and Ritonavir.
    


Intervention name(s): Tipranavir; Ritonavir; Atazanavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TPV; RTV; TAZ
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tipranavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Timing on Motor Learning
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this research study is to compare different methods for training hand movement
      at home after stroke. This study involves research because it will test two experimental
      devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand
      and arm exercises. The MusicGlove is a glove that measures finger movements and allows its
      user to play a musical computer game using those movements. The RAE is a lever that attaches
      to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the
      arm.
    

Detailed description: 
      The purpose of this research study is to compare different methods for training hand movement
      at home after stroke. This study involves research because it will test two experimental
      devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand
      and arm exercises. The MusicGlove is a glove that measures finger movements and allows its
      user to play a musical computer game using those movements. The RAE is a lever that attaches
      to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the
      arm.
    

Intervention name(s): Conventional hand exercise; MusicGlove; Conventional Arm Exercise; Resonating Arm Exerciser
Intervention type(s): Other; Device; Other; Device
Intervention description(s): Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers; The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.; Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises; The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.
Other intervention name(s): RAE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke
Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic
      oil. The two components were confirmed to have complementary effects because of different
      operational mechanism in animal experiments, and were examined on humans in this study. Both
      BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity
      caused by toxic substances, and the purpose of this study is to confirm efficacy of and
      safety on human body of the agent and to determine its optimal dose.
    


Intervention name(s): PENNEL capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule
1 or 2 capsule, T.I.D; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will characterize the pharmacokinetics (PK) of AK0529, the effect of food and
      evaluate the safety of AK0529 in healthy Chinese adult subjects. 50 subjects will be
      randomized to receive a dose level of AK0529 or placebo in five groups. The total study
      duration will be approximately 18-27 days for each subject.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single-center, Phase I study in
      healthy Chinese subjects. The objectives of the study are to evaluate the safety of AK0529,
      characterize the PK of AK0529 and to evaluate the effect of food in healthy Chinese subjects.
      50 healthy Chinese subjects will be randomized to orally receive one of four dose levels of
      AK0529 (single dose:100 mg and 300 mg, Multiple dose: 600 mg, Cross-over Food Effect: 300 mg)
      or placebo. The total duration of the study will be approximately 18 to 27 days for each
      subject.
    

Intervention name(s): AK0529; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Active Substance: AK0529, Pharmaceutical Form: Capsule, Route of Administration: Oral; Active Substance: Placebo, Pharmaceutical Form: Capsule, Route of Administration: Oral
Intervention MeSH terms: Ziresovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Down's syndrome (DS) is a genetic condition characterized by the presence of an extra
      chromosome 21, leading to various clinical symptoms. Individuals with DS often experience
      challenges in balance, posture, and motor skills, which can impact their daily activities.
      Pilates activities focus on the concept of control of muscles. Pilates increases trunk
      flexibility, abdominal and core strength and endurance, and deep core muscle activation hence
      improving balance and posture.
    

Detailed description: 
      The study will be randomized controlled trial used to evaluate the effectiveness of pilates
      on posture and balance in children with down's syndrome. Subjects with down's syndrome
      meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups
      using non-probability sampling technique. Assessment will be done using Pediatric balance
      scale(PBS) and Timed up and go test (TUG).). Control group will receive regular physical
      therapy with balance training and experimental group will receive regular physical therapy+
      Pilates.
    

Intervention name(s): Pilates exercise; Balance training
Intervention type(s): Other; Other
Intervention description(s): Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.; Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.
Other intervention name(s): Experimental group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Balance; Contrology; Down syndrome; Pilates; Pediatric Balance Scale
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
Condition: Gastrointestinal Neoplasm
MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms
Study type: Interventional

Summary: 
      To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes
      is not inferior to the similar products produced by Johnson & Johnson when the Fengh
      Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal
      Tissue Cutting and Anastomosis
    

Detailed description: 
      In this clinical trial, prospective, multi-center, stratified group randomization, incomplete
      blind setting, parallel positive control and non-inferiority test were used to evaluate the
      Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu
      Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To
      determine whether there is any difference in the incidence of adverse events, serious adverse
      events, device defects and other safety evaluation indicators compared with similar products
      produced by Johnson & Johnson.
    

Intervention name(s): Disposable Powered Articulating Endoscopic Linear Cutter Stapler; ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Intervention type(s): Device; Device
Intervention description(s): Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment; Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients randomized to the trial group and the control group will not cross use the product
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment