bioihbjkbjnl/mcl2 huggingface dataset:
Cervical Foley Plus Vaginal Misoprostol for Labor Induction
Condition: Induction of Labor
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of the combination of the supracervical
      foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We
      hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter
      induction to delivery time.
    

Detailed description: 
      More than 22% of all gravid women undergo induction of labor in the United States for various
      indications. Although there are several techniques and methods for induction of labor, the
      best agent and method still remains uncertain. To date, there has been no randomized trial
      comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The
      combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an
      additive or synergistic effect, resulting in greater degree of cervical ripening and shorter
      induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb
      may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb
      without effacement.
    

Intervention name(s): Foley bulb
Intervention type(s): Device
Intervention description(s): This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.
Other intervention name(s): cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: labor induction; foley bulb; misoprostol
An Exploratory Trial of a Health Education Programme Based on the Social and Emotional Competence in Children
Condition: Health Behavior; Emotional Intelligence
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate whether an intervention based on the social and
      emotional competence development improves the healthy lifestyles adoption in young children.
    

Detailed description: 
      This study has designed, implemented and evaluated an intervention to promote healthy
      lifestyles in children addressing the development of the social and emotional competence.
      This research followed the first three stages of the Medical Research Council framework for
      complex interventions: the theoretical, modeling phase and the exploratory trial. A
      randomised control trial with 37 children (5 y 6 years old) was conducted at the exploratory
      trial. The first unit was implemented in 8 sessions. A multi-method and multi-informant
      approach was used to assess the preliminary efficacy, acceptability and feasibility of the
      programme.
    

Intervention name(s): CRECES programme
Intervention type(s): Behavioral
Intervention description(s): The first unit of CRECES programme was implemented in 8 sessions. Each session was 40-50 minutes long and delivered during four weeks. Parents were provided with home-extension activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: social and emotional competence; healthy lifestyles; children; educational programme
A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus
Condition: Pruritus
MeSH terms: Liver Diseases; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-center, randomized, double-blind, placebo-controlled study. About 90
      liver disease subjects with moderate or above pruritus are planned to be enrolled. They will
      be randomized to two dose groups (0.3 μg/kg and 0.6 μg/kg) and a placebo control group at a
      1:1:1 ratio, with about 30 subjects in each group.
    


Intervention name(s): HSK21542; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Signaling Pathway Activation After Exercise in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary
      disease (COPD). Although resistance exercises increase strength and muscle mass in patients
      with COPD, the response to training appears to be suboptimal in these individuals. A
      dysregulation in the signaling pathways involved in the regulation of muscle mass could play
      an important role in this phenomenon.

      Hypothesis: Proteins involved in muscle mass regulation will be less activated in the
      quadriceps of patients with COPD following the acute bout of resistance training exercise
      compared to healthy age-matched controls.
    

Detailed description: 
      Our objective is to investigate the impact of an acute bout of resistance training on key
      signaling pathways involved in the regulation of muscle mass in moderate to severe COPD (FEV1
      under 60% of predicted). Key proteins of signaling intramuscular pathways involved in protein
      synthesis and degradation will be measured before after 72 contractions of the quadriceps.
      The exercise protocol was designed to match the actual exercise prescription model use in the
      context of pulmonary rehabilitation. A squat, leg press and leg extension will be done at 80%
      of max with one minute rest between sets. A biopsy of the quadriceps will be done before and
      after exercise in order to measure phosphorylated kinases, total protein content and mRNA
      expressions. All our patients will undergo a thorough baseline assessment in pulmonary
      capacity, muscle force and body composition.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): resistance training exercise, 1 session, 3 exercises, 80% of max
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; exercise training
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel
      disease.
    

Detailed description: 
      This is an open-label, non-randomised, single-dose study to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory
      bowel disease (Crohn's Disease and Ulcerative Colitis).
    

Intervention name(s): MT-1303
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease; Ulcerative Colitis
Dilute Versus Concentrated Epidural Bupivacaine in Labor
Condition: Pain; Labor Complications
MeSH terms: Obstetric Labor Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated
      (0.25%) bupivacaine.

      We hypothesize that patients randomize to receive the concentrated drug will require more
      drug, will have a more profound motor block, will be more likely to require instrumental
      delivery and will be less satisfied than those receiving dilute epidural drugs.
    

Detailed description: 
      This study examines the effect of two different local anesthetic concentrations used for
      epidural analgesia in labor. Patients are randomized to receive epidural bupivacaine, either
      as a concentrated (0.25%), or a dilute (0.0625%) solution, both administered by
      patient-controlled epidural analgesia (PCEA).
    

Intervention name(s): Epidural bupivacaine (0.25% versus 0.0625%)
Intervention type(s): Drug
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Labor Pain; Analgesia, Obstetrical; Pharmacology; Treatment Outcome
Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective
      in treating the behavioral symptoms of Fragile X Syndrome.
    


Intervention name(s): AFQ056; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fragile X Syndrome; Martin-Bell Syndrome; Genetic Diseases; X-Linked; Escalante's syndrome
Endometriosis Patients Undergoing Quinagolide Treatment
Condition: Hyperprolactinemia; Endometriosis
MeSH terms: Hyperprolactinemia; Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies,
      diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic
      lesions.
    


Intervention name(s): ENDOMETRIAL BIOPSY
Intervention type(s): Procedure
Intervention description(s): Two routine laparoscopies in period of three months with endometrial biopsy comparative study performed.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Hyperprolactinemia; Endometriosis; laparoscopy; angiogenesis, VEGF
The Relationship Between Gait Velocity and Gait Parameters
Condition: Gait Velocity
Study type: Observational

Summary: 
      Previous reports have the evidence implicating gait velocity may affect kinematic parameters.
      However, how the gait velocity will influence kinematic parameters remain unclear. The
      purpose of this research is to find out kinematic characteristics among different gait
      velocity. To do this, it will provide a reference for future prospective studies or
      investigations and make us fully understand the impact of gait velocity.
    


Intervention name(s): Gait velocity
Intervention type(s): Procedure
Intervention description(s): Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk on the treadmill in barefoot at selected gait speed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All the participants will be recruited via university advertisement.
      
Keywords: knee; gait velocity; kinematic parameters
Placebo-Controlled Pilot Trial of Mecamylamine for Treatment of Autism Spectrum Disorders
Condition: Autistic Disorder; Pervasive Developmental Disorder
MeSH terms: Autistic Disorder; Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety and efficacy of mecamylamine for the core
      symptoms of autism.
    

Detailed description: 
      This is a placebo-controlled pilot clinical trial of a nicotinic agent based on evidence that
      a disturbance occurs in nicotinic cholinergic transmission in the brain of autistic children.
      This pharmacotherapeutic trial will be conducted as a direct result of findings of a
      nicotinic receptor abnormality in autopsied brain tissue from individuals who suffered from
      autism. A pharmacological agent, mecamylamine, with specificity for the nicotinic receptors
      implicated in autism, will be tested in children with autism spectrum disorder. Twenty
      children who meet inclusion/exclusion criteria will be randomized in a 2:3 ratio to 14 weeks
      of either matched placebo (n=8) or mecamylamine (n=12). Children randomized to placebo who do
      not respond will be given the opportunity to enroll in a ten week open label extension.

      The trial has been completed and published in J. of Child & Adolescent Psychopharmacology.
    

Intervention name(s): mecamylamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosage is titrated at 6 weeks of .5mg, 2 weeks of 2.5 mg, and 6 weeks of 5.0 mg. One pill is taken once daily.; One pill is taken once daily.
Other intervention name(s): Inversine
Intervention MeSH terms: Mecamylamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autistic Disorder; Autism; Mecamylamine; Pervasive Developmental Disorder-Not Otherwise Specified
Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Biliary Tract Cancer.
Condition: Biliary Tract Cancer; Anti-PD-1 Therapy; Targeted Molecular Therapy; Capecitabine
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Biliary tract cancer (BTC) is a series of rare malignancies with poor overall prognosis.
      Radical surgery the preferred treatment option, but most patients have lost the opportunity
      of surgery at the time of diagnosis. At present, there are limited systematical treatment
      options for biliary tract cancer, with poor efficacy and short duration of responses. In the
      past few years, immune checkpoint inhibitors (ICIs) therapy has gradually been added to the
      advanced biliary comprehensive treatment. However, in view of the low incidence and high
      heterogeneity of BTC, more large number of clinical trials and practices need to be carried
      out, and the effective combination regimens and predictive biomarkers need to be explored.
      This study is a single-arm, open-label, prospective cohort study, combining Camrelizumab with
      apatinib and capecitabine as the first-line or second-line treatment for patients with
      advanced biliary tract cancer. The study aims to explore the efficacy and safety of the
      combination regimen, and try to find biomarkers that can guild treatment. In this study, 34
      patients were enrolled by the Simon's two-stage design, with the objective response rate as
      the primary endpoint and the disease control rate, progression-free survival, overall
      survival and safety as secondary endpoints. It is expected that the three-drug combination
      regimen will have significant efficacy and manageable adverse reactions, and predictive
      biomarkers can be found.
    


Intervention name(s): Camrelizumab; apatinib; Capecitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Camrelizumab was administered 200mg iv every 3 weeks.; Apatinib A safety-run-in was conducted in the first cycle to identify the recommended dose of Apatinib, the initial dose was administered 250mg orally daily every 3 weeks (Day 1-14 of a treatment cycle) The dose of Apatinib increase and reduction was 250 mg orally q.d. and 250 mg orally q.o.d. every 3 weeks respectively according to the number of doses limiting toxicity events (DLTs) in the initial group.
The final dose of Apatinib for the extension stage was detemained by the result of safety-run-in stage.; Capecitabine was administered 1000mg/m2 orally, b.i.d. every 3 weeks (Day 1-14 of a treatment cycle)
Intervention MeSH terms: Capecitabine; Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Capecitabine; Targeted Molecular Therapy; Biliary Tract Cancer; Camrelizumab
Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

        -  To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy
           followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by
           consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC
           (stage IIIA- multiple cN2 or IIIB).

      Secondary Objective:

        -  To estimate efficacy parameters in overall response rate, progression free survival and
           1 year survival for each of the two above mentioned arms.
    


Intervention name(s): docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy; docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): docetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy; docetaxel (20mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
Intervention MeSH terms: Cisplatin; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The
      purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ
      [MSC2499550A]) oral dispersible tablet (ODT) formulation (150 milligram [mg]) versus the
      current marketed racemate praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male
      volunteers under fed conditions.
    


Intervention name(s): MSC2499550A; Cysticide; MSC2499550A; MSC2499550A; MSC2499550A; MSC2499550A
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each intervention period.; Subjects will receive a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
Other intervention name(s): L-PZQ; Praziquantel; L-PZQ; L-PZQ; L-PZQ; L-PZQ
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Praziquantel; L-PZQ; PZQ; MSC2499550A; Bioavailability; Pharmacokinetics
Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
Condition: HIV; Inflammation; Obesity; Aging, Biological
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The primary objective of this proposal is to compare a moderate or high intensity exercise
      intervention to improve physical function in persons aging with Human Immunodeficiency Virus
      (HIV).
    

Detailed description: 
      The primary objective of this proposal is to compare a moderate or high intensity exercise
      intervention to improve physical function in persons aging with HIV. Both HIV-infected and
      HIV-uninfected older adults will be assigned to a moderate intensity cardiovascular and
      resistance training intervention for 12 weeks, and then randomized to either continue
      moderate intensity exercise, or increase to high intensity exercise for an additional 12
      weeks. The primary outcome is the impact of exercise on physical function, as measured by the
      overall score of a modified Short Physical Performance Battery (mSPPB) and the chair rise
      time from the mSPPB. The secondary outcomes include changes in insulin-like growth factor-1
      (systemic and local) and inflammation (interleukin-6 (IL-6), soluble tumor necrosis factor
      receptors 1 and 2 (sTNFR-1 and sTNFR-2)).
    

Intervention name(s): High-intensity cardiovascular and resistance exercise; Moderate-intensity cardiovascular and resistance exercise
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Frail Elderly; IGF-1
Visual Function Changes After Intraocular Pressure Reduction
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      During the glaucomatous disease process, subpopulations of cells may be dead, damaged or
      healthy. Visual function changes could be observed due to a recovering of the suffering
      ganglion cells after the intraocular pressure reduction. This study aims at evaluating the
      correlation between intraocular pressure reduction and visual function changes in glaucoma
      patients after using antiglaucoma medications.
    

Detailed description: 
      Primary open angle glaucoma patients without use of antiglaucoma medications will be enrolled
      in this study. After inclusion, the patients will randomly receive one of three antiglaucoma
      medications (timolol maleate 0,5%, brimonidine tartrate 0,2% or travoprost 0,004%) in one
      randomly selected eye.

      The patients will be evaluated with Goldmann applanation tonometry, visual acuity test,
      contrast sensitivity test, visual quality perception test (visual analogue scale) and
      standard automated perimetry before and after 4 weeks of glaucoma treatment onset.
    

Intervention name(s): timolol maleate 0,5%; brimonidine tartrate 0,2%; travoprost 0,004%
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Travoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: intraocular pressure; contrast sensitivity; visual function