bioihbjkbjnl/mcl2 huggingface dataset:
Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG
      products, and provide scientific evidence for the National Immunization Program and long-term
      polio vaccine immunization policy.

      The overall objective of this research is to determine the seroconversion rates of two
      reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
    

Detailed description: 
      In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after
      polio eradication, with a schedule seroconversion target of at least 90%. The recommendation
      was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of
      age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule
      among Chinese infants.Two Sabin IPV products that are available to China's National
      Immunization Program - produced by Kunming Bio institute and China National Biotec Group
      (CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for
      approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the
      CNBG products, and provide scientific evidence for the National Immunization Program and
      long-term polio vaccine immunization policy.

      The overall objective of this research is to determine the seroconversion rates of two
      reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.

      The specific objectives of the study are to:

        1. Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule,
           with the first dose given at 4 months and the second dose given ≥4 months after the
           first dose.

        2. Measure neutralizing antibody titers against poliovirus type I, II and III among
           two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule.
    

Intervention name(s): Sabin IPV
Intervention type(s): Biological
Intervention description(s): We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites.
Other intervention name(s): Sabin strain Inactivated Poliovirus Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inactivated Poliovirus Vaccine; Sabin strain
First-in-Human Single and Multiple Dose of GLPG2222
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to evaluate the safety and tolerability after
      single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part
      1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to
      healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).

      Furthermore, during the course of the study after single and multiple oral dose
      administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics)
      will be characterized.

      The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222
      will be explored as well.
    


Intervention name(s): GLPG2222 single dose; Placebo single dose; GLPG2222 multiple doses; Placebo multiple doses
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single ascending doses, oral suspension; single doses, oral suspension, matching placebo; multiple ascending doses, daily for 14 days, oral suspension; multiple doses, daily for 14 days, oral suspension, matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents
Condition: Underage Alcohol Use; Smoking, Non-Tobacco Products
MeSH terms: Underage Drinking
Study type: Interventional

Summary: 
      The purpose of this study is to compare two versions of an intervention focused on teaching
      10-14-year-old Latina/o adolescent's skills that will decrease the likelihood that they will
      use tobacco, alcohol, and other drugs. We are also interested in determining how cultural
      context is related to substance use and whether additional information about other tobacco
      products should be added to the GMIT intervention.
    

Detailed description: 
      All adolescents will receive the Group Motivational Interviewing for Teens (GMIT)
      intervention. GMIT is an evidence-based group intervention that has been shown to prevent
      substance use among adolescents. In this project, GMIT will be delivered virtually in a group
      setting to multiple Latina/o adolescents. In addition, some parents will virtually
      participate in a parent-only support group; the other parents will not participate in any
      group.

      In this study, participants will be randomly assigned (like flipping a coin) to receive one
      of two versions of an alcohol, drug, and tobacco program. As part of the program teen
      participants will virtually attend six 30-min intervention sessions with other teens. Parents
      may also participate in virtual group sessions. Participants will be asked on three separate
      occasions (before, immediately after, and 3 months after the sessions) to complete forms
      (phone/online) that ask questions about teens behavior at home, school, and in the community.
    

Intervention name(s): GMIT; GMIT+
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six 30-minute sessions delivered virtually in a group format. Each week a group facilitator will elicit adolescents' feedback on important topics related to substance use and provide experiential activities to help adolescents explore their beliefs and practice making healthy choices.; Six 30-minute sessions delivered virtually in a group format. Each week a group facilitator will elicit adolescents' feedback on important topics related to substance use and provide experiential activities to help adolescents explore their beliefs and practice making healthy choices. Parents and/or guardians will virtually participate in parent-only support group sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study aims to investigate the effects of anodal tDCS combined with conventional physical
      therapy for 5 consecutive sessions on motor functions and brain activity in acute stroke
      patients at immediate and 1-month follow-up.
    

Detailed description: 
      Stroke or cerebrovascular accident is a leading cause of disabilities. Physical therapy is a
      standard treatment to help motor recovery after stroke. However, disabilities remained in
      some stroke patients despite intensive training. After stroke, there are changes of cortical
      excitability and brain activity in both hemispheres. Lesioned hemisphere decreases cortical
      excitability and increases number of low-frequency brain activity, while the non-lesioned
      hemisphere increases cortical excitability and increases number of high-frequency brain
      activity. Transcranial direct current stimulation (tDCS) is a technique which delivers weak
      direct current through scalp and can be used as an adjunctive treatment. Anodal tDCS can
      increase cortical excitability and amount of high-frequency brain activity. Increased amount
      of high-frequency brain activity in the lesioned hemisphere can indicate better recovery of
      stroke. Meta-analysis has reported the benefits of anodal tDCS for motor recovery in stroke
      patients. However, only few studies have investigated tDCS effects in acute phase of stroke
      which is a crucial time for enhancing motor recovery. This study aims to investigate the
      effects of anodal- and cathodal tDCS combined with conventional physical therapy for 5
      consecutive sessions on motor functions and brain activity in acute stroke patients at
      immediate and 1-month follow-up. Participants will be randomly assigned into 2 groups (sham-,
      and anodal tDCS). Participants in the anodal group will receive 1.5 mA tDCS for 20 minutes
      before physical therapy programs for 5 consecutive sessions, while the sham group will
      receive sham tDCS with physical therapy. Brain activity by electroencephalography and motor
      performances by Fugl-Meyer Assessment and Wolf Motor Function Test will be evaluated at
      baseline, post-intervention (day 5), and follow-up at 1 month. We hypothesize that anodal
      tDCS combined with physical therapy for 5 consecutive days can immediately increase number of
      high-frequency brain activity and improve motor functions and this effect will last for a
      month compared to the sham group.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Anodal or Sham tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      Single-arm prospective, interventional clinical trial. Results will be compared to a
      historical control in the treatment of benign prostatic hyperplasia
    


Intervention name(s): AquaBeam System
Intervention type(s): Device
Intervention description(s): Aquablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aquablation; AQUABEAM; BPH; LUTS
The Effect of Exenatide on Fasting Bile Acids
Condition: Type 2 Diabetes Mellitus in Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective
      analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were compared
      before and after exenatide treatment and correlation analysis between changes of FTBAs and
      glycemic parameters.
    

Detailed description: 
      Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective
      analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were tested
      at baseline. Then exenatide were applied to the T2DM participants for 12 weeks. FTBAs and
      glycemic parameters were measured again after exenatide treatment, and correlation analysis
      between changes of FTBAs and glycemic parameters were conducted to investigate the role of
      BAs in the glycemic control effect of exenatide.
    

Intervention name(s): Exenatide treatment
Intervention type(s): Drug
Intervention description(s): 12 weeks of exenatide injection, 5 μg twice a day by subcutaneous injection for 4 weeks, followed by 10 μg twice a day for 8 weeks, as recommended by the drug manufacturer.
Other intervention name(s): exenatide
Intervention MeSH terms: Exenatide
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Chinese population
Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics
Condition: Gut Microbiota
Study type: Interventional

Summary: 
      A mono center, open label, pilot study in term newborn infants. The study will investigate
      the effect of supplementation with probiotics on the presence of total Bifidobacterium in the
      infant feces.
    

Detailed description: 
      The four weeks intervention starts within 24 hours after birth of the study subject and the
      investigational product will be given for 28 days, followed by a two weeks follow-up period
      without any intake of the investigational product.

      During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits
      by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the
      parents will be asked to complete a diary daily.

      Infant stool samples will be collected on multiple occasions during the study, as well as
      maternal breast milk samples, stool and urine samples and samples from vagina. In addition,
      sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be
      collected. Mothers will be asked to complete electronic questionnaires daily during the
      course of the study.
    

Intervention name(s): Probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Exercise Consultation in Obese Youth
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Exercise consultation, an intervention approach based on the transtheoretical model has been
      successful in promoting physical activity (PA) among adults. It is unknown whether this
      approach would be efficacious with youth. The purpose of this pilot study was to assess
      whether exercise consultation would increase PA levels and improve anthropometric measures
      and metabolic markers in obese adolescents.
    


Intervention name(s): review of "Canada's Physical Activity Guide for Youth"; Exercise consultation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The contents of the exercise booklet was reviewed with each participant of the control group by the research fellow. Health Canada's "Canada's Physical Activity Guide for Youth" was used for the exercise booklet; The exercise consultation consisted of a one-to-one discussion designed to educate the participant, strengthen his/her motivation and develop realistic goals and strategies to promote physical activity based on the patient's stage of change. The consultation was based upon the standardized protocol previously published by Loughlan and Mutrie. The Consultation Guidelines describe the 5 steps involved in an exercise consultation, including: 1) discussing current & past activities; 2) reviewing the pros & cons of exercising; 3) discussing the barriers to exercising and strategies for overcoming them; 4) determining the social support available to the patient; and finally, 5) setting realistic, attainable short term and long term goals to enhance physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Physical activity; Adolescents; Exercise counseling intervention
Changes in Stabilometry After Neural Mobilisation in Foot
Condition: Postural Balance; Foot; Therapy; Rehabilitation
Study type: Interventional

Summary: 
      Investigation will consist of measuring before and after applying nerve mobilization
      exercise. Measurements will be made on the same day without the need to go at another time.

      In this study, participants will be asked to stand on a pressure platform several times in a
      relaxed manner and with eyes open and closed before and after a neuromeningeal mobilization
      technique indicated for the treatment of pain in your feet. Measurements or tests to be
      carried out are totally innocuous and do not carry any risk to your health and integrity.

      Participants will have to remain barefoot for a maximum of 30 seconds, a total of 8 times on
      a pressure platform
    


Intervention name(s): neural mobilization
Intervention type(s): Other
Intervention description(s): neural mobilisation of the posterior tibial, deep peroneal and lateral, intermediate and medial dorsocutaneous nerves.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platform; Stabilometry
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits
Condition: Attention Deficit Hyperactivity Disorder (ADHD); Deficient Emotional Self-Regulation (DESR)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to a) assess the efficacy of omega-3 fatty acids in the
      treatment of Deficient Emotional Self-Regulation (DESR) among stimulant treated Attention
      Deficit Hyperactivity Disorder (ADHD) adults, b) assess the side effect profile of omega-3
      fatty acids in the treatment of DESR among stimulant treated ADHD adults, c) assess effects
      of omega-3 fatty acid supplementation on ADHD symptoms and associated features in stimulant
      treated ADHD adults, and d) predict value of fatty acids present in red blood cell membranes.
      This study will be a 12-week trial with adults 18-55 years of age with ADHD and symptoms of
      DESR.
    


Intervention name(s): ADHD Medication; Omega-3 Fatty Acids
Intervention type(s): Drug; Drug
Intervention description(s): For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.; Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.
Other intervention name(s): Methylphenidate extended release (OROS-MPH); Concerta; Vyvanse; Dextroamphetamine; Adderall; Mixed Amphetamine Salts; Amphetamine; Strattera; Atomoxetine; Focalin; Dexmethylphenidate; Nordic Natural EPA Xtra
Intervention MeSH terms: Methylphenidate; Amphetamine; Adderall; Dexmethylphenidate Hydrochloride; Dextroamphetamine; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics,
      safety and tolerability of HCP1903 in healthy subjects.
    


Intervention name(s): HGP1910; HGP1909; HCP1903
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take it once per period.; Take it once per period.; Take it once per period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Incidence of Urinary Retention in Patients Undergoing Unilateral Total Knee Arthroplasty- Comparison Between Continuous Epidural Analgesia and Single Shot Femoral Nerve Block- a Randomized Controlled Study (UriKANE)
Condition: Acute Pain; Urinary Retention; Post Operative Pain
MeSH terms: Urinary Retention; Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      This study aims to compare the incidence of urinary retention and requirement of bladder
      catheterization in patients undergoing total knee arthroplasty while receiving either
      continuous epidural analgesia or single shot femoral nerve block.
    


Intervention name(s): Femoral Nerve Block; Epidural
Intervention type(s): Procedure; Procedure
Intervention description(s): For patients in Femoral nerve Block Group (Group F), ultrasound guided Femoral nerve block was performed using 0.375% bupivacaine, 20 ml for femoral nerve; Patients in Epidural Group (Group E) were turned in lateral position for epidural catheter placement in lumbar region. Epidural was loaded with 0.25% bupivacaine and infusion of M2 (Bupivacaine 0.1% + Fentanyl 2mcg/ml) was started at 8 - 12 ml per hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Total Knee Arthroplasty; Femoral Nerve Block; Epidural Analgesia; Urinary Retention; Lumbar Epidural
Carbidopa for the Treatment of Excessive Blood Pressure Variability
Condition: Dysautonomia, Familial; Baroreflex Failure Syndrome
MeSH terms: Primary Dysautonomias; Autonomic Nervous System Diseases; Dysautonomia, Familial
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well
      tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension
      and normalize or reduce the exaggerated blood pressure variability in patients with familial
      dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or
      Riley-Day syndrome). Funding Source- FDA OOPD.
    

Detailed description: 
      The investigators propose to perform a double-blind randomized trial with a cross over design
      to compare high dose (600 mg/day) and low dose (300 mg per day) carbidopa blockade with
      placebo. Patients will be randomly assigned to a high-dose/low-dose/placebo sequence,
      lowdose/placebo/high-dose sequence or placebo/high-dose/low-dose sequence. Participants will
      remain on each treatment period for 28-days.

      Aim 1: To evaluate the safety and tolerability of carbidopa in FD patients with particular
      emphasis on the orthostatic fall in blood pressure.

      Aim 2: As proof of concept, examine the hemodynamic effects of carbidopa and determine its
      effects on norepinephrine production, BP variability and paroxysmal hypertension.

      Aim 3: In a dose finding study, compare the effects of low (300 mg/day) and high (600 mg/day)
      dose carbidopa blockade vs. placebo on BP variability and paroxysmal hypertension.
    

Intervention name(s): Carbidopa Low-Dose; Placebo; Carbidopa High-Dose
Intervention type(s): Drug; Other; Drug
Intervention description(s): 300 mg/day; A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.; 600 mg/day
Other intervention name(s): Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486; Placebo control pill; Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486
Intervention MeSH terms: Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Familial dysautonomia (HSAN III); Norepinephrine; Sympathetic nervous system; Autonomic nervous system; Blood pressure variability; Hypertension; Carbidopa/Lodosyn; Afferent baroreflex failure; Clinical trial