bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      There will be four study periods: Screening (up to 14 days in length), the Treatment Period
      (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects
      will be randomized to receive either STX209 (5 mg twice daily [BID], 10 mg BID or 10 mg three
      times daily [TID]) or placebo. Efficacy,safety and tolerability assessments will be performed
      periodically
    


Intervention name(s): arbaclofen; arbaclofen; arbaclofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mg bid; 10 mg bid; 10 mg tid; tid
Other intervention name(s): R-baclofen, STX209; R-baclofen, STX209; R-baclofen, STX209
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Poplar-type Propolis Dry Extract ESIT12 : Nutrikinetic and Bioavailability Studies
Condition: Nutrition, Healthy
Study type: Interventional

Summary: 
      The aim of this study is to investigate phenolic compounds from ESIT12, a poplar-type
      propolis ingredient, bioavailability and nutrikinetics by measuring urinary excretion and
      metabolic profile over 48h by means of high-performance liquid chromatography coupled with
      tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind,
      randomized and placebo control design on 10 healthy subjects.
    


Intervention name(s): ESIT12 D; ESIT12 4D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 D contains 400 mg of ESIT12; ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 4D contains 1600 mg of ESIT12; Placebo is composed of the carriers of ESIT12 : arabic gum, sucrose and silicon dioxide mix
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Correlation of Mesalamine Pharmacokinetics With Local Availability
Condition: Local Drug Concentration in Gastrointestinal Tract
Study type: Interventional

Summary: 
      This study is designed to provide data to the FDA correlating pharmacokinetics with local
      availability of medications within the gastrointestinal tract. This study will support the
      establishment of scientifically based standards for evaluating drugs which act locally within
      the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the
      plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are
      correlated with the concentrations in gastrointestinal fluids; and (2) improve the
      physiologically based models for drug absorption from the intestine. Information from this
      study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro
      correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of
      mesalamine products.
    

Detailed description: 
      This study evaluated the pharmacokinetics of mesalamine and its major metabolite of
      mesalamine known as N-acetyl-mesalamine in plasma. Mesalamine is available in different
      formulations that control the rate at which they are released in the gastrointestinal tract.
      Three formulations of mesalamine, Pentasa, Apriso, and Lialda, were studied in the crossover
      phase, while an oral solution formulation of mesalamine was studied in the single-arm phase.
      Each subject participated in a crossover phase study with one of the three formulations
      assigned at random using block randomization. Then the subject entered the single-arm phase
      study. After participation in one crossover phase study and one single-arm phase study, the
      subject could opt to participate in crossover phase studies using the other formulations also
      chosen at random until all three formulations were studied. The single-arm phase study was
      not repeated on returning subjects who participated in more than one crossover phase study.
    

Intervention name(s): Pentasa 500 mg capsule x 2 with 240 mL water; single dose; Apriso 375 mg capsule x 3 with 240 mL water; single dose; Lialda 1200 mg tablet x 1 with 240 mL water; single dose; Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
Condition: Single Ventricle Heart Disease After Fontan Surgery
MeSH terms: Heart Diseases; Univentricular Heart
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan
      physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic
      measures of exercise capacity, ventricular performance, and vascular function.
    

Detailed description: 
      A dose escalation trial to determine the pharmacokinetics, safety and tolerance of udenafil
      in male and female adolescent subjects with single ventricle physiology that that have
      undergone the Fontan surgical procedure. Pharmacodynamic data will also be collected to
      evaluate the effect of udenafil on acute exercise performance, peripheral vascular function
      and indices of myocardial performance. Five udenafil cohorts will be evaluated in additional
      to one drug free cohort
    

Intervention name(s): Udenafil
Intervention type(s): Drug
Intervention description(s): Drug
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fontan; Pharmacokinetics; Pharmacodynamics; Exercise capacity; Maximal Oxygen Consumption; Vascular function; EndoPAT; Myocardial performance
Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The study determines whether standard medical care (dopamine) affects learning and retention
      of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on
      the feeding task generalises to performance on an untrained upper limb buttoning task. Half
      the participants will train on the feeding task after they have taken their first dose of
      dopamine for the day (i.e. "on" medication state), while the other half will train on the
      same feeding task before taking their first daily dose of dopamine (i.e. "off" medication
      state).
    

Detailed description: 
      Parkinson disease (PD) is an age related neurodegenerative disorder with symptomatic declines
      in motor function due to a loss of dopaminergic neurons within the basal ganglia.

      Ironically, treatment with exogenous dopamine-replacement medication (e.g. levodopa) may have
      positive effects on existing motor skills such as handwriting or walking, but may have
      detrimental effects on the learning of motor skills necessary for effective rehabilitation.

      Although dopamine medications are routinely prescribed to replace lost dopamine in the
      sensorimotor areas of the striatum, they may actually be "overdosing" the associative
      striatum, a candidate neuroanatomical correlate for motor learning. To date, however, this
      'overdose' hypothesis has not been widely tested, given that few studies of motor learning in
      PD have reported or controlled for whether individuals were tested "on" or "off" their
      dopamine replacement medication.
    

Intervention name(s): Upper limb feeding training
Intervention type(s): Behavioral
Intervention description(s): Participants will spoon two raw kidney beans at a time from a center proximal "start" cup to three distal "target" cups positioned 16 cm away at 45°, 90° and 135° around the start cup as fast as possible using their non-dominant hand. Spooning two beans between the start cup and a target cup is considered one repetition; each trial will consist of 15 repetitions. Participants will perform 50 trials per day for 3 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Voltage Only Adjustment Versus Multiple Parameters Adjustment of Bilateral STN DBS Treatment in PD Patients.
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's
      disease (PD) is complex work because the parameter setting has not been standardized so far.
      The objective of the present study is to set up a standardized programming algorithm for
      Chinese PD patients treated with bilateral STN DBS.
    

Detailed description: 
      A total of 150 subjects will be recruited from the concurrent NCT01922388 study and followed
      up for four years. All patients will be evaluated using the Movement Disorder
      Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part
      III at baseline (one week before surgery) and at 12 and 48 months postoperatively.

      Stimulation parameters setting: The first programming is performed at 4 weeks after surgery.
      Bilateral contacts are as cathode for monopolar configuration. The initial voltage, pulse
      width and frequency are bilaterally 1.0-1.5 V, 60 μs and 130 Hz for each individual,
      respectively. Voltage is gradually increased to a stable level first, until the optimal
      efficacy is achieved. Two weeks later, when patients came back to hospital for reprogramming,
      the voltage is also first adjusted to optimize the stimulation parameters. Either pulse width
      or frequency will be adjusted when increasing voltage more than 0.4 V for one time still can
      not get satisfactory outcomes. The frequency is adjusted when bilateral symptoms are
      unresponsive to voltage. Frequency is increased by 15-20 Hz for each time. Pulse width is
      then adjusted for the satisfactory clinical response of unilateral symptoms which are not
      satisfied after increasing voltage or frequency. Pulse width is increased to 90 μs if
      necessary (e.g. severe tremor).

      Groups: Patients are divided into two groups according to the parameter settings during
      follow-up. Group I: patients with voltage adjustment only. The pulse width is kept to 60 μs
      and frequency to 130 Hz constant throughout the follow-up period. Group II: patients with
      adjustment of more than two stimulation parameters (voltage, pulse width or frequency) during
      the follow-up.
    

Intervention name(s): voltage adjustment only; Multiple parameters adjustment
Intervention type(s): Device; Device
Intervention description(s): Only voltage will be adjusted in all programming sections.; More than one parameter, including voltage, frequency and pulse width, will be adjusted in the programming sections.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        PD Patients are selected from the outpatient department of three centres.
      
Keywords: Deep Brain Stimulation; programming
Clinical Study to Examine Brushing on Dental Implants
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants
    


Intervention name(s): Fluoride; Triclosan, fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Brush twice daily; Brush twice daily
Other intervention name(s): Ultrabrite toothpaste; Total toothpaste
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients
Condition: Vascular; Change; Dietary Modification; Physical Activity; Health Behavior; Attitude to Health
Study type: Interventional

Summary: 
      Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their
      long-term outcomes and survival. Currently, no effective cardiovascular preventative care is
      provided for this pediatric population, in part, due to the fact that clinic-based programs
      are not easily accessible to children and their families. However, tele-health has been show
      to improve medical outcomes by making care more accessible to these patients. This study aims
      to meet the urgent need for an effective and sustainable delivery of preventative care to
      pediatric heart transplant patients using a diet and exercise intervention program delivered
      live over the internet direct to these patients' homes.
    


Intervention name(s): On-Line Diet and Exercise Intervention
Intervention type(s): Other
Intervention description(s): Initial 16 weeks of on-line, live exercise instruction 3x/week and on-line, diet sessions followed by 16 weeks of weekly exercise and diet sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Heart Transplantation; Tonometry; Exercise Test; Diet; Cardiovascular Physiology; Telemedicine; Pediatrics; Health Behavior; Physical Fitness; Exercise Movement Techniques; Adolescent Behavior; Child Behavior
Effects of the Elastic Bandage on the Postural Balance of Young Women
Condition: Postural Control
Study type: Interventional

Summary: 
      Elastic Bandaging Therapy (BET) is a technique that consists of the application of elastic
      adhesive tape directed on a skin, and is used for pain reduction, improvement of flexibility,
      postural alignment. It is believed that it can help proprioception by increasing or reducing
      muscle tension by acting on motor coordination and balance. The present study aims to
      evaluate the effect of the application of different BET strategies on the postural balance of
      healthy young women through measures obtained through a proper instrument for a balance
      assessment, a force platform.
    


Intervention name(s): Bandage
Intervention type(s): Device
Intervention description(s): Application of Elastic Bandage Therapy by the Therapy Taping method
Other intervention name(s): Therapy Taping; Elastic Tape; Elastic bandage; Therapeutic elastic bandage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial where participants will be allocated into four intervention groups: G1 (n = 12) will receive therapeutic elastic bandage by the Therapy Taping® method (BET) in the ankles; G2 (n = 12) will receive the application of the BET in the lumbar region and G4 (n = 12) will receive the application for all the strategies. The individuals' balance will be evaluated in four moments: pre-intervention (Pre), immediately (Ime), 24 and 48 hours after intervention (24h and 48h). The main equilibrium parameters analyzed will be: ellipse area (95%) of COP in square centimeters (A-COP in cm2), average speed in centimeters per second (VM in cm / s) and average frequency in Hertz (FM in Hz) Of COP oscillations in the anterior-posterior (A / P) and mid-lateral (M / L) directions, during three postural control tasks: open-eye semitandem (STOA) and right and left unipodal support (UNPD And UNPE).
Masking: Single (Participant)
Primary purpose: Other
Keywords: Balance; Postural control; Elastic Bandages; Force plate
Study of Bone Marrow Samples From Patients With Acute Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying the genes expressed in samples of bone marrow from patients with cancer
      may help doctors identify biomarkers related to cancer.

      PURPOSE: This research study is looking at bone marrow samples from patients with acute
      leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To perform high throughput sequencing of a set of megakaryocyte specific transcription
           factors, tyrosine kinases, and Src kinases in DNA isolated from bone marrow specimens of
           adults with acute megakaryoblastic leukemia (AMKL).

        -  To assay the ability of Src kinase inhibitors (SU6656, dasatinib) to induce
           differentiation of AMKL blasts in these patients.

      OUTLINE: DNA from previously collected bone marrow samples are sequenced to analyze genes
      associated with transcription factors (GATA1, GATA2, SCL, FOG-1, ETS1, ETS2, ERG, FLI-1,
      GABP, HOXA11, NF-E2, and RUNX1), tyrosine kinases (JAK2, JAK3, and c-MPL), and Src family
      kinases (LYN, FYN, and HCK) and compared with control DNA. Using bioinformatics, gene
      alterations are compared to known polymorphisms and subsequent changes in the amino acid
      sequence of the encoded protein. Subsequent assays assess the effect on proliferation and
      differentiation and in vitro studies evaluate the consequences of mutations on transcription
      factor and kinase activity abilities. The effect of SU6656 and dasatinib on cell death and
      polyploidization is evaluated by flow cytometry and compared with control DNA.
    

Intervention name(s): gene expression analysis; mutation analysis; polymorphism analysis; protein analysis; flow cytometry; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Other; Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Acute Leukemia
      
Keywords: adult acute megakaryoblastic leukemia (M7)
Safety and Effects of SLx-2101 Taken for up to 14 Days on Blood Pressure in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to determine the effective dosage and to study the effects of this dosage
      taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.
    

Detailed description: 
      1. Office seated peripheral systolic and diastolic blood pressure

        2. Adverse events and vital signs

        3. Plasma concentrations of SLx-2101
    

Intervention name(s): SLx-2101
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery
Condition: Gynecologic Disease; Laparoscopic Surgery
MeSH terms: Shoulder Pain; Genital Diseases, Female
Study type: Interventional

Summary: 
      Research objective to compare outcomes (shoulder pain score, wound pain score, post-operative
      residual pneumoperitoneum, lung complication, GI discomfort, administered additional
      analgesics, time to hospital staying) of using Pulmonary Recruitment maneuver with pressure
      30 cmH2O, 40 cm H2O and control group in women with post laparoscopic gynecologic surgery in
      Rajavithi hospital.
    

Detailed description: 
      Research design is Randomized control trial. The women who go to laparoscopic gynecologic
      surgery don't know the allocation. Women will be randomizes in to 3 group: PRM 30 cmH2O, 40
      cmH2O and control

      After laparoscopic surgery has finished in operator room (before moving off trocar), woman
      all group will be set in Trenderlenberg position (Tilted head low) and then surgeon will
      compress abdomen to release residual gas after operation about 2 minutes.

      The patients in group of using Pulmonary Recruitment Maneuver will be received positive
      pressure from balloon bag from anesthesiologist 5 times of setting pressure [30 cmH2O, 40
      cmH2O], 5 seconds per time to increase indirect abdominal pressure to release residual gas

      After surgery at 12, 24 and 48 hours, patients will be follow up and evaluate shoulder and
      wound pain. Chest X-ray will be done to evaluate residual pneumoperitoneum and lung
      complication. GI discomfort, administered additional analgesics and time to hospital staying
      will be evaluated and recorded.
    

Intervention name(s): Pulmonary recruitment maneuver
Intervention type(s): Procedure
Intervention description(s): Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Low pressure; Pulmonary Recruitment Maneuver; Post-laparoscopic Shoulder Pain
A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study
      in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be
      assessed in healthy adult subjects.
    

Detailed description: 
      The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a
      total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase
      enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both
      fasted and fed conditions to investigate the effect of food.
    

Intervention name(s): AP303 50 μg; AP303 150 μg; AP303 300 μg; AP303 600 μg; Placebo 50 μg; Placebo 150 μg; Placebo 300 μg; Placebo 600 μg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): AP303 tablet; AP303 tablet; AP303 tablet; AP303 tablet; Placebo tablet; Placebo tablet; Placebo tablet; Placebo tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects