bioihbjkbjnl/mcl2 huggingface dataset:
A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Condition: Cerebral Palsy, Dyskinetic
MeSH terms: Cerebral Palsy; Dyskinesias
Study type: Interventional
Phase: Phase 3

Summary: 
      CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or
      early childhood and permanently affect body movement and muscle coordination. CP is caused by
      damage to or abnormalities inside the developing brain that disrupt the brain's ability to
      control movement and maintain posture and balance. The signs of CP usually appear in the
      early months of life, although specific diagnosis may be delayed until the age of 2 years or
      older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for
      safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in
      Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved
      treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options
      address some of the manifestations of DCP. The study population will include pediatric and
      adolescent participants (6 through 18 years of age) with DCP with predominant choreiform
      movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age).
      Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria.

      This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered
      as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18
      years, inclusive) with DCP with predominant choreiform movement disorder. The study will be
      conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and
      placebo) in which participants will be randomized in a 2:1 ratio.

      "Predominant" in this instance indicates that the choreiform movement disorder is the main
      cause of impairment or distress.
    


Intervention name(s): TEV-50717; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosage ranging from 6 mg to 48 mg.; Dosage ranging from 6 mg to 48 mg.
Other intervention name(s): Deutetrabenazine, (previously SD-809)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DCP
A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on
      the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a
      single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a
      cross-over design. The anticipated time on study treatment is 40 days.
    


Intervention name(s): Carbamazepine; RO4917523
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses of carbamazepine; Single dose of RO4917523
Intervention MeSH terms: Carbamazepine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan
      Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were
      separated by a washout period of 17 days during fasting study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Torrent's Felodipine Extended-Release Tablets
Intervention type(s): Drug
Intervention MeSH terms: Felodipine
The Effect of Aerobic Exercise on Nomophobia and Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      It was aimed to examine the effect of aerobic exercise on nomophobia and anxiety in
      nomophobic university students.
    

Detailed description: 
      It was aimed to examine the effect of aerobic exercise on nomophobia and anxiety in
      nomophobic university students. There is no study in the literature examining the
      relationship between aerobic exercise and nomophobia in young people. Since our study will be
      the first to investigate the subject, we foresee that it is scientifically important and will
      shed light on future studies. In addition, national or international publications are planned
      after the study is completed.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment
Masking: Single (Participant)
Primary purpose: Treatment
Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide
Condition: Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia
MeSH terms: Anxiety Disorders; Panic Disorder; Phobia, Social; Agoraphobia
Study type: Interventional

Summary: 
      Anxiety disorders affect over a quarter of the population, yet very little is known about the
      variables that predict treatment outcome. The planned study explores whether a patient's
      response to a physiological test involving inhalation of carbon dioxide predicts their
      response to exposure therapy.
    

Detailed description: 
      Anxiety Sensitivity (AS) refers to an individual's fear of experiencing anxiety-related
      symptoms (e.g., dyspnea or heart palpitations) and is a core construct underlying the
      initiation and maintenance of pathological anxiety. Recent evidence suggests that reducing AS
      may be critical for the prevention and treatment of anxiety across diagnostic categories.
      Exposure therapy, an important component of cognitive behavioral therapy (CBT), is one of the
      most effective treatments for reducing AS, and has been shown to improve symptoms across a
      number of different anxiety disorders. Meta-analyses reveal an approximately 50% treatment
      response rate, with the remaining half of patients showing either no response or dropping out
      of treatment early. Unfortunately, there is a paucity of research exploring which variables
      predict treatment outcome and there are currently no tests for predicting which patients
      would benefit the most from exposure therapy. In this study, participants will complete two
      sessions of a carbon dioxide (CO2) habituation paradigm, a safe and noninvasive physiological
      test that entails repeated exposures to single vital capacity inhalations of 20% CO2. Both
      CO2 testing sessions will be completed within a 72-hour time period. Patients then complete a
      10-week group-based exposure therapy to determine whether an individual's degree of
      habituation to CO2 predicts treatment outcome.
    

Intervention name(s): Exposure therapy
Intervention type(s): Behavioral
Intervention description(s): 10 weekly sessions of group-based exposure therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
Condition: Liver Cirrhosis, Biliary
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline
      phosphatase levels in PBC participants, over a 12-week treatment period, as compared to
      placebo.
    

Detailed description: 
      The study included 2 phases: a 3-month randomized, double-blind (DB), placebo-controlled,
      parallel group phase, followed by a long-term safety extension (LTSE). The planned duration
      of the LTSE phase was country-specific, ranging from 108 months to indefinitely. On-site
      visits occurred at least every 6 months.

      Following completion of the 3-month DB phase, participants who continued to meet protocol
      requirements were given the opportunity to enroll in the LTSE phase of the study at selected
      study sites. The participants who enrolled in the LTSE phase started OCA administration, from
      a starting dose (10 or 50 milligrams [mg]) based on the dose of OCA or placebo received in
      the DB phase or on the timing of entry into the LTSE phase.

      Because the LTSE phase was not planned in the original study design, participants had varied
      gaps between the end of the DB phase and the start of the LTSE phase. Moreover, some
      participants initiated ursodeoxycholic acid during the course of that break.
    

Intervention name(s): Placebo; Obeticholic Acid (OCA)
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo tablets were administered orally once daily.; Starting dose of 10 or 50 mg administered orally once daily, followed by dose titration planned from 10 mg to 25 mg to 50 mg once daily, which could be modified for safety and tolerability issues or to achieve adequate therapeutic response.
Other intervention name(s): INT-747; 6α-ethyl-chenodeoxycholic acid (6-ECDCA)
Intervention MeSH terms: Chenodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy
Condition: Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Observational

Summary: 
      This study aims to assess the associations of maternal food timing with glucose levels during
      pregnancy.
    

Detailed description: 
      A novel line of research has emerged, suggesting that synchronizing the timing of food intake
      with body's circadian rhythms or day-night cycle has metabolic implications. Eating at the
      inappropriate time can disrupt circadian system which might induce metabolic perturbations,
      including glucose abnormalities. Recent evidence showed that circadian timing of eating was
      associated with glucose regulation in pregnant women. However, little is known about
      night-eating pattern during pregnancy, particularly the influence of nocturnal snacking on
      glycaemic control.

      This cross-sectional study aims to recruit 400 pregnant women at 18-21 weeks' gestation. The
      investigators will assess maternal dietary intake, monitor 24-hour activity-rest pattern and
      light-dark exposure, and measure glucose and insulin profiles during the second trimester of
      pregnancy. Maternal socio-demographic status, lifestyle characteristics, health conditions
      and pregnancy outcomes will be asked through interview or retrieved from medical notes.

      This study allows understanding the importance of circadian eating pattern, which is a
      modifiable behavior, in glycaemic control during pregnancy, and help to provide evidence for
      developing nutritional guidelines which can ameliorate metabolic health for mothers.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy pregnant women aged 18-45 years old and at 18-21 weeks of gestation upon
        recruitment.
      
Keywords: Food timing; Gestational diabetes mellitus; Glucose tolerance; Night-eating; Pregnancy outcomes; Snacking
EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The aim is to evaluate the electrocardiogram quality signal of the Cardioskin device and
      compare it with a Holter signal. For that, volunteers subjects will wear the Cardioskin and
      Holter, non-simultaneously, for about 24 hours.

      This study is open, and will be carried out according to a cross plan. The trial will include
      approximately 36-40 subjects between 18 and 70 years old.
    

Detailed description: 
      The wear of the first device will be randomized. Each subject will wear the two devices.

      One group will start with a 24-hour environmental recording with Cardioskin and then will
      perform another recording of about 24 hours with the Holter. Conversely, group B will start
      with the Holter and then will continue with Cardioskin. It is a randomization software that
      will assign a group to each included participant.

      Each participant will come three times at hospital : one for inclusion and equipment of the
      first device, another to be unequipped and equipped of the second device. They will come
      another time to bring back the material. The total time of participation is of two days and
      half.

      The first aim is to evaluate if the signal interpretability is non-inferior to an Holter, for
      a recording of 24h (classic analysis of rhythm).

      The second aim is to evaluate if the 24 hours signal interpretability is non-inferior to an
      Holter in the case of a repolarization analysis.

      The third aim is to compare the comfort and usability between Cardioskin and Holter.
    

Intervention name(s): Cardioskin; Holter
Intervention type(s): Device; Device
Intervention description(s): Subjects will have a 24h recording with Cardioskin, next will be unequipped.; Subjects will have a 24h recording with Holter, next will be unequipped.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Monocentric, cross study, randomized
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase l double-blind, placebo-controlled, randomized study to investigate the
      safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of
      APX001 administered intravenously and orally, followed by an evaluation of the safety,
      tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of
      APX001 administered orally.
    


Intervention name(s): APX001 single IV dose; APX001 single oral dose 1; APX001 single oral dose 2; APX001 single oral dose 3; APX001 single oral dose fasted; APX001 single oral dose fed; APX001 multiple oral doses 1; APX001 multiple oral doses 2; APX001 multiple oral doses 3; Cytochrome P450 substrates; Matching placebo control
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cross Sectional Area of Umbilical Cord Versus Hadlock's Formula in Prediction of Neonatal Birth Weight
Condition: Birth Weight; Fetal Body Weight
MeSH terms: Body Weight; Birth Weight; Fetal Weight
Study type: Observational

Summary: 
      Ultrasound measurement of cross sectional area of umbilical cord might offer advantage over
      Hadlock's formula for accurate estimation of actual birth weight at term gestation leading to
      prevention of large number of maternal and neonatal morbidity and mortality.
    

Detailed description: 
      Umbilical cord is a vital structure of maternal-fetal life that can be used to evaluate
      pregnancy outcomes. In the past, sonographic investigations of the umbilical cord were
      limited to identification of the number of vessels and Doppler evaluation of the blood flow.
      Various formulas have developed to calculate Estimated Fetal Weight (EFW) using fetal
      biometry. While it is being accurate to a degree, they are associated with error especially
      with extreme birth weight. In this study using the ultrasound to look for a relation between
      the umbilical cord cross sectional area and estimated birth weight, as it's easy to use and
      readily available, comparing the estimated birth weight obtained by this method with that of
      Hadlock's formula measures at term gestation. Trying to prove that the umbilical cord area
      formula might gave advocacy for future usage for birth weight prediction.
    

Intervention name(s): Obstetric ultrasound
Intervention type(s): Device
Intervention description(s): ultrasound measurement of the cross sectional area of umbilical cord within 1 cm from the cord insertion in to fetal abdomen and the standard Hadlock's formula
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women at term gestation admitted at labor room or prepared for cesarean section
      
Keywords: Birth weight; Hadlock's formula; Cross sectional area of umbilical cord; Umbilical cord; Fetal biometry
Superb Microvascular Imaging in Focal Nodular Hyperplasia
Condition: Focal Nodular Hyperplasia
MeSH terms: Focal Nodular Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      Focal nodular hyperplasia (FNH) in liver is the second common benign hepatic tumor. It
      usually shows hypervascular mass on imaging studies and it is not easy to differentiate with
      other hypervascular malignant tumor. For diagnosis of FNH, contrast-enhanced ultrasonography
      (US) has been used to detect 'spoke-wheel sign', which can be typically seen in FNH. However,
      temporal window of vascular phase using contrast-enhanced US (CEUS) is very short (about 10
      sec) and coordination of patient's respiration during US exam is absolutely needed. Thus, the
      investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for detection of
      'spoke-wheel sign' in patients with proven FNH, which enable to detect slow micro vascular
      flow without using CEUS.

      First, to compare the detection rate of 'spoke-wheel sign' between CEUS using sonazoid
      (Perfluorobutane, GE healthcare) and SMI.

      Second, to compare the accuracy of size measurement between gray-scale US and SMI (reference
      standard: CEUS using sonazoid.)
    

Detailed description: 
      1. To evaluate the detection rate of 'spoke-wheel sign' on CEUS using sonazoid and SMI
           (primary outcome).

           Each US findings during exam for patients with FNH were recorded by radiologist. The
           results were interpreted by consensus using 4 scale bar.

           0. Absence of 'spoke-wheel sign'

             1. Mild suspicious of 'spoke-wheel sign'

             2. Highly suspicious of 'spoke-wheel sign'

             3. Definite "spoke-wheel sign'

        2. To evaluated the accuracy of size measurement for FNH on gray-scale US and SMI
           (reference standard: CEUS using sonazoid).

           To calculate the measurement error between each method and CEUS using sonazoid on US
           images using measurement of maximum diameter of tumor.

        3. Sample size calculation according to the primary outcome.

      Expecting the detection rate of "spoke-wheel sign" on SMI, 20% (known detection rate on CEUS
      using sonazoid, 23.5%), a sample size of 62 patients was required using 95% confidence
      interval.
    

Intervention name(s): Sonazoid; Superb-Microvascular imaging
Intervention type(s): Drug; Device
Intervention description(s): Sonazoid: Commercially available contrast material for ultrasonography; Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography
Other intervention name(s): Perfluorobutane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Focal nodular hyperplasia; Ultrasonography; Superb-Microvascular imaging; Contrast-enhanced ultrasonography
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over
      1 Month of Daily Wear
    

Detailed description: 
      Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each
      study lens.
    

Intervention name(s): comfilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.; Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
Condition: Advanced Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study:

      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics
      characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the
      advanced malignant tumor subjects;
    

Detailed description: 
      1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the
           Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for
           injection in the advanced malignant tumor subjects;

        2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;

        3. Preliminary observation the effectiveness and effective dose;

        4. Provide the basis for the dosage regimen of phase II/III.
    

Intervention name(s): Chlorogenic acid
Intervention type(s): Drug
Intervention description(s): Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment