bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Condition: Sleep-Related Eating Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the study is to learn about the safety and effectiveness of oral (taken by
      mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).
    

Detailed description: 
      This is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled,
      parallel group, pilot study of topiramate in subjects with Sleep-Related Eating Disorder
      (SRED). The primary objective of this study is to investigate the efficacy and safety of
      topiramate compared to placebo in the treatment of Sleep-Related Eating Disorder. SRED is a
      disorder that consists of out of control eating during the night with little or no awareness
      of the events. In this study we are comparing topiramate to placebo. A placebo is a pill that
      looks exactly like the study drug, but it does not have any active drug in it. Topamax
      (topiramate) is approved by the U.S. Food and Drug Administration (FDA) as a therapy for
      epilepsy, but topiramate has not been approved by the FDA for SRED.
    

Intervention name(s): Topiramate or Placebo
Intervention type(s): Drug
Intervention description(s): 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other intervention name(s): Brand Name: Topamax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sleep-Related Eating Disorder; Topiramate; Parasomnia
The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients
Condition: Device Success Rate; Device Performance
Study type: Interventional

Summary: 
      In the following randomized, crossover study, the investigators test the hypothesis that ease
      of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM
      in anesthetized pediatric patients.
    


Intervention name(s): i-Gel; ProSeal
Intervention type(s): Device; Device
Intervention description(s): Oropharyngeal leak pressure Insertion success; Oropharyngeal leak pressure Insertion success
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prevalence of Urinary Incontinence in Different Age Categories
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      Introduction: Urinary incontinence (UI) is considered erroneously by many as being a
      phenomenon of the aging process, however there is a growing prevalence of complaints of UI in
      nulliparous and nulligest young women.

      Objective: To investigate the prevalence of urinary incontinence in women of different age
      groups.

      Method: 78 nulliparous and nulligest women of different resident age groups in the city of
      France, being these divided in: G1 (10-18 years); G2 (20-35 years); G3 (45-60 years) and G4
      (65-75 years). Excluded from this study were women with cancer or surgeries of the inferior
      urinary treatment, urinary infection, alterations cognitive, pregnant and obesity. All the
      participants were questioned as a perception of urine loss, to the efforts or effortlessly
      evident.
    

Detailed description: 
      All participants were asked about perceived loss of urine, the effort or without apparent
      effort. The responses of participants from G1 were offered by parents and / or responsible.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        The study included 78 nulliparous and nulligest women of different ages living in the city
        of Franca, and these are divided into: G1 (10-18 years), G2 (20-35 years), G3 (45-60 years)
        and G4 (65-75 years).

        Women with a history of cancer or surgery of the lower urinary tract, urinary tract
        infection, cognitive changes, pregnancy and obesity, were excluded from this study.
      
Keywords: Urinary Incontinence
The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
Condition: Menopausal Syndromes
MeSH terms: Lower Urinary Tract Symptoms; Psychophysiologic Disorders; Somatoform Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction and
      even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal
      symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol
      valerate (E2V) 1mg & medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine
      estrogens & MPA.

      However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack
      of comparison research about their therapeutic effect on somatic symptoms, psychosomatic
      symptoms, sexual dysfunction and even urinary symptoms. The knowledge of the above
      therapeutic effects should be important for choosing a suitable medication. Therefore, the
      aim of this study is to assess the therapeutic effect on somatic symptoms, psychosomatic
      symptoms, sexual dysfunction and even urinary symptoms between tibolone and E2V/MPA.
    


Intervention name(s): Tibolone; Estradiol & medroxyprogesterone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid); Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug
Intervention MeSH terms: Medroxyprogesterone Acetate; Tibolone; Medroxyprogesterone; Estradiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopause; Tibolone; Estradiol; Hormone therapy
Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging.Magnetic Resonance Imaging
Condition: Anesthesia, Epidural; Magnetic Resonance Imaging
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the thoracic skin to epidural space depth in
      children and define the ratio between the straight and inclined thoracic skin to epidural
      depth.
    

Detailed description: 
      Thoracic epidural in children confers clinical benefits but are technically challenging. The
      prediction of thoracic skin epidural depth (SED) might increase the success rate and decrease
      complications. Magnetic resonance imaging (MRI) is the most comprehensive imaging modality of
      the spine, and the measurements derived can be more accurate.

      The present study is based on Magnetic Resonance Imaging (MRI)-based measurements to evaluate
      the thoracic SED and define the ratio between the straight and inclined SED at the two
      thoracic levels (T6-7 and T9-10) in children.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        MRI images of children aged 1 month to 8 years undergoing Magnetic Resonance Imaging
        evaluation unrelated to spine pathology were studied.
      
Keywords: Thoracic epidural; Magnetic Resonance Imaging; Children
Efficacy and Safety Study of XP12B in Women With Menorrhagia
Condition: Menorrhagia; Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether XP12B is effective and safe in the
      treatment of women with heavy menstrual bleeding associated with menorrhagia.
    


Intervention name(s): Tranexamic acid tablets; Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): 3900 mg/Day
Other intervention name(s): Lysteda; XP12B; Lysteda; XP12B
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heavy Menstrual Bleeding; Menorrhagia
An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled study to assess the safety and
      tolerability of multiple ascending doses of BT051 in subjects with moderately to severely
      active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3
      ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose
      levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be
      based on the safety and tolerability of the previous cohort.
    

Detailed description: 
      This is a randomized, placebo-controlled, multiple-ascending-dose (MAD) study enrolling
      subjects with moderately to severely active UC. Subjects with prior exposure to biologic or
      JAK inhibitors will be limited to 30% of the total subject population; those who have failed
      2 or more biologic therapies (i.e., biologic and JAK inhibitor, 2 biologics in the same
      class, or 2 biologics from different classes) will be limited to 20% of the total subject
      population. Subjects will be randomized to one of 3 doses of oral BT051 (200 mg, 800 mg, or
      3200 mg) or placebo, in ascending dose groups based on the safety and tolerability of the
      previous cohort. Safety and tolerability will be assessed by a Safety Review Committee (SRC)
      after all subjects in each cohort have completed at least 14 days of treatment, before
      proceeding to the next higher dose cohort. The SRC may recommend that the next cohort proceed
      with a higher dose as planned, or the SRC may recommend additional subjects be dosed at the
      current, previous, or lower dose of study drug.

      Each planned dose escalation cohort (Cohorts 1-3) will include 8 subjects randomized 3:1 to
      receive active drug or placebo. Starting with the lowest dose, each cohort of subjects will
      receive once daily oral BT051 or placebo for a period of 28 days. Follow-up visits will be
      performed at 7 and 30 days after the last dose.
    

Intervention name(s): BT051 200 mg; BT051 800 mg; BT051 3200 mg; Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral BT051 200 mg once daily for 28 days.; Oral BT051 800 mg once daily for 28 days.; Oral BT051 3200 mg once daily for 28 days.; Placebo Matching BT051
Other intervention name(s): ADS051; ADS051; ADS051
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis
Safety Study Designed to Study the Effects of Two Different Doses of CXA-101/Tazobactam, a Low Dose and a High Dose, on the QT/QTc Intervals in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is look at the possible side effects of two different doses of
      CXA-101/tazobactam, a low dose and a high dose, on participant's heart.
    

Detailed description: 
      Some drugs can have effects on the cardiovascular system (hearts and blood vessels) including
      the QT interval. The QT interval is the time between the contraction and relaxation of the
      chambers of the heart, called ventricles, which collect and pump blood. The use of some drugs
      can lead to serious issues such as QT interval prolongation (lengthen) and potentially
      serious arrhythmias (abnormal heart beat), and sudden death. Therefore, it is important to
      study effect of medications on the heart.

      The drug, Moxifloxacin, will be introduced as a control to be able to compare the effect, if
      any, that CXA 101/tazobactam might have on participant's heart.Moxifloxacin is an approved
      antibiotic commonly used to treat common bacterial infections. Moxifloxacin is known to
      slightly increase the electrical conduction of participant's heart.
    

Intervention name(s): CXA-101/tazobactam; CXA-101/tazobactam; Moxifloxacin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000/500 mg single IV dose administered over 60 minutes; 3000/1500 mg single IV dose administered over 60 minutes; 400 mg tablet; single IV dose of a saline solution administered over 60 minutes plus oral over-encapsulated moxifloxacin placebo tablet administered at the start of infusion.
Intervention MeSH terms: Moxifloxacin; Tazobactam; Ceftolozane; Cephalosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: QT/QTc Intervals
Regulation of Choroidal Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
Condition: Autoregulation
Study type: Interventional

Summary: 
      Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in
      perfusion pressure. For a long time it had been assumed that the choroid is a strictly
      passive vascular bed, which shows no autoregulation. However, recently several groups have
      identified some autoregulatory capacity of the choroid. Choroidal autoregulation was first
      shown in a rabbit model where intraocular pressure (IOP) and arterial blood pressure could be
      varied independently. In these experiments regulation of choroidal blood flow was not only
      dependent on ocular perfusion pressure, but was also dependent on the value of IOP. This
      indicates that a myogenic mechanism contributes to choroidal autoregulation, because the
      regulatory capacity is dependent on the transmural pressure. In the model of myogenic
      autoregulation arterioles change their vascular tone depending on the pressure inside the
      vessel and outside the vessel. The present experiments are designed to test whether a
      myogenic mechanism may also be involved in choroidal autoregulation in humans. For this
      purpose the investigators perform experiments during which the IOP and the arterial blood
      pressure is increased. According to the myogenic theory of autoregulation one would expect
      stronger vasoconstriction at lower IOPs for the same increase in ocular perfusion pressure.
    


Intervention name(s): Suction cup application; Squatting
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Choroid; Regional blood flow; Autoregulation; Laser Doppler flowmetry
Thai Version of Functional Rating Index
Condition: Questionnaire
Study type: Observational

Summary: 
      The purposes of this study were to conduct cross-cultural adaptation of the Functional Rating
      Index (FRI), to test psychometric properties of the translated questionnaire and to examine
      head-to-head comparisons with other questionnaires.
    

Detailed description: 
      This study comprised 2 major stages: 1) Cross-cultural adaptation and 2) psychometric
      properties testing.

      Cross-cultural adaptation stage:

      The FRI was cross-culturally adapted to Thai following the well-accepted guideline for the
      process of cross-cultural adaptation of self-report measure.

      Psychometric properties testing stage:

      The patients with back or neck pain completed the questionnaires at the first visit, the
      second visit and at 2-week (or at discharge or when reporting 80% improvement from the first
      visit).
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): Cross-cultural adaptation stage:
The FRI was cross-culturally adapted to Thai (called the Thai FRI) and the pre-final version of the Thai FRI was administered to patients.
Psychometric properties testing stage:
The questionnaires were administered 3 times: the first visit, the second visit and at 2 weeks.
At the first visit: the patients with back pain completed the Thai FRI , Thai Roland-Morris Disability (Thai RM), Thai modified Oswestry Low Back Pain Disability (Thai modified ODQ), Thai multi-level Roland-Morris Disability (Thai multi-level RM). The patients with neck pain completed the Thai FRI and Thai Neck Disability Index.
At the second visit: all patients completed the Thai FRI and Global Perceived Effect Scale (GPES).
At 2 weeks: the patients completed the same questionnaires as the first visit. All patients and their treating physical therapists completed the GPES.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From physical therapy department in 9 settings in Thailand
      
Keywords: Questionnaire; Functional Rating Index; Cross-cultural adaptation; Psychometric properties testing
Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval
Condition: Duchenne and Becker Muscular Dystrophy; Polycytemia Vera
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the effect of a therapeutic dose and a supratherapeutic dose of
      ITF2357 on the QT/QTc interval.
    


Intervention name(s): ITF2357 10 mg/mL; ITF2357 10 mg/mL; Placebo; Moxifloxacin Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose: 100 mg (administered as 10 mL); Dosage form: suspension; Route of administration: oral; Dose: 300 mg (administered as 30 mL); Dosage form: suspension; Route of administration: oral; Dose: 20 mL; Dosage form: suspension; Route of administration: oral; Dose: 400 mg; Dosage form: tablet; Route of administration: oral; Dose: 30 mL; Dosage form: suspension; Route of administration: oral
Other intervention name(s): Givinostat; Givinostat
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Givinostat hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this research study is to learn about how long hypertonic saline (HS) works in
      healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic
      Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up
      in the lungs. Hypertonic saline and other medications currently being developed may help
      patients with these lung diseases by speeding up mucus clearance from the lung. For these
      treatments to be effective, they likely need to be able to act for at lease several hours.
      Investigators are able to measure how lung treatments like hypertonic saline work by
      conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how
      long hypertonic saline works in people who do not have CF. Investigators plan to use this
      information to improve the design and testing of new treatments for patients with chronic
      bronchitis.

      Objectives:

        1. The investigators will use MCC measurements to determine the durability of action of
           hypertonic saline in healthy (i.e. non-CF) subjects.

        2. The investigators will determine the intra- and inter-individual variability of baseline
           MCC measurements using a slow inhalation/large particle protocol in healthy subjects to
           guide future sample size calculations.
    


Intervention name(s): Hypertonic Saline
Intervention type(s): Device
Intervention description(s): 2.8% NaCl x 4ml via nebulizer
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects completed mucociliary clearance measurements (via gamma scintigraphy) at baseline, 30 minutes after inhaling 2.8% NaCl, and 4 hours after inhaling 2.8% NaCl at separate study visits to characterize acute vs. sustained effects of inhaled 2.8% NaCl on this physiologic process.
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the
      pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers.
    

Detailed description: 
      To healthy subjects of thirty-six (36), following treatments are administered dosing in each
      period and wash-out period is a minimum of 7 days.

      Reference drug: D569 Tab. / Test drug: CKD-374 5mg Tab. Pharmacokinetic blood samples are
      collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed
    

Intervention name(s): D569 Tab.; CKD-374 5mg Tab.
Intervention type(s): Drug; Drug
Intervention description(s): D569 Tab. 1T single oral administration under fasting condition; CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment