bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in
      the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo
      control. Third, to evaluate the efficacy of each treatment for specific symptom clusters
      (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on
      going fluoxetine treatment leads to additional therapeutic benefit.
    

Detailed description: 
      This is a double blind, randomized, placebo controlled, parallel study that will randomize 60
      women at the Yale site into treatment. Participants will be screened at various collaborating
      ob-gyn centers for possible PMS symptoms, and direct referrals from the community will also
      be accepted. Subject participation length is about 7 months with 6 scheduled study visits.

      Methodology: After successfully completing the screening and qualification phase,
      participants will be randomized to treatment at Visit 1 for 5 cycles of double-blind
      treatment. Participants will be evaluated monthly during the randomization phase for adverse
      events, concurrent medication, and primary and secondary efficacy variables.

      .
    

Intervention name(s): Fluoxetine; Calcium; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium.; 1200 mg of calcium to be taken for 5 menstrual cycles.; For 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premenstrual syndrome; PMS; calcium
Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
Condition: Sleep Quantity; Sleep Efficiency
Study type: Interventional

Summary: 
      Adolescent's poor sleep habits have been linked to adverse outcomes. Recent advances in
      activity tracking have provided researchers with cost-effective and non-invasive measurements
      of sleep in a free-living environment. The primary objective is to determine the mean
      differences in Fitbit accelerometer sleep quantity (mins) between High School
      student-athletes and non-athletes during a competitive academic semester over continuous
      monitoring for two weeks.
    

Detailed description: 
      Secondary objectives are to measure and determine:

        -  If a relationship exist between self-reported Pittsburgh Sleep Quality Index (PSQI)
           sleep scores and Perceived Stress Scale (PSS) scores compared to mean Fitbit
           accelerometer sleep quantity and efficiency (sleep quality) based on heart rate, time
           awake or restless over two weeks

        -  If dietary habits have a significantly correlated relationship to subject group, sleep
           quantity, sleep efficiency and steps/day

        -  If mean differences exist in Fitbit steps counted between student-athletes and
           non-athletes over two weeks

        -  If a relationship exists between mean Fitbit accelerometer steps counted and mean sleep
           quantity and efficiency over two weeks

      All Fitbits are monitored remotely by the Principal investigator. This is a fully remote
      study (no physical study sites). Participants are recruited from 3 high schools (IRB
      approved). Consent, study forms and other e-mail communication and texting is directly
      between the participant and the Principal Investigator.
    

Intervention name(s): Accelerometer
Intervention type(s): Other
Intervention description(s): Fitbit brand
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Fitbit accelerometers are distributed to both groups, student athletes and non-athletes who continue to live their lives as usual during the 2 week monitoring.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sleep; adolescent; Fitbit; accelerometer; athlete; stress; students
Sleep Apnea After Extubation
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Observational [Patient Registry]

Summary: 
      Sleep apnea is common after extubation, approximately 71%, and is independently associated
      with hypertension and metabolic disease contributing to increased morbidity and mortality.
      Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the
      management of more symptomatic patients with obstructive sleep apnea.

      The aim of this study is to evaluate the prevalence of sleep apnea after extubation by
      respiratory polygraphy.
    


Intervention name(s): Respiratory polygraphy
Intervention type(s): Device
Intervention description(s): The respiratory polygraphy consisted of continuous polygraphical recordings for a whole night from 22:00 h to 07:00 h with standardised equipment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tertiary referral hospital
      
Keywords: Sleep Apnea; Respiratory polygraphy; Extubation
Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the safety and tolerability of varying dose and load
      regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.
    


Intervention name(s): ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 200 mg subcutaneous injection - every other week for 11 weeks; 200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 100 mg subcutaneous injection - every other week for 11 weeks; 300 mg subcutaneous injection - every week for 13 weeks; 400 mg subcutaneous injection - every week for 13 weeks; 200 mg subcutaneous injection - every week for 13 weeks
Intervention MeSH terms: Mipomersen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LDL-cholesterol; apoB-100; apoB-48
Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Neck Pain Patients
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of cervical manual mobilization on head repositioning accuracy and
      postural balance in patients with chronic mechanical neck pain in a randomized controlled
      trial. Hypothesis: There is no difference between the intervention group (manual
      mobilization) and control group head repositioning accuracy and postural balance.
    

Detailed description: 
      The aim of the study is to investigate the effectiveness of manual therapy to standing
      balance and head-neck proprioception sense in patients with chronic neck pain. The study will
      recruit 120 chronic neck pain patients and randomize the into 2 groups of 60. Group 1 will
      receive a course of manual therapy and infrared radiation for 15 minutes (twice weekly for 12
      sessions). The other group (control) will receive infrared radiation therapy only. Manual
      therapy will be provided by experienced physiotherapists and assessed by a separate assessor.
      All outcome measures will be assessed at the beginning of study, upon completion of
      intervention, 3-month and 6-month after the completion of study. All measurements collected
      will be analysed by computerized statistical software in order to calculate the effectiveness
      of manual therapy and relationship among those outcome measurements.
    

Intervention name(s): Manual mobilization on cervical spine; Infra-red therapy with self exercise pamphlet
Intervention type(s): Procedure; Procedure
Intervention description(s): Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin; Infra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal manipulations; Proprioception; Postural balance
A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets
Condition: Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction
MeSH terms: Leiomyoma; Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the relative bioavailability of SHR7280 dry suspension and tablets in healthy
      subjects.

      To assess the safety and tolerability of a single dose of SHR7280 dry suspension and tablets.
    


Intervention name(s): SHR7280 tablets; SHR7280 dry suspension
Intervention type(s): Drug; Drug
Intervention description(s): SHR7280 tablets 1 time; SHR7280 dry suspension 1 time
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Systolic Function in Heart Failure With Middle Ejection Fraction by 3D Speckle Tracking Imaging
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      In 2016, the European Heart Association defined the median ejection fraction heart failure
      for the first time. More research is needed to improve our understanding of this population,
      so as to make the best clinical decision and improve the prognosis. In this study, 3D-STI was
      used to evaluate left ventricular systolic function in heart failure with median ejection
      fraction.
    

Detailed description: 
      As the final manifestation of cardiovascular disease and the main cause of death, heart
      failure is one of the important challenges threatening human health in the 21st century. In
      2016, the European Heart Association proposed a new classification standard for heart
      failure. In particular, for the first time, heart failure with median ejection fraction has
      been clearly defined. These patients have received more and more attention, but there are
      still relatively few studies on them. More research is needed to improve our understanding of
      this part of the population in order to make the best clinical decisions and improve the
      prognosis. 3D speckle tracking technology is a new technology developed on the basis of
      real-time three-dimensional echocardiography and speckle tracking technology. It is gradually
      recognized in the evaluation of left ventricular systolic and diastolic function, especially
      in the evaluation of cardiotoxicity of chemotherapy drugs. At present, the application of
      3D-STI in the evaluation of left ventricular systolic function in heart failure with median
      ejection fraction is limited and needs further study.In this study, 3D-STI was used to
      evaluate left ventricular systolic function in heart failure with median ejection fraction.
    

Intervention name(s): diagnose
Intervention type(s): Other
Intervention description(s): HF was divided into HF with preserved ejection fraction, HF with median ejection fraction and HF with reduced ejection fraction.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients meet the diagnostic and classification criteria of heart failure proposed in the
        2016 ESC guidelines for HF but not the exclusion criteria
      
Keywords: median ejection fraction; 3D-STI
Clinical-Genetic Variation in GABA/Alcohol Sensitivity
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      The purpose of the study is to better understand how genetic factors influence individual
      sensitivity to alcohol.
    

Detailed description: 
      We want to find out if there are specific characteristics of a person's genes which will
      cause them to respond differently to alcohol. Genes are parts of the chromosomes found in the
      cells of our bodies which control our physical characteristics such the color of our hair,
      eyes, and other features. Genes are made up of molecules called "DNA" which carry the genetic
      information we receive from our parents. Just as genes control our physical characteristics,
      differences in genetic information may also explain why some people are more sensitive to
      alcohol or have problems drinking too much.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are English-speaking, children of Hispanic ancestry, 21-25 years of age, who
        drink alcohol but are not alcohol dependent will be recruited.
      
Biospecimen description: 
      Specifically, we will determine whether the subject's gene for a brain protein called
      GABA-alpha-6 is of the "Pro" type or "Ser" type.
    
Keywords: alcohol; GABA; genetic variation
Association Between Fractional Exhaled Nitric Oxide and Asthma Control
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to determine mean or median of fractional exhaled nitric oxide
      (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma
      control according to the global initiative for asthma guideline.
    

Detailed description: 
      From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as
      non-invasive, easily to perform, less time consume, has direct association with severity of
      inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and
      monitoring the treatment in asthmatic patients.

      In Thailand, this field of study is less extend, especially in children population. We
      hypothesized that in uncontrolled or partly controlled group may have high level of
      fractional exhaled nitric oxide (FeNO) than controlled group.

      It is therefore desirable to examine the association between fractional exhaled nitric oxide
      (FeNO) and level of asthma control among atopic asthmatic Thai children and will be the main
      objective of this research.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)
      
Keywords: Bronchial asthma; level of control of asthma; fractional exhaled nitric oxide (FeNO); asthma control test (ACT)
Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
Condition: Conscious Sedation Failure During Procedure
Study type: Interventional
Phase: Phase 4

Summary: 
      There are multiple retrospective studies detailing the use of etomidate in pediatric
      procedural sedation but few to no prospective clinical trials. None have compared etomidate
      to ketamine, currently the most commonly used sedative in the emergency department for
      pediatric procedural sedation. The investigators propose a randomized, controlled trial
      comparing etomidate versus ketamine for procedural sedation for fracture reduction for
      children presenting with extremity fracture requiring sedation for reduction. The
      investigators hypothesize that etomidate in combination with fentanyl will have similar
      reduction of distress and procedural recall as ketamine in combination with midazolam.
    

Detailed description: 
      There are multiple retrospective studies detailing the use of etomidate in pediatric
      procedural sedation but few to no prospective clinical trials. None have compared etomidate
      to ketamine, currently the most commonly used sedative in the emergency department for
      pediatric procedural sedation. The investigators propose a randomized, controlled trial
      comparing etomidate versus ketamine for procedural sedation for fracture reduction for
      children presenting with extremity fracture requiring sedation for reduction. The
      investigators hypothesize that etomidate in combination with fentanyl will have similar
      reduction of distress and procedural recall as ketamine in combination with midazolam.
    

Intervention name(s): ketamine and midazolam; etomidate, fentanyl, and lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg; etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
Intervention MeSH terms: Lidocaine; Midazolam; Fentanyl; Ketamine; Etomidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: procedural sedation; fracture reduction; pediatric emergency medicine; etomidate; ketamine; analgesia
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
Condition: Primary Sclerosing Cholangitis (PSC)
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and
      1000 mg BID) to placebo in adult subjects with PSC.
    


Intervention name(s): HTD1801; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HTD1801 tablets, 250 mg; tablets manufactured to mimic HTD1801 tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A primary parallel group comparison for a 6-week treatment period (Period 1), followed by a 6-week dose-controlled extension (Period 2), and followed by a 6-week placebo-controlled randomized withdrawal (Period 3).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to
      propofol for sedation in mechanically ventilated ICU patients.
    

Detailed description: 
      This is a single-center, prospective, randomized, controlled pilot study using remimazolam
      and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to
      remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the
      analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.
    

Intervention name(s): Sedation drugs
Intervention type(s): Drug
Intervention description(s): Different sedation drugs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Remimazolam besylate; Propofol; Intensive care unit; Mechanical ventilation
Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore,
      and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors
      will require specialized rehabilitation. In recent years, robot-aided therapy has been
      proposed as a means of complementing traditional therapy to alleviate the burden on
      therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots
      have been proposed in the literature but only half a dozen have been commercialized and
      typically none are seen in local clinics, due to exceedingly high costs. A novel, compact,
      inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for
      experiments in motor control neuroscience. The H-man can generate computer-controlled force
      fields to assist or resist a subject's motion and is potentially an optimal trade-off between
      clinical efficacy and robotic complexity. A first prototype of the H-Man is available at
      NTU.The primary aim of this proposed project is to assess to what extent the investigators
      H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design
      involving stroke survivors. The investigators believe that H-Man can be used for
      neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and
      motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU
      engineers, a portable version of the H-Man will be developed which will be tested in a 12
      subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT)
      study. At the same time, the feasibility of H-Man integration for a pared down home use model
      will be assessed in 4 subjects.

      The investigators primary hypothesis is that sub-acute/chronic patients will exhibit
      clinically significant decreases of impairment when training with the H-Man combined with
      standard arm therapy on robot-measured scales and standardized clinical scales, at the level
      of elbow/shoulder after 18 sessions of training on the H-Man.
    

Detailed description: 
      As above
    

Intervention name(s): H-Man; Additional Conventional Therapy
Intervention type(s): Device; Other
Intervention description(s): H-man is a portable end-effector planar upper limb robot.; Repetitive goals based arm therapy
Other intervention name(s): No other names.; No other names
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Motor recovery, robotics, stroke rehabilitation