bioihbjkbjnl/mcl2 huggingface dataset:
The Outcome of CPAP Titration Under Sleep Endoscopy
Condition: Obstructive Sleep Apnea; CPAP; DISE
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial
    

Detailed description: 
      This is the study entitled "The outcome of CPAP titration under sleep endoscopy: A randomized
      controlled crossover trial". CPAP is first line golden standard treatment for Obstructive
      sleep apnea (OSA). However, the overall CPAP compliance is about 50%. One of the reasons
      responsible for the poor compliance is the inadequate pressure setting initially. Therefore,
      it is crucial for us to find out the adequate pressure as soon as possible. Sleep endoscopy
      is the way to evaluate upper airway obstruction of OSA patients. Meanwhile, the investigators
      used CPAP to titrate the adequate pressure to keep upper airway open under sleep endoscopy
      guidance. While the investigators find out this adequate pressure, the investigators set this
      pressure into CPAP program, which OSA patient will use for 1 month. To compare the different
      effect of CPAP under either auto-CPAP titration pressure or sleep endoscopy guidance
      pressure, those OSA patients will use auto-titration CPAP for 1 month as well. Another
      highlight of this study is the sedative agent-dexmedetomidine. Dexmedetomidine is a α2
      antogonist, which cause patients sedative but less respiratory drive suppression. The
      mechanism of dexmedetomidine is more physiological for nature sleep.
    

Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): CPAP treatment with different pressure for OSA patients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Safety and Tolerance of a Nutritional Intervention Program- In.Form 1.2
Condition: Obesity
Study type: Interventional

Summary: 
      The study evaluated and the safety, tolerance and acceptability of a lifestyle modification
      program with nutritional supplementation in generally healthy overweight subjects with
      cardiometabolic risk factors. Experience will be compared to a historical controls.
    

Detailed description: 
      To investigate the safety, tolerance and acceptability of a low-glycemic load diet combined
      with exercise and lifestyle modification education and a meal replacement formula and
      targeted nutraceuticals (PROG 2) in generally healthy, overweight subjects, fifty subjects
      with two or more cardiometabolic risk factors, aged 18 to 69 will be randomized into
      different arms, 13-week intervention trial. To evaluate safety and tolerability,
      questionnaires were collected weekly. Additionally, baseline, week 9 and 13 fasting blood
      samples will be drawn for blood counts, metabolic profiles, plasma lipids, and additional
      cardiovascular risk factors. Vitals signs, weight and body composition were monitored weekly.
    

Intervention name(s): PROG2
Intervention type(s): Other
Intervention description(s): Nutritional Supplements to be administered:
Protein Shakes: one shake po twice daily
Phytosterol supplement: one capsule po twice daily
Cinnamon: one tablet twice daily
Fiber supplement; one shake twice daily
Antioxidant supplement: 2 capsules daily with dinner
Fish Oil supplement: 1 capsule twice daily with food
Probiotic supplement: 1 capsule twice daily with food
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the
      treatment of outpatient subjects with Major Depressive Disorder (MDD)
    

Detailed description: 
      A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled,
      Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of
      GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225
      mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder
    

Intervention name(s): GSK372475; venlafaxine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): daily administration during the 10-week treatment phase; daily administration during the 10-week treatment phase; daily administration during the 10-week treatment phase
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Flexible-dose; GSK372475; MDD; Venlafaxine XR; Major Depressive Disorder
Digoxin Drug-Drug Interaction With Lurasidone HCl
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the pharmacokinetic profile of digoxin when
      administered alone and when administered with repeated dose of lurasidone 120mg.
    


Intervention name(s): Lurasidone
Intervention type(s): Drug
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Keywords: Lurasidone; Schizophrenia; Latuda
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study has the following objectives:

      Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine
      administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective
      To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in
      different antigen/adjuvant formulations at 0 and 2 months.
    

Detailed description: 
      Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST
      negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG
      vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed
      adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate
      arms at day 0 (right) and day 56 (left).
    

Intervention name(s): Antigen (Ag85B-ESAT-6); Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Intervention type(s): Biological; Biological
Intervention description(s): Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval; Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; immunogenicity; adjuvanted TB subunit vaccine
Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the bioequivalence and the within-subject variability
      between the test formulation of extended-release tablet of cilostazol (PMR) administered once
      daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol)
      administered twice-daily in normal healthy male and female subjects under fasting conditions.
    


Intervention name(s): Cilostazol 100 mg; PMR 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): One Cilostazol 100 mg at 08:00 and another at 20:00, two oral doses (total daily dose of 200 mg); Two PMR 200 mg at 08:00, single oral dose (total daily dose of 400 mg)
Other intervention name(s): Treatment R; Treatment T
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Artery Disease; Cilostazol; PMR; Extended-Release Tablet of Cilostazol
Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to study the transporters of serotonin and dopamine in ALS
      patients in relation with the clinical phenotype, i.e., patients without stiffness, patients
      with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.

      For such a goal the investigators will use SPECT to compare the binding of two specific
      tracers in ALS patients and in matched healthy controls.
    

Detailed description: 
      Study design This study is a prospective cross-sectional controlled multicentric clinical
      study in 60 ALS patients and 20 controls.

      Three cohorts of 20 ALS patients(patients without stiffness, patients with pyramidal
      stiffness, patients with mixed pyramidal and extra pyramidal stiffness) and 20 healthy
      controls will be included in this study

      Study centres 40 ALS patients and 13 controls will be included in the Paris ALS center, 20
      ALS patients and 7 controls will be included in the Tours ALS center.

      MRI will be performed at the Neuroradiology department of salpetriere hospital (Paris) and
      Bretonneau hospital (Tours) SPECT will be done in the nuclear medicine center of each
      hospital (Paris- Tours).

      Study duration Per patient or control, the study will be lasted one month. The total study
      duration will be two years
    

Intervention name(s): SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
Intervention type(s): Drug
Intervention description(s): 123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter.
123I-ADAM:185 MBq,5 ml will be injected via an arm intravenous catheter.
Other intervention name(s): PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ALS; serotonin; dopamine
Comparison of Remifentanil With Dexmedetomidine or Midazolam in Regards of Sedation Effectivity and Postoperative Cognitive Functions in Cystoscopies
Condition: Postoperative Cognitive Functions
Study type: Interventional

Summary: 
      The aim of the study was to compare the effects of remifentanil-dexmedetomidine and
      remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia care
      (MAC) patients undergoing cystoscopy.
    

Detailed description: 
      Forty patients undergoing cystoscopy receiving remifentanil infusion of 0.05 microgram per
      kg-1 min-1 were randomized into two groups: Either dexmedetomidine 1 microgram per kg -1
      (GroupD) or midazolam 0.2 mg kg-1h-1 (GroupM) were administered intravenously for the first
      10 minutes. Subsequently anesthesia was maintained by using the bispectral index(BIS) as a
      continuous infusion of dexmedetomidine 0.2-0.7 microgram per kg-1h-1 or midazolam 0.05-0.15
      mgkg-1h-1. Heart rate, mean arterial pressure, MMSE, sedation and the patient's and surgeon's
      satisfaction were determined.
    

Intervention name(s): Remifentanil; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; IV infusion
Intervention MeSH terms: Midazolam; Remifentanil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dexmedetomidine; midazolam; remifentanil; mini-mental state examination; monitored anaesthesia care; cystoscopy; sedation
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1
Condition: Vitamin D Serum Levels
Study type: Observational

Summary: 
      Seasonal variations in vitamin D status will be determined on a cohort of Slovenian adults
      using longitudinal study design, and association between vitamin D status and different
      Caucasian phototypes, skin colour and melanin index investigated .
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        General Slovenian adult population, men and women, skin phototypes I-IV.
High-Intensity Exercise in Older Adults
Condition: Functional Fitness; Cognitive Abilities
Study type: Interventional

Summary: 
      The goal of this interventional study was to test the high-intensity interval training called
      Aphasia Physical Exercise (APEX) in healthy older adults. The main questions it aimed to
      answer were:

        1. what is the safety and feasibility of APEX?

        2. what are APEX's acute physiological effects?

        3. what is APEX's effects on functional fitness?

        4. what is APEX's effects on cognition?

      Participants underwent:

        -  Baseline testing session (#1) with cognitive measures only (a week before the
           Pre-exercise session);

        -  Pre-exercise session (#2) with maximum oxygen consumption and heart rate assessment,
           functional fitness and cognitive measures (3-7 days before the start of the exercise
           program);

        -  APEX program, two APEX classes per week for four weeks (eight classes in total);

        -  Post-exercise session (#3), functional fitness and cognitive measures, (0-2 days after
           the end of the exercise program).
    


Intervention name(s): APEX
Intervention type(s): Behavioral
Intervention description(s): Three phases: warm-up, high-intensity interval training (HIIT) phase, cool-down. A 10-minute warm-up included deep breathing meditation and dynamic joint mobility exercises. Then, a 40-minute strength and balance workout in HIIT format with five different high-intensity (HI) exercises interspersed with five different postural stability recovery exercises. The HI intervals focused on enhancing cardiovascular fitness, muscle strength, and motor performance. The recovery intervals incorporated balance and mobility exercises. The HI exercises lasted 30 seconds for the first three weeks and then increased to 45 seconds in the fourth week while the recovery exercises lasted 60 seconds throughout the entire intervention. The HIIT phase was repeated three times in the 40 minute block. Lastly, a 10-minute cooldown consisting of standing and seated exercises similar to the warm-up.
Other intervention name(s): Physical exercise intervention incorporating high-intensity interval training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to
      continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects
      with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue
      treatment.
    


Intervention name(s): ALKS 9072, Low Dose; ALKS 9072, High Dose
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular injection, given monthly; Intramuscular injection, given monthly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications (Study P04574)(COMPLETED)
Condition: Allergies
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab
      2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg

      Chewable Tablet). Subject preference for one product or the other was determined.
      Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a
      "smile" face scale.
    


Intervention name(s): Desloratadine; Zyrtec® (cetirizine)
Intervention type(s): Drug; Drug
Intervention description(s): SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day; Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day
Other intervention name(s): Clarinex, SCH 034117
Intervention MeSH terms: Cetirizine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Intrathecal Hydromorphone for Pain Control After Cesarean Section
Condition: Pain; Cesarean Section
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of intrathecal opioids for analgesia in the setting of cesarean section has become
      standard obstetric anesthesia practice. Currently, two opioids are commonly used. These
      opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of
      analgesia and act to reduce the stress response to surgery.

      Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after
      cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use
      of this medication is associated with side effects such as pruritus and nausea and vomiting.

      Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for
      cesarean delivery when morphine was unavailable. As groups began to use hydromorphone,
      retrospective data became available that demonstrated its safety and efficacy for use during
      cesarean section.

      In order to fully elucidate the analgesic and side effect properties of hydromorphone for
      cesarean delivery, a prospective randomized, double blind study comparing morphine and
      hydromorphone is necessary. The investigators need to understand whether hydromorphone is as
      effective as morphine for analgesia after cesarean section, and whether it is associated with
      fewer or more side effects. The results of the study will allow providers to make educated
      decisions to better care for their patient.
    


Intervention name(s): Intrathecal morphine; Intrathecal hydromorphone
Intervention type(s): Drug; Drug
Intervention description(s): 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.; 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Other intervention name(s): Duramorph; Dilaudid
Intervention MeSH terms: Morphine; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intrathecal hydromorphone; Intrathecal morphine; Primary cesarean section; Analgesia
Epidemiology of Body Mass Index Rebound
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To investigate the relationship between obesity, body mass index (BMI) rebound, body
      composition changes, associated factors (e.g., diet, physical activity), and cardiovascular
      risk factor status in a longitudinal study of young children, age three at the beginning of
      the study.
    

Detailed description: 
      BACKGROUND:

      Obesity is the most prevalent nutritional problem in the United States. It appears that both
      the prevalence and severity of obesity have been increasing in recent years. Obesity often
      begins in childhood and has a number of severe sequelae, including non insulin dependent
      diabetes mellitus and cardiovascular disease. Unfortunately, obesity is very resistant to
      treatment. This places a premium on prevention. However, the identification of clinically
      useful predictors of obesity which are present prior to the onset of excess weight gain has
      been problematic. Recently, it has been shown that the timing of body mass index (BMI)
      rebound may be a predictor of future obesity. BMI increases during the first year of life. It
      then declines until it reaches a minimum value during childhood and subsequently increases
      into adolescence and adulthood. The nadir of BMI is called BMI rebound. Studies have shown
      that BMI rebound at a young age is associated with increased risk of obesity later in life.
      Currently, very little is known about the epidemiology of BMI rebound.

      DESIGN NARRATIVE:

      The investigation is a cohort study designed to follow 320 children from age three to age
      seven years. The study design will be a longitudinal one in which the children will be
      followed for a period of four years during which repeat measurements of body composition,
      diet, and physical activity will be made every four months. Parental height and weight data
      will be collected, in addition to family health history, parental smoking and alcohol intake.
Healthy Kids I-PAL
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention
      (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and
      healthy weight among children and their parents.
    


Intervention name(s): m-health approach
Intervention type(s): Behavioral
Intervention description(s): Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment