bioihbjkbjnl/mcl2 huggingface dataset:
Snooze Control: Sleep Duration & Glucose Metabolism
Condition: Glucose Metabolism Disorders
MeSH terms: Sleep Deprivation; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      This project investigated how glucose metabolism differs due to sleep deprivation for three
      consecutive nights as compared to sufficient sleep for three nights by examining
      concentrations of glucose, insulin, and other factors involved in glucose metabolism.
    

Detailed description: 
      16 participants were enrolled in the study (8 females, 8 males) aged 18-25 years. In order
      for the participants to qualify for the study, each had to wear a pedometer for a week before
      the study began to determine eligibility. Each participant came to the lab for an oral
      glucose tolerance test on a morning, following three nights when they were sleep deprived,
      and on another morning when they had three nights' sufficient sleep. The sequence of the oral
      glucose tolerance tests were randomly assigned. The sleep duration for participants was
      monitored by the readings of the sleep monitors that each participant wore. The oral glucose
      tolerance tests were performed after an overnight fast. A 20-gauge polyethylene catheter was
      placed in the antecubital vein for blood sampling. Blood samples were drawn once (0 min)
      before and 4 times (30, 60, 90, and 120 min) after a 75g glucose drink was consumed for the
      determination of plasma glucose, insulin, and concentrations of other factors. Each
      participant was told to continue their regular routine during the study period, including
      diet, caffeine usage, and exercise.
    

Intervention name(s): OGTT after deprived sleep first; OGTT after sufficient sleep first
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants slept 1-3 hours less than their normal amount for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept as much as they wanted for three nights.; Participants slept as much as they wanted for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept 1-3 hours less than normal for three nights.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: glucose metabolism; sleep deprivation
Surgical Site Infection Rates in Obese Patients After Cesarean Delivery
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional

Summary: 
      The aim of this study is to determine the surgical site infection rate and patient
      satisfaction for subcuticular versus interrupted mattress suture in closure of skin at
      Cesarean delivery in obese patients.
    

Detailed description: 
      This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on
      the period from March 2012 till August 2012. It included 130 pregnant women who underwent
      elective Cesarean section.

      The aim of this study is to determine the surgical site infection rate and patient
      satisfaction for subcuticular versus interrupted mattress suture in closure of skin at
      Cesarean delivery in obese patients.
    

Intervention name(s): Interrupted suturing; Subcuticular suturing
Intervention type(s): Other; Other
Intervention description(s): Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]; Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Surgical site infection; Cesarean section
Mobile Subthreshold Exercise Program for Concussion
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat
      youth with prolonged symptoms of concussion.
    

Detailed description: 
      6-week pilot study of a novel intervention for concussion, administering a sub-threshold
      exercise program in a mobile fashion using video conferencing and providing feedback using
      wrist-worn accelerometry and heart rate monitoring.
    

Intervention name(s): M-STEP
Intervention type(s): Behavioral
Intervention description(s): Youth will be assessed using actigraphy at baseline, and will then be asked to exercise for 1) a duration of 10 minutes > MVPA at baseline with 2) HR>120 while being monitored by a Fitbit. Youth will be asked to exercise daily, and intensity and duration will be increased every few days for a goal of 60 minutes per day at a HR>140 (low end of MVPA). The intervention will be 6 weeks in duration.
Other intervention name(s): Sub-threshold exercise
Intervention model: Single Group Assignment
Intervention model description: All youth will receive the intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child; Adolescent; exercise; rehabilitation; physical activity; virtual; mobile health
Vitamin D Supplementation and Glycemic Outcomes
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The investigators examined the effect of vitamin D supplementation on glucose homeostasis and
      metabolic markers in healthy normal weight and overweight young subjects and healthy
      normal-weight and overweight elderly subjects living in Beirut, Lebanon.
    

Detailed description: 
      A low serum 25-hydroxyvitamin D (25(OH)D) concentration has been shown to correlate with
      higher fasting blood glucose (FBG) and insulin levels and other metabolic abnormalities like
      dyslipidemia. Previous studies suggest that vitamin D supplementation is able to improve
      insulin sensitivity and metabolic markers. The aim of the study was to investigate the effect
      of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal
      weight and overweight young subjects and healthy normal-weight and overweight elderly
      subjects living in Beirut, Lebanon. Participants (n= 180; 93 men and 87 women) deficient in
      vitamin D were recruited from Saint Charles Hospital, Beirut, Lebanon. Four groups were
      recruited: normal-weight adults (n=30, age ≤ 65 years and BMI < 25 kg/m²), overweight adults
      (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²), normal-weight elderly (n=60, age ≥ 65 years and
      BMI < 25 kg/m²) and overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²).

      Participants received a supplement of 10,000 IU cholecalciferol to be taken three times per
      week for a period of 6 months. Glucose homeostasis and metabolic markers were measured at
      start of treatment, at 3 months and at 6 months.
    

Intervention name(s): cholecalciferol (Euro-Pharm International, Canada)
Intervention type(s): Dietary Supplement
Intervention description(s): All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vitamin D; Glucose; HbA1C; Insulin resistance; Blood lipids
Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month
      dispensing study
    

Detailed description: 
      The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses
      can be confidently refit into fanfilcon A toric lenses and can be successful after one month
      of daily wear.
    

Intervention name(s): fanfilcon A
Intervention type(s): Device
Intervention description(s): contact lens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of the Ability of Betaine Hydrochloride to Increase Stomach Acid in Healthy Volunteers
Condition: Pharmacodynamic
Study type: Interventional

Summary: 
      In this study the investigators will test a nutritional supplement called betaine
      hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers
      who have decreased stomach acid because they take a medicine called rabeprazole.
    

Detailed description: 
      Investigators will evaluate the extent and time course of gastric re-acidification after oral
      betaine HCl in healthy volunteers with pharmacologically-induced hypochlorhydria. After
      betaine HCl dose, gastric pH will be continuously monitored for 2 hours.
    

Intervention name(s): betaine hydrochloride; Rabeprazole
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): betaine hydrochloride 1500mg po x 1 on day 5; rabeprazole po daily x 5 days
Intervention MeSH terms: Rabeprazole; Betaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™
Condition: Malaria, Falciparum
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers
      and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the
      relative bioavailability of DHA and PQ.
    


Intervention name(s): Eurartesim
Intervention type(s): Drug
Intervention description(s): Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pulmonary Hypertension in Hypersensitivity Pneumonitis
Condition: Pulmonary Hypertension
MeSH terms: Pneumonia; Hypertension, Pulmonary; Alveolitis, Extrinsic Allergic; Hypertension; Hypersensitivity
Study type: Observational

Summary: 
      The investigation serves the identification of pulmonary hypertension (PH) among patients
      with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data
      from South America indicate that the prevalence of pre-capillary PH amongst patients with HP
      is higher than 20%. There are no reliable data from Europe so far. According to the
      investigators previous analysis, more than 400 HP patients have participated in pulmonary
      rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg
      (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is
      to be invited to participate in the study.

      A diagnostic algorithm will be applied in the clinical trial, in the case of clinical
      suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the
      determination of the prevalence of PH in patients with HP the investigators aim to assess the
      reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.
    


Intervention name(s): Right heart catheterization (in case of suspected PH)
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with confirmed Hypersensitivity Pneumonitis
Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers
Condition: Hypoxia; Anesthetics; Conscious Sedation; Hypercapnia
MeSH terms: Hypoxia; Hypercapnia
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall aim with this project is to investigate the effect of dexmedetomidine on control
      of breathing in healthy volunteers and to compare it with propofol at the same degree of
      sedation.
    

Detailed description: 
      15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response
      during sedation with dexmedetomidine and propofol in a randomized cross-over study.

      6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in
      order to validate the method.
    

Intervention name(s): Hypoxic ventilatory response; Hypercapnic ventilatory response
Intervention type(s): Procedure; Procedure
Other intervention name(s): HVR; HCVR
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dexmedetomidine; Propofol; Hypoxic ventilatory response; Hypercapnic ventilatory response
Effect of Postbiotic Product on Colonic Barriers in IBS
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Impaired intestinal permeability and microbial dysbiosis are important pathophysiological
      mechanisms underlying irritable bowel syndrome (IBS). ReFerm®, also called Profermin®, is a
      postbiotic product of oat gruel fermented with Lactobacillus plantarum 299v. In this
      experimental study, we investigated whether ReFerm® has a beneficial effect on the intestinal
      epithelial barrier function in patients with IBS.
    

Detailed description: 
      A single-blinded, randomised experimental study was conducted. Potential participants were
      screened based on the inclusion and exclusion criteria during telephone interviews. As the
      patients were their own controls, self-reported allergy was not an exclusion criterion as
      long as both interventions were carried out during unchanged allergic exposure.

      Patients were then randomly allocated to one of two study arms: Referm® or thickened water
      (Thick-it ®, commercially available; Kent Precision Foods Group, Inc., Muscatine, IA, USA) as
      placebo. The patients underwent sigmoidoscopy with biopsies obtained from the distal colon at
      baseline and after 14 days of intervention with ReFerm® or placebo enema twice a day. The
      enema was administered rectally, in the left side position, and retained for as long as
      possible (at least 10 min) both in the left-sided and supine body position to activate
      retrograde peristalsis. To assess clinical improvement of symptoms, questionnaires were
      completed twice: before and after the intervention. During the 14 days of the intervention,
      the patients completed daily questionnaires. To improve compliance with the study
      intervention, the patients were given a check-up call by a principal investigator (OBe) twice
      per week during the intervention period.
    

Intervention name(s): ReFerm(R)
Intervention type(s): Dietary Supplement
Intervention description(s): Enemas of approx 250 mL twice daily
Other intervention name(s): Profermin(R)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly allocated to ReFerm® (18 patients, two men) or placebo (12 patients, three men) arms. There were no significant differences between the groups in terms of age, BMI, or disease severity.
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Preschoolers Learning and Active in PlaY
Condition: Physical Activity
Study type: Interventional

Summary: 
      The overall aim of this proposal is to develop and test early childhood education
      setting-based physical activity (PA) interventions that are innovative by using wearable
      technology to facilitate monitoring, feedback and motivation for physical activity across
      multiple levels (child, parent, educator). We posit that our intervention strategies will
      promote behavior changes in parents and educators, leading to greater awareness and
      communication about physical activity, more active play opportunities, and ultimately more
      physical activity for preschoolers. In the R21, we will test the acceptability, feasibility
      and initial efficacy of three 6 month early childhood education setting- based, multi-level
      interventions to promote preschoolers' PA using wearable technology and additional behavior
      change techniques to engage educators and parents. The results of this study will inform a
      larger intervention trial.
    


Intervention name(s): PLAY; PLAY Parents; PLAY Teachers
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Activity trackers + curriculum information; Enhanced parental engagement; Enhanced teacher engagement with active living initiates for the teachers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Amoxicillin Bioequivalence Study Brazil - Fast
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods. The volunteers received, in each period, the
      reference or the test formulation, according to the randomization list, under fasting
      conditions, in order to evaluate if the reference and test formulations are bioequivalent.
    

Detailed description: 
      This study is prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods. The objective is to confirm if two formulations of
      Amoxicillin trihydrate, in the form powder for oral suspension, are bioequivalent. The test
      product is Amoxicillin trihydrate - Clamoxyl 500mg/5mL (Glaxo Wellcome Production.) in the
      form powder for oral suspension and reference product is Amoxil ® 500mg/5mL (GlaxoSmithKline
      Mexico SA) in the form of powder for oral suspension. Twenty eight healthy volunteers, of
      both genders, were evaluated. The volunteers received, in each period, the reference or the
      test formulation, according to the randomization list, under fasting conditions. In each
      period blood samples are collected in the following times: 0.00 (prior to administration of
      medication); 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00;
      8.00 (after administration of medication). The comparative bioavailability of the two
      formulations was evaluated based in statistical comparisons of relevant pharmacokinetic
      parameters, obtained from data of drug concentrations in blood.
    

Intervention name(s): Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL; Amoxil® 500mg/5mL powder for oral suspension
Intervention type(s): Drug; Drug
Intervention description(s): Test formulation; Reference formulation
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Endometriosis and Brominated Flame Retardant (ENDOTOX Study)
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The investigators wish to highlight, in a Case-Control design, if there is an increased
      concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis
      with surgical indication ) versus bioaccumulation recorded in a control cohort ( women
      recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis )
      . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes
      described by the HAS) and previous breastfeeding experience (yes / no , opposite the release
      expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        38 women with severe and deep endometriosis, aged 18 to 45 years old and hospitalized at
        Nantes University Hospital for surgical indication of endometriosis lesions ablation.

        And 38 women aged 18 to 45 years old without suggestive signs of endometriosis
      
Biospecimen description: 
      omental adipose tissue
    
Keywords: Endometriosis, chemical contaminants, BFRs
Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To determine the tolerability of different SAR153191 drug products that differ with respect
      to manufacturing processes and formulation, at different concentrations and doses, after
      administration of single subcutaneous doses to healthy male subjects.

      Secondary objectives:

      To determine the pharmacokinetic profile of the different SAR153191 drug products
      administered subcutaneously.

      To assess the safety of the different SAR153191 drug products administered subcutaneously.
    

Detailed description: 
      Up to 35 Days
    

Intervention name(s): SAR153191-P3 drug product; SAR153191-P2 drug product; SAR153191-C1F3 drug product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
Other intervention name(s): SAR153191; SAR153191; SAR153191
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment