bioihbjkbjnl/mcl2 huggingface dataset:
Automated & Coached Web-based Programs to Improve and Strengthen Romantic Relationships
Condition: Relationship, Marital
Study type: Interventional

Summary: 
      This study investigates the effectiveness of self-help, web-based programs to improve
      romantic relationships and related outcomes. Couples will be randomly assigned to complete
      the OurRelationship program, the ePREP program, the OurRelationship program with the addition
      of a coach, the ePREP program with the addition of a coach, or a wait-list control group and
      followed for six months.
    

Detailed description: 
      Nationwide, lower-income (LI) couples (those with household incomes <200% of the federal
      poverty level) - many of whom are also African American, Hispanic/Latino, or rural couples -
      face numerous challenges to their relationships. Chief amongst those challenges are: 1)
      higher risk of relationship problems and 2) lack of access to effective relationship services
      to prevent or intervene with relationship distress. Compared to higher-income couples, LI
      married and cohabiting couples are significantly more likely to divorce or separate and
      report lower relationship quality. Unfortunately, LI couples are least likely to receive
      interventions to prevent or solve relationship problems. To overcome these barriers, we
      propose to test the effectiveness of two effective web-based curricula - OurRelationship and
      PREP Online.

      A total of 1,246 LI couples will be recruited nationwide and randomly assigned to the ePREP
      program, the OurRelationship program, the ePREP program plus a coach, the OurRelationship
      program plus a coach, or a wait-list control group and followed for six months. Once randomly
      assigned to group, couples will be assessed at one month, two months, four months, and six
      months following randomization. After couples randomized to the wait-list control group
      finish their waiting period, they will be able to select the program they would like to
      complete (OurRelationship or ePREP) but will not complete research assessments during or
      following their participation in the program.
    

Intervention name(s): ePREP Program; OurRelationship Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): see arm descriptions; see arm descriptions
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The model is a partial/limited SMART design. Couples are initially randomly assigned to one of five groups - a waitlist control, the ePREP program (with and without a coach) and the OurRelationship program (with and without a coach). Following initial randomization, couples initially assigned to complete either program without a coach and who are not completing activities in a timely manner will be re-randomized to either continue without a coach or received a coach.
Masking: None (Open Label)
Primary purpose: Other
Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, controlled, multi-center, double-blind, parallel-group comparison study in
      Subjects with moderate to severe acne vulgaris on the face.

      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide
      (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl
      Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of
      moderate to severe acne vulgaris.

      The safety of the two treatment regimens will also be evaluated.
    


Intervention name(s): Adapalene/ BPO gel with Lymecycline capsules; Adapalene/ BPO vehicle gel with Lymecycline capsules
Intervention type(s): Drug; Drug
Intervention description(s): Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning; Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Other intervention name(s): Adapalene/BPO with Lymecycline; Adapalene/BPO vehicle with Lymecycline
Intervention MeSH terms: Lymecycline; Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne vulgaris
A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      GR181413A/AT1001 (migalastat hydrochloride) is a low molecular weight iminosugar, an analog
      of the terminal galactose group that is cleaved from the substrate GL-3. This compound was
      researched and developed as a drug for treatment of Fabry disease. This study, MGM115806,
      will be the first administration of GR181413A/AT1001 to Japanese subjects to investigate the
      safety, tolerability and pharmacokinetics of single oral doses in healthy Japanese adult
      subjects. Approximately 12 subjects will receive three treatments of 50, 150 and 450 mg
      GR181413A/AT1001 under fasted conditions plus placebo in a dose ascending crossover design.
      Serial pharmacokinetic samples will be collected and safety assessments will be performed
      following each dose. The pharmacokinetics and dose proportionality of GR181413A/AT1001 after
      single oral doses of GR181413A/AT1001 at the dose levels of 50, 150 and 450 mg under fasted
      conditions will be assessed.
    


Intervention name(s): GR181413A/AT1001 solution; GR181413A/AT1001 capsule; Potable water; Placebo capsule
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Powder for reconstitution; Size 2, hard gelatin capsule, white opaque / blue opaque; Matched, Size 2, hard gelatin capsule, white opaque/blue opaque; Solution matched
Intervention MeSH terms: 1-Deoxynojirimycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to determine whether giving insulin like growth factor-I
      (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone
      formation markers.
    

Detailed description: 
      Adolescents with anorexia nervosa (AN) are at high risk for low bone mineral density at a
      time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass
      and fracture risk in later life. They are also deficient in insulin-like growth factor I
      (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH),
      despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important
      for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in
      AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied.
      The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism
      in adolescent girls with AN.

      Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would
      respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone
      turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over
      10 days with concomitant measurement of indices of bone turnover, and calcium regulatory
      hormones.
    

Intervention name(s): RhIGF-1
Intervention type(s): Drug
Intervention description(s): 35-40 mcg/k/dose twice daily SC
Other intervention name(s): Increlex
Intervention MeSH terms: Mecasermin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adolescents; Anorexia nervosa (AN); Bone formation markers; Insulin like growth factor-1 (IGF-I)
Detection of Immunotoxic Gluten Peptides in Feces
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by
      assessment of gliadin 33-mer equivalent epitopes in feces.
    

Detailed description: 
      Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can
      interact with celiac patient factors to trigger immunological response. Gluten-free diet
      (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be
      monitored to avoid accumulative damage. However, practical methods to monitor diet compliance
      and to detect the origin of an outbreak of celiac clinical symptoms are not available.

      This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD
      compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic
      epitopes in human feces.
    

Intervention name(s): Detection of gluten in feces
Intervention type(s): Other
Intervention description(s): Detection of Gluten in Feces
Other intervention name(s): Gluten-free diet; Celiac patients
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Celiac patients, 1-12 years old
      
Biospecimen description: 
      Fecal samples
    
Keywords: celiac disease; gluten-free diet; gluten peptides; feces
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day
      dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The
      currently approved regimen is twice daily for 10 days.
    


Intervention name(s): ofloxacin otic solution 0.3%
Intervention type(s): Drug
Intervention description(s): ofloxacin otic solution 0.3% instilled twice a day for seven days
Intervention MeSH terms: Ofloxacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Condition: Hyperlipidemia; Blood Pressure; Oxidative Stress
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries,
      that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative
      stress. The purpose of this study is to evaluate whether pterostilbene will help control
      cholesterol and blood pressure, as well as improve markers for oxidative stress in patients
      with dyslipidemia meeting inclusion criteria. The investigators also want to look at the
      safety of pterostilbene in these patients.
    

Detailed description: 
      Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2)
      pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily;
      (4) matching placebo twice daily taken either one hour before or two hours after a meal.
      Blood and urine will be collected at enrollment and final study visits. If the patient's low
      density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria
      based on enrollment blood drawn, the patient will not be allowed to initiate study
      medication. All study visits will consist of brief clinical examination (including vital
      signs), subjective adverse event reporting, and fasting donated blood and urine for clinical
      laboratory tests. Pill counts will be done to assess compliance.
    

Intervention name(s): Pterostilbene 50 mg twice daily; Placebo; Grape Extract; Pterostilbene 125 mg twice daily
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks; Matching placebo by mouth twice daily for 6 to 8 weeks; Grape extract 100 mg twice daily for 6-8 weeks; Pterostilbene 125 mg twice daily for 6-8 weeks
Other intervention name(s): pTeroPure; ShanStar Concord Grape; pTeropure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperlipidemia; Cholesterol; Blood Pressure; Oxidative Stress; Pterostilbene; Blueberry; Grape Extract
Mitochondrial Dysfunction in Diabetes
Condition: Diabetes; Obese
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether insulin resistance is accompanied by
      "exercise resistance". Investigators will use mass spectrometry and proteomics analysis to
      test the hypothesis is that a bout of exercise that increases mitochondrial protein abundance
      in lean, healthy individuals is less effective in insulin resistant patients.
    

Detailed description: 
      The investigators' prior research has focused on defining the changes in expression of
      nuclear encoded mitochondrial genes that predict changes in insulin sensitivity in skeletal
      muscle, with the goal of defining the molecular mechanisms underlying the connection between
      mitochondrial dysfunction and insulin resistance in skeletal muscle.

      Three groups of subjects will be studied: lean, healthy control subjects (n=12) obese
      non-diabetic subjects (n=12) and patients with type 2 Diabetes Mellitus (n=12) for a total of
      36 subjects. Twenty subjects have completed the study at Arizona State University; the
      remaining 16 subjects will be accrued at the Mayo Clinic in Arizona.

      Subjects will come to the Mayo Clinic 4 times. On Study Day 1 Subjects will be screened with
      a medical history & physical and a 75 g oral glucose tolerance test to determine if they are
      eligible for the study. On Study Day 2, subjects will report to the clinic after an overnight
      fast, undergo a euglycemic clamp (using deuterated glucose) to determine insulin sensitivity,
      and in addition have a muscle biopsy (basal biopsy for comparison). On Study Day 3, subjects
      will report to the clinic after an overnight fast, and undergo a Volume Oxygen Maximum (VO_2
      max) determination. On Study Day 4, subjects will report to the clinic after an overnight
      fast to perform an exercise bout with muscle biopsy 30 minutes after the end of exercise.
      This will be followed by an overnight fast, and an additional muscle biopsy at 24 hours post
      exercise.
    

Intervention name(s): Exercise and muscle biopsies
Intervention type(s): Behavioral
Intervention description(s): Subjects will undergo a euglycemic clamp, VO_2 max determination, exercise periods and muscle biopsies.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin resistance
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the frequency of hypotension between hyperbaric
      anesthetics and isobaric anesthetics during cesarean section and determine whether continuous
      infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.
    


Intervention name(s): Bupivacaine; Levobupivacaine; Phenylephrine; normal saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): spinal anesthesia with hyperbaric bupivacaine; spinal anesthesia with isobaric levobupivacaine; continous infusion of phenylephrine; continous infusion of normal saline
Other intervention name(s): Heavy bupivacaine; chirocaine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Bupivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hypotension; cesarean section
A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of
      single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.
    


Intervention name(s): DS-8500a; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): DS-8500a 25mg tablet; 200mg itraconazole
Intervention MeSH terms: Firuglipel; Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The following study seeks to provide information regarding to the RobHand exoskeleton for
      hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid,
      Spain.
    

Detailed description: 
      The following study seeks to provide information regarding to the RobHand exoskeleton for
      hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid,
      Spain. The study was carried out by the Neurotchnology Group of the Research and Development
      Area of the Corporación de Rehabilitación Club de Leones Cruz del Sur, Chile. Clinical test
      were implemented on four subjects with Stroke sequelae who participated in two evaluations of
      manual function and 16 training sessions with the robotic exoskeleton, in order to know the
      clinical effects on manual function, safety and satisfaction of users who utilize the
      exoskeleton RobHand.
    

Intervention name(s): Training with Robotic Hand Exoskeleton
Intervention type(s): Device
Intervention description(s): The intervention consists in Robotic Hand training sessions. Each subject received 16 sessions lasting 60 minutes each and a frequency of 2 sessions per week. The sessions will be applied by an Ocupational Therapist with experience in Robotic training. Robhand exoskeleton (ITAP, Valladolid, Spain) is an exoskeleton-type electromechanical device, which is attached to the patient's hand and provides assistance for performing different types of finger movement rehabilitation therapies. The exoskeleton is composed of five independent subassemblies that are placed on a platform which is located on the back of the hand, with the exception of the thumb subassembly that is mounted on a separated module connected to the hand support platform through a linkage device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Hand Rehabilitation; Exoskeleton
A Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic
      of TAS-303 in female patients with Stress Urinary Incontinence.
    

Detailed description: 
      This study is double-blind, placebo-controlled crossover study. The main purpose of this
      study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence
      patients who will receive single dose of TAS-303 or Placebo.
    

Intervention name(s): TAS-303 18mg single-dose; Placebo 18mg single-dose; TAS-303 9mg single-dose; Placebo 9mg single-dose
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Urinary Incontinence; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms
Effects of Supplementation in Healthy Russian Population
Condition: Heart Health Markers; General Nutritional Status
Study type: Interventional

Summary: 
      The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin
      multimineral with phytonutrient product vs. placebo on heart health risk factors following
      twice-daily consumption for eight weeks; (2) To test the safety and tolerability of the
      multivitamin multimineral with phytonutrient product vs. placebo following twice-daily
      consumption for eight weeks.
    

Detailed description: 
      More and more evidence shows the benefit of fruit and vegetable intake on the maintenance of
      good health throughout the lift span. Unfortunately, many people in developed and developing
      societies do not eat a diet with the variety and quantity of fruits and vegetables. Because
      of this, prevalence of chronic disease increases rapidly in worldwide as well as the burden
      on the health care system. Therefore, promoting healthy lifestyle and dietary behavior
      becomes a critical approach in preventing chronic disease development. According to results
      from the Moscow Behavioural Risk Factor Survey performed from 2000-2001 found that mean fruit
      and vegetable intake in men and women in Moscow was 190 grams per day, much lower than the
      World Health Organization's recommended 400 grams per day. This lower than recommended intake
      would correlate to a lower intake of phytonutrients and antioxidants and may be associated
      with higher risks for chronic diseases such as cardiovascular disease (CVD) and cancer. In
      this study, we are particularly interested in understanding whether a multivitamin
      multimineral with phytonutrient product can improve nutritional status and reduce heart
      health risk factors in Russian population with low fruit and vegetable intake. This study is
      conducted in Russia Institute of Nutrition (ION) clinic, which has 200 beds and outpatients
      department.
    

Intervention name(s): multivitamin multimineral with phytonutrient supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): The multivitamin multimineral with phytonutrient product consists of four tablets per dose, two "Vitamin" tablets, a "Mineral" tablet, and a "Phytonutrient" tablet. The placebo for this trial will be formulated to match the shape and color of all multivitamin multimineral with phytonutrient product tablets, e.g., a Vitamin Placebo, a Mineral Placebo and a Phytonutrient Placebo.
Other intervention name(s): Active is Nutrilite Double X
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: heart health; general well-being