bioihbjkbjnl/mcl2 huggingface dataset:
Integrating Quantitative Energetics Determines the Microbiome's Contribution to Energy Balance
Condition: Obesity
Study type: Interventional

Summary: 
      We propose to study the role of the gut microbiome in the development of obesity, and whether
      we can change the microbiome's contribution to host energy balance through diet. We have
      created a novel model that explicitly links the effects of microorganisms on human energy
      balance and modeled weight change, and will use the power of metabolic ward studies to
      measure small changes in energy absorption, total daily energy expenditure, and/or food
      intake that affect long-term weight gain or loss. By integrating clinical measurements,
      bioreactor experiments, and mathematical modeling, we will be able to describe
      cause-and-effect mechanisms that will enable a quantification of the microbiota's
      contribution to weight gain and inspire future studies on the interactions of diet, the gut
      microbiome, and human physiology.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Participants will consume either a Control Western Diet or a Microbiome Enhancer Diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Adipose tissue; calorimetry; energy expenditure; microbiome
Implementing a Comprehensive Handoff Program to Improve Patient Safety
Condition: Medical Errors
Study type: Interventional

Summary: 
      The investigators propose to test the hypothesis that implementation of a comprehensive
      handoff program (CHP) - i.e., implementation of a computerized handoff tool along with
      teamwork training for internal medicine residents on inpatient units at Walter Reed and
      Madigan Army Medical Centers - will lead to reductions in resident miscommunications /
      medical errors and improvements in workflow and experience on the wards.
    

Detailed description: 
      Following collection of baseline data on inpatient wards at both hospitals, teamwork training
      will be provided, accompanied by the introduction of a new computerized handoff tool that
      facilitates accurate transmission of data. The effects of this combined intervention on
      safety and workflow will be assessed on the intervention wards at both hospitals as compared
      with the historical control period.
    

Intervention name(s): Computerized handoff tool; Team training
Intervention type(s): Other; Behavioral
Intervention description(s): Computer program that facilitates accurate transmission of patient information between residents; Training in teamwork and reorganization of handoff processes to optimize transmission of information and team care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: resident; intern; patient safety; medical error; time motion; handoff; sign-out; Resident Workflow; Resident Communications
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
Condition: 15q Duplication Syndrome; CDKL5 Deficiency Disease
MeSH terms: Deficiency Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of soticlestat on the frequency of
      motor seizures for participants with Dup15q or CDD during the Maintenance Period.
    

Detailed description: 
      The drug being tested in this study is called soticlestat. Soticlestat is being tested to
      treat people with Dup 15q or CDD. This study will assess the effects of TAK-935 on seizure
      frequency, safety.

      The study will enroll approximately 30 participants. Participants will be enrolled into 2
      groups based on their diagnosis as: Dup 15q or CDD.

      All participants will be asked to take soticlestat tablets twice daily with or without food.

      The study comprises of 2 periods: Screening/Baseline Period and Treatment Period (Dose
      Optimization and Maintenance). The overall time to participate in this study is approximately
      30 weeks, including 4 to 6 weeks Screening/Baseline Period, 20 weeks Treatment Period, 2
      weeks Taper, and 2 weeks safety follow up period. Participants completing this study will
      have an option to enroll in the open-label extension (OLE) study, under a separate protocol.
    

Intervention name(s): Soticlestat
Intervention type(s): Drug
Intervention description(s): TAK-935 tablets
Other intervention name(s): TAK-935
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy; 15q Duplication Syndrome (Dup15q); CDKL5 Deficiency Disorder (CDD); Brain Diseases; Epilepsy; Central Nervous System Diseases; Autism; Cholesterol 24S-hydroxylase inhibitor; Anti-epilepsy drug; Anticonvulsants
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance
Condition: Obesity; Diabetes; Insulin Resistance; Fatty Liver
MeSH terms: Fatty Liver; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether substituting saturated fats with
      polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic
      variables in abdominally obese subjects
    

Detailed description: 
      Specific goals:

        1. Investigate if substituting saturated fats with polyunsaturated fats reduces steatosis
           and improves hepatic and/or peripheral insulin action in abdominally obese subjects with
           type 2 diabetes

        2. Investigate if changes of lipogenic enzymes in response to dietary fat intervention are
           associated with changes in hepatic/peripheral insulin sensitivity or liver fat content

        3. Investigate potential mechanism of the effects of dietary fatty acids; e.g. gene
           expression and lipogenic enzyme activity
    

Intervention name(s): PUFA Diet; SFA diet
Intervention type(s): Other; Other
Intervention description(s): Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).; Diet high in saturated fat (15E%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Diabetes; Insulin resistance; Fatty liver; NAFLD; Steatosis; Dietary fatty acids
Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The implications of sleep as it relates to the physiology and pathogenesis of a number of
      diseases has until recently been ignored. With the evolution of sleep laboratories, there is
      an emerging recognition of the relationship between sleep and various gastrointestinal
      diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that
      waking/daytime activities or events may affect sleep and that any consequent sleep
      dysfunction may reciprocally further affect daytime function
    

Detailed description: 
      The implications of sleep as it relates to the physiology and pathogenesis of a number of
      diseases has until recently been ignored. With the evolution of sleep laboratories, there is
      an emerging recognition of the relationship between sleep and various gastrointestinal
      diseases in particular gastroesophageal reflux disease (GERD). Twenty five (25) patients
      meeting entry criteria will be compared with 25 matching historical control patients who do
      not have GERD symptoms or sleep disturbance. Patients will record heartburn symptoms and
      GERD-associated sleep disturbances on a diary card. These patients will be evaluated for
      baseline functionality GERD symptom scores, PSQI, driving simulator, bed partner
      questionnaire (optional) and receive 40 mg daily of Nexium® for 4 weeks. Primary outcome
      variable driving simulator performance will be the relief of nighttime heartburn during the
      last 7 days of the trial as recorded by the patient on a diary card. Secondary outcome
      variables include change from baseline to week 4 in the PSQI score, percentage of patients
      with complete resolution of sleep disturbances, relief of sleep disturbances, and percentage
      of days without GERD-associated sleep disturbances. Assessment of patients with complete
      resolution of daytime, night times, and 24-hour heartburn symptoms, and the percentage of
      patients with relief of daytime and 24-hour heartburn symptoms. The driving simulator
      performance will be compared at baseline and after 4 weeks of therapy with Nexium®. Also,
      where available, the bed partner PSQI will be compared at baseline and following treatment of
      the primary patient with Nexium® for 4 weeks.
    

Intervention name(s): esomeprazole 40 mg
Intervention type(s): Drug
Intervention description(s): 40 mg daily for 4 weeks
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
Condition: Childhood Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way
      cross-over study in asthmatic children already treated with inhaled corticosteroids.
    


Intervention name(s): CHF 1535 50/6µg; beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Intervention type(s): Drug; Drug
Intervention description(s): fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg; free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Intervention MeSH terms: Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Training Sequence for Subacromial Impingement Syndrome
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Randomized crossover trial evaluating the impact of exercise training sequence of
      axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement
      syndrome.
    

Detailed description: 
      While physical therapy is an effective element in the rehabilitation of rotator cuff (RC)
      disease, the most effective sequence of training interventions has not been defined. The
      purpose of this study is to determine if there is a difference in pain or function in
      patients who are given RC strengthening prior to or after initiating scapular stabilization
      exercises.

      The study was a prospective randomized crossover design. 26 men and 14 women, mean age 51,
      diagnosed with subacromial impingement syndrome (SAIS) were randomly assigned to one of two
      groups for a comprehensive and standardized rehabilitation program over six visits at an
      orthopedic outpatient clinic. One group was prescribed a 4-week program of scapular
      stabilization exercises while the other group began with RC strengthening exercises. The
      crossover design had each group add the previously excluded four exercises to their second
      month of rehabilitation.
    

Intervention name(s): Rotator Cuff Training; Scapular Training
Intervention type(s): Other; Other
Intervention description(s): four specific band-resisted strength training exercises for scapula; four specific band-resisted strength training exercises for rotator cuff
Other intervention name(s): exercise; exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Controlled Clinical Study of 2 Different Moisturizers for the Relief of Dry Skin
Condition: Skin; Skin Care; Skin Cream
Study type: Interventional

Summary: 
      Dry skin is characterized by a lack of moisture in the outer layer of the skin and can occur
      as a result of numerous factors including cold weather, low humidity, age, etc. In this
      study, the moisturizing benefits of two formulas were evaluated for barrier function
      improvement/impact when used by women with moderately to severely dry skin on their lower
      legs.
    


Intervention name(s): Moisturizer A, F#9155-005; Moisturizer B, F#E1387-004; Regression; Non-Regression
Intervention type(s): Drug; Other; Procedure; Procedure
Intervention description(s): OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.; Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.; 2 week regression period after 6 weeks of moisturizer use.; Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were assigned to one of two procedural groups (Regression or Non-Regression) based on Visit 1 scheduling. Subjects were provided with a commercial cleanser to use during a 3-day period with no moisturizers and no hair removal allowed on their lower legs, and to continue using throughout the study. At Visit 2, all subjects received the two test moisturizers to use split-leg (right vs. left lower leg randomized) to use for 6 weeks. Subjects returned for evaluations at Week 2 (Visit 3), Week 4 (Visit 4), and Week 6 (Visit 5). At Week 6, subjects in the Regression group entered a 2-week regression period (no moisturizer usage) and returned for evaluations at Regression Days 1, 4, 7, 10, and 14. Meanwhile, at Week 6, subjects in the Non-Regression group (exploratory) continued using the moisturizers; they returned for evaluations at Week 6 + Days 1, 2, 3, and 4.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin; Stratum Corneum; Skin Care; Skin Cream; Dryness; Moisturization; Hydration
Muscular and Functional Performance in FAIS Patients
Condition: Femoroacetabular Impingement
MeSH terms: Femoracetabular Impingement
Study type: Observational

Summary: 
      Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip
      muscle strength for adduction, extension, flexion, and external rotation including impaired
      functional performance have been observed. However, no studies are lacking on more demanding
      muscular and functional parameters such as hip muscle rate of force development and reactive
      strength index. Information on such muscular properties following hip arthroscopy for FAIS
      may help guide future planning of post-operative rehabilitation strategies.

      This is a cross-sectional study with an embedded prospective non-randomized study. The aim of
      the cross-sectional study is to investigate hip muscle function and functional performance in
      patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months.

      The aim of the prospective non-randomized study is to investigate the effect of a 12-week
      structured and supervised physiotherapy-led intervention aiming at improving hip muscular
      function on self-reported hip and groin function including hip muscle function and functional
      performance.

      Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip
      arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional
      study. Additionally, all included subjects will be offered to take part in the prospective
      non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led
      treatment.

      The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are
      included in the prospective study. All testing, and supervised physiotherapy-led treatment,
      will be performed at Hvidovre Hospital:

        1. Hip muscle function

        2. Single leg jump performance

        3. Self-reported hip and groin function

        4. Evaluation of return to sport

        5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation
    


Intervention name(s): Testing of performance
Intervention type(s): Other
Intervention description(s): The cross-sectional evaluation will involve assessment of:
Hip muscle function
Single leg jump performance
Self-reported hip and groin function
Evaluation of return to sport
Evaluation of satisfaction regarding usual-care post-operative rehabilitation
The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk.
Other intervention name(s): Exercise-based treatment
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have undergone hip arthroscopy for femoroacetabular impingement syndrome
        during the preceding 6-30 months in the Greater Copehangen Area
Saturated Fatty Acids and HDL Metabolism
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid
      (C18:0) have different effects on HDL metabolism during the fasted state.
    

Detailed description: 
      Study design:

      Double blind, randomized, cross-over study with two different diets: one diet will be high in
      palmitic acid (C16:0) and the other diet will be high in stearic acid (C18:0). Subjects will
      receive both diets for 4 weeks with a wash-out period of 4-6 weeks in between. Contrast in
      the intakes of palmitic acid and stearic acid is 6% of energy. A postprandial test will be
      carried out at the end of each dietary period.

      Study population:

      Accounting for a dropout rate of 20%, 40 healthy men and postmenopausal women, aged between
      45 and 70 year, having a BMI (body mass index) between ≥ 18.0 and ≤ 30.0 kg/m2 will be
      recruited.
    

Intervention name(s): Palmitic acid; Stearic acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Experimental products are enriched with C16:0; Experimental products are enriched with C18:0
Intervention MeSH terms: Palmitic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Palmitic acid; Stearic acid; HDL-metabolism; Human intervention study
Meditoxin® Treatment in Patients With Cervical Dystonia
Condition: Dystonia; Dystonic Disorder
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared
      with placebo (normal saline)
    


Intervention name(s): Meditoxin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Meditoxin (Botulinum toxin type A); Placebo (Normal saline)
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Electronic fetal hear rate monitoring (EFM), or cardiotocography (CTG), records changes in
      fetal heart rate and their temporal relationship to uterine contraction. It has been
      developed with the aim of detecting fetal hypoxia during labor and hence to prevent metabolic
      acidosis. Despite being the standard for intrapartum management, this technique,
      significantly increase the operative delivery rate, and is associated only with less seizures
      as neonatal benefit. Another concern is also the variability in the interpretation.

      Several techniques have been studied in order to decrease the high false positive rate. Fetal
      ST waveform analysis (STAN) has been studied combined with CTG. A recent meta-analysis of
      randomized trials, however, showed that STAN during labor did not improve perinatal outcomes
      or decrease operative delivery rates, except for a 9% decrease in operative vaginal
      delivery.Comparisons of visual and computerized interpretation of EFM have also been
      reported. However, whether or fetal monitoring with computer analysis improve perinatal
      outcomes is still subject of debate.

      Thus, we aim to evaluate whether intrapartum fetal monitoring with computer analysis increase
      the incidence of obstetric intervention when compared with visual analysis through a
      single-center randomized controlled trial.
    


Intervention name(s): computerized cardiotocography
Intervention type(s): Diagnostic Test
Intervention description(s): computerized cardiotocography (C-CTG)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Saxagliptin and Atherosclerosis
Condition: Coronary Artery Disease; Diabetes Mellitus Type 2
MeSH terms: Coronary Artery Disease; Atherosclerosis; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve glycaemic
      control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone
      glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased
      insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in
      atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and
      chemokines associated with atherosclerosis/inflammation.

      The purpose of this study is to explore the effects of 3 months intervention with DPP-4
      inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable
      coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in
      circulating monocytes and adipose tissue.

      A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic
      effect of DPP-4 inhibitors beyond glycaemic control alone.

      Due to reduced sample size (recruitment problems) the main focus has changed and will now be
      on cellular aspects and gene regulation (initially secondary outcome measure).
    


Intervention name(s): Saxagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Saxagliptin 5 mg, 1 tablet per day for 3 months; Placebo, 1 tablet per day for 3 months.
Other intervention name(s): Onglyza
Intervention MeSH terms: Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment