bioihbjkbjnl/mcl2 huggingface dataset:
Dietetic Effects of Mare's Milk in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of mare's milk on SCORAD, faecal
      microbiota and immunological parameters in patients with atopic dermatitis.
    

Detailed description: 
      Mare's milk has been used in the treatment of inflammatory illnesses for centuries since it
      was known to contain antimicrobial, anti-inflammatory and immunomodulatory substances. The
      aim of this study was to examine whether the consumption of mare's milk by patients with
      atopic dermatitis (AD) has a beneficial effect.

      As a precondition for participating in this study, the subjects were provided information in
      writing and verbally about the details of the study. Informed consent was obtained from all
      volunteers. Before the beginning of the study, all participants were subject to a medical
      examination in the Clinic for Dermatology and Dermatologic Allergology of the Friedrich
      Schiller University Jena. The AD was diagnosed according to the atopy-score of Diepgen.
      Severity of eczema was evaluated by using the SCORAD score. A skin prick test was performed
      for the exclusion of type 1 sensitivity to mare's milk.

      The study was designed as a double blind, placebo-controlled crossover trial. Twenty-three
      patients received 250-ml mare's milk or placebo orally for 16 consecutive weeks. Between the
      two intervention periods, a four week wash-out period without drinking any test substances
      was introduced. The intensity of AD was examined using the Severity Scoring of Atopic
      Dermatitis (SCORAD), which was determined at the start of the study and after 4, 8, 12 and 16
      weeks of each intervention period. Blood samples were taken at the start of the study and
      subsequently after 8 and 16 weeks. Fresh stool samples were taken at the beginning of the
      study and at the end of each intervention period.
    

Intervention name(s): mare's milk
Intervention type(s): Dietary Supplement
Intervention description(s): The participants received 250 ml mare's milk or placebo daily. The placebo drink was based on a hypoallergenic infant formula.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mare's milk; atopic dermatitis; endogenous eczema; SCORAD; Bifidobacteria
Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of two physiotherapeutic treatments of
      fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and
      segmental muscle stretching exercises associated with cognitive behavioral therapy.
    

Detailed description: 
      Fibromyalgia is characterized mainly by chronic widespread pain. Segmental muscle stretching
      therapeutic exercises reduce the shortening of myofascial structures and recover the body
      flexibility. It is indicated for the treatment of chronic pain caused by osteo-myo-articular
      dysfunction. The pain behavior may be defined as the adoption of body postures and attitudes
      that a person communicates his/her pain. In this way, the global postural reeducation - a
      method of muscles chains stretching exercises - could be an important intervention. In
      addition, negative thoughts and dysfunctional beliefs are usual in situations of chronic
      pain, compromising the health recovery process. As part of a pain catastrophizing-related
      therapeutic approach, physiotherapist may help patients with chronic pain to develop
      positive, realistic and hope attitudes as based on the cognitive behavioral therapy model.
    

Intervention name(s): Global postural reeducation; Segmental muscle stretching exercises; Cognitive behavioral therapy
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to assess the single-dose relative bioavailability of Actavis Group
      hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study
      of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy
      Adult Volunteers under FedConditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose; NorvasC® 10 mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions; B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fed conditions
Other intervention name(s): amlodipine besylate; amlodipine; amlodipine besylate; amlodipine
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; amlodipine besylate; amlodipine; Healthy subjects
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term
      increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function
      and increase the risk of CVD. Greater intakes of dairy foods have been associated with a
      lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods
      in the diet that might increase CVD risk is unclear. Further controversial is the extent to
      which dietary fat derived from dairy foods regulate the risk of CVD. The health benefits of
      dairy on CVD risk are at least partly attributed to its ability to limit PPH and resulting
      PPH-mediated responses leading to vascular dysfunction. This provides rationale to
      investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart
      disease. The objective of this project is to define the extent to which full-fat dairy milk
      compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing
      oxidative stress responses that limit nitric oxide bioavailability to the vascular
      endothelium in adults with prediabetes.
    

Detailed description: 
      This study consists of three, 3-hour postprandial trials in response to consuming the
      following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in
      combination with non-fat milk, and 3. oral glucose challenge in combination with whole milk.
      For three days preceding each trial, participants will be provided all meals to standardize
      physiologic responses to test meals. On each trial day, vascular function will be assessed
      and blood samples collected prior to and at 30 minute intervals for 3 hours following test
      meal ingestion.
    

Intervention name(s): Glucose; Glucose with Whole Fat Milk; Glucose with Non-fat Milk
Intervention type(s): Other; Other; Other
Intervention description(s): Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.; Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes.; Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dairy; Milk; Glucose; Postprandial; Hyperglycemia; Prediabetes; Blood glucose; Oxidative stress; Vascular health; Vascular function
Resistance Exercise, Muscle Mass, Strength and Body Composition
Condition: Sarcopenia; Obesity
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A plethora of trials reported the positive effect of resistance exercise on functional and
      morphological parameters. Although a large amount of the studies used suboptimum devices and
      obsolete methods the results of these older studies were still considered as golden standard.
      The aim of the present study is thus to determine the proper effect of different resistance
      exercise protocols with and without adjuvant protein supplementation on functional and
      morphological muscle and body composition parameters in male untrained subjects 30-50 years
      old under special regard of modern medical imaging and segmentation technologies.

      Our general study hypothesis is that HIT-resistance exercise significantly impact relevant
      muscular parameters of the upper leg.
    


Intervention name(s): HIT-exercise, low repetition range; HIT-exercise, high repetition range; HIT-exercise with protein; Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM; High Intensity Resistance Exercise Training, high repetition range, 60 - < 75 1RM; High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM and Protein Supplementation; control group, no intervention, maintenance of physical activity
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: resistance exercise; muscle mass; abdominal fat; strength; Coronary Heart Disease (CHD)-risk; myocardial mass
Pharmacokinetic Study of Multiple Doses of ORM-12741 (Nebula PK 2)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate ORM-12741 concentrations in blood at steady state.
    

Detailed description: 
      The purpose of this study is to evaluate pharmacokinetic and safety of ORM-12741 after
      multiple oral dosing of modified release formulations.
    

Intervention name(s): ORM-12741 MR A; ORM-12741 MR B; ORM-12741 IR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Modified release formulation of ORM-12741; Modified release formulation of ORM-12741; Immediately release formulation of ORM-12741
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer study
Remote Preconditioning and Myocardial Protection
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 2

Summary: 
      Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may
      mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.
    

Detailed description: 
      The investigators will test if RIPC will be associated with differential effects depending on
      background anesthesia. Specifically, the investigators hypothesized that RIPC during
      sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac
      defects repair surgery and that effects may be different during propofol anesthesia.
    

Intervention name(s): Sevoflurane plus remote ischemic preconditioning; Total intravenous anesthesia plus remote ischemic preconditioning
Intervention type(s): Drug; Drug
Intervention description(s): Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning; Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning
Other intervention name(s): Group A; Group B
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: remote ischemic preconditioning; sevoflurane; total intravenous anesthetic
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose exploration study to assess the safety and immunogenicity of two doses of the
      candidate HRV vaccine at different virus concentrations in the target age group (infants
      approximately 2 months of age and previously uninfected with human rotavirus) and receiving
      concomitant administration of routine vaccinations. The study also aims at exploring the
      effect of unrestricted feeding on the immunogenicity of the vaccine.
    

Detailed description: 
      All subjects enrolled from Eastern United States and Eastern Canada will continue their
      participation in the pilot efficacy follow-up (pilot efficacy subset).

      The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the
      investigator's discretion.

      Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of
      Comvax administered according to the prescribing information.
    

Intervention name(s): Human Rotavirus Vaccine - two different formulations; Prevnar; IPOL; Infanrix; OmniHIB; Pentacel
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Two oral doses; Three-dose intramuscular injection (US subjects only); Two-dose intramuscular injection (US subjects only); Three-dose intramuscular injection (US subjects only); Three-dose intramuscular injection (US subjects only); Three-dose intramuscular injection (Canada only)
Other intervention name(s): ActHIB
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rotavirus Gastroenteritis; Human rotavirus vaccine
Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome (pSS)
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase2a, multicenter, double-blind, placebo control, randomized study to
      investigate the efficacy and safety of SA001 in subjects with pSS. A total of 28 subjects
      (including dropout rate of 30%) will be randomized in a 1:1:1:1 ratio to receive 3 different
      doses of SA001 or placebo everyday for 8 weeks.

      Screening visit will be performed within 1 to 2 weeks(run-in period) prior to dosing after
      signing the informed consent form (ICF). During the run-in period, if necessary, subjects
      will apply artificial tears in the symptomatic eyes according to the dosage of artificial
      tears. Only subjects who have completed the run-in period and who are determined to be
      suitable for the study eligibility(inclusion/exclusion) criteria as a result of the screening
      evaluations are randomized to one of the four groups.

      Subjects will receive investigational product start on Day 0 for 8 weeks during the active
      treatment period. Subjects will visit to the study site on 4 and 8 weeks after starting
      dosing investigational product.

      Subjects will be in this study approximately 12weeks, which includes run-in period of 1 to
      2weeks and a safety follow-up period of 2weeks.
    


Intervention name(s): SA001 Low dose; SA001 Mid dose; SA001 High dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 tablets b.i.d for 8 weeks; 3 tablets b.i.d for 8 weeks; 3 tablets b.i.d for 8 weeks; 3 tablets b.i.d for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this exploratory study is to evaluate the rejection rate in patients treated with
      cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo
      liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h
      monitoring. In addition, this study will assess the safety of this treatment regimen.
    


Intervention name(s): Cyclosporine (Sandimmun® i.v.); Cyclosporine (Sandimmun® Optoral)
Intervention type(s): Drug; Drug
Intervention description(s): Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.; Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Other intervention name(s): Sandimmun; Sandimmun
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantation, Cyclosporine
Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity
Condition: Sedentary Behaviour; Adherence; Traditional Exercise; Lifestyle Exercise
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a comparison of the traditional prescription versus the lifestyle exercise
      prescription in sedentary adults over 6 months. Biological and psychological parameters will
      be assessed over the 6 month study. Biological indicators will be assessed pre and post
      including body composition, muscular strength, endurance, and flexibility, aerobic fitness,
      and blood tests. Psychological parameters will be assessed pre, mid, and post including
      self-efficacy, motivation, need satisfaction, physical self-description, leisure-time
      exercise, as well as all constructs from the thepry of planned behaviour.
    


Intervention name(s): traditional vs. lifestyle exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adherence; lifestyle; exercise; pedometer; training
Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purposes of this study are to assess the prognostic value of serum and urinary biomarkers
      Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression
      of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis
      clinical score at 12 months. Additionally, this study will search for correlations between
      serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI
      and clinical severity of knee osteoarthritis.
    


Intervention name(s): Serum and urine samples collections; Imaging (x-rays and MRI)
Intervention type(s): Other; Other
Intervention description(s): Serum and urine samples will be collected at baseline, 3 month, 6 month, 12 month to assess the predictive value of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 on OA progression (MRI, Clinical and radiological progression); MRI will be done at baseline and 12 month and x-rays will be done at baseline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
Condition: Obesity
Study type: Interventional

Summary: 
      This study seeks to determine whether artificial sweeteners in the context of diet soda may
      alter the brain's response to food cues and thus impact appetite.
    


Intervention name(s): diet soda; Regular soda; Carbonated Water
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas); 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas); 12oz can of carbonated water (sparking water, selzter water) unflavored
Other intervention name(s): Diet Coke; Diet Pepsi; Coke; Pepsi
Intervention MeSH terms: Cocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: artificial sweeteners; diet soda
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol is designed to evaluate the metabolic effects of adding exenatide,
      rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate
      glycemic control.
    


Intervention name(s): exenatide; rosiglitazone
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, 5mcg or 10mcg, twice a day; oral tablet, 2mg or 4mg, twice a day
Other intervention name(s): Byetta; Avandia
Intervention MeSH terms: Exenatide; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; exenatide; rosiglitazone; Amylin; Lilly
Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Bronchitis; Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary
      Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times.
      Subjects will be given breathing tests, and will record their breathing symptoms daily on
      diary cards.
    

Detailed description: 
      Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis,
      Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol
      Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic
      Obstructive Pulmonary Disease
    

Intervention name(s): fluticasone propionate/salmeterol combination DISKUS; salmeterol xinafoate
Intervention type(s): Drug; Drug
Other intervention name(s): fluticasone propionate/salmeterol combination DISKUS
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Chronic Bronchitis; Emphysema