bioihbjkbjnl/mcl2 huggingface dataset:
Milk Types and Fish Oil in 9- to 12-Month-Old Infants
Condition: Obesity; Metabolic Syndrome; Growth; Blood Pressure; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      The objective of this intervention study is to examine the effect of whole cow's milk versus
      infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth,
      nutritional status, development, risk factors for later diseases and the impact on the
      intestinal microbiota and inflammation in 9 - 12 months old infants.
    


Intervention name(s): Cow's milk with fish oil; Cow's milk without fish oil; Formula with fish oil; Formula without fish oil
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Children; Complementary feeding; Breast feeding; Cow's milk; Formula; Protein; LCPUFA; Fish oil; Lipid profile; Intestinal inflammation; Intestinal microbiota
Add Glucokinase Activator to Target A1c
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active-
      controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of
      TTP399 on HbA1c following administration for 6 months.
    


Intervention name(s): TTP399 400 mg; TTP399 800 mg; Sitagliptin 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily; once daily; once daily; once daily
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg
      metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt
      Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet
      (manufactured in Evansville, IN) in fed healthy subjects.
    

Detailed description: 
      This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/500 mg metformin
      extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered
      5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, Indiana)
    

Intervention name(s): saxagliptin; metformin XR; saxagliptin + metformin XR (FDC tablet)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 5 mg, once daily, Single dose; Tablets, Oral, 500 mg. once daily, Single dose; Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose
Other intervention name(s): Onglyza; Glucophage XR
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection
Condition: Glutathione-cyclodextrin Complex Absorption
MeSH terms: Mycobacterium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed clinical trial will confirm the therapeutic absorption of glutathione following
      topical Glutaryl application in increasing blood GSH levels without an invasive procedure.

      GOAL: Confirm therapeutic level of glutathione following topical transdermal application.

      HYPOTHESIS: The hypothesis of the proposed study is that the glutathione administration will
      increase RBC levels of glutathione above 80%.

      AIM: Determine a non-invasive way to increase glutathione levels in the plasma and blood
      cells.

      This aim will be accomplished as follows:

      STEP 1: We will recruit eligible healthy participants in the two study groups who are not
      currently taking any glutathione or N-acetyl cysteine (NAC) supplementation.

      STEP 2: Determine baseline levels of GSH, free radicals and cytokines through analysis of
      venipuncture blood draws.

      STEP 3: Study subjects will be asked to spray themselves with either placebo or Glutaryl four
      times twice a day for three days on the ventral part of the abdomen. Measure the levels of
      GSH, free radicals and cytokines after 1 hour, 4 hour and 72 hours.
    


Intervention name(s): Glutaryl Solution; Placebo Solution
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Glutathione, ascorbic acid, cyclodextrin, potassium sorbate and radish root extracts; Empty nanoparticles
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Releasing Quadratus Lumborum Muscle on Hip Joint Range of Motion in Asymptomatic Individuals
Condition: Muscle
Study type: Interventional

Summary: 
      The purpose of this study are to compare angles of hip joint between before and after
      releasing quadratus lumborum muscle.
    

Detailed description: 
      The 1st physical therapist performed the modified Thomas test position. The participant was
      asked to lie supine over the edge of the couch. The participant hold one knee to the chest
      tightly while the other knee was bent over the end of the couch. The 2nd physical therapist
      measured angles of hip and knee using a standard goniometer at baseline. The quadratus
      lumborum muscle was released. Then the same measurement was repeated.
    

Intervention name(s): releasing muscle
Intervention type(s): Other
Intervention description(s): At baseline, hip and knee angles were measured. The quadratus lumborum muscle was released. After that, the hip and knee angles were re-measured.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: releasing muscle; quadratus lumborum; hip angle
Effect of Growth Hormone in Children With Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Growth Disorder; Idiopathic Short Stature
MeSH terms: Dwarfism, Pituitary; Dwarfism; Endocrine System Diseases; Growth Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). The purpose of the trial is to
      compare the effect of Norditropin® using different dosing regimens in children suspected of
      growth hormone deficiency.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional
Phase: Phase 1

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


Intervention name(s): Cilostazol 100 mg; PMR 150 mg; PMR 200 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One immediately-release tablet (Cilostazol 100 mg) at 08:00 and another at 20:00, twice daily oral dose (total daily dose of 200 mg); Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg); Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Artery Disease; Cilostazol; PMR; Extended-Release Tablet of Cilostazol
Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of high-dose human
      Immunoglobulin G Intravenous (IGIV) 10% in subjects with Kawasaki diseases (KD).
    

Detailed description: 
      This is a multicenter, single-arm, and open-label clinical trial to evaluate the coronary
      artery lesions (CALs) at 2 and 7 weeks after single dose of IGIV 10% (2 g/kg) administration
      for at least 12 hours to evaluate the efficacy and safety of IGIV 10%.
    

Intervention name(s): Immunoglobulin G; Acetylsalicylic acid
Intervention type(s): Drug; Drug
Intervention description(s): single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours; Coadministration
Intervention MeSH terms: Aspirin; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Immunoglobulin G
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an
      investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a
      (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1
      hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment
      of interferon therapy.
    


Intervention name(s): Telaprevir; Ribavirin; Pegylated Interferon Alfa 2a; Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet; tablet; Solution for injection; Tablet
Other intervention name(s): VX-950; RBV; Peg-IFN-alfa-2a
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Genotype 1
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
Condition: type1diabetes
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Physical activity, along with proper nutrition, is the basis for the behavioral treatment of
      diabetes. In recent years exercise training in normobaric hypoxia is used in training
      programs for athletes and in rehabilitation. The aim of this study is the assessment of
      physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood
      glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and
      time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric
      parameters.
    

Detailed description: 
      Hypoxia leads to HIF-1 production (hypoxia inducible factor 1) which regulates expression of
      many genes (eg. gene responsible for erythropoetin production). It also stimulates
      angiogenesis, muscle hypertrophy and glycolytic energy production by transactivating genes
      involved in extracellular glucose import.

      Before starting the training program all participants will be assessed by cardiologist. Then
      the incremental exercise test will be performed to determine aerobic capacity (VO2max).

      Recruited patients ( type 1 male diabetic patients) will be divided into 2 arms: exercise in
      normoxia or in normobaric hypoxia. Hypoxic chamber is set to contain equivalent to an
      altitude of 2500 meters above see level (indoor air composition: 15,4% of O2 and 84,7% of N).

      Training program will be the same for all participants: 60 minutes sessions twice a week for
      6 weeks of mixed exercise: aerobic and anaerobic.

      Glycemia will be monitored by Flash Glucose Monitoring (Free Style Libre) and the same
      glucometer model by all patients.

      At baseline and after 6 weeks: echocardiography, ECG and incremental exercise test, ECG and
      blood pressure monitoring, lipid profile and diabetes control parameters will be performed in
      all patients.
    

Intervention name(s): Exercise in hypoxia; Exercise in normoxia
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 60 minutes training program of mixed exercise in normobaric hypoxic chamber; 60 minutes training program of mixed exercise in regular air conditions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, randomized, two-period, two-treatment [Treatment A (Investigational product
      administration under fasting condition) vs Treatment B (Investigational product
      administration under fed condition)], two-sequence, crossover, balanced, single dose oral
      food effect bioavailability study.
    

Detailed description: 
      Single dose oral food effect bioavailability study of Vortioxetine Hemihydrobromide Orally
      Disintegrating Tablets 20 mg in healthy adult human subjects under fasting and fed
      conditions.

        -  To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally
           Disintegrating Tablets 20 mg in healthy, adult, human subjects under fasting and fed
           conditions.

        -  To monitor the safety and tolerability of the subjects. An open label, randomized,
           two-period, two-treatment [Treatment A (Investigational product administration under
           fasting condition) vs Treatment B (Investigational product administration under fed
           condition)], two-sequence, crossover, balanced, single dose oral food effect
           bioavailability study.
    

Intervention name(s): Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Intervention type(s): Drug
Intervention description(s): Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg administration under fasting condition
Other intervention name(s): SF001 ODT
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy
      of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of
      the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g.
      physiotherapy, simple analgesics, intra-articular injection).
    

Detailed description: 
      A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the
      efficacy of a single dose of Autologous Protein Solution (APS) in patients with
      Osteoarthritis (OA) of the knee who have failed at least 1 conservative OA therapy (e.g.
      physiotherapy, simple analgesics, intra-articular injection).
    

Intervention name(s): APS; Saline
Intervention type(s): Device; Device
Intervention description(s): Intra-articular Injection; Intra-articular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autologous Protein Solution; APS; Osteoarthritis; Intra Articular Injection
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Non-invasive monitoring to measure changes in blood volume.
    


Intervention name(s): CM 1500
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: blood loss
A Pooled Analysis of the Data From Two Studies of Ammonium Succinate for Menopausal Symptoms
Condition: Menopause Related Conditions
Study type: Observational

Summary: 
      This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of
      ammonium-succinate based dietary supplement. In both studies group 1 took the
      ammonium-succinate based dietary supplement and the group 2 took placebo.
    

Detailed description: 
      Both studies were conducted previously and were randomized, double-blind and
      placebo-controlled. They followed very similar protocols, were of nearly identical design,
      had common inclusion and exclusion criteria. Both studies achieved statistical significance
      for ammonium succinate-based dietary supplement on most of pre-specified endpoints of Greene
      Climacteric Scale symptoms severity reduction at week 12. Nevertheless, some minor variation
      in the patient population, both within the studies (e.g., between different centres, as well
      as seasonal variability) and between the studies can be expected.

      Naturally occuring estrogen deficiency over the course of the menopausal transition and
      postmenopause causes hot flushes and other psychosomatic and vasomotor symptoms. Menopausal
      hormone therapy is a method of choice, however in many cases it is contraindicated or
      unacceptable for other reasons. Many alternatives exist, generally acting via estrogen
      receptors (ER). The dietary supplement tested in the aforementioned studies contains ammonium
      succinate, which does not bind to ER, instead acting by supporting the Krebs cycle. It does
      not have phytoestrogenic ingredients.
    

Intervention name(s): Ammonium succinate; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.; 2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Both studies chosen for pooled analysis recruited women with vasomotor and psychosomatic
        complaints, in the late phase of the menopausal transition and postmenopause according to
        the Stages of Reproductive Aging Workshop +10 classification.
      
Keywords: menopause; ammonium succinate
Acute Heart Health Benefits of Whole Grain Barley and Oats in Healthy Men and Women
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objectives of this study are the following: 1) to determine the acute effect of whole
      grain barley on risk factors of cardiovascular disease compared to a diet low in whole grain,
      and 2) to compare the effects of whole grain barley to those of whole grain oats to determine
      if the response to these two grains is similar.
    

Detailed description: 
      Whole grains contain bioactive components that may contribute to reduced risk of
      cardiovascular disease, and there may be significant differences among whole grain sources
      with respect to ability to alter biomarkers of cardiovascular disease. This acute study is
      designed to determine if whole grain barley improves postprandial lipid metabolism and
      improves endothelial function. Further, we will determine if acute consumption of whole grain
      barley versus acute consumption of whole grain oats results in differential response with
      respect to biomarkers of cardiovascular disease risk.
    

Intervention name(s): Controlled diet with whole grain barley, whole grain oats, or low grain diet
Intervention type(s): Other
Intervention description(s): Participants will consume a standardized diet for 3 days prior to the treatment intervention meal. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Whole grains; Barley; Oats; Cardiovascular disease; Postprandial lipid metabolism; Endothelial function; Risk of cardiovascular disease in healthy men and women