bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
Condition: Sarcopenia; Metabolic Disease; High Blood Pressure
MeSH terms: Sarcopenia; Hypertension; Overweight; Metabolic Diseases; Weight Loss
Study type: Interventional

Summary: 
      . The purpose of this study is to examine the effects of eating a larger amount of
      dairy-based protein on risk factors for metabolic syndrome
    

Detailed description: 
      Currently, over 47 million adults in the United States are known to have metabolic syndrome.
      Metabolic syndrome is comprised of a cluster of conditions including obesity, elevated
      cholesterol, high blood sugar, and high blood pressure. People with metabolic syndrome have
      an increased risk for the development of chronic diseases such as cardiovascular disease and
      diabetes. Recent studies have shown that a build-up of fat in the muscle of overweight and
      obese people may partially explain the link between metabolic syndrome and the development of
      chronic diseases. There is evidence to suggest that diets with a higher amount of protein can
      improve some aspects of metabolic syndrome, including the build-up of fat in muscle. The
      purpose of this study is to examine the effects of eating a larger amount of dairy-based
      protein on risk factors for metabolic syndrome.
    

Intervention name(s): Energy Restriction
Intervention type(s): Other
Intervention description(s): Subjects consume 750 kcal/d of energy below their need
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: the impact of a higher dairy-based protein diet in; combination with energy restriction on muscle health,; metabolic health (including blood pressure) in overweight; and obese, middle aged adults
Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses
Condition: Normal Weight; Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of the proposed study is to investigate the effect of cinnamon on the
      postprandial glycemic response to a high glycemic index meal in normal and overweight/obese
      prediabetic subjects
    

Detailed description: 
      A randomized crossover study design will be carried out in accordance with the guidelines of
      the Human Subjects Protection Committee of the University of California, Los Angeles. All
      subjects will give written informed consent before the study begins. There will be two groups
      of participants (normal and overweight/obese). Each participant will consume oatmeal prepared
      with 1 cup of 2% milk served with or without 6 g of ground cinnamon in random sequence. At
      each meal consumption blood will be collected to measure postprandial glucose and insulin at
      0, 30, 60, 90, 120, 150 and 180 minutes.
    

Intervention name(s): cinnamon
Intervention type(s): Dietary Supplement
Intervention description(s): 6 g of ground cinnamon
Other intervention name(s): control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cinnamon; insulin; glucose; postprandial; acute
Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants
Condition: Healthy Volunteers; Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of
      REGN5713-5714-5715 in healthy adult participants.

      The secondary objectives of the study are:

      In Part A and Part B:

        -  To characterize the concentration time profile of single doses of REGN5713-5714-5715 in
           healthy adults

        -  To assess the immunogenicity of single dose of REGN5713-5714-5715.

      In Part B:

        -  To assess the inhibition of allergic symptoms as measured by total nasal symptom score
           (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized
           allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715

        -  To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch
           allergen titration after a single SC dose of REGN5713-5714-5715.
    


Intervention name(s): REGN5713-5714-5715; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose; Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heart Rate Variability in White Coat Hypertension and Essential Hypertension
Condition: Essential Hypertension; White Coat Hypertension; Healthy
MeSH terms: Hypertension; Essential Hypertension; White Coat Hypertension
Study type: Observational

Summary: 
      The aim of the study is to investigate heart rate variability in patients with white coat
      hypertension and patients with essential hypertension.
    


Intervention name(s): Monitoring of heart rate variability
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Other
Effects of Single-dose and Steady-state TPV/RTV on the Steady-state Pharmacokinetics of Fluconazole in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effects of single-dose and steady-state TPV/RTV 500/200 mg on the
      steady-state pharmacokinetics of fluconazole
    


Intervention name(s): Tipranavir (TPV); Ritonavir (RTV); Fluconazole (FCZ)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 mg bid on days 7-14; 200 mg bid on days 7-14; 200 mg loading dose on day 1, followed by 100 mg qd until day 13
Intervention MeSH terms: Ritonavir; Tipranavir; Fluconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Condition: Erectile Dysfunction; Erectile Dysfunction With Diabetes Mellitus
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this current study is to estimate serum level of YKL-40, serum total testosterone
      and platelets indices in diabetic patients with erectile dysfunction treated by daily
      tadalafil 5mg for 3 months.
    


Intervention name(s): Tadalafil 5mg
Intervention type(s): Drug
Intervention description(s): Estimate serum level of serum YKL-40, total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3months.
Penile color Doppler ultrasound examination before and after treatment
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Flavanoids in Essential Hypertension, Type 2 Diabetes and Healthy Persons
Condition: Vascular Complications, Diabetic
MeSH terms: Hypertension; Essential Hypertension; Diabetic Angiopathies
Study type: Interventional

Summary: 
      Flavanols are natural substances who are frequently found in our nutrition. A lot of research
      has already been executed in the past to investigate what effects this flavanols could have
      in the human population. Based on these examinations, the investigators think and suggest
      that flavanols can have positive effects on the vascularly system, more specifically on the
      peripheral and cerebral blood vessels. The effects are only observed in a healthy
      populations, meanwhile patient populations like diabetes patients could really benefit from
      this. This is why the investigators will execute this study.
    

Detailed description: 
      The study population is divided into 3 main groups, namely healthy controls, patients with
      diabetes type 2 (defined by American Diabetes Association's (ADA)) and patients with
      essential hypertension (the latter group is again divided into 3 subgroups: use of
      betablockers, angiotensin-converting enzyme (ACE)-inhibitors, angiotensin-receptor blockers
      (ARBs). Each main goup will consist of minimal 20 subjects.

      In this interventional study the investigators ask the patient to come twice. One time they
      get capsules with real flavanols and the other time they get capsules with a placebo. The
      study will be double blinded so nor the investigators, nor the patients now at which
      investigation they get the real flavanols or the placebo.

      Before and after the intake of these capsules, a few measurements will take place. These
      measurements will be compared on the one hand with the second investigation day
      (inter-patients and intra-patient) and on the other hand with the pre-intake measurements
      (intra-patient).

      The different examinations are a Flow-mediated dilatation (FMD) test, blood pressure analysis
      and an exercise test.

      The investigator who performs the FMD-test, followed a course and needed to pass an
      examination.

      The blood pressure measurements will be continuously for 20 minutes to avoid to much bias.
    

Intervention name(s): flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances); single intake of capsules with a placebo
Other intervention name(s): flavanoids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: flavanols; diabetes type 2; essential hypertension; peripheral vascular function
Long-term Lifestyle Change and Testosterone Replacement
Condition: Hypogonadism; Aging; Overweight and Obesity
MeSH terms: Overweight; Hypogonadism
Study type: Observational

Summary: 
      Older hypogonadal obese veterans previously participated in a 6 month lifestyle change
      (diet-induced weight loss and exercise) study with or without testosterone replacement
      therapy before being followed for the following year at the clinic while receiving standard
      of care consisting of diet and exercise counseling (for healthy lifestyle change) and
      testosterone replacement therapy. This study will determine if long-term lifestyle change and
      testosterone replacement therapy with associated improvement in physical and metabolic health
      can be maintained in obese older adults.
    

Detailed description: 
      Background: There are studies on long-term testosterone replacement in older adults with
      hypogonadism showing benefits on body composition, sexual function and mood but not on
      testosterone replacement therapy in combination with lifestyle change (diet-induced weight
      loss and exercise) in the specific population of older adults with both obesity and
      hypogonadism.

      Purpose: To determine if long-term lifestyle change and testosterone replacement therapy with
      associated improvement in physical and metabolic health can be maintained in obese older
      adults .

      Design: Overweight/obese older veteran patients with obesity and hypogonadism who are being
      followed at the endocrine clinic while receiving standard of care consisting of diet and
      exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will
      be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body
      composition testing.
    

Intervention name(s): Testosterone replacement; lifestyle
Intervention type(s): Drug; Behavioral
Intervention description(s): Testosterone replacement therapy; lifestyle intervention consisting of diet and increased physical activity
Intervention MeSH terms: Testosterone
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Older adults with hypogonadism following lifestyle change (diet and exercise on their own
        for at least one year) with testosterone replacement therapy.
A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effects of sitagliptin and metformin alone and after
      co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
    


Intervention name(s): sitagliptin phosphate; metformin hydrochloride; Comparator: placebo sitagliptin; Comparator: placebo metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.; Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods.; Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.; Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.
Other intervention name(s): Januvia; Glucophage
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pre-anesthetic Evaluation and Cost Reduction
Condition: Surgical Procedures; Anesthesia
Study type: Observational

Summary: 
      Study conducted in large Brazilian hospital, with the main objective of evaluating the impact
      of pre-anesthetic in reducing costs related to the preoperative preparation of patients
      admitted to undergo surgery or diagnostic procedures under anesthesia.
    

Detailed description: 
      The pre-anesthetic evaluation is essential in the care of surgical patients. Among its
      benefits stands the reduction of costs related to preoperative preparation. However, most
      studies evaluating costs was performed in hospitals abroad, whose reality does not always
      apply to our environment. The aim of this study is to compare the costs of preoperative
      evaluation performed by the surgeon (conventional tillage), with the cost of preparation
      performed by the anesthesiologist (pre-anesthetic evaluation). Two hundred patients scheduled
      for surgical or diagnostic procedures under anesthesia form included in the study. After
      admission patients were assessed by physician anesthesiologists. In Form 1 (conventional
      tillage), it was noted tests or specialist consultations made in the preoperative period. In
      Form 2 (pre-anesthetic evaluation) was noted comorbidities, physical examination and
      complementary examinations given in accordance with the guidelines adopted by the
      Anesthesiology Department of the institution. Form data were compared with a data form 2.
      Besides the costs, we compared the number of tests considered unnecessary and disagreements
      in the classification of physical status according to the American Society Anesthesiology
      (ASA).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients admitted to the institution to undergo elective surgery or diagnostic procedures
        with anesthesia.
      
Keywords: preoperative period; preoperative care; anesthesia; program evaluation
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV
      administered ERB-257 as single ascending doses to healthy Japanese male subjects
    


Intervention name(s): ERB-257; placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Endometrial Scratching in Couples With Unexplained Subfertility
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase
      pregnancy rate in women with unexplained infertility.
    


Intervention name(s): scratching
Intervention type(s): Procedure
Intervention description(s): scratching endometrium on day 21-26 of a spontaneous menstrual cycle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unexplained infertility-endometrial scratching; effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility
A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
Condition: HIV Infections; Peripheral Nervous System Disease
MeSH terms: Nervous System Diseases; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor (
      rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To
      compare the change in viral load between the double-blind phase baseline and week 4 in
      placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in
      viral load compared with viral load changes seen with placebo.

      Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on
      pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important
      in the development and maintenance of sympathetic and sensory neurons and their outgrowths,
      it is proposed that recombinant human nerve growth factor may provide a specific restorative
      treatment for HIV-associated painful sensory neuropathy.
    

Detailed description: 
      Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on
      pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important
      in the development and maintenance of sympathetic and sensory neurons and their outgrowths,
      it is proposed that recombinant human nerve growth factor may provide a specific restorative
      treatment for HIV-associated painful sensory neuropathy.

      Patients are randomized to receive either rhNGF at one of two doses or placebo, administered
      subcutaneously twice weekly for 18 weeks. Patients are stratified into three groups within
      their regimens by use of didanosine, zalcitabine, or stavudine as follows: current use vs.
      discontinued between 8 and 26 weeks before randomization vs. never used or discontinued use
      at least 26 weeks before randomization. Patients will assess their pain daily using the
      Gracely Pain Scale. AS PER AMENDMENT 5/6/97: After completion of the double-blind phase (18
      weeks on treatment followed by 4 weeks off treatment), patients may receive open-label,
      active drug treatment according to their previously assigned regimen for an additional 48
      weeks.
    

Intervention name(s): Nerve Growth Factor, Recombinant Human
Intervention type(s): Drug
Intervention MeSH terms: Mitogens
Masking: Double
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Peripheral Nervous System Diseases; Nerve Growth Factors; Growth Substances
Safety Evaluation of β-arbutin in Healthy Human Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of synthetic beta-arbutin, a dietary
      supplement that aids in the prevention and treatment of calcium oxalate kidney stones, when
      administered to healthy human subjects.
    

Detailed description: 
      The objective and purpose of this Phase I study is to investigate the safety of synthetic
      beta-arbutin, administered to healthy human subjects for: i) 12 weeks, at a dose of 150
      mg/day, and ii) 4 weeks, at a dose of 400mg/day. Safety will be determined by assessing
      adverse event rates between treatment groups and mean changes relative to baseline in serum
      biochemical, hematological and urinary markers.
    

Intervention name(s): Beta-arbutin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Beta-arbutin capsules; Placebo capsules containing non-medicinal ingredients
Other intervention name(s): SP001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment