bioihbjkbjnl/mcl2 huggingface dataset:
Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of the study is to identify things that influence the ability to "turn on" the
      thigh muscle (quadriceps). The thigh muscle tends to be under active with knee
      osteoarthritis, which may make it difficult to strengthen the muscle. The investigators are
      also testing a new technology called repetitive transcranial magnetic stimulation (rTMS) to
      determine whether it may help "turn up" activity in the under active thigh muscle immediately
      after its application. rTMS uses a targeted pulsed magnetic field, similar to what is used in
      an MRI (magnetic resonance imaging) machine to send an electrical signal from the brain to
      the thigh muscle.
    

Detailed description: 
      The investigators will recruit up to 20 people with symptomatic knee osteoarthritis. The 20
      eligible participants will attend 3 sessions in the laboratory. Session 1 is to collect data
      for Aim 1. Sessions 2 and 3 will include the rTMS interventions and data collection for Aim
      2.

      Aim 1 is a descriptive study to compare the neural (cortical and corticospinal) excitability
      of the quadriceps in the symptomatic knee to the asymptomatic knee in participants with knee
      osteoarthritis. The investigators will examine the associations between neural excitability
      and clinical measures of pain, strength, function, and coping styles.

      Aim 2 is a double blind, crossover study design. Each participant will partake in two testing
      sessions, spaced 1 week apart. The investigators will evaluate outcome measures prior to and
      following the "true" intervention versus the "sham" intervention. The true intervention is
      rTMS + exercise. The sham is sham rTMS + exercise. The primary outcome measures are
      quadriceps strength, as measured from a maximal isometric voluntary contraction, and
      quadriceps central activation ratio (CAR), as calculated from the torque values from the
      voluntary strength measurement and a brief, intense electrical stimulus. Secondary measures
      evaluate effects of the intervention on 1) clinical measures of pain and functional
      performance, 2) corticospinal excitability, and 3) intracortical inhibition and facilitation.
    

Intervention name(s): rTMS and exercise; Sham rTMS and exercise
Intervention type(s): Device; Device
Intervention description(s): rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC); rTMS unit is on and running but mu metal is placed between the coil and the skull
Other intervention name(s): repetitive TMS; sham repetitive TMS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMS; rTMS; corticospinal; quadriceps
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fed Conditions
Condition: Bioequivalence
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2
      mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States
      Pharmacopeia (USP), 2 mg (Mylan Pharmaceuticals Inc.) are bioequivalent under fed conditions.
    

Detailed description: 
      The specific aim was to conduct a single dose, open-label, randomized, two period crossover
      pivotal study to determine the bioequivalence of two formulations containing haloperidol 2 mg
      in healthy males and females under fed conditions.

      A total of 32 healthy female and male volunteers (age 18 to 55 years old) were entered into
      the study. Volunteers were determined to be free of significant medical conditions as
      assessed by medical history, physical examination, and blood and urine tests. Volunteers were
      randomly allocated to a treatment sequence, before administration of investigational
      medicinal product (IMP) under fed conditions.

      A wash-out period of at least 14 calendar days (minimum number of days based on half-life of
      the analyte) between consecutive administrations of the IMP was maintained.

      Blood samples were collected at at pre-dose (0 hours), at 30 minutes, at 1 hour,

      1 hour 30 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hours 30 minutes, 4 hours, 4 hours
      30 minutes, 5 hours, 5 hours 30 minutes, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 30
      hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours and 192 hours
      post-dose (total: 26 samples per treatment period).
    

Intervention name(s): Haloperidol Tablets, Mylan Pharmaceuticals Inc.; Haloperidol Tablets, Cycle Pharmaceuticals Ltd
Intervention type(s): Drug; Drug
Intervention description(s): single dose, 2 mg Haloperidol tablet; single dose, 2 mg Haloperidol tablet
Other intervention name(s): Benztropine Mesylate Tablets; Benztropine Mesylate Tablets
Intervention MeSH terms: Haloperidol; Benztropine; Haloperidol decanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
Condition: Inflammatory Bowel Disease; Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer
MeSH terms: Neoplasms; Colorectal Neoplasms; Intestinal Diseases; Inflammatory Bowel Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases
Study type: Observational

Summary: 
      The primary objective of this study is to gather stool samples from subjects with
      inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be
      utilized to help select molecular markers and determine the optimal sensitivity and
      specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).
    


Intervention name(s): Stool Collection Kit
Intervention type(s): Device
Intervention description(s): Stool Collection Kit.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are at risk of developing colorectal cancer at the time of their colonoscopy and
        the colonoscopy resulted in normal findings.
      
Biospecimen description: 
      Provide anonymous, clinically characterized specimens for bio-repository for future
      colorectal cancer-related test development.
    
Keywords: Inflammatory Bowel Disease; Cancer; Colorectal Cancer; Neoplasm; Colorectal Neoplasm; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases
Post-exercise Insulin Reductions in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators hypothesise that reducing rapid-acting insulin dose after exercise will
      help prevent Type 1 diabetes individuals experiencing hypoglycaemia.
    


Intervention name(s): Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose
Intervention type(s): Other
Intervention description(s): Dosage after exercise
Intervention MeSH terms: Insulin; Insulin Lispro; Insulin, Short-Acting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: T1DM, Exercise
Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without Epidermal Growth Factor Receptor (EGFR) Mutations
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among
      epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a
      2nd line setting.
    


Intervention name(s): Pemetrexed (Alimta); Gefitinib (IRESSA)
Intervention type(s): Drug; Drug
Intervention description(s): treatment of single pemetrexed with vitamin supplement until discontinued conditions are met; treatment of Gefitinib will be applied until discontinued conditions are met
Intervention MeSH terms: Pemetrexed; Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC; EGFR; Pemetrexed; Gefitinib; without EGFR mutations
An Acceptance-Based Behavioral Intervention vs. Nutritional Counselling for Weight Loss in Psychotic Illness
Condition: Psychotic Illnesses
MeSH terms: Weight Loss; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Obesity occurs at 2-3 times the general population rate in persons living with a psychotic
      illness. The risk of obesity-related serious medical conditions like diabetes and heart
      disease are also two to three times higher in this population. Traditional behavioral weight
      management approaches help more than half of these individuals to lose weight, but a
      significant proportion are not helped. This pilot study is intended to determine the
      feasibility, efficacy, acceptability, and potential clinical utility of an intervention that
      integrates mindfulness, acceptance, distress tolerance, and motivation and commitment
      combined with traditional behavioral strategies for weight loss. This is the first study to
      investigate such an acceptance-based behavioral intervention for weight loss in psychotic
      illness. The results from this study will help to determine whether future research in this
      area is warranted with a larger sample, over a longer period of time.

      Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance
      based behavioral intervention, relative to those who receive nutritional counseling.
    


Intervention name(s): Acceptance-Based Behavioral Intervention; Nutritional Counselling
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Glutathione is normally present at high (millimolar) levels in blood and plays an important
      role in the body's defense against oxidative stress, that is, against the damage caused to
      the body by reactive oxygen species produced by the metabolism of most nutrients, including
      glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and
      glycine.

      This study is looking at how blood sugar levels may affect the way glutathione is made and
      used by the body. Since glutathione is continuously synthesized and broken down, the amount
      of glutathione present in blood depends on the balance between its rate of synthesis and its
      rate of use.

      In earlier studies, the investigators found that in poorly controlled diabetic teenagers,
      glutathione was low, not because its production was decreased, but because it was used at an
      excessive rate. In this study, the investigators want to determine how short-term changes in
      blood sugar levels affect glutathione levels. This will help improve our understanding of how
      diabetes affects metabolism.
    

Detailed description: 
      Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled
      cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using
      intravenous insulin infusion:

        -  in the hyper-glycemic range (200-250 mg/dL) on one study day, and

        -  near normoglycemia (80-140 mg/dL) on the other study day.

      The order of the study days will be randomized.

      We will determine whether the level of blood glucose at the time of study affects blood
      glutathione concentration, and, if so, whether this is associated with changes in the
      fractional rate of glutathione synthesis, as determined from the incorporation of labeled
      cysteine into blood glutathione over the course of the 5-hr infusion of labeled cysteine.
    

Intervention name(s): Cysteine isotope infusion at normoglycemia vs hyperglycemia; Regular Insulin
Intervention type(s): Other; Drug
Intervention description(s): L-[3,3-2H2]cysteine; Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glutathione
Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ)
      combination tablet and coadministration of losartan and hydrochlorothiazide.
    


Intervention name(s): losartan potassium (+) hydrochlorothiazide (HCTZ); losartan potassium; hydrochlorothiazide (HCTZ)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.; Single dose losartan 100 mg tablet in one of two treatment periods.; Single dose HCTZ 12.5 mg capsule in one of two treatment periods.
Other intervention name(s): COZAAR™; MICROZIDE™
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Adolescents are often reluctant to receive psychological help. The investigators developed a
      web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes.
      The investigators aimed to examine the participation rate and outcomes on glycemic control
      and quality of life.
    

Detailed description: 
      Adolescents are often reluctant to receive psychological help. The investigators developed a
      web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes.
      The investigators aimed to examine the participation rate and outcomes on glycemic control
      and quality of life.

      Single center study was conducted to describe participation and efficacy of internet
      cognitive-behavioral intervention for youth with type 1 diabetes. Adolescents with type 1
      diabetes, aged 13-20 years, treated at a Juvenile Diabetes Center, were offered to
      participate in the intervention. Recruitment period lasted for 2 months, during
      January-February, 2011.

      HbA1c measures of adolescents that agreed to participate, were obtained from medical
      records.The adolescents, that logged in, were asked to complete questionnaires before the
      intervention assessing their expectations of the program, quality of life and parental
      support. After completion of questionnaires, the adolescents were encouraged to complete 6
      virtual sessions. Satisfaction was assessed after each session. In the end of the program,
      participants were asked again to complete questionnaires. HbA1c levels were obtained again
      for participants that logged in, and for participants that passively refused, 3 months or
      more after the recruitment.
    

Intervention name(s): An Internet Cognitive-Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): We developed a cognitive behavioral program for adolescents with type 1 Diabetes and their parents, that consists of six virtual sessions at https://minustress.com/diabetes/gate.asp.
Other intervention name(s): Minustress For Type 1 Diabetes Program; An Internet CBT for Youth with Type 1 Diabetes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: adolescents; cognitive behavioral internet intervention
Fructooligosaccharide and Calcium Absorption in Adolescent Girls
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Fructooligosaccharides (FOS) are believed to have positive effects on calcium absorption and
      bone accrual during growth. This study aims to see whether the addition of fiber in the form
      of FOS to a calcium-containing beverage will increase calcium absorption. During two clinical
      visits, participants will receive a beverage containing a small amount of calcium,
      supplemented with either no dietary fiber or a small amount of fiber. Height, weight, bone
      density and geometry, calcium absorption, and physical fitness will be measured. The effects
      of this fiber intervention may provide support for improving bone health with minimal fiber
      supplementation.
    


Intervention name(s): Fructooligosaccharide
Intervention type(s): Dietary Supplement
Intervention description(s): Zero or 3 g of a fructooligosaccharide will be administered in a beverage containing 300 mg total calcium as well as 15 mg 44Ca (calcium carbonate). Participants will be given one of the above beverages in addition to intravenously receiving 5 mg 43Ca (calcium chloride)in 10 ml saline.
Other intervention name(s): Fiber and Calcium
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Calcium; Bone and Bones; Girls; Bone Mineralization; Fiber; Fructooligosaccharide; Female; Healthy; Adolescents
Mirena in Idiopathic Menorrhagia
Condition: Idiopathic Menorrhagia
MeSH terms: Menorrhagia
Study type: Observational

Summary: 
      This is an open-label, uncontrolled, multi-centre observational study that analyses a
      follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a
      period of one year.The patients evaluated at four visits, beginning with the insertion visit
      and 3, 6 and 12 months after insertion.
    


Intervention name(s): Levonorgestrel IUS (Mirena , BAY86-5028)
Intervention type(s): Drug
Intervention description(s): One group
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34
      
Biospecimen description: 
      Serum
Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.
Condition: Contrast-induced Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This prospective study is intended to evaluate if carvedilol has any potential protective
      effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following
      cardiac catheterization in patients with moderate to high risk for CIN.
    

Detailed description: 
      This study enrolled 150 patients planned for CC, and randomly assigned for one of the three
      groups. Group (A)include 49 patients who received two atorvastatin dose 80 mg 12 hours before
      CC and 40 mg just before CC. Group (B) include 48 patients who received 12.5 mg carvedilol
      twice daily for 7 days before CC and continue for 24hrs after the day of CC, Group (C)
      include 47 patients who only hydrated with saline. All included patients were hydrated with
      saline intravenous 0.9 sodium chloride (NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and
      4-6 hours after cardiac catheterization. Serum creatinine(Scr), blood urea nitrogen (BUN) and
      estimated glomerular filtration rate were evaluated at the baseline and after 48 from CC.
      Serum neutrophil-associated lipocalin (NGAL) was evaluated after 4 hours from CC.
    

Intervention name(s): Atorvastatin; Carvedilol; saline
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): 0.9%NaCl
Intervention MeSH terms: Carvedilol; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cardiac catheterization, carvedilol, atorvastatin.
Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults
Condition: Healthy Nutrition
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that the equivalent glycemic load (EGL)
      value of portions of white bread containing 5 g available carbohydrate measured in this study
      is accurate and precise to within 1 gram. Additionally, the EGL of 7 low carbohydrate foods
      will be measured to determine their glycemic impact.
    


Intervention name(s): Food
Intervention type(s): Other
Intervention description(s): Food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Acute Effect of Exenatide on Brain Glucose Metabolism
Condition: Impaired Glucose Tolerance (IGT); Diabetes
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      This research study will examine brain glucose metabolism after an overnight fast to
      determine the effect of exenatide on brain glucose metabolism and lipid metabolism.
    

Detailed description: 
      This study will elucidate if exenatide has an effect on brain glucose metabolism. This will
      be accomplished by measuring the rate of glucose binding in various brain regions by Positron
      Emission Tomography (PET) after glucose load with exenatide injection and compare it with
      placebo injection measured in the same subject. The changes will be compared with peripheral
      and hepatic glucose metabolism and lipolysis.
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study; Placebo was administered in random order 30 min before OGTT-PET study in the same subject
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Impaired glucose tolerance (IGT); Diabetes