bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine
      after single and multiple doses of Rotigotine transdermal patch, and also to investigate the
      safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.
    


Intervention name(s): Rotigotine, Period 1; Rotigotine, Period 2
Intervention type(s): Drug; Drug
Intervention description(s): Formulation: transdermal
Dosage: 2 mg / 24 hours once at Day 2
Frequency: once every 24 hours
Duration: from Day 1 to Day 3; Formulation: transdermal
Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12
Frequency: once every 24 hours
Duration: from Day 1 to Day 3
Other intervention name(s): Neupro; Neupro
Intervention MeSH terms: Rotigotine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neupro, Pharmacokinetics, healthy Chinese subjects
A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of PD 0332334 for the treatment of
      generalized anxiety disorder.
    


Intervention name(s): PD 0332334; Placebo; PD 0332334; PD 0332334
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.; Capsules, oral, placebo BID, 8 weeks with 2 week taper.; Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.; Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
Other intervention name(s): imagabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the maximum single dose of Aleve® (two tablets,
      equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength
      (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain
      associated with primary dysmenorrhea.
    


Intervention name(s): Naproxen Sodium, (Aleve, BAY117031); Acetaminophen (Tylenol Extra Strength)
Intervention type(s): Drug; Drug
Intervention description(s): 220 mg *2 tablets, orally, single dose; 500 mg *2 caplets, orally, single dose
Intervention MeSH terms: Acetaminophen; Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary dysmenorrhea of at least moderate severity
Effects of Glutamine on GLP-1 and Insulin Secretion in Man
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like
      peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.
    

Detailed description: 
      In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on
      GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our
      group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested
      the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the
      dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glutamine 30g +sitagliptin 100mg; Glutamine 30g +placebo (matching sitagliptin 100 mg)
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
InFlux System for Nasal Breathing Improvement
Condition: Nasal Airway Obstruction
MeSH terms: Airway Obstruction; Nasal Obstruction
Study type: Interventional

Summary: 
      Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
    

Detailed description: 
      This is a non-significant risk, prospective, non-randomized pilot study to evaluate the
      incidence of serious adverse events directly attributable to the Aerin Medical Wand, when
      used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment
      of nasal obstruction.
    

Intervention name(s): Procedure: thermal coagulation of tissue in the nasal airway
Intervention type(s): Device
Intervention description(s): The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
Other intervention name(s): Vivaer Stylus; Aerin Medical Wand
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasal obstruction
Person-Centered, Occupation Based Therapy for Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Occupational Therapy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study was conducted to investigate the effect of a person-centered, occupation-based
      intervention program supported with problem-solving strategy in individuals with type 2
      diabetes (T2D).

      Method: The study was a randomized controlled trial, that included intervention (n=33) and
      control group (n=34), between the ages of 18 and 65 years.
    

Detailed description: 
      It was planned as a single-blind, randomized controlled study with 3-month follow-up in
      adults. A total of 67 subjects were randomly allocated to the intervention (n=33) or the
      control group (n=34). This program prepared with consider to meaningful activities for
      individual and overcome to barriers via problem solving. That was designed as 6 modules
      including evaluations, diabetes education and problem-solving therapy. Each module was
      implemented at least 1 session per week, about 60 minutes, and was arranged according to
      individual needs.
    

Intervention name(s): Person centered, occupation based intervention support with problem solving therapy
Intervention type(s): Behavioral
Intervention description(s): This program that was developed from the occupational therapy perspective which is person centered and occupation based for T2D intervention was designed as 6 modules. The intervention group received person centered, occupation based intervention support with problem solving therapy as 6 modules. The control group had not any intervention, just had a education about effect of diabetes on life.
Other intervention name(s): self management
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The problem solving therapy is an social cognitive therapy approach. And ıt support to solve meaningfull occupational performance problems realted to diabetes by invdividuals and this way, it helps to improve the self-management of diabetes.We used that with person centered perspective and support to person with education which was perspective of person environment occupation model.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Problem Solving; Occupational Therapy; Healthy Lifestyle; Occupational Performance; Person-Centered; Occupation Based
Validation of the Sleep Assessment Algorithm in the Medical Application Nightly
Condition: Sleep Disorder; Nightmare
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      The Nightly medical application prototype is a potential, non-invasive class I medical
      device. The application has the potential to combine both diagnostic and therapeutic
      procedures for sleep. At home, Nightly measures the user's motion during sleep and then
      records the sleep pattern from the received data. The obtained data are then used for the
      diagnosis of sleep disorders (REM and NREM sleep). Using acoustic and visual stimulation, the
      application has the capability to support the natural process of falling asleep, provide a
      better night's sleep by minimizing sleep deprivation and nightmares, while awakening the user
      at the appropriate moment (during light sleep).
    

Detailed description: 
      The study is a cohort, single-center, randomized trial. The duration of one participant
      included in the study is three successive nights. Visual analysis of polysomnographic
      recordings taken from the second and third nights will be performed independently by two
      independent, blinded experts. According to the sleep architecture description derived from
      the Nightly application, polysomnographic and actigraphy studies will be assessed using the
      intraclass correlation coefficient, ICC, version "Two-Way Random". Parameters of the sleep
      architecture will be the average total length of the individual sleep phases (provided with
      standard deviations and coefficients of variability defined as the quotient of standard
      deviation and mean).
    

Intervention name(s): Nightly App
Intervention type(s): Device
Intervention description(s): The Nightly application will be installed independently on the user's smartphone. Once the user has set up their account and has logged in, they can then perform regular sleep quality assessments. In order to record a measurement, the user must first select a film (first screen) and watch it (second screen), the visualizations and acoustics aid in the process of falling asleep. After the film finishes, the participant places the phone on the corner of the bed, firstly with the screen facing up, and then under his/her pillow. Throughout the night, the application registers sleep phases that will be analyzed later.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: sleep; nightmare; app
Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
Condition: Anxiety; Virtual Reality
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study evaluate the effectiveness of the Virtual Reality Educational Program (RVEP) in
      the Paediatric Surgical Prehabilitation Unit to reduce the perioperative anxiety in children
      who undergo to elective surgery. Half of the patients will received the virtual reality
      program, and the other half will received de common treatment.
    

Detailed description: 
      During preoperative time, anxiety is one of the most frequent problems in children, causing
      an important health problem as long with pain. In the surgical fields there are two
      especially stressful moments for the child, the first one is the parent´s separation, and the
      second is the anaesthetic induction, which in up to 42% of cases can be traumatic.

      Methods to treat paediatric anxiety have evolved in the last decades. Pharmacological therapy
      is one of the most used methods to treat anxiety in the immediate preoperative period, but
      complications and unwanted side effects are described. Due to this side effects, this study
      will evaluate the the effectiveness of the Virtual Reality Educational Program (RVEP) to
      reduce the perioperative anxiety in children.
    

Intervention name(s): Virtual Reality Educational Program
Intervention type(s): Device
Intervention description(s): The study group, in addition to providing the usual information about the anaesthetic-surgical process, will visualize an educational video through virtual reality glasses, of a maximum duration of 5 minutes. The video's explanation will be adapted according to the age ranges. Once the video is finished, if there aren't doubts, the visit will be concluded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preanesthetic visit
Influence of Selenium on Prostate Cancer Related Biomarkers
Condition: Effect of Selenium on Oxidative Stress in Healthy Men
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Penn State Milton S. Hershey Medical Center researchers are trying to compare the effects of
      two different forms of selenium (selenium yeast and selenomethionine) on blood selenium
      levels and biomarkers of oxidative stress as primary endpoints. One in six men are at risk of
      getting prostate cancer in their lifetime. Participants will be asked to take
      over-the-counter selenium yeast supplements and selenomethionine or a placebo for nine out of
      twelve months.
    

Detailed description: 
      We will conduct a double-blind, randomized, placebo-controlled clinical study of selenium
      supplementation in the form of L-selenomethionine (SM)(200 µg/day) and selenium-enriched
      yeast (SY) (200 µg/day and 285 µg/day) for 9 months; the 285 µg/day SY is selected to deliver
      an equivalent selenium as in 200 µg/day SM to healthy men. The variability of SM in SY that
      will be used here is less than 3% and it accounts for 70.5% of the SM content in SY. As
      primary endpoints, we will determine the effects of these two forms of selenium on plasma
      levels of selenium and its metabolites as well as biomarkers of oxidative stress at several
      time points. As a secondary endpoint, the effect of these two forms of selenium on plasma PSA
      levels will be examined.
    

Intervention name(s): Placebo; selenomethionine; low dose selenized-yeast; high dose selenized-yeast
Intervention type(s): Other; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): no active medication; 200 µg/day of selenomethionine (SM); 200 µg/day of SY; 285 µg/day of SY
Other intervention name(s): SM; low dose selenium-enriched yeast; SY; high dose selenium-enriched yeast; SY
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: selenium; oxidative stress; prostate cancer; PSA; glucose
Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal
      stem cells in the patients with spinal cord injury, Phase I Clinical study.
    


Intervention name(s): autologous adipose tissue derived mesenchymal stem cells
Intervention type(s): Drug
Intervention description(s): autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous adipose tissue
Immunogenicity and Safety Study of NBP606 in Healthy Toddlers
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the immunogenicity and safety of booster vaccination with NBP606
      compared to the existing commercial vaccine, when given concomitantly with routine pediatric
      vaccinations.
    


Intervention name(s): NBP606; Prevnar13
Intervention type(s): Biological; Biological
Intervention description(s): A single intramuscular injection into the thigh; A single intramuscular injection into the thigh
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Supplementation Trial on Arginine With Metabolic Profiling
Condition: Protein; Amino Acid; Arginine
Study type: Interventional

Summary: 
      This study will assess effects of an acute dose of the amino acid arginine on metabolism in
      healthy young men.
    

Detailed description: 
      A double - blind randomized, crossover design trial examining arginine vs. placebo beverage
      treatments will be performed. The primary objective is to determine the effects of arginine
      assessed by standard laboratory assays and metabolomics. To accomplish the objective
      standardized meals will be provided for 2 days preceding treatment for dietary consistency.
      Participants will arrive at the center following a 10-12 hr fast. Blood samples will be
      collected at baseline (fasting), 1.5 hrs, 3.0 hrs, 6.0 hrs, and 24 hrs post treatment. Plasma
      prolactin, growth hormone, amino acids, glucose, insulin, triacylglycerols, thyroid hormones
      (TSH, T3, and T4), sex hormone binding globulin (SHBH), testosterone, cortisol, DHEA, and
      citrulline will be measured. Metabolomics will be measured at 3 time points for each
      treatment. Peripheral arterial tonometry (PAT) will also be performed at ~2 hrs following
      treatment to examine endothelial function in response to nitrous oxide release. In addition,
      psychological status including fatigue will be assessed using a standardized mood
      questionnaire (POMS).
    

Intervention name(s): Arginine Drink; Plain Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 g of arginine in a formulated drink; formulated drink
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double - blind randomized, crossover design trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: growth hormone
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
Condition: Peripheral (Sensorimotor) Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film
      coated tablets of Ilko Ilac San. Ve Tic. A.S. versus reference Thioctacid (Alpha Lipoic acid)
      600 mg HR film coated tablets of Meda Pharma GmbH& CO .KG, Germany.
    


Intervention name(s): Alpha Lipoic acid 600 mg HR film coated tablets
Intervention type(s): Drug
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alpha-lipoic acid; bioequivalence; replicate design
A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer
Condition: Early Stage Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study is designed to randomly assign breast cancer patients requiring and agreeing to
      chemotherapy into two groups. One group will be receive an exercise prescription aimed at
      increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per
      week. The other group will not receive a exercise prescription but their activity will be
      recorded. The hypothesis is that participants that are most active will exhibit improved
      chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for
      inflammation in their blood.
    

Detailed description: 
      This is a prospective, randomized, single institution feasibility trial. The efficacy of an
      exercise intervention during chemotherapy for sedentary breast cancer patients will be
      tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate,
      96 will be randomized to two arms, comparing patients assigned to a physical activity program
      plus general health education materials versus patients assigned to receive standard general
      health education materials only. Study measures will be obtained before intervention, at 24
      weeks, and at the end of the intervention, approximately week 32.
    

Intervention name(s): Exercise prescription
Intervention type(s): Behavioral
Intervention description(s): A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer, exercise
Yoga for Men Attempting Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a
      quit-smoking program that combines behavioral therapy with either yoga, or a health &
      wellness program that serves as a contact control.
    

Detailed description: 
      Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for
      smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health & wellness
      program that serves as a control for number of contacts and subject burden between study
      conditions. Qualitative data from open ended surveys and interviews is used to supplement
      survey data to enhance the investigators understanding of study outcomes. Participant accrual
      and retention rates, acceptance of randomization, and compliance with study protocols will be
      examined along with perceptions and beliefs about yoga and its relationship to quitting
      smoking specifically, and health in general.
    

Intervention name(s): Cognitive Behavioral Therapy for Smoking Cessation; Yoga; Health & Wellness
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation; One hour, twice weekly for 8 weeks of vinyasa yoga; Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Smoking; yoga; men; intervention