bioihbjkbjnl/mcl2 huggingface dataset:
Transtheoretical Model of Behavior Change and Anxiety
Condition: Psychological; Physical Activity
Study type: Interventional

Summary: 
      Examine the utility of the Transtheoretical Model in influencing anxiety among college
      students. Employ a randomized controlled intervention including a static and dynamic Facebook
      intervention. The static group accessed a Facebook page featuring 96 statuses. Statuses were
      intended to engage cognitive processes, followed by behavioral processes of change per the
      Transtheoretical Model of behavior change. Content posted on the static Facebook page was
      identical to the dynamic page. However, the static group viewed all 96 statuses on the first
      day of the study, while the dynamic group received only 1-2 of these status updates per day
      throughout the intervention. Anxiety was measured using the Overall Anxiety Severity and
      Impairment Scale (OASIS). Time spent engaging in physical activity was assessed using the
      International Physical Activity Questionnaire (IPAQ).
    


Intervention name(s): Transtheoretical Model
Intervention type(s): Behavioral
Intervention description(s): Exposure to content on Facebook, either daily (dynamic) or just at one time period (static).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the absorption of a test inhalation product with the
      reference product in healthy volunteers.
    

Detailed description: 
      Healthy subjects will be enrolled and will receive doses of a test inhalation product and a
      reference inhalation product for 28 days according to a crossover design. Plasma tiotropium
      levels will be measured predose and over 24 hours postdose on days 1 and 28.
    

Intervention name(s): Tiotropium
Intervention type(s): Drug
Intervention description(s): inhalation
Other intervention name(s): Spiriva Respimat
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inhalation; anticholinergic
Evaluation and Validation of Metabolic Markers for the Assessment of CYP3A Activity and Prediction of DDI
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation and validation of metabolic markers for the assessment of CYP3A activity and
      prediction of drug-drug interaction in Korean healthy subjects.
    

Detailed description: 
      Eligibility for participation of this study will be determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 4 weeks before study drug administration. Subjects suitable for this study will be
      admitted to the Clinical Trials Center, Seoul National University Hospital on the day before
      dosing, and they were overnight-fasted from 10 p.m. of Day -1. Urine collection is scheduled
      drug 12 hour before and 24 hour after midazolam administration. Subjects will be dosed study
      drug via intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures.

      In period 2, Subjects will be admitted on Day 3-5. Subjects performed scheduled period 2
      (Itraconazole co-administration phase, 2 times administration of itraconazole 200 mg), and
      period 3 (rifampicin 150 mg co-administration phase) procedure. Study participation was
      terminated on post-study visit (Day 23~35).
    

Intervention name(s): Midazolam; itraconazole; rifampicin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Bukwang Midazolam, Korea
Intervention MeSH terms: Itraconazole; Rifampin; Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CYP3A; Metabolomics
the Effect of Simple Clinical Maneuver on Shoulder and Abdominal Pain a Laparascopic Gynecological Surgery:a Prospective Randomised Trial
Condition: Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic Surgery
Study type: Interventional

Summary: 
      The investigators think that a simple maneuver at laparascopic surgery to reduce the
      postoperative pain.
    


Intervention name(s): CO2 was removed by means of trandelenburg positions
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Strength Training Following Gastric Bypass for Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      We will assess whether undesirable loss of lean tissue following gastric bypass surgery for
      obesity can be minimized by protein supplementation and exercise training.
    


Intervention name(s): strength training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; gastric bypass; obesity surgery; bariatric surgery; exercise
Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
Condition: Papillomavirus Infections; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Adenocarcinoma in Situ; Condylomata Acuminata
MeSH terms: Papillomavirus Infections; Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Adenocarcinoma in Situ; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of V503 (GARDASIL™9, 9vHPV vaccine)
      administered to 9- to 26-year-old females and males in Vietnam. The study hypothesis states
      that V503 induces acceptable anti-human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52,
      and 58 seroconversion at 4 weeks postdose 3.
    


Intervention name(s): 9vHPV vaccine
Intervention type(s): Biological
Intervention description(s): 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine in a 0.5-mL intramuscular injection
Other intervention name(s): V503; GARDASIL™9
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of
      fospropofol disodium in comparison to propofol. In addition, the study will compare the
      maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.
    


Intervention name(s): Fospropofol disodium, propofol; Fospropofol disodium, propofol; Fospropofol disodium, propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus.; Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus.; Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.
Intervention MeSH terms: Propofol; Fospropofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of QAX576 in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment
      with QAX576 in patients with persistent asthma not adequately controlled with inhaled
      corticosteroids and long acting beta2-agonists.
    


Intervention name(s): QAX576; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): every 3 weeks via intravenous infusion; every 3 weeks via intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; QAX576
Safety and Immunogenicity of Prime-Boost Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-002)
Condition: Ebola Viruses
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Zaire ebolavirus
      (ZEBOV) has affected several thousand people. There is no approved effective way to treat or
      prevent Ebola. Researchers are trying to develop a vaccine for it. This is a study of the
      anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (V920; BPSC-1001) to see if it is
      safe and to see how it affects people's immune system.
    

Detailed description: 
      Between 1994 and the present, there have been many Ebola virus (EBOV) outbreaks affecting
      mostly central Africa. However, the 2014 West African outbreak significantly exceeds all
      previous outbreaks in geographic range, number of individuals affected and in disruption of
      typical activities of civil society.

      This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a
      live VSV replacing the gene encoding the G envelope glycoprotein with the gene encoding the
      envelope glycoprotein from the Zaire strain of Ebola (VSVΔG-ZEBOV also known as V920 and
      BPSC-1001).
    

Intervention name(s): Placebo; V920
Intervention type(s): Other; Biological
Intervention description(s): Normal saline placebo.; Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Reversal of Cognitive Decline (ReCODE) Study
Condition: Alzheimer Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Observational

Summary: 
      Prospective study on patients enrolled in the ReCODE treatment protocol
    

Detailed description: 
      The objective of the study is to determine if the ReCODE treatment has a measurable impact on
      the typical progression of neurocognitive decline observed in patients with Alzheimer's
      Disease (AD) and patients who are exhibiting Mild Cognitive Impairment (MCI). MCI is often a
      precursor to an AD diagnosis. For this study, there will be no distinction made between
      participants who have been diagnosed with AD and those who show signs of MCI.
    

Intervention name(s): ReCODE Protocol
Intervention type(s): Behavioral
Intervention description(s): Functional medicine approach to address symptoms of Alzheimer's and cognitive decline
Other intervention name(s): Bredesen Protocol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People who have signs of reduced neurocognitive function
      
Keywords: Dementia; Alzheimer's Disease; Cognitive Decline; MCI
Hypertrophic Scarring After Facial Burn
Condition: Burn
MeSH terms: Cicatrix, Hypertrophic; Burns
Study type: Observational

Summary: 
      Subjects with a burn to the face and/or neck will be enrolled into the study and a
      Three-Dimensional scanner used to see if it can objectively measure scar color and volume and
      measure the effect of scar on motion of the face and neck.
    

Detailed description: 
      Subjects will have 11 clinic visits over a 2-year period. An initial scan of the subject's
      head and neck will be made. Ten reproducible landmarks on the face and neck will be
      determined. The subject will return for follow up scans at Day 14, Day 28 and Month
      2,6,9,12,18 and 24.
    

Intervention name(s): 3-Dimensional Color Scanning
Intervention type(s): Device
Intervention description(s): Color imaging of the face and neck.
Other intervention name(s): Cyberware 3030 RGB Color Scanner
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population includes patients with burn injuries to their face and or neck.
A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose.
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory
      Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.
    


Intervention name(s): CT-868 as SC Injection; Placebo as SC Injection; Active Comparator as SC Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CT-868; Placebo; Active Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Metabolic Diseases; Body Weight
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Condition: Safety; Tolerability; Ocular Surface; Ocular Comfort
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical phase I, controlled, non comparative, open, single center study evaluating the
      safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of
      healthy volunteers.
    


Intervention name(s): Bepotastine Besilate
Intervention type(s): Drug
Intervention description(s): Bepotastine Besilate 1.5% QID (quater in die) for 7 days
Other intervention name(s): PRO-172
Intervention MeSH terms: Bepotastine besilate
Intervention model: Single Group Assignment
Intervention model description: Controlled, single center, non comparative
Masking: None (Open Label)
Primary purpose: Other
Metabolomic Analysis of Hepatic Insulin Resistance
Condition: Type 2 Diabetes; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This is a pilot study to show that it is possible to identify the specific types of fats in
      blood, adipose tissue, and liver tissue. The study doctors hope to use the analysis of these
      fats to learn more about nonalcoholic fatty liver disease (NFLD). Nonalcoholic fatty liver
      disease is the accumulation of fat in the liver of people who have minimal alcohol exposure.
      Nonalcoholic Fatty Liver Disease is associated with obesity and insulin resistance, and
      predicts development of Type 2 Diabetes. The study doctors are interested in looking at the
      relationship between liver fat and insulin resistance.
    


Intervention name(s): Hyperinsulinemic-euglycemic clamp
Intervention type(s): Other
Intervention description(s): Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery
--------------------------------------------------------------------------------
Other intervention name(s): glucose clamp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bariatric surgery, l; liver insulin resistance,
Reduction of Sperm DNA Fragmentation by Oral Ginger
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double blind, controlled clinical trials assess the efficacy of
      the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.
    

Detailed description: 
      Sperm DNA fragmentation is known to affect male fertility. Previous findings have suggested
      the implication of oxidative stress in the etiology of this pathological condition. The
      present study was designed to find out DNA fragmentation in ejaculated spermatozoa can be
      reduced by oral treatment with Ginger extract. 71 men with unexplained or Idiopathic
      infertility were randomized between a Ginger treatment (500 milligram daily for 3months)
      group and a placebo group.

      Sperm DNA fragmentation was evaluated by Terminal deoxyribonucleotidyltransferase-mediated
      dUTP nick-end labeling assay (TUNEL) before and after treatment. No differences in basic
      sperm parameters were found between the Ginger treatment and the placebo group before or
      after treatment. However, the percentage of DNA-fragmented spermatozoa was markedly reduced
      (P< .005) in the Ginger treatment group after the treatment as compared with the pretreatment
      values). No difference in the pretreatment and post treatment incidence of sperm DNA
      fragmentation was observed in the placebo group. These data show that sperm DNA damage can be
      efficiently treated with oral Ginger extract administered during a relatively short time
      period.
    

Intervention name(s): oral administration of ginger; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of ginger in patients with infertility.
Other intervention name(s): Administration of herbal drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine
Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
Condition: Respiratory Viral Infections; Respiratory Syncytial Virus Infections; Parainfluenza Virus 3, Human
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall objective of the MEDI-534 clinical development program is to evaluate the safety,
      efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in
      young infants.
    

Detailed description: 
      The primary objective of this study is to describe the safety and tolerability of multiple
      doses of MEDI-534 at 10^4, 10^5, or 10^6 TCID50 when administered to RSV and PIV3
      seronegative children 6 to <24 months of age.
    

Intervention name(s): MEDI-534; MEDI-534; MEDI-534
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Multiple doses of MEDI-534 or Placebo at 10^4 TCID50; Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.; Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lower Respiratory Tract Illness; RSV and PIV3 infection
Promoting Clinical Preventive Services Among Adults With Disabilities
Condition: Physical Disability
Study type: Interventional
Phase: Phase 1

Summary: 
      Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a
      participatory action research project to test an intervention package combining a resource
      kit with peer mentoring in improving consumer education about primary preventive services
    

Detailed description: 
      Adults with disabilities use primary preventive health care services (basic screenings,
      immunizations, and hevior health counseling) at rates below those recommended by the US
      Preventive Services Task Force and Healthy People 2010. This projects is to carry out a
      community-based campaign to increase preventive care knowledge and service use among adults
      with physical disabilities. Focus group methodology will be used to determine the specific
      preventive service priorities of the disability community so that targeted resource materials
      for consumers and physicians can be developed. Second, a randomized control group experiment
      will be implemented to evaluate the effectiveness of the targeted resource materials,
      followed by dissemination of the Preventive Services Resource Kits.
    

Intervention name(s): Preventive Services Prevention Kit; peer mentors (control group)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Yoga Program in Respiratory Function
Condition: Elderly
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study tested the hypothesis that yoga practice can improve respiratory function in the
      elderly.
    

Detailed description: 
      Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a
      manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were
      assessed by a ventilometer. The yoga program comprised 70 min sessions, 3 times/week during
      12 weeks.
    

Intervention name(s): yoga practice
Intervention type(s): Other
Intervention description(s): The yoga program comprised 70 min sessions, 3 times/week during 12 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedentary elderly women that had medical assignment
Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that
      the effectiveness is lower than efficacy outcomes measured in clinical trials
    

Detailed description: 
      This is a prospective, long-term, observational study of routine clinical care. The study
      measurements will be integrated into the clinical assessment and follow-up procedures of the
      outpatient services under the Provincial ADHD Program. The study is designed for systematic
      follow-up of children and adolescents, diagnosed with ADHD irrespective of comorbidity or
      whether they elect to receive medication treatment. Evaluations occur every 6 months for 24
      months. The population to be examined is children and adolescents with a diagnosis of ADHD,
      aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical
      assessment. No studies have been conducted that have evaluated the outcome of core ADHD
      symptoms in a clinic setting. Metaanalysis of clinical trials of medication treatment for
      ADHD have suggested an effect size of approximately 0.8. Because of the heterogeneity of the
      clinic sample, a much lower effect size can be anticipated. Two hundred patients will be
      enrolled in this study with primary measure of effectiveness being change in ADHD symptoms.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline),
        referred to the Provincial ADHD Program for clinical assessment.
      
Keywords: ADHD Effectiveness