bioihbjkbjnl/mcl2 huggingface dataset:
Diabetes Prevention Program for Obese Latino Youth
Condition: Obesity; Insulin Resistance; Diabetes
MeSH terms: Diabetes Mellitus; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of 12 week lifestyle intervention on
      diabetes risk in obese Latino adolescents.
    

Detailed description: 
      Obesity in the United States has reached epidemic proportions and Latinos youth are
      disproportionally impacted. Pediatric obesity is associated with several chronic health
      conditions including insulin resistance and type 2 diabetes. However, very few interventions
      specifically targeting diabetes prevention for obese Latino adolescents have been developed.

      Therefore, the purpose of this study is to examine the effects a culturally-grounded,
      community-based lifestyle intervention on psychosocial and health outcomes among obese Latino
      adolescents. Eligible participants of this study will be randomly selected to the
      intervention group or the delayed-intervention group (control group) after an initial health
      screening for eligibility.

      Participants selected to the intervention group will attend weekly healthy lifestyle
      education sessions with their parent(s)/guardian(s) and three physical activity sessions /
      week with other youth. After which, participants will attend monthly booster group meetings
      for three months.

      All participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin
      sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity
      behaviors.
    

Intervention name(s): Every Little Step Counts Intervention
Intervention type(s): Other
Intervention description(s): Youth participants randomized to participate in the experimental group will attend weekly healthy lifestyles education session with their parent(s)/guardian(s) and will also attend exercise sessions 3 times a week for 12 weeks. The education sessions will cover topics such as healthy eating choices, roles and responsibilities of both parents and youth in the realm of the family unit as well as in youth's own health, and self esteem among other topics. The exercise sessions will incorporate both aerobic and resistance training as well as other "free-play" physical activities i.e. basketball, volleyball etc.
Other intervention name(s): ELSC Intervention; DPP-ELSC; ASU ELSC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetes prevention program; community based interventions; childhood obesity; insulin resistance; glucose tolerance; quality of life; Latino youth; physical activity; nutrition
Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group
      Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of
      Tezepelumab after Single-Dose Subcutaneous Administration in Healthy Chinese Subjects.
    

Detailed description: 
      This is a Phase 1, single centre, randomized, double-blind, placebo-controlled, single dose,
      parallel group study in healthy Chinese male or female subjects. 48 healthy subjects will be
      randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose
      and High dose) to receive a single dose of tezepelumab or placebo in a 3:1 ratio. Each
      subject will only participate in one cohort. Dose level is unblinded and treatment
      (tezepelumab or placebo) will be double-blinded within each treatment cohort. Following a
      screening period of a maximum of 28 days, subjects will stay at the study facility for two
      nights starting from the day before dosing (Day -1) to Day 2. Subjects will receive a single
      dose of tezepelumab or placebo subcutaneously on Day 1 and safety monitoring and serial
      collection of blood samples for PK evaluation will be followed throughout the study period.
      The follow up period after the dosing will be 112 days.
    

Intervention name(s): Experimental: Tezepelumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Tezepelumab single dose subcutaneously injection.; Placebo single dose subcutaneously injection.
Other intervention name(s): Tezepelumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose). 16 subjects will participate in each treatment cohort. Within each cohort, subjects will be randomized in a 3:1 ratio to receive a single dose of tezepelumab or placebo. Each subject will only participate in one cohort.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Tolerability; Immunogenicity; Tezepelumab; Healthy Chinese Subjects
Bone Microarchitecture in Young Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD)
      potentially leading to pathological fractures at adult age. Recent data from our center and
      others have suggested that low BMD could be observed very early in life. However,
      quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be
      confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).

      High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology
      with very high spatial resolution. Images obtained with this technic are considered as
      virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces
      exploration in a three-dimensional manner, and therefore provides informations on bone
      microarchitecture as well as bone density.

      The aim of this study is to evaluate bone microarchitecture of paediatric patients matched to
      sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be
      collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore
      potential correlations HR-pQCT parameters.
    


Intervention name(s): scan examination HR-pQCT
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cystic Fibrosis; High-Resolution peripheral Quantitative Computed Tomography; Bone Mass Density
Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
Condition: Stimulant Use; MDMA ('Ecstasy'); Social Behavior; Motivation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To study the effects of MDMA, compared to a prototypical stimulant, on social motivation,
      social ability, and neural indices of social function in healthy volunteers
    


Intervention name(s): MDMA; Methamphetamine; placebo oral tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be given 125 mg of MDMA.; Participants will be given 20 mg of MA.; Participants will be given a placebo capsule that will only contain lactose.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of HQK-1001 administered
      for a total of 12 weeks (with one dosing break) in subjects with sickle cell disease.
    


Intervention name(s): Placebo; HQK-1001
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo capsule. Administered orally once a day on dosing days.; HQK-1001 capsules. 10 mg/kg, 20 mg/kg or 30 mg/kg administered once a day on dosing days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in
      subjects with active rheumatoid arthritis.
    


Intervention name(s): ISIS CRP Rx or Placebo
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
CG Future® Annuloplasty Ring/Band Clinical Trial
Condition: Mitral Valve Insufficiency
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary goal of the study is to document the number of patients that are successfully
      implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
    


Intervention name(s): CG Future Annuloplasty Ring/Band
Intervention type(s): Device
Intervention description(s): A CG Future Annuloplasty Ring or Band will be implanted, following standard care
Other intervention name(s): Colvin Galloway Future Annuloplasty Ring; Colvin Galloway Future Annuloplasty Band; CG Future Annuloplasty Ring; CG Future Annuloplasty Band
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
    


Intervention name(s): ezetimibe; simvastatin; Placebo (Unspecified)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.; simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.; Matching ezetimibe placebo
Other intervention name(s): Zetia®; EZETROL®; MK0653; Zocor®; MK0733
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multi-Wavelength Laser Tattoo Removal Pivotal Study
Condition: Tattoo Removal
Study type: Interventional

Summary: 
      Multi-center study to evaluate the safety and efficacy of an investigational version of the
      Cutera enlighten laser that offers multiple wavelengths for tattoo removal
    

Detailed description: 
      A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and
      efficacy of an investigational version of the Cutera enlighten laser that offers multiple
      wavelengths for tattoo removal.
    

Intervention name(s): enLighten Laser
Intervention type(s): Device
Intervention description(s): Laser tattoo removal treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bortezomib Consolidation Trial
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this trial is to determine whether bortezomib improves response and delays
      progression for multiple myeloma patients after high dose therapy and autologous stem cell
      transplant. It will also assess the effect of bortezomib treatment on patient bone health.
    


Intervention name(s): Bortezomib
Intervention type(s): Drug
Intervention description(s): 1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
Other intervention name(s): Velcade
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MM; HDT; ASCT; consolidation; bortezomib
Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
Condition: Brain and Central Nervous System Tumors
MeSH terms: Ependymoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one drug and combining chemotherapy with radiation therapy may kill more
      tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      radiation therapy in treating adult patients with brain cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the complete and partial response rate of patients with adult medulloblastoma,
           primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation
           combination chemotherapy.

        -  Determine the progression free survival and overall survival of these adult patients
           treated with combination chemotherapy followed by craniospinal radiation.

        -  Determine the toxic effects associated with this treatment in these patients.

      OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over
      1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3;
      filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on
      day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease
      progression or unacceptable toxicity.

      Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a
      week for 6 to 7 weeks.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually for 5-10 years.

      PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.
    

Intervention name(s): filgrastim; cisplatin; cyclophosphamide; etoposide; vincristine sulfate; adjuvant therapy; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Etoposide; Vincristine
Primary purpose: Treatment
Keywords: adult medulloblastoma; adult anaplastic ependymoma; adult ependymoma; adult supratentorial primitive neuroectodermal tumor (PNET)
The Comparison of Oxidative Stress Between Inhalation Anesthetics
Condition: Oxidative Stress; Cardiac Surgery
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been
      demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The
      aims of this study are(1)to develop an accurate liquid chromatography-tandem mass
      spectrometry methods for the detection of urinary isoprostane isomers in samples collected
      from healthy volunteers(for method quality control) and patients receiving a cardiac surgery
      (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to
      investigate the effect of different anesthetics on isoprostanes.
    

Detailed description: 
      Enhanced production of oxygen free radicals can lead to the generation of oxidative stress,
      which is harmful to human tissue and organs. Reactive oxygen species are released abruptly
      during some surgical procedures, and they are the major causes of ischemia-reperfusion
      injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of
      oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of
      oxidative stress during surgery is an important clinical issue.

      Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic
      peroxidation of arachidonic acid.The aims of this study are(1)to develop an accurate liquid
      chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane
      isomers in samples collected from patients receiving a cardiac surgery (2)to investigate the
      change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different
      anesthetics on isoprostanes during surgery.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients receiving cardiac valve surgery in Taipei Change Gung Memorial Hospital will be
        invited to participate this study
      
Biospecimen description: 
      thirty milliliters of urine was collected from urine bag of patients at the following times:
      baseline before anesthesia, 30 minutes before cardiopulmonary bypass, during cardiopulmonary
      bypass, after the end of cardiopulmonary bypass.
    
Keywords: isoprostanes; mass spectrometry
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the effect of 6-month administration of CP-945,598 on:

        -  weight loss and waist circumference,

        -  blood pressure, cholesterol, glucose

        -  other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-Î±
           and hsCRP

        -  the relationship between the concentration of the drug on the blood and the above
           parameters

        -  physical and psychosocial functioning, weight related symptoms, treatment satisfaction,
           appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression
    


Intervention name(s): CP-945,598; sibutramine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
18793 - Human Photoallergy Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Photoallergic
Study type: Interventional

Summary: 
      To evaluate the potential of a test material to produce a photoallergic response.
    


Intervention name(s): BAY987517; Untreated skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.; One site is patched without treatment as control
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
AdvisaTM IPG Clinical Evaluation Study
Condition: Bradycardia; Atrial Tachyarrhythmia
MeSH terms: Bradycardia; Tachycardia
Study type: Interventional

Summary: 
      The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and
      clinical performance of the Advisa DR Implantable Pulse Generator (IPG).
    

Detailed description: 
      The Advisa IPG is an investigational dual chamber pacemaker that provides rate-responsive
      bradycardia pacing and diagnostics and atrial tachycardia detection and therapy.

      The study will be a prospective, non-randomized, multicenter clinical study, conducted.

      To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted
      with the Advisa device. Data will be collected at baseline (enrollment), implant, 1-, 3- and
      6- months post implant and every 6 months thereafter or until study closure (whichever occurs
      first), unscheduled follow-up visits, System Modifications, Technical Observations, Study
      Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of
      death.
    

Intervention name(s): Advisa IPG
Intervention type(s): Device
Intervention description(s): Implantable Pulse Generator will be implanted
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is investigating the possible mechanisms of action of an inhaled treatment
      (Seretide), currently used worldwide in millions of patients with COPD (Chronic Obstructive
      Pulmonary Disease) and how it improves the symptoms of these patients. Previous research has
      failed to identify the mechanisms at play other than dilation of the airways. The research
      community has long thought the mechanism to be immune based or anti inflammatory but despite
      intensive research this has not yet been identified.
    

Detailed description: 
      We aim to recruit equal numbers of healthy smokers, mild, moderate and severe COPD patients
      (12 patients to be recruited from each group). These patients will never have been prescribed
      the components present in Seretide (Salmeterol and Flixotide or similar compounds).

      The patients will have spirometry at the beginning of the study to confirm the presence of
      COPD. Healthy smokers will defined as ex or current smokers who match the study population
      but have normal lung function.

      Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other
      significant respiratory disease will be excluded.

      The patients will have a total of four study visits, 2 off treatment and 2 while on
      treatment, over a 56 day study period. At each study visit induced sputum will be performed
      and blood extracted. The cells fom both of these samples will be analysed for cells type and
      activation. Sputum and serum will be stored for cytokine analysis at a later date.

      The Sputum will be induced using standardised protocols using nebulised saline solution.
    

Intervention name(s): Seretide 500 Accuhaler
Intervention type(s): Drug
Intervention description(s): Seretide 500 accuhaler one inhalation BD
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; Emphysema; Bronchitis