bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional

Summary: 
      A randomized controlled trial measuring surgical site infection rate as a function of timing
      of wound dressing removal.
    

Detailed description: 
      A randomized controlled trial with a sample size of 602 patients to study the effect of
      timing of wound dressing removal on the surgical site infection rate. 300 patients were
      randomized to a group that had the wound dressing removed between 12-30 hours
      postoperatively. 302 patients were randomized to a group that had the wound dressing removal
      between 30-48 hours postoperatively. Statistical analyses were performed to determine if the
      timing of dressing removal had statistical significance on the surgical site infection rate,
      the primary outcome.
    

Intervention name(s): Wound dressing removal.
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial evaluated the comparative bioavailability of two injectable suspension
      formulations of medroxyprogesterone acetate + estradiol cypionate, a test (Depomês®, 25 mg/mL
      medroxyprogesterone acetate + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.)
      and a reference formulation (Cyclofemina®, 25 mg/0.5 mL medroxyprogesterone acetate + 5
      mg/0.5 mL estradiol cypionate, Millet Roux Ltda.) in healthy female volunteers after a single
      intramuscular dose administration. In addition, this study also evaluated the safety and
      tolerability of these drugs.
    

Detailed description: 
      This study was performed in a monocentric, open label, parallel design, with 2 treatments, 1
      period, in which twelve subjects received the test product (Depomês®, 25 mg/mL
      medroxyprogesterone acetate + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.)
      and twelve subjects received the reference product (Cyclofemina®, 25 mg/0.5 mL
      medroxyprogesterone acetate + 5 mg/0.5 mL estradiol cypionate, Millet Roux Ltda.). The
      formulations (test or reference) were administered in a single intramuscular dose (1 ampoule)
      after an overnight fast (approximately 8 h). Blood samples (9 mL) were collected via a venous
      catheter into heparinized tubes at times pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168,
      240, 288, 336, 432, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848, and 2016 h after drug
      administration to measure medroxyprogesterone; and pre-dose (-48, -24 and 0 h) e 2, 4, 6, 8,
      10, 12, 24, 48, 72, 96, 120, 168, 240, 288, 336, 432, 504, 672, 840, and 1008 h after drug
      administration to measure estradiol cypionate.

      The safety assessment was based on recording adverse events throughout the study duration.
      The subjects systolic and diastolic pressures, heart rate and temperature were determined
      prior and at approximately 4, 8 and 12 h after drug administration. The clinical evaluation
      and the laboratory tests were also performed at the end of the study.
    

Intervention name(s): Test formulation; Reference formulation
Intervention type(s): Drug; Drug
Intervention description(s): Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/mL + estradiol cypionate 5 mg/mL after an overnight fast.; Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/ampole + estradiol cypionate 5 mg/ampole after an overnight fast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medroxyprogesterone acetate; estradiol cypionate; bioavailability; monthly contraceptive
Effects of Pilates on Respiratory Mechanics
Condition: Exercise
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the influence of a fitness program from the application
      of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in
      women.
    

Detailed description: 
      Study in the Cardiorespiratory Physiotherapy laboratory and clinics of Pilates in the region,
      in which the voluntary of the Pilates group would start the Pilates method.

      The study included women with body mass index (BMI) ≤ 29 kg/m2 were not engaged in regular
      physical activity, or sedentary lifestyle with scores up to eight, according to Baecke et
      al., non-smoker, non-alcoholic, without any abnormalities of the cardiovascular, respiratory
      and neuromuscular.

      The study excluded women with disabling diseases, pregnancy, postpartum less than a year,
      inability to understand the tests and exercises proposed or refuse to participate in the
      study.

      The volunteers, aged between 25 and 55 years, were allocated in to two groups:

        1. Pilates Group (n = 16): sedentary volunteers, but that would begin activities with the
           Pilates method and evaluated three months.

        2. Control group (n = 13): sedentary volunteers and remain sedentary and evaluated in three
           months.
    

Intervention name(s): Pilates method
Intervention type(s): Other
Intervention description(s): Therapeutic intervention in the Pilates method has two regular weekly sessions for 12 weeks, totaling 24 sessions. For the protocol of Pilates exercises, exercises on soil and equipment, with gradual progression of the load.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; spirometry; muscle strength; physical therapy modalities
Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes
Condition: Postprandial Lipemia; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Hyperlipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether ezetimibe in association with statins is
      more effective than statins alone on postprandial lipemia in type 2 diabetic patients.
    


Intervention name(s): ezetimibe tablets; simvastatin tablets; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ezetimibe tablets 10 mg/die; simvastatin tablets 20 mg/die; placebo
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postprandial lipemia; type 2 diabetes; ezetimibe; hypercholesterolemia
Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the
      laboratory may help doctors learn more about changes that may occur in DNA and identify
      biomarkers related to cancer, and may help doctors learn how well patients will respond to
      treatment.

      PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon
      therapy in patients with melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Generate a comprehensive multiplexed array of melanoma-associated serological markers
           and validate it using serum samples from patients with melanoma and healthy control
           participants.

        -  Determine changes in the profile of serological markers induced by interferon-alfa 2b
           (IFN-α2b) therapy.

        -  Define panels of serological markers with prognostic and predictive power for IFN-α2b
           therapy responses in patients with melanoma.

      OUTLINE: This is a multicenter study.

      Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines,
      chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases
      (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast
      growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin,
      vasostatin, and vascular endothelial growth factor inhibitor.

      PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.
    

Intervention name(s): laboratory biomarker analysis
Intervention type(s): Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E1690 and E1694
      
Keywords: recurrent melanoma; stage IV melanoma; stage IA melanoma; stage IB melanoma; stage IIA melanoma; stage IIB melanoma; stage IIC melanoma; stage IIIA melanoma; stage IIIB melanoma; stage IIIC melanoma
The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of topical application of
      IDP-108 versus vehicle in treating patients with onychomycosis.
    


Intervention name(s): IDP-108; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Topical application once a day for 48 weeks; Topical application once a day for 48 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Individualized Obesity Pharmacotherapy
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The researchers are trying to identify the specific characteristics (phenotypes) that may be
      useful to help select the right medication for weight loss.
    

Detailed description: 
      All participants will be phenotype and participants will randomized to randomly assigned
      medications vs phenotype guided medications for obesity. All participants will receive a
      standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At
      the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and
      they could contact their physician to continue a FDA-approved medication as part of clinical
      care. Study team will prospectively follow the patients' weight, waist circumference and use
      of obesity medications every 3 months for 1 year.
    

Intervention name(s): Phentermine-Topiramate; Liraglutide; Naltrexone/bupropion; Phentermine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Extended Release at dose of 7.5/46 mg oral daily; dose of 3 mg subcutaneous daily; Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening); 15-37.5 mg oral daily
Other intervention name(s): Qsymia; Saxenda; Contrave; Adipex-P; Lomaira
Intervention MeSH terms: Liraglutide; Topiramate; Phentermine; Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmacological; Obesity Management; Individualized
Marginal Fit of Porcelain Veneers After Finishing Prepared Surfaces With Ultrasonic Tips
Condition: Tooth Discoloration
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      The aim of the study is to assess the marginal fit following preparation finishing with
      ultrasonic tips of porcelain veneers compared to the ordinary preparation using burs only.
      Two-hundred and forty crowns prepared to receive porcelain veneers (in a split-mouth design).
      On one side of the mouth, the prepared surfaces will be finished with ultrasonic tips.
      Marginal fit is measured by a 'cement replica technique'.
    

Detailed description: 
      All-ceramic restoration are increasing in daily routine treatments although remain less
      popular than metal-ceramic crowns especially as the cost of metal rises and aesthetic
      requested people increases The increased demand for aesthetic treatments has led to the
      widespread use of metal-free ceramics for conservative restorations. Whilst studies for
      clinical porcelain restorations clarifies satisfactory success rates describes the reasons
      for failure is due to advance the techniques and materials used in dental restorations.
      All-ceramic restorations failures are due to several reasons, such as restoration fractures,
      discoloration in marginal area, marginal misfits and secondary decays. However, secondary
      caries is the main failure mentioned by the studies, responsible for 21% of the suddenly
      crown replacements. The etiology of secondary caries is as classified to primary caries, with
      the involvement of the same cariogenic microorganisms. The place and spread where to invade
      of primary and secondary lesions are also similar, with secondary caries developing mainly in
      the gingival tooth interface of restored teeth. Different authors have mentioned different
      instrumentation to prepare teeth appropriately.Preparation may be applied using diamond burs
      attached to sonic devices or high-speed rotating instruments with diamond or tungsten carbide
      burs. The action of conventional high-speed instruments applied for tooth preparation has
      been widely researched as well as the adhesion strengths and marginal microleakage it
      produces. Some authors insisted that dental surface morphology of prepared teeth is
      influenced by the type of bur used for preparation.
    

Intervention name(s): Ultrasonic tips
Intervention type(s): Procedure
Intervention description(s): These tips are going to be used to give the final shape of the prepared surfaces before taking the impression for the construction of the veneers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tooth preparation; Prosthodontics
Study of LC23-1306 in Healthy Male Subjects
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a dose block-randomized, double-blind, active and placebo controlled, single and
      multiple dosing, dose-escalation study to evaluate tolerability, safety and
      pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital
      signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and
      serial blood samples and urine collections for pharmacokinetic and pharmacodynamic
      evaluations will be conducted at specified time points.
    


Intervention name(s): LC23-1306; placebo; Ticagrelor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg; LC23-1306 placebo; Ticagrelor 90mg
Other intervention name(s): antiplatelet agent
Intervention MeSH terms: Ticagrelor; Platelet Aggregation Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: phase1; healthy subjects; antiplatelet agent
Diagnostic Value of HS-CRP in Stable Angina.
Condition: Stable Angina; Positive ETT
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional

Summary: 
      The aim of this study was to assess the amount of additive value of HS-CRP levels to a
      positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using
      coronary angiography as the gold standard. The investigators concluded that HS-CRP can be
      used as a single predictor of coronary vessel involvement in patients with stable angina and
      positive ETT.
    

Detailed description: 
      the investigators included 97 patients with positive ETT and stable angina and saw that
      Hs-CRP is the only predictor of severity of CAD as compared with coronary angiography in
      stable angina patients.
    

Intervention name(s): coronary angiography
Intervention type(s): Procedure
Intervention description(s): effect of level of HS-CRP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Exercise tolerance test; HS-CRP; Coronary angiography; Patients
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
Condition: Enterovirus Infections
MeSH terms: Enterovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the immune response and safety profiles of two
      injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg
      and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required),
      0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.
    


Intervention name(s): EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose); EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose); EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose); EV71 vaccine (2 μg total protein per dose); EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose); EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose); EV71 vaccine (1 μg total protein per dose)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Two vaccinations at 28 days apart; Two vaccinations at 28 days apart; Two vaccinations at 28 days apart; Two vaccinations at 28 days apart; Two vaccinations at 28 days apart; Two vaccinations at 28 days apart; Two vaccinations at 28 days apart
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccines; Hand, Foot and Mouth Disease; EV71 enteroviruses vaccine
Community Characteristics and Physical Activity Among Adolescent Girls - Ancillary to TAAG
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To investigate the role of community characteristics in physical activity levels of
      adolescent girls.
    

Detailed description: 
      BACKGROUND:

      The NHLBI-funded multi-centered Trial of Activity for Adolescent Girls (TAAG) is a group
      (school)-randomized controlled intervention trial to increase physical activity among a
      cohort of sixth grade girls over 2.5 years.

      DESIGN NARRATIVE:

      Because environmental factors can influence the likelihood that a person will engage in
      physical activity, the study investigates the role of community characteristics in physical
      activity levels. The research forms an ancillary study to the NHLBI-funded multi-centered
      Trial of Activity for Adolescent Girls (TAAG), a group (school)-randomized controlled
      intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5
      years. The parent TAAG study will be collecting measures of physical activity using both
      self-report and CSA accelerometers, small monitors worn at the hip that record acceleration
      and deceleration of movement without the need for any reporting from the participants. Using
      a radius of 5 miles around each participating TAAG school and around the homes of each study
      participant, the investigators plan to use geographic information systems (GIS) to gather
      information documenting proximity of recreational facilities, street design, population
      density, population mix (ethnic/age distribution), crime, availability of mass transit,
      neighborhood socioeconomic status (SES), geographic elevations and topography and types of
      land use. Using hierarchical linear modeling, with girls nested within neighborhoods, while
      controlling for individual level factors such as race and socioeconomic status, they plan to
      investigate the relationship of the environment to individual physical activity. In addition,
      by following girls over time, they plan to investigate whether the effect of the TAAG
      intervention will be modified by community characteristics. This study will be unique in its
      scope of exploring the role of community environments in physical activity across six very
      different urban, suburban, and rural areas: San Diego, CA, Minneapolis, MN, Baltimore, MD,
      New Orleans, LA, Tucson, AZ and Columbia, SC.
    

Observational model: Cohort
Time perspective: Prospective
Keywords: built environment; parks; retail outlets; adolescent girls; physical activity
Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the
      AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who
      previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E
      vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously
      received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens as part of the HVTN 205 study.

      Participants in this study will be assigned to one of five groups based on their previous
      vaccine regimen received in HVTN 205. Depending on their group, participants will receive the
      MVA/HIV62B vaccine, the AIDSVAX B/E vaccine, or both the MVA/HIV62B vaccine and the AIDSVAX
      B/E vaccine. All participants will receive their assigned vaccines at study entry (Day 0) and
      Month 4. Participants will attend several study visits through Month 10. Visits will include
      physical examinations, blood collection, HIV testing and risk reduction counseling, and
      interviews and questionnaires. Optional procedures at some visits include collection of
      rectal fluids, cervical fluids, and semen. Study staff will contact participants 2 years
      following the initial study injection for follow-up health monitoring.
    

Intervention name(s): MVA/HIV62B vaccine; AIDSVAX B/E vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1×10^8 TCID50 dose to be administered as a 1 mL intramuscular (IM) injection in the deltoid; 600 mcg/mL dose to be administered as a 1 mL IM injection in the deltoid; Sodium Chloride for Injection USP, 0.9% to be administered as a 1 mL IM injection in the deltoid
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention