bioihbjkbjnl/mcl2 huggingface dataset:
A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the difference, if any, in the area under the
      sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post
      Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and
      gender.
    

Detailed description: 
      Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and
      Volume of Distribution between the two groups. Also, assessment of subject tolerance of
      sertraline utilizing the UKU side effect rating scale.
    

Intervention name(s): bariatric surgery; control
Intervention type(s): Procedure; Other
Intervention description(s): Roux en Y bariatric surgery; No surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gastric Bypass; Sertraline; Pharmacokinetics
Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the
      enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more
      tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose
      of giving gefitinib with everolimus and to see how well it works in treating patients with
      stage IIIB or stage IV or recurrent non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of everolimus when administered with gefitinib in
           patients with stage IIIB or IV or recurrent non-small cell lung cancer. (Phase I)

        -  Determine the efficacy of this regimen in these patients. (Phase II)

      Secondary

        -  Assess the pharmacokinetics of everolimus, alone and in combination with gefitinib, in
           these patients. (Phase I)

      OUTLINE: This is an open-label, phase I, dose-escalation study of everolimus followed by a
      phase II study.

        -  Phase I: Patients receive oral everolimus once on day 1. Beginning on day 8, patients
           receive oral gefitinib once daily. Beginning on day 22, patients receive oral everolimus
           once daily. Both drugs are then given concurrently for the rest of the treatment.
           Treatment continues in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6
      patients experiences dose-limiting toxicity.

        -  Phase II: Patients receive oral everolimus at the MTD determined in phase I and oral
           gefitinib once daily. Treatment continues in the absence of disease progression or
           unacceptable toxicity.
    

Intervention name(s): everolimus; gefitinib
Intervention type(s): Drug; Drug
Intervention MeSH terms: Everolimus; Gefitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral
      palsy patients, by means of standardized and internationally accepted scales
    

Detailed description: 
      Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral
      palsy patients, by means of standardized and internationally accepted scales
    

Intervention name(s): Administration of intrathecal baclofen
Intervention type(s): Drug
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparion of Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoskopic Cholecystectomy
Condition: Postoperative Pain; Anesthesia, Local
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many
      indications has been identified by case reports in the literature. As the investigators have
      considered that erector spinae plane block could be efficacious for providing postoperative
      analgesia in laparoscopic cholecystectomy, the investigators have implemented the application
      of this blockade into practice at the clinic.Quadratus Lumborum block (QLB) type 2 is another
      regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy.
      Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector
      spinae block and QLB in laparoscopic cholecystectomy.
    


Intervention name(s): erector spinae plane block; quadratus lumborum block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided bilateral Erector spinae plane (ESP) block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.; Ultrasound-guided bilateral Quadratus lumborum (QLB) type 2 block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
Other intervention name(s): Standard Pain Followup and Monitorization; Standard Pain Followup and Monitorization
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery
Condition: The Impact of Adipose Tissue Quality on Fat Graft Retention
Study type: Interventional

Summary: 
      The primary aim of this project is to standardize the method for lipofilling by identifying
      the best technique. In this context, the study will investigate the impact of adipose tissue
      composition and ideal quantity of the injected fat particularly in view of resorption rate.
      Correlations between adipose tissue composition, amount of transferred fat, already existing
      subcutaneous fat layer at the grafting site and resorption rate will be made.

      The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous
      fat layer thickness in the harvesting and grafting region will be performed in 10 female
      subjects that undergo elective lipofilling.

      The study was registered on Clinicaltrials.gov after start of recruitment.
    


Intervention name(s): fat grafting
Intervention type(s): Procedure
Intervention description(s): Fat will be removed from abdomen or legs, processed and re-injected into grafting sites.
Other intervention name(s): lipofilling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fat graft, adipose tissue
A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI
Condition: STEMI
MeSH terms: ST Elevation Myocardial Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The PANACEA trial is an investigator-initiated prospective, single-center, two-arm,
      non-blinded pilot randomized controlled trial of high-dose IV N-Acetylcysteine therapy used
      as an adjunct to pharmaco-invasive reperfusion in patients presenting early after a large
      STEMI.
    

Detailed description: 
      Patients presenting with ST-segment elevation myocardial infarction within 3 hours of symptom
      onset and satisfying all of the inclusion criteria after informed consent would be randomly
      allocated to either intravenous N-Acetylcysteine or standard treatment using a 1:1 allocation
      ratio. Those randomized to IV N-Acetylcysteine would be administered a bolus of 1200 mg over
      0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5%
      dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours. The
      infusion is continued during the primary percutaneous coronary intervention. Patients would
      be followed up for a minimum of 90 days. The primary clinical endpoint will be myocardial
      infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first
      medical contact. Primary feasibility outcome will be the rate of recruitment, the number of
      patients undergoing cardiac MRI within the stipulated time frame, and completeness of the
      study data collection.
    

Intervention name(s): Intravenous N-Acetylcysteine
Intervention type(s): Drug
Intervention description(s): Intravenous N-acetyl cysteine bolus and infusion as described in the experimental arm.
Other intervention name(s): Generic
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigator-initiated prospective, single-center, double- arm non-blinded randomized controlled trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: STEMI
Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to show that a prandial insulin regimen, consisting of
      premeal insulin lispro "mid mixture" (or a combined regimen of insulin lispro "mid mixture"
      and insulin lispro "low mixture") plus metformin will result in significantly better overall
      glycemic control (lower HbA1c) at endpoint than once-daily insulin glargine plus metformin.
      Insulin lispro "mid mixture" consists of 50% insulin lispro and 50% NPL. Insulin lispro "low
      mixture" consists of 25% insulin lispro and 75% NPL.

      In a substudy of approximately 60 patients, additional data will be collected on markers
      associated with risk of atherosclerosis or cardiovascular disease in the context of a
      controlled, outpatient, high-fat test meal.
    


Intervention name(s): premeal insulin lispro mixtures; insulin glargine; metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
What Are the Determinants of Explicit and Implicit Motor Imagery Ability in Stroke Patients?
Condition: Stroke; Healthy
MeSH terms: Stroke
Study type: Observational

Summary: 
      Motor imagery (MI) might be described as a dynamic process in which an individual mentally
      stimulates an action without any overt movement. After stroke, motor imagery ability is
      impaired and also due to structure of MI, not every stroke patients is able to perform MI.
      Therefore, the aim of the study is a) to compare both explicit and implicit motor imagery
      ability (MIA) between patients with stroke and healthy subjects, b) to examine predictive
      effects of clinical characteristics for MIA after stroke.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Stroke patients and age, sex, education matched healthy volunteers who meet the inclusion
        criteria
Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed
      combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the
      dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene
      0.1%/ benzoyl peroxide 2.5% treatment

      Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm),
      Intra-subject & inter subject comparisons
    


Intervention name(s): Epiduo; Salicylic Acid; Hydréane légère
Intervention type(s): Combination Product; Drug; Other
Intervention description(s): 100 per arm Adapalene/ Benzoyl Peroxide; Salicylic Acid; moisturizer
Intervention MeSH terms: Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 100 subjects per arm
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Roentgen Stereophotogrammetric Analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty (TKA) Components
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is twofold: 1) to use RSA to determine the migration patterns of
      the PA coated Triathlon Total Knee Arthroplasty components during the first 2 years
      postoperatively and thus determine the proportion of cases where adequate fixation is
      achieved, and 2) to use DEXA scanning to document peri-prosthetic bone mineral density
      changes in response to the PA coated Triathlon Total Knee arthroplasty over the first two
      postoperative years.

      In addition, gait assessment and validated outcome questionnaires will be utilized to
      quantify changes in functional status of subjects after surgery and migration patterns will
      be compared to results obtained from previous studies of uncemented total knee arthroplasty
      components conducted at this centre. Questions to be asked are: 1. Do the components achieve
      adequate fixation to the underlying bone? 2. What are the migration patterns (translations
      and rotations) of the PA coated arthroplasty components during the first two years
      postoperatively and are they different from that seen for other implants that have been
      studied with RSA at this institution? 3. For what proportion of implants does migration
      continue to increase during the two year follow-up? 4. Are inducible displacements, measured
      at weight-bearing follow-ups, consistent over time and do they indicate that adequate
      fixation has been achieved? 5. Are there changes over time in bone mineral density of
      peri-prosthetic bone in the PA coated Triathlon total knee arthroplasty? 6: Where do changes
      in bone mineral density occur? 7: Is there a significant difference in health status and
      functional outcome before and after total knee arthroplasty using PA coated Triathlon total
      knee arthroplasty components? 8: Are there changes in gait symmetry and centre of mass (COM)
      displacements as assessed with the Walkabout Portable Gait Monitor pre- and post-operatively
      and how does study gait data compare to asymptomatic gait? and finally, Question 9: Are there
      differences in the micromotion patterns between the when compared to other samples of knee
      implants in our RSA database?
    


Intervention name(s): Triathlon Periapatite (PA)-coated Tibial Component
Intervention type(s): Device
Intervention description(s): Triathlon Periapatite (PA)-coated Total Knee Arthroplasty Tibial Component for uncemented fixation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee; arthroplasty; RSA; migration; micromotion; osteoarthritis
Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects
Condition: Drug Use
Study type: Interventional

Summary: 
      The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet
      Manufactured by PT. Harsen Laboratories was bioequivalent to the reference product, 3 mg
      Amaryl® Tablet Manufactured by PT. Aventis Indonesia Pharma, Indonesia.
    

Detailed description: 
      The study was conducted following an oral administration of one tablet of the test drug (3 mg
      Glimepiride Tablet) or one tablet of the reference drug (3 mg Amaryl® Tablet ). Blood samples
      were drawn before dosing (0 h) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5,
      6, 9, 12, 18, 24, and 30 hours after drug administration. The entire subjects were given 60
      mL of 20% glucose solution to minimize hypoglycemic effects at 15, 30, 45 minutes, and 1,
      1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 and 4 hours after drug
      administration. Following a washout period of one week, this procedure was repeated using the
      alternate drug. The plasma concentrations of glimepiride were determined by means of LC-MS/MS
      system. The LLOQ is 1.99 ng/mL of glimepiride. The pharmacokinetic parameters used in this
      study were area under the concentration-time curve of glimepiride from time zero to 30 hours
      (AUCt), area under the concentration-time curve from time zero to infinite (AUCinf), maximum
      concentration (Cmax), time required to reach the maximum concentration (tmax) and the
      elimination half life (t½).
    

Intervention name(s): Glimepiride; Amaryl®
Intervention type(s): Drug; Drug
Intervention description(s): Glimepiride is a sulfonylurea, indicated as an adjunct to proper dietary management, exercise and weight reduction to lower the blood glucose in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone.; Amaryl®
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single blind, two-period, single dose, cross-over study with one week washout period under fasted condition
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Bioequivalence study; Glimepiride; Indonesia; cross-over design study; pharmacokinetics
Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients
Condition: Fontan Physiology
Study type: Interventional
Phase: Phase 1

Summary: 
      The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers
      (ventricles) to allow blood flow within two distinct circuits: "pulmonary" and "systemic".
      The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic
      circuit delivers oxygen-rich blood throughout the body. In children born with a single
      ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen
      levels in the blood delivered to the body (cyanosis).

      The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to
      deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made
      connection (whereby two large body veins [cavae] are sewn to the pulmonary arteries), thereby
      preventing mixing of blood through restoration of two distinct circuits without mixing of
      blood. Although the Fontan operation effectively eliminates cyanosis and enables survival
      into adulthood, increased systemic venous pressure is an unavoidable systemic complication
      and low cardiac output (CO) is pervasive finding.

      Despite excellent pediatric surgical results, the risk of late complications and death
      dramatically increases in the decades following Fontan surgery. A chronically low CO state
      secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction
      and shortened life expectancy. Short of heart transplantation, deemed suitable only for a
      minority of patients, effective therapies for low CO are largely absent. The investigators
      aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO.
      Specifically, external suction is applied intermittently to the chest wall, much like a
      vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass®
      ventilator (Hayek Medical). Although used in patients with lung disease, the investigators'
      proposal is to evaluate this novel, portable, ventilation system would be the first study of
      its kind in adults with congenital heart disease, specifically those with a Fontan
      palliation.
    


Intervention name(s): Hayek RTX ventilator
Intervention type(s): Device
Intervention description(s): Negative pressure ventilation in Fontan patients.
Other intervention name(s): Cuirass; Negative pressure ventilation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a cross-sectional study designed to evaluate the immediate impact of negative pressure ventilation (NPV) in an ambulatory Fontan population using cardiovascular magnetic resonance imaging (CMR) for assessment of cardiovascular flows.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fontan operation; Negative pressure ventilation; MRI