bioihbjkbjnl/mcl2 huggingface dataset:
Cangrelor Ticagrelor Transition Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate that patients treated with cangrelor can be directly switched to oral
      ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a
      significant decrease in the extent of inhibition of platelet aggregation.
    


Intervention name(s): cangrelor; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.; Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion
Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.
Other intervention name(s): Brilinta
Intervention MeSH terms: Ticagrelor; Cangrelor
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
PCO2 ELSO (Extracorporeal Life Support Organization)
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      Investigation of the association between PaCO2 change after extra corporeal membrane
      oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by
      ECMO for respiratory failure.
    

Detailed description: 
      Retrospective analysis of the ELSO database investigating the association between the change
      of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by
      the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure
      and/or brain death.
    

Intervention name(s): ECMO for neonates
Intervention type(s): Other
Intervention description(s): Neonates (<28 j) supported by ECMO for severe respiratory failure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates (<28 j) supported by ECMO for severe respiratory failure
      
Keywords: Ecmo; Neonates
Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians
Condition: Rheumatoid Purpura
MeSH terms: IgA Vasculitis; Purpura; Emergencies
Study type: Observational

Summary: 
      The main objective of this study is to describe the management of children with rheumatoid
      purpura from admission to the pediatric emergency room to follow-up by primary care
      physicians after hospital discharge.
    

Detailed description: 
      Secondary objectives The secondary objective is to assess general practitioners current
      knowledge and practice of the condition and potential barriers to monitoring and follow-up by
      general practitioners.

      Conduct of research Children diagnosed with rheumatoid purpura within the past 2 years at the
      3 participating sites will be included in the study if parental authority holders do not
      object.

      Patients will be identified through the Medical Information Department of each hospital.

      Parents will be contacted - first by mail, then by phone - to request permission to collect
      the child's medical data from medical records, and to retrieve information on the
      surveillance and follow-up of the disease by general practitioners up to two years after
      diagnosis.
    

Intervention name(s): Management of rheumatoid purpura
Intervention type(s): Other
Intervention description(s): Collection of data on the management in pediatric emergency departments (method of diagnosis, complementary examinations, proposed treatment, number of hospitalizations, follow-up after hospital discharge).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be identified by the Medical Information Department of each site. The study
        will be conducted on patients who have been managed for rheumatoid purpura within the last
        two years at one of the three participating centers.
Radiofrequency Ablation in Treating Patients With Bone Metastases
Condition: Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.

      PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing
      pain in patients who have bone metastases.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the side effects of radiofrequency ablation in patients with bone metastases.

        -  Determine the effect of this regimen on pain in these patients.

        -  Determine the effect of this regimen on mood in these patients.

        -  Determine the effects of narcotic usage in patients treated with this regimen.

        -  Determine the relationship between laboratory and imaging features of this treatment and
           the effects of the treatment in these patients.

      OUTLINE: This is a multicenter study.

      Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic
      lesion over approximately 12 minutes.

      Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3
      months after treatment.

      Patients are followed at 1 week and then at 1 and 3 months.

      PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5
      months.
    

Intervention name(s): pain therapy; radiofrequency ablation
Intervention type(s): Procedure; Procedure
Other intervention name(s): RFA
Intervention model: Single Group Assignment
Intervention model description: The outcomes of the study will be adverse event analysis and pain relief.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone metastases; pain; unspecified adult solid tumor, protocol specific
Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
Condition: RSV
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the
      safety, tolerability, and immunogenicity of 3 lots of RSVpreF in healthy adults.
    

Detailed description: 
      This randomized, double-blinded, placebo-controlled Phase 3 study will examine the immune
      response and the safety and tolerability profiles across 3 manufactured lots of RSVpreF when
      administered as a single 120 µg dose to healthy adults to demonstrate lot equivalence in
      manufacturing of RSVpreF.
    

Intervention name(s): RSVpreF (Group 1); RSVpreF (Group 2); RSVpreF (Group 3); Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): RSV vaccine (RSVpreF); RSV vaccine (RSVpreF); RSV vaccine (RSVpreF); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: RSV; Vaccine
A Phase 1 Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA Levels in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to verify whether a significant decrease in glucose levels can be
      achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels
      and a placebo will be evaluated in a three period crossover study with two active doses and
      one placebo dose per subject, in order to determine whether there is a dose that produces
      glucose lowering in the target population. In addition, this study will investigate the
      optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by
      comparing once a day versus twice a day regimens.
    

Detailed description: 
      This is a multi-center study that will enroll approximately 36 subjects. The study consists
      of three periods of two days of dosing each. The study will evaluate 5 potential dose
      regimens. Each subject will receive a randomized sequence of treatments over three periods,
      with placebo treatment in one period and two different active dose regimens in the other two
      periods. There will be 5 to 12 days of outpatient washout between treatment periods. Subjects
      will continue their current treatment on metformin throughout the study. Subjects will
      monitor blood glucose levels daily via glucometer during oupatient washout periods. A
      follow-up visit will occur between 5 and 10 days after the last period of the study.
    

Intervention name(s): GSK256073; GSK256073; GSK256073; GSK256073; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 5mg in the AM and 5mg in the PM; 10mg in the AM; 50mg in the AM; 25mg in the AM and 25mg in the PM; 2 placebo tablets in the AM and 2 placebo tablets in the PM
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: T2DM; Pharmacodynamics; GSK256073
Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment
Condition: Type 2 Diabetes Mellitus; Dyslipidemia
MeSH terms: Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The structural and functional alterations of high density lipoproteins (HDL) levels in type 2
      diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance,
      inflammation and oxidation, play a major role in the increased macrovascular risk in these
      patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL
      concentrations.

      Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by
      ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship
      between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of
      arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in
      Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the
      impact of HDL increasing drugs on HDL qualitative changes.
    

Detailed description: 
      Groups of subjects: a) Diabetic patients with low HDL; b) Non-diabetic patients with low HDL;
      c) Diabetic patients with normal HDL levels; and d) Non-diabetic patients with normal HDL
      levels. The studies will be performed after washing out lipid lowering drugs. Intima media
      thickness (IMT) will be performed in all groups. Main biochemical techniques will be
      centralised. Isolation and characterisation of HDL subclasses and remnant HDL, as well as a
      determination and preβ1 HDL will be performed. HDL studies examining HDL proteomic and
      metabolomic profiles will be performed. Functional studies will determine the effects on the
      endothelium, inflammation, cholesterol efflux and oxidation according the qualitative
      changes. These HDL measurements will be repeated in group (a), after they are treated with
      fibrates or Niacin. HDL metabolism in adipocytes will be extensively studied, and the
      clinical associations between HDL alterations and plasma AT-derived molecules will be
      examined.
    

Intervention name(s): Fenofibrate; Niacin plus laropiprant
Intervention type(s): Drug; Drug
Intervention description(s): fenofibrate 145/day for 12 weeks; Niacin 2 g/day plus Laropiprant for 12 weeks
Other intervention name(s): Secalip; Tredaptive
Intervention MeSH terms: Niacin; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HDL; Niacin; Fenofibrate; Diabetes; Metabolomics
Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin/Pioglitazone Compared With Single Linagliptin and Pioglitazone Tablets Administered Together to Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Determination of the relative bioavailability of 2 different formulations of a 5 mg
      linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5
      and formulation C8, compared with the mono-components linagliptin and pioglitazone
      administered together
    


Intervention name(s): Linagliptin/pioglitazone, FDC formulation C5; Linagliptin/pioglitazone, FDC formulation C8; Linagliptin tablet; pioglitazone tablet (Actos®)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): film coated tablet (5 mg/45 mg); film coated tablet (5 mg/45 mg); 5 mg; 45 mg
Intervention MeSH terms: Pioglitazone; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life
Condition: Aged
Study type: Interventional

Summary: 
      This study evaluates the determinants of mobility, measured by the 6-minute walk test, and
      its correlation with quality of life in near elderly patients.
    

Detailed description: 
      To evaluate the determinants of mobility an its correlation with quality of life, we
      conducted a study that evaluated patients ability to perform the 6-minute walk test and their
      corresponding quality of life measured by the EQ-5D. Cognition was evaluated used the
      Callahan six-item screener, and additional measures of physical performance were assessed
      using the Short Physical Performance Battery. Participants disclosed self reported physical
      function and physical activity. Additionally, other participant characteristics including
      vital signs, medication history and healthcare utilization were determined as well as social,
      economic and health related information was collected.
    

Intervention name(s): 6 Minute Walk Test; EQ-5D Survey; Short Physical Performance Battery
Intervention type(s): Other; Other; Other
Intervention description(s): The 6 minute walk test measures the distance walked in 6 minutes without sitting and without the use of a walker or the help of another person (a cane may be used). The walk was conducted in a wide hallway, specifically designed for this type of assessment, with a defined 20-meter course. The subject walked back and forth in the hallway for six minutes and the distance covered was recorded.; The EQ-5D is a self-reported questionnaire that describes a respondent's health using a descriptive system comprised of five items, each representing a different health dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity.; The SPPB is a brief performance battery based on timed short distance walk, repeated chair stands and balance test administered by trained examiners. The measurement goal for this battery is to assess lower extremity functional limitations, which indicate functional abilities and are a strong measure of risk for future disability.
Other intervention name(s): SPPB
Intervention model: Single Group Assignment
Intervention model description: All subjects enrolled in our trial performed the 6-minute walk test and completed an EQ-5D quality of life questionnaire.
Masking: None (Open Label)
Primary purpose: Other
Observational Study of Preoperative Screen for Substance Abuse
Condition: Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency Operation
MeSH terms: Emergencies; Substance-Related Disorders
Study type: Observational

Summary: 
      Substance abuse is a growing problem world wide, and treatment of substance abusers in the
      perioperative period, especially for emergency operation is challenging. The objectives of
      this study are to determine the proportions of substance abusers in the trauma patients
      undergoing emergency operation by preoperative screen, observe the differences of consumption
      of anesthetics and other medications during perioperative period between substance abusers
      and non-abusers, as well as postoperative complications, and explore an optimal scheme for
      substance abusers.
    


Intervention name(s): Substance use
Intervention type(s): Drug
Intervention description(s): Patients are found use of substances by preoperative screen
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The trauma patients undergoing emergency operation
      
Keywords: Substance abuse; Emergency operation; Preoperative screen
Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function Healthy Men
Condition: Healthy Men
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis was that an increase in serum lycopene levels following supplementation with
      capsules containing natural lycopene rich tomato extract would reduce oxidative stress and
      improve endothelial function in healthy men with low intake of fruits and vegetables. A
      randomized double-blind, placebo-controlled study was designed to assess the changes in serum
      lycopene levels, oxidative stress and endothelial function in response to an 8-week treatment
      with lycopene supplementation.
    

Detailed description: 
      The healthy men aged 20-60 years, who frequently smoked cigarettes or consumed alcohol, were
      enrolled in this study. Subjects were excluded if they consumed more than 3 servings/day of
      vegetables and fruit, or more than one serving/week of lycopene-rich foods; took antioxidant,
      vitamin, or mineral supplements; had any history of chronic disease; or were taking
      lipid-lowering or antihypertensive medications.The subjects were randomly assigned to receive
      placebo, 6mg, or 15mg lycopene capsule per day for 8 weeks. Study substances were suspended
      in soybean oil and given in acid-soluble gelatin capsules. A placebo containing soybean oil
      (100%) was supplied in identical-looking capsules. All the subjects were instructed to
      consume one capsule per day right after any meal of their choice. All participants were
      encouraged to maintain their usual lifestyle and dietary habits.
    

Intervention name(s): lycopene
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Piedmont Aging, Cognition & Exercise Study-2
Condition: Mild Cognitive Impairment; Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this research study is to examine the effects of high and low intensity
      exercise for those with mild memory loss and pre-diabetes. The investigators will also
      examine the effects of this exercise on certain proteins and hormones in body fluids, and on
      brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate
      that exercise improves memory and thinking abilities for adults with mild memory loss OR
      pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND
      pre-diabetes.
    


Intervention name(s): Exercise/Aerobic; Exercise/Stretching
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mild Cognitive Impairment; Cognitive disorders; Prediabetes; Exercise
Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.
Condition: Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Comparing the reproductive outcomes of different sperm selection techniques; Density gradient
      centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic
      activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.
    


Intervention name(s): Density Gradient Centrifugation; Physiological ICSI; Magnetic activated cell sorting; Testicular sperm
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Semen processing is done by double layer density gradient method.; Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head; Sperm selection by using Annexin V micro-beads and separation columns; Using testicular sperm retrieved by TESA or TESE
Other intervention name(s): DGC; PICSI; MACS; Testi
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sperm DNA fragmentation; PICSI; MACS; Sperm Selection; DGC