bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Evaluate The Safety,Tolerability, PK and PD Of DA-1241 In Healthy Male Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double blind, placebo controlled, single ascending dose study to assess
      the safety, tolerability, PK, PD and IE with metformin following a single oral dose of
      DA-1241 in healthy male subjects.
    


Intervention name(s): Placebo; Metformin; DA-1241
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period.; Subjects in the IE cohort will receive 500 mg metformin (IR formulation) at 12 hours on Day 1 and a single oral dose of the IMP with 500 mg metformin (IR formulation) after an overnight fast on Day 1, in Treatment Period 2.; After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period .
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
Condition: Hypertension; Hyperlipidemias
MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy
      and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with
      concomitant hypertension and hyperlipidemia
    


Intervention name(s): Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg; Olmesartan 40 mg, Rosuvastatin 20mg; Amlodipine/Olmesartan 10/40mg (Combination drug)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg; co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).; co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg
Intervention MeSH terms: Amlodipine; Olmesartan; Olmesartan Medoxomil; Amlodipine Besylate, Olmesartan Medoxomil Drug Combination; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Biotin Status in Pregnancy
Condition: Biotin Deficiency
MeSH terms: Biotinidase Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to estimate the number of pregnant women who, during pregnancy,
      have low levels of the vitamin biotin. The hypothesis of this study is that a large number of
      pregnant women will have low biotin levels. This information will be used to later determine
      if low biotin levels during pregnancy cause certain birth defects.
    


Intervention name(s): biotin; biotin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsule approximately 30 mcg daily 21 days; capsule 300 mcg daily 21 days
Intervention MeSH terms: Biotin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: biotin; deficiency; pregnancy; lymphocyte propionyl-CoA carboxylase
A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder, Healthy Volunteer
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the safety, tolerability, and pharmacokinetics of basimglurant compared
      to placebo after multiple ascending oral doses for up to 22 days in healthy subjects and in
      patients with MDD on stable selective serotonin reuptake inhibitor (SSRI) or
      serotonin-norepinephrine reuptake inhibitor (SNRI) background therapy.
    


Intervention name(s): Basimglurant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive once-daily oral basimglurant capsules in a multiple ascending dose regimen. Basimglurant dose will be titrated over 22 days; dose escalations will be separated by at least 4 days, with the final dose administered for a minimum of 14 days. The minimum starting dose will be 1.5 mg, which can be titrated up to a maximum dose of 4.0 mg. Intrapatient dose increments will not exceed 1.0 mg every 4 days.; Participants will receive 22 days of once-daily oral matching placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose
      concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal
      denervation) or in subjects after renal sympathectomy (63) can add insight about the possible
      role of a neural arc which mediates the changes in plasma glucagon and/or insulin
      concentration in response to glucosuria.
    

Detailed description: 
      Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose
      concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal
      denervation) or in subjects after renal sympathectomy (63) can add insight about the possible
      role of a neural arc which mediates the changes in plasma glucagon and/or insulin
      concentration in response to glucosuria.

      Research Design/Plan: After screening, eligible subjects will receive 2 measurements of
      endogenous glucose production with a prime-continuous infusion of 3-3H-glucose. Each
      measurement will be performed on a separate day in random order after a 10-12 hour overnight
      fast and will last 8 hours (from 6 AM to 2 PM). After a 3-hour tracer equilibration period,
      each subject will receive one of the following medications in random order: (i) placebo and
      (ii) dapagliflozin 10 mg. Following the test medication at 9 AM, blood samples will be drawn
      every 20 minutes for an additional 5 hours and plasma glucose, insulin, C-peptide, glucagon,
      catecholamine concentrations and tritiated glucose sp act will be measured.

      Methods: Visit 1: Screening Visit 2: Endogenous Glucose Production Measurement (EGP) Visit 3:
      After completing the first EGP measurement, subjects will return to the Diabetes Research
      Unit for the second study.
    

Intervention name(s): Dapagliflozin 10mg then Placebo Oral Tablet; Placebo Oral Tablet then Dapagliflozin 10mg
Intervention type(s): Drug; Drug
Intervention description(s): SGLT2 inhibitor - Dapagliflozin then Placebo; Placebo then SGLT2 inhibitor - Dapagliflozin
Other intervention name(s): Farxiga then placebo; Placebo then Farxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Post renal transplant type 2 diabetes mellitus patients and non-diabetic mellitus patients after renal transplant with a control group of type 2 diabetes mellitus who have not undergone renal transplant
Masking: None (Open Label)
Primary purpose: Basic Science
Optimum Time for Intravenous Cannulation After Induction With Sevoflurane in Pediatric Patient
Condition: Movement After Intravenous Cannulation
Study type: Interventional

Summary: 
      This study aimed to determinate effective dose 95 (ED95) intravenous cannulation in pediatric
      patient after induction of sevoflurane 8 vol%
    

Detailed description: 
      Twenty-two subjects were given informed consent before study enrolled. Anesthesia was induced
      by 8% sevoflurane with 6 L flow of 100% oxygen. IV cannulation was attempted at 2 min in the
      first child in each group. The time for cannulation in the next child was stepped up or down
      by 15 s depending on positive or negative response, respectively, in the previous child.
      Children were recruited till a minimum of six pairs of failure-success sequence which was
      obtained in the group. The mean of midpoints of the failure-success sequence was calculated
      to obtain the time for cannulation in 50% of the group.
    

Intervention name(s): IV cannula
Intervention type(s): Device
Intervention description(s): We measure the time duration needed for IV cannulation
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child, general anesthesia, induction of anesthesia, sevoflurane, venous cannulation
Ecological Momentary Determinants of Sedentary Behavior
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      A two phase trial to understand the personal, behavioral, environmental, and contextual
      factors that underpin sedentary behavior and to systematically test a series of contextual
      prompt characteristics that may lead to subsequent change in sedentary behavior.
    

Detailed description: 
      Phase 1: This is an observational study that will utilized Ecological Momentary Assessment,
      to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching
      TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of
      the day, and weather) and contextual factors were associated with sedentary behavior. Three
      EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for
      four consecutive weeks (total of 20 days). During these days, participants will also wear an
      activPAL device to objectively measure sedentary behavior. The purpose of the study is to
      identify the combination of factors most likely to precede and proceed short (<30 min) and
      long (≥30 min) bouts of sedentary behavior.

      Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based
      prompt to elicit a proximal effect (e.g., a postural response defined as a transition from
      seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting)
      compared to a no prompt condition. A secondary aim of this study is to determine whether
      prompts that encourage standing are more likely to elicit a response than those that
      encourage moving. An exploratory aim is to examine whether varying the content of the stand
      or move prompt to include combinations of short term goals and employer approval, influence
      the magnitude of response.
    

Intervention name(s): Prompt sent
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: PART B: A three-factor design with two-levels yielded eight experimental conditions, half of which encouraged standing more (stand; n prompt types = 80, n total prompts =800) and the other half encouraged moving more (move; n prompt types = 80, n total prompts =800).
Masking: None (Open Label)
Primary purpose: Prevention
Symbicort SMART Satisfaction From Patient Perspective 2009
Condition: Asthma
Study type: Observational

Summary: 
      To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma
      sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in
      Malaysia.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Control; Satisfaction
Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation
Condition: Cardiopulmonary Resuscitations
Study type: Interventional

Summary: 
      Whether teaching leadership with a short debriefing has a positive influence on the
      performance of cardiopulmonary resuscitation remains largely unknown. The investigators will
      assess the sustained efficacy of a short leadership debriefing compared to a technical
      debriefing in a high fidelity simulated cardiopulmonary resuscitation.
    

Detailed description: 
      Context:

      Whether the performance of cardiopulmonary resuscitation can be positively influenced by
      teaching leadership with a short debriefing remains largely unknown

      Objective:

      To test the hypothesis that (1) leadership instruction are effective and (2) improved
      leadership results in better performance in a high fidelity simulated cardiopulmonary
      resuscitation.

      Design:

      Prospective, randomized-controlled superiority trial

      Setting:

      Simulator Center of the University Hospital Basel in Switzerland

      Patients or Other Participants:

      237 volunteer medical students in teams of 3

      Intervention:

      During a baseline visit, the medical students participate in a video-taped simulated
      witnessed cardiac arrest. Participants are randomized to receive thereafter a short
      video-assisted debriefing focusing either on correct positions of arms and shoulders
      (technical debriefing) or on leadership and communication to enhance team coordination
      (leadership debriefing). A follow-up simulation is conducted after 4 months. Leadership
      utterances, technical skills and the resuscitation performance of the teams are compared
      based on videotapes coded by two independent researchers.

      Main Outcome Measures:

      The primary outcomes for this study are the amount of hands-on time in the first 180 seconds
      after the onset of the cardiac arrest and the time elapsed until cardiopulmonary
      resuscitation was started. Secondary endpoints are the effectiveness of the technical and
      leadership instructions, respectively.
    

Intervention name(s): instruction
Intervention type(s): Other
Intervention description(s): Debriefing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Leadership; Team building; Resuscitation
DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

      PURPOSE: This laboratory study is looking at tissue samples from patients with T-cell acute
      lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Identify the transcriptional signatures associated with the presence of NOTCH1 mutations
           in primary T-cell acute lymphoblastic leukemia (T-ALL) cells using oligonucleotide
           microarrays.

        -  Characterize the global changes on gene expression resulting from the inactivation of
           NOTCH signaling in human T-ALL lymphoblasts.

      OUTLINE: This is a multicenter study.

      Frozen lymphoblast samples from patients with T-cell acute lymphoblastic leukemia
      (NOTCH1-mutated and wild type) are assessed for genetic expression profiles and mutations by
      microarray analysis and activated NOTCH1 protein by western blot analysis.

      PROJECTED ACCRUAL: A total of 48 samples from patients will be accrued for this study.
    

Intervention name(s): microarray analysis; mutation analysis; immunologic technique
Intervention type(s): Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E2993
      
Biospecimen description: 
      bone marrow and blood nucleic acids and cells.
    
Keywords: T-cell adult acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; untreated childhood acute lymphoblastic leukemia; recurrent adult acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; adult acute lymphoblastic leukemia in remission; childhood acute lymphoblastic leukemia in remission
To Study the Effects of Co-ingesting Different Forms of Almond, Almond Paste, Fibre, and Almond Phytochemicals With Bread on Postprandial Glucose and Insulin Profiles
Condition: Cardiovascular Diseases; Metabolic Disease
MeSH terms: Cardiovascular Diseases; Metabolic Diseases
Study type: Interventional

Summary: 
      Food is emerging as the new medicine. There has been growing evidence of the beneficial
      effects of foods, including nuts on human health. Modulation of both glucose and insulin are
      at the heart of reducing the risk of cardiovascular and other metabolic diseases. The
      contribution that nuts have on human health has been studied extensively and it is well
      established that the consumption of nuts revealed improvements in both blood glucose profile
      and reduced the risk of coronary heart diseases. Nuts, such as almonds, are nutrient-dense
      foods that are particularly rich in a-tocopherol. They are excellent sources of protein (~25%
      of energy) and fibre, low in saturated fatty acid content (4-6%) and high in monounsaturated
      fatty acids. They also contain significant amounts of essential micronutrients such as folate
      (B vitamin) and polyphenols. Recently, strong interests on the health effects of nuts
      improving metabolic syndrome and controlling diabetes has been reported. Preliminary studies
      have indicated that the inclusion of nuts in the diets of individuals with diabetes and/or
      metabolic syndrome may improve postprandial glycaemic response, and lipid metabolism in the
      long run.
    


Intervention name(s): Glucose control; Bread control; Almond paste; Almond paste and inulin; Low dose almond paste and inulin
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 50 g glucose dissolved in 250 mL water; 91.4 g white bread; 88.7 g white bread and 15 g almond paste; 88.7 g white bread, 15 g almond paste and 4 g inulin; 89.6 g white bread, 10 g almond paste and 3.8 g inulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Nuts
Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether electrical stimulation is effective in the
      expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.
    

Detailed description: 
      30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were
      randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES
      group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions).
      Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first
      and last treatment sessions before and after intervention. Wound surface area (WSA) was
      measured at 1st, 6th, and 12th session.
    

Intervention name(s): Electrical Stimulation; Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): Direct current with sensory intensity for one hour; Direct current with zero intensity for one hour
Other intervention name(s): Direct current ES; Placebo Direct current ES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess the effect of a two-week pre-surgery treatment
      with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid)
      methyltransferase (MGMT) activity in patients with gliomas.
    


Intervention name(s): temozolomide
Intervention type(s): Drug
Intervention description(s): Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also be given at the same dose for up to 28 days after surgery, per investigator discretion.
Other intervention name(s): SCH 052365
Intervention MeSH terms: Temozolomide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Consuming a Plant-based Enriched Meal on the Adult Gut Microbiome
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut
      microbiome and its composition.
    


Intervention name(s): oat based porridge; plant based preparation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consume one preparation per day, orally; Consume one preparation per day, orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      CALAVI US will investigate the safety, efficacy and pharmacokinetics of acalabrutinib
      together with Best Supportive Care in the treatment of COVID-19.
    


Intervention name(s): Acalabrutinib
Intervention type(s): Drug
Intervention description(s): Acalabrutinib administered orally
Intervention MeSH terms: Acalabrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study will consist of two arms Arm 1 is acalabrutinib + best supportive care or Arm 2 is best supportive care alone
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 2019 novel coronavirus disease; Acalabrutinib; Btk inhibitor