bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components
Condition: Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin and
      Sitagliptin, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual
      tablets in Healthy Subject
    

Detailed description: 
      This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, crossover
      study in healthy subjects (males and females), performed at a single study center. The study
      will assess the bioequivalence between a dapagliflozin/sitagliptin FDC tablet (test
      formulation) and a free combination of dapagliflozin 10 mg + sitagliptin 100 mg
      co-administered as individual tablets (reference formulation) in fasted conditions to healthy
      subjects. The study will also assess the Pharmacokinetics (PK) and safety and tolerability of
      dapagliflozin 10 mg and sitagliptin 100 mg when co-administered as individual tablets and as
      an FDC tablet.

      The study will comprise:

        -  A Screening Period of maximum 28 days.

        -  Two Treatment Periods (Treatment A or B)

        -  A final Safety Follow-up Visit 7 to 14 days after the last dosing with the
           Investigational medicinal product (IMP) (Treatment A or B).

      There will be a minimum washout period of 7 days and a maximum of 14 days between each
      treatment period.

      All subjects will receive a single dose of the following treatments after an overnight fast
      of 10 hours:

        -  Treatment A: 1 × dapagliflozin/sitagliptin FDC tablet (test formulation).

        -  Treatment B: 1 × dapagliflozin 10 mg tablet + 1 × sitagliptin 100 mg tablet
           co-administered as individual tablets (reference formulation).

      Subjects will be randomized to one of 2 treatment sequences: Treatment A followed by
      Treatment B or Treatment B followed by Treatment A.
    

Intervention name(s): Dapagliflozin/sitagliptin FDC; Sitagliptin; Dapagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive single dose of Dapagliflozin/sitagliptin FDC orally.; Subjects will receive 100 mg single dose of Sitagliptin orally.; Subjects will receive 10 mg single dose of Dapagliflozin orally.
Other intervention name(s): JANUVIA™; FORXIGA™
Intervention MeSH terms: Sitagliptin Phosphate; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sodium-glucose co-transporter-2 (SGLT2) inhibitor; Dipeptidyl peptidase 4 (DPP4) inhibitor; fixed dose combination (FDC)
Continuous Glucose Monitors for Children With Diabetes Mellitus
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Good control of blood glucose levels is important in preventing complications from diabetes.
      This study assessed the accuracy and reliability of two FDA-approved continuous glucose
      monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer
      (GW2B), in children with type 1 diabetes mellitus (T1DM).
    

Detailed description: 
      Intensive control of blood glucose levels has been shown to substantially prevent or delay
      complications of T1DM in adolescents and adults. The major limitation to implementation of
      intensive glycemic control is hypoglycemia. Younger children may be at increased risk for
      hypoglycemia and the risk/benefit ratio of intensive glycemic control may be less favorable
      in this population. Intensive therapy has not been systematically evaluated in children less
      than 13 years of age. This study was conducted by the Diabetes Research in Children Network
      (DirecNet) to assess the accuracy of the CGMS and the GW2B glucose monitors in comparison
      with standard blood glucose measurements in an inpatient setting.

      During 24-hour clinical research center stays at five clinical centers, approximately 90
      children and adolescents with T1DM (1 to 17 years of age) wore two FDA-approved continuous
      glucose monitors, CGMS and GW2B, and had frequent serum glucose determinations during the day
      and night. To assess glucose monitor function during periods of rising and falling blood
      glucose, insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also
      performed.
    

Intervention name(s): The GlucoWatch® G2™ Biographer (GW2B); The Continuous Glucose Monitoring System (CGMS™)
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Insulin-Dependent; Type 1 Diabetes; Diabetes in Children; Continuous Glucose Monitoring Devices
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
Condition: Focus of Study is on Healthy Lactating Women
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical lactation study is to provide information regarding the PK and amount of
      OLZ/SAM in breast milk and estimated infant exposure.
    


Intervention name(s): LYBALVI
Intervention type(s): Drug
Intervention description(s): 5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder
Other intervention name(s): Olanzapine/samidorphan (OLZ/SAM); ALKS 3831
Intervention MeSH terms: Olanzapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Samidorphan; Healthy Lactating Women; LYBALVI; ALKS 3831; Breast milk
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
Condition: Chronic Kidney Disease; Cardiovascular Disease; Death
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this randomized clinical trial is to determine if lowering homocysteine levels
      in renal transplant recipients with a multivitamin will reduce the occurrence of
      cardiovascular disease outcomes.
    

Detailed description: 
      The hypothesis of the trial is as follows: Treatment with a high dose combination of folic
      acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic
      cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal
      arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular
      disease events) relative to treatment with an identical multivitamin containing no folic
      acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic,
      stable renal transplant recipients
    

Intervention name(s): High Dose Multivitamin; Low Dose Multivitamin
Intervention type(s): Drug; Device
Intervention description(s): Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg; Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
Other intervention name(s): multivitamin; multivitamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: homocysteine; multi-vitamin; cardiovascular disease; renal transplant recipients
Lifeflight: Fentanyl Versus Morphine
Condition: Pain Relief; Adverse Events
Study type: Interventional

Summary: 
      The study is exempt from informed consent by the MetroHealth Medical Center institutional
      review board (IRB), because two standards of care are used and there is no increased clinical
      risk to the patient due to the study. The researchers randomize either fentanyl or morphine
      to be given to trauma patients and record how their pain scale is treated along with
      observing for adverse events. They are looking to see if the hypothesized benefits of
      fentanyl (which is much more expensive than morphine) actually exist.
    

Detailed description: 
      Periodic reports are made to the IRB.
    

Intervention name(s): either fentanyl or morphine
Intervention type(s): Drug
Intervention description(s): either morphine 4mg IV or fentanyl 50mcg IV
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: helicopter; aeromedical; pain relief; analgesia; fentanyl; morphine; adverse events
Testing Tissue Sodium Stores in CAPD Patients-Aims 1 & 2
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      The investigators' overarching goal is to improve long-term outcomes for end stage renal
      disease (ESRD) patients. In this study we focus specifically on patients receiving peritoneal
      dialysis (PD). Volume regulation in PD patients is related to hypertension, heart failure,
      nutritional status, and survival. Salt (NaCl) is the body's ion transport target to normally
      regulate volume via the kidneys; however, in hemodialysis (HD) patients the dialyser or in PD
      patients the peritoneal membrane, must serve that purpose. Determining volume status in PD
      patients is not easy and monitoring sodium (Na+) is more difficult still. The investigators
      have developed a novel, noninvasive approach to this problem involving 23Na+ magnetic
      resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in mostly the skin. Our
      technique measures Na+ in skin and skeletal muscle. In this study, we propose to apply this
      novel technique to PD patients.

      Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls using
      Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency bioimpedance
      measurements and cross-sectional clinical data.

      Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are
      increased in PD patients with volume expansion and in those patients with high soluble
      vascular endothelial growth factor receptor-3 (sFlt-4) levels.

      Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal
      function in PD patients.

      Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was
      found to have no utility in predicting preservation of residual renal function in PD
      patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will
      fulfill that function and will be inversely, rather than directly, related.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients on PD and healthy controls
      
Biospecimen description: 
      blood and urine samples
    
Keywords: Na+ MRI; salt stores
Asthma Intervention Research (AIR) Trial
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the effectiveness and safety of the Alair System
      for the treatment of asthma.

      This will be a multicenter, randomized controlled study comparing the effects of treatment
      with the Alair System to standard drug therapy. One-hundred and ten subjects will be
      randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control
      Group (Medical management only).
    

Detailed description: 
      Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4
      countries (Canada, United Kingdom, Denmark, and Brazil).

      Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up
      evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit.
      In order to maximize the power of the study, Baseline and Follow-up testing was conducted in
      2 parts. In the first part subjects continued to take their asthma maintenance medications
      (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period.
      This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to
      abstain from LABA for the second part of the testing, and these results are designated as the
      "OFF-LABA" Phase.
    

Intervention name(s): Bronchial thermoplasty with the Alair System; Conventional therapy with ICS+LABA
Intervention type(s): Procedure; Drug
Intervention description(s): Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.; Conventional therapy with ICS+LABA.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Bronchial Thermoplasty; Airway Hyperresponsiveness
Timed Exercise Study
Condition: Circadian Timing - Exercise
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of timed exercise on human circadian
      rhythms. Subjects were randomized to 5 days of morning or evening treadmill exercise. A
      measure of internal circadian timing, or phase, was measured at baseline and following the
      exercise intervention. Change in circadian phase was compared between the morning and evening
      group.
    

Detailed description: 
      This study investigated the effect of morning versus evening exercise on internal circadian
      timing, or phase. Young, sedentary subjects were recruited for this study. Baseline measures
      included anthropometric, body composition, cardiorespiratory fitness, chronotype, and
      circadian phase. Subjects were randomized to 5 consecutive days of morning or evening
      exercise. Thirty minutes of exercise was performed at the designated time and intensity was
      maintained at a heart rate corresponding with 70% peak VO2. The measure of circadian phase
      was salivary dim light melatonin onset, indicated by the time when saliva melatonin
      concentration exceeded 4pg/ml. Post-exercise circadian phase was measured the evening
      following the last day of exercise. Changes in circadian phase were compared between morning
      and evening groups.
    

Intervention name(s): Morning Exercise; Evening Exercise
Intervention type(s): Other; Other
Intervention description(s): moderate intensity exercise (70% VO2 max) each morning for 5 days; moderate intensity exercise (70% VO2 max) each evening for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: circadian; phase shift; exercise
Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses
Condition: Visual Disturbances and Blindness; Visual Acuity Reduced Transiently
MeSH terms: Blindness
Study type: Interventional

Summary: 
      This multicentre randomised controlled trial aimed to reduce the visual discomfort that
      patients implanted with trifocal diffractive intraocular lenses may experience after surgery.
      To this end, a visual training software (Optictrain) was developed in which Gabor patches
      were presented to the patient on a hand-held electronic device. Patients who met all
      inclusion criteria and consented to participate underwent half an hour of visual training per
      day for a period of 20 consecutive days remotely on a colourimetrically characterised Samsung
      Galaxy Tab A device on which the Optictrain software (n=30) or a placebo software (n=30),
      respectively, was pre-installed. Corrected and uncorrected near, intermediate and distance
      visual acuity (VA) and mesopic near and distance contrast sensitivity (CS) were measured
      monocularly and binocularly at two visits: during the first postoperative week (V0) and after
      20 days of visual training with the assigned software (V1). The statistical analysis of the
      results obtained in the study has not yet been carried out.
    


Intervention name(s): Implantation of trifocal diffractive intraocular lenses
Intervention type(s): Procedure
Intervention description(s): Postsurgical monocular and binocular assessment of corrected and uncorrected near, intermediate and distance visual acuity and near and distance mesopic contrast sensitivity before and after the assigned vision training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group vs control group
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In period I, the treatment effect of FK949E was compared with that of placebo in a blind
      manner in bipolar disorder patients with major depressive episodes. In period II, the
      long-term safety and efficacy of FK949E was evaluated.
    

Detailed description: 
      This study consisted of two parts. In Treatment Period I, FK949E or placebo was administered
      orally in a blind manner to bipolar disorder patients with major depressive episodes, with
      the aim of evaluating the superiority of FK949E over placebo and the dose response of two
      doses of FK949E based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) total
      score. In Treatment Period II, the long-term safety, efficacy and pharmacokinetics of
      open-label FK949E was evaluated in patients who completed Treatment Period I. An analysis was
      performed for data in Treatment Period I and another analysis was done for data in combined
      Treatment Periods I and II.
    

Intervention name(s): FK949E; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Taken by mouth (orally).; Taken by mouth (orally).
Other intervention name(s): quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FK949E; Major depressive episode; patients
Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on Human Skin
Condition: Healthy
Study type: Observational

Summary: 
      Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser
      Ablation on human skin
    

Detailed description: 
      The study is being conducted to evaluate the safety and efficacy of the UltraClear Mid IR
      Fiber Laser Workstation using both superficial epidermis ablation capabilities and the deep
      ablative and coagulative capabilities into the dermis. Epidermis is the skin most outer layer
      that is supported by the dermis, which is the thick layer of living tissue below the
      epidermis which forms the true skin, containing blood capillaries, nerve endings, sweat
      glands, hair follicles, and other structures. Superficial ablative properties of the laser
      are the ability to remove thin and controlled layer of epidermis without damaging the
      underlaying layers of the skin, while the deep ablative properties of the laser are the
      ability to create a controlled and consistent mechanical and thermal injury in the skin that
      will lead to strong healing process that will improve the skin properties such as softness,
      elasticity and appearance. Round ø4.0 mm ( ~ø 1/8") Biopsies will be taken to examine the
      histologic effects of the treatments.
    

Intervention name(s): UltraClear
Intervention type(s): Device
Intervention description(s): Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on human skin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal and healthy Subjects
Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
Condition: Upper Respiratory Tract Infection Bacterial
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Bacterial Infections
Study type: Interventional

Summary: 
      The aim of the study was to assess the efficacy and safety of AP203 preparation (RESCOVIN®)
      in a group of patients with increased incidence to viral and/or bacterial upper respiratory
      tract infections.
    

Detailed description: 
      Randomized, double-blind, cross over study conducted under medical supervision on 1) group of
      30 patients receiving AP203 mixture in capsule form and 2) group of 30 receiving placebo.
      After a washout period a group receiving placebo receiver AP203 mixture in syrup form.

      The study group was adult patients with an increased incidence of upper respiratory tract
      infection. During the study, the effect of a mixture of AP203 extracts (RESCOVIN®) on markers
      of inflammation and oxidative stress and the effect on the incidence of upper respiratory
      tract infections was assessed.
    

Intervention name(s): AP203 mixture (RESCOVIN®); AP203 mixture (RESCOVIN®); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Polyphenol-rich plant extracts Twice a day; Polyphenol-rich plant extracts Twice a day; Twice a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Upper Respiratory Tract Infections; Bacterial Infections; Viral Infections; RESCOVIN; Plant extract; Chokeberry extract; Echinacea extract
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in
      treating Post Traumatic Stress Disorder in Veterans.
    

Detailed description: 
      This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study
      designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy
      (MRT) in combat veterans with Posttraumatic Stress Disorder. A total of 2004 subjects will be
      treated in two phases: double-blind and open label.
    

Intervention name(s): Magnetic EEG/ECG-guided Resonance Therapy; Sham
Intervention type(s): Device; Device
Intervention description(s): A coil delivers a pulsed magnetic field to the cortex of the brain; Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
Other intervention name(s): Magnetic Resonant Therapy; Magnetic e-Resonance Therapy; MeRT; MRT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sham controlled
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: PTSD; TMS; EEG