bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)
      tablets of canagliflozin and metformin immediate release (IR) in comparison with the
      individual components of canagliflozin and metformin IR.
    

Detailed description: 
      This is an open-label (identity of study drug will be known to volunteer and study staff),
      single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when
      administered orally (by mouth) as individual components (ie, separate tablets of
      canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination
      (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment
      B). Healthy volunteers participating in the study will be randomly (by chance) assigned to
      receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a
      washout period of approximately 15 days between treatments.
    

Intervention name(s): A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets); B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 50/1000, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2; Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 50/1000, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Bioequivalence; Canagliflozin (JNJ-28431754); Metformin IR
Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood
Condition: Healthy
Study type: Interventional

Summary: 
      Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.

      The main objective is to identify one or two flour compositions in a carbohydrate-based food
      that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative
      absorption of exogenous glucose compared to the control.
    

Detailed description: 
      Twelve volunteers will participate in the study; each person will be studied on three
      different occasions at least one week apart, consuming the three different test products in a
      randomized order. Test products are carbohydrate-based food made from different flour mixes
      differing in their expected rate of intestinal starch digestion. The products are labeled
      with 13C starch.
    

Intervention name(s): Carbohydrate based food mix 1; Carbohydrate based food mix 2; Control carbohydrate based food
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Carbohydrate based food; Carbohydrate based food; Carbohydrate based food
Other intervention name(s): Slowly digestible carbohydrate; Slowly digestible carbohydrate; Rapidly digestible carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Flour,; carbohydrate,; digestibility; subjects
Brexpiprazole in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety and efficacy of brexpiprazole during long-term treatment.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
Condition: Complicated Skin and Structure Infection; Nosocomial Pneumonia
MeSH terms: Healthcare-Associated Pneumonia
Study type: Observational

Summary: 
      This is a retrospective, observational, non-interventional drug study using de-identified
      data from two administrative claims datasets. The study design and analysis will reflect the
      perspective of the commercially insured. The objectives of this study are twofold:

        1. To compare the rates of re-hospitalization among patients treated with either linezolid
           orally or IV, or vancomycin IV for complicated skin and skin structure infections
           (cSSSI) or pneumonia hospitalization.

        2. To compare the total direct medical costs of patients treated with linezolid orally or
           IV, or vancomycin IV for cSSSI or pneumonia hospitalization.
    

Detailed description: 
      A sampling method is not used in this study since it is a retrospective, non-interventional
      claims database analysis. Pre-specified inclusion/exclusion criteria and ICD-9, NDC, HCPC
      codes are applied to identify the study cohorts.
    

Intervention name(s): Linezolid; Vancomycin; Linezolid; Vancomycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).; IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).; IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).; IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).
Intervention MeSH terms: Vancomycin; Linezolid
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of patients with a hospitalization for complicated skin
        and skin structure infections (cSSSI) or pneumonia. We will identify cases from January 1,
        2007, to September 30, 2009, with additional 6 months pre-period and up to 6 months of
        post-index follow-up period.
A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects
Condition: Healthy Subjects; Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first time in human study to investigate the safety of GSK626616AC given as oral
      single and repeat doses in healthy subjects. An additional group of subjects will be assessed
      to determine the effect of several drugs given at the same time as GSK626616.
    


Intervention name(s): GSK626616, placebo, midazolam; omeprazole, caffeine, flurbiprofen, rosiglitazone
Intervention type(s): Drug; Drug
Other intervention name(s): omeprazole; caffeine; flurbiprofen; rosiglitazone; GSK626616; placebo; midazolam
Intervention MeSH terms: Rosiglitazone; Flurbiprofen; Midazolam; Caffeine; Omeprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: repeat dose,; GSK626616AC,; pharmacokinetic,; single dose,; cytochrome P450,; First time in human,; healthy volunteers
Effect of Vestibular Stimulation on Sleep in Elderly
Condition: Sleep
Study type: Interventional

Summary: 
      Vestibular stimulation might be beneficial for sleep. Previous research demonstrated that
      lateral rocking movements can facilitate the transition from wake to sleep during an
      afternoon nap. However, the relationship between rocking movements and sleep is poorly
      understood to date. Furthermore, studies looking at the effects of rocking on sleep have not
      yet been performed in an elderly population. Due to age related changes in sleep, people
      often experience a decrease in sleep efficiency and sleep quality later in life. Therefore,
      it is particularly this population that could benefit from a possible enhancement in sleep
      efficiency and sleep quality. In order to assess the effect of vestibular stimulation on
      sleep and sleep-dependant memory, measurements of two nights with stimulation will be
      compared to two baseline nights. The primary outcomes are changes in sleep onset, sleep
      architecture and power density spectra of the EEG due to vestibular stimulation. Secondary
      endpoints are sleep dependent changes in memory, the proximal-distal temperature gradient,
      cardiorespiratory variables and dream content.
    


Intervention name(s): Somnomat V4
Intervention type(s): Device
Intervention description(s): Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study has a two-by-two cross-over design. Participants spend two consecutive baseline nights (without stimulation) and two consecutive movement nights (with stimulation) in the laboratory. The order of baseline and movement nights is randomized.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
RCT of the Naturopathic Anti-Inflammatory Diet
Condition: Diabetes Mellitus, Type 2; Prediabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the naturopathic Anti-Inflammatory Diet results
      in reduced inflammation and a better response by the immune system when compared to a
      standard diabetic diet based on the current American Diabetes Association guidelines.
    

Detailed description: 
      This study will test the effects of two different diets on the immune system and inflammation
      in diabetes and pre-diabetes. These diets are the "Anti-Inflammatory Diet" (AI Diet) used by
      many naturopathic doctors and a standard diabetic diet based on the American Diabetes
      Association recommendations (ADA Diet). The AI diet excludes wheat, dairy products, eggs, red
      meat, caffeine, alcohol, peanuts and certain fruits and vegetables. The ADA diet includes
      most foods but controls the amount of each of the food groups.

      Naturopathic physicians often use healthful diets to treat diseases but many of these diets
      have not been compared to usual medical diet treatments. We will be looking at blood markers
      that show how the immune system responds to the different diets. We are expecting that the AI
      diet will result in less inflammation and a better response by the immune system than the ADA
      diet. We will also be looking at levels of blood lipids and glucose to see any effects on
      these risk factors.
    

Intervention name(s): Diet (Anti-Inflammatory or standard diabetic diet)
Intervention type(s): Behavioral
Intervention description(s): 6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Pre-Diabetes; Anti-Inflammatory Diet; Diet Study; Inflammation; Diabetic Diet
SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
Condition: Symptomatic Cervical Disc Disease
Study type: Interventional

Summary: 
      The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of
      the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease
      at one level between C3 and C7, compared to anterior cervical discectomy and fusion.

      The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy
      associated with the use of the SECURE-C Cervical Artificial Disc
    

Detailed description: 
      Ages Eligible for Study: 18 to 60 years

      Genders Eligible for Study: Both

      Accepts Healthy Volunteers: No
    

Intervention name(s): SECURE-C Cervical Artificial Disc; ASSURE Cervical plate and an allograft interbody spacer
Intervention type(s): Device; Device
Intervention description(s): Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc; Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Neck Pain; Arm Pain
Survey of Housestaff Attitudes Toward Patient Care and Safety
Condition: Safety Issues; Patient Care
Study type: Observational

Summary: 
      Background: The occurrence of medical errors and their deleterious effects on quality of care
      delivered are widely recognized phenomena in healthcare today. This has spurned an aggressive
      nationwide campaign to improve the quality of care all hospitals throughout the country.
      Currently, there are numerous reports of quality improvement initiatives across medical
      centers in the United States. However, a review of the literature failed to identify any
      publications regarding targeted resident/housestaff involvement in hospital quality
      improvement and safety related activities.

      Purpose: To investigate and track housestaff attitudes on patient care, patient safety,
      communication and overall quality within the institution.

      Objective: To investigate, analyze and publish the results of this prospective study. The
      information obtained will help us and others understand whether proactive attempts to change
      housestaff culture can indeed change attitudes towards the better with regards to patient
      care and safety. It is assumed that improved attitudes ultimately translates into improved
      care and safety.

      Methods: Each residency coordinator in each clinical department will be asked to distribute a
      survey, which has already been validated for this type of investigation, to each resident in
      the respective program (see attachment).

      The Vice-President of Medical Affairs will provide a cover letter to help with the process.
      After a week, a reminder will be distributed by the coordinators to each resident asking them
      to fill out the survey. The surveys will be filled out anonymously. However, each participant
      will be asked to note their sex, department and year of postgraduate training. This process
      will be repeated every eight months until June of 2010. The Housestaff Quality council (HQC)
      has already distributed and collected this survey. The results of those surveys will be used
      in a retrospective part of this study. The results of (HQC) survey will be used to establish
      a baseline of the housestaff attitudes at the New York Presbyterian Hospital-Weill Cornell.

      Data will be stored on a password protected computer. The Institutional Review Board (IRB),
      Office of Human Research Protection and Food and Drug Administration and all appropriate
      federal oversight agencies may have access to those files.
    

Detailed description: 
      Each residency coordinator in each clinical department will be asked to distribute a survey,
      which has already been validated for this type of investigation, to each resident in the
      respective program
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Housestaff
      
Keywords: Housestaff; Patient Safety; Patient Care; Focus of Study: To assess safety climate amongst housestaff
Safety and Efficacy of Dr. Tagliaferri's Menopause Formula
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary goal of this study is to evaluate the safety and efficacy of 12 weeks of
      treatment of 4 grams/day of Dr. Tagliaferri's Menopause Formula (administered as 2 grams PO
      BID) in reducing the frequency of menopausal vasomotor symptoms among healthy, postmenopausal
      women, aged 40-65, with moderate to severe hot flushes.
    


Intervention name(s): Dr. Tagliaferri's Menopause Formula
Intervention type(s): Dietary Supplement
Intervention description(s): Administered as 2 grams PO BID
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hot flashes, night sweats
Stem Cell Transplantation (SCT) for Genetic Diseases
Condition: Thrombocytopenia; Metachromatic Leukodystrophy; Fanconi's Anemia; Thalassemia Major; Pure Red-Cell Aplasia; Inborn Errors of Metabolism
MeSH terms: Leukodystrophy, Metachromatic; Fanconi Syndrome; Anemia; Thrombocytopenia; Thalassemia; beta-Thalassemia; Fanconi Anemia; Red-Cell Aplasia, Pure; Metabolism, Inborn Errors
Study type: Interventional

Summary: 
      OBJECTIVES: I. Ascertain whether stem cell transplantation (SCT) is an effective method by
      which missing or dysfunctional enzymes can be replaced in patients with various inborn errors
      of metabolism.

      II. Determine whether clinical manifestations of the specific disease may be arrested or
      reversed by this treatment.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients receive either cyclophosphamide and high dose total body
      irradiation (TBI) or busulfan and cyclophosphamide.

      Cyclophosphamide IV is given on days -5 and -4 and TBI on days -2, -1, and 0. Busulfan is
      given orally every 6 hours on days -9 through -6 and cyclophosphamide IV on days -5 through
      -2. Patients rest on day -1.

      Patients receive bone marrow infusion on day 0. For GVHD prophylaxis, patients receive
      methotrexate on day 1, then on days 3, 6, and 11. Cyclosporine IV begins on day -2 over 12
      hours, followed by continuous infusion for 21 days. Then, oral doses of cyclosporine are
      given every 12 hours to patients who tolerate oral feeding. Cyclosporine is continued 6
      months posttransplant, then tapered 10% per week and stopped.

      Patients who receive genotypically HLA nonidentical stem cells undergo additional GVHD
      prophylaxis with methylprednisolone (IV or PO) or its equivalent every 12 hours on days 3 to
      day 100. Dose is then tapered as tolerated over 1 month.

      Patients who receive cord blood stem cells receive methylprednisolone instead of methotrexate
      for GHVD prophylaxis. Methylprednisolone is given 3 times daily beginning on day 5 and
      continuing until day 17. Then, methylprednisolone is tapered 10% per week as clinically
      tolerated.

      To accelerate engraftment, patients receive filgrastim IM daily beginning on day +1 and
      continuing until ANC equals 5000.
    

Intervention name(s): Stem Cell Transplantation
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: Fanconi's anemia; amegakaryocytic thrombocytopenia; aplastic anemia; congenital pure red cell aplasia; genetic diseases and dysmorphic syndromes; hematologic disorders; inborn errors of metabolism; metachromatic leukodystrophy; pure red cell aplasia; rare disease; sphingolipidoses; thalassemia major
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2
Condition: Infant,Premature
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is
      associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved
      stability of oxygenation.
    

Detailed description: 
      Preterm infants who remain intubated or on nasal mechanical ventilation (IMV) at 14 days
      postnatal age, meet blood gas criteria, have transcutaneous carbondioxide (TcCO2) monitoring
      with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too
      unstable by Attending neonatologist will qualify.

      The investigators will use the data from the 96 hours of intensive multiparametric
      physiologic monitoring at 2 weeks postnatal age.

      The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the
      investigators will evaluate 3 interventions in a cross-over manner with the initial
      intervention randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of
      data) and Intervention 3 (72-96h of data).
    

Intervention name(s): Cardiorespiratory monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): We will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The investigators will use the data from the 96 hours of intensive multiparametric physiologic monitoring at 2 weeks postnatal age. The first 24 hours of the data collection will be the baseline data, followed by evaluation of 3 interventions in a cross-over manner, with the initial intervention randomly assigned (computer-generated): Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h). The interventions will be to adjust transcutaneous carbondioxide measurements (TcCO2) up or down by 5 mm Hg, while maintaining TcCO2 within usual safe thresholds.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: apnea of prematurity; bradycardia; hypoxemic episode; permissive hypercapnia
A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic
      Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): MK633; Comparator: Placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): MK0633 100mg capsules qd for a 12-wk treatment period.; MK0633 100mg Pbo capsules for a 12-wk treatment period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment