bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome
Condition: Major Depression
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy of Quetiapine SR versus placebo over 8 weeks in unipolar
      non-psychotic adult outpatients depression and comorbid fibromyalgia. This will be measured
      by the last observation carried forward (LOCF) mean change from baseline to week 8 on the
      Hamilton Depression Scale (HAM-D) total score.

      For the purposes of this study, response regarding improvement in depressive symptoms will be
      defined as a 50% decrease in HAM-D scores over 8 weeks. Furthermore, proportion of patients
      achieving remission is defined as an HAM-D total score of 7 at end of treatment. The anxiety
      comorbid symptoms often associated with major depression will be assessed with the HAM-A (14
      items) scale. Proportion of patients responding and achieving remission of anxiety symptoms
      are defined respectively as a reduction of 50% in the HAM-A total score from baseline and a
      HAM-A total score of 7 at the end of treatment.
    

Detailed description: 
      Secondary Endpoints include

        -  Change from baseline to week 8 in Brief Pain Inventory (short form) total score.

        -  Changes from baseline to week 8 in HAM-A total scores Changes from baseline to week 8 in
           CGI Severity of illness scores. Clinical Global Impression - Improvement (CGI-I) score
           from randomisation to Week 8 Change from baseline in the Fibromyalgia Impact
           Questionnaire (FIQ). Change from baseline in the Sleep Scale from the Medical Outcome
           Study (MOS). Change from baseline in the Sheehan Disability Scale (SDS). Change from
           baseline in the Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
           (Q-LES-Q-SF).

      Change from baseline in the Patient Health Questionaire-15 (PHQ-15). Change from baseline in
      the Global Assessment Scale (GAS).

      The side effects and the tolerability profiles of Quetiapine SR at the dose range used in the
      study will be assessed at every visit following the initial visit.
    

Intervention name(s): Quetiapine Fumarate Sustained Release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/day for the first 2 days and then up to 150mg/day. After two weeks the dose will be doubled up to 300mg at night at the discretion of the investigator; 1 tablet at HS for 2 days then 3 tablets at HS for 2 weeks
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: major depression with comorbid fibromyalgia.
Music During Labor Epidural Placement and Patient Satisfaction
Condition: Satisfaction
Study type: Interventional

Summary: 
      Patient satisfaction is becoming increasingly important to hospital administrators as a
      metric for quality of patient care services because it is now being linked to reimbursements
      (Maher 2015). Patient satisfaction is a complex problem, and may be affected by a variety of
      factors. A recent study found that higher patient satisfaction was associated with patients
      who received music therapy during their hospital stay (Mandel 2014). Given that music may
      positively affect patient satisfaction, we are designing a study to examine the effects of
      patient-preferred music on patient satisfaction in women undergoing labor epidural placement.
    

Detailed description: 
      PROCEDURES STEP-BY-STEP

        1. Once enrolled in the study, patient will be randomized to either:

             -  The intervention group (music played on a portable speaker system), or

             -  The control group (no music).

        2. Prior to epidural placement, patients in both groups will be asked to answer one
           question about their music preference: "What is your favorite music? You can name an
           artist, genre, album, or any other identifier"

           • If patient preferred music is not available on the Pandora app, other apps will be
           searched (Spotify, Youtube, itunes Radio, etc.)

        3. If patients are randomized to the intervention group, the investigator will create a
           station in the Pandora music app using the patient's preferred music. Volume will be
           initially set on low and portable speaker system placed within 3 feet of the patient (in
           order to ensure that she can hear the music). The music will be started and volume will
           then be adjusted to the patient's preference, avoiding music that is too loud but
           ensuring it is loud enough so the patient can hear it.

        4. At that point, epidural placement will begin. Patients will receive an epidural in the
           normal fashion. Music will be continued throughout the duration of the epidural
           placement procedure, unless the patient requests that it be discontinued earlier.

        5. If patients are randomized to the control group, no music will be played.

        6. One hour after epidural placement, the patient will be asked to fill out the patient
           satisfaction survey to assess their satisfaction with the epidural placement. All
           patients from both the intervention and control group will be asked to complete the
           survey.

        7. Data (see below) will be collected from the chart at time of enrollment and at time of
           study completion.
    

Intervention name(s): Music; Control
Intervention type(s): Other; Other
Intervention description(s): Listening to music that the patient likes; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole
Condition: Candidiasis, Oral; HIV Infections
MeSH terms: Infections; Candidiasis; Candidiasis, Oral
Study type: Interventional

Summary: 
      To provide maintenance treatment with itraconazole solution for patients who were clinical
      responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
    

Detailed description: 
      Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole
      oral solution for up to 6 months.
    

Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention MeSH terms: Itraconazole
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Itraconazole; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Candidiasis, Oral
Leucine Supplementation in Elderly Men
Condition: Sarcopenia; Atrophy; Aging
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In the present study the investigators aim to determine whether leucine supplementation can
      augment muscle mass and strength and improve body composition in healthy elderly men
    


Intervention name(s): placebo; leucine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): wheat meal capsules with each main meal; daily leucine capsules with each main meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Protective Effect of EPA on Cardiovascular Events
Condition: Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease
MeSH terms: Myocardial Infarction; Peripheral Arterial Disease; Angina Pectoris; Death, Sudden, Cardiac; Angina, Unstable; Infarction; Death
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to test the hypothesis that the long-term use of highly (>98%)
      purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective
      than statin alone in preventing cardiovascular events in Japanese patients with
      hypercholesterolemia.
    

Detailed description: 
      Epidemiological studies from many countries including Finland, Italy, Japan, and The
      Netherlands have suggested that an increased intake of dietary fish or fish oil rich in the
      long-chain polyunsaturated n-3 fatty acids (PUFAs), eicosapentaenoic acid (EPA) and
      docosahexaenoic acid (DHA), is inversely related to the risk of atherothrombotic diseases, in
      particular coronary artery disease (CAD).

      Results of many prospective observational cohort studies have found that diets rich in marine
      PUFAs may be protective against major cardiovascular events, including mortality from CAD,
      total cardiovascular death, all-cause mortality, and nonfatal myocardial infarction. To date,
      only a few studies have examined the effects of purified n-3 PUFA preparations in human
      subjects for short observation periods. The principle aim of the current study is to test the
      hypothesis that the long-term use of highly purified EPA(eicosapentaenoic acid: 1800mg/day),
      in addition to HMG-CoA reductase inhibitor, is effective in preventing cardiovascular events
      in Japanese patients with hypercholesterolemia.
    

Intervention name(s): Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)
Intervention type(s): Drug
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Eicosapentaenoic acid; Coronary artery disease
Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung
      cancer and from healthy participants in the laboratory may help doctors learn more about
      changes that occur in DNA and identify biomarkers related to cancer.

      PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples
      from patients with lung cancer and from healthy participants.
    

Detailed description: 
      OBJECTIVES:

        -  To identify new molecular abnormalities specific to the development of squamous cell
           carcinoma of the lung.

        -  To determine the prevalence of candidate biomarkers in lung cancer progression.

        -  To determine the odds of developing lung cancer according to biomarker status in
           preinvasive lesions.

        -  To determine the odds of developing lung cancer according to proteomic biomarker status
           in the normal bronchial epithelium of high-risk patients.

      OUTLINE: This is a multicenter study.

      Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory
      biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein
      expression studies are performed on the samples using comparative genomic hybridization
      array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of
      flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and
      immunohistochemistry (IHC).

      Patients' medical records are reviewed to collect information about the patient's past
      medical history and pertinent laboratory and radiography results.

      Patients and healthy volunteers are followed annually via telephone or a mailed
      questionnaire.
    

Intervention name(s): comparative genomic hybridization; fluorescence in situ hybridization; gene expression analysis; microarray analysis; protein expression analysis; immunohistochemistry staining method; laboratory biomarker analysis; matrix-assisted laser desorption/ionization time of flight mass spectrometry; medical chart review; diagnostic bronchoscopy
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Other; Other; Other; Other; Procedure
Keywords: stage 0 non-small cell lung cancer; stage I non-small cell lung cancer; extensive stage small cell lung cancer; limited stage small cell lung cancer; stage II non-small cell lung cancer; stage IV non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer
ESM in Functional Dyspepsia
Condition: Dyspepsia; Dyspepsia and Other Specified Disorders of Function of Stomach
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      Background:

      Reliable patient reported outcome measures (PROM's) for symptom assessment in functional
      dyspepsia (FD) are essential in order to evaluate dyspeptic symptoms, identify potential
      symptom triggers and optimize therapeutic strategies, since biological markers are
      unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week
      questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an
      electronic questioning method characterized by random and repeated, momentary assessments in
      the subject's current state and environment, might overcome these limitations. The aim of
      this study is to assess the validity and reliability of an FD-specific electronic
      patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle,
      for symptom assessment and identification of symptom triggers in patients with functional
      dyspepsia.

      Objective:

      The aim of this study is to assess the validity and reliability of an FD-specific electronic
      patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle,
      for symptom assessment and identification of symptom triggers in patients with functional
      dyspepsia. In order to measure this, internal consistency, test-retest reliability,
      concurrent validity and the accuracy to differentiate between dyspeptic patients and healthy
      controls of the developed ePRO will be assessed. In addition, to objectify specific triggers
      for the onset of gastrointestinal symptoms in dyspepsia, using the FD-specific ESM tool.
    


Intervention name(s): Experience Sampling Method (ESM)
Intervention type(s): Other
Intervention description(s): Experience Sampling Method (ESM) is a method for real time complaints assessment where people are asked to fill out a questionnaire 10 times per day at random moments. This will be done via a mobile phone application.
Other intervention name(s): ESM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      Allergic rhinitis (AR) is a common Ig-E mediated disease of nasal mucosa, induced by an
      immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10%
      to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal
      AR (SAR). Allergen specific immunotherapy (AIT) is the only etiological treatment available
      for AR. Traditionally, AIT is divided into 2 types, subcutaneous immunotherapy (SCIT) and
      sublingual immunotherapy (SLIT), both of which are effective and safe alternatives.

      The trial is a randomized, double-blind, placebo-controlled trial. 72 eligible SAR patients,
      who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial,
      followed by either a 32-week SLIT schedule, where the maintenance dose would be reached
      within 5 weeks, or placebo SLIT schedule. Standardized depot preparations of sweet sagewort
      (artemisia annua) extract (Zhejiang Wolwo Bio-pharmaceutical Co., Ltd., China ) were
      administered by means of sublingual drops.
    


Intervention name(s): sublingual immunotherapy drops; Placebo drops
Intervention type(s): Drug; Drug
Intervention description(s): artemisia annua (sweet sagewort) allergen extract drops; sublingual placebo drops
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: experiment:placebo=2:1
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's
      test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in
      healthy, adult, human male subjects under fasting conditions and to assess the
      bioequivalence.
    

Detailed description: 
      This was an open-label, balanced, randomized, two-treatment, four-period, two-sequence,single
      dose, replicate crossover bioequivalence study in healthy, adult, human, male subjects under
      fasting conditions.48 healthy male adults were enrolled.A washout period of 07 days was
      maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500
      mg was administered orally with 240 mL water in sitting posture, after an overnight fast of
      at least 10 hours in each period. This activity was followed by a mouth check to assess
      compliance to dosing. The subjects were not allowed to lie down for the first three hours
      after dosing.
    

Intervention name(s): Mycophenolate Mofetil
Intervention type(s): Drug
Intervention description(s): Mycophenolate Mofetil 500 mg tablets
Other intervention name(s): Cellcept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
Condition: Pharmacokinetics
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare the pharmacokinetic profiles of colchicine
      and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of
      colchicine in healthy adults with normal renal function, in patients with mild, moderate or
      severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An
      additional objective of this study is to study the clearance of colchicine and its
      metabolites by hemodialysis. Secondary objectives include evaluation of the safety and
      tolerability of colchicine in the study population.
    

Detailed description: 
      40 male and female subjects will be enrolled in the study and stratified into one of five
      groups based on their renal status as determined from creatinine clearance (CrCL) estimated
      using the serum creatinine (sCR) and the Cockcroft-Gault and Modified Diet in Renal Disease
      (MDRD) equations as follows: Treatment group 1 - healthy adults with normal renal function
      (CrCL/eGFR> 90 mL/min); Treatment groups 2, 3 and 4 - patients with mild (CrCL/eGFR 60-89
      mL/min), moderate (CrCL/eGFR 30 to 59 mL/min), and severe (CrCL/eGFR 15 to 29 mL/min) renal
      impairment, respectively; and Treatment group 5 - subjects with end-stage renal disease
      requiring hemodialysis. On study day 1, participants in Treatment Groups 1 to 4 will be
      administered one colchicine 0.6 mg tablet at 8 a.m. under standard fasting conditions. Blood
      samples will be collected from all participants before dosing and both blood and urine
      samples will be collected for 120 hours post-dose on a confined basis at times sufficient to
      adequately define the pharmacokinetics of colchicine and its primary metabolites. There will
      be two study periods for treatment group 5; Period 1 off dialysis and Period 2 on dialysis
      with a 14 day washout period between the two study periods. On study day 1, participants in
      treatment group 5 will be administered one colchicine 0.6 mg tablet under standard fasting
      conditions immediately following dialysis. Blood samples will be collected from all
      participants before dosing and for up to 70 hours post-dose at times sufficient to adequately
      determine the pharmacokinetics of colchicine and its primary metabolites. All adverse events
      will be evaluated by the investigator and reported in the participant's case report form.
    

Intervention name(s): Colchicine
Intervention type(s): Drug
Intervention description(s): Colchicine tablets
Other intervention name(s): COLCRYS
Intervention MeSH terms: Colchicine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.
Condition: HIV Infection With Other Conditions; Cardiovascular Risk Factor; Atherosclerosis; Inflammation
MeSH terms: Atherosclerosis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigator tested the efficacy of maraviroc intensification on down-regulating
      atherosclerotic progression in HIV infected patients with optimal viro-immunologic control
      and at high cardiovascular risk.
    

Detailed description: 
      Experimental CCR5 antagonism with maraviroc in atherosclerosis-prone mice and preliminary
      data in humans suggest an anti-atherosclerotic effect of the drug. The investigators assessed
      the impact of maraviroc treatment in HIV-infected patients on several subclinical indicators
      of atherosclerosis and putative mechanisms for such an effect.

      HIV-treated patients under effective antiretroviral (ART) therapy, with a Framingham risk
      score >20% and a brachial flow-mediated dilation (bFMD) <4%, as indices of high
      cardiovascular risk, were recruited. Maraviroc (300 mg per os for 24 weeks) was administered
      on top of ART to all participants using a cross-over design. Brachial FMD, carotid-femoral
      pulse wave velocity (cfPWV) and carotid intima-media thickness (cIMT) were measured as
      non-invasive markers of atherosclerosis. Vascular competence, as expressed by the ratio of
      circulating endothelial micro-particles (EMPs) to endothelial progenitor cells (EPCs), as
      well as markers of systemic inflammation, monocyte activation and platelet activation were
      assessed.
    

Intervention name(s): Maraviroc 300 mg
Intervention type(s): Drug
Intervention description(s): Patients were randomly allocated with an AB/BA cross over design to either maraviroc 300 mg/day to current ART for 24 weeks (A) or no additional treatment (B). At the end of the first 24-week period patients were switched to the alternative arm.
Intervention MeSH terms: Maraviroc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Maraviroc; Atherosclerosis