bioihbjkbjnl/mcl2 huggingface dataset:
Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but
      is hampered by peginterferon-induced psychopathology.

      Prevention of peginterferon-induced psychopathology with selective serotonin reuptake
      inhibitors (SSRI's) (paroxetine) has been shown to be effective in patients treated with
      interferon for malignant disease. The aim is to study the effects of prophylactic treatment
      with escitalopram (another SSRI) on peginterferon-associated psychopathology in patients
      treated with peginterferon and ribavirin for chronic hepatitis C.
    

Detailed description: 
      The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but
      is hampered by peginterferon-induced psychopathology.

      Prevention of peginterferon-induced psychopathology with SSRI's (paroxetine) has been shown
      to be effective in patients treated with interferon for malignant disease. The aim is to
      study the effects of prophylactic treatment with escitalopram on peginterferon-associated
      psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C.

      Design: double blind, randomized controlled trial with two arms, maximum 40 patients per arm.
      Patients, starting with peginterferon and ribavirin, will be randomized to receive
      escitalopram therapy 10 mg per day (however, 5 mg in the first two weeks) or placebo.

      Study population and selection: eighty patients receiving peginterferon alfa-2a (Pegasys 180
      microgram) and ribavirin (Copegus 400 mg twice daily) will be included in the study.

      Aims of the study:

        1. to asses whether prophylactic treatment with escitalopram avoids significantly the
           occurrence of peginterferon-induced psychiatric disturbance; defined as an increase of
           two points on observer-based rating scales reflecting anxiety (BAS:BriefAnxietyScale),
           loss of concentration, depression and loss of impulse control (Montgomery and Asberg
           Depression Rating Scale: MADRS), and

        2. to assess the frequency of major depression according to DSM IV criteria, in the
           escitalopram and placebo-treated patients.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Other
Intervention description(s): OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis C; Peg-interferon; Psychiatric side-effects
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
Condition: Vasomotor Symptoms Associated With Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether bazedoxifene/conjugated estrogens
      combinations are effective in the treatment of moderate to severe vasomotor symptoms
      associated with menopause.
    


Intervention name(s): Bazedoxifene/Conjugated Estrogen
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Menopause
NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A 28-day phase 2a, double-blind, placebo-controlled (1:1), multi-center study of 20 mg
      NE3107, twice daily of safety, potential drug-drug interactions, and MDS-UPDRS defined
      activity in patients with Parkinson's disease . Study will enroll 40 patients that are
      currently taking immediate release levodopa/ carbidopa (IRLC) and have a practically defined
      early morning off-state for IRLC. Day one- baseline UPDRS and IRLC PK sampling; day 2- start
      NE3107 dosing, assess UPDRS during onset and NE3107 PK sampling, rescue meds as needed after
      4 hours; day 3 and 14- NE3107 + IRLC UPDRS assessment and PK sampling; day 28- NE3107 + IRLC
      UPDRS assessments. Optional overnight stays in clinic prior to Day 1-3, 14, and 28.
    


Intervention name(s): NE3107; placebo
Intervention type(s): Drug; Drug
Intervention description(s): NE3107 is an investigational orally bioavailable, blood-brain barrier permeable anti-inflammatory agent with a new mechanism of action targeting multiple mechanisms of pathology in Parkinson's disease; Hard gelatin capsule containing only common excipients for oral formulations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDS-UPDRS
Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients
Condition: Obesity
Study type: Observational

Summary: 
      This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve
      gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals
      with normal BMI were enrolled.
    

Detailed description: 
      This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve
      gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals
      with normal BMI were enrolled.

      All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with
      obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic
      indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis
      assessed by FibroScan(CAP value and E value) were measured baseline and postoperative.
    

Intervention name(s): Laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): bariatric surgery
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        300 subjects with obesity or overweight
      
Keywords: Laparoscopic sleeve Gastrectomy; Nonalcoholic Fatty Liver; Type 2 Diabetes; Polycystic Ovary Syndrome; Acanthosis nigricans; Hyperuricemia; Hyperinsulinemia; Sleep apnea Syndrome
Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study in Women
Condition: Female Stress Incontinence
MeSH terms: Bacteriuria; Urinary Incontinence, Stress
Study type: Observational [Patient Registry]

Summary: 
      Urodynamic Study (UDS) represents a series of agreed-upon clinical tests and is used to
      evaluate the functional status of the lower urinary tract, providing a pathophysiological
      basis for urinary symptoms. Urodynamic Study involves catheterization of the lower urinary
      tract. The prevalence of urinary tract infection after UDS ranges from 1,5% to 30 %.

      Studies of prophylactic antibiotics for UDSs have offered data of contradictory and limited
      predictive values. Some investigators concluded that prophylactic antibiotics were valuable
      and others have not.

      The objective of this study is to evaluate the efficacy of antibiotic prophylaxis before UDS
      in women, using different antibiotic regimens.
    

Detailed description: 
      This study is randomized, double blind study was carried out in the Department of Gynecology
      at Sao Paulo Federal University from January 2009 to December 2012.

      The patients were randomized in four groups: Group A received 500mg of levofloxacin, group B
      received placebo, group C received 80mg trimethoprim and 400mg sulfamethoxazole (SMZ-TMP) and
      group D received 100mg of nitrofurantoin. The tablets were administered 30 minutes before de
      UDS.

      All patients were instructed to collect midstream urine sample to the microbiology laboratory
      14 days after the UDS. Significant bacteriuria was considered when >1.000.000 organisms/mL of
      a single species was isolated.

      All data were entered into Statistical Package for Social Sciences (SPSS) 16.0 for
      statistical analysis and graphic representation. Likelihood -ratio test and Fisher's exact
      test were used to compare the prevalence of significant bacteriuria after UDS in the
      different groups and Student's t-test and ANOVA test were used to compare continuous
      variables. To compare the groups regarding the BMI variable and parity, the model analysis of
      variance (ANOVA) was used, or if necessary, the nonparametric Kruskal-Wallis test and to
      compare the groups in relation to menopause variable, we used the Chi-square test. A
      significance level of 0.05 was established for statistical analysis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women with urinary dysfunction
      
Keywords: urodynamics; cystitis; prophylactic antibiotics; bacteriuria
The Effect of Transcranial Direct Current Stimulation on Motor Performance in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      to investigate the effect of stimulation intensity on motor performance in healthy adults.
    

Detailed description: 
      60 healthy subjects were randomly allocated to one of three groups: (a) 20-min of
      High-Definition transcranial direct current stimulation (HD-tDCS) with an intensity of 2 mA
      (HD-tDCS 2 mA); (2) 20-min of HD-tDCS with an intensity of 1.5 mA (HD-tDCS 1.5 mA); and (3)
      20-min of sham HD-tDCS (HD-tDCS sham). The stimulation was administered noninvasively using
      an M x N 9-channel high definition transcranial electrical current stimulator from Soterix
      Medical (New York, NY). The anodal stimulation targeted the right Brodmann area 4 (primary
      motor cortex) based on HD-Targets brain modelling software (Soterix Medical, New York, NY).

      Tests: The non-dominant left arm was tested. The subjects performed a sequential
      point-to-point movement task on the graphics tablet. Initially, the participants were
      required to perform 3 sequences without errors to familiarize themselves with the setup, the
      task and the sequence. Then, they performed the pre-test which consisted of two blocks of 6
      sequences, i.e. 12 sequences, with a 30 s break between blocks. Two min after starting the
      appropriate stimulation, they performed 2 blocks of 6 sequences (identical to the pre-test).
      After finishing the tDCS stimulation, the participants performed a post-test, which was also
      identical to the pre-test. The participants returned after 24 hours to perform a retention
      test, which was equivalent to the pre- and post-tests. Two outcome measures were used:
      movement time (s) and the reaction time (s) of the reaching movements.
    

Intervention name(s): HD-tDCS 2 mA; HD-tDCS 1.5 mA; HD-tDCS sham
Intervention type(s): Device; Device; Device
Intervention description(s): anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA; anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA; sham stimulation of the right primary motor cortex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial (RCT)
Masking: Single (Participant)
Primary purpose: Other
Keywords: transcranial direct current stimulation; motor performance
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
Condition: Diabetes Mellitus, Type 2; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is designed to provide additional information on the safety and
      tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2
      diabetes mellitus (T2DM) and moderate or severe renal insufficiency
    


Intervention name(s): vildagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50mg qd; qd
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes, vildagliptin
Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The investigators aimed to evaluate the clinical results and the inflammatory response of the
      minimal extracorporeal circulation system (MECC) Compared with off-pump coronary
      revascularization (OPCABG).

      This is a randomized and prospective study in 230 patients with indications for coronary
      surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were
      the clinical and biochemical results, intra-operative outcomes and the determination of 19
      inflammatory circulating markers, 17 of them for the first time analyzed comparing both
      techniques.
    


Intervention name(s): Off-pump coronary artery bypass graft; Mini extracorporeal circulation bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients operated with the heart beating, without heart arrest.; Patients operated with a modified extracorporeal circulation system
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        230 patients with indication for coronary surgery established on the basis of current
        published guidelines. All patients provided written consent to enter the study.
      
Keywords: Off-pump bypass graft surgery; Mini extracorporeal circulation bypass surgery
Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and
      improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care
      Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's
      absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and
      hemoglobin without oxygen.

      During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by
      comparing the amount of oxygen available to discrete regions of the body nourished by
      different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen
      available to the brain (cerebral), while leads placed over the kidney reflect oxygen
      available to the internal organs (somatic).

      NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and
      disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS
      monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying
      cardiac output through the patterning of somatic and cerebral oxygenation in combination with
      exercise stress test data has not been researched.

      We hypothesize that addition of multi-site NIRS monitoring to the standard data collection
      already achieved during exercise testing, will enable calculation of anaerobic threshold and
      cardiac output prediction. This will assist in determining appropriate timing for surgical
      intervention, predicting the post operative course and testing response to medication.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents from age 6 to 20 undergoing exercise stress testing
      
Keywords: NIRS; cardiac output; anaerobic threshold; exercise stress; congenital heart defect
Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial
Condition: Stroke; Ischemic Stroke; Cerebrovascular Disease
MeSH terms: Stroke; Ischemic Stroke; Cerebrovascular Disorders
Study type: Interventional

Summary: 
      Background: Several risk score models are now available to assist clinicians estimate
      outcomes after an acute ischemic stroke. Limited information is available on the predictive
      value of these scores compared to real outcomes and clinical judgment.

      Objectives: To compare clinician judgment with the use of a validated stroke risk score
      (iScore) and patients' outcomes.
    

Detailed description: 
      A convenience sample of 111 practicing clinicians (general and vascular neurologists,
      internists, and ER physicians) predicted the outcomes of 5 stroke patients based on case
      summaries. Cases were randomly selected as being representative of the 10 most common
      clinical scenarios (n=1,415) from a pool of over 12,000 patients admitted to stroke centers
      in Ontario, Canada. Stroke cases had known clinical presentation, comorbidities, stroke
      severity, and outcomes.

      All participants are active practicing physicians caring for patients with acute stroke.
      Conditions were standardized to mimic clinical practice.

      Main outcomes of interest included 30-day mortality and death or disability at discharge.

      Secondary outcome: death or institutionalization at discharge
    

Intervention name(s): Clinical scenarios
Intervention type(s): Other
Intervention description(s): Clinicians will be randomized to a sequence of 5 clinical scenarios with a variable range of expected outcome [i.e. from low (<10%) to high (>50%) expected risk death at 30 days].
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: stroke; risk score; iScore; outcomes; mortality; disability; institutionalization
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the low-density lipoprotein cholesterol
      (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg
      versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in
      Japanese patients with hypercholesterolemia treated for 12 weeks.
    


Intervention name(s): 180mg of ETC-1002(bempedoic acid); 120mg of ETC-1002(bempedoic acid); 60mg of ETC-1002(bempedoic acid); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 180mg, tablet, once daily, for 12 weeks; 120mg, tablet, once daily, for 12 weeks; 60mg, tablet, once daily, for 12 weeks; placebo, tablet, once daily, for 12 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects
Condition: Atopic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether senicapoc can decrease changes in FEV1
      following allergen challenge in atopic allergic subjects.
    

Detailed description: 
      Based on the unmet medical need for new agents in the treatment of asthma and the role of
      KCa3.1 in the function of several different cell types involved in the inflammatory response,
      and the effects seen in an animal model of allergic asthma, it is reasonable to explore the
      utility of senicapoc, a KCa3.1 blocker, as a novel treatment of asthma. This study will test
      the ability of senicapoc to alleviate bronchospasm induced by an allergen challenge in
      patients with allergic asthma. It is analogous to the study performed in animals in which
      senicapoc demonstrated the ability to reduce airway resistance and hyper-responsiveness
      induced by airway challenge with antigen and carbachol, respectively. This study is also the
      first to test the ability of senicapoc to reduce airway inflammation, which is the key
      pathophysiologic process in asthma. In summary, with a demonstrated safety profile across a
      wide range of doses in humans and efficacy in an animal model of allergic bronchospasm and
      hyper-responsiveness, the initiation of exploratory studies of senicapoc for treatment of
      asthma is justified.
    

Intervention name(s): senicapoc; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Loading Dose: 80 mg twice daily x 3 days followed by Maintenance Dose: 40 mg daily x 11 days; Placebo comparator
Other intervention name(s): ICA-17043
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; inflammation; bronchoconstriction; allergen challenge; KCa3.1
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a randomized study investigating the bioequivalence of COREG CR and
      Lisinopril to COREG CR and ZESTRIL
    


Intervention name(s): COREG CR
Intervention type(s): Drug
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coreg CR