bioihbjkbjnl/mcl2 huggingface dataset:
Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and
      during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and
      health-related quality of life in stable, symptomatic heart failure patients with reduced
      left ventricular ejection fraction.

      The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce
      the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).
    


Intervention name(s): Empagliflozin 10 MG; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Capsule, once a day for 90 days; Capsule, once a day for 90 days
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      An oral dose in healthy subjects to obtain information about the absorption, metabolism, and
      excretion (AME) of BMS-986165
    


Intervention name(s): BMS-986165
Intervention type(s): Drug
Intervention description(s): Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA
Intervention MeSH terms: Deucravacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded,
      examining the feasibility and acceptability of Buprenorphine extended-release vs. daily
      sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at
      community re-entry.
    


Intervention name(s): Buprenorphine Extended Release; Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Intervention type(s): Drug; Drug
Intervention description(s): XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.; SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.
Other intervention name(s): SUBLOCADE
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid dependence; Buprenorphine; primary care treatment; extended-release buprenorphine
Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to provide critical information on the safety, reactogenicity
      and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type
      155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will
      assess a single lower dose and a higher two dose regimen, before moving to future studies.
      This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease'
      after vaccination of these infants with the ChAd155-RSV vaccine.
    


Intervention name(s): RSV (GSK3389245A) lower dose formulation vaccine; RSV (GSK3389245A) higher dose formulation vaccine; GSK's multicomponent meningococcal B vaccine; Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine; GSK's pneumococcal polysaccharide conjugate vaccine; GSK's meningococcal group A, C, W-135 and Y conjugate vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Drug
Intervention description(s): 1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.; 2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.; 3 doses of GSK's multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.; 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.; 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.; 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.; 1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 31 and Day 121, depending on the vaccination schedule.
Other intervention name(s): Bexsero; Nimenrix; Synflorix; Menveo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Respiratory syncytial virus (RSV); Vaccine; Reactogenicity; Immunogenicity; Infants
Effects of Anke Malz on Women During Lactation
Condition: Non-alcoholic Malt Product in Lactation
Study type: Interventional

Summary: 
      Human milk is the most optimal food to provide all infants' needs before eating solid food.
      However, underproduction of milk is a common and concerned problem for breastfeeding women.
      In this case, proper milk-making foods reveal their importance on lactation. In many European
      countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate the
      secretion of breast milk. This study estimates the effects of non-alcoholic malt product
      during first three months of lactation.
    


Intervention name(s): Anke Malz
Intervention type(s): Dietary Supplement
Intervention description(s): non-alcoholic malt drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: lactation; human milk; maltz; antioxidant
Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
Condition: Anovulation; Infertility
MeSH terms: Infertility; Anovulation
Study type: Interventional
Phase: Phase 4

Summary: 
      Ovulation disorders are a common cause of infertility in women. Most of these women can be
      classified as World Health Organization (WHO) Group II anovulatory patients as they have
      irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation
      hormone (FSH) and estradiol.

      The purpose of this study is to optimize the low-dose-step-up protocol traditionally used for
      ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory
      infertility WHO Group II.

      Previous studies have established that menstrual cycle history, mean ovarian volume and BMI
      are significant predictors of FSH threshold dose in women with anovulatory infertility WHO
      Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram
      has been constructed based on these variables.

      The aim of this study is to evaluate the clinical use of the nomogram in order to test the
      use of the variables to determine whether an individualized starting dose of FSH can be used
      for ovulation induction in anovulatory patients.

      It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the
      disadvantages of the treatment and that the stimulation period of the individualized
      nomogram-based treatment will be 25% shorter than observed in the standard protocol.

      The primary endpoint is the proportion of patients who reach the criteria for
      hCG-administration within 14 days of Menopur stimulation. The results of the study will be
      compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al.,
      2006).
    


Intervention name(s): Menopur
Intervention type(s): Drug
Intervention description(s): The medication used in this study is the follicle-stimulating hormone "highly purified human menopausal gonadotrophin" (HP-HMG), Menopur, (Ferring a/s).
Stimulation with HP-hMG (Menopur) is started on day 2-5 of menstrual bleeding.The HP-hMG starting dose is calculated based on the nomogram predicting the threshold dose. The dose-range is from 75 IU/day to 187.5 IU/day.
Intervention MeSH terms: Menotropins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Anovulation; Ovulation induction
AMPLIFY - D6571C00001 Duaklir USA Phase III Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and
      multinational Phase III study to determine the efficacy and safety of Aclidinium bromide
      400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO
      (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary
      disease (COPD).
    

Detailed description: 
      This study was conducted to assess the bronchodilator efficacy and safety as well as effect
      on health related quality of life of AB/FF 400/12 μg compared to the individual components
      (AB 400 μg and FF 12 μg) in COPD patients. The trial duration of 24 weeks allows the
      assessment of the effect on symptoms improvement of the combined treatments versus individual
      components as well as the long term bronchodilation comparison between AB 400 μg and TIO 18
      μg in minimizing the risk of COPD exacerbations in current or former smokers, aged ≥40 in
      symptomatic COPD patients.
    

Intervention name(s): Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg); Aclidinium bromide 400 μg (AB 400 μg); Formoterol fumarate 12 μg (FF 12 μg); Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg; Tiotropium 18 μg (TIO 18 μg); Placebo to TIO 18 μg
Intervention type(s): Drug; Drug; Drug; Other; Drug; Other
Intervention description(s): Inhalation powder; Inhalation powder; Inhalation powder; Inhalation powder; Powder in capsules for oral inhalation; Powder in capsules for oral inhalation
Other intervention name(s): Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler); Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler); Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler); Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler); Oral Inhalation (by Handihaler® Dry Powder Inhaler, DPI); Oral Inhalation (by Handihaler® Dry Powder Inhaler, DPI)
Intervention MeSH terms: Bromides; Formoterol Fumarate; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Efficacy; Aclidinium bromide; Formoterol fumarate; Tiotropium; Bronchodilation; COPD
A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single
      ascending dose study in healthy male volunteers conducted at a single centre. The effect of
      food on the pharmacokinetics of AZD7687 will also be studied.

      The study will consist of two parts, a dose escalation part and a food interaction part. The
      two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different
      panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation.
      Each subject will receive dose only once, except for the volunteers included in the dose
      steps repeated for food interaction.
    


Intervention name(s): AZD7687; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: First in human; Safety
Smartphone Application for Smoking Cessation
Condition: Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of a smartphone application for
      smoking cessation in smokers ages 18 to 65 years.
    

Detailed description: 
      In this randomized control trial, subjects will be randomly assigned to receive one of two
      treatments: (1) a standard smartphone application to support smokers working to become
      quit-free, or (2) the tested intervention, an app that trains behavioral strategies for
      smoking cessation. The primary endpoint of interest will be 1-week point prevalence
      abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.
    

Intervention name(s): Experimental App; Active Comparator App
Intervention type(s): Behavioral; Behavioral
Intervention description(s): It is comprised of twenty-two modules of 10-15 minutes each, designed to teach behavioral strategies for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules; It is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cigarette smoking
A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy, safety, and tolerability of centanafadine
      sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD).
      Participants will either receive a twice-daily dose of centanafadine sustained-release
      tablets, or twice-daily placebo.
    

Detailed description: 
      Screening & Washout Period: up to 28 days Investigational Treatment Period: 49 days Follow-up
      Period : 7 days or 10 days
    

Intervention name(s): Centanafadine SR; Placebo; Centanafadine SR
Intervention type(s): Drug; Other; Drug
Intervention description(s): 100 mg, BID, oral tablets; BID, oral tablet.; 200 mg, BID, oral tablets
Other intervention name(s): EB-1020; EB-1020
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Centanafadine; ADHD; ADD
The Impact of Psychological Interventions on Psychometric and Immunological Measures in Patients With Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the impact of i) Cognitive Behavioral Therapy (CBT)
      combined with exercise, ii)CBT combined with euthymic therapy, and iii) 'Cognitive Behavioral
      Analysis System of Psychotherapy' (CBASP) on psychometric and immunological measures in
      patients with major depression.
    

Detailed description: 
      The interest of the investigation is to compare the impact of CBT combined with exercise, CBT
      combined with euthymic therapy and CBASP on depression and further psychopathological
      variables (assessed at 5 points).

      Previous findings indicate increased concentration of pro-inflammatory cytokines in
      depression. A bidirectional relationship between depression and immunological alterations has
      been suggested: On the one hand pro-inflammatory cytokines may contribute to depression, on
      the other hand depression-linked changes (e.g. a reduction of activity, increased
      stress-sensitivity) may lead to increased secretion of pro-inflammatory cytokines. Therefore,
      this study is also supposed to investigate the influence of above mentioned interventions on
      pro-inflammatory cytokines. Using a waiting group, potential changes in psychometric and
      biological parameters without any intervention are controlled. Assessments take place at
      baseline, after 4 weeks of treatment, after 8 weeks of treatment, after 16 weeks of treatment
      and 6 months follow up.

      200 patients with Major Depression (DSM IV, BDI II at baseline ≥18) will be included.
      Patients will be randomized and assigned to one of the 4 groups.
    

Intervention name(s): CBT - active; CBT - euthymic; CBASP
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).; Patients get the same common CBT treatment as group I, but instead of physical exercise they receive an enjoyment training Patients get CBT treatment combined with euthymic exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).; Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, psychodynamic and interpersonal strategies.
Foci of the CBASP-therapy are situation analysis and subsequent behavioral trainings as well as interpersonal strategies to create a therapeutic relationship.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Exercise; Psychoneuroimmunology; Cognitive Behavioral Therapy; CBASP
A Comparison of Skin Prick Tests, Clinical Symptoms, and Nasal Challenge Using a New Mouse Extract
Condition: Mouse Allergies; Mouse Sensitization
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      The purpose of this study is to test a new mouse skin test extract on people who work with
      mice in a lab or through animal care. It has a higher level of the major allergen and
      therefore may be better at diagnosing mouse allergies in this population.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy individuals between the ages of 18-60 who are exposed to mice through occupation or
        animal care.
      
Keywords: Skin testing for mouse allergies
Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of BIA 5-1058 200 mg on the pharmacokinetic
      (PK) of treprostinil
    

Detailed description: 
      This study was an open-label, three period, fixed sequence study in healthy male and female
      subjects performed at a single study center.

      The study comprised:

        -  Screening during Days -28 to -2 (both inclusive).

        -  Three treatment periods separated by a washout period of at least 10 days.
    

Intervention name(s): BIA 5-1058; treprostinil
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg (2 x 100 mg tablets), oral route; 1 mg (1 extended-release tablet), oral route
Other intervention name(s): Zamicastat; Orenitram
Intervention MeSH terms: Treprostinil; Zamicastat
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Condition: Major Depression; Mania; Anxiety Disorders; Psychotic Disorder; Alcohol Dependence; Drug Dependence; Eating Disorders; Suicidality; Dysthymia; ADHD; Tourettes Disorder; Conduct Disorder; Oppositional Defiant Disorder; Pervasive Developmental Disorder
MeSH terms: Tourette Syndrome; Alcoholism; Substance-Related Disorders; Anxiety Disorders; Feeding and Eating Disorders; Psychotic Disorders; Developmental Disabilities; Conduct Disorder; Autism Spectrum Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Observational

Summary: 
      The primary aims of this study are to assess:

        1. The inter-rater and test-retest reliability of the MINI-KID

        2. The validity of the standard MINI-KID interview in relation to the parent rated
           pencil/paper version (MINI-KID-P) and th longer clinician rated "Schedule for Affective
           Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version
           (K-SADS-PL) and "expert opinion" (when available).

      Secondary aims will include evaluating the concordance between: The Children's Global
      Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability
      Scale (to be administered with the MINI-KID) as a measure of illness severity.
    

Detailed description: 
      The MINI-KID is a short, structured diagnostic interview used to assess the presence of 24
      DSM-IV child and adolescent psychiatric disorders as well as the risk of suicide.

      To achieve adequate representation of the major psychiatric disorders and sufficient normal
      controls, we propose recruiting 230 children and adolescents (ages 6 to 17 years 11 months),
      comprised of 200 subjects identified as having one or more psychiatric disorders and 30
      normal controls in the community. These subjects will be from diverse socioeconomic, racial
      and ethnic backgrounds. We will assess the inter-rater and test-retest reliability of the
      MINI-KID and examine its validity with the "gold-standard" diagnostic interview for children
      and adolescents as well as expert opinion.
    

Intervention name(s): MINI-KID
Intervention type(s): Other
Intervention description(s): Structured Diagnostic Interview for children and adolescent psychiatric disorders.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents between the ages of 6 and 18 years.
      
Keywords: MINI-KID; structured diagnostic interview; reliability and validity; K-SADS; Sheehan Disability Scale