bioihbjkbjnl/mcl2 huggingface dataset:
Beta-Blocker Evaluation in Survival Trial (BEST)
Condition: Cardiovascular Diseases; Heart Diseases; Heart Failure, Congestive; Heart Failure
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if addition of a beta-blocker to standard therapy in Class III and Class IV
      heart failure patients reduced total mortality.
    

Detailed description: 
      BACKGROUND:

      Controlled and uncontrolled studies suggested that beta-blockade improves ventricular
      function in congestive heart failure. Several trials suggested that beta-blockers may also
      reduce mortality. In the Beta-Blocker Heart Attack Trial, patients with a history of heart
      failure had less cardiac and sudden-death mortality than those who did not. Patients with a
      low ejection fraction in the Cardiac Arrhythmia Suppression Trial who were treated with
      beta-blockade also had a reduction in mortality. The Metoprolol in Dilated Cardiomyopathy
      trial randomized patients with dilated cardiomyopathies to treatment with metoprolol or
      placebo. There was a trend toward reduction in a morbidity and mortality endpoint in patients
      treated with metoprolol, but this was due entirely to a reduction in the need for cardiac
      transplantation. Thus, despite a reasonable theoretical basis and suggestive clinical
      studies, the concept that beta-blockers reduced mortality in congestive heart failure
      patients was unproved.

      DESIGN NARRATIVE:

      Randomized, double-blind, multicenter. Patients were assigned to standard therapy plus the
      addition of a beta-blocker (bucindolol) versus a placebo. The primary endpoint was total
      mortality. A radionuclide ventriculogram was performed within 60 days of randomization.
      History, physical examination, clinical laboratory studies, chest x-ray, electrocardiogram,
      and plasma norepinephrine levels were obtained within 14 days of randomization. Patients were
      stratified by hospital, congestive heart failure etiology, ejection fraction, and gender, and
      were assigned to a treatment group by an adaptive balancing scheme ("biased coin"
      randomization). Patients were randomized to either placebo plus standard congestive heart
      failure treatment or to the beta-blocker plus standard congestive heart failure treatment and
      followed for a minimum of 18 months. The over three year recruitment period began in May 1995
      at the first 35 sites. An additional 55 sites began recruitment on August 14, 1995.
      Recruitment ended in December, 1998 with the enrollment of 2,708 patients.
    

Intervention name(s): adrenergic beta antagonists
Intervention type(s): Drug
Intervention MeSH terms: Adrenergic Agents; Adrenergic beta-Antagonists
Allocation: Randomized
Masking: Double
Prospective Comparison Between SADI-S and Gastric Bypass
Condition: Morbid Obesity; Diabetes
MeSH terms: Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a
      variable limb length between 250 cm and 300 cm or gastric bypass.

      Results on weight loss, comorbidities resolution, complications, re-operations, need of
      supplements are registered.
    

Detailed description: 
      Morbid obese patients and patients with an initial BMI over 35 with associated comorbidities
      - as diabetes mellitus - are evaluated for bariatric surgery. Candidates are offered a
      standard gastric bypass or a single anastomosis duodeno-ileal bypass with sleeve gastrectomy.
      Patients with higher BMI and those with worse metabolic condition are encouraged to accept
      the malabsorptive option.

      Gastric bypass is performed with a 150 cm alimentary limb and a calibrated pouch and
      anastomosis over a 14 mm bougie. SADI-S is performed with a sleeve gastrectomy over a 54
      French (18 mm) gastric bougie and a 250 cm common limb.

      Patients are managed equally during admission: 6 hours to initiate oral intake, 2 days to
      remove abdominal drain and 3 days to discharge unless contraindicated. Follow up is performed
      through visits every 3 months the first 2 postoperative years and every 6 months from the 3rd
      to the 5th year.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Morbid obesity patients asking for surgery
      
Biospecimen description: 
      Liver biopsy
    
Keywords: obesity, malabsorption, gastric bypass, SADI-S
Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease
Condition: Depression; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Depression
Study type: Interventional

Summary: 
      In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly
      relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of
      the current study is to evaluate the effects of a psychotherapy intervention on symptoms of
      depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be
      randomised into a controlled intervention trial, comparing a stepwise psychotherapy
      intervention with usual cardiological care. The manualized psychotherapy intervention starts
      with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression
      will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25
      sessions of psychodynamic group psychotherapy over a total period of one year. The
      psychodynamic approach was chosen in order to specifically take into account personality
      traits such as negative affectivity and social inhibition, the components of the Type D
      personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials
      produced only small effects in depressed CAD patients. The investigators expect that the
      intervention will reduce depressive symptoms as well as the prevalence of depressive
      disorders. It will also improve both behaviourally and physiologically mediated
      cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs.
      Subgroup analyses will be performed in order to identify gender-specific treatment effects,
      effects on immunological stress reactivity, and genetic predictors of treatment success.
    


Intervention name(s): Psychotherapy; Information session; Usual cardiological care
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.; One information session about living with heart disease.; Usual cardiological care
Other intervention name(s): Stepwise manualized psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary artery disease; depression; psychotherapy; randomized controlled trial
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
Condition: Atopic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the
      Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen
      Challenge (BAC)
    


Intervention name(s): ADX-629; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week; Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Consumption of Caraway on Treatment of Obesity
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This study aims to investigate the applicability of caraway (black cumin) intake on the
      treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to
      examine the applicability of caraway product in terms of safety and efficacy.
    

Detailed description: 
      A randomized placebo-controlled clinical trial, was done on 120 healthy overweight and obese
      women aged 20-55 in Iran. data were collected trough questionaires, interview and physical
      examination. the required parameters including anthropometric indices, body composition vital
      parameters (heart rate and blood pressure)and full blood parameters, were measured before and
      after intervention. volunteers were randomized into test and control group and were asked to
      consume either caraway samples or placebo during 12 intervention weeks.

      the outcome measure will be assessed for both primary and secondary data from baseline
      through week 12 (3 months).
    

Intervention name(s): caraway sample; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): caraway water extract product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; overweight; BMI
A Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, single centre, open-label study to investigate the pharmacokinetics (PK), safety
      and tolerability of single and multiple twice daily doses of inhaled Aclidinium Bromide in
      healthy Chinese male and female subjects.
    

Detailed description: 
      Screening will be performed within 21 days of dosing on Day 1. Eligible participants will be
      admitted to the trial center on Day -1.

      Subjects will receive single dose on Day 1, twice daily regimen is from D5 to D8, and only
      morning dose will be given on Day 9.

      During treatment period, from Day 1 through Day 11 at Visit 2, safety measurements (blood
      pressure, 12-lead ECG; and AE/SAE monitoring) and blood samples for PK assessments will be
      collected at predetermined time points.

      Clinical laboratory tests (haematology, serum biochemistry and urinalysis) will be performed
      under fasting conditions at Day -1 at Visit 2.

      A follow-up visit will be performed on Day 15.
    

Intervention name(s): Aclidinium Bromide 400 μg
Intervention type(s): Drug
Intervention description(s): Aclidinium Bromide 400 μg BID inhalation powder. One oral inhalation via Genuair® dry powder inhaler (DPI)
Intervention MeSH terms: Bromides
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single and Multiple Dose (Twice-Daily)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this clinical study is to investigate the safety and tolerability of
      different dose strengths of IC47 up to 6 months after the first vaccination.

      A total of 32 healthy subjects (male or female) will participate in this clinical study. The
      subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47
      will be administered three times in intervals of 42 days each.
    

Detailed description: 
      This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study
      center. 32 subjects will be enrolled. The following table shows the design of the different
      study groups. The amount of protein shown in the table refers to the total protein content
      and is comprised of an equal amount of the three individual components.
    

Intervention name(s): IC47
Intervention type(s): Biological
Intervention description(s): solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Prevention of pneumococcal infections
A Study of DZD2269 in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study in healthy participants. The purpose of this study is to see how
      safe the study drug is and how well it is tolerated after dosing. This study will also
      investigate pharmacokinetics of DZD2269; renal excretion of DZD2269 will also be evaluated.
      The study will also measure biomarkers such as pCREB in the blood.
    

Detailed description: 
      A phase 1, randomized, double-blinded, placebo-controlled, study in healthy participants.
      This study includes two parts, Part A (single ascending dose escalation) and Part C (multiple
      ascending dose escalation).
    

Intervention name(s): DZD2269; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A: A single oral dose at 5mg, 10mg, 20mg, 40mg, 80mg, 160mg. Part C: Twice daily dosing for 7 days at 10mg, 30mg, 80mg.; Part A: A single oral dose. Part C: Twice daily dosing for 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
DECT Study in Allopurinol-Treated Gout Patients
Condition: Gout
MeSH terms: Gout
Study type: Observational

Summary: 
      The purpose of this study is to determine presence and volume of monosodium urate (MSU)
      crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout
      subjects treated with allopurinol with and without visible tophi.
    

Detailed description: 
      DECT is a technique that enables visualization of MSU crystal deposits by analysis of the
      chemical composition of the scanned materials. This study will determine the extent of MSU
      crystal volume in the hands/wrists, feet/ankles, and knees as determined by DECT of subjects
      with gout taking a dose of at least 300 mg allopurinol daily for the past 12 weeks.

      Patients with gout on allopurinol with and without tophi to be assessed using DECT imaging
      for crystal deposition with assessments, which include patient and provider assessments of
      disease severity and pain, prior to and after the scan.
    

Intervention name(s): DECT scan
Intervention type(s): Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Gout subjects taking a stable dose of at least 300 mg allopurinol daily for at least 12
        weeks prior to Day 1 as the sole urate-lowering therapy
      
Biospecimen description: 
      Whole blood sample may be used for optional genetic testing in subjects who give consent.
      Serum aliquots will be collected and may be used for the analysis of potential analytes and
      biomarkers, but may not be used for genetic testing without the subject's written consent.
Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine
      Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2
      to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics
      (study of the action of a drug in the body) in these children
    


Intervention name(s): Olopatadine Hydrochloride Nasal Spray 0.6%; Olopatadine Hydrochloride Nasal Spray Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): one spray in each nostril twice daily for 2 weeks; one spray in each nostril twice daily for 2 weeks
Intervention MeSH terms: Olopatadine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Allergic Rhinitis; Pediatric; PATANASE
AI-Assisted Facial Surgical Planning
Condition: Facial Plastic and Reconstructive Surgery; Periocular Diseases; Orbital Diseases; Artificial Intelligence
MeSH terms: Orbital Diseases; Facies
Study type: Observational

Summary: 
      Computer vision using deep learning architecture is broadly used in auto-recognition. In the
      research, the deep learning model which is trained by categorized single-eye images is
      applied to achieve the good performance of the model in blepharoptosis auto-diagnosis.
    

Detailed description: 
      This auto-diagnosis system of blepharoptosis using machine learning architecture will assist
      in telemedicine, such as early screening of childhood ptosis for prompt referral and
      treatment. People could use this software via mobile devices to get a primitive diagnosis
      before they reach the physicians. Furthermore, in primary health care, where there is no
      oculoplastic surgeon, the software could assist primary care physicians or general
      ophthalmologists, in identifying the need for a referral.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All data was collected at ophthalmic outpatient clinics of National Taiwan University
        Hospital.
      
Keywords: Facial Plastic and Reconstructive Surgery; Periocular Diseases; Orbital Diseases; Artificial Intelligence
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
Condition: Preterm Infant; Placental Insufficiency; Placental Transfusion
MeSH terms: Premature Birth; Placental Insufficiency
Study type: Interventional

Summary: 
      To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells
      (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in
      premature infants (34 weeks gestational age or less) with placental insufficiency.We
      hypothesized that preterm infants with placental insufficiency underwent DDC could have
      better hematologic parameters and hematopoietic progenitor cells compared to immediate cord
      clamping.
    

Detailed description: 
      • A prospective randomized controlled study will be performed on preterm infants 34 weeks
      gestational age or less with placental insufficiency, and those without placental
      insufficiency where DCC will be performed in both groups. A third group of preterm with
      placental insufficiency and immediate cord clamping will be performed as a control.
    

Intervention name(s): Delayed cord clamping
Intervention type(s): Procedure
Intervention description(s): Cord clamping 60 seconds after delivery of fetus in preterm infants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Delayed cord clamping; Preterm Infant; Placental Insufficiency; Intrauterine growth restriction
The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery
Condition: Postoperative Enfectious Morbidity; Postoperative GİS Functionally Recovery
Study type: Observational

Summary: 
      The investigators hypotheised that irrigating the abdominal cavity with saline at the time of
      cesarean delivery will increase Gastrointestinal System Disfunction without maternal
      infectious morbidity(especially febril morbidity).
    


Intervention name(s): irrigation in the peritoneal cavity
Intervention type(s): Procedure
Intervention description(s): irrigation in the peritoneal cavity after uterine wall closed at cesarean
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all pregnant women between 18 years or older and who requıred cesarean delivery.
      
Keywords: focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery
An mHealth Exercise Intervention for Sedentary Adults
Condition: Exercise Behavior
Study type: Interventional

Summary: 
      This pilot trial examines the feasibility and acceptability of a web-based, social networking
      exercise intervention in improving physical activity behavior in adults who do not perform
      regular exercise.
    

Detailed description: 
      Primary Objective To determine the feasibility and acceptability of an 8-week
      remotely-delivered exercise intervention by conducting a randomized controlled study
      comparing 3 levels of behavioral engagement.

      Secondary Objectives

      To compare the effectiveness of 3 levels of web-based interaction on physical activity
      behavior, physiological training dose, motivation and quality of life. Participants are
      randomly assigned to 1 of 3 groups:

      Level 1 (attention control): Participants receive health educational materials through email
      and the web portal.

      Level 2 (videos): Participants receive health education materials + access to 24 pre-recorded
      exercise videos.

      Level 3 (livestream classes): Participant receive health education materials + livestream
      exercise classes 3 days/week for 8 weeks.
    

Intervention name(s): Wellness Education; Exercise Videos; Livestream Classes
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Receive wellness education through a weekly email and web portal content.; Receive pre-recorded exercise videos through a weekly email and web portal content.; Receive 3 videoconference group exercise classes per week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment