bioihbjkbjnl/mcl2 huggingface dataset:
Aldosterone Blockade in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      Heart failure causes significant morbidity and mortality and is the most rapidly increasing
      cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%.
      Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of
      patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor
      prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be
      admitted to hospital in the next year. There are no proven therapies for this type of heart
      failure.

      Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart
      failure) are used in other types of heart failure. Our goal is to see if this type of drug
      improves the function of the heart by looking at the thickness of the heart muscle using MRI.
      Also we will measure the amount of tissue formation and breakdown in the heart. The trial
      will be done using both the drug and a placebo so that we can see what effects are due to the
      drug.
    

Detailed description: 
      Aldosterone antagonists have shown efficacy in systolic heart failure and in patients with
      post-myocardial infarction systolic dysfunction in three major randomized placebo controlled
      trials. Together these trials have demonstrated a reduction in mortality, hospitalization and
      a regression in left ventricular mass by MRI.

      Primary Objective The primary objective of this study will be to assess the change in markers
      of collagen turnover and correlate this with specific measures of left ventricular mass
      regression and diastolic function on MRI after 4 months of aldosterone blockade.

      Study Design and Methods This study is a double-blind, concealed allocation, randomized trial
      at the University of Alberta where patients with diastolic heart failure will be randomized
      to spironolactone or matching placebo for 4 months. Outcomes assessed include LV mass by MRI,
      collagen markers, other biomarkers, clinical outcomes, quality of life and exercise testing
    

Intervention name(s): Spironolactone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure; collagen; diastolic function
Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects
Condition: Qt Interval, Variation in
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of a single therapeutic dose and a single
      supra-therapeutic dose of imeglimin on the QT/QTc interval
    


Intervention name(s): Placebo; Imeglimin; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: QT/QTC interval; Hypoglycemic Agents; Imeglimin; Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and blood levels of orally
      administered anle138b as well as the effect of food and early signs of efficacy in patients
      with mild to moderate Parkinson´s disease.
    

Detailed description: 
      This is a two centre, double-blind, randomised, placebo-controlled, multiple ascending dose
      study in patients with mild to moderate Parkinson´s disease. It is planned to enrol up to 5
      cohorts. Cohorts A-C consist of up to 8 subjects. In Cohorts A and B, subjects will be
      randomly assigned to receive multiple ascending oral doses of anle138b or matching placebo (6
      active investigational medicinal product [IMP], 2 placebo per cohort in cohorts A-C) for 7
      days in a sequential escalating manner. Subjects in cohort A and B will be dosed once dialy
      and subjects in cohort C will be dosed twice a day. Subjects in Cohorts A and B will also
      receive an additional single oral dose of active IMP or matching placebo on Day 9 of the
      study for an assessment of the effect of food on the PK of anle138b in PD patients. Subjects
      in cohort D will be randomly assigned to receive QD doses of anle138b or matching placebo
      (placebo vs 150 mg vs 300 mg; 1:1:1) for 7 days in fasted state. Subjects in Cohort E will be
      randomly assigned to receive QD doses of either 300 mg anle138b or matching placebo (1:1) for
      28 days taken in the non-fasted state.
    

Intervention name(s): anle138b; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule containing excipient and anle138b; matching placebo capsule containing excipient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anle138b; alpha-Synuclein; Oligomer modulator; Multiple System Atrophy; Parkinson Disease; Alzheimer Disease; Neurodegenerative diseases; Tauopathies; Amyloid
The Alberta Diet: Effectiveness Study
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA
      intervention, will have improved compliance with the nutritional therapy recommendations of
      the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of
      the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a)
      to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention
      program that promotes the individual factors required for effective self-management practices
      AND that explicitly incorporate strategies to improve food availability, accessibility and
      acceptability and (b) to use these interventions as a means to examine the relationships
      between food availability, accessibility, acceptability, adherence to Nutrition Therapy
      Guidelines, and metabolic indicators of diabetes control in people with type 2 diabetes.
    


Intervention name(s): PANDA intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides
Condition: Lidocaine; Injection Pain
Study type: Interventional

Summary: 
      Propofol is widely used in general anesthesia induction, but the occurrence of peripheral
      intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in
      patients , aggravating the stress response, and even leading to adverse events of
      cardiovascular system . The use of mediate-long chain fat emulsion propofol partly reduces
      the incidence of injection pain but patients can still suffer from different degrees of pain.
      Advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but
      its application method and dose are controversial. It is worthy of further discussion on how
      to select the appropriate dose of advanced intravenous injection of lidocaine to effectively
      prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously
      avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and
      perioperative safety. In this study, in order to provide clinical references, sequential
      method was used to find the median effective dose (ED50) by means of pre-intravenous
      injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol
      injection.
    


Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): Advanced intravenous injection of lidocaine before the propofol injection
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Beta Blocker Therapy in Mild to Moderate Asthmatics
Condition: Asthma
MeSH terms: Asthma; Respiratory Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Current asthma medicines include inhalers. A common type of inhaler is called a
      'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the
      airway causing it to widen. Although these drugs are useful short term, long term use can
      make asthma worse in some people.

      'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in
      patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including
      severe asthma attacks.

      The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer'
      medication. These work by dampening down the inflammation in the lungs that occurs in asthma.

      New research has suggested that longer term use of beta-blockers can also reduce airway
      inflammation which may improve asthma control. This research was done in asthmatic patients
      who didn't need inhaled steroids to control their asthma. At the moment the investigators are
      studying to see if there is a benefit of beta-blocker use for asthma over and above
      asthmatics own usual doses of inhaled steroids.

      In this study, the investigators will be trying to find out if adding a beta blocker to a
      smaller dose of steroid inhaler has the same effect on asthma control as just using a higher
      dose of steroid inhaler by itself.
    


Intervention name(s): Propranolol; Placebo; Qvar 50; Qvar 100
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.; Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks; Qvar 50, 1 puff bd for 6 weeks; Qvar 100, 2 puffs bd for 6 weeks
Intervention MeSH terms: Beclomethasone; Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Propranolol; Inhaled corticosteroids; Steroid sparing agent; Airway hyper-responsiveness
Effects of a Self-management Course for Adults on Sick-leave
Condition: Workers on Sick-leave, Insured by The Danish Welfare State
Study type: Interventional

Summary: 
      The purpose of the current study is to determine the efficacy of a self-management course for
      workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment
      as usual). Outcomes are registry based measures of return to work, and questionnaire based
      measures of well-being and quality of life.

      We thus, hypothesize that the program will improve workers return to work rates and
      self-reported/psychological well-being.
    

Detailed description: 
      The intervention course is a Danish adaptation of The Chronic Disease Self-Management Program
      (CDSMP), tailored towards workers on sick-leave. The original program has been developed by
      The Stanford Patient Education Research Center. The translation and adaptation has been
      conducted by The Danish Committee for Health Education.

      Previous studies have examined the program with respect to specific chronic diseases (e.g.,
      Arthritis), quality of life, well-being and health-care utilization, though non-otherwise
      specified workers on sick-leave and return work have not been examined before.

      The framework of CDSMP is social-cognitive learning theory in which self-efficacy plays a
      central role.
    

Intervention name(s): Self-management program (SMP)
Intervention type(s): Behavioral
Intervention description(s): A self-management course
Other intervention name(s): Stanford patient education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sick-leave; Return to work; Self-management; Self-efficacy; Quality of Life and Well-being; Motivation
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of calcipotriol plus betamethasone
      dipropionate ointment compared with calcipotriol ointment in the treatment of patients with
      psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change
      of the psoriasis area and severity index (PASI) from baseline to the end of week 4.
    


Intervention name(s): Calcipotriol plus betamethasone dipropionate ointment
Intervention type(s): Drug
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV)
      on the duration of ventilation compared to conventional modes in COPD patients.
    

Detailed description: 
      COPD patients often need invasive mechanical ventilation and due to the difficulties in the
      weaning of these patients, duration of mechanical ventilation can be relatively longer when
      compared with other ICU patients. Automated systems show promising results in shortening the
      weaning time in some patient groups. The aim of this study is to evaluate the effect of
      Intellivent-ASV with Quickwean function on the total duration of invasive mechanical
      ventilation as a primary outcome. Secondary outcomes are success rate and duration of
      weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV)
      when compared to conventional ventilation with t-piece weaning.
    

Intervention name(s): Intellivent ASV
Intervention type(s): Device
Intervention description(s): Automated Invasive mechanical ventilation and weaning strategy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiration, Artificial; weaning; critical care
Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial
Condition: Brain Injury; Cognitive Deficits
MeSH terms: Brain Injuries; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the early and late effects of Transcranial Led
      Therapy (TLTC) in memory and executive functions in patients with moderate and severe TBI
      history (TBI time longer than 3 months).
    

Detailed description: 
      In the current study patients in the outpatient center - Neurotrauma Unit at University of
      São Paulo (HCFMUSP) diagnosed with moderate / severe blunt head trauma that meet the
      inclusion criteria will be divided randomly and blindly in two groups: Group A (n = 18) will
      receive stimulation through active helmet and Group B (n = 18) given placebo stimulation or
      sham through the inactive helmet. All patients will be subjected to 3 times of
      neuropsychological assessment: Study 1 (E1) - up to 4 weeks before the start of TLTC
      sessions; Study 2 (E2) - a week after the end of TLTC; and Study 3 (E3) - three months after
      the intervention. The evaluations will take in order to verify the early and late effects of
      TLTC in attention, memory and executive functions in patients with moderate and severe TBI.
    

Intervention name(s): Transcranial LED Therapy (TCLT); Sham
Intervention type(s): Device; Device
Intervention description(s): Whereas the geometry of the skull and to uniformly distribute the light radiation, the TLTC is applied using as light source a set of LEDs installed in a helmet, emitting radiation in the range between 600nm and 650nm with a peak at 630nm, so in the red region.; A SHAM identical helmet will be used in the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Cognitive
Bilateral Uterine Artery Ligation After Intrapartum or Postpartum Hemorrhage on Ovarian Reserve Markers and Pregnancy Outcome
Condition: Bilateral Uterine Artery Ligation; Intrapartum or Postpartum Hemorrhage; Ovarian Reserve Markers; Pregnancy Outcome
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      The aim of this study is to assess the possible negative effects of uterine artery ligation
      on ovarian reserve markers and subsequent pregnancy outcomes
    

Detailed description: 
      One of the most common surgical methods for preserving fertility is uterine artery ligation.
      It is simple to do and effective at reducing Postpartum hemorrhage after delivery .
      Additionally, it is rather safe and permits future childbearing for the patients.
    

Intervention name(s): Bilateral uterine artery ligation
Intervention type(s): Procedure
Intervention description(s): Bilateral UAL was done 2 cm under the Kerr incision (lower segment transverse). A 2-Vicryl absorbable suture (Ethicon, Neuilly-surSeine, France) was introduced from the anterior to posterior views of the myometrium 2-3 cm medial to the descending part of the uterine vessels within an avascular area in the broad ligament and tied. Following the surgery, the uterine tone and hemorrhage were managed.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients will be classified into two equal groups control group: underwent normal cesarean
        section without Postpartum hemorrhage, case group: cases underwent bilateral uterine artery
        ligation after Postpartum hemorrhage or intrapartum hemorrhage after cesarean section.

        All patients will be subjected to the following clinical parameters assessment (age, cycle
        history, body mass index, parity, preceding treatment and/or surgery menstruation
        characteristics (quantity of menstruation and dysmenorrhoea) and endometrial biopsy.
Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult
      outpatients with MDD.
    


Intervention name(s): DVS-233 SR; Venlafaxine ER
Intervention type(s): Drug; Drug
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome
Condition: Focus of Study
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      the study compare the hormonal-metabolic and reproductive outcome between combined
      metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic
      syndrome
    


Intervention name(s): metformin plus letrozole; ovarian drilling
Intervention type(s): Drug; Procedure
Other intervention name(s): cidophage plus fumara; ovarian dithermy drilling
Intervention MeSH terms: Metformin; Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; letrozole; ovarian drilling; clomiphene resistance; polycystic ovary.
Study of Oral Morphine Sulfate Administration in Pediatric Subjects
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label study to evaluate the safety and PK of oral morphine
      sulfate in pediatric subjects with post-operative pain.
    


Intervention name(s): Morphine Sulfate
Intervention type(s): Drug
Intervention description(s): Morphine every 4 hours as needed for up to a maximum of 5 days
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of TP US in Women With Prolapse
Condition: Prolapse
MeSH terms: Prolapse
Study type: Observational [Patient Registry]

Summary: 
      Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms
      in menopause
    

Detailed description: 
      The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity
    

Intervention name(s): Ultrasonography TP
Intervention type(s): Diagnostic Test
Intervention description(s): TP us will be made to the included women
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who complains from genital prolapse with previous normal deliveries
A Study in Healthy Men to Test How BI 730357 is Processed by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of the study are as follows:

        -  To assess the mass balance recovery of (C-14) BI 730357-radioactivity (also expressed as
           14C-BI 730357-EQ) in urine and faeces after a single oral dose of 50 mg BI 730357 base
           (BS) (C-14) in healthy male subjects

        -  To provide plasma, urine, and faecal samples for metabolite profiling and structural
           identification
    


Intervention name(s): BI 730357 mixed with [C-14]BI 730357 BS
Intervention type(s): Drug
Intervention description(s): Oral Solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment