bioihbjkbjnl/mcl2 huggingface dataset:
Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)
Condition: Left Atrial Fibrosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to validate the technique for the detection of left atrial
      fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained
      with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of
      healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.
    

Detailed description: 
      3D reconstructions obtained by GIMIAS® will be evaluated. Processing images will be carried
      out by two independent operators, and will calculate the kappa interobserver agreement .

      Subsequently, the processed images are compared with images previously obtained in 10
      patients with persistent atrial fibrillation adjusted for sex and age. A qualitative visual
      comparison will be made.
    

Intervention name(s): gadobutrol
Intervention type(s): Drug
Intervention description(s): Gadobutrol administration in healthy volunteers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Segmentation; GIMIAS® program; Atrial fibrillation; Left atrial fibrosis; Healthy volunteers
A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf®
      in stable liver transplantation patients. It shall be demonstrated that FK506MR is
      non-inferior to Prograf® with regards to the efficacy and safety.
    

Detailed description: 
      A multicentre, randomized, open label, two parallel group study The patients will be
      randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12
      weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue
      to use MR4 until MR4 commercial available or authority notification.
    

Intervention name(s): Prograf; FK506MR capsule
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): tacrolimus; FK506; Advagraf; tacrolimus modified release capsule; MR4; Prograf XL
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FK506; tacrolimus; prograf; Liver transplantation
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
Condition: Pharmacological Action
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can
      initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing
      the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of
      hypoglycemic episodes in the case that they should occur. The endpoints have defined such
      that consequences of this hypothesis can be measured.
    


Intervention name(s): Sitagliptin 100 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.; The treatment consists of placebo tablets for up to 24 weeks.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a postmarketing phase 2 trial. The trial is designed as single centre, randomised, double blind, two-way treatment, placebo controlled crossover trial in subjects with type 2 diabetes mellitus treated to fasting plasma glucose targets with insulin glargine and metformin.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Previous studies have shown that women on anti-seizure medications are not informed about the
      pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, AEDs)
      and certain hormonal contraceptive. The goal of this proposed study is to develop and assess
      the efficacy of an educational handout for participants on the ways AEDs and certain hormonal
      contraceptives can interact to alter effectiveness of the medications. Reproductive age women
      (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a patient
      agrees to participate, she will be given a knowledge exam prior to the clinic appointment to
      establish baseline understanding of hormonal contraceptive and AED interactions and then the
      participant will be randomized to receive the intervention (educational handout) or the
      standard of care (no educational handout). Those in participants in the intervention group
      will read an educational handout on hormonal contraceptives/AED interactions. Those in the
      standard care group will not receive this handout and the same knowledge exam will be
      re-administered to all of the participants after they have completed their appointments to
      check for knowledge comprehension and short-term knowledge retention. A same-day post-test
      questionnaire will evaluate participant's intention to discuss hormonal contraceptives/AED
      interactions with their gynecologist, neurologist or primary care physician.
    


Intervention name(s): Educational handout
Intervention type(s): Other
Intervention description(s): Topics include: interactions between AED and certain hormonal contraceptives, Center for Disease Control and Prevention (CDC) recommendations for alternative contraceptive methods that are not known to interact with AEDs, contraceptive failure rates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Drug interactions
18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine if olmesartan plus amlodipine combination therapy alone and with
      hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive,
      type 2 diabetic subjects.
    

Detailed description: 
      This is a single group study in which participants were titrated to the next of 6 regimens if
      blood pressure (BP) goals were not met.
    

Intervention name(s): Amlodipine; amlodipine / olmesartan medoxomil combination; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amlodipine 5 mg tablets , Daily for 3 weeks;; amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg; hydrochlorothiazide tablets, 12.5 mg or 25 mg.
Other intervention name(s): Norvasc; Azor
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood pressure reduction
Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
Condition: Respiratory Depression
MeSH terms: Respiratory Insufficiency; Depression; Depressive Disorder
Study type: Observational

Summary: 
      Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in
      detection of postoperative respiratory depression in high risk patients.
    

Detailed description: 
      Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk
      patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative
      respiratory depression in high risk patients as detected by continuous respiratory volume
      monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and
      continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative
      respiratory depression in high risk patients
    

Intervention name(s): Expiron respirator
Intervention type(s): Device
Intervention description(s): Respiratory volume monitor (RVM) (ExSpiron, is a non-invasive FDA approved device that monitors minute ventilation (MV) and provides an early indication of respiratory status in non-intubated patients. The system consists of a lightweight monitor, a patient cable, and a disposable electrode PadSet, which detects changes in breathing.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group A; which will involve pregnant women with gestational age between 32-40 weeks. It
        will take place at:

        i. Labor and delivery floor/obstetric floor: 100 patients scheduled for cesarean section
        under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine.

        ii. Antenatal care: (obstetric floor, Long Wharf women clinic, Women center at Yale)

        Group B; in post anesthesia care units (PACU) and surgical floor: 100 patients scheduled to
        receive General Anesthesia (GA) and planned to receive opioid intravenously
        (boluses/patient controlled analgesia (PCA).

        Group C: in step down/ICU; 50 patients suffered from rib fracture and 50 patients after
        weaning from mechanical ventilation and extubation.
Influence of BRAF and PIK3K Status on the Efficacy of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFIRI) Plus Bevacizumab or Cetuximab in Patients With RAS Wild-type Metastatic Colorectal Carcinoma and < 3 Circulating Tumor Cells (CTC)
Condition: Colorectal Cancer Metastatic
MeSH terms: Carcinoma; Colorectal Neoplasms; Neoplastic Cells, Circulating
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to explore the influence of BRAF and PIK3K status on the efficacy
      of FOLFIRI plus Bevacizumab or Cetuximab, as first line therapy of patients with RAS
      wild-type metastatic colorectal carcinoma and < 3 circulating tumor cells
    


Intervention name(s): FOLFIRI + bevacizumab; FOLFIRI + cetuximab
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab 5 mg/kg iv, followed by
Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by
Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by
5-FU 400 mg/m2 iv bolus, followed by
5-FU 2,400 mg/m2 for 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).; Cetuximab in an initial 120-minute infusion on day 1 of 400 mg/m2, followed by 60-minute infusions of cetuximab at a dose of 250 mg/m2, once weekly
FOLFIRI:
Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by
Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by
5-FU 400 mg/m2 iv bolus, followed by
5-FU 2,400 mg/m2 for 46 h continuous infusion FOLFIRI will be given after the cetuximab infusion on day 1 of each period (every 2 weeks: 1 cycle).
Intervention MeSH terms: Bevacizumab; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal carcinoma; BRAF and PIK3K; FOLFIRI -Bevacizumab -Cetuximab; circulating tumor cells
Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20)
      will change the exposure and action of approved insulin analogs when given by continuous
      subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).

      This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before
      Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2.
      Stage 2 was not initiated due to a strategic business decision and termination was not based
      on safety or efficacy concerns. No participants were enrolled in Stage 2.
    


Intervention name(s): Insulin aspart; Recombinant human hyaluronidase PH20 (rHuPH20)
Intervention type(s): Drug; Drug
Other intervention name(s): Novolog; PH20; Hylenex
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Insulin analog; Type 1 diabetes mellitus; Pharmacokinetic; Glucodynamic; Phase 1
Atraumatic Care Practice From the Child and Parent Perspective
Condition: Nurse's Role
Study type: Interventional

Summary: 
      It is important for pediatric nurses to apply atraumatic care while providing care to
      children and their families. Pediatric nurses should use methods appropriate for the child's
      age and developmental period within the scope of atraumatic care.
    

Detailed description: 
      The use of atraumatic care approaches such as supporting the active participation of the
      family in the care of the child, using therapeutic communication techniques with parents and
      children during procedures, providing emotional support, reducing pain during painful
      procedures, using techniques to distract the child's attention during medical procedures,
      informing parents about the procedures to be performed on their children, and supporting
      parents and teaching techniques to cope with stress is recommended to be used by the nurses.
    

Intervention name(s): Atraumatic nursing care
Intervention type(s): Behavioral
Intervention description(s): Children in the intervention group were allowed to choose a distracting method (foam balloons, stress balls, musical books) to be occupied with during the procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: child; fear; pain; phlebotomy; distraction methods; atraumatic care
Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of quetiapine compared to placebo in
      the treatment for a major depressive episode in patients with bipolar disorder after
      receiving treatment for up to 8 weeks.
    


Intervention name(s): Quetiapine Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar I Disorder
Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Cystic fibrosis is a genetic disease (autosomal recessive) which involves malfunction of the
      exocrine glands, leading to abnormal secretions in the body. It is a progressive disease that
      causes persistent lung infections and limits the ability to breathe over time. Clinical
      symptoms include persistent coughing, at times with phlegm, wheezing or shortness of breath,
      fatigue, difficulty with bowel movements sinus infections, poor growth, clubbing of the
      fingers and toes, and infertility in most males. The disease must be managed throughout life
      with diet, medication and preventive chest physical therapy as soon as any symptoms are noted
      in the young child. The purpose of the study was to evaluate the difference between the
      effects of Manual Chest Physiotherapy (CPT) and Active Cycle of Breathing Techniques (ACBT)
      in patients of Cystic Fibrosis. The tools of our study were Modified Borg Dyspnea Scale and
      Quality of well-being Scale. The total sample of our study was 14 out of which 7 were
      included in GROUP A and 7 Group B. SPSS 23 was used for statistical analysis and parametric
      tests were used for analysis
    


Intervention name(s): MCPT; ACBT
Intervention type(s): Other; Other
Intervention description(s): Postural Drainagewith percussion and vibration; ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The objective of the project is to develop, implement and evaluate a prevention program for
      obesity among adolescents in Brazil combining the primary care health system implemented in
      the country in recent decades with primary prevention at schools.
    

Detailed description: 
      The study will combine primary prevention activities at the school level with secondary
      prevention at the household level, both focusing on behavior strategies such as mindfulness,
      reduction of eating rate; eating with others at a dinning table; healthy eating, increasing
      physical activity and reducing sedentary lifestyle habits.
    

Intervention name(s): Intervention group
Intervention type(s): Behavioral
Intervention description(s): The proposed intervention will focus on encouraging students to change their eating habits and food consumption over 9 months (from March to November). Monthly 1-h sessions in the classroom will be given by the class teacher, and includes playing games, staging theater sketches, watching movies and puppet shows, and writing and drawing contests. The activities were designed to discourage students from consuming sugar-sweetened beverages as well as getting them to replace snacks, particularly processed foods (especially cookies) with fresh fruit or healthy homemade food. To reinforce the messages of the in-class nutritional sessions, a set of messages will be sent to the families in the form of illustrated booklets and recipes.
The secondary prevention strategy at households will be developed for those with excessive weight. The family will receive additional motivation to change these behaviors, using the community health agents as the encourager.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: school-based intervention; sedentary behavior; physical activity; sugar sweetened beverages
PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study is to determine an optimal dose and dosing regimen of
      PT001 MDI for further evaluation in later stage studies.
    

Detailed description: 
      The primary objective of this study is to assess efficacy relative to placebo of GP MDI in
      subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the
      range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared
      to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
    

Intervention name(s): PT001 MDI; Tiotropium Bromide; PT001 Placebo MDI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as two puffs BID for 14 days; Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
Other intervention name(s): Spiriva® Handihaler®
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy in MICS
Condition: Mitral Regurgitation
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to
      allow access to the heart through a small incision in the right chest. This avoids the use of
      a sternotomy incision through the bone in the front of the chest. The benefits of such an
      approach are cosmetic (smaller incision not easily visible) and faster recovery. The
      minimally invasive approach also eliminates the risk of sternal wound infection. Minimally
      invasive cardiac surgery however poses additional challenges; one of the biggest is access to
      the large blood vessels which need to be cannulated to allow the heart lung machine to
      function. In conventional surgery, these vessels are easily accessed as they are entering or
      leaving the heart. In minimally invasive surgery, the cannula are placed into easily
      accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller
      than those by the heart and so require smaller cannula, which provide challenges to the heart
      lung machine. One way around this is to use more cannulae and so cannulation of a vein in the
      neck is also performed. This cannula however, has been associated with neck hematoma, tearing
      of the vein and blood loss. While placement of the cannula in the neck is routine at LHSC
      now, when this surgery was first performed here 10 years ago, it was done so without the neck
      cannula and with no injury to patients. The purpose of this study therefore, is to more
      rigorously study the effect of the neck cannula on heart lung bypass, and more specifically
      to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid
      hypoxia.
    


Intervention name(s): PSVC line clamped
Intervention type(s): Procedure
Intervention description(s): A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: minimally invasive cardiac surgery; cardiac surgery; near infrared spectroscopy; mitral valve repair; mitral valve replacement