bioihbjkbjnl/mcl2 huggingface dataset:
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      This project will evaluate the impact of a patient decision aid created by the American
      College of Cardiology for patients considering treatment of aortic stenosis. The decision aid
      describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve
      replacement surgery (TAVR).
    

Detailed description: 
      The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac
      surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The
      study will recruit patients at Massachusetts General Hospital or at the University of
      Colorado Health Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly
      assign them to usual care arm or decision aid arm. The decision aid will be given to the
      participant in clinic at the time of their appointment. Patient participants in both arms
      will be asked to complete a short survey after the visit. The survey will assess knowledge,
      treatment preference, shared decision making (SDM), and decisional conflict. Analyses will
      compare the two arms on these outcomes to generate preliminary data on impact of the
      intervention.
    

Intervention name(s): "Treatment Choices for Aortic Stenosis" Decision Aid
Intervention type(s): Behavioral
Intervention description(s): A decision aid, titled "Treatment Choices for Aortic Stenosis," produced by the American College of Cardiology that contains information for patients deciding between TAVR and surgery to treat their aortic stenosis.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomly assigned to receive the decision aid or usual care.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Shared Decision Making
Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy
Condition: Hepatic Transplantation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether clamp-crush technique for liver parenchymal
      transection is as safe as Harmonic scalpel device. outcomes will include: perioperative
      mortality, surgery-related complications, blood loss, amount of blood loss during
      hepatectomy, operating time, transection speed, markers of liver parenchymal injury and
      hospital stay.
    


Intervention name(s): Harmonic scalpel; Kelly clamp crush technique
Intervention type(s): Device; Device
Intervention description(s): a method for liver parenchymal transection; a method for liver parenchymal transection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
What Benefit of a Full Analysis of Exome? Routine Care Study in Patients With Solid Tumors
Condition: Carcinoma
Study type: Observational

Summary: 
      The management of cancers and their therapeutic guidance was until shortly mostly based on
      histopathological considerations of the tumor. the development of targeted therapies is a
      turning point and keeps increase. These molecules target a specific molecular defect in the
      tumor making it more effective and more specific treatment. But these treatments are only
      effective if the tumor has a specific molecular abnormality that is characterized and known.

      These therapeutic progresses have been made possible through the decoding of the human genome
      and the molecular defects occurring during the carcinogenesis process. Now, dozens of
      therapies targeting a specific molecular abnormality are available in the therapeutic arsenal
      and dozens more are under development in clinical trials Phase 1 to 3.

      In recent years, the democratization of next generation sequencing has opened a new era in
      cancer research but also for molecular diagnostics. Indeed, the enormous sequencing
      capabilities offered by high-throughput sequencing technologies allow analysis in a limited
      time the entire coding sequence of the genome (exome), or even the entire genome of a tumor
      (whole genome sequencing). Thus, the evolution and the development of broadband and
      associated bioinformatics tools for genomics techniques now make it possible to establish the
      genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to
      propose and specifically targeted direct therapeutic identified genetic alterations and
      supposedly responsible for tumor development. An analysis of tumor exome by next-generation
      sequencing (NGS) and provides information on genetic modifications of these tumors.

      This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this
      study is to evaluate the clinical benefit of an analysis of exome performed in current
      practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by
      quantifying the number of patients undergoing therapeutic proposal based on the results of
      the analysis of the profile of the tumor.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patient with all types of solid malignant tumors not treatable metastatic
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of
      sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive
      Disorder. This study includes an 8-week double-blind phase.
    


Intervention name(s): Agomelatine (AGO178C); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agomelatine; Major Depressive Disorder; MDD; depression
PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is being conducted to evaluate the relative bioavailability and single- and
      multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.
    


Intervention name(s): mesalamine
Intervention type(s): Drug
Intervention description(s): encapsulated mesalamine granules
Intervention MeSH terms: Mesalamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetic study; Healthy subjects
Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to show that ViscoGel® is safe when administrated alone and as
      an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the
      quantitative and qualitative effect on the immune response.
    


Intervention name(s): 0.2μg Act-HIB®; ViscoGel® and 0.2μg Act-HIB®; ViscoGel® and 2μg Act-HIB®; 2μg Act-HIB®; 10μg Act-HIB®
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.; Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.; Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.; 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.; Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use
A Pharmacokinetic Study of Narlaprevir as a Single Dose or With Ritonavir Combination in Patients With Hepatic Impairment and Healthy Matched Volunteers
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was conducted to evaluate narlaprevir (NVR) pharmacokinetics (PK) after a single
      dose with or without ritonavir (RTV) in cirrhotic Child-Pugh class A patients without active
      HCV infection versus healthy subjects as well as to assess safety and tolerability of such
      treatment combination.
    

Detailed description: 
      The objective of this study was to evaluate PK after a single oral dose of NVR alone and in
      combination with RTV in patients with compensated liver cirrhosis and in matched healthy
      controls.

      The study consisted of 2 parts. In Part I of the study, 8 patients with compensated cirrhosis
      (Child-Pugh Class A) and 8 matched healthy adult subjects received single doses of NVR at 200
      mg with 240 ml of water after a standard breakfast. The 200-mg NVR dose was chosen since this
      is the intended therapeutic dose. Blood and urine samples were obtained to determine
      narlaprevir concentration in plasma and urine.

      As an additional safety precaution, patients with Child-Pugh Class A hepatic impairment were
      studied successively in Part I and Part II on the basis of the results of an interim safety
      analysis data and PK data.

      Based on the results of the interim analysis after the Part I of the study, it was decided to
      reduce the dose of narlaprevir from baseline 200 mg to 100 mg in Part II of the study.

      In part 2 of the study, 8 patients with compensated cirrhosis (Child-Pugh Class A) and 8
      healthy subjects received NVR at 100 mg in combination with RTV at 100 mg with 240 ml of
      water after a standard breakfast. Blood and urine samples were obtained to determine
      narlaprevir concentration, its metabolite and ritonavir in plasma and urine.

      The total duration of the study for each subject was a maximum of 35 days.
    

Intervention name(s): Narlaprevir; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg film-coated tablets; 100 mg film-coated tablets
Intervention MeSH terms: Ritonavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fitness Assessment in Young Adults Recovered From Lymphoma
Condition: Young Adults; Lymphoma, Non-Hodgkin; Hodgkin Disease
MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin
Study type: Interventional

Summary: 
      Regular physical activity (PA) is associated with maintaining body composition, increased
      cardiorespiratory capacity, muscle mass and bone mineral density. In the event of a cancer,
      the development of physical capacities and metabolism may therefore be disturbed by cancer,
      these associated treatments (chemotherapy, radiotherapy and hematopoietic stem cell
      transplantation) but also undernutrition and the reduction in physical activity or even a
      sedentary lifestyle.

      Although the benefits of PA in oncology are now well identified for adult populations,
      studies are still rare in the population of children, adolescents and young adults, and the
      results are still difficult to generalize. As a result, there is no recommendation on the
      practice of physical activity in pediatric oncology or adolescents and young adults and the
      levels of physical activity of cured patients remain lower than those of the general
      population.

      Fitness is a marker of health in adults as well as in adolescents. Physical condition is a
      set of components such as cardiorespiratory capacity (transport and use of O2), body
      composition (distribution of bone, muscle and fat masses) and muscle function (strength,
      power, fatigue, energy metabolism) .

      The investigators hypothesize that, compared to young adults, recovered from lymphoma are
      expected to exhibit impaired physical condition, due to physical deconditioning.
    


Intervention name(s): Indirect calorimetric test during submaximal exercise
Intervention type(s): Other
Intervention description(s): metabolic evaluation by indirect calorimetry at rest and during exercise
evaluation of cardiac output
peripheral quantitative computed tomography (pQCT) of the muscle cross section
evaluation of body composition
assessment of physical capacity (chair test and 3 min step-test)
blood test
assess the level of physical activity
Other intervention name(s): cardiac output; body composition; assessment of physical capacity; blood test; accelerometry; peripheral quantitative computed tomography
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: group 1: healthy controls group 2 : young adults recovered from lymphoma or Hodgkin's disease
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: physical fitness; fat oxidation; metabolism; exercise
The Adjustment of Doses in Diabetes Mellitus Type I
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational [Patient Registry]

Summary: 
      The study was carried out in a diabetic patient who was starting a new approach for
      treatment. Previously the patient was treated with Novo-mix insulin injection twice per day,
      the physician decided to change the treatment strategy to be with three doses of novo-rapid
      insulin injections per day plus one injection of Lantus SoloStar in dinner. For two weeks we
      were monitoring the blood glucose level by the FreeStyle Libre sensor. Moreover, the right
      statistical technique was used for data analysis.
    

Detailed description: 
      In this study a diabetic patient is starting a new approach to treatment. Previously, the
      patient received Novo-Mix insulin injection twice per day (48 Units in breakfast & 28 Units
      in dinner). Moreover, the physician decided to change the treatment strategy to be with
      Novo-Rapid insulin injection three times per day (36 Units in breakfast, 36 Units in lunch &
      50 Units in dinner) plus one time injection of Lantus SoloStar (50 Units) in dinner. Thus,
      for monitoring blood glucose level, we are using the FreeStyle Libre-Link. Moreover.
      Moreover, FreeStyle Libre sensor continuously measures glucose every time when scanned by the
      mobile and saves the glucose data in the library. Moreover, scanning the FreeStyle Libre
      sensor with a phone or the reader measures the glucose levels from the interstitial fluid, a
      thin layer of fluid that surrounds the cells of the tissues in the skin of the patient [4].
      The Scan was done every 1-2 hours for a full glycemic profile.
    

Intervention name(s): Insulin injection and blood glucose
Intervention type(s): Drug
Intervention description(s): The FreeStyle Libre sensor continuously measures glucose every minute and saves the glucose data. Scan the sensor at least every 8 hours for a full glycemic profile. The below data is displayed after a typical 1-second scan of the FreeStyle LibreLink app or FreeStyle Libre reader via the sensor:
Other intervention name(s): FreeStyle Libre sensor
Intervention MeSH terms: Insulin
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The study was carried out in a diabetic patient who was starting a new approach for
        treatment. Previously the patient was treated with Novo-mix insulin injection twice per
        day, the physician decided to change the treatment strategy to be with three doses of
        novo-rapid insulin injections per day plus one injection of Lantus SoloStar at dinner.
      
Keywords: Diabetes mellitus, Insulin injection, Patients training
Oral Propionate to Treat and Prevent Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of these studies is to firstly determine the pharmacokinetic profile of orally
      administered enteric coated sodium propionate. Subsequently, the most efficacious dose at
      improving glucose tolerance following an oral glucose challenge will be determined. The
      investigators will then determine the mechanism of action of propionate, whether it acts by
      altering beta cell function directly or by augmenting the incretin effect or both
    

Detailed description: 
      The NHS spends £1M per hour, 10% of its yearly budget, treating diabetes. In the UK cases of
      diabetes are expected to top 4 million by 2025. There is an urgent need for new therapies.
      The short chain fatty acid propionate is a natural substance produced by digestion of
      fermentable carbohydrates. Preclinical and early human data demonstrate it improves
      pancreatic function and glucose control. The investigators aim to conduct proof of principle
      studies to determine if oral delivery of propionate improves glucose control in patients at
      risk of developing diabetes.
    

Intervention name(s): Sodium propionate; Sodium Chloride; Oral glucose tolerance test; Intravenous glucose tolerance test.
Intervention type(s): Dietary Supplement; Dietary Supplement; Procedure; Procedure
Intervention description(s): Sodium propionate capsule or tablet; Placebo capsule or tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes Mellitus; Propionate
Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
Condition: Infantile Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional

Summary: 
      The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical
      activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi
      is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the
      esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and
      delivers respiratory assistance according to measured Edi signal which allows synchronous
      assistance, proportional to the respiratory efforts of the patient.

      To date, no measure of the effectiveness of NAVA NAV has been performed in children with
      neuromuscular pathology whereas this technique could reduce the use of invasive ventilation,
      very iatrogenic in these fragile subjects.
    

Detailed description: 
      This is a prospective, interventional, sequential, open-label research involving ASI II
      children with acute respiratory decompensation requiring ventilatory support by NIV. Airway
      pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded
      continuously during the study, after inclusion of the patient.
    

Intervention name(s): NAVA
Intervention type(s): Device
Intervention description(s): The study has 3 phases:
Phase 1:
The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements.
Phase 2:
Switch to NAVA mode (1h).
Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode.
NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min.
Phase 3:
The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infantile Spinal Muscular Atrophy; Respiratory Decompensations
High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance
Study type: Observational

Summary: 
      In the present study, serum pentraxin 3 level and its relationship with insulin resistance
      were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3
      level is increased in patients with PCOS and it is positively correlated with HOMA-IR.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        40 PCOS patients and 40 healty controls
      
Keywords: PCOS and PTX3 levels
Timing of Initiation of LMWH Administration in Pregnant Women With APS
Condition: Recurrent Miscarriage; Antiphospholipid Syndrome
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Antiphospholipid Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of the effect of altering the timing of initiation of low molecular weight heparin
      (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)
    

Detailed description: 
      Women will be randomly divided into two groups; one will start Enoxaparin therapy once
      positive pregnancy test is established and the other will start Enoxaparin therapy after
      sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given
      in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of
      pregnancy
    

Intervention name(s): Enoxaparin; Enoxaparin
Intervention type(s): Drug; Drug
Intervention description(s): Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy; Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy
Other intervention name(s): Clexan; Clexan
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antiphospholipid syndrome; APS; LMWH