bioihbjkbjnl/mcl2 huggingface dataset:
Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise
Condition: Heat Stress; Heat
MeSH terms: Heat Stress Disorders
Study type: Observational

Summary: 
      Military personnel are called upon to serve in hot, dry or humid climates, which places great
      demands on their ability to tolerate heat. Induced heat stress can impair performance and
      lead to pathologies. Faced with the challenges of global warming, this issue is becoming
      increasingly important in the practice of sport. While hyperthermia is known to impair
      endurance performance, the underlying thermophysiological responses and regulatory mechanisms
      during prolonged exercise remain poorly understood. The effects of hyperthermia on mental
      performance raise questions about the degradation of interoceptive capacities and the
      deleterious impact on behavioral regulation, an important component of thermal risk
      management in ultra-endurance exercise. What's more, despite the muscular and hydromineral
      consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are
      available on recovery kinetics. A better understanding of the factors conditioning recovery
      quality could help limit the deleterious consequences of ultra-endurance exercise.
    


Intervention name(s): Passive heat exposure; Active heat exposure
Intervention type(s): Other; Other
Intervention description(s): Participants will be exposed to heat in a chamber.; Participants will participate to a 6-hour run.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be composed of healthy young athletes.
      
Biospecimen description: 
      Blood and urine samples
    
Keywords: ultra-endurance
Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in
      subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects
      with normal hepatic function.
    


Intervention name(s): liraglutide
Intervention type(s): Drug
Intervention description(s): Single dose of 0.75 mg injected subcutaneously (under the skin)
Intervention MeSH terms: Liraglutide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants
Condition: Chronic Graft-versus-Host Disease (cGVHD)
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a
      single dose of AMG 592 administered subcutaneously in healthy Japanese participants.
    


Intervention name(s): AMG 592; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered as SC injection; Administered as SC injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Chronic Graft-versus-Host Disease; AMG 592; Inflammatory Conditions
Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether low concentration inhaled carbon monoxide
      is effective in treating idiopathic pulmonary fibrosis.
    

Detailed description: 
      Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by
      destruction of normal epithelial structure, proliferation of fibroblasts, and deposition of
      connective-tissue matrix proteins. There are currently no effective therapies for IPF. Over
      the past two decades, preclinical studies of inhaled low dose carbon monoxide (CO) have shown
      that this biologically active diatomic gas possesses properties that would make it a viable
      novel therapy for IPF. CO therapy has been well tolerated in Phase I and Phase II human
      trials to date. This phase II study is designed to investigate whether IPF patients show
      evidence of decreased peripheral blood levels of matrix metalloproteinase-7 (MMP7) and
      stability of secondary indicators of disease progression after 3 months of inhaled therapy.
    

Intervention name(s): inhaled carbon monoxide; Oxygen
Intervention type(s): Drug; Other
Intervention description(s): The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.; Room air oxygen concentrations will be administered as placebo
Other intervention name(s): CO; O2
Intervention MeSH terms: Carbon Monoxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: idiopathic pulmonary fibrosis; IPF; pulmonary fibrosis; carbon monoxide
IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability and to determine the dose
      of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in
      subjects with advanced solid tumors.
    

Detailed description: 
      Study D6770C00001 is a Phase 1, first-in-human, multicenter, open-label, dose-escalation
      study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, and
      immunogenicity of IPH5201 in adult subjects with advanced solid tumors, when administered as
      monotherapy or in combination with durvalumab ± oleclumab.
    

Intervention name(s): IPH5201; durvalumab; oleclumab
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years; Durvalumab Q3W for a maximum of 2 years; Oleclumab Q3W for a maximum of 2 years
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Implantable Loop Recorder in Hemodialysis Patients
Condition: Hemodialysis; Cardiac Arrhythmia; Cardiac Death
MeSH terms: Arrhythmias, Cardiac; Death
Study type: Interventional

Summary: 
      The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic
      hemodialysis to record arrhythmias and conduction disorders and correlate them with
      hemodialysis parameters.
    

Detailed description: 
      Primary cause of death in patients under chronic hemodialysis is Sudden Cardiac Death (SCD)
      (25% of all cause mortality). SCD is mainly due to cardiac arrhythmias (conduction
      disturbances or ventricular arrhythmias). These cardiac arrhythmias are highly sensitive to
      hydro-electrolytic disorders which are extremely frequent in patients under hemodialysis. In
      addition, other conditions leading to cardiac arrhythmias are frequent in this population
      such as ischemic myocardiopathy or dilated myocardiopathy. However, so far, little is known
      about the occurrence of arrhythmias because of studies using only standard Holter monitoring
      (24 to 48 hours monitoring at best).

      The investigators sought to evaluate the incidence of cardiac arrhythmias by using an
      implantable loop recorder (ILR)(Reveal XT, Medtronic) that allows continuous rhythm
      monitoring for 24 months. This ILR will be implanted under local anesthesia.

      Clinical follow-up will be performed during hemodialysis and rhythm management will be
      performed automatically using a remote-monitoring system (Carelink, Medtronic).
      Pre-programmed alerts (conduction disturbances, supra-ventricular arrhythmias or ventricular
      arrhythmias) recorded by the ILR will be sent automatically on a daily basis in our center.
      These data will be analyzed during week days from 9AM to 5PM. They will be reviewed by an
      electrophysiologists and depending on the potential lethality, the patients will be called
      and ask to come to the emergency room in case of high risk or the nephrologist will be
      contacted and he will see the patients during the next hemodialysis in case of on vital
      event.
    

Intervention name(s): Implantation of ILR
Intervention type(s): Device
Intervention description(s): Subcutaneous implantation of ILR under local anesthesia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hemodialysis; Cardiac Arrhythmia; Cardiac Death; Implantable Loop Recorder
Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy
Condition: Skin Aging
Study type: Interventional

Summary: 
      This study evaluates the statistics of anti-age treatment in outpatient sites in Russia
      (involution indicators: clinical scales; instrumental diagnostics, ultrasonic scannings,
      assesment of allergic state, efficacy assesment in according with GAIS scale) in routine
      clinical practice with focus on collagen therapy.
    

Detailed description: 
      This non-interventional study covers 60 patients (females with involuntary changes of the
      face skin) from Russian sites.

      The following data will be collected and analyzed after the end of treatment:

        -  demography

        -  assessment of allergic state

        -  safety data

        -  severity of aging effect

        -  clinical scales results before 1visit and after end of treatment

        -  GAIS effectiveness assessment

        -  instrumental diagnostic before 1visit and after end of treatment

        -  hydration

        -  elasticity

        -  microcirculation level

        -  lipofuscin level

        -  ultrasound scanning

        -  derma echo density
    

Intervention name(s): Collagen for injections 7%; Hyaluronic acid for injections 2%
Intervention type(s): Device; Device
Intervention description(s): Injection of medical device; Injection of medical device
Other intervention name(s): Collost; Viscoderm
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Collagen; anti-age therapy; cosmetology; lifting
Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.
Condition: Hematologic Malignancies; Allogeneic Stem Cell Transplantation
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine the safety and efficacy of a reduced
      intensity conditioning regimen during a double umbilical cord blood unit transplant with one
      of the cord blood units modulated with ProHema.
    

Detailed description: 
      The purpose of this research study is to determine the safety and efficacy of a reduced
      intensity conditioning regimen during a double umbilical cord blood unit transplant with one
      of the cord blood units modulated with ProHema.

      -As part of this research study cord units will be modulated in the laboratory with ProHema
      before it is given to the participant. Two different treatment groups will be tested. Group
      1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first
      cord blood unit modulated with ProHema.
    

Intervention name(s): Fludarabine; Melphalan; Antithymocyte Globulin; Sirolimus; Tacrolimus
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30mg/m2/day IV x 6 days; 100 mg/m2/day IV x 1 day; 1mg/kg/day x 4 days; GVHD Prophylaxis: Target range 3-12 ng/ml; GVHD Prophylaxis: Target range 5-10 ng/ml
Intervention MeSH terms: Sirolimus; Fludarabine; Melphalan; Tacrolimus; Antilymphocyte Serum
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients
Condition: Hypertension; Overweight and Obesity
MeSH terms: Hypertension; Overweight
Study type: Interventional

Summary: 
      This research will constitute a 3-year follow-up that includes a re-evaluation and
      re-intervention of overweight or obese adults suffering from hypertension, who already
      participated in a similar programme with the same objectives 3 years ago.

      Patients will be recruited in the Hypertension Unit of a public hospital and assigned to a
      experimental group. The evaluation will include: eating behaviour, body mass index (BMI) and
      physical activity levels.
    

Detailed description: 
      Hypertension incidence and overweight or obesity related, constitute a worrying public health
      problem nowadays. Evidence indicates that, despite the existence of several factors involved
      in their etiology, diet and physical activity play a particularly important role in the
      treatment and prevention of obesity and associated disorders.

      However, interventions for the treatment of obesity encounter some environmental and personal
      barriers, specifically problems or deficits in motivation. These barriers sometimes make it
      difficult to implement intervention strategies. In this sense, there is an important
      agreement about the need to generate alternatives and strategies which promote intrinsic
      motivation, self-regulation and self-efficacy as fundamental variables which have a direct
      relationship with the adherence and success of obesity treatments.

      To achieve this, Information and Communication Technologies (ICTs) are a very promising
      alternative, as they can provide personalised feedback and can be flexibly adapted to each
      user. In addition, ICTs also present other important advantages, especially their excellent
      cost-benefit ratio, and the possibility of increasing the efficiency of the interventions,
      since they allow to reach a greater number of users at a lower cost.

      This research will constitute a 3-year follow-up that includes a re-evaluation and
      re-intervention of overweight or obese adults suffering from hypertension, who already
      participated in a similar programme with the same objectives 3 years ago.

      Patients will be recruited in the Hypertension Unit of a public hospital and assigned to a
      experimental group. The evaluation will include: eating behaviour, body mass index (BMI) and
      physical activity levels.
    

Intervention name(s): REINTERVENTION
Intervention type(s): Behavioral
Intervention description(s): This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Obesity; Internet; Re-intervention; Eating Behaviour; Physical Activity
Insulet Artificial Pancreas Early Feasibility Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose is to perform an early investigation on the safety and performance of an
      Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and
      gather clinical data that will be used to make improvements or modifications to the algorithm
      for subsequent studies in adults, adolescents and children with type 1 diabetes.
    


Intervention name(s): Insulet Artificial Pancreas (AP) System
Intervention type(s): Device
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Pituitary Size and Function in Familial Dwarfism of Sindh
Condition: Growth Hormone Deficiency
Study type: Observational

Summary: 
      OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging
      (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.

      II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs.
    

Detailed description: 
      PROTOCOL OUTLINE: Pituitary size and anatomy and growth hormone response are evaluated.

      All patients undergo MRI of the pituitary fossa on day 1. On day 2, homozygous patients
      receive a slow infusion of normal saline with blood sampling every 10 minutes.
    

Keywords: endocrine disorders; growth hormone deficiency; rare disease
Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of
      Treprostinil Inhalation Powder in Healthy Normal Volunteers
    

Detailed description: 
      Up to 48 subjects will be enrolled in 8 cohorts of 6 subjects each. The treatments are
      intended to establish the maximum tolerated dose in healthy normal volunteers, starting at 30
      mcg. Each subject will receive one dose of Treprostinil Inhalation Powder by oral inhalation
      during the treatment period.

      A total of 12 pharmacokinetic blood samples will be collected from each subject. Plasma
      pharmacokinetic samples will be analyzed for treprostinil.
    

Intervention name(s): Treprostinil Inhalation Powder
Intervention type(s): Drug
Intervention description(s): Single ascending dose
Intervention MeSH terms: Treprostinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Efficacy and Safety of AD-203
Condition: Acute Gastritis; Chronic Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, active-controlled , randomized, double-blinded, paralleled group
      clinical study to evaluate the efficacy and safety of AD-203 to demonstrate the
      non-inferiority of AD-203 compared with Mucosta tab. in patients with acute or chronic
      gastritis
    


Intervention name(s): AD-203; Mucosta tab.
Intervention type(s): Drug; Drug
Intervention description(s): AD-203 administered two times daily for two weeks; Mucosta tab. administered three times daily for two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Condition: Autistic Disorder in Children and Adolescents
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in
      children and adolescents with irritability associated with autistic disorder.
    

Detailed description: 
      This is a randomized (the drug is assigned by chance), 8-week, double-blind (neither
      physician nor patient knows the treatment that the patient receives), placebo-controlled
      (placebo is an inactive substance that is compared with a drug to test whether the drug has a
      real effect in a clinical trial), parallel-group (each group of patients will be treated at
      the same time), flexible-dose, multicenter study. It will be followed by a 48-week,
      flexible-dose, open-label (all people know the identity of the intervention) extension, to
      evaluate the efficacy and safety of risperidone in children and adolescents with a diagnosis
      of autistic disorder (severe form of pervasive developmental disorder) who have associated
      irritability. The study consists of up to 2-week screening phase, an 8-week double-blind
      phase, a 48-week open-label phase, and a 1-week follow-up phase.
    

Intervention name(s): Risperidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.; Subjects will receive placebo matching with risperidone orally up to 8 weeks.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Autistic disorder in children and adolescents; Risperidone (R064766); Children; Adolescents; Irritability; Autistic disorder