bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      ALS is a debilitating disease with varied etiology characterized by rapidly progressive
      weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking
      (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is
      the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment
      that has been found to improve survival but only to a modest extent. It lengthens survival by
      several months, and may have a greater survival benefit for those with a bulbar onset. It
      also extends the time before a person needs ventilation support.Stem cell transplantation is
      a new hopeful way to improve the patients conditions and reduce the period of disabilities.
    

Detailed description: 
      In this study our purpose is to evaluate the safety of intraventricular injection of bone
      marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow
      aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell
      intraventricular injection by stereotaxis.after injection he will be under observed in ICU to
      monitor the adverse events(allergic and neurological side effects).patients are followed
      1th,3th ,6th and 12 months after injection and each time these parameters are
      checked:ALS-FRS,EMG-NCV,FVC,side effect check list.
    

Intervention name(s): intra venous injection of stem cell
Intervention type(s): Biological
Intervention description(s): Intra venous injection of mesenchymal stem cell
Other intervention name(s): Stem cell transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS bone marrow mesenchymal stem cell intravenous injection
Group Size in Basic Life Support (BLS) Courses
Condition: Educational Problems; Resuscitation
Study type: Interventional

Summary: 
      Basic Life Support (BLS) is important for outcome in cardiac arrest.Therefore, it is crucial
      to improve the quality of education in resuscitation training. Better training will
      eventually lead to more effective CPR skills in course participants. BLS courses in both
      international resuscitation associations (European Resuscitation Council and American Heart
      Association are typically taught in small groups of 6 participants. In reality group sizes of
      up to 10 participants are used, because these courses are highly demanded and cost intensive.
      There is no evidence for the effective group size to be clinical and cost effective.
      Therefore the investigators perform this prospective study to determine the maximum number of
      participants an instructor can oversee without missing more than 20% of errors made during an
      instructional BLS session.
    


Intervention name(s): errors made in one BLS session
Intervention type(s): Other
Intervention description(s): BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
Condition: Erosive Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the
      elderly population. Usually considered as a minor illness, it nevertheless leads to an
      important functional impairment. The mechanism of this disease is still poorly known.
      Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from
      which mechanisms may differ.

      Methods:

      This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in
      consultation of rheumatology and plastic surgery in Rouen University Hospital.

      Two groups of patients will be studied: 20 patients with non erosive subtype of hand
      osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.

      A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic
      analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.
    


Intervention name(s): Biological sampling; Radiographic evaluation
Intervention type(s): Procedure; Device
Intervention description(s): Biological sampling to identify by label-free proteomic analysis of a combination of serum biomarkers in patients with Erosive and non erosive hand Osteoarthritis; Radiographic assessments using Bone Mineral Analyser and Hand MRI will be done in patients with Erosive and non erosive hand Osteoarthritis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Performance of Glass-ionomer Cements: 2-year Follow-up
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this randomized clinical trial was evaluate the performance of two
      conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative
      treatment in high caries risk children.
    

Detailed description: 
      Sealants were applied on sound permanent first molars by "press finger technique" and carious
      deciduous molars that required either class I or class II restorations were restored
      according to manufacturers' recommendations in order to caries prevention and control.
    

Intervention name(s): Glass ionomer; Glass ionomer cement; -Glass ionomer-; -Glass ionomer cement-
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Application of preventive agent; Application of preventive agent; Atraumatic Restorative Treatment; Atraumatic Restorative Treatment
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: glass-ionomer cement; atraumatic restorative treatment; pit and fissure sealants
Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML
Condition: Leukemia, Myelocytic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed trial will address two clinically important questions for younger patients with
      newly diagnosed acute myeloid leukemia (AML): the optimal dose of daunorubicin in induction
      therapy and the necessity of a second induction cycle in patients with a good response after
      the first induction. The primary endpoint is the rate of good responders. Secondary outcomes
      will be relapse-free survival, overall survival and minimal residual disease kinetics.
      Patients will be recruited in about 40 treatment centers of the Study Alliance Leukemia study
      group over a period of 40 months. The results will be of great clinical relevance: First, the
      study could facilitate the establishment or confirmation of the optimal daunorubicin dose.
    

Detailed description: 
      In the first part of the trial, patients will be randomly assigned to receive either 90 mg/m2
      or 60 mg/m2 daunorubicin in the first induction cycle in addition to standard dosed
      cytarabine. Assuming a superiority of 90 mg/m2, 436 patients will be recruited. In the second
      part of the trial, good responders will be randomized to receive either a second or no
      further induction cycle. Assuming a non-inferiority of the single induction regarding the
      rate of complete remissions, a number of 360 patients will be included in the second part.
      Furthermore, in case of a non-inferiority of single versus double induction in good
      responders, about half of all younger AML patients could be spared a second induction cycle,
      leading to a reduction in treatment-related mortality, fewer days spent in hospital and
      improved quality of life.

      As a result of the preplanned interim analysis of part I, the sponsor decided to suspend
      randomization in trial part I and to offer all patients the standard dose of 60 mg/m2
      daunorubicin in both induction cycles (part I and II of the trial). Because of this an
      Amendment was sent to and approved by regulatories and ethics comitee.

      The inclusion age was raised to 65 years based on the current German treatment guidelines in
      which patients up to the age of 65 are considered eligible for intensive induction
      chemotherapy with DA60 [Onkopedia-Leitlinie 2017].
    

Intervention name(s): study part 1 - dose daunorubicin; induction cycles
Intervention type(s): Drug; Procedure
Intervention description(s): standard induction dose of daunorubicin 60 mg/m2 on days 3-5; single induction cycle versus double induction cycles (only patients with good response after first induction) Allocation is randomized for cytogenetic risk.
Intervention MeSH terms: Daunorubicin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; leukemia; induction treatment; daunorubicin; 7+3
Exercise and Noninvasive Ventilation in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF)
      subjects, hampering performance in activities of daily living. In this context, noninvasive
      ventilation (NIV) has been used to minimize such impairment, increasing functional capacity
      Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A
      randomized crossover clinical trial with allocation concealment consisted of two experimental
      phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level
      ventilation was performed. Any type of ventilator support was offered during control phase.
      Functional capacity was assessed by cardiopulmonary exercise test on a treadmill.
    


Intervention name(s): noninvasive ventilation
Intervention type(s): Other
Intervention description(s): Ventilatory support with bilevel positive pressure was held for 30 minutes with the volunteer sitting comfortably. A fan with two pressure levels (Vivo 40 Bi-Level, General Electric Company), which was attached to the face of the individual through a face Macara ( Respironics), was initially adopted one of 15 cmH2O IPAP and EPAP was used 5 cmH2O, making admissible pressure of 10 cm H2O, where the IPAP would be increased, subject to the comfort of the patient until the patient reached a tidal volume of 6-8 ml / kg, not exceeding the maximum of 20 cmH2O for IPAP.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Bioenergetic Alterations After Exenatide Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out how exenatide causes weight loss. Specifically, the
      study is assessing how exenatide may change how people take in energy (energy intake), as
      well as how it may effect how people use energy (energy expenditure).
    

Detailed description: 
      The bioenergetics study is looking at how and why the diabetes drug exenatide causes people
      to lose weight.Bioenergetics is the study of how your body burns calories.

      Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may
      be eligible. Women who could get pregnant must be on birth control during the study and women
      who are pregnant cannot participate in the study.

      Subjects will take exenatide for 12 weeks. There are 6 study visits in the Univ. Wisconsin
      Hospital General Clinical Research Center. Visits range from 1 to 6 hours and include blood
      and urine tests, resting metabolic rate testing over a four hour period, physical exam, ECG,
      and a be bone mineral density testing at another clinic during 2 clinic visits of the study.

      All study procedures and testing are free of charge.
    

Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exenatide; Byetta; weight loss; energy expenditure; normal volunteers
Mobile Health Intervention in Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
Condition: Healthy Subject
Study type: Interventional

Summary: 
      This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV)
      vaccine intervention works in increasing HPV vaccine coverage among young adult gay and
      bisexual men. Giving young men information about the HPV vaccine and the importance of
      vaccination may encourage them to get the HPV vaccine.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Pilot test a mobile health (mHealth) HPV vaccine intervention for young gay and bisexual
      men to establish feasibility and acceptability.

      II. Obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention
      increases HPV vaccine initiation compared to the control group.

      SECONDARY OBJECTIVES:

      I. Examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared
      to the control group.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I (CONTROL): Patients receive standard information about HPV and HPV vaccine, such as
      the vaccine information statement (VIS), on a mobile-friendly website study portal.

      GROUP II (INTERVENTION): Patients receive the mHealth HPV vaccine intervention consisting of
      content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination
      reminders sent by the portal via text or e-mail.

      All patients complete a survey on the study portal at baseline, immediately after the mHealth
      intervention or control materials, and at 3 months and 7 months thereafter for about 10-15
      minutes each.
    

Intervention name(s): Educational Intervention; Educational Intervention; Survey Administration
Intervention type(s): Other; Other; Other
Intervention description(s): Receive standard HPV and HPV vaccine information; Receive mHealth HPV vaccine intervention; Ancillary studies
Other intervention name(s): Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Condition: Hyperphosphataemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to see whether PT20 can help people with a high level of
      phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for
      kidney disease.
    

Detailed description: 
      PT20 represents a mechanism to address many of the limitations associated with current
      phosphate binding agents. The available clinical and non clinical evidence suggests that PT20
      binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs
      and may therefore either reduce the pill burden associated with controlling phosphate levels,
      or result in lower phosphate levels with the same pill burden.

      The this study is the first to investigate the efficacy and safety of PT20 in subjects with
      dialysis-dependent chronic kidney disease (CKD).
    

Intervention name(s): PT20; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Modified ferric oxide adipate tablets; Placebo tablets matched to each PT20 dose arm
Other intervention name(s): Iron (III) oxide adipate; ferric oxide adipate; iron (III) oxide hydroxide adipate; M10L78; Matched Placebo for PT20
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dialysis Dependent Chronic Kidney Disease
The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC
Condition: Critically Illness
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal
      Cannula compared with noninvasive positive-pressure ventilation in the prevention of
      extubation failure in patients with prolonged mechanical ventilation.
    

Detailed description: 
      There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal
      Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure.

      These review all have similar results summarized here:

      Compared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal
      Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood
      of interface displacement, and, lower reintubation rate than Noninvasive positive pressure
      ventilation.

      However, most of these clinical trials focused on participants experiencing acute respiratory
      failure.

      Investigators of this study want to find something difference between oh these two groups.
    

Intervention name(s): Heated Humidified High-Flow Nasal Cannula
Intervention type(s): Device
Intervention description(s): Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.
Other intervention name(s): Noninvasive Ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Injection Site Tolerability

      Secondary Objectives:

        -  To assess the safety profile of alirocumab SAR236553 (REGN727)

        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553
           (REGN727)
    

Detailed description: 
      The total duration of study for each subject is up to 15 weeks including a screening period
      up to 3 weeks.
    

Intervention name(s): alirocumab SAR236553 (REGN727); alirocumab SAR236553 (REGN727)
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Solution Route of administration: Subcutaneous; Pharmaceutical form:Solution Route of administration: Subcutaneous
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anderson-Fabry Disease in Chronic Kidney Disease Patients Not on Renal Replacement Therapy
Condition: Focus of Study: Prevalence of Fabry Disease in CKD Population
MeSH terms: Fabry Disease; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Anderson-Fabry disease is a rare X-linked lysosomal storage disorder due to the deficiency of
      alfa-galactosidase A (AGAL). The subsequent accumulation of glycosphingolipids may lead to to
      cardiac, renal, and central nervous system impairment as well as premature death. Recently
      published studies suggest that the true incidence of the disease may be underestimated in
      certain risk groups, e.g. in patients with chronic kidney disease (CKD).

      Therefore, the investigators initiated a multicenter case-finding study in Austria by
      screening patients with chronic kidney disease not yet on renal replacement therapy.
      Molecular isoforms of globotriaosylceramide (Gb3), characterized by different chain lengths
      of their N-acyl residues, will be determined in a urine sample. Characteristic parameters,
      including the ratio of C24/C18 isoforms will be used for identifying patients liable to have
      the disease. A positive result will be confirmed by biochemical and genetic testing.

      A sample size of 5.000 chronic kidney disease patients is envisaged allowing for detection of
      1 to 25 patients with Anderson-Fabry disease.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic kidney disease KDOQI stage 1-5 attending outpatient nephrology
        clinics in Austria and willing to participate
      
Keywords: Anderson Fabry disease; chronic kidney disease; prevalence
Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetic characteristics after
      administration of HIP1503 and HGP1103 in healthy male volunteers.
    


Intervention name(s): HIP1503; HGP1103
Intervention type(s): Drug; Drug
Other intervention name(s): Solifenacin tartrate 10.66 mg; Solifenacin succinate 10 mg
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment