bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Convalescent Immune Plasma Therapy
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the safety, improvement of clinical symptoms and
      laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients
      with ARDS.
    

Detailed description: 
      The aim of the study is to evaluate the safety, improvement of clinical symptoms with
      hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma
      treatment in severe Covid-19 patients followed up in critical care unit.
    

Intervention name(s): Convalescent Immune Plasma
Intervention type(s): Other
Intervention description(s): One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Use of Earplugs on Temporomandibular Joint
Condition: Ear Protective Devices; Temporomandibular Joint Disorders; Physical Therapy Modalities
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The term temporomandibular joint disorder (TMD) refers to a group of disorders affecting the
      temporomandibular joint and/or muscles of mastication. Typical symptoms are; joint noises,
      pain, and limited mouth opening. Many therapeutic modalities have been advocated for the
      treatment of TMD as intraoral splints, laser, ultrasound, physical therapy, surgery, and
      medications with inconsistent reported results due to the multifactorial etiology of this
      disorder. Although intraoral splints are the most widely used therapy, it has some drawbacks
      as being inconvenient for the patient due to their relatively large size interferes with
      eating and affects speech, therefore their use is mostly limited to sleeping time, which
      decreases its effectiveness.

      Recently some commercial earplugs that claim to treat TMD have been introduced, however,
      there is no validated data regarding these appliances. Thus, this study aimss to evaluate the
      possible effect of earplugs on myogenous TMD.
    


Intervention name(s): Earplug; occlusal splint; exercise
Intervention type(s): Device; Device; Other
Intervention description(s): Using earplugs to reduce the symptoms of temporomandibular disorder; Using occlusal splints to reduce the symptoms of temporomandibular disorder; Applying exercise to reduce the symptoms of temporomandibular disorder
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised controlled clinical trial
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Splints
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the following in very young children with Down syndrome:

        -  the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically
           and by ultrasensitive thyreostimulating hormone (TSH) assay),

        -  the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,

        -  any interaction between these two treatments.
    


Intervention name(s): thyroid hormone and folinic acid
Intervention type(s): Drug
Intervention description(s): thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
Intervention MeSH terms: Leucovorin; Folic Acid; Hormones; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Down syndrome; Young children; Psychomotor development; Thyroid hormone; Folinic acid; Psychometric tests; GMDS; Griffiths; Genetic factors; Biochemical factors
Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction
Condition: Non Invasive Ventilation; Patient Ventilator Interaction
Study type: Interventional

Summary: 
      The present study aims to compare various parameters reflecting patient-ventilator synchrony
      during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a
      group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory
      failure of various origin.
    

Detailed description: 
      The present study aims to compare various parameters reflecting patient-ventilator synchrony
      during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a
      group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory
      failure of various origin. The subgroup of COPD patients will be analyzed separately. The
      effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator
      interaction will also be explored.
    

Intervention name(s): Neurally Adjusted Ventilatory Assist
Intervention type(s): Device
Intervention description(s): Non invasive ventilation under Neurally adjusted Ventilatory Assist
Other intervention name(s): NAVA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mechanical ventilation; Non invasive Ventilation; Patient-ventilator interaction; Pressure support; Neurally adjusted ventilatory assist
A Study in Pediatric Participants With Generalized Anxiety Disorder
Condition: Anxiety Neuroses; Anxiety States, Neurotic; Neuroses, Anxiety
MeSH terms: Anxiety Disorders; Neurotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a
      day by mouth for 10 weeks to children and adolescents, is better than placebo when treating
      Generalized Anxiety Disorder (GAD).
    


Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): Cymbalta; LY248686
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Food-Drug Interaction Study of Serum Urate After Oral Inosine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of food on the amount of urate in the body
      after a single oral dose of inosine.
    

Detailed description: 
      Eighteen (18) eligible healthy male subjects will be randomly assigned to two groups with 9
      subjects per group to receive a single oral dose of 1000 mg inosine with or without food on
      day 1 after an overnight fast. Subjects who receive inosine with food on day 1 will receive a
      second dose of inosine without food on day 8 after an overnight fast. Subjects who receive
      inosine without food on day 1 after an overnight fast will receive a second dose of inosine
      with food on day 8 after an overnight fast.

      Subjects will be admitted to the clinic before dinner on days 0 and 7, the days before
      dosing, and will stay in the clinic for 48-h post-dose. During the clinic stay, blood samples
      will be taken for urate measurements.
    

Intervention name(s): Inosine
Intervention type(s): Drug
Intervention description(s): Inosine, 1000 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
Condition: Generalized Tonic Clonic Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate the safety, tolerability and efficacy of two doses of
      pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized
      Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of
      pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC
      seizure frequency and that pregabalin will be safe and well tolerated.
    


Intervention name(s): Pregabalin Dose Level 1; Pregabalin Dose Level 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.; Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.; Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
Other intervention name(s): Lyrica Dose Level 1; Lyrica Dose Level 2
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Primary Generalized Tonic Clonic Seizures; Epilepsy; Safety; Efficacy; Tolerability; Pregabalin; Lyrica; Adjunctive treatment; Placebo Controlled; Blinded
Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study is a randomized, open-label, international, multi-center, comparative
      study of efficacy and safety of BCD-148 and Soliris® in PNH patients.

      It is planned to investigate the efficacy, safety, and immunogenicity of one-year eculizumab
      course in this study.

      PNH - Paroxysmal nocturnal hemoglobinuria
    


Intervention name(s): BCD-148; Soliris
Intervention type(s): Biological; Biological
Intervention description(s): Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.
Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period).
QW - once weekly; Active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5.
Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period).
Intervention MeSH terms: Eculizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During the main period (first 27 weeks), test product BCD-148 and reference product Soliris®.
After Week 27, patients of both study arms will be switched to BCD-148 900 mg biweekly as maintenance therapy. Duration of this maintenance therapy will be 25 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the
      pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.
    


Intervention name(s): Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
Intervention type(s): Drug
Intervention description(s): Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: drug interactions; ketoconazole; pharmacokinetics; human volunteers
Comparison of Characteristics of Bronchoalveolar Lavage Dusting and of Specific Questionnary Data in Healthy Volunteers and Patients Suffering From Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional

Summary: 
      Comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients
      suffering from sarcoidosis.

      Blind analysis of bronchoalveolar lavage with Optical Microscopy, Transmission Electron
      Microscopy and MicroAnalysis.

      For patients, comparison of bronchoalveolar lavage, pathological examination of biopsies
      (Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis) and specific
      Professional and environmental questionnary.

      Healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco
      consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year,
      smoking more than 10 pack-year)
    


Intervention name(s): Bronchoalveolar lavage
Intervention type(s): Other
Intervention description(s): Bronchoalveolar lavage in order to determine rate of dust
Intervention MeSH terms: Dimercaprol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dust rate; Microscopic analysis
A Prospective, Remote Observational Study in Pediatric Participants With Early-Onset SCN2A-Developmental and Epileptic Encephalopathy
Condition: SCN2A-DEE; Epilepsy
MeSH terms: Epilepsy; Brain Diseases
Study type: Observational

Summary: 
      This prospective observational study is designed to assess the individualized baseline
      disease burden in pediatric participants aged 1 year to 16 years, with early-onset SCN2A-DEE
      by characterizing and quantifying changes in clinical features over a period of up to 12
      months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This trial will enroll eligible pediatric participants with confirmed early-onset
        SCN2A-developmental and epileptic encephalopathy.
      
Keywords: SCN2A-DEE; Epilepsy; SCN2A variant; Pediatric epilepsy; Electroencephalogram; Developmental and Epileptic Encephalopathy; DEE
Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis
Condition: De Quervain Disease
MeSH terms: Tenosynovitis; De Quervain Disease
Study type: Interventional

Summary: 
      68 De Quervain tenosynovitis(MPS) diagnosed patients will be randomly divided into 2 groups.
      To groups; splinting+exercise+high-intensity laser therapy (HILT) and splinting+exercise+sham
      HILT will be applied. Visual anolog scale (VAS) scores, quick Disabilities of the Arm,
      Shoulder, and Hand (QDASH) questionnaire and Hand grip strength measurements of the patients
      before-after treatment will be recorded and will be evaluated statistically.
    


Intervention name(s): high intensity laser therapy
Intervention type(s): Device
Intervention description(s): Laser treatment is noninvasive and painless and can be easily administered in therapy units for a wide range of conditions. High-intensity laser therapy (HILT) has gained importance for the treatment of different kinds of sports injuries such as tendon injuries, contusions, and muscle spasms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hand grip strength; high-intensity laser therapy; De Quervain Disease
The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine if postprandial (after a meal) endothelial (inner
      lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of
      exercise
    

Detailed description: 
      Endothelial dysfunction is due to an imbalance between vasodilating and vasoconstricting
      substances produced by the endothelium. An imbalance in these substances limits the ability
      of the blood vessel to relax in response to a shear stress stimulus. Endothelial dysfunction
      is a major risk factor for cardiovascular disease.

      High-sugar intakes result in postprandial hyperglycemia and endothelial dysfunction. Exercise
      may attenuate the endothelial dysfunction induced by a high-sugar meal. There are only two
      studies that have examined the effect of exercise on endothelial dysfunction induced by
      high-sugar intake. Both studies found that a bout of aerobic exercise attenuated the impaired
      flow mediated dilation induced by high-sugar ingestion. Neither study measured important
      markers of endothelial dysfunction such as blood nitric oxide, endothelin I, and angiotensin
      II concentrations, however. In addition, whether the same results apply to older
      post-menopausal women is unknown. Understanding how acute exercise affects meal-induced
      endothelial dysfunction in older women is important given that age is related to endothelial
      dysfunction and cardiovascular disease.
    

Intervention name(s): Exercise Condition; Control Condition
Intervention type(s): Other; Other
Intervention description(s): A bout of exercise in the evening followed by high-sugar meal consumption the following morning; Rest in the evening followed by high-sugar meal consumption the following morning
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The prognosis for older individuals with acute myelogenous leukemia (AML) has been
      historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients
      with AML in first complete remission are routinely treated using a full intensity
      (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient
      with AML, full intensity therapy transplants have been greatly limited by increased rates of
      toxic effects related to this type of conditioning regimen. Reduced intensity
      (non-myeloablative) conditioning regimens have been used in a number of clinical settings,
      including AML therapy, to lessen the regimen related toxicity in the older patient. Recent
      data from the University of Michigan Blood and Marrow Transplant Program suggests improved
      survival for individuals > 55 years in age undergoing reduced intensity, transplants from
      unrelated donors. This study will investigate the safety and efficacy of this treatment
      option for older patients with AML, with the primary goal being to improve the survival and
      lifespan for older patients with AML.
    


Intervention name(s): Fludarabine; Busulfan; Total Body Irradiation; Stem Cell Transplant
Intervention type(s): Drug; Drug; Radiation; Procedure
Intervention description(s): Fludarabine (40 mg/m2/day x 4 days); Busulfan (3.2 mg/m2/day x 2 days or x 4 days).; Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.; Allogeneic stem cell transplant from related or unrelated donor
Intervention MeSH terms: Fludarabine; Busulfan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML
Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the relative bioavailability of the test
      formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference
      formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fasting conditions in healthy adult
      male subjects.
    

Detailed description: 
      This randomized, single-dose, two-treatment, two-way, crossover study was conducted to
      compare the relative bioavailability of two formulations of 5 mg finasteride tablets under
      fasted conditions. The study was conducted with 26 (25 completed) healthy adults. The
      subjects received the test product in one study period and the reference product in the other
      period; the order of administration was according to the dosing randomization schedule. There
      was a 7-day interval between treatments.
    

Intervention name(s): Finasteride
Intervention type(s): Drug
Intervention description(s): Finasteride Tablets 5 mg
Other intervention name(s): Proscar
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Finasteride; crossover