bioihbjkbjnl/mcl2 huggingface dataset:
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
Condition: Bioequivalence, AUC, Cmax, Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of
      Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma
      GmbH & Co. KGaA, Germany) 20 mg tablets in normal healthy subjects
    

Detailed description: 
      Study to evaluate the bioequivalence of orally administered memantinol preparations,
      film-coated tablets, 20 mg
    

Intervention name(s): Memantinol tablets, 20 mg; Akatinol Memantine® tablets, 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition; Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg film-coated tablets fasting condition
Other intervention name(s): memantine; memantine
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: None (Open Label)
Primary purpose: Basic Science
Early Warning of Intradialytic Hypotension in Hemodialysis Patients
Condition: Hypotension of Hemodialysis
MeSH terms: Hypotension
Study type: Observational

Summary: 
      In this study, the investigators will monitor patients undergoing hemodialysis treatment with
      a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart
      rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular
      resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than
      with current noninvasive methods and prevent related poor outcomes.
    


Intervention name(s): Continuous monitoring
Intervention type(s): Device
Intervention description(s): Identifying intradialytic hypotension using a PPG-based wearable monitor
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        150 adult subjects (≥18 years) with end stage kidney disease (ESKD) undergoing chronic
        hemodialysis (HD) treatments in Hadassah Ein-Kerem medical center. A patient can
        participate more than once.
      
Keywords: Hemodialysis; Intradialytic hypotension; Remote Monitoring
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
Condition: Partial Seizure Disorder; Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate
      in infants with refractory partial onset seizures (POS).
    

Detailed description: 
      This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of
      topiramate compared with placebo as an adjunct therapy in infants with refractory partial
      onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double
      blind treatment phase of 20 days, a one year open label extension phase and a posttreatment
      (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this
      study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25
      mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the
      four phases of the study.
    

Intervention name(s): topiramate; topiramate; topiramate; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 15 mg/kg/day; 5 mg/kg/day; 25 mg/kg/day; placebo
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Partial seizure disorder; Topiramate; Epilepsy; Infants
Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline
      hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with
      SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC
      28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,
      adult, male, human subjects under fasting condition.
    

Detailed description: 
      Test for drugs of abuse (opiates and cannabinoids) in urine and breath test for alcohol were
      carried out prior to admission in each period of the study. Following an overnight fast of at
      least 10 hour, a single oral dose of minocycline hydrochloride extended release tablet 135 mg
      of either test or reference formulation was administered during each period of the study,
      along with 240 mL of drinking water at ambient temperature under low light condition and
      under supervision of trained study personnel.

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study.
    

Intervention name(s): Minocycline hydrochloride
Intervention type(s): Drug
Intervention description(s): extended release tablets 135 mg
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs
Condition: Scoliosis Idiopathic; Scoliosis; Adolescence
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of Schroth 3D exercise method on home
      symmetry, trunk topography, scapula symmetry, pelvic symmetry, health related quality of life
      and cosmetic deformity perception in adolescents with idiopathic scoliosis
    

Detailed description: 
      Cobb angle measurement, which is accepted as the gold standard in patients with scoliosis, is
      a radiological measurement. However, in continuous follow-up, the search for other methods to
      obtain objective data that will provide a short term evaluation on the patient in determining
      the efficacy of conservative treatment continues.

      In our study, individuals who meet the criteria will be evaluated at the beginning and end of
      the study. Sociodemographic features and scoliosis characteristics (Cobb angle, degree of
      bone maturation according to Risser, apex, vertebra rotation angle) will be recorded.
      Posterior Trunk Asymmetry Index (POTSI) will be used to determine body asymmetry, and
      topographic measurements will be performed with Artec Eva 3D Scanner and motion analysis will
      be performed with Biomechanical Motion Analysis Sistem (Model is BTS Smart DX100) .
      Individuals will evaluate their cosmetic deformities with the Walter Reed Visual Evaluation
      Scale. Scoliosis Research Society-22 will be used to measure quality of life.
    

Intervention name(s): Schroth Exercise Group; Home Exercise Group
Intervention type(s): Other; Other
Intervention description(s): 12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise; Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schroth exercise, conservative treatment, scoliosis
Magnetic Resonance (MR) Guided Functional Ultrasound-Neurosurgery for Movement Disorders
Condition: Essential Tremor; Dystonia; Parkinson's Disease
MeSH terms: Parkinson Disease; Dystonia; Movement Disorders; Essential Tremor
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to asses the efficacy and the clinical safety of the transcranial
      magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec
      Ltd. for functional neurosurgery in the treatment of movement disorders. The treatments to be
      conducted in this study are non-invasive, i.e. without opening the skull, and will create
      microthalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The
      data obtained in this study will be used to evaluate the basic safety aspects of this new
      treatment technology and will serve as a basis for the clinical introduction of MR-guided
      ultrasound neurosurgery.
    


Intervention name(s): Non-invasive intervention with focused ultrasound (ExAblate 4000)
Intervention type(s): Device
Intervention description(s): Non-invasive brain intervention using MR-guided focused ultrasound
Other intervention name(s): ExAblate 4000
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: FUS; focused ultrasound; functional brain disorder; neuropathic pain; movement disorders; malignant brain tumors
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK
      following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants
      will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT.
      Patients enrolled into the study will be followed for 3 months after treatment with IA TNK.
    

Detailed description: 
      As current MT technology is not amenable to retrieval of distal occlusions (M3/M4, etc), we
      hypothesize that IA lytic may play an important role as an adjunctive therapy to open up
      distal vessels (after the primary LVO has been removed) to achieve complete or near complete
      reperfusion. In this pilot trial, our goal is to assess the feasibility and safety of IA
      Tenecteplase (TNK) as an adjunctive therapy following standard of care mechanical
      thrombectomy (MT) in patients with AIS. A total of 20 patients will be enrolled into the ALLY
      pilot study.
    

Intervention name(s): intra-arterial tenecteplase
Intervention type(s): Drug
Intervention description(s): intra-arterial drug administered after mechanical thrombectomy
Intervention MeSH terms: Tenecteplase
Intervention model: Single Group Assignment
Intervention model description: Participants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care mechanical thrombectomy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thrombolytic; stroke; distal emboli
Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
Condition: Obesity; Bariatric Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      Intravenous lidocaine is efficient for management of post operative pain in abdominal
      surgery. As previously published in literature the investigators use it during bariatric
      surgery.

      Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a
      widespread use.

      Investigators propose in this work to bring an objective proof that administration of
      lidocaine based on a modified body weight is safe.

      Intravenous administration concerned the peri operative period. A total of six samples are
      taken for each patient.

      Investigators get approbation of local ethic committee for this work.
    


Intervention name(s): Blood sampling; Lidocaine
Intervention type(s): Biological; Drug
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective of Period 1 of this study is to compare the safety and efficacy (signs
      and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone
      versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis
      (RA) with an inadequate response to MTX.

      The study objective of Period 2 is to evaluate the long term safety, tolerability, and
      efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
    

Detailed description: 
      The study includes a 35-day screening period; a 14-week randomized, double-blind,
      parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period
      (Period 2); and a 30-day follow-up visit.

      Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of
      four treatment groups:

        -  Group 1: upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2)

        -  Group 2: upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2)

        -  Group 3: MTX (Period 1) → upadacitinib 30 mg QD (Period 2)

        -  Group 4: MTX (Period 1) → upadacitinib 15 mg QD (Period 2)

      Starting with implementation of Protocol Amendment 5, all participants in the extension
      period will receive open-label upadacitinib 15 mg QD, including those currently on
      upadacitinib 30 mg QD.
    

Intervention name(s): Methotrexate; Upadacitinib; Placebo Upadacitinib; Placebo Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsule; Oral; Tablet; Oral; Tablet; Oral; Capsule; Oral
Other intervention name(s): ABT-494; Rinvoq
Intervention MeSH terms: Methotrexate; Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal Disease; Arthritis; Joint Disease; Anti-inflammatory agents; Antirheumatic agents; Upadacitinib; ABT-494
The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      "The impact on fluid loading after cardiac surgery by use of two different priming solution"

      Fluid overloading with oedema formation is a regular finding following on-pump cardiac
      surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been
      reported to impair both systolic and diastolic function. An association between
      intraoperative fluid loading and postoperative adverse outcome has been demonstrated in
      cardiac patients.

      The investigators have experience with the use of both colloides and combination fluids
      (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the
      investigators used colloides as an additive to the CPB-prime. The investigators observed
      reduced fluid leakage and less total tissue water in several organs.

      The planned study includes patients scheduled for coronary artery bypass, and who have no
      co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated
      Ringer's solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and
      diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume
      (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be
      monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.
    


Intervention name(s): Tetraspan; acetated Ringer's solution
Intervention type(s): Drug; Drug
Other intervention name(s): Tetraspan® (HES 130/0,42 , 6%),; B. Braun Medical AS; Kjernåsveien 13 B; 3142 Vestskogen
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Cilostazol is an kind of oral antiplatelet agent with a rapid onset of action that
      selectively inhibits phosphodiesterase III, a mechanism different from adenosine diphosphate
      (ADP) receptor antagonists. Previous studies had suggested that cilostazol has
      lipid-modifying and vasodilating effects in addition to antiplatelet effects. From those
      experimental and clinical backgrounds, we assumed that triple antiplatelet therapy with
      aspirin, clopidogrel, and cilostazol might have a beneficial effect on the prevention of
      atherothrombosis complications following coronary stenting. Therefore, we evaluated the
      safety and efficacy of triple antiplatelet regimen of aspirin, clopidogrel and cilostazol
      compared with dual antiplatelet regimen of aspirin and clopidogrel in patients with acute
      coronary syndrome undergoing successful coronary artery stenting.

      Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy
      (aspirin plus clopidogrel) and triple antiplatelet therapy (aspirin and clopidogrel plus
      cilostazol) groups. All enrolled patients in triple regimen group will receive cilostazol
      100mg, b.i.d., for 6 months in addition to standard dose and duration of aspirin and
      clopidogrel for post-PCI. The primary endpoints included death, myocardial infarction, target
      lesion revascularization, stent thrombosis within 30 days, binary restenosis at six month and
      major adverse cardiac events (MACE) at one year. The secondary endpoints were side effects of
      study drugs, including major bleeding, vascular complication, hypersensitivebility, and
      bleeding complications. The study will be powered to test the hypothesis that triple
      antiplatelet therapy is better than dual antiplatelet therapy.
    


Intervention name(s): Cilostazol
Intervention type(s): Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone
      system impairs glycemic control via effects on insulin sensitivity and insulin secretion.

      Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone
      system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor
      dependent mechanism.
    

Detailed description: 
      In aim 1 subjects are randomized to cross over between an 8 day high salt and 8 day low salt
      diet and assessments are made.

      In aim 2, subjects are randomized to a 2x2 cross over study with an 8 day low salt diet and
      either eplerenone 50mg or amlodipine 5mg.
    

Intervention name(s): Low Salt diet plus Placebo tablet; Low Sodium diet plus Salt tablet; Epleronone; Amlodipine
Intervention type(s): Other; Other; Drug; Drug
Intervention description(s): 50mg daily; 5mg daily
Other intervention name(s): Inspra; Norvasc
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or
      severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or
      severe impairment, compared to matched healthy control subjects.
    


Intervention name(s): belapectin
Intervention type(s): Drug
Intervention description(s): intravenous
Other intervention name(s): galactoarabino-rhamnogalacturonate; GR-MD-02
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic impairment; GR-MD-02
Omega-3 Fatty Acids and Muscle Protein Synthesis
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether omega-3 fatty acid supplementation
      influences muscle protein synthesis rates in young and older adults.
    

Detailed description: 
      Loss of muscle mass is a normal consequence of aging. The decline in muscle mass is estimated
      to be 0.2-0.5% per year from 60 years old onwards in healthy subjects with the decline
      worsened by chronic illness, poor appetite and diet, and reduced physical activity in the
      elderly. Increased morbidity is demonstrable with as little as a 5% loss of muscle mass -
      therefore, treatments that can prevent or slow the progression of muscle loss with aging are
      much desired.

      A major cause for loss of muscle mass in advanced age appears to be an impaired ability to
      stimulate the synthesis of muscle protein in response to increased levels of amino acids (the
      building blocks of proteins) and insulin as occurs after eating because of low-grade
      inflammation and insulin resistance in muscle of old persons. We propose that long-chain
      omega-3 polyunsaturated fatty acids (fish oil) slow the loss of muscle mass because fish oil
      has anti-inflammatory properties and increases the sensitivity of muscle protein synthesis to
      insulin and amino acids. We will test this by studying the effect of fish oil supplementation
      on the muscle protein synthesis process in young and older adults.
    

Intervention name(s): omega-3 fatty acids; corn oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 grams per day for 8 weeks; 4 grams per day for 8 weeks
Other intervention name(s): Lovaza
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Healthy volunteers; young adults; Aged