bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Rehabilitation robotics is increasingly used because it enables the patients to practice a
      wide array of movements. Dynamic balance training is essential for gait rehabilitation and
      robotised devices enhance repeatability, objectivity and precision of such training combined
      with monitoring and recording of kinematic and kinetic data. The aim of the study is to
      explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off
      in patients after stroke. The investigators will conduct a randomised intervention study
      where one group will receive visual feedback on gait status and the other group will receive
      kinetically-assisted training using a robotised device in addition to the visual feedback.
    

Detailed description: 
      Gait training will start 3 weeks after admission to inpatient rehabilitation. It will last
      for 3 weeks, 5 times per week, 30 minutes per day. The first few sessions with the robotic
      device will serve to familiarise the patient with the BART device and training conditions.
      Further details are described in the Arms and Interventions section.
    

Intervention name(s): Standard gait training on BART without pelvic perturbations; Robotised gait training with BART with pelvic perturbations
Intervention type(s): Device; Device
Intervention description(s): The Balance Assisted Robot on Treadmill (BART) enables various types of gait training on treadmill with visual feedback. It interfaces to the pelvis of the walking subject in an actuated and admittance-controlled manner, thus providing transparent haptic interaction with negligible power transfer.; In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: gait training; dynamic balance; gait symmetry; rehabilitation robotics
Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL
Condition: Adult T-Cell Leukemia and Lymphoma (ATL); Adult Peripheral T-Cell Lymphoma (PTCL)
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4
      positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).
    

Detailed description: 
      This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4
      positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This
      study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary
      efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended
      Phase II dose (RPIID) have been established.
    

Intervention name(s): KW-0761
Intervention type(s): Drug
Intervention description(s): IV administration at 4 escalating dose levels.
Intervention MeSH terms: Mogamulizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult T-Cell Leukemia; ATL; Adult Peripheral T-Cell Lymphoma; PTCL
Effects of HFOT on Exercise Performance in Patients With COPD. A Randomized, Controlled Trial.
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen
      therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with
      chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      This will be a randomized, cross-over trial evaluating the efficacy of nasal HFOT vs. LFOT on
      cycling endurance in patients with COPD. Each patient will perform two constant load cycling
      exercise tests to exhaustion using HFOT and LFOT on two consecutive days, respectively,
      according to randomization. The load of the cycle ergometer will be set at 75% of the
      individually estimated maximum work rate (Wmax). During exercise tests, LFOT will be provided
      by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator. HFOT will
      be applied by a dedicated large bore nasal cannula at a flow rate 60 L/min, FiO2 45%,
      temperature 32 °C, using a HFOT device.
    

Intervention name(s): High-flow oxygen therapy (HFOT); Low-flow oxygen therapy (LFOT)
Intervention type(s): Combination Product; Combination Product
Intervention description(s): HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher&Paykel, New Zealand).; LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise endurance; High-flow oxygen therapy; Low-flow oxygen therapy
Duration of Untreated Psychosis (DUP) and Pathways to Care in Nordland
Condition: Schizophrenia and Disorders With Psychotic Features; Affective Psychosis, Bipolar; Psychoses
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorders, Psychotic; Bipolar Disorder
Study type: Observational

Summary: 
      During the 1990s, evidence began to emerge of the long duration of untreated illness prior to
      receiving treatment for patients with psychotic disorders. Studies across the world on first
      episode psychosis have consistently found an average of 1 - 2 years between the onset of
      psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate
      implications such as unnecessary distress for patients and families, and may also compromise
      potential recovery when treatment is initiated.By understanding how and why substantial
      delays occur the investigators may be able to better design interventions to facilitate
      better earlier treatment. The components of DUP can be conceptualised as comprising 3
      distinct intervals: help-seeking delay, referral delay and delay in mental health services.
      In this study the primary aim is to establish the level of DUP in nordland, and explore the
      components of this variable. Help-seeking delay will be investigated by interviewing patients
      presenting at the central mental health hospital in Nordland about their psychosis onset and
      pathways to care. Referral delay will be investigated by a questionnaire about the referral
      pratices among GPs in Nordland. Delays in mental health services will be investigated by
      focus group interviews with leaders and professionals at the 7 community mental health
      centers in Nordland. This knowledge is believed to be crucial for developing services that
      can reduce DUP and give this patient population earlier access to adequate treatment.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study is a naturalistic cohort study. All patients registrered in a 3 year period with
        the acute and/or rehabilitation units will be invited to participate.

        The eight units (acute and rehabilitation) will be able to provide a potential sample size
        of 150 participants over the 3-year period of the study. We are confident of minimal
        attrition and assume that we will achieve at least 85% follow up. This means that we can
        expect to have collected data on approximately 120 people.
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal
      patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently
      manufactured by Alza (Reference).
    

Detailed description: 
      This is a 2-arm, single center, single dose, open-label, randomized, two-sequence, two-period
      crossover, bioequivalence study in healthy adult smokers that have smoked more than 10
      cigarettes per day for 1 year prior to initial dose. Carry-over effects will be avoided by a
      wash-out interval of at least 2 days (but no more than 4 days) from patch removal in the
      first treatment period to subsequent patch application. The study will consist of an ambulant
      screening day within 21 days prior first patch application.
    

Intervention name(s): NicoDerm CQ patch (GSK Dungarvan); NicoDerm CQ (Alza)
Intervention type(s): Drug; Drug
Intervention description(s): A single patch of a NicoDerm CQ (GSK Dungarvan) 21 mg per system of 22 centimeter square (cm^2) surface area will be placed topically.; A single patch of a NicoDerm CQ (Alza) 21 mg/system of 22 cm^2 surface area will be placed topically.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic
      Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects,
      immediately after bilateral tympanostomy tube surgery.
    


Intervention name(s): EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Intervention type(s): Drug; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pushing Behaviors in Individuals Post-stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this
      study is to see if there are immediate changes in pushing behaviors in individuals who have
      had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking
      overground.

      The investigators do not think there will be a change with sitting in the wheelchair, but the
      investigators think there may be an improvement in pushing behaviors after walking training.
    

Detailed description: 
      The study population of interest is primarily individuals in inpatient rehabilitation.
    

Intervention name(s): Sitting in wheel chair; Gait training on treadmill; Gait training overground
Intervention type(s): Other; Other; Other
Intervention description(s): Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes; Walking on a treadmill with or without body weight support during 30 minute treatment; Walking overground with or without body weight support during 30 minute treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Pusher Syndrome; Lateropulsion; Pushing Behaviors; Burke Lateropulsion Scale
Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
Condition: Lung Cancer
Study type: Observational

Summary: 
      The study is a case-controlled observational trial. Sixty patients will be divided into 2
      groups (good or poor sleepers) depending on their first postoperative night Bispectral index
      data. Firstly, this study aims to characterise the gut and lung microbiota in patients with
      lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence
      on plasma kynurenine.
    

Detailed description: 
      The study is a case-controlled observational trial. Sixty patients will be divided into 2
      groups (good or poor sleepers) depending on their first postoperative night Bispectral index
      data. Firstly, this study aims to characterise the gut and lung microbiota in patients with
      lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence
      on plasma kynurenine.
    

Intervention name(s): General anesthesia
Intervention type(s): Drug
Intervention description(s): For maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min) was given to all patients during the operation. Additional cisatracurium （0.05 mg/kg）and fentanyl (30-50 μg at the end of surgery) were used as needed, in accordance with the clinical requirements.
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study is a case-controlled observational trial. Sixty patients will be divided into 2
        groups (good or poor sleepers) depending on their first postoperative night Bispectral
        index data.
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
Condition: Corneal Endothelial Cell Loss; Ocular Pain; Ocular Inflammation; Cataract Surgery
MeSH terms: Cataract; Corneal Endothelial Cell Loss; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408)
      ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract
      surgery.
    

Detailed description: 
      Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative
      stress is also known to adversely impact corneal endothelial cells, and may be a factor
      resulting in the acute decrease in corneal endothelial cell density following ocular surgery.
      While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and
      chronic inflammatory ocular diseases, their use is limited by their side effect profile,
      which includes the potential to elevate IOP and induce cataract formation. In addition, most
      available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly
      protect against the underlying oxidative stress component of the disease process.
      Consequently, there is a clinical need for agents that protect against oxidative stress and
      provide anti-inflammatory efficacy without inducing steroid-like side effects.

      This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic
      Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in
      patients undergoing cataract surgery.

      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Vehicle Ophthalmic Solution; Omaveloxolone Ophthalmic Suspension 0.5%; Omaveloxolone Ophthalmic Suspension 1%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Opthalmic suspension manufactured to mimic RTA 408 suspension; 0.5% ophthalmic suspension of RTA 408; 1% ophthalmic suspension of RTA 408
Other intervention name(s): RTA 408 Ophthalmic Suspension 0.5%; RTA 408 Ophthalmic Suspension 1%
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: RTA 408; Cataract surgery; Corneal Endothelial Cells; omaveloxolone
Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects
Condition: Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm a significant influence of ezetimibe and sirolimus on
      each others pharmacokinetics
    

Detailed description: 
      Hypercholesterolemia is a frequent finding in organ transplant recipients receiving
      immunosuppressive drugs such as sirolimus. To prevent increased cardiovascular morbidity and
      mortality in these patients, co-medication with lipid-lowering statins is recommended.
      However, treatment with statins is limited in many patients by insufficient
      cholesterol-lowering efficacy, drug interactions and serious adverse drug reactions (e.g.
      rhabdomyolysis). These patients may benefit from comedication with the cholesterol absorption
      inhibitor ezetimibe (EZE). Since SIR and EZE were shown to be substrates of the efflux
      transporter ABCB1 (P-glycoprotein), drug interactions between both compounds may occur.
      Therefore, this clinical study in healthy subjects was initiated to evaluate the clinical
      relevance of drug/drug interactions between sirolimus and ezetimibe according to the accepted
      bioequivalence approach.
    

Intervention name(s): 1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany; 1 tablet Rapamune(R) (sirolimus), Wyeth Pharma, Germany; 1 tablet Ezetrol(R) + 1 tablet Rapamune(R)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling; administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling; administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
Other intervention name(s): Ezetrol; Rapamune; Ezetrol+Rapamune
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; drug interactions; ezetimibe; sirolimus; human experimentation
Metformin in Obese Children and Adolescents
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether metformin is effective in reducing BMI and
      insulin resistance in obese children and adolescents.
    

Detailed description: 
      The prevalence of obesity in children and adolescents is increasing rapidly and is associated
      with significant medical and psychosocial consequences persisting into adulthood.

      Obesity may lead to metabolic complications, such as insulin resistance, which can progress
      via impaired fasted glucose and impaired glucose tolerance to type 2 diabetes mellitus (T2DM)
      and to the development of micro- and macro-vascular complications.

      Metformin, an oral anti-diabetic licensed for T2DM for adults and children from 10 years
      onwards, is already used off label in obese children and adolescents with insulin resistance,
      even though the specific effects of metformin in these obese children and adolescents have
      not been elucidated, particularly upon long-term use.

      The rationale for this study is based on the hypothesis that metformin may reduce body mass
      index (BMI), insulin resistance and percentage of body-fat in obese children and adolescents
      with insulin resistance. Further more it is anticipated that metformin may delay the
      progression to T2DM and thereby micro- and macro-vascular complications in obese children and
      adolescents with insulin resistance.
    

Intervention name(s): Metformin; Lifestyle intervention
Intervention type(s): Drug; Behavioral
Intervention description(s): Oral administration, 500 mg daily at week 1. Every week metformin dosage increases with 500 mg, to a maximum dose of 1000 mg bid. This maximum dose will be administered till the end of the study.; Lifestyle intervention: 18 months physical therapy and dietary advice
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Children; Adolescents; Metformin; Insulin resistance
Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, parallel group, single dose study in healthy Chinese
      subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety
      profile of 200 mg single dose of belimumab, administered either intravenously or
      subcutaneously via auto-injector. Each subject will be randomized in a 1:2 ratio to receive a
      single dose of either intravenous (IV) or subcutaneous (SC) administration of belimumab 200
      mg. The total study duration will be approximately 13 weeks.
    


Intervention name(s): Belimumab for IV; Belimumab for SC
Intervention type(s): Drug; Drug
Intervention description(s): Belimumab will be available as white to off-white lyophilized cake at a unit dose strength of 400 mg to be reconstituted and diluted in normal saline to obtain 200 mg per dose.; Belimumab will be available as clear to opalescent, colorless to pale yellow sterile solution at unit dose strength of 200 mg/milliliter (mg/mL) for SC injection in a single-use, prefilled syringe contained within an auto-injector device.
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:2 ratio to receive one treatment of either IV or SC administration of belimumab 200 mg.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: belimumab; Chinese; intravenous; subcutaneous; auto-injector