bioihbjkbjnl/mcl2 huggingface dataset:
VR-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      A prospective, randomized controlled single-blind trial will test the hypotheses that a 6-
      week intervention that combines treadmill training (TT) with virtual reality (VR)
      significantly improves real-life, functional mobility and cognitive abilities, keys to
      health-related quality of life in patients with MS.
    

Detailed description: 
      A prospective, single blinded,randomized controlled trial with 6 month follow-up will be
      employed to investigate the effects of treadmill training augmented with virtual reality on
      patients with MS. The study will include 200 participants. Participants will be randomized to
      either the intervention or active comparator. The intervention group will receive 18 sessions
      of Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will
      receive 18 training sessions of treadmill training alone (TT) without the VR simulation All
      interventions will be delivered by therapists trained in the standard protocols. All subjects
      will be trained 3 times a week for 6 weeks, each session will last approximately 45
      minutes.Training progression will be based on increasing both motor and cognitive challenges,
      individualized to the participant's level of performance.
    

Intervention name(s): Treadmill training with Virtual Reality; Treadmill training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): VR is defined in general as a "high-end-computer interface that involves real time simulation and interactions through multiple sensorial channels". The VR system to be used requires subjects to negotiate virtual obstacles while walking on a treadmill, in a safe environment. This dual task activity has large cognitive components such as information processing, planning, and attention while allowing for training in a more stimulating and enriching environment that includes both cognitive and motor components.; The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.
Other intervention name(s): TT+VR; TT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Virtual Reality; Treadmill; Multiple Sclerosis
Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate safety, tolerability and pharmacokinetics of
      increasing repeated oral doses of BAY1830839 in healthy male participants including the
      investigation of any potential drug-drug interactions of BAY1830839 with midazolam and
      methotrexate. In addition, the effects of BAY180839 on exploratory pharmacodynamics
      biomarkers in healthy participants will be investigated.
    


Intervention name(s): BAY1830839; Placebo; Midazolam; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, oral.; Tablet, oral.; For all dose steps. Oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2; Only for Dose 3 step. Tablet, oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2.
Intervention MeSH terms: Methotrexate; Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Observational

Summary: 
      The investigators are trying to investigate the coagulation status of idiopathic (immune)
      thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von
      Willebrand factor level, thromboelastography.
    

Detailed description: 
      In patients with chronic coagulation disorder, laboratory model and clinical data have shown
      evidence for a rebalanced hemostasis. Previous study showed that the platelet count may not
      predict the risk of bleeding since the platelet count is not an indicator of platelet
      function. Thromboelastography may be the choice of investigation when platelet function is in
      question especially in patients with idiopathic (immune) thrombocytopenic purpura (ITP).
      Previous study have shown that maximum clot formation is the most important
      thromboelastography parameter in predicting bleeding in ITP patients that makes
      thromboelastography superior to other hemostatic tests. The investigators are trying to
      evaluate the rebalanced hemostasis in patients with ITP by comparing the value of platelet
      count, von Willebrand factor antigen level, and thromboelastography parameters.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Those who visits the outpatients clinic of Samsung Medical Center with a diagnosis of
        idiopathic (immune) thrombocytopenic purpura between March, 2012 and February, 2013.
      
Keywords: rebalanced hemostasis; idiopathic thrombocytopenic purpura; coagulation status
The Study of Atypical Antipsychotics-induced Metabolic Disturbances
Condition: Schizophrenia; Antipsychotics
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Schizophrenia is one of the most severe mental illnesses. The antipsychotic drugs, introduced
      in early 1950s, have revolutionized the treatment of schizophrenia. About 2 to 4 times as
      many patients relapse when treated with a placebo as do those treated with antipsychotic
      drugs. For these medications to be maximally beneficial, they must have an acceptable side
      effect profile and be taken as prescribed. One untoward effect of many antipsychotic drugs is
      weight gain. The extent of weight gain apparently varies by drug, which may be because of
      drugs'differing degrees of action on serotonergic, dopaminergic, histaminergic, and other
      neurotransmitter systems. Obesity is a threat to health and longevity. Weight gain may also
      cause patients taking antipsychotic medication to discontinue their medication, which may
      predispose them to relapse.

      The pattern of weight gain and metabolic disturbance may vary between the different
      antipsychotic agents. The underlying mechanism and treatment of these adverse metabolic
      effects remain unclear. This study will recruit 60 schizophrenic patients during. The
      patients received monotherapy with atypical antipsychotics (olanzapine, quetiapine, or
      risperidone). The assessment of metabolic profile will be monitored at baseline, week 2, week
      4, and week 8. The measurements include anthropometrical parameters, body composition,
      glucose level, insulin level, lipid profile, and leptin level. Intra-venous glucose tolerance
      test will be used to assess the insulin secretion and insulin sensitivity.

      This proposal broadly aims to discover the underlying mechanism of antipsychotics induced
      metabolic disturbance and develop efficient treatment to correct it.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        psychiatric outpatient clinic and inpatient units
      
Keywords: schizophrenia; antipsychotics; glucose homeostasis; metabolic disturbance
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
Condition: Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing
      postoperative pain following a bunionectomy
    

Detailed description: 
      (Non-clinical summary)

      Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with
      opioidlike effects. Tramadol is extensively metabolized following administration, which
      results in a number of enantiomeric metabolites that display different opioid-receptor
      binding properties, and monoaminergic reuptake inhibition.
    

Intervention name(s): Tramadol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Otteroo Case Series
Condition: Infants With or at Risk/Concern for Developmental Delay
Study type: Interventional

Summary: 
      Rationale. The Otteroo is a floatie which supports an infant or young child with their head
      above and their body in water. Researchers are proposing that the Otteroo may be a good
      "tool" to facilitate exploring the ability to move and control one's body before locomotion
      develops. Intervention. Otteroo will be used as an adjunct to standard care for 4 weeks.
    

Detailed description: 
      Objectives or purpose. The purpose of this project is to measure overall developmental status
      before, during, and after Otteroo experience. Study population or sample characteristics.
      Participants will be 4 pre-locomotor infants or young children for whom a healthcare provider
      or caregiver has identified concerns about potential developmental delay. Study methodology.
      A single-subject research design will be used: measures of infant development will be
      collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard
      care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). Study
      endpoints or outcomes. The end of the study is the final assessment at 12 weeks. Follow-up.
      None. Statistics and plans for analysis. Researchers will calculate descriptive statistics
      (mean, range, coefficient of variation) for all measures and describe changes over time,
      relating the participant's performance at each time point to norm-referenced results for
      their age.
    

Intervention name(s): Otteroo
Intervention type(s): Other
Intervention description(s): Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.
Intervention model: Single Group Assignment
Intervention model description: single subject research design case series
Masking: None (Open Label)
Primary purpose: Treatment
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Observational

Summary: 
      This is an exploratory study. No formal hypothesis will be tested.

      The objectives of this study are to follow Lupus Nephritis patients over a period of 12
      months to:

        -  Establish the baseline biomarker characteristics of patients

        -  Determine the variability of biomarker measures over time

        -  Correlate biomarkers with disease phenotype
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 50 adult patients, 25 with lupus nephritis 25 control patients who have
        greater than 1 gram per day proteinuria and non-SLE diagnoses, and who qualify for this
        study based upon the stated inclusion/exclusion criteria will be recruited from the
        Glomerular Center at Columbia University Medical Center.
      
Keywords: Lupus Nephritis
Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a single-armed, open-label, single-center phase II trial of signal transduction
      inhibitor number 571 (STI-571) systemic therapy in selective patients with metastatic
      melanoma, and aims to study the efficacy and safety. The primary endpoint is progression-free
      survival (PFS) and the second endpoints are overall response rate (ORR), overall survival
      (OS), 1-year OS and safety.
    

Detailed description: 
      Only patients who meet the inclusion and exclusion criteria will be enrolled. The estimated
      recruitment duration is 1 year. Imatinib will be given in the dose of 400 mg orally each day
      unless disease progression or intolerance. The follow-up is 12 months.

      Forty-eight subjects will be recruited for this study. This sample size is justified by the
      number of patients required to establish an improvement in PFS with statistical significance
      compared to historical control.

      The standardized RECIST (Response Evaluation Criteria in Solid Tumors) method of
      unidimensional tumor assessment will be employed to evaluate tumor lesion size per 2 months
      in the determination of response rate and progression free survival. Repeated radiographic
      assessment at 4 week intervals is consistent with general oncological practice associated
      with computerized tomography (CT) or magnetic resonance imaging (MRI) scan testing. All
      efficacy endpoints will be evaluated by the investigator.

      Safety will be characterized in terms of the incidence, timing, severity, and relatedness of
      adverse events and laboratory abnormalities. Severity will be graded according to the NCI
      CTCAE Version 3.0.
    

Intervention name(s): Imatinib (Gleevec)
Intervention type(s): Drug
Intervention description(s): Imatinib will be given for enrolled patients to investigate efficacy and safety
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic acral or mucosal melanoma with c-kit mutation or copy number increase
Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects
Condition: Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult
      subjects
    


Intervention name(s): NGM120; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous Injection; Subcutaneous Injection
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized double-blinded study is performed to compare ketamine versus lidocaine for
      nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
    

Detailed description: 
      Difficult airway is one of the major challenges facing anesthesiologists. This challenge is
      compounded when the patient is treated while awake. The additional burden is to complete this
      procedure comfortably thus ensuring patient cooperation which is a vital part of successful
      performance. Several methods have been tried in literature to facilitate awake intubation by
      fiberoptic bronchoscope (FOB)

      This randomized double-blinded study is performed to compare ketamine versus lidocaine for
      nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
    

Intervention name(s): Ketamine; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): While in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation..; While in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation
Other intervention name(s): Ketalar; xylocaine
Intervention MeSH terms: Lidocaine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Colonic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Combining radiation therapy with chemotherapy may kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus irinotecan in
      treating patients with colon cancer that is recurrent or that cannot be removed surgically.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of weekly irinotecan that will
      result in an acceptable level of toxicity when given in combination with concurrent external
      beam radiation therapy. II. Determine the objective response rate of these patients at the
      dose level below the MTD.

      OUTLINE: Patients receive irinotecan IV over 90 minutes beginning within 24 hours of
      radiotherapy on days 1, 8, 15, and 22. External beam radiotherapy is administered 5 days per
      week for 5.5-6 weeks starting on day 1 concurrent with chemotherapy. Cohorts of 3-6 patients
      are treated until the maximum tolerated dose (MTD) has been determined. The MTD is defined as
      the dose level at which the incidence of dose limiting toxicity is no greater than one-third
      of the patients treated at that dose level. Once the MTD has been determined, additional
      patients receive irinotecan at the dose level below the MTD with external beam radiation
      therapy on the same treatment schedule as above. Patients are followed at 4 weeks after
      treatment, then every 3 months for 2 years, and then every 6 months for 3 additional years.

      PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into the Phase I portion of
      this study. Approximately 15-25 patients will be accrued into the Phase II portion of this
      study.
    

Intervention name(s): irinotecan hydrochloride; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Irinotecan
Primary purpose: Treatment
Keywords: stage II colon cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer; recurrent colon cancer; recurrent rectal cancer
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the efficacy and safety of 2 different durations of treatment with
      pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen
      (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a
      treatment alone and in combination with lamivudine (LAM). The anticipated time on study
      treatment is 1-2 years, and the target sample size is 100-500 individuals.
    


Intervention name(s): Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg; Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg; Lamivudine (LAM)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.; PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.; Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.
Other intervention name(s): Pegasys®; Pegasys®
Intervention MeSH terms: Interferons; Lamivudine; Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a
      patient's quality of life and cause strokes. Abnormal electrical activity from the pulmonary
      veins are thought to be the most common cause of this condition. Current ablative strategy in
      drug refractory AF is pulmonary vein isolation (PVI), where the pulmonary veins are
      electrically isolated from the body of the left atrium. However, success rate of this
      procedure remain ~50-70% for a single procedure despite advances in mapping and ablation
      techniques.

      Ganglionated plexuses (GP) are dense clusters of nerves in the atria that are implicated in
      AF. Endocardial high frequency stimulation (HFS) delivered within the local atrial refractory
      period can trigger ectopy and AF from specific GP sites (ET-GP). The aim of this study was to
      understand the role of ET-GP ablation in the treatment of AF by comparing two different
      strategies:

        1. Pulmonary vein isolation alone

        2. GP ablation alone
    

Detailed description: 
      This is a prospective, multi-centre study recruiting patients with paroxysmal AF indicated
      for AF ablation.

      180 patients will be recruited. Patients are randomised to either GP ablation alone or to
      PVI. All antiarrhythmics are stopped for at least 48 hours prior to their procedures.

      All have general anaesthesia and CARTO system (Biosense Webster, inc.) are used for 3D
      electroanatomical mapping of the left atrium.

      Patients randomised to GP ablation will have high frequency mapping performed within the
      atrial refractory period to identify ectopy or AF triggering GP (ET-GP) sites in the left
      atrium. Patients in this group will only have GP ablation and will not have pulmonary veins
      isolated.

      The primary endpoint is any documented atrial arrhythmia 30 seconds or more after a 3 month
      blanking period. This will be assessed for up to 12 months post-procedure, using 48hr Holter
      monitors at 3, 6, 9 and 12 month intervals.

      Secondary endpoints include mortality, major complications and redo procedures.
    

Intervention name(s): Pulmonary vein isolation; Ganglionated plexus ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.; Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Other intervention name(s): PVI; GP ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Paroxysmal atrial fibrillation; Pulmonary vein isolation; Ganglionated plexus; Radiofrequency ablation; Pulmonary vein ectopy; High frequency stimulation; autonomic nervous system; Ganglionated plexi; atrial fibrillation