bioihbjkbjnl/mcl2 huggingface dataset:
Impact of tDCS on Locomotion and Equilibrium in Hemiplegic Patients
Condition: Gait Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this trial is to quantify the improvement of locomotion and equilibrium induced
      par tDCS in anode polarity position in post stroke hemiplegic patients.
    

Detailed description: 
      This is a pilot prospective randomised crossover double blind study. 40 patients will be
      enrolled in two sites, with 20 patients each site.

      The duration of this study is planned to be 25 months: 24 months will be for enrollment and 1
      month for the follow-up.

      The follow-up of patient comprises 3 visits, will be extended to 28 days for each patient:

      • V1: inclusion visit:

      After obtained an informed consent signed, the following analysis will be realized: a
      clinical assessment, quantify analysis of walking using 3D motion analysis system, assessment
      of equilibrium using force plate and functional abilities.

      The patient will record him-self clinical scales and will respond auto-evaluation
      questionnaires. A cerebral magnetic resonance imaging and a blood collection of 5 ml will
      also be realized.

      • V2-V3 (Locomotion /equilibrium assessment visit):

      V2 and V3 will begin with tDCS experimental visit (EV) or tDCS placebo visit (PV), the visit
      order for each patient will be defined by randomization result.

      During the 2 visits, the tDCS will be placed on the scalp of the patient. The anode will be
      placed at the hot spot of the tibialis anterior motor cortex area on the damage hemisphere,
      and the cathode will be placed at the controlateral orbit. The intensity of stimulation will
      be 2 mA.

      In tDCS experimental visit, the stimulation will last 30 minutes. In tDCS placebo visit, the
      duration of the stimulation will only be 120 seconds, with the identical other conditions.

      Before the beginning of the stimulation, a clinical assessment, a functional gait related
      activities evaluation and a 3D gait motion analysis associated with an evaluation of the
      equilibrium will be performed.

      During the stimulation period, the gait and the equilibrium assessments, using 3D motion
      analysis will be done.

      After the stimulation, the evaluations such as clinical, functional and motion analysis will
      be realized again.

      The tDCS experimental visit and the tDCS placebo visit will be spaced one week.
    

Intervention name(s): anodal tDCS and sham tDCS stimulations
Intervention type(s): Device
Intervention description(s): Two conditions will be tested in randomized order: 2 arms in the first one anodal tDCS and then sham tDCS. In the other arm sham tDCS and then anodal tDCS.
All the investigations will associate with clinical, functional and 3D motion analysis assessments.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS, gait disorders, equilibrium, hemiplegic, stroke
Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in
      participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare
      the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog +
      recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 administered
      subcutaneously.
    

Detailed description: 
      This study design was chosen to assess the differences between pharmacokinetic (PK) and
      pharmacodynamic (PD) parameters, including postprandial glycemic response, of Humalog +
      recombinant human hyaluronidase PH20 (rHuPH20), Humalog alone, and Humulin-R + rHuPH20 at
      optimal doses following a liquid meal.
    

Intervention name(s): Humalog; Humulin-R; Recombinant human hyaluronidase PH20 (rHuPH20)
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Insulin lispro; Humulin; Regular human insulin; PH20; HYLENEX
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: recombinant human hyaluronidase PH20 (rHuPH20); Insulin lispro; Regular human insulin
Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Psoriasis is a persistent condition which demands prolonged management, so it puts heavy
      financial as well as psychological burden on patients. Severe psoriasis makes work impossible
      for patients. If it affects exposed parts of the body, it may lead to decrease in
      self-esteem, social avoidance, and shame. Patients with even mild form of psoriasis have high
      stigma as compared to other cutaneous diseases. As a result, psoriasis affected individuals
      experience greater difficulty in social interactions and employment. Patients experience
      symptoms in psoriasis includes bleeding, itching and inflamed joints. Psoriatic patients
      develop psoriatic arthritis approximately at 40 years of age which contributes to fatigue in
      these individuals. Moreover, early age onset of psoriasis leads to more physical impairment.
      Hence, patients get trapped in a vicious cycle as stress leads to further aggravation of
      disease. The European Medicine Agency has given its approval regarding the usage of
      INFLIXIMAB bio similar REMSIMA for psoriasis after taking in consideration its effectiveness
      from other studies conducted on ankylosing spondylitis and rheumatoid arthritis. This study
      is being conducted as no data is present on REMSIMA SC in psoriasis patient in Pakistan.
    


Intervention name(s): Remsima
Intervention type(s): Drug
Intervention description(s): The patient will be given one Injection of REMSIMA 120 mg subcutaneously at week 0, 1, 2, 3, 4 and then every 2 weeks i.e., at 6, 8, 10 and 14 weeks. If the weight of the patient is >80 kg, 2 injections will be given.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who
      have chronic lymphocytic leukemia that has not been previously treated.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the overall response rate (complete and partial) in patients with previously
           untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine.

        -  Determine the molecular complete response rate in patients who achieve a clinical or
           immunophenotypic complete response when treated with this drug.

        -  Determine the progression-free and treatment-free survival of patients treated with this
           drug.

        -  Determine the toxicity of this drug in these patients.

        -  Determine the baseline incidence of defined genetic abnormalities in patients treated
           with this drug.

        -  Determine the prognostic and predictive significance of defined genetic abnormalities in
           patients with respect to response to treatment with this drug.

        -  Determine the prognostic and predictive significance of immunophenotypic profile of
           patients with respect to response to treatment with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive oral fludarabine on days 1-5. Treatment repeats every 28 days for 6-8
      courses in the absence of disease progression or unacceptable toxicity. Patients in complete
      remission after 6 courses do not receive further study therapy.

      Patients are followed at 2 months and then every 4 months for 2 years.

      PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.
    

Intervention name(s): fludarabine phosphate
Intervention type(s): Drug
Intervention MeSH terms: Fludarabine; Fludarabine phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
ThermaChoice III Under Local Sedation in the Office Setting
Condition: Heavy Uterine Bleeding
MeSH terms: Uterine Hemorrhage
Study type: Interventional

Summary: 
      Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can
      be tolerated in the office setting without the use of intravenous medication.
    

Detailed description: 
      A safe and effective treatment , called endometrial ablation, has been used in a hospital
      setting under general anesthesia for the treatment of heavy uterine bleeding. This study will
      evaluate if patients would tolerate the same procedure in an office setting using local
      anesthetics and common pain medication. This study will include twenty patients.
    

Intervention name(s): Uterine Ablation
Intervention type(s): Device
Intervention description(s): Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation
Intervention model: Single Group Assignment
Masking: None (Open Label)
DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo- and active-controlled study of a new
      experimental drug called darusentan. Darusentan is not currently approved by the United
      States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this
      drug. The purpose of this study is to determine if darusentan is effective in reducing
      systolic and diastolic hypertension despite treatment with full doses of three or more
      antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan
      (optimized dose), an active comparator, or placebo, administered orally. The treatment period
      for this trial is 14 weeks.
    


Intervention name(s): Darusentan; Guanfacine; Darusentan Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Darusentan capsules administered orally once daily; Guanfacine capsules administered orally once daily; Placebo to match darusentan administered orally once daily
Other intervention name(s): LU 135252
Intervention MeSH terms: Guanfacine; Darusentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in
      adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
    


Intervention name(s): Lisdexamfetamine dimesylate; Methylphenidate Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance; Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance; Daily oral dosing in the AM for 6 weeks
Other intervention name(s): SPD489, Vyvanse, LDX; Concerta, OROS-MPH
Intervention MeSH terms: Methylphenidate; Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
Bioequivalence Study of CJ-30060 in Healthy Male Volunteers
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and
      Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
    

Detailed description: 
      The purpose of this study is to compare the pharmacokinetics and safety after a single dose
      administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
    

Intervention name(s): Exforge® tab 10/160mg, Crestor® tab 20mg; CJ-30060 10/160/20mg
Intervention type(s): Drug; Drug
Intervention description(s): Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg; Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg
Intervention MeSH terms: Amlodipine, Valsartan Drug Combination; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the bioequivalence of the test product
      Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL
      following intravenous administration to healthy subjects.
    

Detailed description: 
      Iron is essential to the synthesis of hemoglobin (Hb) to maintain oxygen transport and to the
      function and formation of other physiologically important heme and nonheme compounds. Iron
      deficiency may be caused by blood loss during dialysis, increased erythropoiesis following
      administration of epoetin, and insufficient absorption of iron from the gastro-intestinal
      tract. Most dialysis patients require intravenous iron supplementation to replenish iron
      stores.

      Iron sucrose is used to replenish body iron stores in patients with iron deficiency on
      chronic hemodialysis and receiving erythropoietin. In these patients iron deficiency is
      caused by blood loss during dialysis procedure, increased erythropoiesis, and insufficient
      absorption of iron from the gastrointestinal tract. Most hemodialysis patients require
      intravenous iron to maintain sufficient iron stores to achieve and maintain a hemoglobin
      level of 11-12 g/dL.

      Subjects who fulfill the inclusion/exclusion criteria after screening will be randomized to
      receive 100 mg of iron sucrose as either Hospira Iron Sucrose or Venofer®.
    

Intervention name(s): Iron Sucrose; Iron Sucrose
Intervention type(s): Drug; Drug
Intervention description(s): Venofer 20 mg/mL; Iron sucrose 20 mg/mL
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Park Prescription Trial
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of prescribing park use (i.e., ''Park
      Prescription'') to insufficiently active individuals. It is hypothesized that Park
      Prescription will motivate the target population to increase physical activity and thereby
      improve their physical and mental health.
    

Detailed description: 
      BACKGROUND: There are substantial international research findings supporting the role that
      natural environments play in enhancing human health and the prevention of chronic diseases.
      Also, there is evidence highlighting the (cost-) effectiveness of prescribing physical
      activity to promote one's physical activity and health. However, there is a lack of
      methodologically rigorous studies that have looked into the effectiveness of combining these
      two promising approaches; i.e., physical activity prescription with a focus on the use of
      parks and green spaces: Park Prescription.

      AIMS: This Randomized Controlled Trial (RCT) will investigate the concept of Park
      Prescription as a health promoting intervention for individuals. The primary objective is to
      investigate the effectiveness of a park prescription interventions to increase participant's
      time spent in moderate to vigorous physical activity (MVPA). Main secondary objectives are to
      assess; A) improvement in physical health (e.g., blood sugar and blood pressure) and health
      behaviour (e.g., sitting time); B) improvement in mental health (e.g., quality of life); 3)
      intervention implementation fidelity and the association with park use and perceived study
      participant satisfaction.

      METHODOLOGY: Participants aged between 40 and 65 years will be recruited from the Singapore
      Population Health Community Screening Programme conducted by Alexandra Health Pte Ltd. They
      will be randomly assigned to one of the following two arms; 1) park prescription +
      participation in a weekly structured physical activity program conducted in the park, and 2)
      control group. Participants will be enrolled in the study for a period of 6 months. They will
      have to complete a baseline assessment, 3-month and 6-month follow-up. The investigators aim
      to recruit 80 participants in each arm, making a total of 160 study participants.
    

Intervention name(s): Park Prescription
Intervention type(s): Behavioral
Intervention description(s): Please refer to the information included in the arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: RCT; Park Prescription; Park Use; Physical Activity; Health Promotion; Health Behavior; Mental Well-Being; Body composition; Blood levels; Accelerometry; Improving general physical and mental health
Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Intravenous Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics
      parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following
      administration of single intravenous dose. The objective of this randomized, crossover,
      clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T
      produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by
      Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa),
      as surrogate markers for their circulating concentrations of the drug.
    

Detailed description: 
      In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI)
      activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as
      secundary obectives.
    

Intervention name(s): Heparin, Low-Molecular-Weight
Intervention type(s): Drug
Intervention description(s): single intravenous administration of 3mg/Kg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
Other intervention name(s): Clexane; Enoxalow
Intervention MeSH terms: Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subjects
RAS-Peptide-Profile Study in Healthy Male Subjects
Condition: RAS Peptide Profile in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is the characterization of the RAS peptide profiles after single and
      repeated oral administration of a renin inhibitor, an ACE inhibitor and an angiotensin
      receptor blocker in healthy volunteers.

      Secondary objectives are the correlation of RAS peptide profiles with pharmacokinetic
      profiles of the different RAS inhibitors and with pharmacodynamic parameters such as blood
      pressure and heart rate. Output of the classic RAS system will be assessed using aldosterone
      concentrations. Fluid and sodium intake will be monitored using sodium concentration and
      total volume in 24h urine.
    

Detailed description: 
      The results of a pilot study have shown that single doses of different RAS inhibitors produce
      characteristic changes of the RAS peptide profiles. In a first step this finding needs to be
      verified in a larger number of healthy subjects. Since it is unknown, whether the changes
      that were observed within hours after a single inhibitor dose are stable over time, the
      profiles also need to be investigated under steady-state conditions of the different
      inhibitors. Comparison of RAS peptide profiles after single dose and under steady-state
      conditions will also allow to detect whether the peptide profiles are altered by compensatory
      mechanisms.
    

Intervention name(s): ACEI-ARB-RI; ARB-RI-ACEI; RI-ACEI-ARB
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): angiotensin converting enzyme inhibitor (ACEI); angiotensin receptor antagonist (ARB); renin inhibitor (RI); angiotensin converting enzyme inhibitor (ACEI); angiotensin receptor antagonist (ARB); renin inhibitor (RI); angiotensin converting enzyme inhibitor (ACEI); angiotensin receptor antagonist (ARB); renin inhibitor (RI)
Intervention MeSH terms: Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Renin Inhibitors; Angiotensin Receptor Antagonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: RAS-Peptide Profile; Renin-Angiotensin-System; Angiotensin-Converting-Enzyme-Inhibitor; Angiotensin-Receptor-Antagonist; Renin-inhibitor
Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in
      adult patients.
    


Intervention name(s): NS2359; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADHD
Airway Anatomy of the SimBaby
Condition: Airway Reality
Study type: Observational

Summary: 
      The aim of the present study is to compare radiographic upper airway measurements of the
      SimBabyTM pediatric patient high-fidelity simulator with actual human airway anatomy to
      assess the grade of realism of the simulator.
    


Intervention name(s): CT, MRI
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infants undergoing routine head MRI