bioihbjkbjnl/mcl2 huggingface dataset:
Extension of the MIME Robotic System for Stroke Rehabilitation
Condition: Stroke; Impaired Upper Extremity Function
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this project is to develop and test a new robotic system to accommodate practice
      of tasks requiring reach, grasp and release of objects. Our previous work has shown that the
      MIME robot is safe and effective for improving reach in stroke subjects. But adequate control
      of hand movements is critical to a functional upper limb, and is often resistant to
      conventional therapeutic interventions. Many stroke survivors have residual ability to flex
      the fingers, but extension is often limited and impeded by increased passive stiffness in
      flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent
      study, 38% of stroke survivors reported that impaired hand function was the most disabling
      motor impairment they faced.
    

Detailed description: 
      Research Design:

      We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after
      robotic training will be greater than after dose-matched conventional therapy; 2) Unlike in
      previous studies, gains in hand function immediately after robotic training will be greater
      than after dose-matched conventional therapy.

      Methodology:

      In the first year of the study, we will develop a robotic system with the ability to assist
      hand movement. Since many stroke survivors in the subacute and chronic recovery stages have
      residual ability to flex the fingers but severely limited finger extension, we will build a
      hand exoskeleton that can apply precise extension forces to the digits of the hand. This
      exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm
      reach, grasp of an object and release of the object can be trained. In the last 2 years of
      the project, we will perform a pilot clinical trial comparing this new training paradigm to
      dose-matched conventional therapy in chronic stroke survivors. Outcome measures will be taken
      before training and immediately after training.
    

Intervention name(s): robotic therapy; conventional functional training; robotic therapy; conventional functional training
Intervention type(s): Device; Other; Device; Other
Intervention description(s): 12 sessions of robot therapy for arm and hand function; 12 sessions of conventional therapy for the arm and hand from a physical therapist; 12 sessions of robot therapy for arm and hand function; 12 sessions of conventional therapy for the arm and hand from a physical therapist
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; function; arm; hand; robotic; therapy; motor; movement; treatment
Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure
Condition: Healthy
Study type: Interventional

Summary: 
      The adverse effects of air pollution on cardiovascular and respiratory health have been
      demonstrated in an extensive series of epidemiological, observational and experimental
      studies. In the current project the investigators aim to determine whether an acute exposure
      to diesel exhaust causes impacts on sympathetic nervous system activation in healthy
      volunteers.
    

Detailed description: 
      Brief as well as chronic exposures to air pollution have been linked with increases in
      cardiovascular morbidity and mortality. Evidence suggests that the strongest associations
      between air pollution exposure and adverse cardiovascular effects are found for
      combustion-derived particulate matter, especially in the fine and ultrafine ranges such as is
      found in diesel engine emissions. Despite a greater understanding of the cardiovascular
      effects of air pollution, the underlying mechanism through which exposure to fine particulate
      air pollution alters vascular function has yet to be determined. Microneurography is a method
      that records nerve impulse traffic in human peripheral nerves, allowing for the assessment of
      sympathetic nervous activity. The current study will employed microneurography techniques to
      evaluate autonomic function in association with inhaled air pollution exposure in healthy
      human volunteers.
    

Intervention name(s): Diesel exhaust exposure
Intervention type(s): Other
Intervention description(s): Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute diesel exhaust via mask.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Microneurography; Air pollution
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
Condition: Allergic Rhinitis; Chronic Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety of levocetirizine in children ages 6-11 months with symptoms of
      allergic rhinitis or chronic idiopathic urticaria.
    


Intervention name(s): Levocetirizine 1.25 mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks; Placebo oral liquid once a day for two weeks
Other intervention name(s): Xyzal
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Xyzal; Levocetirizine; Allergy; Children; Seasonal Allergies
Ceftaroline China Pharmacokinetics Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of
      ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.
    

Detailed description: 
      A Phase I, Single Center and Open Label Study to Assess the Safety and Pharmacokinetics of
      Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600
      mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute
      Intravenous Infusion Every 8 hours.
    

Intervention name(s): Ceftaroline; Ceftaroline
Intervention type(s): Drug; Drug
Intervention description(s): 60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.; Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.
Intervention MeSH terms: Ceftaroline fosamil; Cephalosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics
The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Exercise has been shown to improve health in patients with schizophrenia. However, it remains
      unclear which modality of exercise reports better benefits.

      Aim: To compare the effects of different modalities of exercise training on psychological and
      physiological variables in schizophrenia.
    

Detailed description: 
      Exercise has been shown to improve psychological, physiological, and biological correlates in
      patients with schizophrenia. However, it remains unclear which modality of exercise reports
      better health benefits.

      Aim: To compare the effects of three different modalities of exercise (aerobic, strength,
      aerobic-strength) on psychological and physiological variables in patients with
      schizophrenia.

      Design: Randomized clinical trial
    

Intervention name(s): Experimental-Exercise training
Intervention type(s): Other
Intervention description(s): Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength or/and aerobic training exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine if the GSK Biologicals' human rotavirus
      (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on
      immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the
      20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV
      strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until
      Visit 5.

      The primary objective will be reached if the lower limit of the 95% confidence interval (CI)
      on vaccine efficacy is >0%.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      The study will have three groups: Rotarix 3-Dose Group, Rotarix 2-Dose Group and Placebo
      Group. Three-dose immunisation will be administered in healthy infants at approximately 6,
      10, and 14 weeks of age. Routine EPI vaccinations will be administered concomitantly with the
      study vaccines. This study will also evaluate immunogenicity and safety relative to the
      placebo.
    

Intervention name(s): Rotarix™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two or Three doses, oral administration; One or three doses, oral administration.
Other intervention name(s): GSK Biologicals' HRV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rotavirus gastroenteritis; HRV vaccine
Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD
Condition: Retinal Detachment
MeSH terms: Retinal Detachment
Study type: Interventional

Summary: 
      Internal limiting membrane peeling is performed during vitrectomy for macular diseases such
      as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.

      The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment
      has been reported to range from 4.4% to 12.8%.

      In this study, the efficacy and safety of internal limiting membrane peeling will be studied
      in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in
      those cases or not.
    

Detailed description: 
      interventional observational study comparing vitrectomy with versus without internal limiting
      membrane peeling in cases of rhegmatogenous retinal detachment.
    

Intervention name(s): Pars Plana Vitrectomy
Intervention type(s): Other
Intervention description(s): vitrectomy with and without ILM peeling
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Internal limiting membrane; multifocal electoretinogram (ERG); OCT-Angiography
Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Condition: Obesity
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The main objective is to evaluate the effects of a multicomponent, school-based intervention
      combining change in nutritional behaviors with after school physical activity activities in
      reducing the excessive weight gain in schoolchildren.
    

Detailed description: 
      Specific objectives are:

      - evaluate the effect of the program on: change in nutritional behaviors, such as reducing
      sugar sweetened beverages and cookies intake reduction of time spent in sedentary activities
      gains in school performance and cognition outcomes the amount of daily physical activity on
      the percentage of body fat, changes in biochemical markers and blood pressure.
    

Intervention name(s): Eating behavior and physical activity change
Intervention type(s): Behavioral
Intervention description(s): A combination of two prevention school based programs will be addressed to schoolchildren over one year. Primary prevention will be developed monthly in order to reduce cookies and sugar sweetened beverages consumption, reduction of sedentary activities, increase meal consumption frequency and quality etc, in all children from 6th and 7th grades. Overweight and obese children will be invited to participate on a secondary prevention program in which daily physical activity classes will be performed by physical education teachers in school facilities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: school-based intervention; after school physical activity; sugar sweetened beverages; sedentary behavior; schoolchildren
Incorporating Avocados in Meals
Condition: Satiety; Glycemic Index; Insulin; Gastrointestinal Peptides and Hormones
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of incorporating avocados in meals on
      post-ingestion glycemic index, insulin response, sensations of satiety and on
      appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming
      avocado containing meals on the caloric intake of participants in subsequent eating episodes
      will be explored.

      Each subject will participate in one intervention for one day, wait one or two weeks, come
      for another intervention, wait one or two weeks and come for a final intervention- three in
      total. Participants will be randomly assigned to one of six treatment sequences. Postprandial
      response to the control and two avocado-containing test meals will be assessed and compared
      using a 3 x 3 single blind cross-over design. The Subjects will be between 25 and 60 years
      old, female or male, with a BMI of 23 to 32, stable weight, no sports involvement,
      non-smoking and not dependent on caffeine. Thirty subjects will be recruited.
    


Intervention name(s): Avocado supplement; Avocado included
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Calories from avocados replace calories of the control lunch; Calories from avocados will be added to calories from the control lunch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Keywords: Avocados; Satiety; Feeding study
The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent
      seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged
      18-60 years old, and 60 healthy older people aged > 60 years.
    


Intervention name(s): 2012-2013 trivalent seasonal influenza vaccine
Intervention type(s): Biological
Intervention description(s): trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: 2012-2013 trivalent seasonal influenza vaccine; immunogenicity,; safety
Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Observational

Summary: 
      Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the
      measurement of skin conductance.

      Withdrawal of chest tube can be painful and the purpose of the study was to compare
      auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.
    


Intervention name(s): Chest drain withdrawal; Pain Monitor
Intervention type(s): Procedure; Device
Other intervention name(s): Measurement of Pain Monitor index
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lung surgical patients
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 4

Summary: 
      This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection
      when given to an expanded population in the outpatient setting in experienced VL centers and
      subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin
      IM Injection to progressively more resource-constrained clinics in Bihar, India.
    

Detailed description: 
      Safe, effective, and affordable treatments for visceral leishmaniasis (VL) that are widely
      available to the poorest population of rural India where the disease is endemic are urgently
      needed. Resistance to antimonials, which have historically been the first line of treatment
      for VL in Bihar and adjoining states, is a major problem. Other available treatments are
      limited by their high cost, toxicity, or contraindications in certain populations.
      Paromomycin IM Injection was approved for the treatment of VL in August 2006 by the Drug
      Controller General of India (DCGI).

      The study is designed to establish a Phase 4 Access Program in a modular, stepwise fashion
      (Modules 1 to 3). The study will first confirm the safety and efficacy of Paromomycin IM
      Injection in an expanded VL population treated as an outpatient in experienced centers
      (Module 1); and then progressively extend the network of treatment facilities, the number and
      reach of the trained staff, and the implementation of the requisite logistics systems to
      rural Bihar (Modules 2 and 3). An expanded network of healthcare workers will be trained and
      supervised to make a preliminary diagnosis of VL; to make appropriate referrals to confirm
      the diagnosis of VL; to treat with Paromomycin IM Injection; and to assess patient safety and
      clinical response on an outpatient basis.
    

Intervention name(s): Paromomycin sulfate
Intervention type(s): Drug
Intervention description(s): Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
Other intervention name(s): Paromomycin IM Injection
Intervention MeSH terms: Paromomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: visceral leishmaniasis; kala-azar; Bihar, India
Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine if the concomitant administration of either
      ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess
      safety and tolerability of BMS-708163
    


Intervention name(s): BMS-708163; BMS-708163 + Ketoconazole; Ketoconazole; Fluconazole; BMS-708163 + Fluconazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule, Oral, 50 mg, once, Day 1; (BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day; Tablet, Oral, 400 mg, daily, 16 days; Tablet, Oral, 1 day 400 mg then 3 days 200 mg; (BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days
Intervention MeSH terms: Fluconazole; Ketoconazole; BMS 708163
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Enhanced Recovery After Surgery in Major Intrabdominal Procedures.
Condition: Complication of Surgical and Medical Care.
Study type: Interventional

Summary: 
      Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating
      the stress response to surgery and enabling rapid recovery. There is strong evidence of the
      usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of
      significantly reduced postoperative complications and shorter length of hospital stay,
      compared to the patients of traditional treatment. However, few studies exist about the
      implication of ERAS programs in major upper abdominal surgery patients.

      The aim of this study was to compare morbidity, mortality and length of stay in patients
      undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving
      either conventional postoperative care or an ERAS program.
    


Intervention name(s): ERAS perioperative care; Traditional
Intervention type(s): Other; Other
Intervention description(s): Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.; Nasogastric tube until bowel function, late oral eating, opioid analgesics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fast-tract surgery, Enhanced recovery after surgery, multimodal surgery.