bioihbjkbjnl/mcl2 huggingface dataset:
Improving Hand Motor Function After Stroke: Role of Robotics
Condition: It is Possible That Amadeo Will Guarantee a Greater Clinical Improvement as Compared to an Occupational Therapy Thanks to the Strengthening of Brain Plasticity
Study type: Interventional

Summary: 
      Two recent randomized clinical trials reported a significant contribute of Amadeo toward the
      recovery of hand motor function in acute stroke patients in association with physiotherapy
      and/or occupational therapy. However, no data are available in patients with chronic stroke,
      and the neurophysiological mechanisms underlying such clinical improvement need to be
      elucidated. Given that robotic devices harness brain plasticity to foster motor function
      recovery, a deeper understanding of the neurophysiological bases of Amadeo training could
      help clinician to realize patient-tailored rehabilitative training based brain plasticity
      knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the
      effects of intensive robot-assisted hand therapy compared with intensive occupational therapy
      in chronic phase after stroke. We estimated that 40 patients per group will be required to
      demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect
      size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and
      randomized into two groups. The experimental group will be provided with Amadeo training. The
      Control group will be provided with occupational therapy executed by a trained
      physiotherapist.
    


Intervention name(s): Amadeo Training
Intervention type(s): Device
Intervention description(s): To understand the cortical modifications related to movement preparation and execution after robot-assisted training we will study the EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh).
Friedman ANOVA with post-hoc t-test (corrected for multiple comparisons) will be used to assess the significance of training-induced changes in the two groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5
      days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a
      total of 5 days, in children between 6 months and 6 years of age, with AOM.
    


Intervention name(s): cefdinir (Omnicef); azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, 7 mg/kg every 12 hours for 5 days; oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
Other intervention name(s): ABT-198; Omnicef; cefdinir
Intervention MeSH terms: Azithromycin; Cefdinir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Exer-gaming on Upper Extremity Function and Activities of Daily Living in Sub-acute Stroke Patient.
Condition: Stroke; Cardiovascular Stroke; Cerebrovascular Accident
MeSH terms: Stroke; Myocardial Infarction
Study type: Interventional

Summary: 
      Stroke is one of the leading cause of death, in adult stroke causes permanent disability.
      Stoke impact the life of a person significantly including the quality of life of an
      individual and especially performing the task of daily activities independently. About 50%
      survival of stroke have daily life activity limitation which is affecting their quality of
      life. Among stroke patients, 69% experience functional motor disturbance in their upper
      extremity.

      The aim of this study is to evaluate the effect of Exer-gaming by using the Xbox Kinect game
      system on upper extremity motor functions and the ability to perform ADLs in sub-acute
      stroke. Various treatment methods are used for the rehabilitation of stroke. This study will
      be a randomized controlled trial, used to compare the effectiveness of Exer gaming on upper
      extremity function and activities of daily living in sub-acute stroke patient. Subjects with
      Sub-acute stroke meeting the predetermined inclusion & exclusion criteria will be divided
      into two groups using simple random sampling technique. Pre assessment will be done using FMA
      & SIS measurements. Subjects in one group will be treated with Conventional therapy and exer
      gaming and the other will be treated with conventional therapy and activities training
      session. Each subject will be received a total 18 treatment sessions, with 3 treatment
      sessions per week for 6 weeks. Post treatment reading for FMA and SIS will be recorded after
      the end of treatment session. Recorded values will be analyzed for any change using SPSS.
    


Intervention name(s): Control group; Experimental Group
Intervention type(s): Other; Other
Intervention description(s): Conventional Therapy Passive ROM and/or AROM exercises Muscle strengthening; Therapeutics stretching of the shoulder, the elbow, the wrist, and the fingers. Activities of daily living training, including eating, grooming, dressing, toileting, and transfer; Interventional therapy Xbox Kinect (Xbox 360, Microsoft,) For training, programs such as Boxing and Bowling in the Kinect sports pack and Rally Ball, 20,000 Leaks, and Space Pop in the Kinect adventure pack, all of which required the use of the upper extremities, will be selected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Mesh Fixation With Intraperitoneal Tisseel
Condition: Postoperative Pain; Ventral Hernia
MeSH terms: Pain, Postoperative; Hernia; Hernia, Ventral
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical
      hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and
      recovery.
    


Intervention name(s): tack fixation of mesh; glue fixation of mesh
Intervention type(s): Procedure; Procedure
Intervention description(s): tack fixation of mesh; glue fixation of mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: surgical fixation devices; postoperative pain; ventral hernia; fibrin tissue adhesive; laparoscopy; quality of life; fatigue
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea and Healthy Controls.
Condition: Healthy; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and
      mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis
      stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which
      might be responsible for hypertension in these patients.

      The aim of this study is to measure the secretion of vasoactive hormones at night and to
      analyse the relationship between vasoactive hormones, oxygen saturation and the blood
      pressure at night.
    


Time perspective: Prospective
Keywords: Obstructive sleep apnea; Vasoactive hormones; Blood pressure
Renal Sympathetic Denervation and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors
Condition: Hypertension, Resistant to Conventional Therapy
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is
      done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive,
      percutaneous technique where an ablation catheter is inserted through a femoral artery into
      the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia
      by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys,
      which in the "Symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11
      mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have
      beneficial effects not only on blood pressure, but also on insulin sensitivity and
      hyperinsulinaemia.

      The investigators aim to introduce RDN as a clinical study where blood pressure reduction and
      methodical, technical aspects will be evaluated, but more importantly, also additional
      effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness,
      fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The
      investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and
      sub-clinical organ damage.
    


Intervention name(s): Renal sympathetic denervation
Intervention type(s): Procedure
Intervention description(s): This is a mini-invasive trans-catheter procedure with access via a 6F introducer in one of the femoral arteries. The renal sympathetic nerves arise from T10-L2, arborize around the renal artery and primarily lie within the adventitia. A specialized radiofrequency (RF) ablation catheter is introduced into the renal arteries, first one side, then on the other. Usually, 4-6 two-minute treatments per artery using a proprietary RF generator with automated low power and built-in safety algorithms are sufficient to ablate the sympathetic afferent and efferent fibers.
Other intervention name(s): Symplicity Catheter (Medtronic)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal denervation; Resistant Hypertension; Cardiovascular disease; Diabetes; Quality of LIfe
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Condition: Masseter Muscle Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type
      A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
    


Intervention name(s): botulinum toxin Type A; Normal saline
Intervention type(s): Biological; Drug
Intervention description(s): Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.; Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
Other intervention name(s): BOTOX®; onabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
Condition: Peritonitis
MeSH terms: Peritonitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using
      normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load
      after giving lavage with SOS solution and in other group normal saline. SOS is a high level
      disinfectant, non-flammable and no special training is required to handle it.
    

Detailed description: 
      Aim - To investigate the efficacy of super-oxidized solution (SOS) over normal saline in
      peritonitis. The investigators objectives are to present the potential clinical impact of
      intraperitoneal lavage with solutions for early recovery of the patient by reducing the
      infection rate.

      Methods - A double-blind random clinical trial was performed in 240 patients diagnosed as
      peritonitis at MMIMSR, Mullana, Ambala, India, from December 2014 - November 2015. Subjects
      were divided into 2 groups, i.e. 120 patients in the study group and 120 cases in the control
      group. Both the groups underwent peritoneal lavage ; the study group received SOS where as
      control group underwent normal saline lavage. The effectiveness of both the solutions were
      compared.
    

Intervention name(s): Super Oxidized Solution in group I
Intervention type(s): Procedure
Intervention description(s): Two groups were made as group I and group II. Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.
Other intervention name(s): normal saline solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: peritonitis; solutions; normal saline; infection; peritoneal lavage
MSC2364447C Phase 1b in Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to
      evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C
      administered for 4 weeks in systemic lupus erythematosus subjects (SLE).
    


Intervention name(s): MSC2364447C; MSC2364447C; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks.; Subjects will be administered with MSC2364447C 75 milligrams orally once daily for 4 weeks.; Subjects will be administered with placebo matching to MSC2364447C orally once daily for 4 weeks.
Other intervention name(s): M2951, Evobrutinib; M2951, Evobrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: MSC2364447C; Phase 1; BTK inhibitor; Systemic Lupus Erythematosus; M2951; Lupus
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
Condition: HIV Infections
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe to give Varivax to HIV-positive children
      and whether it protects children from infection. Varivax is a vaccine against varicella
      zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).

      VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine
      that has been approved for use in healthy children. More research is needed to find out how
      this vaccine will affect HIV-infected children.
    

Detailed description: 
      Primary varicella infection, or chickenpox, can be devastating to HIV-infected children
      because complications occur at higher rates in immunocompromised hosts. Current passive
      prophylaxis measures with varicella-zoster immune globulin are suboptimal because
      administration must be repeated for each exposure during the child's lifetime and timely
      notification of exposure is not always possible. Since Varivax has been licensed for routine
      vaccination of healthy individuals, it must be determined whether this vaccine can be safely
      administered to HIV-infected children.

      Thirty-six children who are varicella zoster virus (VZV)-naive (treatment group) receive
      Varivax at Weeks 0 and 12, with a possible boost at Week 52 if the patient is still
      seronegative for VZV and cytomegalovirus infection. Twenty children who have a history of
      wild-type varicella exposure within the past year (control group) receive no study treatment.
      All patients are either asymptomatic or mildly symptomatic for HIV infection. Patients make
      12-14 visits to the clinic. [AS PER AMENDMENT 9/9/99: This study has been reorganized into
      two cohorts (asymptomatic and symptomatic). In the asymptomatic cohort, accrual has been
      completed with 40 patients in Treatment Group I and 19 in the control group. This phase of
      the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with
      asymptomatic disease. The symptomatic cohort includes Treatment Groups II and III, each with
      30 patients. The first 10 patients from Group II are monitored for 42 days following the
      first dose of vaccine before the remaining 20 are accrued. Once the first 10 patients in
      Group II have been evaluated with acceptable toxicity and immunologic profiles, the remaining
      20 Group II and the first 10 Group III patients are enrolled. The first 10 Group III patients
      are also followed for acceptable toxicity and immunologic response before accrual of the
      remaining 20 Group III patients.]
    

Intervention name(s): Varicella Virus Vaccine (Live)
Intervention type(s): Biological
Primary purpose: Prevention
Keywords: Herpesvirus 3, Human; Viral Vaccines; AIDS-Related Complex; Vaccines, Attenuated; Chickenpox; Chickenpox Vaccine
Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      Alleviating pain in children undergoing renal transplant is extremely challenging. Large
      incisions as those of renal transplant (Gibson's incision) require special techniques of pain
      control that don't affect hemodynamics or renal function. Since the transplant incision
      doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control
      in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior
      abdominal wall together with the underlying parietal peritoneum.
    


Intervention name(s): bupivacaine; Pethidine; perfalgan; fentanyl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): bupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane; pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia; intravenous paracetamol
Intervention MeSH terms: Fentanyl; Meperidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pediatric; renal transplant; pain; dual TAB
Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing
Condition: Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently, there is no pharmacological intervention for mild symptomatic obstructive sleep
      disordered breathing (SDB) in the form of loud habitual snoring, inspiratory flow limitation
      (i.e. upper airway resistance syndrome), or mild sleep apnea. Here the investigators study
      the effect on SDB of stimulating pharyngeal muscles during sleep with AD036. The key
      hypothesis of the study is that AD036 is superior to placebo on self-reported and objective
      measures of SDB severity.
    

Detailed description: 
      This is a randomized placebo-controlled 2-period crossover study. Each crossover period will
      consist of 14 days of QHS dosing of either AD036 or placebo, with a washout period of 7 days
      between each period.

      Polysomnography will be performed at screening (baseline) and on the last dosing day of each
      of the two crossover dosing period.

      The trial will enroll participants until a total of 24 responders are randomized into the
      crossover portion of the study.
    

Intervention name(s): AD036; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AD036 will be given for 14 days; Placebo will be given for 14 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inspiratory flow limitation; Snoring; Mild Sleep Apnea
Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Observational

Summary: 
      Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm
      infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary
      dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is
      directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker
      of BPD.
    


Intervention name(s): blood sampling
Intervention type(s): Other
Intervention description(s): blood sampling
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        infants born before 32 weeks gestational age
      
Biospecimen description: 
      EDTA plasma
Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard
      to its total and to its maximum serum insulin concentrations.
    

Detailed description: 
      The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between
      Wosulin N and Novolin® N.The study also compares the pharmacokinetic and pharmacodynamic
      profiles as well as assessing safety and local tolerability of the two insulin preparations
      in healthy subjects.
    

Intervention name(s): Wosulin N; Novolin N
Intervention type(s): Biological; Biological
Intervention description(s): Total Dose per subject will be 0.4IU/Kg given Subcutaneously.; Total dose per subject will be 0.4 IU/Kg given Subcutaneously.
Intervention MeSH terms: Insulin; Isophane Insulin, Human
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Bioequivalence; pharmacokinetic; Pharmacodynamic; Isophane insulin
Safety/Efficacy Study of Restylane® in Lip Augmentation
Condition: Lip Augmentation
Study type: Interventional

Summary: 
      To determine the safety and effectiveness of Restylane® when used for lip augmentation.
    


Intervention name(s): Restylane®; Non-Treatment
Intervention type(s): Device; Device
Intervention description(s): Restylane® injections in the lips; Non- Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment