bioihbjkbjnl/mcl2 huggingface dataset:
Gait Re-education Program in Subjects With Parkinson´s Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Randomized controlled study that will include participants diagnosed with Parkinson's disease
      in mild or moderate stage with altered gait pattern who will be randomized following a simple
      randomization procedure in which one group will perform an intervention based on a gait
      re-education program called "TAPIZ FISIOR"- motor control and learning added to a
      conventional physiotherapy program; and the other group will perform only a conventional
      physiotherapy program. The evaluators will be unaware of the patient's treatment status.
    

Detailed description: 
      All participants interested in participating in the present study will be part of the
      research project. Once recruited, they will be randomly assigned to two intervention groups:
      A and B. Group A (control group) will perform a conventional physiotherapy treatment 2/3
      sessions per week of 30 minutes duration; on the other hand, group B (intervention group)
      will perform the treatment of group A and a therapeutic supplement of 2-3 sessions per week
      of about 30 minutes. During the research period, several measurements of the variables
      studied will be taken: one before the intervention, one immediately after the end of the
      intervention, and another measurement 12 weeks after the end of the intervention.

      The treatment will be carried out and supervised at all times by qualified physiotherapists,
      who will explain to you what the treatment consists of, the days you should attend, and the
      schedules. No adverse effects are expected from this therapy that could pose a risk for
      health.
    

Intervention name(s): GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE
Intervention type(s): Other
Intervention description(s): Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
Condition: Stroke; Hemiparetic Patients After Subacute Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted
      locomotor training on motor recovery of lower extremities and walking ability compared with
      the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.

      72 first-ever stroke patients who could not walk independently (FAC < 2), and suffered within
      6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive
      heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk
      independently before stroke attack were excluded.

      Two groups received 30 minutes conventional gait training including Neurodevelopmental
      Treatment (NDT) basically. The robotic assisted locomotor training group received additional
      robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily
      for 4 weeks, and the conventional gait training group received additional daily conventional
      gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3),
      Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA),
      Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles
      were assessed before, during (2weeks) and after training. And the independent walking ability
      were followed until 3 months.
    


Intervention name(s): Robot-assisted gait therapy; conventional gait training
Intervention type(s): Other; Other
Intervention description(s): Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.; Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and
      nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when
      administered for 48 weeks in antiretroviral drug naïve paediatric patients.
    

Detailed description: 
      A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and
      safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in
      combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients.

      Primary objective: To evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2
      in antiretroviral drug naive pediatric patients.

      Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine
      4/7mg/kg after 24 and 48 weeks of treatment

      Study Hypothesis:

      Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface
      area rather than body weight might be a better therapeutic regimen to achieve steady state
      plasma concentrations. The goal in this study was to determine if a Nevirapine suspension
      dose of 150 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma
      nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in
      adult safety and efficacy trials.

      Comparison(s):

      ACTG 245
    

Intervention name(s): Nevirapine; Lamivudine; Zidovudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Nevirapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food
      effect study conducted at one study center in the United States. Safety and tolerability will
      be assessed throughout the study and serial blood samples and urine samples will be collected
      for the safety and pharmacokinetic assessment of SXC-2023.
    


Intervention name(s): SXC-2023; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Placebo given as oral capsule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Current oral anti-coagulation for atrial fibrillation is most commonly performed with
      warfarin. Warfarin is a vitamin K antagonist that has been shown in non-randomized trials to
      increase vascular calcification. Increased vascular calcification has been tied to increased
      cardiovascular events (CVE). This study will randomize patients currently taking warfarin to
      either continue on warfarin or be switched to rivaroxaban. Rivaroxaban is an oral
      anti-coagulant that works by inhibiting Factor Xa, and has no interaction with vitamin K.
      This study is a randomized, open label study that will randomize 120 patients and have them
      undergo blood tests and a calcium scan at baseline, and again after 12 months. Patients will
      be seen quarterly for examinations, safety checks and supply of rivaroxaban, as well as
      follow up INR testing for warfarin.
    

Detailed description: 
      Rivaroxaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk
      of stroke in a similar population in comparison with warfarin. The rate of myocardial
      infarction was 9% lower in the rivaroxaban group than in the warfarin group in the Rocket AF
      study and similarly the myocardial infarction rate was 12% lower in the apixaban group in
      Aristotle, but the difference was not significant in either trial. The potential of long term
      benefit by avoiding VKA therapy may be much greater for a CV event reduction. The study
      proposed will evaluate markers of CAC progression and atherosclerosis development, which have
      long term outcome data supporting that slowing these processes will be associated with lower
      CV events.
    

Intervention name(s): rivaroxaban; Warfarin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Warfarin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial, with blinded randomization to one of two groups.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: atherosclerosis; coronary artery disease; cardiac CT; computed tomographic angiography
Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
    

Detailed description: 
      In this placebo-controlled study, using functional resting state MRI, the investigators aim
      to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90
      days, in stroke patients with a moderate to severe motor deficit.
    

Intervention name(s): Fluoxetine; Placebo; fMRI
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 20 mg of fluoxetine capsule per day from D0 to D90; cellulose placebo per day from D0 to D90; functional resting state MRI
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute ischemic stroke
The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      Community Case Management (CCM) is a clinical decision aid used by frontline Health
      Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and
      malaria (amongst other conditions). Children identified has having complicated illness are
      urgently referred to larger health facilities better equipped to clinically manage these more
      complex presentations. There is evidence to suggest HSAs are missing opportunities to refer
      seriously ill children, and parents/caregivers are failing to comply with urgent referral
      recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of
      mobile technology for deploying CCM has been demonstrated in prior research as feasible to
      evaluate, acceptable to health workers and parents/caregivers and improving health worker
      fidelity to the guidelines, but it is unknown if this translates into increased referral and
      referral completion rates. This trial seeks to evaluate the added value of a purpose
      developed mobile solution for CCM, called Supporting LIFE electronic Community Case
      Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.
    


Intervention name(s): Supporting LIFE electronic Community Case Management; Standard care
Intervention type(s): Other; Other
Intervention description(s): The SL eCCM App is smartphone application developed to run on Android operating systems 3.0 Honeycomb and above. The SL eCCM App represents an electronic format of the WHO and UNICEFs paper-based CCM clinical decision rule, currently adopted as national policy in Malawi for assessing children presenting to village clinics with acute illness.The App includes a tap-sensitive breath counter for measuring breathing rate.
Other intervention name(s): SL eCCM App
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma
Condition: Pediatric Aphakic Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and
      Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of
      age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication
      respectively and we came to this point that; T+MMC and AGI are comparable in terms of success
      rate and complications in pediatric aphakic glaucoma.
    


Intervention name(s): trabeculectomy with mitomycin-C
Intervention type(s): Procedure
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Aphakic Glaucoma; trabeculectomy with mitomycin- C; Ahmed glaucoma implant
Tranexamic Acid and Pediatric Adenotonsillectomy
Condition: Tonsillectomy; Adenoidectomy; Tranexamic Acid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the use of tranexamic acid prior
      adenotonsillectomy in children can reduce surgical and postoperative bleeding.
    

Detailed description: 
      Tonsillectomy with or without adenoidectomy is the most common major surgical procedure
      performed in children. Although it's a relatively simple procedure, may present complications
      as hemorrhage and death. The mortality associated to the surgery range between 1/1.000 and
      1/27.000 in the literature, with approximately 30% due to hemorrhage.

      Tranexamic acid is an antifibrinolytic hemostatic indicated to control bleeding in cases of
      hyperfibrinolysis or defective hemostasis diseases. It's major indications are prostatic
      surgery and menorrhagia.
    

Intervention name(s): Tranexamic Acid; normal saline solution
Intervention type(s): Drug; Other
Intervention description(s): 10mg/Kg, IV (in the vein), first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose; normal saline solution in the same volume calculated as treatment (tranexamic acid 250mg/mL, 10mg/Kg), IV (in the vein) first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose
Other intervention name(s): Transamin; Hemoblock
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adenotonsillectomy; Tranexamic acid; Blood loss; Postoperative hemorrhage
Pharmacokinetic Study of Nanoencapsulated Gel of Lidocaine, Prilocaine and Combination of Lidocaine and Prilocaine
Condition: Topical Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial evaluated the pharmacokinetic interaction between fixed doses of lidocaine (2.5%),
      prilocaine (2.5%) or the association of both (Nanorap®) in healthy volunteers. The drug
      safety and tolerability was also evaluated.
    

Detailed description: 
      This study was performed as a monocentric, open, randomized, double-blind, with 3 treatment
      regimen (lidocaine, prilocaine, or Nanorap®) in 3 periods design. Volunteers were submitted
      to clinical and laboratory examination before enrollment. Treatments were carried out on 3
      different days with a washout period of 7 days between each dose.

      After a fasting period (8 h), volunteers received topically 2g of the formulation in a
      delimited area of 16 cm2 in the volar surface of the forearm. The product was applied to the
      left arm and venous blood was collected from the right arm. The remaining product was removed
      with a cotton swab 10 minutes after application. Blood samples (3.5 mL) were collected into
      heparinized tubes before (0:00) and at 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5,
      8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 12.0, 14.0, 16.0 and 24.0 h after the hydrogel
      application.

      Blood samples were centrifuged at 2000 g (4 ⁰C) for 10 minutes and the obtained plasma
      samples were stored at -20 °C until analysis.

      Following dosing, volunteers were monitored for 36 h in a clinical setting safety and
      tolerability (signs, symptoms, adverse events, and laboratory parameters). The vital signs
      (blood pressure and pulse rate) were evaluated. ECGs were obtained before (30 min) and at
      drug Cmax (6 h) for each product application. QT interval corrected by heart rate (QTc) data
      were obtained from a Bionet Cardiocare 2000 and BMS-Plus software program, using Bazett's
      formula: QTc = QT/(sqrt RR Interval).
    

Intervention name(s): Lidocaine + Prilocaine; Lidocaine; Prilocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single topical dose of 2g lidocaine + prilocaine 2.5 % formulation.; Single topical dose of 2g lidocaine 2.5 % formulation.; Single topical dose of 2g prilocaine 2.5 % formulation.
Other intervention name(s): Nanorap®
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: local anesthetics; pharmacokinetics; nanotechnology
Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of Chinese medicine Qinbudan
      in Patients Receiving Standard Combination Therapy for Retreatment Pulmonary Tuberculosis.
    

Detailed description: 
      Retreatment of tuberculosis involves the management of entities as diverse as relapse,
      failure, treatment after default, and poor patient adherence to the previous treatment. The
      emergence of conditions for selection of resistance (failure and partial abandonment) is a
      matter of great concern. The current chemotherapy is the primary interventions, but the
      long-term drug combination therapy often leads to adverse reactions. The purpose of this
      study that is to exploring the role of Chinese medicine Qinbudan on Patients who are
      initially sputum smear positive or culture-positive who have been treated previously for
      pulmonary tuberculosis.
    

Intervention name(s): Qinbudan; Qinbudan Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice; Qinbudan Placebo was the same as therapeutic drug in package,shape,size.
Other intervention name(s): Qinbudan table; Qinbudan table Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Retreatment Pulmonary Tuberculosis, Qinbudan,
Effect of Site on Pain in Preterm Neonates
Condition: Great Premature Newborn
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Numerous experimental and clinical studies have shown that preterm neonates are particularly
      sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each
      situation causing pain or discomfort can alter their development and cause short term
      cardiovascular consequences but also have long-term neurocognitive influences. Repetitive
      procedural pain can also lead to changes in the pain sensitivity threshold therefore. The
      most common painful procedures are lancing for blood glucose testing. In adults, infants and
      term newborns, forearm blood glucose testing has been demonstrated to be less painful than
      conventional sites (heel, fingers). But data is lacking in preterm neonates.

      The primary purpose of this study is to demonstrate a significant reduction in pain response
      during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born
      up to 32 weeks gestation.

      This study is an interventional multicenter (3 centers), randomized, double bind trial with a
      cross over assignment. 60 premature neonates born between 23 to 32 weeks.

      Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose
      pricks will be included. The different sites will be randomly successively tested.
    


Intervention name(s): Blood puncture site
Intervention type(s): Biological
Intervention description(s): Blood puncture site
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift
Condition: Sleep Disorders, Circadian Rhythm
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 2

Summary: 
      The general aim of this study is to assess the effects of Pharmaton® Caplets on mental
      performance and physical fatigue in nurses and nursing auxiliaries working night shifts
    


Intervention name(s): Pharmaton® Caplets; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment