bioihbjkbjnl/mcl2 huggingface dataset:
tDCS and Its Therapeutic Effects in CK Fever
Condition: Chikungunya Fever
MeSH terms: Chikungunya Fever; Fever
Study type: Interventional

Summary: 
      One of the major challenges faced by researchers working in the field of rehabilitation
      science is the ability to provide integrative approaches to the use of clinical practice. In
      this context it becomes increasingly necessary to construct investigative approaches, so that
      they can reach clinical practice in a shorter period of time,since the large volume of
      information produced globally does not impact in the short or medium term on new therapeutic
      recommendations. Among the various chronic painful entities, there is chikungunya fever as a
      highlight for having a rich clinical chronology in relation to pain. Its therapy is used done
      by drugs in almost all national and international consensuses, therefore therapy against pain
      in chikungunya fever is limited during the rehabilitation process. It is very important that
      the science of rehabilitation enhances methods of noninvasive brain modulation that enable,
      through the excitation or inhibition of specific cortical areas to produce pain inhibiting
      effects, providing a simple and low cost treatment to the clinical routine.Technological
      advances and non-invasive techniques to modulate brain function have been developed, for
      instance, Transcranial Direct Current Stimulation (tDCS).

      The objective of the present project is to present the tDCS as a new modality of physical
      rehabilitation for the patient with chronic pain resulting from chikungunya fever. The
      purpose of the study is to present physical, behavioral and social results of the application
      of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional
      status of the individual.
    


Intervention name(s): Transcranial Direct Current Stimulation; Sham Transcranial Direct Current Stimulation
Intervention type(s): Device; Device
Intervention description(s): For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.; For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator was turned off after 30 seconds of stimulation. Therefore, patients in the sham group felt the initial itching sensation but received no current for the rest of the stimulation period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children
Condition: Nosocomial Infection
MeSH terms: Infections; Cross Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      Nosocomial infections are infections that occur from the time of 'entry in the hospital up to
      48h after discharge. In most developed countries, the incidence of nosocomial infections in
      children is between 5% and 44% with the predominance of respiratory infections and
      gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce
      the effectiveness of treatment, significantly increasing hospital costs. Current measures for
      prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with
      sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the
      possible methods of prevention, between which has been already tested the use of probiotics
      such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against
      placebo, noted a significant reduction in the risk of gastrointestinal infections and
      respiratory infections in hospitalized children treated with LGG, compared with patients who
      received placebo. There are also evidence which demonstrate a potential role zinc in reducing
      the incidence of respiratory infections is that bowel. We thought, therefore, to perform a
      multicenter randomized controlled trial with the aim to evaluate the role of a complex
      containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and
      respiratory tract infections in pediatric wards.
    


Intervention name(s): Lactobacillus Rhamnosus GG; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 vials q12 for 15 days; 1 vials q12 for 15 days
Other intervention name(s): LGG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: LGG; Probiotics; nosocomial infection prevention; pediatrics
Local Registration Trial in China Humalog Mix 50
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the 2-hour PPBG excursion following a
      standard test meal in insulin-requiring diabetic patients treated twice daily with human
      insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with
      insulin lispro mix 50/50.
    


Intervention name(s): Humalog Mix 50; Human Insulin Mix 50:50
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin Lispro; Insulin, Globin Zinc; Isophane insulin, insulin lispro drug combination 50:50
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aerobic Exercise in Children With Moderate and Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Regular aerobic physical activity in short-term moderate asthma and severe:

        -  Reduce the levels of inflammatory mediators

        -  Improves functional capacity

        -  Improves Quality of Life

        -  Improved lung function

        -  Reduces the sensation of dyspnea

        -  Improves symptoms scores and medication use
    

Detailed description: 
      Methods: Is designed a randomized clinical trial, efficacy, outpatient physical therapy
      developed in the Institute of Integrative Medicine Teacher Fernando Figueira (IMIP). A pilot
      study with 20 participants will be made initially to obtain a sample calculation.
      Subjectively estimated it will take about 50 participants, with possible losses. Will include
      children older than eight years, diagnosis of moderate and severe persistent asthma according
      to criteria of Global Initiative National Asthma (GINA) and forced expiratory volume in one
      minute (FEV1) below 80% predicted. Will be excluded from the study associated with disease
      that limits physical activity, such as neuromuscular diseases, congenital or acquired heart
      disease, chronic lung disease associated exacerbation of the crisis and significant cognitive
      deficit, which makes the participant to respond adequately to the questionnaire and / or
      inability to meet the commands. Eligible patients will be randomized into two groups: control
      group, which is not subjected to any kind of exercise and the intervention group, which will
      be submitted to aerobic exercise for 30 minutes three times a week for six weeks. The two
      groups will be evaluated before and at the end of six weeks by testing for 6-minute walk,
      analysis of dyspnea, questionnaire of quality of life, pulmonary function test (FEV1, FVC),
      inflammatory markers (cytokine ).
    

Intervention name(s): aerobic exercise
Intervention type(s): Other
Intervention description(s): Performed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training.
Other intervention name(s): physical exercise, physical training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: asthma, aerobic exercise, child, cytokines
Acetaminophen/Naproxen Sodium Dose Ranging Study
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Study assessing the relative efficacy of five strengths of a fixed combination of
      acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s)
      for further development and to evaluate the safety of a fixed combination of naproxen sodium
      and acetaminophen.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic
      efficacy and safety profile of the following doses of a fixed combination of Acetaminophen
      (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen
      Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C,
      Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo]
      following surgical extraction of four third molars.
    

Intervention name(s): Acetaminophen/naproxen sodium Dose A; Acetaminophen/naproxen sodium Dose B; Acetaminophen/naproxen sodium Dose C; Acetaminophen/naproxen sodium Dose D; Acetaminophen/naproxen sodium Dose E; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.; Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.; Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.; Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.; Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.; Placebo tablets administered as a single two-tablet dose.
Intervention MeSH terms: Acetaminophen; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesics; Dental Pain; Acetaminophen; Naproxen Sodium; Pain; Fixed-Dose
Different Resectoscopes Effects to Optic Nerve Sheath Diameter
Condition: Optic Nerve Sheath Diameter
Study type: Interventional

Summary: 
      In this study, in patients with benign prostatic hypertrophy, monopolar and transurethral
      prostate using bipolar techniques in resection; serum electrolytes in the perioperative
      period, osmolarity can occur in hemodynamic parameters the effect of changes on optic nerve
      diameter by ultrasonography.
    

Detailed description: 
      This study is for TURP operation for Benign Prostate Hypertrophy patients. When patient comes
      to the operating room, routine preparations will be made. Haemodynamic parameters and
      over-the-eye with Optic nerve diameter will be checked with ultrasound before and 10 minutes
      after spinal anesthesia. Monopolar for patients according to the preference of the surgical
      team resectoscope technique or bipolar resectoscope technique will be applied. During the
      operation Blood pressure, pulse minute the number of irrigation solutions used and the amount
      of intravenously administered serum, operation time will be saved. Optic nerve sheath
      diameter after the operation would be checked again. intraoperative and postoperative
      complications in the waking room (respiratory distress, hypotension, hypertension,
      bradycardia, tachycardia, vomiting, headache, restlessness, seizure, arrhythmia, vision
      disorder) will be recorded.
    

Intervention name(s): Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound
Intervention type(s): Procedure
Intervention description(s): During the operation Blood pressure, pulse minute the number of irrigation solutions used, and intravenous serum amounts, operation time will be saved. If there is an abnormal parameters or increased optic nerve sheath surgical team will be informed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: According to the resectoscopes used during the operation, patients will be divided into 2 groups as Monopolar one (Group M) and Bipolar one (Group B).
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Monopolar Resectoscope; Bipolar Resectoscope
CD133+ Autologous Cells After Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial
      infarction.

      TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.

      SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction
      (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty
      (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB)
      grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al.,
      Circulation, 2002).

      OBJECTIVES Primary:

        1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone
           marrow (ABM) and mobilized peripheral blood (MPB) in the target population.

        2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in
           the culprit vessel of the target population, on regional and global contractile function
           and on perfusion and metabolism of the infarcted area, depending on cell dose and
           comparing to controls.

           Secondary:

        3. To evaluate the disease-related morbility of the target population.
    


Intervention name(s): cd133+cell intracoronary administration
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cell therapy; acute myocardial infarction
A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while
      treatment measures are limited. This study plans to recruit 39 subjects with Hepatitis B
      virus (HBV) related HCC after liver transplantation. The objective of the study is to assess
      the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR)
      redirected T cell in the target population.
    

Detailed description: 
      A open-label, cohort clinical study of T cell receptor-redirected T cells to prevent
      recurrence of HBV-related hepatocellular carcinoma after liver transplantation. Subjects will
      be enrolled into the observation cohort or treatment cohort.

      Subjects enrolled in the treatment group will receive escalating doses of HBV/ TCR expressing
      autologous T cells after confirming eligibility. The interval between the first two doses is
      14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month
      interval in between. Thereafter, subjects would enter into observation period of the safety
      and tolerability of the treatment and will be followed up until disease relapse.

      Upon disease recurrence, eligible patient may receive HBV specific T-cell receptor (TCR-T)
      treatment.
    

Intervention name(s): TCR-T; No intervention and TCR-T (at crossover)
Intervention type(s): Biological; Biological
Intervention description(s): Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR; Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatocellular carcinoma; hepatitis B virus-related; post liver transplantation; HCC
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
Condition: Pseudomonas Infection
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate
      antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This
      planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation
      Powder in the pediatric population of 6 to 12 years of age.
    


Intervention name(s): Ciprofloxacin (Cipro, BAYQ3939)
Intervention type(s): Drug
Intervention description(s): 25 mg inhaled Ciprofloxacin
Intervention MeSH terms: Ciprofloxacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Pharmacokinetics; Pediatrics; Inhalation; Sputum
Pharmacokinetics of Two Formulation of Tenofovir Disoproxil Fumarate
Condition: Pharmacokinetic of Tenofovir in Healthy Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate pharmacokinetic profiles of Viproof Film Coated Tablets 300 mg manufactured by
      Yung Shin Parm. Ind. Co., Ltd., Taiwan and Viread Tablets manufactured by Patheon, Inc. in
      terms of plasma concentrations of tenofovir after a single oral dose of 300 mg tenofovir
      disoproxil fumarate in healthy subjects under fasting conditions.
    


Intervention name(s): Tenofovir Disoproxil Fumarate 300 MG
Intervention type(s): Drug
Intervention description(s): One tablet of Viproof Film Coated Tablets or Viread Tablets will be orally administrated with 240 mL of water in the morning.
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal
      transplant patients are investigated to look for potential interaction between these drugs.

      All patient enrolled in this PKI-Study had no changes in the therapy before or because of the
      study. Only patients without changes more than 4 weeks were included
    


Intervention name(s): Fluvastatin, Tacrolimus, Mycophenolat Mofetil
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: renal transplantation; pharmacokinetics; Fluvastatin; Mycophenolat mofetil; tacrolimus
A Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single-center
      phase I clinical trial of JS026 and JS026 + JS016 Injection. The objective of the study is to
      evaluate the safety, tolerability, PK profile and immunogenicity of a single intravenous
      infusion of JS026 and JS026 + JS016 Injection in healthy subjects.

      In this study, the single ascending dose design will be adopted, JS026 will be administered
      sequentially from low dose group to high dose group, and each subject can only receive an
      intravenous infusion at one dose level. Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and
      1000 mg) will be set to receive an intravenous infusion of JS026, and two dose groups (300 mg
      JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set for JS026 + JS016. The
      investigational product and placebo will be distributed in each dose group in a ratio of 3:1.
      Four subjects will be enrolled in each of JS026 30 mg and 100 mg groups, and 8 subjects will
      be enrolled in each of other dose groups, totally 48 subjects.
    

Detailed description: 
      The entire trial period consists of a screening period of up to 14 days, a single dosing day
      (D1), and a 12-week follow-up period (84 days after dosing). Subjects will be admitted to the
      phase I clinical trial ward on the day before administration (D-1), and discharged after all
      examinations and assessments are completed on D4 after administration. Moreover, they will
      return to thestudy site for follow-up visits and relevant procedures and assessments as
      scheduled in the protocol.
    

Intervention name(s): JS026/placebo; JS016/placebo
Intervention type(s): Biological; Biological
Intervention description(s): Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026/placebo on Day1, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.; Two dose groups (300 mg + 1200 mg, and 600 mg + 1200 mg) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment