bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
Condition: Bronchospasm; Bronchiolitis; Bronchospasm; Bronchitis
MeSH terms: Bronchiolitis; Bronchitis; Bronchial Spasm; Respiratory Sounds
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be conducted in two hospitals of the same geographic area. It will be included
      children <3-years-old with recurrent wheezing attacks, confirmed by the review of the medical
      records, in the previous 12 months or a shorter time for those younger than one year.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, parallel-group study will included 120
      children <3 years old with ≥3 episodes of wheezing during the previous year. They will
      receive active treatment or placebo for six months. The main outcome will be the number of
      wheezing attacks during one year. Other outcomes were duration and severity of wheezing
      attacks , symptom and medication scores, and use of health resources.
    

Intervention name(s): Biological vaccine
Intervention type(s): Biological
Intervention description(s): daily spray (2 puff of 100 µL) for six months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vaccine; Bronchospasm
Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System
Condition: Time in Range
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4
      inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood
      glucose levels with low risk of hypoglycemia.

      Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among
      adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of
      Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.
    

Detailed description: 
      Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin
      therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia;
      hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial
      insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to
      calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and
      inaccurate for some patient, with an estimation error of around 20% in adults demonstrating
      only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the
      wide variability using ICRs suggests it should be improved upon.

      However, there have been only a few randomized control studies that investigated the efficacy
      and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin.
      Therefore, we conducted a one-month randomized control trial to investigate the efficacy and
      safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM
      on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .
    

Intervention name(s): Dipeptidyl peptidase-4 inhibitors
Intervention type(s): Drug
Intervention description(s): Dipeptidyl peptidase-4 inhibitors with Iftar meal
Intervention MeSH terms: Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
Condition: Pregnant Women; Pain; Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 3

Summary: 
      Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia
      using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite
      effective surgical anesthesia, bupivacaine is associated with long duration motor block and
      dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its
      new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and
      faster regression of motor block compared to other local anesthetics without noteworthy
      side-effects when used intrathecally. The aim of this randomized, multicenter, powered
      clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric
      bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid
      rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers
      shorter motor block and more rapid rehabilitation than bupivacaine.
    


Intervention name(s): Hyperbaric bupivacaine; Hyperbaric prilocaine
Intervention type(s): Drug; Drug
Intervention description(s): The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.; The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
Other intervention name(s): Marcaine; Tachipri
Intervention MeSH terms: Bupivacaine; Prilocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean delivery; Spinal anesthesia; Local anesthetics
Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer (MASTER)
Condition: Primary Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      We aimed to evaluate the noninferiority of a short-term anthracycline-free chemotherapy (TC,
      six cycles of docetaxel and cyclophosphamide) or a short-term anthracycline-based
      chemotherapy (CEF-T, three cycles of cyclophosphamide/epirubicin/fluorouracil followed by
      three cycles of docetaxel) to a standard anthracycline/taxane-containing chemotherapy (EC-P,
      epirubicin and cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in
      operable breast cancer.
    

Detailed description: 
      It was initiated as an adjuvant chemotherapy trial in 2010 to test noninferiority of an
      anthracycline-free short-term regimen (T75C600 x 6 [TC] once every 3 weeks) or a short-term
      regimen (C500E100F500 x 3 once every 3 weeks followed by T100 x 3 every 3 weeks [CEF-T])
      compared with a standard long-term anthracycline-containing regimen (E90C600 x 4 once every 3
      weeks followed by P80 x 12 once every week [EC-P]). Patients were randomly assigned (1:1:1)
      to each arm after completing surgical excision of primary tumor. Trastuzumab was administered
      in combination with chemotherapy to patients with HER2-positive breast cancer and sustained
      monotherapy as per the current guidelines.
    

Intervention name(s): Paclitaxel; Docetaxel; Cyclophosphamide; Epirubicin; 5-fluorouracil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Paclitaxel chemotherapy (injection); Docetaxel chemotherapy (injection); Cyclophosphamide chemotherapy (injection); Epirubicin chemotherapy (injection); 5-fluorouracil chemotherapy (injection)
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental: Arm 1 6 cycles of (Docetaxel 75mg/m2 ivgtt d1+ Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) .
Experimental: Arm 2 3 cycles of FEC (Epirubicin 100 mg/m2 ivgtt d1+Cyclophosphamide 500 mg/m2 iv d1+ 5-fluorouracil 500 mg/m2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg/m2, ivgtt d1, 21 days per cycle)
Experimental: Arm 3 4 cycles of EC (Epirubicin 90 mg/m2 ivgtt d1+Cyclophosphamide 600 mg/m2 iv d1+ , 21 days per cycle) followed by 4 cycles of Paclitaxel (Paclitaxel 80mg/m2, ivgtt d1,8,15, 21days per cycle).
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen
      administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).
    


Intervention name(s): hokt3g1 (ALA-ALA)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and
      lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only
      therapeutic option now. Recently several studies have shown that stem cell transplantation is
      safe and can be effective in reduction of disease progression and increase of quality of
      life.
    

Detailed description: 
      the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating
      Test) ALS-FRS> 24 and (Forced Vital Capacity) FVC>40% . The adipose sample is provide from
      healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem
      cells, the cells are injected intravenously (2 million cells/kg). All the patients will be
      followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after
      transplantation to find the adverse events. During follow up the assessments including:
      ALS-FRS, FVC and electromyography and serologic tests.
    

Intervention name(s): mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): mesenchymal stem cells injection via peripheral vein.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adipose tissue mesenchymal stem cell intravenous injection ALS
Effects of NUTRIOSE®FB Dietary Fiber Supplementation on Satiety, Body Fat, and Metabolic Syndrome in Overweight Adult Men
Condition: Overweight; Metabolic Syndrome X
MeSH terms: Overweight; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to determine the effects of NUTRIOSE® supplementation on body
      composition, satiety, and determinants of metabolic syndrome in overweight men.
    

Detailed description: 
      Previous trials of fiber supplementation have yielded equivocal results on body composition,
      satiety, and determinants of metabolic syndrome. This double-blind, randomized,
      placebo-controlled study was conducted to determine the effects of a proprietary soluble
      dextrin dietary fiber supplement (NUTRIOSE®) on these parameters in overweight males.
    

Intervention name(s): NUTRIOSE; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 17 grams of NUTRIOSE consumed twice daily for 12 weeks; 17 g maltodextrin consumed twice daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: fiber; metabolic syndrome; overweight; satiety
Role of Adipose Tissue in Pathogenesis of Insulin Resistance
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The aim of the study was to investigate the relationship between insulin resistance and body
      composition in relation to secterion and expression of adipocytokines. Obese subjects undergo
      6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and
      subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body
      composition and insulin resistance are measured before and during the diet.
    

Detailed description: 
      The aim of the study was to investigate the relationship between insulin resistance and body
      composition in relation to secterion and expression of adipocytokines. Obese subjects undergo
      6 months hypocaloric diet without any medication and, before, during and at the end of the
      diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent
      analysis. Adipose tissue samples are obtained using needle biopsy. In addition, before and
      during the diet,body composition is measured using multifrequency bioimpedance and insulin
      resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived
      indices.
    

Intervention name(s): Hypocaloric diet
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Insulin resistance; Hypocaloric diet; Adipose tissue; adipocytokine
A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour
      continuous infusion of conivaptan in subjects with severe liver impairment compared to
      subjects with normal liver function.
    

Detailed description: 
      Subjects will be admitted to the Phase 1 unit Day -2 and will remain confined to the unit
      until discharge on Study Day 5 after completion of all study procedures.
    

Intervention name(s): conivaptan hydrochloride
Intervention type(s): Drug
Intervention description(s): Intravenous
Other intervention name(s): Vaprisol; YM087
Intervention MeSH terms: Conivaptan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Protein Binding; Conivaptan; Vaprisol; Liver Disease; YM087
Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children
Condition: Radial Artery Canulation
Study type: Interventional
Phase: Phase 4

Summary: 
      Local nitroglycerin (NTG) was successfully used as a vasodilator to facilitate cannulation of
      the radial artery. NTG was used in adults by topical application as well as subcutaneous
      infiltration. Subcutaneous infiltration of NTG resulted in significant vasodilatation,
      improved palpability of the radial artery, reduced the number of punctures and the time
      needed for cannulation in adults. Topical NTG was reported to increase radial artery diameter
      in healthy volunteers without reduction in arterial blood pressure. In pediatric population,
      there no sufficient evidence for the effectiveness of NTG in improving radial artery
      cannulation. In a case report on two neonates, topical nitroderm ointment successfully
      reversed tissue ischemia secondary to radial artery cannulation The aim of this work is to
      evaluate the use of topical NTG (patch) for increasing the diameter of radial artery,
      improving the cannulation success, and decreasing catheter-related ischemic complications.
    

Detailed description: 
      A written informed consent will be obtained from patient's parents or guardians.
      Randomization will be obtained using computer-generated sequence. Concealment will be
      obtained using opaque envelopes.

      On arrival to the preparing room, patients will be randomized into one of the two groups:

      - NTG group or, Control group

      Ultrasound examination:

      The diameter of radial artery will be measured using a linear, high frequency probe (12 mHz)
      of Simens machine. Measurement will be obtained in the short axis plane at the point with
      maximal pulsation. The point will be marked to guide the post-intervention examination. The
      operator will be an experienced single operator blinded to the study group. Measurements will
      be obtained in both limbs at baseline (before application of NTG patch application,30
      minutes,60minutes after NTG application After induction of anesthesia, radial artery will be
      punctured by 22-g catheter by an experienced anesthetist
    

Intervention name(s): NTG patch; gauze cover
Intervention type(s): Drug; Other
Intervention description(s): A half-NTG patch (dose calculated at 5-12.5 mcg/kg/hr) will be applied to patients at the site of radial pulsation one hour before induction of anesthesia. The NTG patch will be applied to the right upper in half of the patients and will be applied to the left upper limb in the other half; A gauze will be applied near the radial artery pulsation to ensure blinding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Sleep disorders are among the non-motor signs more common in Parkinson's disease (PD). This
      case series evaluated the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on
      acupoints in the self-assessment of sleep in 14 PD patients classified between stages 1 and 3
      of Hoehn and Yahr original (HY). Patients were assessed using the Sleep Scale for Parkinson's
      Disease (PDSS) and subjected to treatment with eight TENS sessions on acupoints, with the
      current Burst. We used the paired sample t-test, considering p ≤ 0.05.
    


Intervention name(s): Transcutaneous Electric Nerve Stimulation
Intervention type(s): Procedure
Intervention description(s): Eight sessions were held, once a week, lasting twenty minutes. For this purpose, the electrodes of the acoustic surface Taichong (LR-3), Hé gǔ (Ll-4), Yanglingquan (GB-34) and Neiguan (PC-6) connected to the TENS equipment (EL 608, brand NKL). The current of choice for a BURST type, with intermittent pulses, isolated at a frequency of 2 Hz, ranging from 1 to 10 mA.
Other intervention name(s): Tens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to evaluate the outcomes of patients undergoing total knee
      replacement with two different methods of local pain control:shots of liposomal bupivacaine,
      a long acting anesthetic, directly into the knee during surgery or anesthetic delivered
      continuously to the adductor canal to provide long term pain relief. The goal is to try to
      find a standard protocol that provides the greatest pain relief for patients undergoing total
      knee replacement.
    


Intervention name(s): liposomal bupivacaine; bupivacaine HCl; Ropivacaine; Saline
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Exparel; Marcaine; Naropin
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bupivacaine; Osteoarthritis; Arthritis; Joint Diseases; Ropivacaine; Anesthetics, Local; Anesthetics
PRIME Care (PRecision Medicine In MEntal Health Care)
Condition: Major Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The focus of this application is on the impact of providing depressed Veterans and their
      providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The
      project focuses on whether and how patients and providers use genetic test results given to
      them at the time an antidepressant is to be initiated to treat Major Depressive Disorder
      (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most
      common conditions associated with military service and combat exposure, increases suicide
      risk, and worsens the course of common medical conditions, making it a leading cause of
      functional impairment and mortality. Validation of a PGx test to personalize the treatment of
      MDD represents an important opportunity to improve the healthcare of Veterans.
    

Detailed description: 
      Background: In the last several years, commercial pharmacogenetic (PGx) testing for
      psychotropic medications has become widespread as a means of implementing "precision
      medicine", with some insurers electing to cover the cost of testing. These developments have
      put increasing pressure on the Veterans Health Administration to implement a mental health
      focused PGxs program, especially for treating depression, but without sufficient scientific
      study to support the utility of clinical application.

      Objectives: The investigators propose a program of research to evaluate the utility of PGx
      testing in treating Major Depressive Disorder.

      Methods: The investigators plan a multi-site RCT (n=2000), patient/provider dyads will be
      randomly assigned to receive results of the PGx battery right after randomization (i.e.
      intervention group) or after 6 months of treatment as usual (i.e. delayed results group)The
      study will test the following hypotheses:

        1. Veterans with MDD whose care is guided by the results of the PGx battery (the
           intervention group) will have a higher rate of remission of depression than the delayed
           results group. (Primary Hypothesis)

        2. Provider/patient dyads in the intervention group will use fewer medications that have
           potential gene-drug interactions based on commercial PGx test results than dyads in the
           delayed results group (Primary Hypothesis).
    

Intervention name(s): Pharmacogenetic Test
Intervention type(s): Other
Intervention description(s): The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study intervention is the provision of pharmacogenetic test results which can then be used to choice appropriate medication.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment; Pharmacogenetics; Depression