bioihbjkbjnl/mcl2 huggingface dataset:
Post-marketing Safety Monitoring Program of Fluticasone Propionate (FP) in Chinese Subjects With Asthma Aged 1 to <4 Years
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      For the prophylactic treatment of asthma, FP inhaled aerosol (Flixotide ®) administered via a
      pressurized metered-dose inhaler (pMDI) was approved in China in adults, adolescents older
      than 16 years of age and children aged 4 to 16 years. This post-marketing safety monitoring
      program will evaluate the safety profile of FP 50 micrograms (µg) inhaled via a pediatric
      spacer device with a face mask in Chinese subjects aged 1 to <4 years. The adverse drug
      reactions (ADRs) and predictors of these adverse reactions among subjects will be reported.
      This single arm observational study will include subjects prescribed with FP 50 µg inhaled
      via a pediatric spacer device with a face mask. The maximum duration of the study will be 12
      weeks with 3 visits. Visit 1 (Day 1) will be on-site visit and will also mark the start of
      the observational program. The follow-up visits will be scheduled at Visit 2 (Week 4), and
      Visit 3 (Week 12) conducted on site or by telephone. A total of 150 asthmatic subjects who
      have been prescribed FP 50 µg treatment for appropriate medical use for the first time in
      China will be enrolled in the study. Flixotide is a registered trademark of GlaxoSmithKline
      (GSK) group of companies.
    


Intervention name(s): Fluticasone propionate
Intervention type(s): Drug
Intervention description(s): Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma.
Intervention MeSH terms: Fluticasone; Xhance
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects aged between 1 to <4, diagnosed with asthma, who have been prescribed FP 50 µg for
        appropriate medical use for the first time in China will be included in this study.
      
Keywords: CCI18781; Observational; Post-marketing; Fluticasone propionate; Asthma
Physiotherapy in the Haemophilic Arthropathy of the Elbow.
Condition: Patients With Hemophilia
MeSH terms: Joint Diseases; Hemophilia A
Study type: Interventional

Summary: 
      The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one
      with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
      (PNF), and the other with education sessions and home exercises, for the improvement of the
      ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of
      the elbow.
    

Detailed description: 
      The intervention was carried out during twelve weeks, performing evaluations before and after
      treatment, and six months of finalizing this. The treatment of MT group consisted of two
      sessions per week, one hour each, and the treatment of group E consisted in a session for 90
      minutes every two weeks, with daily home exercises. The control group (group C) did not
      receive any intervention.
    

Intervention name(s): Manual Therapy; Educational group
Intervention type(s): Other; Other
Intervention description(s): 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility).
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin; Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elbow; Joint disease; Hemophilia; Physiotherapy modalities
Kettlebell Swings & Low Back Pressure Pain Threshold
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a high intensity kettlebell workout,
      utilizing a Tabata protocol format, can decrease objective measures of pain pressure
      threshold in subjects without low back pain. The results of the study could have implications
      for the use of high intensity kettlebell workouts in the rehabilitation of patients with low
      back pain.
    

Detailed description: 
      The kettlebell swing is a full body, posterior-chain focused, ballistic exercise shown to
      register large recruitment of the gluteal muscles, which are frequently weak in a patients
      suffering from low back pain. The Tabata protocol is a high-intensity training protocol in
      which subjects perform 20 seconds of all out effort (i.e. as many swings as possible),
      followed by 10 seconds of rest, repeated for a total of eight rounds. The rapid
      contraction-relaxation cycles utilized in the kettlebell swing are theorized to aid in the
      pumping out of muscle metabolites in the low back musculature, thus providing potential
      relief of chronic low back pain.
    

Intervention name(s): Tabata Kettlebell Swing Workout; Control
Intervention type(s): Other; Other
Intervention description(s): See description of experimental arm.; see description of control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: high-intensity
Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Condition: Anterior Cervical Discectomy and Fusion (ACDF)
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will help the investigators learn more about the best way to give anesthesia for
      these kinds of surgery. The investigators will be using 2 different groups of medications
      that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does
      not. The investigators wish to test whether a narcotic free anesthetic will result in an
      overall safer surgery, better patient recovery, and satisfaction. The investigators think
      also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover
      faster after surgery , and consume less pain medicines in the postoperative period.
    


Intervention name(s): Remifentanil; Ketamine; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.; Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.; dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.
Intervention MeSH terms: Dexmedetomidine; Ketamine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation
Condition: Lung Disease
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      Early after allogeneic hematopoietic stem-cell transplantation (allo-HSCT), reductions of
      absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently
      detected even in the absence of overt idiopathic pneumonia syndrome (IPS). It can be
      hypothesized that these changes might be due to an occult intersitial lung disease associated
      with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens
      or any combination of these. To test this hypothesis, we will simultaneously measure the lung
      diffusing capacity for nitric oxide (DLNO) and DLCO and estimate the changes of membrane
      diffusing capacity (DM) and pulmonary capillary volume (Vc) by the DLNO/DLCO ratio. As we
      hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT)
      recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with
      those of subjects undergoing allo-HSCT.
    

Detailed description: 
      In allogeneic hematopoietic stem-cell transplantation (allo-HSCT) recipients, early
      reductions of absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are
      frequently detected even in the absence of overt idiopathic pneumonia syndrome (IPS)[PMID:
      22221781]. Two months after allo-HSCT, we have recently shown an increase in lung tissue
      density determined by quantitative CT scan [PMID: 22898044]. It can be hypothesized that
      these parenchymal changes might be due to an occult intersitial lung disease associated with
      infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens or
      any combination of these [PMID: 21531955]. To test this hypothesis, we will simultaneously
      measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO. Assuming, for clinical
      purposes, that the reaction rate of NO with blood hemoglobin is infinite so that DLNO = DMNO
      = DMCO*alpha (alpha = NO/CO diffusivity ratio), as to partition the effect of HSCT on
      membrane diffusing capacity (DM) and pulmonary capillary volume (Vc) we will use the
      DLNO/DLCO ratio [PMID:16478855]. As we hypothesize that GHVD should be intuitively absent
      amongst autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO
      ratio showed by the latter group with those of subjects undergoing allo-HSCT.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive patients undergoing allogeneic and autologous HSCT for hematological
        malignancies.
      
Keywords: Allogeneic and autologous; hematopoietic stem-cell transplantation; Lung diffusing capacity; for nitric oxide; carbon monoxide; Lung tissue density; microvascular damage
Phase I Trial of a Single Dose of CRS3123
Condition: Clostridium Difficile Colitis
MeSH terms: Colitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-blind, randomized, placebo-controlled Phase I Trial to determine the safety and
      pharmokinetics of a single dose of CRS3123 in healthy adult volunteers. Forty healthy male
      and female subjects 18 to 45 years will be admitted in 5 dosing Cohorts, 8 subjects per
      Cohort. Up to two alternates may be used per dosing Cohorts for study subjects that drop out.
      The primary objective of the study is to determine the safety and tolerability of escalating
      doses of CRS3123 following oral administration to healthy subjects.
    

Detailed description: 
      This is a Phase I, multi-center, placebo-controlled, double-blind, dose-escalation study to
      evaluate the safety and tolerability of CRS3123, a methionyl-tRNA synthetase inhibitor. Since
      this is a FIH study of a new class of drugs, the maximum safe starting dose was estimated
      from the NOAEL from preclinical studies in accordance with FDA guidance documents (FDA
      Guidance for Industry, July 2005). A very low starting dose has been chosen. In the initial
      Cohorts, doses of 100, 200 and 400 will be given; all are below the estimated human starting
      dose. If any significant safety signals are encountered, the investigators will notify the
      SMC and call for a review. Dose escalation to Cohorts D and E will require a full SMC review
      of all safety data obtained through Day 7 for the preceding Cohorts. Forty healthy male and
      female subjects 18 to 45 years, inclusive, will be admitted for an inpatient study. Each
      subject will receive a single oral dose of CRS3123 or placebo. There will be 8 patients for
      each cohort (6 active, 2 placebo). The ascending doses are 100, 200, 400, 800 and 1200 mg
      respectively for cohorts A through E. The primary objective is the safety and tolerability of
      escalating doses of CRS3123 following oral administration to healthy subjects. The secondary
      objective is to assess whether there is measurable systemic exposure and if so, to determine
      the plasma pharmacokinetic characteristics of CRS3123 after a single oral dose.
    

Intervention name(s): CRS3123; Placebo
Intervention type(s): Drug; Other
Intervention description(s): CRS3123, a methionyl-tRNA synthetase inhibitor, will be supplied in 100 and 200 milligram capsules. Subjects randomized to active drug in Cohorts A through E will receive 100 mg, 200 mg, 400 mg, 800 mg and 1200 mg respectively, as a single oral dose.; Matching placebo capsules will be given to 2 subjects of each cohort.
Intervention MeSH terms: REP 3123
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: C. diff; C. difficile; Clostridium difficile; CRS3123
The Effect of Ticagrelor or Clopidogrel on Endothelial Function During Acute and Chronic Treatment
Condition: Ischemia
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate if treatment with ticagrelor can mitigate the transient loss of
      endothelium-dependent vasodilatation of the resistance vasculature following a short period
      of ischemia, compared with clopidogrel at standard clinical doses. The effect of ticagrelor
      or clopidogrel will be studied after a loading dose and after a two weeks period of regular
      intake on FBF in response to the vasodilators acetylcholine or nitroglycerin before and 10
      min after a 20 min forearm ischemia, respectively.
    

Detailed description: 
      Ischemia-reperfusion (IR) causes tissue injury. Preclinical animal data suggest that
      ticagrelor but not clopidogrel protects against IR injury due to inhibition of cellular
      adenosine uptake and NO-synthase stimulation. It is unclear if this action is part of the
      beneficial clinical effect of ticagrelor in patients with a history of acute coronary
      syndrome. The preventive action of ticagrelor on IR injury may also be of interest for the
      peripheral vasculature, where IR injury is known to result in endothelial dysfunction. This
      study aims to investigate if treatment with ticagrelor can mitigate the transient loss of
      endothelium-dependent vasodilatation of the resistance vasculature following a short period
      of ischemia, compared with clopidogrel at standard clinical doses. We will study the effect
      of ticagrelor or clopidogrel after a loading dose and after a two weeks period of regular
      intake on forearm blood flow (FBF) reactivity in response to the vasodilators acetylcholine
      (ACh; endothelium-dependent agonist) or nitroglycerin (GTN; endothelium-independent
      vasodilator) before and 10 min after a 20 min forearm ischemia, respectively
    

Intervention name(s): Ticagrelor; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive an oral loading dose of 180 mg ticagrelor on study day
1 followed by a maintenance dose of 90 mg twice daily for 14 days (until study day 15).; Subjects will receive a loading dose of 600 mg clopidogrel on the first study day followed by a maintenance dose of 75 mg once daily for 14 days
Other intervention name(s): Brilique; Plavix
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
rTMS for MDD: 5.5cm Rule vs. F3 Targeting
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of different treatment locations using
      repetitive transcranial magnetic stimulation (rTMS) to treat major depressive disorder.
    

Detailed description: 
      Currently there is little standardization between rTMS treatment programs as to what is the
      best way to localize the left dorsolateral prefrontal cortex, which is the FDA-approved
      treatment location for clinical rTMS for major depressive disorder (MDD). Different targeting
      methods yield locations that can vary by up to a few centimeters. By comparing different
      treatment locations and obtaining neurobehavioral, neuroimaging, cognitive, and
      neuropsychological measures, this study would provide the opportunity to identify the optimal
      treatment targeting method when using rTMS for major depressive disorder in a clinical
      setting. This study will specifically be focusing on comparing the two most common targeting
      methods: a target 5.5cm anterior to the motor strip on the left prefrontal scalp and the F3
      target location on the left prefrontal scalp as identified using the 10-20 EEG system
      nomenclature.
    

Intervention name(s): Repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; rTMS; TMS; F3; 5.5cm rule; Targeting
Vitamin D Supplementation in HIV Youth
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the correct dose of Vitamin D to give to prevent
      HIV related complications.
    

Detailed description: 
      The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d)
      to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d)
      on HIV-related comorbidities including immune activation, inflammation, cardiovascular
      diseases, and metabolic complications in HIV-infected youth.
    

Intervention name(s): Vitamin D control dose; Vitamin D supplementation-
Intervention type(s): Drug; Drug
Intervention description(s): 18,000 IU per month; 60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Other intervention name(s): 25(OH)D3 low dose; 25(OH)D3 medium dose or 25(OH)high dose
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Calcifediol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Vitamin D Deficiency
Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether patient rehabilitation is equal for
      patients operated with two different knee implant designs.

      The patients are randomized to treatment with either a simple hinge design implant (fixed
      bearing) or an implant with a mobile bearing polyethylene. This design difference might in
      principle enable the patients in the latter group to rehabilitate towards a more normal gait
      pattern.
    


Intervention name(s): P.F.C. Sigma knee arthroplasty
Intervention type(s): Device
Intervention description(s): Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene
Other intervention name(s): PFC Sigma from DePuy International implants used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Knee arthroplasty; RSA; DXA; Gait analysis; Motion analysis
A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI
      320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed
      following a single dose administration on the first treatment day (Day 1) and will be
      assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to
      28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at
      least 5 days but no longer than 7 days after the last dose of study drug.
    


Intervention name(s): PT010
Intervention type(s): Drug
Intervention description(s): PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.
Other intervention name(s): PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol
Intervention MeSH terms: Budesonide; Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Evacetrapib (LY2484595) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure and compare the amounts of the study drug evacetrapib
      found in the blood after taking two different formulations. The study has 3 periods.
      Participants will take each formulation by mouth at least once. A minimum of 14 days will
      pass between study drug doses. The safety and tolerability of the study drug will also be
      examined. Information about any side effects that may occur will also be collected. This
      study will last approximately 6 weeks.
    


Intervention name(s): Evacetrapib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY2484595
Intervention MeSH terms: Evacetrapib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science