bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Sensory and Motor Thresholds During Transcutaneous Electrical Stimulation in Different Sexes and Ages
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      The sensory and motor perception thresholds can influence the therapeutic effects of
      Transcutaneous Electrical Nerve Stimulation. This study aimed to determine the threshold of
      sensory perception and the threshold of motor response in young and elderly subjects of both
      sexes. Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal
      groups of young and elderly subjects. Half of the individuals in each group were stimulated
      with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on
      the flexor muscle bellies of the wrist and fingers. The threshold of sensory perception was
      identified as the first sensation of increased current intensity and the threshold of motor
      response as the minimum muscle contraction detected. The results were submitted to ANOVA
      test, followed by the Tukey test, with a significance level of 5%.
    


Intervention name(s): Transcutaneous electrical nerve stimulation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of
      TR701 FA in subjects with advance renal impairment.
    

Detailed description: 
      To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of
      TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched
      control subjects with normal renal function
    

Intervention name(s): TR-701 FA single infusion; TR-701 FA; TR-701 FA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single IV infusion, 200 mg daily for 7 days; Two separate infusions of 200 mg; Single IV infusion, 200 mg daily for 7 days
Other intervention name(s): Tedizolid; Tedizolid; Tedizolid
Intervention MeSH terms: Tedizolid phosphate; Tedizolid; Oxazolidinones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Impairment
Pilot Testing for Midline Measuring Device
Condition: Ventriculo-Peritoneal Shunt Infection
Study type: Interventional

Summary: 
      Identifying the exact middling on the patient's head during the planning phase of surgery is
      crucial yet can be challenged by patient's head position and hair. The investigators have
      invented a device that uses anatomical landmark to quickly and gracefully identify the
      midline on a patient's head. The device is a U-shaped instrument equipped with a laser
      pointer at the midline. The instrument also has smooth spheres that can be positioned over
      the patients' ears bilaterally. The midline laser pointer will identify the midline on the
      patients' head. this measurement procedure is typically done after the patient is placed
      under anesthesia. The standard way of determining the midline on the skull is simply by
      surgeon's vision without any measurements. This new technique will be contrasted against the
      standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew
      Howard III). This is not patented it at this time. There is no company involved in
      manufacturing (assembly was completed with the help of the hospital's machine shop).
    


Intervention name(s): midline localizer
Intervention type(s): Device
Intervention description(s): a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Condition: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Asthma and COPD are characterized by an accelerated decline in lung function associated with
      incompletely reversible airflow obstruction. This could be the result of lung structural
      changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum
      of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the
      "remodeling" is characterized by mucus cells hyperplasia, overproduction of mucus, and
      physicochemical, biological and immunological changes. Clinically, this mucus overproduction
      is reported by patients as the clinical symptom called "chronic bronchitis". Generally, it
      develops at a bronchiolar level where it is responsible for the progression of these
      diseases. There is a paradox, because the intrinsic properties of mucus seem rather
      beneficial so fighting against it may not be really wise at long-term. Especially its
      defensive effect against microbial agents which remains poorly explained. Currently, no
      treatment aims to reduce the production of mucus and mechanisms leading to such an
      overproduction are poorly understood in severe asthma and COPD. The identification of new
      targets to treat this overproduction of mucus in COPD is therefore of major interest.

      In view of current knowledge, inflammatory mediators and signal transduction leading to
      increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL
      -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways
      seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2
    


Intervention name(s): bronchial biopsies; Determination of CO in exhaled air
Intervention type(s): Procedure; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
Condition: Liver Transplant Rejection
Study type: Observational

Summary: 
      Liver is an organ that is well-known for its immune tolerant capacity. However, there were
      still controversial issues about the impact of immunologic challenge after liver
      transplantation on the graft function. Different results of graft function affected by
      immunologic factors such as pre-transplant panel reactive antibody (PRA) status,
      pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor
      specific antibody (DSA) has been reported according to individual institutes. There was no
      trial for presenting anti-donor lymphocyte antibody change after liver transplantation.

      The investigators designed this study to analyze the correlation between pre- and
      post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the
      investigators will find aspects of anti-donor lymphocyte antibody change after liver
      transplantation.
    

Detailed description: 
      Study Design: Target study population is forty patients who will undergo liver
      transplantation for 1 year in YUHS. Pediatric and early mortality cases will be excluded.
      Blood sample will be collected at pre-transplant period, post-transplant 7, 14, 21 day, 3
      month and 6 month.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult recipients who will undergo liver transplantation during study period
      
Biospecimen description: 
      Whole blood (serum)
    
Keywords: Liver transplantation; Rejection; Tolerance
A Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham
      Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets (Kahira
      Pharm &Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration of each
      to healthy adults under fasting conditions.
    

Detailed description: 
      14 blood samples will be drawn in each period. The total volume of blood will not exceed 200
      ml throughout the whole study. 0.00, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00,
      6.00, 8.00, 10.00 and 12.00 hours., Primary Pharmacokinetic Parameters: Cmax, AUC0→t and
      AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVAusing 5% significance
      level for transformed (with the 90% confidence intervals) and untransformed data of Cmax,
      AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios forCmax, AUC0→t
      and AUC0→∞ to be within 80.00-125.00%.
    

Intervention name(s): Cefadroxil
Intervention type(s): Drug
Intervention description(s): 1 tablet from test vs 1 tablet from reference
Other intervention name(s): Biodroxil
Intervention MeSH terms: Cefadroxil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
Condition: Aortic Diseases
MeSH terms: Aortic Diseases
Study type: Observational

Summary: 
      Reliable prediction of the preoperative risk is of crucial importance for patients undergoing
      vascular operations. The assessment of the metabolic equivalent of task (MET) is an easy
      clinical evaluation of the functional capacity of an individual. A MET is defined as the
      resting metabolic rate, that is the amount of the consumed oxygen at rest. According to the
      MET concept a patient would be considered as "fit for surgery" when the stairs of two flights
      can be climbed and the housework can be fully managed by oneself.

      Hypothesis: Patients with a functional capacity over 4 MET (fit for surgery) have less
      perioperative complications with the focus on cardiac pathology than patients with less than
      4 MET during aortic operations.

      Patients and Method: Retrospective analysis of a single center unit of 296 patients
      undergoing open or endovascular aortic repair.
    


Intervention name(s): MET
Intervention type(s): Diagnostic Test
Intervention description(s): Testing of the metabolic equivalent of task before aortic procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        296 patients who received an aortic repair with open or endovascular technique at Triemli
        Hospital from May 2009 till March 2016
Gut Hormones After Meal Ingestion in Males Versus Females
Condition: Normal Non-fluency
Study type: Interventional

Summary: 
      The study hypothesis is that the release of gut hormones is increased proportionally to
      caloric load in each meal. Three different meals with different meal size will therefore be
      served and gut hormones determined.
    

Detailed description: 
      In healthy males and females, meals with 511, 743 and 1034 kcal will be given orally. Samples
      will be taken during the following 300 min and gut hormones (glucose-dependent insulinotropic
      polypeptide and glucagon-like peptide-1) will be determined along with insulin and glucagon
      levels.
    

Intervention name(s): Meal ingestion
Intervention type(s): Other
Intervention description(s): Meal 511 kcal, meal 743 kcal or meal 1034 kcal
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Gut hormones; Insulin secretion
Clinical Research of Electro-acupuncture Combined Psychological Intervention on Internet Addiction Disorder
Condition: Addiction
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Interventional

Summary: 
      this research adopted multicentered, randomly and parallel control methods to observe the
      clinical effects of electro-acupuncture combined psychological intervention on internet
      addiction disorder, aim to provide a convenient, affordable and effective clinical protocol.
    

Detailed description: 
      This research was aimed to discuss the impact of acupuncture treatment on the impulsive
      behavior of Internet Addiction Disorder (IAD) sufferers, with the detection of magnetic
      resonance spectroscopy (MRS), the assessment of Young's Internet Addiction Test (IAT),
      Barratt Impulsivity Scale (BIS-11) and Go/No-go task, hopefully that this research could
      provide basis for the further study as well as the establishment of comprehensive assessment
      and treatment protocol of IAD.
    

Intervention name(s): electro-acupuncture; psychological intervention
Intervention type(s): Other; Other
Intervention description(s): 13points were selected including he-gu(LI4), nei-guan(PC6), tai-chong(LR3) and san-yin-jiao(SP6) from both sides, bai-hui(GV20) and si-shen-cong(EX-HN1) from head.
HANS-200A acupoints stimulator, which had two output channels, was connected to some selected points. Dilatational wave was adopted in this research, the frequency of rarefaction wave was 2 hertz and condensation wave was 100 hertz, with a waviness width of 0.3ms. Switched the stimulator on after connected the poles to the needles, adjusted the intensity of output gradually from 0 milliampere to the extent of subject's maximum tolerance. Then needles would be remained on the body for half an hour.; Cognitive behavioral therapy was adopted by national accredited professional psychologist, in the form of team work and individual counseling, aim to help IA participants to understand their deviant behaviors, correct unhealthy cognitive states and eventually retrieve normal life style.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
ST-T Segment Changes in Emergency Physicians While on Duty
Condition: ST-T Segment Changes
MeSH terms: Emergencies
Study type: Observational

Summary: 
      Preclinical emergency management is frequently associated with a combination of physical and
      psychological stress.

      This stress is known to lead to a broad variety of changes in the physiology even extending
      in the cardiovascular system. Both physical and psychological stress induces ECG changes.
      These changes include not only arrhythmias but also deviations in ST-T segment representing
      the phase of repolarization.

      Information about changes in ST-T segment are missing until now. The investigators
      hypothesise that ST-T deviations occur in emergency physicians during shift at an emergency
      response car.

      In order to show changes in ST-T segment a prospective observational trial will be conducted.
      By using a 12 lead ECG Holter the investigators will obtain ECGs during shifts of emergency
      physicians at an emergency response vehicle.

      During 12-hour shifts emergency physicians will be attached to the 12 lead Holter ECG. ECGs
      will be analysed after blinding of names and reason of call (code) to the investigators. The
      primary outcome will be ST-T segment changes greater than 0.1mV in two corresponding leads
      for more than 30 seconds per 100 calls.

      As secondary outcomes, other ECG changes such as ST-T segment changes <0.1mV, T wave
      inversion or HRV will be analysed. Furthermore, surrogate parameter of stress will be
      measured using NASA-Task Load Index and cognitive appraisal and correlated to ST-T segment
      changes. Correlations between different phases of calls, different indications of calls and
      ECG changes will be assessed. Furthermore, correlation between alarm codes apriori defined as
      stressfull using a delphi process and ST-T segment changes as well es surrogate parameters of
      stress will be assessed.
    


Intervention name(s): Holter ECG
Intervention type(s): Device
Intervention description(s): A Holter ECG will be recorderd during shifts
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Emergency physicians working at the Medical University of Vienna's emergency response cars
        will be invited to take part in this trial. Participants will be recruited by personalised
        phone contact, via email or direct approach and will not financially benefit for
        participation. The emergency physicians are anaesthesiologists and emergency medicine
        consultants and senior anaesthesia or emergency medical residents with prehospital
        emergency medicine credentials.
      
Biospecimen description: 
      Blood samples
    
Keywords: ST segment; preclinical emergency medicine; stress; occupational health; emergency medicine; 24h ECG
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug with peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral
      stem cell transplantation followed by combination chemotherapy in treating patients with
      metastatic prostate cancer that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the complete and partial remission rates and event free and overall
      survival of patients with metastatic hormone refractory prostate cancer treated with high
      dose chemotherapy plus peripheral stem cell transplantation followed by consolidation
      chemotherapy. II. Evaluate the toxic effects associated with this treatment in these
      patients. III. Evaluate the quality of life, and need for analgesics, in these patients.

      OUTLINE: Patients are stratified by stage of disease and extent of metastatic disease.
      Patients receive daily filgrastim (G-CSF) subcutaneously for 4 days until peripheral blood
      stem cells are collected. Patients then receive carmustine IV over 2 hours on day -2 and
      melphalan IV over 20 minutes on day -1. Stem cell infusion will be on day 0. At 3, 6, 9, and
      12 months after transplant, patients receive vinorelbine IV over 10 minutes and cisplatin IV
      over 24 hours. Quality of life and pain are assessed before the transplantation, just before
      discharge after transplantation, prior to each consolidation course, and then at 3, 6, and 12
      months after the final course of chemotherapy. Patients are followed at least every 3 months
      for the first 2 years, and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 2 years.
    

Intervention name(s): filgrastim; carmustine; cisplatin; melphalan; vinorelbine tartrate; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Melphalan; Vinorelbine; Carmustine
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer
Attenuation of Pain in Men and Women
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to examine opioid and endocannabinoid mechanisms of
      exercise-induced analgesia in men and women.
    


Intervention name(s): Naltrexone, then placebo; Placebo, then Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg of naltrexone; sugar pill
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Registry for Eosinophilic Gastrointestinal Disorders (REGID)
Condition: Eosinophilic Gastrointestinal Disorders (EGID); Eosinophilic Esophagitis; Eosinophilic Disorder
MeSH terms: Esophagitis; Eosinophilic Esophagitis; Gastrointestinal Diseases; Digestive System Diseases; Enteritis; Gastritis; Eosinophilia
Study type: Observational

Summary: 
      Develop Registry tool
    

Detailed description: 
      The purpose of this research study is to develop a registry tool used for the management and
      care of patients with eosinophilic disorders, and create a research resource that will
      provide further insights into these disorders.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Eosinophilic Gastrointestinal Disorders
      
Keywords: Eosinophilic Gastrointestinal Disorders; EGID; Eosinophilic Esophagitis; Registry; Eosinophils; Eosinophilia; Eosinophilic enteropathy; Eosinophilic enteritis; Eosinophilic gastritis; Eosinophilic gastroenteritis; Eosinophilic gastroenteropathy