bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given
      through a needle into a vein in your arm) is safe and effective in controlling fever when
      compared to placebo. Acetaminophen given this way is the investigational part of this study.
    

Detailed description: 
      A Phase III, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Efficacy
      and Safety of Intravenous Acetaminophen (IVAPAP) Versus Placebo for the Treatment of
      Endotoxin-Induced Fever in Healthy Adult Males
    

Intervention name(s): IV Placebo; IV Acetaminophen; Reference Standard Endotoxin (RSE)
Intervention type(s): Drug; Drug; Biological
Intervention description(s): IV Placebo; Intravenous acetaminophen solution 1 g / 100 ml; Administration of Reference Standard Endotoxin (RSE) to induce fever. Applicable to both study arms: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.
Other intervention name(s): Placebo; IV APAP; APAP; IV Acetaminophen; APAP
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan
Condition: Small Fiber Neuropathy; Fabry Disease; Ehlers Danlos Syndrome; Mitochondrial Disease
MeSH terms: Fabry Disease; Small Fiber Neuropathy; Ehlers-Danlos Syndrome; Mitochondrial Diseases; Rare Diseases
Study type: Interventional

Summary: 
      Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel
      noninvasive method to detect sudomotor dysfunction. Several small studies have recently shown
      that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes mellitus) can
      be performed non-invasively, quickly and effectively. The investigators aim to study the use
      of Sudoscan in rare disease condition associated with small fiber polyneuropathy.
    

Detailed description: 
      Small fiber polyneuropathy (SFPN) is diagnosed through a combination of symptoms, signs and
      confirmatory diagnostic testing. Nerve conduction studies are not sensitive enough in most of
      the cases leaving the ankle skin biopsy with measurement of intraepidermal nerve fiber
      density (IENFD) as the main diagnostic tool. Despite its utility and reproducibility, skin
      biopsy is invasive, expensive and requires a central laboratory for processing and
      interpretation. Quantitative sudomotor axon reflex testing (QSART) is also routinely used for
      evaluation of small fiber neuropathy as sudomotor axons can also be involved. This test
      however remains technically challenging and requires testing conditions in specialized labs
      that are not always suitable for all patients' population. By comparing findings on skin
      biopsy and/or QSRT, accepted gold standard for diagnosing SFPN, the investigators seek to
      find faster, less-invasive ways to diagnose and monitor small-fiber polyneuropathy in rare
      diseases using Sudoscan measurement.
    

Intervention name(s): Sudoscan; Skin biopsy; QSART
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.; For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).; QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured.
Other intervention name(s): Quantitative Sudomotor Autonomic Reflex Testing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Plyometric Training, in the Improvement of Explosive Strength and Speed in Soccer Players
Condition: Football Player
Study type: Interventional

Summary: 
      Football requires a high number of actions at high speed and intensity. The application of
      plyometrics can improve explosive strength and speed levels in soccer players.

      The main objective of the study is to assess the effectiveness of a program based on
      plyometric exercises for the improvement of the explosive force in vertical jump and the
      speed in running with and without the ball in soccer players of youth category.

      Randomized clinical study, simple blind, with follow-up period. 30 players will be randomized
      to the study groups: experimental and control. The intervention will last 4 weeks, with 2
      weekly sessions lasting 20 minutes. The study variables will be: Vertical Countermovement
      Jump Test with Arms and Twenty-Centimeter Drop Jump Reactive Strength Index (Explosive
      Force), running speed without ball and ball (20 meter speed test), hitting speed of ball
      (Maximal Kicking Velocity Test), hamstring extensibility (Sit and Reach Test) and sural
      triceps extensibility (Leg Motion Basic). Normality will be calculated using an analysis of
      Kolmogorov Smirnov. With the t-student test the differences between assessments will be
      calculated and with an ANOVA of repeated measures, the effect between intersubject will be
      calculated. The effect size will be obtained with Cohen's formula.

      It is expected to obtain an improvement in the explosive force in the vertical jump, as well
      as in the running speed with and without the ball.
    


Intervention name(s): Plyometric exercise
Intervention type(s): Other
Intervention description(s): The plyometric program to be followed by the subjects assigned to the experimental group during the four weeks includes: Squat jumps, alternate lunge, cyclic horizontal jump, horizontal left leg jump, horizontal right leg jump, vertical left leg jump, right leg vertical jump, squat box jumps, box jumps left leg, box jumps right leg, box to box squat jumps, box to box left leg, box to box right leg.
In all the exercises the subjects will be able to help themselves with the arms and a rest period of 120 seconds will be left between each series.
The intervention will be carried out prior to training, keeping a minimum of 48 hours of rest between sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Football, Youth players; Plyometric exercises; Strength; Running speed; Muscular extensibility; Youth players
Integrated Behavioral Intervention for Cigarette Smoking and Binge Drinking in Young Adults
Condition: for Cigarette Smoking and Binge Drinking Cessation
MeSH terms: Binge Drinking
Study type: Interventional

Summary: 
      RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and
      binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine
      patches with or without behavioral therapy in reducing cigarette smoking and binge drinking
      in young adults.
    

Detailed description: 
      OBJECTIVES: I. To evaluate the efficacy of Integrated Intervention that targets both
      cigarette smoking and binge drinking on the cigarette smoking behavior of young adult smokers
      at 6-month follow-up. II. To evaluate the efficacy of Integrated Intervention that targets
      both cigarette smoking and binge drinking on binge drinking behavior of young adult smokers.
      III. Examine the effect of Integrated Intervention on several possible mediators of change
      corresponding to mechanisms that have been proposed to account for the relationship between
      cigarette smoking and alcohol use. These mediators include cravings to smoke, perceived
      similarity to the typical smoker, and self-efficacy for smoking abstinence. OUTLINE: Patients
      are randomized to 1 of 2 treatment arms.All patients receive nicotine patch therapy in weeks
      4-11. ARM I: Patients attend behavioral sessions for smoking and binge drinking cessation
      over 30 minutes once weekly in weeks 1-6. ARM II: Patients attend behavioral sessions for
      smoking cessation over 30 minutes once weekly in weeks 1-6.After completion of study
      treatment, patients are followed up at weeks 12, 16, 20, and 24.
    

Intervention name(s): behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): 8 session behavioral intervention.
Other intervention name(s): Behavior or Life Style Modifications; Behavior Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Physical Activities on the Expression of Nrf2 and Nf-kb Hemodialysis Patients
Condition: Chronic Kidney Disease; Hypertension; Diabetes
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Oxidative stress and inflammation are cardiovascular risk factors in patients with chronic
      kidney disease (CKD) undergoing hemodialysis (HD). Nuclear transcription factors play roles
      in the coordinated expression of genes involved in inflammation, such as nuclear factor Kappa
      B (NFkB) that increase the cytokines synthesis and Nuclear factor erythroid 2-related factor
      2 (Nrf2) that increase the transcription of genes encoding enzymes of phase II detoxifying
      and antioxidant enzymes. The aim of this study was to evaluate the effects of resistance
      exercise program on the expression of transcription factors Nrf2 and NF-kB in HD patients.
    

Detailed description: 
      This study included 44 patients on regular HD program which 25 patients (54.5% women, age
      45.7 ± 15.2 years and time on dialysis, 71.2 ± 45.5 months) composed the exercise group and
      19 patients (61.5% women, age 42.5 ± 13.5 years and time on dialysis, 70.1 ± 49.9 months) the
      control group. The exercise program was performed during HD sessions, 3 times a week (36
      exercises sessions). Peripheral blood mononuclear cells (PBMC) were isolated and processed
      for expression of Nrf2, NF-kB and NADPH quinone oxidoreductase 1 (NQO1) by quantitative
      real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and
      glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) and nitric oxide
      (NO) products were assessed using an enzyme-linked immunosorbent assay (ELISA).
    

Intervention name(s): physical exercises
Intervention type(s): Other
Intervention description(s): Physical exercises were performed during HD sessions, at second hour of HD, three times per week for 3 months. The first exercise was knee extension from 90° to 0°. The patient remained in the 0° position for 5 seconds (an isometric contraction) and then returned to the starting position (90º). 2) The second exercise consisted of a triple flexion followed by extension of the lower limbs. The patient flexed the thigh, knee and ankle (elastic band placed at the level of the metacarpals) followed by a double extension of the thigh and knee. 3) In a co-isometric contraction, the patient performed a leg extension against the ankle-cuff resistance (located under the distal third of the leg at the level of the malleolus) for 10 seconds. 4) The patient performed a unilateral hip joint flexion of the lower limb with the knee extended by rising to their functional limit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction Statin
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This purpose of this study is to assess the effects of BMS-919373 on the single dose
      Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.
    

Detailed description: 
      Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of
      Rosuvastatin and Atorvastatin in healthy subjects
    

Intervention name(s): BMS-919373; Rosuvastatin; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): IKur Inhibitor; Crestor®; Lipitor®
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
Condition: Pediatric Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 4

Summary: 
      The standard clinical cardiovascular MRI practice for children with CHD frequently involves
      the use of gadolinium-based contrast agents (GBCA) to enhance tissue contrast. Most GBCAs are
      small molecules that quickly cross the capillary wall and access the interstitial space, a
      process which diminishes the signal contrast between blood vessels and surrounding tissue.
      Therefore, these types of GBCA are most useful for first-pass MR angiography, wherein the
      images are acquired quickly during the initial 15-30 seconds post-injection when the GBCA
      concentration is much higher in the arteries than in the interstitial space. For young
      children with complex CHD, the stringent requirements for high spatial resolution, and the
      need for cardiac gating and good blood-myocardium contrast in order to provide detailed
      evaluation of intracardiac structures are not compatible with conventional GBCA-based
      first-pass MR angiography. Even with Ablavar® (gadofosveset trisodium), an FDA approved GBCA
      with longer intravascular half-life than other GBCAs, cardiac-gated Ablavar®-enhanced MRI may
      be insufficient for young children with CHD based on our institutional experience and on data
      from the literature; there remains diminished blood-tissue contrast during the
      high-resolution cardiac-gated MRI. Furthermore, there have been safety concerns regarding
      gadolinium deposition in brain tissues after repeated GBCA exposure as well as concerns of
      nephrogenic systemic fibrosis (NSF) associated with GBCA injection in young children < 2
      years old who may have immature renal function. The long-term health consequences of these
      effects in the pediatric population are unclear. For the above reasons, we seek to study the
      diagnostic imaging effectiveness of Feraheme (Feraheme®), an FDA-approved drug for parenteral
      iron supplementation, as an MRI contrast agent in children with CHD. Although Feraheme® has
      been approved for the treatment of iron deficiency anemia secondary to renal disease,
      Feraheme® has been used as an off-label MRI contrast agent at select medical centers.
    


Intervention name(s): ferumoxytol; gadofosveset
Intervention type(s): Drug; Drug
Intervention description(s): ferumoxytol as an MRI contrast agent infused over several minutes; gadofosveset as an MRI contrast agent injected over several seconds
Other intervention name(s): Feraheme; Ablavar
Intervention MeSH terms: Ferrosoferric Oxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ferumoxytol
Study of the Immunogenicity, Safety and Tolerability of the Convacell Vaccine.
Condition: COVID-19; Immunologic Factors; Coronavirus Infections; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A two-stage trial will involve healthy volunteers. The first stage is open trial, and the
      second stage is a double-blind trial with randomization of volunteers into three groups. At
      stage I of the trial, the maximum number of screened healthy volunteers will be 30 of which
      20 men aged 18 to over 60 years. At stage II of the trial, the maximum number of screened
      healthy volunteers will be 150, of which 135 men and women aged 18 to over 60 years eligible
      according to the inclusion and exclusion criteria are planned to be included and randomized
      to collect data that will be used for the subsequent safety and immunogenicity assessment.
      The enrollment of volunteers at stage II will be competitive.
    

Detailed description: 
      Trial product is subunit recombinant vaccine for the prevention of coronavirus infection
      caused by the SARS-CoV-2 virus.

      Vaccination forms humoral and cellular immunity that prevents the development of coronavirus
      infection caused by the SARS-CoV-2 virus. On the surface of excipients emulsion droplets
      N-protein is presented to monocytes attracted from the bloodstream due to a local increase in
      the level of cytokines. Antigen-bearing cells migrate to draining lymph nodes with activation
      of innate and adaptive immunity cells in them. Due to the activation of natural killer cells
      in combination with specific antibodies, the mechanism of lysis of infected cells is
      realized. The nucleocapsid protein (N) is conserved and little susceptible to mutational
      changes. This makes the vaccine based on it universal for various strains of coronavirus
    

Intervention name(s): Subunit recombinant vaccine for the prevention of coronavirus infection; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): solution for intramuscular injection, 0.5 ml; solution for intramuscular injection, 0.5 ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; COVID; recombinant vaccine; nucleocapsid protein; cellular immunity; SPbSRIVS; Convacell
Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Using a retrospective analysis of a large commercial claims database and a Medicare database,
      the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back
      pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450
      enzyme system, concomitant with other CYP450-metabolized drug(s)
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic low back pain on opioids
      
Keywords: retrospective chronic low back pain
Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and
      pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of
      nontuberculous mycobacterial (NTM) lung disease.
    

Detailed description: 
      The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and
      pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of
      nontuberculous mycobacterial (NTM) lung disease.

      Aim 1: Determine the PK profile of oral antimycobacterial drugs (azithromycin, rifampin and
      ethambutol) under both fasting conditions and when taken with food plus supplemental
      pancreatic enzymes in subjects with pancreatic insufficient, compared to healthy controls.

      Aim 2: Begin to investigate the influence of inflammation, host characteristics, and drug
      metabolism on the PK of the antimycobacterial drugs.

      Aim 3: Estimate an optimized dosing regimen for the antimycobacterial drugs against
      Mycobacterium avium complex (MAC) using historic minimum inhibitory concentration (MIC) data
      and models of Mycobacterium tuberculosis or MAC infection.

      The central goal of this study is to improve treatment of NTM infection in CF. Upon
      completion of this study the investigators will determine if and why PK of the
      antimycobacterial drugs are altered in CF. More importantly, the investigators will develop
      CF-specific guidelines to achieve therapeutic goals with recommendations for drug dosing
      (including dose, dose frequency and timing in relation to meals and supplemental pancreatic
      enzymes) and timing of therapeutic monitoring to be used for future treatment of NTM lung
      disease in CF.
    

Intervention name(s): Ethambutol; Rifampin; Azithromycin; Pancrelipase
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Anti-mycobacterial oral drug; Anti-mycobacterial oral drug; Anti-mycobacterial oral drug; Pancreatic enzyme replacement therapy
Other intervention name(s): Myambutol; Rifadin; Zithromax; Creon; Zenpep; Pertzye
Intervention MeSH terms: Azithromycin; Rifampin; Ethambutol; Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Pharmacokinetics; Pharmacodynamics; Nontuberculous Mycobacteria; Treatment
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in
      healthy male subjects.
    


Intervention name(s): varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT; varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR
Intervention type(s): Drug; Drug
Intervention description(s): varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.; varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: an open-label, randomized, single-dose crossover clinical trial
Masking: None (Open Label)
Primary purpose: Treatment