bioihbjkbjnl/mcl2 huggingface dataset:
The Pain in Intensive Care Unit: Different Rating System Comparing
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      The purpose of this research is to find the best system for assessing the pain of critically
      ill patient in Intensive Care Unit (ICU).

      At first the investigators assess the sedation of the patient with the scale
      sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the
      patient is too sedated or delirious the investigators consider him unable to use the Visual
      Analogic Scale (VAS).

      The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and
      Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in
      three different moments: before, during and after the nurses' care.

      The investigators compare the scales between them. Then, every time the investigators value
      the score of these scales with the self-report of patients with the VAS scale (when it is
      possible) and finally with the physiological parameters (blood pressure, heart rate and
      respiratory rate).

      In the end, the investigators compare two different classes of patient: the surgical and
      medical one. The investigators search for some differences in the perception of the pain
      between these two classes.
    

Detailed description: 
      This study has specific aims:

        1. to find the best method to evaluate the pain in critically ill patients;

        2. to compare the perception of pain analysed trough CPOT and BPS;

        3. to compare CPOT and BPS between medical and surgical patients.
    

Intervention name(s): CPOT, BPS
Intervention type(s): Other
Intervention description(s): Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult male and female Critically ill patients Mechanically ventilated patients
      
Keywords: Pain; ICU; Mechanical ventilation; CPOT; BPS
A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial
      assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will
      be randomized to gel or film, tenofovir or placebo. This study will provide additional
      information in the evaluation of vaginal films containing microbial agents in humans. In
      addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy
      challenge model will be compared.

      This study is the first study assessing the safety of tenofovir film in humans. Tenofovir
      film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl
      cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose
      (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical
      settings.

      While the tenofovir film has not been studied extensively in preclinical studies, there are
      favorable safety data from the macaque study and a substantial body of research with
      tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical trial
      for the following reasons:

        -  No safety concerns were note in the tenofovir film macaque trial.

        -  The toxicity of tenofovir administered vaginally has been studied extensively. No
           clinically significant toxicity associated with this route of administration has been
           observed to date.

        -  All of the active ingredients of the tenofovir film have been tested in pre-clinical
           toxicity studies; therefore, the influence of these ingredients on the toxicity profile
           of tenofovir has been adequately evaluated and has been shown to result in no local or
           systemic effects.

        -  The individual components of the tenofovir film have been adequately evaluated and have
           been shown to be safe.
    


Intervention name(s): 1% vaginally applied tenofovir gel; Tenofovir film- 10mg; Tenofovir Film-40 mg; HEC Placebo Gel; Placebo Vaginal Film
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy Women
Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular
      markers and on gene expression of some cardiometabolic genes
    

Detailed description: 
      The investigators have designed a study project to evaluate in a sample of patients with high
      cardiovascular risk:

        1. The effects of adherence to Mediterranean Diet on serum levels of some metabolic
           variables (glucose blood levels, serum LDL cholesterol, serum total cholesterol, serum
           triglycerides)

        2. The effects of adherence to Mediterranean Diet on serum levels of some ceramides and of
           adiponectin and resistin at 6 and 12-month follow-up

        3. The effects of adherence to a Mediterranean Diet style on some surrogate markers of
           vascular damage such ad endothelial function measured by means of the evaluation of
           reactive hyperemia index (RHI) and arterial stiffness markers (PWV, AIX) at 6 and
           12-month follow-ups

        4. The effects of adherence to Mediterranean Diet on the genetic expression of some
           cardiometabolic and atherothrombotic candidate genes at 12-month follow-up

        5. The effects of the Mediterranean diet adherence on the incidence of cardio and
           cerebrovascular events at 12 and 18 month follow-ups considering respectively:

             1. composite endpoint: myocardial infarction, ischemic stroke and death from
                cardiovascular causes

             2. secondary endpoint: myocardial infarction, stroke, death from cardiovascular causes
    

Intervention name(s): low fat; mediterranean diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): subjects subjected to a low-fat dietary regime; subjects subjected to a mediterranean dietary regime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
Condition: Hepatic Cirrhosis; Liver Fibrosis
MeSH terms: Hepatitis C; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic
      fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after
      the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver
      and leads to inflammation).
    


Intervention name(s): BMS-986263; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered by intravenous (IV) infusion; Administered by intravenous (IV) infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
vibroX-training in Endurance Trained Men
Condition: Health Behavior
Study type: Interventional

Summary: 
      In endurance sports competitions such as cycling, an athlete's capacity to sustain submaximum
      power (i.e. endurance capacity) strongly influences overall race performance. Endurance
      capacity can be increased by both long, continuous endurance exercise at moderate oxygen
      consumption, and high-intensity (at or above peak oxygen consumption) interval training.
      However, it has also been shown that resistance exercise, if performed in addition to
      endurance exercise, can further enhance endurance capacity. The investigators have recently
      described a novel training method, which is based on combined vibration and resistance
      training and superimposed vascular occlusion. Based on the investigators previous results
      showing that this type of training leads to marked increases in endurance capacity in
      previously untrained young women, the investigators aim at investigating whether the method
      is also effective in increasing endurance capacity in highly endurance-trained young men, and
      whether the method leads to bigger improvements relative to resistance exercise alone.
      Besides the functional outcomes the investigators are also interested in the specificity of
      the cellular adaptations with respect to the two trainings methods.
    


Intervention name(s): vibrox- vs. resistance training
Intervention type(s): Other
Intervention description(s): Comparison between two exercise interventions
Other intervention name(s): vibrox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that selective vitamin D receptor
      activation reduces left ventricular hypertrophy and ameliorates inflammation and
      atherosclerosis in stage 3 -5 chronic kidney disease.
    

Detailed description: 
      Cardiovascular disease is the leading cause of mortality and morbidity in patients with
      chronic kidney disease. According to a previous study, only 15.6% of the patients beginning
      dialysis therapy had a normal echocardiogram, with left ventricular hypertrophy, left
      ventricular dilatation and systolic dysfunction occurring in 40.7%, 28% and 15.6% of
      patients, respectively. In addition, these patients are at an accelerated risk of developing
      atherosclerosis. The Kidney Disease Outcome Quality Initiative guideline recently raised
      concerns of a high prevalence of vitamin D deficiency in chronic kidney disease patients not
      yet requiring dialysis treatment. In addition, very recent data suggested that vitamin D
      deficiency is an important predictor of mortality in end-stage renal disease patients.
      Furthermore, hemodialysis patients treated with paricalcitol, a selective vitamin D receptor
      activator, showed a significantly lower risk of cardiovascular death than those not receiving
      vitamin D therapy. A number of studies also showed positive benefit of vitamin D receptor
      activator treatment on regression of left ventricular hypertrophy in dialysis patients.
      However, there is so far no data in patients with stage 3 and 4 chronic kidney disease where
      a high prevalence of vitamin D deficiency and cardiac hypertrophy has been reported.
    

Intervention name(s): paricalcitol
Intervention type(s): Drug
Intervention description(s): oral paricalcitol capsule 1 microgram once daily if iPTH <500pg/mL or 2 microgram once daily if iPTH >=500pg/mL. Thereafter, dose titration in 1 microgram decrement will be done based on safety reasons (that is, for low PTH or high calcium and phosphorus level). The duration of treatment will be for 1 year.
Other intervention name(s): Zemplar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: paricalcitol; chronic kidney disease; cardiac hypertrophy
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
Condition: Hepatitis C Virus
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen
      containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not
      having received treatment with any approved or investigational drug) participants with
      chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early
      stages of liver fibrosis or with cirrhosis.
    

Detailed description: 
      This is an open-label (participants and researchers are aware about the treatment
      participants are receiving), and multicenter (when more than 1 hospital or medical school
      team work on a medical research) study. The study will consist of a Screening Phase (6
      weeks); an Open-label Treatment Phase (6 weeks for Arm A and 8 weeks for Arm B); and a
      Post-treatment Follow-up Phase (until 24 weeks after end of study treatment). Using a
      staggered approach, all eligible participants will be assigned to 1 of the 2 arms, according
      to their level of fibrosis. Arm A (consists of chronic HCV genotype 1 infected participants
      with early stages of liver fibrosis): participants will receive a combination therapy of SMV
      150 milligram (mg), DCV 60 mg and SOF 400 mg once daily for 6 weeks. Arm B (consists of
      chronic HCV genotype 1 infected participants with cirrhosis): participants will receive a
      combination therapy of SMV 150 mg, DCV 60 mg and SOF 400 mg once daily for 8 weeks. A
      sub-study will be performed at a selected study site, where only participants who will be
      eligible to participate in both the main study and the sub-study will be enrolled.
      Intra-hepatic and plasma HCV ribonucleic acid (RNA) levels; intra-hepatic, peripheral innate
      and adaptive immune responses during the treatment, will be assessed in the sub-study.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Simeprevir 150 mg; Daclatasvir 60 mg; Sofosbuvir 400 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Simeprevir 150 mg capsule orally once daily.; Daclatasvir 60 mg tablet orally once daily.; Sofosbuvir 400 mg tablet orally once daily.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C virus; Hepatitis C virus genotype 1; Chronic Hepatitis C Virus Genotype 1 Infection; Liver fibrosis; Cirrhosis; Simeprevir; Daclatasvir; Sofosbuvir
Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique
Condition: Antibiotic Prophylaxis Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The surgical site infection is one of the most important causes of postoperative morbidity.
      The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical
      site infections. The recommendations of the French Society of Anesthesia Resuscitation on
      antibiotic prophylaxis in long surgeries are based on low documentation, including frequency
      and dosage of reinjection.

      The main objective of the study is to describe the tissue and plasma pharmacokinetics of
      cefoxitin after repeated injections.

      This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of
      major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic
      prophylaxis by cefoxitin.

      They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then
      every 2 hours until closing.

      The primary endpoints are:

        -  Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after
           start of each infusion cefoxitin

        -  Tissue free concentrations of cefoxitin every 20 minutes after the start of the first
           infusion cefoxitin until skin closure

        -  Urinary concentrations of cefoxitin
    


Intervention name(s): cefoxitin
Intervention type(s): Drug
Intervention description(s): Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing
Intervention MeSH terms: Cefoxitin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy
      subjects
    

Detailed description: 
      This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL
      following single dose administration in healthy subjects.
    

Intervention name(s): Tenofovir exalidex (TXL)
Intervention type(s): Drug
Intervention description(s): Oral formulations
Other intervention name(s): Lipid conjugate YTFV
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV
Masking: None (Open Label)
Primary purpose: Other
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
Condition: Nicotine Dependence, Other Tobacco Product
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to examine if inhaled doses of menthol that produce low and high cooling
      effects change the appeal of e-cigarettes containing low and high doses of nicotine in
      adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when
      compared with menthol or nicotine alone, will result in greater increase in liking of an
      e-cigarette and greater reduction in nicotine withdrawal.
    


Intervention name(s): Nicotine; Low Dose Menthol; High Dose Menthol
Intervention type(s): Drug; Other; Other
Intervention description(s): Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml); A low dose of menthol will be added to the tobacco flavor.; A high dose of menthol will be added to the tobacco flavor.
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: tobacco; electronic cigarettes; menthol; flavors
A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose
Condition: Relapse-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to test if a new higher dose of Copaxone is more effective in treating
      relapsing-remitting multiple sclerosis than the currently available 20 mg dose.
    


Intervention name(s): glatiramer acetate 20 mg; glatiramer acetate 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): glatiramer acetate 20 mg; glatiramer acetate 40 mg
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1
Condition: Heroin Dependence
MeSH terms: Heroin Dependence
Study type: Interventional
Phase: Phase 1

Summary: 
      Stress is one of the more common reasons cited by addicts for continual drug use and relapse.
      Treatment approaches that target both drug-induced and stress-induced relapse may prove to be
      more beneficial than targeting drug-induced relapse alone. Lofexidine is a drug that reduces
      the physical symptoms of opiate withdrawal and may prove to have stress-reducing capabilites
      in drug addicts. The purpose of this study is to determine the maximal safe dose of
      lofexidine tolerated in naltrexone-treated heroin addicts and to find an optimal lofexidine
      induction schedule.
    

Detailed description: 
      Stress is one of the more common reasons cited by addicts for continual drug use and relapse.
      Naltrexone treatment of opiate addicts suffers from high rates of drop-out and relapse. This
      may be a result of naltrexone's inability to reduce symptoms of stress during early recovery.
      Treatment approaches that target both drug-induced and stress-induced relapse may prove to be
      more beneficial than targeting drug-induced relapse alone. Lofexidine is a drug that reduces
      the physical symptoms of opiate withdrawal and may prove to have stress-reducing
      capabilities. The purpose of this study is to determine the maximal safe dose of lofexidine
      tolerated in naltrexone-treated opiate addicts and to find an optimal lofexidine induction
      schedule. The study will also assess any side effects that occur during a discontinuation
      phase of lofexidine.

      This pilot study will last a total of 8 weeks. Recently detoxified opiate dependent
      participants who are eligible for naltrexone treatment will enter a 4-week single-blind dose
      tolerability phase, during which participants will receive naltrexone and 1 of 3 twice-daily
      lofexidine induction schedules. All participants will be required to remain in the clinic for
      2 hours immediately following dosing in order to monitor vital signs and side effects. Study
      visits will occur three times each week, at which time naltrexone medication for
      self-administration will be handed out and participants will be evaluated in terms of
      tolerability to treatment. After the 4 weeks of treatment, a double-blind lofexidine
      detoxification phase using a 5-day taper will occur. Participants will be randomly assigned
      to one of two maintenance-taper schedules. The first group will undergo a 5-day tapering,
      followed by a placebo for three weeks, followed by a 5-day tapering during Week 4. Withdrawal
      symptoms and side effects will be evaluated.
    

Intervention name(s): Lofexidine
Intervention type(s): Drug
Intervention MeSH terms: Lofexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment