bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)
Condition: Schizophrenic Disorders; Schizoaffective Disorders; Bipolar Disorders
MeSH terms: Bipolar Disorder; Psychotic Disorders; Schizophrenia
Study type: Interventional

Summary: 
      The aim is to evaluate the effectiveness of an intervention based on a program of physical
      activity and diet coordinated between primary care teams (PCT) and Mental Health Centres
      (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist
      circumference in patients with severe mental disorder diagnoses. To assess changes in
      cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized
      clinical trial with a control group, of one year of follow-up, carried out in four MHC
      Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18
      - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with
      antipsychotic medication and a low level of PA. 240 patients will be selected in each group
      (difference to be detected in the BMI:> 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention:
      group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8
      sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of PA
      (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure,
      cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED
      questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose.
      Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for
      repeated measures to adjust for differences attributable to the effect of the intervention
      for potential confounders: pharmacological treatment, care level of intervention and mental
      state.
    


Intervention name(s): Physical and diet educational group
Intervention type(s): Behavioral
Intervention description(s): educational group of: physical activity program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks, carried out by mental health nurses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Psychotic Disorders,; Heart Diseases
The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids
Condition: Obesity; Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The metabolic syndrome is associated with hyperdynamic circulation and sympathetic
      activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free
      fatty acids are responsible for this association. The investigators hypothesize that in
      patients with obesity and the metabolic syndrome, an increased intracellular concentration of
      long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces
      an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and
      sympathetic activation.

      The investigators aimed to assess this effect of free fatty acids on the adenosine system in
      healthy volunteers.
    


Intervention name(s): Intravenous infusion of Intralipid/heparin; Intravenous infusion of Glycerol/heparin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Heparin; Calcium heparin; Soybean oil, phospholipid emulsion; Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Educational/Counseling/Training
Keywords: free fatty acids; vasodilation; sympathetic activity
Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Condition: Polyarticular Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy
      and PK of MRA in patients with pJIA who participated in Study MRA318JP.
    


Intervention name(s): MRA(Tocilizumab)
Intervention type(s): Drug
Intervention description(s): 8mg/kg/4weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, first in human, three-part, single centre study to assess the safety,
      tolerability, PK and PD of single ascending subcutaneous doses of HTL0030310 in healthy
      subjects
    

Detailed description: 
      This is a first in human, three part study with the objective to assess the safety,
      tolerability, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of
      HTL0030310 in healthy subjects. Part 1 is a double-blind, placebo-controlled, randomised
      study assessing single ascending doses of HTL0030310. Part 2 is a site-blind (sponsor
      unblinded), placebo-controlled, part-randomised, fixed-sequence, single-dose, 4-period study
      assessing the PD of a positive control, pasireotide, following administration of challenge
      agents. Part 3 is a double-blind, placebo-controlled, part-randomised, fixed-sequence,
      single-dose, HTL0030310 proof of pharmacological effect study, where PD effects of HTL0030310
      will be investigated following administration of challenge agents. The challenge agents
      administered in this study will be: oral glucose tolerance test (OGTT), Growth
      hormone-releasing hormone (GHRH), and corticotrophin releasing hormone (CRH) combined with
      desmopressin.
    

Intervention name(s): HTL0030310; Pasireotide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution for Subcutaneous injection; Pasireotide 600 μg for subcutaneous injection; Matching placebo Solution
Intervention MeSH terms: Pasireotide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First in Human; Single Ascending Dose
Ramosetron Pre-treatment for PONV and QT Prolongation
Condition: PONV; Prolonged QTc Interval
MeSH terms: Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the
      Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the
      pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.
    

Detailed description: 
      This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic
      surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia
      induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at
      arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-,
      and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival
      to PACU, and 24-h after discharge from PACU.

      Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size
      difference of 0.9.
    

Intervention name(s): Ramosetron
Intervention type(s): Drug
Intervention description(s): Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery
Other intervention name(s): ramosetron pre-treatment
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ramosetron
Preoperative Level of Hemoglobin A1c and Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Background: The development of acute kidney injury (AKI) is an important indicator of
      clinical outcomes after cardiac surgery. Elevated preoperative hemoglobin A1c level may be
      associated with acute kidney injury in patients undergoing coronary artery bypass grafting.
      This study will investigate the association of preoperative HbA1c levels with AKI after
      isolated coronary artery bypass grafting (CABG).
    


Intervention name(s): increase in serum creatinine
Intervention type(s): Diagnostic Test
Intervention description(s): any of the following: increase in serum creatinine by ≥ 0.3 mg/dl within 48 h of surgery or increase in serum creatinin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study compared the AKI incidence between patients with prediabetic level of HbA1c
        (5.7-6.4) and patients with elevated levels of HbA1c (> or = 6.5). Forty patients who
        underwent elective CABG were enrolled in this cohort study.
Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
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. Interferon alfa may interfere with the growth of the cancer cells.
      Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not
      yet known which treatment regimen is more effective in treating melanoma.

      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of
      combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have
      metastatic melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the rate of disease stabilization in patients with metastatic melanoma when
           treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.

        -  Assess toxicity, overall response rate, and response duration in these patients when
           treated with this regimen.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center. Patients are randomized to one of two treatment arms.

        -  Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days
           1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and
           interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days
           for a maximum of 4 courses in the absence of disease progression or unacceptable
           toxicity.

        -  Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses.
           Patients then receive treatment as in arm I for a maximum of 4 courses.

      Patients are followed every 2 months for 6 months, then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.
    

Intervention name(s): aldesleukin; recombinant interferon alfa; cisplatin; dacarbazine
Intervention type(s): Biological; Biological; Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Aldesleukin; Dacarbazine
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV melanoma; recurrent melanoma
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic
      Stress Disorder population.
    

Detailed description: 
      The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed
      by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a
      1-week follow-up Period. Subjects eligible for the study will be randomized to receive either
      NYX-783 (4-weeks) or placebo (4 or 8-weeks).
    

Intervention name(s): Placebo oral capsule; NYX-783
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo capsules.; NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive placebo or NYX-783.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers
Condition: Pharyngeal Dysfunction; Pharyngeal Swallowing
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether remifentanil influence the pharyngeal phase
      of swallowing using using pressure and impedance recordings. The purpose is also to compare
      remifentanil to morphine and younger to elderly volunteers.
    

Detailed description: 
      Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical
      procedures and as pain relief in postoperative patients when the patient is spontaneously
      breathing and the airway is not secured by endotracheal intubation. In a previous study (not
      yet published) we showed that remifentanil induce pulmonary aspiration in healthy volunteers
      and the aim of this study is to objectively determine weather remifentanil infusion in
      healthy volunteers influence the pharyngeal phase of swallowing. The purpose is also compare
      the effect of remifentanil to morphine and younger volunteers to elderly volunteers. To
      assess this question we are going to study 24 volunteers, 12 younger and 12 elderly, who are
      randomised to receive remifentanil infusion with target concentration 3 ng/ml during 30
      minutes at one occasion and an injection of morphine (younger: 0.1 mg/kg, elderly 0.07 mg/kg)
      at the other. The volunteers are asked to swallow 10 ml normal saline several times both
      before and after opioid administration and pharyngeal motility is parallelly recorded using
      combined manometry and impedance catheter placed transnasally into to the pharyngo-esophageal
      segment. Any subjective swallowing difficulties are also recorded.
    

Intervention name(s): Morphine; Remifentanil
Intervention type(s): Drug; Drug
Other intervention name(s): ACT-code: N02AA01; Younger volunteers: injection 0.1 mg/kg; Elderly volunteers: injections 0.07 mg/kg; Ultiva; ATC-code: N01AH06; Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 30 min ( 0,15 ug/kg/min)
Intervention MeSH terms: Morphine; Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Remifentanil; Pharyngeal dysfunction; Subjective swallowing difficulties; Pulmonary aspiration
CHOCOlate MeLatonin for AdolescenT MigrainE
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Existing treatments for acute migraine are not effective for all children and adolescents,
      and can cause side effects. Investigator propose a dose-finding study of melatonin for acute
      migraine treatment in children and adolescents to determine the best dose to bring forward in
      a future fully-powered efficacy trial.
    

Detailed description: 
      This pilot randomized trial is a dose-finding study to determine which dose of melatonin is
      most effective for treating acute migraine in children and adolescents who have episodic
      migraine. Investigator will identify the most effective dose to pull forward into a future
      fully-powered placebo-controlled efficacy study. If both doses are equally effective,
      Investigator will bring forward the best tolerated dose. If doses are equally well tolerated,
      Investigator will bring forward the lowest effective dose, as this will minimize cost to
      families should this treatment become widely adopted.
    

Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention description(s): melatonin
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mindfulness Meditation Format Pilot Study
Condition: Posttraumatic Stress Disorder; Depression
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess feasibility of an internet and individual format of
      mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression
      symptoms
    

Detailed description: 
      Internet and individual formats of mindfulness meditation have not been previously evaluated.
      In order establish feasibility of such formats a pilot study is need. The current study will
      randomize up to 20 people with PTSD and depression symptoms and evaluate changes in PTSD and
      depression symptoms from before to after the internet and individual mindfulness meditation
      interventions.
    

Intervention name(s): Internet Mindfulness Meditation; Individual Mindfulness Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): one hour session each week for six weeks; one hour session each week for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma
Condition: Choroidal Melanoma
MeSH terms: Melanoma
Study type: Observational

Summary: 
      This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment
      with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.
    

Detailed description: 
      The study was done in a Clinical practice setting. Forty six eyes of 46 patients with small
      or medium-sized choroidal melanomas were treated with i-TTT using infrared light delivered
      from a diode laser. All patients were evaluated to rule out systemic metastasis and underwent
      a complete ophthalmological evaluation including: Slit lamp biomicroscopy, dilated fundus
      examination, Fluorescein angiography, Optical coherence tomography and A/B ultrasonography.
      Main outcome measures were: Changes in visual acuity, complications associated with the
      treatment and local control of the tumor.
    

Intervention name(s): TTT + ICG-based PDT
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects selected from retina specialist general patient population.
      
Keywords: Transpupillary thermotherapy; Choroidal melanoma; ICG-Photodynamic therapy
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under
      the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone®
      (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting
      multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and
      neuroprotective properties, which are believed to be of therapeutic value in ALS. The study
      treatment duration is 1 year (52 weeks).
    


Intervention name(s): 40 mg glatiramer acetate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): parenteral drug
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Capnometry Monitoring in Post Anesthesia Care Unit
Condition: VENTILATION; Capnography
Study type: Interventional

Summary: 
      There is few information about the best capnometry value in recovery room for intubated
      awakening patients. Furthermore, capnometry values could influence ventilation applied by
      nurses on these patients. The aim of this study is to observe the effects of capnometry
      monitoring on intubated awakening patients in recovery room.
    

Detailed description: 
      In France, there is actually no recommandation about capnography monitoring in recovery
      rooms. Nevertheless, some patients are still ventilated in post-anesthesia care units during
      awakening period. Alveolar hypoventilation could induce moderate hypercapnia, thereby
      stimulate central ventilatory command. However, this hypoventilation could delay the
      clearance of anesthetic gases. Capnometry monitoring could influence ventilation applied to
      these patients. Recovery rooms nurses would perform moderate hyperventilation in response to
      hign capnometry values. This method could enhance gases elimination, with faster spontaneous
      breathing recovery and extubation. Length of stay in recovery room could also be shortened.
      An objective surrogate of ventilation is maximal End Tidal CO2, if there is no
      alveolo-capillary gradient abnormality (Obesity, Chronic respiratory disease, Cyanogenic
      heart disease). Thus, this study will compare the percentage of patients who reached a
      maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care
      unit (PACU) in 2 groups :

        -  first group ("non-blind group") with capnography monitoring see by the PACU nurses

        -  second group ("blind group") with capnography monitoring but PACU nurses cannot see the
           values Other parameters like the time between ventilator's disconnection and the first
           ventilatory cycle in spontaneous ventilation, the time between ventilator's
           disconnection and tracheal extubation or laryngeal mask's withdrawal, the minimal SpO2
           reached after tracheal extubation or laryngeal mask withdrawal or the length of stay in
           PACU are also recorded.
    

Intervention name(s): CAPNOGRAPHY
Intervention type(s): Device
Intervention description(s): MONITORING OF CAPNOMETRY USING ETCO2 METHOD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Capnometry; Capnography; ETCO2; Recovery room; Post-anesthesia care unit
A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being
      developed for the treatment of chronic obstructive pulmonary disease. This is a randomised,
      double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety,
      tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of
      GSK233705B for 7 days, in COPD subjects.
    


Intervention name(s): GSK233705B
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Diagnostic
Keywords: muscarinic receptor,; bronchodilators; Chronic obstructive pulmonary disease,