bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Residual Paralysis After Cardiac Surgery
Condition: Postoperative Residual Curarization
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional

Summary: 
      The main objective of this study is to describe the incidence of postoperative residual
      paralysis (mean train-of-four <90%) when weaning from the ventilator in patients admitted to
      the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a
      widely used term for the peripheral nerve stimulation used in neuromuscular blockade
      monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will
      perform a measurement of the train-of-four at the thumb with a neuromuscular transmission
      monitor. Every value below 90% will be considered as residual paralysis and treated
      appropriately by means of a reversal agent.
    

Detailed description: 
      Postoperatively, in the ICU, readiness-for-weaning is based on ICU doctor-nurse-driven
      institutional weaning guidelines: 6 hours after arrival in the ICU, a patient who is
      normothermic, hemodynamically stable, has normal blood gasses and absence of residual
      bleeding. The ICU nurse caring for the patient will start weaning the patient from the
      ventilator, following these departmental guidelines.
    

Intervention name(s): peripheral neuromuscular monitor
Intervention type(s): Device
Intervention description(s): Residual paralysis can only be measured by neuromuscular transmission monitoring of a peripheral nerve, typically the ulnar nerve innervating the adductor pollicis muscle.
Intervention model: Single Group Assignment
Intervention model description: Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: neuromuscular blockade; neuromuscular monitoring
Metformin-Dipyridamole Interaction Trial
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole
      are often used concomitantly in patients with diabetes who have suffered a transient ischemic
      attack or stroke. It has recently been suggested that the gastrointestinal absorption of
      metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has
      been reported to inhibit hENT4 transport in vitro. The aim of this research proposal is to
      study the pharmacokinetic interaction between metformin and dipyridamole. The investigators
      hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. If this
      hypothesis can be confirmed, then the results of this study can explain in part the high
      variability in plasma metformin concentrations in patients treated with diabetes, and can be
      used to optimize pharmacotherapy in patients with diabetes.
    


Intervention name(s): Metformin, dipyridamole; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days; Metformin 500 mg twice daily for four days
Intervention MeSH terms: Metformin; Dipyridamole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Effect Dipyridamole on pharmacokinetics of metformin
Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
Condition: Microphthalmos With Congenital Cataracts
MeSH terms: Cataract; Microphthalmos
Study type: Observational

Summary: 
      Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.

      In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus,
      glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of
      cataract surgery.

      In our previous study, the investigators examined the intraoperative performance and
      postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients
      before their first birthday. At 1 year, the postoperative results showed that good visual
      outcomes could be obtained in microphthalmic eyes.

      Since only a few studies have reported outcomes, and that too only short term of cataract
      surgery on microphthalmic eyes, in this prospective observational study we evaluated the
      long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators
      examined the outcomes, complication rates, influence of age at surgery on pattern of axial
      growth and central corneal thickness and visual and orthoptic assessment in these eyes.
    


Intervention name(s): Cataract surgery
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract
        surgery between January 2003 and June 2008.
Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, randomised, double blind, placebo-controlled, parallel-group, phase
      III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution
      0.6% in children with a documented history of seasonal allergic conjunctivitis (SAC) or
      perennial allergic conjunctivitis (PAC).
    


Intervention name(s): Bilastine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ophthalmic solution 0.6%; Ophthalmic solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
Condition: Healthy
Study type: Interventional

Summary: 
      ORi is a unitless index that could help clinicians with their assessments or normoxic and
      hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi
      of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to
      PaO2 values of 200mmHg and above. In this study, the PaO2 is varied by controlling the
      concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by
      comparing it to corresponding changes in PaO2 measurements from blood samples.
    


Intervention name(s): INVSENSOR00025
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Prescription Opioid Misuse Assessment
Condition: Chronic Pain
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Observational

Summary: 
      Chronic pain is a worldwide health problem due to its high prevalence and its difficult
      management with a significant impact on quality of life. Pain and addiction co-occur
      frequently. Indeed, the prevalence of addiction in patients with chronic non-cancer pain may
      affect from 0% to 50% of patients (Højsted et al 2010). This large variability in the
      estimation of addiction prevalence in chronic non-cancer pain patients is at least partly due
      to a lack of standardization of the selected patients from the clinical or therapeutic point
      of view and the lack of consensus in the use of a specific evaluation tool or gold standard.
      Indeed, several tools are currently available at the international level with varying
      efficiencies and precisions (Chou et al 2009, Turk, Swanson, and Gatchel 2008, Højsted and
      Sjøgren 2007). In France, no data are available on the prevalence of analgesic opioid misuse
      in chronic non-cancer pain patients, due to the lack clinical studies and validated tools in
      French.
    

Detailed description: 
      This is an observational study . Each addictovigilance centre will contact Pain Clinics in
      order to enroll patients meeting the inclusion criteria. The questionnaires will be prepared
      and sent to the participating centres by the coordinating centre (Clermont-Ferrand).
      Participation in the study will be systematically proposed by the physician during the study
      inclusion period (3 months). Patients meeting all inclusion criteria will be enrolled after
      receiving oral information about the study.

      This questionnaire can be semi-directed (doctor / nurse / CRA) and will be carried out during
      a consultation as part of their usual care. Answering the questionnaire should take no more
      than 10 minutes. No additional diagnostic or monitoring procedures will be applied to
      patients.
    

Intervention name(s): Prescription Opioid Misus Index
Intervention type(s): Other
Intervention description(s): Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale. A score ≥ 2 is considered positive and will define a misuse behavior.
Intervention MeSH terms: Analgesics, Opioid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting
        the inclusion criteria.
      
Keywords: Analgesic opioids; Misuse; Use disorder; Pain
An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a
      period of 24 weeks
    


Intervention name(s): SYNOLIS VA 80/160; SYNOLIS VA 40/80
Intervention type(s): Device; Device
Intervention description(s): Single 4mL intra-articular injection of SYNOLIS VA 80/160; Single 2mL intra-articular injection of SYNOLIS VA 40/80
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee Osteoarthritis; Hyaluronic acid
Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this work, the investigators report the effects of consume of 15g walnuts and 15g almonds
      for 8 week on weight, waist and hip circumferences, body mass index, fat mass, serum
      LDL-cholesterol adiponectin, lipocalin-2 concentration and fatty acids profile.
    

Detailed description: 
      The study consists of a diet-intervention in a single group under-free-living conditions. The
      diet was enriched with 15g of almonds and 15g of walnuts per day for eight weeks, supplied
      directly to the patient by the researcher. This amounts of walnuts and almonds contain
      polyunsaturated fatty acids of approximately 2.02g of omega 3 (alpha-linolenic acid) and
      11.1g of omega 6 (linoleic acid) mostly. In a period of 14 months, the investigators
      recruited forty-eight sedentary subjects of 30 to 50 years old, and body mass index between
      30 and 34.9 kg/m2, without evidence of chronic degenerative, infectious or neoplastic
      diseases, neither medication nor actually dietary treatment, and a physical level of exercise
      < 2 hours/week. All participants gave their written informed consent to participate in the
      study. The study was approved by the Institutional Ethics Committee of the Universidad de
      Guanajuato.

      Collected data included the clinical-nutritional history, 24-hour recalls, and the
      International Physical Activity Questionnaire was applied to evaluate if subjects were
      sedentary. The dietary intake evaluation was estimated in kilocalories/day, the amount and
      type of macronutrients according to the database of United States Department of Agriculture
      and the National Institute of Public Health (Mexico). In order to evaluate adherence to the
      diet, volunteers were visited every two weeks to carry out three 24-hour recalls (two on
      weekdays and one on weekends). Positive Adherence to the diet plan was considered when the
      food consumption, walnuts and almonds were not modified more than ± 20% of the amount
      indicated by the researcher.

      The investigators recorded the anthropometric measures, body composition, and measured serum
      glucose, lipid profile, insulin, lipocalin 2, high sensitivity C-reactive protein,
      adiponectin, and fatty acids profile, which were analyzed at the baseline and after dietary
      intervention.
    

Intervention name(s): walnuts and almonds
Intervention type(s): Dietary Supplement
Intervention description(s): The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Walnuts; almonds; adiponectin; lipocalin-2; obesity
RCT Computer-tailored Intervention on Workplace Sitting
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      A theory-driven, web-based, computer-tailored advice to influence sitting at work was
      developed. The study investigated the effects of this computer-tailored intervention to
      influence workplace sitting on behavioural measures.
    

Detailed description: 
      The study investigated the effects of the theory-driven, web-based, computer-tailored
      intervention to influence workplace sitting on objectively measured sitting time, standing
      time and breaks from sitting, as well as self-reported context-specific sitting. The
      computer-tailored advice was compared to a generic advice and a 'no-advice' control at
      1-month and 3-months follow-up. The 'tailored' group received a web-based computer-tailored
      intervention including personalized feedback and tips on how to reduce and/or interrupt
      workplace sitting. The 'generic' group received a web-based intervention containing generic
      information and tips to reduce and/or interrupt workplace sitting. The control group was a
      waitlist control condition and received the generic intervention after completing all
      measurements. Participants were recruited from a convenience sample of two companies
      (university and environmental agency) in Flanders (i.e. northern Dutch-speaking part of
      Belgium), mainly employing desk-based workers, having more than 100 staff members and each
      having at least three different worksite locations.
    

Intervention name(s): Start to stand; generic advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): web-based computer-tailored intervention including personalized feedback and tips on how to reduce and/or interrupt workplace sitting; general, non-tailored web-based generic advice with tips
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      This study examines the impact of Cognitive-Behavior Therapy (CBT) on symptoms, physiological
      arousal, stressors, and the ways to deal with them in individuals with schizophrenia and
      related disorders. The primary aim of this study is to investigate the role cognitive coping
      strategies play in mediating the link between stress, physiological arousal, and psychotic
      symptoms in individuals with schizophrenia during recovery from psychosis.
    

Detailed description: 
      This study examines the mechanisms of recovery from psychosis. Specifically, the study aims
      to evaluate the putative impact of enhancing cognitive coping strategies via
      Cognitive-Behavior Therapy for psychosis (CBTp) on subjective stress, autonomic regulation
      (physiological arousal), and psychotic symptoms in individuals with schizophrenia and related
      disorders. As part of the study, participants will be randomized to receive up to 26 weekly
      sessions of CBTp (over 30 weeks) or "treatment as usual". Research evaluations will completed
      at baseline, and after 10, 20 and 30 weeks. The study outcome measures include psychotic
      symptoms as measured by clinical interviews, along with ambulatory measures of autonomic
      regulation and self-reports of psychotic experiences during daily functioning using mobile
      devices (i.e., Palm computers).
    

Intervention name(s): Cognitive-Behavior Therapy; Standard Psychiatric Treatment
Intervention type(s): Behavioral; Other
Intervention description(s): Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.; Standard psychiatric treatment.
Other intervention name(s): CBT for psychosis; Treatment As Usual (TAU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective; Schizophreniform; Psychosis; Psychotic; Hallucinations; Delusions; Paranoia; Paranoid; Voices; CBT; Cognitive Behavior Therapy; Cognitive Therapy
Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      The purpose of this study is to better understand why women choose to have their fallopian
      tubes removed as a method for ovarian cancer prevention. This will be done through a paper
      questionnaire and phone interviews. The investigators hope to gain information that will
      allow us to better counsel women about ovarian cancer prevention.
    

Detailed description: 
      Women will be found eligible for this study after an eligibility questionnaire given over the
      phone. If one is found eligible, she will be sent a consent and paper survey to fill out and
      send back to the research coordinator. Once that is completed, she will be given a phone
      interview in order answer additional questions of interest. Lastly, the study participant
      will be contacted once a year over the phone to obtain follow-up information.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who have had their fallopian tubes removed as a method of ovarian cancer prevention.
      
Keywords: fallopian tube removal; salpingectomy; ovarian cancer prevention
Effects of Gastric pH on the Pharmacokinetics of Dasatinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to evaluate the ability of a natural supplement (betaine
      hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators
      predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers
      pre-treated with proton-pump inhibitors (PPIs).
    


Intervention name(s): Dasatinib; Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dasatinib (100mg) PO x1; Rabeprazole (20mg) PO twice daily (Days 1-3); Dasatinib (100mg) PO x1 (Day 4); Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Dasatinib (100mg) PO x1 on Day 4
Intervention MeSH terms: Dasatinib; Rabeprazole; Betaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dasatinib; betaine; betaine hydrochloride; pharmacokinetics; healthy volunteer
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction
Condition: Non-ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Acute coronary syndromes (ACS) are still associated with high morbidity and mortality,
      despite several improvements in their management. This may indicate that important pathogenic
      mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms.

      Based upon previous research, the investigators believe that providing a block in the
      damaging inflammatory loop though short term inhibition of Interleukin-6 receptor signalling,
      could be an attractive therapeutic target in ACS; and of particular interest in patients with
      non-ST elevation myocardial infarction (NSTEMI), a disease often characterized by widespread
      coronary inflammation with multiple unstable plaques.

      The investigators hypothesize that a single administration of the anti-Interleukin 6 receptor
      antagonist Tocilizumab, in patients with NSTEMI, may interrupt the self-perpetuating
      inflammatory loops which could improve plaque stability, with potential secondary beneficial
      effects on myocardial damage.

      This will be investigated in a randomized, double blind, placebo-controlled study, including
      a total of 120 patients.
    


Intervention name(s): Tocilizumab 280 mg; NaCl 0.9% 100 ml
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl; Placebo
Other intervention name(s): Brand name RoActemra (Roche); ATC: L04A C07
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Indoleamine 2,3-dioxygenase (IDO) Activity in Patients With Chronic Lymphocytic Leukemia (CLL)
Condition: CLL
MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Observational

Summary: 
      The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia
      (CLL) is studied.
    

Detailed description: 
      The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia
      (CLL)is studied in patients and healthly controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with CLL
      
Biospecimen description: 
      Ido expression
    
Keywords: CLL; IDO