bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery
Condition: Hypotension Drug-Induced
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypotension in patients who are taken to surgery, is a very frequent complication, when the
      spinal anesthetical technique is used, associating this with significant adverse effects that
      can lead to morbidity specially in the obstetric patient. The objective of the study is
      determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance
      of hypotension in obstetric patients led to Caesarea under spinal anesthesia.
    

Detailed description: 
      Worldwide, the caesarean section is one of the surgical procedures most frequently performed,
      representing a challenge to the anesthesiologist, who must administer anesthesia to the
      mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an
      important option in the management of the obstetrical patient who is going to be taken to
      Caesarea. The hypotension, is one of the most frequent events adverse associated to this
      technical anesthetic, represented a risk of complications both, in the mother as in the
      fetus, by this reason the anesthesiologist must implement different strategies to treat it
      when this be present. From there arises the necessity of establishing if the phenylephrine, a
      drug used to treat hypotension, when is administed prophylactically, allows to avoid this
      effect. We designed a randomized clinical trial in elderly patients over 18 years who are
      taken to Caesarea, where they formed two groups of patients, one that will administer a
      prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of
      hypotension in the two groups and the adverse events most commonly associated with this.
    

Intervention name(s): Phenylephrine
Intervention type(s): Drug
Intervention description(s): prophylactic infusion of phenylephrine 40 mcg/min
Other intervention name(s): prophylactic Phenylephrine
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
Condition: Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5
      colon segments prior to colonoscopy.
    

Detailed description: 
      All participants enrolled to the study will be allocated to one of two arms. Patients of the
      experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full
      dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy
      clinical procedure. Participants in the standard split-dose regimen arm will prepare and take
      MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1
      litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.

      The study consists of three visits. Participation in the study lasts no more than 11 days; 3
      days as minimum.

      There is no follow-up period planned except in case of any adverse events (AEs) when the
      follow-up period will last until the participant has recovered or until all AE-related
      queries for the participant have been resolved.
    

Intervention name(s): MOVIPREP
Intervention type(s): Drug
Intervention description(s): MOVIPREP solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bowel preparation, MOVIPREP®
Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders After Gastric Bypass
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The aim of the study is to describe differences in meal-stimulated gut hormone response,
      appetite and intestinal transit time between good and poor responders 1-2 years after Gastric
      Bypass surgery for obesity.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Case subjects are recruited from the outpatient clinic of endocrinology at Hvidovre
        University Hospital. Control subjects are recruited through announcement in local
        newspapers.
      
Biospecimen description: 
      Plasma and serum specimens are retained
    
Keywords: Obesity; Gastric bypass; Gut hormone; Intestinal transit time
STRAIN - Work-related Stress Among Health Professionals in Switzerland
Condition: Stress; Health Care Professionals; Work-Related Condition
MeSH terms: Occupational Stress
Study type: Interventional

Summary: 
      The aim of this study is to identify work stressors, stress reactions and long-term
      consequences among nurses, physicians, medical-technical and medical-therapeutic professions
      in Switzerland and to reduce those factors by an educational intervention for the
      supervisors.
    

Detailed description: 
      Methods: This study is a cross-sectional design and randomly selected hospitals, nursing
      homes and home care organizations. The study sample included nursing staff and midwives,
      physicians, medical-technical and medical-therapeutic professionals at all hierarchical
      levels. Data were collected using self-report questionnaires and analysed using multiple
      regression models.
    

Intervention name(s): educational intervention for the supervisors
Intervention type(s): Other
Intervention description(s): The educational intervention is based on a systematic literature review as well as focus-group interviews with health care professionals. It will be developed until the end of 2018
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia
Condition: Cholecystectomy, Laparoscopic; Anesthesia, General; Reflex, Pupillary
Study type: Interventional

Summary: 
      In this study, the investigators measure a pupil size every 5 minutes during the operation in
      patients undergoing laparoscopic cholecystectomy under general anesthesia. The investigators
      would compare the intraoperative opioid consumption and postoperative pain between the group
      adjusted the anesthetic drug concentration based on the changes of the pupil (Pupil group)
      and the group based on the changes of a surgical pleth index (SPI group).
    


Intervention name(s): Pupillometry guided anesthesia; SPI guided anesthesia; Standard management
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): At least 10 min after anesthesia induction by target-controlled infusion of propofol and remifentanil, baseline values for pupillary diameter is recorded before any surgical procedure.
During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60. Remifentanil Ce is adapted every 5 min based on the changes of pupillary diameter. If the pupillary diameter is increased by more than 30% compared to baseline value, remifentanil concentration is increased by 0.5 ng/ml. If the pupillary diameter is maintained between 5 and 30 % change compared with baseline, remifentanil is not modified. In a case of pupillary diameter is decreased less than 5 % change of baseline, remifentanil concentration is decreased by 0.5 ng/ml.; During the operation, SPI value should be maintained between 20 and 50 by changing the infusion rate of remifentanil. Even if the SPI is maintained within the target range, the remifentanil infusion rate is increased by 0.5 ng/ml in a case of the SPI value suddenly arises by more than 10.; During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60.
Remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients.
Other intervention name(s): PUPIL; SPI; Control
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the effect of a high-fat meal on the PK of
      TAK-788 administered in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-788. The study will characterize the effect
      of a high-fat meal on the PK of TAK-788 administered in healthy participants.

      The study will enroll approximately 14 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment sequence

        -  TAK-788 160 mg Fasted (Reference) in Period 1 + TAK-788 160 mg Fed (Test) in Period 2

        -  TAK-788 160 mg Fed (Test) in Period 1 + TAK-788 160 mg Fasted (Reference) in Period 2

      All participants will be asked to take capsules of assigned TAK-788 on Day 1 of each period.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is 61 days. Participants will be contacted by telephone for 30 days
      after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-788
Intervention type(s): Drug
Intervention description(s): TAK-788 Capsule.
Other intervention name(s): AP32788; Mobocertinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Efficacy Analysis of Comparison of CAMS（Chinese Academy of Medical Sciences）-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia, Pediatric
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for
      pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a
      risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes
      of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.
    


Intervention name(s): Risk-stratified therapy
Intervention type(s): Other
Intervention description(s): Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the Department of Pediatrics, Institute of Hematology & Blood Disease
        Hospital.
Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      While antiretroviral drugs have shown great promise in reducing HIV replication and thus in
      reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial
      and side effects are a potentially limiting factor. Development of an effective
      safe-affordable vaccine is likely to be the best way to stop further virus spread. The study
      aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg
      delivered id in combination with MVA-CMDR boost im.
    


Intervention name(s): DNA HIVIS and MVA-CMDR; DNA HIVIS and MVA-CMDR; Saline solution; Saline solution
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 600 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12; 108 pfu i.m. MVA boosting at weeks 24 and 36; 1200 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12 ; 108 pfu i.m. MVA boosting at weeks 24 and 36; 2 x 0.1 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36; 2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Vaccine; DNA; Prevention
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I trial will assess the feasibility of using a vaginal ring to deliver the
      candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13
      healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical
      and laboratory assessments. Feasibility of drug delivery will be assessed by measuring
      dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue,
      and plasma.
    


Intervention name(s): dapivirine (TMC120) vaginal ring
Intervention type(s): Drug
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Seronegativity
Beijing Children and Adolescents Metabolic Syndrome Study (BCAMS Study)
Condition: Obesity; Metabolic Disease
MeSH terms: Metabolic Syndrome; Metabolic Diseases
Study type: Observational [Patient Registry]

Summary: 
      Base on enriched resources from the Metabolic Syndrome cohort in children, a long-term
      prospective cohort study will be carried out. This cohort is a unique biochemical and genetic
      database of Chinese population with large number of subjects in the world. By collecting
      information of disease history and lifestyle, measuring clinical and metabolic parameters,
      especially biomarkers which can reflect the underlying mechanism of insulin resistance and
      metabolic syndrome, we intend to sort out some unique biochemical and genetic markers for
      Chinese population.
    

Detailed description: 
      A representative sample of 19,593 school children, aged 6-18 years, were chosen from four of
      the eight urban districts and three of seven rural districts in the Beijing area between
      April and October, 2004. Among these children and adolescents, 4,500 were recognized as
      having risk factors defined by the presence of any one of the following: overweight, total
      cholesterol (TC) ≥ 5.2 mmol/L, triglyceride (TG) ≥ 1.7 mmol/L or fasting glucose (FG) ≥ 5.6
      mmol/L based on initial finger capillary blood tests. Moreover, all subjects at increased
      risk for metabolic syndrome, together with a parallel reference population of 1,095 children,
      were invited to undergo medical examinations for verification based on venipuncture blood
      samples. Clinical data, biomarkers including adipokines, and lifestyle factors such as
      physical activity and diet were measured and documented. Genetic variants previously reported
      from genome-wide association study (GWAS) of obesity and diabetes and DNA-methylation were
      also assessed. Further, high-throughput analysis of proteomics and metabolomics of the blood
      samples were conducted. Cross-sectional and follow-up evaluations will be undertaken. The
      unique biochemical and genetic markers for Chinese population will be identified in the BCAMS
      study. The biomarkers will build a solid foundation for progressive study on mechanism of
      metabolic diseases and lead to early prediction of these diseases.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        School children, aged 6-18 years, from four of the eight urban districts and three of seven
        rural districts in the Beijing area
      
Biospecimen description: 
      Blood sample
    
Keywords: Children; Obesity; Metabolic Disease
Building Employment Skills Through Therapy for Veterans
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive
      skills, social skills, and functional skills (like employment). There is a new form of
      cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that
      specifically addresses the cognitive, social, and functional deficits of
      schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that
      Veteran's receive. The investigators compared iCBT to UC in subjects with
      schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE)
      program, and evaluate whether iCBT is more helpful in improving job performance, and other
      areas of functioning, both right after treatment, and 6 months after the end of treatment.
    

Detailed description: 
      The objective of the current study was to evaluate whether integrated cognitive behavior
      therapy (iCBT) can improve engagement and success in an existing Supported Employment (SE)
      program among the most functionally disabled patients with schizophrenia/schizoaffective
      disorder. The iCBT condition also included computerized cognitive remediation. The primary
      specific aim was to determine whether iCBT will significantly improve work outcomes at
      post-treatment to a greater extent than Usual Care (UC) in low functioning patients with
      schizophrenia/schizoaffective disorder who join the SE program. The secondary aims were to
      evaluate the whether iCBT will significantly improve work outcomes at 6 month follow-up
      relative to UC, and whether iCBT will improve functional outcomes post-treatment and at
      follow-up relative to UC in subjects who join the SE program.
    

Intervention name(s): integrated Cognitive Behavioral Therapy; Usual Care; Computerized cognitive remediation (CCR)
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): Novel CBT paradigm for schizophrenia/schizoaffective disorder; The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition); Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.
Other intervention name(s): iCBT; UC; CCR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive Behavioral Therapy; Cognition; Vocational Rehabilitation; Supported Employment; Schizoaffective Disorder
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to assess the safety, tolerability and activity of
      escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.
    


Intervention name(s): SBR759; SBR759; SBR759; SBR759; SBR759; SBR759; SBR759
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.; Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.; Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.; Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.; Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.; Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.; Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Intervention MeSH terms: Ferric Compounds
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic kidney disease,; hemodialysis,; serum phosphorus,; phosphate binders
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
Condition: Prurigo Nodularis; Nodularis Prurigo; Prurigo
MeSH terms: Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER
      tablets during a treatment period of up to 50 weeks.
    


Intervention name(s): nalbuphine HCl ER
Intervention type(s): Drug
Intervention description(s): nalbuphine HCl ER BID for up to 50 weeks
Other intervention name(s): nalbuphine
Intervention MeSH terms: Nalbuphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Itch; Chronic Itch; Nalbupine
18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the long-term efficacy and safety of two doses of
      safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with
      idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable
      dose of levodopa.
    


Intervention name(s): Safinamide; Safinamide; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; PD; Levodopa; Patients with idiopathic Parkinson's Disease with motor fluctuations,