bioihbjkbjnl/mcl2 huggingface dataset:
Influence of the Neuromuscular Blockade on Mask Ventilation
Condition: Complication of Ventilation Therapy; Observation of Neuromuscular Block
Study type: Interventional

Summary: 
      Mask ventilation during induction of anesthesia can be improved by administration of
      neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask
      ventilation; however, muscle relaxants may improve mask ventilation and they do not alter
      mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before
      testing mask ventilation. We will study different dosages of rocuronium; we assume that
      higher dosages of rocuronium will improve mask ventilation compared with lower dosages.
    

Detailed description: 
      Mask ventilation during induction of anesthesia can be improved by administration of
      neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask
      ventilation; however, muscle relaxants may improve mask ventilation and they do not alter
      mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before
      testing mask ventilation.We will administer rocuronium 0.3 mg/kg, 0.6 mg/kg, 0.9 mg/kg and
      saline (placebo group) before starting with mask ventilation. We will grade mask ventilation
      based on various scores before and after rocuronium application. Afterwards patient's
      tracheas will be intubated. We assess risk factors for difficult mask ventilation.

      We hypothesize that rocuronium 0.9 mg/kg will be superior to rocuronium 0.3 mg/kg and saline.
    

Intervention name(s): Rocuronium 0.3 mg/kg; Rocuronium 0.6 mg/kg; Rocuronium 0.9 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients receive rocuronium 0.3 mg/kg; Patients receive rocuronium 0.6 mg/kg; Patients receive rocuronium 0.9 mg/kg; Patients receive saline
Other intervention name(s): Esmeron; Esmeron; Esmeron; Saline
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Muscle relaxants
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
Condition: Prostate Cancer; Hirsutism
MeSH terms: Hirsutism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50
      mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.
    


Intervention name(s): Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA); Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment
The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl
Condition: Surgery; Individuality
Study type: Observational

Summary: 
      Purpose: This study aimed to find a quick and timely way to investigate the individual
      variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries.
      Methods: 120 female patients receiving elective surgery under general anesthesia were
      recruited into this study. At the time of routine intravenous anesthetic induction we observe
      the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index,
      sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.
    

Detailed description: 
      Patients with the following diseases were excluded: known history of chronic pain,
      psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular
      diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy
      smoker, pregnancy or at the lactation period.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        120 Chinese female patients receiving elective surgery under general anesthesia
      
Keywords: fentanyl; sufentanil; individual variation; pain threshold; nacro-trend index
A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and
      relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation
      BTDS patches.
    

Detailed description: 
      The objective is to examine a new 2nd generation BTDS patch formulation at 2 strengths: 3.15
      mg and 12.6 mg, compared to 1st generation patches at 2 strengths: 5 mg and 20 mg, to assess
      dose proportionality and relative bioavailability before proceeding to a definitive program
      of studies. Determination is by measurement of drug concentrations in the blood at serial
      collection time points pre-dose until 288 hours post-patch application.
    

Intervention name(s): Second generation BTDS patch; First generation BuTrans patch
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers; Pharmacokinetics
Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin
Condition: HIV Infections; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to
      treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food
      and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given
      with pravastatin, they can increase the blood levels of pravastatin. The degree of this
      interaction varies from person to person. The way that darunavir and ritonavir interact with
      pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those
      that people are born with and that make each person unique. Genetic differences are the
      reason why one person's body traits such as height and hair color are different from another
      person's body traits. Genetic differences can also affect the way a medication works in the
      body or the way two medications interact in the body. The purpose of this clinical study is
      to determine if a person's genetic make-up affects the way darunavir and ritonavir interact
      with pravastatin in the body.
    


Intervention name(s): Pravastatin; Darunavir; Ritonavir; Pravastatin; Washout
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Pravastatin 40 mg by mouth daily on days 1-4; Darunavir 600mg by mouth twice daily on days 12-18; Ritonavir 100mg by mouth twice daily on days 12-18; Pravastatin 40 mg by mouth daily on days 15-18; Washout (no medication) on days 5-11.
Other intervention name(s): Pravachol; Prezista; Norvir; Pravachol
Intervention MeSH terms: Ritonavir; Darunavir; Pravastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Pravastatin; Darunavir; Ritonavir; Genetic
Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis:

      Based on available pharmacokinetic data from healthy volunteers we hypothesize that the
      administration of a cumulative dose of 210μg of the continuous erythropoietin receptor
      activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI)
      does not result in hemoglobin (Hb) levels >15 g/dl in patients with ST-segment elevation
      myocardial infarction (STEMI)

      Design:

      Prospective, open label single center pilot study
    

Detailed description: 
      This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform
      representative statistics of expected Hb kinetics in response to Mircera®.
    

Intervention name(s): methoxy-polyethyleneglycol epoetin beta
Intervention type(s): Drug
Intervention description(s): Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI
Other intervention name(s): Mircera
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myocardial infarction; continuous erythropoetin receptor activator; Mircera; hemoglobin kinetics
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)
      affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how
      the drug affects the body) of a single dose of simvastatin.
    

Detailed description: 
      This study will be an open-label (all volunteers and study staff know the identity of the
      assigned treatment), single-center, fixed-sequence study (all volunteers receive the same
      medication on the same days and in the same order) to determine how multiple doses of
      canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes
      mellitus) affects the pharmacokinetics and pharmacodynamics of a single dose of simvastatin
      (a drug used to treat raised cholesterol). The study will consist of 3 phases: a screening
      phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. During the
      open-label treatment phase, each volunteer will receive a single 40 mg dose of simvastatin on
      Day 1, followed by 300 mg of canagliflozin once daily on Days 2 through 6. On Day 7,
      volunteers will receive both simvastatin 40 mg and canagliflozin 300 mg. Each volunteer will
      participate in the study for approximately 32 days
    

Intervention name(s): Simvastatin; Canagliflozin (JNJ-28431754)
Intervention type(s): Drug; Drug
Intervention description(s): One 40 mg tablet taken orally (by mouth) on Day 1 and Day 7.; One 300 mg dose (ie, one 100 mg and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Days 2 through Day 7.
Other intervention name(s): Zocor; JNJ-28431754
Intervention MeSH terms: Canagliflozin; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Simvastatin (ZOCOR)
Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks
Condition: Colorectal Cancer; Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this research study is to compare a new educational material to another widely
      available educational brochure. The goal is to see if the new educational material will
      change knowledge and behaviors about colorectal cancer and colorectal screening.
    


Intervention name(s): Fecal Immunochemical Test (FIT) Kit; Culturally targeted Photo Novella Booklet; Screen for Life Brochure
Intervention type(s): Other; Behavioral; Behavioral
Intervention description(s): Free FIT Kits distributed at study entry.; Culturally targeted Photo Novella Booklet + culturally targeted reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.; Screen for Life Brochure + standard reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this modified "block" random assignment, all individuals recruited from the same geographic unit will receive the intervention assigned to that area in order to reduce intervention contamination. Individuals will not be made aware of their randomization (intervention) condition until after baseline assessment. The research assistants will also be assigned at random to work with one geographic area (i.e., one intervention condition) in order to reduce risk of intervention contamination by study staff.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: cancer screening
Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to quantify the effect of food on the extent of absorption of
      palbociclib.

      The caloric content of the food and the time of the meals with respect to palbociclib
      administration may influence the capacity of the body to absorb the drug.

      High and low calorie meals will be given to the subjects 30 minutes before palbociclib
      administration as 2 of the 3 conditions to compare with completely absence of food in the
      body when dosing (fasted).The third condition to test and compare with fasted stage will be
      the administration of food before and after palbociclib administration.

      This information will help the program to decide wether or not the presence of food when
      dosing palbociclib help with its absorption and to what extent it does help. Based on the
      collected information, a recommendation about the administration of palbociclib with food
      will be provided to patients.
    


Intervention name(s): Palbociclib administered Fasted; Palbociclib administered Fed high calorie; Palbociclib administered Fed low calorie; Palbociclib administered Fed moderate calorie
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose; palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose; palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose; palbociclib given between moderate calorie meal; capsule form, 125 mg single dose
Intervention MeSH terms: Palbociclib
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food; Bioavailability; Fasted; Fed
Comparison of Pharmacokinetic Profiles of 3 New Nicotine Gum Formulations With a Reference Gum
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess
      bioequivalence between three new nicotine gum formulations and a reference nicotine gum in
      healthy smokers.
    


Intervention name(s): Nicotine gum
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, nonrandomized, open-label phase 2 study (with a safety run-in phase)
      of azacitidine (AZA) 75 mg/m2 given IV or SQ on days 1-7 every 28 days in combination with
      pembrolizumab 200 mg given IV every 3 weeks (starting on day 8 of cycle 1). The dose/schedule
      of AZA selected for this study is FDA approved for patients with MDS/AML.
    

Detailed description: 
      Acute myeloid leukemia (AML) remains a therapeutic challenge. Although 60-80% of newly
      diagnosed patients with AML respond to induction chemotherapy, the relapse rate remains high
      (40%-50%) even after allogeneic stem cell transplant (alloHSCT). Data suggests that
      epigenetic therapy with azacitidine combined with blockade of PD-1/PD-L1 pathway is a
      rational therapeutic approach both in newly diagnosed older patients and those with relapsed
      and refractory AML. Furthermore, recent data suggest that the addition of PD-1 blockade
      (nivolumab) to azacitidine in patients with AML who have previously failed hypomethylating
      agents may induce responses in up to 20% patients

      We plan to examine two AML patient cohorts:

      Cohort 1: relapsed/refractory AML. Cohort 2: newly diagnosed AML in older patients (≥65
      years) not candidates for induction chemotherapy. Azacitidine and pembrolizumab have distinct
      mechanisms of action with no common overlapping toxicities; however, as azacitidine and
      pembrolizumab have not been tested previously in combination in AML patients, we plan to
      start enrollment with Cohort 1 (a safety run-in phase) and include only relapsed/refractory
      AML patients excluding those relapsing after allogeneic hematopoietic stem cell transplant
      (alloHSCT). The primary objective of the run in safety phase would be to determine the safe
      and tolerable dose/schedule of azacitidine and pembrolizumab in patients with AML. We will
      perform safety run in phase only in Cohort 1 as Cohort 2 patients would be expected to have a
      same or better tolerability given that they are not heavily pretreated
    

Intervention name(s): pembrolizumab; Azacitadine
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous pembrolizumab; Intravenous or subcutaneous
Other intervention name(s): MK-3475; Vidaza
Intervention MeSH terms: Pembrolizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis
Condition: Acute ST Segment Elevation Myocardial Infarction; Thrombolysis in Myocardial Infarction Flow
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with
      pharmacological thrombolysis
    

Detailed description: 
      Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of
      Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor
      Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated
      with Pharmacological Thrombolysis.
    

Intervention name(s): Ticagrelor 180 mg; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.; 300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months.
For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.
Other intervention name(s): Ticagrelor
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of
      alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates
      of about 30% of individuals in the United States. A subset of these will develop progressive
      disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis
      and liver failure. NAFLD is expected to be the most common indication for liver
      transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will
      decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy
      (1H-MRS).
    


Intervention name(s): Growth hormone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): growth hormone, Genotropin (Pfizer); placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)
Other intervention name(s): Genotropin (Pfizer Inc.)
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors
Condition: Behaviour Change
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research
      that have unique psychosocial, medical and survivorship issues. Physical activity (PA) has
      important effects on health-related outcomes in middle-aged and older cancer survivors and
      preliminary research suggests similar benefits in YACS (18-39 years). Unfortunately, only
      about half of YACS report meeting public health PA guidelines and there are no interventions
      or resources available to help YACS increase their PA. The purpose of this study is to test a
      physical activity guidebook that was developed for YACS based on the theory of planned
      behavior (TPB). The PA guidebook will be evaluated in a randomized controlled trial.
      Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or
      (b) the YACS PA guidebook. YACS will complete assessments of PA, quality of life, and
      psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. The
      primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3
      months. Secondary endpoints will include changes in TPB constructs and quality of life. It is
      hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater
      increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).
    


Intervention name(s): Stride to Survive:An Exercise Guide for Young Adult Cancer Survivors; Canadian Physical Activity Guidelines
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Physical Activity; Young Adult Cancer; Behavior Change