bioihbjkbjnl/mcl2 huggingface dataset:
An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)
Condition: Cancer
Study type: Observational

Summary: 
      The purpose of this extension is to observe the incidence rates of cancer, total mortality,
      and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial
      (2004_050, MK0653A-043; NCT00092677).
    

Detailed description: 
      The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050, MK0653A-043;
      NCT00092677). The main objective of the extension is to observe the incidence rates of
      cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from
      04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial. The sources of
      study data will include data collected from national cancer and death registries as well as
      data from the original clinical trial. No patient visits will occur. National cancer and
      death registries exist in 5 of the 7 countries that participated in the base SEAS trial. At
      the time of Follow-up study initiation, accessing the registry data in Ireland was not
      feasible due to local regulations and Cancer and Death registries did not exist in Germany.
      As a result, data will be collected only for all SEAS patients known to be alive at the end
      of the base study originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The cohort will include all patients from the five participating countries (Sweden,
        Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study
        and who were known to be alive at the end of the base study.
      
Keywords: New Incidence of Cancer
Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users
Condition: Abuse Potential
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4 clinical study in healthy non-drug dependent recreational opioid users to
      assess the abuse potential of Lyrica when taken alone or in combination with oxycodone.
    

Detailed description: 
      This is a randomized, double-blind, double-dummy, placebo- and active-controlled,
      6-treatment, 6-period crossover, single-dose study in healthy male and/or female adult, non
      drug-dependent recreational opioid users. The study includes Screening, a Qualification
      Phase, a Treatment Phase and Follow-up. This study will randomize approximately 60 adult male
      and female (at least 20% female) participants (10 participants in each sequence) in the
      Treatment Phase to ensure at least 48 participants complete the Treatment Phase of the study.
      There will be 8 visits to the clinic in total and a follow-up telephone call at the end of
      the study. The duration of participation will be approximately 16 weeks and 7 of the visits
      will involve clinic stays of 4 days/3 nights.
    

Intervention name(s): Pregabalin 300mg; pregabalin 450 mg; Pregabalin 300 mg with oxycodone 20 mg; pregabalin 450 mg with oxycodone 20 mg; oxycodone 20 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participant will receive an oral dose of pregabalin 300 mg; Participant will receive an oral dose of pregabalin 450 mg; Participant will receive an oral dose of pregabalin 300 mg and oxycodone 20 mg; Participant will receive an oral dose of pregabalin 450 mg and oxycodone 20 mg; Participant will receive an oral dose of oxycodone 20 mg; Participant will receive an oral dose of placebo
Intervention MeSH terms: Pregabalin; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, double-dummy, placebo- and active-controlled, 6-treatment, 6-period crossover, single-dose, Williams square design study in healthy male and/or female adult, non drug-dependent recreational opioid users.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Lyrica; Pregabalin; Oxycodone; Opioid; Abuse liability
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Condition: Anesthesia, Local
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective randomized controlled triple-masked study looking at the duration of
      nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and
      clonidine) plus ropivacaine versus plain ropivacaine alone.
    

Detailed description: 
      This is a prospective randomized controlled triple-masked study looking at the duration of
      nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and
      clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on
      patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will
      be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2.
      A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine
      with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their
      regimen in the interscalene block for their surgery. The patients will then be called within
      3 days post-operatively to follow-up. Follow-up data collected will be when did the patient
      experience return of pain to the operative limb (duration of analgesia), when did the patient
      experience return of motor function of the operative limb (duration of motor block) and when
      did the patient experience return of sensation of the operative limb (return of sensory
      block). All three of these adjuvants have been studied previously and shown to have increased
      analgesic duration with local anesthesia, but have never had a good comparative study. The
      mechanism of action of the analgesia for these adjuvants pain relief has never been shown
      although it is likely a indirect effect as there are animal studies looking at their effect
      on A and C fibers that did not show those results.
    

Intervention name(s): Ropivacaine 0.75%; Ropivacaine 0.75% + 300 mcg Buprenorphine; Ropivacaine 0.75% + 75 mcg clonidine; Ropivacaine 0.75% + 8 mg dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Only ropivacaine 0.75% is administered for this arm of the interscalene block; Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block; Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block; Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Other intervention name(s): Naropin; Naropin + Buprenex; Naropin + Duraclon; Naropin + Decadron
Intervention MeSH terms: Dexamethasone; Clonidine; Buprenorphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brachial Plexus Block; Clonidine; Dexamethasone; Buprenorphine
Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
Condition: Obesity
MeSH terms: Obesity; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible
      for the improvements in metabolic health after a single session of endurance exercise. The
      investigators will determine the effect of a single session of endurance exercise on
      whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of
      factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity
      (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise,
      effect insulin signalling and insulin sensitivity. Every effort will be made to recruit
      subjects from ethnic and minority groups. Before participating in the study, subjects will be
      informed of all the procedures and potential risks, and they will sign an informed consent
      form approved by The University of Michigan Institutional Review Board. Eligible volunteers
      will participate in three separate trials, in a randomized order. In two trials subjects will
      eat exactly the same amount of calories, except in one trial they will exercise (eucaloric +
      exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial
      subjects will again remain sedentary but instead they will ingest appropriate calories to
      maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also
      able to investigate the effect of acute caloric perturbations on insulin sensitivity, because
      it is possible that the enhanced insulin sensitivity evident after exercise, as compared to
      the sedentary state, is due to caloric deficit and not the exercise bout, per se.
    


Intervention name(s): Exercise - caloric balance; No Exercise - hyper-caloric diet; No exercise - caloric balance
Intervention type(s): Other; Other; Other
Intervention description(s): 90 min exercise on Day 1 with meals afterward resulting in caloric balance for the day (i.e.; extra kcals provided to account for energy expended during exercise)]; Subjects remain sedentary on Day 1 and they ingest meals that are identical to those ingested on the day they performed exercise (i.e.; more calories ingested than expended because no exercise performed).; Subjects remain sedentary on Day 1 and they ingest a similar proportion of macronutrients however, the total calories ingested will be lower than the other two trials, resulting in caloric balance for the day.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise; fatty acid metabolism; insulin sensitivity
Perception and Knowledge About Menopause Among Pakistani Woman
Condition: Menopause
Study type: Observational

Summary: 
      This study is conducted to find out perception and knowledge about Menopause among Pakistani
      Woman.
    

Detailed description: 
      The survey for was conducted in various location and clinics all over Pakistan. 1200 numbers
      of questionnaires were distributed of which 910 numbers responded from 1st January 2018 to
      28th February 2018. Those who agreed to be part of study where ask a self-structured
      questionnaire related to awareness and symptoms of menopause. Data was analyzed using SPSS
      Version 23.0. Frequencies were calculated for categorical data.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Females aged 35 to 55 were enrolled after taking their oral informed consent. The survey
        for was conducted in various location and clinics all over Pakistan. 1200 numbers of
        questionnaires were distributed of which 910 numbers responded from 1st January 2018 to
        28th February 2018. Those who agreed to be part of study where ask a self-structured
        questionnaire related to awareness and symptoms of menopause.
Aripiprazole Once-monthly in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To obtain information on the safety, tolerability and effectiveness of aripiprazole
      once-monthly in a manner consistent with its intended use in everyday clinical practice in
      patients with schizophrenia who completed Study 14724A / NCT01795547.
    


Intervention name(s): Aripiprazole once-monthly
Intervention type(s): Drug
Intervention description(s): 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Other intervention name(s): Abilify Maintena®
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients
Condition: Atrial Fibrillation; Obesity; Sleep Apnea
MeSH terms: Atrial Fibrillation; Obesity
Study type: Interventional

Summary: 
      Study hypothesis:

      Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an
      obesity treatment after atrial fibrillation ablation.

      Study design:

      A prospective randomized, open-label clinical trial.
    

Detailed description: 
      Study protocol:

      The purpose of this study is to proof a professional care of overweight patients with
      symptomatic atrial fibrillation, as well as the treatment of the risk factors for atrial
      fibrillation, especially obstructive sleep apnea and hypertension.

      There is a 1:1 randomization. In the intervention group, patients are followed up in a
      6-month intensive care after atrial fibrillation ablation. During the follow up time patients
      will visit the nutritional advice every two weeks for 6 months.

      The Follow-up in the control group is standard of care. At baseline, a screening test for
      obstructive sleep apnea and arterial hypertension will be performed as standard care.

      The documentation of atrial fibrillation after ablation is made possible by the implantation
      of an event recorder before atrial fibrillation ablation.

      Follow up:

      A follow-up will be performed after 3,6 and 12 months in both groups. Patients in the
      intervention group will be followed-up every 2 weeks in the first 6 months.
    

Intervention name(s): Intervention group; control group
Intervention type(s): Procedure; Procedure
Intervention description(s): Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.; Followed for a period of 3,6 and 12 months after the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMI >40
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.
Condition: Influenza, Human; Acute Respiratory Infection; Viral Infection; Common Cold
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Virus Diseases; Common Cold
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective
      and safe in the treatment of influenza and other acute respiratory viral infections in 13-17
      years old patients.
    


Intervention name(s): Ingavirin; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.; Placebo, capsules daily for 5 days.
Other intervention name(s): Imidazolyl ethanamide pentandioic acid
Intervention MeSH terms: Pentanedioic acid imidazolyl ethanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Trough and Peak Effect of Once Daily Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg (Micardis Plus) by Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80
      mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential
      hypertension.
    

Detailed description: 
      This study is designed as an open label study. After a 2-week placebo run-in phase, qualified
      patients will be administered with telmisartan 80mg for 2 weeks, then forcefully titrated to
      telmisartan 80 mg and hydrochlorothiazide 12.5 mg fixed dose combination for 6 weeks. 24 hour
      ABPM will be performed at the end of placebo run-in period (baseline) and after 8 weeks of
      active treatment.

      Study Hypothesis:

      The primary analyses will be the calculation of trough to peak ratios (T/P ratios) for DBP
      and SBP. The T/P ratio will be calculated on the basis of changes in hourly means (related to
      dosing time) from baseline (DeltaHM). Trough is defined as the mean of the last three hours
      of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to
      8 after dosing. Thus, T/P is calculated as T/P = mean(DeltaHM22 - DeltaHM24)/min (DeltaHM2 -
      DeltaHM8).

      Comparison(s):

      To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to
      moderate essential hypertension.
    

Intervention name(s): Telmisartan; Telmisartan/HCTZ
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral
      Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or
      without additional asthma controller medications.
    

Detailed description: 
      This is an open-label, multicenter study designed to evaluate efficacy and safety of reducing
      daily oral corticosteroid (OCS) use after initiation of 30 mg dose of benralizumab
      administered subcutaneously (SC) in patients with severe eosinophilic asthma receiving
      high-dose inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) and OCS with or without
      additional asthma controller(s).
    

Intervention name(s): Benralizumab
Intervention type(s): Biological
Intervention description(s): Benralizumab subcutaneous injection
Intervention MeSH terms: Benralizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Severe Asthma; Oral Corticosteroids
Bioavailability Study Of PF-06651600 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will
      test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral
      solution formulation under fasting conditions and the effect of a high fat meal on the
      bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and
      tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed
      under fasting and fed conditions.
    


Intervention name(s): PF-06651600
Intervention type(s): Drug
Intervention description(s): PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inflammatory Bowel Disease
Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use
Condition: Alcohol Drinking; Marijuana
MeSH terms: Marijuana Abuse; Alcohol Drinking; Marijuana Use
Study type: Interventional

Summary: 
      This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use
      that adds a 4-week course of tailored text messaging to a brief motivational intervention for
      13-18-year-old adolescents.
    


Intervention name(s): Text Messaging and Brief Negotiation Interview
Intervention type(s): Behavioral
Intervention description(s): An in-person brief motivational intervention coupled with 4 weeks of motivational text messages
Intervention model: Single Group Assignment
Intervention model description: A brief motivational interview and four weeks of text messaging.
Masking: None (Open Label)
Primary purpose: Prevention
A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to observe the safety and concentrations of PF-05297909 and proteins
      in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
    


Intervention name(s): PF-05297909 25 mg; PF-05297909 100 mg; PF-05297909 250 mg; PF-05297909 525 mg; PF-05297909 525 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral (PO) dose, PF-05297909 25 mg; Single oral (PO) dose, PF-05297909 100 mg; Single oral (PO) dose, PF-05297909 250 mg; Single oral (PO) dose, PF-05297909 525 mg; Single oral (PO) dose, 525 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: healthy volunteer; safety; pharmacokinetic; pharmacodynamic
Dexmedetomidine as Adjuvant for FNB in TKA
Condition: Nerve Block; Dexmedetomidine
Study type: Interventional

Summary: 
      The aim of the study was to find out whether addition of dexmedetomidine to lower
      concentration of ropivacaine preoperatively in femoral nerve block (FNB) would intensify
      analgesia and preserve quadriceps muscle strength after TKA.
    

Detailed description: 
      We designed this study to evaluate whether dexmedetomidine added to lower concentration of
      ropivacaine for FNB can intensify analgesic effect and meanwhile reduce the possibility of
      lower limb (or quadriceps) weakness. Three groups were compared: 0.2% ropivacaine (H group),
      0.1% ropivacaine (L group) and ropivacaine 0.1% added with 2 μg/kg dexmedetomidine (LD
      group).
    

Intervention name(s): Dexmedetomidine; ultrasound-guided femoral nerve block; intravenous patient-controlled analgesia pump with morphine; Continuous femoral nerve block
Intervention type(s): Drug; Procedure; Device; Procedure
Intervention description(s): Dexmedetomidine added to lower concentration of ropivacaine for postoperative analgesia in FNB; ultrasound-guided femoral nerve block, a single bolous of 20 ml ropivacaine (concentration 0.2% for H group or 0.1% for L group) before surgery followed by continuous femoral nerve block using an infusion rate of ropivacaine 0.2% 5 ml/h for postoperative analgesia started right after surgery; All subjects received intravenous patient-controlled analgesia (IV-PCA) pumps to measure additional morphine consumption, which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.; All the continuous femoral nerve block infusion regimes in the pump were connected to CFNB catheter, which contained only ropivacaine with different concentrations (ropivacaine 0.1% for L group and LD group; ropivacaine 0.2% for H group, 5 ml/h).
Other intervention name(s): FNB; IV-PCA pump; CFNB
Intervention MeSH terms: Dexmedetomidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: femoral nerve blockade; dexmedetomidine; ropivacaine; anesthesia