bioihbjkbjnl/mcl2 huggingface dataset:
6-month Follow up After Sevoflurane Postconditioning
Condition: Heart Surgical Procedures
Study type: Observational

Summary: 
      Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac
      surgery with pharmacological postconditioning (sedation on intensive care unit with
      sevoflurane)
    

Detailed description: 
      Introduction: In a recent randomized controlled (RCT; NCT00924222) trial the investigators
      demonstrated in 102 patients that late post-conditioning with sevoflurane performed in the
      intensive care unit (ICU) reduced myocardial injury. These patients presented with lower
      troponin T values on the first post-operative day compared with patients undergoing propofol
      sedation. In order to assess possible clinical relevant long-term implications in patients
      enrolled in this study, the current retrospective analysis is performed focusing on cardiac
      and non-cardiac events during the first six months after surgery.

      Methods: All patients who had successfully completed the late post-conditioning trial were
      included in this follow-up. Primary and secondary endpoints were the proportion of patients
      experiencing cardiac and non-cardiac events, respectively. Additionally, therapeutic
      interventions such as initiation or change of drug therapy, interventional treatment or
      surgery were assessed.
    

Intervention name(s): no intervention; retrospective study
Intervention type(s): Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who had successfully completed the late postconditioning trial (NCT00924222)
        were included in this retrospective follow-up analysis.
      
Keywords: postconditioning; six month follow up; cardiac event; non-cardiac event
Physical Therapy for Liver Cirrhosis
Condition: Liver Cirrhosis, Biliary
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional

Summary: 
      Patients with liver cirrhosis have severe physical deconditioning. Aim: To compare between
      the effect of neuromuscular electric stimulation(NMES) and exercises (EX)on treatment of
      patients with liver cirrhosis.
    

Detailed description: 
      70 patients have been chosen from department of internal medicine, Cairo university
      hospitals, Egypt. 5 patients refused to participate .65 patients divided randomly into 2
      groups. All the procedures were explained to patients.2 patients refused to sign informed
      consent and excluded from the study. 31 patients in group1 and 32 patients in group2.
      1patients dropped in group1 and excluded from the study and two patients didn't continued the
      programmed treatment in group 2 and their data removed.

      Thirty patients in each group signed an informed consent and complete the treatment program.
    

Intervention name(s): neuromuscular electric stimulation; Exercises
Intervention type(s): Other; Other
Intervention description(s): A total of eight electrodes were placed on the quadriceps femoris muscles (four on each leg): two on the vastus medialis, one on the rectus femoris muscle, and one on the vastus lateralis muscle. The stimulation protocol of the NMES consisted of a symmetrical biphasic square pulse at 75 Hz, a duty cycle of 6 seconds (sec.) on and 29 sec. off, a pulse time of 410 sec. during a session lasting 20 min. The intensity was increased to maximum individual toleration. The muscle contractions were visible and palpable.; The chair-seated exercises were used in the early stages of the program because the participants were frail adults. Repetitions of toe raises, heel raises, knee lifts, knee extensions, and others were performed while seated on a chair. Hip flexions, lateral leg raises, and repetitions of other exercises were performed standing upright behind the chair and holding the back of the chair for stability. To strengthen lower extremities, a fixed weight was placed on the ankle while participants performed strengthening exercises. Weights of 0.50, 0.75, 1.00, and 1.50 kg were used in accordance with each participant's strength level as the resistance progressively increased. The exercises performed using these ankle weights included seated knee flexion and extension and standing knee flexion and extensions. Exercises using a resistance band: Resistance bands were used to strengthen lower body. Lower body exercises included leg extension and hip flexion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: liver cirrhosis; exercises; neuromuscular electric stimulation; exercise capacity; quality of life
Lantus Effect on Myocardial Glucose Metabolism in T2
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the present study is to assess changes of myocardial glucose uptake
      (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with
      type 2 diabetes and idiopathic left ventricular dysfunction (LVD).

      The secondary objectives of the study are: assessment of changes of myocardial
      microcirculation at rest and during adenosine stimulation using PET; assessment of changes in
      myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment
      of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels;
      assessment of safety (adverse event profile, laboratory data).
    


Intervention name(s): Insulin glargine
Intervention type(s): Drug
Intervention description(s): once a daily, sc injection, 100IU/ml
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal
      exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold
      and disability in patients with non-specific chronic low back pain. A randomized clinical
      trial will be carried out. A total sample of 40 patients with non-specific chronic low back
      pain will be recruited and divided into 2 groups including an experimental group (n=20) which
      will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20)
      which will not receive any training program. Inspiratory muscle strength, diaphragm
      thickness, pressure pain threshold and disability will be assessed.
    


Intervention name(s): Hypo-pressive abdominal exercise intervention
Intervention type(s): Other
Intervention description(s): An 8-week hypo-pressive abdominal exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Troponin Elevation in Consecutive Patients With Hip Fracture
Condition: Hip Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      The aims of this study is to study the occurrence of the troponin elevations, ECG changes,
      and cardiac symptoms in unselected consecutive patients with hip fracture.

      Followup will be carried out up to one year period.
    


Intervention name(s): observation
Intervention type(s): Other
Intervention description(s): observation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        200 patients with hip fracture
      
Keywords: patients with hip fracture
Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis
Condition: Asthma
MeSH terms: Asthma
Study type: Observational [Patient Registry]

Summary: 
      this study is designed to identify the genetic factors which can be implicated in the
      salbutamol responsiveness for asthmatic children in pediatric emergency department
    

Detailed description: 
      Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a
      treatment by salbutamol according to the usual care could be recruited.Saliva from patient
      were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP
      were chosen:ADBR2 gene), ARG gene, and GSNOR gene.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children 6-16 years old asthmatic patients consulting for an exacerbation in a pediatric
        emergency department
      
Biospecimen description: 
      Saliva from patient were collected using Oragen®.DNA OG-500 kit, (DNA Genotek, Kanata,
      Canada) or swabs (Catch-All™ sample collection swabs from Epicentre Biotechnologies, Madison,
      WI), and stored at room temperature or -20°C, respectively.
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329
Condition: Overweight; Healthy; Male
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of AZD8329 following multiple ascending dose administrations in in
      overweight to obese but otherwise healthy male subjects.
    

Detailed description: 
      A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study
      to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral AZD8329
      after Administration of Multiple Ascending Doses in Abdominally Obese but otherwise Healthy
      Male Subjects
    

Intervention name(s): AZD8329; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AZD8329 Oral Solution 20mg/ml; Placebo AZD8329 Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Safety; tolerability; PK; healthy; overweight; obese
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
Condition: Agitation; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923
      compared to placebo, for the treatment of symptoms of agitation in participants with
      Alzheimer's Disease (AD).
    

Detailed description: 
      Eligible participants for this study must have a diagnosis of probable AD and must have
      clinically meaningful agitation secondary to AD.

      This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study,
      consisting of 10 weeks of treatment.

      Up to 200 participants will be enrolled at approximately 30-40 centers in the US.

      Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening
      must occur within within approximately 4 weeks prior to randomization. Following screening
      procedures for assessment of inclusion and exclusion criteria, eligible participants will be
      randomized into the study.
    

Intervention name(s): AVP-923-20; Placebo; AVP-923-30
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine; Placebo capsule; AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Other intervention name(s): Nuedexta
Intervention MeSH terms: Quinidine; Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AVP-923-20; AVP-923-30; AVP-923; Dextromethorphan; Quinidine; Neuropsychiatric Inventory; Aggression; Efficacy; Safety
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative)
      treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic
      migraine.
    


Intervention name(s): onabotulinumtoxinA; Topiramate
Intervention type(s): Biological; Drug
Intervention description(s): 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.; Topiramate up to a maximum oral dose of 100 mg/day.
Other intervention name(s): BOTOX®; botulinum toxin Type A; Topamax®
Intervention MeSH terms: Topiramate; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of this study are to evaluate the safety and tolerability of multiple ascending
      doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma
      and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally
      to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of
      PF-04634817 on circulating monocytes will be explored.
    


Intervention name(s): PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.; Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.; Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.; Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.; Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.; Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers; pharmacokinetics; safety; tolerability; multiple dosing; Diabetic Nephropathies
A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary
      purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single
      oral doses of PF-06427878 in healthy adult subjects.
    


Intervention name(s): PF-06427878; Placebo; PF-06427878; Placebo; PF-06427878; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Single Ascending Dose; healthy subjects; Hyperlipidemia; Lipid Metabolism Disorders; Metabolic Diseases
Evaluating the Bioequivalence of HIP1403, HGP0919
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence after administration of
      HIP1403 and HGP0919 in healthy male volunteers
    

Detailed description: 
      A randomized, open-label, single dose, crossover clinical trial to investigate and compare
      the pharmacokinetics between HIP1403 and HGP0919 in healthy male volunteers.
    

Intervention name(s): HIP1403; HGP0919
Intervention type(s): Drug; Drug
Intervention description(s): Oseltamivir 75mg; Oseltamivir phosphate 75mg
Other intervention name(s): Oseltamivir 75mg; Tamiflu 75mg
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study of Working Women and Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this research is to better understand the relationship between employment and
      breast cancer. Research is being conducted to understand how workplace factors influence
      breast cancer patients' ability to adhere to recommended cancer treatment and effectively
      recover from cancer. Investigators hope to use the findings from the study to help working
      breast cancer survivors make informed decisions about treatment and employment in
      collaboration with their employers and healthcare providers.
    

Detailed description: 
      Patients enrolled will be interviewed three times over a six month period. They will be asked
      questions about their experiences in managing their cancer while taking care of their job
      responsibilities. Patients will be asked to complete a survey that asks questions about their
      breast cancer treatment, their job, and how they manage their responsibilities while
      undergoing cancer treatment.

      The first initial meeting will be conducted at a time and location that is convenient for the
      patient. This meeting should last about an hour to an hour and a half.

      Three and six months after the initial interview, study participants will be asked to
      complete a follow-up survey by either telephone or Internet/Web, depending on their
      preference. These telephone surveys will last between 15-30 minutes.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women diagnosed with a new, primary breast cancer within 3 months of enrollment and who
        were employed at the time of diagnosis.
      
Keywords: Breast Cancer; Working Women
AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, double-blind, placebo-controlled, randomised within each dose group,
      single ascending dose study, with the objective to assess the safety, tolerability and
      pharmacokinetic profile of AZD8529 in healthy Japanese subjects.
    


Intervention name(s): AZD8529; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I; Japanese healthy volunteer; AZD8529
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding
      pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol
      (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.
    


Intervention name(s): 15 mg E4/3 mg DRSP
Intervention type(s): Drug
Intervention description(s): 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
Other intervention name(s): 15 mg estetrol and 3 mg drospirenone
Intervention MeSH terms: Drospirenone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Estetrol; Drospirenone; Prevention of pregnancy; Oral contraception
Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Due to minimal volitional activation of the impaired arm, these individuals are less able to
      engage in activities of daily living (ADL's). Moreover, simultaneous use of the hand and arm
      are needed throughout ADL's. The effects of these two approaches (circuit class training and
      individual task-specific training) on upper extremity function and activities of daily living
      (ADL's) have not yet been clearly identified, and studies on its effects on chronic stroke
      patients are limited.
    

Detailed description: 
      several research found that circuit training improved various functional parameters after
      stroke. And most of the circuit based tasks from the published studies were focused on the
      leg strength, walking speed, distance and balance etc. Previous literature found that circuit
      class training is effective in improving upper extremity function in chronic stroke patients
      disregarding the type of stroke and the results of that study are not generalized for chronic
      stroke patients with upper extremity deficit. Secondly, circuit class training and
      task-specific training are effective for improving upper limb function following a stroke but
      in the acute stage. In fact, there is no evidence in which comparison of these two approaches
      has been done in chronic stroke patients and thirdly, between these two approaches which
      approach is more effective towards improving upper limb function in chronic stage.
    

Intervention name(s): Circuit Class Training; Individual Task specific training
Intervention type(s): Other; Other
Intervention description(s): Station 1 will include tasks for warm-up specific for upper extremity, station 2 will include shoulder exercises, station 3 will include elbow exercises, station 4 will include wrist exercises and station 5 will include hand activities and functional training. Variables such as speed, or/and resistance will progressively increase in diﬃculty according to each patient's ability.; Variables such as speed, or/and resistance will progressively increase in diﬃculty according to each patient's ability.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spasticity; Motor function