louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01840371: Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP
Sedation
Fentanyl
Propofol
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.


Eligibility criteria: Inclusion Criteria:

* The patients who scheduled for ERCP

Exclusion Criteria:

* The patients with ASA physical classification V
* The patients with history of sulfite, egg or soy bean allergy
* The patients during pregnancy or latency period
* The patients who informed consent could not be obtained
* The patients who were under 20 years old

Primary outcomes:
measure: Recovery time
timeFrame: time from scope withdrawal to full recovery at averange 24 hours
Secondary outcomes:
measure: Adverse event during and after procedure
timeFrame: measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
Study officials:
References:
citation: Lee TH, Lee CK, Park SH, Lee SH, Chung IK, Choi HJ, Cha SW, Moon JH, Cho YD, Hwangbo Y, Kim SJ. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci. 2012 Aug;57(8):2113-21. doi: 10.1007/s10620-012-2234-0. Epub 2012 May 22.
citation: Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Kongkam P, Poonyathawon S, Ponauthai Y, Sumdin S, Kullavanijaya P. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study. BMC Anesthesiol. 2012 Aug 9;12:20. doi: 10.1186/1471-2253-12-20.
Clinical trial NCT00695071: Study to Assess Blood Levels of Itraconazole During a Two-Week Period
Official title: Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-06-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.


Eligibility criteria: Inclusion Criteria:

* BMI between 18.0 and 28.0 kg/m2
* Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
* Vital signs (blood pressure and heart rate) in supine position within the normal range
* Electrocardiogram (12 lead) considered as normal
* Non-smoker.
* Able to swallow pills
* If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol

Exclusion Criteria:

* Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug
* History or presence of drug abuse or consumption of alcohol
* History of sensitivity or allergy to azoles or related drugs
* Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
* Unsuitable veins for repeated venipuncture.
* Clinically significant abnormal ECG
* Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.

Primary outcomes:
measure: Steady State Plasma levels of Itraconazole
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Advanced Biomedical Research
state: New Jersey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00336271: The Effects of Coffee
Official title: The Effects of Coffee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Keywords: coffee
caffeine
healthy subjects
Lead sponsor: American University
Sponsor class: OTHER
First posted: 2006-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: In this study, participants will be eligible to participate in a paid research study that will examine the effects of regular coffee drinking. The study takes approximately 2 hours total, 55 min. on 2 separate days. Participants will be asked to do computer tasks and drink only coffee provided to them during the study.

Detailed description: The purpose of the experiment is to evaluate how coffee affects different individuals while completing computer tasks. If an individual agrees to participate, particpants will be asked to come to the laboratory to drink coffee on 2 days. During each visit, participants will be asked to drink coffee, complete forms, and perform computer tasks. To be eligible to participate, participants must be medically healthy.

Eligibility criteria: Inclusion Criteria:

* Participants must be regular coffee drinkers.

For more information or to set up an appointment, please send a contact number (and a convenient time to call) via e-mail and a BPHP laboratory member will contact you or call the BPHP laboratory at the number listed below.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Room 137 Asbury Building-American University
state: District of Columbia
Study officials:
affiliation: American University
name: Sarah Moore, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: American University
name: Laura Juliano, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00442871: Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
Official title: An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50 mg Eltrombopag in Healthy Subjects and in Subjects With Mild, Moderate, or Severe Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: Renal Impairment,
chronic immune thrombocytopenia purpura,
thrombocytopenia,
chemotherapy induced thrombocytopenia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.


Eligibility criteria: Inclusion Criteria:

* Healthy or have renal impairment
* Females (the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy
* Negative drug, alcohol, and HIV tests.

Exclusion Criteria:

* Taking a medication or therapy not approved by the study doctor
* Rapidly changing kidney function
* Drug or alcohol abuse within past 6 months
* Used an investigational drug in the past 30 days
* Females who are pregnant or nursing
* Have active hepatitis B or C

Primary outcomes:
measure: Plasma levels and protein binding of eltrombopag
timeFrame: at Day 1 to Day 6.
Secondary outcomes:
measure: Safety will be assessed by: -eye exam
timeFrame: at Screening, Day -1, & followup
measure: adverse assessment
timeFrame: Day 1 to followup
measure: clinical labs, vital signs, & 12-lead electrocardiograms done
timeFrame: all days but Day 4
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Paul
country: United States
facility: GSK Investigational Site
state: Minnesota
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bauman JW, Vincent CT, Peng B, Wire MB, Williams DD, Park JW. Effect of hepatic or renal impairment on eltrombopag pharmacokinetics. J Clin Pharmacol. 2011 May;51(5):739-50. doi: 10.1177/0091270010372106. Epub 2010 Jul 27.
Clinical trial NCT05546671: Impact of Hand Grip Strength on Length of Hospital Stay After Cardiac Surgery Among Elderly Patients
Official title: Usefulness of Hand Grip Strength as a Predictor of Prolonged Hospital Stay in Elderly Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Frailty
Lead sponsor: Kartal Kosuyolu High Speciality Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-21
Enrollment: 240
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be comprised of all consecutive patients ≥70 years of age undergoing elective coronary artery bypass and/or valve surgery at the Department of Cardiovascular Surgery at Kosuyolu Training and Research Hospital.

Brief summary: Hand grip strength has been shown to be a predictor of adverse cardiovascular outcomes in the elderly population. This study aims to investigate whether measurement of hand grip strength could be used as a predictor of prolonged hospital stay after cardiac surgery in elderly patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥70 years
* Undergoing isolated coronary artery bypass grafting or isolated valve surgery or combined coronary and valve procedures
* Being oriented and cooperative enough to understand and comply with the instruction of gripping the hand dynamometer

Exclusion Criteria:

* Age \<70 years
* Emergent status
* Hemodynamic instability
* Inability to cooperate due to neurocognitive disorder
* Loss of upper extremity motor function of any degree (such as due to previous stroke)
* History of upper extremity amputation of any level

Primary outcomes:
measure: Prolonged hospital stay
timeFrame: 14 days
Secondary outcomes:
measure: Prolonged intensive care unit stay
timeFrame: 48 hours
measure: Prolonged mechanical ventilation
timeFrame: 12 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kosuyolu High Specialization Education and Research Hospital
Study officials:
References:
citation: Perry IS, Pinto LC, da Silva TK, Vieira SRR, Souza GC. Handgrip Strength in Preoperative Elective Cardiac Surgery Patients and Association With Body Composition and Surgical Risk. Nutr Clin Pract. 2019 Oct;34(5):760-766. doi: 10.1002/ncp.10267. Epub 2019 Mar 13.
citation: Fu L, Zhang Y, Shao B, Liu X, Yuan B, Wang Z, Chen T, Liu Z, Liu X, Guo Q. Perioperative poor grip strength recovery is associated with 30-day complication rate after cardiac surgery discharge in middle-aged and older adults - a prospective observational study. BMC Cardiovasc Disord. 2019 Nov 27;19(1):266. doi: 10.1186/s12872-019-1241-x.
citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
Clinical trial NCT02984371: Epicardial Fat Pads Ablation During Coronary Surgery
Official title: Ablation of the Epicardial Fat Pads to Treat Paroxysmal Atrial Fibrillation During Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Fibrillation
Ischemic Heart Disease
Keywords: atrial fibrillation
ganglionated plexi
ischemic heart disease
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-12-06
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized study was to assess the efficacy of ablation of the ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.


Eligibility criteria: Inclusion Criteria:

* History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years, with 2 documented episodes over the last 6 months)
* Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Exclusion Criteria:

Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned maze procedure or pulmonary vein isolation Unwillingness to participate

Primary outcomes:
measure: Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
timeFrame: 12 month
Secondary outcomes:
measure: atrial fibrillation burden
timeFrame: 12 month
measure: incidence of congestive heart failure
timeFrame: 12 month
measure: incidence of sustained ventricular arrhythmias
timeFrame: 12 month
measure: rehospitalization
timeFrame: 12 month
measure: stroke or transient ischemic attack
timeFrame: 12 month
measure: number of Deaths
timeFrame: 12 month
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute
Study officials:
References:
Clinical trial NCT01762371: Khalifa Acute Effects
Official title: Interdisciplinary Evaluation of Acute Effects From Khalifa's Therapy at Patients With Fully Ruptured Anterior Cruciate Ligament (ACL).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Totally Ruptured Anterior Cruciate Ligament in the Knee
Keywords: ACL
Knee
Ligament
Cruciate
Anterior
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary hypothesis is that Khalifa's therapy has different acute effects in various organ systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects might indicate the pathway of the therapy.

Detailed description: According to our previous study that evaluated the efficacy of Khalifa's therapy the investigators have seen that the therapy has acute effects which resulted in better knee function and later even in better healing of the ACL injury. This study should clear exactly which effects and pathways are involved in the therapy from multiple (interdisciplinary) point of views. Therefore the investigators will measure parameters that might be associated with this special technique directly before and after the therapy.

Eligibility criteria: Inclusion Criteria:

* totally ruptured ACL - MRI verified, 2 weeks old as a maximum
* knee function: Any functional inhibition (stretching, bending or load)
* BMI: 18-25
* athletically active

Exclusion Criteria:

* any surgical procedures at the injured knee at any previous time
* any acute surgical indication
* diabetes mellitus and/or high blood pressure
* any permanent drug treatment

Primary outcomes:
measure: Laser Doppler-Flow
timeFrame: 1 hour
measure: NIRS
timeFrame: 1 hour
measure: IR Thermography
timeFrame: 1 hour
measure: QST
timeFrame: 1 hour
measure: HRV
timeFrame: 1 hour
measure: EEG
timeFrame: 1 hour
measure: Knee function
timeFrame: 1 hour
measure: SportsScience
timeFrame: 2 hours
measure: Blood
timeFrame: 1 hour
Secondary outcomes:
measure: Questionnaire
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hallein
country: Austria
facility: Sports Center of University Salzburg
state: Salzburg
Study officials:
affiliation: AKH Linz
name: Andreas Kastner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Med Uni Graz
name: Andreas Sandner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05819671: Prevalence of Upper Limb Musculoskeletal Abnormalities in Type 2 Diabetic Patients and Its Relation to Hypoglycemic Control.
Official title: Prevalence of Upper Limb Musculoskeletal Abnormalities in Type 2 Diabetic Patients and Its Relation to Glycemic Control.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Limb Musculoskeletal Abnormalities
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2023-04-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetics type 2 - comparable control

Brief summary: to investigate prevalence of upper limb musculoskeletal disorders and correlations to glycemic control.

Detailed description: ). DM is associated with a number of complications including renal disease, peripheral neuropathy, retinopathy, vascular events and musculoskeletal complications. DM is complicated by musculoskeletal problems of upper extremity and particularly the hand, collectively referred as "the diabetic hand." (3) The most common upper limb musculoskeletal disorders associated with DM are adhesive capsulitis, rotator's cuff tendinitis, limited joint mobility (LJM), Dupuytren's disease (DD), trigger finger (TF), and carpal tunnel syndrome (CTS). Upper limb musculoskeletal disorders affect hand functions and activities of daily living (ADL). Aim of the study: to investigate prevalence of upper limb musculoskeletal disorders and correlations to glycemic control.

Inclusion criteria: patients will be included to this study(cases) if they are:

1) Diabetic patients. 2) Age \> 18 years. 3) Diagnosed as type 2.

Exclusion criteria:

Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.

Sample size calculation: By reviewing literature, it is found that the most relevant study (3) to our work found that the prevalence of upper limb musculoskeletal abnormalities in type 2 diabetic patients is .22 and for control group is .05 so, by using piface calculator (version 1.76) to calculate sample size (power = 0.8, alpha error = 0.05 and beta= 0.2) it is found that we need 71 participants for every group. To increase power of the study will enroll 100 participants for every group.

Eligibility criteria: Inclusion Criteria:

* patients will be included to this study(cases) if they are: 1) Diabetic patients. 2) Age \> 18 years. 3) Diagnosed as type 2.

Exclusion Criteria:

- Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.

Primary outcomes:
measure: prevalence of upper limb musculoskeletal disorders and correlations to glycemic control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Al ahrar teaching hospital
state: Sharkia
Study officials:
affiliation: GOTHI
name: Eslam Dr Shohda, hd,pt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04337671: Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension
Official title: Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Artery Hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigated the effect of 12 weeks of aerobic training on sleep quality and aerobic fitness in patients with Pulmonary arterial hypertension(PAH).

Detailed description: Thirty male PAH patients were included in the study. They were randomized into two equal groups; Training group (A) and Control group(B). Right ventricular systolic pressure (RVSP) measured using Doppler Echocardiography , Pittsburg sleep quality index (PSQI) questionnaire with the wrist worn actigraph used for the assessment of sleep disturbance, and Cardiopulmonary exercise testing (CPET) measurements included maximal heart rate and VO2max .All were measured before and after the study period for both groups.The training was a moderate intensity aerobic training on a bicycle ergometer (corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).

Eligibility criteria: Inclusion Criteria:

* Patients who were clinically stable and compensated under optimized medical therapy
* World health organization (WHO) Classification of functional class II to III PAH
* Patients with ejection fraction ≥ 40%
* Non-smokers
* body mass index ≤ 35 kg/m2

Exclusion Criteria:

* Any patient with respiratory failure
* unstable angina
* renal, hepatic or neuromuscular disorders
* history of syncopal attacks
* uncontrolled systemic hypertension
* peripheral vascular disease
* serious cardiac dysrhythmias on resting ECG
* evidence of severe COPD at pulmonary function testing,
* any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise

Primary outcomes:
measure: Pulmonary artery systolic pressure (PASP)
timeFrame: change from baseline at 12 weeks
measure: Subjective self-report questionnaire that assesses sleep quality
timeFrame: change from baseline at 12 weeks
measure: Determining sleep patterns
timeFrame: change from baseline at 12 weeks
measure: Measuring aerobic fitness
timeFrame: change from baseline at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
citation: Atef H, Abdeen H. Effect of exercise on sleep and cardiopulmonary parameters in patients with pulmonary artery hypertension. Sleep Breath. 2021 Dec;25(4):1953-1960. doi: 10.1007/s11325-020-02286-9. Epub 2021 Feb 18.