louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00973375: Angiographic and Intravascular Ultrasound (IVUS) Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Eluting Stent
Keywords: Drug-eluting stent
coronary restenosis
coronary thrombosis
Lead sponsor: Liuhuaqiao Hospital
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.

Brief summary: The purpose of this study is to investigate if there is any different follow-up results by angiography and IVUS between two different drug-eluting stents after implanted simultaneously in same individuals.


Eligibility criteria: Inclusion Criteria:

* These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.

Exclusion Criteria:

* Dual anti-platelet therapy less than 12 months.

Primary outcomes:
measure: Segment and instent restenosis measured by coronary angiography and IVUS.
timeFrame: at 12 months after implantation
Secondary outcomes:
measure: Uncovered and malposition of stent.
timeFrame: at 12 months after implantation.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Liuhuaqiao Hospital
state: Guangdong
Study officials:
References:
citation: Waseda K, Miyazawa A, Ako J, Hasegawa T, Tsujino I, Sakurai R, Yock PG, Honda Y, Kandzari DE, Leon MB, Fitzgerald PJ; ENDEAVOR IV Trial Investigators. Intravascular ultrasound results from the ENDEAVOR IV trial: randomized comparison between zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease. JACC Cardiovasc Interv. 2009 Aug;2(8):779-84. doi: 10.1016/j.jcin.2009.05.015.
citation: Lee CH, Zhang J, Kailasam A, Tai BC, Ye F, Low AF, Hou X, Hay ET, Teo SG, Lim YT, Chen S, Tan HC. An intravascular ultrasound study of Cypher, Taxus, and endeavor stents on relation between neointimal proliferation and residual plaque burden. J Interv Cardiol. 2008 Dec;21(6):519-27. doi: 10.1111/j.1540-8183.2008.00397.x. Epub 2008 Oct 21.
citation: Miyazawa A, Ako J, Hongo Y, Hur SH, Tsujino I, Courtney BK, Hassan AH, Kandzari DE, Honda Y, Fitzgerald PJ; ENDEAVOR III Investigators. Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: intravascular ultrasound results from ENDEAVOR III. Am Heart J. 2008 Jan;155(1):108-13. doi: 10.1016/j.ahj.2007.08.008. Epub 2007 Sep 14.
Clinical trial NCT03302975: Running Retraining to Minimize Braking Forces
Official title: The Effect of a Gait Modification Training Program on Impact Loading and Running-related Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Injuries
Keywords: Running
Biomechanics
Kinetics
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Fortius Sport & Health
First posted: 2017-10-05
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The proposed research study aims to investigate whether a gait modification training program to decrease peak braking forces during the stance phase of running will result in a reduction in impact loading and the incidence of running-related injuries among recreational distance runners.


Eligibility criteria: Inclusion Criteria:

* Ability to commit to a 15-week half-marathon training program
* Have been running for at least 3 months prior to study commencement
* Have participated in 2 or less half-marathons previously
* Ability to run on a treadmill unaided
* Ability to travel to testing facility for running analysis pre- and post-training program as well as for gait retraining sessions
* Ability to understand written and spoken English
* Meet the screening requirements (display less than -0.27BW mean peak braking force at baseline/screening assessment)

Exclusion Criteria:

* Any lower extremity pathology in the previous 3 months or currently have pain in their lower back or lower extremities while running
* Have undergone hip, knee, or ankle joint surgery

Primary outcomes:
measure: Peak Braking Force
timeFrame: 15 weeks
Secondary outcomes:
measure: Average Vertical Loading Rate
timeFrame: 15 weeks
measure: Step Length
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Fortius Sport & Health
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michael A Hunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Napier C, MacLean CL, Maurer J, Taunton JE, Hunt MA. Real-Time Biofeedback of Performance to Reduce Braking Forces Associated With Running-Related Injury: An Exploratory Study. J Orthop Sports Phys Ther. 2019 Mar;49(3):136-144. doi: 10.2519/jospt.2019.8587. Epub 2018 Dec 7.
Clinical trial NCT04214275: Pulmonary Rehabilitation and Quality of Life
Official title: The Effect of Pulmonary Rehabilitation on Respiratory Functions and Quality of Life Following Coronial Artery Bypass Grafting: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft
Keywords: coronary artery bypass
pulmonary rehabilitation
quality of life
respiratory functions
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the effect of a pulmonary rehabilitation (PR) program on the respiratory function and quality of life of patients undergoing CABG surgery with an open-heart technique is examined. A randomized controlled experimental design was used. The study was conducted with two groups: the intervention group (n=25) and control group (n=25). The control group received standard care after CABG. In contrast, the experimental group, in addition to standard care, participated in a PR program created by the researchers. After CABG, the respiratory functions of both groups (clinical care day 4) and quality of life (6th week) evaluated


Eligibility criteria: Inclusion Criteria:

* Patients who were extubated in twenty-four hours,
* aged 18 or above,
* had undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
* who were conscious,
* without visual and hearing problems,
* who spoke Turkish,
* had not orthopedic, psychiatric and neurological problems,
* no co-morbid lung disease,
* who had not been re-operated on,
* had not postoperative cardiac dysfunction,
* had not developed postoperative atrial fibrillation,
* who were willing to participate in the study.

Exclusion Criteria:

* Patients who were not extubated in twenty-four hours,
* who were under 18 years of age,
* had not undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
* who were not conscious,
* were visual and hearing problems,
* who don't spoke Turkish,
* had orthopedic, psychiatric and neurological problems,
* co-morbid lung disease,
* who had been re-operated on,
* had postoperative cardiac dysfunction,
* had developed postoperative atrial fibrillation,
* who were not willing to participate in the study.

Primary outcomes:
measure: The Pulmonary Function Test (PFT)
timeFrame: Preoperative day
measure: The Pulmonary Function Test (PFT) Change
timeFrame: 4th day of clinical care
Secondary outcomes:
measure: The Short-Form Health Survey (SF-36)
timeFrame: preoperative day
measure: The Short-Form Health Survey (SF-36) Change
timeFrame: postoperative sixth week
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Science University
state: Centre
Study officials:
affiliation: +90 272 444 0304
name: Yeliz Ciğerci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02252575: Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices
Official title: Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromagnetic Interference
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates such potential interferences in vivo.

Detailed description: E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates different types of electric motors with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

Eligibility criteria: Inclusion Criteria:

* implanted cardiac implantable electronic device with regular function

Exclusion Criteria:

* implanted cardiac implantable electronic device with irregular function

Primary outcomes:
measure: Occurrence of electromagnetic interference
timeFrame: acute setting
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum München
name: Christof Kolb, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05882175: Prospective Validation of the OHI Index
Official title: A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HLH
Hemophagocytic Lymphohistiocytoses
Hemophagocytic Syndrome
Hematologic Malignancy
Hematologic Neoplasms
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: Rabin Medical Center
name: Sheba Medical Center
name: Schneider Children's Medical Center, Israel
First posted: 2023-05-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and females with new diagnosis/transformation/reactivation of hematologic malignancies

Brief summary: Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) \> 3,900 U/mL and ferritin \>1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.

Detailed description: The investigators will enroll patients with new/transformed hematologic malignancies. The investigators will follow the patients until the end of the study, report their survival at one year and examine their prognosis.

Eligibility criteria: Inclusion Criteria:

* Patients with hematologic malignancies
* At least 18 years old

Exclusion Criteria:

* Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)

Primary outcomes:
measure: To assess 365 days mortality of OHI+ and OHI- patients
timeFrame: Mortality rate one year from OHI assessment
Secondary outcomes:
measure: To determine the incidence of OHI+ patients in our cohort
timeFrame: The investigators will assess the incidence after three years of enrollment
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Meir Medical Center
name: Adi Zoref-Lorenz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zoref-Lorenz A, Murakami J, Hofstetter L, Iyer S, Alotaibi AS, Mohamed SF, Miller PG, Guber E, Weinstein S, Yacobovich J, Nikiforow S, Ebert BL, Lane A, Pasvolsky O, Raanani P, Nagler A, Berliner N, Daver N, Ellis M, Jordan MB. An improved index for diagnosis and mortality prediction in malignancy-associated hemophagocytic lymphohistiocytosis. Blood. 2022 Feb 17;139(7):1098-1110. doi: 10.1182/blood.2021012764.
Clinical trial NCT04380675: Music During ESWL for Entire Treatment
Official title: Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (ESWL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Keywords: Urolithiasis
Kidney Calculi
Lithotripsy
Pain Management
Music
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 150
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: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).

Detailed description: Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the ESWL treatment, patients in group B do not.

At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing ESWL and interested in music listening

Exclusion Criteria:

* Contraindication to ESWL
* No interest in music listening
* Age \< 18 and \> 80

Primary outcomes:
measure: change in VAS score
timeFrame: 10 mins after SWL treatment completed
Secondary outcomes:
measure: change in Soundwave voltage (kV)
timeFrame: 10 mins after SWL treatment completed
measure: change in analgesic request
timeFrame: 10 mins after SWL treatment completed
measure: change in requested interruptions
timeFrame: 10 mins after SWL treatment completed
measure: change in Soundwave number
timeFrame: 10 mins after SWL treatment completed
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
affiliation: AOU Città della Salute e della Scienza, Torino
name: Andrea Bosio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05234775: Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product
Official title: Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product in Subjects With or Without Statin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: LIB Therapeutics LLC
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2022-02-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: assignment to initial treatment group with cross over to alternate treatment group
Primary purpose: TREATMENT

Brief summary: To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy

Detailed description: Comparison of the pharmacokinetics (PK), and pharmacodynamics (free PCSK9 and LDL-C) of single subcutaneous (SC) doses of 300 mg of both LIB003 drug product manufactured by Process 1 (P1) and Process 2 (P2) in subjects with or without statin therapy

Eligibility criteria: Inclusion Criteria:

* Provision of written and signed informed consent prior to any study-specific procedure
* LDL-C 70 mg/dL or above on stable diet alone or diet plus statin
* Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2
* Females of childbearing potential must be using a highly effective form of birth control
* Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control

Exclusion Criteria:

* Fasting triglyceride \>400 mg/dL
* excluded lipid lowering medication
* severe renal impairment (eGFR \<30 ml/min)
* fasting glucose \>200 mg/dL plus HbA1c \>9%
* hepatic transaminases \>2.5 x ULN for laboratory
* History of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the Investigator,
* NYHA class III-IV heart failure or last documented left ventricular EF \<30%
* Any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the Investigator that continued participation is not in the best interest of the subject

Primary outcomes:
measure: pharmacodynamics
timeFrame: 4 weeks
measure: Cmax pharmacokinetics
timeFrame: 4 weeks
measure: AUC 0-last pharmacokinetics
timeFrame: 4 weeks
measure: T-Half pharmacokinetics
timeFrame: 4 weeks
Secondary outcomes:
measure: comparison of LDL-C
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Metabolic & Atherosclerosis Research Center (MARC)
state: Ohio
Study officials:
affiliation: Metabolic & Atherosclerosis Research Center
name: Traci A Turner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00639275: Deep Brain Stimulation and Digestive Symptomatology
Official title: Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease patients with subthalamic nucleus deep brain stimulation

Brief summary: Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal disorders. During the disease, weight loss is often noticed. Recently, many studies have demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain weight after STN-DBS, at least in part due to a decrease in resting energy expenditure.

Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility.

Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index, dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin concentrations, hormones involved in the homeostatic regulation of appetite.

Perspectives: This physiopathological study should allow us to understand the mechanisms of the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD patients.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* Electrode implantation for deep brain stimulation in progress
* Age \<70 yr
* Motor fluctuations and dyskinesias
* Motor symptoms improvement with L-dopa \> 50%
* No dementia
* No depression
* No major psychiatric symptom
* Normal brain MRI

Exclusion Criteria:

* Contra-indication of neurosurgery
* Pregnancy
* Diabetes
* Obesity
* Compulsive eating disorders
* Organic digestive disease
* Gastrointestinal resection
* Prokinetic treatment
* Coagulopathy

Primary outcomes:
measure: the gastric emptying measurement with the 13C-octanoic acid breath test
timeFrame: M0 and M6
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT00738075: Automatic Recognition of Freezing of Gait Episodes
Official title: Online Automatic Recognition of Freezing of Gait Episodes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease prone to freezing of gait

Brief summary: The investigators hypothesize that mathematical algorithm can identify freezing episodes based on data obtained from accelerometer.

Detailed description: The subjects will walk with an accelerometer. The acceleration traces will be online analyzed, and if freezing episode is recognized, an auditory cue will be heard.

Eligibility criteria: Inclusion Criteria:

* Patients with Parkinsons disease prone to freezing of gait

Exclusion Criteria:

* Patients who are not able to ambulate independently

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Meir Plotnik, PhD
role: STUDY_DIRECTOR
References:
citation: Moore ST, MacDougall HG, Ondo WG. Ambulatory monitoring of freezing of gait in Parkinson's disease. J Neurosci Methods. 2008 Jan 30;167(2):340-8. doi: 10.1016/j.jneumeth.2007.08.023. Epub 2007 Sep 2.