louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04293198: Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
Official title: PROOF: Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrium; Fibrillation
Ablation
Keywords: Atrial Fibrillation
AF
Cryoballoon
Ablation
KODEX-EPD
Lead sponsor: EPD Solutions, A Philips Company
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Arrhythmia patients scheduled to undergo a cryo balloon ablation procedure for their atrium fibrillation. Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study

Brief summary: Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation.

Detailed description: The study is designed to evaluate the performance of the KODEX-EPD occlusion viewer using a standardized workflow in a blinded setting in a homogenous patient group. Furthermore, in an effort to minimize therapy, a direct comparison between the success of the freeze when initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with fluoroscopy will be evaluated. The study design indicates a post-market interventional clinical investigation to evaluate the endpoints of the study. No follow-up is foreseen ensuring a minimal burden to the subjects participating in the study.

Eligibility criteria: Inclusion Criteria:

1. Subject must be aged \>18 years.
2. Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. Subject receives a de novo ablation procedure for treatment of atrial fibrillation.

Exclusion Criteria:

1. Pregnant women.

Primary outcomes:
measure: Effectiveness of the KODEX-EPD Occlsuion Viewer
timeFrame: up to approximately 6 months
measure: Freeze success of the KODEX-EPD Occlusion Viewer
timeFrame: up to approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT03635398: Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
Official title: Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Sedation
Intra-nasal Delevery Device
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: SipNose
First posted: 2018-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration


Eligibility criteria: Inclusion Criteria:

* every child \>1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair

Exclusion Criteria:

* ASA\>2
* Active respiratory infection
* systemic illness
* Allergy to Midazolam

Primary outcomes:
measure: Anexiety level
timeFrame: within 60 minute
measure: Sedation level
timeFrame: within 60 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
References:
Clinical trial NCT01509898: The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease
Official title: The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-implantitis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 40
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: The aim of this study was to evaluate the effect of a dental water jet on initial peri-implant disease resolution.

Detailed description: Peri-implant disease is becoming more frequent during the last decade. Till today, there is no effective evidence-based treatment. The use of water-jet might improve those situations and reduce morbidity and implant loss.

Eligibility criteria: Inclusion Criteria:

* Signed and dated Informed Consent Form.
* Patient suffer from peri- implant disease
* Age Eligible for study: 18 year old and older
* Genders Eligible for study: Both

Exclusion Criteria:

* Patient substantially fails to comply with the study schedule, or treatment program as described in this Protocol.

Primary outcomes:
measure: Probing depth
timeFrame: one month
Secondary outcomes:
measure: Bleeding on probing
timeFrame: one month
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Hospital
Study officials:
affiliation: Department of periodontology
name: Dr. Liran Levin, DMD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05915598: Right/Left Discrimination Training on Fibromyalgia Patients
Official title: Investigating the Effects of Right/Left Discrimination Training on Pain Perception and Functional Disability in Fibromyalgia Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 64
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
* Adults between 35 - 55 years old
* Both sexes
* Stable medication use for at least one month prior to enrollment

Exclusion Criteria:

* History of other musculoskeletal or neurological disorders
* Current involvement in another pain management program or study

Primary outcomes:
measure: Pain intensity by The Numeric Pain Rating Scale (NPRS)
timeFrame: Changes in pain intensity at baseline, 6 weeks and 12 weeks.
measure: Functional disability by The Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Changes in FIQ at baseline, 6 weeks and 12 weeks.
measure: Right/left discrimination ability by Recognize smartphone application
timeFrame: Changes in Right/left discrimination ability at baseline, 6 weeks and 12 weeks.
Secondary outcomes:
measure: Cognitive function by The Montreal Cognitive Assessment (MoCA)
timeFrame: Changes in MoCA at baseline, 6 weeks and 12 weeks.
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT01136798: Impact of Exenatide on Sleep in Type 2 Diabetes
Official title: Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Sleep Disordered Breathing
Keywords: slow wave sleep
exenatide and sleep
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

Exclusion Criteria:

* Patients with unstable cardiac, neurological or psychiatric disease
* Women who are pregnant or report trying to get pregnant will be excluded.
* Patients treated for obstructive sleep apnea (OSA) will be excluded.
* Patients with established OSA will be included only if they have declined treatment of OSA.
* Patients with morbid obesity (BMI ≥ 40 gk/m2)
* Patients on insulin
* Patients already taking an incretin-based drug will not be included
* Patients with renal disease (creatinine clearance \<30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
* Patients taking an insulin secretagogue will be excluded.
* Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.

Primary outcomes:
measure: Non-REM Slow Wave Sleep
timeFrame: baseline and after 6 weeks of treatment
measure: Total Amount of Slow Wave Activity
timeFrame: baseline and after 6 weeks of treatment
Secondary outcomes:
measure: Sleep Efficiency During Polysomnographic Recording
timeFrame: baseline and after 6 weeks of treatment
measure: Minutes of Wake After Sleep Onset During Sleep Recording
timeFrame: baseline and after 6 weeks of treatment
measure: Severity of Obstructive Sleep Apnea
timeFrame: baseline and after 6 weeks of treatment
measure: Mean 24-h Blood Glucose Levels
timeFrame: baseline and after 6 weeks of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Eve Van Cauter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02989298: Peritoneal Dialysis Registration System (PERSIST)
Official title: Peritoneal Dialysis Registration System (PERSIST)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ESRD
Disorders Associated With Peritoneal Dialysis
Keywords: Peritoneal Dialysis (PD)
Residual renal function
Peritoneum function
Peritonitis rate
Technical survival
Patient survival
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ESRD patients receiving PD treatment

Brief summary: Brief Summary: The investigators are registering all PD patients at recruited hospitals and developing a PD database in China. Patients will be followed up every 3 months, and both baseline and follow-up information will be collected and input into the registration system. The patient survival, technical survival, peritonitis rate, longitudinal changes of residual renal function and peritoneum function, and quality of life for PD patients, etc, will be compared using the PD database.

Detailed description: Detailed Description: The investigators are registering all end stage renal disease (ESRD) patients receiving peritoneal dialysis (PD) treatment, and developing a PD database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education, etc), clinical characteristics (primary cause of ESRD, dialysis prescription, patient's condition and lab measurements of serum, urine, and dialysate), drug information, complications and scores of quality of life at the baseline will be collected. Patients will be followed up every 3 months. Demographic and clinical characteristics, complications, drug information of patients will be collected at each visit. The patients' clinical outcomes, such as mortality (including all-cause mortality and cardiovascular disease mortality), technical survival, kidney transplantation, transfer to hemodialysis, hospitalization, occurrence of peritonitis, etc. were also followed up till the end of the study. The data of patient survival, technical survival, peritonitis rate, hospitalization rate, clinical lab parameters, longitudinal changes of residual renal function and peritoneum function, peritonitis rate, hospitalization rate, clinical lab parameters and quality of life for PD patients will be analyzed using the PD database.

Eligibility criteria: Inclusion Criteria:PD patients -

Exclusion Criteria:No

-

Primary outcomes:
measure: Patient survival of PD patients
timeFrame: 10 years
Secondary outcomes:
measure: Technical survival of PD patients
timeFrame: 10 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01074398: Biomarkers in Predicting Response in Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Treated on GOG-0172 or GOG-0182
Official title: ERCC1 Expression as a Predictor of Progression Free and Overall Survival in Patients With Epithelial Ovarian Cancer Treated on GOG Protocols 0172 and 0182
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-24
Enrollment: 513
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in predicting response in patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed description: OBJECTIVES:

Primary

* To evaluate ERCC1 tumor expression, as measured by IHC, as a predictor of progression-free and overall survival of patients with advanced ovarian epithelial cancer.

Secondary

* To correlate ERCC1 single-nucleotide polymorphisms (C8092A and codon 118) with ERCC1 tumor expression.

OUTLINE: This is a multicenter study.

Blood and paraffin-embedded tumor tissue samples are analyzed for ERCC1 tumor expression by IHC and single-nucleotide polymorphisms.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed advanced invasive ovarian epithelial carcinoma, fallopian tube adenocarcinoma, or primary peritoneal carcinoma
* Has undergone optimal surgical staging
* Has received chemotherapy on either GOG-0172 or GOG-0182
* Adequate blood or DNA available for ERCC1 analysis
* Adequate tumor on paraffin-embedded tissue for IHC staining

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Association between ERCC1 tumor expression and progression-free and overall survival
Secondary outcomes:
measure: Association between ERCC1 polymorphisms and ERCC1 tumor expression
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Thomas C. Krivak, MD
role: STUDY_CHAIR
References:
citation: Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086.
Clinical trial NCT01560598: Adipokines and the Risk of Reflux Esophagitis
Official title: Adipokines and the Risk of Reflux Esophagitis : Prospective Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Visceral Obesity
Reflux Esophagitis
Keywords: GERD
reflux esophagitis
adipokine
especially
endoscopically proven
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults who visit healthcare system for routine checkup

Brief summary: We aimed to risk faoctors for GERD and association between visceral obesity, plasma adipoline(leptin, adiponectin, IL-6, TNF-α)and development of reflux esophagitis in healthy Koreans.


Eligibility criteria: Inclusion Criteria:

* endoscopically proven reflux esophagitis

Exclusion Criteria:

* those with esophageal hiatal hernia, current PPI medication, upper GI operation history

Primary outcomes:
measure: Difference in serum adipokine levels between case and control groups
timeFrame: 2 month lager (after sampling)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Healthcare System Gangnam Center
Study officials:
References:
Clinical trial NCT00519298: Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects
Official title: A Double-Blind, Placebo-Controlled, Balanced, 4-Way, Incomplete Block Design to Evaluate the Effects of a Single Administration of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG (qEEG) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Adult
Keywords: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women of non-childbearing potential aged 18 to 50 years inclusive on study day 1.
* Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, hematologic, neurologic, or psychiatric disease.
* Clinically significant abnormal standard EEG at screening.
* Consumption of any caffeine-containing products or alcoholic beverages within 48 hours before study day 1.

Primary outcomes:
measure: Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouffach
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For France: infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489798: Comparison of Two Protocols of Misoprostol (PGE1) and the Rate of Cesarean Section Due to Failed Induction.
Official title: Comparison of Two Protocols of Misoprostol (PGE1) and Their Effect on the Rate of Cesarean Section Due to Failed Induction. A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Keywords: Induction of labor
Misoprostol
Failed induction
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
Collaborators: name: Sistema Nacional de Investigadores de Panamá
First posted: 2018-04-05
Enrollment: 310
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score \> 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 34 and 42 weeks of gestation.
* Obstetric indication for termination of pregnancy.
* No fetal evidence of fetal distress

Exclusion Criteria:

* Any contraindication for the use of misoprostol.
* Oligohydramnios.

Primary outcomes:
measure: Vaginal birth
timeFrame: 48 hours
Secondary outcomes:
measure: Maternal complications
timeFrame: 48 hours
measure: Fetal complications
timeFrame: 48 hours
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
References: