louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03418662: EndoRings Colonoscopy vs Standard Colonoscopy
Official title: A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Polyp
Colon Cancer
Keywords: Colonoscopy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: US Endoscopy
First posted: 2018-02-01
Enrollment: 592
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Detailed description: This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Eligibility criteria: Inclusion Criteria:

* Screening or Surveillance Colonoscopy
* Able to provide written informed consent

Exclusion Criteria:

* Known narrow colon or colon stenosis
* Personal history of Colorectal cancer
* History of inflammatory bowel disease
* Familial adenomatous polyposis syndrome (FAP)
* Hyperplastic polyposis syndrome
* Referral for incomplete colonoscopy or polyp clearance

Primary outcomes:
measure: Adenoma Detection Rates
timeFrame: During colonoscopy procedure
measure: Number of Adenomas Per Colonoscopy
timeFrame: During colonoscopy procedure
Secondary outcomes:
measure: Polyp Detection Rate
timeFrame: During colonoscopy procedure
measure: Number of Detections Per Colonoscopy
timeFrame: During colonoscopy procedure
measure: Total Number of Detections
timeFrame: During colonoscopy procedure
measure: Cecal Intubation Rate
timeFrame: During colonoscopy procedure
measure: Time Comparison for Each Method
timeFrame: During colonoscopy procedure
measure: Patient Comfort Score
timeFrame: After colonoscopy was completed while patient was in recovery area of endoscopy unit
measure: Problems Encountered With Equipment
timeFrame: During colonoscopy procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Kessler WR, Sagi SV, Rogers NA, Fischer M, Bohm ME, Wo JM, Dewitt JM, McHenry L, Lahr RE, Searight MP, MacPhail M, Sullivan AW, McWhinney CD, Vemulapalli KC. Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial. Gastrointest Endosc. 2020 Jan;91(1):115-120. doi: 10.1016/j.gie.2019.06.042. Epub 2019 Jul 9.
Clinical trial NCT02030262: Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
Official title: Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 32
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 purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
* ETDRS visual acuity worse or equal to 20/30
* Adult able to give consent

Exclusion Criteria:

* Diagnosis of age-related macular degeneration
* Opacity blocking the fundus visualisation
* Presence of active intraocular inflammation
* Presence of intraocular tumor
* Presence of retinal detachment

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
state: Quebec
Study officials:
affiliation: Centre de recherche du CHU de Québec; Université Laval
name: Mathieu Caissie, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02482662: Diagnosis Test for Gestational Diabetes Mellitus
Official title: Assessment of the Diagnosis Test for Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Keywords: Diagnosis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 104
Sex: FEMALE
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: Women with abnormal GDM screening test.

Brief summary: Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by pregnant women. As many OGTT are false positive according to self-monitoring blood glucose (SMBG), the investigators need now to determine the percentage of OGTT results that are false negative.

The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of OGTT will determine the exact percentage of false negative OGTT results.

The opinion of women will also be taken into account. In the everyday clinic, many report that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been performed, the investigators will investigate formally what women think using a questionnaire.


Eligibility criteria: Inclusion Criteria:

* positive GDM screening test (glycemia post-50g of glucose ≥ 7.2 mmol/L),
* between 24 and 28 weeks of gestation from the last menstruation,
* single pregnancy,
* able to read and understand French.

Exclusion Criteria:

* known type 1 or type 2 diabetes,
* disease or treatment interfering with the metabolism of glucose,
* deficiency may hinder the understanding of the study.

Primary outcomes:
measure: proportion of OGTTs falsely negative
timeFrame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
Secondary outcomes:
measure: preference of participants regarding the two tests (OGTT vs. SMBG)
timeFrame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche clinique du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01038180: Complications Following Pacemaker Implantation
Official title: Complications Following Pacemaker or ICD Implantation: Results From The Danish Pacemaker and ICD Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Keywords: pacemaker
adverse effects
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 28000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Danish patients receiving a permanent cardiac pacemaker during the years 1997 to 2008

Brief summary: This study examines possible risk factors with regard to complications following pacemaker implantation.

Detailed description: This study examines possible risk factors with regard to complications following pacemaker implantation. We are using data from The Danish Pacemaker Register.

Eligibility criteria: Inclusion Criteria:

* permanent cardiac pacemaker

Exclusion Criteria:none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital, Skejby
Study officials:
affiliation: Aarhus University Hospital
name: Rikke E Kirkfeldt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirkfeldt RE, Johansen JB, Nohr EA, Moller M, Arnsbo P, Nielsen JC. Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients. Heart Rhythm. 2011 Oct;8(10):1622-8. doi: 10.1016/j.hrthm.2011.04.014. Epub 2011 Apr 14.
Clinical trial NCT01773980: CROSSROAD II: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
Official title: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cervical Cancer
Colorectal Cancer
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-01-23
Enrollment: 1570
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics

Brief summary: The goal of this project is to develop and pilot test an innovative approach for overcoming barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon. Many studies have shown that people with disabilities receive fewer indicated cancer screening services and are more likely to have poor cancer-related outcomes, such as late stage at diagnosis, compared to those without disabilities.


Eligibility criteria: Inclusion Criteria:

* Female
* Aged 50-75 at time of screening
* No personal history of breast, cervical or colorectal cancer
* Not being up-to-date with at least one screening test for breast, cervical, and/or colorectal cancer
* Meets the study definition of disability per screening survey OR
* Be a woman who does not meet the definition of disability per screening survey, but has been matched to a participant who does (observation group).

Exclusion Criteria:

* Non female
* Personal history of breast, cervical, or colorectal cancer
* Coming into clinic for an urgent care issue

Primary outcomes:
measure: Number of participants with improved cancer screening
timeFrame: Duration of the study; Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Buckley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03487380: Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
Official title: Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Intestinal Microbiota
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 86
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will compare three groups of 100 patients, corresponding to 200 patients with Alzheimer disease (whom 100 patients in the rapid cognitive decline group and 100 patients without rapid cognitive decline) and 100 patients in the control group.
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota


Eligibility criteria: Inclusion Criteria:

For Alzheimer groups without DCR and Alzheimer with DCR:

* patients between 70 and 90 years old
* with mild to moderate Alzheimer's disease (MMSE\> 15/30),
* followed in the CMRR of the University Hospital of Nantes or Angers
* having given their informed consent

For the control group (non-Alzheimer's)

* more patients between 70 and 90 years
* consultant for a subjective memory complaint isolated at the CMRR of Nantes or Angers University Hospital,
* having given their informed consent

Exclusion Criteria:

* Major patients under tutorship, curatorship or safeguard of justice
* Cognitive disorders possibly related to a metabolic or psychiatric cause
* History of prescription of antibiotic treatment in the last month
* History of acute gastrointestinal illness in the last month
* History of hospitalization for an acute medical pathology or for a surgical procedure in the last month

Primary outcomes:
measure: analysis of the taxonomic and functional composition of the microbiome
timeFrame: 1 year
Secondary outcomes:
measure: to determine if there is a specific modification of the composition of the intestinal microbiota of patients with Alzheimer's disease, compared to control group.
timeFrame: Day 0
measure: create a prognostic score of DCR based on clinical data, including the responses to the MMSE, BREF and MNA questionnaires, and taking into account the microbiota analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU de Angers
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT01776580: The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function
Official title: The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Sexual Dysfunction
Lower Urinary Tract Symptoms
Keywords: Pelvic organ prolapse
lower urinary tract symptoms
sexual dysfunction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lower urinary tract symptoms

Brief summary: Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.

Detailed description: Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.

Eligibility criteria: Inclusion Criteria:

* all patients with lower urinary tract symptoms and will undergo urodynamic studies

Exclusion Criteria:

* none

Primary outcomes:
measure: To assess the correlation of bladder descent and lower urinary tract symptoms.
timeFrame: 1 day
Secondary outcomes:
measure: To identify the correlation of bladder descent with sexual dysfunction.
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics & Gynecology, National Taiwan University Hospital
Study officials:
affiliation: Department of Obstetrics & Gynecology, National Taiwan University Hospital
name: Ho-Hsiung Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03132480: Fluid Responsiveness Using Forehead Sensor in Children
Official title: Study on TFA-1 Adhesive Forehead Sensors to Predict Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovolemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children

Detailed description: The investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing general anesthesia for neurosurgery, major abdominal surgery, and cardiac surgical procedures.

Exclusion Criteria:

* preoperative Ejection fraction \<30%
* underlying lung disease
* cardiac arrhythmia

Primary outcomes:
measure: Area under the Receiver operating characteristic(ROC) curve (AUC)
timeFrame: before fluid resuscitation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
citation: Kim EH, Kim H, Lee JH, Kim JT, Jang YE, Ji SH, Kim HS. Role of TFA-1 adhesive forehead sensors in predicting fluid responsiveness in anaesthetised children: A prospective cohort study. Eur J Anaesthesiol. 2020 Aug;37(8):713-718. doi: 10.1097/EJA.0000000000001235.
Clinical trial NCT01627262: Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
Official title: Double-blind, Randomised, Placebo-controlled, Parallel-group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Pellets vs. Placebo in Diverticular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonic Diverticulosis
Keywords: diverticular disease
colonic diverticulosis
mesalamine
placebo
randomized
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 123
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of diverticular disease with acute pain without serious complications
* Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion

Exclusion Criteria:

* Chronic inflammatory bowel disease
* Fever or other signs of serious complications.

Primary outcomes:
measure: The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Ev. Krankenhaus Kalk, University of Cologne
Study officials:
affiliation: Ev. Krankenhaus Kalk, University of Cologne
name: Wolfgang Kruis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruis W, Meier E, Schumacher M, Mickisch O, Greinwald R, Mueller R; German SAG-20 Study Group. Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon--a placebo-controlled study. Aliment Pharmacol Ther. 2013 Apr;37(7):680-90. doi: 10.1111/apt.12248. Epub 2013 Feb 17.
Clinical trial NCT06616662: Transsphincteric Fistula Management Using LIFT and MAF
Official title: Comparative Outcomes of Ligation of the Intersphincteric Fistula Tract and Mucosal Advancement Flap Techniques in Elderly Patients with Transsphincteric Perianal Fistulas: Recurrence, Incontinence and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perianal Fistula
Keywords: perianal fistula,flap,ligation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-09-27
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: two hundred and fifty seven elderly patient with PAF

Brief summary: a study that detect the most suitable surgical techniques for treating transsphincteric fistula

Detailed description: we compared between LIFT and MAF in elderly with PAF

Eligibility criteria: Inclusion Criteria:

* elderly persons with PAF

Exclusion Criteria:

* recurrent fistula
* associated autoimmune diseases

Primary outcomes:
measure: healing rate
timeFrame: three years
Secondary outcomes:
measure: incontinence
timeFrame: three years
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Tamer. A.A.M. Habeeb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05776862: Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
Official title: A Pilot Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injuries
Tetraplegia
Paraplegia
Muscle Loss
Atrophy, Muscular
Insulin Resistance
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Florida
First posted: 2023-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
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 will evaluate if Ursolic Acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the SCI community.


Eligibility criteria: Inclusion Criteria:

1. Male and female individuals with paraplegia having chronic (\> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8
2. Male and female individuals wi4.th chronic (\> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7

Exclusion Criteria:

1. Pregnant or planning to become pregnant
2. Women who are breastfeeding

Primary outcomes:
measure: Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)
timeFrame: Baseline, 12 weeks
measure: Changes in Peak Isokinetic Strength
timeFrame: Baseline, 12 weeks
measure: Changes in Fasting Insulin Resistance (IR)
timeFrame: Baseline, 12 weeks
measure: Changes in Glucose Disposal
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami - Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami
name: Mark S Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References: