louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00153127: Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications
Official title: Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.


Eligibility criteria: Inclusion Criteria:

* Adult male or female ambulatory outpatient age 19 or older.
* Patients meet ROME II Criteria
* Patients not meeting ROME IBS criteria
* Use of a constipating medication (\>= 3% in PDR)
* If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
* Written informed consent.

Exclusion Criteria:

* Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
* Prior small bowel or colonic resection or colostomy.
* Weight \< 80 lbs.
* Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.
* Positive stool hemoccult.
* Significant cardiac, renal or hepatic insufficiency.
* Pregnant or expecting to become pregnant within 120 days of study enrollment.
* Lactating or breast feeding.
* Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
* Use of investigational drugs in the last 30 days.
* Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions

Primary outcomes:
measure: A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary outcomes:
measure: Analysis of individual ROME I criteria
measure: Safety (adverse event and laboratory testing)
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: St. Petersburg
country: United States
state: Florida
city: St. Louis
country: United States
state: Missouri
city: Raleigh
country: United States
state: North Carolina
Study officials:
affiliation: University of South Alabama
name: Jorge Herrera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02826876: The Efficacy of Surgical Site Treatment With Ropivacaine in Laparoscopic Surgery
Official title: Local Analgesia in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Laparoscopic surgery
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2016-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.

Detailed description: At the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs

Eligibility criteria: Inclusion Criteria:

* Laparoscopic bariatric surgery
* Laparoscopic inguinal hernia surgery

Exclusion Criteria:

* Cardiac arrythmias
* Active ischemic heart disease
* pregnancy

Primary outcomes:
measure: Pain scale as measured by pain scale questionnaire
timeFrame: 1 Week
Secondary outcomes:
measure: Reducing use of narcotics according to nurse records
timeFrame: 1 Week
Other outcomes:
Locations:
city: Naharia
country: Israel
facility: Naharia Medical Center
Study officials:
affiliation: Galilee Medical Center
name: Moaad H Farraj, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04867876: Qol Following Management for Pediatric UI
Official title: Quality of Life Following Conservative Management for Pediatric Daytime Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Incontinence
Keywords: Quality of Life
Pediatric
Incontinence
Lead sponsor: University of South Dakota
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A comparison of changes between symptoms of incontinence and pediatric quality of life will be used to draw conclusions about whether differences in quality of life are noted with changes in symptoms of incontinence.

Detailed description: Although positive physiological results are associated with successful treatment for bowel and bladder dysfunction and daytime incontinence (BD-UI), there are few studies examining the effects of treatment on quality of life (QoL) for children. The purpose of our study is to determine whether successful physical therapy treatment improves QoL for children with BD-UI.

Consent will be obtained from parents and assent from children. Children will be asked to complete a global, age appropriate quality of life assessment and a quality of life instrument specific to incontinence. Information will be provided by the parent through completion of a parent report instrument matched to the child's global quality of life tool as well as completion of an instrument depicting child symptoms. Clinicians will report general information about related physiological changes and progress with established outcomes individualized to the child. A repeated measures MANOVA will be used to analyze the results.

Eligibility criteria: Inclusion Criteria:

* Children between ages 5-18 who were currently receiving conservative treatment for daytime UI with or without constipation or encopresis met inclusion criteria.

Exclusion Criteria:

* Exclusion criteria included children who only had nocturnal enuresis or children with neurogenic bladders.

Primary outcomes:
measure: Dysfunctional Voiding Symptom Scale
timeFrame: 3-6 months
measure: Kid KINDL Questionnaire
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vermillion
country: United States
facility: University of South Dakota
state: South Dakota
Study officials:
affiliation: University of South Dakota
name: Patti J. Berg-Poppe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02273076: Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging
Official title: Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disorders of Skin Grafts and Flaps
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2014-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study Population will be recruited from UCI Anesthetic and Plastic Surgery Institute clinics, seen by the Plastic Surgery Service. Subjects requiring breast reconstructive surgery using either implant based or autologous reconstruction will be identified.

Brief summary: The current surgical procedure for breast diseases places an emphasis on the conservation of breast skin in order to provide more optimal reconstruction.

The purpose of this study is to use portable, non-contact optical imaging device developed at the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes in a skin during reconstructive surgery procedure and healing process.

Detailed description: The researchers can use Spatial Frequency Domain Imaging instrument to measure the concentration of blood flow in the skin tissue and can determine of the changes that observed in the properties of the mastectomy flap that may be delay in healing process.

The imaging device can determine the change from baseline measurement to the development of skin necrosis, wound infection, or implant extrusion.

Eligibility criteria: Inclusion Criteria:

* Adult male and female 18 years and older scheduled for breast reconstructive surgery.

Exclusion Criteria:

* Minor and pregnant women

Primary outcomes:
measure: skin flap healing
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCIMC
state: California
Study officials:
affiliation: UCIMC
name: Gregory Evans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00881127: To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions
Official title: A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergies
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueyu (Eric) Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02077127: Monocyte Chemoattractant Protein-1 2518A/G Polymorphism
Official title: Association of Monocyte Chemoattractant Protein-1 (MCP-1)2518A/G Polymorphism With Proliferative Diabetic Retinopathy in Northern Chinese Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 1043
Sex: ALL
Minimum age (years): 41
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of a certain province

Brief summary: The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood. Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated with diabetic microvascular or macrovascular complications. However, the relationship between SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains controversial. In the present study, we evaluated the association of a single nucleotide polymorphism (SNP) in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular edema (DME) in Chinese population from Southern China with type 2 diabetes.

Detailed description: The association between polymorphism of MCP-1 c.2518A/G and DR had been reported in Japan and Korea, but their opinion were inconsistent. However there is no report in China so far. This study was designed to clarify the relationship of polymorphism of MCP-1 c.2518A/G with type 2 diabetes with or without DR. The relationship between MCP-1 c.2518A/G and different stage of DR has also been studied.This article proved that the MCP-1 c.2518G/G genotype is a susceptibility gene for DR in Chinese type 2 diabetic patients, especially the High-risk PDR. There is no association with DME and c.2518G/G.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic retinopathy
* age at diagnosis ≥30 years and a known duration of diabetes of ≥5 years.

Exclusion Criteria:

* eyeball atrophy
* epimacular membrane
* age-related macular degeneration (ARMD)
* intravitreal injection medicine
* vitreous hemorrhage

Primary outcomes:
measure: Genetic association
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Ping Liu, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01875627: Satiety Study of a Carbohydrate Meal to a Highly Viscous Gel Meal
Official title: Comparing the Satiety Scores of a Carbohydrate Meal to a Meal of Equal Volume in Which Half of the Volume is Replaced With a Highly Viscous Gel.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To evaluate the effects of Konjac on satiety and subsequent food intake in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Age 18-65 years
* Having a BMI of 18.5 - 25 kg/m2
* No presence of major disease

Exclusion Criteria:

* Known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, gastrointestinal disease, AIDS or AIDS-related complications; subjects using prescription medications or Natural Health Products; Subjects will be excluded if they have any condition which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results

Primary outcomes:
measure: Objective Satiety
timeFrame: 90 minutes
Secondary outcomes:
measure: Subjective Satiety
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Risk Factor Modification Centre
state: Ontario
Study officials:
affiliation: Risk Factor Modification Centre - St. Michael's Hospital
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05497427: Normative Database and Test-Retest Reliability for BrainCheck Assessments
Official title: Normative Database and Test-Retest Reliability for BrainCheck Assessments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Change
Cognitive Decline
Cognitive Deterioration
Neurocognitive Deficit
Keywords: Healthy Volunteers
Dementia
Alzheimer's Disease
Mild Cognitive Impairment
Older Adults
Lead sponsor: BrainCheck, Inc.
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of healthy volunteers 50 years of age or older.

Brief summary: The purpose of this study is to collect normative test values and demographic information for normative and referential data for a rapid, portable, computerized neurocognitive testing device from healthy adults 50 and older.

Detailed description: BrainCheck's battery of 12 cognitive assessments will be used in this study, which aims to measure a variety of cognitive domains (memory, attention, mental flexibility, executive function, processing speed, balance, reasoning, visuospatial construction, language, and visual hallucinations).

With the decline in cognition occurring at a quicker rate at older ages, this study aims to collect additional data from healthy older adults to better capture the normative distribution among these age groups from existing and new assessments.

Eligibility criteria: Inclusion Criteria:

* Aged 50 or older
* Willing and able to comply with study requirements and activities

Exclusion Criteria:

* TBI within the last 6 months
* Neurosurgery within the last month
* Experienced a stroke
* Self reported neurological condition (including mild neuropsychological impairment, dementia, Parkinson's disease, amyotrophic lateral sclerosis, Multiple sclerosis, or long-covid)

Primary outcomes:
measure: Mean, standard deviation, and percentiles of values of BrainCheck Assessments
timeFrame: 5 months
Secondary outcomes:
measure: Test-retest reliability of BrainCheck Assessment values between two different time points
timeFrame: 5 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: BrainCheck
state: California
city: Multiple Locations
country: United States
facility: Maplewood Senior Living
state: Connecticut
city: Austin
country: United States
facility: BrainCheck
state: Texas
city: Houston
country: United States
facility: BrainCheck
state: Texas
city: Seattle
country: United States
facility: BrainCheck
state: Washington
Study officials:
References:
Clinical trial NCT04124627: Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
Official title: Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Stenosis, Familial
Keywords: Ultrasound guidance
surgery for lumbar spine
irradiation
wrong site surgery
Lead sponsor: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
Sponsor class: NETWORK
First posted: 2019-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The identification of the operative site of lumbar ductal stenosis and lumbar disc herniation is classically done by radioscopy, thus inducing irradiation of the patient.

The use of ultrasound in spine surgery is little studied and poorly mentioned in the scientific literature. However, it is commonly used for other types of scouting (especially anesthetics). Thus, in the absence of consensus and clear recommendations, some practitioners perform ultrasound scans . Methodological developments also validate the feasibility of the ultrasound approach.

The double benefit of an ultrasound identification is firstly a lack of exposure to X-rays for both the patient and the operating team and secondly a lower cost than a conventional radiography.

The main objective is to demonstrate the interest of the ultrasound identification of the surgical site in the intervention of lumbar ductal stenosis and lumbar disc herniations in terms of concordance of the operating site between ultrasound and fluoroscopy.


Eligibility criteria: Inclusion Criteria:

* Major patients
* Patients who gave their consent
* Patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation

Exclusion Criteria:

* Pregnant or lactating women according to article L1121-5 of the CSP.
* Vulnerable persons according to article L1121-6 of the CSP.
* Major persons placed under guardianship or curatorship

Primary outcomes:
measure: concordance of the operating site after radiological and ultrasound guidance
timeFrame: day 1
Secondary outcomes:
measure: number of shots made and preventable
timeFrame: day 0
measure: preventable radiation dose
timeFrame: day 0
measure: exam costs (based on national cost scale)
timeFrame: day 0
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Centre MCO Côte d'Opale
state: Pas De Calais
Study officials:
References:
Clinical trial NCT00547027: Promoting Physical Activity Among Patients With Type 2 Diabetes
Official title: Promoting Physical Activity Among Patients With Type 2 Diabetes in a Community-Based Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Physical Activity
Keywords: diabetes
physical activity
print-based intervention
tailored intervention
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2007-10-19
Enrollment: 85
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of a tailored, print-based physical activity intervention for patients diagnosed with type 2 diabetes.

Detailed description: Given the growing rates of type 2 diabetes and the documented benefits of physical activity in the treatment of this illness, further research is needed to examine methods of targeting this patient group to achieve improvements in physical activity behavior. The primary aim of this planning grant is to implement a pilot study examining the feasibility and efficacy of an individually-targeted, theoretically-based physical activity intervention for patients with type 2 diabetes. The physical activity intervention is compared to usual care, and the primary outcome is weekly physical activity at a one-month follow-up. These pilot data would demonstrate the feasibility of partnering with a community agency for participant recruitment and program implementation, as well as the potential efficacy of this intervention to promote physical activity in this high-risk population.

Eligibility criteria: Inclusion Criteria:

* adults diagnosed with type 2 diabetes
* current patients referred to diabetes center

Exclusion Criteria:

* medical contra-indication to moderate-intensity physical activity

Primary outcomes:
measure: weekly physical activity
timeFrame: one month
Secondary outcomes:
measure: physical activity stage of change
timeFrame: one month
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Gareth Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References: