louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06937671: Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
Official title: Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polyp of Colon
Endoscopic Mucosal Resection
Keywords: EMR
Cold EMR
Hybrid EMR
Endoscopic mucosal resection
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 194
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 goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps.

Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.


Eligibility criteria: Inclusion Criteria:

* Adult patient (age 18 years or older)
* Polyp size of at least 20 mm
* - Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)

Exclusion Criteria:

* Polyps with previous failed resection attempts or polyp recurrence
* Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)
* Polyps with nodules too large (\>1-1.5cm) for the use of a cold snare
* Inflammatory bowel disease

Primary outcomes:
measure: Recurrence of polyps
timeFrame: 3-6 months after the procedure
Secondary outcomes:
measure: Adverse events
timeFrame: 3-6 months after the procedure
measure: Polyp recurrence rates
timeFrame: 3-6 months after EMR procedure
measure: Cost benefit analysis
timeFrame: 3-6 months after the procedure
measure: Subgroup polyp recurrence rate
timeFrame: 3-6 months after the procedure
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Weston
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Cleveland Clinic Florida (Weston Hospital)
name: Tilak Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588871: Comparison of the Efficacy and Quality of Life of Three Bleaching Products
Official title: Comparison of the Efficacy and Quality of Life of Three Bleaching Products
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tooth Bleaching
Quality of Life
Keywords: Tooth bleaching
Quality of life
Lead sponsor: Grupo de Investigação em Bioquímica e Biologia Oral
Sponsor class: OTHER
Collaborators: name: Ivoclar Vivadent AG
First posted: 2018-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments.

Products to be used represent three different techniques and formulations: in office, universal tray and custom tray (respectively VivaStyle Paint On Plus (Ivoclar Vivadent, Liechtenstein), Opalescence GO 6% (Ultradent, USA) and Opalescence PF 15% (Ultradent, USA).

All products contain 6% hydrogen peroxide or its equivalent.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Be willing to refrain from use of tobacco products during the study
* Be willing to sign an informed consent form
* At least one teeth 13,11,21,23,33,43 has a gradable VITA shade A3,5 or darker by clinical assessment

Exclusion Criteria:

* Teeht with restorations in frontal teeth
* Patients with untreated periodontitis or caries
* Patients with fixed orthodontics appliances
* Patients with know allergies to ingredients
* Patients who are nursing or pregnant
* Patients with severe systemic illnesses
* Patients with development tooth anomalies
* Patients with non vital anterior teeth
* Patients with insufficient oral hygiene

Primary outcomes:
measure: Change on visually determination of tooth colour
timeFrame: 2 weeks (before and after treatment)
measure: Change on spectrophotometer determination of tooth colour
timeFrame: 2 weeks (before and after treatment)
measure: Subjective evaluation of tooth colour change during follow-up
timeFrame: 1, 3 and 6 months
measure: Change on quality of life during treatment and follow-up
timeFrame: 2 weeks (before and after treatment), 1 month, 3 months and 6 months
measure: Objective evaluation of tooth colour change during follow-up
timeFrame: 1, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Faculty of Dental Medicine of the University of Lisboa
Study officials:
References:
Clinical trial NCT00004771: Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Muscular Atrophy
Amyotrophic Lateral Sclerosis
Spinobulbar Muscular Atrophy
Keywords: amyotrophic lateral sclerosis
motor neuron disease
neurologic and psychiatric disorders
rare disease
spinal and bulbar muscular atrophy
spinal muscular atrophy
Kennedy's Syndrome
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Ohio State University
First posted: 2000-02-25
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.

Detailed description: PROTOCOL OUTLINE:

All patients receive androgen suppression with leuprolide acetate injections every 4 weeks for 6 months, plus hormone replacement therapy with testosterone enanthate injections every week for 24 weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Men aged 18 and over with motor neuron disease, i.e.:

* X-linked spinal and bulbar muscular atrophy (Kennedy's disease)
* Confirmed by androgen receptor, exon-1 mutation genotype
* Amyotrophic lateral sclerosis
* Spinal muscular atrophy

Significant muscle weakness on manual muscle testing

No prisoners

No mental disability

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Jerry R. Mendell
role: STUDY_CHAIR
References:
Clinical trial NCT04309071: Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
Official title: Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet Modification
Insulin Resistance
Hyperinsulinemia
Keywords: Salivary insulin
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Mitacs
name: Core-Health Technologies Inc.
First posted: 2020-03-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Recent evidence suggests that hyperinsulinemia (i.e., elevated insulin levels) is the primary causative factor in obesity. Insulin promotes fat storage and prevents fat breakdown, suggesting that weight loss would be optimized if insulin levels are managed and kept low. Understanding how different foods impact insulin levels could therefore aid in personalized weight loss (or weight maintenance) advice. It has been shown that salivary insulin can track plasma insulin following different meals and can delineate between lean and obese people. Thus, it was suggested that salivary insulin could be a potential surrogate for plasma insulin. The purpose of this study is to measure fasting saliva insulin, and salivary insulin responses to a standardized meal tolerance test in individuals with different body mass index (BMI).


Eligibility criteria: Inclusion Criteria:

* non-smoker
* have a body mass index greater than 18.5 kg/m2
* have not been diagnosed with type 2 diabetes or other medical conditions affecting glucose or insulin levels

Exclusion Criteria:

* You have been. diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) or any other diagnosed chronic condition that may impact your glucose or insulin levels or the outcomes of this study.
* You take any medication which may affect your glucose and insulin level
* Unable to travel to make your testing appointments.
* Unable to consume the meal tolerance test drink/shake and/or provide finger stick glucose or saliva samples for the study.

Primary outcomes:
measure: Saliva insulin area under the curve
timeFrame: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
measure: Saliva insulin at different time points
timeFrame: Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
Secondary outcomes:
measure: Glucose area under the curve
timeFrame: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
measure: Glucose
timeFrame: Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
References:
Clinical trial NCT02708771: Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
Official title: Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Hospital San Juan de la Cruz
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 42
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: Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin

Detailed description: Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin

Assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on:

* Inflammatory activity (C-reactive protein)
* The development of biomarkers (NTproBNP).
* The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (CRP ?2,5 mg / dl).

Exclusion Criteria:

* Impending doom
* Participating in other clinical trials
* Treatment with ?-3 acids in the last month prior to admission
* Percutaneous or surgical treatment of the cause of heart failure during hospitalization.
* Pregnant women.
* Renal failure on dialysis.
* Chronic liver disease Child-Pugh B or C.
* Acute infectious process.
* Active malignant neoplasia.

Primary outcomes:
measure: Serum albumin levels
timeFrame: Four weeks
Secondary outcomes:
measure: C-reactive protein levels
timeFrame: Four weeks
measure: NTproBNP levels
timeFrame: Four weeks
measure: Combined event of death from any cause or readmission for heart failure
timeFrame: Three months
Other outcomes:
Locations:
city: Úbeda
country: Spain
facility: Hospital San Juan de la Cruz
state: Jaen
Study officials:
References:
Clinical trial NCT03348371: The Effects of Ethanol on Intestinal Permeability and Gut Hormones
Official title: The Effects of Orally Ethanol vs. Isoethanolaemic i.v. Infusion of Ethanol on Intestinal Permeability and Gut Hormones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Ethanol
Incretin Effect
Keywords: Incretin effect
Ethanol
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.


Eligibility criteria: Inclusion Criteria:

* Caucasian male between 20 and 50 years of age
* Body mass index (BMI) between 19 and 25 kg/m2
* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
* Normal fasting plasma glucose concentration (i.e. \<6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (i.e. ≤42 mmol/mol)
* Normal haemoglobin
* Informed consent

Exclusion Criteria:

* First-degree relatives with diabetes and/or liver disease
* Liver disease or other alcohol-related diseases, diabetes mellitus
* Liver disease (serum ALAT and/or serum ASAT \>2 × normal values)
* Nephropathy (serum creatinine above normal range and/or albuminuria)

Primary outcomes:
measure: Serum insulin level
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01321671: Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Official title: The Pharmacokinetics Of Pregabalin Controlled Release Formulation In Fed State Compared To The Controlled Release And Immediate Release Formulations In The Fasted State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve from 0 to infinity (AUCinf) and peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) fed and CR fasted
timeFrame: 3 days
measure: Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatment
timeFrame: 3 days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
Clinical trial NCT00974571: Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-09-10
Enrollment: 1365
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.


Eligibility criteria: Inclusion Criteria:

* Patient has a documented clinical history of perennial allergic rhinitis
* Patient is a nonsmoker
* Patient is in good general health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is \<8 weeks postpartum or is breast-feeding
* Patient is a current or past abuser of alcohol or illicit drugs

Primary outcomes:
measure: Mean Change From Baseline in Daytime Nasal Symptoms Score
timeFrame: Baseline and first 4 weeks of a 6-week treatment period
Secondary outcomes:
measure: Mean Change From Baseline in Nighttime Symptoms Score
timeFrame: Baseline and first 4 weeks in 6-week treatment period
measure: Mean Change From Baseline in Composite Symptoms Score
timeFrame: Baseline and first 4 weeks in 6-week treatment period
measure: Patient's Global Evaluation of Allergic Rhinitis
timeFrame: End of the first 4 weeks in 6-week treatment period
measure: Physician's Global Evaluation of Allergic Rhinitis
timeFrame: End of the first 4 weeks in 6-week treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. doi: 10.2500/aap.2007.28.3000.
Clinical trial NCT01211171: COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland
Official title: COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Cough
Telmisartan
Bradykinin
Tolerability
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 2498
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: Primary care clinic hypertensive patients with cough caused by the ACE-i regardless any other factors.

Brief summary: In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.


Eligibility criteria: Inclusion Criteria: - hypertension

* age \> 18
* ACE-I related cough Exclusion Criteria: - Current treatment with telmisartan
* Cholestatic disorders and severe hepatic failure
* Allergy to telmisartan
* Pregnancy and lactation period

Primary outcomes:
measure: Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough
timeFrame: 4 months after initiation
Secondary outcomes:
measure: General tolerability and safety of telmisartan treatment among patients, who had to stop their previous ACE-I treatment due to cough
timeFrame: 4 months after initiation
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: