louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04048447: Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications
Official title: Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study Involving Gastroenterologists From Trainees to Experts.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasia
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colic Neoplasia Patients

Brief summary: Endoscopic characterization is now essential in front of a colorectal lesion to predict its histology and choose the best therapeutic strategy. Different classifications have been proposed to predict histology depending on the endoscopic aspect. Thus, the aspect of the shape of the lesion is described in the Paris classification, the aspect of the mucosal pattern in Kudo's classification and the vascular pattern in Sano's one. Recently, classifications combining several color and mucosal and vascular pattern criteria have been described as the NICE classification or even more recently the Japanese JNET classification. However, although the interest in combining the Paris, Sano and Kudo criteria has recently shown its interest, there was not yet an overall classification covering all the published criteria. We have created a synthetic classification called CONECCT grouping the different criteria for an initial educational purpose. We have demonstrated that this tool allows interns and gastroenterologists to progress in the histological prediction of colorectal lesions presented in the form of photo files. Nevertheless, comparative data of the performances of those different classifications to predict the histology and the concordance intra and inter-observer have never been published. To validate this CONECCT classification, we created this comparative study evaluating the endoscopic characterization performances of these different classifications in terms of histological prediction and intra- and interobserver concordance in a group of gastroenterologists with varying levels of expertise in front of colorectal lesions presented in the form of photographic records.


Eligibility criteria: Inclusion Criteria:

* The participants were gastroenterologist doctors (experts, general or internal).
* Lesions presented were resected endoscopically after completion of a picture file.
* Pathology available for presented lesions.
* Participants signed informed consent and voluntarily participated in the characterization of these 206 lesions.

Exclusion Criteria:

* None

Primary outcomes:
measure: Evaluation of the interobserver Concordance of the CONECCT classification compared to the 6 other existing ones
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Edouard Herriot Hospital
state: Rhône Alpes
Study officials:
References:
Clinical trial NCT02754947: Need for the Assessment and Consultation Team (ACT) Following Anesthetic Care
Official title: Etiology of Post-anesthetic and Post-sedation Events on the Inpatient Ward: Data From a Rapid Response Team at a Tertiary Care Children's Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Respiratory Diseases
Neurologic Diseases
Keywords: Assessment and Consultation Team (ACT)
Rapid Response Team (RRT)
Perioperative complications
Respiratory insufficiency
ASA status
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility reviewed from an existing Department of Anesthesiology \& Pain Medicine database.

Brief summary: The goal of this study was to identify the etiology of events and demographics of patients that experience complications requiring activation of the Rapid Response Team (RRT) during the first 24 h following anesthetic care.


Eligibility criteria: Inclusion Criteria:

* Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.

Exclusion Criteria:

* Any study subject that has not experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.

Primary outcomes:
measure: Identifying post-operative criteria for activation of Rapid Response Teams (RRTs) in caring for the pediatric population using Pediatric Early Warning Scores (PEWS)
timeFrame: 24 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: N'Diris Barry, BS, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06991647: Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation
Official title: Effectiveness of Adjuvant Premedication of Intranasal Dexmedetomidine on the Intubation Procedure in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Elective Surgical Procedure
ASA Physical Status I
ASA Physical Status II
Keywords: intranasal dexmedetomidine
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if a medicine called dexmedetomidine, given as a nasal spray, can help patients stay calm and comfortable before having a breathing tube placed (intubation). Researchers want to see if using this nasal spray affects blood pressure, heart rate, comfort with the oxygen mask, how quickly the tube is placed, and how sleepy patients become. They also want to check if patients who receive dexmedetomidine need less pain medicine (Fentanyl) during the procedure. Participants will receive either the dexmedetomidine nasal spray or a plain saltwater spray (placebo). Doctors will then measure blood pressure, heart rate, comfort levels, time needed for intubation, sleepiness, and the amount of pain medication used.


Eligibility criteria: Inclusion Criteria:

* Children aged 1-6 years undergoing elective surgery
* ASA physical status 1 and 2

Exclusion Criteria:

* Children with difficult airway
* Active infection in nasal and oral area
* Subjects with mental retardation, ADHD, and cerebral palsy
* Difficult intravenous access

Primary outcomes:
measure: Mean arterial pressure
timeFrame: immediately before premedication and immediately after intubation
measure: Heart rate
timeFrame: immediately before premedication and immediately after intubation
measure: Mask acceptance
timeFrame: Before induction
measure: Intubation duration
timeFrame: during intubation
measure: Sedation Score
timeFrame: Immediately upon arrival to the operating room, before induction of anesthesia
measure: Opioid use
timeFrame: Immediately after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
Study officials:
References:
Clinical trial NCT00053547: Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
Official title: Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
End Stage Renal Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-02-03
Enrollment: 28
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.


Eligibility criteria: Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism

Primary outcomes:
measure: Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements.
Secondary outcomes:
measure: Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Buffalo
country: United States
facility: The Children's Hospital of Buffalo
state: New York
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas at Houston
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Abbott
name: Laura Williams, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06914947: Brain Health Together: Development and Pilot Test
Official title: Brain Health Together: Use of Human-centered Design to Develop and Pilot a Virtual Group Brain Health Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Subjective Cognitive Decline
Mild Cognitive Impairment (MCI)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-04-07
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population included people who were active participants in the Moving Together program as well as a purposeful sample of individuals who were not familiar with the Moving Together program. Together these individuals' perceptions would facilitate further examination and identification of challenges in understanding and managing MCI.

Pilot Inclusion Criteria:

* Mild cognitive impairment or subjective cognitive decline
* English language proficiency
* Active participants in Moving Together (Intervention Arm)

Pilot Exclusion Criteria:

* wheelchair user; medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually delivered multicomponent intervention
* moderate/severe dementia severity

Brief summary: The objectives of this study were to develop and pilot-test Brain Health Together (BHT), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults with cognitive impairment.

Detailed description: Our study design for developing, pilot-testing, and refining the BHT program was conducted in 2 phases. In Phase 1, the investigators used a human-centered design approach to deeply understand and respond to the needs, challenges, and motivations of potential users when developing the BHT program. In Phase 2, the investigators performed a pilot study to refine BHT program content and assess acceptability and potential feasibility.

Eligibility criteria: Inclusion Criteria:

* Mild cognitive impairment or subjective cognitive decline
* English language proficiency
* Active participants in Moving Together (Intervention Arm)

Exclusion Criteria:

* wheelchair user
* medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually-delivered multicomponent intervention
* moderate/severe dementia severity

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT01648647: Copeptin in Aortic Valve Replacement
Official title: GE DHM-AN-OR-2012/01
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copeptin in Patients Undergoing Aortic Valve Replacement
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for surgical or transcatheter aortic valve replacement

Brief summary: Copeptin is accepted as a marker of stress. We want to evaluate the preoperative and early postoperative copeptin leavens in patients undergoing different aortic valve procedures


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgical aortic valve replacment
* Patients undergoing transcatheter aortic valve replacment

Exclusion Criteria:

* denial by patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
state: Bavaria
Study officials:
References:
Clinical trial NCT03496077: Addictive Potential of LCCs in Dual Users
Official title: Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Dual Tobacco Use
Tobacco Dependence
Smoking
Smoking, Cigar
Smoking, Cigarette
Smoking, Tobacco
Keywords: Dual Use
Little Cigars and Cigarillos
Cigarettes
Flavored Tobacco Use
Addiction Potential
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over study
Primary purpose: OTHER

Brief summary: This study is about whether or not little cigars and cigarillos cause or maintain addiction, and if flavors, such as fruit, make them more addictive. The purpose of this study is to understand the addiction potential of little cigars and cigarillos compared to cigarettes in young adults who smoke both products. This study will also look at the differences between men and women. In the rest of this form, little cigars or cigarillos will be referred to as LCCs.


Eligibility criteria: Inclusion Criteria:

* Current regular dual user of little cigars/cigarillos (LCCs) and cigarettes, defined as: (a) report smoking cigarettes on ≥ 8 of the past 30 days, and (b) report smoking unaltered LCCs (without marijuana) on ≥ 8 of the past 30 days.
* Able to speak, read and understand English
* Age 18-34 years of age
* Stable residence (not planning to move during study period)
* Not intending to quit smoking cigarettes or LCCs within the next 2 weeks
* An expired carbon monoxide (CO) level of at least 4 ppm of expired air to verify smoking status

Exclusion Criteria:

* Pregnant for women (verified by urine pregnancy test at Visits 1 and 2)
* Current use of (or plans to use in the next 2-3 weeks) nicotine replacement products or cessation products (e.g., bupropion) to minimize confounding effects of another product)
* Positive breath alcohol screen (breath alcohol level (BAL) \> 0 g/ml; one re-test allowed; assessed at Visits 1, 2, and 3)
* Illicit drug use other than marijuana (verified by positive drug toxicology test at Visits 1 and 3; one re-test allowed)
* Met criteria for Cannabis Dependence assessed by the Cannabis Use Disorders Identification Test-Revised (CUDIT-R)

Primary outcomes:
measure: Demand elasticity for preferred flavor LCCs
timeFrame: Post-treatment (after being assigned to use it for 7 days)
measure: Demand elasticity for unflavored LCCs
timeFrame: Post-treatment (after being assigned to use it for 7 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health, Farmington, CT
name: Erin L Mead, PhD,MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590277: Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
Official title: Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Active Ethanol and Active Iomazenil
Active Ethanol and Placebo Iomazenil
Placebo Ethanol and Active Iomazenil
Placebo Ethanol and Placebo Iomazenil
Alcohol Effect
Driving Under the Influence
Alcohol Impairment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-05-02
Enrollment: 33
Sex: MALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's effects on driving using a driving simulator.

Detailed description: Alcohol is abused commonly, but there is no antidote for alcohol intoxication the way naltrexone or naloxone is an antidote for opioids. A medication that has the potential to block alcohol actions in the Central Nervous System could act as a unique medication in the treatment of alcohol intoxication and alcoholism. This project is evaluating the benzodiazepine partial inverse agonist, iomazenil, as an agent that could reverse alcohol's effects on subjective intoxication, alcohol's effects on driving using a driving simulator and on measures of electrophysiology in the laboratory in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Males
* 21-35 years old
* Medically healthy

Exclusion Criteria:

* Under the age of 21 or greater than the age 35
* History of seizures

Primary outcomes:
measure: Biphasic Ethanol Effects Scale (BAES)
timeFrame: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Deepak C D'Souza, MD MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04775277: Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy
Official title: Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: IPF
pregnancy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients were diagnosed to have IPF of childbearing age, patients were presented during pregnancy

Brief summary: case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy.


Eligibility criteria: Inclusion Criteria:

* Patients with pulmonary diseases during pregnancy

Exclusion Criteria:

* Patients with pulmonary diseases other than IPF and bronchial asthma were excluded.

Primary outcomes:
measure: any adverse events including gestational complication or disease specific complication
timeFrame: from the start of inclusion to the study till termination of pregnancy, average 9 months period
measure: neonatal outcome
timeFrame: December 2018 to April 2020
measure: neonatal outcome
timeFrame: December 2018 to April 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
citation: American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
citation: Sharma CP, Aggarwal AN, Vashisht K, Jindal SK. Successful outcome of pregnancy in idiopathic pulmonary fibrosis. J Assoc Physicians India. 2002 Nov;50:1446-8.
Clinical trial NCT03455777: Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
Official title: A Phase 2 Open-Label Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Patients With Homozygous Familial Hypercholesterolemia (HoFH)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Homozygous Familial Hypercholesterolemia
Lead sponsor: Akcea Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Ionis Pharmaceuticals, Inc.
First posted: 2018-03-07
Enrollment: 0
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: This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≤ 35 kg/m2,
* Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus OR an untreated LDL-C \> 500 mg/dL (13 mmol/L) or treated LDL-C ≥ 300 mg/dL (2.59 mmol/L) together with either cutaneous or tendon xanthoma before age 10 years OR familial medical history of genetically confirmed heterozygous FH in both parents OR untreated elevated LDL-C and TC \> 250 mg/dL consistent with the disease,
* Patients must be on stable LDL-C lowering agents or on regular apheresis

Exclusion Criteria:

* Myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to Screening, or cerebrovascular accident within 24 weeks prior to Screening.
* Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%

Primary outcomes:
measure: Reduction of low density lipoprotein cholesterol (LDL-C).
timeFrame: 14 weeks
Secondary outcomes:
measure: Effect of ISIS 703802 on plasma angiopoietin like 3 (ANGPTL3).
timeFrame: 7 and 14 Weeks
measure: Effect of ISIS 703802 on lipid parameters.
timeFrame: 7 and 14 Weeks
measure: Evaluate plasma trough levels of ISIS 703802.
timeFrame: 14 Weeks
measure: The safety of ISIS 703802 by the incidence of treatment-emergent adverse events
timeFrame: 14 Weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Clinical Site
state: Quebec
Study officials:
References: