louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02910635: A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
Official title: A Randomized, Placebo-Controlled, Four-Period Crossover, Study to Evaluate the Effect of Volanesorsen on the QTc Interval Using a Therapeutic and Supra-Therapeutic Dose Compared With Placebo in Healthy Volunteers: a Thorough QT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abnormalities, Cardiovascular
Keywords: Thorough QTc, Therapeutic dose, supra therapeutic dose
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Akcea Therapeutics
First posted: 2016-09-22
Enrollment: 52
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 primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.


Eligibility criteria: Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Males and females aged 18-55 at the time of informed consent
* Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* The subject has a BMI of 19 to 32 kg/m\^2 inclusive
* Consumption of nicotine or nicotine-containing products for at least 6 months before Screening

Exclusion Criteria:

* History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia
* Abnormal screening ECG
* Use of concomitant medications unless authorized by the Sponsor Medical Monitor
* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
* Treatment with another Study Drug, biological agent, or device within one-month of Screening
* Tests positive for drugs of abuse or cotinine
* Considered unsuitable for inclusion by the Principal Investigator

Primary outcomes:
measure: Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)
timeFrame: 24 Hours
Secondary outcomes:
measure: Placebo corrected change from baseline heart rate (HR, PR and QRS)
timeFrame: 24 Hours
Other outcomes:
measure: Volanesorse plasma pharmacokinetics (PK)
timeFrame: 0 to 24 hours
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
References:
Clinical trial NCT03298035: A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
Official title: A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea of Prematurity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 19
Sex: ALL
Standard ages: CHILD
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 nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).


Eligibility criteria: Inclusion Criteria:

* Infants born at \< 30 weeks gestational age who develop clinically significant apnea while on NCPAP \> 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
* Infants on maximum caffeine therapy (10mg/kg/day)

Exclusion Criteria:

- Major congenital anomalies including congenital heart disease

Primary outcomes:
measure: Number of Participants Who Were Intubated
timeFrame: 28 days after randomization
measure: Duration of Intubation
timeFrame: 28 days after randomization
Secondary outcomes:
measure: Number of Apneic Events
timeFrame: 28 days after randomization
measure: Number of Participants With Bronchopulmonary Dysplasia (BPD)
timeFrame: 36 weeks corrected gestational age
measure: Number of Participants With Necrotizing Enterocolitis (NEC)
timeFrame: 36 weeks corrected gestational age
measure: Number of Participants With Air Leak Disorders
timeFrame: 36 weeks corrected gestational age
measure: Weight Gain
timeFrame: 36 weeks corrected gestational age
measure: Length of Hospital Stay
timeFrame: about 10 to 18 weeks
measure: Number of Participants Who Died
timeFrame: until discharge (about 10 to 18 weeks) or death
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Claire Beaullieu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476735: Individual Approach for Bowel Preparation Before Colonoscopy
Official title: A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Split-dose Bowel Preparation
Polyethylene Glycol Solution
Risk Factors Inadequate Preparation
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 266
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: This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.

Detailed description: Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation.

Eligibility criteria: Inclusion Criteria:

* men and women more than 18 years of age undergoing colonoscopy for routine clinical indications
* provided written informed consent

Exclusion Criteria:

* lack of written informed consent or inability to provide informed consent or refusal to consent to the study
* pregnancy and breast feeding
* known allergy to PEG or bisakodyl
* presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs
* colonoscopy performed under conscious sedation

Primary outcomes:
measure: the index of preparation quality for the whole colon
timeFrame: 24 hours
Secondary outcomes:
measure: compliance safety
timeFrame: 24 hours
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology
Study officials:
affiliation: Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
name: Jaroslaw Regula, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
name: Michal F. Kaminski, MD
role: STUDY_CHAIR
affiliation: Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
name: Dorota Wretowska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00110435: A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-05-10
Enrollment: 1229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Type 2 Diabetes Mellitus that is poorly controlled

Primary outcomes:
measure: Percent reduction in LDL-C from baseline after 6 weeks of treatment
Secondary outcomes:
measure: Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Goldberg RB, Guyton JR, Mazzone T, Weinstock RS, Polis A, Edwards P, Tomassini JE, Tershakovec AM. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006 Dec;81(12):1579-88. doi: 10.4065/81.12.1579.
citation: Tomassini JE, Mazzone T, Goldberg RB, Guyton JR, Weinstock RS, Polis A, Jensen E, Tershakovec AM. Effect of ezetimibe/simvastatin compared with atorvastatin on lipoprotein subclasses in patients with type 2 diabetes and hypercholesterolaemia. Diabetes Obes Metab. 2009 Sep;11(9):855-64. doi: 10.1111/j.1463-1326.2009.01061.x. Epub 2009 Jun 5.
Clinical trial NCT05414435: Informed Consent in Endoscopy: Read, Understood or Merely Signed?
Official title: Informed Consent in Endoscopy: Read, Understood or Merely Signed?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informed Consent
Gastrointestinal Endoscopy
Lead sponsor: Centro Hospitalar Tondela-Viseu
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients refered for elective endoscopic procedures

Brief summary: Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed.

The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.


Eligibility criteria: Inclusion Criteria:

* Adult patients able to autonomously give informed consent
* Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.

Exclusion Criteria:

* Patients refered to urgent endoscopic procedures
* Patients refered for endoscopic procedures with deep sedation

Primary outcomes:
measure: Assessing the percentage of patients who adequate read informed consent forms
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Centro Hospitalar Tondela Viseu
Study officials:
affiliation: Centro Hospitalar Tondela-Viseu, E.P.E.
name: Ricardo A Cardoso, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04378335: Assessment of Orality Disorders in Children With Food Allergies
Official title: Assessment of Orality Disorders in Children With Food Allergies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy in Children
6 Years Old Maximum
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.

The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.


Eligibility criteria: Inclusion Criteria:

* Every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of University Hospital of Angers
* obtention of informed consent

Exclusion Criteria:

* Child with allergy other than food
* poor understanding of french

Primary outcomes:
measure: Prevalence of orality disorder in children with food allergy
timeFrame: Enrollment
Secondary outcomes:
measure: Link between orality disorder and number of excluded food, time from excluded regimen, age of the beginning of diet diversification, breastfeeding and duration,status of the child in the family and demographic data.
timeFrame: Enrollment
measure: Link between food allergies and orality disorder
timeFrame: Enrollment
measure: Prevalence of dysphagia criteria
timeFrame: Enrollment
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References:
Clinical trial NCT04570735: MRI Biomarkers in Diabetic Kidney Disease
Official title: MRI Biomarkers in Diabetic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Nephropathies
Keywords: obesity
diabetic nephropathies
biomarkers
metabolites
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes with or without diabetic kidney disease and patients with obesity and no diabetes

Brief summary: Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.


Eligibility criteria: Inclusion Criteria:

Common to all 3 category

* Male or female,
* Age≥ 35 years,
* Subject free, with legal protection guardianship or curatorship;
* Enrollment in the French Social Security system;
* Informed consent signed by the patient

Obese patients

* BMI \>30 kgm² ;
* With no known diabetes;
* estimated glomerular filtration rate (eGFR) \> 60 ml/min/1.73m² and urine albumin-creatinin ratio (ACR) \< 3 mg/g

Type 2 diabetic patients without kidney disease

- eGFR \> 60 ml/min/1.73m² AND ACR \< 3 mg/g,

Type 2 diabetic patients with diabetic kidney disease defined as eGFR 30 to 60 ml/min/1.73m² OR ACR \> 30 mg/mmol.

Exclusion Criteria:

Age \< 35 years History of kidney transplant Any contraindication to an MRI examination Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations Pregnant or lactating women, women of childbearing age who do not have effective contraception

Primary outcomes:
measure: Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups
timeFrame: 1 month
Secondary outcomes:
measure: Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years
timeFrame: 3 years
measure: Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.
timeFrame: 1 month
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
Clinical trial NCT02779335: Enteral Formula Tolerance in Pediatric Patients
Official title: Enteral Formula Tolerance in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Keywords: tube-fed
Formula Tolerance
Pediatric Patients
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.

Detailed description: In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.

Eligibility criteria: Inclusion Criteria:

* 1 - 13 years of age
* Currently tolerating enteral feeding
* Has enteral access
* Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
* Having obtained his/her and/or his/her legal representative's informed consent

Exclusion Criteria:

* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
* Judged to be at risk for poor compliance to the study protocol
* Lack of informed consent
* Currently participating in another conflicting clinical trial

Primary outcomes:
measure: Daily percentage of caloric nutritional goal met
timeFrame: 9 days
Secondary outcomes:
measure: Daily percentage of protein goal met
timeFrame: 9 days
measure: Daily assessment of gastrointestinal tolerance - stool consistency
timeFrame: 9 days
measure: Daily assessment of gastrointestinal tolerance- Stool frequency
timeFrame: 9 days
measure: Daily assessment of gastrointestinal tolerance- Vomit
timeFrame: 9 days
measure: Daily assessment of gastrointestinal tolerance - Flatulence
timeFrame: 9 days
measure: Daily assessment of gastrointestinal tolerance - Abdominal pain
timeFrame: 9 days
measure: Frequency and nature of adverse events
timeFrame: 9 days
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Children's Center for GI and Nutrition
state: Florida
Study officials:
affiliation: Children's Center for GI and Nutrition
name: Gerard Minor, MMS, PA-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06156735: Music Therapy on Cognition in Neurorehabilitation
Official title: The Effect of Music Therapy on Cognition in Neurorehabilitation - A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Stroke
Traumatic Brain Injury
Keywords: Music therapy
Active
Passive
neurorehabilitation needs
Cognition
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: participant will receive one passive music therapy session consisting of relaxation to music, one active music therapy session consisting of instrument-playing, and one control condition.
Primary purpose: TREATMENT

Brief summary: Music therapy has received more attention with its surging application in neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation research conducted in Malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.

Detailed description: Music therapy has received more attention with its surging application in neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation research conducted in Malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.

Thirty subjects participated in this study. Each participant received one session of each of the following: active music therapy intervention, passive music therapy intervention, and standard card. Mini-Cog tests were conducted before and after each session and the scores were collected for data analysis. Throughout the study, observations ensured the troubleshooting of any potential flaws for future recommendations.

Eligibility criteria: Inclusion Criteria:

* NeuroRehabilitation Needs

Exclusion Criteria:

* obtain a score of above 22 or below 10 on the MMSE
* have documented current/active episodes of hallucinations and/or delusions
* have documented hearing impairments with or without hearing aid(s)
* have language barrier, i.e. do not speak or understand English, Mandarin or Malay

Primary outcomes:
measure: Mini-Cog™ test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Malaca
country: Malaysia
facility: SOSCO Rehabilitation Centre
state: Malacca
Study officials:
References: