louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01496768: Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects
Official title: Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects: a Randomized, Double-blind, and Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Effect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and Strenght
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effects of chronic leucine supplemetion on glucose homeostasis, body compositin, muscle mass and strength of healthy and young subjects


Eligibility criteria: Inclusion Criteria:

* Non-smokers;
* Healthy;
* Non-users of dietary supplements and drugs
* Not engaged in any regular physical activity program

Exclusion Criteria:

* Vegetarians

Primary outcomes:
measure: Muscle strenght
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
measure: Muscle cross-sectional area
timeFrame: 3 months
Secondary outcomes:
measure: Glucose homeostasis
timeFrame: 3 months
measure: Lipid profile
timeFrame: 3 months
measure: Systemic inflammation
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of São Paulo - School of Physical Education and Sports
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Kerolyn de Souza Valente
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03329768: Evaluation of Medical Device
Official title: Evaluation of Peripheral Intravenous Catheter and Urinary Catheters Present on Admission to the "Maladies Infectieuses aiguës" Department.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Infectious Diseases
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an intravenous and/or urinary catheter on admission in the department of "Maladies infectieuses aigues" (MIA) Hopital de la Timone AP-HM.

Brief summary: A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to MIA with an intravenous and/or a urinary catheter.

the investigators analyzed:

* the demographic characteristics of the patient
* the final diagnosis
* the patient's severity and the patient outcome after discharge from MIA
* the justification of the venous and or a urinary catheter
* the duration of the prescription of the device Evaluation on admission of the need to maintain an intravenous or urinary catheter. Adjusting the prescription in terms of duration or withdrawal of the device in order to limit their complications (lymphangitis, superficial thrombophlebitis, bacteremia related to health care, urinary tract infection).

Hypothesis:

Limit the length of stay and reduce the cost of hospitalization.


Eligibility criteria: Inclusion Criteria:

* Patient with an intravenous catheter and/or a urinary catheter.
* Patient is more than 18 years old.
* Patient who accepts to have his medical records reviewed for research.
* Patient with health insurance

Exclusion Criteria:

* Refusal of participation in the study

Primary outcomes:
measure: number of patients with intravenous catheter
timeFrame: 3 YEARS
measure: number of patients with urinary catheter
timeFrame: 3 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: jean-olivier ARNAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05184868: AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study
Official title: Phase 1 Randomized, Double-blind, Three Period, Crossover Study Comparing PD/PK, Safety and Tolerability Profiles for Arecor Ultra-rapid Insulin Aspart (AT247), NovoLog® and Fiasp® in Participants With T1DM During CSII
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Arecor Limited
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus (T1DM) during continuous subcutaneous infusion (CSII)


Eligibility criteria: Inclusion Criteria:

1. Subjects diagnosed with T1DM for at least 12 months.
2. Subjects who have been using an approved insulin pump or use multiple daily injections with basal and bolus insulin, with a stable total insulin dose \<1.2 U/kg/day and bolus insulin dose \<0.7 U/kg/day for at least 3 months.
3. Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration \>90 mg/dL.
4. HbA1c concentration of ≤8.5% (≤69 mmol/mol).
5. BMI within the range ≥18.5 - ≤28.0 kg/m2.

Exclusion Criteria:

1. Known or suspected hypersensitivity to IMP or related products.
2. History or presence of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any in-situ carcinomas are allowed.
3. Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.
4. Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and/or for diastolic blood pressure greater than 90 mmHg.
5. Smoking more than 5 cigarettes per day or equivalent use of any tobacco containing product, and unable to refrain from smoking during the in-house periods of the study. A positive urine cotinine test at screening and check-in.

Primary outcomes:
measure: Area under Curve for serum insulin
timeFrame: 0-30 minutes
measure: Area under Curve for Glucose Infusion Rate
timeFrame: 0-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento, Inc
state: California
Study officials:
References:
Clinical trial NCT01024868: Assessment of Spread of Transversus Abdominis Plane Block
Official title: Assessment of Spread of Transversus Abdominis Plane Block After Administration of 20 ml Ropivacaine 0,5% Bilaterally
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transversus Abdominis Plane Block
Keywords: Transversus Abdominis Plane Block
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
First posted: 2009-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing abdominal surgery

Brief summary: For the purpose of assessing the spread of the local anaesthetic after injecting it between abdominal muscles on both sides, the investigators will test if the patient can feel a change in the perception of cold and warm, as well as being pricked with a blunt needle. The investigators will also take several blood samples, together with routine samples, to measure the concentration of the local anesthetic in the blood.


Eligibility criteria: Inclusion Criteria:

* undergo abdominal surgery, eligible for TAP block, over 18, BMI 20-40

Exclusion Criteria:

* does not speak danish, does not consent, does not fulfill inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital
Study officials:
affiliation: Herlev Hospital
name: Ann M Møller, dr. med.
role: STUDY_DIRECTOR
References:
citation: Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.
citation: Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.
Clinical trial NCT03331068: French Validation of the Memorial Anxiety Scale for Patients With Prostate Cancer.
Official title: Memorial Anxiety Scale for Patients With Prostate Cancer: French Validation, Links With Quality Of Life and Future Temporal Perspective.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-11-06
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists in adult patients with prostate cancer diagnosed within 12 months.

Brief summary: A specific scale allowing the measure of anxiety of patients with protate cancer has been designed and validated but the French version needs to be validated. This study aims at validating the French translation of this scale.

Detailed description: The psychological difficulties encountered by patients with prostate cancer are widely known. There are, however, problems in the identification of certain disorders that require appropriate psychological management. In order to diagnose patients with anxiety more finely, a prostate cancer-specific anxiety measurement scale (MAX-PC) was developed and validated. This scale includes three sub-dimensions: anxiety related to prostate cancer, anxiety related to the PSA assessment and fear of recurrence. This scale generally has good psychometric properties which are found in different populations and in different countries. The dimensions of the MAX-PC correlate with other anxiety measurement scales such as Beck or HADS, but do not show redundancy: it captures a specific anxiety related to the experience of patients with prostate cancer.

To date, this sclae is not validated in French, and its use in the frame of clinical trials or in routine practice require a first validation.

Eligibility criteria: Inclusion Criteria:

* Patients with prostate cancer diagnosed within 12 months

Exclusion Criteria:

N/A

Primary outcomes:
measure: Total anxiety score assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC scale)
timeFrame: At inclusion
Secondary outcomes:
measure: Quality of Life (QoL) scores assessed by the SF-12 scale
timeFrame: At inclusion
measure: Anxiety score assessed by the HADS scale
timeFrame: At inclusion
measure: Depression score assessed by the HADS scale
timeFrame: At inclusion
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Gwenaelle GRAVIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172868: Home Ventilatory Support in Children
Official title: Home Ventilatory Support in Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep Apnea Syndromes in Children
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 94
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 93 patients treated by a multidisciplinary paediatric home ventilatory support -team from January 2010 to December 2020 in Tampere University Hospital. The individuals were identified combining two sources: the team´s clinical list of patients and a database search from patient records with ICD-10 diagnose G47.3 (Sleep Apnea) in Pediatric Patient records.

Brief summary: The study consist of children, who have used home ventilatory support during years 2010-2020 in Tampere University Hospital. The study will describe retrospectively different diagnoses and symptoms which will lead to home ventilatory support. We also study compliance to treatment and it's disanvantages. The prospective part of the study describes the quality of live of these children by using questionnaires (PedSQL).


Eligibility criteria: Inclusion Criteria:

- ICD-10 Code for Sleep apnea diagnose G47.3 AND G47.3 diagnose found from pediatric electronic patient records between years 2010-2020 OR Patient name found from pediatric multidisciplinary home respiratory team's clinical list

Exclusion Criteria:

* Age over 16
* Patient starting home ventilation after 31st December 2020 or treatment ending before 1st January 2010
* patients with sleep apnea but without home respiratory support treatment
* Only theophylline treatment
* High-flow oxygen therapy
* Age over 16 at treatment onset
* Never started treatment
* Treatment starting point and ending before year 2010

Primary outcomes:
measure: Patient demographics of patients from 0 up to 16 years old treated by a multidisciplinary home respiratory support-team during January 2010 to December 2020 in Tampere University Hospital, Finland
timeFrame: 2022-2023
measure: Number of patients with clinical characteristics
timeFrame: 2022-2023
Secondary outcomes:
measure: The duration of treatment
timeFrame: 2022-2023
Other outcomes:
Locations:
city: Ilmajoki
country: Finland
facility: Mervi Järvelä
Study officials:
References:
Clinical trial NCT03927768: Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP)
Official title: Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP): a Short, Comprehensive Breast MRI Exam Ready for Clinical Prime Time.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 women scheduled for clinical breast MRI

Brief summary: The purpose of this study is to use a magnetic resonance imaging (MRI) sequence called golden-angle radial compressed sensing and parallel imaging (GRASP) as a noninvasive and fast way to measure the wash-in contrast (dye) in the breast. MRI uses a strong magnetic field and radio waves to create images of structures in the body. The goal is to determine if benign and malignant breast lesions have different patterns of contrast wash in.

This study will ask woman planning to undergo a clinical breast MRI with contrast (dye) as part of their standard care.


Eligibility criteria: Inclusion Criteria:

* No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet)
* Able and willing to provide informed consent

Exclusion Criteria:

* Currently undergoing neoadjuvant chemotherapy for breast cancer treatment.

Primary outcomes:
measure: To evaluate the diagnostic accuracy of GRASP AB-MRI temporal kinetics in the diagnosis of breast malignancies.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Laura Heacock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04651972: Measurement of vanilloïd Compounds in Urin of Autistic vs Control Patients, as Potential Biomarkers
Official title: Diagnostic of Autism by Measurement of vanilloïd Compounds in Urin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 140
Sex: MALE
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Autistic children according to CM-10 (F84.0)

Brief summary: In a former study, four vanilloid compounds were observed increased in the urin of autistic patients. The present study is aimed at performing a ambispective study to confirm or not these preliminary results. 70 urins from autistic children (already collected) will be compared to 70 urins of non autistic children (collected without intervention, remaining sample from the standard care), in terms of measurements of four vanilloid compounds using a GCMS apparatus.


Eligibility criteria: Inclusion criteria :

For cases :

* Male children aged 2 years to less than 15 years inclusive years at time of sample collection
* Children with a diagnosis of autism (ICD-10 F84.0) after assessment by a child psychiatrist.

For healthy chlidren:

* Children aged 2 years to less than 15 years old performing an ECBU at the CHRU of Nancy as part of their care.
* Patient whose ECBU is negative with respect to cytobacteriology (absence of urinary infection).
* Child can be matched to a CAS

Exclusion criteria

For cases:

* Children in whom one of the following pathologies is found during the anamnesis or in the clinical record : (i) renal insufficiency; (ii) urinary tract infection at the time of sampling and/or metabolic disease
* Children on antibiotic treatment at the time of collection

For healthy chlidren :

* children whose urine culture come from one of the following departments: Pediatric Nephrology (potential risk of renal failure) or Pediatric Neurology (potential risk of neurological disorder).
* with a diagnosis of autism
* with a metabolic disease
* children undergoing antibiotic treatment at the time of collectio

Primary outcomes:
measure: measurements of vanilloid compound in urins
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHRU Nancy
name: Jean-Luc Olivier, MD, PhD,
role: STUDY_DIRECTOR
References:
Clinical trial NCT02553772: A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
Official title: A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 242
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 study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Used artificial tears for dry eye
* Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
* Herpes keratitis in the last 6 months
* Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months

Primary outcomes:
measure: Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
timeFrame: Baseline, Day 90
Secondary outcomes:
measure: Change From Baseline in Tear Break-up Time (TBUT)
timeFrame: Baseline, Day 90
measure: Change From Baseline in Corneal Staining Score
timeFrame: Baseline, Day 90
measure: Change From Baseline in Conjunctival Staining Score
timeFrame: Baseline, Day 90
measure: Change From Baseline in the Schirmer Test
timeFrame: Baseline, Day 90
Other outcomes:
Locations:
city: Azusa
country: United States
facility: The Private Practice of Milton Hom, OD
state: California
city: Burbank
country: United States
facility: Havana Research Institute LLC
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: San Diego
country: United States
facility: Eric M. White, OD, INC
state: California
city: Kansas City
country: United States
facility: Moyes Eye Center, PC
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott and Christie and Associate
state: Pennsylvania
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Parkville
country: Australia
facility: Department of Optometry & Vision Sciences, The University of Melbourne
city: Randwick
country: Australia
facility: Prof. M.T. Coroneo Pty. Ltd.
city: Sydney
country: Australia
facility: The University of New South Wales School of Optometry and Vision Science
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00521872: Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
Official title: Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Constipation
Keywords: surgery (STARR operation)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-08-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.

* Trial with surgical intervention


Eligibility criteria: Inclusion criteria:

* All patients at our institution treated with the STARR operation

Exclusion criteria:

* Age under 18,
* Chronic or acute inflammatory disease of the bowel or rectum

Primary outcomes:
measure: Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References: