louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01801150: CPAP in Diabetes Type 2 Patients With Sleep Apnea
Official title: Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Sleep Apnea
Keywords: Diabetes
Apnea- hypopnea Syndrome
Glycemic control
Prevalence
SAHS
life quality
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To assess if six months of treatment with CPAP associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome SAHS)

Detailed description: Main objective:

To assess the effect of 6 months of CPAP treatment associated with conventional drug therapy on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)

Eligibility criteria: Inclusion Criteria:

* subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of HbA1c\> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (BMI ≥ 25 kg/m2)

Exclusion Criteria:

* professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale\> 18); morbid obesity (BMI\> 40 kg/m2); CPAP treatment

Primary outcomes:
measure: Glycemic control
timeFrame: Six months
Secondary outcomes:
measure: To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.
timeFrame: 6 months
Other outcomes:
measure: Impact of CPAP on glycemic control
timeFrame: 6 months
measure: Quality of life after CPAP
timeFrame: 6 months
measure: Inflammatory markers after CPAP
timeFrame: 6 months
measure: Endocrine control with CPAP treatment
timeFrame: 6 months
measure: Influence of body distribution and activity on metabolic control
timeFrame: 6 months
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz- IdiPaz
Study officials:
affiliation: Hospital Universitario La Paz, IdiPAZ
name: Francisco Garcia-Rio, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Paz, IdiPAZ
name: Elizabet Martínez-Cerón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espasses
name: Alberto Alonso-Fernández, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Ceron E, Barquiel B, Bezos AM, Casitas R, Galera R, Garcia-Benito C, Hernanz A, Alonso-Fernandez A, Garcia-Rio F. Effect of Continuous Positive Airway Pressure on Glycemic Control in Patients with Obstructive Sleep Apnea and Type 2 Diabetes. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Aug 15;194(4):476-85. doi: 10.1164/rccm.201510-1942OC.
Clinical trial NCT00132223: Effects on the Diagnostic Accuracy of Magnetic Imaging Angiographies of the Supra-Aortic Vessels by Three Different Magnetic Resonance Contrast Agents in Patients
Official title: Effects on the Diagnostic Accuracy of Magnetic Imaging Angiographies of the Supra-Aortic Vessels by Three Different Magnetic Resonance Contrast Agents in Patients With Headache and Dizziness or Epilepsy and Clinical Indication for an Angiography by Magnetic Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Headache
Epilepsy
Dizziness
Keywords: magnetic imaging
angiography
contrast agent
signal/noise ratio
contrast/noise ratio
vessel
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Angiographies of the supra-aortic vessels by magnetic imaging have become common recently. So it was the purpose of this study to evaluate the imaging potential of different contrast agents.

Three contrast agents for magnetic resonance imaging are compared in angiographies of the supra-aortic arteries in a intraindividual study of 10 patients.

All applications of these contrast agents are performed with a flow of 2 ml/s. One contrast medium is applicated a second time with a reduced flow of 1 ml/s.

The angiographies of the supra-aortic vessels are evaluated by two experienced readers in a consensus reading. The signal/noise- and contrast/noise-ratio of anatomic vessel segments of the carotic and vertebral arteries are measured and compared to each other.


Eligibility criteria: Inclusion Criteria:

* Headache
* Epilepsia
* Dizziness

Exclusion Criteria:

* Pregnancy
* Metal implants (e.g. pacemaker)
* Contraindication for contrast agent
* Multiple allergies

Primary outcomes:
measure: intensity of vessels, muscle, air
Secondary outcomes:
measure: signal/noise ratio
measure: contrast/nose ratio
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University of Muenster, Dept. of Clinical Radiology
Study officials:
affiliation: University of Muenster, Dept. of Clinical Radiology
name: Bernd Tombach, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04712123: Recurrent S. Aureus Infections in Osteoarticular Infections
Official title: Recurrent S. Aureus Infections in Osteoarticular Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Aureus Infection
Bone and Joint Infection
Keywords: Staphylococcus Aureus Infection
Bone and Joint Infection
relapse
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 40
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: patients having had an osteoarticular infection with or without material due to S. aureus and treated at CRIOAc Lyon, presenting a recurrence of S. aureus infection

Brief summary: Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side.

The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus


Eligibility criteria: Inclusion Criteria:

* patients having had an osteoarticular infection with or without material due to S. aureus presenting a recurrence of S. aureus infection

Exclusion Criteria:

-

Primary outcomes:
measure: rate of patients having had an osteoarticular infection due to S. aureus
timeFrame: between 2015 and 2020
measure: Description of patients having had an osteoarticular infection due to S. aureus
timeFrame: between 2015 and 2020
measure: Description of Bone and Joint Iinfection/Prosthesis Joint Infection
timeFrame: between 2015 and 2020
Secondary outcomes:
measure: rate of patients having had a relapse due to persistence of S. aureus
timeFrame: between 2015 and 2020
measure: rate of S. aureus strain identical between the initial episode and the relapse
timeFrame: between 2015 and 2020
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT01349023: Energy Content and Energy Density of Pre-portioned Entrees
Official title: Effects of Energy Density and Energy Content of Pre-portioned entrées on Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: energy content
energy density
energy intake
pre-portioned entrees
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-05-06
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Pre-portioned entrées are commonly consumed to help control portion size and limit energy intake. Few studies, however, have investigated the influence of the characteristics of pre-portioned entrées on energy intake. This study investigates how the characteristics of solid pre-portioned entrées, specifically, variations in their energy content and energy density influence energy intake over a day. The investigators hypothesize that reducing the energy content and energy density of compulsory entrées will act independently and add together to reduce daily energy intake.

Detailed description: This experiment uses a crossover design with repeated measures within subjects. One day a week for four weeks, participants are provided with all of their foods and beverages for breakfast, lunch, and dinner meals. Across test days, the entrée at each meal is varied in both energy content and energy density between a standard level (100%) and a reduced level (64% of the standard). Following consumption of a compulsory entrée, a variety of unmanipulated foods will be served for ad libitum consumption. The order of experimental conditions is counterbalanced across the subjects.

Eligibility criteria: Inclusion Criteria:

* regularly eat three meals per day
* do not smoke
* do not have any food allergies or restrictions
* are not athletes in training
* are not dieting
* are not taking medications that would affect appetite
* are willing to consume the foods served in the test meals

Exclusion Criteria:

* a score \> 40 on the Zung scale
* a score \> 20 on the Eating Attitudes Test
* reported known health problems
* weight not maintained within 10 lb during the 6 months before the start of the study

Primary outcomes:
measure: Daily Energy Intake (kcal/day)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00333723: AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes Not Controlled by Glyburide Alone
Official title: A 24-Week Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of AVANDIA (8mg Once Daily) in Combination With Glyburide in African American and Hispanic Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Glyburide Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Rosiglitazone
Glyburide
Type 2 Diabetes Mellitus
African American
Hispanic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 245
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As microvascular and macrovascular disease are significant contributors to diabetes morbidity and mortality and previous studies suggest that the thiazolidinedione compounds could have potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum parameters associated with endothelial dysfunction, vascular inflammation and impaired fibrinolysis were examined in this study. Improvement in these parameters suggests that rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to improve glycemic control.


Eligibility criteria: Inclusion criteria:

* African American or Hispanic.
* Type 2 diabetes mellitus.
* FPG\>=140mg/dL plus HbA1c\>=7.5% whilst receiving SU monotherapy.

Exclusion criteria:

* Patients who use insulin.
* Clinically significant liver, kidney or heart disease, including high blood pressure.

Primary outcomes:
measure: Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy in reducing glycosylated hemoglobin (HbA1c).
timeFrame: 24 Weeks
Secondary outcomes:
measure: Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy upon FPG, c-peptide, HOMA and responder rates.
timeFrame: 24 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Abstract: Rosiglitazone Added to Sulfonylurea Improves Glycemic Control and Insulin Sensitivity in African American and Hispanic American Subjects with Type 2 Diabetes, CAMPBELL, JOHN C.; GOULD, ERROL M.; WATERHOUSE, BRIAN R.; COBITZ, ALEXANDER R. Orlando, FL; USA. 64th Annual Scientific Sessions of the American Diabetes Association. 6/4/2004
citation: Campbell JC, Gould EM, Waterhouse BR, Cobitz AR. Rosiglitazone added to sulfonylurea improves glycemic control and insulin sensitivity in African American and Hispanic American subjects with type 2 diabetes. Diabetes 2004;53(Suppl 2):A154. Poster 645 presented at ADA.
Clinical trial NCT04543123: Effect of Self-administered tDCS in Patients With MDD
Official title: Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Ybrain Inc.
First posted: 2020-09-09
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.

Detailed description: Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
* Greater than 22 points of Montgomery-Asberg Depression Rating Scale
* Aged 19 to 65.
* Has provided informed consent
* Has received Escitalopram as a combined antidepressant during the study period

Exclusion Criteria:

* Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
* History of suicidal attempt in the last 6 months
* Diagnosed with bipolar or psychotic major depressive disorder
* Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
* Has hypersensitivity to Escitalopram ingredients
* A score of 5 or greater for the question #10 in MADRS
* Diagnosed with closed angle glaucoma or has a history of glaucoma.
* History of participation in other clinical trials within 30days.
* A major and/or unstable medical or neurologic illness
* Currently taking substances pimozide
* Pregnant or has a positive pregnancy serum test.

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: Change from Baseline Hamilton Depression Scale at 6 weeks
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Weeks 0, 2, 4, and 6
measure: Montgomery-Asberg Depression Rating Scale
timeFrame: Weeks 0, 2, 4, and 6
measure: Beck Anxiety Inventory
timeFrame: Weeks 0, 2, 4, and 6
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
Study officials:
References:
Clinical trial NCT05187923: Computer Aided Tool for Diagnosis of Neck Masses in Children
Official title: Computer Aided Tool for Diagnosis of Neck Masses in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Mass
Thyroglossal Duct Cysts
Branchial Cleft Anomalies
Dermoid and Epidermoid Cysts
Infantile Hemangiomas
Teratomas
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 1500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were found neck masses, and had completed clinical information and radiological images before operation, biopsy, neoadjuvant chemotherapy, and radiotherapy.

Brief summary: The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for neck masses using machine learning and deep learning techniques on clinical information and radiological images in children.

Detailed description: This study is a retrospective-prospective design by West China Hospital, Sichuan University, including clinical data and radiological images. A retrospective database was enrolled for patients with definite histological diagnosis and available radiological images from June 2010 and December 2020. The investigators have constructed deep learning and machine learning diagnostic models on this retrospective cohort and validated it internally. A prospective cohort would recruit patients found neck masses since January 2021. The proposed computer aided diagnostic models would also be validated in this prospective cohort externally. The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for neck masses using machine learning and deep learning techniques on clinical data and radiological images in children.

Eligibility criteria: Inclusion Criteria:

* Age up to 18 years old
* Receiving no treatment before diagnosis
* With written informed consent

Exclusion Criteria:

* Clinical data missing
* Unavailable radiological images
* Without written informed consent

Primary outcomes:
measure: The diagnostic accuracy of neck masses with AI-based screening tools in children
timeFrame: 1 month
Secondary outcomes:
measure: The diagnostic sensitivity of neck masses with AI-based screening tools in children
timeFrame: 1 month
measure: The diagnostic specificity of neck masses with AI-based screening tools in children
timeFrame: 1 month
measure: The diagnostic positive predictive value of neck masses with AI-based screening tools in children
timeFrame: 1 month
measure: The diagnostic negative predictive value of neck masses with AI-based screening tools in children
timeFrame: 1 month
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT03948750: Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis
Official title: Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Toxoplasmosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis

Brief summary: Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

Detailed description: Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.

GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)

0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, \> 4: Diagnostic of intraocular antibody production to a specific microbial pathogen

Eligibility criteria: Inclusion Criteria:

* Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis

Exclusion Criteria:

* Immunocompromised patients

Primary outcomes:
measure: Comparison of Goldmann-Witmer coefficient and immunoblotting results
timeFrame: Assessment of each test result at the inclusion of the patient
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)
Study officials:
References:
Clinical trial NCT04177550: Early Results of Empyema Thoracis Treatment in Children by Video-assisted Thoracoscopic Surgery
Official title: Early Results of Empyema Thoracis Treatment in Children by Video-assisted Thoracoscopic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Empyema Thoracis in Children
Keywords: empyema thoracis
Thoracoscopic
VATS
Video-assisted Thoracoscopic Surgery
Pediatric Empyema Thoracis
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
Collaborators: name: Ho Trung Cuong
name: Trinh Nguyen Ha Vi
name: Tran Nhu Quynh
name: Vu Minh Thuy
name: Nguyen Thi Tuong Lam
First posted: 2019-11-26
Enrollment: 44
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient had empyema who treated by Video-assisted Thoracoscopic Surgery in Children hospital 1 from 01/01/2015 to 30/04/2019

Brief summary: The aim of study is to assess early results of Empyema Thoracis treatment in Children by Video-assisted Thoracoscopic Surgery


Eligibility criteria: Inclusion Criteria:

* All patients had empyema.
* All patients had been treated by Video-assisted Thoracoscopic Surgery in Children hospital 1 from 01/01/2015 to 30/04/2019.

Exclusion Criteria:

* The patient had empyema caused by Tuberculosis.

Primary outcomes:
measure: Recover
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Children hospital no.1
Study officials:
References: