louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03696927: Active Powered Prosthesis (APEX) for Spinal Cord Injury
Official title: Active Powered Prosthesis (APEX) for Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: AbiliTech Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Allina Health System
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-10-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. The objective of this study is to perform focus groups with users and clinicians to evaluate a proof of concept active powered assistance device.


Eligibility criteria: Inclusion Criteria:

1. Spinal cord injury at levels C3 to C5, and AIS A, B, or C
2. Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder
3. Ability to provide informed consent
4. Age 18 or over
5. Selected for participation based on investigator discretion

Exclusion Criteria:

1. Unable to follow instructions
2. Exhibit significant behavioral problems or impaired cognitive ability
3. Inability to provide consent
4. Non-English speaker

Primary outcomes:
measure: User Ability to Operate the APEX Device
timeFrame: Two hours of in-clinic prototype evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Allina Health Courage Kenny Rehabilitation Institute
state: Minnesota
Study officials:
affiliation: Allina Health System
name: Jennifer L Theis, MS, OT/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03312127: Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
Official title: Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Iliac Aneurysm
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.


Eligibility criteria: Inclusion Criteria:

* High surgical risk:

  * Comorbidity cardiopulmonary
  * Renal insufficiency
  * Hostile abdomen including ascites or portal hypertension
* Anatomic criteria:

  * Primitive iliac aneurysm superior to 25 mm without collar
  * Primitive iliac length superior to 40 mm
  * Primitive iliac distal diameter superior to 14 mm
  * Presence of internal iliac collar
* Affiliation to a social security system

Exclusion Criteria:

* Patient without surgical risk
* Non-respect of the Anatomic criteria
* Patient with known allergy to the materials of the device
* Patient with systemic infection
* Patient with severe renal insufficiency
* Patient unable to complete the oximetry test
* Persons under legal protection

Primary outcomes:
measure: Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
timeFrame: At the immediate post-operating follow-up visit
measure: Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
timeFrame: at 3 months after surgery
measure: Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
timeFrame: at 12 months after surgery
Secondary outcomes:
measure: Morbidity
timeFrame: peri-operative, at short term (3 months), mean-term (12 months)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Jean-Pierre BOSSAVY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01692327: Study About High Fat Meal and Postprandial Lipemia
Official title: Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: glucose intolerance (20)
Control (20)
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.

These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.

Detailed description: Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.

Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.

Eligibility criteria: Inclusion Criteria:

* all patients should have obesity class I (BMI between 30 and 35kg/m2);
* Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
* Presenting the age between 19 to 40 years.
* Waist circumference\> 80 cm (IDF)

Exclusion Criteria:

* Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
* Presence of dyslipidemia;
* smokers;
* Significant loss of body weight six months prior to the study.

Primary outcomes:
measure: Microvascular function
timeFrame: up to 180 minutes after high fat meal
Secondary outcomes:
measure: incretins hormones
timeFrame: basal, 30, 60, 120,180 minutes after high fat meal
Other outcomes:
Locations:
city: Rio de janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
References:
citation: de Souza MDGC, Maranhao PA, Panazzolo DG, Nogueira Neto JF, Bouskela E, Kraemer-Aguiar LG. Effects of a high-fat meal on inflammatory and endothelial injury biomarkers in accordance with adiposity status: a cross-sectional study. Nutr J. 2022 Oct 19;21(1):65. doi: 10.1186/s12937-022-00819-4.
Clinical trial NCT03686527: Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement
Official title: Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 277
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 with tight aortic stenosis with an indication of surgical treatment.

Brief summary: Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.


Eligibility criteria: Inclusion Criteria:

* major patient freely accepting to participate in the study
* non-opposition signed
* aortic surface \<1cm² or \<0.6cm² / m² of indication surgical restraint
* oriented to short interventional management surgical term
* LVEF Left ventricular ejection fraction\> 50%
* In the subgroup "MRI-fibrosis", absence of indication for performing MRI

Exclusion Criteria:

* patient under guardianship, curatorship or safeguard of justice
* minor patient
* pregnant woman
* patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement
* patient with severe coronary artery disease requiring revascularization
* allergy to the contrast product

Primary outcomes:
measure: The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement.
timeFrame: 1 day of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
state: Bretagne
Study officials:
References:
Clinical trial NCT03132727: Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer
Official title: Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypopharyngeal Carcinoma
Laryngeal Carcinoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 73
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 a laryngeal or hypopharyngeal cancer at any stage, with a doubt about cartilage invasion and eligible for surgical treatment.

Brief summary: To determine if MRI can detect preoperative invasion of cartilage by laryngeal and hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised larynges and/or hypopharynges.


Eligibility criteria: Inclusion Criteria:

* Patient ≥18 years old
* Patient with a laryngeal or hypopharyngeal cancer at any stage
* Patient eligible for a surgical treatment in multidisciplinary consultation
* Patient who did not oppose its participation to the study
* Indication for performing an MRI in addition to CT at the discretion of the investigator

Exclusion Criteria:

* Patient with an ASA ("American Society of Anesthesiologists", international anesthesia classification) score ≥ 3,
* Patient with a chirurgical contraindication
* Patient with a MRI contraindication
* Pregnant or nursing woman
* Adult requiring protection (guardianship, supervision)
* Patient participating in interventional research (Excluding physiological studies and interventional research involving only minimal risks and constraints that do not interfere with the analysis of the primary outcome).

Primary outcomes:
measure: Endoscopy
timeFrame: 1-4 weeks
measure: CT scan
timeFrame: 1-4 weeks
measure: MRI
timeFrame: 1-4 weeks
measure: Anatomopathological analysis
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse
Study officials:
affiliation: Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse
name: Philippe CERUSE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06647927: GenLab: Unveiling the Genetic Landscape of Brugada Syndrome: Novel Biomarker Discovery for Precise Diagnosis
Official title: Unveiling the Genetic Landscape of Brugada Syndrome: Novel Biomarker Discovery for Precise Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brugada Syndrome (BrS)
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria di Sassari
name: The National Research Council, Italy
First posted: 2024-10-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 350 patients affected by BrS coming from the same geographical area and age-sex balanced, when it's possible. The total sample includes at least 300 individuals from Sardinia, to whom pre-existing data of 100 patients will be added, already subject to the Whole Exome Sequencing (WES) at Policlinico San Donato.

Brief summary: This research makes several significant contributions to the field of BrS. It employs advanced genetic sequencing techniques to develop a genetic signature to improve the accuracy and efficiency of BrS diagnosis. The identification of specific biomolecular profiles and genetic signatures enhances our understanding of the syndrome's molecular mechanisms, facilitating targeted therapies and refined risk stratification. These advancements optimize patient care by enabling personalized treatment plans and risk assessment. Overall, this research adds value by advancing diagnostic methods, providing molecular insights, optimizing patient care, and positively impacting public health outcomes in BrS.

Detailed description: Our work on BrS is dedicated to decipher the pathogenic mechanism and to ameliorate diagnostic approaches by developing a non-invasive test. Employing a multi-omic strategy, we've identified potential biomarkers across proteins, metabolites, and lipids, leading to a filed patent for a promising biomolecular signature. Additionally, we've discovered associated gene mutations. This grant proposal aims to enhance our preliminary findings by studying a larger BrS cohort, supported by a meticulously curated patient registry. By integrating advanced whole-exome sequencing (WES) and machine learning , we aim to identify a genetic signature for BrS diagnosis and uncover altered pathways integral to BrS etiology. This could refine risk stratification strategies, contributing to improved diagnostic accuracy and deeper understanding BrS molecular mechanisms.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients affected by Brugada Syndrome
* Patients who signs the Informed Consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Multigenic Risk Score (MRS)
timeFrame: from October 2025 to June 2026
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: Irccs Policlinico San Donato
state: Milan
Study officials:
References:
Clinical trial NCT00115427: Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Parkinson's Disease
Keywords: Bilateral, Idiopathic Parkinson's Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-06-23
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period followed by implantation of the IPu delivery system and then a 6-month double-blind treatment period.


Eligibility criteria: Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease

Primary outcomes:
measure: United Parkinson's Disease Rating Scale
Secondary outcomes:
measure: Timed Motor Tests
measure: Dyskinesia ratings
measure: Diary ratings
measure: Patient reported outcomes measures
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01766427: Electroacupuncture for Hypertension Patients With Chronic Kidney Disease
Official title: Electroacupuncture for Hypertension Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HYPERTENSION RENAL
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: in the ward of the department of nephrology

Brief summary: 1. To observe the Efficiency of Electroacupuncture for Hypertension Patients With Chronic Kidney Disease.
2. To observe if different-time treatment having an impact on Hypertension Patients With Chronic Kidney Disease.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease patients with Hypertension

Exclusion Criteria:

* renal replacement therapy
* heart failure
* severe valvular disease
* sustained arrhythmias
* secondary hypertension excluded from renovascular hypertension
* acute cardiovascular events
* infection

Primary outcomes:
measure: 24 hours Ambulatory Blood Pressure Monitoring Mean arterial pressure change of participants
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Longhua hopsital
state: Shanghai
Study officials:
References:
Clinical trial NCT04863027: Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.
Official title: PHASE I-II Study on the Use of Dual Energy Computed Tomography for Assessment of Lung Function in Thoracic Conventional and Stereotactic Body Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lung Function Decreased
Radiation Pneumonitis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2021-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lung cancer planned for curative intent radiotherapy (conventional or stereotactic)

Brief summary: This is a prospective observational study aiming: 1) To quantify lung function using perfusion dual energy computed tomography (DECT) and use this information at the time of treatment planning with preferential sparing of functional lung parenchymal 2) to validate results of lung function obtained using DECT with lung perfusion scintigraphy results, the current standard method; 4) to compare dosimetry of whole lungs vs. functional lungs in patients treated with either stereotactic body radiotherapy (SBRT) for early stage lung cancer or conventional radiotherapy for locally advanced lung cancer and 5) to evaluate lung function 6, 12 and 24 months post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* ECOG 0-2
* Pulmonary neoplasia, confirmed histopathologically or by imaging
* Prognosis evaluated ≥ 1 year by attending MD
* Clinically acceptable lung capacity to undergo radiotherapy
* Initial assessment including history, physical examination, biochemistry, PFT, chest radiograph, chest and abdominal-pelvic scan, PET
* Written consent
* The patient must be available for treatment and monitoring. Patients registered in the study should be treated in our center.

Exclusion criteria

* Previous radiotherapy in the radiation field
* Presence of any major medical condition that, in the opinion of the investigator, would prevent follow-up at 6, 12 and 24 months post-radiotherapy.
* Iodine allergy
* Pregnancy and lactation

Primary outcomes:
measure: Lung function quantification at baseline
timeFrame: Baseline
measure: Radiation-induced lung function damage quantification
timeFrame: at 12 months after radiotherapy
measure: Radiation-induced lung function damage quantification
timeFrame: at 24 months after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT01437527: Body Image Therapy in Anorexia Nervosa
Official title: Body Image Therapy in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
CMME-TCA Unit
Centre Hospitalier Sainte Anne
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test a new procedure of body image therapy in anorexia nervosa, using the anamorphic micro software.

Detailed description: Anorexia nervosa is a severe psychiatric disorder, with high level of mortality and hospitalization is often necessary for the treatment of severe and/or chronic cases.

Anorexic patients often experience a serious disturbance in body and their own shape perception. Body image work should be enhanced in the treatment of anorexia nervosa.

The aim of the study is to test a new body image therapy using the anamorphic Micro software.

Ten sessions of assessment of the patient's own shape and of correction of distorted perceptions of body size with Anamorphic Micro software will be compared to ten sessions of body image therapy as usual.

French 100 anorexia women hospitalized in a specialized Eating Disorder Unit will participate to the study, randomized in 2 arms :

* Body image therapy with Anamorphic Micro software
* Body image therapy as usual

Eligibility criteria: Inclusion Criteria:

* woman
* more than 18 years old
* anorexia nervosa
* hospitalized in the CMME (CHSA) TCA Unit
* Body Mass Index ≥ 16
* Informed consent

Exclusion Criteria:

* pregnancy
* severe motor, sensitive or sensorial impairment
* no affiliation of national health service
* dependent of a trusteeship or guardianship

Primary outcomes:
measure: Body Shape Questionnaire
timeFrame: after the 10 sessions of body image therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
Study officials:
affiliation: Centre Hospitalier Sainte Anne
name: Alexandra PHAM - SCOTTEZ, MD
role: PRINCIPAL_INVESTIGATOR
References: