louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02523924: Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Official title: Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.

Detailed description: 18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* History of adenocarcinoma of the prostate treated with radical prostatectomy
* Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment
* Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment

Exclusion Criteria:

* Intention to enroll in a blinded therapeutic clinical trial
* History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)

Primary outcomes:
measure: Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
timeFrame: 6 months
measure: Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
timeFrame: 6 months
measure: Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)
timeFrame: 6 months
measure: Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens
timeFrame: 6 months
Other outcomes:
measure: Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression
timeFrame: 6 months
measure: Assessment of Treatment Response by 18F-DCFPyL PET/CT
timeFrame: 6 months
Locations:
city: Baltimore
country: United States
facility: SKCCC
state: Maryland
Study officials:
References:
Clinical trial NCT02851524: Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.
Official title: Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Stimulation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Falls in the elderly population are a major public health problem because of their frequency and their consequences, notably in terms of dependence their cost to society. In most cases, balance disorders related to an impaired vestibular system are blamed, even though there is no formal evidence that this is the case.

Vestibular tests in routine otoneurological practice are based on the exploration of vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to screen for vestibular disorders in falls.

A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as the pathways via which vestibular afferents are transported to the subject's conscience. Thanks to this apparatus, a stimulus of body movement will be generated, but with limited tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone is able to indicate to subjects their position in space. The subject will be required to detect oscillatory movement, and then to distinguish between a vestibular stimulus and a pulsed auditory stimulus.

The study hypothesis is that the movement stimulation generated by our prototype will be sufficient to stimulate the vestibular system, which will manifest itself as a conscious sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* National health insurance cover
* Written consent
* Subjects able to understand simple instructions and packaging information and to provide informed consent

Exclusion Criteria:

* Vertigo, consciousness disorders, nausea or pain before the tests
* Bilateral deafness
* History of neurological, rheumatic or orthopaedic disease likely by itself to trigger a fall
* Psychiatric disorder likely to compromise participation.
* Personal history of falls of undetermined cause.
* Présence de saccades et/ou nystagmus en position statique
* Femme enceinte

Primary outcomes:
measure: Cinematics of eye movements (amplitude and direction) evaluated by videonystagmography (VNG).
timeFrame: At Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01842724: Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study
Official title: Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-rheumatoid Wrist Arthritis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.


Eligibility criteria: Inclusion Criteria:

* Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
* Age 18-70 years
* ASA class 1-3

Primary outcomes:
measure: PRWHE (Patient rated Wrist and Hand Evaluation score)
timeFrame: 24 months postop
Secondary outcomes:
measure: Wrist movement
timeFrame: 24 months postop
measure: Grip Strength
timeFrame: 24 months postop
measure: Pain in affected wrist
timeFrame: 24 months postop
measure: Quick-DASH
timeFrame: 24 months postop
measure: intraoperative complications
timeFrame: intraoperative
measure: Postoperative complications
timeFrame: 24 months postop
measure: Implant loosening
timeFrame: 24 months postop
measure: Implant migration
timeFrame: 24 months postop
measure: Periprosthetic bone mineral density
timeFrame: 24 months postop
measure: Reoperations
timeFrame: 24 months postop
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Trygve Holm Glad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02899624: Whole Exome Sequencing in Bicuspid Aortic Valve Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bicuspid Aortic Valve
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined by the presence of two sigmoid valves instead of three. It is conventionally associated with histological abnormalities of the wall of the ascending aorta, risk factors of aortic dystrophy observed in 50% of cases, and dissection. Long considered an accident of development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and aortic dystrophy suggests the existence of a genetic predisposition and a common genetic origin for these two pathologies.

Data on the genetic basis of the BAV are still limited, but the existence of a large phenotypic diversity suggests the involvement of other genes. The establishment of large collections of DNA will allow great advances in this field.

The purpose of this project is to confirm the existence of a genetic determinism at the origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying genetic defects associated with the presence of a BAV in a series of candidate genes.


Eligibility criteria: Inclusion Criteria:

* bicuspid aortic valve, confirmed by transthoracic or transesophageal echocardiography
* With or without an aneurysm of the ascending thoracic aorta nonsyndromic

Exclusion Criteria:

* aortic syndromic pathology
* antecedent of acute articular rhumatism

Primary outcomes:
measure: number of genetic abnormalities
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT05400824: Metabolic and Infectious Diseases in La Réunion (the REUNION Population-based Study)
Official title: Pathologies métaboliques et Infectieuses en Population générale à La Réunion : étude REUNION
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infectious Disease
Cardiovascular Diseases
General Population
Metabolic Disease
Keywords: epidemiology
risk factors
prevalence
cognitive impairment
dengue
hypertension
dyslipidemia
social inequalities
autonomous nervous system
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2022-06-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult men and women ramdomly selected from the voter registration lists in La Réunion island

Brief summary: The aim of the present study is to determine the prevalence of cardiometabolic and infectious disease in La Reunion (french oversea department and region of France).

Known or suspected risk factor for these diseases will also be assessed, such as microbiota, cognitive impairement, social inequalities, and genetics.

Detailed description: Overall, 2000 men and women will be recruited during two years for an extensive clinical examination including a microbiota, blood, hair and DNA collection, cognitive tests, autonomous nervous system assessment, spirometry, pulse wave velocity measurement, a carotid doppler echo tracking.

Eligibility criteria: Inclusion Criteria:

* 18-67 years
* given consent for genetic analysis,
* written consent for participating in the study

Exclusion Criteria:

* judicial protection or guardianship

Primary outcomes:
measure: Prevalence of cardiometabolic diseases
timeFrame: cross sectional (at inclusion)
measure: Prevalence of infectious diseases
timeFrame: cross sectional (at inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: La Réunion
country: France
facility: Centre Hospitalier Universitaire de La Réunion
state: Saint-Pierre
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Maxime COURNOT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Olivier MEILHAC, PhD
role: STUDY_DIRECTOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Patrick MAVINGUI, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02323724: APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.
Official title: APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillary Thyroid Carcinoma
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí

Brief summary: To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System)

Detailed description: Aim of the study To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System).

Design: Retrospective observational study. Scope: The study will be peformed at the Pathology Service, from cytological samples and paraffin file post-diagnosis. Mutations are detected by pyrosequencing technique.

Subject of study:

Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí.

Methodology:

* Identification of cases
* Detection of BRAF V600E mutation, initially in histological material from the surgical specimen, and if present, detection in cytological material.

The statistical analysis will use SPSS. Univariate and bivariate analysis will be done. Results will be presented in the form of frequency tables and percentages for qualitative variables and by average, median and standard deviation for quantitative variables. Pearson chi-square or Fisher's exact test will be applied. The Student t test or the Mann-Whitney test will be performed for quantitative variables.

Eligibility criteria: Inclusion Criteria:

* Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí

Exclusion Criteria:

* Non available cytological or histological material

Primary outcomes:
measure: Improvement in diagnosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
References:
Clinical trial NCT01589224: Risk Factor Analysis for Coronary Atherosclerosis Measured by MDCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Metabolic Syndrome
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Apparently healthy people who underwent medical routine check up in Korea Helath Promotion Center.

Brief summary: Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well as various inflammatory markers have been known as direct regulators of atherosclerosis. Therefore, the investigators examine the correlation of various metabolic risk factors including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT in apparently healthy people.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy people who underwent medical routine check up in Korea Health Promotion Center.
* age \> 20 years

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension
* Severe renal or hepatic disease

Primary outcomes:
measure: relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT
timeFrame: 3month
Secondary outcomes:
measure: relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT
timeFrame: 3months
measure: the correlation of various inflammatory markers with coronary atherosclerosis
timeFrame: 3months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: korea University Guro Hospital
Study officials:
References:
Clinical trial NCT00926224: Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
Official title: Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fibrosis
Cirrhosis
Keywords: Adult patients with chronic liver disease scheduled for a liver biopsy and a BMI superior or equal to 28 kg/m²
Lead sponsor: Echosens
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the study is to evaluate the diagnostic performance of the XL probe for estimating degree of liver fibrosis/cirrhosis in obese patients \> 28 kg/m² with various liver diseases in patients with chronic liver disease scheduled for a liver biopsy.


Eligibility criteria: Inclusion Criteria:

* Patient of at least 18 years of age
* Patient able to give written informed consent form
* Patient with a BMI superior or equal to 28kg/m²
* Patient scheduled to have a liver biopsy within 1 month after the enrollment or with a liver biopsy performed within 6 months before the enrollment.
* Patient for which abdominal ultrasound is technically possible

Exclusion Criteria:

* Unable or unwilling to provide written informed consent
* Confirmed diagnosis and/or history of malignancy, or other terminal disease
* Patients with clinical ascites
* Pregnant women
* Patient with a BMI \< 28 kg/m²
* Patients with any active implantable medical device (such as pacemaker or defibrillator)
* Transplanted patient and patient with heart disease
* Refusal to undergo a liver biopsy

Primary outcomes:
measure: diagnosis accuracy for the assement of significant fibrosis and cirrhosis
timeFrame: at enrollement
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary University Hospital
state: Alberta
city: London
country: Canada
facility: London University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Montreal
country: Canada
facility: Saint-Luc University
state: Quebec
Study officials:
References:
Clinical trial NCT04103424: Mitochondrial Remodeling After Exercise
Official title: Mitochondrial Remodeling After Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Insulin Resistance
Metabolic Disease
Mitochondrial Metabolism
Sedentary Lifestyle
Lead sponsor: Oregon State University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be asked to complete 2 screening visits to determine eligibility. If participants remain eligible, they will be asked to complete 2 metabolic study visits, 1 before and 1 after 2 weeks of supervised exercise training on a stationary bike.
Primary purpose: BASIC_SCIENCE

Brief summary: Regulation of mitochondrial health in overweight and obese individuals may be impaired. The purpose of this study is to identify impairments in regulation of mitochondrial health within skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such impairments. The investigator's hypothesis is that pathways that serve to degrade poorly functioning mitochondria in overweight and obese individuals are down-regulated, but that short-term exercise training can restore these pathways to improve skeletal muscle mitochondrial function.


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years
* Body mass index (BMI) 18-45 kg/m2
* Sedentary (\<1 hour of planned exercise per week)

Exclusion Criteria:

* Regular exercise (\>1 hour of planned exercise per week)
* Smoking, tobacco or nicotine use within the last 1-year
* Fasting glucose \>126mg/dL
* Hypertension (systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg)
* Chronic metabolic or cardiovascular health conditions
* Pregnant, nursing, irregular menses or post-menopausal
* Lidocaine allergy
* Certain medications
* Physical limitations that prevent safe or successful exercise completion
* Diminished capacity for consent

Primary outcomes:
measure: Change in skeletal muscle mitochondrial protein degradation peptide products
timeFrame: After 2-weeks of exercise training compared with before training.
Secondary outcomes:
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Sean Newsom, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon State University
name: Matthew Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02989324: Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy
Official title: Low Dose Vaginal Misoprostol With or Without Foley Catheter for Late Second Trimester Pregnancy Termination in Women With Previous Multiple Cesarean Sections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Late Second Trimester Termination of Pregnancy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2016-12-12
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Detailed description: this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.

Eligibility criteria: Inclusion Criteria:late second trimester

* IUFD
* Previous Multiple Cesarean Sections

Exclusion Criteria:Low lying placenta

* asthma
* allergy to misoprostol
* patient refuse to participate

Primary outcomes:
measure: induction to expulsion interval
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
name: ibrahim A el sharkwy, MD
role: PRINCIPAL_INVESTIGATOR
References: