louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01556360: Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study
Official title: Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Hemochromatosis
Keywords: genetic hemochromatosis
Iron overload
C282 homozygosity
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with genetic hemochromatosis diagnosed in western France hospitals

Brief summary: The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.

Detailed description: Bone diseases have been recognized recently as complications of genetic hemochromatosis. Further studies are needed to describe the role of iron in bone injuries. The purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 80 years
* C282 homozygosity

Exclusion Criteria:

* corticosteroids during the last 3 months
* following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.
* following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate.
* cancer or evolutionary hemopathy (including monoclonal gammopathy)
* pregnancy at inclusion time
* treated osteoporosis
* patient in wich follow up seems hard
* inclusion in another study incompatible with this one

Primary outcomes:
measure: Bone mineral density
timeFrame: Change from baseline in bone mineral density at three years
Secondary outcomes:
measure: Predictive value of iron overload on Bone Mineral Density
timeFrame: 1 day
measure: Number of vertebral fractures
timeFrame: 3 years
measure: Number of peripheral fractures
timeFrame: 3 years
measure: Number and location of joint lesions detected by the examination (pain and swelling)
timeFrame: 3 years
measure: Determination of genetic polymorphism of BMP 2 and 4
timeFrame: Baseline
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Orleans
country: France
facility: Orleans Regional Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Guggenbuhl Pascal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967860: Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy
Official title: Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: CT Scan
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients with BMI ≥ 40 kg/m2 or between 35 e 40 kg/m2 with evidence of obesity related comorbidity

Brief summary: Obesity is a extremely widespread condition in Europe and North America, burdened by a series of complications characterized by major morbidity and morbility. In recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures, such as laparoscopic vertical sleeve gastrectomy are common.

The aim of the study is to retrospectively determine the value of postoperative CT after LSG as an early tool to identify risk factors for the subsequent development of gastric fistula and enable to stratify postoperative risk in asymptomatic patients and ensure effective management of these risk factors.


Eligibility criteria: Inclusion Criteria:

* adult obese patients with LSG
* BMI ≥ 40 kg/m2 or BMI between 35 and 40 kg/m2
* evidence of obesity related comorbidity
* availability of upper abdomen CT scan with IV and oral contrast medium within 72 hours of surgery

Exclusion Criteria:

* Pregnant women
* allergy to contract medium
* lack of venous access
* patients who did not have a post-surgical upper abdomen CT

Primary outcomes:
measure: Value of Post surgery CT in identifying risks for subsequent development of gastric fistula
timeFrame: 72 hours post LSG
Secondary outcomes:
measure: Post surgery risk
timeFrame: 72 hours post LSG
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Deaprtment of Radiology, IRCCS Ospadale San Raffaele
Study officials:
References:
Clinical trial NCT05640960: Undifferentiated Embryonal Sarcoma of the Liver: Evaluation of the Relapse Profile According to the Therapies Administered
Official title: Undifferentiated Embryonal Sarcoma of the Liver
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Sarcoma
Keywords: Embryonal Sarcoma
Embryonic Sarcoma
Hepatoblastoma
Hepatocarcinoma
Hepatic Sarcoma
Undifferentiated (Embryonal) Sarcoma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 0 to 25 with treatment carried out in France from 01/01/2008 to 31/12/2018

Brief summary: Undifferentiated embryonal sarcoma of the liver is the 3rd most common malignant liver tumor after hepatoblastoma and hepatocellular carcinoma with a peak incidence between 6 and 10 years of age. Historically, it is a tumor treated only by surgery with a poor prognosis. In the last decade, the combination of more intensive chemotherapy and, more randomly, radiotherapy, has significantly improved the survival rate of these patients. Due to its low incidence, there are few series reported in the literature and to date there is no specific treatment protocol for the management of these tumors.

It seems appropriate to review the management of these tumors in France in order to discuss the best therapeutic strategy.


Eligibility criteria: Inclusion criteria:

* Any patient aged 0 to 25 on the date of inclusion in the study
* Treatment carried out in France (included in NRSTS 2005, in the childhood cancer registry or in an SFCE center)
* Start of treatment from 01/01/2008 to 31/12/2018
* Diagnosis of undifferentiated embryonal sarcoma of the liver defined by a compatible histological analysis
* Adult subject who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research
* Minor subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

* Refusal to participate in this research
* Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET
* Absence of histological and/or molecular documentation.

Primary outcomes:
measure: Describe the relapse profile of children with undifferentiated hepatic sarcoma according to the therapies received
timeFrame: 3 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03715660: Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study
Official title: Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Non muscle invasive bladder cancer, recurrence, progression
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Cepheid
First posted: 2018-10-23
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting recurrent bladder cancer.


Eligibility criteria: Inclusion Criteria:

* The patient shall meet all of the following criteria in order to be considered eligible for enrollment:

  * Patient has been diagnosed with NMIBC within 24 months of enrollment
  * At the time of the enrollment visit, the patient is scheduled for a cystoscopy within the next 6 weeks of enrollment

Exclusion Criteria:

* Patient has had an excision procedure or BCG treatment within six weeks (42 days) before enrollment.

Primary outcomes:
measure: Accuracy of Xpert Bladder Cancer Monitor in monitoring of non muscle invasive bladder cancer by comparing its results to the results of the standard tool of monitoring of bladder cancer (diagnostic cystoscopy)
timeFrame: within 1 month after test assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Urology and Nephrology Center
Study officials:
References:
Clinical trial NCT06631560: Hepatitis E Virus Infection in Oncological Patients
Official title: Hepatitis E Virus Infection in Oncological Patients - a Prospective Study in Rural Eastern Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis E Infection
Hepatitis; Epidemic
Oncologic Disorders
Lead sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany. Consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of HEV infection using two distinct anti-HEV IgG and IgM enzyme-linked immunosorbent assays (ELISAs). Serum was taken from each patient before treatment initiation and during treatment follow-up. Primary endpoint was determination of HEV seroprevalence. A healthy cohort was established alongside a cohort of patients who had been hospitalised due to a diagnosis of SARS-CoV-2 infection. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.


Eligibility criteria: Inclusion Criteria:

* different hemato-oncological entities without age restriction

Exclusion Criteria:

* patients already receiving antineoplastic therapies
* not given written consent

Primary outcomes:
measure: Anti HEV-IgM and IgG prevalences
timeFrame: In the oncological cohort, multiple samples were prospectively collected over a one-year period, commencing on 1 September 2020 and concluding at the end of October 2021. In the remaining two control samples, analysis was conducted retrospectively.
Secondary outcomes:
measure: Identification of risk factors for HEV infection in oncological patients
timeFrame: The questionnaire was handed out at the beginning of the study
Other outcomes:
Locations:
city: Brandenburg An Der Havel
country: Germany
facility: Medical School (MHB) Theodor Fontane
state: Brandenburg
Study officials:
affiliation: Medical School (MHB) Theodor Fontane
name: Isabel-Elena Haller
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00674960: Far Infrared Irradiation for the Management, Control and Treatment of Frontotemporal Dementia
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for the Management, Control and Treatment of Frontotemporal Dementia (Pick's Disease)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pick Disease of the Brain
Keywords: Brain Atrophy, Circumscribed Lobar
Circumscribed Lobar Atrophy of the Brain
Lobar Atrophy (Brain)
Pick Disease
Pick's Disease
Picks Disease of Brain
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pick's disease, also known as Pick disease,or FTD is a rare fronto-temporal neurodegenerative disease. This study will investigate the use of far infrared radiation for the control, management and treatment of Pick's disease.

Detailed description: This disorder causes progressive destruction of nerve cells in the brain and causes tau proteins to accumulate into the "Pick bodies" that are a defining characteristic of the disease. Tau proteins are microtubule-associated proteins that are abundant in neurons in the central nervous system and are less common elsewhere.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have FTD.

Eligibility criteria: Inclusion Criteria:

* People with Pick's Disease

Exclusion Criteria:

* None

Primary outcomes:
measure: Therapy for FTD patients
timeFrame: 1 year
Secondary outcomes:
measure: Rehabilitation of FTD Patients
timeFrame: 1 Year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604094: Ultrasound Measurement of RIJV in Patients Between 0-2 Years
Official title: The Evaluation of Anatomical Variations and Dimensions of RIJV With Ultrasound in Pediatric Patients Between 0-2 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anatomic Abnormality
Internal Jugular Vein
Neonates
Infants, Premature
Children
Keywords: central venous catheter, pediatrics, ultrasound imaging
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 156
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy 0-2 year-old patients undergoing elective surgery.

Brief summary: After obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. The success rates and outcomes of catheterization will be recorded.


Eligibility criteria: Inclusion Criteria:

0-2 years Elective surgery Requirement for central venous cannulation

Exclusion Criteria:

Congenital cardiovascular anomalies Emergency surgeries Previous cannulation or any intervention on the neck

Primary outcomes:
measure: Anatomical variations and dimensions of right internal jugular vein
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Filiz Uzumcugil
Study officials:
References:
Clinical trial NCT04118894: Wright Foot & Ankle Post-Market Observational Study
Official title: Wright Foot & Ankle Post-Market Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis
Rheumatoid Arthritis
Fracture
Trauma Injury
Fusion of Joint
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2019-10-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Instructions for Use (IFU) for each individual product can be found at http://www.wright.com/prescribing-use-3.

Brief summary: WRIGHT FOOT \& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device

Detailed description: The selected design is a global, multi-center, non-randomized, prospective observational study. The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.

Eligibility criteria: Inclusion Criteria:

* Willing and able to consent to participate (written, informed consent);
* Willing and able to attend/complete the requested follow-up visits;
* Considered for treatment with one or more approved or cleared Wright Medical products included in this study

Exclusion Criteria:

* Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
* Unable to consent to participate (written, informed consent);
* Unable to attend/complete the requested follow-up visits

Primary outcomes:
measure: EuroQol (EQ-5D-5L).
timeFrame: 1 year
Secondary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 1 year
measure: Safety Assessment
timeFrame: 1 year
measure: Surgeon Survey
timeFrame: 1 year
measure: Patient Survey
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Mercer-Bucks Orthopaedics
state: New Jersey
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Tours
country: France
facility: CHRU Tours, Hôpital Trousseau
city: Augsburg
country: Germany
facility: Hessingpark Clinic
city: Oswestry
country: United Kingdom
facility: Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
state: Shropshire
Study officials:
affiliation: Stryker Trauma and Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02029794: ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer
Official title: ASPIRE Pilot: Determining Optimal Cervical Cancer Screening in a Low-resource Setting: A Randomized Controlled Trial Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid (VIA) Screening in Kampala, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Cervical Cancer Screening
Low Resource setting
HPV
Self-Collection
VIA
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Makerere University
First posted: 2014-01-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Cervical cancer remains a public health burden, particularly in developing countries such as sub-saharan Africa where the infrastructure for organized screening programs does not exist. As a result, other screening modalities (visual inspection with acetic acid) are the standard of care in such regions. It is now known, persistent infection with an oncogenic Human papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing HPV testing is a potential, safe and effective alternative to cytology testing (The Pap smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs. VIA in a cohort of women from Kisenyi, Uganda.


Eligibility criteria: Inclusion Criteria:

* Aged 30-65yrs
* Living or working in community of Kisenyi, Uganda
* Access to mobile telephone
* Fluent in Luganda, Somali or English
* Competent to provide informed consent

Exclusion Criteria:

* Known to be pregnant at study entry (self-reported)
* Complete hysterectomy
* Prior diagnosis or treatment of cervical dysplasia or cervical cancer

Primary outcomes:
measure: Histologically confirmed cervical intra-epithelial lesions grade 2 (CIN2) or greater in self-collected HPV arm and VIA arm at 12 months by colposcopy
timeFrame: At the 12 month follow-up visit
Secondary outcomes:
measure: Uptake of HPV self-collection compared to VIA in women in Kampala, Uganda
timeFrame: One Year
measure: Prevalence rates of high-risk HPV in the self-collection arm.
timeFrame: One year
measure: Assess screen positive rates by nurse-midwife exam in VIA arm
timeFrame: One year
measure: Evaluation of adverse events or complications documented at time of sample collection, 4-6 weeks after cryotherapy and at 12 and 36 months by study questionnaire
timeFrame: 36 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Gina Ogilvie, MD FCFP DrPH
role: PRINCIPAL_INVESTIGATOR
References: