louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06506942: The TRICURE EFS Study
Official title: The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Valve Regurgitation
Heart Valve Diseases
Cardiovascular Diseases
Lead sponsor: TRiCares
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Detailed description: The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria:

* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Primary outcomes:
measure: Composite of MAE
timeFrame: 30 day post-intervention
measure: Device Success
timeFrame: immediately post-intervention
Secondary outcomes:
measure: Six minute walk test
timeFrame: 30 days, 6 months, annual for five years post-intervention
measure: Reduction in Tricuspid Regurgitation (TR) Grade
timeFrame: 30 days, 6 months, annual for five years post-intervention
measure: New York Heart Association (NYHA) Function Class
timeFrame: 30 days, 6 months, annual for five years post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Healthcare Inc.
state: Georgia
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Hospital and Health Systems
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Bronx
country: United States
facility: Montefiore
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Columbia University Medical Center/ NewYork Presbyterian Hospital
name: Susheel Kodali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan Hospital and Health Systems
name: Gorav Ailawadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01407042: Patellofemoral Pain After Unicondylar Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mobile-bearing Unicondylar Knee Arthroplasty
Keywords: unicondylar knee arthroplasty
mobile-bearing
patellofemoral pain
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients scheduled for unicondylar knee arthroplasty at the Dept. for orthopaedic surgery of our medical university

Brief summary: Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance.

We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery.

In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala \& KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.

The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.


Eligibility criteria: Inclusion Criteria:

- osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment

Exclusion Criteria:

* failed upper tibial osteotomy
* insufficiency of the collateral or anterior cruciate ligaments
* a fixed varus or valgus deformity (not passively correctable) above 15°
* a flexion deformity greater than 15°
* rheumatoid arthritis

Primary outcomes:
measure: Size of anterior femoral notch
timeFrame: day 0
measure: Kujala Score changes
timeFrame: -1 days, 3 months, 6 months, 1 year
measure: KOOS questionnaire changes
timeFrame: -1 days, 3 months, 6 months, 1 year
measure: Radionuclide tracer uptake at the surgically created notch
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
Study officials:
References:
citation: Dammerer D, Liebensteiner M, Rochau H, Uprimny C, Smekal V, Rosenberger R, Servien E. Influence of the anterior notch in mobile-bearing UKA on patellofemoral radiotracer uptake and clinical outcome. BMC Musculoskelet Disord. 2017 Dec 16;18(1):532. doi: 10.1186/s12891-017-1885-6.
Clinical trial NCT05062642: Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments
Official title: Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meningitis
Keywords: BMS score
Meningitis
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 1000
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: The study population will be extracted from the population having consulted the Adult Emergency Departments of the Le Mans Hospital, the Angers and Nantes University Hospitals and the Beaujon University Hospital between January 1, 2009 and December 31, 2020 and for whom a lumbar puncture will have been performed for suspected meningitis.

Brief summary: Meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. Many pathogens can cause meningitis, the severity of which varies greatly. Patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis.

Viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. Bacterial meningitis is less frequent but more serious.The current public health objective is to save antibiotics.

Investigator hypothesizes that the BMS score can be used to exclude bacterial meningitis in the emergency department in an adult European population of patients with suspected bacterial meningitis.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to the Adult Emergency Department of CH Le Mans,CHU Angers, CHU Nantes or Beaujon Hospital.
* Over 18 years old
* Having had a lumbar puncture during their stay in the Adult Emergency Department
* Having had a diagnosis of meningitis defined as a pleocytosis ≥ 5leukocytes/mm3 after correction with CSF red blood cells at a standardized ratio of 500/1.

Exclusion Criteria:

* Antibiotic therapy within 72 hours of inclusion
* Immunosuppression from any cause
* Presence of petechiae or purpura
* History of recent neurosurgery or head trauma
* Other associated bacterial infection
* Inability to collect information for the BMS score calculation or primary endpoint (e.g., transfer to another facility)
* Minor or adult patient under guardianship or protection

Primary outcomes:
measure: External validation of the BMS score in a European adult population to exclude bacterial meningitis
timeFrame: 1 month after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT02051842: Effect of Metadoxine on Oxidative Stress in Non-alcoholic Hepatic Steatosis
Official title: Effect of Metadoxine on Oxidative Stress in Non-alcoholic Fatty Liver Disease Prediabetic Mexican Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: NAFLD
Pre-diabetes
Keywords: NAFLD
oxidative stress
malondialdehyde
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant systems. This state is frequently associated with chronic diseases like obesity, insulin resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may trigger the progression of fatty liver disease, from triglyceride accumulation to inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative stress, could be an important therapeutic target to lessen the severity of the disease. Until now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic complex of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver diseases share molecular mechanisms in the generation of oxidative stress, the investigators propose metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease, prediabetic patients.


Eligibility criteria: Inclusion Criteria:

* Male and female
* 18 to 65 years old
* Ultrasonographic diagnosis of NAFLD
* Prediabetes diagnosis

Exclusion Criteria:

* Alcoholism
* Hepatitis C or B Virus Infection
* Pregnancy
* Autoimmune hepatitis
* Metformin or metadoxine allergy
* Parenteral nutrition in the last month
* Weigh loss greater than 10% in the last month
* Taking vitamin supplements in the last month

Primary outcomes:
measure: Oxidative stress
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Oxidative stress
timeFrame: 3 month follow-up
measure: Oxidative stress
timeFrame: 6 months follow-up
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre, MD MSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03051542: Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Natural Killer/T-cell Lymphoma
Official title: Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography / Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, Extranodal NK-T-Cell
Keywords: Lymphoma, Extranodal NK-T-Cell
Positron-Emission Tomography
Prognosis
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospitals
First posted: 2017-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F- FDG PET/CT and predict disease progression during chemotherapy or survival in NK/T-cell lymphoma.

Detailed description: In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in NK/T-cell lymphoma. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed NK/T-cell lymphoma
* treated using an anthracycline-containing regimen
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.

Primary outcomes:
measure: Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles
timeFrame: baseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)]
Secondary outcomes:
measure: 3 year progression-free survival
timeFrame: up to 3 years after initial diagnosis
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01518842: Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
Official title: Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia
Keywords: ischemic retinopathy, stem cell,bone marrow
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: intravitreal injection of autologous bone marrow stem cells
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.

Detailed description: Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Ischemic Retinopathy
* Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of \>30% on Fluorescein retinography
* logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse
* Able (in the Investigator's opinion) and willing to comply with all study requirements

Exclusion Criteria:

* previous ocular surgery other than cataract
* presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
* other ophthalmic disease like glaucoma and uveitis
* previous history of blood disorders like leukemia
* known allergy to fluorescein or indocyanine green

Primary outcomes:
measure: Change in size of FAZ at 48 weeks
timeFrame: 1 day to 48 weeks
Secondary outcomes:
measure: Change in central foveal thickness and best corrected visual acuity at 48 weeks
timeFrame: 1 day to 48 weeks
Other outcomes:
Locations:
city: Sao Jose do Rio Preto
country: Brazil
facility: Rubens Siqueira Research Center
state: SP
Study officials:
affiliation: Rubens Siqueira Research Center
name: Rubens C Siqueira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siqueira RC, Messias A, Gurgel VP, Simoes BP, Scott IU, Jorge R. Improvement of ischaemic macular oedema after intravitreal injection of autologous bone marrow-derived haematopoietic stem cells. Acta Ophthalmol. 2015 Mar;93(2):e174-6. doi: 10.1111/aos.12473. Epub 2014 Jun 22. No abstract available.
Clinical trial NCT02588742: The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients
Official title: The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients : Randomized, Placebo-controlled, Double Blind Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delirium
Keywords: elderly ICU patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Delirium in older patients is associated with increased mortality and health care costs. And delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the most important risk factor for developing delirium. In this study, investigators will investigate the effect of administration of melatonin on postoperative delirium in elderly ICU patients.

Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening from the day before surgery to the the 5th postoperation day. In contrast, patients in the control group are given placebo.

Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC (Intensive Care delirium Screening Checklist). And secondary outcome includes intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood pressure, total amount of sedatives, total amount of analgesics, duration of mechanical ventilation, duration of ICU stay.

Thus, investigators perform this study to investigate the relationship between delirium and circadian rhythm.


Eligibility criteria: Inclusion Criteria:

* older than 50 years old
* patients who admitted to ICU after surgery

Exclusion Criteria:

* Subjects are ineligible if they have cognitive dysfunction,
* disabling mental change disorder,
* alcohol addiction,
* dementia,
* cerebrovascular accident,
* transient ischemic attack,
* carotid artery stenosis,
* autoimmune disease,
* patients who are unable to communicate or speak Korean,
* emergent operation

Primary outcomes:
measure: incidence of delirium
timeFrame: 5 days after surgery
Secondary outcomes:
measure: change of amount of used vasopressors as a measure of intraoperative hemodynamics
timeFrame: up to 5 days
measure: total amount of sedatives
timeFrame: up to 5 days
measure: total amount of analgesics
timeFrame: up to 5 days
measure: duration of mechanical ventilation
timeFrame: up to 5 days
measure: duration of ICU stay
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02869542: Institut Paoli Calmettes Lymphoma Database
Official title: Institut Paoli Calmettes Breast Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a lymphoma

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with lymphoma


Eligibility criteria: Inclusion Criteria:

* Hodgkin or non-hodgkin lymphoma

Exclusion Criteria:

* Non applicable

Primary outcomes:
measure: Survival of patients
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
Clinical trial NCT03939442: Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity
Official title: Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleeve Gastrectomy With Jejunoileal Anastomosis
Keywords: obesity, diabetes mellitus, bariatric surgery
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged between 18 and 60 years with a body mass index greater than 40, no comorbidity or a body mass index of 35-40, with a comorbidity (diabetes mellitus, hypertension, obstructive sleep apnea)

Brief summary: Laparoscopic sleeve gastrectomy operations performed for morbid obesity are among the most common methods in the world. Gastric or intestinal bypass surgery with or without sleeve gastrectomy is thought to be more effective in controlling both weight loss and metabolic diseases. For this purpose, Roux-en-y gastric bypass, transit bipartition, duodenal switch, jejunoileal bypass are performed. The aim of this study was to evaluate the effects of jejunoileal bypass surgery on weight loss and metabolic diseases in patients with sleeve gastrectomy.

Detailed description: Bariatric surgery results in more and more long-term weight loss than traditional treatment in moderate and severe obesity. Due to morbid obesity, jejunoileal bypass has been applied since 1970. Laparoscopic sleeve gastrectomy and jejunoileal anastomosis are among the rare techniques described in 2012. There are few studies on this technique.

Between 2015 and 2018, jejunoileal bypass operations with laparoscopic sleeve gastrectomy for morbid obesity will be evaluated in Inonu University gastroenterology surgery clinic. The patients' age, gender, body mass index, weight loss in follow-up periods, whether there is back weight gain, the effects on metabolic diseases, early and late complications will be evaluated.

Eligibility criteria: Inclusion Criteria:All patients who underwent the sleeve gastrectomy with jejunoileal bypass between 2015-2018 for the treatment morbid obesity

Exclusion Criteria:other operations for morbid obesity except sleeve gastrectomy with jejunoileal bypass

Primary outcomes:
measure: Excess weight loss
timeFrame: 2 years
measure: diabetes remission
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Cihan Gökler
Study officials:
References: