louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06228378: Comparative Spectroscopic Analysis of Synovial Fluid From the Stable and Unstable Ankle
Official title: Comparative Spectroscopic Analysis of Synovial Fluid From the Stable and Unstable Ankle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ankle Instability
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-centre, open-label study of patients undergoing ankle stabilisation surgery.
Primary purpose: TREATMENT

Brief summary: A population of patients with chronic ankle instability for whom arthroscopic ligament stabilisation was indicated.

Main objective: to use the Raman microspectroscopy technique to characterise the synovial fluid of the unstable ankle in comparison with the synovial fluid of the healthy ankle.

Detailed description: Single-centre, prospective, open-label study of patients undergoing ankle stabilisation surgery.

Patients will participate in the study for six months. Three arthrocentheses with synovial fluid sampling will be performed Two at D0: on the healthy ankle and the pathological ankle One at M6: on the operated ankle A follow-up visit will take place 10 days after the arthrocentesis performed at D0 and after the one performed at M6. The purpose of these visits, which are carried out systematically by the centre's doctors as part of the surgical procedures, is to check that there are no complications.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or over who have signed their consent to participate in the study
* Patients with chronic unilateral lateral ankle instability
* Patients who have not responded to medical treatment and for whom arthroscopic stabilisation of the ankle is planned.

Exclusion Criteria:

* Any history, anomaly or symptom relating to the contralateral ankle
* Patient under court protection, guardianship or curatorship

Primary outcomes:
measure: Spectral intensity of synovial fluid components
timeFrame: Month 6
Secondary outcomes:
measure: Functional criterion (American Orthopaedic Foot and Ankle Society-AOFAS score)
timeFrame: Month 6
measure: Tribological criteria (drop surface measurement)
timeFrame: Month 6
measure: Tribological criteria (drop thickness measurement)
timeFrame: Month 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique du Sport
Study officials:
affiliation: Clinique du sport
name: Alexandre HARDY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06789978: Rapid Prehospital ACcess to ECPR in Prague
Official title: Prehospital Extracorporeal Cardiopulmonary Resuscitation: A Pilot Study in Prague
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out of Hospital Cardiac Arrest
Extracorporeal Cardiopulmonary Resuscitation
Keywords: Cardiac arrest
ECPR
ECMO
Prehospital
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 20
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: Single-arm interventional study with a historical control from Prague OHCA study
Primary purpose: TREATMENT

Brief summary: A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA

Detailed description: The aim of this pilot prospective study is to assess the feasibility and effectiveness of a prehospital extracorporeal cardiopulmonary resuscitation (ECPR) system for refractory out-of-hospital cardiac arrest (OHCA) in Prague, compared to a historical cohort of in-hospital ECPR recipients from the Prague OHCA trial.

Eligibility criteria: Inclusion Criteria:

* Estimated age 18-70 years
* Refractory out-of-hospital cardiac arrest (3 unsuccessful defibrillations and/or at least 10 minutes of resuscitation in case of pulseless electrical activity)
* Witnessed cardiac arrest
* ECPR team available
* ECPR team alert within 20 minutes from the emergency call

Exclusion Criteria:

* Unwitnessed cardiac arrest
* Asystole
* ETCO2 less than 10 mmHg upon ECPR team arrival
* Known limitations of intensive care (Do Not Resuscitate - DNR status)
* Known severe neurological impairment prior to cardiac arrest (mRS 4-6)
* Suspected or known pregnancy

Primary outcomes:
measure: Time from collapse to ECPR
timeFrame: Time from estimated collapse to start of VA ECMO flow (estimated range: 20-100 minutes)
Secondary outcomes:
measure: All cause survival at 30-days
timeFrame: 30-days
measure: Modified Rankin Scale at 30-days
timeFrame: 30-days
Other outcomes:
measure: Major bleeding
timeFrame: 30-days
measure: Vascular complications
timeFrame: 30-days
measure: Infectious complications
timeFrame: 30-days
Locations:
city: Prague
country: Czechia
facility: General University Hospital in Prague
Study officials:
References:
Clinical trial NCT02678078: Characterization of Cancer Tissue Using 3D Biosynthetic Material
Official title: Characterization of Cancer Tissue Using 3D Biosynthetic Material
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: cancer
diagnosis
biopsy
chemotherapy drugs
tumor
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
Collaborators: name: Rambam Health Care Campus
First posted: 2016-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: every man or women 18 years old or older, with a liver tumor.

Brief summary: Characterization of Cancer Tissue Using 3D Biosynthetic Materials. Using liver biopsy from stage 4 cancer patients, the investigators will evaluate and characterize the metastatic cells.

Detailed description: The investigators' biomaterial lab has developed an in vitro diagnostic system in which a cancer tumor is placed inside a 3D hydrogel. This material has similar properties to the human tissue and can visualize cell migration and proliferation. In this system, the investigators have already characterised human metastatic cells obtained from nude mice tumors. The diagnostic assay is able to evaluate the reduction in cell growth associated with anti-cancer drug therapy. The next step is to test the in vitro diagnostic system using human tissue samples from human patients, and to validate the system as a simple and effective a priori diagnostic tool for characterizing patient tumours.

Eligibility criteria: Inclusion Criteria:

* liver tumor

Exclusion Criteria:

* refuse to volunteer

Primary outcomes:
measure: cell growth
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam
Study officials:
affiliation: Technion, Israel Institute of Technology
name: Dror seliktar, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05372978: Cash Transfers for People Experiencing Homelessness
Official title: Cash Transfers for People Experiencing Homelessness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Homelessness
Personal Satisfaction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Foundations for Social Change
First posted: 2022-05-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to condition (cash vs control).
Primary purpose: TREATMENT

Brief summary: The primary goal of the study is to determine the impacts of a one-time unconditional cash transfer on the well-being of people experiencing homelessness.

Detailed description: The goal of this project is to examine the effect of cash-transfers for people experiencing homelessness in Metro Vancouver. In partnership with Foundations for Social Change, we will distribute a one-time unconditional cash transfer of $8,500 to each of the 200 participants, with 200 additional participants in a control group who will not receive the cash transfer. To evaluate the effect of the cash transfer, participants will complete surveys 1, 2, 3, 6, 9, and 12 months after the cash transfer, and we will track important life outcomes such as housing, employment, health, cognitive function, and well-being.

Eligibility criteria: Inclusion Criteria:

1. Participants must be homeless at the time of recruitment.
2. Participants must be between 18 and 65 years of age, inclusive.
3. Participants must be a Canadian citizen or permanent resident in Canada

Exclusion Criteria:

The following participants will be excluded:

1. Participants who report severe problematic substance use (score ≥ 6 on DAST).
2. Participants who report severe problematic alcohol use (score ≥ 20 on AUDIT).
3. Participants who report severe psychiatric symptoms (score above 2 on item 5 or above 4 on items 13 or 14 on CSI).
4. Participants who report problematic gambling behavior (score ≥ 8 on PGSI).

Primary outcomes:
measure: Stable housing
timeFrame: 1-3 months
measure: Homelessness
timeFrame: 1-3 months
measure: Savings
timeFrame: 1-3 months
measure: Total Spending
timeFrame: 1-3 months
measure: Spending on Rent
timeFrame: 1-3 months
measure: Spending on temptation goods
timeFrame: 1-3 months
measure: Cost of shelter use
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
References:
Clinical trial NCT06522178: Oldest-old Patients Anesthesia in Orthopedic Surgeries
Official title: Anesthetic Techniques and Clinical Outcomes in the Oldest-old Patients Operated for Orthopedic Surgery: A Seven-year Retrospective Analysis of Data in a Third Level Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 1356
Sex: ALL
Minimum age (years): 80
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 1356 oldest-old patients underwent orthopedic surgery between January 02 2016 and December 31 2022 in our hospital.

Brief summary: Average life span, life expectancy, and the number of older people, aged 65 years and over, have increased during the last decades. As life expectancy increased, the rate of emergency and elective surgical interventions has also increased in the older age group. Although good health is required to reach an advanced age, over time, organ functions may deteriorate, and some challenges may develop that will negatively affect the balance of homeostasis. Stress, such as trauma or surgery, can cause deterioration in organ functions or aggravation of impaired functions. The risk of developing undesirable events is higher, due to the diminished reserve and function, during anesthesia applied to these patients. There is a limited number of studies in the literature about the relation between the anesthesia technique and morbidity and mortality in oldest old patients operated for orthopedic surgery. In this study, we aimed to analyze the data of the oldest-old patients operated on for orthopedic surgery between 2016-2022, retrospectively, and to investigate the relationship between anesthesia technique and adverse effects including morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* Aged 80 years and above
* Underwent orthopedic surgery

Exclusion Criteria:

* Those who had the operation with local anesthesia

Primary outcomes:
measure: Mortality
timeFrame: one month after operation
measure: Anesthesia Techniques
timeFrame: up to 6 hours
measure: Type of operation
timeFrame: up to 6 hours
Secondary outcomes:
measure: Presence and type of comorbidities
timeFrame: 6 month period before operation
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References:
Clinical trial NCT01002378: The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib
Official title: A Phase I, Randomized, Open Label, 3-Way Cross-Over Study to Determine the Effect of a High-Fat Breakfast, a Low-Fat Breakfast and Fasting State on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dietary Fats
Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first Screening examination
* BMI: between 18 and 32 kg / m²

Exclusion Criteria:

* Regular use of medicines at the time of Screening, including prescription medications, herbal supplements and high dose vitamins
* Sitting systolic BP \> 140 mmHg or Diastolic BP \> 90 or \< 60 mmHg
* History of hypersensitivity or allergy
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study

Primary outcomes:
measure: Primary PK parameters: AUC, Cmax of BAY 73-4506
timeFrame: Samples up to 336 hours post dose
Secondary outcomes:
measure: Sec. PK Parameters: tmax and t1/2 of BAY73-4506
timeFrame: Samples up to 336 hours post dose
measure: AUC, Cmax, tmax and t1/2 of Metabolites
timeFrame: Samples up to 336 hours post dose
Other outcomes:
Locations:
city: Brighton
country: United States
state: Massachusetts
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01284478: Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery
Official title: Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pseudophakic Cystoid Macular Edema,
Diabetic Macular Edema
Keywords: pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone
Lead sponsor: Northern California Retina Vitreous Associates
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-01-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery


Eligibility criteria: Inclusion Criteria:

* DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
* VISUAL ACUITY WORSE THAN 20/32

Exclusion Criteria:

* VISUAL ACUITY WORSE THAN 20/200
* MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING \>2 TOPICAL GLAUCOMA MEDIATIONS.
* USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT

Primary outcomes:
measure: BEST CORRECTED VISUAL ACUITY (ETDRS)
timeFrame: AT DAY 180
Secondary outcomes:
measure: RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY
timeFrame: 90 and 180 DAYS
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
Study officials:
affiliation: Northern California Retina Vitreous Associates
name: Rahul Khurana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05155878: Prognostic Factors in Periampullary Tumors and Cysts
Official title: Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Pancreas Neoplasm
Pancreas Cyst
Pancreatic Fistula
Pancreas Disease
Bile Duct Cancer
Periampullary Cancer
Surgery
Surgery--Complications
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 500
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: Patients that have been recommended or already undergone surgery for a cyst or tumor in the pancreas or periampullary region

Brief summary: The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.

Detailed description: From november 2021 an onward, study participants will be prospectively enrolled within the observational study. Before that, study participants are retrospectively enrolled. The study has a broad perspective including studies on clinical outcomes and prognostics based on patient and tumor characteristics.

Eligibility criteria: Inclusion Criteria:

* Recommended surgery for tumor or cyst in the pancreas or periampullary region
* Information avalible in electronic journal files
* Informed consent (or deceased for retrospective part of the study)

Exclusion Criteria:

* No informed consent (and still alive at study initiation)

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Complications
timeFrame: 10 years
measure: Radical resection
timeFrame: 10 years
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Surgical Clinic at Umeå University Hospital
Study officials:
affiliation: Umeå University Hospital
name: Oskar Franklin, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362178: Thromboelastographic Guide for Blood Products in Cirrhotics
Official title: USE OF THROMBOELASTOGRAPHY TO GUIDE BLOOD PRODUCTS REPLACEMENT IN DECOMPENSATED CIRRHOTIC PATIENTS UNDERGOING INVASIVE PROCEDURES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cirrhosis
Coagulation Disorder
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.


Eligibility criteria: Inclusion Criteria:

* Histologic or imaging-proven liver cirrhosis of any etiology
* INR\>1.8 and/or PLTs count \<50x103/μl

Exclusion Criteria:

* Ongoing bleeding
* Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
* Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
* Presence of sepsis according to ACP-SCCP criteria
* Hemodialysis performed within 7 days

Primary outcomes:
measure: Comparison in the amount of blood products transfused between the groups
timeFrame: 48 hours from admission
Secondary outcomes:
measure: Post-procedure bleeding
timeFrame: 48 hours from admission
measure: Survival
timeFrame: 90 days patient survival
measure: Transfusion related side effects
timeFrame: 48 hours from admission
measure: Procedure-related complications
timeFrame: during hospitalization (mean 4 weeks)
measure: Comparison between blood products costs between groups
timeFrame: 48 hours from admission
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit
name: Lesley De pietri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381678: A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve or Aortic Valve Replacement
Keywords: Heart Valve Replacement
Perimount 2900
China
Perimount 6900P
Lead sponsor: Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 225
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: The patients who had the Perimount Heart Valve (Type: 6900P and 2900) Replacement Surgery during 2001-2007 in Guangdong General Hospital in China

Brief summary: The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis.

This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.


Eligibility criteria: Inclusion Criteria:

* The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China
* The patients agree to join the study and sign the ICF

Exclusion Criteria:

* No specific exclusion criteria

Primary outcomes:
measure: The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography
timeFrame: 7-15 years after heart valve replacement surgery (during 2001-2007)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Huiming Guo, M.D
role: PRINCIPAL_INVESTIGATOR
References: