louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05223998: Manual Implantation of Full-Thickness Skin Microcolumns
Official title: Manual Implantation of Full-Thickness Skin Microcolumns for 'Donor-Free' Skin Renewal
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wound of Skin
Burns
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof of concept
Primary purpose: TREATMENT

Brief summary: The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

Detailed description: Previously three patients have been successfully treated with the use of manual FTSM for wound coverage. To provide additional proof of concept data, this study will validate manual FTSM implantation on a larger scale with a 10-patient population. This will be measured by the following hypothesized parameters: time to re-epithelization, pigmentation, wound contraction, scar thickness, pain at the donor site and injury site healing outcome. The approach to testing this hypothesis will be to perform manual FTSM harvest, placement on the injured site, covered by an inert dressing for 10 patients with open wounds necessitating tissue coverage. The rationale is that although preliminary proof of concept data has already been obtained from three patients treated with FTSM implantation, additional proof of concept data would strengthen the conclusions made based on these cases.

Eligibility criteria: Inclusion Criteria:

* 8-85 years of age
* 10-125 cm2 open wound on the scalp, neck, torso or extremities necessitating tissue coverage
* Sufficiently healthy skin to serve as a donor site

Exclusion Criteria:

* Wound area involving the face\*
* Wound area involving joints\*
* Pregnancy
* Prisoner
* Active wound infection at potential treatment sites
* Exposed muscle, joint, tendon, or bone within the wound bed

Primary outcomes:
measure: Donor site re-epithelization between day 10 to 14
timeFrame: 10-14 days
Secondary outcomes:
measure: Donor site
timeFrame: up to 6 months
measure: Injured site
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Metis Foundation
name: Rodney Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06325098: Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome
Official title: Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nephrotic Syndrome
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with nephrotic syndrome (SSNS, SRNS)
Primary purpose: DIAGNOSTIC

Brief summary: Nephrotic syndrome (NS) is a clinical picture common to several diseases resulting from damage to podocytes and glomerular filtration barrier. Currently, there is limited consensus regarding the diagnostic pathway and management of the specific etiology. Some patients show complete response to first-line steroid therapy (steroid-sensitive nephrotic syndrome, SSNS), especially in children and young adults. The prognosis of this group is generally favorable. In contrast, patients unresponsive to steroids (steroid-resistant NS, SRNS) frequently undergo immunosuppressive therapies, which are burdened with numerous side effects. Resistance to treatment is associated with a high likelihood of progression to chronic renal disease (CKD) and kidney failure (ESKD). Recent evidence suggests that immunological mechanisms (including permeabilizing factors) are involved in the pathogenesis of post-transplant NS recurrence and SSNS.

Providing patients with NS with a correct diagnosis is the cornerstone of personalized medicine, reducing morbidity and side effects of therapies, ensuring their appropriate prescription, and slowing or preventing progression to ESKD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of NS (SSNS, SRNS, or NS relapsed after transplantation regardless of initial response to steroid therapy)
* Age below 40 years at disease onset
* Availability of clinical information
* Signed informed consent form

Exclusion Criteria:

* Age at onset above 40 years
* Kidney biopsy proving lesions other than FSGS and MCD

Primary outcomes:
measure: Role of anti-nephrin antibodies in the pathogenesis of NS
timeFrame: From enrollment until the last patient visit (up to 12 months from enrollment)
Secondary outcomes:
measure: Functional role of VUS in the pathogenesis of SRNS
timeFrame: From enrollment until the last patient last visit (up to 12 months from enrollment)
measure: Identification of potential predictive biomarkers of renal outcome.
timeFrame: From enrollment until the last patient visit (up to 12 months from enrollment)
measure: Cost-effectiveness analysis
timeFrame: From enrollment of the last patient until the last visit (up to 12 months from enrollment)
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital IRCCS
Study officials:
References:
Clinical trial NCT06594198: Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study
Official title: Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Monitor
Anaesthesia
Keywords: Brain Monitor
ARGOS Platform
SctO2
ANI
bcSEF
EEG bispectral index
Cerebral tissue oxygen saturation
Analgesia Nociception Index
Lead sponsor: Braindex
Sponsor class: INDUSTRY
Collaborators: name: Clinique de la Sauvegarde
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-centre, prospective, interventional clinical study
Primary purpose: OTHER

Brief summary: The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic).

Detailed description: SctO2 values from ARGOS and INVOS will be resampled every 30 seconds. The two signals will then be resynchronized and compared on a sample-by-sample basis using a Pearson correlation test. Bias and agreement limits will be assessed using Bland \&amp; Altmann graphs. This test will be carried out for the entire duration of the recording.

Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient scheduled for cardiac surgery with programmed extracorporeal circulation (ECC)
* Patient with no history of scalp injury or or skin diseases
* Patient with an Euroscore 2 of less than 7%.
* Patient affiliated or entitled to a social assurance

Exclusion Criteria:

* Weight under 40 kg
* Frontal surface too small to allow application of SctO2, BIS electrodes on the same hemifront
* Patient with severe, unbalanced hypertension
* Measurement of systolic blood pressure (SBP) \&gt; 180 mm Hg and/or diastolic blood pressure (DBP) \&gt; 110 mm Hg
* Patients undergoing emergency surgery
* Patient with chronic renal failure, with glomerular filtration \&lt; 30 ml/min/1.73m², or requiring renal transplantation or requiring renal transplantation
* Patient with left ventricular ejection fraction \&lt; 40%
* Patient with a history of ischemic stroke
* Patients with preoperative sepsis
* Patient requiring noradrenaline infusion noradrenaline infusion in the 24 hours prior to surgery
* Patient with preoperative uni or bilateral carotid stenosis bilateral carotid stenosis \&gt; 50%.
* Protected patient: adult under guardianship, curatorship or legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, parturient or breast-feeding women.
* Patients hospitalized without consent.

Primary outcomes:
measure: Comparison of SctO2 values from ARGOS and INVOS
timeFrame: During the surgical procedure
Secondary outcomes:
measure: ANI and Database
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT04211298: Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
Official title: Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sedation Complication
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.

The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications


Eligibility criteria: Inclusion Criteria:

* All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center

Exclusion Criteria:

* known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine \> 2 mg/dL) or hepatic impairment (elevated liver enzymes \> 2 times normal), haemodynamic instability (bradycardia with HR \< 50 bpm or hypotension with SBP \< 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III

Primary outcomes:
measure: number of de-saturation events
timeFrame: During the procedure
measure: Oxygen saturation time < 90%
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
citation: Pertzov B, Krasulya B, Azem K, Shostak Y, Izhakian S, Rosengarten D, Kharchenko S, Kramer MR. Dexmedetomidine versus propofol sedation in flexible bronchoscopy: a randomized controlled trial. BMC Pulm Med. 2022 Mar 15;22(1):87. doi: 10.1186/s12890-022-01880-9.
Clinical trial NCT00697398: Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
Official title: Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 38
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: Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

Detailed description: We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.

Eligibility criteria: Inclusion Criteria:

* Female or male patient, aged from 18 to 65 years
* Patient presenting a primary fibromyalgia answering the criteria of the ACR
* At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10
* Patient presenting a stable treatment since at least 1 less

Exclusion Criteria:

* Patient minor
* pregnant woman
* women in age to procreate without contraception
* patient deprived of freedom further to a court or administrative order
* patient presenting a secondary fibromyalgia

Primary outcomes:
measure: Analgesic efficiency
timeFrame: 36 months
Secondary outcomes:
measure: Additional evaluation of the pain
timeFrame: 36 months
measure: Evaluation of the quality of life
timeFrame: 36 months
measure: Evaluation of the tolerance of the treatment
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire
Study officials:
affiliation: Assistance Publique des hopitaux de Marseille
name: Eric Guedj, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyer L, Dousset A, Roussel P, Dossetto N, Cammilleri S, Piano V, Khalfa S, Mundler O, Donnet A, Guedj E. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. Neurology. 2014 Apr 8;82(14):1231-8. doi: 10.1212/WNL.0000000000000280. Epub 2014 Mar 26.
Clinical trial NCT02222298: Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment
Official title: Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sacrococcygeal Pilonidal Sinus
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have designed a comparative study between the conventional and the minimally invasive treatment. Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision with a Bascom out-midline closure (Control group).


Eligibility criteria: Inclusion Criteria:

* Chronic sacrococcygeal pilonidal sinus

Exclusion Criteria:

* Absence of consent to the study
* Acute abscess

Primary outcomes:
measure: Infection
timeFrame: at 30 days after surgery
Secondary outcomes:
measure: recurrence
timeFrame: at 1 year after surgery
measure: return at work
timeFrame: up to 30 days after surgery
measure: Pain
timeFrame: up to 30 days after surgery
measure: satisfaction
timeFrame: up to six months after surgery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
References:
Clinical trial NCT05910398: Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
Official title: Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer Invasive
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 and ≤70 years;
* Histologically confirmed invasive HER2 positive breast cancer;
* Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
* Adequate organ functions.

Exclusion Criteria:

* Metastatic disease (Stage IV);
* Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
* Treated or treating with anti-HER2 tyrosine kinase inhibitor;
* Less than 4 weeks from the last clinical trial;
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Primary outcomes:
measure: Invasive Disease-free Survival (iDFS)
timeFrame: From randomization until time of event up to 2 years.
Secondary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: From randomization until time of event up to 2 years
measure: Overall Survival (OS)
timeFrame: From randomization until time of event up to 2 years
measure: Adverse events
timeFrame: From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Wenjin Yin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00419198: Clinical Outcomes of Angioplasty Postconditioning
Official title: Postconditioning and Functional Recovery After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Ischemia
Reperfusion
Myocardial infarction
Postconditioning
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

Detailed description: Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow \>2 after direct stenting by angioplasty.

Exclusion Criteria:

* Cardiac arrest or cardiogenic shock
* occlusion of the circumflex coronary artery

Primary outcomes:
measure: Infarct size as measured by cardiac enzymes and MRI at day 5 to 7
timeFrame: during 72 hours after angioplasty, and at day 5 to 7
Secondary outcomes:
measure: Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.
timeFrame: at 6 month
Other outcomes:
Locations:
city: Lyon
country: France
facility: Michel Ovize
Study officials:
affiliation: Hospices Civils de Lyon
name: michel Ovize, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thibault H, Piot C, Staat P, Bontemps L, Sportouch C, Rioufol G, Cung TT, Bonnefoy E, Angoulvant D, Aupetit JF, Finet G, Andre-Fouet X, Macia JC, Raczka F, Rossi R, Itti R, Kirkorian G, Derumeaux G, Ovize M. Long-term benefit of postconditioning. Circulation. 2008 Feb 26;117(8):1037-44. doi: 10.1161/CIRCULATIONAHA.107.729780. Epub 2008 Feb 11.
Clinical trial NCT06245798: Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension
Official title: Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension: A Chinese Multicentre Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Carcinoma
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study data were extracted from a nationwide database of HCC patients treated at 15 Chinese centres between January 2012 and December 2022. We included patients who were diagnosed with HCC according to the American Association for the Study of the Liver Disease/European Association for the Study of the Liver Guidelines and who received conventional liver resection or transarterial chemoembolisation

Brief summary: Clinically significant portal hypertension limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. HCC patients with CPSH are heterogeneous and treatment allocation remains controversial. The aim of this study was to compare the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in these populations.


Eligibility criteria: Inclusion Criteria:

* HCC patients treated conventional liver resection or transarterial chemoembolisation

Exclusion Criteria:

* (1) presence of types III/IV portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion; (2) presence of extrahepatic spread (EHS); (3) underwent previous treatments; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) \>1; (5) diffuse tumor nodules; (6) combined with other tumours or severe cardiac, cerebral, and renal insufficiency; (7) non-Clinically significant portal hypertension（CSPH）, and (8) absence of baseline information

Primary outcomes:
measure: overall survival rate
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xian
country: China
facility: Tangdu hospital
state: Shaanxi
city: Xian
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References: