louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04539743: Modified Step by Step Mitrofanoff Continent Cystostomy : Functional Results of a Teachable Procedure
Official title: Modified Step by Step Mitrofanoff Continent Cystostomy : Functional Results of a Teachable Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitrofanoff Continent Cystostomy
Cystostomy; Complications
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 70
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: adult who has undergone a Mitrofanoff cystostomy by Dr. BOILLOT

Brief summary: The creation of an abdominal continental cystostomy orifice is an irreplaceable surgical technique that allows for the simple self-sounding of the bladder in patients with severe disabilities or malformations, and to obtain urinary continence.

This operation, the principle of which was described by Paul Mitrofanoff in 1980, has benefited from countless descriptions, difficult realization and questionable design, so it is insufficiently proposed.

Faced with this learning difficulty at the beginning of the year, we decided to define a "step-by-step" technique, in seven well-differentiated steps. This approach has simplified the teaching and dissemination of this technique.

To validate its quality, it is necessary to evaluate the expected results of a continental cystostomy, by answering two simple questions:

-is the cystostomy opening really continent? Is the cystostomy tube easy to catheterize?

Detailed description: This research consists in highlighting that the Mitrofanoff surgery technique used by the CHUGA surgeons during a cystostomy is easier to perform while having the necessary same results as the other methods.

To do this, we must validate the quality of this method and therefore we will evaluate the results expected from a continuous cystostomy via a questionnaire. After a first telephone contact by Dr BOILLOT for a presentation of the study, patient will therefore be contacted by telephone by the Clinical Research Associate of the service.

During this interview patient will be asked to answer a questionnaire consisting of five questions.

Eligibility criteria: Inclusion Criteria:

* adult who has undergone a Mitrofanoff cystostomy by Dr. BOILLOT

Exclusion Criteria:

* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure)
* Patients operated on by other surgeons

Primary outcomes:
measure: To evaluate, in a series of identically operated patients, the expected results of a continuous cystostomy: -is the cystostomy hole really continental? -is the cystostomy tube easy to catheterize
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
References:
Clinical trial NCT06051643: Use of Motor Rehabilitation Courses in Children With Cerebral Palsy
Official title: Use of Motor Rehabilitation Courses in Children With Cerebral Palsy in 2022
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Children
Motor rehabilitation course
Survey and Questionnaire
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Represents children with cerebral palsy aged 6 to 18

Brief summary: In 2022, the prevalence of Cerebral Palsy (CP) is 2.5 cases per 1000 live births. In France, 125,000 persons are affected by CP. Many treatments and therapies exist to reduce CP-related disorders, but CP remains uncurable. Motor Rehabilitation Courses (MRC) are one of those therapies used with children with CP. Their uses has not been studied in France yet.

The aim of this survey is to find out about the use of motor rehabilitation courses for children with CP and, where appropriate, the content of these courses. This questionnaire will be used to determine the use and different types of MRS in which children participate.

Detailed description: In total, the questionnaire contains 131 items divided into 13 groups. The estimated filling time is 20 minutes.

The questionnaire is divided as follows:

1. INFORMATION DOCUMENT FOR THE RESEARCH PARTICIPANT
2. About the person with cerebral palsy
3. About the respondent
4. About the usual motor rehabilitation
5. About participation in motor rehabilitation courses
6. 7) 8) Information about MRS

9) Relationship of care or treatment received to participation in MRS 10) Information about the child 11) Information about the child's environment 12) Additional comments from the respondent regarding the MRS 13) Respondent's opinion on the questionnaire

Eligibility criteria: Inclusion Criteria:

* Child with a diagnosis of cerebral palsy
* Aged between 6 and 18 years

Exclusion Criteria:

* Child diagnosed with CP after age 6
* Between 1 and 6 years of age

Primary outcomes:
measure: Prevalence of the use of motor rehabilitation courses in children with cerebral palsy
timeFrame: Each participant will answer for 20 minutes an expert-validated questionnaire on the internet once recruited in the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03364543: The UTHealth Medical-Legal Partnership: Improving Health by Addressing Health-Harming Legal Needs
Official title: The UTHealth Medical-Legal Partnership: Improving Health by Addressing Health-Harming Legal Needs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Determinants of Health
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 911
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: These are adults patients accessing primary care clinics.

Brief summary: The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of the UTHealth medical-legal partnerships (MLP) against usual care.


Eligibility criteria: Inclusion Criteria:

* English- or Spanish- speaking
* screen positive for health-harming legal needs (HHLNs)

Exclusion Criteria:

* Those unable or unwilling to consent to legal services

Primary outcomes:
measure: Number of participants who had an emergency department visit
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: UTHealth Comprehensive Sickle Cell Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Winston Liaw
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382043: Angiographic and IVUS Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals (AIFSIDDES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Angioplasty
Keywords: percutaneous coronary angioplasty
zotarolimus-eluting stent
sirolimus-eluting stent
biodegradable polymer
biocompatible polymer
Lead sponsor: Liuhuaqiao Hospital
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patiemts who underwent simultaneous implantation of one or more Endeavor stents and one or more Excel stents during the same index procedure and were evaluated with coronary angiography and intravascular ultrasound (IVUS) at least one year post-procedure.

Brief summary: The safety and efficacy of drug-eluting stents (DES) with a biocompatible polymer have been demonstrated in randomized clinical trials as well as in real world practice. Theoretically, a new DES with a biodegradable polymer should reduce the incidence of late in-stent thrombosis, however, the long-term safety and efficacy of these stents remains unknown. This study was aimed to compare the safety and efficacy of the Excel DES with a biodegradable polymer to the Endeavor DES with a biocompatible polymer in same individuals.


Eligibility criteria: Inclusion Criteria:

* simultaneous implantation of one or more Endeavor stents and one or more Excel stents during the same index procedure
* willing to be followed up with coronary angiography and intravascular ultrasound at least one year post-procedure.

Exclusion Criteria:

* Patients were excluded from the study if they had more than two kinds of stents implanted or if the two study stents were implanted during separate interventional procedures or in coronary artery bridge vessel or restenotic lesions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Liuhuaqiao Hospital
state: Guangdong
Study officials:
affiliation: Liuhuaqiao Hospital
name: Dingcheng Xiang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05877443: Barotrauma in Adults With Critical COVID-19
Official title: Barotrauma in Adults With Critical COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Barotrauma
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 669
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with critical COVID-19 admitted to an intensive care unit at Södersjukhuset, Stockholm, Sweden, March 2020 to May 2021.

Brief summary: During the pandemic of COVID-19, studies reporting a high incidence of barotrauma, both pneumothorax but also pneumomediastinum, in patients with critical COVID-19. If this is complications of the respiratory support used to treat patients hypoxemia or if it is a direct consequence of COVID-19 damaging the lung tissue is not known.

The aim of this study is to investigate the incidence and type barotrauma, if there is an association between barotrauma and level of respiratory support used in the intensive care unit, and if barotrauma is associated with worse outcome compared to patients without barotrauma.


Eligibility criteria: Inclusion Criteria:

* Positive polymerase chain reaction for SARS-CoV-2
* Admitted to ICU due to respiratory failure

Exclusion Criteria:

* Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible

Primary outcomes:
measure: Barotrauma
timeFrame: 28 days from ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Stockholm South General Hospital
name: Sandra Jonmarker, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01606943: Clinical Profiles and Outcomes of Acute Aortic Dissection in the Chinese Patients
Official title: The Study of The Chinese Registry of Acute Aortic Dissection and Clinical Study of Acute Aortic Dissection in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aorta Thoracic Ascending Dissection
Dissection of Descending Aorta
Keywords: Aortic dissection
Risk factor
Feature
Management
Outcome
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
First posted: 2012-05-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese population suffering acute aortic dissection

Brief summary: Clinical profiles and outcomes of patients with acute aortic dissection have not yet been evaluated in China. The aim of this study is to establish clinical registry of acute aortic dissection in China and to analyze clinical features, managements and outcomes of Chinese patients with acute aortic dissection.

Detailed description: In 1996, the Internation Registry of Acute Aortic Dissection(IRAD) was established to improve clinical diagnosis and treatment of acute aortic dissection. However, most patients from the IRAD are Caucasian. These data were not sufficient to reflect clinical profiles and outcomes of Chinese patients with acute aortic dissection. In China, little is known about clinical features, managements and outcomes of acute aortic dissection involving a large number of patients. The investigators established clinical multicenter registry of acute aortic dissection. Between January 2009 and February 2012, about 2000 were enrolled in the Chinese registry of acute aortic dissection(CRAD) database. The aim of this study is to analyze clinical profiles and outcomes of Chinese patients with acute aortic dissection.

Eligibility criteria: Inclusion Criteria:

* Stanford type A dissection
* Stanford type B dissection
* Retrograde Stanford Type B dissection
* Unclassified dissection with primary tear located in the aortic dissection

Exclusion Criteria:

* Aortic aneurysm
* Active infection or active vasculitides
* Myocardial infarction or Cerebral accident within 2 months
* Unwillingness to cooperate wiht study procedures or follow-up visits

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Dihua Yi, MD
role: STUDY_DIRECTOR
affiliation: General Hospital of Beijing Military Area command of Chinese PLA
name: Yang Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xijing Hospital
name: Wenxun Duan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03238443: Interest of the Donor-specific Antibodies After Liver Transplantation
Official title: Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant
Keywords: DSA
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 120
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: All consecutive adult patients transplanted at the University Hospital of Lille will be included in a prospective observational study.

Brief summary: The study is a prospective observational mono center study

Primary objective :

Study the anti-HLA antibodies frequency preformed before liver transplantation and the kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver transplantation.

Secondary objective :

* Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)
* Impact of DSA on:

  * Graft and patients survivals
  * Onset of allograft rejection (acute, late-onset, chronic)
  * Unexplained liver graft dysfunction
  * Unexplained liver enzymes abnormalities
  * Liver fibrosis development (liver stiffness study using fibroscan©)


Eligibility criteria: Inclusion Criteria:

* Liver transplanted patients older than 18, transplanted in Lille University Hospital.
* Written consent by the patient or his/her legal representative (especially patient with hepatic encephalopathy).
* Patients with health insurance

Exclusion Criteria:

* Minor patients.
* Pregnant women or during lactation.
* Patient under curatorship.

Primary outcomes:
measure: Prevalence DSA positivity (or anti-HLA).
timeFrame: At baseline
Secondary outcomes:
measure: Fluorescence quantification
timeFrame: at 3 months, 1 year and 2 years after transplantation
measure: Presence of C1q binding-complement anti-HLA antibodies
timeFrame: at 3 months, 1 year and 2 years after transplantation
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Sébastien Dharancy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00030043: An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
Official title: Penetrating Auditory Brainstem Implant for Neurofibromatosis 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neurofibromatosis 2
Keywords: Electric Stimulation
Implants, Artificial
Brainstem
Electrodes
Speech Perception
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.

Detailed description: Neurofibromatosis Type 2 (NF2) is characterized by multiple tumors of the cranial and spinal nerves, and, in particular, by bilateral acoustic tumors. Surgical resection of these tumors generally results in the transection of the VIIIth nerve, destruction of the cochlea and auditory nerve, and total hearing loss. Due to the loss of the auditory nerve, these patients are not candidates for cochlear implantation. The Auditory Brainstem Implant (ABI) provides the only available intervention to restore some auditory sensation to these patients. An ABI is an implantable prosthesis that produces sound sensation by electrical stimulation of the ascending auditory pathway at the level of the cochlear nucleus.

The PABI may be placed surgically during tumor resection. Efficacy will be assessed using psychophysical and standard speech reception measures.

Eligibility criteria: Inclusion criteria:

* Diagnosis of neurofibromatosis type 2
* Speak English as a primary language

Exclusion criteria:

* Physical, psychological, or medical conditions that contraindicate the surgical procedure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Institute
state: California
city: Pasadena
country: United States
facility: Huntington Medical Research Institutes
state: California
city: Englewood
country: United States
facility: Cochlear Corporation
state: Colorado
Study officials:
References:
Clinical trial NCT01192243: Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Official title: Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Toxicity
Non-small Cell Lung Cancer
Keywords: Objective response rate
Time to Progression
Quality of Live
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 68
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: The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
* Age from 18 to 70 years old
* At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
* ECOG 0-1
* Expected life time longer than 12 weeks
* Normal laboratory values:

leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis)

Exclusion Criteria:

* Patients have not used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception

Primary outcomes:
measure: response rate
timeFrame: six weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: six weeks
measure: Progression free survival
timeFrame: six weeks
measure: quality of life
timeFrame: six weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University affiliated cancer hospital
name: Jianhua Chang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03213743: Expression Profiling of microRNA Following Administration of Dexmedetomidine
Official title: Expression Profiling of microRNA Following Administration of Dexmedetomidine in Patients Undergoing Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Lead sponsor: First Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to find out the differential expression profiling of microRNA before and after adiministration of dexmedetomidine in patients undergoing procedures, and then investigators will do some in vitro studies to validate the functions of the microRNA.

Detailed description: Background and objective: The use of dexmedetomidine may have benefits on the clinical outcomes of cardiac surgery. MicroRNAs are non-coding RNA sequences that act as regulators of gene expression. Investigators conduct a study to determine the role of microRNAs in cardioprotection mediated by dexmedetomidine.

Methods: In this study 3 patients were selected. The blood sample were taken before administration of dexmedetomidine.Investigators infused loading dose of dexmedetomidine for 10 minutes and maintaining dese of dexmedetomidine for 20 minutes.Thirty minutes after the administration, another blood samples were taken and stored in the liquid nitrogen and both the samples were marked. Those sample were analyzed for differentially expressed microRNA with Exiqon miRNA Array.

Eligibility criteria: Inclusion Criteria:

* The patients without arrithmia will undergo procedure.

Exclusion Criteria:

* The patients have bradycardia (hear rate is less than 60 beats per minute) or conduction block.

Primary outcomes:
measure: microRNA differential expression
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Jinqiao Qian
state: Yunnan
Study officials:
affiliation: First Affiliated Hospital of Kunming Medical University
name: Jinqiao Qian, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: