louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03291366: Mesenchymal Stem Cells in Central Nervous System injury2017
Official title: Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Central Nervous System Injury
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 30
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: Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.


Eligibility criteria: Inclusion Criteria:

* CNS injury \> 3 months
* age \> 18 years
* willing to give consent
* stable vital signs
* absence of active infectcion

Exclusion Criteria:

* any contradiction to intrathecal infusion
* age \< 18 years
* CNS injury \< 3 months
* CNS injury \> 3 years

Primary outcomes:
measure: life quality score
timeFrame: 1y
Secondary outcomes:
measure: adverse events
timeFrame: 1y
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01685866: 3V- Improve Venous Access in Pediatric Anesthesia
Official title: Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: anesthesia
venous access
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Ministry of Health, France
First posted: 2012-09-14
Enrollment: 311
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

Detailed description: Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.

Eligibility criteria: Inclusion Criteria:

* children aged less than 7
* DIVA score ≥ 4
* patient needing venous peripheral access for general anesthesia

Exclusion Criteria:

* no social security
* opposition of the parent(s) to the participation of their child in the trial

Primary outcomes:
measure: reduce the time necessary to find the venous access during inhalation anesthesia induction
timeFrame: 1 day of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital, APHP
state: Ile de France
city: Paris
country: France
facility: Fondation ophtalmologique Adolphe de Rothschild
state: Ile-de-France
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Jean-Michel Devys, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467.
Clinical trial NCT00205166: Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
Official title: Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: adenosine tracer scans
coronary artery disease
caffeine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2005-09-20
Enrollment: 50
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: DIAGNOSTIC

Brief summary: We are studying the affect of caffeine on the sensitivity of detecting coronary artery disease (blockages in the blood flow to the heart) with adenosine tracer scans. Adenosine is a drug used routinely in patients to relax heart blood vessels in order to assess for the presence of coronary artery disease. Often, if patients have had caffeine, the adenosine scan is not used because of the belief that caffeine may reduce the ability to detect coronary artery disease. We would like to test whether caffeine affects our ability to detect coronary artery disease with adenosine tracer scanning. We will perform an imaging study of the heart with adenosine after you have received caffeine.


Eligibility criteria: Inclusion Criteria:

* Patients who have already completed rest/stress 99mTc sestamibi or 99mTc tetrofosmin imaging will be given a form describing this protocol and asked to volunteer for the additional scan

Exclusion Criteria:

* history of asthma, bronchospastic COPD, or renal failure

Primary outcomes:
measure: This protocol has a specific aim of determining whether prior caffeine administration affects the sensitivity and specificity of adenosine perfusion scintigraphy for detection of impaired coronary vascular reserve.
timeFrame: Assessment is made at the time of research adenosine perfusion scintigraphy
Secondary outcomes:
measure: determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging
timeFrame: Assess at time of lab sample results obtained
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Univeristy of Wisconsin
name: Charles K Stone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03338166: Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma
Official title: Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients resident at oncology department at luxor international hospital who diagnosed as apatient with Hepatocellular carcinoma

Brief summary: Hepatocellular carcinoma represents the commonest primary cancer of the liver.serum lactate dehydrogenase is an indirect marker of tumor hypoxia,angioneogenesis and worse prognosis.

Detailed description: Hepatocellular carcinoma (HCC) represents the commonest primary cancer of the liver. Incidence is increasing and HCC has risen to become the 5th commonest malignancy worldwide and the third leading cause of cancer related death, exceeded only by cancers of the lung and stomach. HCC prevalence is higher in sub-Saharan Africa, central and Southeast Asia.Serum lactate dehydrogenase (LDH) levels is an indirect marker of tumor hypoxia, angioneogenesis and worse prognosis. Lactic dehydrogenase (LDH), which is a glycolytic enzyme, composed of four polypeptide chains, each one encoded by separate gene (M and H), exists in various types of human tissue and neoplasms. LDH is a key enzyme in the conversion pyruvate to lactate under anaerobic conditions .Five isoforms of LDH have been identified as a result of the five different combinations of polypeptide subunits.

Hypoxia represents a clinical biological mechanism for treatment resistance in cancer cells via the formation of new blood vessels. Furthermore, a growing body of evidence indicates that hypoxia might actually promote cancer development.

Eligibility criteria: Inclusion Criteria:

* patients with Hepatocellular carcinoma diagnosed by biopsy or imaging criteria and alpha feto protein.
* signed informed consent before registration in study
* Eastern Cooperative oncology Groups Performance status between 0 and 2.

Exclusion Criteria:

* Cachexia or poor condition
* pregnant or human chorionic gonadotropin positive
* patient with another liver tumor
* Any previous treatment

Primary outcomes:
measure: serum LDH level as a predictor of response in hepatocellular carcinoma
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Aml R Ibrahim, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355666: Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Official title: Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcers
Keywords: pressure ulcers
stage 1
stage 2
stage 3
stage 4
wounds
sores
infection
bioburden
bacterial contamination
bed linen
sheets
underpad
skin assessment
microclimate
shear
friction
moisture
fabrics
long term care
nursing home
decubitus ulcer
bed ridden
anti-microbial
Lead sponsor: Precision Fabrics Group, Inc.
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2011-05-18
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.

Detailed description: Additional objectives of this research study are:

* To evaluate healing of pressure ulcers already present or pressure ulcers that develop during the study.
* To evaluate the effectiveness of DermaTherapy® bedding and alternative diapers to reduce the potential for bacterial contamination associated with patients' bed linens, underpads, gowns and pajamas, and thereby help reduce the incidence of facility-acquired infections.

Study nurses will assess the skin of the subjects once or twice a week for the presence of pressure ulcers and measure the size of the pressure ulcers if they are present. Study nurses will also obtain bacterial culture swabs of the bedding weekly for the first eight weeks of the study from five participants in each group.

Eligibility criteria: Inclusion Criteria:

* Residents admitted for long term care.
* Residents admitted for Hospice Care with an expected length of stay greater than one week.
* Residents with an expected length of stay equal to or greater than 90 days.

Primary outcomes:
measure: Prevention and reduction in the incidence of pressure ulcers
timeFrame: Weekly assessments for 1 year
Secondary outcomes:
measure: Reduction of bacterial contamination
timeFrame: Weekly for 8 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Duke University Medical Center
name: Jack I Twersky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA medical Center, Duke University Medical Center
name: Kenneth E Schmader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06016166: Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
Official title: The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial (RCT) was aimed to determine the effects of eye masking on sleep quality and tear layer function in patients with dry eye disease. In this regard, a total of 34 patients with dry eye disease aged between 20 to 35 years old will be participated. They will be randomly divided into case and control (n=17) groups. Patients in the case group will be instructed to wear the eye mask as long as two weeks and the controls will be recommended to not wear it at the same time. Afterwards, the eye mask application will be cross- over for the next 2 hours between the two groups. Tear layer will be investigated in baseline and repeated in both follow- ups of weeks 2 and 4, either quantitatively and qualitatively, by using Schirmer and TBUT tests. Furthermore, the sleep quality will be checked by the PSQI test.


Eligibility criteria: Inclusion Criteria:

* Patients with dry eye disease according to the OSDI test

Exclusion Criteria:

* Patients with eye disease except dry eye
* Patients using systemic and ophthalmic drugs
* Patients using sleeping and sedative pills

Primary outcomes:
measure: The effect of using eye mask on tear layer functions between baseline and follow- ups of weeks 2 and 4 in patients with dry eye
timeFrame: between baseline and follow- ups of weeks 2 and 4
measure: The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye
timeFrame: between baseline and follow- ups of weeks 2 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamideh Sabbaghi
Study officials:
References:
Clinical trial NCT03634566: Effect of N_Acetylcysteine on Liver Functions in Donors in Living Liver Transplantation
Official title: Effect of N_Acetylcysteine on Liver Functions in Donors in Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Transplant; Complications
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: our practice for the past 10 years we have noticed a transitional impairment of liver function (elevated liver enzymes, total and direct bilirubin, and elevated serum lactate levels) following donors' liver resection. Several drugs have been investigation on liver regeneration , proven benefit of N-Acetylcysteine (NAC) on rats with steatohpatitis


Eligibility criteria: Inclusion Criteria:

* ASA I or II donors
* healthy adult

Exclusion Criteria:

* kidney, liver disease
* any contraindications for organ donation

Primary outcomes:
measure: Serum lactate
timeFrame: 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT01289366: Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Inflammatory Bowel Disease (IBD)
Official title: Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn´s Disease
Ulcerative Colitis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy.

Brief summary: Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine the extent and severity of the disease for further specific therapy. Nevertheless, despite ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still relies on the interpretation of histopathological features of intestinal biopsies taken during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the gut at a magnification level of up to 1400-fold.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy
* Patients with known Crohn´s disease or ulcerative colitis

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Impaired renal function (Creatinine \> 1.2 mg/dl)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Known allergy to methylene blue or toluidine blue
* Residing in institutions (e.g. prison)

Primary outcomes:
measure: To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells.
timeFrame: 40 patients
Secondary outcomes:
measure: To evaluate the potential of endocytoscopy for the determination of intestinal inflammatory activity in patients with quiescent IBD and to compare endocytoscopy results with the results of standard histopathology
timeFrame: 40 patients
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg
state: Bayern
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Helmut Neumann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neumann H, Vieth M, Neurath MF, Atreya R. Endocytoscopy allows accurate in vivo differentiation of mucosal inflammatory cells in IBD: a pilot study. Inflamm Bowel Dis. 2013 Feb;19(2):356-62. doi: 10.1002/ibd.23025.
Clinical trial NCT05969366: Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor
Official title: Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty Complications
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 79
Sex: ALL
Minimum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any people of 85 years of more who received total hip arthroplasty with uncemented stem fully hydroxyapatitis coated

Brief summary: Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022.

This is a femoral stem survival study with calculation of the complication rate in this population.

The study does not focus on total hip replacements in the context of trauma. The secondary endpoint was the search for complication risk factors.


Eligibility criteria: Inclusion Criteria:

* receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated

Exclusion Criteria:

* trauma context
* less than 3 month follow up
* Any surgery of the hip as medical history

Primary outcomes:
measure: rate of complication
timeFrame: minimum of 3 months follow up
Secondary outcomes:
measure: risk factor of complications
timeFrame: minimum of 3 months follow up
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Chirurgical Emile Gallé
Study officials:
References:
Clinical trial NCT00963066: NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury
Official title: NAV-ALI: Effects of Different Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Patients Recovering Spontaneous Breathing After Acute Lung Injury: A Physiological Evaluation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
Mechanical Ventilation
Keywords: NAVA
Acute Lung Injury
Pressure Support Ventilation
Intubation
Tracheostomy
Mechanical ventilation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2009-08-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.

Detailed description: Physiological evaluation of two modes of mechanical ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation, at different levels of ventilator assistance.

Evaluation in term of physiological parameters: Tidal volume, Respiratory rate, Inspiratory effort, PaCO2, evaluation of subject-ventilator synchrony.

Evaluation of physiological response to varying levels of ventilator assistance.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Hospitalized in intensive care unit
* Acute Lung Injury
* Intubated or tracheotomized and mechanically ventilated

Exclusion Criteria:

* Hemodynamic instability
* Absence of consent

Primary outcomes:
measure: Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
timeFrame: 24 hours
Secondary outcomes:
measure: Subject-ventilator synchrony
timeFrame: 24 hours
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de CAEN
Study officials:
affiliation: University Hospital, Caen
name: Nicolas TERZI, MD
role: PRINCIPAL_INVESTIGATOR
References: