louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05012228: Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal Syndrome
Official title: Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Fibrosis, CKD
Keywords: LTBP4
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with chronic kidney disease, which has remaining specimens in NTUH. The investigators want to use 2008-2016 specimens in Department of Pathology, NTUH.

Brief summary: This project is to understand the LTBP4 expression in human renal fibrotic tissues. The investigators will exam major location of LTBP4 expression and check any similar or discrepancy in renal fibrosis with different etiologies.

Detailed description: The investigators will obtain the residual renal tissues with different etiologies and check the expression of LTBP4. The location and quantitation of LTBP4 in renal tissues will be checked. It will be great to understand the association between the severity of fibrosis and the expression of LTBP4 and other matrix proteins.

Eligibility criteria: Inclusion Criteria:

* Abnormal kidney function, proteinuria, hematuria

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Expression of LTBP4 in human renal fibrotic tissue
timeFrame: 5 years
measure: Expression of biomarkers in human renal fibrotic tissue
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00323128: Validation of Serum Creatinine Dosage and Renal Clearance
Official title: Validation of Serum Creatinine Dosage and Renal Clearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Failure
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study has an open study design. The GFR will be measured using the renal clearance of inulin (Inutest) in volunteers with different stage of renal disease or without renal disease. A blood sample will be obtained for measuring serum creatinine in different laboratories.

Detailed description: In this study we will investigate the correlation between the GFR as measured by inulin clearance (golden standard) and the estimated GFR as measured by laboratories which used different serum creatinine assays in patients without renal disease and in patients with different stage of kidney failure.

Eligibility criteria: Inclusion Criteria:

* Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2.
* Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
* The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months.
* Persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the GFR or Admitted volunteers who easily obtain urine samples.

Exclusion Criteria:

* Transplant patients
* Medication that will influence the serumcreatinine.
* Morbid obesity
* Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide).
* History of allergy or hypersensitivity to inulin
* Donation of blood in the 60 days preceding the first visit.
* Liver disease, heart failure, nephrotic syndrome.
* Patients in critically ill conditions.
* Malnutrition
* Postrenal kidney failure

Primary outcomes:
measure: Glomerular filtration ratio
timeFrame: At time T0
measure: Serum creatinine
timeFrame: At time T0
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis Aalst
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Van Holder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Arjan Van der Tol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430728: Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life
Official title: Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infant, Very Low Birth Weight
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Very low birthweight infants treated in our hospital

Brief summary: The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.

Detailed description: In this observational trial we want to examine cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD as measured by near infrared spectroscopy during the first 72h of life in very low birthweight infants.

Differences between relatively healthy and sick preterm infants will be explored. A focus is to find differences between those infants who develop germinal matrix hemorrhage and those who are at risk only but do not develop hemorrhage.

Eligibility criteria: Inclusion Criteria:

* Very low birthweight infants

Primary outcomes:
measure: Cerebral tissue oxygen saturation during first 72 hours of life
timeFrame: during first 72 hours of life
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Medical Center
state: Baden-Württemberg
Study officials:
affiliation: University of Ulm
name: Manuel B Schmid, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwab AL, Mayer B, Bassler D, Hummler HD, Fuchs HW, Bryant MB. Cerebral Oxygenation in Preterm Infants Developing Cerebral Lesions. Front Pediatr. 2022 Apr 12;10:809248. doi: 10.3389/fped.2022.809248. eCollection 2022.
Clinical trial NCT00223028: Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation
Official title: Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: fluvastain
sirolimus
mycophenolat mofetil
renal transplantation
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks before startin the study were included


Eligibility criteria: Inclusion Criteria:

* renal transplant patients (18 - 65 years, inclusive)
* cadaver and living renal transplants(1. Ntx, 2. Ntx)
* Immunsuppression: sirolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
* writen informt consent by the patient

Exclusion Criteria:

* contraindications for statins
* pregnancy or lactating
* elevated liver or muscle encymes (\> 2x up to normal values: AST, ALT, bilirubine, CPK)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
name: Lutz Renders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05962528: Soft Contact Lens Fitting With Different Sagittal Height
Official title: Soft Contact Lens Fitting With Different Sagittal Height
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* No active eye disease
* 5 soft lenses for the experiment can be successfully worn and all examinations can be completed as required

Exclusion Criteria:

* Active eye disease
* BCVA less than 20/25
* Those who are too small or tight eyelids are not suitable for wearing soft lenses

Primary outcomes:
measure: Subjective questionnaire
timeFrame: 1 day (Once time after wearing the soft lens)
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
References:
Clinical trial NCT05796128: NIPPV vs.nCPAP During LISA Procedure
Official title: Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Surfactant
LISA procedure
Preterm infant
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 202
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants.

The main question it aims to answer is:

• Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 \>0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.


Eligibility criteria: Inclusion Criteria:

* -Infants with gestational age between 25+0 and 31+6 gestational weeks,
* -RDS which does not require MV
* -Treatment with NCPAP and FiO2 \>0.30 within the first 6 hours of life,
* -First dose of caffeine administered

Exclusion Criteria:

* -absence of informed consent,
* -major congenital malformations,
* -hydrops fetalis,
* -chromosomal diseases,
* -previous treatment with surfactant,
* -cardiorespiratory instability requiring treatment with vasoactive drugs,
* -pneumothorax,
* -death within 72 hours of life.

Primary outcomes:
measure: Surfactant or mechanical ventilation
timeFrame: The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life
Secondary outcomes:
measure: Noninvasive ventilation
timeFrame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
measure: Mechanical ventilation
timeFrame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
measure: Bronchopulmonary dysplasia
timeFrame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi University Hospital, Division of Neonatology
Study officials:
References:
Clinical trial NCT03346928: Free Flaps : Should we Propose Them to the Elderly ?
Official title: Free Flaps for Head and Neck Reconstruction : Should we Propose Them to the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and neck cancer undergoing microsurgical free flap reconstruction

Brief summary: The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.

Detailed description: The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction. A retrospective chart review of all patients undergoing head and neck free flap reconstruction was conducted and the overall hospital length of stay and the incidence of perioperative medical and surgical complications were assessed.

Eligibility criteria: Inclusion Criteria:

* Head and neck cancer
* Microsurgical free flap reconstruction
* 18 years of age or older

Exclusion Criteria:

-

Primary outcomes:
measure: Medical complications
timeFrame: One month post-surgery
Secondary outcomes:
measure: Surgical complications
timeFrame: One month post-surgery
measure: Hospital length of stay
timeFrame: Approximately 20 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT01550328: Bias Source of Signal in SCOUT DS
Official title: Bias Source of Signal in SCOUT DS
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes
Keywords: Screening for Type 2 diabetes
Lead sponsor: VeraLight, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 25
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: Subjects must be 18 years of age or greater.

Brief summary: The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.

Detailed description: In the process of calibrating multiple SCOUT DS units, consistent inter-device score differences were found. These differences could create a bias in the measurement of Diabetes Risk scores (DRS) in human subjects. This study is intended to examine two of the various subsystems of the SCOUT DS to determine whether either of them might be capable of introducing bias into the measurements, with the ultimate aim of eliminating inter-device measurement variation.

The testing of human subjects in this trial is necessary to determine whether variability in the performance of these device subsystems actually affect DRS scores in a real world setting.

The trial will be a prospective, single site, investigational trial. The trial will utilize four SCOUT DS devices. Subjects will report to the investigative site for multiple visits. The number of visits will vary between three to seven visits.

Eligibility criteria: Inclusion Criteria:

* Males and/ or females greater than or equal to 18 years of age

Exclusion Criteria:

* Have received investigational treatments in the past 14 days
* Have psychosocial issues that interfere with an ability to follow study procedures
* Are known to be pregnant
* Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Have been treated in the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion
* Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H)
* Are known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Primary outcomes:
measure: Determine Device Bias
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: VeraLight
state: New Mexico
Study officials:
affiliation: VeraLight, Inc.
name: Jon Aase, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241928: Stem Cell Therapy in Muscular Dystrophy
Official title: Role of Autologous Mononuclear Cell Therapy in Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Muscular Dystrophy
Keywords: Muscular Dystrophy
Autologous Mononuclear cell therapy
Stem Cell
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to analyze the effect of autologous bone marrow mononuclear cells in muscular dystrophy.


Eligibility criteria: Inclusion Criteria:

* age group of 6 months and above
* muscular dystrophy diagnosed on the basis of clinical presentation

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding

Primary outcomes:
measure: Manual Muscle Testing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
Clinical trial NCT06591728: PCA Loading Time Before Knee Prosthetic Joint Infection Revision
Official title: The Effects Of Dietary Protocatechuic Acid (PCA) On The Function And Structure Of Participants With Prosthetic Joint Infection (PJI) Before Revision Surgery, As Measured By Standard Biomarkers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prosthesis-Related Infections
Lead sponsor: Dr. Dean Reeves Clinic
Sponsor class: OTHER
Collaborators: name: Lanny Johnson, M.D.
name: Leo Whiteside, M.D.
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Proof of principle pilot study of the effect of dietary nutritional loading of protocatechunic acid (PCA) on the health and welfare of individuals with prosthetic joint infection (PJI), as measured by standard biomarkers

Detailed description: Our purpose in the pre-surgery serial aspiration study is to determine the optimal PCA loading time duration for those with knee PJI with planned single or two stage revision.Our hypothesis, related to changes in structure and function as a result of PCA administration is that dietary nutritional loading of this nutraceutical PCA via the oral route will benefit the health and welfare of such a subject and alter the function and or structure of the human body having a PJI, as measured by improvemen in a pain biomarker, and one or more laboratory-based biomarkers.

Eligibility criteria: Inclusion Criteria:

* More than 3 weeks after total knee arthroplasty
* One or more symptoms of injection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
* WBC count of aspiration \>50,0000 cells per μL

Exclusion Criteria:

- Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks

Primary outcomes:
measure: Change in Walking Pain 0-10 NRS
timeFrame: 0,1, 2, 3, and 4 weeks
measure: Change in CRP
timeFrame: 0,1, 2, 3, and 4 weeks
measure: Change in ESR
timeFrame: 0,1, 2, 3, and 4 weeks
measure: Change in WBC count in aspirate
timeFrame: 0,1, 2, 3, and 4 weeks
measure: Bacterial colony count in aspirate
timeFrame: 0,1, 2, 3, and 4 weeks
Secondary outcomes:
measure: CXCL9
timeFrame: 0 and 3 months
measure: HbA1c
timeFrame: 0 and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: K. Dean Reeves, M.D., P.A.
name: Kenneth D Reeves
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102528: Acute Kidney Injury Following Cardiac Surgery
Official title: Acute Kidney Injury After Cardiac Surgery - A Retrospective Single-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 495
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery (elective, urgent and emergent; coronary artery bypass, valve replacements, combined or other surgery, with cardiopulmonary bypass) between November 2014 and October 2015 at the Division of Cardiac Surgery, San Bortolo Hospital, in Vicenza, Italy

Brief summary: Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. The investigators sought to examine the risk factors associated with the development of AKI and renal recovery in patients undergoing cardiac surgery at San Bortolo Hospital, Italy 2014-2015.

Detailed description: Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. The investigators sought to examine the risk factors associated with the development of AKI and renal recoveryin patients undergoing cardiac surgery at San Bortolo Hospital, Italy during November 2014 - October 2015.

Eligibility criteria: Inclusion Criteria:

- Adult cardiac surgery

Exclusion Criteria:

1. Missing baseline serum creatinine (defined as a serum creatinine value within 90 prior to surgery) or missing serum creatinine within 3 days before hospital discharge
2. Stage 5 chronic kidney disease (estimated glomerular filtration rate \<15 ml/min/1.73 m2 or receipt of chronic dialysis)
3. Solid organ transplant recipients

Primary outcomes:
measure: Prevalence of acute kidney injury using full Kidney Disease Improving Global Outcomes criteria
timeFrame: within 7 days
Secondary outcomes:
measure: Renal recovery
timeFrame: Within 1 month
Other outcomes:
Locations:
Study officials:
affiliation: International Renal Research Institute of Vicenza
name: Claudio Ronco, MD
role: STUDY_DIRECTOR
References:
citation: Ryden L, Sartipy U, Evans M, Holzmann MJ. Acute kidney injury after coronary artery bypass grafting and long-term risk of end-stage renal disease. Circulation. 2014 Dec 2;130(23):2005-11. doi: 10.1161/CIRCULATIONAHA.114.010622. Epub 2014 Sep 19.
citation: Pickering JW, James MT, Palmer SC. Acute kidney injury and prognosis after cardiopulmonary bypass: a meta-analysis of cohort studies. Am J Kidney Dis. 2015 Feb;65(2):283-93. doi: 10.1053/j.ajkd.2014.09.008. Epub 2014 Nov 5.