louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01694914: Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
Official title: Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Corneal Transplantation
Keywords: Corneal Transplantation
corneal organ culture medium
free animal compound medium
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-09-27
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.


Eligibility criteria: Inclusion Criteria:

* Male and female patients
* over 18 years of age
* Clinically proven corneal disease
* Registered on the French National waiting list (GLAC)
* Patient informed consent
* Patient who needs a 8.25mm of diameter perforating keratoplasty, either isolated or combined with lens surgery
* Low immune rejection risk (\< 2 quadrants of neovascularization, no previous history of herpetic keratitis nor graft rejection)
* No previous history of glaucoma or elevated intra ocular pressure (\>22 mm

Exclusion Criteria:

* Patient is unlikely to comply with the requirements of the protocol

Primary outcomes:
measure: the primary outcome is the endothelial cell density (ECD) of the corneal grafts.
timeFrame: one year after graft
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besançon
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Gilles Thuret, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944814: Acceptability of Zinc-fortified Lipid-based Nutrient Supplements
Official title: Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Lipid-based nutrient supplement
Prevention of malnutrition
Prevention of micronutrient deficiencies
Zinc
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Université Polytechnique de Bobo-Dioulasso
name: Helen Keller International
name: Bill and Melinda Gates Foundation
First posted: 2009-07-23
Enrollment: 36
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to assess the acceptability of the two lipid-based nutrient supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g dose of LNS). The hypothesis is that both products will be equally accepted by children and mothers.

Detailed description: We plan to conduct a series of acceptability studies to: 1) assess the amounts of zinc-free and high-zinc LNS consumed by children during direct observation, 2) compare their mothers' sensory assessments of the respective products, and 3) review maternal reports of their child feeding experiences during more prolonged home feeding trials.

Eligibility criteria: Inclusion Criteria:

* Currently breast-feeding and consuming complementary foods for at least 30 d

Exclusion Criteria:

* Height-for-age and weight-for height Z-scores \<-3 with respect to WHO growth standards
* Edema
* Diarrhea and other diseases that could interfere with food intake
* Severe systemic illness
* History of peanut allergy
* History of anaphylaxis/serious allergic reaction

Infants meeting these criteria and their mother's will be invited to participate

Primary outcomes:
measure: Amount of each type of LNS formulation consumed by young children
timeFrame: 3 days
measure: Preference and detection of differences between LNS formulations among mothers
timeFrame: 3 days
measure: Acceptability of feeding LNS to young children at home
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Santé
Study officials:
affiliation: University of California, Davis
name: Kenneth H. Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hess SY, Bado L, Aaron GJ, Ouedraogo JB, Zeilani M, Brown KH. Acceptability of zinc-fortified, lipid-based nutrient supplements (LNS) prepared for young children in Burkina Faso. Matern Child Nutr. 2011 Oct;7(4):357-67. doi: 10.1111/j.1740-8709.2010.00287.x. Epub 2010 Dec 15.
Clinical trial NCT02541214: Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.


Eligibility criteria: Inclusion Criteria:

* Aged 18+
* Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
* Existing nasal or nasal pillows user
* Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))

Exclusion Criteria:

* Inability to give informed consent
* Pregnant or think they may be pregnant
* Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
* Patients who are in a coma or decreased level of consciousness
* Current diagnosis of CO2 retention
* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)

Primary outcomes:
measure: Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
timeFrame: 2 weeks in home
Secondary outcomes:
measure: Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.
timeFrame: 2 weeks in home
measure: Objective leak data through the Positive Airway Pressure therapy device
timeFrame: 2 weeks in home
measure: Treatment efficacy through the Positive Airway Pressure therapy device
timeFrame: 2 weeks in home
measure: Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
timeFrame: 2 weeks in home
Other outcomes:
Locations:
city: Hamilton
country: New Zealand
facility: Waikato District Health Board
city: Hastings
country: New Zealand
facility: Hawke's Bay District Health Board
Study officials:
References:
Clinical trial NCT01173614: Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes
Official title: Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Subjects, Ametropia
Lead sponsor: European Vision Institute Clinical Research Network
Sponsor class: NETWORK
First posted: 2010-08-02
Enrollment: 1646
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal subjects

Brief summary: The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.


Eligibility criteria: Inclusion Criteria:

* Two normal eyes
* Ametropia between -10D and +10D.

Exclusion Criteria:

* One pathological eye
* Prior ocular surgery
* Amblyopia, refraction larger than ±10D
* Corneal or retinal pathologies
* Systemic diseases (e.g. diabetes, multiple sclerosis, ...)
* More than 5 months pregnant at the moment of testing
* Recent wear of hard contact lenses
* Epilepsy (if C-Quant is used).

Primary outcomes:
measure: to obtain a predetermined number of valid ocular biometry measurements per participating site
timeFrame: 19 months
measure: To obtain a predetermined number of valid visual function measurements per participating site
timeFrame: 19 months
Secondary outcomes:
measure: Provide a reference database for research purposes
timeFrame: 19 Months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: VISSUM - Instituto Oftalmológico de Alicante
Study officials:
affiliation: Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium
name: Jos Rozema, MSc PhD
role: STUDY_CHAIR
affiliation: Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium
name: Marie-José Tassignon, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Vision and Optics (IVO), University of Crete, School of Health Sciences, Heraklion Crete, Greece 71003
name: Sotiris Plainis, MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zocher MT, Rozema JJ, Oertel N, Dawczynski J, Wiedemann P, Rauscher FG; EVICR.net. Biometry and visual function of a healthy cohort in Leipzig, Germany. BMC Ophthalmol. 2016 Jun 7;16:79. doi: 10.1186/s12886-016-0232-2.
Clinical trial NCT01098214: The Role of Cytokines in Apparently Normal Pregnancies
Official title: The Role of Cytokines (and Other Biomarkers) in Apparently Normal Pregnancies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy
Keywords: Normal pregnancy
Amniotic fluid
Cytokines
Biomarkers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 0
Sex: FEMALE
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: Women undergoing amniocentesis with an apparently normal pregnancy

Brief summary: To provide rigorous, detailed normative data for diagnostics and comparative studies, to determine relationships between cytokine levels (and other biomarkers) and clinical data, and gain further insight into the pro-/anti-inflammatory cytokine profile of normal midtrimester amniotic fluid.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Pregnancies between 15-25 weeks gestation.
* Able to provide informed consent.
* No apparent major sonographic abnormality.

Exclusion Criteria:

* Any major fetal anomaly

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Winthrop University Hospital
name: Nazeeh Hanna, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03066414: Respiratory Variations For Assessing Blood Withdrawal
Official title: Respiratory Variations in Diameters of the Inferior Vena Cava and the Internal Jugular Vein to Assess Blood Withdrawal in Patients With Genetic Hemochromatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Hemochromatosis
Keywords: hemochromatosis
blood withdrawal
respiratory variations
inferior vena cava
internal jugular vein
ultrasound
ultrasonography
echography
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 27
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: Non-obese patients with genetic hemochromatosis

Brief summary: OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC) and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST) increase after a therapeutic bleeding in spontaneously breathing and non-obese patients with genetic hemochromatosis.

DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.

PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.

INTERVENTIONS: Ultrasound measures and collected clinical parameters before and after a therapeutic bleeding, during a standardized respiratory maneuver.

MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. It measured the minimal and maximal IVC and IJV diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.


Eligibility criteria: Inclusion Criteria:

* adult patients of \> or equal 18 years
* genetic hemochromatosis
* undergoing a therapeutic blood withdrawal
* health insured
* non-obese (body mass index \<30Kg/m²)

Exclusion Criteria:

* pregnancy
* transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
* clinical signs of active exhalation

Primary outcomes:
measure: blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST)
timeFrame: during a standardized respiratory maneuver, an average 1 hour maximum
Secondary outcomes:
measure: blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST)
timeFrame: during a standardized respiratory maneuver, an average 1 hour maximum
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Sébastien Preau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707914: Clinical Investigation on the Effects of Bayberry Juice Treatment in Adult Subjects With Features of Fatty Liver Disease
Official title: Effects of Chinese Bayberry Juice on Liver Enzymes and Plasma Antioxidant Activity in Adult Subjects With Features of Fatty Liver Disease: a Randomised Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: oxidative stress
dyslipidemia
inflammation
Lead sponsor: Shaoguan University
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous animal studies from us and other investigators, anthocyanins have been shown to ameliorate dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on levels of biomarkers related to antioxidant status in young adults with features of fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* Subject inclusion criteria were age 18-25 y,
* BMI \[body weight divided by height squared (in kg/m2)\] \> 23,
* lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
* the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

* overuse of alcohol,
* viral hepatitis,
* type 1 or 2 diabetes,
* gastrointestinal or connective diseases,
* chronic pancreatitis,
* liver cirrhosis,
* kidney stones, or renal failure;
* use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;
* supplementation with vitamins or antioxidants.

Primary outcomes:
measure: Plasma lipids profile
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shaoguan
country: China
facility: The affiliated hospital of Shaoguan University
state: Guangdong
Study officials:
affiliation: Shaoguan University
name: Wenyi Zhong, MD
role: STUDY_DIRECTOR
References:
citation: Guo H, Zhong R, Liu Y, Jiang X, Tang X, Li Z, Xia M, Ling W. Effects of bayberry juice on inflammatory and apoptotic markers in young adults with features of non-alcoholic fatty liver disease. Nutrition. 2014 Feb;30(2):198-203. doi: 10.1016/j.nut.2013.07.023.
Clinical trial NCT06736314: Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus
Official title: A Single-center Exploratory Clinical Study on the Use of Removable Titanium Clips for the Treatment of Acute Variceal Hemorrhage from the Gastric Fundus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Variceal Bleeding
Keywords: a removable titanium clip
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus

Detailed description: During the procedure, a removable titanium clip was used to block the bleeding vessels, enabling rapid hemostasis. Five days later, secondary preventive measures such as ECI or TIPS were performed. The titanium clip was removed during or after the procedure, avoiding its retention in the body, which could interfere with subsequent MRI examinations and related treatments. In situations where emergency ECI or other treatments are not feasible, this method can serve as a 'temporary bridge' for the treatment of acute gastric fundal variceal hemorrhage, potentially saving the patient's life.

Eligibility criteria: Inclusion Criteria:

1. The patient and their family agree to and sign the relevant informed consent form.
2. Diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging findings, or pathological examinations.
3. History of symptoms related to variceal upper gastrointestinal bleeding, such as hematemesis, melena, or rectal bleeding.
4. Patients confirmed by endoscopy to have bleeding from ruptured gastric varices.
5. Patients who are hemodynamically stable before or after initial fluid resuscitation.
6. Aged 18 to 75 years.

Exclusion Criteria:

1. Those with concomitant bleeding from ruptured esophageal varices.
2. A history of gastrointestinal-related surgical procedures.
3. Individuals with altered consciousness who are difficult to treat.
4. Those with concomitant malignant tumors.
5. Individuals with serious diseases involving the heart, brain, lungs, or kidneys.
6. Pregnant and breastfeeding women.
7. Those with contraindications to relevant treatments.

Primary outcomes:
measure: Rebleeding rate within 5 days after treatment
timeFrame: within 5 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Removable Titanium Clip
state: Jiangsu
Study officials:
References:
Clinical trial NCT03309514: Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease
Official title: Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Lead sponsor: NeuroGeneration
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

1. Able to give informed consent prior to study
2. Male or Female with Diagnostic Criteria of Parkinson's disease
3. Age 35 to 85 years old
4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
5. Hoehn and Yahr Stage III or IV
6. Parkinson's disease observed in the absence of:

   * Oculomotor palsy
   * Cerebellar sign
   * Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
   * Pyramidal sign
   * Amyotrophy
7. Good general health or stable medical condition well controlled, without contraindications to anesthesia

Exclusion Criteria:

1. Patients with severe dementia and brain atrophy on MRI
2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
3. Patients older than 85 or younger than 35
4. Patients who withhold informed consent
5. Patients with a history of alcohol or drug abuse
6. Sexually active women of childbearing potential without adequate form of birth control
7. Evidence of abnormal coagulation or anticoagulant therapy
8. Pregnancy or lactation
9. History of seizure disorders or current use of antiepileptic medication
10. Severe cognitive impairment
11. Clinically significant laboratory abnormality

Primary outcomes:
measure: Motor UPDRS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: