louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06375473: Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients
Official title: Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer
Keywords: real word study, irinotecan hydrochloride liposome injection II, pancreatic cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic cancer patients in China

Brief summary: This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen.


Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic ductal adenocarcinoma diagnosed by pathology or imaging;
* Age ≥18 years old, male or female;
* Patients receiving treatment based on irinotecan hydrochloride liposome injection II;
* The subjects voluntarily joined the study and signed the informed consent.

Exclusion Criteria:

* Confirmed pregnant or lactating women;
* The researchers determined that other conditions were not suitable for inclusion in the study.

Primary outcomes:
measure: rwTEAE
timeFrame: 3 years
Secondary outcomes:
measure: OS
timeFrame: 3 years
measure: PFS
timeFrame: 3 years
measure: ORR
timeFrame: 3 years
measure: TTP
timeFrame: 3 years
measure: DCR
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Beijing, China
name: Taiping Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Renji Hospital, Shanghai, China
name: Liwei Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05683873: Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package
Official title: Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to analyze the relationship between the blood biomarker GDF-15 and heart damage after stroke.

It is being conducted in France, in the Neurology Department of the Dijon University Hospital (Burgundy). The research is interventional because a biological blood test will be performed, as well as a heart rhythm recording and several cardiac echograms during the hospitalization of the participants and during the follow-up consultation scheduled 4 to 6 months after the stroke.

A total of 130 stroke patients will participate in this study.

Participation includes 4 visits:

* Inclusion visit (within 24 hours of the first stroke symptoms)
* visit 1 (within 24 to 72 hours of stroke)
* visit 2 (within 48 hours of visit 1)
* Visit 3 (approximately 4-6 months post-stroke)


Eligibility criteria: Inclusion Criteria:

* Adult with acute symptomatic cerebral infarction documented by brain imaging on admission (cerebral angioscan or cerebral MRI)
* Whose first symptoms appeared within 24 hours before inclusion
* Whose consent to participate in this study was obtained from the patient or a close relative.

Exclusion Criteria:

* Person with a history of symptomatic stroke, either ischemic or hemorrhagic
* Anyone with a history of heart disease including: atrial fibrillation or flutter (known or discovered on admission), chronic heart failure, pacemaker, defibrillator, or other cardiac devices
* Person with acute heart failure, suspected infective endocarditis, STEMI, or concurrent pulmonary embolism
* A person who is not a member or beneficiary of a social security system
* Person deprived of liberty
* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant, parturient or breastfeeding woman

Primary outcomes:
measure: Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)
timeFrame: within 24 to 72 hours post-stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03302273: Corneal Epithelial Stem Cells and Dry Eye Disease
Official title: Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Dry Eye
Ocular Inflammation
Ocular Surface Disease
Ocular Discomfort
Blepharitis
Keywords: stem cell therapy
dry eye disease
Lead sponsor: Panhandle Eye Group, LLP
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments. This pilot study will carefully observe and monitor each qualifying and willing individual for response to treatment, signs of toxicity and adverse effects from the treatment, and for ability of the treatment to improve comfort and restore vision.

Detailed description: Eligible patients presenting with severe dry eye disease that have failed treatment with conventional measures will be screened for inclusion into the study. The treatment will consist of administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived product. These eye drops will be transplanted by topical self-administration by the patient four times daily in both eyes for a three month interval.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of advanced dry eye disease
* Severe dry eye symptoms despite having tried over a half dozen treatments

Exclusion Criteria:

* Not willing to undergo clinical trial
* Unable to comply with treatment regimen

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 3 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: 3 months
measure: Corneal Topography
timeFrame: 3 months
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Rush Eye Associates
state: Texas
Study officials:
References:
Clinical trial NCT06336473: Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome
Official title: Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ehlers-Danlos Syndrome
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center study performed on biopsied skin samples
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS).

Detailed description: This is a single-center study based on skin biopsies. The skin biopsies will be taken at the non-vascular Ehlers-Danlos syndromes reference center at the Raymond Poincaré Hospital (Garches), by Dr. Karelle Benistan. This center regularly performs this type of biopsy as part of its routine care, and has set up a fibroblast bank for Genethon (Authorization for biological collection at Genethon: SED BACG n° DC-2021-4628).

Samples will be transported to the Centre de Recherche Saint-Antoine (UMR-S 938) where they will be processed, cut and placed on histological slides.

Atomic force microscopy analyses will be carried out at the Laboratoire de Réactivité de Surface (CNRS/Sorbonne University).

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or over, having read and signed the consent form for participation in the study
* Patient with classic or hypermobile Ehlers-Danlos syndrome
* Regularly followed-up at the non-vascular Ehlers-Danlos Syndrome Reference Center at Garches Hospital.

Exclusion Criteria:

* Patient under court protection, guardianship or curatorship
* Pregnant or breast-feeding patient
* Patient not affiliated to the French social security system
* Impossibility of giving the subject informed information and/or written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient
* Contraindication to anaesthesia or allergy to local anaesthetic product

Primary outcomes:
measure: Young's modulus quantification
timeFrame: Day 0
Secondary outcomes:
measure: Collagen fibril diameter measurement
timeFrame: Day 0
measure: Collagen fibril D-period length measurement
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Maussins-Nollet
Study officials:
References:
Clinical trial NCT00006273: Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
Official title: Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Indiana University School of Medicine
First posted: 2000-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY

Brief summary: OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls.

II. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.

Detailed description: PROTOCOL OUTLINE: Patients and healthy controls receive an oral dose of doubly labeled water following initial urine collection on day 1. Patients undergo additional urine collection at 4-6 hours following doubly labeled water consumption and then daily for 7 days.

Additionally, at the beginning of the study, patients and healthy controls undergo respiratory calorimetry over approximately 45 minutes at rest, starting approximately 2-3 hours after the last meal consumption and last use of aerosol bronchodilators (if required).

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of cystic fibrosis (CF) by two positive sweat tests No exacerbations of present condition within past 2 months FEV1 less than 50% of predicted No other uncorrected lung disease No requirement for supplemental oxygen

OR

* Healthy (control group) Age matched to CF patients No preexisting lung disease Clinically well No hospitalizations within past 6 months

--Prior/Concurrent Therapy--

* Concurrent pancreatic enzyme supplementation for CF required Clinically stable on current medications (CF patients)

--Patient Characteristics--

* Age: Birth to 12 months 6 to 10 years
* Cardiovascular: No major cardiovascular problems (CF patients) No preexisting heart disease (control group)
* Pulmonary: See Disease Characteristics
* Other: No chromosomal abnormalities (CF patients) No acute infection (CF patients) No diabetes mellitus (both groups)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Catherine A. Leitch
role: STUDY_CHAIR
References:
Clinical trial NCT03202173: The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy
Official title: The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Squamous Cell Carcinoma of the Head and Neck
Keywords: Probe-based confocal laser endomicroscopy
Optical biopsy
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.

Detailed description: The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Male or female \> 18 years of age
2. Indicated for nasal endoscope for indeterminate NPC
3. Willing and able to comply with study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

1. Subjects for whom pCLE procedures are contraindicated
2. Known allergy to fluorescein dye
3. If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Primary outcomes:
measure: pCLE classification and scoring system
timeFrame: 3 months
Secondary outcomes:
measure: the quantitative image analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
affiliation: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
name: Huawei Li, Phd &MD
role: STUDY_CHAIR
References:
Clinical trial NCT01313273: Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients
Official title: Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients.

Detailed description: LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of prostate cancer
* Evidence of PSA progression despite castrate levels of testosterone (\<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a)
* Patients with non-metastatic or stable metastatic disease
* Chromogranin A elevation above normal range (confirmed by a second evaluation at least 1 week later) \[cut off levels will be \> 20 U/L for enzyme linked immunosorbent (ELISA) assay and \> 100 ng/ml for immunoradiometric (IRMA) assay\]

Exclusion Criteria:

* Patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel)
* First line treatment with antiandrogen in monotherapy
* Visceral metastasis
* Previous or concomitant treatment with a somatostatin analogue

Primary outcomes:
measure: Progression-free Survival
timeFrame: Week 96
Secondary outcomes:
measure: Prostate Specific Antigen (PSA) Response
timeFrame: Week 96
measure: Median Time to PSA Response
timeFrame: Week 96
measure: Reduction in Chromogranin A Serum Levels
timeFrame: Baseline, Week 96
Other outcomes:
Locations:
city: Orbassano ( TO)
country: Italy
facility: A.O. S. Luigi Gonzaga
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06773273: A Novel Approach to Lens Subluxation
Official title: A Novel Approach to Lens Subluxation: CapsuLaser and Flanged Prolene Suture for Cionni Ring Scleral Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subluxation
Keywords: Subluxation, CapsuLaser, Prolene, Cionni
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-01-14
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This retrospective interventional randomized study included 15 eyes of 15 patients; six of them were due to pseudo exfoliation, five of them were males while the other nine cases were due to hereditary lens subluxation eight of them were females.
Primary purpose: TREATMENT

Brief summary: Evaluating new technique for treating patients with subluxation using specific laser type and new 6-0 proline fixating novel technique for the capsular bag

Detailed description: The management of a subluxated crystalline lens remains a challenge for anterior segment surgeons, largely due to the complex anatomical and functional changes in such cases. Capsulaser is safe and effective tool in creating well centered CCC with consistent 360 degree IOL coverage that ensures better lens stability and effective lens positioning . Combined with using flanged 6-0 Prolene sutures for scleral fixation of Cionni rings, this technique addresses previous limitations by improving intraoperative control.

Eligibility criteria: Inclusion Criteria:

* Lens subluxation with clear corneal media.

Exclusion Criteria:

* Associated macular lesions.

Primary outcomes:
measure: Number of cases with IOL centration inside the capsular bag
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jedda
country: Saudi Arabia
facility: Maghrabi Eye Hospitals
Study officials:
affiliation: Zagazig University
name: AHMED SAMIR, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03014973: Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
Official title: Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment


Eligibility criteria: Inclusion Criteria:

* group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment
* group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression
* group 2a: without radiotherapy
* group 2b: with radiotherapy
* Affiliated to a social security scheme
* Having given a written consent.

Exclusion Criteria:

* Patient unable to supply a written consent (patient not understanding French, under guardianship patient).
* neuro-endocrine form or sarcomatoid form prostate cancer

Primary outcomes:
measure: intra-prostatic concentration of sexual steroids
timeFrame: 2 weeks
Secondary outcomes:
measure: Androgen receptor immuno-histochemical expression level
timeFrame: 2 weeks
measure: Androgen receptor RNA expression level
timeFrame: 2 weeks
measure: Steroid 5-alphareductase immuno-histochemical expression level
timeFrame: 2 weeks
measure: Steroid 5-alphareductase RNA expression level
timeFrame: 2 weeks
measure: Steroid aromatase immuno-histochemical expression level
timeFrame: 2 weeks
measure: Steroid aromatase RNA expression level
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Yann NEUZILLET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Foch
name: Henry Botto, MD
role: STUDY_CHAIR
References: