louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06070883: Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis
Official title: Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratitis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Corneal infection or infectious keratitis (IK) is the most common cause of corneal blindness worldwide, particu-larly in the developing countries1. The incidence was estimated at 2.5-799 per 100,000 population/year. It is a painful and potentially blinding ocular emergency that often requires hospital admission for intensive medical and/or surgical treatment. Depending on the geographical and temporal variations and population-based risk factors (e.g. agricultural practice, trauma, use of contact lens and others), bacteria and fungi have been shown to be the main causative microorganisms for IK, followed by viruses, parasites and polymicrobial infection. Amniotic membrane (AM) is the innermost layer of the placenta, which consists of a single layer of meta-bolically active epithelium, a thick basement membrane, and an avascular stromal matrix (15).

It has been shown to exhibit a wide array of biological properties, including wound healing, anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others. To date, a number of studies have evaluated the benefit of AMT for treating active IK, though the majority of them were of small case series or case reports. In clinical practice, AMT is usually reserved as a second-line therapy in IK, mainly to promote cornea healing in non-healing ulcer after the sterilization phase.


Eligibility criteria: Inclusion Criteria:

* Size more than 5 mm.
* Deep ulcers i.e. \> 50% stromal thickness.
* Located within 3mm of the visual axis.
* Patients with descemetoceles and corneal perforations will also be included

Exclusion Criteria:

* Corneal ulcers of size \< 5mm depth \< 50%
* Associated glaucoma
* Associated chronic dacryocystitis
* Ulcers with entropion

Primary outcomes:
measure: Corneal Pain
timeFrame: Baseline
measure: Corneal Pain
timeFrame: one month post operative
measure: Corneal Pain
timeFrame: three months post operative
measure: Size of the ulcer
timeFrame: Baseline
measure: Size of the ulcer
timeFrame: one month post operative
measure: Size of the ulcer
timeFrame: three months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References:
Clinical trial NCT05589883: A Study of the EMPOWER Program for Latinx Caregivers of ICU Patients
Official title: Pilot Feasibility of the Cultural Adaptation of EMPOWER for Latinx Informal Caregivers in Intensive Care Units in the Context of COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Informal Caregiver
Keywords: EMPOWER Program
Latinx Caregivers
ICU Patients
22-141
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The design of this study is a single-arm open trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The researchers are doing this study to find out whether EMPOWER (Enhancing \& Mobilizing the Potential for Wellness \& Emotional Resilience) may reduce emotional distress in Latinx caregivers of patients in the ICU.


Eligibility criteria: Inclusion Criteria:

* Informal caregivers of patients, who were admitted in an ICU or step-down unit during their current admission/stay or within 2 weeks of discharge from their last admission/stay.
* Informal caregivers listed as a designated health care proxy or decision-making patient surrogate by ICU medical staff.
* Age 18 years or older as per self-report.
* Residing in New York or New Jersey as per self-report or able to complete modules while complying with current telehealth regulations.
* Spanish-speaking as per the Spanish language assessment items below and willing to receive the intervention in Spanish.

  * What is the participant's preferred language?
  * (Specify Lang)___________________________
  * How well does the participant speak Spanish?
  * Very well (PARTICIPANT IS ELIGIBLE)
  * Well (PARTICIPANT is ELIGIBLE)
  * Not well (PARTICIPANT is NOT ELIGIBLE)
  * Not at all (PARTICIPANT is NOT ELIGIBLE)

Exclusion Criteria:

* Informal caregivers who score low, moderate or high on the Columbia Suicide Severity Rating Scale.

Primary outcomes:
measure: feasibility of EMPOWER-Latinx
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Rosairo Costas Muniz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06696183: Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Official title: Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: AML - Acute Myeloid Leukemia
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 60
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: Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy


Eligibility criteria: Main Inclusion Criteria:

* Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of \>=20%, excluding APL
* FLT3 mutation at initial diagnosis
* Ineligibility of standard induction chemotherapy
* Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)

Main Exclusion Criteria:

* R/R AML
* Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC)
* Previous treatment with Gilteritinib
* Known active CNS involvement
* QTcF \>450 ms or long QT Syndrome at screening
* Treatment with concomitant strong CYP3A inducers or St. John's wort

Primary outcomes:
measure: Ratio of dose delivered/dose planned
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden
Study officials:
References:
Clinical trial NCT02306083: Effect of Glucosamine on Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intraocular Pressure Changes After Glucosamine Sulfate Consumption.
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are included. Those with the history of intraocular and corneal surgery, diabetic and heavy smokers are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3 and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.


Eligibility criteria: Inclusion Criteria:

* History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes).
* No history of using drugs tested in the study.

Exclusion Criteria:

* History of any kind of corneal surgery.
* History of intraocular surgery.
* History of diabetes mellitus.
* Heavy smokers.
* Unwillingness to participate in the study.

Primary outcomes:
measure: Intraocular pressure changes
timeFrame: until 6 months
Secondary outcomes:
measure: corneal biomechanical changes
timeFrame: until 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Islamic Republic OF Iran
Study officials:
References:
Clinical trial NCT01015183: Prevention Chemotherapy Induced Mucositis by Zinc Sulfate
Official title: Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mucositis
Bone Marrow Transplantation
Keywords: Mucositis
Bone Marrow Transplantation
BMT
HSCT
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two groups: intervention and control with balanced block randomization method. Intervention group received Zinc sulfate immediately after start conditioning regimen and continued for two weeks. Control group received placebo at the same manner. Prevalence and severity of mucositis will be compared in two groups.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing bone marrow transplantation
* Signed informed consent

Exclusion Criteria:

* Unable take drug (or placebo) orally

Primary outcomes:
measure: The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of Zinc Sulfate concentration
timeFrame: 1 year
measure: Evaluation of Zinc Sulfate advance effects
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
Study officials:
affiliation: Hematology-Oncology and SCT Research Center
name: Molouk Hadjibabaie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820183: A Quality Improvement Plan for Hypertension Control
Official title: A Quality Improvement Plan for Hypertension Control: the INCOTECA Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Intervention
Primary Care
Quality improvement
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 34327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study hypothesis is that the implementation of a plan for quality improvement at the primary care health teams taking care of hypertensive patients, will increase the level of blood pressure control among those patients.

Detailed description: The study is to compare the results on the hypertension control between two groups of primary health care teams. The intervention group will undertake a quality improvement plan for hypertension control, in which the following aspects will be included in the intervention:

Specific training programme on how to diagnose hypertension , and measure blood pressure correctly To send feed back information to primary care health professionals about poorly controlled hypertensive patients An audit will be performed, every 6 months, to see the adhesion to the recommended clinical guidelines , and the information will be diffused among the participant primary health care professionals Each participant primary health care team will have a designated reference person, that will provide support on any doubts on the programme implementation.

The non intervention group will follow hypertensive patients following the same clinical practice guide as the intervention group, with no intervention on the primary health care professionals

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hypertension before January 1st, 2006
* Patients assigned at the primary health team participating, and with clinical electronic records

Exclusion Criteria:

* Patients diagnosed with hypertension after January 1st, 2006
* Patients under 18 years of age
* Patients with a diastolic blood pressure higher than systolic blood pressure as recorded in the clinical records

Primary outcomes:
measure: good control of hypertension as a dichotomous variable, based on systolic blood pressure and diastolic blood pressure records over the last 12 months
timeFrame: every three months, for a whole year
Secondary outcomes:
measure: treatment with antihypertensive drugs, number of antihypertensive drugs, assessment of therapeutic compliance
timeFrame: every three months, for a whole year
Other outcomes:
Locations:
city: Cerdanyola del Vallès
country: Spain
facility: SAP Cerdanyola-Ripollet Institut Català de la Salut
state: Barcelona
Study officials:
affiliation: Institut Català de la Salut
name: Roser Valles Fernandez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097628: Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian
Official title: Comparison of Volume- and Pressure- Controlled Ventilation With Laryngeal Mask Airway Guardian in Obese Patients Undergoing Laparoscopic Gynecologic Surgery-A Perspective, Randomized, Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Keywords: volume controlled ventilation
pressure controlled ventilation
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2014-03-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare volume- and pressure- controlled ventilation with laryngeal mask airway Guardian in obese patients undergoing laparoscopic gynecologic surgery in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and complications.

Detailed description: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. The aim of the following perspective, randomized, blind trial study id to compare how the volume-controlled ventilation and pressure-controlled ventilation modes using the Laryngeal Mask Guardian affect the pulmonary mechanics, the gas exchange and the cardiovascular responses particularly in obese patients undergoing gynecological laparoscopy.

Eligibility criteria: Inclusion Criteria:

* Ambulatory patients scheduled to undergo laparoscopic gynecologic surgery under a short general paralysed anesthesia of less than 2 hours (ASA physical status I-II)
* 18 to 65 years of age
* A body mass index \<40 kg • m-2

Exclusion Criteria:

* Difficult airway
* Recent history of upper respiratory tract infection and sore throats
* A history of esophageal reflux disease
* Kinesia patients
* Inability to understand the Study Information Sheet and provide a written consent to take part in the study

Primary outcomes:
measure: peak pressure
timeFrame: 5 min
Secondary outcomes:
measure: Blood pressure
timeFrame: intraoperative
measure: heart rate
timeFrame: intraoperative
Other outcomes:
measure: Pharyngolaryngeal complication
timeFrame: 1,24h
Locations:
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Haiyun Wang, M.D.Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02214628: Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD
Official title: A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-related Macular Degeneration
Keywords: Wet AMD
Choroidal neovascularization
Fovista®
E10030
Avastin®
Eylea®
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-08-12
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Detailed description: The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Eligibility criteria: Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years
* All fluorescein angiographic subtypes with presence of active choroidal neovascularization

Exclusion Criteria:

* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
* Subjects with subfoveal scar or subfoveal atrophy
* Any ocular or periocular infection in the past twelve (12) weeks
* History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant

Primary outcomes:
measure: Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
timeFrame: 2 years
measure: Number of Subjects With Serious Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Augusta
country: United States
state: Georgia
city: Oak Forest
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Cincinnati
country: United States
state: Ohio
city: Ladson
country: United States
state: South Carolina
city: Abilene
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT06925828: Application of in Vivo Splitting Technique in Adult Liver Transplantation
Official title: Application of in Vivo Splitting Technique of Brain-dead Donor Liver in Adult Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Transplantation
Keywords: Split liver transplantation
Whole liver transplantation
Short-term Outcomes
Surgical complications
Morbidity and Mortality
Lead sponsor: Ningbo Medical Center Lihuili Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult recipients who underwent SLT or WLT

Brief summary: The feasibility of split liver transplantation (SLT) remains controversial. This study aimed to evaluate the outcomes of SLT in adult recipients and to identify specific areas of improvements. A retrospective analysis was conducted on adults who underwent full size SLT between January 2021 and December 2023. The short-term outcomes of these patients who underwent SLT were compared with those of patients who underwent whole liver transplantation (WLT) during the same period.


Eligibility criteria: Inclusion Criteria:

* For the donor graft:

  1. age of 18-60 years;
  2. BMI of 19-28 kg/m2;
  3. hemodynamic stability or use of a single vasoactive drug with a small dosage (norepinephrine ≤ 0.1 μg/kg/min or dopamine ≤ 5 μg/kg/min);
  4. liver steatosis ≤ 10%;
  5. liver functional indicators (ALT, AST, total bilirubin quantification) ≤ 3 times the normal value;
  6. blood sodium ≤ 160 mmol/L;

For the SLT recipients

1. Patients who had registered in the China Organ Transplant Response Systems.
2. Initial liver transplantation.
3. Graft-to-Recipient Weight Ratio (GRWR) ≥ 1%.

Exclusion Criteria:

* For the donor graft

  1. uncontrollable infection
  2. significant vascular and biliary variation.

For the recipients

1. Severe portal hypertension.
2. Significant vascular variation.

Primary outcomes:
measure: Overall survival
timeFrame: 2021.01.01-2025.12.31
Secondary outcomes:
measure: Postoperative complications
timeFrame: 2021.01.01-2025.12.31
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Medical Centre Lihuili Hospital
state: Zhejiang
Study officials:
References: