louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04072029: Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy
Official title: Escala de Riesgo de descompensación Corneal en cirugía de Catarata en Pacientes Con Distrofia Corneal de Fuchs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fuchs' Endothelial Dystrophy
Cataract
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred for cataract surgery to the Cornea Department

Brief summary: Justification. Fuchs' corneal endothelial dystrophy (FECD) is one of the main causes of corneal transplantation. In many cases, the corneal decompensation derived from this dystrophy is triggered as a consequence of cataract surgery, so the dilemma of facing isolated cataract surgery or combined with endothelial keratoplasty is often raised.

Objective. The present study aims to evaluate and select the most important predictive factors for corneal decompensation after cataract surgery in patients with FECD.

Method. Prospective observational study of the preoperative and intraoperative variables presumably associated with postoperative corneal edema requiring Descemet stripping endothelial keratoplasty (DMEK). Consecutive candidates for cataract surgery with FECD will be selected and anterior segment imaging will be performed, along with a complete ophthalmological examination. Clinical, pachymetric, tmographic, densitometric, specular microscopy, and intraoperative variables will be registered.


Eligibility criteria: Inclusion Criteria:

* FECD grade 2 or worse (modified Krachmer scale)
* Cataract requiring surgery
* Epithelial corneal edema evident in slit lamp examination

Exclusion Criteria:

* Concurrent anterior corneal dystrophy
* History of ocular trauma, ocular surgery, previous ocular inflammation or infection,uncotroled glaucoma, amblyopia, neovascular age-related macular degeneration, or active vacular retinal disease.
* Non-collaborative or unable to receive postoperative care at our institution.

Primary outcomes:
measure: Rate of progression to endothelial keratoplasty (DMEK)
timeFrame: 2 months after cataract surgery
Secondary outcomes:
measure: Best spectacle corrected visual acuity
timeFrame: 2 months after cataract surgery
measure: Corneal tomography changes
timeFrame: 2 months after cataract surgery
measure: Postoperative refraction
timeFrame: 2 months after cataract surgery and after DMEK surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: H.U. Ramón y Cajal
name: Francisco Arnalich Montiel, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01539629: ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0
Official title: Evaluation of Left Ventricular Autothreshold
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Autothreshold
Pacing
CRT-D recipients
Left Ventricular evoked response signals
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be a sample of patients with COGNIS CRT-D devices.

Brief summary: This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.

Detailed description: ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.

Eligibility criteria: Inclusion Criteria:

* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
* Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead
* Patients who have an active LV bipolar or unipolar lead
* Patients who have an active RV defibrillation lead
* Patients who are willing and capable of participating in all testing associated with this Clinical Investigation

Exclusion Criteria:

* Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
* Patients who are pacemaker-dependent as defined as VVI 40 without intrinsic atrial or ventricular activity
* Patients who will not tolerate a pacing pause of up to 6 seconds
* Patients with a pre-existing unipolar pacemaker
* Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
* Patients enrolled in any concurrent study, without Boston Scientific CRM written approval
* Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.

Primary outcomes:
measure: Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.
timeFrame: Minimum of 24 hrs post CRT-D implant.
Secondary outcomes:
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Health Care
state: Wisconsin
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Kenneth L Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876629: Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers
Official title: Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: MR Elastography
kidney
fibrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: MR Elastography is a new technique aimed at non-invasively measuring the stiffness of tissues. It has recently given interesting results in the assessment of liver fibrosis.

The objectives of the current study are:

1. to develop an imaging protocol for MR Elastography of the kidneys;
2. To calculate the stiffness of normal kidneys;
3. To evaluate the variability of the measurements of kidney stiffness by repeating the procedure twice on the same volunteers.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40
* Signed informed consent form
* Insured by the French Social Security

Exclusion Criteria:

* Pregnancy
* Personal or familial history of kidney disease
* Hypertension
* Diabetes
* Contraindication to MRI

Primary outcomes:
measure: Normal kidney stiffness (measured from MRE data)
timeFrame: 2 months
measure: Variability of stiffness measurement (on repeat examination)
timeFrame: 2 months
Secondary outcomes:
measure: Tolerance of the procedure
timeFrame: 2 months
measure: Percentage of partial and total technical failures
timeFrame: 2 months
measure: Quality criteria of stiffness measurements (area of the ROIs used for measurement, mean induced displacement measured in the ROIs)
timeFrame: 2 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Urinary an Vascular Radiology, Hôpital E. Herriot
Study officials:
affiliation: Hôpital E. Herriot
name: Olivier Rouvière, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rouviere O, Souchon R, Pagnoux G, Menager JM, Chapelon JY. Magnetic resonance elastography of the kidneys: feasibility and reproducibility in young healthy adults. J Magn Reson Imaging. 2011 Oct;34(4):880-6. doi: 10.1002/jmri.22670. Epub 2011 Jul 18.
Clinical trial NCT00447629: Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart
Official title: A Randomized, Double-Blind, Placebo- and Moxifloxacin (Open-Label)- Controlled, 4-Period Crossover Study of the Effects of Single Oral Doses of PPM 204 on Cardiac Repolarization in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of the heart.


Eligibility criteria: Inclusion Criteria:

* Men or women, aged 18 to 55 years
* Body mass index in the range of 18 to 30 kg/m2
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG

Exclusion Criteria:

* History of cardiac, thyroid, muscle, or kidney abnormalities
* A family history of long QT syndrome and/or sudden cardiac death
* History of any clinically significant drug allergy, hypersensitivity to sulfonomides or the quinolone class of antibiotics

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Pharmacokinetics
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05080829: Myeloid Mutations Register in R/R CML
Official title: ABL Mutation Register in Patients With ITK Relapsed or Refractory Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Myeloid Leukaemia Recurrent
Chronic Myeloid Leukemia, in Relapse
Keywords: chronic myeloid leukemia
Lead sponsor: Grupo Cooperativo de Hemopatías Malignas
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to know the percentage of ABL mutations in patients with chronic myeloid leukemia that relapsed or are refractory to tyrosine-kinase inhibitors measured with a myeloid mutations panel by NGS.


Eligibility criteria: Inclusion Criteria:

* CML diagnosis by the WHO 2016 criteria
* Failure to reach cytogenetic response of Ph chromosome of 36 to 95% at 3 months or BCR/ABL \<10% at 6 months of treatment with TKI
* Progression or relapse of the disease after previous response to treatment with TKI
* Validation of adherence to treatment
* Inform consent

Exclusion Criteria:

* Lack of information to complete the register
* Failure to response achievement due lack of adherence to treatment

Primary outcomes:
measure: Presence of myeloid mutations by Next Generation Sequence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Huixquilucan
country: Mexico
facility: Grupo Cooperativo de Hemopatías Malignas
state: Estado De México
Study officials:
References:
Clinical trial NCT06867029: Onlay and Sublay Mesh in Treatment of Ventral Hernia
Official title: Comparative Study Between Onlay and Sublay Mesh in Treatment of Ventral Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hernia is defined as aprotrusion of viscus or part of viscus usually within a peritonial sac through a defect in the abdominal wall.

Ventral abdomenal hernias include all the hernias occuring through the anterior abdominal wall excluding groin hernias ( incisinal hernia, epigastric hernias, paraumbilical hernias, umbilical and lumbar hernias)

Detailed description: Ventral hernia can be categorized according to their characteristic into reducible, irreducible or incarcerated , strangulated and recurrant ventral hernia.

The cause of a primary ventral hernia ia s far from completely understood, but it is undoubtedly multifactorial. familial prediposing play a role with increasing evidance of connective tissue disorders, they are considered as a leading cause of abdominal surgery and account for 2-10% of all abdomenal wall hernias .

Clinical data show that 52% of incisional hernias occur within 6 months postoperative as a result of excessive tension and inadeqate healing of aprevious incision.

The history of prothetic repair in abdominal wall hernias began in 1844 within the use of silver wire coils placed in the floor of groin to induce an inflammatory fibrosis . meny prosthetic material have been tried in hernia repair, but the two most common in current use are polypropylene mesh and expanded polytetrafluoroethylene.

The repair of ventral hernia varies from primary closure, primary closure with an onlay mesh reinforcement, sublay mesh placement, and intraperitonial mesh placement. Primary closure techniques are usually performed for smal fascial defects less than 5 cm in the greaters diameter

An onlay , usually of polyproptlene mesh is sutured to the anterior rectus sheeth after the fascial defect has been closed primary, thes type of repair has the potential advantage of keeping the mesh separeted from the abdomenal content by full abdominal muscle fascial wall thikness.

The sublay (retrorectus) placement of mesh, became popular in 1990, the recurence rates with this repair have been stated to be less than 10%.

Eligibility criteria: Inclusion Criteria:

* Ventral Hernia patients

Exclusion Criteria:

* Age below 18 years.
* Complicated hernia.
* Uncompensated heart or lung diseases, haemorrhagic disorders

Primary outcomes:
measure: Post operative Pain
timeFrame: 4 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Al-Azhar University Hospitals
Study officials:
affiliation: General Surgery, Faculty of Medicine, Al Azhar University, Assiut
name: Ahmed M Hassan, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00590629: Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Women with and without CAD
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: General Clinical Research Center (GCRC)
name: Kos Pharmaceuticals
First posted: 2008-01-10
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low HDL appears to be a more important risk for heart disease in women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women.

Women already taking lipid lowering statin will receive niacin therapy. We will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. After 3 months of therapy we will repeat these measures.


Eligibility criteria: Inclusion Criteria:

* Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl

Exclusion Criteria:

* History of MI, PTCA or surgery within previous 3 months

  * Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin
  * Active or known gall bladder disease
  * Pregnant or nursing women
  * Significant comorbidity that precludes participation
  * Significant liver disease, active alcoholism, or LFT \>1.5x's ULN at screening
  * Diabetes or glucose \> 126 mg/dl at screening
  * PI perceived inability to comply with protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: CSMC
state: California
Study officials:
References:
Clinical trial NCT06826729: The Characteristics of Blood Glucose Profile and the Changes of Hormones in PPDM-C Population
Official title: The Characteristics of Blood Glucose Profile and the Changes of Endogenous and Exogenous Hormones in Patients with Post-chronic Pancreatitis Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Pancreatitis
Diabetes
Keywords: chronic pancreatitis
PPDM-C
CGM
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic pancreatitis

Brief summary: The purpose of this study was to explore the characteristics of blood glucose spectrum, changes of endocrine/exocrine pancreatic function and the correlation between them in patients with PPDM-C.

Detailed description: The benefits of this study to participants include:

1. It will help to make early diagnosis or risk screening for the potential related risks and concomitant diseases of the disease;
2. Provide necessary suggestions for the treatment and intervention of the disease, or provide useful information for the related research of the disease.
3. We will provide Abbott version h dynamic glucose meter and assessment of internal and external secretion function. The researcher will provide professional endocrine related lifestyle and drug guidance for the subjects according to their CGMS data.

The risks that this study may bring to participants are:

There may be some very small risks in specimen collection, including transient pain, local cyanosis, etc. a few people will have mild dizziness or extremely rare needle infection.

Eligibility criteria: Inclusion Criteria:

* Male or female Chinese subjects;

  * Was ≥ 18 years old when signing the informed consent;

    * Patients with complete diagnosis of chronic pancreatitis; ④ Those who voluntarily signed informed consent; ⑤ Those who complete serum samples in multiple centers and put them into storage.

Exclusion Criteria:

* Patients with impaired glucose tolerance but undiagnosed diabetes;

  * Patients with T1DM related autoimmune markers or other types of DM;

    * Patients with autoimmune pancreatitis, recurrent acute pancreatitis or acute onset of chronic pancreatitis;

      * Patients who underwent pancreatic surgery or related invasive procedures during treatment;

        * Previous or current malignant tumor; ⑥ Pregnancy or lactation; ⑦ Suffering from severe heart, liver or kidney dysfunction or malignant disease; ⑧ Failure to sign informed consent for cognitive impairment or other reasons.

Primary outcomes:
measure: Blood glucose profile characteristics of patients with PPDM-C
timeFrame: From February 2025 to December 2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06908629: Addressing Social Determinants of Health Among Metro Detroit Cancer Survivors
Official title: Addressing Social Determinants of Health (SDOH) Among Metro Detroit Cancer Survivors: A Pilot Feasibility Study (The Resource Ready Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Cancer Survivors
Gastrointestinal Cancers
Neuroendocrine Tumors
Multiple Myeloma, Neoplasms
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this screening study is to determine the feasibility of completing a social needs screening tool in participants who have a past or current cancer diagnosis and reside in Metro Detroit, Michigan. Main questions to answer are:

* Can we have a completion rate of at least 80% of participants filling out the screening tool?
* Can we determine procedures for patient referrals based on social needs
* Can we implement brief interventions based on food access and digital inclusion (ensuring everyone has access to the digital technologies they need to participate in society)

Detailed description: In part 1 of the study, Participants will be administered a social screening tool either in person or via telephone. Responses to the screening tool will be translated into diagnosis codes which identify non-medical factors that may influence a patient's health status. In part 2 of the study, participants will be referred to community-based resources based on their responses to the social needs screening tool. Follow up will be made via telephone call at 2, 4, 6 and 8 weeks.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* past or current cancer diagnosis
* reside in metropolitan Detroit (Wayne, Oakland, Macomb counties)
* English proficient
* Actively receiving care through one of Karmano's Cancer Institute's outpatient clinics OR post treatment survivors in the Detroit Research on Cancer Survivors (ROCS) longitudinal cohort study who have reported past food insecurity and agreed to be contacted for further research

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of participants completing the screening tool
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
Study officials:
References: