louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06445361: Prevalence of NAFLD in T1DM Patients
Official title: The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 1 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
Type 1 Diabetes
Fatty Liver, Nonalcoholic
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 138
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: To determine the prevalence of NAFLD in T1DM patients.


Eligibility criteria: Inclusion Criteria:

* T1DM
* ≥ 18 years of age
* Written informed consent obtained

Exclusion Criteria:

* Excessive alcohol use
* Exclusion of other causes of liver disease and secondary causes of liver steatosis

Primary outcomes:
measure: Prevalence of NAFLD in T1DM
timeFrame: During the intervention
measure: Prevalence of fibrosis in T1DM
timeFrame: During the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References:
Clinical trial NCT06431061: Clinical Evaluation of Proclear Toric and Biofinity Toric
Official title: Clinical Evaluation of Proclear Toric and Biofinity Toric
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.

Detailed description: The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.

Eligibility criteria: Inclusion Criteria:

1. Are at least 17 years of age and has full legal capacity to volunteer.
2. Have understood and signed an information consent letter.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Are an adapted soft toric contact lens wearer.
5. Do not habitually wear either of the two study lens types.
6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.
7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.
8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.

Exclusion Criteria:

1. Are participating in any concurrent clinical or research study.
2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use.
3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable.
4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study.
6. Have a history of not achieving comfortable CL use (5 days per week; \> 8 hours/day)
7. Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. on the delegation log).

Primary outcomes:
measure: Overall fit acceptance
timeFrame: 15 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
Study officials:
affiliation: Centre for Ocular Research and Education
name: Lyndon Jones
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870661: Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement
Official title: Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Need for IV Access
Keywords: Intravenous placement
Ultrasound
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 0
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: Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the short axis technique. Our hypothesis is that long axis ultrasound placement will increase the longevity of the IV catheter.


Eligibility criteria: Inclusion Criteria:

* A patient who needs PIV access for intravenous medications and resuscitation either on a medical-surgical floor or in the ICU
* After floor team (including RN and/or house staff) and IV Nurse have attempted and failed or is not available

Exclusion Criteria:

* Need for vasopressors
* Need for TPN
* Need for hemodynamic monitoring
* Non English speaking patient
* Patients who are unable to consent

Primary outcomes:
measure: catheter survival
timeFrame: 3 days
Secondary outcomes:
measure: Need for central venous access
timeFrame: for 3 days
measure: success rate of peripheral IV using ultrasound assistance
timeFrame: 30 minutes
measure: Complication rate
timeFrame: 3 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Isreal Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Michael Silverberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233661: Short Atrioventricular Delay Pacing
Official title: Short Atrioventricular Delay Pacing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker
Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers.


Eligibility criteria: Inclusion Criteria:

* Chronically (i.e. implanted for at least six months) dual-chamber pacemaker
* Stable cardiac status (i.e. no hospitalizations or cardiac medication changes within 3 months)
* Ability to provide informed consent

Exclusion Criteria:

* Age \<18 years or \>80 years
* Pregnancy (if pregnancy is suspected, a urine pregnancy test will be performed)
* Recent (within 12 months) left ventricular ejection fraction \<50%
* Significant valvular heart disease (mitral regurgitation of greater than mild severity, any degree of mitral stenosis, aortic stenosis or insufficiency of greater than mild severity)
* Prior coronary artery bypass graft or valve surgery, recent (i.e. within 3 months) acute coronary syndrome or percutaneous coronary intervention, or chronic stable angina
* History of clinically important atrial or ventricular tachyarrhythmias, defined as complex ventricular ectopy (i.e. couplets, triplets, or ventricular tachycardia), AF, atrial tachycardia, or other supraventricular tachycardias not cured with prior ablative therapy).
* Significant chronic systemic inflammatory or neoplastic disease
* Chronic renal or hepatic insufficiency. Renal insufficiency will be defined as a creatinine clearance of less than 20 cc/min. Evidence of hepatic insufficiency will consist of abnormal synthetic function (INR \>1.4 without oral anticoagulant use, albumin \< 3.0 mg/dL) or abnormal clearance function (total bilirubin \>2.0).
* Uncorrected thyroid abnormalities

Primary outcomes:
measure: serum biomarker concentrations
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Atrial Arrhythmia Center, UPMC
state: Pennsylvania
Study officials:
affiliation: Universtity of Pittsburgh
name: David S. Schwartzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00269061: Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin
Official title: An Exploratory MRI Study in Type 2 Diabetic Subjects: A Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Measurement of Fluid Volumes by MRI in the Lower Extremities of Subjects Receiving Pioglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Insulin-Dependent Diabetes Mellitus
Keywords: pioglitazone
diabetes
fluid
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.


Eligibility criteria: Inclusion criteria:

* Must have been diagnosed with Type 2 diabetes at least three months prior to screening.
* Must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
* Must have a Body Mass Index (BMI) of between 24 and 35.
* If female, the subject must be post-menopausal.
* HbA1c levels must be between 7% and 10%.
* Subjects must be eligible for MRI scanning (ie, no metal implants, pacemaker, etc).

Exclusion criteria:

* Suffer from claustrophobia.
* Use of tobacco, nicotine, or illegal drugs of abuse.
* Use of caffeine within two days prior to each study visit.
* HIV, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
* Use of drugs or medications that affect the levels of fluid in the body, such as diuretics.

Primary outcomes:
measure: Changes in interstitial fluid volume in the lower extremities as measured by MRI.
Secondary outcomes:
measure: Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf.
Other outcomes:
Locations:
city: Belmont
country: United States
facility: GSK Investigational Site
state: Massachusetts
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04737161: Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome
Official title: A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acute Respiratory Distress Syndrome
Covid19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 0
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: This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS.

Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.


Eligibility criteria: Inclusion Criteria:

* Age 18 years to 75 years
* All patients at entry are required to be at high risk for the development of ARDS or receiving mechanical ventilatory support
* Provision of signed written informed consent from the patient or patients legally authorized representative
* Only patients who are committed to full life support (Do not resuscitate (DNR) allowed)
* Initiation of study drug within 120 hours of the diagnosis of acute lung injury (ALI)/ARDS
* COVID positive by PCR testing

Exclusion Criteria:

* Concurrent illness that shortens life expectancy to less than 6 months
* Inability to obtain adequate study follow-up
* Greater than 90 hours since first meeting ARDS criteria per the Berlin definition

Primary outcomes:
measure: The number of participants that experience the occurrence of infusion associated adverse events (AEs)
timeFrame: within 6 hours of study infusion
measure: The number of patients that experience treatment emergent AEs
timeFrame: 6 to 24 hours after infusion treatment
measure: The number of patients who receive the target dose for one or more intravenous infusions
timeFrame: up to 14 days (approximately 1.5 hours average per infusion)
Secondary outcomes:
measure: The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time
timeFrame: up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion)
measure: World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement
timeFrame: assessed at 28 days post-infusion
measure: Change in Sequential Organ Failure Assessment (SOFA) Score over time
timeFrame: up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion)
measure: Mortality following initial infusion
timeFrame: 28 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Joe L Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01472861: Autologous Endometrial Coculture (AECCT)
Official title: A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: coculture
endometrial biopsy
IVF poor responders
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the use of Autologous Endometrial Coculture (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves pregnancy outcome.

Detailed description: Young women with poor ovarian reserve are commonly given a poor prognosis for IVF success. Standard culture media for fertilizing oocytes (unfertilized eggs) is commonly used in IVF which closely resembles tubal fluid. Efforts to create optimal culture conditions for fertilization of human embryos for women with poor quality embryos and/or repeated implantation failures have been developed at our center by using AECC. AECC involves placing a patient's fertilized eggs on top of a layer of cells from her own uterine lining, creating a more natural environment for embryo development and maximizing the chance for IVF pregnancy. The investigators will prospectively randomize young patients (≤ age 38 years) poor ovarian reserve to AECC or no AECC with standard culture media to study pregnancy outcome.

Eligibility criteria: Inclusion Criteria:

* Healthy women undergoing IVF at CRMI
* Age ≤ 38 years
* Poor ovarian reserve with antral follicle count less than 6 follicles, cycle day 2/3 FSH \> 12 ng/ml, AMH \< 0.5 ng/ml

Exclusion Criteria:

* Healthy women undergoing IVF with male factor, severe endometriosis, or tubal factor infertility
* Donor patients
* Contraindications for the use of gonadotropins (i.e. pregnancy, lactation, undiagnosed vaginal bleeding or ovarian cysts)
* Recent or current medical conditions where the patient is not medically stable to undergo stimulation or egg retrieval, HIV infection, diabetes, cardiovascular disease, gastrointestinal, hepatic disease, renal or pulmonary disease.
* Any patient who is not a candidate for IVF

Primary outcomes:
measure: Pregnancy outcome
timeFrame: 1 month
Secondary outcomes:
measure: Embryo quality
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Reproducutve Medicine; Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College
name: Spandorfer Steven, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04144361: Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
Official title: Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: post sleeve gastrectomy leak
post sleeve gastrectomy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 400
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: three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding

Detailed description: three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures

Primary outcomes:
measure: the incidence of postoperative stable line bleeding
timeFrame: 2-24 hours
measure: the incidence of stable line leakage
timeFrame: 1-30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
city: Minya
country: Egypt
facility: Minya university hospital
Study officials:
affiliation: Minia University
name: alaa M Sewefy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00361361: The Efficacy of 308nm Excimer Laser in White Striae
Official title: The Efficacy of 308nm Excimer Laser in White Striae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: White Striae
Excimer Laser
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether 308nm Excimer Laser therapy are effective in the color correction of white striae.

Detailed description: The use of excimer laser in modified program in white striae during a few months.

Eligibility criteria: Inclusion Criteria:

* White Striae

Exclusion Criteria:

* Red Striae

Primary outcomes:
measure: Clinical darkening of striaes
Secondary outcomes:
measure: Colorimetric assessment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Skin Research Center, Shaheed Beheshti Medical University
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Nima Ostovari, M.D.
role: STUDY_DIRECTOR
affiliation: skin research center of shaheed-beheshti medical university
name: Parviz Toossi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00457561: Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis
Keywords: The relationship between all-cause mortality in patients introduced hemodialysis and recombinant human erythropoietin dose and serum adiponectin level
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2007-04-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Decreased body fat mass, possibly mediated through the effects of elevated serum adiponectin levels, may be associated with requirements for higher recombinant human erythropoietin doses and a subsequent worse prognosis in patients beginning hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Patients who started hemodialysis therapy from August 2000 to May 2001 in 11 dialysis centers in the Shizuoka prefecture area, and who survived for more than 3 months after the start of hemodialysis.

Exclusion Criteria:

* Nothing particular.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Department of Medicine, Hamamatsu University School of Medicine
name: Naro Ohashi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: