louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02405039: Study of EBI-005 in Dry Eye Disease (DED)
Official title: A Multi-Center, Double-Masked, Randomized, One-Year Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle-Control in Subjects With Dry Eye Disease (DED)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dry Eye
Keywords: DED
Disease
Lead sponsor: Eleven Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.


Eligibility criteria: Key Inclusion Criteria:

1. Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to Visit 1
2. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study

Key Exclusion Criteria:

1. Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)
2. Have had penetrating intraocular surgery within 12 months prior to Visit 1
3. Be unwilling to comply with the study requirements

Primary outcomes:
measure: Safety of EBI-005 (vital signs)
timeFrame: 1 year
measure: tolerability of EBI-005 (adverse events)
timeFrame: 1 year
measure: Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)
timeFrame: 1 year
measure: Safety of EBI-005 (laboratory changes over time)
timeFrame: 1 year
Secondary outcomes:
measure: Biological effect of EBI-005 (Changes over time in the OSDI)
timeFrame: 1 year
measure: Biological effect of EBI-005 (Total corneal fluorescein staining)
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Newport Beach
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: New Albany
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Winchester
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Asheville
country: United States
state: North Carolina
city: Mason
country: United States
state: Ohio
city: Cranberry Township
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Eleven Biotherapeutics
name: Michael Goldstein, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03489239: Entecavir to TAF Switch
Official title: Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2018-04-05
Enrollment: 27
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: A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B


Eligibility criteria: Inclusion Criteria:

* Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
* Maintained on Entecavir for a minimum of 48 weeks
* Viral suppression (HBV DNA \<20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
* Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.

Exclusion Criteria:

* Subjects with known poor or non-compliance
* Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
* Pregnant women and those who wish to become pregnant during the course of the study.

Primary outcomes:
measure: Results of viral Hepatitis B DNA to be <20 IU/mL
timeFrame: 48 weeks
Secondary outcomes:
measure: Complete viral suppression at study completion
timeFrame: 96 Weeks
measure: Positive eGFR changes at study completion compared to Baseline visit
timeFrame: 96 weeks
measure: Improved Bone Mass Density at study completion
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03529539: Expanded Access for PSV Personalized Oncolytic Viruses
Official title: Expanded Access for PSV Personalized Oncolytic Viruses
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancer
Keywords: Cancer
Lead sponsor: EpicentRx, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.

Detailed description: Patients will receive intratumoral or subcutaneous injection of an oncolytic virus called PSV (short for Personalized Virus) every other week until the occurrence of immune related RECIST progression, intolerable toxicity, change to another anti-cancer treatment due to lack of apparent benefit, or personal choice.

Eligibility criteria: Inclusion Criteria:

* Ability to understand and sign a written informed consent form.
* Measurable or evaluable disease with least one (1) tumor that is accessible to intratumoral injection.
* Eastern Cooperative Group (ECOG) performance status is 0-3 at Screening.
* Acceptable liver function at Screening, as evidenced by:

  * Bilirubin ≤ 3.0 X upper limit of normal (ULN) since this patient has
  * been diagnosed with Gilbert's Disease
* AST (SGOT) and ALT (SGPT) ≤ 5 X ULN.
* Serum creatinine \< 3 x institution upper limit of normal.
* Patient has acceptable hematologic status at Screening, as evidenced by:

  * Absolute neutrophil count ≥ 1,500 cells/mm3; and
  * Platelet count ≥ 70,000/mm3; and
  * Hemoglobin (HGB) ≥ 8.5 g/dL.
* Medically acceptable contraception.
* Willingness to comply with all protocol procedures, evaluations and rescue measures.

Exclusion Criteria:

* Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
* An active bacterial, fungal, or viral infection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Cincinnati
name: John Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06808139: Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair
Official title: Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Penile Hypospadias
Keywords: Plasma-Rich Platelet Graft
Dartos Flap
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 70
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

Detailed description: Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

Eligibility criteria: Inclusion Criteria:

* Age \>6 months
* Distal penile hypospadias
* Denovo hypospadias

Exclusion Criteria:

* Recurrent hypospadias -Mid and proximal penile hypospadias

Primary outcomes:
measure: incidence of occurrence of uretherocutanous fistula
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05064839: Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)
Official title: Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transthyretin Cardiac Amyloidosis
Keywords: cardiology
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2021-10-01
Enrollment: 553
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.

Detailed description: Not Provided

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 60 years, hospitalised in cardiology wards of the Centre Hospitalier Universitaire of Poitiers
* Left ventricle hypertrophy on echocardiography
* Patient able to comply with study procedures
* Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
* Patient having signed an informed consent after clear and fair information on the study

Exclusion Criteria:

* CardiacTransplant
* Complex congenital cardiopathies
* Know diagnosis of amylosis
* Contra-indication to bony scintigraphy : hypersensitivity to sodium oxidronate or one of its excipients, or to one of the components of radiopharmaceutic marked product ;
* Subject not able to comply with study procedures
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, patients staying in a health or social establishment, adults under legal protection, and patients in emergency situation.
* Women not menopausal

Primary outcomes:
measure: Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.
timeFrame: At Visit 2, one to four months after inclusion visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: C.H.U. de Poitiers
Study officials:
References:
Clinical trial NCT01540539: Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-02-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to study the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of REGN1154 in normal healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
3. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
4. Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)

Exclusion Criteria:

Exclusion criteria include, but are not limited to the following:

1. Any illness or condition that would adversely affect the subject's participation in this study
2. Any clinically significant abnormalities observed during the screening visit
3. Use of certain medications taken before the screening visit
4. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit
5. Hospitalization within 60 days of the screening visit
6. Any condition that would place the subject at risk, interfere with participation in the study
7. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
8. History of certain other conditions
9. Positive urine, drug or alcohol screen result at screening
10. Known sensitivity to any of the components of the investigational product formulation
11. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
12. Live/attenuated vaccinations within 12 weeks of screening or during the study

Primary outcomes:
measure: Total number and severity of TEAEs
timeFrame: Day 1 through Day 113
Secondary outcomes:
measure: Serum concentration
timeFrame: Day 1 through Day 113
measure: Presence or absence of antibodies
timeFrame: Day 1 through Day 113
Other outcomes:
Locations:
city: Melbourne
country: Australia
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT02637739: Hysteroscopy for Pregnancy of Unknown Location
Official title: Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: hysteroscope
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on first visit and are classified as pregnancy of unknown location (PUL). The etiology includes ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D\&C, and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.

Detailed description: If TVU showed no evidence of intra-uterine and extra-uterine pregnancy, a blood test for β-hCG was done. If β-hCG was \< 1000 IU/L, the woman was followed with β-hCG 2 days later. Women with β-hCG \> 1000 IU/L or abnormal β-hCG trend (increase \< 66% or decrease \< 15%) were offered HSC. If gestational tissues were visualized, ectopic pregnancy was ruled out. Otherwise, the tentative diagnosis was ectopic pregnancy.

Eligibility criteria: Inclusion Criteria:

* women with PUL

Exclusion Criteria:

Primary outcomes:
measure: percentage of women with PUL waived from laparoscopic examination
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Gong-Jhe Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02494739: Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
Official title: Investigation of the Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Inflammation
Keywords: antioxidant
oxidative stress
inflammation
polyphenols
yogurt
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the possible antioxidant and anti-inflammatory effects of yogurt enriched with polyphenols after 2-week consumption by healthy individuals.

Detailed description: Eighteen healthy adult volunteers of both sexes consumed yogurt (400g per day) enriched with polyphenols (10mg/100g yogurt) or yogurt (400g per day) not enriched with polyphenols for two weeks in a double-blind, crossover, randomized manner.There was a washout period of at least 10 days. Physiological data and blood samples were collected before and after consumption of each yogurt.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Non-smokers

Exclusion Criteria:

* Current use of dietary supplements or drugs
* Metabolic disease
* Lactose intolerance
* Pregnant, pregnancy intention or breast feeding

Primary outcomes:
measure: Antioxidant effects
timeFrame: Two weeks
measure: Anti-inflammatory effects
timeFrame: Two weeks
Secondary outcomes:
measure: Body composition
timeFrame: Two weeks
measure: Blood pressure
timeFrame: Two weeks
measure: Hydration
timeFrame: Two weeks
measure: Resting heart rate
timeFrame: Two weeks
measure: Blood glucose levels
timeFrame: Two weeks
measure: Triglyceride levels
timeFrame: Two weeks
measure: Total cholesterol levels
timeFrame: Two weeks
measure: High Density Lipoprotein cholesterol levels
timeFrame: Two weeks
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: Department of Physical Education & Sport Science of the University of Thessaly
state: Karyes
Study officials:
affiliation: University of Thessaly
name: Athanasios Z Jamurtas, PhD
role: STUDY_DIRECTOR
References:
citation: Najgebauer-Lejko D, Grega T, Tabaszewska M. Yoghurts with addition of selected vegetables: acidity, antioxidant properties and sensory quality. Acta Sci Pol Technol Aliment. 2014 Jan-Mar;13(1):35-42. doi: 10.17306/j.afs.2014.1.3.
citation: Lamothe S, Azimy N, Bazinet L, Couillard C, Britten M. Interaction of green tea polyphenols with dairy matrices in a simulated gastrointestinal environment. Food Funct. 2014 Oct;5(10):2621-31. doi: 10.1039/c4fo00203b. Epub 2014 Aug 26.
Clinical trial NCT01349439: Reducing Reconsolidation of Trauma Memories With Propranolol
Official title: Reduction of the Reconsolidation of the Trauma Memory With Propranolol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-05-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.


Eligibility criteria: Inclusion Criteria:

* Suffer from chronic PTSD for at least 6 consecutive months;
* Obtain a score of 33 or more on the Impact of Events Scale-Revised:
* For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal;
* Accept to not commence taking new medications on a regular basis during the study.

Exclusion Criteria:

* Hypotension;
* Cardiac rhythm below 55 beats per minute;
* Medical conditions that contraindicates the administration of propranolol;
* Previous adverse reaction to, or non-compliance with, beta-blockers;
* Current use of medication that may involve potentially dangerous interactions with propranolol;
* Any medication that can have an impact on cardiac rhythm;
* Women who are breast feeding;
* Past or present bipolar disorder or psychosis,
* Present substance abuse or dependence, suicidal ideation;
* Participating in psychotherapy other than support psychotherapy;
* An average score above 20 on the Dissociative Experience Scale.

Primary outcomes:
measure: Electromyogram
timeFrame: Two weeks post-treatment
measure: Heart rate
timeFrame: Two weeks post-treatment
measure: Skin conductance
timeFrame: Two weeks post-treatment
Secondary outcomes:
measure: PTSD symptom levels
timeFrame: 2 to 26 weeks
measure: Quality of life
timeFrame: 2 to 26 weeks
measure: Memory Experience
timeFrame: 2 to 26 weeks
measure: Psychophysiological assessments
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Verdun
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: Douglas Institute Research Centre
name: Alain Brunet, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.