louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00765921: Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Official title: A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Choroidal Melanoma
Keywords: glaucoma, neovascular
macular edema
eye enucleation
antibodies, monoclonal
radiation oncology
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-10-03
Enrollment: 40
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: The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed choroidal melanoma undergoing proton therapy
* Tumors \>15 mm in largest diameter and/or \>5 mm in height
* Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye

Exclusion Criteria:

* History of prior treatment for choroidal melanoma
* Pregnancy or lactation
* Presence of diabetic retinopathy
* History of retinal vascular occlusion or other retinal vascular disease
* Active ocular inflammation or history of uveitis in either eye
* History of uncontrolled glaucoma (defined as intraocular pressure \>30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
* Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
* Concurrent use of systemic anti-VEGF therapy

Primary outcomes:
measure: incidence and severity of ocular adverse events and systemic adverse events
timeFrame: 12 months and 24 months after initial treatment
Secondary outcomes:
measure: incidence of radiation-induced complications, vision loss and eye loss
timeFrame: 12 months and 24 months after initial treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye & Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Ivana Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06320821: RAKT OUTCOME ANALYSIS
Official title: ROBOT-ASSISTED KIDNEY TRANSPLANTATION VERSUS OPEN KIDNEY TRANSPLANTATION: a COMPARISON USING PROPENSITY SCORE MATCHING
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Kidney Transplantation
Robotic Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients received kidney-only transplants between Jan 2018 and Jan 2024 in Seoul National University Hospital.

Brief summary: The goal of this observational study is to compare outcomes of robot-assisted kidney transplantation and open kidney transplantation. The main questions are

- comprehensively analyze our early experience of robot-assisted kidney transplant patients and compare the results with those of open kidney transplant patients


Eligibility criteria: Inclusion Criteria:

* Patients received kidney transplantation in SeoulNUH between Jan 2018 and Jan 2024

Exclusion Criteria:

* patients with multi-organ transplant
* patients with missing operative data

Primary outcomes:
measure: learning curve
timeFrame: transplantation to 6 months post-transplant
Secondary outcomes:
measure: renal function
timeFrame: transplantation to 6 months post-transplant
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01787721: Effect of Manipulation of the Ankle Joint on Gait
Official title: Effect of Manipulation of the Tibiotalar Joint on Gait
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gait
Keywords: Gait
Ankle joint
Manipulation, Chiropractic
Lead sponsor: University of Bridgeport
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if manipulation of the ankle improves some measurable characteristics of how a person walks. The investigators hypothesize that the ankle will be able to bend better after manipulation and thus improve walking speed and reduce differences between the two limbs.


Eligibility criteria: Inclusion Criteria:

* Students will be screened for eligibility by testing their ability to perform a squat.

Exclusion Criteria:

* a recent (within one month) ankle sprain
* evidence of ankle instability
* cardiac condition

Primary outcomes:
measure: Change in self-selected walking speed
timeFrame: Day 1 and 6 weeks
Secondary outcomes:
measure: Change in side-to-side difference in stance phase
timeFrame: Day 1 and 6 weeks
measure: Change in difference in step length from side-to-side
timeFrame: Day 1 and 6 weeks
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: University of Bridgeport College of Chiropractic Human Performance Laboratory
state: Connecticut
Study officials:
affiliation: University of Bridgeport
name: Stephen M Perle, DC, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652664: Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Official title: A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Glaucoma
Elevated IOP in Pediatric Patients
Ocular Hypertension in Pediatric Patients
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 184
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pediatric glaucoma or ocular hypertension.
* Qualifying mean IOP at the Eligibility Visit in at least one eye.
* Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures.
* History of chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
* Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
* Clinically significant or progressive retinal disease.
* Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker.
* Intraocular surgery in the study eye within 30 days prior to the Screening Visit.
* Any abnormality preventing reliable applanation tonometry.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in IOP at Month 3
timeFrame: Baseline (Day 0), Month 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Subha Venkataraman, Clinical Project Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT05921864: Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise
Official title: Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heat Stress
Heat
Keywords: ultra-endurance
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of healthy young athletes.

Brief summary: Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. While hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. The effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. What's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. A better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* BMI between 18 and 25 kg/m2
* Weight ≥ 51 kg
* Minimum training volume 6 days/7, aerobic
* Participation in a running competition ≥ 6hours
* Having given informed consent

Exclusion Criteria:

* Presence or history of medical pathology
* Presence of significant deviation from normal electrocardiogram values
* History of heat stroke
* Known intolerance to heat
* Inability to swallow a capsule or refusal of rectal probe
* Alcohol consumption exceeding the equivalent of 3 glasses of wine per week
* Consumption of narcotics
* Smoking \> 0.5 pack of cigarettes per day
* On usual medication
* Pregnant or breast-feeding women
* Protected adult, under legal protection, guardianship or curatorship, or unable to give personal written consent

Primary outcomes:
measure: Degree of correlation between core temperature measured at the end of passive heat exposure and that measured at the end of active heat exposure
timeFrame: Through study completion (1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References:
Clinical trial NCT02090764: Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Official title: A Phase III 2 Arms, Multicenter, Randomised, Double-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impetigo
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 412
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area.
* Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate score of at least 1

Exclusion Criteria:

* Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
* Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)

Primary outcomes:
measure: Clinical Success
timeFrame: Visit 3 (Day 6-7)
Secondary outcomes:
Other outcomes:
Locations:
city: Rio Grande
country: Puerto Rico
facility: Caparra Internal Medicine Center
Study officials:
References:
citation: Hebert AA, Albareda N, Rosen T, Torrelo A, Grimalt R, Rosenberg N, Zsolt I, Masramon X. Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials. J Drugs Dermatol. 2018 Oct 1;17(10):1051-1057.
citation: Rosen T, Albareda N, Rosenberg N, Alonso FG, Roth S, Zsolt I, Hebert AA. Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):806-813. doi: 10.1001/jamadermatol.2018.1103.
Clinical trial NCT01894464: The Early Truancy Prevention Project
Official title: The Early Truancy Prevention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Absenteeism by Primary School Students
Keywords: truancy
attendance
education
primary school
elementary school
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2013-07-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Early Truancy Prevention Project is designed to prevent elementary school truancy through teacher-led interventions that are individualized to meet student needs.

Detailed description: The Early Truancy Prevention Project is an innovative intervention program designed to prevent elementary school truancy and later school dropout. The intervention model emphasizes the important role of teachers as change agents to address early attendance problems and emerging truancy. Specifically, the goals of this pilot project are: 1) to facilitate positive, trusting, and collaborative home-school relations and to promote a positive teacher-child relationship; 2) to provide teachers with timely information about a student's attendance pattern; and 3) to train and supervise teachers in the implementation of individualized attendance interventions to improve student attendance and prevent emerging truancy among elementary school students. As this is a pilot study, another important goal is to obtain teacher and administrator feedback to improve and refine all aspects of the project.

Eligibility criteria: Inclusion Criteria:

* all first and second grade teachers in 6 schools

Exclusion Criteria:

* none

Primary outcomes:
measure: Percent of students who are truant
timeFrame: June, 2014
Secondary outcomes:
measure: Average number of absences per classroom
timeFrame: June, 2014
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Philip J Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05824364: Exercise aNd hEArt Transplant
Official title: Exercise aNd hEArt Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Transplant
Keywords: cardiac rehabilitation
telerehabilitation
rehabilomics
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel and cross over designs will be adopted according to the specific purposes of that given clinical study
Primary purpose: TREATMENT

Brief summary: Registry-based randomized clinical trial (RRCT) to assess the safety and efficacy of two different schemes of exercise training in patients who have recently undergone heart transplantation

Detailed description: 40 patients who achieved Heart transplantation (HTx) will be randomized in a pilot study to 4 weeks of on-site standard CR (control arm) versus two-four weeks of on-site CR followed by 12 weeks of telerehabilitation (experimental arm). Both surrogate endpoints \[cardiometabolic equivalents (Vo2 peak)\] and clinical endpoint \[primary outcome defined as acute rejection, hospitalization for heart failure, stroke, myocardial infarction, all-cause mortality, at the longest follow-up available (minimum 6-month follow-up)\] will be evaluated.

The rehabilomic approach will be applied in order to identify specific patients' phenotype. To identify the potential variations of circulating molecules levels that could be indicators of the rehabilitation outcome and/or progression of the disease, the research team will focus on the analysis of extracellular vesicles (EVs) isolated from the serum of the 40 patients at admission (T0) and after cardiac rehabilitation (T1). In particular, researchers will detect and analyze the relative amount of serum EVs derived from platelets, endothelium, cardiomyocytes, and macrophages, as their levels are reported to be associated with the occurrence of heart failure.

Eligibility criteria: Inclusion Criteria:

* All the patients admitted in the on-site CR after HTx

Exclusion Criteria:

* unable to sign informed consent

Primary outcomes:
measure: Cardiovascular events
timeFrame: 6-months
Secondary outcomes:
measure: Vo2 peak
timeFrame: 6-months
measure: extracellular vesicles (EVs) analysis with Surface Plasmon Resonance imaging (SPRi)
timeFrame: up to 4 weeks
measure: EuroQol 5-Dimension (EQ-5D-5L)
timeFrame: 6-months
measure: Short Form 36 (SF36)
timeFrame: 6-months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6-months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Gnocchi, Milan
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
name: Nuccia Morici, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03778164: Improving Prevention Systems to Reduce Disparities for High Priority Populations
Official title: Improving Prevention Systems to Reduce Disparities for High Priority Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a cross sectional stepped wedge cluster randomized design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project collaborates with the New York City Department of Health and Mental Hygiene (NYC DOHMH) to develop and test a field-based comprehensive sexual health intervention for HIV-exposed contacts notified by its Partner Services (i.e., HIV contact tracing) program. The goal of the study is to develop and test the impact of this new intervention on improving rates of HIV testing, linkage to HIV prevention/care, and PrEP uptake among highest risk contacts recently exposed to HIV. We will conduct a 6-month pilot project, followed by a cross-sectional stepped wedge cluster randomized trial in which 12 clusters of NYC neighborhoods are exposed to the intervention sequentially, with three clusters moving from control to intervention every 6 months (n = 1150). Primary outcomes are HIV testing, timely PrEP/ARV uptake, and linkage to PrEP/HIV care. Secondary outcomes are STD testing and receipt of STD treatment (if indicated).


Eligibility criteria: Inclusion Criteria:

* Contacts referred to the Partner Services program during the study time period

Exclusion Criteria:

* None

Primary outcomes:
measure: Acceptance of HIV Testing
timeFrame: 1 month
measure: PrEP/ARV Initiation
timeFrame: 3 months
measure: Linkage to PrEP/HIV Care
timeFrame: 6 months
Secondary outcomes:
measure: STI testing
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College of CUNY
state: New York
Study officials:
References:
Clinical trial NCT02718664: Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
Official title: Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Safety Biomarkers
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteer; not known with cancer or current treatment for cancer
2. Age at least 18 years
3. Able and willing to give written informed consent
4. Able and willing to consume the prescribed breakfast
5. Able and willing to undergo blood sampling

Exclusion Criteria:

1. Any treatment with investigational drugs within 30 days before the start of the study
2. Any condition that may interfere with the study protocol
3. Women who are pregnant
4. Allergies or intolerance for components of the prescribed breakfast

Primary outcomes:
measure: Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition
timeFrame: 2 test days
Secondary outcomes:
measure: dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)
timeFrame: baseline
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
Study officials:
affiliation: The Netherlands Cancer Institute
name: Jan Schellens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: