louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06492850: Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa
Official title: A Phase I/II Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of FT-002 Subretinal Injection in Subjects With RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: X-Linked Retinitis Pigmentosa (XLRP)
Keywords: X-Linked Retinitis Pigmentosa (XLRP)
FT-002
Lead sponsor: Frontera Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 32
Sex: MALE
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).


Eligibility criteria: Inclusion Criteria:

* Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form;
* Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;
* Clinically diagnosed XLRP, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.;

Exclusion Criteria:

* Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.

Primary outcomes:
measure: To evaluate the safety and tolerance of FT-002
timeFrame: from FT-002 administration through up to 1 years
Secondary outcomes:
measure: To evaluate the efficacy of FT-002
timeFrame: from FT-002 administration through up to 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Ruifang Sui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01924650: A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804
Official title: A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
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 effects of varying particle size on the pharmacokinetics of PH-797804


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for males.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Time 72 hours (AUC72)
timeFrame: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01990950: Fenestrated AAA Endovascular Graft Post-Approval Study
Official title: Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm (AAA)
Aorto-iliac Aneurysm
Juxtarenal Aneurysm
Keywords: Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.


Eligibility criteria: Inclusion Criteria:

* abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
* aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

Exclusion Criteria:

* proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
* renal artery stenosis greater than 50 percent

Primary outcomes:
measure: Treatment Success : AAA Related Mortality
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University Health
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
References:
Clinical trial NCT02343250: A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan
Official title: A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2015-01-21
Enrollment: 54
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 40
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypertension of hypotension

Primary outcomes:
measure: AUClast
timeFrame: 0~24hr
measure: Cmax
timeFrame: 0~24hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyungsang Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01851850: Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
Official title: Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: PD
Off periods
quality of life
dyskinesia
end-off-dose motor fluctuations
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for additional three years.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis with PD
* subjects who are willing to participate in the trial.
* subjects who participated in the BIA 9-1067-302 clinical trial.

Exclusion Criteria:

* subjects who didn't take part at the BIA 9-1067-302 clinical trial.

Primary outcomes:
measure: off periods
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tiqva
country: Israel
facility: Rabin Medical Center
state: Hamerkaz
Study officials:
References:
Clinical trial NCT02962050: Delineating Swallowing Impairment and Decline in ALS
Official title: Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2016-11-11
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Amyotrophic Lateral Sclerosis

Brief summary: The purpose of this study is to 1) evaluate the discriminant ability of simple clinical markers to detect swallowing impairment in individuals with ALS, 2) develop and validate a minimally invasive clinical screening tool for use at multidisciplinary ALS clinics, and 3) determine the natural history of swallowing impairment and decline in ALS.

Detailed description: This research study is being performed to determine screening tools or tests that are able to identify and track swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS) over time. Also, this study will provide insight into the natural progression of swallowing impairment in persons with ALS over time.

Participants enrolled in this study will complete an evaluation at the University of Florida Aerodigestive Research Core laboratory located at Shands Hospital, Gainesville every three months. Each evaluation will take approximately 90 minutes. During these evaluations, a videofluoroscopy (X-ray of swallowing) examination, cough tests and questionnaires will be completed.

Eligibility criteria: Inclusion Criteria:

* diagnosis of probable or definite ALS

Exclusion Criteria:

* allergies to barium or capsaicin
* History of stroke
* Head and Neck Cancer
* Other disorder that might contribute to swallowing impairment
* Not enrolled in other research investigations that might impact swallowing
* Not pregnant

Primary outcomes:
measure: Global Swallowing Function
timeFrame: Baseline, every 3 months through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02527850: Effect of Low Level Laser Irradiation on Muscle Performance and Recovery
Official title: Effect of Low Level Laser Irradiation on Muscle Performance and Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Exertion
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of this study is to investigated the effect of B-cure laser on muscle performance and recovery after intense exercise.


Eligibility criteria: Inclusion Criteria:

* Healthy physical education students, ages 20-35, light or intermediate skin color

Exclusion Criteria:

musculoskeletal injury to hips or knees in the previous 2 months, use pharmacological agents or nutritional supplements regularly, smokers, physical limitations on completing the exercise tests -

Primary outcomes:
measure: improvement in muscle power as indicated in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment
timeFrame: 1 hour
measure: evaluation of muscle power after induction of muscle fatigue in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment
timeFrame: 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
References:
Clinical trial NCT03411850: Sjogrens Syndrome Measured by Ultrasound
Official title: Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sjogren's Syndrome
Lead sponsor: Arthritis & Rheumatism Associates, P.C.
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2018-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Ultrasound study focused on salivary gland outcomes in Sjogren's subjects

Detailed description: A 32 week ultrasound study for subject diagnosed with Sjogren's Syndrome. Subjects will receive Orencia (Abatacept) as intervention therapy during this trial.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with Sjogren's Syndrome

Exclusion Criteria:

* Subjects previously diagnosed with Sarcoidsis
* Subjects with positive for Hepatitis B, Hepatitis C, HIV
* Subjects diagnosed with Cancer within 5 years of screening

Primary outcomes:
measure: Salivary gland changes
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.
state: Maryland
Study officials:
References:
Clinical trial NCT00303550: Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)
Official title: Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections (ASSIST-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Diseases, Bacterial
Keywords: skin infection
complicated skin infection
skin structure infection
Complicated Skin and Skin Structure Infection
Lead sponsor: Arpida AG
Sponsor class: INDUSTRY
First posted: 2006-03-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is now completed

Detailed description: Primary Objective:

The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).

Secondary Objectives:

The secondary objectives of this study are to compare iclaprim with linezolid regarding:

* Clinical efficacy at the end of study medication treatment;
* Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);
* Clinical outcome in the microbiologically evaluable (ME) population;
* Bacteriologic outcome in the ME population;
* Bacteriologic eradication rates of Baseline (BL) pathogens;
* Clinical outcome in the modified intent-to-treat (MITT) population;
* Bacteriologic outcome in the MITT population;
* Baseline in vitro susceptibility of isolated pathogens in the ME population; and
* Safety and tolerability of iclaprim treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.

Exclusion Criteria:

* Known or suspected hypersensitivity to any study medication or other related anti-infective medication
* Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
* Previous enrollment in this study
* Treatment with any investigational drug within 30 days before enrollment

Primary outcomes:
measure: Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy
Secondary outcomes:
measure: Microbiological eradication rate at 7-14 days after end of therapy
measure: Safety evaluations conducted during the study
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Edward Hospital & Health Services
state: Illinois
city: Casper
country: United States
facility: Wyoming Medical Center
state: Wyoming
Study officials:
References:
Clinical trial NCT04008550: Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)
Official title: Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Pulmonary Hypertension
Keywords: TAVI (Transcatheter Aortic Valve Implantation)
Aortic Stenosis
Pulmonary Arterial Hypertension
Right Heart Catheterization
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Several studies have shown that pulmonary arterial hypertension (PAH) was common in AS patients referred for TAVI and that it was an independent predictor of mortality after TAVI.

Currently, there is no data in the literature regarding the evolution and prognosis value of PAH measured using right heart catheterization (reference method). PAH could either regress after TAVI or continue to progress despite the treatment of valvulopathy, resulting in a refractory right heart failure that can lead to death.

The hypothesis of this study is that patients with PAH before TAVI procedure and at the 3-month follow-up visit (PAH persistence) have an increased risk of cardiovascular mortality compared to patients with no PAH at 3 months or having a significant reduction of their PAH (PAH regression).

The aim of the study is to evaluate the prognostic impact of the evolution of PAH after TAVI in 424 patients using right heart catheterization.


Eligibility criteria: Inclusion Criteria:

* Aortic stenosis
* Indication of TAVI

Exclusion Criteria:

* Contra-indication of right heart catheterization
* Pregnancy
* Persons deprived of their liberty

Primary outcomes:
measure: Hospitalization for heart failure or death any cause (composite endpoint)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Post-operative evolution of the PAH, according to the type of pre-operative PAH
timeFrame: Year 2
measure: Prevalence of pre-TAVI PAH
timeFrame: Year 0
measure: Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)
timeFrame: Year 2
measure: Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH
timeFrame: Month 3
measure: Concordance between the PAH measurement techniques: echocardiography and right heart catheterization
timeFrame: Month 3
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Eric Durand, MD
role: PRINCIPAL_INVESTIGATOR
References: