louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02033200: Safety Study Looking at the Effects of Stendra on Vision
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Parallel Study to Assess the Effects of Avanafil (STENDRA™) on Multiple Parameters of Vision, Including, But Not Limited to Visual Acuity, Intraocular Pressure, Pupillometry, and Color Vision Discrimination, in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vision
Keywords: vision
Stendra
avanafil
PDE5 inhibitor
visual acuity
intraocular pressure
pupillometry
color vision discrimination
healthy males
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2014-01-10
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if Stendra causes any changes in vision, eye pressure, pupil dilation, and color vision in healthy males.

Detailed description: The objectives of this study are to assess the effect of Stendra on visual acuity, intraocular pressure, pupillometry, and color vision discrimination in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy adult males 18 to 45 years of age, inclusive
* Non-tobacco user for at least 6 months prior to first dose

Exclusion Criteria:

* History or presence of retinal disease or any vision defects including color vision
* Intraocular pressure value ≥ 22mm Hg
* Resting heart rate \< 45 or \> 90 beats per minute (3 rechecks)
* Systolic blood pressure \< 90 or \> 140 mm Hg or Diastolic blood pressure \< 50 or \>90 mm Hg (3 rechecks)
* Initiation or change in dose of any α-blockers 14 days prior to randomization

Primary outcomes:
measure: Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing
timeFrame: 1 hour
measure: Change From Baseline in Visual Acuity 1 Hour Post Dosing
timeFrame: 1 hour
measure: Change From Baseline in Pupil Dilation 1 Hour Post Dosing
timeFrame: 1 hour
measure: Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
timeFrame: 1 hour
Secondary outcomes:
measure: Change From Baseline in Visual Acuity 24 Hours Post Dosing
timeFrame: 24 hours
measure: Change From Baseline in Pupil Dilation 24 Hour Post Dosing
timeFrame: 24 hour
measure: Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing
timeFrame: 24 hours
measure: Change From Baseline in Intraocular Pressure 24 Hour Post Dosing
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion Inc
state: Arizona
Study officials:
References:
Clinical trial NCT04984200: Assessment of EyeArt Performance With Retinal Cameras
Official title: Assessment of EyeArt Performance With Retinal Cameras
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Eyenuk, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 246
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be enrolled at primary care and/or eye care centers

Brief summary: The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of diabetes mellitus;
* Understanding of study and provision of written informed consent; and
* 22 years of age or older.

Exclusion Criteria:

* Persistent visual impairment in one or both eyes;
* History of retinal vascular (vein or artery) occlusion;
* History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
* Subject is contraindicated for fundus photography (for example, has light sensitivity);
* Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
* Subject is currently enrolled in an interventional study of an investigational device or drug; or
* Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable dilated fundus photographs.

Primary outcomes:
measure: Overall agreement between the results from multiple EyeArt operations
timeFrame: 1 visit (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes Center
state: Idaho
Study officials:
References:
Clinical trial NCT02618200: Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
Official title: Creation of a Multimodality Image Database (MRI + Ultrasound) for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Computer-Aided Diagnosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.

In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.


Eligibility criteria: Inclusion Criteria:

* Patient referred for radical prostatectomy
* Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery
* Informed consent signed
* Patient affiliated to the French Health Insurance system

Exclusion Criteria:

* History of prostatic surgery or radiation therapy (prostatic or pelvic)
* History of hormone therapy for prostate cancer
* Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound
* Patient on protection of the court, under supervision or under trusteeship
* Inability to express a consent

Primary outcomes:
measure: Obtention of 3D ultrasound images
timeFrame: the day before radical prostatectomy
Secondary outcomes:
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Hôpital Edouard Herriot - Service Service de radiologie
Study officials:
References:
Clinical trial NCT00391300: Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
Official title: Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Melanoma (Skin)
Non-melanomatous Skin Cancer
Keywords: melanoma
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2006-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: New diagnostic procedures, such as bioelectric field imaging, may help find and diagnose melanoma and other skin cancers. It may also be a less invasive way to check for skin cancer.

PURPOSE: This phase I trial is studying bioelectric field imaging in diagnosing melanoma and other skin cancers in patients with skin lesions.

Detailed description: OBJECTIVES:

* To determine if the hand-held Bioelectric Field Imager can be used to measure the electric field in skin of various body surfaces, including face, neck, shoulders, arms, hands, chest, back, legs, and feet, during the course of examination and treatment of patients with suspected malignant skin lesions.
* To determine if there is a significant difference between the lateral electric field strength near benign and malignant skin lesions in the same individual.

OUTLINE: Patients undergo scanning of their skin lesions and nearby healthy skin using the Bioelectric Field Imager (BFI). The lesions are then biopsied for histological diagnosis. Histological data from the biopsy is correlated with the electric field data from the BFI.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Suspected malignant skin lesion
* Seeking treatment for skin lesion at the VA Medical Center

PATIENT CHARACTERISTICS:

* Not pregnant
* No acute illness, including upper respiratory tract infection or flu that could result in fever
* No trauma to the skin lesion area
* No prisoners

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces
measure: Use of BFI in detecting significant electric field differences between malignant and benign skin lesions
Secondary outcomes:
Other outcomes:
Locations:
city: Hampton
country: United States
facility: VA Hospital
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Antoinette F. Hood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005000: Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Official title: A Randomized, Open-Label, Study of Nelfinavir or Efavirenz in HIV-1 Infected, Antiretroviral Naive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Lymphoid Tissue
HIV Protease Inhibitors
Genotype
Phenotype
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Adipose Tissue
Glucose
Lipids
Immunophenotyping
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two drugs (nelfinavir \[NFV\] and efavirenz \[EFV\]) used in start-up anti-HIV treatment. Doctors want to see if one is better than the other in extending the time that viral load (level of HIV in the blood) is kept low. The study will also look at the response of the immune system to each drug.

Detailed description: Patients are randomized to initiate therapy and receive either nelfinavir (NFV) or efavirenz (EFV) in the first regimen (R1). All patients also receive zidovudine (AZT) and lamivudine (3TC). Patients are further randomized in a factorial fashion and by stratification based on HIV RNA level (less than 10,000, 10,000-100,000, or greater than 100,000 copies/ml) to be administered a single injection of a neo-antigen (KLH) at Week 12, 24, or 48. Therapy continues until switch criteria are met either before or after Week 24. When switch criteria are met, patients advance to the next regimen (R2).

R2 patients previously taking NFV switch to EFV; those randomized to EFV switch to NFV; the additional NRTIs change to stavudine (d4T) and didanosine (ddI). Therapy is continued for an additional 24 weeks.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this trial if they:

* Are HIV-positive.
* Have a CD4 count of at least 100 cells/mm3.
* Have a viral load of at least 5,000 copies/ml.

Exclusion Criteria

Patients may not be eligible for this study if they:

* Have taken any antiretroviral (anti-HIV) agent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Agouron Pharmaceuticals Inc
state: California
Study officials:
References:
Clinical trial NCT05618600: Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid
Official title: Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Paxlovid
Rebound
COVID-19
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: eMed
First posted: 2022-11-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be obtained from the eMed platform and will consist of participants that tested positive using an eMed rapid antigen test, who underwent a telemedicine visit and opted in or out of receiving a prescription for a 5-day course of Paxlovid.

Brief summary: A prospective monitoring study for those individuals treated with Paxlovid

Detailed description: The purpose of this study is to understand the epidemiology and pathophysiology of Paxlovid rebound in patients with acute Covid-19 infection who have been prescribed the Paxlovid per standard of care.

The study will be a collaborative effort between Scripps and eMed, digitally recruiting 800 participants who have tested positive for Covid-19 and have agreed to be prescribed Paxlovid on the eMed platform.

The vision of the study is to understand Paxlovid rebound and ultimately inform management of acute Covid-19 infection.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Covid positive
* Qualified for Paxlovid prescription (treatment decision already made prior to enrollment)

Exclusion Criteria:

* Non-english speaking
* Resides outside of the United States

Primary outcomes:
measure: Paxlovid Rebound
timeFrame: 16 day period
Secondary outcomes:
Other outcomes:
measure: Symptomatology long term
timeFrame: 6 month period
measure: Number of viral rebound
timeFrame: 16 day period
measure: Number of grouped symptomatology
timeFrame: 16 day period
measure: Immune profile
timeFrame: 6 month period
measure: Viral Evolution
timeFrame: 6 month period
Locations:
city: San Diego
country: United States
facility: Scripps Research Institute
state: California
Study officials:
affiliation: Scripps Research Institute
name: Jay Pandit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00426400: Anti-Aggregative Therapy and Laser Iridectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Eyes With Narrow Angle
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our study investigates the effect of anti-aggregative treatment on success and complications of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow angles.Patients will undergo first laser treatment with the anti-aggregative treatment and will scheduled for next lase in the other eye after discontinuing the anti-aggregative treatment. The patients will be followed-up for 3 months.


Eligibility criteria: Inclusion Criteria:

* patients with narrow angle that need laser iridectomy and take anti- aggregative treatment
* over 20 years old
* patients who can stop their anti-aggregative treatment for 10 days

Exclusion Criteria:

* under coumadin treatment
* post ocular surgeries

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Goldschleger Eye Institute
Study officials:
affiliation: Goldscheleger Eye Institute, Sheba Medical Center
name: Hani Levkovitch-Verbin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05796700: Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma
Official title: Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma: a Multicentre Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overall Survival
Progression-free Survival
Cost
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 1585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As the most common subtype of liver cancer (85% \~ 90%), HCC is highly malignant; thus, one of the crucial issues in HCC management is an effective therapy for tumors at an early stage, which is vital for improving the prognosis of patients. For ≤3cm HCC, ablation has been recommended by international guidelines as a first-line or alternative treatment because of similar survival outcomes and milder liver function injury with liver resection (LR). However, the appropriate treatment options for 3-5cm HCC remain controversial. Thus, none of the international guidelines recommend ablation as a first-line treatment for 3-5cm HCC. In the past few decades, treatment for HCC has tended to be less invasive, have fewer complications, and have higher cost-effectiveness. Compared with LR, laparoscopic Hepatectomy (LH) demonstrates the advancement of minimal invasion. As another minimally invasive technique for HCC, Microwave Ablation (MWA) has the potential to eradicate larger HCCs with larger coagulation areas and is less affected by the heat sink effect caused by vessels around the tumor. Many studies have identified the potential advantages of MWA over other ablation techniques. However, to date, no clinical studies have compared the efficacy of LH and MWA therapies for 3-5cm HCC with periodic progression.


Eligibility criteria: Inclusion Criteria:

i) age ≥18 years ii) all patients with an initial diagnosis of 3-5cm HCC(within 3 tumors, at least one 3-5cm) by histopathology iii) Child-Pugh class A or B iv) no vascular invasion or distant metastasis v) no other malignant neoplasms within the last 5 years

Exclusion Criteria:

i) age \<18 years ii) Child-Pugh class ≥B iii) vascular invasion or distant metastasis iv) with other malignant neoplasms within the last 5 years

Primary outcomes:
measure: Overall survival
timeFrame: More than 3 years
measure: Progession-free survival
timeFrame: More than 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05401500: Familial Aortopathies and Cellular Exploration
Official title: ACTA2 and Familial Aortopathies: Creation and Validation of an Exploratory Cellular Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Familial Aortopathies
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The prevalence of hereditary aortic disease (HTAD), responsible for aneurysm or dissection, is estimated at 25%. Mutations in the ACTA2 gene represent the main cause of non-syndromic forms (10-21%). ACTA2 is expressed in vascular wall smooth muscle cells (VSMC) and encodes alpha actin (α-SMA). This actin isoform is in the majority in VSMCs and plays a key role in their contractile properties. The mutations are dominant-negative and lead, in a fibroblast model, to defects in the organisation of the actin cytoskeleton and to an increase in the migratory and proliferative potential of the cells. In vivo, VSCMs exist in a phenotypic continuum ranging from a quiescent differentiated contractile state to a so-called synthetic state in which cells are proliferative, synthesise extracellular matrix elements and exhibit enhanced migratory capabilities. To understand how ACTA2 mutations deregulate VSMC functions and steer them towards a synthetic phenotype, it is necessary to have a cellular model as close as possible to the affected tissue..


Eligibility criteria: Inclusion Criteria:

* patient with a mutation in the ACTA2 gene

Exclusion Criteria:

* patient under 18 years of age at the time of inclusion

Primary outcomes:
measure: analysis of the impact of ACTA2 mutations on the morphology of the actin cytoskeleton
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: François Cremieux
role: STUDY_DIRECTOR
References:
Clinical trial NCT05699200: A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection
Official title: Role of the Neurovascular System in Spontaneous Coronary Artery Dissection (SCAD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spontaneous Coronary Artery Dissection
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-01-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to compare sympathetic function (flight or fight system) and arterial health including structure and mechanics of participants with history of spontaneous coronary artery dissection (SCAD) to age and sex matched control participants.


Eligibility criteria: Inclusion Criteria:

* For SCAD patients: history of SCAD as confirmed by coronary angiography or cardiac computed tomography angiography
* For controls: no cardiac disease history

Exclusion Criteria:

* Pregnancy
* Known or suspected unstable cardiac condition within 4 weeks of the study
* Active treatment with anticoagulation or dual antiplatelet therapy
* Prisoner

Primary outcomes:
measure: Arterial thickness
timeFrame: Baseline
measure: Arterial stiffness
timeFrame: Baseline
measure: Baroreflex sensitivity
timeFrame: Baseline
measure: Sympathetic response to stress
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marysia Tweet, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: