louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05449509: Abdominal Aortic Aneurysm Screening Before Coronary Artery Bypass Surgery
Official title: Association of SYNTAX Score With Abdominal Aortic Aneurysm in Patients Undergoing Coronary Artery Bypass Graft Surgery: Who Should be Screened?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Abdominal Aortic Aneurysm
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients undergoing elective CABG in the Department of Cardiovascular Surgery in Basaksehir Cam Sakura City Hospital

Brief summary: Coronary artery disease (CAD) and abdominal aortic aneurysm (AAA) are two separate entities with common risk factors such as hypertension, advanced age, male sex. Atherosclerosis plays an important role in the etiology of both diseases. It has been reported that AAA is more prevalent in patients undergoing coronary artery bypass grafting (CABG). Despite all the evidence, current guidelines do not recommend routine screening for AAA before CABG. Syntax score shows anatomical significance of CAD and is associated with the degree of atherosclerotic load. The investigators aim to investigate if there were any differences regarding AAA prevalence in high-SYNTAX patients versus intermediate/low-SYNTAX patients.


Eligibility criteria: Inclusion Criteria:

* Undergoing coronary artery bypass graft surgery
* Age \>18 years

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Breastfeeding
* Emergency surgery

Primary outcomes:
measure: Infrarenal abdominal aortic diameter
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura City Hospital
Study officials:
References:
citation: Bergersen L, Kiernan MS, McFarlane G, Case TD, Ricci MA. Prevalence of abdominal aortic aneurysms in patients undergoing coronary artery bypass. Ann Vasc Surg. 1998 Mar;12(2):101-5. doi: 10.1007/s100169900124.
citation: Yammine M, Itagaki S, Pawale A, Toyoda N, Reddy RC. SYNTAX score may predict the severity of atherosclerosis of the ascending aorta. J Thorac Dis. 2017 Oct;9(10):3859-3865. doi: 10.21037/jtd.2017.09.17.
Clinical trial NCT01903109: Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dry Mouth
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fed conditions


Eligibility criteria: Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to cevimeline or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 33 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Novum Pharmaceutical Research Services
state: Nevada
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Darin Brimhall, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391009: Comparison of PNF and Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients
Official title: Comparison of PNF and Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of PNF and Task Related Techniques Along with Tens on Upper Limb Function Among Stroke Patients

Detailed description: The objective of this study is to determine the comparison of PNF and TRT along with TENs on upper limb function recovery among stroke patients.

Eligibility criteria: Inclusion Criteria:

* Duration of illness before participation in the study ranged from six to eighteen months' post stroke.
* Patients who diagnosed with ischemic stroke stage 2 and 3
* Patients' age ranged from 50-70 years (male/female)
* Patients with sufficient cognitive abilities that enables them to understand and follow instructions (mini mental scale)

Exclusion Criteria:

* Patients with communication problems
* Patients with a history of previous stroke or other neurological diseases or disorders
* Patients with inflammation, old fracture or prosthesis in the affected limb, neurological diseases that affect upper limb function other than stroke (e.g.: Multiple sclerosis, Peripheral neuropathy, Parkinsonism .... etc.), infection or dermatological conditions on acupuncture sites, musculoskeletal disorders such as severe arthritis, cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, arrhythmia, implanted pacemaker or unstable hypertension) or pulmonary disorders, visual and auditory problems and patients with cognitive impairment.
* Any Contra indications for TENS, Other neurological \& orthopedic conditions affecting upper limb, Patient with subluxed shoulder, Patient with shoulder hand syndrome.

Primary outcomes:
measure: Task Related Techniques Along With Tens on Upper Limb Function Among Stroke Patients
timeFrame: 6 Months
Secondary outcomes:
measure: PNF Techniques Along With Tens on Upper Limb Function Among Stroke Patients
timeFrame: 6 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: General hospital, Al Shafi hospital, CH. Muhammad Akram Hospital Hameed Latif Hospital.
Study officials:
References:
Clinical trial NCT01948609: Prospective Research of Outcomes After Salpingo-oophorectomy
Official title: Prospective Research of Outcomes After Salpingo-oophorectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRCA1 Gene Mutation
BRCA2 Gene Mutation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2013-09-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be women 35-50 years old with a confirmed diagnosis of a deleterious BRCA 1/2 mutation recruited through UCSF.

Brief summary: PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical management. The investigators will compare the change in cardiovascular health, bone health, sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not undergo RRSO.

The investigators hypothesis is that women who undergo a premature surgical menopause induced by RRSO have worse cardiovascular health and bone health compared with women who do not undergo RRSO.


Eligibility criteria: Inclusion Criteria:

* BRCA mutation 1/2 or "Variant suspected deleterious" mutation.
* Female
* Age 35-50 years
* Able to undergo RRSO
* Speaks English
* Able to give informed consent

Exclusion Criteria:

* Prior history of bilateral oophorectomy
* BRCA 1/2 deleterious mutation
* Plans to move out of geographic region in next 3 years
* Unable to travel to study visits

Primary outcomes:
measure: Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months.
timeFrame: Baseline to 36 Months
measure: Change in baseline sexual functioning and quality of life at 36 months.
timeFrame: Baseline to 36 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Vanessa Jacoby, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00953056: A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Reassortant Rotavirus Vaccine in Chinese Healthy Adults, Children and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rotavirus Gastroenteritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 144
Sex: ALL
Minimum age (years): 6
Maximum age (years): 47
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.


Eligibility criteria: Inclusion Criteria:

* Healthy adults ages 19 to 47 years for Cohort I
* Healthy children ages 2 to 6 years for Cohort II
* Healthy infants ages 6 to 12 weeks for Cohort III
* Negative pregnancy test for females in Cohort I
* Signed Informed Consent Forms (ICFs)

Exclusion Criteria:

* Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
* Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
* Prior administration of any rotavirus vaccine
* Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
* Prior or active gastrointestinal illnesses, immunodeficiency
* Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant

Primary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: up to 14 days post vaccination
measure: Number of Serious Adverse Events
timeFrame: 14 days post vaccination
Secondary outcomes:
measure: Number of Infants With Fecal Vaccine Virus Shedding
timeFrame: Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01367756: A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers
Official title: A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 32
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: This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.


Eligibility criteria: Inclusion Criteria:

* Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)
* Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
* Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug
* Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)
* Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug

Exclusion Criteria:

* Pregnant or lactating females
* Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2
* Hepatitis B, hepatitis C or HIV infection
* Smokers of \>5 cigarettes or equivalent tobacco intake per day
* Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)
* Participation in an investigational drug or device study within 3 months prior to dosing

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to 58 days
Secondary outcomes:
measure: Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram
timeFrame: 17 days
measure: Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram
timeFrame: up to 58 days
Other outcomes:
Locations:
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01349556: Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream
Official title: Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Reaction
Keywords: cancer
chemotherapy
EGFR inhibitors
tretinoin
EGFRi drug rash
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib.

Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash.

Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or over
* Scheduled to begin treatment with an EGFR inhibitor drug

Exclusion Criteria:

* Pregnant or nursing
* History of bleeding disorder
* History of keloids or large, thick, puffy-looking scars in the last 10 years
* Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)

Primary outcomes:
measure: EGFRi rash severity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Dermatology
name: Anna L Chien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577109: A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.
Official title: An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2007-12-19
Enrollment: 0
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 single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* colorectal cancer;
* advanced or recurrent disease;
* \>=1 measurable lesion;
* \>=6 months since prior adjuvant therapy, and \>=4 weeks since prior radiotherapy.

Exclusion Criteria:

* previous treatment for colorectal cancer;
* significant history of cardiac disease in past 6 months;
* other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Objective response rate, rate of resection of hepatic metastases, overall survival.
timeFrame: Event driven
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04763109: Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Official title: Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurofibromatosis Type 1
Keywords: Pediatric
Neurofibromatosis Type 1
magnetic resonance imaging
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single arm pilot trial of a novel whole-body Magnetic Resonance Imaging paired with artificial intelligence intervention, to evaluate feasibility defined as scan-rescan reliability, and to estimate the positive predictive value of changes in Magnetic Resonance Imaging scans from baseline to 12-month visit using an Artificial Intelligence algorithm, among 15 pediatric patients with neurofibromatosis type 1 at Cedars-Sinai Medical Center.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 5 and \<18 years at the start of study. If subject will turn 18 during the study, they will be allowed to enroll.
* Clinically or molecularly confirmed diagnosis of NF-1. Subjects with mosaic/segmental NF-1 also qualify for the study.

Exclusion Criteria:

* Requiring sedation for imaging.
* Implants and/or Devices: Mechanical, magnetic or electrical activated implants; Ferromagnetic implants and foreign bodies
* Claustrophobia, problems being in enclosed spaces, or inability to lie facing upwards.
* Allergy to animal dander or animal-instigated asthma.

Primary outcomes:
measure: For scan re-scan reliability, utilize T2 imaging to evaluate the agreement between the baseline scan and the 1 Month scan, which is performed within 4 weeks of the baseline scan.
timeFrame: From Baseline to within 4 weeks of baseline
Secondary outcomes:
measure: For change over time, the initial scan imaging using T1 and apparent diffusion coefficient (ACD) imaging, the baseline scan will be compared to the third scan, which is performed 12 months (+/- 3 months) after the baseline scan.
timeFrame: From Baseline to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Nicole Baca, MD
role: PRINCIPAL_INVESTIGATOR
References: