louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06187532: Carotid Plaque-Burden Scale and Outcomes. A Real Life Study
Official title: Carotid Plaque-Burden Scale and Outcomes. Improvements in Risk Stratification for Future Cardiovascular Disease by Adding to SCORE2. A Real Life Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atheroscleroses, Cerebral
Carotid Plaque
Keywords: carotid ultrasound.
Carotid plaque-burden
atheroscleroses events prediction
Lead sponsor: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a major vascular risk factor, hypertension, diabetes or hypercholesterolemia, from vascular risk office at the Hospital Universitario San Pedro de Alcántara, Cáceres, Spain

Brief summary: Carotid ultrasonography has been proposed as a tool for prediction of future cardiovascular disease (CVD). Nevertheless, its role in clinical practice remains controversial.

Methods: The investigators analyse the incidence of CVD and mortality in a cohort of 1004 participants without preexisting CVD according to a simple plaque scale recorded in different segments of the carotid artery assess by ultrasound. A prognostic tool for CV events was development adding Carotid Plaque-Burden (CPB) scale to the Systematic COronary Risk Evaluation (SCORE2) table (CPB- SCORE2 scale).

Detailed description: Based in number of plaques and stenosis a simple plaque scale was recorded in different segments of carotid artery, involving a cohort of 1004 participants with vascular risk factors. Outcomes were recorded during 14 years. A prognostic tool for CV events was development adding simple Carotid Plaque-Burden (CPB) scale to the SCORE2 table (CPB- SCORE2 scale).

Eligibility criteria: Inclusion Criteria:

* Any of these vascular risk factors: Total cholesterol \>200 mg/dL, hypertension, or diabetes, or receiving medication for them
* No cardiovascular disease: coronary, cerebral o peripheral arterial disease.

Exclusion Criteria:

* Associated conditions: cancer, heart failure, chronic obstructive disease, renal insufficiency, neurodegenerative diseases, rheumatic diseases or chronic infections.
* Neck anatomical barriers to perform ultrasound.
* Enrolled in a clinical trial.
* Attend \<70% of regular appointments

Primary outcomes:
measure: Differences in rates of major adverse cardiovascular events (MACE)
timeFrame: 12 year follow-up
measure: Differences in rates of all-cause death
timeFrame: 12 year follow-up
Secondary outcomes:
measure: Diagnostic value of Carotid Plaque-Burden-Systematic COronary Risk EvaluationSystematic COronary Risk Evaluation2 (CPB-SCORE2) table compared to Systematic COronary Risk Evaluation2 (SCORE2) for MACE
timeFrame: 12 year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Extremadura
name: JUAN SANCHEZ M-TORRERO, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05264532: Usefulness of Video-Based Intervention in Helping Participants Encourage Their Families to Get Tested for BRCA Gene Mutations
Official title: BRCAShare: Video Intervention for Relatives of BRCA Mutation-Positive Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: BRCA1 Gene Mutation
BRCA2 Gene Mutation
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial studies how well a video-based intervention works in helping participants encourage their families to get tested for BRCA gene mutations. Testing in families with BRCA gene mutations can allow for risk management and reduction with the overall goal of reducing cancer burden. Video-based intervention sent via text messages may help participants easily share information about BRCA gene mutations with family members.

Detailed description: PRIMARY OBJECTIVES:

I. To understand whether the use of a video-based message to encourage cascade testing, delivered via short message service (SMS) (text message) or shared on social media, is superior to a written message as a method of information-sharing among families that have BRCA gene mutations.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants receive a 2-minute information-graphic video via text message consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives that they can share with family via text message, email, or social media.

ARM B: Participants receive family letter via U.S. postal service mail consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives.

Eligibility criteria: Inclusion Criteria:

* Individuals who test positive for mutations in BRCA1 or BRCA2 are eligible for this study
* Family members who receive the video message/family letter will be invited to participate

Primary outcomes:
measure: Impact of a web-based video delivered via text message or shared on social media on information sharing among relatives belonging to families with BRCA gene mutations
timeFrame: Up to 3 years
measure: Impact of participant-reported family dynamics on information sharing
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Leigha Senter, LGC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579032: Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.
Official title: Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
CHRONIC RENAL FAILURE
Left Ventricular Hypertrophy
Keywords: CKD,
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD patients

Brief summary: The aims of the presented study are as follows:

1. To evaluate the endothelial function and arterial stiffness in a large cohort of prevalent CKD patients by means of non-invasive applantion tonometry.
2. To evaluate the association between the serum levels of the representatives of the various classes of uremic toxins and markers of endothelial function and arterial stiffness.
3. To evaluate the association between markers of inflammation and oxidative stress and markers of endothelial function and arterial stiffness.
4. To evaluate the association between echocardiographic parameters and markers of arterial stiffness


Eligibility criteria: Inclusion Criteria:

* Age: 18-60
* Chronic kidney disease: according to the K-DOQI guidelines ( kidney damage ≥ three months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either: pathological abnormalities; or markers of kidney damage, including damage in the composition of blood or urine test, or abnormalities in imaging tests; GFR\< 60 ml/min/1.73m² for ≥ three months, with or without kidney damage)
* Written informed consent

Exclusion Criteria:

* major illnesses( life expectancy of \< 1 year)
* history of atrial fibrillation
* history of myocardial infarction, unstable angina, congestive heart failure, peripheral vascular diasease ,cerebrovascular disease, diabetes

(nonechogenic)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT05042232: A Prospective Virtual Study of Patient Reported Behaviors and Health Outcomes in Individuals With COVID-19
Official title: Assessing Behavioral, Functional, and Clinical Patient-Reported Outcomes (PROs) in Subjects Diagnosed With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Acute Respiratory Disease
Lead sponsor: Everly Health
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have valid COVID-19 test results.

Brief summary: The primary objective of this study is to identify and describe patient behaviors and clinical outcomes among patients who have tested positive for mild to moderate COVID-19.

Detailed description: This virtual observational cohort study will describe patient behaviors and clinical outcomes of subjects who tested positive for COVID-19. Among those with positive tests, predictors of time to recovery, post-COVID function and outcomes will be identified. Individuals who test negative and positive for SARS-CoV-2 will be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* Individuals with a valid diagnostic COVID-19 test result

Exclusion Criteria:

- Unable or unwilling to provide informed consent

Primary outcomes:
measure: To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19
timeFrame: Up to 12 months
Secondary outcomes:
measure: To describe recovery in patients with test-confirmed COVID-19 infection including time to recovery and functional improvement
timeFrame: Up to 12 months
measure: To develop prediction tools for time to recovery, function and outcomes in patients with COVID-19 identified by home testing
timeFrame: Up to 12 months
measure: To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity
timeFrame: Up to 12 months
measure: To describe the feasibility of COVID-19 home testing
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Everlywell, Inc
state: Texas
Study officials:
affiliation: Everly Health
name: Timothy Bauer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05005832: Influence of Walking Pilgrimage on Changes in Body Composition, Biochemical Parameters, Circulatory and Respiratory Efficiency and Foot Biomechanics in Healthy Women and Men of All Ages.
Official title: Influence of Walking Pilgrimage on Changes in Body Composition, Biochemical Parameters, Circulatory and Respiratory Efficiency and Foot Biomechanics in Healthy Women and Men of All Ages.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Health Behavior
Foot Injuries and Disorders
Skin Condition
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People taking part in a walking pilgrimage from Biała Podlaska to Częstochowa (Poland) over a distance of approximately 350 kilometres and a duration of approximately 14 days in August 2021

Brief summary: The aim of the study is to assess the health habits and changes in body composition and exercise capacity as well as blood biochemical parameters of people participating in 14-21-day walking pilgrimages. This type of physical activity can be classified as long-term and multi-stage hiking tours. Among the people participating in the pilgrimage, a significant part of the population are people aged\> 50 years. Moderate physical activity is an important pro-health element, however, it has not been determined yet how long and accumulated activity may affect the health of pilgrims. Suddenly taking up activity and the challenge of walking several hundred kilometres may be a heavy burden for the body, and its effects may have a negative impact on the body. The evaluation of the processes taking place in the body under the influence of this type of physical activity, motivated by religious goals, will expand the scope of knowledge about safety as well as health indications and contraindications for this type of activity. It will also allow identifying adaptive changes and their effects


Eligibility criteria: Inclusion Criteria:

women and men aged 18-65

BMI (body mass index) at the level of 18-39

Exclusion Criteria:

Chronic diseases Musculoskeletal injuries Mental disorders Surgery or hospitalization in the last year before the start of the study Pregnancy

Primary outcomes:
measure: Systematic Coronary Risk Evaluation
timeFrame: 14-21 days
Secondary outcomes:
measure: Tiffeneau-Pinelli index
timeFrame: 14-21 days
measure: Clarke angle
timeFrame: 14-21 days
measure: Transepidermal water loss
timeFrame: 14-21 days
Other outcomes:
Locations:
city: Biała Podlaska
country: Poland
facility: Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Study officials:
References:
Clinical trial NCT01389232: The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Support and Repair
Lead sponsor: Sofregen Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 104
Sex: FEMALE
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 is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.


Eligibility criteria: Inclusion Criteria:

* Be female, greater or equal to 18 years of age
* Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
* Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon
* Be in good health other than breast pathology and be suited to general anesthesia and planned treatments

Exclusion Criteria:

* Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
* Have a known allergy to silk
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
* Have had a prior soft tissue support device implanted in the breast
* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Primary outcomes:
measure: Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
timeFrame: Month 6
Secondary outcomes:
measure: Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
timeFrame: Month 3, Month 12, Month 18, Month 24
measure: Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
timeFrame: Immediately Following Stage 1 Surgery
measure: Breast Anatomy Measurements
timeFrame: Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24
measure: Subject Satisfaction With Breasts on a 5-Point Scale
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
city: Munich
country: Germany
city: Milan
country: Italy
city: Barcelona
country: Spain
city: Nottingham
country: United Kingdom
Study officials:
References:
Clinical trial NCT00570232: UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Official title: Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Resectable, recurrent head and neck cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: OSI Pharmaceuticals
First posted: 2007-12-10
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.

Detailed description: An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.

Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
3. Prior radiation therapy for head and neck cancer
4. Disease must be considered surgically resectable or candidate for curative reirradiation
5. Adequate diagnostic workup
6. Zubrod Performance Status 0-2
7. Life expectancy 12 weeks
8. Age 19, 9. Adequate laboratory data.

Exclusion Criteria:

1. Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)
2. Patients who are pregnant or lactating
3. Psychological condition that renders the patient unable to understand the informed consent
4. Any situation or condition that will interfere with adherence to study activities.

Primary outcomes:
measure: Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
timeFrame: 12 - 24 months
measure: Percentage of Participants With Disease Free Status at 12 Months and 24 Months
timeFrame: 12 - 24 months
Secondary outcomes:
measure: Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
timeFrame: 12 - 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Eben Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06175832: PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
Official title: PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ovarian Stimulation
Quality of Life
Preimplantation Genetic Testing
Fertility Preservation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: P-CCROSS is a randomized, prospective monocentric phase 4 study with a crossover study design. The aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with IVF treatment with CFA (corifollitropin alfa) and PPOS (Progestin-Primed Ovarian Stimulation) versus conventional IVF treatment with a recombinant FSH/GnRH antagonist. The study will also compare patients undergoing elective fertility preservation versus PGT-A (pre-implantation genetic testing for aneuploidy) patients.The study will have a crossover design so that patients will receive both forms of treatment. The investigators will also compare the endocrine profile and ovarian response of CFA/PPOS versus rFSH/GnRH ovarian stimulation cycles.


Eligibility criteria: Inclusion Criteria:

* first ovarian stimulation cycle
* aged ≥ 18 and \< 41 years old at the time of first OPU
* Body Mass Index (BMI) ≥ 18 kg/m² and \< 32 kg/m²

Exclusion Criteria:

* contra-indication for ovarian stimulation
* expected poor ovarian response (Bologna Criteria)
* PCOS patients
* refusal to fill out questionnaires before, during and after treatment
* simultaneous participation in another clinical study
* untreated and uncontrolled thyroid dysfunction;
* current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy;
* pregnant or breastfeeding women. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Primary outcomes:
measure: Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05926232: Expanded Access for Repotrectinib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-03
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access designed to provide access to Repotrectinib for eligible participants.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: