louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04906369: Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring
Official title: Optimizing Treatment of Metastatic Breast Cancer Through Real-Time Disease Monitoring
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Mayo Clinic Cancer Center that are undergoing treatment for stage IV breast cancer.

Brief summary: This study evaluates if blood tests can detect changes in disease status during treatment for stage IV breast cancer. Information from this study may help researchers learn more about metastatic breast cancer and how to optimize treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To identify subtype-specific signatures for breast cancer using genomic positioning of plasma deoxyribonucleic acid (DNA) fragments.

II. To validate changes in circulating tumor-derived DNA (ctDNA) levels as a biomarker for treatment monitoring in patients with metastatic breast cancer.

OUTLINE:

Patients undergo collection of blood samples at baseline, 2 weeks after the start of treatment, and at the beginning of each new treatment cycle.

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years of age
* Stage IV breast cancer undergoing cancer treatment

Exclusion Criteria:

* Stage I-III breast cancer
* Unwilling or unable to give consent
* Patients with a prior or concurrent malignancy, excluding non-melanoma skin cancers and non-invasive cancers whose natural history or treatment does not have the potential to interfere with the assessment of the investigational marker

Primary outcomes:
measure: Identification of patients with high circulating tumor-derived deoxyribonucleic acid (ctDNA) fractions (> 50%)
timeFrame: Up to 1 year
measure: Detection of treatment failure
timeFrame: Up to 1 year
Secondary outcomes:
measure: Correlation of shallow whole genome sequencing circulating tumor-derived DNA analysis results with available serologic tumor biomarkers used as a standard in clinical practice
timeFrame: Up to 1 year
Other outcomes:
measure: Evaluation of immunity to target antigens and neoantitopes in metastatic breast cancer
timeFrame: Up to 1 year
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Brenda J. Ernst, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06605469: Ejaculatory and Orgasmic Dysfunction Registry
Official title: Ejaculatory and Orgasmic Dysfunction Registry (Climax Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ejaculatory Dysfunction
Premature Ejaculation
Delayed Ejaculation
Anorgasmia
Anejaculation
Dysejaculation
Dysorgasmia
Keywords: ejaculatory dysfunction
premature ejaculation
delayed ejaculation
anorgasmia
anejaculation
dysejaculation
dysorgasmia
Lead sponsor: Charitable Union for the Research and Education of Peyronie's Disease
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 500
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: Adult men (\>18) diagnosed with ejaculatory and/or orgasmic dysfunction who were recommended to begin any treatment for the condition

For partners, inclusion is being a sexual partner of a man with ejaculatory and/or orgasmic dysfunction who is receiving treatment

Brief summary: The goal of this observational study is to evaluate the safety and efficacy of various therapies used to treat ejaculatory and/or orgasmic dysfunctions in men. The objective is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction.

Participants will submit questionnaires about their diagnosis and treatment efficacy and multiple time intervals.

Detailed description: The objective of the current study is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction. To accomplish this registry, CURE PD has partnered with the Sexual Medicine Society of North America (SMSNA) to help inform sexual medicine providers of the existence of the study and to help encourage patients to enroll.

Subjects meeting criteria will be offered study entry by their local provider who will refer them to an email address to indicate their interest. Participants will then be administered questionnaires at baseline and every 3 months x 1 year, followed by every 6 months x 2 years. Patient partners will also be allowed to enroll and will receive questionnaires on the same schedule (baseline, q3 months x 1 year, q6 months x 2 years).

Eligibility criteria: Inclusion Criteria:

* Men being treated for either ejaculatory and/or orgasmic dysfunction
* For partners, inclusion is being a sexual partner of a man with ejaculatory and/or orgasmic dysfunction who is receiving treatment

Exclusion Criteria:

* None

Primary outcomes:
measure: Primary Objective
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orem
country: United States
facility: The Male Fertility and Peyronie's Clinic
state: Utah
Study officials:
References:
Clinical trial NCT05900869: Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia
Official title: Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plastic Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on a reduction nymphoplasty, for uni or bilateral labia minora hypertrophy

Brief summary: Reduction nymphoplasty is the treatment of benign hyperplasia of the labia minora. This surgery is indicated in the event of functional, aesthetic or sexual discomfort. There has been a growing demand for this surgery over the past twenty years. It is necessary to remain vigilant because a request for cosmetic surgery can also be part of an obsession with body dysmorphism, former dysmorphophobia.

Investigators wish to study the postoperative results concerning sexuality, self-esteem and obsession with body dysmorphia in a cohort of patients followed prospectively and at more than 3 years postoperatively.


Eligibility criteria: Inclusion Criteria:

Patients informed of the objectives of the study and its progress,

Exclusion Criteria:

Patients in a period of exclusion determined by another study. Patients under judicial safeguard, guardianship or curatorship. Patients for whom it is impossible to give informed information.

Primary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: Change from Baseline 3 yers after surgery
Secondary outcomes:
measure: Body Esteem Scale (BES)
timeFrame: Change from Baseline 3 yers after surgery
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Jenifer SALERNO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232869: A Study of the SMART Stent in the Treatment SFA Disease.
Official title: A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 93
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.

Detailed description: This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and delivery system as compared to the uncoated SMART™ stent and delivery system. It is anticipated that a total of 90 patients will be entered into the study. Patients will be randomized on a 1:1 basis of coated to uncoated stents.

Ninety (90) patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART™ nitinol self-expanding stent or to the uncoated (bare) SMART™ stent.

Patients will be followed for 24 months post-procedure, with all patients having duplex ultrasound and clinical assessments at discharge, 1, 6, 9, 18 and 24 months, angiography at 6 six months and plain X-ray at 18 months. This study will be conducted at nine investigational sites. (Protocol was amended where 56 additional patients were recruited and followed for up to 5 years.)

Eligibility criteria: Inclusion Criteria:

1. One superficial femoral artery presenting \> 70% stenosis(es) or total occlusion
2. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)

Exclusion Criteria:

1. Tissue loss due to ischemic disease (Rutherford category 5 or 6).
2. Tandem lesion requiring non overlapping stents;

Primary outcomes:
measure: In-stent mean lumen diameter percent stenosis via quantitative angiography.
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital
Study officials:
affiliation: Tübingen - Germany
name: Stephan H Duda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006 Dec;13(6):701-10. doi: 10.1583/05-1704.1.
Clinical trial NCT02916069: Multi Modal Brain Monitoring and Cardiac Surgery
Official title: The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Neurophysiological Monitoring
Keywords: Spectroscopy
Transcranial Doppler
Bispectral index
Cardiac surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.

Detailed description: The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery with cardiopulmonary bypass
* Valve replacement
* Coronary artery bypass

Exclusion Criteria:

* Emergency surgery
* Hepatic
* Renal impairment
* Diabetes Mellitus

Primary outcomes:
measure: S100 protein
timeFrame: up to 24 hours
Secondary outcomes:
measure: Mini-mental state examination
timeFrame: up to 30 days after surgery
measure: Western perioperative neurological scale
timeFrame: up to 30 days after surgery
measure: Major neurological out come as stoke
timeFrame: up to 30 days after surgery
measure: Duration of mechanical ventilation
timeFrame: up to 30 days after surgery
measure: Hospital stay
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine Assiut University
Study officials:
affiliation: associate professor of anesthesia and critical care
name: Mohamed Ali, PhD. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00426569: Normal Paranasal Sinuses Microflora Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paranasal Sinuses
Flora
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults undergoing orthognatic procedure

Brief summary: The purpose of this study is to check if bacterial and fungal flora exists in healthy paranasal sinuses, and whether it is identical to the flora of nasal cavity.

We plan to harvest tiny examples of maxillary sinus and nasal mucosa for tissue cultures during the orthognathic procedures involving maxillary remodeling.


Eligibility criteria: Inclusion Criteria:

* Necessity of maxillary sinus opening during orthognathic surgery
* Negative history of chronic rhinitis or chronic sinusitis
* Informed concent

Exclusion Criteria:

* Recent(1 month or less before the operation) event of acute sinusitis or other disease leading to nasal discharge
* Recent(1 month or less before the operation) antibacterial or antifungal parenteral treatment

Primary outcomes:
measure: presence of bacteria in normal paranasal sinuses
timeFrame: at time of orthgnatic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Sheba Medical Center, Israel
name: Arkadi Yakirevitch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05271669: COVID-19 Immunity and Changes Over Time
Official title: Patterns of SARS-CoV-2 Immunity At Household Level and Their Changes Over Time
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19
Keywords: serology
cohort study
SARS-CoV-2 antibody
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults of households enrolling in a population cohort covering residents from all 18 districts in Hong Kong.

Brief summary: The risk of household spread of SARS-CoV-2 hinges on both the transmission dynamics of the virus circulating in the community as well as the seroprotection pattern of constituent members, which can be attributed to vaccination and previous infections. This study is conceptualised to assess the dynamicity of SARS-CoV-2 risk at the household level, through monitoring the pattern of seroprotection, in conjunction with the vaccination coverage, history of infection and exposure risk in the setting of Hong Kong.

Detailed description: The aim of this study is to assess the SARS-CoV-2 risk at the household level, with the objectives of (a) determining the coverage of vaccination and its changes over time; (b) monitoring pattern of exposure and history of infection; and (c) evaluating the level of seroprotection and its longitudinal trend.

A cohort of households comprising 900 persons would be recruited. Invited participants would be attend the Research Centre for blood sampling and the completion of a simple questionnaire at 3 different timepoints at 12-18 months apart. A questionnaire would be administered to capture the following characteristics: (a) Socio-demographics; (b) History of SARS-CoV-2 infection; (c) adoption of precautionary measures; (d) SARS-CoV-2 testing history and (e) SARS-CoV-2 vaccination uptake.

Participants would be tested for SARS-CoV-2 serology. The main markers for measurement are nucleocapsid antibody for inferring past infection, spike antibody for the immunological responses, and seroprotection by SARS-CoV-2 surrogate virus neutralisation test.

Eligibility criteria: Inclusion Criteria:

* adults of age 18 or above, or children under the age of 18 with informed consent of the legal guardian
* normally residing in Hong Kong
* could communicate in spoken and written Chinese and/or English

Exclusion Criteria:

* individuals with mental illness
* prisoners

Primary outcomes:
measure: Proportion of participants with COVID-19 protective immunity
timeFrame: 1 year
measure: Proportion of participants with marker of past COVID-19 infection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Shui Shan Lee
state: Hong Kong
Study officials:
References:
Clinical trial NCT01250769: Evaluating the Effect of Tooth Cleaning Devices on Oral Health
Official title: Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Keywords: dental
dentist
plaque
IP Cleaning
Lead sponsor: Philips Oral Healthcare
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.


Eligibility criteria: Inclusion Criteria:

* are in good/excellent health;
* are 18 - 70 years old;
* have a minimum of 20 natural teeth (excluding 3rd molars);
* have sufficient test sites;
* have ≥ 20 bleeding sites;
* are willing to participate and available for participation.

Exclusion Criteria:

* have systemic diseases such as Down's syndrome, or known AIDS/HIV;
* have insulin dependant Diabetes;
* are pregnant or nursing by subject report;
* have a cardiac pacemaker
* are undergoing or require extensive dental or orthodontic treatment;
* require antibiotic treatment for dental appointments;
* have heavy deposits of calculus;
* have severe gingivitis or periodontitis;
* have extensive crown or bridge work and/or rampant decay;
* currently use bleaching trays;
* have any oral or extraoral piercing on lips or in mouth;
* have a professional prophylaxis within 4 weeks of study;
* participation in a prior study ≤ 20 days;
* employed by a oral healthcare products company or research institution.

Primary outcomes:
measure: Residual Protein Concentration
timeFrame: 14 days
Secondary outcomes:
measure: Residual Protein Concentration
timeFrame: 28 days
measure: Modified Gingival Index
timeFrame: 14 days
measure: Modified Gingival Index
timeFrame: 28 days
measure: Gingival Bleeding Index
timeFrame: 14 days
measure: Gingival Bleeding Index
timeFrame: 28 days
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: University Park Research Center
state: Indiana
Study officials:
affiliation: POHC
name: Wendy Jenkins
role: STUDY_DIRECTOR
References:
Clinical trial NCT04959669: Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain
Official title: Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Back Pain
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 210
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: Low back pain is a common health problem where over than half a billion people worldwide suffers from it. In Malaysia, back pain is among the top ten reasons why people see a doctor. Although there are many guidelines available, healthcare professionals still find managing low back pain as challenging.

The Decision Support System for Low Back Pain (DeSSBack) has been developed by adopting and re-packaging STaRT system, incorporate with the local clinical practice guidelines and feedback from local experts. It aims to aid healthcare professionals in managing low back pain through a stratified approach.

The objective of the study is to evaluate the effectiveness of DeSSBack in improving the management of patients with low back pain in a primary care clinic. We hypothesise that the implementation of DeSSBack will improve the outcomes of low back pain patients including quality of life, emotional state and level of pain.

This study protocol presents the rationale and design of a cluster randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Patient seeking care for low back pain at the primary care clinic in UMMC
* Male and female
* Age 18 years and above
* Can understand Malay and English

Exclusion Criteria:

* Potentially serious pathology (eg: cauda equina compression, inflammatory arthritis, malignancy and etc)
* Serious co morbidity
* Psychiatric illness or personality disorder
* Spinal surgery in the last 6 months
* Pregnant
* Already receiving treatment other than primary care for this episode of back pain
* Inability to attend regular physiotherapy appointments.

Primary outcomes:
measure: Changes in health status measure for low back pain between baseline and 2-month
timeFrame: Baseline, 2-months
measure: Changes in health status measure for low back pain between baseline and 6-month
timeFrame: Baseline, 6-months
Secondary outcomes:
measure: Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 2-month
timeFrame: Baseline, 2-months
measure: Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 6-month
timeFrame: Baseline, 6-months
measure: Changes in the back pain severity score between baseline and 2-month
timeFrame: Baseline, 2-months
measure: Changes in the back pain severity score between baseline and 6-month
timeFrame: Baseline, 6-months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
Study officials:
References: