louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05441189: Precise Gene Signature for Predicting Outcomes in PDAC
Official title: Gene Signature Developed Using Machine Learning for Precise Prediction of Relapse and Survival in Resected Stage I-II Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC)
Precise Prognostic and Predictive Signature
Lead sponsor: The Fourth Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators enrolled two independent cohorts of consecutive patients with incident, primary, microscopically-confirmed stage I-II PDAC undergoing radical R0 resection only. For the training cohort, data were retrieved for 30 patients undergoing resection between March 2015 and December 2016 at Chinese PLA General Hospital in Beijing, China. Patients who did not relapse or die within 1 year after resection had follow-up of at least 1 year. The investigators also included 40 patients from The Cancer Genome Atlas (TCGA) database (https://www.cancer.gov/about-nci/organization/ccg/research/structural-genomics/tcga) as the validation cohort, with the same criteria as above; they were diagnosed between January 2010 and December 2013.

Brief summary: The current TNM staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC). Tumor mutation and copy number variation (CNV) markers may have a higher predictive value. In this study, whole exosome sequencing was performed for patients with stage I-II PDAC undergoing R0 resection. The investigators aimed to identify genes with discrepant statuses of mutations or CNVs between patients with and without relapse within 1 year after R0 resection, and then to construct a support vector machine (SVM)-based prognostic classifier (the SVM signature) for PDAC using machine learning; the investigators then aimed to further validate the SVM signature in an independent cohort.


Eligibility criteria: Inclusion Criteria:

* Availability of hematoxylin and eosin slides with invasive tumor components
* Availability of clinicopathologic characteristics and follow-up data
* No previous history of cancer

Exclusion Criteria:

* No formalin-fixed, paraffin-embedded (FFPE) tumor sample of primary tumor
* Receipt of any neoadjuvant and/or adjuvant cancer-directed therapy
* Survival time \<3 months after resection

Primary outcomes:
measure: Disease-free survival
timeFrame: 3-year
measure: Overall survival
timeFrame: 3-year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT05893589: The Impact of the Social Cognitive Theory Based Educational Program on Women-headed Households' Social Health : A Field Trial
Official title: The Impact of the Social Cognitive Theory Based Educational Program on Women-headed Households' Social Health : A Field Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Behavior
Health Behavior
Lead sponsor: Gonabad University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this field trial was to compare in emale-headed households. The main question it aims to answer are:

determine the effect of education based on social cognitive theory on the social health of female-headed households in female-headed households in Gonabad.

Women in the intervention group participated in face-to-face and virtual meetings based on social cognitive theory structures for 4 weeks. The control group did not receive any training related to the intervention.


Eligibility criteria: Inclusion Criteria:

* Informed consent to participate in the study, being the head of the household, age range from 20 to 64 years, ability to speak and listen, reading and writing literacy, access to a mobile phone with Android operating system to receive educational messages (access to the Internet and virtual networks) or Having access to a person who will help him in using virtual networks, not suffering from acute diseases and hospitalization during the intervention.

Exclusion Criteria:

* Dissatisfaction to continue cooperation, not completing the questionnaire completely

Primary outcomes:
measure: social health
timeFrame: before
measure: social health
timeFrame: After 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Neyshabur
country: Iran, Islamic Republic of
facility: A;ian
state: Khorasan Razavi
Study officials:
References:
Clinical trial NCT05542589: Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing
Official title: Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Phenytoin
phonophoresis
pressure ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of phenytoin phonophoresis on pressure ulcer healing

Detailed description: The purpose of the study is to evaluate the therapeutic effect of phenytoin phonophoresis on the healing of pressure ulcers.

Subjects: Forty patients suffering from pressure ulcers will be randomly divided into two equal groups each one has 20 patients, they will be selected from Al Kaser Al Aini. In this study, the patients will be randomly assigned into two equal groups (20 patients for each group) and will receive the treatment program three sessions per week for 6 weeks as a total period of treatment.

Phenytoin phonophoresis group (Study group): This group includes 20 patients with pressure ulcers who will receive topical phenytoin with ultrasound in addition to their conventional treatment.

Phenytoin phonophoresis group (Control group): This group will include 20 patients with pressure ulcers who will receive phenytoin with a placebo ultrasound.

Equipment and tools:

Measurement equipment: Saline injection method. Therapeutic equipment: Ultrasonic device, topical phenytoin, and hydrogel sheet.

Eligibility criteria: Inclusion Criteria:

Ages range from 40 to 60 years, both genders, patients with pressure ulcers, and patients who will sign their informed consent.

Exclusion Criteria:

Patients with a history of hypersensitivity to phenytoin, pneumonia, immune deficiency, infection, advanced diabetic patients, radiotherapy in the ulcer area, osteomyelitis in the ulcer area, venous ulcers, burn wounds, leprosy trophic ulcers, traumatic wounds, pregnant subjects, terminally ill subjects, and the use of antineoplastic agents or systemic glucocorticosteroids.

Primary outcomes:
measure: Change in wound volume
timeFrame: Baseline and six weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaimaa Mohamed Ahmed Elsayeh
state: New Cairo
Study officials:
affiliation: Cairo University
name: Shaimaa MA Elsayeh, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00406289: Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor
Official title: Phase I Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) With Patients With Head and Neck Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Tumor
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Head and neck tumor
* Aged \> 18 years

Primary outcomes:
measure: Tumor recurrences
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02835989: Community Paramedicine at Home
Official title: Community Paramedicine at Home (CP @Home)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Diabetes Mellitus
Accidental Falls
Social Isolation
Food Insecurity
Keywords: Community Paramedicine
Paramedic
Emergency Medical Services
High Frequency Callers
Lift Assists
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 2826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Community Paramedicine @Home (CP@Home) is a novel community paramedicine health assessment program for high users of Emergency Medical Services (EMS). Individuals who have been identified as active callers to EMS, individuals who have called EMS for lift-assists, and direct paramedic referrals are referred into the community paramedicine home visit program. The program will focus on in-home chronic disease management, community health service connections, and EMS usage education. Aside from chronic disease management, aspects of the program include health-related quality of life, social isolation and other social determinants of health. Participants in the program will have up to 3 one-on-one home visits from a community paramedic to ultimately reduce repeat EMS calls and improve their overall health.


Eligibility criteria: Inclusion Criteria:

* 3 or more EMS calls in the last 6 months from intervention start date AND active caller in the last 30 days OR
* Any call for a lift assist to EMS in the past 30 days OR
* Paramedic referral into program (identified by paramedic through usual practice)

Exclusion Criteria:

* Individuals living in long term care facilities
* Individuals currently involved in a home visit or social navigator program

Primary outcomes:
measure: Change in number of repeat EMS calls
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Change in number of ED presentations
timeFrame: Baseline and 1 year
measure: Change in number of hospital admissions
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Gina Agarwal, MBBS MRCGP CCFP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal G, Pirrie M, McLeod B, Angeles R, Tavares W, Marzanek F, Thabane L. Rationale and methods of an Evaluation of the Effectiveness of the Community Paramedicine at Home (CP@home) program for frequent users of emergency medical services in multiple Ontario regions: a study protocol for a randomized controlled trial. Trials. 2019 Jan 23;20(1):75. doi: 10.1186/s13063-018-3107-4.
Clinical trial NCT02460289: Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia
Official title: Multicenter, Open Label Clinical Trial to Evaluate the Effect and Tolerability of Minoxidil 5% Foam and Botanical Hair Solution Regimen in Men With Thinning Hair and Male Pattern of Hair Loss/Androgenic Alopecia (Norwood III & IV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Pattern of Hair Loss, Androgenic Alopecia
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic alopecia (Norwood III \& IV).


Eligibility criteria: Key Inclusion Criteria:

1. Male patients age 18 to 60 years at the time of enrollment.
2. Men who have self-perceived thinning hair.
3. Men who have presentation of male pattern hair loss/androgenic alopecia (Norwood III \& IV).

Key Exclusion Criteria:

1. History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
2. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.

3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.

4. Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.

Primary outcomes:
measure: Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12
timeFrame: At Week 12
measure: Change From Baseline in Participant Rating at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Mean Change From Baseline in Shed Hair Count
timeFrame: At Week 12
measure: Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire
timeFrame: At Week 4,6 and 12
Other outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From start of study up to Week 12
Locations:
city: Richardson
country: United States
facility: Stephens & Associates
state: Texas
Study officials:
affiliation: Galderma R&D
name: Warren Winkelman, MD, PhD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02172989: Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.
Official title: Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Breast Neoplasm
Keywords: Near-infrared fluorescence
Indocyanine green, ICG
Radio-guided surgery
breast cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2014-06-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.

Brief summary: Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Detailed description: Indocyanine green, ICG (ICG-fluorescence)

* ICG is the most commonly used fluorophore which approve by FDA.
* NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
* Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

* New method for the localization and resection of non-palpable breast lesions.
* The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Eligibility criteria: Inclusion Criteria:

* nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.
* patients who need breast biopsy as treatment for breast cancer.
* Eastern Cooperative Oncology Group Performance status 0 or 1
* consented patients with more than 20 years, less than 70 years

Exclusion Criteria:

* nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer.
* pregnancy
* history of severe allergy to ICG(Indocyanine Green)
* iode hypersensitiveness

Primary outcomes:
measure: non-palpable lesion localization rate
timeFrame: up to 6month
Secondary outcomes:
measure: lesion of resection size, completeness of resection
timeFrame: up to 6month
Other outcomes:
measure: physical assess
timeFrame: following up a week to 6 month
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: So-Youn Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05433389: App Delivered Brief Mindfulness Intervention for Surgical Patients
Official title: App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain
Anxiety State
Depressive State
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 823
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: This will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥18,
* Scheduled to undergo total joint arthroplasty of the knee or hip

Exclusion Criteria:

* Inability to read English
* Cognitive impairment preventing completion of study procedures

Primary outcomes:
measure: Change in Pain Unpleasantness
timeFrame: Immediately before to after 5-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity
timeFrame: Immediately before to after 5-minute audio recording
measure: Change in Pain Medication Desire
timeFrame: Immediately before to after 5-minute audio recording
Other outcomes:
measure: Change in Anxiety
timeFrame: Immediately before to after 5-minute audio recording
measure: Change in Depression
timeFrame: Immediately before to after 5-minute audio recording
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
timeFrame: During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT05009589: HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms
Official title: HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-08-17
Enrollment: 552
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include participants identified at pre-planned screening events for cardiovascular disease who provide informed consent.

Brief summary: This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease.


Eligibility criteria: Key Eligibility Criteria:

1. at least 50 years of age on the day of the screening event
2. informed of the nature of the study, agrees to its provisions, and has provided written informed consent
3. does not have any conditions that would interfere with obtaining an echocardiogram of the heart

Primary outcomes:
measure: Abnormal structural heart findings
timeFrame: 30 days
measure: Abnormal electrocardiography findings
timeFrame: 30 days
measure: Risk factors associated with cardiovascular disease
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Lifewellness Institute
state: California
Study officials:
affiliation: Lifewellness Institute, San Diego, CA
name: E. Lee Rice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02997189: Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
Official title: A Multicenter, Randomized, Phase 2 Study to Assess the Feasibility, Safety and Efficacy of OTO-104 Given by Intratympanic Administration in Subjects at Risk for Ototoxicity From Cisplatin Chemotherapy Regimens in the Treatment of Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cisplatin Induced Hearing Loss
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.


Eligibility criteria: Inclusion Criteria:

* Subject is aged 6 months to 21 years inclusive.
* Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin.
* Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m2.
* Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000 Hz, in both ears and does not have a history of sensorineural hearing loss.

Exclusion Criteria:

* Subject has middle ear effusion upon clinical examination.
* Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study.
* Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
* Subject is currently participating on a separate otoprotection clinical study.

Primary outcomes:
measure: Feasibility assessed via a questionnaire
timeFrame: Up to 18 weeks
Secondary outcomes:
measure: Hearing function in each ear according to SIOP-Boston Ototoxicity Scale
timeFrame: Up to 6 months
measure: Safety as assessed by adverse events
timeFrame: Up to 6 months
measure: Local tolerability as assessed by otoscopic examinations
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Contact Otonomy call center for trial locations
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Kathie Bishop, PhD
role: STUDY_CHAIR
References:
citation: Fernandez R, Harrop-Jones A, Wang X, Dellamary L, LeBel C, Piu F. The Sustained-Exposure Dexamethasone Formulation OTO-104 Offers Effective Protection against Cisplatin-Induced Hearing Loss. Audiol Neurootol. 2016;21(1):22-9. doi: 10.1159/000441833. Epub 2016 Jan 21.