louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03786458: Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients
Official title: Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Female Infertility
Keywords: Infertility
young female cancer patients
decision aids
fertility concerns
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 115
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to develop a patient-centered, user-center, interactive web-based decision aid to support the young women with cancer in making an informed fertility-related decision and further evaluate its efficacy.

Detailed description: This study uses mixed-method and involves 2 stages. As following the IPDAS recommendation for developing decision aids, the first sample of 25 young woman survivors with breast, hematology or ovarian cancer, and oncologist, fertility specialists or nurses will be interviewed to assess the fertility-related decision needs from and. The decision aid is then developed further process of evidence synthesis and multidisciplinary external review. After the draft being evaluated for its validity via Think-aloud cognitive interview method, field testing via one-group quasi-experimental design on 90 young women with newly diagnosed breast, hematology or ovarian cancer will be applied to test its outcomes of decision quality, emotional health and fertility concerns.

Eligibility criteria: Inclusion Criteria:

* Age between 20 to 44
* Have been diagnosed with breast, hematology or ovarian cancer, and will conduct cancer treatment, such as chemotherapy, hormonal or radiation.
* Willing to take questionnaire via computer and tablet.
* Ability to answer the questionnaire with functional emotion and cognition.
* Ability to read newspaper.
* Had been consulted and advised by Doctor on the ability of fertility, but have not decided to give birth to a baby.

Exclusion Criteria:

* Age below 20 or above 45.
* Had been diagnosed with stage 4 cancer.
* Do not require chemotherapy, hormonal or radiation therapy.
* Not able to read newspaper or do not access the internet.

Primary outcomes:
measure: Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei
Study officials:
affiliation: National Taiwan University Hospital
name: Wen-Fang Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03380858: REINFORCEMENT ANASTOMOSIS WITH Modified Cyanacrylate IN Patients Undergoing to Oncologic Colorectal Surgery With Colorectal Anastomosis
Official title: REINFORCEMENT ANASTOMOSIS IN ONCOLOGIC COLORECTAL SURGERY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 390
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: 390 consecutive patients undergoing colorectal resective surgery with intestinal anastomosis

Brief summary: In colorectal surgery about 30% of postoperative mortality is attributed to anastomotic leak, whit an incidence range between 1.8% and 15.9%. Preventing the anastomotic leak can therefore bring benefits to the patient and the health system. To date we have technologically advanced suturizers and the correct realization (well-vascularized margins, not in tension, etc.) remains crucial to prevent anastomotic dehiscence. Experimental results demonstrate that modified cyanacrylate is a suitable potential "reinforcement" on intestinal anastomoses (manual or linear intra-corporeal). Applied after mechanical anastomosis, it polymerizes in a short time, closing the spaces of the suture line between one point and the other, expressing an adhesive, hemostatic and sealing action on the tissues, also creating an effective antiseptic barrier towards of the most common infectious or pathogenic agents.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* patients undergoing to oncologic colorectal surgery with colorectal anastomosis

Exclusion Criteria:

* refuse informed consent
* patients undergoing to oncologic colorectal surgery without colorectal anastomosis

Primary outcomes:
measure: fistula incidence
timeFrame: From day of surgery up to 30 postoperative days
Secondary outcomes:
measure: anastomitic bleeding
timeFrame: From day of surgery up to 30 postoperative days
measure: infection
timeFrame: From day of surgery up to 30 postoperative days
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: IRCSS Pascale
Study officials:
References:
Clinical trial NCT03285958: Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit
Official title: Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 57
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Wearable, commercially-available physical activity monitors are being increasingly incorporated into chronic pain self-management interventions as a tool to help patients set goals and to tailor intervention content based on patient progress. Yet older adults from resource-challenged communities may face significant barriers to using these monitors and reporting activity data. Our pilot study will focus on wearable monitor use among older adults in Detroit with chronic musculoskeletal pain, testing the feasibility and validity of various technology-based strategies for reporting daily step count data. The study will also assess whether six weeks of monitor use is associated with improvements in functioning, relative to a control group.


Eligibility criteria: Inclusion Criteria:

* Age \> 60 years
* Ambulatory with or without assistive device
* Community living
* Have a SMS-capable cell phone
* Internet access (via smartphone, in-home or elsewhere);
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months)
* \>4 (0-10 scale) average pain level over last week
* \>1 day/previous 30 when pain made it difficult to do usual activities
* Ability to travel to study location in Detroit for a one-time session

Exclusion criteria:

* Serious acute illness or hospitalization in last month
* Planned surgery in next month
* Severe cognitive impairment

Primary outcomes:
measure: Change in Pain Interference
timeFrame: Baseline, eight weeks
measure: Adherence to Step Count Reporting - SMS
timeFrame: Two weeks
measure: Adherence to Step Count Reporting - IVR
timeFrame: two weeks
measure: Adherence to Step Count Reporting - Sync
timeFrame: two weeks
Secondary outcomes:
measure: Change in Physical Functioning
timeFrame: Baseline, eight weeks
measure: Change in Social Participation
timeFrame: Baseline, eight weeks
measure: Validity of Manually-reported Step Count Data - SMS
timeFrame: Two weeks
measure: Validity of Manually Reported Step Count Data - IVR
timeFrame: Two weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan School of Public Health
name: Mary Janevic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03293758: Food and Microbiome Longitudinal Investigation (FAMiLI)
Official title: Food and Microbiome Longitudinal Investigation (FAMiLI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Cardiovascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-26
Enrollment: 14000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects in the United States identified at NYU clinics, community organizations, and online participant databases.

Brief summary: The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease


Eligibility criteria: Inclusion Criteria:

* Age \> 40

Exclusion Criteria:

* Use of long term antibiotics.
* Pregnant

Primary outcomes:
measure: Demographic
timeFrame: 5 Years
Secondary outcomes:
measure: Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without.
timeFrame: 5 Years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jiyoung Ahn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05026658: Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study
Official title: A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digital Acuity Product
Lead sponsor: Visibly
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 358
Sex: ALL
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Visual acuity is the relative ability of the eye to resolve detail that is usually expressed as the reciprocal of the minimum angular separation in minutes of two lines just resolvable as separate and that forms in the average human eye an angle of one minute.

Visibly Inc. has developed a method for determining a patient's visual acuity electronically via a web-based software system that can be self-administered wherever convenient. This method provides an efficient alternative for people to have immediate access to visual acuity measurements.

Detailed description: The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, at home, to evaluate visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:

* A computer screen (the Display) which displays optotypes
* A touchscreen mobile device (the Remote) which operates as a remote control and interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away

The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's visual acuity into one of two buckets:

* 20/25 or better
* Worse than 20/25

Eligibility criteria: Inclusion Criteria:

* 1. Be between 22 and 40 years (inclusive) of age at the time of consent 2. Be able and willing to provide written informed consent, attend all scheduled visits and comply with all study procedures

Exclusion Criteria:

* 1. Have any of the following conditions (based on subject report):

  1. Advanced eye disease in either eye;
  2. Poor vision as a result of refractive surgery in either eye;
  3. Unable to walk;
  4. Unable to hear or follow audio instructions.

Primary outcomes:
measure: Effectiveness
timeFrame: Up to 3 hours
measure: Reproducibility
timeFrame: Up to 3 hours
Secondary outcomes:
measure: Effectiveness
timeFrame: Up to 3 hours
measure: Reproducibility
timeFrame: Up to 3 hours
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Shelby
country: United States
facility: Core, Inc
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
Study officials:
References:
Clinical trial NCT06169358: Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy
Official title: Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Left Ventricular Hypertrophy
Fabry Disease
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical case collection of patients with hypertrophic cardiomyopathy or left ventricular hypertrophy

Brief summary: The purpose of this study was to understand the epidemiological status of Fabry in patients with hypertrophic cardiomyopathy or left ventricular hypertrophy through multi-center early identification of high-risk patients in cardiology according to high-risk profiles, supplemented by DBS (dried blood disc) screening tools, and to explore the screening and diagnosis methods of patients with Fabry disease in cardiology, so as to promote the early identification, diagnosis and treatment of Fabry in cardiology.


Eligibility criteria: Inclusion Criteria:

* Meet diagnostic criteria for hypertrophic cardiomyopathy (HCM) in adults (age ≥ 18 years):Imaging of one or more left ventricular segments reveals a maximum end-diastolic ventricular wall thickness of ≥15 mm or end-diastolic ventricular septal thickness or posterior left ventricular wall thickness of ≥13 mm on either cardiac imaging at rest.

Exclusion Criteria:

* 1. Identification of hypertrophic cardiomyopathy caused by mutations in pathogenic genes; 2. Identify the cause of left ventricular hypertrophy (LVH); 3. Aortic valve or mitral valve lesions that can cause hemodynamic changes.

Primary outcomes:
measure: diagnosis of Fabry disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Jinan
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiaoping Ji
role: STUDY_CHAIR
References:
Clinical trial NCT03773458: Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis
Official title: Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis Using Back Images
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder of Spine
Artificial Intelligence
Scoliosis
Keywords: Orthopedic Disorder of Spine
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 500
Minimum age (years): 10
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Traditional school scoliosis screening approaches remains debatable due to unnecessary referal and excessive cost. Deep learning algorithms have proven to be powerful tools for the detection of multiple diseases; however, the application of such methods in scoliosis screening requires further assessment and validation. Here, the investigators develop an artificial system for the automated screening of scoliosis using disrobed back images, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.


Eligibility criteria: Inclusion Criteria:

* 1.Patients included both pretreatment back photos and whole spine (C7-S1) standing X-ray or ultrasound images (for healthy population); 2. All the documents are clear to be recognized by naked eyes; 3. Back photos and are taken at the same time (not \>1month); 4.Patients were consider as idiopathic scoliosis according to clinical photos.

Exclusion Criteria:

* 1. Patients were considered as non-idiopathic scoliosis for obvious abnormal features of trunck,such as Cafe-au-Lait spots for neurofibromatosis, Spider finger, Abnormal hair spot of back, pelvic tilt, lower limb discrepancy and so on; 2.The taken time between back photo and X-ray or ultrasound was more than 1month; 3.The clinical photos and images were not clear; 4. The X-ray film or ultrasound images not including whole spine (C7-S1).

Primary outcomes:
measure: The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system.
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03448458: Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer
Official title: Molecular Imaging With Ga-68 DOTATATE PET to Investigate Neuroendocrine Differentiation in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage IV Prostate Cancer AJCC v7
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in treating patients with castration resistant prostate cancer that has spread to other placed in the body. Gallium Ga 68-DOTATATE PET/CT may help doctors to identify those patients with early neuroendocrine transdifferentiation and who are at greater risk for poor outcomes.

Detailed description: PRIMARY OBJECTIVE:

Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer.

SECONDARY OBJECTIVE:

Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination.

OUTLINE:

Patients receive gallium Ga 68-DOTATATE intravenously (IV). Within 55-70 minutes, patients undergo PET/CT.

After completion of study, patients are followed up for at least 1 year.

Eligibility criteria: Inclusion Criteria:

* Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
* Ability to lie still for PET scanning
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients less than 18 years of age
* Patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
* Inability to lie still for PET scanning
* Patients unable to provide written informed consent

Primary outcomes:
measure: Gallium Ga 68-DOTATATE uptake
timeFrame: Up to 1 year post-therapy
Secondary outcomes:
measure: Progression free survival
timeFrame: Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Mehmet Asim Bilen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05264558: Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%
Official title: Preparing for the Final Phase of Hepatitis C Elimination in Cairns: An Implementation Trial of a Test and Treat Approach to Reach the Final 30%.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
Collaborators: name: Cairns Hinterland Health Hospital and Health Services
name: The University of Queensland
First posted: 2022-03-03
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The model will permit all interventions to be explored for their impact on testing and treatment numbers in the HCV care cascade
Primary purpose: TREATMENT

Brief summary: The study aims to assess the impact of models of HCV care on HCV testing, treatment uptake and cure within Cairns. Point of care testing for HCV , with test and treat strategies will be offered within a primary care service.

Detailed description: Available testing and treatment data will be explored pre and post the intervention period of the project within Cairns Hinterland health services that provide hepatitis C care.

Test and treat strategies of the project will include:

Part A: Same day test and treat clinical trial. The study will explore a 'same day test and treat' model to determine the impact on HCV treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis C that are transient, and struggle to return to a care provider to engage in hepatitis C testing and care.

1. HCV RNA point of care (POC) testing
2. Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.

Part B: Refresher and clinic in reach support work Primary care service/ General practitioner education and training \~1 hour in-person training for all clinic staff on hepatitis C testing, treatment, retention in HCV care cascade.

Part C: Services evaluation with incentive and peer intervention in HCV care cascade.

Eligibility criteria: Inclusion Criteria:

* attending primary health care service of CHHS aged 18 years or over

Exclusion Criteria: only for intervention arm test and treat

* Known to have hepatitis B or HIV infection
* Known to have cirrhosis
* Previous treatment with direct acting antivirals
* Previously received interferon-based hepatitis C treatment that did not work
* Women that are pregnant or breastfeeding
* Already receiving hepatitis C treatment.

Primary outcomes:
measure: HCV testing
timeFrame: 12 months
measure: HCV treatment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairns
country: Australia
facility: Cairns and Hinterland Hospital and Health Service
state: Queensland
Study officials:
References: