louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06699615: Assessing Perceptions of ML Explanations by Medical Oncologists
Official title: Survey of Medical Oncologists to Assess Trustworthiness of Various Approaches to AI Explainability for Prognostic Models
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Oncology
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Consented participants will complete a one time de-identified Qualtrics survey.
Primary purpose: OTHER

Brief summary: The objective of this proposal is to conduct a vignette-based survey among practicing oncology clinicians who treat non-small cell lung cancer to assess the trustworthiness of explainable predictions from a neurosymbolic AI vs. State-of-the-art post-hoc explanatory algorithms, using simulated patient data.


Eligibility criteria: Inclusion Criteria "Medical oncologist" or "Hematologist/Oncologist" designation at Penn Treats lung cancer

Exclusion Criteria:

Non-medical oncologists No email address or physical address listed Does not treat lung cancer

Primary outcomes:
measure: Determine whether neurosymbolic AI explainability methods improve the trustworthiness of explanations from a prognostic model, relative to post-hoc explainers.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02058615: Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer
Official title: Living With Hope: Development and Feasibility Evaluation of a Transition Toolkit for Make Partners of Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Male caregivers
Breast cancer
Intervention
Online toolkit
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2014-02-10
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Male partners of women with breast cancer experience distress, so we want to develop a way to support them so they, in turn, can care for their wives. The purpose is to pilot test an online male spouse transition toolkit (MaTT) that the research team has developed. The specific aims are to: a) evaluate the Toolkit for ease of use, acceptability, and feasibility, and; b) collect preliminary data to determine potential effectiveness of the Toolkit in increasing hope, general self-efficacy and quality of life, and its potential effectiveness in decreasing guilt scores for male partners of women with breast cancer (stages 1-3).


Eligibility criteria: Inclusion Criteria:

* male
* 18 years of age or older
* living with a spouse who has breast cancer (Stage 1, 2, or 3)
* English speaking.

Exclusion Criteria:

* persons who are non-autonomous adults
* cognitively impaired as determined by the Registered Nurse (RN) researcher
* unable to participate, in the opinion of the RN researcher
* non-English speaking
* does not have a spouse who is diagnosed with having breast cancer (State 1, 2, or 3)

Primary outcomes:
measure: Hope
timeFrame: Change from baseline at day 7, 14, 28, and 56
Secondary outcomes:
measure: Quality of Life
timeFrame: Change from baseline at day 7, 14, 28 and 56
Other outcomes:
measure: General self-efficacy
timeFrame: change from baseline at day 7, 14, 28, and 56
measure: Caregiver guilt
timeFrame: change from baseline at day 7 , 14, 28, and 56
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Wendy D Duggleby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06548815: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4
Official title: A Single-center, Single-administration, Randomized, Placebo-controlled, Dose-escalation Trial Evaluated the Safety, Tolerability, PK, and PD Parameters of GZR4 in Healthy Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: GZR4
PK
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.


Eligibility criteria: Inclusion Criteria:

* Chinese healthy male adult subjects aged 18-45 years old
* Body mass index \[BMI between 19.0-24.0 kg/m2
* Hemoglobin A1c (HbA1c)≤6%

Exclusion Criteria:

* Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
* Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
* Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
* Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
* Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening

Primary outcomes:
measure: Incidence of TEAE
timeFrame: Baseline to Day29
Secondary outcomes:
measure: GIRmax
timeFrame: Day2-Day3
measure: Tmax,GIR
timeFrame: Day2-Day3
measure: AUCGIR
timeFrame: Day2-Day3/Day7-Day8
measure: Cmax
timeFrame: Baseline to Day29
measure: Tmax,GZR4
timeFrame: Baseline to Day29
measure: T1/2
timeFrame: Baseline to Day29
measure: AUC0-inf
timeFrame: Baseline to Day29
measure: AUC0-last
timeFrame: Baseline to Day29
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gan & Lee Pharmaceuticals Co., Ltd
state: Beijing
Study officials:
References:
Clinical trial NCT00824915: Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)
Official title: Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Keywords: Lead Integrity Algorithm
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 1779
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed Lead Integrity Algorithm download with a device download within the open and closed date of data collection

Brief summary: The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release.


Eligibility criteria: Inclusion Criteria:

* Lead Integrity Algorithm download; requires a Medtronic device that supports the LIA algorithm; requires an RV lead; selected as part of the identified cohort

Exclusion Criteria:

* A device that does not support the Lead Integrity Algorithm,

Primary outcomes:
measure: Sensitivity of the LIA algorithm
timeFrame: 2 years
measure: Positive predictive value of the LIA algorithm
timeFrame: 2 years
measure: Number of false positives per patient-year of the LIA algorithm
timeFrame: 2 years
measure: Reduction in the percent of patients with the LIA algorithm with an RV lead fracture who receive at least one inappropriate shock
timeFrame: Event driven (analysis requires 50 events)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medtronic
name: RVLIA Trial Leader
role: STUDY_CHAIR
References:
Clinical trial NCT03946215: Cardiorespiratory Responses to Treadmill Running at Different Slopes
Official title: Comparison of Cardiorespiratory Responses to Treadmill Running at Different Slopes in Well-trained Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorespiratory Responses
Well-trained Athletes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. The investigators hypothesized that maximal oxygen uptake will be lower in downhill running. The investigators also anticipate attenuated cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or uphill running performed at similar velocity but not when the comparison is done at similar metabolic power.


Eligibility criteria: Inclusion Criteria:

* to be a well-trained runner with a VO2max \> à 55 ml/kg/min
* nonsmoker or stopped smoking for 5 years
* BMI \< 25
* affiliation to the social health insurance scheme
* signing an informed consent form.

Exclusion criteria:

* impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, ...);
* subject under the protection of justice
* subject under guardianship or curatorship
* contraindication to the practice of physical and sport activities
* lower limbs musculotendinous or articular problems
* respiratory, cardiovascular or metabolic pathology
* drug treatment in progress and impossibility to stop it within 7 days before the beginning of the study

Primary outcomes:
measure: Peak oxygen
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT01385085: Impact of Work Environment Absent of Natural Light on Vitamin D Levels
Official title: Impact of Work Environment Absent of Natural Light on Vitamin D Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Sunlight
Deficiency
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People employed in three types of natural sunlight exposure.

Brief summary: Three types of workers exposed to different levels of natural sunlight will be tested for Vitamin D blood level, PTH, Ca, P, albumin and alkaline phosphatase.

In addition, each tested worker will be asked to fill a questionnaire for demographic, medical and personal habit information.


Eligibility criteria: Inclusion Criteria:

* people employed in their current work place at least 6 months,

Exclusion Criteria:

* people who consume food additives containing Vitamin D.
* people who have a chronic illness which harms the Vitamin D absorption, such as Celiac, chronic Pancreatitis, Cystic Fibrosis and IBS.
* people who have a chronic illness which harms Vitamin D metabolism, such as chronic hepatitis, kidney insufficiency and Nephrotic Syndrome.
* pregnant women.
* people who require prescribed medicine like steroids, anti-convulsion, and HIV treatments.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03104985: LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
Official title: New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trophic Ulcers
Chronic Venous Insufficiency
Keywords: Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency
Lead sponsor: Research Center Matrix
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate comparatively the efficiency of traditional treatment methods in patients with chronic venous diseases of C6 class, and a new combined low level laser therapy (LLLT) by LASMIK device.

The results of outpatient examination and treatment of patients with venous trophic ulcers, observed in the City Polyclinic of "Tula Municipal Clinical Hospital №2" were analyzed.

Detailed description: During a longitudinal study, a group of patients was followed up in the period of complete or partial recovery. International classification of lower extremity chronic venous disorders СЕАР was used as a clinical classification of chronic venous insufficiency (CVI).

Depending on the applied treatment method, patients were divided into 2 groups:

1. (n=34) Conventional treatment
2. (n=34) Conventional treatment + combined LLLT, including external exposure with 635nm wavelength + intravenous laser blood illumination (ILBI) with 365-405nm (UV-spectrum) and 520-525nm (green spectrum) wavelength alternately, according to the special scheme

Eligibility criteria: Inclusion Criteria:

* over 18 years of age,
* CVI Stage 6 (S6) in compliance with СЕАР

Exclusion Criteria:

* hemorrhagic syndrome,
* neoplastic syndrome,
* hyperthermic syndrome (fever, patient body temperature over 38°C),
* syndrome of systemic (cardiac, vascular, respiratory, renal and hepatic) and multiple organ failure (general severe illness),
* cachexic syndrome (severe general exhaustion),
* epileptic syndrome,
* hysterical syndrome,
* convulsive syndrome

Primary outcomes:
measure: Number of Participants With Trophic Ulcer Healing
timeFrame: 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Tula
country: Russian Federation
facility: Tula Municipal Clinical Hospital №2
Study officials:
affiliation: State Scientific Center of Laser Medicine, Russia, Moscow
name: Sergey Moskvin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03185585: Validation of a Comprehensive Older Adult Screening Tool (COAST)
Official title: Development and Validation of a Comprehensive Older Adult Screening Tool (COAST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-dwelling Older Adults
Keywords: Nutritional screenings
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 301
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults who attend congregate meal sites and other community groups in Florida will be recruited.

Brief summary: The COAST nutrition screening tool will be validated in 300 community-dwelling older adults in Florida.

Detailed description: The population to be studied (n=300) will be individuals who are 60 years or older and participate in congregate meal sites or other community groups in Florida. Demographic information will be collected and participants will be assessed by the MNA® (Mini Nutrition Assessment) and screened by the COAST nutrition screening tool. Participants' hand grip strength and performance on the five times Sit to Stand test will be used to evaluate their functional status. Weight, height, mid-arm circumference and calf circumference will be measured as part of the MNA screening tool.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling adults 60 years and older.

Exclusion Criteria:

* Non-English speaking/reading

Primary outcomes:
measure: At Risk of Malnutrition
timeFrame: 1 year
Secondary outcomes:
measure: Handgrip strength
timeFrame: 1 year
measure: COAST
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05985785: Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection
Official title: Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).
Primary purpose: OTHER

Brief summary: Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.

Detailed description: The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up.

All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-70
* Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks
* 7-day average pain score of at least 4 on VAS scale

Exclusion Criteria:

* Systemic diseases (Diabetes, malignancies, infections, etc.)
* Post-traumatic arthritis
* Patient had intra-articular injection on affected knee in last three months

Primary outcomes:
measure: Visual analogue scale (VAS) for pain
timeFrame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
measure: Intermittent and Constant Osteoarthritis Pain (ICOAP)
timeFrame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center Associate Professor and Surgeon
name: Jorge Chahla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04258085: Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System
Official title: Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Benign Breast Disease
Keywords: Rwanda
breast cancer
screening
early detection
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Rwanda Biomedical Centre
name: Partners in Health
name: Breast Cancer Research Foundation
First posted: 2020-02-06
Enrollment: 17379
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is the population served by the health centers that are implementing the nationally-led breast cancer early detection program.

Brief summary: This observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. For scaleup, breast cancer screening with CBE was added to a cervical cancer screening initiative, in a combined Women's Cancer Early Detection Program (WCEDP).

Detailed description: Investigators previously conducted a cluster randomized controlled trial of a clinician training program to facilitate prompt evaluation of women with breast symptoms in one rural district of Rwanda. Subsequently, Rwanda Biomedical Centre (RBC) has scaled up the curriculum in 3 districts, adapting the program to integrate CBE screening into a cervical cancer screening initiative. In this study, we will evaluate implementation of this combined screening initiative. Investigators will assess patient volume, services, diagnoses, and loss to follow up.

Eligibility criteria: Inclusion Criteria:

* All women and men who are evaluated for a breast concern or receive breast cancer screening through implementation of the nationally-led early detection programs

Exclusion Criteria:

* None

Primary outcomes:
measure: Cancer detection rate
timeFrame: 2 years
measure: Loss to follow-up
timeFrame: one year
measure: Patient volume and services received
timeFrame: two years
Secondary outcomes:
measure: Breast cancer stage
timeFrame: 2 years
measure: Patients' costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Rwanda Biomedical Centre
Study officials:
affiliation: Brigham and Women's Hospital
name: Lydia Pace
role: PRINCIPAL_INVESTIGATOR
References: