louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04637893: The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study
Official title: The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent colonoscopy between the 1st October 2020 and the 31st December 2020 (pandemic cohort), and all patients who underwent colonoscopy between the 1st October 2019 and the 31st December 2019 (pre-pandemic cohort).

Brief summary: Screening programs have been associated with a substantial reduction in colorectal cancer (CRC) mortality through endoscopic resection of preneoplastic lesions and detection of early-stage invasive cancers.

In March 2020, the World Health Organization declared as a pandemic the outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2. Since then, the SARS-CoV-2 have never stopped spreading, causing an unprecedented situation with highly restrictive considerations to be adopted by the majority of countries worldwide.

Health-care facilities have been making an enormous effort to assist patients affected by COVID-19, while adopting measures to maintain a safe environment for patients and healthcare professionals. As a result, the usual workflow in endoscopy departments changed dramatically, leading to an increase in cancelled procedures, probably increasing the future burden of Colorectal Cancer due to delays in diagnosis.


Eligibility criteria: * patients who underwent colonoscopy between the 1st October 2020 and the 31st December 2020 (pandemic cohort)
* patients who underwent colonoscopy between the 1st October 2019 and the 31st December 2019 (pre-pandemic cohort)

Primary outcomes:
measure: Colorectal Cancer prevention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
affiliation: IRCSS Humanitas Research Hospital
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201993: Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients
Official title: Observational Study Following After Patients Admitted With Syncope
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Diagnosis
Recurrence
Keywords: syncope
evaluation
recurrence
morbidity
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted patients the medical ward

Brief summary: The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.

Detailed description: 1. Patients with diagnosis of syncope who were admitted to the medical ward will be interviewed and their charts reviewed to rule in or out the diagnosis of syncope.
2. Assess physical and mental injury as a result of syncope.
3. The lab workup will be documented including;

   1. - Routine blood tests.

      * troponin level.
   2. - ECG.

      * Echocardiogram
      * Brain CT.
      * EEG.
      * U/S doppler of carotids.
      * Tilt tests.
4. At the time of diagnosis the final diagnosis will be documented including recommendations for patients to prevent syncope after discharge.
5. Follow up after patients by phone verifying recurrence of syncope and resulting physical and or mental injury if any.

Eligibility criteria: Inclusion Criteria:

* patients with diagnosis of syncope on admission to the medical ward.

Exclusion Criteria:

* patients with loss of consciousness due to other than low perfusion of the brain
* patients that can't sign a consent form
* patients that we can't get details about the episode of the syncope

Primary outcomes:
measure: diagnosis
timeFrame: 1 year
Secondary outcomes:
measure: recurrence
timeFrame: 6 months
measure: physical injury
timeFrame: 6 months
measure: Mental effect
timeFrame: 6 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Medicine, Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: George S Habib, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05797571: SOSteniamoci: Stakeholders' Survey
Official title: Informal Caregivers and Clinicians' Knowledge, Awareness, Attitude and Expect Barriers Towards Internet-based Interventions: A Stakeholders' Survey in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informal Caregivers
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Formal and informal caregivers

Brief summary: Informal care is defined as the unpaid care provided to an older, frail, or ill person, by a person such as a spouse, a parent, a child, another relative, a neighbor, or a friend. This phenomenon may lead to stress, burden, and decreased informal caregivers' quality of life. Since lack of time, distance from services, and financial strains make the provision of psychological interventions to informal caregivers often challenging, Internet-based (self-help) programs might represent a viable solution to promote their emotional well-being. Still, despite the proven benefits of internet-based intervention, no available programs for informal caregivers are available for the Italian population. Nevertheless, planning and developing an online intervention, involving possible stakeholders (caregivers), might facilitate the understanding and dissemination of, willingness to use, and success of the future intervention. Thus, the goal of the current study is to assess Italian stakeholders' knowledge about, awareness of, attitudes towards, willingness to participate and use, and expected barriers to internet-based interventions.

Detailed description: The present study assessed the knowledge and awareness, attitudes, willingness to participate in, and expected barriers towards using Internet-based interventions to alleviate caregivers' burden in a sample of Italian caregivers and clinicians. To this aim, an online stakeholders' survey was conducted in Italy among clinicians and informal caregivers, using a snowballing sampling technique. Participants were asked to fill in the informed consent and complete the online survey as a clinician, a caregiver, or both. Data were monitored daily. Descriptive statistics and Pearson correlation analysis were used for data analysis.

Eligibility criteria: Inclusion Criteria:

* clinicians and informal caregivers
* aged 18 years or older
* internet access
* basic computer literacy

Primary outcomes:
measure: Mean score in Online survey for clinicians
timeFrame: At baseline, during online survey, performed after signing informed consent
measure: Mean score in Online survey for informal caregivers
timeFrame: At baseline, during online survey, performed after signing informed consent
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Giada Pietrabissa
Study officials:
affiliation: Istituto Auxologico Italiano
name: Giada Pietrabissa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04813393: Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire
Official title: Psychometric Properties of Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: home program
cerebral palsy
questionnaire development
parent
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 225
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in the current study were parents of chlidren with 2 to 18 years and recruited at Hecettepe Univercity Physical Therapy and Rehabilitation Faculty Cerebral Palsy and Pediatric Rehabilitation Unit.

Brief summary: This study aims to evaluate the psychometric properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.


Eligibility criteria: Inclusion Criteria:

1. having a child with CP 2 to 18 years,
2. being a primary caregiver,
3. understanding of Turkish without an interpreter, and Turkish literacy,

Exclusion Criteria:

1. having any chronic illness or disability to prevent the home program,
2. haven't applied home program before.

Primary outcomes:
measure: Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q)
timeFrame: At baseline
Secondary outcomes:
measure: Assessment of Life Habits for Children questionnaire (LIFE-H)
timeFrame: At baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe Univercity
name: Mutlu Hayran, PhD
role: STUDY_CHAIR
affiliation: Hacettepe Univercity
name: Meltem Şengelen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01594593: Acceptance-Based Treatment for Prostate Cancer Distress
Official title: Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Stage Prostate Cancer
Keywords: prostate cancer
behavioral
acceptance and commitment therapy
distress
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: Alliant International University
name: University of California, San Diego
First posted: 2012-05-09
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause of death in American men. Those diagnosed with localized prostate cancer encounter three sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3) the often life-altering side effects of treatment. In addition, patients who choose to undergo active surveillance which focuses on monitoring cancer in lieu of treatment, experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is an established psychosocial intervention that has been used extensively for mental health treatment and has shown benefits for various chronic conditions. ACT is a behavioral intervention that focuses on tolerating distress and improving function. This pilot study is designed to test the feasibility of ACT for distress reduction and improved quality of life in patients recently diagnosed with early-stage, localized PCa.


Eligibility criteria: Inclusion Criteria:

* Localized prostate cancer in Stages I or II
* Ability to give informed consent
* Age 18 to 80 years old
* Willingness to come in for a day long intervention

Exclusion Criteria:

* Acute psychosis
* Suicidal ideation
* Homicidal ideation
* Active substance abuse
* Dementia

Primary outcomes:
measure: Number of dropouts
timeFrame: 6 months
measure: Number of refusals
timeFrame: 6 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention
measure: Memorial Anxiety Scale for Prostate Cancer
timeFrame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Niloofar Afari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04360993: Role of PET/MRI in Head and Neck Cancer
Official title: PET/CT and PET/MRI Based Treatment Modalities in the Modern Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Benign Neoplasm
Malignant Neoplasm
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 110
Sex: ALL
Minimum age (years): 41
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population were patients who have been diagnosed with head and neck cancer.

Brief summary: Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer.

Detailed description: This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating between benign and malignant lesions in Head and neck cancer as well as studying the relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC) for better tumor assessment.

Eligibility criteria: Inclusion Criteria:

* Proved Head and neck cancer
* Underwent PET/CT and PET/MRI
* Lymph nodes due to primary Head and neck cancer.

For healthy subject:

* No previous history of malignancy.
* no inflammation or infection in the neck region.
* lymph node size \<10mm.

Exclusion Criteria:

* patients treated before by radiotherapy / chemoradiotherapy
* patients underwent surgery
* artifacts

Primary outcomes:
measure: Difference in Apparent diffusion coefficient value between benign and malignant lesions
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pecs
name: Arpad Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Csolnoky Ferenc Kórház, Veszprém, Hungary
name: Cselik Zsolt, MD, PhD
role: STUDY_CHAIR
affiliation: Doctoral school of health sciences, Pécs University, Hungary
name: Omar Freihat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freihat O, Toth Z, Pinter T, Kedves A, Sipos D, Cselik Z, Lippai N, Repa I, Kovacs A. Pre-treatment PET/MRI based FDG and DWI imaging parameters for predicting HPV status and tumor response to chemoradiotherapy in primary oropharyngeal squamous cell carcinoma (OPSCC). Oral Oncol. 2021 May;116:105239. doi: 10.1016/j.oraloncology.2021.105239. Epub 2021 Feb 25.
citation: Freihat O, Pinter T, Kedves A, Sipos D, Cselik Z, Repa I, Kovacs A. Diffusion-Weighted Imaging (DWI) derived from PET/MRI for lymph node assessment in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). Cancer Imaging. 2020 Aug 8;20(1):56. doi: 10.1186/s40644-020-00334-x.
Clinical trial NCT01321593: Hemoglobin Measured by "Orsense NBM-200MP" Device and Laboratory Measurement
Official title: Comparison of the Hemoglobin Results Obtained With the "Orsense NBM-200MP" Device and the Clinical Laboratory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: emergency unit patients requiring an hemoglobin determination

Brief summary: The purpose of this study is to compare the hemoglobin results obtained with the "Orsense NBM-200MP" device and the Clinical Laboratory.


Eligibility criteria: Inclusion Criteria:

* emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

* none

Primary outcomes:
measure: Hemoglobin measurement using the "Orsense NBM-200MP" device
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
Clinical trial NCT05066893: Pediatric Boot Camp Program
Official title: Type 1 Diabetes Boot Camp Program: An Intensive Program to Improve Glycemic Control in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Children, Only
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 32
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.

Detailed description: Our new PeDi-BoCa Program aims to help children with type 1 diabetes achieve better diabetes control by interacting weekly with their doctor/nurse practitioner (NP) and also by using a "smart pen" that can facilitate the burden of daily calculations with the use of an app on the phone.

Your child's doctor/NP will be able to remotely monitor your child's glucose every week (Dexcom) and make recommendations for changes, discuss solutions to possible obstacles and offer intensive diabetes education.

Eligibility criteria: Inclusion Criteria:

1. Age 11-18 years old
2. HbA1c \> 8.5%
3. Duration of type 1 diabetes \>1 year
4. Child uses Dexcom and has a phone that is compatible with the InPen app and Dexcom Clarity app.

Exclusion Criteria:

Not able to attend telehealth visits

Primary outcomes:
measure: Change in HbA1c
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Pediatrics
state: District of Columbia
Study officials:
References:
Clinical trial NCT04090593: Chronic Disease Mobile Educational Experience
Official title: Chronic Disease Mobile Educational Experience for Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Heart Failure
Lead sponsor: Los Angeles County Department of Public Health
Sponsor class: OTHER_GOV
First posted: 2019-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study is randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the effectiveness of a mobile health education module, in increasing hospitalized patients' understanding of their chronic illness, and in reducing 30-day hospital readmission rates. Half of the participants will receive the educational module intervention in addition to standard education, the other half will receive hospital standard practice education only.

Detailed description: Chronic disease is the leading cause of death and disability, costing the US healthcare system 1 trillion dollars annually. Successful management of these conditions critically requires patient understanding and engagement. Patients are advised to adhere to medications, redesign lifestyles, and navigate the health care system. Most of these care plan items require careful instruction and confirmation of shared understanding.

Mobile health technology has the potential to assist greatly with patient education, especially for hospitalized patients. This prospective study evaluates a specific mobile technology intervention, an educational and emotionally-engaging video patients watch while admitted for a complication related to one of these chronic diseases: Heart Failure, Diabetes, COPD, Asthma, Cirrhosis, Atrial Fibrillation, Hypertension.

Eligibility criteria: Inclusion Criteria:

* admission to medical service primary team for decompensation or complication of chronic disease.(e.g. heart failure)

Exclusion Criteria:

* cognitive disability or visual/auditory limitation that prevents self-interaction with educational module

Primary outcomes:
measure: 30-Day hospital readmission rate
timeFrame: 9 months (270 days)
measure: Self-reported quality of life: Short Form (36) Health Survey
timeFrame: 9 months (270 days)
measure: Patient understanding of chronic disease: 8-item disease focused survey.
timeFrame: 9 months (270 days)
measure: Patient satisfaction with treatment: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 9 months (270 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LAC+USC Medical Center
name: Josh Banerjee, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03285893: Oral Cell DNA Adducts in Smokers
Official title: Quantitation of Oral Cell DNA Adducts in Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Hawaii
First posted: 2017-09-18
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 each of three ethnic groups: Native Hawaiians, Japanese Americans, whites

Brief summary: DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches.

Detailed description: Using high resolution mass spectrometry, quantify known DNA adducts in oral mucosa cells of 100 smokers from each ethnic group - Native Hawaiians, Whites, and Japanese Americans. DNA adducts of tobacco-specific compounds, formaldehyde, and acrolein will be quantified.

2. Analyze the urine of 100 smokers and 100 non-smokers from each of these groups for mercapturic acids of acrolein and crotonaldehyde, as well as total nicotine equivalents and total NNAL (smokers only). These data will provide critical information relevant to the high risk of Native Hawaiians for lung cancer, and in relationship to the DNA adduct measurements of Specific Aim 1.

Eligibility criteria: Inclusion Criteria:

* currently smoke at least 5 cigarettes per day, self-identified Japanese Americans, European Americans, or Native Hawaiians.

Exclusion Criteria:

* no current use of other nicotine containing products, no acute or uncontrolled medical or psychiatric conditions, no greater than 14 alcoholic drinks per week, not pregnant, not breastfeeding, not currently taking any medications that affect relevant metabolic enzymes, no active infection.

Primary outcomes:
measure: Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct
timeFrame: Baseline
Secondary outcomes:
measure: εdAdo, Per 10^9 Nucleotides
timeFrame: Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Tobacco Use Research Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Stepehn Hecht, PhD
role: PRINCIPAL_INVESTIGATOR
References: