louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05888610: Caregiver Solutions for Dementia Patients
Official title: Identifying Specifications for Caregiver-assisted Solutions to Assess Dementia Patient Needs at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Dementia
Caregivers
Remote Monitoring
Lead sponsor: Prepped Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2023-06-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with Alzheimer's Disease and Related Dementias (ADRD). The main question it aims to answer is: Will caregivers supporting patients diagnosed with ADRD utilize a mobile application to routinely report symptoms of the patients they care for?


Eligibility criteria: Inclusion Criteria:

* Caregiver of a Duke patient with Alzheimer's disease or Alzheimer's disease-related dementias (ADRD), participating in the Duke Dementia Family Support Program
* The ability to speak and understand English
* Age \> 18 years

Exclusion Criteria:

* Those unable to speak and understand English
* Age ≤ 18 years

Primary outcomes:
measure: Number of Days that Participants Use Digital Outpost
timeFrame: Time Frame up to week 2
measure: Number of Clinical Assessments Completed
timeFrame: Time Frame up to week 2
Secondary outcomes:
measure: Usability as Measured by the System Usability Scale at 2 weeks
timeFrame: Time Frame 2 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT05460910: Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
Official title: Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Down Syndrome
Keywords: core stability exercises
balance
treadmill
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome


Eligibility criteria: Inclusion Criteria:

* able to stand and walk independently
* able to understand and follow a verbal command
* cutoff score less than 6 or 7 in functional balance in indicated

Exclusion Criteria:

* patients have any neurological issue,
* Instability of atlantoaxial joint
* Vision and hearing loss
* History of fall

Primary outcomes:
measure: Berg balance scale
timeFrame: 8th week
Secondary outcomes:
measure: Reach test
timeFrame: 8week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: International Therapy Services Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajiha Shahid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szafraniec R, Baranska J, Kuczynski M. Acute effects of core stability exercises on balance control. Acta Bioeng Biomech. 2018;20(4):145-151.
citation: Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
citation: Amini HA, Fazel Kalkhoran J, Salehi M, Jazini F. Effect of backward walking training on improves postural stability in children with down syndrome. International Journal of Pediatrics. 2016;4(7):2171-81.
Clinical trial NCT06933810: Examining the Ethical Attitudes of Nurses Working in a University Hospital
Official title: Examining the Ethical Attitudes of Nurses Working in a University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ethics
Keywords: nursing
ethics
attitudes
nurse behavior
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 507
Sex: ALL
Minimum age (years): 21
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study consisted of a total of 690 nurses working in the internal medicine, surgery, intensive care, and emergency services of the hospital where the study was conducted. Without selecting a sample, nurses who were actively working between the specified dates and volunteered to participate in the study were included in the study. The entire population could not be reached because 50 nurses were on maternity leave and 133 nurses did not want to participate in the study. The study was completed with a total of 507 volunteer nurses, 144 of whom worked in internal medicine, 122 in surgery, 141 in intensive care, and 100 in emergency services.

Brief summary: This study aims to examine the ethical attitudes of nurses working in a university hospital.

The study includes nurses from departments such as internal medicine, surgery, intensive care, and emergency services.

A standardized data collection tool was used, and the study was conducted with volunteer participants.

This is a descriptive and cross-sectional observational study.

Detailed description: This descriptive and cross-sectional study was conducted to evaluate the ethical attitudes of nurses working in a university hospital setting.

Nurses from various departments, including internal medicine, surgery, intensive care, and emergency services, participated in the study voluntarily.

Data were collected using the Nurse Information Form and the Ethical Attitudes in Nursing Care Scale.

The study aimed to gain insights into nurses' perceptions and behaviors related to ethical principles in clinical practice.

The findings are expected to contribute to the development of ethics training programs for nurses and to improve ethical standards in nursing care.

\*No results or conclusions are included in this section, as required by ClinicalTrials.gov.\*

Eligibility criteria: Inclusion Criteria:

* Nurses who are actively working in the hospital during the study period
* Nurses who agree to voluntarily participate in the study

Exclusion Criteria:

* Nurses who do not want to participate in the study
* Nurses who withdraw from the study at any stage

Primary outcomes:
measure: Nurses' Ethical Attitude Scores
timeFrame: Within 1 month from the date of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Gazi̇antep
country: Turkey
facility: Hasan Kalyoncu University
state: Centre
Study officials:
affiliation: HASAN KALYONCU UNIVERSİTY
name: NURAN TOSUN, PROF. DR.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06803810: Peer to Peer (P2P): Mental Health Interventions with Persons with Substance Use Disorders
Official title: Peer to Peer (P2P): Mental Health Interventions with Persons with Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Standard of Care
P2P Intervention
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: South Carolina Center for Rural and Primary Healthcare
First posted: 2025-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study provides substance use and mental health peer support services to address behavioral health disparities in rural areas. Specifically, the project aims to address persistent mental health symptoms, such as anxiety and depression, that become barriers to care for patients working towards long-term recovery from co-occurring mental health and substance use disorders. Participants will be assessed and evaluated for opioid use disorder (OUD), social determinants of health (SDoH), and infectious diseases by a nurse practitioner and a social worker. A certified peer support specialist (CPSS) will provide additional support, connecting patients to sustainable mental health resources and implementing a modified version of the Friendship Bench intervention, which involves six weekly 45-minute problem-solving therapy sessions with the option to participate in six or more peer support sessions. The CPSS will follow the patient for up to 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OUD via Diagnostic Statistical Manual (DSM)-V Text Revision (TR)
* Receiving MOUD through the Mobile Recovery Program for at least 3 months
* Age 18 or older
* Moderate to Severe Depression with or without co-occurring anxiety as determined by PHQ-9 conducted during the most recent MRP clinical visit

Exclusion Criteria:

* Severe cognitive, medical, or psychiatric disability that could impair ability to perform study-related activities as determined by the MRP clinician or principal investigator.
* Unable to read/speak English
* Unable to read and comprehend the consent materials and other study materials
* Current suicidal ideation based on the Patient Health Questionnaire-9

Primary outcomes:
measure: Reduction in depressive symptoms
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Alain Litwin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01862510: Detection of Celiac Disease in Patients With Hypothyroidism
Official title: Detection of Celiac Disease in Patients With Hypothyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Hypothyroidism
Celiac Sprue
Malabsorption
Keywords: Celiac Disease
Hypothyroidism
Celiac Sprue
Malabsorption
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hypothyroidism who take thyroid replacement therapy

Brief summary: The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.

Detailed description: This study is looking at whether hypothyroid patients who require above 125 mcg/day (or \>1.5mcg/kg/day) of levothyroxine are more likely to have celiac disease than those who require smaller doses. It also looks to see if the prevalence of celiac disease in hypothyroid patients who require elevated doses of levothyroxine is high enough to warrant screening in that population.

Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy.

Exclusion Criteria:

* Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.

Primary outcomes:
measure: presence of celiac disease
timeFrame: 1 month
Secondary outcomes:
measure: Symptoms associated with celiac disease
timeFrame: 6 months
measure: medication adjustment
timeFrame: 6 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: University of Vermont
name: Richard Zubarik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins D, Wilcox R, Nathan M, Zubarik R. Celiac disease and hypothyroidism. Am J Med. 2012 Mar;125(3):278-82. doi: 10.1016/j.amjmed.2011.09.003.
citation: Zubarik R, Ganguly E, Nathan M, Vecchio J. Celiac disease detection in hypothyroid patients requiring elevated thyroid supplementation: A prospective cohort study. Eur J Intern Med. 2015 Dec;26(10):825-9. doi: 10.1016/j.ejim.2015.09.011. Epub 2015 Sep 28.
Clinical trial NCT02268110: The Effect of Conservative Interventions on the Signs and Symptoms of Diastasis Recti
Official title: The Effect of Exercise Therapy and/or Abdominal Binding on Inter-rectus Distance, Abdominal Muscle Strength, Lumbopelvic and Urogynecological Complaints, Perceived Function, and Body Image in Post-partum Women With Diastasis Recti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastasis Recti And Weakness Of The Linea Alba
Keywords: diastasis recti
physiotherapy
exercise therapy
abdominal binding
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2014-10-20
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of two different physiotherapeutic interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of diastasis recti in post-partum women.

Detailed description: This study is investigating the effect of exercise therapy and/or abdominal binding on inter-rectus distance, abdominal muscle strength and endurance, lumbopelvic dysfunction, urogynecological complaints, perceived function, and body image in post-partum women with diastasis recti

Eligibility criteria: Inclusion Criteria:

* 18 to 35 years old
* given birth to their first child, vaginally, in the last three to four weeks
* inter-rectus distance of two finger widths of greater on palpation during head lift

Exclusion Criteria:

* history of persistent pain with intercourse prior to pregnancy
* diagnosed with neurological impairments affecting the central nervous system or sacral nerves
* diagnosed with connective tissue disorders

Primary outcomes:
measure: Change in Inter-Rectus Distance
timeFrame: baseline, 12 weeks post intervention, 9 months post intervention
Secondary outcomes:
measure: Change in Abdominal Strength and Endurance
timeFrame: baseline, 12 weeks post intervention, 9 months post intervention
measure: Change in Body image
timeFrame: baseline, 12 weeks post intervention, 9 months post intervention
measure: Change in Lumbopelvic dysfunction
timeFrame: baseline, 12 weeks post intervention, 9 months post intervention
measure: Change in Urogynecological Complaints
timeFrame: baseline, 12 weeks post intervention, 9 months post intervention
measure: Change in Severity of Lumbopelvic and/or Abdominal Pain
timeFrame: baseline, 12 weeks post intervention, 9 months post intervention
measure: Change in Perceived Function
timeFrame: baseline, 12 weeks post intervention, 9 months post intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Rehabilitation Sciences Institute
state: Ontario
Study officials:
affiliation: Queen's University
name: McLean Linda, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00692510: Drug Interaction Study Between AZD3480 and Cytochrome P450
Official title: A Phase I, Double Blind, Randomized, Two-Way Cross Over, Single- Centre Study in Healthy CYP2D6 Extensive Metabolizers and Poor Metabolizers to Investigate the Potential of AZD3480 to Inhibit Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism
Alzheimer's Disease
Keywords: AZD3480
Cocktail
caffeine
bupropion
omeprazole
midazolam
rosiglitazone
metabolism
Drug Drug Interaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent
* Clinically normal physical findings and laboratory values

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within three weeks before the first dose
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during the treatment periods
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Hans-Göran Hårdemark, MD
role: STUDY_DIRECTOR
affiliation: ICON Development Solutions Manchester, Manchester Science Park, Manchester, UK
name: Cyril Clarke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05064410: Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative
Official title: Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colon Cancer
Cancer prevention
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-01
Enrollment: 188
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to provide educational materials and information regarding colorectal cancer (CRC), CRC screenings, and United States Preventive Services Task Force's (USPSTF) screening recommendations. USPSTF recommends screening for colorectal cancer starting at age 45 years and continuing until age 75 years.


Eligibility criteria: Inclusion Criteria:

* Between 45 and 75 years of age
* Spanish or English speaking
* Able to provide informed consent
* Reside in the Tampa Bay area (namely Hillsborough, Pinellas, Polk or Pasco county)

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening
timeFrame: Baseline, immediately following intervention, at 3 months and at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Clement K Gwede, PhD, MPH, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Cathy D Meade, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05220410: The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Official title: The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Treatment Resistant Depression
Suicidal Ideation
Keywords: Psilocybin
Psychedelic
Major depression
Treatment resistant depression
Suicidal ideation
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
Collaborators: name: COMPASS Pathways
First posted: 2022-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation


Eligibility criteria: Inclusion Criteria:

* Between 18 and 65 years of age at Screening
* Diagnosis of Major Depressive Disorder (MDD)
* Significant level of suicidal thoughts with active ideation and without immediate intent
* Failure to respond to 2 medications in the current episode

Exclusion Criteria:

* Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
* Current alcohol or substance use disorder

Primary outcomes:
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: All Visits - Baseline (Day -1 [V2]) to Week 12 (V10)
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9), and Week 12 (V10)
measure: Clinical Global Impression - Modified for Depression (CGI-D)
timeFrame: Baseline (V2) to Week 3 (V7) and Week 12 (V10)
measure: Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)
timeFrame: Baseline (V2) to Week 3 (V7), and Week 12 (V10)
measure: Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)
timeFrame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)
Other outcomes:
measure: Modified Scale for Suicidal Ideation (MSSI)
timeFrame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)
Locations:
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
Study officials:
affiliation: Sheppard Pratt Health System
name: Scott Aaronson, MD
role: PRINCIPAL_INVESTIGATOR
References: