louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05172752: A University-Community Partnership to Reduce Exposure to Disinfection Byproducts In Appalachia
Official title: A University-Community Partnership to Reduce Exposure to Disinfection Byproducts In Appalachia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disinfection By-products
Keywords: Community-engaged
Appalachia
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2021-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Appalachian Kentuckians in Martin and Letcher Counties are grappling with a health-threatening drinking water crisis arising from exposures to disinfection by-products (DBPs). DBPs include trihalomethanes (THMs), haloacetic acids (HAAs), chlorate, and other compounds that have been associated with a variety of adverse health effects, including increased risk of bladder cancer and cardiovascular birth defects. This study implements a multi-stakeholder, multi-method approach to improve understanding of, characterize spatial and temporal variations in, and reduce exposure to DBPs in these Appalachian Kentucky counties.


Eligibility criteria: Inclusion Criteria:

* Located in Martin or Letcher County water districts
* At least 18 years old
* Able to read/speak in English

Exclusion Criteria:

* Located outside of Martin or Letcher County water districts

Primary outcomes:
measure: Change in Environmental Health Literacy (EHL) - Knowledge
timeFrame: Baseline, 5-years
measure: Change in Environmental Health Literacy (EHL) - Attitudes/Behaviors
timeFrame: Baseline, 5-years
measure: Change in participant network density
timeFrame: Baseline, 5-years
measure: Change in participant centrality
timeFrame: Baseline, 5-years
measure: Change in participant reciprocity
timeFrame: Baseline, 5-years
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Anna Hoover, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706752: A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy
Official title: A Randomized, Blinded, Placebo-controlled Trial of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Patients With Cancer Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to assess whether Shengbai Oral Formula is a viable option for treatment of fatigue, pain, and neutropenia in patients undergoing their third cycle of chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. 18-80 years of age
2. A cancer diagnosis and scheduled to undergo at least three rounds of chemotherapy for curative or palliative intent
3. Chemotherapy is given at a minimum of every 2 weeks
4. At least 30 days past radiation therapy
5. Nonpregnant and use of method of contraception per the treating clinician standard of care
6. Life expectancy \> 3 months
7. Stable on all herbal or complementary therapeutics for the past 30 days and agree to not include new complementary therapeutics until after study completion
8. Baseline ECOG ≤ 2
9. In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study including all scheduled evaluations and required tests

Exclusion Criteria:

1. Abnormal ALT/AST: \> 2.5 to 3 times normal range
2. eGFR \<60
3. Platelets \< 75,000
4. Hb \<8.0
5. ANC \<1000
6. Documentation of a bone marrow transplant
7. Documentation of brain metastases, diagnosis with other cancer, except skin cancer history with basal cell carcinoma, squamous carcinoma
8. Documentation of current seizure disorder
9. Documentation of new cardiac arrhythmias and myocardial infarction
10. Any active bacterial or viral infection, pneumonia, sepsis, active gastric ulcer, gastritis, nonhealing wound, intractable nausea or vomiting, diarrhea, bleeding disorder
11. Hyperthyroidism, connective tissue disease including systemic lupus erythematous, rheumatoid arthritis
12. Documentation of a current drug abuse disorder
13. Current participation in other clinical trial

Primary outcomes:
measure: Brief Fatigue Inventory
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Sutter Health
state: California
Study officials:
References:
Clinical trial NCT00975052: A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)
Official title: A Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Four-Period Crossover Study to Assess the Effects of Concomitant Administration of MK0431 and Metformin Alone and in Combination on Post-Meal Incretin Hormone Concentrations in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject has been a nonsmoker for at least 6 months
* Subject is willing to avoid strenuous activity from the screening visit until the end of the study
* Subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration

Exclusion Criteria:

* Any history of stroke or neurological disorder
* Subject has a history of cardiovascular, blood, endocrine or liver diseases
* Subject has a history of cancer

Primary outcomes:
measure: Weighted average active GLP-1 (glucagonlike peptide-1) concentrations
timeFrame: 4 hours after the postdose meal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Migoya EM, Bergeron R, Miller JL, Snyder RN, Tanen M, Hilliard D, Weiss B, Larson P, Gutierrez M, Jiang G, Liu F, Pryor KA, Yao J, Zhu L, Holst JJ, Deacon C, Herman G, Thornberry N, Amatruda J, Williams-Herman D, Wagner JA, SinhaRoy R. Dipeptidyl peptidase-4 inhibitors administered in combination with metformin result in an additive increase in the plasma concentration of active GLP-1. Clin Pharmacol Ther. 2010 Dec;88(6):801-8. doi: 10.1038/clpt.2010.184. Epub 2010 Nov 3.
Clinical trial NCT06230952: Reliability of BASDAI and BASFI Applied by Tele-Assessment Method in Axial SpA Spondyloarthritis
Official title: Reliability of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) Applied by Tele-Assessment Method in Patients With Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Keywords: axial spondyloarthritis
BASDAI
BASFI
self assessment
tele-assessment
reliability
Lead sponsor: Siirt University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: It was planned to include at least 100 axial SpA patients in the study.

Brief summary: The goal of this observational study is to investigate the reliability of BASDAI and BASFI questionnaires applied via tele-assessment in axial spondyloarthritis patients.

Detailed description: Telehealth is the provision of healthcare services and clinical practices remotely through information and communication technologies. In recent years, the use of telehealth applications has increased worldwide. Telehealth is an umbrella term that covers practices such as telemedicine, telerehabilitation, and tele-assessment. Tele-assessment has gained importance in terms of monitoring patients with chronic diseases. Although BASDAI and BASFI have been shown to be valid and reliable in AS patients, there is no study in the literature examining the reliability of BASDAI and BASFI applied via tele-assessment. The aim of our study is to investigate the reliability of BASDAI and BASFI questionnaires administered via tele-assessment in axial SpA patients.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Axial spondyloarthritis according to the Assessment in SpondyloArthritis international Society (ASAS) criteria
* Volunteering to participate in the study
* Being between the ages of 20-60

Exclusion Criteria:

* Having another systemic, orthopedic, neurological or cognitive disease other than axial spondyloarthritis
* Pregnancy
* The patient wishes to withdraw from the study

Primary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline and after 24 hours after baseline assessment
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline and after 24 hours after baseline assessment
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Disease duration
timeFrame: Baseline
measure: Medications
timeFrame: Baseline
measure: weight
timeFrame: Baseline
measure: height
timeFrame: Baseline
measure: Education
timeFrame: Baseline
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
affiliation: Siirt University
name: Yasemin ACAR, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06520852: The Effect of the Use of Artificial Intelligence in the Preparation of Patient Education Material
Official title: The Effect of the Use of Artificial Intelligence in the Preparation of Patient Education Material on the Comprehensibility, Actionability and Quality of the Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Artificial Intelligence
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research was conducted to examine the effect of students' use of AI tools while preparing patient education material on the quality, understandability and actionability of the material in terms of content. Students in the control group used auxiliary tools such as books, journals and websites while preparing patient education materials. Students in the intervention group used AI tools in addition to tools such as books, journals, and websites.

Detailed description: This research was conducted to examine the effect of students' use of AI tools while preparing patient education material on the quality, understandability and actionability of the material in terms of content. Students in the control group used auxiliary tools such as books, journals and websites while preparing patient education materials. Students in the intervention group used AI tools in addition to tools such as books, journals, and websites. Patient Education Materials Assessment Tool and Global Quality Scale were used to evaluate the educational materials.

Eligibility criteria: Inclusion Criteria:

* agreeing to participate in the study,
* taking the Fundamentals of Nursing II course for the first time,
* not working as a nurse in a hospital or any health institution.

Exclusion Criteria:

* not agreeing to participate in the study
* having prepared patient education materials before
* repeating the Fundamentals of Nursing II course
* not having internet access
* not having a computer or smartphone.

Primary outcomes:
measure: Understandability of the material
timeFrame: After the students have completed the materials (5 days later)
measure: Actionability of the material
timeFrame: After the students have completed the materials (5 days later)
measure: Quality of the material
timeFrame: After the students have completed the materials (5 days later)
Secondary outcomes:
Other outcomes:
Locations:
city: Talas
country: Turkey
facility: Sevda Korkut
state: Kayseri
Study officials:
affiliation: TC Erciyes University
name: SEVDA KORKUT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366652: Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Official title: A Randomized, Open-Label, Crossover, Drug Interaction Study to Evaluate the Effects of DVS SR And Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Keywords: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.


Eligibility criteria: 1. Healthy men and women between 18 to 55 years of age.
2. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs and a 12-lead electrocardiogram.
3. History of being a nonsmoker for a least 1 year.

Primary outcomes:
measure: The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
Secondary outcomes:
Other outcomes:
Locations:
city: Neptune
country: United States
state: New Jersey
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06909552: Use of an Educational Video to Improve Adherence to Treatment in Voiding Dysfunction
Official title: Use of an Educational Video to Improve Caregiver Knowledge, Adherence to Recommendations, and Outcomes in Children With Dysfunctional Voiding
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysfunctional Voiding
Keywords: dysfunctional voiding
educational video
treatment adherence
behavioral modification
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to see whether an educational video on a common urinary dysfunction leads to improved parent and child perceived adherence to treatments recommendations.

Detailed description: This study aims to explore whether the use of an educational video on voiding dysfunction, a common urinary dysfunction, leads to improve parents and child perceived adherence to behavioral treatment recommendations. Our main hypothesis explores whether there is improved perceived adherence, and whether this improved perceived adherence leads to better symptom outcomes in this condition.

Eligibility criteria: Inclusion Criteria:

* Parents and Caregivers of pediatric urology patients with a diagnosis of Dysfunctional voiding (minimum 100 participants)
* 5-18 years old, no younger than 5 and no older than 18 years old
* Potty-trained - fully independent with toileting, can complete every step of the process and can do so satisfactorily by themselves.

Exclusion Criteria:

* Children with Voiding dysfunctionDysfunctional voiders with medically complex conditions (neurogenic bladder, POTS, EDS, etc.)
* Parent's child is notNot a first-time patient (i.e. has been seen in the past for dysfunctional voiding)
* Child has severeSevere intellectual disability, developmental delay, or cognitive impairment.

Primary outcomes:
measure: Perceived Adherence
timeFrame: 4 weeks, 8 weeks.
Secondary outcomes:
measure: Video Acceptability
timeFrame: 0 weeks.
measure: Dysfunctional Voiding Scoring System
timeFrame: 0 weeks, 4 weeks, and 8 weeks.
Other outcomes:
Locations:
Study officials:
References:
citation: Feldman AS, Bauer SB. Diagnosis and management of dysfunctional voiding. Curr Opin Pediatr. 2006 Apr;18(2):139-47. doi: 10.1097/01.mop.0000193289.64151.49.
citation: Dyson PA, Beatty S, Matthews DR. An assessment of lifestyle video education for people newly diagnosed with type 2 diabetes. J Hum Nutr Diet. 2010 Aug;23(4):353-9. doi: 10.1111/j.1365-277X.2010.01077.x. Epub 2010 May 20.
Clinical trial NCT02103452: Edessy Stem Cell Score (ESS), Endometrium, Endometrioma
Official title: Edessy STEM CELL SCORE (ESS), Endometrium, Endometrioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis, Ovarian
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non endometriotic ovarian and endometrial tissues.

Detailed description: This study was conducted on 40 women at Al-Azhar University Hospitals. They are divided into two equal groups, group 1 with ovarian endometrioma and group 2 with normal ovary. Ovarian and endometrial samples were evaluated by hematoxlin \& eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE.

Evaluation of IH parameters revealed that the most important factors for evaluating SC were arranged as score ( Edessy Stem Cell Score=ESS).

Eligibility criteria: Inclusion Criteria:

* 20 to 40 years and did not receive hormonal treatment for three month

Exclusion Criteria:

* Diabetes mellitus, cardiovascular and kidney diseases, adenomyosis, Uterine fibroid Endometrial carcinoma and Poly cystic ovary

Primary outcomes:
measure: Edessy Stem Cell Score (ESS)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
Study officials:
affiliation: Al-Azhar University
name: Mahmoud Edessy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Hala hosni, MD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Magdy Olama, MD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Mohammad A Sattar, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Ahmad Monir, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT06631352: Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy
Official title: Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatopancreaticobiliary (HPB) Malignancy
Gall Bladder Cancer
Bile Duct Cancer
Pancreatoduodenectomy
Hepatectomy
Keywords: Hepatopancreatoduodenectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 51 patients who underwent HPD at Seoul National University Hospital between January 2000 and December 2023. One patient who had an R2 resection was excluded from the analysis.

Brief summary: 1. In biliary tract malignancies, achieving a microscopically clear resection margin (R0) is considered the only treatment for a cure.
2. Hepatopancreatoduodenectomy(HPD) has been considered a surgical option for patients with extensive bile duct or gallbladder cancer to achieve an R0 resection.
3. The associated high morbidity and mortality rates have prevented HPD from becoming a standard surgical procedure worldwide.
4. Over the past few decades, the understanding of the bile duct anatomy has significantly improved, and many methods have been developed to assess liver function and future remnant liver volume.
5. We aimed to evaluate the short- and long-term outcomes of HPD and to assess risk factors associated with survival, early recurrence, and major complications to better evaluate the potential of the procedure as a standard treatment.


Eligibility criteria: Inclusion Criteria:

* Patients who received hepatopancreatoduodenectomy between January 2000 and December 2023.

Exclusion Criteria:

* Patients who had R2 resection

Primary outcomes:
measure: 5-year overall survival
timeFrame: assessed up to 60months
measure: 5-year disease-free survival
timeFrame: assessed up to 60months
Secondary outcomes:
measure: Post operative complications
timeFrame: assessed up to 30 days from the surgery
Other outcomes:
Locations:
Study officials:
References: