louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04712617: Overlap FGIDs and Genetic Polymorphism
Official title: Sex and Gender Difference in Overlap Syndrome of Functional Gastrointestinal Disorder and the Effect of Genetic Polymorphism in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Gastrointestinal Disorders
Overlap Syndromes
Keywords: functional gastrointestinal disorder
overlap syndromes
functional dyspepsia
irritable bowel syndrome
non-erosive reflux disease
reflux hypersensitivity
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who were diagnosed with NERD/RH, FD, IBS and their overlaps (NERD/RH-FD, NERD/RH-IBS, FD-IBS, NERD/RH-FD-IBS) and healthy controls.

Brief summary: 1. To analyze the prevalence of overlap syndromes among NERD or RH, FD, and IBS patients, and to identify and to compare the differences in their characteristics and symptoms, and to determine their risk factors.
2. To identify the differences in clinical features according to sex and gender.
3. To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up period.


Eligibility criteria: Inclusion Criteria:

FGID group

* No organic diseases in routine laboratory tests, abdominal imaging, esophagogastroscopy, and colonoscopy
* NERD or reflux hypersensitivity (RH): typical heartburn occurring at least once a week without visible esophageal mucosal break detected by endoscopy
* FD or IBS: based on the Rome III criteria

Control group

- Subjects who underwent GI evaluations as part of health check-up or for other problems, such as mild abdominal discomfort or pain for a relatively short period of time, but had no organic problems during GI endoscopy

Exclusion Criteria:

* history of GI surgery except appendectomy
* inflammatory bowel disease
* any malignancy, or systemic diseases requiring chronic medication except for hypertension and diabetes mellitus
* pregnant or lactating women
* hepatic, biliary, or psychiatric disorders requiring medication.

Primary outcomes:
measure: Symptom severity score (5 Likert scale, from 0 to 4)
timeFrame: per 16 years
measure: Hospital anxiety and depression scale (HADS)
timeFrame: per 16 years
measure: Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene
timeFrame: per 16 years
Secondary outcomes:
measure: Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients
timeFrame: per 16 years
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06550817: Growth Mindset Intervention for Older Adults With Chronic Disease
Official title: Growth Mindset Intervention Improves Positive Response to E-Health for Older Adults With Chronic Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Lead sponsor: Huzhou University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 77
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was conducted to develop and investigate the effectiveness of a growth mindset intervention based on growth mindset theory.

Detailed description: The study employed a quasi-randomized controlled trial design conducted over 12 weeks. Before conducting the study, the researchers numbered the wards of internal medicine departments (excluding intensive care units) according to the order of bed number. The wards were then randomly divided into intervention wards and control wards using a random number generator. Patients were recruited to the control group (e-health only) in the control ward and the intervention group (growth mindset intervention+ e-health) in the intervention unit. Participants in the control group could undergo the training after the study concluded.

Eligibility criteria: Inclusion Criteria:

* aged≥60 years
* diagnosed≥1 chronic disease
* owned at least one smartphone
* could communicate clearly in writing or orally
* were willing to participate in this study

Exclusion Criteria:

* could not use WeChat or phone to communicate
* diagnosed as mental illness or cognitive impairment
* suffered from acute severe disease or lost self-care ability
* undergoing other similar training

Primary outcomes:
measure: Implicit Theories of Intelligence Scale-6
timeFrame: Baseline,Week 6, and Week 12
measure: Questionnaire of Knowledge, Willingness, Confidence, and Practice of Smart Medicine (KWCP-SM)
timeFrame: Baseline,Week 6, and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Huzhou
country: China
facility: School of Medicine and Nursing， Huzhou University
state: Zhejiang
city: Huzhou
country: China
facility: School of Nursing Huzhou University
state: Zhejiang
Study officials:
affiliation: Huzhou University
name: Meijuan Cao
role: STUDY_CHAIR
References:
Clinical trial NCT03878017: A Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .
Official title: Feasibility of a Novel Method of Axilla Staging by Using Ultrasound Visible Clips to Mark the Involved Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2019-03-18
Enrollment: 15
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy


Eligibility criteria: Inclusion Criteria:

* breast cancer patients with involved axillary LN \<3,
* going for neoadjuvant chemotherapy

Exclusion Criteria:

-stage 4 breast cancer patients

Primary outcomes:
measure: retrieval rates of the clipped node using this novel technique
timeFrame: at an average of a year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Geok H Lim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01616017: Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique
Official title: Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Post Surgery Patients
Keywords: Cardiac output
ultrasound dilution
thermodilution
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-06-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age ≥ 18 years of age Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

Brief summary: Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest in less invasive methods of measuring CO. This study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution (COUD).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age
* Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

Exclusion Criteria:

* Age \< 18 years of age
* Patients with structurally abnormal heart (e.g. shunt) (confirmed by history taking)
* Patients who have heparin allergy. (Confirmed by history taking)

Primary outcomes:
measure: Compare Cardiac Output Measurements
timeFrame: During the stay in the ICU with in situ catheters (expected avg 3 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
Study officials:
References:
Clinical trial NCT00729417: Obstetrical Risk Factors for the Development of Urinary and/or Fecal Incontinence
Official title: Obstetrical Risk Factors for the Development of Urinary and/or Fecal Incontinence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstetric Risk Factors
Keywords: incontinence
obstetric risk factors
women
of age 18
above
Lead sponsor: Maaynei Hayesha Medical Center
Sponsor class: OTHER
First posted: 2008-08-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of age 18 or above

Brief summary: Evaluation of Obstetrical Risk Factors for the development of Urinary and/or Fecal Incontinence according to a questionaire

The questionaire will be filled by the study investigators after the women participating in the study sign their consent. The study is based solely on a questionaire and does not include any physical examination, blood exam or intervention.

The study will be performed on the premises of Maaynei Hayeshua medical center. The inclusion criteria include women above the age of 18 who arrive to Maaynei Hayeshua Medical center for any reason. The data will be transferred to a computerized data base and analyzed statistically.


Eligibility criteria: Inclusion Criteria:

* women of age 18 or above

Exclusion Criteria:

* women under the age of 18
* men

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05725317: Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses
Official title: Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

Detailed description: The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

Eligibility criteria: Key Inclusion Criteria:

* Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Habitual monovision or multifocal contact lens wearers.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Kindred Optics at Maitland Vision
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Franklin Park
country: United States
facility: Franklin Park Eye Center PC
state: Illinois
city: New York
country: United States
facility: SUNY College of Optometry Clinical Vision Research Center
state: New York
city: Wyomissing
country: United States
facility: Wyomissing Optometric Center
state: Pennsylvania
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: Wichita Falls
country: United States
facility: Clarke Eyecare Center
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06202417: Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study
Official title: Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Refractory Colorectal Cancer
Metastatic Colorectal Cancer
Keywords: Fruquintinib
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 520
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: Patients diagnosed with refractory mCRC and administered fruquintinib from January 1, 2021 to June 31, 2022

Brief summary: Fruquintinib is an oral tyrosine kinase inhibitor (TKI), which improves progression-free survival (PFS) and overall survival (OS) in patients with refractory metastatic colorectal cancer (mCRC). Here, we explore the real-world treatment patterns of fruquintinib in the third- or late-line setting for mCRC in six centers in China.


Eligibility criteria: Inclusion Criteria:

(1) histology-confirmed metastatic CRC (mCRC); (2) disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab; (3) fruquintinib administered as salvage treatment; (4) available clinical data.

Exclusion Criteria:

(1) lack of follow-up data; (2) fruquintinib administration as second-line treatment; (3) fruquintinib administration stopped after less than two cycles.

Primary outcomes:
measure: PFS
timeFrame: Three years
measure: OS
timeFrame: Three years
measure: DCR
timeFrame: During the medication period
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianmin Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02843217: Regional Native American Community Networks Program (RNACNP)
Official title: Innovations in Enhancing Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2016-07-25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Aim: Determine the overall effectiveness of a targeted digital messaging intervention at improving colorectal cancer (CRC) screening rates compared to care as usual.

Hypothesis: Screening rates will be higher for patients who receive the digital messaging intervention, compared to the control group in which patients receive care as usual.

Detailed description: Native People for Cancer Control is one of the projects under Partnerships for Native Health, and is 1 of 23 Community Networks Programs funded by the National Cancer Institute. The aim of Native People for Cancer Control is to reduce cancer health disparities by conducting training, research, education and outreach, in collaboration with American Indian and Alaska Native communities. We do this work in partnership with Native people, communities, and organizations in an 8-state area, including: Alaska, Washington, Wyoming, Oregon, Idaho, Montana, North Dakota, and South Dakota. Our program consists of 4 cores:

Administrative Core: assists with grant administration, budgeting, sub-contracts with Tribes, program planning, and reporting.

Outreach/Education Core: assists with cancer education, outreach, health promotion, and cancer prevention activities among urban and rural AI/AN people.

Training Core: builds capacity for Native faculty-level investigators, and students, to conduct research.

Research Core: conducts community-based participatory research on colorectal cancer screening, health literacy, health communication, and cancer risk factors among American Indian and Alaska Native people.

The main research project under Native People for Cancer Control is titled, "Innovations in Enhancing Colorectal Cancer Screening". The goal of this project is to develop, implement, and evaluate a community wide, multi-media campaign to improve colorectal cancer screening among American Indians and Alaska Natives in 3 communities.

Eligibility criteria: Inclusion Criteria:

* AI/AN
* Age 50-75
* Active clinical patient

Exclusion Criteria:

* Not AI/AN

Primary outcomes:
measure: Colorectal Cancer Screening, beginning age 50
timeFrame: 9 month intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pullman
country: United States
facility: Washington State University
state: Washington
Study officials:
References:
Clinical trial NCT06743217: TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMIES IN ELDERLY PATIENTS
Official title: IS THERE A DIFFERENCE IN TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMY IN ELDERLY PATIENTS COMPARED TO OTHERS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Keywords: Acute Cholecystitis
Textbook Outcome
Emergency Surgery
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years old and underwent emergency cholecystectomy

Brief summary: Textbook outcome is a measure used to assess the quality of surgical practice. The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\&lt;65 years ) via using aforementioned criteria

Detailed description: Textbook outcome is a measure used to assess the quality of surgical practice and has been implemented in various areas of surgical literature. It is defined as an uneventful operative and postoperative period that leads to successful surgery without negative outcomes. There is still no consensus on the textbook outcome concept for emergency cholecystectomy. SPRIMACC Collaborative Study has presented and offered a list of textbook outcome criteria.

Their proposal was: no 30-day mortality, no 30-day postoperative complications (any CD≥I is considered non-TO), no readmission within 30 days, and hospital stay≤7 days (75th percentile) and full laparoscopic surgery.

The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\&lt;65 years ) via using aforementioned criteria

Eligibility criteria: Inclusion Criteria:

* All patients underwent emergency cholecystectomy with a diagnosis of acute choleystitis

Exclusion Criteria:

* Patients underwent open surgery directly. Patients diagnosed as malignant postoperatively in the pathology report

Primary outcomes:
measure: Textbook Outcome
timeFrame: 30 days
Secondary outcomes:
measure: Subtotal cholecystectomy
timeFrame: 1 day
measure: Postoperative Serious Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery
Study officials:
affiliation: University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery, Istanbul,Türkiye
name: Yasir Musa Kesgin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00104117: Study of XL999 in Adults With Solid Tumors
Official title: A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2005-02-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumor
* Cancer that has progressed on currently available therapies
* Life expectancy of \>3 months
* Adequate bone marrow, liver, and kidney function
* Willing to use accepted method of contraception during the course of the study
* Negative pregnancy test (females)
* Written informed consent

Exclusion Criteria:

* Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
* Radiotherapy within 4 weeks of the start of treatment
* Subjects with known brain metastasis
* Uncontrolled medical disorder such as infection or cardiovascular disease
* Subjects known to be HIV positive
* Pregnant or breastfeeding women

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors
timeFrame: Inclusion until 30 days post last treatment
Secondary outcomes:
measure: To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors
timeFrame: Various timepoints from pre-dosing until 48 hours post dose.
measure: To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.
timeFrame: At various timepoints from pre-dosing until 48 hours post dosing
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University, Univserzity Hospitals of Cleveland
state: Ohio
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center, Institute for Drug Development
state: Texas
Study officials:
affiliation: Exelixis
name: Paul Woodard, MD
role: STUDY_DIRECTOR
References: