louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04955730: NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
Official title: Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Surgical Wound Infection
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections


Eligibility criteria: Inclusion Criteria:

* Scheduled surgical procedure for the management of gastrointestinal cancer
* Scheduled surgical procedure planned for incision that will result in wound \>5cm
* Scheduled surgical procedure planned for skin wound that will be closed by primary intention with either: Staples covered by sterile Telfa® and Tegaderm® or Medipore® OR Dermal or subcuticular sutures covered by Octil®
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Scheduled surgical procedure where wound considered dirty
* Scheduled surgical procedure for wound left for closure by secondary intention
* Emergency surgery
* Pregnancy. Pregnancy status is confirmed per protocol the day of surgery in the preoperative space by urine pregnancy test in patient younger than 65 and with intact uterus. Pregnant patient will be excluded from this study
* History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems

Primary outcomes:
measure: Surgical Site Infection - Superficial Incisional
timeFrame: 30 days post operation
measure: Surgical Site Infection - Deep Incisional
timeFrame: 30 days post operation
measure: Surgical Site Infection - Organ/Space Incisional
timeFrame: 30 days post operation
Secondary outcomes:
measure: Return to Intended Oncologic Therapy (RIOT)
timeFrame: Up to 12 months after surgery
measure: Time to Initiation of Planned Oncologic Therapy
timeFrame: Up to 12 months after surgery
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Jose M Pimiento, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Daniel Anaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825730: Follow-up Study for Participants of Jointstem Investigator Initiated Trial by Arthroscopy
Official title: Long-Term Extension Study of Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy in Patients With K-L Grade III Knee Osteoarthritis After 『JOINTSTEM』 Administration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Degenerative Arthritis
Knee Arthritis
Keywords: Stem cell
Adipose tissue derived mesenchymal stem cell
Osteoarthritis
degenerative arthritis
long term
Biostar
Rbio
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial is conducted to assess the long-term safety of "jointstem" in patients with degenerative knee arthritis who participated in the previous BS-JS-IIT1 investigator initiated trial.

Detailed description: JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

This clinical trial is planned to follow-up the long-term safety of "jointstem" in patients with degenerative knee arthritis who participated in the previous BS-JS-IIT1 investigator initiated trial.

Subjects who participate in the BS-JS-IIT1 study and agree to this extension test in writing will be assessed for safety by conducting laboratory tests, vital signs, physical examinations and adverse events every 12 months after Visit 1.

However, after unblinding of the BS-JS-IIT1 investigator initiated trial, subjects in the control group (placebo administration) will terminate the follow-up of this extended clinical trial and conduct routine treatment for degenerative knee arthritis at the discretion of the researcher. Appropriate measures and follow-up observations shall be implemented for abnormal reactions occurred during this extended test period until they are terminated (such as the loss of the relevant adverse event or inability to conduct follow-up investigations).

Eligibility criteria: Inclusion Criteria:

* Participants of Jointstem IIT by arthroscopy (BS-JS-IIT1)
* Participants who signed informed consent document of this study

Exclusion Criteria:

* No applicable

Primary outcomes:
measure: Adverse Events
timeFrame: 60 Month
Secondary outcomes:
measure: Adverse Events (Special Attention Target)
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02372630: The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Official title: The Effect of TRADJENTA ® (LINAGLIPTIN) on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Kaleida Health
First posted: 2015-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single center, prospective randomized double blind, parallel and placebo controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.

Detailed description: This is a single center, prospective randomized double blind, parallel and placebo-controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. The study enrolls type 2 patients with diabetes.

Eligibility criteria: Inclusion Criteria:

Age 20-80 years inclusive. Type 2 diabetes BMI ≥30 kg/m2 Subjects on statins, ACE inhibitors, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.

HbA1c ≤ 8.0%

Exclusion Criteria:

- Use of GLP-1 agonists or DPP-IV therapy in the last 3 months. History of Pancreatitis. Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and hypertriglyceridemia.

Subjects who are taking antiplatelet or anticoagulant medications will be excluded from the fat biopsy portion of the study.

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks Hepatic disease (liver function tests more than 3 times the upper limit of normal) Renal impairment (serum eGFR \<30 ml/min) Any other life-threatening, non-cardiac disease Uncontrolled hypertension (BP \> 160/100 mm of Hg) Congestive Heart Failure class III or IV. Use of an investigational agent or therapeutic regimen within 30 days of study Participation in any other concurrent clinical trial

Primary outcomes:
measure: JNK-1 Protein in MNC
timeFrame: Week 0, Week 2, Week 4, Week 12
Secondary outcomes:
measure: IL-1β mRNA Levels
timeFrame: Week 0, Week 2, Week 4, Week 12
measure: Oxidative Stress (as ROS Generation Level)
timeFrame: Week 0, Week 2, Week 4, Week 12
measure: Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp
timeFrame: At baseline and week 12
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: ECMC Ambulatory Center, 3rd Floor
state: New York
Study officials:
References:
Clinical trial NCT01227330: Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
Official title: Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypercholesterolemia
Medication Adherence
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 43
Sex: ALL
Minimum age (years): 60
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 pilot test a behavioral medication adherence (MA) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia.

Detailed description: This study will answer the following primary research question:

1. What is the estimated effect size of a behavioral MA intervention on MA rates in older adults who are poorly adherent to statin medications?

   The study will also explore the following secondary research questions:
2. What is the estimated effect size of a behavioral MA intervention on low-density lipoprotein cholesterol (LDL-C) levels in older adults?
3. What is the estimated effect size of a behavioral MA intervention on high-density lipoprotein cholesterol (HDL-C) levels in older adults?
4. What is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?

Eligibility criteria: Inclusion Criteria:

* Age 60 or older at the time of study entry,
* Take a once-daily prescription statin medication for ≥ 6 months with no changes to statin prescription for at least 30 days prior to study entry,
* A score of ≤ 9 on the Short Blessed Test,
* Participants must self-administer his or her own medications without prompts from any other person or device.
* Baseline medication adherence rate of ≤ 90%.
* Participants agree to complete all study contacts and measurements, including the use of a special medication bottle with a Medication Event Monitoring System (MEMS) cap for the duration of the study.
* Able to open and close MEMS caps.

Exclusion Criteria:

* Participant's medications are managed by someone other than the participant
* Participant is unable or unwilling to use MEMS caps.

Primary outcomes:
measure: Medication adherence
timeFrame: 6 months
Secondary outcomes:
measure: Serum cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Todd Ruppar, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05521230: Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
Official title: Randomised Clinical Trial on the Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Dental Plaque
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Lacer, S.A.
First posted: 2022-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software


Eligibility criteria: Inclusion criteria were as follows:

* Systemically healthy volunteers
* Age between 20-45 years
* Presence of minimum of 24 permanent teeth
* No evidence of gingivitis or periodontitis (CPITN= 0)
* No presence of untreated caries at the start of the study.

Exclusion criteria were as follows:

* Smoker or ex-smoker
* Presence of dentures or orthodontic appliances
* Antibiotic treatment in the last 3 months or routine use of oral antiseptics

Primary outcomes:
measure: Change in the plaque area: baseline vs 4 days
timeFrame: Baseline, 4 days
measure: Change in the plaque area: baseline vs 8 days
timeFrame: Baseline, 8 days
measure: Change in the plaque area: 4 days vs 8 days
timeFrame: 4 days, 8 days
measure: Change in the growth rate of dental plaque area: baseline vs 4 days
timeFrame: Baseline, 4 days
measure: Change in the growth rate of dental plaque area: baseline vs 8 days
timeFrame: Baseline, 8 days
measure: Change in the growth rate of dental plaque area: 4 days vs 8 days
timeFrame: 4 days vs 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela, Spain
name: Inmaculada Tomás, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901130: Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection
Official title: Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Keywords: Artificial Intelligence
Colonoscopy
Quality Control
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Binzhou Medical University
name: Shengli Oilfield Hospital
name: Linyi People's Hospital
name: Zibo Central Hospital
name: The People's Hospital of Zhaoyuan City
First posted: 2021-05-25
Enrollment: 1254
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: OTHER

Brief summary: The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.

Detailed description: We carried a multicenter randomised controlled trial to assess the performance of this system in quality control of real-time colonoscopy, including the adenoma detection rate (ADR), withdraw time, adequate bowel preparation rate and other indicators.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.

Exclusion Criteria:

* Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
* Patients with a history of colorectal surgery.
* Patients with a contraindication for biopsy.
* Patients with prior failed colonoscopy.
* Patients with known stenosis or obstruction.
* Patients in pregnancy or lactation phase.
* Patients refused to participate in the trial.

Primary outcomes:
measure: Colorectal adenoma detection rate (ADR)
timeFrame: 10 months
Secondary outcomes:
measure: Colorectal polyp detection rate (PDR)
timeFrame: 10 months
measure: The mean number of adenomas detected per colonoscopy (APC)
timeFrame: 10 months
measure: The mean number of polyps detected per colonoscopy (PPC)
timeFrame: 10months
measure: Withdrawl time
timeFrame: During procedure
Other outcomes:
Locations:
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Dezhou
country: China
facility: Linyi People's Hospital
state: Shandong
city: Dongying
country: China
facility: Central Hospital of Shengli Oilfield
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Yantai
country: China
facility: The People's Hospital of Zhaoyuan City
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, PhD
role: STUDY_CHAIR
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03129230: Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients
Official title: Yulin Orthopedics Hospital of Chinese and Western Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Diseases
Lead sponsor: Yulin Orthopedics Hospital of Chinese and Western Medicine
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 16
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in pediatric patients, by presenting the clinic-radiological outcome and complications.


Eligibility criteria: Inclusion Criteria:

1. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck.

Exclusion Criteria:

1. pediatric patients with tumor-like lesions in femoral neck after epiphyseal closure;
2. pediatric patients with benign bone tumors and malignant bone tumors in the femoral neck after epiphyseal closure;
3. adult patients with benign or malignant bone tumors and tumor-like lesions in femoral neck.

Primary outcomes:
measure: change of peri-implant bone level from baseline at 7 and 54 months
timeFrame: 7 months to 54 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Yulin
country: China
facility: Yulin Orthopedics Hospital of Chinese and Western Medicine
state: Guangxi
Study officials:
References:
Clinical trial NCT05569330: Effect of Aerosol Filtering on Infectious Diseases in Day Care
Official title: Effect of Aerosol Filtering on Infectious Diseases in Day Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Respiratory Tract Infection
Diarrhea
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Effect of aerosol flitration and removal on typical infectious diseases such as upper respiratory tract infectinos is studied in day care. Many filtration methods such as filters and electrical filtering are used to remove aerosol particles from room air.


Eligibility criteria: Inclusion Criteria:

* Subject is expected to be in the same day care unit for the duration of the study

Exclusion Criteria:

* Subject is known not to be in the same day care unit for the duration of the study

Primary outcomes:
measure: Incident infections
timeFrame: During the study periods 11/22-4/23 and 11/23-4/24. These are identical for every subject.
Secondary outcomes:
measure: Days absent from work
timeFrame: During the study periods 11/22-4/23 and 11/23-4/24. These are identical for every subject.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: City of Helsinki Day care
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Vartiainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912430: Retrospective Data Analysis of VitalCare Targeted Population Management on Scott and White Chronically Ill Beneficiaries
Official title: Retrospective Data Analysis of the Impact of Vital Care Targeted Population Management Upon a Matched Cohort of Scott and White Health Plan Beneficiaries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Keywords: Integrated Care Coaching
Chronic Care Coaching
Care Coaching
Lead sponsor: Scott & White Health Plan
Sponsor class: INDUSTRY
First posted: 2013-07-31
Enrollment: 17559
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: New payment methods such as Accountable Care Organization (ACO's) and medical homes facilitate are new models for providers to deliver cost effective, quality patient outcomes. Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic interventions with an intelligent information technology platform that offered validated protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated program of Integrated Care Coaching (ICC), which was branded as "VitalCare", and implemented with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for participants.

Detailed description: A prospective, pre-post historical control design trial with a concurrent control group cost/satisfaction analysis with a retrospective clinical study was undertaken with adult, Scott and White Health Plan (SWHP) patients with chronic illnesses. From 2007 to 2010, a total of 7,411 ICC and 10,148 control patients participated. Variables were costs, return on investment (ROI), iterative Patient Health Questionnaire (PHQ)9 scores, and satisfaction.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Having one or more of 21 chronic conditions, including those with depression and multiple chronic comorbidities.

Exclusion Criteria:

* Presence of Major Cancer, HIV, or ESRD in either the baseline or measurement periods
* Claims in excess of $100,000 in either baseline or intervention period.
* Claims for long term care or hospice in either baseline or intervention period.

Primary outcomes:
measure: Return of Investment and Cost of Medical Care
timeFrame: 6 to 12 months
Secondary outcomes:
measure: Level of Depressive Symptoms per Interactive Patient Health Questionnaire (PHQ-9) scores
timeFrame: 6 to 12 months
Other outcomes:
measure: Patient Satisfaction
timeFrame: 6 to 12 months
Locations:
city: Temple
country: United States
facility: Scott & White Health Plan
state: Texas
Study officials:
affiliation: Scott and White Health Plan
name: Marylou Buyse, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: