louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06032949: Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
Official title: Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Keywords: groin infections
quality of life
readmission
groin incisions
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients from 2 populations will be included: high-risk patients (any of the following: redo groin incision, active smoker, A1c \>/= 9.0, BMI \>/= 30) and non-high-risk patients.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Groin incisions in vascular surgery have complications in up to 30% of cases at 30 days, resulting in reductions in patient quality of life and increased costs. Prior attempts at reducing this complication rate have been largely unsuccessful. The purpose of this study is to determine the feasibility of routine Vialize use for vascular surgeries involving a groin incision and to determine the rates of surgical site infection/dehiscence in such patients receiving subcutaneous Vialize.


Eligibility criteria: Inclusion Criteria:

* The study population will consist of patients undergoing vascular procedures with groin incisions. Patients must be at least 18- years-old and able to complete baseline measurements. All subjects will be compensated. Patients undergoing treatment for peripheral arterial disease (e.g., femoropopliteal bypass), aneurysm disease (e.g., aortofemoral bypass), end-stage kidney disease (e.g., loop thigh graft), and miscellaneous procedures (e.g., femoral exposure for delivery of device) will be eligible.

Exclusion Criteria:

* Patients undergoing use of negative pressure wound therapy (e.g., Prevena) and local antibiotic placement (e.g., vancomycin powder) will be excluded. Additionally, organ-transplant recipients will be excluded.

Primary outcomes:
measure: The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
timeFrame: 90-day post-op follow-up
Secondary outcomes:
measure: The patient quality of life (EQ-5D)
timeFrame: 90-day post-op follow-up
measure: return to OR for groin infection
timeFrame: 90-day post-op follow-up
measure: Readmission or prolongation of the index admission for groin infection
timeFrame: 90-day post-op follow-up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Heart & Vascular Hospital
state: Florida
Study officials:
affiliation: COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR
name: Samir Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06159049: Clinical Translation of a Novel FAPI Dimer [68Ga]Ga-LNC1013
Official title: Clinical Translation of a Novel FAPI Dimer [68Ga]Ga-LNC1013
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Cancer
Keywords: FAPI dimer
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Claustrophobia (unable to accept PET/CT scanning)

Brief summary: Fibroblast activation protein (FAP) emerges as a highly promising target for cancer diagnostic imaging and targeted radionuclide therapy. To exploit the therapeutic potential of current FAP inhibitors (FAPIs), this study presented the design and synthesis of a series of FAPI dimers to increase tumor uptake and retention. Preclinical evaluation and a pilot clinical PET imaging study were conducted to screen the lead compound with the potential for radionuclide therapy.

Detailed description: Three new FAPI dimers were synthesized by linking two quinoline-based FAPIs with different spacers. The in vitro binding affinity and preclinical small animal PET imaging of the compounds were compared with their monomeric counterparts, FAPI-04 and FAPI-46. The lead compound, 68Ga-LNC1013, was then evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.

Eligibility criteria: Inclusion Criteria:

1. Histologically and/or clinically confirmed and/or suspicious of gastrointestinal cancer.
2. Signed informed consent.

Exclusion Criteria:

1. pregnancy;
2. breastfeeding;
3. any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Number of discrepancies between [68Ga]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG PET scans
timeFrame: 5 months
measure: SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Jian Li
state: Hunan
Study officials:
affiliation: Xiangya Hospital, Central South University, Changsha, P.R. China
name: Shuo Hu, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT03646149: Improving Housing Outcomes for Homeless Veterans
Official title: Improving Housing Outcomes for Homeless Veterans (CDA 15-074)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Veterans
Homeless Persons
Mentally Ill Persons
Keywords: Social Skills
Housing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-08-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Many homeless Veterans with serious mental illness (SMI) enroll in the VA's Supported Housing (VASH) program but struggle to obtain and sustain housing. Social skills are an important-but underappreciated-determinant of housing outcomes for homeless adults. The investigators hypothesize that homeless Veterans with SMI who participate in a social skills training program, tailored for housing-related social skills, will obtain housing quicker, retain housing longer, and show improved mental health outcomes compared to Veterans with similar needs not participating in such a program.


Eligibility criteria: Inclusion Criteria:

* Identified by VA Greater Los Angeles homeless program staff as a participant in Housing Skills Training:

  * Must have a history of homelessness
  * Must be a Veteran over the age of 18 years
  * Must have a serious mental illness (mood disorder, anxiety disorder, psychotic disorder)

Exclusion Criteria:

None

Primary outcomes:
measure: Client Satisfaction Questionnaire - 8
timeFrame: 12 weeks after baseline assessment at start of intervention
Secondary outcomes:
measure: Percent Days Housed for One Year After Intervention Completion
timeFrame: 1 year
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Sonya Emi Gabrielian, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04225949: Patients Understanding of PROM Graphs
Official title: Patients Understanding of PROM Graphs: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 0
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 evaluates patients' ability to understand PROM scores when presented in graphs. One half will receive one version of the survey, while the other half will receive a second version of the survey.


Eligibility criteria: Inclusion Criteria:

* patient at Stanford Clinics
* orthopaedic condition

Exclusion Criteria:

-

Primary outcomes:
measure: Knowledge test
timeFrame: immediately after completing survey
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00423449: Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)
Official title: A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.


Eligibility criteria: Inclusion Criteria:

* Patient must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment

Exclusion Criteria:

* Patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin
timeFrame: every 21 days (every cycle), up to 126 days (6 cycles)
measure: Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease
timeFrame: every 21 days (every cycle), up to 126 days (6 cycles)
Secondary outcomes:
measure: Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)
timeFrame: every 21 days (every cycle), up to 126 days (6 cycles)
measure: Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)
timeFrame: every 21 days (every cycle), up to 126 days (6 cycles)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05332249: Registry for Degenerative Spinal Disease (RDSD)
Official title: Registry for Degenerative Spinal Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degeneration Spine
Surgery
Keywords: Spine
Outcomes
Degeneration spine
Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are going to take surgery at Seoul National University Hospital.

Brief summary: The outcome after spinal surgery is important and the evidence is critical to develop treatment. The purpose of this study is to make a prospective registry of database for further research.

Detailed description: The outcome after spinal surgery is important and the evidence is critical to develop treatment. The purpose of this study is to make a prospective registry of database for further research.

Included patients Degenerative cervical spinal disease. Degenerative lumbar spinal disease.

Eligibility criteria: Inclusion Criteria:

* Degenerative lumbar spinal disease.
* Degenerative Cervical spinal disease

Exclusion Criteria:

* combined progressive cancer disease

Primary outcomes:
measure: Disability index
timeFrame: 20 years
Secondary outcomes:
measure: C7-sagittal vertical axis (C7-SVA)
timeFrame: 20 years
measure: European quality of life questionnare _ 5 dimension (EQ-5D)
timeFrame: 20 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
Study officials:
affiliation: Seoul National University Hospital
name: Chi Heon Kim, pf.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02213549: Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: KAWAMOTO FOODS CO., LTD.
First posted: 2014-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.


Eligibility criteria: Inclusion Criteria:

* Fasting plasma glucose 105-125 mg/dL

Exclusion Criteria:

* Taking anti-diabetic drugs
* Taking drugs or functional food that may affect blood glucose level
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
* History of severe disease and/or major surgery

Primary outcomes:
measure: Change in fasting plasma glucose from baseline
timeFrame: Every 6 weeks (Overall 12 weeks)
measure: Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
timeFrame: Weeks 0 and 12
Secondary outcomes:
measure: Change in HbA1c from baseline
timeFrame: Weeks 0 and 12
measure: Change in glycoalbumin from baseline
timeFrame: Weeks 0 and 12
measure: Change in fasting insulin from baseline
timeFrame: Weeks 0 and 12
measure: Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
timeFrame: Weeks 0 and 12
measure: Change in serum total cholesterol from baseline
timeFrame: Every 6 weeks (Overall 12 weeks)
measure: Change in serum LDL cholesterol from baseline
timeFrame: Every 6 weeks (Overall 12 weeks)
measure: Change in serum HDL cholesterol from baseline
timeFrame: Every 6 weeks (Overall 12 weeks)
measure: Change in serum triglyceride from baseline
timeFrame: Every 6 weeks (Overall 12 weeks)
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00871949: Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
Official title: A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PNU-100480 (PF-02341272) After First Time Administration Of Ascending Oral Doses To Healthy Adult Subjects Under Fed And Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tuberculosis
Keywords: Safety tolerability pharmacokinetics PK first in human FIH
Lead sponsor: Sequella, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
* Women of non-childbearing potential only.

Exclusion Criteria:

* History of hypersensitivity to, or intolerance of, linezolid.
* Antibiotic treatment within 14 days prior to dosing.

Primary outcomes:
measure: Evaluation of safety and tolerability of escalating single oral doses of PNU-100480.
timeFrame: Daily, Days 1-3 or 4, and 7-14 days after dosing.
Secondary outcomes:
measure: Characterize pharmacokinetics of single oral doses PNU-100480.
timeFrame: Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.
measure: Characterize the effect of food on the pharmacokinetics of a single oral dose of PNU-100480.
timeFrame: Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.
measure: Characterize the bactericidal activity in blood of orally administered PNU-100480 against intracellular Mycobacterium tuberculosis in relation to blood concentrations of PNU-100480 (and its metabolites) (some periods only)
timeFrame: Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Sequella, Inc.
name: Lisa Beth Ferstenberg, M.D.
role: STUDY_DIRECTOR
References:
citation: Wallis RS, Jakubiec WM, Kumar V, Silvia AM, Paige D, Dimitrova D, Li X, Ladutko L, Campbell S, Friedland G, Mitton-Fry M, Miller PF. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010 Sep 1;202(5):745-51. doi: 10.1086/655471.
Clinical trial NCT03094949: Comparison Between Partial Nephrectomy and Ablation for Renal Tumor
Official title: Comparison Between Laparoscopic Partial Nephrectomy and Ultrasound Guided Percutaneous Microwave Ablation for T1a Renal Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: microwave ablation
partial nephrectomy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The therapeutic effectiveness of ultrasound guided cooled-probe microwave ablation and laparoscopic partial nephrectomy on T1a renal cell carcinoma is compared to find a better approach for renal tumor.


Eligibility criteria: Inclusion Criteria:

* Patients with the RCC of ≤4 cm maximum diameter were included in the study.

Exclusion Criteria:

* Patients having RCCs with vascular invasion, extrarenal spread or with benign renal tumors were excluded.

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: local tumor progress(new lesion found adjacent to ablation zone)
timeFrame: 5 years
measure: rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone)
timeFrame: 5 years
measure: rate of extrarenal metastasis(new lesion found outside of treated kidney)
timeFrame: 5 years
measure: number of patients with side-effect and major complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05684549: Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer
Official title: Effects of Coronavirus Infection (COVID-19) on the Timing and Prognosis of Radical Surgery in Patients With Early-stage Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgery
Corona Virus Infection
Keywords: Lung cancer
Surgery
Corona Virus Infection
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 2000
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: Patients with clinically diagnosed stage I or stage II lung cancer who are about to receive radical surgery.

Brief summary: The goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. The main question it aims to answer is whether the interval of surgery and COVID-19 infection will affect the surgery and prognosis of the patients.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed stage I and stage II lung cancer, who are about to receive wedge resection, segmental resection, sleeve resection, lobectomy, or pneumonectomy under general anaesthesia.
* Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent.
* ASA score: I-III;
* Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria:

* Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
* Clinically diagnosed stage III and stage IV lung cancer or patients who received neoadjuvant treatment before surgery;
* Patients developed symptoms alike coronavirus infection but are not confirmed by viral RNA detection by quantitative RT-PCR or antigen testing kits.
* Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation

Primary outcomes:
measure: postoperative morbidity
timeFrame: postoperative in-hospital stay up to 30 days
Secondary outcomes:
measure: postoperative hospital stay
timeFrame: postoperative in-hospital stay up to 30 days
measure: operation time
timeFrame: At operation day
measure: R0 rate
timeFrame: postoperative in-hospital stay up to 30 days
measure: blood loss
timeFrame: At operation day
measure: 30-day mortality
timeFrame: postoperative in-hospital stay up to 30 days
measure: quality of life
timeFrame: postoperative in-hospital stay up to 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: