louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02581904: Prevena Vascular Groin Wound Study
Official title: Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Wound Infection
Peripheral Arterial Disease
Aneurysm
Surgical Wound Dehiscence
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 150
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 determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

Detailed description: The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study

Exclusion Criteria:

* Emergency procedure
* Unable to give informed consent

Primary outcomes:
measure: Groin Wound Complication
timeFrame: 30 days
Secondary outcomes:
measure: Hospital Length of stay
timeFrame: 30 days
measure: Return to Operating Room
timeFrame: 30 days
measure: Hospital Readmission
timeFrame: 30 days
measure: Index Hospital Cost
timeFrame: 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Paul DiMuzio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.
Clinical trial NCT05796804: Erector Spinae Block Versus PENG Block for Hip Replacement
Official title: Erector Spinae Block Versus PENG Block for Postoperative Analgesia After Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Papa Giovanni XXIII Hospital
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 64
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: THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. However, no studies investigated the analgesic superiority of either PENG or ESPB. In our study the investigators compare PENG (with a lateral femoral cutaneous nerve block) and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.


Eligibility criteria: Inclusion Criteria:

* primary total hip replacement
* informed consent

Exclusion Criteria:

* allergies to study drugs
* spinal anesthesia contraindicated
* kidney failure
* epilepsy, psychiatric disease, neurologic deficits
* revision surgery
* neuropathies in the lumbar area
* no informed consent
* pregnancy
* alcohol/opioid abuse
* emergency surgery/intensive care

Primary outcomes:
measure: morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative pain
timeFrame: 48 hours
measure: neuropathic pain
timeFrame: 48 hours
measure: postoperative complications
timeFrame: 48 hours
measure: chronic postoperative pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Aast Papa Giovanni Xxiii
Study officials:
References:
Clinical trial NCT04824404: CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
Official title: Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Clemson University
First posted: 2021-04-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.

Detailed description: In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.

Eligibility criteria: Inclusion Criteria:

* adults (≥18 years)
* having a DSM-V diagnosis of OUD
* sublingual buprenorphine/naloxone and/or buprenorphine
* having initiated maintenance treatment for OUD for at least 30 days before the screening
* self-report or toxicology screening positive for any substance within 30 days of screening;
* willing to accept a random assignment to either TAU/CBT4CBT-Buprenorphine + Recovery Coach;
* having adequate computer skills

Exclusion Criteria:

* having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician)
* being pregnant or breastfeeding;
* being unable to independently read and/or comprehend the consent form or other study materials
* being unable to read/speak English;
* having current suicidal ideation based on the Patient Health Questionnaire-9.

Primary outcomes:
measure: Change in drug use
timeFrame: 0-8 weeks
Secondary outcomes:
measure: Retention to buprenorphine
timeFrame: 3 month follow up
measure: Change in drug use
timeFrame: 1 and 3 month follow up
Other outcomes:
measure: Commission errors
timeFrame: 0-8 weeks
measure: Selective attention
timeFrame: 0-8 weeks
measure: Cognitive performance through Electroencephalogram
timeFrame: 0-8 weeks
Locations:
city: Greenville
country: United States
facility: Internal Medicine Recovery Clinic
state: South Carolina
Study officials:
References:
Clinical trial NCT00712504: Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer
Official title: A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Non Small Cell Lung Cancer
Keywords: advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 49
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: This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

Advanced solid tumor malignancy ECOG 0 or 1

Exclusion Criteria:

Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy

Primary outcomes:
measure: Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
timeFrame: November 2007
Secondary outcomes:
measure: Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.
timeFrame: November 2007
measure: Objective disease response
timeFrame: November 2007
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05166304: Rebamipide in Patients With Active Rheumatoid Arthritis
Official title: Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Minia University, faculty of medicine
name: Sohag University, Faculty of pharmacy
First posted: 2021-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the aetiology of RA remains to be fully elucidated, interleukin (IL)-17 are believed to play a critical role in the pathogenesis of RA. Rebamipide is an antiulcer drug that protects gastric epithelial cells,improves gastric defense mechanisms by increasing gastric mucus. Rebamipide inhibited interleukin (IL)-17, also it inhibits IL-1β-induced RASF proliferation.


Eligibility criteria: Inclusion Criteria:

* patients with active rheumatoid arthritis (disease activity score-28 joints: DAS-28 \> 3.2) based on the 2010 American College of Rheumatology (ACR) criteria16 were recruited.

rheumatoid Patients who received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.

Exclusion Criteria:

1. History of biological DMARDS.
2. History of gastrointestinal surgery, GI ulceration,GI bleeding
3. Intolerance or allergy to rebamibide or methotrexate
4. Smoking or alcohol abuse
5. Any changes in using medication (changing the dosage or type of medicines)
6. Receive hormone replacement therapy, warfarin, and other anticoagulants

Primary outcomes:
measure: ACR20
timeFrame: at baseline and at week 12
measure: Disease activity scale in 28 joints (DAS-28)
timeFrame: at baseline and at week 12
Secondary outcomes:
measure: HAQ-DI (Health Assessment Score- Disability index)
timeFrame: at baseline and at week 12
measure: CRP
timeFrame: at baseline and at week 12
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
affiliation: Minia University
name: Esraa Abdallah
role: PRINCIPAL_INVESTIGATOR
affiliation: October 6 University
name: Engy Wahsh
role: STUDY_CHAIR
affiliation: Sohag University
name: Asmaa Elsayed
role: STUDY_DIRECTOR
References:
Clinical trial NCT02856204: Shotgun Sequencing in Diagnosing Febrile Neutropenia in Patients With Acute Myeloid Leukemia
Official title: Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Febrile Neutropenia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients (at Stanford Hospital and Clinics) with acute myelogenous leukemia (AML), who are expected to have neutropenia (defined as absolute neutrophil count \< 500 / cubic mm) lasting ≥ 7 days after chemotherapy

Brief summary: This research trial studies the shotgun sequencing of blood samples in diagnosing febrile neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help identify pathogens and accurately diagnose infections such as febrile neutropenia.

Detailed description: PRIMARY OBJECTIVES:

I. To test the hypothesis that shotgun metagenomics is not inferior to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.

SECONDARY OBJECTIVES:

I. To establish a microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis.

OUTLINE:

Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with febrile neutropenia
* A primary diagnosis of acute myeloid leukemia (AML)

Exclusion Criteria:

* Prior history of febrile neutropenia

Primary outcomes:
measure: Detection of pathogens in patients with febrile neutropenia assessed by shotgun metagenomics
timeFrame: Up to 6 weeks
measure: Number and frequency of novel pathogens found
timeFrame: Up to 6 weeks
measure: Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen
timeFrame: Up to 6 weeks
measure: Proportion of patients with false negative
timeFrame: Up to 6 weeks
measure: Proportion of patients with false positives
timeFrame: Up to 6 weeks
measure: Proportion of patients with mitochondrial DNA detected
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis assessed by shotgun metagenomics
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Stanley Deresinski
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Steven Coutre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00140504: Preventing Adverse Drug Events With PatientSite
Official title: Preventing Adverse Drug Events With PatientSite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Event
Keywords: Adverse drug event
Patient safety
Internet portal
PatientSite
Preventive health
Primary care
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Blue Cross Blue Shield
name: Beth Israel Deaconess Medical Center
First posted: 2005-09-01
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a study to better understand the nature and extent of adverse drug events (ADEs), defined as injuries due to prescription medications, in primary care. We will study whether PatientSite (an internet-based communication program for patients and health care providers) can improve clinicians' ability to detect adverse drug events among primary care patients and to mitigate the consequences by sending electronic queries to patients after they receive new medication prescriptions.

Detailed description: * A drug safety module called MedCheck was developed for PatientSite. This allows physicians to query patients automatically 10 days after they receive a new prescription asking them questions about their new prescription. In this study new enhancements will be tested.
* Participants will be assigned at random to the intervention group or control group. The intervention group will receive a single electronic PatientSite message asking them questions about the new prescription which is then forwarded to their physician. The control group will receive a generic message about medication safety.
* To identify adverse drug events, a telephone survey and medical record review will be conducted of patients in the intervention group and controls.
* This study will run for 12 months.

Eligibility criteria: Inclusion Criteria:

* Adult patients \>18
* Patients that receive a new prescription
* Proficient in spoken and written english

Exclusion Criteria:

Primary outcomes:
measure: To prevent adverse drug events with PatientSite.
timeFrame: 3 years
Secondary outcomes:
measure: Improve patient satisfaction
timeFrame: 3 years
measure: better utilization of services
timeFrame: 3 years
measure: improve patient-clinician communication
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Saul N Weingart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weingart SN, Carbo A, Tess A, Chiappetta L, Tutkus S, Morway L, Toth M, Davis RB, Phillips RS, Bates DW. Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. J Patient Saf. 2013 Sep;9(3):169-75. doi: 10.1097/PTS.0b013e31829e4b95.
Clinical trial NCT03648801: A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.
Official title: A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension, Dyslipidemia
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient diagnosed with hypertention and dyslipidemia

Brief summary: Post-marketing surveillance of Telostop Plus Tab.

Detailed description: This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Eligibility criteria: Inclusion Criteria:

* The patient who is first prescribed and administered Telostop plus Tab.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* The patients with severe renal impairment

Primary outcomes:
measure: Incidence of adverse event after this drug administration in general medical practice
timeFrame: 24 weeks
measure: Incidence of serious adverse event after this drug administration in general medical practice
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04396301: Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco
Official title: Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Corneal Endothelial Cell Loss
Mydriasis
Cataract
Keywords: corneal endothelial cell count
Fydrane
mixed mydriatic and anaesthetic combination
intracameral mydriatic
mydriasis
phacoemulsification
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.

Detailed description: in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.

Eligibility criteria: Inclusion Criteria:

* medium density cataract (nuclear II to III)

Exclusion Criteria:

* soft or hard density cataract (nuclear I or IV)
* history of ocular trauma or previous intraocular surgery
* iatrogenic, congenital or traumatic cataract
* associated eye disease e.g. pseudoexofoliation syndrome
* associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy
* associated systemic disease that can affect endothelium,

Primary outcomes:
measure: safety of intracameral Fydrane on endothelial cell count
timeFrame: 3 weeks postoperative
Secondary outcomes:
measure: effect of Fydrane on pupil diameter during phacoemulsification
timeFrame: pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University - Kasr Alainy hospital
Study officials:
References: