louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05160155: Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block
Official title: Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block for Rib Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rib Fractures
Serratus Anterior Plane Block
Erector Spinae Plane Block
Acute Pain
Keywords: Rib Fractures
Serratus Anterior Plane Block
Erector Spinae Plane Block
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. Many of these adverse outcomes result from poorly controlled pain that interferes with breathing, leading to atelectasis, pneumonia, and respiratory failure. Therefore, early provision of adequate analgesia is crucial in the management of these patients. The basic stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. However, patients with more significant injuries or comorbidities often require interventional procedures to provide adequate analgesia and avoid opioid-related side effects. Thoracic epidural analgesia and thoracic paravertebral blocks have traditionally been used, but these techniques are associated with side effects and may cause hemodynamic instability. Today, the use of ultrasonography (USG) guided block techniques such as erector spinae plane block (ESPB), serratus anterior plane block (SAPB) and intercostal block (ICB) has increased. These techniques are considered to be simpler and theoretically safer. Although ICB is frequently mentioned in the literature, the publications of new plane blocks such as ESPB and SAPB are new and few in number. In this study, SAPB and ICP to be performed with USG will be evaluated in terms of analgesic effect.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-30 kg/m2
* Patients with 6 or less rib fractures

Exclusion Criteria:

* Patient refusing the procedure
* History of chronic analgesic or opioid therapy
* History of local anesthetic allergy
* Infection in the intervention area

Primary outcomes:
measure: Pain scores
timeFrame: 24 hours after block
Secondary outcomes:
measure: Need for additional analgesia
timeFrame: 24 hours after block
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
affiliation: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Musa Zengin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00382655: Prehospital Screening to Prevent Injury and Illness
Official title: Prehospital Screening to Prevent Injury and Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: All Conditions
Keywords: Prevention
Emergency Medical Services
Emergency Medical Technicians
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: The John A. Hartford Foundation
name: University of Chicago
First posted: 2006-09-29
Enrollment: 700
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this project is to prevent injuries and diseases among older adults through the development and evaluation of a novel emergency medical services (EMS)-based screening program to identify preventable injuries and diseases and refer the identified injuries and diseases for intervention.

To prevent injuries and diseases among older adults, this study specifically aims to:

1. Evaluate the feasibility of an EMS-based primary prevention program that screens older adults for need of the influenza and pneumococcal vaccine and for risk of falling during emergency medical responses in a rural setting;
2. Evaluate the outcome of the EMT-implemented screening and education program by performing a 14-day telephone follow-up on older adults cared for by EMTs.

At the conclusion of this award, we will determine if an EMT-implemented primary prevention program for older adults is feasible and benefits the community.


Eligibility criteria: Inclusion Criteria:

* Age 65 or older;
* Request assistance from intervention group EMS agency
* Request assistance from control group EMS agency
* Request assistance between February 2003 and June 2005

Exclusion Criteria:

* Institutionalized
* Previous inclusion in study
* Unable to communicate in English

Primary outcomes:
measure: Receipt of immunizations
measure: Changes to home to prevent falls
Secondary outcomes:
measure: Discussion with physician regarding preventable diseases
measure: Recollection of receiving educational materials
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Department of Emergency Medicine
state: New York
Study officials:
affiliation: University of Rochester
name: Manish N. Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04372355: Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
Official title: Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer (DFU)
Uncontrolled Diabetes With Foot Ulcer
Keywords: DFU
WF10
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
Collaborators: name: Oxo Chemie(Thailand) Co.,Ltd.
name: Altermed Co.,Ltd.
First posted: 2020-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: T2DM patients with DFU and HbA1c \> 8.5%
Primary purpose: TREATMENT

Brief summary: Study in adult Diabetes Mellitus patients with diabetic foot ulcers and elevated HbA1c who will receive standard wound treatment in combination with adjuvant therapy WF10 to compare the change of HbA1c levels at baseline and after treatment.

Detailed description: Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Diabetes Mellitus type II
* Patient male or female 18-80 years old
* Presence of Diabetic foot ulcer/non-healed stump, starting at least 3 weeks before or infected wound degree 3-4
* HbA1c \> 8.5%
* Hematocrit \> 30%

Exclusion Criteria:

* Kanofsky performance status \< 60
* Patient with ABI (Ankle Brachial index) \< 0.4
* Patient who receive steroid ,chemotherapeutic drug
* Pregnant or lactating woman
* Patient had a history of organ transplantation, and using immunosuppressive drug
* Patient with end-stage renal disease requiring hemodialysis, or history of G6PD or severe thalassemia, or ischemic heart disease, Congestive heart failure, Heart arrhythmia
* Patient who is participating in another clinical study or have done it in the past 30 days.

Primary outcomes:
measure: HbA1c change at Week 8 in comparison to Baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: HbA1c change at Week 12 in comparison to Baseline
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ongkharak
country: Thailand
facility: HRH Princess Maha Chakri Sirindhorm Medical Center
state: Nakhon Nayok
Study officials:
affiliation: Srinakharinwirot University
name: Narongchai Yingsakmongkol, MD, FRCST
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982055: Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients
Official title: Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Lead sponsor: Clinique Saint Pierre Ottignies
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients

Detailed description: The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.

Eligibility criteria: Inclusion Criteria:

* Adults patients \> 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated

Exclusion Criteria:

* renal failure determined by glomerular filtration rate (GFR) \< 30 ml/min or need for renal replacement therapy
* liver cirrhosis
* intravascular disseminated coagulation
* contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,...)
* patients receiving low dose of vasopressor (norepinephrine \< 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)

Primary outcomes:
measure: Peak anti-Xa activity
timeFrame: Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
Secondary outcomes:
measure: Trough anti-Xa activity
timeFrame: Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
measure: AUC (0-24h)
timeFrame: 0-24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: De Schryver N, Serck N, Eeckhoudt S, Laterre PF, Wittebole X, Gerard L. Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial. J Crit Care. 2022 Aug;70:154029. doi: 10.1016/j.jcrc.2022.154029. Epub 2022 Apr 2.
Clinical trial NCT04051255: Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis.
Official title: Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis Treated With Non-surgical Mechanical Therapy Associated With Systemic Antibiotic Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Aggressive Periodontitis
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of smoker patients with AgP is considered a challenge to periodontists. To date, only one controlled clinical study (De Genaro Modanese et al., 2016) evaluated the effect of full mouth ultrasonic debridment (FMUD) on smokers with aggressive periodontitis. Its results showed significant improvements in clinical parameters (plaque index PI, bleeding on probing- BoP and probing depth-PD), and immunologic (reductions in interleukin 6- IL-6, tumor necrosis factor- α TNF-α levels), although the results were more favorable for non-smoking patients. Antimicrobials associated to mechanical therapy has been extensively studied (Hafajee et al., 2003, Heitz-Mayfield, 2006). The association of Amoxicillin and Metronidazole have had good clinical and microbiological results in randomized clinical trials in the treatment of AgP (Casarin et al., 2012, Sgolastra et al., 2012, Keestra et al., 2015).

Thus, this study investigates clinical, microbiological and immunological influence of smoking in the periodontal debridement associated to Amoxiciclin and Metronidazole of young individuals with pronounced periodontal destruction, compared with non-smokers individuals.


Eligibility criteria: Inclusion Criteria:

* diagnosis of generalized aggressive periodontitis, according to the American Academy of Periodontology-AAP, 1999;
* presence of at least 15 teeth;
* presence of at least 6 teeth containing 6 deep sites (≥ 7 mm), which are not located in bifurcation areas and
* present less than 20% of plaque index (PI) and bleeding on probing (BoP).

Exclusion Criteria:

* presence of periapical or pulpar alteration;
* presence of systemic alteration or use of medications (6 months prior to the study) that may influence the response to periodontal treatment;
* pregnant and lactating women;
* performing periodontal treatment including subgingival instrumentation in the 6 weeks preceding the study;
* teeth with bifurcation involvement;
* teeth with marked mobility;
* oral pathology;
* history of allergy to any component of the study, and
* previous periodontal surgery in the region of interest.

Primary outcomes:
measure: Clinical attachment level (CAL) changes at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: University of Campinas, UNICAMP
state: Sao Paulo
Study officials:
References:
Clinical trial NCT03047655: Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
NAFLD
Obesity
Hypertension
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now.

"GesundLeben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.

Detailed description: A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. We intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. Using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample.

The "GesundLeben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. The cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance.

Standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, HbA1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (BMI, WHR, BIA).

Eligibility criteria: Inclusion Criteria:

* hypertension
* NAFLD
* obesity
* hyperuricemia
* dyslipoproteinemia

Exclusion Criteria:

* prediabetes / overt diabetes mellitus
* present cancer
* systemic infection
* chronic inflammatory disease
* recent stroke / myocardial infarction (6 months)
* pregnancy
* addiction / severe psychiatric diseases

Primary outcomes:
measure: change in lipidome pattern
timeFrame: 6 weeks
measure: reduction of blood pressure
timeFrame: 6 weeks
measure: NAFLD reduction
timeFrame: 6 weeks
measure: weight loss
timeFrame: 6 weeks
Secondary outcomes:
measure: reduction of insulin resistance
timeFrame: 6 weeks
measure: improvement in quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bergholz-Rehbrücke
country: Germany
facility: German Institut for Human Nutrition; Department for Clinical Nutrition
state: Brandenburg
city: Berlin
country: Germany
facility: DIfE (German Institute for Human Nutrition)
Study officials:
References:
Clinical trial NCT05880355: Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
Official title: Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Myocardial Infarction
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single blind study.
Primary purpose: TREATMENT

Brief summary: Subjects with urgently reperfused type I myocardial infarction (MI) will be recruited and randomized to receive either placebo or the oral inflammasome (NLRP3) inhibitor dapansutrile. The primarily outcome measure will be carotid plaque volume change over 6 months; secondary outcome measures will be plaque inflammatory activity and coronary microvascular function.


Eligibility criteria: Inclusion Criteria:

* Acute type I myocardial infarction (NSTEMI or STEMI)
* Reperfusion therapy planned or performed within prior 48 hrs
* Carotid or femoral artery plaque at baseline, or carotid intima media thickness \>1.5 mm

Exclusion Criteria:

* Type II MI
* Failed primary PCI or need for emergent bypass surgery
* Severe heart failure (NYHA class IV)
* Life-threatening complication of MI (myocardial rupture, ischemic VSD, papillary muscle rupture)
* Refractory ventricular arrhythmias
* Allergy to dapansutril, OLT177, or drugs in the same class
* Co-morbidity limiting 6 month survival
* Active malignancy or recent malignancy with any systemic anti-cancer treatment
* Active infection
* Use of immunosuppressive medications or immunodeficiency disorder
* Neutropenia (ANC \<2,000)
* Moderate or severe renal impairment (GFR \<30 ml/min)
* Recent stroke (within previous 3 months)
* Allergy to ultrasound enhancing agents or polyethylene glycol
* Pregnancy or breastfeeding

Primary outcomes:
measure: Remote plaque volume
timeFrame: 6 months
Secondary outcomes:
measure: Plaque inflammation
timeFrame: 3 months
measure: Coronary microvascular function
timeFrame: 3 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT00207155: An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer
Official title: An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer


Eligibility criteria: Inclusion Criteria:

* Measurable disease Tumor available for biopsies. Life expectancy of at least 3 months.

Exclusion Criteria:

* Known or documented brain metastases prior to Cetuximab therapy.

Primary outcomes:
measure: Prediction of response to Erbitux in subjects with metastatic colorectal cancer
Secondary outcomes:
measure: Radiographic Response
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Local Institution
state: California
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: Bronx
country: United States
facility: Local Institution
state: New York
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Hershey
country: United States
facility: Local Institution
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Barcelona
country: Spain
facility: Local Institution
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: