louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06670157: Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices
Official title: Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices Under X-ray Perspective
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Varices Bleeding
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 6
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
Primary purpose: TREATMENT

Brief summary: A single-arm exploratory clinical study design was used to evaluate the safety and efficacy of a "modified sandwich injection" of tissue glue assisted by a detachable clip for the treatment of gastric varicose veins.


Eligibility criteria: Inclusion Criteria:

* The subject voluntarily signs the informed consent for this experiment; According to clinical manifestation, laboratory examination, imaging examination, or liver biopsy in the diagnosis of liver cirrhosis patients; The endoscopy diagnosed gastric varices (gastroesophageal varices, gastroesophageal varices type 2 or type 1 isolated gastric varices type 1); High risk of gastric varices or has a history of gastric varices bleeding. The initial fluid resuscitation patients before or after the recovery hemodynamic stability; The age of 18 years old or more.

Exclusion Criteria:

* \< 18 years old; Regional portal hypertension; Always have a liver transplant, via the jugular intrahepatic portal vein system bypass or splenectomy combined varices cut-out art history; A concurrent hepatorenal syndrome and/or multiple organ failure; Significant impact on survival of malignant tumor; Pregnancy or lactation; A known allergy to iodine.

Primary outcomes:
measure: Rebleeding rate at 6 weeks after treatment for gastric fundus varicose veins in cirrhosis
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Eastern Theater General Hospital
state: Jiangsu
Study officials:
affiliation: Eastern Theater General Hospital
name: ji xuan, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05732857: Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy
Official title: Perioperative Effects of Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Kidney
Keywords: robotic nephrectomy
pneumoperitoneum
trocar valveless
general anesthesia
mechanical ventilation
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.

Detailed description: In the literature there are studies on the benefit of valveless trocars in robotic surgery. There are no studies on the potential effects even in complex kidney surgery. Through this randomized study we want to investigate whether the ability to clear CO2 is better using valveless trocars

Eligibility criteria: Inclusion Criteria:

* asa status 1-3
* surgical classification RENAL or PADUA score \>9

Exclusion Criteria:

* BMI\>30

Primary outcomes:
measure: carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight
timeFrame: before extubation
Secondary outcomes:
measure: postoperative acute pain: using the NRS scale
timeFrame: at 1 hour and at 4 hour after the end of surgery
measure: subcutaneous emphysema: through clinical observation at the end of the intervention
timeFrame: at 30 minutes afetr the end of anesthesia
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute
Study officials:
References:
Clinical trial NCT01429857: Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure
Official title: Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Troponin concentration in heart failure
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.

Detailed description: Patients admitted for acute decompensated heart failure are included in the study. After gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. The aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.

Eligibility criteria: Inclusion Criteria:

* Hospital admission for acute cardiac decompensation
* Systolic and / or diastolic heart failure

Exclusion Criteria:

* Myocardial infarction in the last 4 weeks
* Serum creatinine \>2.5 mg/dl
* Pulmonary embolism

Primary outcomes:
measure: Time to cardiovascular death or hospitalization
timeFrame: 6 Months Follow-Up
Secondary outcomes:
measure: Time to all cause death or hospitalization
timeFrame: 6 Months Follow-Up
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Innere Medizin III - Kardiologie, Angiologie und Internistische Intensivtherapie
state: Saarland
Study officials:
References:
citation: Poss J, Ukena C, Kindermann I, Ehrlich P, Fuernau G, Ewen S, Mahfoud F, Kriechbaum S, Bohm M, Link A. Angiopoietin-2 and outcome in patients with acute decompensated heart failure. Clin Res Cardiol. 2015 May;104(5):380-7. doi: 10.1007/s00392-014-0787-y. Epub 2014 Nov 19.
Clinical trial NCT07025148: Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
Official title: Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Keywords: Coronary artery disease
Dual antiplatelet therapy
High bleeding risk
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 40
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 primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.


Eligibility criteria: Inclusion Criteria:

* Patients with high bleeding risk (defined according to the ARC-HBR criteria) who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin (81mg qd) with clopidogrel (75 mg qd) as part of standard of care for at least 30 days.
* Age ≥18 years.
* Provide written informed consent.

Exclusion Criteria:

* Prior cerebrovascular event.
* PCI within 30 days.
* Hemodynamic instability.
* On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis).
* Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel.
* Known hematologic malignancies or thrombocytopenia (platelet count \<80x106/mL).
* Known hemoglobinopathies or anemia (hemoglobin \<9 g/dL)
* Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].

Primary outcomes:
measure: Platelet reactivity measured as PRU
timeFrame: 30 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Health
state: Florida
Study officials:
affiliation: University of Florida College of Medicine - Jacksonville
name: Dominick J Angiolillo, MD, PhD
role: STUDY_CHAIR
affiliation: University of Florida College of Medicine - Jacksonville
name: Luis Ortega-Paz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270048: The Effect of Bunsimgieum on the Chest Discomfort of Hwa-byung's Major Symptom
Official title: The Effect of Bunsimgi-eum(Fenxinqiyin) on the Chest Discomfort of Hwa-byung's Major Symptom : Randomized, Double-blinded, Placebo-control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hwa-byung (Disorder)
Keywords: Hwa-byung, Bunsimgi-eum(Fenxinqiyin)
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2011-01-05
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort of Hwa-byung's major symptom and develope and establish pattern identification system in Hwa-byung.


Eligibility criteria: Inclusion Criteria:

* male or female aged 20-65
* subjects who meet structured interview criteria for Hwa-Byung Diagnosis

Exclusion Criteria:

* duration of illness less than 6 months
* current or past history of delusions, hallucination
* past history of at least one manic episode, hypomanic episode, or mixed episode
* current or past history of alcohol abuse or alcohol dependence history
* taking substances(e.g. steroids) which might affect symptoms
* medical conditions(e.g. hyperthyroidism, hypothyroidism, heart disease) that might affect symptoms
* current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure
* pregnancy, lactation, women not using medically accepted means of birth control
* considered not apt to carry out clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Daejon
country: Korea, Republic of
facility: Oriental Hospital of Daejon University
state: Choong-Chung-Do
Study officials:
affiliation: Oriental Hospital of Daejon University
name: In-Chul Jung, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06814548: Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study
Official title: Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Cancer, Gastroesophageal Junction Cancer
Immune Checkpoint Inhibitors (ICIs)
Second-line
Retreatment
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression.

Brief summary: This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.

Detailed description: All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression. The efficacy and safety of treatment were evaluated, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), Pattern of immune progression after cross-line therapy, grade 3-5 treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs). Cox regression model was used to investigate the influence of multiple factors on survival.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic or advanced GC/GEJC;
* Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting;
* Receiving at least 2 cycles of ICI-based second-line therapy;
* ECOG PS 0 or 1;
* Radiographic response was also assessed during treatment and survival.

Exclusion Criteria:

* patients had other malignancies within the past 5 years;
* lack of survival and clinical efficacy data;
* combined radiotherapy regimens in the second-line treatment.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 12 months
measure: overall survival (OS)
timeFrame: 12 months
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: 12 months
measure: disease control rate (DCR)
timeFrame: 12 months
measure: safety
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00625248: Prospective Evaluation of Bleeding Risk of Anticoagulant and Anti-platelet Therapy
Official title: A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Lead sponsor: Pain Management Center of Paducah
Sponsor class: OTHER
First posted: 2008-02-28
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ambulatory surgery center patients

Brief summary: This study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy

Detailed description: 1. To evaluate bleeding risk in interventional procedures in patients with or without antiplatelet and/or anticoagulant therapy.
2. To evaluate differences in outcomes in patients not receiving any anticoagulant or antiplatelet therapy compared to patients receiving various types of drugs with anticoagulant or antiplatelet therapeutic effects.
3. To evaluate and compare the adverse event profiling all patients.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing interventional techniques. Subjects who were able to give voluntary, written informed consent.

Exclusion Criteria:

* All those things, patients on heparin, dextran, and low molecular heparin

Primary outcomes:
measure: To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy.
timeFrame: 24 months
Secondary outcomes:
measure: To assess adverse events in all patients.
timeFrame: 24 months
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Pain Management Center of Paducah
state: Kentucky
Study officials:
affiliation: Ambulatory Surgery Center, Paducah
name: Laxmaiah Manchikanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manchikanti L, Malla Y, Wargo BW, Cash KA, McManus CD, Damron KS, Jackson SD, Pampati V, Fellows B. A prospective evaluation of bleeding risk of interventional techniques in chronic pain. Pain Physician. 2011 Jul-Aug;14(4):317-29.
citation: Manchikanti L, Malla Y, Wargo BW, Fellows B. Infection control practices (safe injection and medication vial utilization) for interventional techniques: are they based on relative risk management or evidence? Pain Physician. 2011 Sep-Oct;14(5):425-34.
Clinical trial NCT04261348: Effects of an Antimicrobial Stewardship (AMS) Program, on the Prevalence of Multidrug-resistant Gram - Negative Pathogens, in an Area of High Consumption of Antibiotics and High Resistance Rates
Official title: Effects of an Antimicrobial Stewardship (AMS) Program, on the Prevalence of Multidrug-resistant Gram - Negative Pathogens, in an Area of High Consumption of Antibiotics and High Resistance Rates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antimicrobial Stewardship Program
Lead sponsor: Laikο General Hospital, Athens
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who will be administered antibiotics

Brief summary: 1. To evaluate the long-term effect of the AMS program on the consumption of broad-spectrum antibiotics and on the consumption of antibiotics in general (sustainability of the efficacy of the program). More specifically, the investigators shall examine the consumption of protected antibiotics during the years 2019 - 2020 and they shall compare it with the consumption of antibiotics before the implementation of the AMS program.
2. To evaluate the impact of the AMS program, combined with an infection control program, on the incidence of MDRGN infections in a hospital with high MDR incidence. Confounding factors are a barrier to analyze the impact of ASPs on antibiotic resistance. In a hospital setting, one of the most important confounding factors is the implementation of infection control practices at the same time as the ASPs. It is extremely difficult to infer causality between an ASP and antibiotic resistance reduction when infection control is a confounding factor, especially if the study intervention combines an ASP and infection control practices performed at the same time. The way to go around the problem is to implement ASP and IC at different time points. The investigators implemented the ASP program in September 2015 and they added the IC program in September 2018. Therefore, the investigators shall be able to compare the two-time periods (i.e. ASP alone vs. ASP/IC) by using the time series analysis and delineate the impact of each intervention.
3. To evaluate the effect of the AMS program on patient outcomes (in-hospital mortality, length of stay)


Eligibility criteria: Inclusion Criteria:

NA

Exclusion Criteria:

NA

Primary outcomes:
measure: Consumption of antibiotics
timeFrame: 2 years
measure: Days of therapy
timeFrame: 2 years
measure: Days of antibiotics
timeFrame: 2 yars
measure: Patients receiving surgical prophylaxis
timeFrame: 2 years
measure: Hospital mortality rate
timeFrame: 2 years
measure: Clinical cure rate
timeFrame: 2 years
measure: Length of stay
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University Hospital of Laikon
state: Attica
Study officials:
References:
Clinical trial NCT04357548: Optimization of Quality in Cardiopulmonary Resuscitation Through Monitor-defibrillator With Feedback System
Official title: Optimization of Quality in Cardiopulmonary Resuscitation Through Monitor-defibrillator With Feedback System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Resuscitation
Keywords: Cardiopulmonary Resuscitation
Feedback
Quality Control
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
Collaborators: name: Zoll Medical Corporation
First posted: 2020-04-22
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects belonging to the General Emergency Department of the Hospital Clinico Universitario Virgen de la Arrixaca corresponding with doctors, resident doctors and nurses who are working in the service during the study period and receive the training session on CPR quality and the use of the defibrillator monitor with feedback system

Brief summary: AIM: To verify the effect of a feedback system on optimizing quality during CPR on mannequins.

Hypothesis: The quality of CPR performed by healthcare professionals through a defibrillator monitor with a feedback system is higher than those that do not use a feedback system on a manikin.

METHOD Type of study: Pre-experimental with pretest-postest design. Sample: Health professionals of the General Emergency Service of the Virgen de la Arrixaca University Hospital (HCUVA).

Sampling type: Non-probabilistic for convenience. Variables: sex, age, profession, years of experience, last CPR training received, last time performing CPR, depth, frequency, quality CPR, perception of the quality of CPR.

Statistical analysis: Student's t for related samples and McNemar.


Eligibility criteria: Inclusion Criteria:

* Health professionals working in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period. They include doctors, resident doctors, and nurses.
* Health professionals from the General Emergency Service of the Virgen de la Arrixaca University Hospital who receive the training session on CPR quality and use of the defibrillator monitor with feedback system.

Exclusion Criteria:

* Health professionals who do not work in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period.
* Health professionals who work in the General Emergency Service of the Virgen de la Arrixaca University Hospital and refuse to carry out the training and demonstration session.

Primary outcomes:
measure: Depth compression
timeFrame: 2 minutes
measure: Rate compression
timeFrame: 2 minutes
measure: Quality CPR
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: José Antonio Jiménez Hernández
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Jose Antonio Jimenez Hernandez, Doctor
role: PRINCIPAL_INVESTIGATOR
References: