louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06163911: In-depth ECG Analysis for the Extraction of Biomarkers of Cardiac Mechanical Dispersion
Official title: In-depth ECG Analysis for the Extraction of Biomarkers of Cardiac Mechanical Dispersion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Pathology
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in consultation at the Cardiology Department of the Nancy CHRU who performed an echocardiography and a 12-lead ECG.

Brief summary: Left ventricular systolic dysfunction (LVSD) refers to impaired contraction of the left ventricle, and can lead to heart failure and death. Early identification of LVSD, which often remains asymptomatic for years, is therefore crucial to mitigate the associated risks through appropriate treatment. Echocardiographic screening of asymptomatic individuals is costly, requires access to experts, and the criteria for selecting potential high-risk individuals for screening remain unclear.

Unlike echocardiography, the electrocardiogram (ECG) is a relatively low-cost procedure, routinely available and requiring little technical training to set up the examination and collect data, making it an interesting tool for early detection of LVSD.


Eligibility criteria: Inclusion Criteria:

* Person who has received full information on the organization of the research and has not objected to the use of this data;
* Age ≥ 50;
* Persons who have undergone an echocardiographic examination and a 12-lead ECG examination during consultations at the CHRU de Nancy;
* Persons with at least one cardiovascular risk (obesity, diabetes, hypertension, etc.).

Exclusion Criteria:

* People with a history of heart disease (ischemic, valvular);
* Patients with significant 12-lead ECG abnormalities (complete bundle branch block, sequelae of myocardial infarction, etc.);
* ECG tracings or echocardiograms that cannot be analyzed.

Primary outcomes:
measure: F1 score for classification of cardiac contractility abnormalities
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
state: CHRU De Nancy
Study officials:
References:
Clinical trial NCT04108611: Immune Adsorption Role in Treatment of Resistant Lupus
Official title: Role of Online Hemodiafiltration With Endogenous Reinfusion in Treatment of Systemic Lupus Erythematosus Activity Resistant to Conventional Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus
Keywords: hemodiafiltration with endogenous re infusion
immune adsorption In Lupus nephritis
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Role of online hemodiafiltration with endogenous re infusion in treatment of systemic lupus erythematosus activity resistant to conventional therapy
Primary purpose: TREATMENT

Brief summary: Background: lupus is a heterogeneous autoimmune disease with autoantibodies formation. Lupus nephritis carries the worst prognosis. C1q deficiency correlates with activity and renal involvement and may help in its evaluation. Therapies include plasma exchange, immune adsorption and recently under evaluation, hemodiafiltration with on-line endogenous re infusion (HFR), in addition to traditional immunosuppressive therapies. Aim: is to evaluate the role of HFR in improving signs and symptoms of SLE activity and laboratory parameters not responding to traditional immune suppressive therapy

Detailed description: Settings and design: A controlled clinical study was conducted on group A, sixty patients with lupus in activity subdivided into cases 1, 47 patients, who received traditional medical treatment and cases 2 group, 13 patients, who underwent HFR in addition to medical treatment. And group B that consisted of two subgroups, control 1, 20 healthy age and sex matched volunteers and control 2, 10 cases with different glomerular diseases other than lupus.

Methods and materials: Serum c1q was done before and after the HFR as well as induction by medical treatment. Disease activity assessed using SLEDAI-2K with responder index - 50, quality of life assessed using SLEQOL v2, and HFR was performed for the non-responder group.

The study will be conducted in Alexandria University Hospitals in compliance with the Declaration of Helsinki; the ethical committee of the investigator's faculty will be requested to approve the protocol and the patients will be requested to give informed consent.

Eligibility criteria: Inclusion Criteria:

* systemic lupus erythematosus in activity

Exclusion Criteria:

* End stage renal disease, other renal replacement therapy

Primary outcomes:
measure: Improvement In signs and symptoms of lupus activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine Alexandria University
state: Sidi Beshr
Study officials:
affiliation: University of Alexandria
name: Naga S Salah, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04083911: Study of DAC Combined With HAAG Regimen in Newly Diagnosed AML Patients Older Than 60
Official title: A Phase 3, Open Label, Single Arm, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Elderly Newly Diagnosed Acute Myeloid Leukemia Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Induction Chemotherapy
Keywords: Decitabine, HAAG, AML
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Soochow University
name: Changzhou No.2 People's Hospital
name: The First People's Hospital of Lianyungang
name: Jingjiang People's Hospital
name: Zhangjiagang First People's Hospital
name: The Second People's Hospital of Huai'an
name: The Third People's Hospital of Kunshan
First posted: 2019-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
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 evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients older than 60 years.

Detailed description: This is a phase 3, open Label, single arm, multi-center study in elderly newly diagnosed AML patients. The patients will receive DAC combined with HAAG in the induction treatment.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
2. 60-79 years old.
3. ECOG score: 0-3.
4. No history of previous chemotherapy or target therapy.
5. Provide informed consent.

Exclusion Criteria:

1. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
2. Patients with another malignant disease.
3. Patients with uncontrolled active infection.
4. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
6. Patients with creatinine clearance rate \< 50ml/min.
7. Patients with active hepatitis B or hepatitis C infection.
8. Patients with HIV infection.
9. Patients with other commodities that the investigators considered not suitable for the enrollment.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Day 28-35 of induction course
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Leukemia-free survival (LFS)
timeFrame: 3 years
measure: Cumulative incidence of relapse (CIR)
timeFrame: 3 years
measure: Number of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Xiaowen Tang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06823011: Effects of Banned Substances on Some Metabolic Functions in Male Amateur Athletes
Official title: Effects of Banned Substances on Some Metabolic Functions in Male Amateur Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Banned Substances
Keywords: Banned Substances
doping
anabolic steroid
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group doing weight training and using banned substances
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to investigate the effects of banned substances on some metabolic functions in male athletes in order to raise awareness among individuals who use these substances by highlighting the potential harms of using banned substances to draw attention to the issue and raise awareness. 2) Methods: The study is a randomised cross-sectional study. The study included 20 male amateur athletes who had actively practised bodybuilding, arm wrestling, powerlifting and weightlifting in the last 5 years and had not participated in competitions. The study group consisted of 10 adult male amateur athletes who had used banned substances at least once a year in the past 5 years, while 10 male amateur athletes who had not used banned substances with similar qualifications formed the control group. Participants were included in the study on a voluntary basis. Participants' age, sports age, height, weight and BMI variables were selected and parameters related to liver, kidney, hormone and lipid profiles were determined. The Shapiro-Wilk test was used to test the normality of the values obtained from the data. The independent t-test was used for the data showing a normal distribution and the Mann Whitney U- test was used for the data not showing a normal distribution.


Eligibility criteria: Inclusion Criteria:

1. Amateur athlete who has been actively involved in bodybuilding, arm wrestling, powerlifting and weightlifting for the last 5 years
2. Adult male amateur athletes who use banned substances in at least 1 period each year

Exclusion Criteria:

1. with chronic illness
2. receiving continuous medication
3. heavy labor
4. who has recently had an infection
5. amateur athletes who performed heavy exercise in the last 72 hours

Primary outcomes:
measure: body mass index BMI in Male Athletes
timeFrame: 6 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Hitit Üniversity gym
state: Si̇vas
Study officials:
References:
Clinical trial NCT00867711: Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients
Official title: Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MALIGNANT PLEURAL MESOTHELIOMA
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 121
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: Malignant Pleural Mesothelioma patients treated with carboplatin and pemetrexed

Brief summary: The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism.

Detailed description: Malignant pleural mesothelioma (MPM) is an aggressive tumor that usually has a poor prognosis. The combination of cisplatin and pemetrexed has recently become the standard of care in the first-line treatment of MPM. For patients who are unfit to receive a cisplatin-based chemotherapy, pemetrexed alone \[7\] or combined with carboplatin \[8\] has been proposed as an alternative treatment choice. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

Eligibility criteria: Inclusion Criteria:

* MPM diagnosis
* Availability of tumor tissue to perform analysis

Exclusion Criteria :

* Other primary diagnosis
* No archival tissue available

Primary outcomes:
measure: Evaluate the expression and allelic variants of a panel of candidate genes involved in the resistance to drugs, the genome wide copy number changes in patients treated with drugs combination in the first line
timeFrame: one year
Secondary outcomes:
measure: Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data.
timeFrame: one year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zucali PA, Giovannetti E, Destro A, Mencoboni M, Ceresoli GL, Gianoncelli L, Lorenzi E, De Vincenzo F, Simonelli M, Perrino M, Bruzzone A, Thunnissen E, Tunesi G, Giordano L, Roncalli M, Peters GJ, Santoro A. Thymidylate synthase and excision repair cross-complementing group-1 as predictors of responsiveness in mesothelioma patients treated with pemetrexed/carboplatin. Clin Cancer Res. 2011 Apr 15;17(8):2581-90. doi: 10.1158/1078-0432.CCR-10-2873. Epub 2011 Jan 24.
Clinical trial NCT03700411: Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery
Official title: Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Open Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Circulating Tumor Cell
Keywords: Perioperative analgesia
Colorectal Cancer
Circulating Tumor Cell
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
name: Tomas Bata Hospital, Czech Republic
name: University Hospital Ostrava
name: Hospital Novy Jicin
First posted: 2018-10-09
Enrollment: 125
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: To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.


Eligibility criteria: Inclusion Criteria:

* patients undergoing open radical surgery for colorectal cancer
* age over 18 years
* signed informed consent

Exclusion Criteria:

* intolerance of the study drugs
* history of CRC surgery
* neoadjuvant therapy
* contraindications to epidural analgesia
* other malignancy not in permanent remission
* chronic opioid medication or opioid administration within 7 days preoperatively
* immunosuppressive or corticosteroid therapy
* surgery within 30 days preoperatively (except minor)
* chronic or acute infection

Primary outcomes:
measure: Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
timeFrame: 1 - 3 days before surgery to 4 weeks after surgery
Secondary outcomes:
measure: Pain assessment
timeFrame: 3 days postoperatively
Other outcomes:
Locations:
city: Zlin
country: Czechia
facility: T. Bata Regional Hospital Zlin
state: Jihomoravsky Kraj
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
affiliation: Institute of Molecular and Translational Medicine, Palacky University, Olomouc
name: Marian Hajduch, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709211: Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block
Official title: A Comparative Study Between Postoperative Analgesia of Fascia Iliaca Compartment Block and Anterior Quadratus Lumborum Block in Proximal Femur Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. However, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. postoperative pain is a nightmare so adequate analgesia has been advocated to reduce the pain. in this study, Facia Iliaca compartment block will be compared to anterior Quadratus lumborum block, both will be done Ultrasound-guided using Bupivacain0.25% for postoperative analgesia at the end of the surgery.

Detailed description: In this prospective, randomized, comparative study patients will be equally divided into two equal groups; GroupI: patients will receive Ultrasound-guided Facia Iliaca compartment block with 50 ml 0.25%bupivacaine at the end of surgery Group Q: patients will receive Ultrasound-guided anterior Quadratus lumborum block with 50 ml 0.25%bupivacaine at the end of surgery

Eligibility criteria: Inclusion Criteria:

* ASA II to IV
* Both sexes
* scheduled for fracture femur surgeries

Exclusion Criteria:

* patients with bleeding disorders and coagulopathy
* infection at the injection site
* known allergy to local anaesthetics
* patients with multiple fractures
* patients with pre-existing myopathy or neuropathy
* patients with significant cognitive dysfunction
* patients who receive long-acting opioids preoperatively

Primary outcomes:
measure: first request of analgesia
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: total opioid consumption
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abassia
Study officials:
affiliation: Ain Shams University
name: Fathy M Tash, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03229811: Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
Official title: Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advance Care Planning
Chronic Kidney Diseases
Conservative Kidney Management
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comprehensive pre-dialysis program incorporating conservative and advance care planning education
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced CKD.

Detailed description: This intervention will be randomized among patients with advanced chronic kidney disease.

Eligibility criteria: Inclusion Criteria:

* Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR \< 30 ml/min/1.73m2)
* Age 65 years or greater or frail
* self-reported Black or White race

Exclusion Criteria:

* History of dementia
* History of legal blindness
* Listed for kidney transplantation

Primary outcomes:
measure: Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention)
timeFrame: Pre-intervention and Day 1 post-intervention
measure: Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention)
timeFrame: Immediate post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Stallings TL, Temel JS, Klaiman TA, Paasche-Orlow MK, Alegria M, O'Hare A, O'Connor N, Dember LM, Halpern SD, Eneanya ND. Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Feb 22;11(2):e042620. doi: 10.1136/bmjopen-2020-042620.
Clinical trial NCT06664411: Pola-ZR2P in Previously Untreated DLBCL
Official title: Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2 trial is to test the safety and efficacy of Pola-ZR2P as induction therapy in patients with DLBCL.

Detailed description: The investigators will evaluate safety and efficacy of Pola-ZR2P as induction therapy in Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Patient has not received chemotherapy previously.
* Anticipated life expectancy at least 3 months

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 years
measure: Progression Free Survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References: