louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00978224: Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
Official title: Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Chronic Inflammatory Syndrome
Keywords: dietary supplement
hemodialysis
Chronic Inflammatory Syndrome
Viusid
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 152
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: TREATMENT

Brief summary: The purpose of the study is to determine whether Viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients enrolled in the study will be receiving the standard treatment for Chronic Inflammatory Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet. Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months
* Signed informed consent

Exclusion Criteria:

* Patients with chronic terminal nephropathy previously treated with peritoneal dialysis
* Receptors of a renal graft
* Patients with malignant neoplastic conditions
* Pregnant women

Primary outcomes:
measure: Body mass index (BMI) at week 72 (end of the treatment)
timeFrame: 72 weeks
measure: Carotidal Doppler at week 72 (end of the treatment)
timeFrame: 72 weeks
measure: C reactive protein at weeks 72 (end of the treatment)
timeFrame: 72 weeks
measure: Hemoglobin at week 72 (end of the treatment)
timeFrame: 72 weeks
Secondary outcomes:
measure: Cholesterol at week 72
timeFrame: 72 weeks
measure: Triglycerides at week 72
timeFrame: 72 weeks
measure: Frequency of infection episodes at week 72
timeFrame: 72 weeks
measure: Creatinine at week 72
timeFrame: 72 weeks
measure: Uric acid at week 72
timeFrame: 72 weeks
measure: Glutamic-pyruvic transaminase (GPT)at week 72
timeFrame: 72 weeks
measure: Glutamic-oxaloacetic transaminase (GOT)at week 72
timeFrame: 72 weeks
measure: Blood glucose concentrations at week 72
timeFrame: 72 weeks
measure: Gasometry at week 72
timeFrame: 72 weeks
measure: Adverse effects at week 72
timeFrame: 72 weeks
measure: Albumin at week 72
timeFrame: 72 weeks
measure: KTV at week 72
timeFrame: 72 weeks
measure: Phosphocalcic metabolism at week 72
timeFrame: 72 weeks
measure: Hematocrit at week 72
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: Institute of Nephrology "Dr. Abelardo Buch López"
Study officials:
affiliation: Institute of Nephrology "Dr. Abelardo Buch López"
name: Mirna Atiés Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02976324: The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
Official title: The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cor Pulmonale
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.

Detailed description: Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.

Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic cor pulmonale and admit to hospital

Exclusion Criteria:

* pneumothorax or mediastinal emphysema
* active tuberculosis
* install a cardiac pacemaker
* acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents.
* pregnancies
* end-stage patients (expected survival time less than 6 months)

Primary outcomes:
measure: cardiopulmonary function
timeFrame: 10 days
Secondary outcomes:
measure: MIP
timeFrame: 10 DAYS
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Tongji University
name: xiangyu zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04436224: Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
Official title: Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hydromorphone
Analgesia
ICU
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 530
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: Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Non-mechanical ventilation patients with expected ICU stay time \>24h
* People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or BPS ≥ 5 points, CPOT ≥ 3);

Exclusion Criteria:

* pregnancy；
* can not get pain score from patients
* allergy to drugs
* ....

Primary outcomes:
measure: successful analgesic proportion
timeFrame: From date of using the intervention drugs until the date of leaving from icu, up to 28 days
Secondary outcomes:
measure: Score
timeFrame: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
measure: dose of analgesics
timeFrame: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
measure: Adverse event
timeFrame: From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days
measure: ICU stay
timeFrame: from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university Nanfang hospital
Study officials:
References:
Clinical trial NCT01630824: Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients
Official title: Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: education program
kidney transplantation
renal transplantation
evaluation
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2012-06-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.


Eligibility criteria: Inclusion Criteria:

* being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation

Exclusion Criteria:

* severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction

Primary outcomes:
measure: transplant survival
timeFrame: 2 years
Secondary outcomes:
measure: number of rejections
timeFrame: 2 years
measure: days at hospital
timeFrame: 2 years
measure: blood pressure control
timeFrame: 2 years
measure: number of infectious complications
timeFrame: 2 years
measure: quality of life (QoL)
timeFrame: 2 years
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Department of Nephrology, University of Jena
state: Thuringia
Study officials:
affiliation: University of Jena
name: Gunter Wolf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03151824: Gender-specific Associations Between Quality of Life and Leukocyte Telomere Length
Official title: Gender-specific Associations Between Quality of Life and Leukocyte Telomere Length: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apparently Healthy People Aged 55 and Over
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 164
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 164 apparently healthy subjects (82 couples) aged 55 and over were included in this study.

Brief summary: Quality of life (QoL) is an important factor for successful aging. Telomere length is an indicator of cellular aging and cumulative biological stress and is thus related to health status and survival. However, the relationship between QoL and telomere length has not yet been examined. In this study we investigated the relationship between leukocyte telomere length (LTL) and QoL.

However, the relationship between overall QoL and LTL has not previously been investigated. Therefore, this study was conducted to examine the relationship between LTL and QoL. QoL was measured by the Korean version of the 36-item short-form health survey (SF-36), which is a multidimensional scale consisting of subjective evaluation.


Eligibility criteria: Inclusion Criteria:

* married couple
* apparently healthy subjects above 55 years

Exclusion Criteria:

* Subjects who had experienced hormone therapy
* Subjects who had been diagnosed with dementia, Parkinson's disease, stroke, ischemic heart disease, congestive heart failure, arrhythmia, depression, cancer, thyroid disorders, or chronic renal disease

Primary outcomes:
measure: leukocyte telomere length
timeFrame: 8months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01667224: Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.
Official title: Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Actiponin
Obesity
Abdominal fat
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent. However, the efficacy and safety of Actiponin supplementation on body weight regulation in humans are lacking.

Detailed description: The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on body weight and fat loss along with changes in metabolic markers based on 12 week, randomized, double-blind, placebo-controlled clinical trial.

Eighty obesity subjects with BMI \> 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group (n=40, 450mg/day) for 12weeks.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)

Exclusion Criteria:

* Significant variation in weight(more 10%) in the past 3 months
* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* History of disease that could interfere with the test products or impede theire absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Abdominal hepatic liver function
* Renal disease, e.g. acute/chronic renal failure, nephritic syndrome
* Used antipsychosis drugs therapy within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding
* History of alcohol or substance abuse
* Allergic or hypersensitive to any of the ingredients in the test products

Primary outcomes:
measure: Changes in Body Fat Mass.
timeFrame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
Secondary outcomes:
measure: Changes in Abdominal Total Fat Area.
timeFrame: study visit 1(0 week), visit 4(12 week)
measure: Changes in Body Weight.
timeFrame: study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)
measure: Changes in Body Mss Index(BMI)
timeFrame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
Other outcomes:
Locations:
Study officials:
affiliation: Chonbuk National University Hospital
name: Soo-Wan Chae, Ph.D, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02200224: Clinical Utility of Rapid CT/NG Testing in the ED
Official title: Clinical Utility of Rapid CT/NG Testing in the ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2014-07-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to:

1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the Emergency Department (ED) for a Sexually Transmitted Infection (STI).
2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic under and over treatment for TV in women evaluated in the ED for an STI
3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) and TV testing in the Emergency Department setting.

To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually Transmitted Infection diagnosis.


Eligibility criteria: Inclusion Criteria:

* The study population includes women between the age of 18 and 50 who present to the ED and are going to receive CT/NG testing in the ED.

Exclusion Criteria:

* Patients will be excluded if they are unable to provide informed consent or are not English speaking.

Primary outcomes:
measure: Overtreatment rate of CT/NG between the control and interventional groups
timeFrame: 2 week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Andrea Dugas, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaydos CA, Ako MC, Lewis M, Hsieh YH, Rothman RE, Dugas AF. Use of a Rapid Diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae for Women in the Emergency Department Can Improve Clinical Management: Report of a Randomized Clinical Trial. Ann Emerg Med. 2019 Jul;74(1):36-44. doi: 10.1016/j.annemergmed.2018.09.012. Epub 2018 Nov 2.
Clinical trial NCT04215224: Histopathology Images Based Survival Prediction of Glioma Patients Using Artificial Intelligence
Official title: Histopathology Images Based Survival Prediction of Patients With Primary Glioma Using Deep Learning or Machine Learning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Keywords: Prognosis
Histopathology imaging
Deep Learning
Machine Learning
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2020-01-02
Enrollment: 3500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Paitents with newly diagnosed glioma who receive tumor resection with life expectancy of greater than 3 months

Brief summary: This registry aims to collect clinical, molecular and histopathology imaging including detailed survival data, clinical parameters, molecular pathology (1p/19q codeletion, MGMT methylation, IDH and TERTp mutations, etc) and images of HE slices in primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine hstopathology imaging based algorithms that able to predict patients' survivals in the frame of molecular pathology or subgroups of gliomas.

Detailed description: Non-invasive and precise prediction for survivals of glioma patients is challenging. With the development of artificial intelligence, much more potential lies in the histopathology images of HE slices in primary gliomas could be excavated to aid prediction of patients' prognosis in the frame of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed survival data, molecular pathology, histopathology image data and with sufficient sample size for deep learning (\>1000) provides opportunities for personalized prediction of survival of glioma patients with non-invasiveness and precision.

Eligibility criteria: Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfuctions

Primary outcomes:
measure: AUC of survival prediction performance
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT06560424: Cardiovascular and Metabolic Sciences Biorepository
Official title: Cardiovascular and Metabolic Sciences Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Metabolic Disease
Keywords: Biorepository
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll persons with diagnosed cardiovascular or metabolic disease(s), persons with a family history of cardiovascular and/or metabolic disease(s), and persons without known cardiovascular or metabolic disease(s). The targeted number of participants to be enrolled is indefinite.

Brief summary: The purpose of the Cardiovascular and Metabolic Sciences Biorepository is to collect and store information and biospecimens (blood, urine, stool, and heart tissue) from patients with and without cardiovascular and metabolic diseases to create a readily available biorepository of samples and related medical health information to expedite future research into the causes and consequences of cardiovascular and metabolic diseases.

Detailed description: Heart disease is the leading cause of death in the United States and other vascular diseases, like stroke, and metabolic diseases, like diabetes, are consistently in the top ten causes of death (CDC, 2024). There is clearly a need for continuing research and innovation into improved diagnosis and treatment of these diseases.

The goal of this biorepository is to provide an easily accessible collection of samples for researchers to utilize. The biorepository will also serve as a place to store residual samples from other cardiovascular disease (CVD) studies for future use, to make the best use of these biospecimen resources.

Eligibility criteria: Inclusion Criteria:

* Willing and able to sign the informed consent document

Exclusion Criteria:

* Chronic anemia (hemoglobin consistently \<9 g/L)

Primary outcomes:
measure: Number of samples enrolled per year
timeFrame: Yearly through study completion (approximately 30 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: W. H. Wilson Tang, MD
role: PRINCIPAL_INVESTIGATOR
References: