louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02347982: Epidemiology of Cardiovascular Disease in Elderly Turkish Population
Official title: Epidemiology of Cardiovascular Disease in Elderly Turkish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Turkey
Epidemiologic
Lead sponsor: Turkish Society of Cardiology
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 2500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥65 years followed-up at cardiology clinics

Brief summary: This study will compose a national database of cardiovascular diseases' risk factors, concomitant diseases and the drug usage among the elderly patients in Turkey.


Eligibility criteria: Inclusion Criteria:

* patients signed patient informed sheet and informed consent form
* patients ≥65 years old
* patients followed-up cardiology clinics

Exclusion Criteria:

* patients under 65 years old

Primary outcomes:
measure: To generate a national database for cardiovascular diseases for elderly patients in Turkey
timeFrame: [Recruited and could be analysed at least 2500 patients after 9 months]
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Faculty of Medicine
Study officials:
affiliation: Ege University
name: Mehdi Zoghi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642120: Dental Support and the Second Stage of Labor Among Multiparous Women
Official title: Dental Support and the Second Stage of Labor Among Multiparous Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Second Stage of Labor
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-12-30
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.

Detailed description: Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery.

The Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. The investigators hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. The researchers will also investigate it's efficiency in pain management.

Eligibility criteria: Inclusion Criteria:

1. Singleton gestation
2. Multiparous women
3. Term gestation (\>37+0/7 weeks)
4. Signed written consent to participate in the study
5. Maternal age 18-45 years
6. Normal vital signs
7. Noraml cardiotocography and biophysical profile at admission

Exclusion Criteria:

1. Multiple gestation
2. Nulliparous women
3. preterm gestation (\<37+0/7 weeks)
4. Refusal to participate
5. Maternal age \<18 or \> 45 years
6. Normal vital signs
7. Abnormal cardiotocography and biophysical profile at admission

Primary outcomes:
measure: Duration of the second stage of labor.
timeFrame: 12 month
Secondary outcomes:
measure: Patient satisfaction (questionnaire)
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Ariel many, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04486820: Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care
Official title: Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chordoma
Keywords: Immunohistochemical
PD-L1
CD8
CDX2
INSM1
FOXA1
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with chordoma

Brief summary: Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly, this tumor often poses diagnostic difficulties due to its resemblance with metastasis or chondrosarcoma, thus, it would be useful to know the expression status of factors used during the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression in a series of chordomas and compare it with clinico-pathological and prognostic features.

Detailed description: Retrospective, non-interventional study. A series of chordomas will be analyzed for detailed histologic features and for various immunohistochemical factors and results will be compared with clinical factors, like overall and disease-free survival.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chordoma
* Sufficient histological material available
* Tumor expression of brachyury

Exclusion Criteria:

- Insufficient histological material

Primary outcomes:
measure: Expression of PD-L1
timeFrame: Baseline
measure: Expression of CD8
timeFrame: Baseline
measure: Expression of CDX2
timeFrame: Baseline
measure: Expression of INSM1
timeFrame: Baseline
measure: Expression of FOXA1
timeFrame: Baseline
Secondary outcomes:
measure: Histological type of tumor
timeFrame: Baseline
measure: Tumor location
timeFrame: Baseline
measure: survival of patients after diagnosis with or without progression
timeFrame: Baseline
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Georgia KARPATHIOU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05099120: Establishment of Risk Indicators and Early Warning System in Infection Patients
Official title: Establishment of Risk Indicators and Early Warning System for Deterioration of Infected Patients in Real-world Data.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infections
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We integrated pooled individual patient data of infected patients treated at a single center in China from 1 January 2010 until 31 July 2021.

Brief summary: Serious infections refer to life-threatening infections with a morbidity and mortality rate of up to 50%, and are the main cause of death in critically ill patients, mainly including systemic inflammatory response syndrome, sepsis, infectious shock, or systemic multiple organ dysfunction syndrome. Patients with severe infections have rapid disease development, which can cause disorders of cellular circulation and metabolism and impairment of multi-organ function in the early stage, mostly accompanied by clinical complications, and despite the progress of medical technology and the popularization of antibiotic application, the mortality and disability rate is high, which is a hot spot of clinical research today. Patients with severe infections are exposed to a wide range of medical risk factors, including patient factors (advanced age, frailty, malnutrition, long hospital stay, prolonged bed rest), disease factors (immune deficiency, malignancy, diabetes, renal failure, liver failure), drug factors (long-term use of steroid hormones, chemotherapeutic drugs, NSAIDs, etc.), interventional factors (central venous catheter, recent invasive surgery, hemodialysis, endotracheal intubation or mechanical ventilation, etc.), which bring great challenges to clinical treatment. Therefore, early identification of risk indicators for deterioration of infected patients provides a strategic basis for the medical team to take early warning measures to prevent deterioration and poor prognosis, and to reduce the risk of deterioration of patients, which is also the key to reduce the risk of death of infected patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with infection

Exclusion Criteria:

* Case information is incomplete
* Do not accept follow-up

Primary outcomes:
measure: Among patients with infections admitted to the hospital
timeFrame: 30 days of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The first Affiliated Hospital of Air Force Medical University
name: Jingwen Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05815420: Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France
Official title: Home Tele-Monitoring of Non-Invasive Ventilation in Chronic Obstructive Pulmonary Disease in France
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Non invasive ventilation
Telemonitoring
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD Patient with a first prescription of NIV treatment

Brief summary: Tele-monitoring emerged and unfolded differently among various healthcare organisations and countries. Evidence regarding its impact on the management of COPD patients is still insufficient to draw firm conclusions. Assumption has been made that remote monitoring of home NIV treatment could help to identify novel predictors of the early detection of NIV failure and deteriorations in patients with COPD.

The incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data in France needs evaluation.

In addition, predictors of unplanned all-cause and COPD-caused hospitalisations as well as of compliance and persistence to NIV therapy should be assessed in this patient population with special respect to continuous tele-monitoring.

The study will determine in France the incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data. Clinical and telemetric predictors of unplanned all-cause and COPD-caused hospitalisations and of NIV therapy compliance and persistence will be assessed in those patients


Eligibility criteria: Inclusion criteria:

* Age ≥18 years
* COPD eligible for NIV treatment
* Prescription of an adequate ResMed NIV device with tele-monitoring option as part of routine clinical care
* Acceptance of tele-monitoring and corresponding data handling
* Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study
* Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data.

Exclusion criteria:

* Invasive ventilation therapy
* Another life-threatening disease with estimated survival \< 12 months (other than COPD, e.g. cancer)
* Further exclusion criteria according to manua of the device intended and prescribed

Primary outcomes:
measure: Incidence of unplanned all-cause hospitalisations in routine clinical care in patients treated with NIV therapy who are continuously monitored by telemetric data
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01472120: Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)
Official title: The Relationship of Adiponectin With Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 160
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A sample of male outpatients with histologically proven NAFLD, who attended the outpatient clinic of the Gastroenterology Department, Gulhane School of Medicine, Ankara, Turkey

Brief summary: In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus.

Detailed description: In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes.

M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus. In addition, these forms also are related to insulin resistance and inflammation in adipose tissue.

Today, there is no study that investigate the role of adiponectin an anti-inflammatory adipokine, on macrophage polarization in non-alcoholic fatty liver disease.

Eligibility criteria: Inclusion Criteria:

* Persistently (at least 6 months) elevated aminotransferases
* Ultrasonographic presence of bright liver without any other liver or biliary tract disease
* Liver histology compatible with a diagnosis of NASH or SS

Exclusion Criteria:

* A history of alcohol consumption \>40 g/wk, as assessed by a detailed interview extended to family members
* Morbid obesity \[body mass index (BMI) ≥40 kg/m2\], hypertension
* Positive blood markers of viral, autoimmune, or celiac disease
* Abnormal copper metabolism or thyroid function tests
* A diagnosis of T2DM and systemic arterial hypertension
* Total cholesterol (TC) ≥250 mg/dL, triglycerides (TG) ≥400 mg/dL, exposure to occupational hepatotoxins or drugs known to affect glucose and lipid metabolism

Primary outcomes:
measure: For laboratory analyses, the collection of all blood samples from the study participants.
timeFrame: Collection of blood samples in one year and analyses of data in 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara,
country: Turkey
facility: Gastroenterology Department, Gulhane School of Medicine
Study officials:
affiliation: Gulhane Medical School
name: halil genc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02023320: Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes
Official title: A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Agricultural Producers' Cooperative Corporation Shinpo-en
First posted: 2013-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.


Eligibility criteria: Inclusion Criteria:

* Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

* Taking anti-diabetic drugs
* Taking drugs or functional food that may affect blood glucose level
* Fruit allergy
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease

Primary outcomes:
measure: Change in fasting plasma glucose from baseline
timeFrame: Every 6 weeks (Overall 12 weeks)
measure: Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
timeFrame: Weeks 0 and 12
measure: Change in HbA1c from baseline
timeFrame: Weeks 0 and 12
Secondary outcomes:
measure: Change in glycoalbumin from baseline
timeFrame: Every 6 weeks (Overall 12 weeks)
measure: Change in fasting insulin from baseline
timeFrame: Weeks 0 and 12
measure: Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
timeFrame: Weeks 0 and 12
measure: Change in serum C-peptide from baseline
timeFrame: Weeks 0 and 12
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00608920: Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
Official title: SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Keywords: SPECT
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called SPECT.

Detailed description: Single photon emission computed tomography (SPECT) uses radioactive tracers and a scanner to record data that a computer constructs into two- or three-dimensional images. A small amount of a radioactive drug is injected into the body and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. Using a gamma camera (a special kind of scanner), we can create a better picture of the lymph node region. We will compare these pictures to images from your CT scan, to help plan your therapy.

The research in this study involves seeing if it is feasible to use SPECT scanning procedures for the purpose of planning your radiation treatment. We hope that doing so will allow us to more accurately and precisely plan radiation treatment to potential sites of cancer, and avoid delivering too much radiation to normal

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy proven adenocarcinoma of the prostate
* Patients with at least one of the following high risk clinical features at the time of presentation:
* Extra-prostatic extension (on palpation or radiographic imaging)
* PSA ≥ 20
* Gleason Score ≥ 8
* Patients scheduled to receive prostatic and pelvic IMRT with ACCULOC® target localization
* Age \> 18 years
* ECOG Performance Status ≤ 2
* Willing and able to sign informed consent document.-

Exclusion Criteria:

* History of radical prostatectomy
* History of prior pelvic radiation-

Primary outcomes:
measure: Determine the feasibility of using SPECT-LM
timeFrame: Completion of enrollment of all patients
Secondary outcomes:
measure: Evaluate the extent to which current target delineation guidelines include actual lymphatic channels visualized on SPECT-LM in the study population.
timeFrame: Completion of enrollment of all patients
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jeff Michalski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482520: Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma
Official title: Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Renal Cell Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.

Once the patient signed written informed consent, two bottles of 5 cc blood will be drawn and subsequently extracted DNA and serum will be stored until genetic analysis.

Brief summary: All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.

No additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only.

Blood samples (10 cc in volume) will be collected from all study participants once they provided written informed consent form. DNA will be extracted from peripheral blood samples using DNA isolation kit.


Eligibility criteria: Inclusion Criteria:

* All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study

Primary outcomes:
measure: Genotypes
timeFrame: 36months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: