louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01276834: Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
Official title: Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Transplantation
Lead sponsor: Dianet Dialysis Centers
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
First posted: 2011-01-13
Enrollment: 13
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: To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.


Eligibility criteria: Inclusion Criteria:

* Age between 18-75 yr
* Willingness to provide written informed consent
* Ability to understand the study procedures

Exclusion Criteria:

* Life expectancy \< 3 months
* Claustrophobia
* Allergy to iodinated contrast
* Treatment incompliance
* Pregnancy
* Highly HLA-sensitized patients
* Severe dyslipidemia or proteinuria
* Severe leucopenia or thrombocytopenia
* GFR \< 30 ml/min

Primary outcomes:
measure: change in coronary artery calcification score
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Franka E van Reekum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01480934: Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus
Official title: A Prospective Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus -A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development of Posterior Capsule Opacification
Keywords: Diabetes,posterior capsule opacification,case control study
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent phacoemulsification for age-related cataract

Brief summary: To compare the development of posterior capsule opacification (PCO) between eyes with and without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not increase the incidence of PCO at 4 years.

Detailed description: There is a paucity of available literature that prospectively evaluates the development of PCO with the single-piece hydrophobic acrylic IOL implantation in diabetic versus non-diabetic eyes on a long-term basis. Therefore, this study was designed to compare the degree of PCO after cataract surgery between diabetic and age-matched non-diabetic patients. This prospective, observational case control study comprised patients who underwent phacoemulsification .The patients were asked to return for postoperative follow-up visits at 1 month, 1 year and 4 years.

the digital images were analyzed for PCO .

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more ,
* use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes.
* Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls (n=75 eyes).

Exclusion Criteria:

* patients with glaucoma,
* high myopia (axial length \> 27.0 mm),
* pseudoexfoliation,
* traumatic cataract,
* subluxated cataract,
* previous ocular surgeries,
* allergy to dilating drops.

Primary outcomes:
measure: Development of Posterior capsule opacification.
timeFrame: 4 years
Secondary outcomes:
measure: duration of diabetes, stage of diabetic retinopathy
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Iladevi Cataract &IOL Research Centre
name: Gauri D Shah, M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00968734: Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
Official title: Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency, Vitamin D
Keywords: Vitamin D
colecalciferol
absorption by Vitamin D
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2009-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.

Detailed description: Clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin D supplement. Participants were randomly in two groups according to sex and BMI.

In the same date, each group of participants received a meal and dietary supplement of vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples were collected in the seventh and fourteenth day after intake the supplement.

Eligibility criteria: Inclusion Criteria:

* Residents of the hospital clinics of Porto Alegre

Exclusion Criteria:

* Don't drink milk
* Obesity
* Malnutrition
* Liver disease
* Kidney disease or diabetes
* Use of dietary supplements containing calcium and vitamin D
* Medications
* Anticonvulsants
* Barbiturates, or steroids.
* Having performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.

Primary outcomes:
measure: Serum Level of Vitamin D3
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Fabiana Viegas Raimundo, graduation
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul
name: Tania Weber Furlanetto, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Rio Grande do Sul
name: Gustavo Faulhaber, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Rosana Scalco, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Leonardo Marques, Graduation
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Paula Menegatti, Graduation
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01311934: Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse
Official title: Clinical Application of the Spectrum of Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Visceral Stiffness
Liver Fibrosis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver diseases

Brief summary: The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness.

Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.

Detailed description: Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.

Eligibility criteria: Inclusion Criteria:

* patients with chronic liver diseases who underwent liver biopsy
* patients with pathologically or radiologically proven cirrhosis

Exclusion Criteria:

* Post major abdominal surgery
* After interferon or neucleos(t)ides treatment
* PBC,PSC,WD,AIH,viral coinfections
* Liver abscess
* Exposure to hepatotoxic drugs or chemicals
* Thrombosis of splenic vein, portal veins
* After resection or embolism of the spleen
* Acute or chronic pancreatitis
* Biopsy contraindications (not exclusive)
* ARFI measurements low quality
* Fibrotest contraindications:

Acute hepatitides, Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, CBD\>0.7cm Severe hemolysis

* Cardiac congestion
* Liver cancer other than HCC
* Treated HCC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
name: Sheng-Hung Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
name: Cheng-Yuan Peng, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05150834: Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines
Official title: Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines: Adenovirus-vectored Vaccine Versus mRNA Vaccine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiome
Vaccine
Covid-19
SARS-CoV-2
Immunogenicity
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From Febrary 25, 2021 to July 16, 2021, 53 healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get either BNT162b2 (n=27) or ChAdOx1 (Oxford/AstraZeneca) (n=26) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results.

Brief summary: Vaccination is the best way to mitigate the coronavirus disease 2019 (COVID-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. There is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. Thus, the investigators investigated the relationship between gut microbiota and humoral immune response after COVID-19 vaccination.


Eligibility criteria: Inclusion Criteria:

* People assigned to get either BNT162b2 or ChAdOx1 vaccines
* informed concents

Exclusion Criteria:

* Participants were excluded if they had a history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs.

Primary outcomes:
measure: Taxonomic biomarkers predicting immune responses
timeFrame: before the administration of first-dose
Secondary outcomes:
measure: Antibody titres after the first dose vaccination
timeFrame: 3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1
measure: Antibody titres after the second dose vaccination
timeFrame: 3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Koera University Guro Hospital
Study officials:
References:
Clinical trial NCT03499834: A Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy
Official title: A Phase II Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer (NSCLC) Stage IV
Keywords: Immune Cell Therapy
IKC
Lead sponsor: Ivy Life Sciences, Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: Tri-Service General Hospital
First posted: 2018-04-17
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, whole blood is drawn from the patient to be used to grow Immune Killer Cells (IKC). After proliferation, the IKC will be infused back into the patient to treat the cancer for a total of 24 weekly treatments.

Possible adverse reaction can include slight fever and headache.


Eligibility criteria: Inclusion Criteria:

1. Age≧20 years old
2. Life expectancy≧3 months
3. Eastern Cooperative Oncology group (ECOG) score 0\~2
4. Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC)
5. Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...

Exclusion Criteria:

1. Patients with history of cardiovascular disease, including uncontrolled hypertension, congestive heart failure, myocardial infarction, angina pectoris, coronary artery disease, uncontrolled arrhythmia , previous history of encephalopathy within the past six months of screening period
2. Patients with HIV, HTLV or active tuberculosis
3. Women who are pregnant or breast-feeding
4. Patients with drug or other substance abuse
5. Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: 7 months
measure: Quality of Life (QOL)
timeFrame: 8 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri Service General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yuh-Min Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068534: A Qualitative and Quantitative Analysis on the Living History of Survivors From Charcoal-burning Suicide
Official title: A Qualitative and Quantitative Analysis on the Living History of Survivors From Charcoal-burning Suicide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide
Keywords: in-depth individual interview
charcoal-burning suicide
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: survivors from charcoal-burning suicide

Brief summary: The current study aims to explore the risk factors, protective factors, resilient factors, and factors jeopardizing the recovery progress on survivors from charcoal-burning suicide. To this end, an in-depth individual interview and Mini-Mental State Examination(MMSE) will be used to acquire the first-hand information on the attempters. As well, a more comprehensive neuropsychological test, WAIS III, will be administered at 3-month, 6-month, and 12-month after the index suicide attempt.


Eligibility criteria: Inclusion Criteria:

* above 20 years old, survivors from charcoal-burning suicide.

Exclusion Criteria:

* under 20 years old
* survivors from other kind of suicide
* prisoner
* suffer from a serious illness
* foreigner/ can't speak Chinese
* the people who can't express themselves
* can not be interviewed in FEMH
* people with severe physical or psychological symptoms

Primary outcomes:
measure: MMSE score
timeFrame: once
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yi-Ju Pan, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04987034: Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
Official title: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: Portal Pressure Measurement
Portal Pressure Gradient
Hepatic Vein Pressure Gradient
Liver Diseases
Portal Hypertension
Intractable ascites
End Stage Liver Disease
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis who have been referred for a HVPG procedure.

Brief summary: The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.


Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.

Exclusion Criteria:

* Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
* Patient is unwilling or unable to sign and date the informed consent
* Patient is unwilling to comply with the follow-up study schedule
* Previous total or partial splenectomy
* Non-cirrhotic portal hypertension
* Known history of spontaneous bacterial peritonitis (SBP) within the last three months irrespective of treatment for SBP
* Patients with known infection which is not controlled by medical intervention
* Portopulmonary hypertension
* Cardiac decompensation
* Pre-sinusoidal liver disease
* Cholestatic liver disease
* Patient who received endoscopic treatment for upper gastrointestinal (GI) variceal bleeding within the past 7 days
* Patients with current hepatocellular carcinoma (HCC)

Primary outcomes:
measure: The correlation between the direct and indirect procedures to measure PPG.
timeFrame: The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Barcelona
country: Spain
facility: Hospital Clinic, Barcelona
Study officials:
affiliation: Department of Gastroenterology and Hepatology and Department of Clinical and Experimental Medicine
name: Schalk Van der Merwe, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05717634: Endometrial Changes in Breast Cancer Women.
Official title: Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Endometrial Hyperplasia With Atypia
Breast Cancer
TAM
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Palermo
name: University of Padova
name: Universita di Verona
name: Federico II University
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: University of Messina
name: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
First posted: 2023-02-08
Enrollment: 829
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors users and no therapies.

Brief summary: This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Detailed description: This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection.

The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Eligibility criteria: Inclusion Criteria:

* Personal history of breast cancer

Exclusion Criteria:

* Personal history of other hormonal sensitive cancers
* Assumption of hormones in the previous 5 years
* Previous medical assisted reproduction technique
* Lynch syndrome or BRCA 1/2 mutations

Primary outcomes:
measure: Incidence of endometrial cancer
timeFrame: One year
Secondary outcomes:
measure: Ultrasonographic soft markers of endometrial pathology
timeFrame: One year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS "Regina Elena" National Cancer Institute
state: Lazio
Study officials:
References: