louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03902665: Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75
Official title: Up-front Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia Aged 65-75
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia, Adult
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Associazione Italiana per la Ricerca sul Cancro
First posted: 2019-04-04
Enrollment: 19
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with acute myeloid leukemia aged 65-75 have a very poor prognosis, irrespective of the treatment strategy, including demethylating agents or conventional chemotherapy. With these approaches, remission rates do not exceed 40%, and overall disease-free survival at 1 year is in the order of 15%. The hypothesis is that up-front allogeneic hematopoietic stem cell transplant will produce a complete remission rate of 60% on day +56-70, and disease-free survival at 1 year of 30%. This is a single arm phase II study of upfront allogeneic stem cell transplantation, for patients with acute myeloid leukemia aged 65-75: the primary endpoint is a complete remission rate on day +56-70. The secondary endpoint is a 1-year overall disease-free survival of 30%.


Eligibility criteria: Inclusion Criteria:

* Patients aged 65-75
* Patients with de novo or secondary acute myeloid leukemia (AML) - intermediate or high risk according to European LeukemiaNet (ELN) recommendations 2017
* Untreated patients at diagnosis of acute myeloid leukemia - patients may have received treatment for high-risk myelodysplastic syndromes with hypomethylating agents (HMA). They should not have received a course of induction chemotherapy to be eligible for this study
* Haploidentical family stem cell donor or other suitable donors available
* Fit and unfit patients by geriatric scale assessment
* Signed informed consent.

Exclusion Criteria:

* Acute Myeloid Leukemia good risk according to European LeukemiaNet 2017
* Positive serology for Human Immunodeficiency Virus.
* Serious organ dysfunction: left ventricular ejection fraction \< 40%, forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) \<50% of predicted, Liver Function Tests \> 5 x the upper limit of normal, or creatinine clearance \<30 ml/min .
* Life expectancy less than 30 days.
* Frail patients by geriatric scale assessment

Primary outcomes:
measure: Rate of complete remission equal or higher than 60%
timeFrame: From day 56 to day +70 post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Andrea Bacigalupo, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268865: Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis
Official title: Clinical Application of Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis in HBV and HCV-infected Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Fibrosis
Keywords: Acoustic Radiation Force Impulse (ARFI)
Virtual Touch Quantification (VTQ)
liver stiffness measurement (LSM)
liver fibrosis
cirrhosis
hepatitis B
hepatitis C
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HBV or HCV-infected patients about to undergo liver biopsy to assist in clinical decision making

Brief summary: Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for hazard evaluation of future disease complication development and thus for the optimal decision making on treatment selections.In the era of antiviral and antifibrotic treatments, clinical and research demands are also increasing for non-invasive surveillance of liver fibrosis to evaluate the progression or regression. However, local baseline data on liver stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to the aims to recruit patients based on strict but appropriate criteria, to complete the correlation and validity studies between ARFI quantification and the referenced METAVIR fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring during the same session of examination. Statistics: The first year's study using ARFI will focus on the correlation testings and validity studies using receiver operating characteristics.

Detailed description: Contribution and Future Works: Using the ARFI quantification either as a causal factor or as a outcome, we can conduct future analyses ranging from validations, regressions to prospective time-to-event analysis among our cohorts.

Eligibility criteria: Inclusion Criteria:

* infected with HBV only or HCV only

Exclusion Criteria:

* concurrent HBV-HCV infection, etc.

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 NCT05562765: Comfort and Quality of Life of Older Cardiac Patients
Official title: Comfort and Quality of Life of Older Cardiac Patients: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Quality of Life
Keywords: comfort
quality of life
cardiac patients
nursing
older patients
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 209
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of individuals aged 65 and over with cardiovascular disease.

Brief summary: The aims of the study were to determine the comfort and quality of life, to examine the relationship between them, and to identify factors that affect the comfort and quality of life in older cardiac patients. The cross-sectional study was conducted in the inpatient cardiology clinic of a university hospital in Bolu. Overall, 209 patients, who met the inclusion criteria, consisted of the sample. A descriptive characteristics form, the General Comfort Scale and Quality of Life Index Cardiac Version-IV was used to collect data. The study was reported in The Strengthening the Reporting of Observational Studies in Epidemiology Statement. Mean of the General Comfort Scale scores was 16.18±0.82, and the mean of the Turkish Quality of Life Index (QLI) Cardiac Version-IV scores was 2.97±0.39. Physical, psycho-spiritual, environmental, and sociocultural comfort levels associated with both the general QLI Cardiac Version-IV scale and sub-dimensions of its (p\<0.05). The location of residence, perception of income status, frequency of hospitalization, dietary adherence, routine health control, and dizziness were the independent variables associated with the General Comfort and Quality of Life scale (p\<0.05).


Eligibility criteria: Inclusion Criteria:

* were to be 65 years and older,
* have a diagnosis of CVDs,
* speak and understand Turkish,
* can communicate verbally.

Exclusion Criteria:

* hearing impairments and cognitive limitations

Primary outcomes:
measure: Comfort level
timeFrame: when recruited (once)
measure: Quality of life level
timeFrame: when recruited (once)
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: cardiology clinic of a university hospital in Bolu
Study officials:
affiliation: Abant Izzet Baysal University
name: Şeyma Demir Erbaş
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02528565: Gastric Banding After Failed Gastric Bypass
Official title: Laparoscopic Adjustable Gastric Banding With the Adhesix Bioring After Failed Gastric Bypass: a Prospective Evaluation in a High-volume Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Duomed
Sponsor class: INDUSTRY
Collaborators: name: Archer Research
First posted: 2015-08-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with failed RYGB receiving revisional LAGB.

Brief summary: The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.


Eligibility criteria: Inclusion Criteria:

* Patient must sign the informed consent form prior to the index-procedure.
* Patient with failed RYGB defined as patients with EWL \<50%.

Exclusion Criteria:

* Patient has a life expectancy of less than 2 year.
* Patient who is most likely expected not to be compliant with the proposed follow-up visits.

Primary outcomes:
measure: Percentage excess weight loss
timeFrame: 2 years
Secondary outcomes:
measure: Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.
timeFrame: During procedure
measure: Complications (perioperative, early and late)
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
measure: Regression of co-morbidities
timeFrame: 2 years
measure: BAROS score
timeFrame: 2 years
measure: Frequency of revisions
timeFrame: 2 years
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
Study officials:
affiliation: AZ Sint-Jan AV
name: Bruno Dillemans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03225365: Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma
Official title: Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Melanoma
Keywords: Melanoma
Nivolumab
Ipilimumab
Immune modulation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is an open bi-centric prospective non-randomized study in patients with metastatic melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and identify the differences between responder and non-responder patients.


Eligibility criteria: Inclusion Criteria:

* Men and women aged ≥ 18 years of age.
* Patient with metastatic or unresectable melanoma
* Nivolumab or Nivolumab + Ipilimumab treatment indication
* Skin biopsies available
* Patient affiliated to or a beneficiary of a social security category.
* Signed Written Informed Consent.
* Patient who agrees to the storage of his biological samples

Exclusion Criteria:

* Treated haematological malignancies Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Patients with autoimmune disease.
* Ocular melanoma

Primary outcomes:
measure: Change description of biological characteristics of immune cells of the blood by immunomonitoring.
timeFrame: Week 1 (baseline, before the 1st injection), week 3 (before the 2d injection treatment), week 7 (before the 4th) , week 13 (before the 5th), week 53 (before the 26th or during radiological evaluation) or at the progression
measure: Change in the immune response by skin biopsy.
timeFrame: Week 1 (Baseline), week 7, week 53 or at the progression.
Secondary outcomes:
measure: Progression-free survival
timeFrame: Week1 , every radiological assessments defined by standard care (not by specific time frame)
measure: Overall survival
timeFrame: week 1, date of patient death
measure: Auto-immune adverse event frequency
timeFrame: baseline, week 53 or at the progression
measure: Subtype of melanoma correlated with biological characteristics of immune cells
timeFrame: baseline
measure: Immunity gene polymorphism correlated with biological characteristics of immune cells
timeFrame: Week 1, week 3, week 7, week 13, week 53 or at the progression.
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)
Study officials:
References:
Clinical trial NCT06028165: CABG Based on CT-FFR Versus Conventional Coronary Angiography
Official title: A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Myongji Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aims of study are (1) to compare early and 1-year graft patency rates in patients who underwent coronary artery bypass grafting (CABG) based on conventional coronary angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR), and (2) to demonstrate difference in clinical outcomes between the 2 groups.

Detailed description: The CABG-COREA trial is designed as a randomized, controlled trial to recruit 96 patients who undergo coronary artery bypass grafting. Patients were randomized by use of a randomization table. Coronary arteries are revascularized based on conventional coronary angiography (quantitative coronary angiography) or cardiac computed tomography-derived fractional flow reserve according to the randomization result.

The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events).

Eligibility criteria: Inclusion Criteria:

* age equal or more than 40
* age equal or less than 80
* patients who undergo coronary artery bypass grafting due to multi-vessel coronary artery disease
* patients who agree to the enrollment

Exclusion Criteria:

* Patients with heart failure (left ventricular ejection fraction \< 25%)
* patients who have intractable ventricular arrhythmia
* patients who has been treated for cancer
* patients who has infectious disease
* patients who are planned to undergo combined cardiac surgery
* patients who has medical co-morbidity with expected survival less than 1 year
* patients with a history of previous cardiac surgery
* Patients with chronic renal failure requiring dialysis
* patients who undergo emergency operation

Primary outcomes:
measure: 1-Year graft patency rates
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 4 years
measure: Freedom from Cardiac Death
timeFrame: 4 years
measure: Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
timeFrame: 4 years
measure: Early Angiographic Patency Rates
timeFrame: 1.5 days
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
Study officials:
affiliation: Cardiovascular Center, Myongji Hospital
name: Min-Seok Kim, MD, PhD, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT03125265: DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study
Official title: DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Habit
End Stage Renal Disease
Keywords: nutrition
hemodialysis
mortality
omega 3
Lead sponsor: University of Bari
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2017-04-24
Enrollment: 9757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: dialysis clinics administered by a single dialysis provider

Brief summary: The DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study is a multinational prospective cohort study designed to evaluate the association between nutrition and dietary patterns and health outcomes in prevalent adult haemodialysis patients in Europe and South America.


Eligibility criteria: Inclusion Criteria:

* End-stage kidney disease
* Long-term haemodialysis for at least the previous 90 days
* 18 years or older
* Treating team agrees to the patient's involvement in the study
* Participant willing to provide written and informed consent.-

Exclusion Criteria:

* significant neurocognitive disability or medical comorbidity that would preclude them from understanding the dietary questionnaire even if assisted
* a life expectancy less than 6 months according to their treating physician
* planned kidney transplantation within 6 months of baseline

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 12 months since baseline dietary evaluation
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12 months since baseline dietary evaluation
measure: Infection-related mortality
timeFrame: 12 months since baseline dietary evaluation
measure: All-cause and cardiovascular related hospitalisation
timeFrame: 12 months since baseline dietary evaluation
Other outcomes:
Locations:
Study officials:
affiliation: University of Bari
name: Giovanni FM Strippoli, MD, PhD
References:
Clinical trial NCT05499065: Real-time Margin Assessment in Head and Neck Cancer
Official title: Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Keywords: Cetuximab-800CW
Fluorescence guided surgery
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.


Eligibility criteria: Inclusion Criteria:

* Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma and scheduled to undergo surgical removal as decided by the multidisciplinary head and neck tumor board of the UMCG;
* Age ≥ 18 years;
* Written informed consent.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
* Concurrent uncontrolled medical conditions;
* Received an investigational drug within 30 days prior to the dose of cetuximab-800CW;
* History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT \>3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment;
* Inadequately controlled hypertension with or without current antihypertensive medications;
* History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies;
* Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause;
* Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
* Patients receiving Class 1a (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
* Life expectancy \< 12 weeks;

Primary outcomes:
measure: Enhanced intra-operative margin detection
timeFrame: Postoperatively, i.e. 7-10 working days
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Floris J Voskuil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Max JH Witjes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: