louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03573869: Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)
Official title: Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Heart Failure, Systolic
Lead sponsor: G.Gennimatas General Hospital
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 404
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month.

A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.


Eligibility criteria: Inclusion criteria:

* A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required),
* LVEF \<40% on sinus rhythm,
* symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
* age \>21 years old.

Exclusion criteria:

* previous left atrial ablation,
* left atrial diameter \>28 mm/m2 BSA on TTE (parasternal long axis view),
* strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
* pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
* known primary electrical heart disease (e.g. Brugada syndrome),
* presence of thrombus in a heart chamber,
* presence of prosthetic valve at any position,
* moderate/severe valvular heart disease,
* active infectious disease or malignancy,
* moderate or severe hepatic impairment (Child-Pugh class B or C),
* severe renal failure (estimated glomerular filtration rate \<20 ml/min/1.73 m2),
* inability or unwillingness to adhere to standard treatment or to provide consent.

Primary outcomes:
measure: Time to exceed AG burden cut-off of 1%
timeFrame: Up to 2 years
Secondary outcomes:
measure: All-cause mortality or hospitalization for heart failure
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens General Hospital "G. Gennimatas"
Study officials:
References:
Clinical trial NCT04405869: Thromboembolic Events in Severe COVID-19 Patients
Official title: Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Thromboembolism
Keywords: Covid-19
Thrombosis
D-Dimers
Anticoagulation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed infection with the Sars-CoV-2 virus

Brief summary: The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events


Eligibility criteria: Inclusion Criteria:

* Confirmed infection with the Sars-CoV-2 virus (RT-PCR)
* Hospitalization in Intensive Care Unit
* Age over 18 years Old

Exclusion Criteria:

* Refusal of the patient to participate in data collection

Primary outcomes:
measure: Analysis of incidence of thromboembolic events in patients with Sars-CoV-2
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil
Study officials:
References:
citation: Tacquard C, Mansour A, Godon A, Godet J, Poissy J, Garrigue D, Kipnis E, Rym Hamada S, Mertes PM, Steib A, Ulliel-Roche M, Bouhemad B, Nguyen M, Reizine F, Gouin-Thibault I, Besse MC, Collercandy N, Mankikian S, Levy JH, Gruel Y, Albaladejo P, Susen S, Godier A; French Working Group on Perioperative Hemostasis. Impact of High-Dose Prophylactic Anticoagulation in Critically Ill Patients With COVID-19 Pneumonia. Chest. 2021 Jun;159(6):2417-2427. doi: 10.1016/j.chest.2021.01.017. Epub 2021 Jan 16.
Clinical trial NCT01946269: Goal-Directed Therapy in Cancer Surgery
Official title: Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Care
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment
* Age over 18 years-old

Exclusion Criteria:

* Weight under 55 kilograms or over 140 kilograms;
* Contra-indication for invasive hemodynamic monitoring;
* Expected ICU permanence less than 24 hours;
* Active bleeding
* Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min
* Enrolled in other study
* Refuse to consent

Primary outcomes:
measure: Composite endpoint of death or major postoperative complications
timeFrame: 30 days after randomization
Secondary outcomes:
measure: Duration of ICU stay and hospital stay
timeFrame: 30 days after randomization
measure: Tissue hypoperfusion markers
timeFrame: 7 days after randomization
measure: Daily SOFA score
timeFrame: 7 days after randomization
measure: Cardiovascular complications
timeFrame: 30 days after randomization
measure: Respiratory complications
timeFrame: 30 days after randomization
measure: Severe Renal complication
timeFrame: 30 days after randomization
measure: Neurological complications
timeFrame: 30 days after randomization
measure: Severe infectious complications
timeFrame: 30 days after randomization
measure: Surgical complications
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Intensive Care Unit of the Cancer Institute of Sao Paulo State
state: SP
Study officials:
References:
citation: Gerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4.
Clinical trial NCT06635369: Taurine in Periodontitis and Aging
Official title: The Role of Taurine in Periodontitis and Aging: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peridontal Disease
Aging
Keywords: Taurine
Periodontitis
Aging
Inflammation
TNF-α
SIRT1
Biomarker
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 66
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are separated into four different groups. Young (25-44 years) with a healthy periodontium, young with periodontitis, old (≥65 years) with a healthy periodontium, and old with periodontitis
Primary purpose: DIAGNOSTIC

Brief summary: Aging leads to a decline in physiological functions and increases the risk of chronic diseases. Periodontitis is a chronic inflammatory disease that causes progressive destruction of the tissues supporting the teeth. Taurine, an amino acid with anti-inflammatory and antioxidant effects, might impact both periodontitis and aging. This study investigated taurine, SIRT1, and TNF-α levels in saliva and blood of 66 healthy people in different age groups, with or without periodontal disease. The findings showed that young people with healthy periodontal status had higher levels of taurine and SIRT1 compared to others. TNF-α, a marker of inflammation, was linked to the severity of periodontitis and may help identifying it in younger individuals. Overall, higher TNF-α levels are associated with periodontal inflammation, while taurine levels decrease with age-related inflammation.


Eligibility criteria: Exclusion Criteria:

* ages 18-25 or 45-64
* use of antibiotics, anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, or anticoagulants within the last 6 months
* presence of diabetes, rheumatoid arthritis, or other systemic conditions such as cardiovascular, renal, hepatic, and neurodegenerative disorders
* pregnancy or lactation
* alcoholism
* smoking
* nonsurgical periodontal treatment in the past 6 months or surgical treatment in the past 12 months
* having less than 20 natural teeth, excluding third molars
* use of orthodontic appliances

Primary outcomes:
measure: Taurine
timeFrame: 12 Weeks
measure: SIRT1
timeFrame: 12 Weeks
measure: TNF-α
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Unkapani
Study officials:
References:
Clinical trial NCT00382369: Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis
Official title: Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vocal Cord Paralysis
Keywords: familial vocal cord paralysis
genetic screening
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-09-29
Enrollment: 11
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Families suffering of familial vocal cord paralysis

Brief summary: Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this study we plan to identify the genetic locus of the genes in two extended families who suffer of the disease.

Detailed description: In a number of families suffering of familial vocal cord paralysis it has previously been shown that the disease is inherited autosomal dominant. In one of the families the gene coding for the disease was located on chromosome 6q16. We will be analyzing 2 extended families with familial vocal cord paralysis to define their genetic defect leading to the disease. All family members will undergo a laryngoscopy to determine the extent of paralysis. For all family members we will isolate DNA and determine their microsatellite polymorphism on chromosome 6q16. If the results are negative we will continue the study and perform a whole genome scan to localize the gene(s) involved.

Eligibility criteria: Inclusion Criteria:

* members of families suffering of familial vocal cord paralysis

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center, Mt Scopus
Study officials:
affiliation: Hadassah MO
name: Eitan Kerem, MD
role: STUDY_DIRECTOR
affiliation: Hebrew University Jerusalem
name: Batsheva Kerem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manaligod JM, Skaggs J, Smith RJ. Localization of the gene for familial laryngeal abductor paralysis to chromosome 6q16. Arch Otolaryngol Head Neck Surg. 2001 Aug;127(8):913-7. doi: 10.1001/archotol.127.8.913.
Clinical trial NCT03465969: A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
Official title: A Bioanalytical Method Cross-validation Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Liver Transplantation
Keywords: Kidney transplantation
A Bioanalytical Method Cross-validation
Advagraf
Liver transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.

Detailed description: This will be a bioanalytical assay method cross-validation study using blood samples donated by liver or kidney transplant participants. Participants will have been on a stable dose of Advagraf and deemed clinically stable for a period of 3-6 months and attend a routine out-patient follow-up visit to receive their usual oral dose of commercial Advagraf. Participants will be asked to provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose and at approximately 1 and 3 hours post-dose. Participants will be kept at the study site for an extra 1 hour to ensure post-sampling safety and will be discharged thereafter.

Eligibility criteria: Inclusion Criteria:

* Subject will be a recipient of either a liver or kidney transplant and on a stable dose of commercial Advagraf minimum of 3 months.
* Subjects will be with clinically stable graft function for at least 3 months.

Exclusion Criteria:

* Subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.

Primary outcomes:
measure: Comparison of blood concentrations of tacrolimus
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Site FR33002
city: Villejuif
country: France
facility: Site FR33001
city: Cambridge
country: United Kingdom
facility: Site UK44002
city: London
country: United Kingdom
facility: Site UK44001
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Clinical Research Physician
role: STUDY_DIRECTOR
References:
Clinical trial NCT05257369: Broad Band Emission LED Phototherapy Source Versus Narrow Band
Official title: Clinical Efficacy of LED Phototherapy Devices With Blue - Green Versus Blue Light of Equal Irradiance in Neonates With Non Hemolytic Jaundice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Hyperbilirubinemia
Jaundice, Neonatal
Keywords: Phototherapy
Blue light LED
Green Light LED
Lead sponsor: Erebouni Medical Center
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 110
Sex: ALL
Minimum age (years): 24
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device.


Eligibility criteria: Inclusion Criteria:

* non-haemolytic hyperbilirubinaemia, but otherwise healthy, indications for phototherapy based on NICE criteria, gestational age ≥33 weeks, birth weight ≥1800 g, postnatal age \>24 hrs and ≤14 days

Exclusion Criteria:

* hemolytic jaundice, major congenital animalities and history of phototherapy. Infants with indication of intensive treatment double phototherapy were not included.

Primary outcomes:
measure: Bilirubin level reduction
timeFrame: 24 hours
Secondary outcomes:
measure: Days of phototherapy
timeFrame: "Through study completion, an average of 1 month.
Other outcomes:
measure: Adverse outcomes
timeFrame: "Through study completion, an average of 1 month.
Locations:
city: Yerevan
country: Armenia
facility: Erebouni Medical Centre, NICU
Study officials:
References:
Clinical trial NCT04619069: Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer
Official title: Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer: A Randomized Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on PSMA PET scan


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years.
2. Able to provide informed consent.
3. Histologic diagnosis of prostate adenocarcinoma.
4. ECOG performance status 0-1.
5. Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT.
6. Up to a maximum of 3 PSMA avid areas of metastatic disease.
7. For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be \> 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate.
8. All sites of disease are amenable to and can be safely treated with SBRT.

Exclusion Criteria:

1. Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
3. Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed.
4. Castrate resistant prostate cancer.
5. Evidence of spinal cord compression.

Primary outcomes:
measure: Proportion of eligible patients who enroll onto the study
timeFrame: Through accrual completion, approx 2 years
Secondary outcomes:
measure: Side Effects and Effectiveness
timeFrame: Through study completion, approx 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT00648869: Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers
Official title: Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: pharmaceutical preparations
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-04-01
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design.

Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg \& Metformin tablet 500mg


Eligibility criteria: Inclusion Criteria:

* Men ranging in age from 18-40
* Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology \& clinical chemistry) obtained within 14 days prior to the start of the study.
* BMI \>18\&\<30.
* Willing and able to abide by the dietary requirements of the study.
* Willing and able to give written informed consent in a manner approved by the Ethics Committee.

Exclusion Criteria:

* History of known or suspected clinically significant hypersensitivity to any drug.
* Any protocol-required laboratory test abnormality that is considered clinically significant.
* Mentally unstable or incompetent.
* Any illness during the week before.

Primary outcomes:
measure: To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).
timeFrame: 45 days
Secondary outcomes:
measure: To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet.
timeFrame: 45 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Diabetes Unit, Hadassah Hebew University Hospital
Study officials:
affiliation: Hadassah Hebrew University Hospital
name: Itamar Raz, MD
role: PRINCIPAL_INVESTIGATOR
References: