louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04931992: Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
Official title: Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients \< 61 years with CBF and/or NPM1-mutated AML in CR1 after induction therapy who did not receive allogeneic stem transplantation and who were followed for measurable residual disease after completion of treatment.

Brief summary: Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 61 years
* Diagnosis between 2010 and 2019
* Core binding factor and/or NPM1 acute myeloid leukemia
* First complete remission after induction therapy
* Measurable residual disease measurement after end of consolidation therapy

Exclusion Criteria:

* Acute promyelocytic leukemia
* Allogeneic stem cell transplantation in CR1

Primary outcomes:
measure: Event-free survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
References:
Clinical trial NCT00106392: A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Prostate Cancer
Keywords: Treatment effectiveness
Treatment efficacy
Investigational, Therapies
Immunosuppressant
Erectile dysfunction
Prostatectomy
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-03-24
Enrollment: 131
Sex: MALE
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

Detailed description: The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Exclusion Criteria:

* Patient is \> 65 years of age
* Patient has been diagnosed with Type 1 or Type 2 diabetes
* Patient is actively smoking on a daily basis

Primary outcomes:
measure: Erectile Function Domain Score Between Treated and Untreated Groups
timeFrame: 18 months
Secondary outcomes:
measure: Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score
timeFrame: 24 months
measure: Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score
timeFrame: 24 months
measure: Percentage of Patients Considered Successful Responders to Impotence Medications
timeFrame: 24 months
measure: Time to Achieve Response to Impotence Medications
timeFrame: 24 months
measure: Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Mulhall JP, Klein EA, Slawin K, Henning AK, Scardino PT. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med. 2018 Sep;15(9):1293-1299. doi: 10.1016/j.jsxm.2018.07.009.
Clinical trial NCT06559592: Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy
Official title: Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthritis
Keywords: orthopedic surgery
unicompartmental knee arthroplasty
high tibial osteotomy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged of at least18 years old, who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. The high tibial osteotomy was made because of genu varum.

Brief summary: This retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum.

Clinical, funtionnal and radiological outcomes were examined.


Eligibility criteria: Inclusion Criteria:

* operated between January 2005 and June 2019
* HTO followed by implantation of medial UKA (Oxford Partial Knee, Zimmer Biomet, Bridgend, UK) in the same knee
* medial knee osteoarthritis with healthy lateral compartment
* patellofemoral pain
* coronal plane deformity of less than 15°

Exclusion Criteria:

* death
* lost to follow-up
* medial UKA implant other than the Oxford Partial Knee

Primary outcomes:
measure: Give the functional results using the Oxford score, for patients who underwent this procedure.
timeFrame: from 4 to 185 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
Clinical trial NCT05034692: Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
Official title: Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Neoplasm
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 60
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: Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery.

Condition or disease：Left colon cancer Intervention/treatment： Procedure:Intracorporeal left colectomy Overlap anastomosis Procedure: Extracorporeal left colectomy convention anastomosis

Detailed description: This a simple randomized, single-center, single-blind, randomized controlled trial study.The patients were randomly divided into experimental groups and control groups by computer.The perioperative recovery data, complications and oncology index of total laparoscopic colectomy with intracorporeal anastomosis and laparoscopic-assisted colectomy with extracorporeal anastomosis would be compared.

Eligibility criteria: Inclusion Criteria:

* ASA\<3 classification
* 18kg/m2≤BMI≤30kg/m2
* Neoplasm staging is T1-4a, N0-2, M0
* No previous history of abdominal surgery
* No previous history of neoplasm chemoradiotherapy
* No status of ileus, bowel obstruction and active hemorrhage of the digestive tract

Exclusion Criteria:

* Age\<18 years or \>75 years
* ASA≥3 classification
* BMI\<18kg/m2 or BMI\>30kg/m2
* Neoplasm staging is T4b or M1 Underwent chemoradiotherapy Appeared status of ileus,bowel perforation or active hemorrhage of digestive tract Patients with pregnant

Primary outcomes:
measure: The incidence of early complications
timeFrame: one month after surgery
Secondary outcomes:
measure: anastomotic orifice stricture and torsion
timeFrame: one month after surgery
measure: the time of first flatus
timeFrame: one month after surgery
measure: the time of first defecation
timeFrame: one month after surgery
measure: the time of first oral feeding
timeFrame: one month after surgery
measure: postoperative hospitalization days
timeFrame: one month after surgery
measure: the incision length and cosmetic
timeFrame: one month after surgery
measure: pain score
timeFrame: postoperative 6 hours, the first day and the third day
Other outcomes:
Locations:
city: Xian
country: China
facility: General Surgery Gastrointestinal Department，Tang-Du of Fourth Military Medical University
state: Shan XI Province
Study officials:
affiliation: General surgery ,Tang Du of Fourth Military Medical University
name: Wang Nan, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00345592: TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Official title: TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.


Eligibility criteria: Inclusion Criteria:

* chronic symptomatic HF despite stable, optimal drug therapy
* indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines
* patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities

Exclusion Criteria:

* Chronic atrial fibrillation
* Valvular disease
* patients who underwent or are planned for ablation of atrial fibrillation
* cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment
* preexisting unipolar pacemaker

Primary outcomes:
measure: Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
timeFrame: 3 years from randomization (39 months total)
Secondary outcomes:
Other outcomes:
Locations:
city: Careggi
country: Italy
facility: Istituto di Clinica Medica I° e Cardiologia A.O.C.
city: San Fermo della Battaglia (CO)
country: Italy
facility: Azienda Ospedale S. Anna
Study officials:
affiliation: Azienda Ospedale S. Anna
name: Gianluca Botto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi
name: Luigi Padeletti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botto GL, Boriani G, Favale S, Landolina M, Molon G, Tondo C, Biffi M, Grandinetti G, De Filippo P, Raciti G, Padeletti L. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial. Trials. 2011 Feb 15;12:44. doi: 10.1186/1745-6215-12-44.
Clinical trial NCT05006092: Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)
Official title: Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surveillance Endoscopy for Colorectal Cancer
Artificial Intelligence
Polyps of Colon
CADe
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Klinikum Stuttgart
First posted: 2021-08-16
Enrollment: 1149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of an artificial intelligence system for polyp detection (CADe)

Detailed description: We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.

Eligibility criteria: Inclusion Criteria:

* indication CRC surveillance endoscopy
* indication post-polypectomy surveillance endoscopy
* positive fecal immunochemical test in patients \>=50 years

Exclusion Criteria:

* reasonable suspicion of inflammatory bowl disease
* reasonable suspicion of familiar polyposis Syndrome
* Patient after radiation/resection of colonic parts

Primary outcomes:
measure: adenoma detection rate
timeFrame: 4 months
Secondary outcomes:
measure: polyp detection rate
timeFrame: 4 months
measure: withdrawal time
timeFrame: 4 months
measure: resection time
timeFrame: 4 months
measure: Boston Bowl Preparation Score
timeFrame: 4 months
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
Study officials:
affiliation: Wuerzburg University Hospital
name: Alexander Hann
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lux TJ, Banck M, Sassmannshausen Z, Troya J, Krenzer A, Fitting D, Sudarevic B, Zoller WG, Puppe F, Meining A, Hann A. Pilot study of a new freely available computer-aided polyp detection system in clinical practice. Int J Colorectal Dis. 2022 Jun;37(6):1349-1354. doi: 10.1007/s00384-022-04178-8. Epub 2022 May 11.
Clinical trial NCT05890092: Vulvar Disease in Nigeria Observational Study
Official title: Vulvar Disease in Nigeria - Registry ( Observationsl Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vulvar Diseases
Vulvar Atrophy
Dermatoses
Lead sponsor: KDRS ltd
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All afab, willing to participate in the study.

Brief summary: Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria


Eligibility criteria: Inclusion Criteria:

* biological females - afab

Exclusion Criteria:

* none-afab

Primary outcomes:
measure: Prevalence of Vulvar disease
timeFrame: 1-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kdrs
Study officials:
References:
Clinical trial NCT04426292: SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak
Official title: SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sars-CoV2
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).

This study is a monocentric interventional prospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel.

* To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.
* To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.


Eligibility criteria: Inclusion Criteria:

* Any adult employee of the UZ Brussel who provided a signed informed consent to participate in the study.

Exclusion Criteria:

* UZ Brussel employees whose contract expires within 6 months of study initiation, with the exception of resident trainees (if training continues in another hospital, resident trainees will be asked to perform the last sampling when leaving the UZ Brussel).
* Staff not active during the inclusion period

Primary outcomes:
measure: Seroprevalence
timeFrame: Change from baseline to 2 months and 5 months timepoint
measure: seroconversions
timeFrame: Change from baseline to 2 months and 5 months timepoint
Secondary outcomes:
measure: Incidence of definite cases
timeFrame: Change from baseline to 2 months and 5 months timepoint
measure: Incidence of probable cases
timeFrame: Change from baseline to 2 months and 5 months timepoint
measure: Antibody kinetics
timeFrame: Change from baseline to 2 months and 5 months timepoint
measure: Potential work-related risk factors
timeFrame: Change from baseline to 2 months and 5 months timepoint
measure: Proportion of asymptomatic seroconversions
timeFrame: Change from baseline to 2 months and 5 months timepoint
measure: Concerns for safety for infection with COVID-19
timeFrame: Change from baseline to 2 months and 5 months timepoint
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT01377792: Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis
Official title: Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: hypertonic saline
cystic fibrosis
pulmonary inflammation
pulmonary exacerbation
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 71
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Cystic fibrosis
* Over 6 years old
* FEV1 over than 30%
* Must be able to perform a spirometry
* Must be able to perform induced sputum
* Must tolerate the maximum dose of 10 ml hypertonic saline
* No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study
* No treatment with hypertonic saline in the 2 weeks before

Exclusion Criteria:

* No clinical diagnosis of Cystic Fibrosis
* No tolerance of 10 ml of hypertonic saline
* Positive pregnancy test
* No tolerance of Beta2-agonist
* Treatment with corticosteroids
* FEV1 \< 30%
* Liver and/or lung transplantation
* Oxygen treatment
* Hospital admission within the 4 previous weeks
* Oral or intravenous antibiotic treatment within the 2 previous weeks
* Smokers
* Pulmonary colonisation with Burkholderia cepacia complex

Primary outcomes:
measure: Free time, specified in days, of pulmonary exacerbation
timeFrame: 12 months
Secondary outcomes:
measure: Changes in lung function test measured by spirometry
timeFrame: 12 months
measure: Changes in inflammatory markers during the treatment
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Cystic Fibrosis Unit. Ramón y Cajal University Hospital
Study officials:
name: Adelaida Lamas, MD
role: PRINCIPAL_INVESTIGATOR
References: