louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06024863: Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram
Official title: Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram. The SEEPRED Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrocardiography
Keywords: prediction
sport
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 1500
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Leisure tim sportmen over 35 years.

Brief summary: The importance of exercise electrocardiogram (ECG) is still controversial in the prevention of cardiac events among sportsmen. The aim of this study was to assess the relevance of exercise electrocardiogram (ECG) as a significant prognostic marker for cardiovascular events when any cardiovascular disease (CVD) risk factors are present.

Detailed description: The SEEPRED (Sport, Exercise ECG, prediction) prospective cohort study included leisure time sportsmen over 35 years old who performed exercise electrocardiogram (ECG) screening in the Sports Medicine Unit of the University Hospital of Saint-Etienne from September 2011 to April 2016. Personal, familial history and physical examination were systematically performed before maximal exercise electrocardiogram (ECG). Cardiovascular events and changes in physical activity were searched after exercise electrocardiogram (ECG).

Eligibility criteria: Inclusion criteria:

* Patients referred as asymptomatic by their general practitioner for an exercise electrocardiogram (ECG) screening test carried out as a standard procedure for resuming physical activity
* Patients referred as a systematic pre-participation screening to be declared an athlete.

Exclusion criteria:

* Patients with coronary artery disease (CAD) and
* Patients with uninterpretable ST segment due to bundle branch block

Primary outcomes:
measure: Silent Myocardial ischemia (SMI)
timeFrame: Day 1
Secondary outcomes:
measure: Gender record
timeFrame: Day 1
measure: Age record
timeFrame: Day 1
measure: Physical activity levels record
timeFrame: Day 1
measure: Treatment record
timeFrame: Day 1
measure: Cardiovascular disease (CVD) risk factors record
timeFrame: Day 1
measure: Body mass index record
timeFrame: Day 1
measure: Score>5% record
timeFrame: Day 1
measure: Maximal heart record
timeFrame: Day 1
measure: Maximal aerobic power record
timeFrame: Day 1
measure: Maximal blood lactate level record
timeFrame: Day 1
measure: Suspected SMI
timeFrame: Day 1
measure: Confirmed SMI
timeFrame: Day 1
measure: Cardiovascular events
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier de Saint-Etienne
Study officials:
affiliation: CHU ST ETIENNE
name: DAVID HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06336863: Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
Official title: An Extension Protocol for Subjects Previously Enrolled in the "Use of Donor Derived-cell Free DNA (AlloSure) and Gene Expression Profiling (AlloMap Kidney) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients"
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Kidney Transplant Immunosuppression
Keywords: Belatacept Monotherapy
Kidney Transplant Recipients
Immunosuppression
Weaning
DNA Testing
Gene Expression
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients."


Eligibility criteria: Inclusion Criteria:

* Completion of the parent study (STU-2020-1339)
* Able to provide informed consent
* Absence of donor specific antibodies
* Stable renal function (eGFR\>40mL/min for 3 months prior to enrollment)

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
* Significant hepatic impairment
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
* Proteinuria \> 0.5 g/g creatinine on spot urine sample within 3 months of enrollment

Primary outcomes:
measure: Incidence of acute kidney graft rejection
timeFrame: 12 months after informed consent
measure: Incidence of facilitation to Belatacept monotherapy
timeFrame: 12 months after the first study visit
Secondary outcomes:
measure: Patient Survival after Immunosuppression Wean
timeFrame: 12 months after informed consent
measure: Kidney Graft Failure after Immunosuppression Wean
timeFrame: 12 months after informed consent
measure: Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean
timeFrame: 12 months after informed consent
measure: Incidence of Proteinuria after Immunosuppression Wean
timeFrame: 12 months after informed consent
measure: Incidence of de-novo donor specific antibodies (dnDSA)
timeFrame: 12 months after informed consent
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: David Wojciechowski, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335463: 3D Single Cell Analysis Using Cell Morphology and Organelle Scattering Texture
Official title: 3D Single Cell Analysis Using Cell Morphology and Organelle Scattering Texture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: optical coherence tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are those who received skin or colon surgery, with their surgical specimens preserved and stored at Department of Pathology, National Taiwan University Hospital.

Brief summary: The investigators will use an advanced high resolution 3D optical coherence tomography (OCT) technology to observe colon and skin images in ex vivo.

Detailed description: Achieved formalin-fixed paraffin embedded tissue specimens from colon cancers and/or other benign and pre-cancer colon lesions as well as melanoma and/or other benign pigmented skin lesions will be used. The achieved specimens were kept in Department of Pathology, National Taiwan University Hospital. Sections of achieved pathological specimens were put on glass slides and tissue image will be observed by 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution and suitable for single cell imaging. This study will not interfere with the normal medical practice and had no impact on patient's safety and health. All of the materials will be destroyed once the experiments are done. The enrollment criteria will be patients who underwent colon/skin surgery or examinations in NTUH with pathological specimens taken and stored at NTUH.

Eligibility criteria: Inclusion Criteria:

• Participants are those who who received skin or colon surgery, with their surgical specimens preserved and stored at Department of Pathology, National Taiwan University Hospital.

Exclusion Criteria:

• Age younger than 20 years old.

Primary outcomes:
measure: Image of colon or skin tissue
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Sheng-Lung HUANG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06503263: Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL
Official title: Zanubrutinib and Lenalidomide as Maintenance Therapy in Patients With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 240
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.

Detailed description: The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large B-cell lymphoma post complete remission and have completed planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Patient has recieved complete remission and has completed planed courses of chemotherapy
* Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma)； Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
* Pregnant or lactating women

Primary outcomes:
measure: EFS
timeFrame: 2 years
Secondary outcomes:
measure: PFS
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: qlr2007@126.com Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457063: Endothelial Cell Loss After Penetrating Keratoplasty
Official title: Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Keratoconus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Primary purpose: TREATMENT

Brief summary: This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Detailed description: Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Eligibility criteria: Inclusion Criteria:

* PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction

Exclusion Criteria:

* Less than 18 and unable to give informed consent

Primary outcomes:
measure: Refraction
timeFrame: 1 year
measure: Visual acuity
timeFrame: 1 year
measure: Intra-ocular pressure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
affiliation: Alexandria Faculty of Medicine
name: Ehab Mossallam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824563: Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing
Official title: Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe-to-profound Hearing Loss
Lead sponsor: Advanced Bionics AG
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals with severe-to-profound hearing loss

Brief summary: The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education.
* Local language proficiency
* Bilateral, sensorineural hearing loss

Exclusion Criteria:

* Previous inner ear surgery or active middle ear pathology.
* Cochlear malformation or obstruction
* Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
* Evidence of central auditory lesion or compromised auditory nerve
* Concurrent participation in other study

Primary outcomes:
measure: CI aided word recognition scores in quiet and noise.
timeFrame: 12 months post activation
Secondary outcomes:
Other outcomes:
measure: Evaluate the potential of preservation of residual low frequency hearing
timeFrame: 12 months
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
Study officials:
affiliation: LUMC - Department of ORL-HNS
name: Johan Frijns, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041663: Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
Official title: Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningococcal Infections
Septic Shock
Severe Sepsis
Keywords: brain natriuretic peptide
cardiac function
meningococcal infections
septic shock
severe sepsis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.

Detailed description: OBJECTIVES: determining sensibility and specificity of BNP blood level to detect myocardial dysfunction in septic shock or severe sepsis due to Neisseria meningitidis in children.

METHODS: Prospective multicentric clinical trial including 7 French pediatric intensive care units. Serial cardiac ultra sounds and blood sampling will be done for patients hospitalized for purpura fulminans beginning at the time of admission in pediatric intensive care. Any child from 6 months to 18 years without preexisting cardiac disease and presenting with purpura fulminans will be enrolled after obtaining consent of both parents. From adult's studies on septic shock and BNP, a total number of 30 patients was calculated to be necessary to prove the interest of BNP in this indication.

Eligibility criteria: Inclusion Criteria:

* Children
* 6 months to 18 years aged
* without previous cardiac pathology
* hospitalized in the participating pediatric intensive care units for serious sepsis with extensive purpura

Exclusion Criteria:

* Heart malformative disorder with right-left shunt
* Pre-existent known cardiac insufficiency whatever is the origin
* Concomitant participation in another trial
* Patient in period of exclusion from another trial
* Not membership in a national insurance scheme

Primary outcomes:
measure: Repeated brain natriuretic peptide (BNP) blood level
timeFrame: Up to day 5
Secondary outcomes:
measure: Repeated cardiac echography
timeFrame: Up to day 5
measure: PRISM II gravity score
timeFrame: Up to day 5
measure: Organ failure PELOD score
timeFrame: Up to day 5
measure: Troponin rate
timeFrame: Up to day 5
measure: mortality and morbidity (aftereffects)
timeFrame: Day 28 and hospital discharge
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Necker hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean Bergougnoux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02348463: Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg and the Effect on Spontaneous Preterm Delivery
Official title: Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg County in Sweden and the Effect on Spontaneous Preterm Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginosis
Lead sponsor: Skaraborg Hospital
Sponsor class: OTHER_GOV
First posted: 2015-01-28
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with bacterial vaginosis in early pregnancy

Brief summary: Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy could reduce the risk for preterm delivery.

Women were screened for bacterial vaginosis during the first visits at the maternal health care unit with a vaginal sample that were taken by the midwife or by herself. After the vaginal samples was air dried it was sent to the gynaecological department and was investigated using Hay/Ison classification. Eligible women were those who had lived in Skaraborg and delivered at Skaraborg hospital.

Detailed description: The study has started 2007 and will continue until 2014. Pregnant women that will come to the maternal health care units in gestational week 8-11 will be offered to be screened for bacterial vaginosis. A vaginal sample will be taken by the midwife or by the women herself. The vaginal sample is air-dried and sent to the gynecological. There it is investigated using Hay/Ison classification for the diagnosis of bacterial vaginosis.

Women with bacterial vaginosis will be offered treatment with topical clindamycin treatment for 7 days if the women has passed the 12th gestational week. A control sample for the test of cure will be done after 10 week. If not cured of BV she will be offered a new treatment.

All women will be followed until delivery.

Eligibility criteria: Inclusion Criteria:

* pregnant women screened for bacterial vaginosis in early pregnancy

Exclusion Criteria:

* women not delivered at Skaraborg hospital.

Primary outcomes:
measure: preterm delivery
timeFrame: before 37th week of gestation
Secondary outcomes:
measure: cure of bacterial vaginosis
timeFrame: after 10 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03664063: PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )
Official title: A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphatic Filariasis
Yaws
Trauma
Lead sponsor: Lihir Medical Centre
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.


Eligibility criteria: Inclusion Criteria:

* Adult aged 18-65
* Able to give informed consent

Exclusion Criteria:

* Known chronic illness
* Hb \<7 at baseline
* Liver function or Creatinine \* 1.5 Upper Limit of Normal
* Urinary tract infection at baseline
* Pregnancy (female participants only)
* Routine medications which interact with study drugs
* Lactose/Gluten intolerance
* Permanent disability impeding study participation

Primary outcomes:
measure: Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
timeFrame: 4 Days
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Four days
Other outcomes:
Locations:
city: Londolovit
country: Papua New Guinea
facility: Lihir Medical Centre
state: New Ireland Province
Study officials:
References:
citation: John LN, Bjerum C, Martinez PM, Likia R, Silus L, Wali C, Elizah A, Chhonker YS, Bala V, King CL, Murry DJ, Mitja O, Marks M. Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases. Clin Infect Dis. 2020 Aug 20:ciaa1202. doi: 10.1093/cid/ciaa1202. Online ahead of print.