louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06792721: MEASUREMENT of CIRCULATING MUTATION BURDEN
Official title: EVALUATION of CANCER RISK by MEASUREMENT of CIRCULATING MUTATIONAL BURDEN in CARRIERS of a GENETIC PREDISPOSITION
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Carcinoma
Genetic Predisposition to Cancer
BRCA Mutation
CfMB
Mutation Burden
Keywords: cfMB
predisposition to cancer
BRCA1
BRCA2
breast cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant is a carrier of a hereditary predisposition linked to a BRCA1/2 mutation (case), and the other participant (sister) is not a carrier (control).

Brief summary: Cancer-free women with a hereditary predisposition to breast and/or ovarian cancer

Detailed description: This proof-of-concept trial will be conducted with family members being monitored for a predisposition to breast and/or ovarian cancer linked to a BRCA1/2 gene mutation.

The study will be proposed to two sisters from the same sibling:

* one is a carrier of the genetic mutation
* and the other not,

Blood tests will evaluate the Mutation Burden cfMB

Eligibility criteria: Inclusion Criteria:

* Female participant
* Participant undergoing oncogenetic follow-up at the Centre François Baclesse
* Participant belonging to a pair of related biological siblings
* Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1/2 mutation (case), and the other participant is not a carrier (control).
* Participant between 30 and 50 years of age
* Participant affiliated to a social security scheme
* Participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure.

Exclusion Criteria:

-

Primary outcomes:
measure: Comparing the mutational burden in a person genetically predisposed to cancer with that of a non-predisposed relative
timeFrame: At the enrollment in the study (one point)
Secondary outcomes:
measure: Mutation profiling, COSMIC-type signature generation
timeFrame: At the enrollment in the study (one point)
measure: Identify and evaluate complementary or alternative molecular signatures
timeFrame: At the enrollment in the study (one point)
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
Clinical trial NCT05864521: Beetroot Juice and Sleep
Official title: Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Blood Pressure
Sleep
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effects of acute inorganic nitrate supplementation (with beetroot) on the regulation of sleep and neurovascular physiology.


Eligibility criteria: Inclusion Criteria:

* 18-35 or 65-80 years of age

Exclusion Criteria:

* Coronary artery disease
* Heart failure
* Pregnancy
* Diabetes
* Sleep disorders
* Shift workers
* Individuals who typically go to sleep after midnight
* Individuals who traveled across ≥2 time zones within one week of study visits
* Individuals with a history frequent kidney stones
* BMI ≥35.0kg/m2
* Use of nicotine-containing products within the two years preceding study visits
* Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with the nitrate-nitrite-nitric oxide pathway or outcome measures

Primary outcomes:
measure: Change in the amount of time in stage three sleep
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in sleep quality
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in self-reported sleep quality
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in sleepiness
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in daytime sleepiness
timeFrame: Baseline, approximately 30 days, and approximately 60 days
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in sympathetic nerve burst frequency
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in sympathetic nerve burst incidence
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in sympathetic nerve burst amplitude (AU)
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in total muscle sympathetic nerve activity (MSNA)
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in arterial stiffness
timeFrame: Baseline, approximately 30 days, and approximately 60 days
measure: Change in endothelial function
timeFrame: Baseline, approximately 30 days, and approximately 60 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05254821: Cell-free Tumor DNA as Minimal Residual Disease in Hodgkin Lymphoma Patients
Official title: Cell-free Tumor DNA Analysis for Minimal Residual Disease Detection in Patients With Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hodgkin Lymphoma
Keywords: ctDNA
Next generation sequencing
Hodgkin lymphoma
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female adults 18 years or older with a documented diagnosis of hodgkin lymphoma according to WHO 2016 classification

Brief summary: Molecular analysis identifies residual disease by overcoming the sensitivity of imaging methods and therefore has the potential for integrating with therapy provided by FDG-PET alone. It is a well known fact that tumor DNA circulating in plasma (ctDNA) reflects the mutational profile of tumor cells and can be used to non-invasively detect specific mutations of Hodgkin's lymphoma without the need for microdissecting the histological sample.

Detailed description: A clinical need, not yet met for the Hodgkin lymphoma disease, brings about the early and accurate identification of chemo-refractory patients who require stepping up of treatment as also, patients with good prognosis receiving treatment de-escalation.Molecular methods identify residual disease by overcoming the sensitivity of imaging methods and therefore have the potential to integrate the response to therapy provided by FDG-PET alone.

ctDNA modification from the basal time point to the interim can be used as a predictor of response to the ABVD scheme and as a complement to the interim-PET in the possible variation of the therapeutic schedule.

Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes) will be collected during the clinico/laboratory visits that are planned as per clinical routine at the time of diagnosis, at each cycle of chemotherapy, at the time of interim PET/CT, at the time of end of treatment PET/CT and during follow up.

Eligibility criteria: Inclusion Criteria:

* Male or female adults 18 years or older
* Documented diagnosis of Hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 WHO classification
* Willing and able to comply with scheduled study procedures
* Evidence of a signed informed consent
* ECOG performance status 0-2 (or 3, if disease related)

Primary outcomes:
measure: Sensitivity of interim ctDNA genotyping
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
References:
Clinical trial NCT03343821: Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly
Official title: Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accidental Fall
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Frail elderly patients over 65 years old hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes

Brief summary: The Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six scenarios of daily life; it is a measurement of falls, but also an evaluation of the modifications taken to prevent future falls. This study will analyze the robustness of this questionnaire.


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 65 years' old
* The patient is fragile (\< 8 score ≤ 11 SEGA score) hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes
* The patient can walk autonomously for 20m (with or without a walking aid)
* The patient is allowed to weight-bear

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent form
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is forbidden to weight-bear
* Comprehension problems preventing the accomplishment of the tasks
* Major short-term memory problems preventing the accomplishment of the tasks

Primary outcomes:
measure: Inter-evaluator reliability of Balance and Daily Life Questionnaire
timeFrame: Day 0
measure: Temporal stability of Balance and Daily Life Questionnaire
timeFrame: Day 3
Secondary outcomes:
measure: Comparison of EVQ score to Timed Up and Go test
timeFrame: Day 0
measure: Comparison of EVQ score to Timed Up and Go test
timeFrame: Month 1
measure: Comparison of EVQ to unipedal stance test
timeFrame: Day 0
measure: Comparison of EVQ to unipedal stance test
timeFrame: Month 1
measure: Comparison of EVQ to Sternal Push Test
timeFrame: Day 0
measure: Comparison of EVQ to Sternal Push Test
timeFrame: Month 1
measure: Comparison of EVQ to Walking and talking test
timeFrame: Day 0
measure: Comparison of EVQ to Walking and talking test
timeFrame: Month 1
measure: Sensitivity of Balance and Daily Life Questionnaire to change
timeFrame: Month 1
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References:
Clinical trial NCT00550121: Does Ascorbic Acid Reduce Sympathoexcitation in CHF?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2007-10-26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In CHF central sympathetic activity is increased. ROS formation seems to play a role in this process. This study analyzes the effect of vitamin C as an antioxidant on central sympathetic activity in CHF


Eligibility criteria: Inclusion Criteria:

* Heart failure of at least New York Heart Association (NYHA) class II
* Left ventricular ejection fraction (LVEF) \<= 40%
* Age 20-80 years

Exclusion Criteria:

* Necessity of short-term PCI, CABG or heart transplantation,
* Chronic disease of the autonomic nervous system,
* diabetes mellitus,
* use of tricyclic antidepressant drugs and/or a-adrenergic receptor antagonists.

Primary outcomes:
measure: change in central sympathetic output after vitamin C vs. placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Centre Nijmegen
name: Cees J Tack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284021: Fraxel Laser for Alopecia
Official title: A Pilot Study on 1550 nm Fractional Erbium-glass Laser for Alopecia Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alopecia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the scalp. Follow-up is at 150 days.

This study was a pilot study designed to determine feasibility of this procedure.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 18 years old
2. Subjects are in good health as judged by the investigator.
3. Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata.
4. Subject is seeking treatment for alopecia.
5. Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
2. Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
3. Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
4. History of recurrent facial or labial herpes simplex infection
5. History of hypertrophic scars or keloids
6. Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
7. Pregnant or breast feeding
8. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
9. Subjects who are unable to understand the protocol or give informed consent.

Primary outcomes:
measure: Clinical change of alopecia from baseline to 150 days.
timeFrame: Baseline and 150 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425021: Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery
Official title: Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Joint Revisions
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing revision total joint surgery.

Brief summary: The goal of this is to improve durability of total joint replacements in patients, thereby improving clinical outcomes and implant performance. To reach this objective, our research program would like to assess the safety, efficacy, performance, and durability of FDA approved biomaterial and implant designs used in joint replacements.

Detailed description: The objective of the investigation will be to determine the mechanism of material failure and identify any design features that put the implant at risk for early failure. Normally all implants are discarded. The investigators will collect the implants indicated for removal and if there are impressive findings the investigators will perform research on the implants, otherwise the implants will be discarded. All patients will be followed prospectively after informed consent is signed. The implants that are chosen for research will be assessed for implant wear and failure at a lab appropriate for evaluating the particular concern.

Eligibility criteria: Inclusion Criteria:

* Patients who will be undergoing revision total joint surgery will be asked to participate in this study.

Exclusion Criteria:

* Patients who are not undergoing revision total joint surgery.

Primary outcomes:
measure: determine the mechanism of material failure
timeFrame: 10 years
Secondary outcomes:
measure: identify any design features that put the implant at risk for early failure.
timeFrame: 10 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah
name: Chris Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598021: Self-correction Evaluation in Scoliosis Patients
Official title: Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis; Juvenile
Scoliosis; Adolescence
Lead sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 185
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adolescent and juvenile idiopathic scoliosis.

Brief summary: To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.

The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.

Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session.

Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).


Eligibility criteria: Inclusion Criteria for both parts:

* Diagnosis of juvenile or adolescent idiopathic scoliosis;
* Age \>= 10 years;
* Single and double curves with amplitude \>= 15 ° Cobb;
* Performing exercises according to SEAS for at least 6 months

Only for part 1 (radiographic)

* Availability of radiographic investigation in upright position and in self-correction Only for part 2 (ultrasound)
* Availability of ultrasound assessment in upright position and in self-correction
* Complete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination.
* Risser between 0 and 2.

Exclusion Criteria:

For both parts:

* Patients with more than 2 scoliotic curves
* Patients with secondary scoliosis
* Patients suffering from learning disabilities or clinical conditions impairing neuromotor control
* Patients lacking the necessary measures to evaluate the outcome.

Part 2 only (ultrasound)

● Patients undergoing brace treatment

Primary outcomes:
measure: Self-correction measure
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISICO
state: Mi
Study officials:
References:
Clinical trial NCT03482921: Body Parameters as an Independent Predictor of Acute Pancreatitis
Official title: Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 1662
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis criteria for AP was defined as the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP; (2) serum amylase and/or lipase levels≥3 times the upper limit of the normal level, and (3) characteristic findings of AP on a CT scanning.

Brief summary: This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.

Detailed description: Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage.

It is well-established that obesity (defined as body mass index\[BMI\]\>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP.

Eligibility criteria: Inclusion Criteria:

1. diagnosed with AP
2. age \>18 years

Exclusion Criteria:

1. age\<18years
2. missing data in the electronic medical record
3. history of AP

Primary outcomes:
measure: Comparisons of variables according to AP severity
timeFrame: the physical examination data in the year of 2017
measure: Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between body parameters and severity outcomes
timeFrame: the physical examination data in the year of 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo NO.1 hospital
state: Zhejiang
Study officials:
affiliation: Department of gastroenterology, Ningbo No.1 Hospital, Ningbo, China
name: Lei Xu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xie J, Xu L, Pan Y, Li P, Liu Y, Pan Y, Xu L. Impact of visceral adiposity on severity of acute pancreatitis: a propensity score-matched analysis. BMC Gastroenterol. 2019 Jun 13;19(1):87. doi: 10.1186/s12876-019-1015-z.