louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06331975: Radiomics and Radiogenomics of Non-small Cell Lung Cancer
Official title: Radiomics and Radiogenomics of Non-small Cell Lung Cancer: Relationships of Radiomic Signature With Gene Driver Mutations and Implications for Emerging Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up

Detailed description: Non-small cell lung cancers (NSCLC) are the first cause of cancer-related deaths.

Recent guidelines suggest the key role of a wide molecular profile because knowledge of the tumor genotype can enable patients with NSCLC to be treated with targeted therapies.

In this study, a first group of patients with lung adenocarcinoma (study group), tested for the presence of genetic alterations in EGFR, ALK, and KRAS, and with available Computer Tomography (CT) scans, will be evaluated to create a radiomic signature and assess its association with mutational status and prognosis.

Then, a second group of patients (validation group) will be enrolled to validate the radiomic signature and the status of the genetic alterations and their association with prognosis. Radiomic signature and liquid biopsies will be evaluated in patients positive for genetic alterations at each follow-up step to verify their association with prognosis and response to targeted therapies.

Eligibility criteria: Inclusion Criteria:

* patients with diagnosis of NSCLC
* patients candidates for mutational status assessment

Exclusion Criteria:

- patients with age \<18 years

Primary outcomes:
measure: Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status
timeFrame: 1 month
measure: Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)
timeFrame: 5 years
measure: Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Francesca Botta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02494375: Sleep and Type 1 Diabetes
Official title: Sleep and Glycemic Control in Type 1 Diabetic Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Sleep
glycemic control
type 1 diabetes
amylase
body composition
lean
overweight
obese
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2015-07-10
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary goal of the study is to determine whether insufficient sleep is associated with poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and somnolence, and whether insufficient sleep is linked to body composition. Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals, in 82 type 1 diabetic children.


Eligibility criteria: Inclusion Criteria:

- Female and male type 1 diabetic children and adolescents who are followed at the Woman, Mother and Child's Hospital (Hôpital Femme Mère Enfant : HFME) of Bron, France.

Exclusion Criteria:

* Refusal of consent of the parents or the child or the adolescent
* Pregnancy
* Concomitant pathology that severly impacts sleep
* Implanted electrical stimulation device
* Diagnosis of type 1 diabetes \<1 year

Primary outcomes:
measure: Association between HbA1c and sleep characteristics
timeFrame: Month 3, Month 6 and Month 9
Secondary outcomes:
measure: Glucose levels
timeFrame: Month 3, Month 6 and Month 9
measure: Daily salivary amylase variation (Enzyme Activity)
timeFrame: Month 3, Month 6 and Month 9
measure: Body composition (BMI fat and lean mass percentage)
timeFrame: Month 3, Month 6 and Month 9
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05598775: Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study
Official title: Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ischemic Stroke
Lead sponsor: ReNeuron Limited
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 9
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study

Brief summary: The purpose of this long-term safety study is to follow up subjects treated with CTX0E03 DP to monitor for delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival

Detailed description: The goal of this study is to assess the long-term safety of subjects treated with intracerebral CTX0E03 DP as measured by the onset of delayed adverse events of special interest (AESIs). AESIs are defined as adverse events leading to death, new oncological adverse events, new neurological adverse events and any other adverse event, which in the opinion of the Safety/Project Physician is related to CTX0E03 DP.

Eligibility criteria: Inclusion Criteria:

Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Long-term safety study is to follow up subjects treated with CTX0E03 DP
timeFrame: 4 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Amy Miller, RPh, PharmD
state: West Virginia
Study officials:
affiliation: UBC
name: Amy Miller, RPh, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04970875: Partial Modified Blair Incision on Benign Tumor Parotidectomy Scar's Characteristics
Official title: Effect of Parotid Mass Location on Benign Tumor Parotidectomy Scar's Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salivary Gland Tumor
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2021-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019

Brief summary: Parotidectomy is the treatment of choice for tumors in the parotid gland, with the modified Blair is the most common incision used. In our medical center, the incision is tailored to the size and location of the specific parotid tumor. This retrospective analysis aims to determine the incidence of complications and to assess the relation between the mass and scar characteristics in patients who had undergone parotidectomy.

Detailed description: The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019 will be evaluated. Patients will complete a questionnaire regarding the occurrence of complications.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years during the surgery
* Clinical diagnosis of a benign parotid pathology

Exclusion Criteria:

* A malignant pathology of the parotid gland
* Unavailable data

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed by a questionnaire.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Galilee Medical Center
Study officials:
References:
Clinical trial NCT04098575: A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes
Official title: Treatment of T2DM Patients in Germany Receiving Empagliflozin: A Retrospective RWE Study Description of Treatment and Population Characteristics of Type 2 Diabetic Patients in Germany Receiving Empagliflozin: A Retrospective Real-World Evidence (RWE) Study Based on German Registries DPV&DIVE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 9571
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin

Brief summary: Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals


Eligibility criteria: Inclusion Criteria:

* At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11)
* At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20)

Exclusion Criteria:

* Any diagnosis of T1DM

Primary outcomes:
measure: Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities
timeFrame: At baseline.
measure: Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications
timeFrame: At baseline.
measure: Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
timeFrame: At baseline.
Secondary outcomes:
measure: Percentage of Participants by Age Category
timeFrame: At baseline.
measure: Percentage of Male Participants
timeFrame: At baseline.
measure: Weight of Participants
timeFrame: At baseline.
measure: Height of Participants
timeFrame: At baseline.
measure: Glycated Hemoglobin (HbA1c)
timeFrame: At baseline.
measure: Duration of Diabetes
timeFrame: At baseline.
measure: Percentage of Participants With Previous Glucose-lowering Treatment
timeFrame: At baseline.
measure: Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes
timeFrame: At baseline.
measure: Number of Participants With Hospitalizations
timeFrame: At baseline.
measure: Dosage of Empagliflozin
timeFrame: At baseline.
measure: Fasting Plasma Glucose (FPG)
timeFrame: At baseline.
Other outcomes:
Locations:
city: Mahlow
country: Germany
facility: Diabetes Agenda 2010 GmbH
Study officials:
References:
Clinical trial NCT05494775: Effect of Corona Virus on Intravitreal Injections
Official title: Effects of Corona Virus Pandemic on Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Macular Edema
Age-Related Macular Degeneration
Choroidal Neovascularization
Myopic Choroidal Neovascularisation
Diabetic Retinopathy
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During pandemic of corona virus, patients compliance may be affected. We aim to study the factors lead to unregulated visits and its implications on the final visual outcome.

Detailed description: The corona virus pandemic may affects patients regular visits to ophthalmic clinic, we aim to study the sequel of the pandemic on intravitreal injections results in diabetic macular edema, wet age related macular degenerations, myopic choroidal new vascularization, and proliferative diabetic retinopathy.

Eligibility criteria: Inclusion Criteria:

* patients with the following conditions (diabetic macular edema, wet age related macular degeneration, myopic choroidal new vascularization and retinal vein occlusion complicated with macular edema).

Exclusion Criteria:

* patients that are known to have hypersensitivity to Anti-VEGFs.

Primary outcomes:
measure: Visual acuity
timeFrame: Baseline and monthly after injection till one year of follow-up
Secondary outcomes:
measure: Central subfield thickness
timeFrame: Baseline and monthly after injection till one year of follow-up
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy Tabl
state: Benha
Study officials:
affiliation: Benha University
name: Ahmed A Tabl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04368975: ARDS Caused by COVID-19
Official title: Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure With Hypoxia
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Ubikare
First posted: 2020-04-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with acute respiratory failure requiring invasive mechanical ventilation

Brief summary: Patients with the acute respiratory distress syndrome (ARDS) have markedly varied clinical presentations. Main characteristics of mechanically ventilated ARDS caused by COVID-19, and adherence to lung-protective ventilation strategies are not well known.

Detailed description: This is a multicenter, prospective, observational study in consecutive, mechanically ventilated patients with ARDS caused by COVID-19 (as defined by the Berlin criteria and confirmed COVID-19 infection in a respiratory tract sample), admitted into a network of 27 Spanish and Andorran intensive care units (ICUs). Clinical features, ventilatory management, and clinical outcomes will be examined

Eligibility criteria: Inclusion Criteria:

* aged 18 years or older
* intubated and mechanically ventilated
* confirmed COVID-19 infection in a respiratory tract sample
* acute onset of ARDS, as defined by the Berlin criteria

Exclusion Criteria:

* patients with non-confirmed SARS-CoV-2 infection according to WHO guidance
* patients with no information on respiratory parameters
* non- intubated patients

Primary outcomes:
measure: Discontinuation from mechanical ventilation
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Ricard Mellado
Study officials:
affiliation: Medical Research and Clinical Consulting
name: Carlos Ferrando
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrando C, Suarez-Sipmann F, Mellado-Artigas R, Hernandez M, Gea A, Arruti E, Aldecoa C, Martinez-Palli G, Martinez-Gonzalez MA, Slutsky AS, Villar J; COVID-19 Spanish ICU Network. Clinical features, ventilatory management, and outcome of ARDS caused by COVID-19 are similar to other causes of ARDS. Intensive Care Med. 2020 Dec;46(12):2200-2211. doi: 10.1007/s00134-020-06192-2. Epub 2020 Jul 29.
Clinical trial NCT01403675: Human Ovarian Autotransplantation
Official title: Human Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
Keywords: women with cancer whose ovarian tissue has been collected and stored in liquid nitrogen before cancer therapy (surgery, chemotherapy, radiotherapy),
who are in remission (no recurrence of disease for 5 years),
who are in normal organ function and have no contraindication for surgery or pregnancy, and
who wish to restore ovarian function using stored ovarian tissue.
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors may find that they are not able to produce female hormones, and they may not be able to have a child. Scientists are trying to find ways to help cancer survivors regain their hormonal function and possibly get pregnant, if they desire. Scientists have developed a method where ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back into her body is called ovarian autotransplantation.

Ovarian autotransplantation is a very new technique, and there have only been a small number of women who have had this procedure. So far, only five babies in the world have been born using this technique.

The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope to find better ways to use this method to help a woman's ovaries start working again after chemotherapy. If the ovaries start working again, it might be possible to have a baby.


Eligibility criteria: Inclusion criteria:

* Adult women (age between 18 and 40) who stored the ovary before cancer therapy.
* Adult women who completed cancer therapy and are in remission.
* Adult women who desire to conceive and are ready to have a baby.

Exclusion criteria:

* Age under 18 or over 40 years old
* Women with a disease at high risk for ovarian metastasis (such as leukemia)
* Women with contraindication for surgery
* Women with contraindication for pregnancy
* Psychological instability to sustain pregnancy (diagnosed by a psychiatrist)
* Women who are HIV Positive

Primary outcomes:
measure: Comparision of orthotopic and heterotopic autotransplantation
timeFrame: 2009-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: The University of Kansas Medical Center
name: Sam Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700375: Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection
Official title: Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emergent Coronary Procedure
Keywords: Patients undergoing an emergent coronary procedure
Lead sponsor: Osaka General Medical Center
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.

Detailed description: This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing an emergent coronary procedure(within 60 minutes from admission)

Exclusion Criteria:

* On dialysis
* Pregnancy
* Past use of bicarbonate or N-Acetyl-Cystein in 48hr
* Past exposure to contrast media in 48hr
* Circulatory insufficiency with lactic acidosis.

Primary outcomes:
measure: Occurrence of Contrast-induced Nephropathy
timeFrame: after procedure and 1,2-3day after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka General Medical Center
Study officials:
affiliation: OsakaGeneralMedicalCenter
name: Takahisa Yamada, directorate
role: STUDY_CHAIR
References:
Clinical trial NCT06966375: Worldwide Yearly Screening for Hypospadias
Official title: Pilot Testing of the Worldwide Yearly Screening for Hypospadias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypospadias
Keywords: Hypospadias Complications
Quality of Life
Patient-Reported Outcomes
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-05-11
Enrollment: 20
Sex: MALE
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to recruit approximately 20 male participants who have a history of repaired hypospadias to test the feasibility and acceptability of the Care Planning Tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Web Application.

Detailed description: Several studies show that patients who undergo hypospadias repair report significant functional and psychosexual issues in adolescence or adulthood (in more than 50% of cases). The Care Planning tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Web Application, developed using expert level consensus from a Delphi Measure including stakeholders (psychologists, urologists, endocrinologists, patients/families), is designed to support the functional and psychosexual health of male youth and adults treated for hypospadias, to support their physical and mental health after repair.

This is a pilot study of the WYSH intervention to access its feasibility and acceptability.

Eligibility criteria: Inclusion Criteria:

* Males who have a documented history of repaired hypospadias.
* Age groups targeted, based on recommended standards for user experience data from pilot studies:

  * 3-5 Males, age 5-10 (with parental consent and child assent)
  * 3-5 Males, age 11-15 (with parental consent and child assent)
  * 3-5 Males, age 16-20 (with parent consent, child assent until age 18)
  * 3-5 Males, age 21-65

Exclusion Criteria:

-

Primary outcomes:
measure: Feasibility: Participant Count to Summarize answers of the Care Planning Tool
timeFrame: Baseline, 3 weeks, 3 months
measure: Acceptability: User Centered Metrics
timeFrame: Baseline, 3 weeks, 3 months
measure: Acceptability: Cognitive Debriefing Measures
timeFrame: Baseline, 3 weeks, 3 months
measure: Feasibility: System Usability Testing
timeFrame: Baseline, 3 weeks, 3 months
Secondary outcomes:
measure: Provider Acceptability: Usability Scale
timeFrame: Data collected after participating patient completes questionnaire, up to approximately 3 months.
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Vinaya Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
References: