louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07024394: Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1
Official title: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Ruvometinib Tablets (FCN-159 Tablets) in Pediatric Participants With Neurofibromatosis Type 1
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neurofibromatosis 1
Plexiform Neurofibroma
NF1
Lead sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 65
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1/2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.


Eligibility criteria: Inclusion Criteria:

Patients from the pediatric cohort of the FCN-159-002 study. Willing to participate in the long-term follow-up study and capable of understanding and voluntarily signing the informed consent form.

Exclusion Criteria:

Any clinically significant condition that, in the investigator's judgment, may interfere with study participation or compliance with safety requirements.

Patients unable to comply with visit-related requirements.

Primary outcomes:
measure: long term safty
timeFrame: Through study completion, about 5 years
Secondary outcomes:
measure: Height in centimeters
timeFrame: Through study completion, about 5 years
measure: Weight in kilograms
timeFrame: Through study completion, about 5 years
measure: Tanner stage
timeFrame: Through study completion, about 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Through study completion, about 5 years
measure: Objective response rate (ORR)
timeFrame: Through study completion, about 5 years
measure: Changes in pain intensity
timeFrame: Through study completion, about 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01612494: Hypertonic Saline as Therapy for Pediatric Concussion
Official title: Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury.

The study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale as compared to normal saline.

The null hypothesis was that there would be no difference in change of reported pain in either group.


Eligibility criteria: Inclusion Criteria:

* 4-17 years old
* consent obtained
* pain as a symptom of concussion
* head CT negative for intracranial pathology

Exclusion Criteria:

* younger than 4 years or older than 17 years
* multi trauma
* cardiac, neuro, renal history of disease
* seizure
* narcotic, drug use
* pregnancy
* head CT with traumatic intracranial pathology
* no consent

Primary outcomes:
measure: Change in Pain
timeFrame: Following therapy to 2-3 days post discharge
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital Emergency Department
state: California
Study officials:
affiliation: University of California, San Diego
name: Angela K Lumba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Mary Hilfiker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06872294: Research of Predictive Factors of in Vitro Fertilization (IVF) Outcome AI-IVF Study
Official title: Research of Predictive Factors of in Vitro Fertilization (IVF) Outcome in Women Affected by Autoimmune Disorders: From Biological Markers to Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Diseases
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Pavia
First posted: 2025-03-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing ART procedures (n= 200, ) at SSD Ostetricia e Ginecologia 2 - PMA of Fondazione IRCCS Policlinico San Matteo, Pavia (Italy)

Brief summary: Infertility is the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected intercourse, while subfertility means a delay in achieving pregnancy. Several factors can contribute to these conditions, such as autoimmune diseases like systemic thyroid and celiac diseases, rheumatoid arthritis, systemic lupus erythematosus, and endometriosis. Some of them may overlap, sharing a common immunological milieu.

In this scenario, medically ART can help women carry on pregnancies if they are in stable disease remission and receive adequate treatment. However, the number of oocytes that can be ovulated under stimulation is highly variable, so the outcome of any IVF is linked to many factors, not only biological but also connected to the mean success rate of the fertility center.

For these reasons, the need to find methods for identifying the best gametes and embryos to guarantee a successful pregnancy is becoming pressing. AI can be essential to develop prediction models for pregnancy outcomes for patients undergoing ART treatments.

AI currently represents a modern way to obtain algorithms from a set of observable data that could help clinical decisions


Eligibility criteria: Inclusion Criteria:

* Women with age below 43 years old
* IVF cycle with fresh semen sample that could be used
* progressive motile spermatozoa expected count of minimum 1 million following density gradient purification on the day of oocyte pick up

Exclusion Criteria:

* Women with uterine abnormalities
* Women with chromosomal and genetic abnormalities
* Positivity to serological test (HCV, HBV, HIV, VDRL-TPHA)

Primary outcomes:
measure: Predictive algorithm creation
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: SSD Ostetricia e Ginecologia 2 - Fondazione IRCCS Policlinico San Matteo, Pavia
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Claudia Omes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398294: To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)
Official title: An Open-Label, Single-Arm, Prospective Study to Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Male or female patient, \>18 years of age
* Patients with hypercholesterolemia who meet the following lipid criteria:

  1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl
  2. secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl
* The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study

Exclusion Criteria:

* Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris
* Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1
* Uncontrolled hypertension with systolic blood pressure \> 160 mmhg or diastolic \> 100 mmhg at visit 1.
* Unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening

Primary outcomes:
measure: Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Merck Sharp & Dohme (I.A.) Corp.
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03008694: Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients
Official title: Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Cancer
Radiotherapy; Complications
Keywords: PET/CT
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol

Detailed description: Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed oral squamous-cell carcinoma
* Age \> 17 years
* Signed informed consent
* ECOG Performance status 0-2
* Must be able to start RT within 4 weeks after PET/CT simulation

Exclusion Criteria:

* stage IV disease diagnosed before acquisition of staging PET/CT
* prior radiotherapy to oral and neck
* Unable to understand study participation
* Claustrophobia
* pregnant or breast feeding mothers

Primary outcomes:
measure: progress free survival
timeFrame: baseline to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03091894: Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy
Official title: Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea of Adult
Keywords: Dexmedetomidine
Sleep
Endoscopy
Propofol
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2017-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.

Detailed description: Propofol is a commonly used intravenous anesthetic drug used for procedural sedation. Dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.In the current study the success of the sedation during drug induced sleep endoscopy will be assessed.

Eligibility criteria: Inclusion Criteria:

* age more than 18 years
* patients with obstructive sleep apnea
* ASA 1and2

Exclusion Criteria:

* patient refusal
* age less than 18 years
* morbid obesity
* known or suspected allergy to the studied drugs

Primary outcomes:
measure: success of sedation
timeFrame: the duration of the procedure under sedation is usually about 20 minutes
Secondary outcomes:
measure: time until sufficient sedation
timeFrame: about 5-10 minutes from start of sedation
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Sharkia
Study officials:
affiliation: Zagazig University
name: essam f abdelgalel, A.professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736094: Ultrasound for Detection of Prostate Cancer
Official title: Dual-frequency Ultrasound for Detection of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: University of Oslo
name: The Research Council of Norway
First posted: 2023-02-21
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.

Detailed description: Prospectively recruited patients before prostatectomy and/or definitive radiotherapy will be included in the study. Dual-frequency ultrasound imaging will be compared to standard transrectal ultrasound and MRI. Imaging of primary tumor with dual-frequency ultrasound technology including the use of microbubble contrast-media.

A prostate biopsy and blood sample will be taken from each patient, for histopathology and explorative biomarkers.

Eligibility criteria: Inclusion Criteria:

* Age 18 years onwards
* Signed written informed consent to perform rectal and transperineal ultrasound

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
timeFrame: 1 day
measure: Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Wolfgang Lilleby, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01249794: Non Invasive Ventilation After Cardiac Surgery
Official title: Effectiveness of Continuous Positive Airway Pressure Outside the Intensive Care Unit After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: NIV
non invasive ventilation
cardiac surgery
continuous positive airway pressure
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2010-11-30
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: Patients with respiratory failure following cardiac surgery are randomized to receive standard therapy versus non invasive ventilation. The hypothesis is that patients receiving non invasive ventilation will perform better than those who received standard therapy.


Eligibility criteria: Inclusion Criteria:

* hypoxia

Exclusion Criteria:

* pneumothorax
* cardiocirculatory instability
* no written consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano, Italy
Study officials:
affiliation: Vita-Salute San Raffaele, Milano, Italia
name: Ottavio Alfieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02807194: Ambulatory Lumbar Disk Surgery
Official title: Epidural Anesthesia Versus General Anesthesia for Elective Lumbar Disk Surgery in a Outpatient Basis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disk Surgery
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in surgery for lumbar disc herniation.

Detailed description: Patients included: All patients in the neurosurgery department of the University Hospital of Reims or in the neurosurgery department of CHG Chalons en Champagne for surgical management of lumbar disc herniation and agreeing to participate in the research. The types of anesthesia (general anesthesia or spinal anesthesia) will be randomized.

Investigation Plan: Participation in the research will be available to any eligible patient during the anesthesia consultation prior hospitalization for surgery. If the patient agrees to participate in research, randomization of the anesthetic technique will be realized. The anesthetist and the patient will be informed of the outcome of this randomization. Hospitalization of patients will not be changed. They will be hospitalized in inpatient, as usual, with an entry the day before surgery and an outlet the next day (without complications). The surgery itself will not be changed. The patient's postoperative monitoring will not be changed. Data will be collected for each patient: demographic data, medical data, data about the intervention and anesthesia, postoperative data management.

Eligibility criteria: Inclusion Criteria:

* single lumbar disk herniation elective for surgery

Exclusion Criteria:

* Patients with haemostatic disorder
* Patients with lumbar spine surgery history
* Patients with sciatica called "hyperalgesia" resistant to treatment including systemic corticosteroids and 3 WHO bearing analgesics (oral morphine)
* Patients with true paralyzing sciatica with motor disorders compatible with the path of the root compressed by the herniation
* Patients with sphincter disorders
* Patients with herniated disc multistage
* Pregnant women
* Patients with comorbid against-showing the elongated position, including cardiorespiratory comorbidities
* Minors patients
* Patients protected by law.

Primary outcomes:
measure: consumption of analgesic Level III (according to WHO criteria)
timeFrame: 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Chu Reims
state: Reims
Study officials:
References:
Clinical trial NCT02714660: The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application
Official title: The Work of Being a Patient: A Mixed Methods Characterization of the Work of Being a Patient With Type 2 Diabetes Mellitus Using Real-time Data Collection Via a Smartphone Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with type 2 diabetes with receiving care at Mayo Clinic endocrinology department.

Brief summary: This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" .

Detailed description: This study will describe how much time persons with type 2 diabetes mellitus spend on health management and the burden they experience from these activities.

Eligibility criteria: Inclusion Criteria:

* receiving medical care at Mayo Clinic endocrine subspecialty clinic
* diagnosis of type 2 diabetes

Exclusion Criteria:

* unable to provide consent
* patients who reside in an extended care of intermediate care facility

Primary outcomes:
measure: Mean Score on Burden of Treatment Questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Victor Montori, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01132560: Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
Official title: A Correlative Science Study for ECOG E5194
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patient enrolled on E5194

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.

Detailed description: OBJECTIVES:

* To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS) genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from patients with DCIS enrolled on clinical trial ECOG-E5194.

OUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of ductal breast carcinoma in situ
* Enrolled on clinical trial ECOG-E5194

  * Local surgery without radiotherapy
  * Treated or not treated with tamoxifen
* Available tissue samples
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Ipsilateral local failure (first event of invasive or DCIS recurrence)
timeFrame: 1 month
Secondary outcomes:
measure: Contralateral breast cancer (invasive or DCIS)
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Lawrence J. Solin, MD, FACR
role: PRINCIPAL_INVESTIGATOR
References: