louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07015190: Neoadjuvant Darovasertib in Primary Uveal Melanoma
Official title: A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Uveal Melanoma
Keywords: Uveal Melanoma
Plaque Brachytherapy
Enucleation
Neoadjuvant
Darovasertib
IDE 196
Ocular Melanoma
Choroidal Melanoma
Ophthalmology
Ocular Oncology
Melanoma
Protein Kinase C
GNAQ
GNA11
Lead sponsor: IDEAYA Biosciences
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma

Detailed description: The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.

In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm).

In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation.

Subjects will then receive primary local therapy following neoadjuvant darovasertib.

All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

Eligibility criteria: Inclusion Criteria:

* Primary non-metastatic uveal melanoma
* Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
* ECOG 0 or 1
* Adequate organ function

Exclusion Criteria:

* Previous treatment for UM
* Evidence of metastatic UM
* Attributes that necessitate enucleation regardless of response to therapy
* Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
* Presence of a malignant disease other than the one being treated in this study

Primary outcomes:
measure: Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
timeFrame: Approximately 3 years
measure: Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
timeFrame: Approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02869490: Institut Paoli Calmettes Cervical Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of cervical Cancer

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of cervical cancer

Exclusion Criteria:

* Non applicable

Primary outcomes:
measure: Survival of patients with cervical cancer
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches du Rhone
Study officials:
References:
Clinical trial NCT05980390: IL35 Level in Vitiligo
Official title: Assessment of Tissue Levels of IL-35 in Active and Stable Vitiligo
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: IL35, Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with active and stable vitiligo together with normal subjects

Brief summary: The aim of this observational study is to evaluate the level of the IL-35 protein in tissue biopsy from patients with active \& stable vitiligo.


Eligibility criteria: Inclusion Criteria:

* Patients with active and stable vitiligo

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with associated autoimmune or other dermatological diseases e.g., Alopecia areata and lupus erythematous.
* Patients already on both topical and systemic treatment at the time of recruitment.
* Patients on Immunosuppressive drugs.
* Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of accentuation by wood's light examination.

Primary outcomes:
measure: level of IL35 in tissue biopsy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05738590: Inflammatory and Degenerative Muscle Disease
Official title: Neurophysiological, Sonographical and Pathological Findings in Patients With Inflammatory Versus Degenerative Muscle Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Muscle Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients with muscle disease of different etiologies aged from 18 years to 75 years, of both sex

Brief summary: Correlation between clinical , ultrasonographical, neurophysiological and histopathological findings in muscle diseases of different etiologies.


Eligibility criteria: Inclusion Criteria:

1. Muscle diseases of different etiologies.
2. Any age.

Exclusion Criteria:

1. Patient refuse to participate.
2. The anatomy is altered due to severe trauma, tumor , or surgery.
3. Severe deformity preventing examination.

Primary outcomes:
measure: microscopic picture of muscle in inflammatory and degenerative muscle disease
timeFrame: 1 year
Secondary outcomes:
measure: muscle ultrasound in inflammatory and degenerative muscle disease
timeFrame: 1 year
measure: neurophysiology in inflammatory and degenerative muscle disease
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06847490: Transfusion Prediction in Major Abdominal Surgery
Official title: Development and Validation of a Predictive Model for Transfusion in Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusions
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 128749
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: This study includes adult patients (≥18 years old) who underwent major abdominal surgery at a tertiary medical center. The study population consists of patients with available preoperative clinical and laboratory data, allowing for the development of a predictive model for intraoperative blood transfusion. Patients with known hematologic disorders, coagulopathy, or prior transfusion before surgery are excluded to minimize confounding factors.

Brief summary: The transfusion nomogram, integrating preoperative variables, may effectively predict intraoperative transfusion in major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older who underwent major abdominal surgery

Exclusion Criteria:

* Patients with known hematologic disease or coagulopathy
* Patients who received a blood transfusion before surgery
* Patients with incomplete data or missing laboratory values

Primary outcomes:
measure: Intraoperative transfusion
timeFrame: From surgical incision to the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa
Study officials:
References:
Clinical trial NCT00903890: Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma
Official title: Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma After Radiation Therapy/Anthracycline Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Disease
Lymphoma, Non-Hodgkin
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously treated at the University of Rochester Department of Radiation Oncology.

Brief summary: This study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy.


Eligibility criteria: Inclusion Criteria:

* All patients with Hodgkin's Lymphoma and Non Hodgkin's lymphoma who underwent Radiation Therapy (RT) to either a mantle or modified mantle field with or without adriamycin at the Wilmot Cancer Center at the University of Rochester are eligible for the study.

Exclusion Criteria:

* Any severe preexisting cardiac disease (e.g., arrhythmia, angina, coronary disease, myocardial infarction, or congestive heart failure) prior to diagnosis

Primary outcomes:
measure: Measure changes in Cardiac ejection fraction score
timeFrame: Post Radiation Treatment
measure: Measure changes in perfusion imaging score on the radionuclide cardiac profusion scan
timeFrame: Post Radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Louis S Constine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01687790: The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease
Official title: The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Abnormalities
Keywords: molecular breast imaging
breast disease
breast biopsy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2012-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy

Exclusion Criteria:

* Known contraindication to mammographic imaging
* women who are pregnant
* women who are lactating
* women who have significant existing breast trauma
* women who have breast implants
* Women under 18 years of age.
* women who had previous benign breast surgery within 1 year
* Males and children
* Women who are unable to understand or execute written informed consent
* Women who refuse to have a biopsy
* Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR \>30 and \<60 can receive the contrast but at a reduced dose (typically half). Those with a GFR \<30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.

Primary outcomes:
measure: Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Christiane Hakim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02067390: Urinary KIM-1 After Vancomycin or Linezolid Administration
Official title: Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 5
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/Terminally Ill (ER, ICU)

Brief summary: Acute renal injury is a common complication of critical illness. Drug induced renal insult compounds the degree of injury in many patients, and a great deal of research has focused on prevention of this complication. Traditional biomarkers of renal injury like serum creatinine and blood urea nitrogen content fail to consistently predict harm among patients at risk. Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours.
* Eligible patients are already prescribed intravenous vancomycin or linezolid per their primary care providers as a standard of care and dosed in manner that is consistent with current institutional practices. Receipt of these antibiotics is not investigational.

Exclusion Criteria:

* Exclusion criteria will include patients who have stage 3or greater Chronic Kidney Disease or who have acute kidney injury prior to the start of intravenous vancomycin therapy, patients that only receive one dose of IV vancomycin or linezolid in total, as well as patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
* Additionally, patients will be excluded if they are to receive more than 1 concurrent nephrotoxic medication within the prior 72 hours, have received intravenous contrast within 120 hours before randomization, exhibit baseline hematuria, or baseline proteinuria.
* A list of concurrent nephrotoxins that would exclude patients from the study is provided in Appendix C.
* Age Range: ≥18 years of age, if age \> 90 will report as \> 90 years

Primary outcomes:
measure: Urinary KIM-1 concentrations
timeFrame: Urinary levels from day -1 to day +5, clinical outcomes and variables followed for duration of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern Memorial Hospital / Midwestern University
name: Marc H Scheetz, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03289390: Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications
Official title: Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 11
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants born between 23 0/7 weeks to 29 6/7 weeks gestational age.

Brief summary: This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.


Eligibility criteria: Inclusion Criteria:

* Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.

Exclusion Criteria:

* Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST\> 150 U/L, ALT\>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations

Primary outcomes:
measure: Rate of PDA closure
timeFrame: 3 days
measure: Change in PDA size
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References:
citation: El-Mashad AE, El-Mahdy H, El Amrousy D, Elgendy M. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017 Feb;176(2):233-240. doi: 10.1007/s00431-016-2830-7. Epub 2016 Dec 21.
citation: EL-Khuffash A, James AT, Cleary A, Semberova J, Franklin O, Miletin J. Late medical therapy of patent ductus arteriosus using intravenous paracetamol. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F253-6. doi: 10.1136/archdischild-2014-307930. Epub 2015 Feb 4.
Clinical trial NCT01877590: Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Official title: Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Coronary Artery Disease
Left Ventricular Mass
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients.

Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with CAD might will be reduced if the investigators can find novel therapies to regress LVH.

Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can improve endothelial function in diabetic conditions. Hence, the main aim of this study was to assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* CAD
* Left ventricular hypertrophy
* HbA1c below 7.0%
* blood pressure \<130/80 mmHg

Exclusion Criteria:

* Patients were excluded if they were currently alpha-lipoic acid for one year, had a previous adverse reaction to alpha-lipoic acid.
* hey were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.
* Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.

Primary outcomes:
measure: Alpha-lipoic acid regress the left ventricular mass
timeFrame: one year
Secondary outcomes:
measure: The change of endothelial dysfunction before and after alpha-lipoic acid intervention.
timeFrame: one year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan General Hospital
state: Hubei
Study officials:
References: