cyrilzakka/clinical-trials huggingface dataset:
PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES

The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases:

Retrospective phase

AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis;

Prospective phase

AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.


Eligibility Criteria:
Inclusion Criteria:

Availability of gBRCA1/2 test results

Transvaginal pelvic US performed providing at least one picture of one healthy ovary

US images stored in .dicom format.

Exclusion Criteria:

Personal diagnosis of OC

Ovarian abnormal findings (eg. ovarian endometriomas, dermoid cyst, ovarian cystoadenofibroma, ovarian borderline tumour...) with the exception of functional cysts at pelvic US

gBRCA1/2 testing results nor provided by an ISO 1589 accredited laboratory

Refusal to provide written informed consent
A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT)

The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria in Type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Hypertension

Exclusion Criteria:

* Albuminuria (Phase A)
* Non-diabetic renal disease
* Subject has a hypersensitivity to ACE inhibitor, CCB
Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I

The goal of this observational study is to identify differential traits in spontaneous migraine attacks that can help us predict the response to treatment with sumatriptan.

Participants will be asked to register the headache characteristics before and after taking sumatriptan and whether the treatment was effective or not during four migraine attacks.

There is still an unmet need in acute migraine treatment, some patients don't respond properly to acute medication.

There are some interindividual differences in clinical characteristics of migraine attacks. These differences may determine the response to acute treatment. Describing the phenotypical differences between patients who are responders and patients non-responders will allow us to offer a personalized treatment.

The aim of the study is to determine which characteristics are associated with a response or a non-response to acute treatment with sumatriptan.

Participants will be asked to register the headache characteristics and accompanying symptoms during 4 spontaneous migraine attacks and its response to treatment with sumatriptan.

Eligibility Criteria:
Inclusion Criteria:

* Migraine with or without aura diagnosis according to ICHD-3 criteria
* \<8 migraine days per month
* Be able to read, write and understand instructions.
* Have internet access and mail address
* Signing of the informed consent

Exclusion Criteria:

* Active preventive treatment for migraine
* Active medication with an effect over the central nervous system
* Serious physical or psychiatric condition
* Cardiovascular or hepatic disease
* Pregnant or breastfeeding women
* Any triptan contraindication
* Severe migraine attacks without previous response to triptans or NSAIDs
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study

The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts \& CD4+ \& CD8+ T cell counts along with increased HIV immunity.

This is a 500 subject Multi Center double-blind randomized, Safety \& Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen \& Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ \& CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection \& to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.

Eligibility Criteria:
Inclusion Criteria:

* Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
* Are at least 16 years old (consent of parent or guardian required if under 18 years).

Exclusion Criteria:

* Healthy Subjects
* Currently abuse alcohol or drugs.
Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

The purpose of this study is to determine the long-term effects of transcorneal electrostimulation (TcES) in patients with retinitis pigmentosa (RP). In a prior study (NCT00804102) the results of short-term stimulation showed a positive effect on the visual field and other parameters. In this study, the patients will be stimulated with either 0%, 150% or 200% of the individually determined phosphene threshold.

The study was performed at the Centre for Ophthalmology, University of Tübingen, Germany. The protocol was approved by the local ethics committee. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for being included in the study. The study was conducted according to the standards of GCP, the European Union Directive for Medical Devices, and the German Medical Product Law.

Patients were seen at 14 visits over a period of 78 weeks: one baseline visit (screening), followed by 12 visits (in week 1-4 weekly, then in weeks 10, 16, 22, 28, 34, 40, 46 and 52; dates varied a maximum of ± 1 week) including application of TcES for 52 weeks and one follow-up visit (in week 78, dates varied a maximum of ± 1 week).

After inclusion patients were randomly assigned to TcES with 0 mA (sham), 150% or 200% of their individual electrical phosphene threshold (EPT) current at 20 Hz.

Patients and technicians who performed kinetic perimetry, as well as full-field electrophysiology (ERG), multifocal ERG (mfERG) and dark adaptation, were blinded to the treatment group for the entire study period. The physicians who performed all other examinations and TcES were not blinded to study treatment because they were responsible for setting the stimulation parameters.

Eligibility Criteria:
Inclusion Criteria:

* Adult subject with RP (rod-cone dystrophy)
* BCVA 0.02 to 0.9
* Reliable visual field measurements
* Reliable ERG measurements
* Skillful enough to use the device at home
* Able to give consent and take part during the whole study

Exclusion Criteria:

* Diabetic retinopathy
* Neovascularisation of any origin
* After arterial or venous occlusion
* After retinal detachment
* Silicone oil tamponade
* Dry or exudative age-related macular degeneration
* Macular edema
* All forms of glaucoma
* Any form of corneal degeneration that reduces visual acuity
* Systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
* Patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
* Forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
* Simultaneous participation in another interventional study or history of interventions whose effect may still persist
Tradeoff Between Spatial and Temporal Resolution

In this study, investigators will examine how temporal rate processing might be affected when the width of neural excitation narrows. The manipulation of neural excitation width will be achieved for example by changing electrode configurations or stimulating single versus multiple electrodes simultaneously. Investigators will then measure if the extent to which rate processing is affected by spatially restricted stimulation can predict a subject's overall speech recognition and predict also whether the subject is likely to benefit from a focused electrode configuration. Lastly, investigators will introduce and test a novel current focusing strategy where current focusing is applied in a channel specific manner and quantify if this intervention improves speech recognition. The primary endpoint of the study is speech recognition, and the secondary endpoint is psychophysical sensitivity to stimulation rate change.


Eligibility Criteria:
Inclusion Criteria:

* Native speakers of English
* Cochlear Nucleus cochlear implant users or Advanced Bionics users
* Postlingually deafened
* Has had device experience for at least one year
* Can be child or adult at the time of enrollment

Exclusion Criteria:

* None
PAncreatic Disease Cohort of TOuLouse

This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.

This collection focuses on pathology of the pancreas requiring specific investigations or management for diagnosis or treatment. Pancreatic pathologies can be classified as malignant, potentially malignant or benign tumors. These can be solid or cystic. There is an inflammatory attack on the pancreas, generating acute pancreatitis in the acute period, if the inflammatory manifestations persist, chronic pancreatitis will develop. Some lesions may be at risk of malignancy during their evolution, it is therefore necessary to improve the performance of monitoring and diagnostic tools in order to adapt the management of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory or cystic exocrine pancreatic pathology
* Patient able to read and understand the information leaflet
* Patients who have agreed to participate in the study and have signed the free and informed consent
* Patients affiliated to a social security system (including AME)

Exclusion Criteria:

* Patient with pancreatic cancer pathology
* Patients with active cancer, whatever the origin
* Pregnant or breastfeeding patients
* Patients under legal protection, guardianship or trusteeship
Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome

The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy complications. It is unknown if there are factors that may predict which women are more at risk.

The goal of this study is to evaluate the risk factors of gestational diabetes, such as dietary and physical activity factors, race, and how the body handles its own hormones during pregnancy. Our long term goal is to contribute in finding ways to successfully prevent gestational diabetes.

The polycystic ovary syndrome is the leading cause of female infertility in the United States. The disorder affects approximately 6-10% of women of reproductive age. Insulin is a hormone that helps the body to take up sugar from the bloodstream. It is widely accepted that "insulin resistance" may be responsible for the polycystic ovary syndrome. Women are insulin resistant when their bodies do not respond to insulin's action to handle sugar as they normally should. Because of this insulin resistance, when women with the polycystic ovary syndrome become pregnant, they are at a higher risk of developing gestational diabetes. Gestational diabetes carries risk to both the mother and the baby. The purpose of this study is to determine whether certain factors in women with the polycystic ovary syndrome are linked to risk of gestational diabetes. We propose to look at demographic factors, as well as the body's handling of estrogen (a female hormone present in high quantities during pregnancy) in this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS prior to pregnancy
* 18-40 years of age
* Documented BMI 30-40 kg/m2 (within 3 months prior to pregnancy or within 8 weeks of gestation)
* Either of Caucasian or African-American decent by self report.
* Pregnant or attempting pregnancy

Exclusion Criteria:

* Preexisting Diabetes (impaired glucose tolerance will not be an exclusion criterion because of the high prevalence of impaired glucose tolerance in the PCOS population).
* Hemoglobin \< 8 or hemoglobin \<10 with symptoms of anemia.
* Use of tobacco, alcohol or illicit substances.
Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer

This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.

In this study, 300 patients will be enrolled. Eligible patients will be those with histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma. Patients must have received one line of platinum-based chemotherapy, and be in clinically complete or partial response following the platinum-based chemotherapy prior to enrollment in the study. Patients will be treated with Niraparib according to the physician's judgement till disease progression, discontinuation for other reasons or death. The primary endpoint is treatment pattern of Niraparib as first-line maintenance treatment for ovarian cancer patients. The second endpoints include AE, PFS and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older
* Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma
* Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy
* Understand the protocol, and Written informed consent before any study-related procedure

Exclusion Criteria:

* Participating in other clinical trials at the same time
* Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators
* Having other malignant tumors (other than breast cancer with BRCA mutation)
* Pregnancy or breast feeding, or planning a pregnancy during the study
* Unable to visit on time
* Patients who are allergic to the study drug or drug components
Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
* Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Exclusion Criteria:

* Non-compliance with washout period
* Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
* Allergy or sensitivity to any component of the test medications
* Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit
Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart

A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, aged 18 to 55 years
* Body mass index in the range of 18 to 30 kg/m2
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG

Exclusion Criteria:

* History of cardiac, thyroid, muscle, or kidney abnormalities
* A family history of long QT syndrome and/or sudden cardiac death
* History of any clinically significant drug allergy, hypersensitivity to sulfonomides or the quinolone class of antibiotics
Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2

Emotional support following Multiple Sclerosis (MS) diagnosis is not part of the current service provision. However, research has identified a need for this as poor adjustment to diagnosis has been linked to higher levels of psychological distress. A previous study, named 'Providing Emotional Support Around the Point of MS Diagnosis' (PrEliMS), explored how best to provide support. People with MS completed a self-help workbook, alongside receiving support from MS nurses. The workbook is based on a psychological therapy called Acceptance and Commitment Therapy and was developed through focus groups of people with MS, relevant stakeholders, and clinical expertise. In this study, issues were found with parts of the workbook content and delivery. Nurses found it difficult to facilitate this alongside their usual MS Nurse care and felt psychological distress was not within their remit.

In this study, the investigators will

* explore how effective the PrEliMS workbook is at reducing distress from MS diagnosis, when delivered by a Psychology Practitioner (Trainee Clinical Psychologist)
* compare delivery by a Psychology Practitioner with the data from the Nurse delivered PrEliMS trial to explore which is more effective
* explore experience of the PrEliMS-2 intervention and potential improvements.

The investigators will recruit between three and seven people from an MS clinic who have received an MS diagnosis in the last year and consent to taking part. Participants will meet with a Psychology Practitioner (over the phone or online) once a week for four weeks, alongside completing the workbook. The investigators will also ask participants to complete questionnaires to examine their levels of psychological distress. Interviews will then be conducted to get feedback for refining the workbook.

The overall study will last a year


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 and/or over.
2. Received a new diagnosis of MS within the last twelve months, confirmed by a Consultant Neurologist.
3. Scores ≥18 on the MSIS-Psy.

Exclusion Criteria:

1. Unable or willing to give informed consent.
2. Individuals currently receiving psychological therapy, to ensure any change cannot be attributed to another intervention.
3. Individuals who have had a prior diagnosis of psychological distress, e.g., Depression or Anxiety Disorder, to ensure participants are as homogenous as possible. The intervention is aimed at distress specifically related to receiving an MS diagnosis.
4. Unable to speak and read English (as all measure used have been standardised and validated in English, and the workbook is only available in English).
5. Unable to use/do not have access to a telephone or a computer with internet connection
A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer

The reason for this study is to see if the CD73 inhibitor LY3475070 alone or in combination with pembrolizumab is safe and effective in participants with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have certain types of cancer such as breast cancer, pancreatic cancer, lung cancer, kidney cancer, skin cancer (melanoma), prostate cancer, and ovarian cancer
* Participants must have stopped other forms of treatment for the cancer
* In the expansion cohorts participants must be able and willing to provide a sample of the tumor before beginning treatment and a sample during the treatment. For certain tumor types, the result of a test on the tumor sample may exclude the participant from the study
* Participants must not be pregnant, and must agree to use birth control
* Participants must have progressed through or be intolerant to therapies with known clinical benefit

Exclusion Criteria:

* Participants must not have a current untreated tuberculosis, lung disease, heart disease, uncontrolled HIV, autoimmune disease, active hepatitis B or C virus infection or using corticosteroids
* Participant must not have cancer that has spread to the brain
* Participant must not have received a vaccine within the last 30 days
* Participant must not have had bowel obstruction within the last 6 months, or intestinal surgery
* Participant must not have an infection that is currently being treated
Improving the Quality of Care for Adults With Inflammatory Bowel Disease

Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared information environment, that highlights collaboration among patients, clinicians and care team members, and researchers; for effective use of data for guiding care, value, improvement, and research.

To demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) Learning Health System approach the study collaborators will design, build, implement, and evaluate in up to 90 IBD care sites the the following four key components of the IBD Learning Health System: 1) a Health Information Technology (HIT) environment that can "feed-forward" Patient Reported Outcomes (PROs) and clinical data to be used at the point of care and integrated into a registry (IBD Plexus); 2) decision-support dashboards for use by patients and clinicians in real time to coproduce care; 3) meaningful reports for patients and clinicians; and 4) multi-stakeholder collaborative networks for improvement and research.

Prior work from Sweden and the US show that successful uptake of the model can offer important benefits. Patients will be able to use web-based tools to monitor their health and manage their care, securely share data with clinicians in a timely manner, visualize outcomes that matter to them, and compare their results to other people. Clinicians will have new information that can improve their ability to track patient outcomes and costs over time; use PRO data to support pre-visit planning, shared decision-making at the point of care, and post-visit monitoring; and receive comparative performance reports to support quality improvement, public reporting, and professional development. Researchers will benefit by having PROs and cost data added to data registries to support clinical, translational, and comparative effectiveness research.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of Crohn's disease or ulcerative colitis or IBD unclassified
* Accept the terms and conditions of Informed Consent and Authorization
* Affiliated with a participating IBD Qorus site

Exclusion Criteria:

* Inability to provide informed consent
* Study key personnel cannot enroll as a study participant