cyrilzakka/clinical-trials huggingface dataset:
Developing a MRI-based Deep Learning Model to Predict MMR Status

In order to develop a convenient, cheap and comprehensive method to preoperatively predict dMMR and reduce the number of people requiring dMMR-related immunohistochemical or genetic testing after surgery, this study aims to establish a deep learning model based on MRI to predict the MMR status of endometrial cancer. Patients diagnosed with endometrial cancer after surgery and who had completed pelvic MRI before surgery were collected. Deep learning was used to combine the clinical model with MR Image data to build the model. ROC curves were constructed for the testing group, internal verification group and external verification group, and the area under ROC curves were calculated to evaluate the diagnostic effect and stability of the model.

The dual threshold triage strategy was used to screen out the pMMR population (below the lower threshold), dMMR population (above the upper threshold) and the uncertain part of the population (between the thresholds).

In this study, patients diagnosed with endometrial cancer after surgery and who had completed pelvic MRI before surgery were collected from 2017 to 2022. It is expected to collect 500 cases in our hospital, which are divided into 375 cases (experimental group) and 125 cases (internal verification group).

100 cases of Sun Yat-sen University Cancer Center for external verification. Clinical data (age, gender, BMI, CA125, CA19-9, MR-T staging, immunohistochemical results of MMR-related proteins) of the study population were collected and logistics regression analysis was conducted to establish clinical models. Extract, segment, integrate and enhance MR Image data.

Deep learning was used to combine the clinical model with MR Image data to build the model. ROC curves were constructed for the testing group, internal verification group and external verification group, and the area under ROC curves were calculated to evaluate the diagnostic effect and stability of the model.

The dual threshold triage strategy was used to screen out the pMMR population (below the lower threshold), dMMR population (above the upper threshold) and the uncertain part of the population (between the thresholds). If the predictive score is above the lower threshold, the patient is advised to undergo further immunohistochemical or genetic testing to confirm MMR status or dMMR type

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with endometrial cancer after surgery and who had completed pelvic MRI before surgery from 2017 to 2022

Exclusion Criteria:

* (1) There was no immunohistochemical detection result of MMR-related protein; (2) Radiotherapy and chemotherapy before MRI; (3) small tumors that are difficult to identify on the image (\<5mm) ; (4) The T2-weighted imaging quality is insufficient to plot ROI, such as obvious motion artifacts; (5) There are other gynecological malignancies
Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

This study has been designed as a 18-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.

60 active IgG4-RD patients with internal organ involvement are enrolled in this study and accept the combination treatment of glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. During remission maintenance period, pateints are randomly divided into two groups at a 1:1 ratio: patients in group I are treated with low dose mycophenolate mofetil (1-1.5g/day) and patients in group Ⅱ accept the treatment of leflunomide (20 mg/day). Patients in two groups will be followed up for another 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 18 months. The secondary endpoints are relapse time, response rate and side effects.

Eligibility Criteria:
Inclusion Criteria:

* 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment.

Exclusion Criteria:

* 1. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

The main objectives of the study were to evaluate the safety and tolerability of afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether afamelanotide can improve the quality of life of EPP patients.


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects with a positive diagnosis of EPP who successfully completed the CUV017 or CUV029 studies;
* aged 18-75 years (inclusive);
* provide written informed patient consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

* any serious adverse event considered to be related to afamelanotide or the polymer contained in the implant;
* any allergy to lignocaine or other local anaesthetic to be used during the administration of the study medication;
* EPP patients with significant hepatic involvement;
* personal history of melanoma or dysplastic nevus syndrome;
* current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
* any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations;
* acute history of drug or alcohol abuse (in the last 12 months);
* female who is pregnant (confirmed by positive serum β-Human Chorionic Gonadotropin (HCG) pregnancy test prior to baseline) or lactating;
* females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
* sexually active men with partners of child-bearing potential not using barrier contraception during the trial and for a period of three months thereafter;
* participation in a clinical trial for an investigational agent within 30 days prior to the screening visit;
* prior and concomitant therapy with medications which may interfere with the objectives of the study.
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters.
* To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment.
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetics of alirocumab.

Total duration per participant of approximately 63 weeks (14 months) (screening: 3 weeks, double-blind treatment period: 52 weeks, and follow-up period: 8 weeks).

Eligibility Criteria:
Inclusion criteria:

Participants with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia who were not adequately controlled with a stable daily dose of statin with or without other lipid modifying therapy, at stable dose prior to the screening visit (Week -3).

Exclusion criteria:

1. LDL-C \<100 mg/dL (\<2.59 mmol/L) at the screening visit in participants with heterozygous familial hypercholesterolemia or in participants with non-familial hypercholesterolemia who had a history of documented coronary heart disease as described in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
2. LDL-C \<120 mg/dL (\<3.10 mmol/L) at the screening visit in participants with non-familial hypercholesterolemia who had a history of documented diseases or other risk factors as categorized in primary prevention category III as described in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
3. Not on a stable daily dose of lipid modifying therapy (including statin) within 4 weeks prior to the screening visit or between screening and randomization visits.
4. Age \<20 years at the screening visit.

The above information is not intended to contain all considerations relevant to a participants' potential participation in a clinical trial.
Vitala 12 Hour Wear Test With Convex Products

The primary objective of this phase II clinical trial is to assess the safety of the Vitala™ device during 12 hours of daily wear with convex products.


Eligibility Criteria:
Inclusion Criteria:

* Is of legal consenting age.
* Is able to read, write, and understand the study, the required procedures, and the study related documentation.
* Has signed the informed consent.
* Has an end colostomy of at least 12 weeks duration with formed or semi-formed effluent.
* Currently uses a convex skin barrier wafer or uses convex inserts into standard skin barrier wafers or is willing to wear SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® or SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes. Enrollment will target 15 current convex product users and 10 non convex users.
* The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® in 45mm or 57mm flange size with a stoma opening size from 13mm up to 50mm or the SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes.
* Is willing to remove and replace the skin barrier wafer after three days, more often if desired, during Stage 2.
* Has a stoma that protrudes no more than 2 cm at rest (lying down on back).
* Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
* Is willing to participate in the trial for a total of 43 days.
* Is willing to meet with the investigator for a total of 5 scheduled visits plus additional visits as deemed necessary by the investigator.
* Has the ability to do complete self-care.

Exclusion Criteria:

* Has known skin sensitivity to any component of the products being tested.
* Has a skin rating of "2" or greater according to the Skin Rating Scale.
* Has peristomal ulcerations, peristomal pressure necrosis, parastomal hernia, Caput Medusa or mucocutaneous separation.
* Is receiving radiation in the area of the pouching system.
* Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
* Requires a pouch belt while wearing Vitala™.
* Requires a moldable skin barrier.
* Has participated in a clinical study within the past 30 days.
Screening for Deep Vein Thrombosis in Intensive Care

Background: venous thromboembolism (VTE) is a common complication in critically ill patients, admitted to the Intensive Care Units (ICUs). At the present time, there is no validated score to estimate risks and benefits of antithrombotic pharmacological prophylaxis in this subset of patients. Results of a pilot study showed that ultrasound (US) screening for deep vein thrombosis (DVT) is associated with a reduced incidence of proximal DVT, up front to an overall increased discovery rate of DVTs. The reduced incidence of proximal DVT could be attributed to an early diagnosis of distal and muscular DVTs, which would eventually receive a more adequate management. Proximal DVTs are associated with a worse long-term prognosis than distal or muscular DVTs, so it can be hypothesized that the active US screening could lead to an improvement of in-hospital and long-term prognosis of patients admitted to the ICU.

Aim of the study: to test whether an active US screening may reduce the incidence of proximal DVT and improve the in-hospital and long-term prognosis of patients admitted to the ICU.

Expected relevance: systematic screening for DVT could improve the management of the pharmacological antithrombotic treatment, leading to a reduction of thromboembolic and bleeding complications. This will eventually lead to an improved in-hospital and long-term prognosis.


Eligibility Criteria:
Inclusion Criteria:

* any patient admitted to ICU with a length-of-stay in ICU \>96 hours

Exclusion Criteria:

* pregnancy
* SARS-CoV-2 infection
* established DVT or pulmonary embolism at admission
* established coagulation disorder
* presence of inferior vena cava filter at the admission
* admission from the ICU of another hospital
An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease) (MK-0873-005)

This is a study to evaluate the effectiveness and tolerability of a once-daily oral medication (MK-0873) for the treatment of COPD (chronic obstructive pulmonary disease) to determine whether the study drug leads to an improvement in pulmonary (lung) function, as well as symptoms, and quality of life.

Following a three-week run-in period (Period I) during which participants received placebo, participants entered into a 12-week double-blind treatment period (Period II) during which they received daily doses of either one of three doses of MK-0873 or placebo. Period I and Period II made up the Base Study. Following the 12-week treatment period in the Base Study, participants were invited to continue in an optional 12-week double-blind extension study (Period III, EXT1). Participants who received any dose of MK-0873 in the Base Study continued on MK-0873 2.5 mg daily in Period III while participants in the placebo arm of the Base Study continued on placebo daily. Following EXT1, participants were invited to continue in an optional open-label second extension study (EXT2) which was to last 80 weeks (Period IV: 28 weeks, Period V: 52 weeks). In EXT2, participants who had been taking MK-0873 2.5 mg in the Base Study were allocated to MK-0873 2.5 mg plus usual care, while participants who had been taking the other two doses of MK-0873 or placebo in the Base Study were allocated to either MK-0873 2.5 mg plus usual care or to usual care alone.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 40 to 75 years old, with a history consistent with COPD (chronic obstructive pulmonary disease)
* Lung function tests that meet the requirements of the study

Exclusion Criteria:

* Severe and unstable medical conditions other than COPD (chronic obstructive pulmonary disease)
* Use of continuous oxygen therapy
* Cardiac (heart) arrhythmias
* Other lung disease
* History of colitis (inflammation of the colon)
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer

The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status.
* HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines27. Triple negative will be classified as ER and PR \<10% and HER2-.
* Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.
* Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients.
* Age ≥ 18.
* Life expectancy ≥ 6 months.
* Eastern Cooperative Oncology Group performance status 0 to 2.
* Patients must be able to understand and the willingness to sign an informed consent for study procedures.
* Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* Prior diagnosis of systemic metastases.
* Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.
* Contraindication towards CT IV contrast.
* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min).
Compassion Focused Therapy for Distressing Experiences

This study aims to develop and test the feasibility of a new therapy called Compassion Focused Therapy (CFT) for psychosis. This therapy helps people with psychosis manage distressing experiences by building internal feelings of safeness and affiliation, and by providing contexts, practices and insights that facilitate the development of compassion to self and others. The focus is on helping people feel safe in relation to their experiences and their social worlds. CFT is a promising new approach that has been successfully provided for people with a range of mental health difficulties. It is also firmly based in the most up-to-date knowledge and science about how the mind works (both normally and under stress).

9 participants will be recruited from NHS psychological therapies services for people with psychosis in South London and Maudsley (SLAM) NHS Foundation Trust. Following a short baseline period they will receive up to 26 weekly sessions (about 6 months) of CFT with a clinical psychologist, and will provide interview and questionnaire research data at five different points during the study. At these assessment points, data will be gathered on participants' experiences, mood, perceptions of their position in the social world, and heart rate variability.

The initial therapy protocol has been developed by psychologists with expertise in CFT, alongside people with lived experience of hearing voices and having distressing beliefs. However, it will continue to be developed and evolve as the study progresses, and as more is learnt (e.g. from the service-user participants) about applying the model in this population. At the end of this study, the aim is to have all the information needed to run a randomised controlled trial of this therapy.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Psychosis related diagnosis (F20-39)
* Distressing positive symptoms of psychosis. Each participant will have been routinely screened with PSYRATS at their service entry assessment. On PSYRATS, at least one positive symptom (i.e. hallucination or delusion) will be present, and distress will be evidenced by an associated intensity score of 2 or above
* Willing to engage in psychological therapy
* Sufficient command of English language
* Able to provide informed consent

Exclusion Criteria:

* Currently engaged in CBT, or have completed a 12+ session course of CBT within the last 3 years. If recruitment is under target, this will be relaxed to 12+ session course of CBT (Cognitive Behavioural Therapy) within the last 6 months
* Currently engaged with another treatment study (e.g. medicine or therapy)
Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease

This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease.

This study will enroll subjects who have a diagnosis of PD with Hoehn-Yahr stage 1.5-3.0 and assess the impact of low dosage of levodopa/carbidopa/entacapone treatment on the motor function and quality of life among PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and greater from 30 to 80.
* Diagnosis of idiopathic PD according to the MDS PD Diagnostic Criteria (2015).
* Hoehn-Yahr stage of 1.5-3.0 ("open" stage).
* Not on anti-PD medication or stable on anti-PD medication for at least 30 days.

Exclusion Criteria:

* Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
* History of surgery within 6 months.
* Alcoholism, drug abuse, or severe cognitive impairment (including severe Alzheimer's disease)
* Psychiatric illness, epilepsy, pregnancy and breastfeeding, and clinically significant concomitant illnesses
* Participation in another clinical trial within 2 months.
* With dyskinesia.
* Any other condition that, in the opinion of the investigator, makes them ineligible for enrolment.
3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic myomectomy..

Laparoscopy is founded as a treatment of choice for benign uterine disease. The advantages of laparoscopic surgery over conventional open surgery are less pain, shorter recovery time, shorter hospital stay, and consequently faster return to normal activity as well as better cosmetic effects. However, laparoscopic surgery is more demanding compared with open surgery because operators should project three-dimensional (3D) field through a two-dimensional (2D) monitor.

However, to date, studies examining the possible benefits and drawbacks of 3D imaging system versus 2D in laparoscopic surgery have brought about conflicting results. Moreover, there have been few studies comparing the surgical outcomes of 3D and 2D laparoscopic laparoscopic myomectomy. The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic myomectomy..

Eligibility Criteria:
Inclusion Criteria:

* Uterine myoma requiring laparoscopic myomectomy
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* absence of pregnancy at the time of surgery.

Exclusion Criteria:

* any suspicious findings of malignant gynecologic diseases,