cyrilzakka/clinical-trials huggingface dataset:
A Study in Participants With End-Stage Renal Disease

The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are a barrier to kidney transplant. Transplantation is currently the definitive treatment for End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.

In this study, LY2127399 will be tested as a potential treatment to reduce the blood proteins in some participants with ESRD. These proteins are called alloantibodies and are made by the body to react with other proteins on cells of transplanted organs called human leukocyte antigen (HLA) proteins. When a participant has these antibodies, they are referred to as HLA-presensitized. Often the presence of these antibodies, categorized by a method called the panel reactive antibody (PRA), can make a person ineligible to receive a transplant or experience very long wait times on the kidney transplant waiting list. Therefore the need to reduce the antibodies is significant for the successful treatment of ESRD. This study will treat ESRD participants for 6 months with LY2127399 and measure PRA levels for a total of 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Have ESRD and are awaiting kidney transplant
* Have a stable PRA score \>50%

Exclusion Criteria:

* Have had a tonsillectomy
* Have a semi-permanent/tunneled catheter
* Have had intravenous immunoglobulin (IVIg) in the past 6 months
* Have had plasmapheresis in the past 6 months
* Uncontrolled hypertension
* Presence of clinically significant cardiac disease in the past 6 months
* Malignancy in the past 5 years, with the exception of cervical, basal cell and squamous epithelial cell cancers
* Have active or recent infection including herpes zoster or herpes simplex in the last 30 days
* Have evidence or suspicion of active Tuberculosis (TB)
* Have had major surgery in the past 2 months
* Have had a serious infection with recovery in the past 3 months
* Have Hepatitis B or C or have Human Immunodeficiency Virus (HIV)
A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis.

The purpose of this study is to establish the clinical efficacy of APT-001 topical therapy 1.8% in patients with blepharitis as compared to its vehicle control, and to establish that the therapeutic is safe and generally well tolerated by patients.

This Phase 2 study is a randomized, controlled, double-blind trial to compare the safety and efficacy of APT-001 1.8% to vehicle control for the treatment of blepharitis. The primary objective of the study is to compare the safety and efficacy of APT-001 compared to its vehicle from Day 1 to Day 43 in patients with blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic blepharitis.
* At least 6 years of age.
* Eyelid collarette count (minimum score 2).
* Willing and able to follow all instructions and attend all study visits.
* Able to avoid prohibited medication for the duration of the study.
* Patients can willingly provide consent or have a legal authorized representative provide consent on the informed consent (IC) Form.

Exclusion Criteria:

* Women with confirmed pregnancies.
* Utilizing any current medical therapy for the eye.
* History of allergic reaction to spinosad or any formulation component.
* Patients using eyelid hygiene or other treatment(s) for blepharitis within 14 days of screening.
* History of ocular surgery within the past 1 year.
* Presence of other ocular diseases that may affect study outcomes (Corneal Dystrophies, Salzmanns disease, Severe dry eye, Keratoconus, Glaucoma filtering blebs).
* Use of investigational drug, chronic glaucoma medications, steroid.
* Uncontrolled systemic disease.
* Acute or chronic illness that would confound study results.
A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy

The purpose of the study is to describe the pharmacological and non-pharmacological treatment utilization pathways in Italian routine clinical practice of participants with Major Depressive Disorder (MDD) and active suicidal ideation with intent.


Eligibility Criteria:
Inclusion Criteria:

* Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for single episode or recurrent Major Depressive Disorder (MDD), based upon clinical assessment
* In the physician's opinion the current depressive episode is moderate-to-severe in terms of severity.
* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's current active suicidal ideation with intent
* Participant must be capable of discernment
* Participant must be able to read and write in the Italian language
* Participant must have signed the informed consent form (ICF) indicating that he/she understands the study purpose and is willing to participate in the study
* Participant is in the site's catchment area, as evaluated by the Investigator

Exclusion criteria:

* Participant currently (that is, at the time of enrolment and based upon clinical assessment) meets DSM-5 criteria for psychotic disorder, bipolar or related disorders, antisocial personality disorder, borderline personality disorder, intellectual disability, autism spectrum disorder, dementia
* Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder (except for nicotine or caffeine) within the 6 months before enrolment, based upon clinical assessment
* Participant has participated in or is currently enrolled in any clinical trial with experimental treatments within the current major depressive episode
Contrast Between Traditional Regression Model and AI in Predicting Prolonged Stay Stay After Head and Neck Tumors

This experiment is an observational study of cohort. By establishing a cohort of patients with head and neck tumors transferred to ICU after surgery, investigators compared the prediction effect of AI and the traditional prediction model on whether patients can be transferred to ICU within 24 hours of head and neck tumors. First retrospective analysis of patients after head and neck tumor surgery, medical records were collected, the test results are divided into training group and validation group according to 7:3, divided into 2 groups according to the patient ICU stay time is greater than 24 hours, the prediction model after the ICU duration of head and neck tumor surgery after more than 24 hours. At the same time, clean the data, train the AI with the data, and compare the effectiveness of both sides with the ROC. After the establishment of prediction model and AI training, the patients included in the cohort were evaluated by prediction model and AI immediately after being transferred to the ICU, predicting the possibility of transferring out of the ICU within 24 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Patients after head and neck tumors;
2. older than 18 years.

Exclusion Criteria:

1. Patients transferred to ICU twice after head and neck tumors;
2. Patients with unplanned transfer to the ICU.
Safety of TKI258 in Advanced/Metastatic Melanoma Subjects

This study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TKI258. Pharmacokinetics and pharmacodynamics will be performed on all subjects. The eligible subject population consists of subjects who have been diagnosed with locally advanced or metastatic melanoma that is refractory to standard therapy or for which no curative standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer \[AJCC\] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.
* Measurable disease
* Must be eighteen years of age or older
* Must meet baseline laboratory requirements
* ECOG performance status 0 or 1
* Adults of reproductive potential must agree to use effective contraception or be sterile

Exclusion Criteria:

* Concurrent therapy with any other investigational agent
* Uncontrolled central nervous system metastases
* Impaired cardiac function or clinically significant cardiac disease
* Received

  * chemotherapy, targeted therapy or monoclonal antibody therapy ≤4 weeks
  * biological therapy or immunotherapy (therapeutic or diagnostic) ≤2 weeks
  * an investigational agent (therapeutic or diagnostic) ≤4 weeks prior to starting study drug or has not recovered from side effects of such therapy
* Received any hematopoietic colony-stimulating factor (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin is allowed.
* Has undergone major surgery ≤ 2 weeks prior to starting study drug or has not recovered from side effects of such surgery.
* Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea, diarrhea, vomiting
* Pregnant or breast feeding women
* History of another primary malignancy that is currently clinically significant or currently requires active intervention.
* Chronic anticoagulation therapy with full strength aspirin, Coumadin, or heparin.
* History of thromboembolic or cerebrovascular events within the last 12 months.
* History of rectal bleeding, bloody vomit, or spitting up blood within the last 3 months.
* Known diagnosis of HIV infection (HIV testing is not mandatory)
* Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort and quinidine is prohibited.
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the patient inappropriate for this study
Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects

This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. This study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart disease, and have been identified being overweight or obese. A total of 40 individuals will participate in this study. The study duration will last for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* overweight or obese (BMI\> 85%) patients
* between 7-17 years of age
* operated or non-operated congenital heart disease
* reside in Southwestern Ontario

Exclusion Criteria:

* inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition
* involvement in any concurrent lifestyle intervention program
Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.

Pulmonary sarcoidosis-associated pulmonary hypertension is classified as WHO Group 5 pulmonary hypertension and may occur in anywhere from 5-20% of sarcoidosis patients. Inhaled treprostinil has shown clinical improvements in exercise capacity after 12 weeks of therapy in patients with WHO Group 1 pulmonary hypertension. More recently, there has been interest in using inhaled PAH-specific therapies for the treatment of pulmonary hypertension associated with interstitial lung disease.

The investigators believe that those patients with pulmonary hypertension in the setting of sarcoidosis-associated interstitial lung disease are a unique population which may potentially benefit from inhaled, targeted pulmonary arterial hypertension therapy (inhaled treprostinil) while minimizing the adverse effects associated with systemic pulmonary vasodilators. This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Study participant willing and able to provide informed consent
* Negative urine pregnancy test at baseline for females of childbearing potential
* Established diagnosis of sarcoidosis by ATS/ERS/WASOG 1999 Statement on of Sarcoidosis
* Presence of interstitial lung disease by Scadding Stage IV chest radiograph or extensive fibrosis on chest computed tomography
* Right heart catheterization within six months of baseline visit showing precapillary pulmonary hypertension (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg, and PVR \> 3 WU)
* Patient on stable sarcoidosis therapy for at least three months prior to screening
* If patients are on oral PAH therapy (PDE5i/SCGS and/or ERA) then dose should be stable for at least three months prior to screening
* A 6MWT within three months of screening visit of \> 100 meters

Exclusion Criteria:

* Pregnant patients or those who are actively lactating
* Patient not willing to use form of birth control (if applicable) during the study
* Inability to undergo 6MWT, RHC, PFTs or CMRI
* Predicted survival \< 6 months
* Patient on any prostanoid or prostanoid analog therapy
* Patients with left sided heart disease as defined by either a PCWP \> 15 mmHg and/or left ventricular ejection fraction \< 40%
* Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization.
Web-based Support for Family Caregivers of Patients With Advanced Cancer

For family caregivers of patients with advanced cancer, preparedness for caregiving is crucial for maintaining health and quality of life both during care and after the death of the patient. This project contributes to earlier research funded by the Swedish Cancer Society, about an intervention that was delivered by a multi-professional team and proved to be successful in promoting preparedness. However, such interventions are often costly and logistically challenging. In addition, the Covid-19 pandemic has further significantly raised the need for digital alternatives in healthcare. As a possible solution, an evidence-based intervention, narstaende.se, has been developed consisting of recorded videos of conversations between clinicians and family caregivers (actors), linked to informational texts and a moderated chat forum. The intervention was pilot tested during 2020 and 2021, exploring feasibility, content and family caregivers' experiences. As preliminary results are promising, the intervention is taken one step further and tested as a web-based intervention in a larger scale.


Eligibility Criteria:
Inclusion Criteria:

* Being a family caregiver, over 18 years of age, to a person with life-threatening illness cared for in specialized home care.

Exclusion Criteria:

* Not being able to communicate in Swedish
Gestural Short Term and Working Memory Task

According to the working memory model, which accounts for the organisation of working memory, the processing of non-meaningful gestures is not clear. Some authors suggest that working memory for non-meaningful gestures has the same characteristics as the phonological loop, made up of a phonological store and of a revival process (articulatory rehearsal). These characteristics are evidenced in memory span tasks, memory span which is itself determined by the duration of the memory trace and the time required to refresh the trace by subvocal rehearsal.

The investigators therefore aim to set up a gestural working memory task, which is specific, simple and reproducible, in the manner of verbal and visuospatial span tasks. It will first be an exploratory and descriptive study with healthy subjects.

In the first instance, each subject performs the gestural working memory test. The test is based on the model of verbal or visuospatial working memory tests. Video clips that display the movement of two, then three, then four different fingers are shown to the subject, who must then reproduce them. There are nine different sub-tests: forward span and backward span for both hands then for each hand, i.e. six sub-tests, in addition to three sub-tests with concomitant interference tasks (verbal, gestural or both). Each sub-test comes to an end when the subject fails both attempts of the same item. The entire test takes approximately 30 minutes.

A questionnaire is then handed to the subject: the subject provides their full name, date of birth, profession, education level (number of years of study post compulsory education), laterality, as well as potential professional or leisure activities that might involve fine finger movement. They also complete the Edinburgh Handedness Inventory assessment.

In order to correlate this new test with other validated tasks, each subject is then required to perform a verbal and visuospatial working memory task: the digit span test and then the spatial memory test, which last approximately 10 minutes.

The entire protocol lasts approximately 45 minutes per subject. The data is then anonymized and processed confidentially.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult volunteers
* 18/50 years old
* they must speak fluent French and give their informed consent

Exclusion Criteria:

* neurological or psychiatric disorder
* uncorrected visual or hearing loss
Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method

The main aim of this study is to compare 2 different measurements of visceral fat that can be easily used in clinical practice (waist circumference versus bioelectric impedance) in relation to known risk factors of coronary artery disease in a large cohort of patients with type 2 diabetes and with a BMI range between 20-45 kg/m2


Eligibility Criteria:
Inclusion Criteria:

* Established type 2 diabetes
* Age 18 - 80
* Body mass index (BMI) between 20-45 Kg/m2.
* Willing to undergo laboratory and anthropometric assessments.

Exclusion Criteria:

* The study will not include women who are pregnant, or are not using reliable birth control methods or who they think that they might be pregnant due to potential risk of fetal affection.
* Subjects with known malignancy, treated or untreated will be excluded (except treated skin melanoma).
* Subjects with major psychological problems or a major eating disorder will be excluded.
* Subjects with heart Pacemaker or any other electronic devices attached to their body will be excluded.
* Subjects with confirmed type 1 diabetes or positive anti GAD antibodies test will be excluded
Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model \[called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction\] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic and hemorrhagic stroke patients
* Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH)
* Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
* Plan to discharge home after stroke
* Ability to provide consent (patient or caregiver)
* Ability to communicate in English

Exclusion Criteria:

* modified Rankin scale \> 4 at the time of enrollment (severe disability)
* life expectancy \< 1 year or terminal illness,
* eGFR \< 30 at time of discharge
* pregnancy
* symptomatic flow limiting carotid stenosis without plan for intervention
* urine toxicology positive for cocaine or methamphetamine or recent use
* long-term BP goal ≥ 130/80 mmHg according to clinical team
External Pancreatic Duct Stent After Pancreaticoduodenectomy

Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low mortality. Reduced mortality rate is largely the result of careful patient selection, improved intraoperative management and a better postoperative care. Unfortunately, there is not a similar reduction in morbidity rates which remains about 40%. Persistent morbidity is predominantly due to pancreatic fistula (PF). Abdominal abscess and hemorrhage are common sequelae of PF which have been associated with a high mortality rate. While many different risk factors have been reported, a soft pancreatic texture and a nondilated pancreatic duct have been most consistently linked to high rates of PF. A number of methods for reducing the incidence of PF have been proposed and analysed. Many of these involve technical features of the anastomosis, including site of reconstruction, anastomotic technique, use of biologic glue, and prophylactic use of somatostatin analogue. The placement of a stent through the pancreatic anastomosis is an attractive strategy to reduce the PF rate. This multicenter prospective randomized trial was designed to compare the outcome after PD with external drainage stent versus no stent in patients with high risk of PF (with soft pancreas and a diameter of wirsung \<3mm).

Analysis:The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P \< 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.

Analysis: The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P \< 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.

PF was defined, according to the International Study Group of Pancreatic Fistula, as amylase rich fluid (amylase concentration more than three times serum concentration) collected from the drainage placed intraoperatively from day 3 or by needle aspiration of an intraabdominal collection. PF were graded according to the clinical impact on the patient's hospital course (grades A,B,C).

Eligibility Criteria:
Inclusion criteria:

* All patients scheduled for elective PD,
* Confirmation of the soft pancreas or nondilated pancreatic duct during PD.

Exclusion criteria:

* Age less than 18 year,
* Emergency surgery,
* Previous pancreatic surgery,
* Previous susmesocolic radiotherapy.