cyrilzakka/clinical-trials huggingface dataset:
Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma

The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for:

* predicting response to immune-therapeutic regimens in HCC in the early phase of treatment,
* to rule out pseudo-progression,
* to early predict the escape from effectiveness of treatment.

* To assess the accuracy of biomarkers from an immunophenotypic test (CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, CD8+PD1+, CD8+PDL1+ peripheral lymphocyte populations and circulating granulocytes) in predicting the response to immuno-therapy in patients affected by hepatocellular carcinoma (HCC).
* To compare the transcriptomic signatures of peripheral blood mononuclear cells (PBMC) of responders and non-responders (assessed at the first imaging study).

RNAseq data will be validated by RT-PCR in independent prospective cohorts.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* diagnosis of HCC
* execution of laboratory tests and subsequent treatments and follow-up at our center.
* obtained written informed consent to the study participation

Exclusion Criteria:

* immune-related concomitant diseases
* HIV infection
Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection.

Exclusion Criteria:

* Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications;
* subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.
Artificial Intelligence Aid Systems in Colorectal Adenoma Detection

The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy.

The secondary aims were:

* To evaluate the benefit of Endo-AID in adenoma detection rate by comparing endoscopists with high and low adenoma detection rate.
* To evaluate serrated detection rate, advanced adenoma detection rate, adenoma detection rate according to the size (\<= 5mm, 6-9mm,\> = 10mm) and number of adenomas by colonoscopy. Stratification by location and morphology.

Priority guidelines have been established regarding IA applied to gastrointestinal endoscopy. Regarding the priority uses for their development, there are applications that improve vision, placing computer-assisted lesion detection (CADe) as one of the most necessary priorities, given the importance of colorectal cancer screening (CRC) and post-polypectomy surveillance. The evaluation of these systems in different clinical practices and patient groups has been recommend. In this regard, studies in the western population are limited and have been carried out by expert endoscopists. It has not been evaluated in endoscopists with different adenoma detection rates. In addition, there are no studies with the recent CADe Endo-AID system (Olympus Corp. Tokyo).

The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy. In addition, the benefit of the CADe system will be assessed according to the endoscopist ADR.

A randomized controlled trial will be carried out in consecutive outpatients meeting the inclusion criteria and none of the exclusion criteria. Patients with be randomized to one of the four groups: CADe system and high ADR endoscopist; CADe system and low ADR endoscopist; Control and high ADR endoscopist; Control and low ADR endoscopist.

For the sample size calculation a 14.4 of difference in favor of the CADe system was considered. Taking onto account an alpha error of 0.05 in a unilateral contrast, a power of 80% and a loss of 10%, 165 patients per group would be required.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients referred for outpatient colonoscopy

Exclusion Criteria:

* Colonic resection
* Taking anticoagulants or antiagregants that contraindicate the performance of therapy
* Patients with a recent colonoscopy (\<6 months) of good quality (e.g. cited for endoscopic therapy)
* Inflammatory bowel disease
* Patients with incomplete colonoscopy
* Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
* Patients with polyposis syndromes
* Refusal to participate in the study.
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy

This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age between18 years and 80 years at time of study entry
2. ECOG performance status of 0 or 1
3. Body weight \>30 kg
4. Adequate bone marrow, liver and kidney function
5. Life expectancy of at least 3 months
6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
7. Histologic or cytologic confirmation of small cell lung cancer
8. Stage III-IV disease (TNM v8)
9. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
10. Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -

Exclusion Criteria:

1. Previous chemo-, immuno- or radiotherapy for SCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women
IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

Primary objective:

* To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab

Secondary objectives:

* To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab
* To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab
* To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab


Eligibility Criteria:
Inclusion Criteria:

* Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures
* Patients ≥ 18 years old
* Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered
* Confirmed HLA status and IMA401 tumor target MAGEA4/8 expression (IMADetect®)
* Life expectancy \> 2 months
* ECOG Performance Status of 0 to 1
* Measurable disease according to RECIST 1.1
* Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status
* Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments
* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy

Exclusion Criteria:

* Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
* History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab
* Patients with prior allogeneic stem cell transplantation or organ transplantation
* Patients with autoimmune diseases needing disease-directed treatment
* Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results
* Positive for HIV or with active hepatitis B or C infection.
* Patients with active infection
* Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment
* Patients with active brain metastases and leptomeningeal metastases
Tracking Outcomes in Pain Patients Using Fitness Devices

The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.

The investigators are attempting to validate the usage of personal fitness trackers against the classical survey tools used. These devices are known to be of use in measuring activity and sleep in healthy patients but their use in chronic pain patients has not been assessed. This study will follow participants with chronic back pain undergoing treatment to see if changes in clinical course can be captured with these fitness devices.

Eligibility Criteria:
Inclusion Criteria:

* Back pain which may benefit from epidural injection
* Assenting to epidural injection for back pain

Exclusion Criteria:

* Inability to wear fitness tracking device
Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion

The purpose of this study is to evaluate the efficacy and safety of DEC103 in the pain control associated with IUD insertion in women with 18 to 49 years.

The DEC103 treatment is composed by two different medications that are already available in brazilian market. One is a sublingual pill and the other is an oral one. The participants must take 02 (two) pills of the sublingual formulation and 01 (one) of the oral formulation.

Eligibility Criteria:
Inclusion Criteria:

* Patient has given written informed consent to participate in the study prior to admission;
* Female patients aged between 18 and 49 years old;
* First IUD users;
* Nulliparous women.

Exclusion Criteria:

* Any finding or clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);
* Presence of chronic pelvic pain and any uterine malformation;
* Presence of psychiatric disorder;
* Chronic use of medications that interfere with the pain threshold, for example: antidepressants and anticonvulsants;
* Use of analgesics and/or ant-inflammatory in the last 24 hours prior the procedure;
* Any sign or symptom of vaginal or cervical infection;
* Participants with any contraindication to one or both medicines that constitute the DEC103 treatment;
* Actual abuse of alcohol or drugs;
* Participants who are nursing;
* Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;
* Participants with a current medical history of cancer and/or cancer treatment in the last five (05) years;
* Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it.
Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:

The aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.

Sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. It appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Must had clinical diagnosis of sepsis induced encephalopathy.

Exclusion Criteria:

* Refusal to participate in the study.
* Cerebral infection.
* Known cerebral lesions (Neoplasm, Traumatic brain injury, Stroke, Ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure).
* Known severe carotid stenosis (\>70％).
* Intoxication due to drugs.
* Pregnancy.
* Patients supported by intra-aortic balloon pumb (IABP).
Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis

Investigate the clinical features of orbital complications of sinusitis in the Egyptian population, and observed that certain ophthalmological manifestations and outcomes were significantly associated with disease stage

Retrospectively review of the medical records of all patients with orbital complications of paranasal sinusitis hospitalized at the ORL-HNS department at the University of Tanta between 2010 and 2020. Sex, age, symptoms, history, ophthalmological findings, laboratory and imaging findings, treatments, and outcomes were analyzed by staging.

The data that will be retrieved from the medical records including:

1. History taking including personal present and previous medical history.
2. General examination
3. Oto-rhinolaryngological clinical examination
4. Routine preoperative laboratory investigations (e.g. complete total and differential blood count, blood sugar, coagulation profile, and renal and liver function)
5. Diagnostic nasal Endoscopy with zero and/or a 30-degree telescope.
6. CT paranasal sinuses with contrast, fine cuts in coronal axial, and sagittal planes.
7. The type of intervention whether medical or surgical. 8- Culture results, treatments, hospital stay durations, and outcomes.

Ophthalmology data collection:

1. Visual acuity (onset of decrease) (unilateral or bilateral) ant its improvement after sinus surgery
2. Presence or absence of double vision (Diplopia)
3. Ocular motility and if its associated with pain
4. Proptosis (present or absent) and calculate the degree and direction
5. Ptosis (present or absent)
6. Pupil reactivity
7. Fundus examination to exclude optic nerve neuropathy
8. Association between ocular pain and headache and its improvement after surgery
9. CT data collection (CT orbit, MRI of sinus and head)
10. Fundus photography after surgery to see improvement of optic nerve neuropathy if present

Eligibility Criteria:
Inclusion Criteria:

* Patient presented with preseptal/orbital inflammation secondary to acute (\<1 month), subacute (1±3 months), or chronic sinusitis (\>3 months) of bacterial, fungal or unidentified pathogens

Exclusion Criteria:

* Patients with chronic rhinosinusitis without orbital complication, Systemic diseases that affect the paranasal sinuses and the orbit e.g autoimmune diseases, lymphoma, leukaemia, Sinus or orbital malignancy, Data is missed from the charts
Effects of Sedentary Behaviour on Metabolic Parameters

The rates of sedentary activity are increasing. Studies have shown that time spent on doing sedentary activities is an independent risk factor for cardiovascular disease. Prior studies have shown that interrupting inactivity improved the body's handling of blood glucose and gene expression. The investigators plan to explore this further by examining the effects of interrupting 4 hours of inactivity with 2 minutes of moderate intensity exercise every 20 minutes on the following metabolic parameters: blood pressure, cortisol, C-Reactive Protein, glucose and insulin levels.

There is a current trend towards increasing time spent in sedentary behaviour. More jobs are being automated, and more time is spent in front of a computer, playing video games and watching television.Current studies suggest that sedentary behaviour is an independent risk factor for cardiovascular disease. Increasing time spent in sedentary behaviour has been linked to all-cause mortality, markers of cardiovascular disease and metabolic syndrome. However, the data is mainly from cross-sectional studies and based on self-recall, limiting the ability to draw definitive conclusions.

Current exercise guidelines recommend at least 150 minutes of moderate to vigorous intensity exercise per week. It may be difficult for some elderly people to meet these guidelines. Older adults with diabetes are already at a higher risk fo conditions that are affected by sedentary behaviour and may stand to benefit the most from intervention.

This study proposes to study the effects of breaking up sedentary activity with moderate intensity exercise on multiple metabolic parameters in older adults with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* type 2 diabetes managed with diet or oral hypoglycemic agents

Exclusion Criteria:

* using insulin to manage diabetes
* baseline of pre-session blood glucose reading equal to or greater than 10 mmol/L
* any medical condition that would limit the ability to perform activity portion of the study
* people not comfortable exercising on a stationary bicycle
* subject answers yes to one of more of the questions in the Physical Activity Readiness Questionnaire
Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.

The purpose of this study is to determine if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase.

Background: The onset of therapeutic action for most anti-depressive treatments is usually two weeks. During this period patients suffer from great symptomatic distress. Treatment options that are effective in this period is therefore of interest for psychiatric wards.

Aim: To explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase.

Method: A randomized controlled trial with 24 patients diagnosed with bipolar disorder. Patients will be randomized to treatment as usual in an psychiatric ward, or sleep deprivation and three days sleep phase advancement. Patients in the treatment as usual group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar disorder, depressive phase

Exclusion Criteria:

* substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
Blood Transfusion Reduction - QI Project

Blood Banks of large medical centers have large annual budgets, typically millions of dollars. Blood product wastage results in not only in a loss of the product's cost, but also of the fees involved in transporting, handling, and administering these products. Optimal utilization of blood products requires a balance between maximizing patient clinical outcomes while avoiding unnecessary costs and risks associated with transfusions. This project will specifically focus on packed red blood cell transfusions (pRBCs). There are clear guidelines for transfusing pRBCs however these guidelines are not always followed. pRBC transfusions outside of recommended guidelines is associated with increased risk of harm to patients.

Our aim is to improve adherence to guideline indicated pRBC transfusions for patient in the UCHealth system thereby decreasing inappropriate (non-guideline indicated) pRBC transfusions. We will conduct a QI project seeking to improve pRBC transfusion guideline adherence. This project will involve data review to establish baseline rates, multimodal interventions to improve adherence to pRBC transfusion guidelines including provider education, modifications to the electronic ordering interface, and changing blood back policies at participating institutions.


Eligibility Criteria:
Inclusion Criteria:

* All physicians and nurses with access to order inpatient blood transfusions through a hospital-based EMR.
* All physicians and nurses ordering blood for individuals over the age of 18.

Exclusion Criteria:

* All physicians and nurses ordering blood transfusion ordering blood in the OR
* Blood ordered through massive transfusion protocol