cyrilzakka/clinical-trials huggingface dataset:
CASTRO1 - Study on CRP Apheresis After Ischemic Stroke

CASTRO1 is a study to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients after primary treatment of ischemic stroke.

The term therapeutic apheresis commonly refers to medical procedures, where pathogenic constituents are being removed from the circulating blood. Elimination is performed by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood (circulation) to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient.

The adsorber "PentraSorb® CRP" used for CRP apheresis is CE-certified. It is designated to the selective depletion of C-reactive protein from human blood.

The purpose of the study is to evaluate the safety and efficacy of CRP apheresis in patients following ischemic stroke. CRP apheresis is to be conducted with the aim of reducing cerebral damage following the guideline-appropriate primary therapy of ischemic stroke.

A possible protective effect of CRP apheresis will be assessed by clinical scores, laboratory determination of immunologic parameters and determination of the size of the infarct area by magnetic resonance imaging (MRI).

The study will be randomized, controlled and monocentric.

Eligibility Criteria:
Inclusion Criteria:

* Ischaemic stroke with determination of infarct size by imaging (MRI)
* NIHSS 1-24
* CRP increase ≥ 5 mg/l within presumed 72 hours after stroke and/or CRP value \> 10 mg/l
* written informed consent of the patient or his legal representative

Exclusion Criteria:

* age \< 18 years
* Severe dysphagia (danger of aspiration pneumonia)
* Clinical or laboratory evidence of a severe systemic infection
* Participation in other interventional studies
* Contraindications against apheresis therapy
* Modified Rankin Scale (mRS) before index event ≥ 3
* Intracranial hemorrhage
* Epileptic seizure in the context of the acute event
* Pregnancy, lactation
rTMS Over the Dorsolateral Prefrontal Cortex for the Treatment of Impulse Control Disorders in Parkinson's Disease

This study's objective is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC) of patients with Parkinson's Disease (PD) who experience impulse control disorders (ICDs) on impulse control symptoms and cognitive behaviors linked to ICDs: reinforcement learning and delay-discounting. This is a randomized sham-controlled cross-over trial. All patients will undergo a session of active rTMS and a session of sham rTMS, with the order of sessions randomized across participants. Following recruitment and eligibility screening, the eligible participants will undergo two sessions of rTMS (active and sham), immediately followed by neurocognitive tasks and questionnaires, no more than 1-2 weeks apart. Each session will have a duration of approximately 1-1.5 hours.


Eligibility Criteria:
Inclusion Criteria:

* Clinician-confirmed diagnosis of PD
* Ability to provide informed consent, written and verbal
* Clinician-diagnosed impulse control disorder or impulse control behaviors including punding/hobbyism and dopamine dysregulation syndrome
* A Beck Depression Inventory (BDI) (Beck et al., 1961) score of 14 or lower
* A Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) score of 20 or higher
* On dopamine-replacement therapy

Exclusion Criteria:

* History of seizures or epilepsy
* History of brain lesions (such as multiple sclerosis, tumor) reported
* History of vascular issues in the brain, such as stroke
* History of a moderate to severe traumatic brain injury
* Meeting the criteria for a major psychiatric illness such as schizophrenia or depression (BDI score of 14 or higher).
* Having significant cognitive impairment (assessed by MoCA, cutoff score of 20) (Nasreddine, et al., 2005)
* Having had TMS done in the recent past (within a year)
* Pregnancy assessed in female patients
* Intracranial metallic objects (except for dental fillings)
* Current use of substances or medications known to significantly reduce seizure threshold.
Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS) who have completed the ORARIALS-01 trial.

The planned duration of the open-label trial was 152 weeks, but the trial was terminated early as a consequence of the results of ORARIALS-01 which did not meet any of its efficacy endpoints. Therefore, the actual mean duration of open-label treatment was approximately 28 weeks (range approximately 2 to 71 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures, or in the circumstance that the subject is incompetent, informed consent/assent is provided in accordance with local regulation and/or procedures
* Subject has completed the ORARIALS-01 trial (i.e., met one of the surrogate survival endpoints of tracheostomy or PAV or has completed the 76 weeks randomized treatment period)
* Subject completed ORARIALS-01 while on treatment, where on treatment is defined as having taken the last dose of IMP within 2 weeks of the End of Trial visit (whether at week 76 or prior)

Exclusion Criteria:

* Known or suspected allergy or intolerance to the IMP (Arimoclomol or constituents)
* Exposure to any other investigational treatment, advanced therapy medicinal product or use of any other prohibited concomitant medications
* Women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants until 3 months after last dose. Pre-menopausal women must have a negative pregnancy test prior to dosing with trial medication.
* Any of the following medically significant conditions:

  1. Clinically significant renal or hepatic disease OR clinical laboratory assessment (results ≥ 3 times the upper limit of normal \[ULN\] for aspartate aminotransferase and/or alanine aminotransferase, bilirubin ≥ 2 times the ULN, or creatinine ≥ 1.5 times the ULN).
  2. Any new condition or worsening of existing condition which, in the opinion of the investigator, would put the subject at undue risk.
* Any serious adverse event or moderate/severe adverse event from the ORARIALS-01 trial which is ongoing at the time of transitioning to ORARIALS-02 and assessed as probably related to IMP
Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients

We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of the disease in ARDS patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute Respiratory Distress Syndrome
* CT scan performed for clinical purposes

Exclusion Criteria:

* Age \< 18 years
* hemodynamic instability
Optical Breath-hold Control System for Image-guided Procedures

The objective or our study is to test the feasibility of a new optical-based breath-hold control (OBC) system for monitoring breath-hold levels and providing patient feedback during CT-guided biopsies of the lung and upper abdomen where respiratory motion is a problem.

1. Specific Aim #1: To further test the feasibility of the new OBC system for guiding accurate and reproducible breath-hold levels that correlate with internal target position in human volunteers. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to accuracy and reproducibility of a reference breath-hold level.
2. Specific Aim #2: To compare the use of 2 optical-based belts (wrapped around the chest and abdomen) versus 1 optical-based belt (wrapped around the chest or abdomen, depending on which region expands the most during respiration) with regard to accuracy and reproducibility of a pre-determined reference breath-hold level in a subset of patients (prone and/or obese). Hypothesis: The use of 2 optical-based belts allows increased accuracy and reproducibility of a pre-determined reference breath-hold level compared with the use of only one belt in this subset of patients.
3. Specific Aim #3: To test the clinical feasibility of the new OBC system in patients undergoing CT-guided biopsy of the lung or upper abdomen where respiratory motion is a problem. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to the accuracy and reproducibility of the reference breath-hold and ease of use.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a CT-guided lung or upper abdomen biopsy (including lesions in the liver, pancreas, stomach, kidneys, adrenals, spleen, or in the peritoneum at or above the level of the kidneys) on the SMH-CT-3M scanner when either Dr. Carlson or Dr. Bender are scheduled.
* Lesions will need to measure 3 cm or less in maximum dimension and cannot be affixed to the chest or abdominal wall.

Exclusion Criteria:

* Inability to cooperate with breath-holding (including cognitive impairment, poor pulmonary function that inhibits patients from being able to hold their breath for at least 10 seconds)
* Patients with bleeding diatheses (platelets \< 50,000, International Normalized Ratio \> 1.5, or activated partial thromboplastin time \> twice normal)
* Lesions that abut the pleura or abdominal wall for a distance greater than 3 cm (these lesions were assumed to be fixed in position and less likely to be affected by respiratory motion).
* Patients with implanted medical devices (pacemakers) (this exclusion is based on the Division of Engineering Safety Review-enclosed in application)
Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer.

The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.

This is a Phase II trial to characterize the feasibility of treating patients with locally advanced cutaneous squamous cell carcinomas of the head and neck with post-operative radiotherapy and cetuximab. Cetuximab has previously been given safely in conjunction with head and neck radiotherapy for mucosal squamous cell carcinoma in multiple phase III trials, and so Phase I data is not necessary here.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma of the head and neck
* Clinical stage \>/= T3 or \>/= N1, M0 including no distant metastases
* Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration
* Performance status of 0-1 within 2 weeks prior to registration
* Age \>/= 18
* Adequate labs within 2 weeks prior to registration

Exclusion Criteria:

* Prior invasive malignancy unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago. Patients with a history of T1-2, N0, M0 resected differentiated thyroid carcinoma are considered eligible.
* Prior systemic chemotherapy or anti-epidermal growth factor therapy for the study cancer or for a different prior cancer
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Mobile Health (mHealth) Black Women With Breast Cancer

This research study will test whether a series of video clips with breast cancer information improves knowledge of breast cancer, breast cancer treatment and living with breast cancer. Questionnaires will be completed to learn if the videos are helpful and pleasant to watch.

Though Black women have a lower breast cancer rate than White women, Black women have the poorest outcomes of all races and ethnicities. Low cancer knowledge and mistrust of the healthcare system have been shown to lead to poorer outcomes following breast cancer diagnosis. Participants are asked to be in this research study if they are a woman age 21 years or older who identifies as Black/ African American and has been diagnosed with breast cancer within the past 6 months.

First, participants will come to a pre-intervention study appointment and will be asked to complete several questionnaires. The questionnaires will ask about breast cancer knowledge, quality of life, and their relationship with their doctor. Participants will then opt-in to the study by sending a text message to the study.

For the next ten ten weeks, participants will receive a text message with a link to one video clip per week. Each video is 15-20 minutes long and contains information about breast cancer. Participants will also receive one supportive text message per week for ten weeks.

At the end of the ten weeks, participants will be scheduled for a follow-up appointment. Participants will again be asked questions about breast cancer knowledge, quality of life, and their relationship with their doctor. Participants will also be asked what was helpful and not helpful about the videos.

Eligibility Criteria:
Inclusion Criteria:

* Age: 21 years or older
* Race/Ethnicity: Black from any cultural background (e.g., African American, Caribbean Islander, Haitian, Black Hispanic, etc.)
* Diagnosed with breast cancer stages 0-III in the past 6 months
* Life Expectancy: ≥12 months
* Income: at or below 200% of the federal poverty line
* Have access to a cellphone
* Able to receive text messages on cell phone
* Able to view video clips on cell phone.

Exclusion Criteria:

* Previous diagnosis of any type of cancer
* Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to understand spoken English at the 8th grade level; unwilling to travel to University of Florida Health Shands hospital or HealthStreet for baseline and follow-up assessment appointments; inpatient psychiatric treatment for major psychiatric disorder in the past year; substance use disorder in the past year; and other conditions which in the opinion of study staff would adversely affect participation in the trial.
A Study of Mircera in Anemic Patients With Multiple Myeloma

This study will investigate the efficacy, safety and pharmacokinetics of Mircera in adult anemic patients with multiple myeloma. In the first stage of the study, patients will be randomized to receive subcutaneous injections of Mircera once every 3 weeks, at doses of 2.0, 3.5 or 5.0 micrograms/kg. Following the administration of 2 doses, an evaluation of hemoglobin increase will be made at week 6. In the second stage, further groups of patients will receive additional doses of Mircera,at doses of 1.0, 6.5 or 8.0 micrograms/kg, depending on efficacy, safety and pharmacokinetic considerations.The anticipated time on treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* confirmed diagnosis of multiple myeloma;
* anemia (hemoglobin \<=11g/dL at screening visit).

Exclusion Criteria:

* transfusion of red blood cells during 2 months prior to first planned dose of study medication;
* therapy-resistant hypertension;
* relevant acute or chronic bleeding within 3 months prior to planned start of study treatment;
* recombinant human erythropoietin or erythropoiesis-stimulating drug therapy within 3 months prior to planned start of study treatment.
Predictors of Node Positivity in Endometrial Cancer

To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histologically confirmed endometrila cancer
* Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)
* Data on histological characteristics of the ttumor
* Execution of sentinel node mapping
* Data on sentinel node status (negative vs. positive)

Exclusion Criteria:

* Stage IVB endoemtrial cancer
* consent withdraw
Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik

The register study CGM@CAD will examine whether cardiogoniometry can provide additional information concerning the indication for a diagnostic coronary angiography and if so, which additional value it has. Therefore, an additional cardiogoniometry will be carried out in consecutive patients who have been diagnosed with myocardial ischemia by means of established methods (exercise ECG, stress echocardiography, myocardial scintigraphy, or stress-MRT) and for whom an intracardiac catheter examination is regarded as indicated. The results of the different methods - particularly the results of the exercise ECG and the cardiogoniometry - will be checked against the results of the invasive examination as gold standard and the discharge diagnosis with regards to any correlation.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a coronary angiography
* Age \> 18 years
* Patients written informed consent

Exclusion Criteria:

* Patients with known CHD (condition after myocardial infarction and/or angio-graphically proven stenosis \> 50% and/ or revascularization )
* Patients with acute coronary syndrome
* Patients with pace maker
* Severe valvular heart defect
* 50% extrasystole
* Patients with dysrhythmia, which make a correct interpretation impossible (e.g. VES, bigeminies and other dysrhythmia with a high impact such as atrial extrasystoles)
* Branch block
* Atrial fibrillation
Machine Learning Model for Perioperative Transfusion Prediction

This study aimed to develop and interpret a machine learning model to predict red blood cell (RBC) transfusion.

A dataset from a multicenter study involving 6121 patients underwent elective major surgery was analysed. Data concerning patients who received inappropriate RBC transfusion were excluded. Twenty one perioperative features were used to predict RBC transfusion. The data set was randomly split into train and validation sets (70-30). Decision tree, random forest, k-nearest neighbors, logistic regression, and eXtreme garadient boosting (XGBoost) methods were used for prediction. The area under the curves (AUC) of the receiver operating characteristics curves for the machine learning models used for RBC transfusion prediction were compared.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Underwent major elective surgery

Exclusion Criteria:

* Pediatric patients
* Emergency cases
Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

There is great interest in the development of novel therapies for acute ischemic stroke because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for acute ischemic stroke therapy because of their effects on the main mechanisms of brain ischemic damage and regeneration.The main purpose of this open label, one arm, dose escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective tool to promote recovery in acute ischemic stroke patients Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be evaluated by the incidence of adverse events and mortality throughout the stimulation period and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical and radiological scores.


Eligibility Criteria:
Inclusion Criteria:

* males or females, aged over 18
* evidence of mono-hemispheric ischemic stroke confirmed by brain MRI
* first onset stroke patients
* onset of symptoms within 48 hours prior to enrollment
* National Institutes of Health Stroke Scale (NIHSS) score greater than 4
* patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
* signed written informed consent prior to entry into the study

Exclusion Criteria:

* acute intracranial hemorrhage confirmed by brain CT or MRI scan
* previous ischemic or hemorrhagic stroke
* seizure at the onset of stroke or a history of epilepsy
* contraindications to transcranial magnetic stimulation: implanted metallic parts of implanted electronic devices, including pacemakers,defibrillators, implanted medication pump, or implanted brain stimulator
* aneurysm clip or other metal in body
* life expectancy less than 3 months
* other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, or complex disease that may confound treatment assessment
* women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
* any condition that would prevent the subject from giving voluntary informed consent
* current participation in another study with an investigational drug or device