cyrilzakka/clinical-trials huggingface dataset:
REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)

Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.

Patients will be randomly assigned to either the control arm and will receive usual AMI care or the experimental arm, which will include routine AMI care as well as intensive therapy intervention.

In addition to the capillary blood glucose measurements obtained to titrate insulin doses in the experimental arm patients, laboratory plasma glucose will be drawn in all patients at randomization, 10, 24, 48, and 72 hours post randomization, 7 days post randomization (or hospital discharge if that occurs first), and 30 days post randomization.

Eligibility Criteria:
Inclusion Criteria:

Both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected AMI are eligible if they meet the following criteria:

* Signs or symptoms of AMI with definite ECG changes, defined as persistent ST-segment elevation (\> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block
* Onset of symptoms within 24 hours before hospital presentation
* Capillary blood glucose level on presentation \> or = 8.0 mmol/L (144 mg/dL)

Exclusion Criteria:

* Patient with conditions that REQUIRE the administration of insulin, including:

  * Type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30
  * Type 2 diabetes mellitus that was treated with insulin prior to AMI presentation
  * Type 2 diabetes mellitus that is known to be very poorly controlled (e.g. admission capillary blood glucose \> 16.0 mmol/L (288 mg/dL)or marked elevation in glucose for which the site investigator plans to treat with insulin therapy)
* A history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years
* Known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis)
* Cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
* Documented pregnancy
* Any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days
* Anticipated poor adherence with study treatments or an other factor that might jeopardize 90-day follow-up (e.g. no fixed address, long distance to hospital, etc.)
* Prior enrollment in this trial or current enrollment in another trial of ST-segment elevation myocardial infarction
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis

The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.

This study is complementary to a multi-center, randomized, double-blind,parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the setting of a SPMS clinical trial.

This study is part of a multi-center study, with the University of Michigan serving as the central site.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in the multicenter, randomized, double-blind, parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with Secondary Progressive Multiple Sclerosis (SPMS) Protocol No. CBAF312A2304 (sponsored by Novartis). Refer to ClinicalTrials.gov record NCT01665144.
* Subjects enrolled at one of the participating AMS04 study sites located in the United States.
* Subject must be able to provide written informed consent.

Exclusion Criteria:

* Subjects with severe bleeding disorders, platelet count less than (\<)50,000/microliters (μL), and/or who are currently on full anticoagulant therapy will be excluded from the optional CSF collections.
Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

This study examines the clinical relevance of early biomarkers to detect and prevent acute kidney injury. High-risk patients for developing acute kidney injury will be screened at initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In case of elevated readings patients will be randomized in two arms: The control group will be treated with standard care, the intervention group will receive an early nephrologic consultation.

This study examines the impact of an early biomarker-guided intervention on the development of acute kidney injury (AKI). New biomarkers indicate kidney damage in an early stage before developing acute kidney injury according to AKI Kidney Disease Improving Global Outcomes (KDIGO) Definition is detectable. The investigators want to test if it's possible to prevent AKI based on elevated urinary biomarkers. Eligible patients will be randomly assigned to two groups, a control and an intervention Group by an early nephrologic consultation. The interventional group will receive an early preventive nephrologist consultation additionally to standard care.

Eligibility Criteria:
Inclusion Criteria:

* no acute kidney injury stage II-III (according to AKI KDIGO definition)
* urinary biomarker levels above cut-off
* inpatient treatment
* age ≥18 years
* informed consent or presumed will

Exclusion Criteria:

* existing acute kidney injury stage II-III (according to AKI KDIGO definition)
* age \< 18 years
* end stage renal disease (ESRD), existing renal replacement therapy
* pregnancy
* withdrawal of consent
* missing presumed will
Renal Arterial Denervation in Sympathetic Dysautonomia

The RANSOM registry is considered as a collection of data with the ultimate purpose of gathering information about the effect of renal denervation in patients of the investigator's center and evaluating the results within the usual clinical practice.

The general objective of the study is to evaluate the clinical results (blood pressure, quality of life and levels of catecholamines) as well as safety of renal sympathetic denervation in hypertensive patients, at least in treatment with an antihypertensive drug and with increased variability, considering as such a standard deviation\> 10 mmHg for systolic BP and\> 5 for diastolic BP of its blood pressure levels, measured by ABPM.


Eligibility Criteria:
Inclusion Criteria:

* All patients included in a prospective manner must sign an informed written consent and meet ALL of the following criteria that are typical of the procedure according to the protocol of our center:
* Be considered adequate and eligible by the group of doctors responsible for the patient and by the multidisciplinary team of the study. Over 18 years, not pregnant.
* Poorly controlled arterial hypertension, under treatment with at least one antihypertensive drug.
* In addition, poorly controlled hypertension + increased variability, considering as such a standard deviation\> 10 mmHg for systolic BP and\> 5 for the diastolic BP of patient´s blood pressure levels, measured by ABPM.
* Renal arteries anatomy suitable for the procedure, considered by CT, MRI, ultrasound or angiography.
* Some criteria of dysautonomia, following the consensus of the American Autonomous Society (AAS) and the European Federation of Autonomous Societies (EFAS) of 2018.

or supine HTN. Defined as sBP ≥ 140 mmHg and / or dBP ≥ 90 mmHg, measured at least after 5 minutes of supine rest. Moderate forms (160-179 mmHg or dBP of 100-109 mmHg) or severe will preferably be included. (sBP≥ 180 mmHg and / or dBP ≥ 110 mmHg). Mild forms will be considered in conjunction with symptoms or other findings (ABPM) or nighttime HTN. Considered as such one that does not fall more than 10% compared to the daytime BP or even rises (riser). They will be considered in conjunction with symptoms or other findings (eg ABMP).

* If the foregoing is not fulfilled, marked orthostatism (\> 30 mmHG in sBP and / or\> 10mmHG in dBP).
* Life expectancy exceeding one year (not presenting terminal illness or any health condition for which a survival of less than one year is estimated).

Exclusion Criteria:

* eGFR \<30 mL / min / 1.73m2.
* Monoxidin treatment.
* Impossibility of informed consent by the patient or legal representative.
* Impossibility for follow-up at least 1 year.
* Do not fulfill inclusion criteria, assessed by the multidisciplinary team.
Health Benefits of Tart Cherry in Crohn's Disease

Crohn's disease (CD) is a long-term inflammatory condition of the digestive tract. People with CD often experience unpredictable and debilitating symptoms, including abdominal pain, diarrhea, and fatigue. Additionally, they require long-term treatment, which is often associated with frequent negative effects, the need for surgery, and hospitalizations. As a result, individuals with CD report a lower health-related quality of life (HRQOL) compared to healthy individuals.

The most common medication for inflammatory bowel disease is a strong immunosuppressant, which was identified in 2017 as the most expensive medication prescribed in NHS hospitals. Unfortunately, biologics have significant side effects, and reducing the reliance on them could benefit both the NHS by lowering costs and patients by minimizing unwanted side effects.

Supplementation with Montmorency tart cherry juice may offer a simple, safe, and cost-effective intervention for improving symptoms in individuals with CD. This is due to its potential to naturally reduce inflammation in the digestive system, thereby alleviating symptoms. Research in animal models has shown potential improvements in physiological responses with similar supplements, including blueberries, black raspberries, and Montmorency tart cherries, though only one study in human participants has explored bilberry supplementation.

Despite Montmorency tart cherries having superior anthocyanin concentrations compared to other berries, dietary interventions using tart cherry supplementation for CD have not been explored in human participants. The primary aim of the proposed investigation is to conduct a placebo-controlled randomized trial to examine whether Montmorency tart cherry juice supplementation can provide symptom relief and improve health-related well-being in individuals with mild to moderately active CD, as well as to understand the biological mechanisms underlying any observed symptom changes.


Eligibility Criteria:
Inclusion Criteria:

* An established diagnosis of CDfor at least 6 months
* Current mild to moderate disease activity
* Age between 18 and 65 years
* Stable use of medication for at least 3 months respectively.

Exclusion Criteria:

* Diabetes
* HIV
* Hepatitis B and C infection
* Abscesses
* Unstable medical conditions that would likely prevent the subject from completing the study
* Food allergies to cherries.
Best Possible Medication History at USB

This pilot project investigates the use of a structured medication history (Best Possible Medication History, BPMH) in patients (primarily admitted at the emergency department of University Hospital Basel) after transfer to a medical ward. Unintentional medication discrepancies are analyzed comparing outpatient and inpatient medication therapy.


Eligibility Criteria:
Inclusion Criteria:

* Admission to Emergency Department of University Hospital Basel and transfer to medical ward

Exclusion Criteria:

* medication history taken at Emergency Department of University Hospital Basel not present
A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects

The objectives of this study are:

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing

Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an ambulatory male or female between 18 and 55 years old at the screening visit
* Subject's body mass index score is \> 18.5 and \< 30.0 kg/m2 at the screening visit
* Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
* Subject is in good health and has no clinically significant findings on a physical examination
* Other inclusion criteria per protocol

Exclusion Criteria:

* History of any clinically significant medical conditions
* Other exclusion criteria per protocol
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis

BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 18 and 65 years
* Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening.
* Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening.
* Mean backache intensity equals 4 points or more.
* If patient have had biologic therapy to treat ankylosing spondylitis for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study.
* Female patients have negative urine pregnancy test.
* Patient has no history of tuberculosis.
* Patients have negative results of Diaskintest.
* Patient has no history of alcohol or drug abuse.

Exclusion Criteria:

* Total spinal ankylosis.
* Allergy or intolerance of monoclonal antibodies or any excipients of study drugs.
* Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.
* Prior use of two or more biologics to tumor necrosis factor alfa.
* Prior use of two or more biologics to other targets. Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.
* Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable.
* Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization, if their dose was not stable for up to 4 weeks before signing informed consent and during screening.
* Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
* Prior use of alkylating agents for up to 12 months prior to signing informed consent.
* Intraarticular use of corticosteroids for up to 4 weeks before randomization.
Beyond TME Origins

All patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.

A prospective and retrospective cohort study to improve surgical and treatment planning using an imaging assessment proforma of advanced and recurrent colorectal cancers. This involves the implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Eligibility Criteria:
Inclusion Criteria:

1. Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice
2. Has a confirmed diagnosis of recurrent pelvic colorectal cancer
3. Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum
4. Are able to undergo high resolution MRI for staging prior to treatment decisions
5. Have provided written informed consent to participate in the study
6. Be aged 16 years or over

Exclusion Criteria:

1. Have irresectable extra-pelvic metastatic disease
2. Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon and sigmoid cancers) are unavailable
3. Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable
Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer

In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.

Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. The operator can track the lymphatic pathway without skin incision in real time. By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. This is why we can identify the lymphatic metastasis pathway of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Operable breast cancer patient
* Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection

Exclusion Criteria:

* Breast cancer history
* Occult breast cancer
* Past history of axillary surgery
* Iodine hypersensitivity
* Pregnancy
Efficacy of Nanodropper-mediated Topical Anesthetic

The goal of this clinical trial is to compare the onset and duration of numbness of the surface of the eye following the administration of numbing drops, called proparacaine, using either a standard eye drop bottle or a "Nanodropper" adaptor. The Nanodropper is designed to administer smaller-sized drops, or microdrops.

Participants will:

1. Complete a baseline eye exam.
2. Receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye.
3. Have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops).
4. Tell the researchers if they feel pain during the eye sensation tests.
5. Complete a survey about their experience with the eyedrops and testing procedure.

This study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and reducing medical waste.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent for topical anesthesia delivery
2. Ability to verbally respond to pain
3. At least 18 years of age

Exclusion Criteria:

1. Have a contraindication to local anesthetics
2. History of intravitreal injections
3. History of ocular surgery
4. History of vitreous or retinal surgery
5. Preexisting diagnosis of ocular surface disease requiring punctal plug placement
6. Evidence of any current ocular inflammation
7. Any previous ocular condition (i.e., neurotrophic keratitis, herpetic eye disease, presence of a corneal graft, etc.) that has permanently altered the native sensation of the ocular surface
8. Use of contact lenses in the past year
9. Use of exclusionary medications: Topical steroid drops, non-steroidal anti-inflammatory drops, intraocular pressure lowering eye drops, any anti-viral medications used for herpes, opioids
Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases

The aim of this study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of R0 excision Colorectal Cancer Liver Metastases.


Eligibility Criteria:
Inclusion Criteria:

Pathologically confirmed diagnosis of colorectal cancer； Karnofsky performance status 0-1; Patients with tumors identified by pathologic immunohistochemistry as pMMR or by genetic testing as MSS/MSI-L; Imaging diagnosis of stage IV, resection of both primary and metastatic tumors and had NED status after surgery; With a high risk of recurrence, such as liver metastasis CRS score \>3 or successful conversion therapy; Multiple peritoneal metastases after CC0; Function of the main organs is normal; Edition Patient's written informed consent

Exclusion Criteria:

Tumor emergencies; Abnormal coagulation function; Contagious diseases, such as HIV, HBV, HCV infection; Mental disorders; Concomitant tumors; Immunological co-morbidities
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer

The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA.

Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer. This study will use the standard dose of 80 mg/m\^2, including the typical pre-medications as per University of Michigan Rogel Cancer Center institutional standard. The only investigational component of this study is lengthening the infusion duration from 1-hour to 2 or 3 hours for a single dose in patients with low SMA.

JAN2025 update, Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer or metastatic gastric or esophageal cancers.

Eligibility Criteria:
Inclusion Criteria:

* Planned paclitaxel 80 mg/m\^2, 1-hour infusion
* Evaluable computed tomography (CT) scan, positron emission tomography computed tomography (PET-CT) scan, or MRI scan (e.g. scan of the chest, abdomen, or pelvis for any indication w/in 1 year)
* Female
* ≥ 18 years old
* Adequate organ function to receive paclitaxel treatment as defined in the protocol
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Concomitant administration of any moderate or strong inducer or inhibitor of CYP2C8, including rifampin or clopidogrel.
* History of hypersensitivity reaction to paclitaxel or any components of paclitaxel (e.g., Cremophor EL) that precludes continued treatment with standard dose and infusion length
* Pregnant or nursing
* Receiving any other dose (i.e., not 80 mg/m2) or infusion rate (i.e., not 60 minute infusion) either due to toxicity during a previous cycle or any other reason