cyrilzakka/clinical-trials huggingface dataset:
Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.

All enrolled participants will undergo baseline cardiovascular risk assessment (using QRISK3 and SCORE 2 risk calculators), cardiac, oncological and medication history. All participants will have serial cardiac symptom assessment, 12 lead ECG and cardiac biomarker assessments(high sensitivity troponin T and NT pro BNP) at baseline, on completion of the first cycle of treatment and post completion of treatment. Participants will be followed up for the development of cardiotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic)
* Capacity to provide consent

Exclusion Criteria:

* Age \<18
* Lacking capacity to consent
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Ulcerative Colitis (ROSETTA)

ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of rosnilimab in subjects with moderate to severe ulcerative colitis (UC).

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18
* Participants with a clinical diagnosis of UC for prior to Day 1
* Subject has moderate to severe, active UC, defined as a mMS ≥ 5 with an endoscopy subscore ≥2
* Subject has had a surveillance colonoscopy that did not detect potential dysplasia or colon cancer performed within 1 year of Day 1.
* Subject has a history of an inadequate response, loss of response, or intolerance to any combination of at least 2 UC therapy classes defined as, but not limited to, aminosalicylates, corticosteroids, immunomodulators, calcineurin inhibitors, or advanced UC therapies (e.g., biologics, JAK inhibitors, oral S1P receptor modulators, etc.)

Exclusion Criteria:

* Subject has a diagnosis of Crohn's disease or indeterminate colitis.
* Subject has a diagnosis of fulminant colitis and/or toxic megacolon.
* Subject has a history of an inadequate response, loss of response, or intolerance to any combination of 3 or more advanced UC therapy classes but not limited to, 1) anti-TNF antibodies (e.g., adalimumab, golimumab, infliximab), 2) other biologics (e.g., ustekinumab, vedolizumab), 3) oral JAK inhibitors (e.g., tofacitinib, upadacitinib), and 4) oral S1P receptor modulators (e.g., ozanimod).
* Subject has disease limited to the rectum (ulcerative proctitis)
* Subject has a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery.
* The subject had prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator.
A Study of the Effects of PEITC on Oral Cells With Mutant p53

The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC), a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53 protein's normal (wild-type) function within cells is to act as a tumor suppressor, or anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral cells will contain measurable levels of mutant p53. The participants will consume watercress juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral cells. This depletion could lead to a possible clinical application of this compound, such as chemopreventives or oncologic treatments of individuals with oral cancers.


Eligibility Criteria:
Inclusion Criteria:

* Heavy Smoker
* Between the ages of 20 and 65
* Must be able to show proof of citizenship or residency of the United States
* Able to sign and understand a standard consent form

Exclusion Criteria:

* Pregnant or Breast-feeding
* Having any of the following medical conditions:
* Leukoplakia
* Oral Lesions
* Cancer
* Any oral disease that causes sores, ulcerations, irritations, etc.
* Stomach or Intestinal Ulcers
* IBS (Irritable Bowel Syndrome)
* Kidney Disease
* Allergies to watercress or other Cruciferous Vegetables
* Strict Vegetarians or Vegans
* Religious Consumers of Watercress or other Cruciferous Vegetable Juices
* On any of the following medications:
* Chlorzoxazone (Parafon Forte, Paraflex)
* Lithium
* Water Pills/Diuretics (Thiazide or Lasix)
* Warfarin (Coumadin)
* Vitamin K supplements
* H2 acid blocker (Zantac, Pepcid, Axid, Tagamet)
* Proton Pump Inhibitor (Prevacid)
* Digoxin
* Antibiotics
* Diabetic Medications (Insulin)
* Inhaled Bronchodilator
* Oral Steroids (Prednisone, Medrol)
* Inhaled Steroids (Flonase)
* Raloxifene or Tamoxifen
* Thyroid Hormone Replacement
Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding

The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.


Eligibility Criteria:
Inclusion Criteria:

- American society of heart association class I-II female patients

* aged 18-60 years
* scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion Criteria:

* known allergy to the study drugs
* significant cardiac-
* respiratory-
* renal or hepatic disease
Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication

The purpose of this study is to assess the strength and duration of the immunological response to COVID-19 vaccines in patients treated with immunosuppressive and/or immunomodulating medication for immune-mediated inflammatory diseases in rheumatology and gastroenterology and after a liver transplantation.

Patients on long-term immunosuppressive and/or immunomodulating medication may be susceptible to serious COVID-19. Hence, it is important they get sufficient protection by a COVID-19 vaccine. However, these patients may also be at risk for a less robust vaccine response. There is an urgent need to assess the humoral and cellular immune response to COVID-19 vaccines in these patient groups. The clinical consequences could be to administer several re-vaccinations or to adjust medication. This prospective, observational study aims to assess the immune response after COVID vaccination in patients suffering from inflammatory diseases and using immunosuppressive medication. Also, liver transplanted patients on immunosuppressive medication will be included.

Serum and whole blood samples will be obtained from all participants before and 1-4 weeks after the vaccination. Additionally, serum samples will be collected every 3-6 months for 5 years. If patients are allotted further vaccine doses , the patient response will be assessed by blood tests 2-4 weeks after any additional vaccine doses. In a subset of patients, samples will be drawn to study cellular immune responses. Demographic data and data regarding immunosuppressive medication will be recorded. Disease activity (clinical activity indices and biomarkers of inflammation) will be assessed. Blood samples will be obtained for biobank. Information regarding vaccination status and potential COVID-19 testing will be obtained from relevant registers.

Eligibility Criteria:
Inclusion Criteria:

1. An established clinical diagnosis of one of the following immune-mediated diseases: rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA), ulcerative colitis (UC,) Crohns disease (CD), autoimmune hepatitis (AIH) or patients who have undergone a liver transplantation
2. Treatment with relevant immunosuppressive and/or immunomodulating medication \*
3. Adult patients (\> 18 years)
4. Patient intends to obtain vaccination against COVID-19 during the next 6 months

   * \* The following drugs are considered relevant immunosuppressants and/or immunomodulators and patients using them may be eligible for this study: Rituximab, infliximab, adalimumab, golimumab, certolizumab, etanercept, tocilizumab, abatacept, secukinumab, vedolizumab, ustekinumab, risankizumab, methotrexate, sulfasalazine, leflunomide, azathioprine, 6-mercaptopurine, tofacitinib, filgotinib, baricitinib, upadacitinib, tacrolimus, mycophenolate, prednisolone

Exclusion Criteria:

1) Allergy or intolerance to elements of the COVID-19 vaccines

-
Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds

This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.

Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. Due to the fact that frequent (multiple times daily) pulse lavage therapy has not been possible previously, it is unknown how effectively serial pulse lavage irrigation reduces bacterial counts. This study evaluates the effectiveness of serial pulse lavage therapy in decreasing bacterial counts in chronic wounds.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a chronic wound (as defined by the wound being present for \>30 days) located on any part of their body
2. The wound must be smaller than 10cm in greatest diameter.
3. Patients must have an expected remaining hospital duration of 4 days
4. Patients must be willing and able to comply with all study procedures

Exclusion Criteria:

1. Patients must not have undergone any surgical excisions or debridements of the wound in the past 30 days
2. The wound may not undergo any surgical procedures or other treatments other than the study treatments during the course of the study.
3. The wound may not require any immediate surgical intervention or debridement
4. Patients may not start any new antibiotic therapy during the course of the study
5. Must not have an allergy to skin adhesives.
6. Patients must not be taking any immunosuppressive medications.
7. Subjects who, in the opinion of the investigator, may not complete the study for any reason.
Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser

The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with port wine stains.


Eligibility Criteria:
Inclusion Criteria:

* Patients with previously untreated and previously laser-treated naevus flammeus. Naevus flammeus measuring at least 5 x 7 cm within a single anatomical area. For example, the face corresponding to dermatomes V1, V2 and V3, back, abdomen, arms and legs.Patients aged two or above.Patients with skin types I-III.

Exclusion Criteria:

* Patients below two years of age.
* Pregnant or breastfeeding patients.
* Patients with known increased sensitivity to visible light.
* Patients with a tendency to produce hypertrophic scars or celoids.
* Patients with skin types IV, V and VI.
* Patients who are clearly pigmented following recent exposure to the sun or a solarium.
* Patients treated with Roaccutane during the last six months.
* Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients, etc.).
Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners

The aim is to evaluate clear aligners' cytotoxicity, leaching, and structural properties and compare them with four cleaning tools. The null hypothesis is the cleansers have no impact on the properties tested.

Orthodontic Invisalign clear aligners patients will be randomly distributed into four groups using four cleaning methods. Participants will be instructed to clean their trays as instructed by the production company.

Leaching, Cytotoxicity, and Structural Confirmation will be evaluated of the Invisalign clear aligners after being used.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are on Invisalign Clear aligner treatment.
* Participants who are 21 years and older and committed to their treatment.
* Participants with caries-free dentition
* Participants with no smoking habits
* Participants are not pregnant females

Exclusion Criteria:

* Participants who are on Orthognathic treatment.
* Participants with Hypodontia.
Ocular Ultrasonography as a Tool for Monitoring the Management of Traumatic Brain Injury

Raised intracranial pressure (ICP) is a common and life threatening condition especially in patients with traumatic brain injury.There are many methods for monitoring the increased (ICP) either invasive or non- invasive ,but the gold standard is invasive method. Optic nerve sheath ultrasonography provides a very promising bedside tool for detection of increased ICP. This study will monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy

Traumatic brain injury is the main cause of increased intracranial pressure (ICP) in the intensive care .

There are multiple methods for monitoring the raised ICP either invasive or non-invasive.The gold standard is the invasive devices because it is more accurate and reliable .However ,it requires a surgical intervention which has many hazards such as (infection ,hemorrhage,malfunction ).

Optic nerve sheath ultrasonography is a promising bedside tool for detection of increased ICP. The optic nerve is surrounded by cerebro-spinal fluid ,thus if the circulation of cerebro-spinal fluid not blocked ,an increase in ICP will be transmitted through the subarachnoid space around the optic nerve within the nerve sheath especially the retro-bulbar segment.

The study will be conducted to monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy as a primary outcome and secondary to evaluate the efficacy of ONSD in assessing the severity of the disease

Eligibility Criteria:
Inclusion Criteria:

* Patients with traumatic brain injury

Exclusion Criteria:

* Patients with history of optic neuritis
* past history of eye trauma
* patient with optic nerve trauma
* patient with history of arachnoid cyst of the optic nerve
* high myopic patients
* patients with cavernous sius mass
Outcomes of Biceps Tenodesis or Labral Repair for Treatment of Type 2 Superior Labrum Anterior and Posterior Lesions

The purpose of the study is to determine which of the two alternative surgical interventions (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior Labrum Anterior and Posterior lesions.

The labrum is a structure which provides stability to the shoulder joint. A superior labral tear from anterior to posterior lesion is an injury to the labrum at the insertion of the biceps muscle. The grading system is related to the severity of the tear. A type 2 tear is an intermediate grade tear. These are commonly treated in two ways: either by repairing the labrum with bone anchors or by cutting the biceps tendon and re-affixing it more distally. No method has been shown to be superior to the other and surgeons generally choose to proceed however they are most comfortable. The study will seek to determine how these injuries are best treated. Inclusion criteria: patients with type 2 superior labral tear from anterior to posterior tears who are under the age of 45. Throwing athletes are excluded due to their unique demands.

Subjects will be randomly assigned to one of two groups. Prior to surgery patients will be evaluated in clinic, full histories and physicals will be performed and their functional status will be evaluated using validated questionnaires including the American Shoulder and Elbow Society score and quality of life measurements.

Both groups will be treated first with a shoulder arthroscopy. The experimental portion of the study will involve whether the patient is then treated with repair of the Superior Labrum Anterior and Posterior lesion or with tenodesis. Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum. A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm. Physical therapy will be initiated after surgery and will be identical in both groups. It will be recommended but not required as part of the study. Progress notes, operative reports, and questionnaires will also be retained as part of the study. Patients will be in a sling for the first 4 weeks after surgery. Post-operatively, physical examinations findings and American Shoulder and Elbow Surgeons scores at 3, 6, and 12 months. These will be compared to the preoperative results and to the other experimental arm of the study. Post-operative imaging will not be obtained. No computerized tomographies will be required as part of the study. No Magnetic Resonance Imagings will be required as part of the study--patients enrolled in the study will likely have had an MRI performed outside of the study period to determine if they have an isolated Superior Labrum Anterior and Posterior tear but no MRIs will be performed as part of the study. No lab reports or Physical therapy reports will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* patients with MRI diagnosed Superior Labrum Anterior and Posterior 2 lesion

Exclusion Criteria:

* none
Neural Activation and Connectivity in Response to Exercise and Cognitive Training

The goal of this pilot study is to evaluate whether healthy, sedentary older adults have increased activation of specific brain areas, in response to exercise and cognitive training, in comparison to a control group, and whether improvements in psychometric test performance are related to increased activation of brain networks. Participants, between age 55-75 years will be recruited from an ongoing study of exercise and cognitive training, to undergo Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fcMRI).


Eligibility Criteria:
Inclusion Criteria:

* meet the inclusion criteria for the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT) study (Unique Protocol ID 201102416).

Exclusion Criteria:

* currently taking chronic psychotropic medication, beta blockers, or calcium channel blockers
* contraindication to MRI scanning
* inability to complete MRI scans in closed scanner
Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.

This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.

Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
* Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
* Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
* Recovered from reversible toxicities of prior therapy
* Karnofsky performance status ≥70
* Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose
* Ability to understand the purposes and risks of the study and provide written informed consent.

Exclusion Criteria:

* Prior chemotherapy for metastatic/locally advanced pancreatic cancer
* Prior administration of gemcitabine
* Radiation therapy within 28 days prior to study start
* Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 days prior to study start
* Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
* Active, clinically significant infection requiring antibiotics
* Known HIV positive or active hepatitis B or C
* History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
* Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
* Major surgery within 3 weeks of the start of study treatment, without complete recovery
* Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)

  * Hemoglobin \<9 g/dL (may receive transfusion or erythropoietin to maintain),
  * ANC \<1500/μL,
  * Platelet count \<100,000/μL,
  * Total bilirubin \> 1.5 ×ULN,
  * AST/ALT \> 2.5-fold above ULN (\>5-fold above ULN if liver metastases),
  * Serum creatinine \> 2 mg/dL,
  * Creatinine clearance \< 60 mL/min (calculated)
* Females who are pregnant or breast-feeding
* Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
* Concomitant disease or condition that could interfere with the conduct of the study
* Unwillingness or inability to comply with the study protocol for any other reason
Creatine Supplementation on Cognition in Children

Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children.


Eligibility Criteria:
Inclusion Criteria:

* healthy children
* age between 10 to 12 years of age

Exclusion Criteria:

* cognitive impairment
* vegetarian diet
* use of creatine in the past 6 months
* chronic kidney disease