cyrilzakka/clinical-trials huggingface dataset:
Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy

This pilot phase II trial studies how well bovine lactoferrin supplement works in improving taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help improve the ability to taste food in patients who are receiving chemotherapy.

PRIMARY OBJECTIVES:

I. To assess the impact of lactoferrin supplementation (bovine lactoferrin supplement) on self-reported taste and smell disturbances in cancer patients receiving chemotherapy.

SECONDARY OBJECTIVES:

I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in cancer patients as measured by the thiobarbituric acid reactive substances (TBARs) assay.

II. To assess the impact of lactoferrin supplementation on the ability of cancer patients to generate increased lipid peroxidation byproducts when challenged with a weak iron-containing solution.

III. To assess the impact of lactoferrin supplementation on self-reported general quality of life and on specific self-reported anorexia/cachexia issues in cancer patients with established chemotherapy-induced taste disturbances.

IV. To assess the incidence of vitamin D deficiency in cancer patients with chemotherapy induced taste changes.

OUTLINE:

Patients receive bovine lactoferrin supplement orally (PO) three times daily (TID) for 1 month.

After completion of study treatment, patients are followed up at 2 weeks and 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed carcinoma of any site; the two exceptions are pancreatic cancer and colon cancer patients who are receiving oxaliplatin; those patients will be ineligible for participation in this current study but will be eligible for Comprehensive Cancer Center of Wake Forest University (CCCWFU) 98112 instead
* There are no restrictions on the amount or types of prior therapy; eligible patients must be receiving ongoing chemotherapy that is planned to continue for at least one month following enrollment in this trial; any dose or schedule of chemotherapy administration is allowed as long as patients have self-reported taste disturbance that has either: 1) developed since the initiation of chemotherapy, or 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating chemotherapy
* Patients must have normal baseline self-reported taste perception prior to the development of cancer
* Life expectancy of \>= 3 months
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
* Patients known to be human immunodeficiency virus (HIV)-positive
* Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
* Patients who are pregnant or breastfeeding are excluded
Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma

The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection or orthotopic liver transplant.


Eligibility Criteria:
Inclusion Criteria:

* HCC (diagnosis: histological or radiological)
* Age: 18-80
* Number of lesions 1-3 lesions
* Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm
* Sufficient non-tumorous liver volume (≥ 800 cm3)
* Child Pugh Score: A5-6 or B7
* BCLC A or B
* Patient is illegible or refused surgical resection or orthotopic liver transplant
* Blood work (within 2 weeks before registration):
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³)
* Platelets ≥50,000 cells/mm³
* AST (and ALT) \< 5 times ULN
* Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

* Evidence of extrahepatic disease (lymph node or distant metastases)
* Evidence of macroscopic vascular invasion
* Evidence of an arterio-portal or arterio-venous fistulas
* History of previous malignancy
* Active hepatitis B
* Previous SIRT
* Previous Sorafenib in the last 8 weeks
* Pregnant and lactating females
A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain

Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in Chest Medicine. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. This often results in the need for further procedures (including drain re-siting), with associated additional risk to the patient and an increase in health care costs. One suggested method to reduce premature drain removal is to use chest drains with ballooned tips, much like a bladder catheter. These would provide a physical obstruction inside the chest cavity at the insertion site, whilst being easy to use as stitching or extensive taping may not be required.

The investigators propose a trial of a dedicated ballooned chest drain to investigate whether a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed during this trial to ensure that irritation of the lining of the lung or chest wall by the balloon is not excessive.


Eligibility Criteria:
Inclusion Criteria:

* Age \>16 years
* Able to give written informed consent
* Requiring intercostal tube drainage of a pleural effusion for clinical reasons

Exclusion Criteria:

* Requiring intercostal tube drainage for chest trauma
* Requiring blunt dissection for drain insertion
Clifutinib Food Effect Study in Healthy Subjects

The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (male or female), age greater than or equal to 18 years and less than or equal to 45 years;
* Weight ≥50 kg (≥45 kg for female), and have a body mass index (BMI) between 18 and 28 (including 18 and 28) at screening;
* Physical examination, clinical laboratory examination and other related examinations are normal or acceptable deviations that are judged to be not clinically significant by the investigator;
* Male or female subjects with child-bearing potential must agree to use effective contraception during the study and within 6 months after the administration of the last dose, and sperm donation is not allowed for male subjects during the study; female subjects must be non-pregnant and non-lactating；
* Volunteer to participate in this study, understand the study procedures and sign the informed consent prior to any study specific procedures, good compliance and willing to follow study procedures.

Exclusion Criteria:

* Have a history of or current cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
* Unable to tolerate standard meals;
* Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) \>470 ms (female \>480 ms), or history of long QT syndrome；
* Have received live vaccine(s) within 3 months prior to screening;
* Have used over-the-counter or prescription medication , including herbal medications, within 14 days prior to dosing and during the study;
* Have known allergy to any drug or food;
* Smoking more than 5 cigarettes per day (or equivalent in tobacco or nicotine products) within 3 months prior to screening, or unwilling to abide by smoking restrictions during the study;
* Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody ,human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody;
* Known history of drug abuse
A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB

Prospective, Non-comparative, Post Market Clinical Follow Up Study to demonstrate safety and performance of Eyefill® S.C. and Eyefill® M.B. as viscoelastic devices for cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects scheduled for cataract surgery with im-plantation of a posterior chamber intraocular lens;
* Signed informed consent;
* Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Known hypersensitivity to sodium hyaluronate;
* Corneal endothelial cell density \<1500 cells/mm2;
* Corneal abnormalities;
* Cataract density of grade 4+;
* Previous intraocular or corneal surgery;
* Chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis);
* Clinically significant, uncontrolled glaucoma with expected negative impact on visual acuity outcomes;
* Ongoing systemic or ocular steroid therapy;
* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes;
* Active ocular or systemic infection (bacterial, viral, or fungal), including fever
* Subjects who may be expected to require a combined or other secondary surgical procedure
* Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: Pregnant, lactating or unwilling to use effective birth control over the course of the study;
* Concurrent or previous (within 30 days) participation in another drug or device investigation.
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI

This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.


Eligibility Criteria:
Inclusion criteria-healthy control:

* Adults aged 18-34 years of age.
* Strong history of athletic participation including high school and collegiate varsity and/or club sports
* Current sport or recreational sport participation at least 3 days per week
* Willingness to participate in 3 times a week 60 minute exercise program conducted at Courage Kenny Research Center (CKRC).

Exclusion Criteria-healthy control:

* History of concussion.
* History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson's Disease, etc.) interfering with subject's ability to exercise
* Unwilling to exercise.
* At risk for cardiopulmonary disease as defined by the American College of Sports Medicine.
* Active medical contraindications by self-report after explanation of dual-task exercise program.
* Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis) by self-report.

Inclusion criteria-subjects with mTBI residual symptoms:

* Adults aged 18-50 years of age.
* Self-report of some consistent exercise or activity a minimum of 2-3 days per week.
* 3 weeks to 24 months post most recent concussion seeking treatment at Courage Kenny Rehabilitation Institute (CKRI) clinics
* Willingness to participate in 3 times a week 60 minute exercise program conducted at CKRC.

Exclusion Criteria- subjects with mTBI residual symptoms:

* History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson Disease, etc.) interfering with subject's ability to exercise
* Unwilling to exercise.
* At risk for cardiopulmonary disease as defined by the American College of Sports Medicine.
* Active medical contraindications by self-report after explanation of dual-task exercise program,
* Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis).
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.

Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The T cells are isolated from the PBMC, transduced with a lentivirus to express the CD19 CAR as well as a truncated EGFR that has no signaling capacity (noted EGFRt) and expanded in vitro and then administered to subjects.

Subjects will have blood tests to assess safety and efficacy, and persistence of the CD19 CAR-T cells on week 4 after their last infusion. Following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, MRD and persistence of CD19 CAR-T.

Some subjects will receive cetuximab for ablation of the genetically modified T cells. Criteria to receive cetuximab include acute toxicities that are life threatening.

Eligibility Criteria:
Inclusion Criteria:

* 1. 2 years to 70 years, expected survival \> 3 months;
* 2. CD19 positive B-cell acute lymphoblastic leukemia;
* 3. ECOG \< 2；
* 4. The tumor load in the bone marrow is less than 60%;
* 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L）;
* 6. No leukemia cells in the central nervous system;
* 7. No serious allergic constitution;
* 8. No other serous diseases that conflicts with the clinical program;
* 9. No other cancer history;
* 10. No serious mental disorder;
* 11. female participants of reproductive potential must have a negative serum pregnancy test;
* 12. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

* 1. Pregnant or lactating women;
* 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
* 3. Active hepatitis B or hepatitis C infection;
* 4. Recent or current use of glucocorticoid or other immunosuppressor;
* 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* 6. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients

The purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)


Eligibility Criteria:
Patients diagnosed with Rheumatoid Arthritis (RA) who newly initiated a biologic DMARD (bDMARD) during a study timeframe of 1/01/06 to 3/31/09.

Inclusion Criteria:

* 18 to 64 years of age at index date
* Diagnosis of RA during the study period (ICD-9CM 714.xx)
* Evidence of at least one biologic DMARD of interest during the study timeframe
* Continuous enrollment during the study timeframe
* Both medical and pharmacy benefits
* No evidence of a claim for a bDMARD in the 6-month pre-period

Exclusion Criteria:

* Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe
The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer

Treatment with immune checkpoint inhibitors such as programmed death receptor 1 (PD-1 inhibitors) for advanced and metastatic esophageal squamous cell carcinoma (ESCC) significantly improves patients' overall survival compared to chemotherapy alone. Despite this milestone breakthrough, immunochemotherapy also has known limitations. Indeed, only 45-72% of patients achieved objective responses. It is urgent to find out easily-determined and convenient biomarkers to identify patients who will benefit from such treatment modality. Due to the luminal structure of the esophagus, the exact diameter of esophageal tumor cannot be precisely measured per RECIST 1.1. Moreover, the definition of the metastatic lymph node in which the short-axis lengths should be longer than 1.5 cm hinders the risk of missing the smaller metastatic lymph node foci. Thus, it is difficult to implement morphology-based criteria for evaluating the neoadjuvant immunochemotherapy response. The current study aimed to investigate the role of iPERCIST in predicting tumor response and the short-term overall survival of patients with locally advanced ESCC after neoadjuvant immunochemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after neoadjuvant immunochemotherapy.
* treatment-naïve and had the adequate cardiopulmonary function

Exclusion Criteria:

* previous autoimmune disease
* unable to complete planned treatment courses and no complete follow-up PET-CT scan
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)

The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements in quality of life.

This is a non-randomized, single group (N=15), repeated measures study. The outcome measure for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis, gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long. Over the 24-week period, the subject will participate in 14 gait training sessions which will be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be 45-60 minutes in duration. Outcome measures (all or part) will be assessed at the following times: initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely monitored throughout the 24 week study and will be un-enrolled by self-request or the following medical reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences affecting gait training, 3. Inability to tolerate the AFO.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a primary diagnosis of multiple sclerosis
* Individuals who are able to maintain a walking velocity of 30 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
* Could have current or past history of single or bilateral AFO use, including neuroprostheses
* Evidence of weakness in plantarflexors

Exclusion Criteria:

* The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
* Individuals with BMI with \>/= 40kg/m2
* Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
* Individuals that plan to begin the use of Ampyra during the course of the study
* Individuals for whom the cost of an orthosis would represent a financial burden
* Individuals who are receiving concurrent physical therapy services elsewhere
* MSNQ of \>22
Detection of COVID-19 Decompensation

In this study we will be monitoring for patient events (emergency department admission, hospital admission, admission to an observation unit, or death) and evaluating the feasibility and utility of using pinpointIQ in the management of patients with COVID-19. Vital sign (physiology data) is collected to build a Covid Decompensation Index and contribute data to a Covid Digital Hub supported by the National Institutes of Health.

This is a prospective, non-randomized, open-label, two-phase design. The primary focus for the study is data collection for index development. This will be done in two phases: the first phase allows for determination of predictor variables that establish the COVID-19 Decompensation Index (CDI) and the second phase establishes performance of the CDI. A participant is considered to have completed the study if he or she completes all phases of the study including the last day of monitoring (day 28).

Eligibility Criteria:
Inclusion Criteria:

Obtained signed and dated informed consent form Patient in the University of Illinois Health System Patient agrees to comply with all study procedures and availability for the duration of the study Male or female, aged \> 18 years of age Patient diagnosed with COVID-19 (positive SARS CoV2 test) Patient agrees to refrain from swimming or taking baths (any activity that submerges the biosensor in water for any period). Showering is okay.

Exclusion Criteria:

Known allergic reactions to components of the hydrocolloid gel adhesives Subject has cognitive or physical limitations that, in the opinion of the investigator, limits the subject's ability to fully follow study procedures Cognitive ability, in the opinion of the investigator, that limits the patient's ability to use the biosensor and smartphone consistent with study requirements.

Does not speak or read English or Spanish
A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.

This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
* Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin