Kornimate/medical-research-clean huggingface dataset:
fluorescence imaging in head and neck cancer

Conditions: Head and Neck Cancer; Cancer of the Head and Neck

Summary: fluorescent technology continues to advance in the detection of sentinel lymph nodes (slns). currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (icg fluorescence) simultaneously. this technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. secondarily, this may reduce operative costs by decreasing the amount of time required to perform the slnb procedure. regarding parathyroid identification, this technology has the potential to identify these very small glands during procedures they are at risk. these glands are not only at risk of inadvertent removal if not adequately identified, but may also be at risk if devascularized by manipulation during the surgical procedure. therefore, early and accurate identification may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. this is not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery where the anatomic region these glands are located are often resected to remove at risk lymph nodes from cancer spread. therefore, identifying these glands may help preserve parathyroid function in this patient population as well.


Eligibility criteria:
inclusion criteria: * adults aged 18 years or older will be considered eligible. * patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection. * candidates for sentinel lymph node biopsy or central neck surgery * newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy. * not pregnant or breast feeding. * able to understand and willing to sign an irb-approved written informed consent document. * able to understand written or spoken english. exclusion criteria: * history of allergy to iodide drugs or shellfish (iodine allergy) * pregnant or breast feeding * do not fit age criteria * prisoners * unable to provide written consent * contraindications for surgery \*presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * receiving any other investigational agents
zalutumumab in non-small cell lung cancer (nsclc) patients refractory to tyrosine kinase inhibitors

Conditions: Non-small Cell Lung Cancer

Summary: a single-arm phase ii trial investigating the efficacy and safety of zalutumumab in patients with non-small cell lung cancer who have progressive disease after treatment with tyrosine kinase inhibitors.


Eligibility criteria:
inclusion criteria: * patients must have documented disease progression after tki treatment (verified by ct scan and/or mri according to recist). exclusion criteria: * estimated life expectancy of less than 3 months. * received the following treatments within 2 weeks prior to visit 2: * cytotoxic or cytostatic anti-cancer chemotherapy * total resection or irradiation of the target lesion * any investigational agent

Keywords: nsclc zalutumumab efficacy safety
efficacy and safety of sorafenib in previously treated advanced hepatocellular carcinoma: sopt study

Conditions: Advanced Hepatocellular Carcinoma

Summary: to investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced hcc.

sorafenib (soranib tablet) will be administered orally at a dose of 600mg daily without food for patients who have been treated with prior systemic therapy for advanced hcc. the study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent, or study closure. response to sorafenib should be assessed at least every 8 weeks (± 7 days) by either ct scan or mri. after the treatment phase, subjects will undergo follow up for survival and the use of other anticancer treatments and/or therapies every 12 weeks (± 7 days) from the last dose and the survival follow up will be performed for at least 12 months after the enrollment of the last subject.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. age of 20 or more 3. histological or clinical diagnosis of hcc based on the guidelines of the korean liver cancer association-national cancer center 4. locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies 5. intolerant to or progressed on at least 1 prior systemic treatment for hcc 6. having at least one measurable target lesion (per recist v1.1) - patients who received prior local therapy (e.g., radiofrequency ablation, transarterial chemoembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with recist 1.1. 7. child-pugh class a or b7 8. eastern cooperative oncology group (ecog) performance status (ps) of 0-1 9. life expectancy of at least 16 weeks 10. adequate hematologic and hepatic function (should be obtained within 14 days prior to initiation of study treatment): 11. women of childbearing potential and men must agree to use highly efficient contraception since signing of the ic form until at least 5 months (women) and 7 months (men) after the last study drug administration. exclusion criteria: 1. fibrolamellar carcinoma or sarcomatoid carcinoma 2. having active brain metastasis or leptomeningeal metastasis 3. moderate to severe or intractable ascites 4. presence of hepatic encephalopathy 5. presence of active bacterial infection 6. uncontrolled severe medical comorbidity 7. other malignant disease (a history of treated malignancy -other than hcc- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years) 8. other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study

Keywords: hcc sorafenib
weekly bortezomib (velcade) in the treatment of patients with refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this phase i study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib

upon determination of eligibility, patients will be receive: * bortezomib

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * multiple myeloma * received no more than 2 previous treatment regimens for multiple myeloma * ecog performance status 0, 1, or 2 * serum creatinine \< 2.0mg/dl * calculated or measured creatinine clearance \> 30ml/minute * measurable or evaluable disease * provide written informed consent prior to receiving protocol therapy. exclusion criteria: you cannot participate in this study if any of the following apply to you: * moderate or severe peripheral neuropathy * other serious medical conditions * other active malignancies * history of treatment for other invasive cancers * women who are pregnant or lactating please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
ahmed glaucoma valve surgery with mitomycin-c

Conditions: Glaucoma; Primary Open Angle Glaucoma; Secondary Glaucoma; Neovascular Glaucoma

Summary: this study will determine the effectiveness of mitomycin-c use in the glaucoma surgery ahmed valve implantation. approximately 100 patients will be enrolled, with half receiving the mitomycin-c treatment and the other half receiving placebo treatment.

glaucoma is a leading cause irreversible blindness worldwide. glaucoma valve surgeries such as ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. mitomycin-c is a commonly used antifibrotic agent used in glaucoma surgeries. this study will evaluate the effectiveness of mitomycin-c injections intraoperatively and postoperatively.

Eligibility criteria:
inclusion criteria: * inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (iop) greater than or equal to 18 mm hg. * ahmed glaucoma valve (agv) implantation as the planned surgical procedure. * for patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled. exclusion criteria: * unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits. * pregnant or nursing women. * previous cyclodestruction or glaucoma drainage device (gdd) surgery. * patients with nanophthalmos. * patients with sturge-weber syndrome or other conditions associated with elevated episcleral venous pressure. * no light perception vision. * va \<20/200 in non-study eye. * need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery. * previous scleral buckling procedure or silicone oil present. * uveitic glaucoma.
peer navigation to improve engagement in care for hiv-positive men who have sex with men in ehlanzeni, south africa

Conditions: Hiv

Summary: this protocol describes the cohort assessment phase of an r34 pilot intervention trial of a peer navigation (pn) intervention tailored to the needs of hiv-positive msm in rural mpumalanga province south africa. the pn intervention to be adapted, i-care, has been implemented among hiv-positive men and women in the general population in north west province, south africa, by members of this research team.


Eligibility criteria:
inclusion criteria: * biological male; * age \>=18 years; * self-identify as a gay or bisexual man, or a transgender woman; * have male sexual partners within the prior six months * resident in the ehlanzeni district municipality for at least six months of the year; * be physically present in ehlanzeni for at least two weeks per month * self-disclosed receiving an hiv-positive diagnosis in the last 5 years; * consent to all serological testing for hiv antibodies, art analytes, and hiv rna * consent for study staff to review participants' clinical records; * consent to the randomization process. exclusion criteria: * inability to provide written informed consent for participation, including being under the influence of alcohol or drugs. * inability to provide laboratory or documentary evidence of hiv diagnosis.

Keywords: peer navigation
continuous positive airway pressure (cpap) promotion and prognosis - the army sleep apnea program (asap)

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to assess the efficacy of eszopiclone in improving short and intermediate-term compliance with continuous positive airway pressure (cpap) in patients newly diagnosed with obstructive sleep apnea (osa).

cpap is the treatment of choice for patients with osa. however, patients are frequently intolerant of this therapy initially. after continued use, tolerance is achieved. however, this initial discomfort or intolerance frequently leads to a patient-initiated discontinuation of therapy. it has been shown that cpap use at 1 month predicts use at 6 months and 1 year. patients who initially struggle with or are intolerant of cpap frequently abandon therapy and are unlikely to use it long term. to prevent this, sleep physicians often prescribe short courses of sedatives to help improve initial tolerance and promote better compliance with therapy. however, the effectiveness of this practice has not been validated in a clinical trial. compliance, in reference to this study is the willingness of the patients to follow the prescribed course of treatment.

Eligibility criteria:
inclusion criteria: * adult patients * newly diagnosed with osa who are prescribed cpap therapy exclusion criteria: * patients \< 18 years old * patients over 65 years * pregnant women * patients with chronic liver disease * patients who abuse alcohol * patients taking narcotics or using sedative-hypnotic agents such as ambien, klonopin or benadryl

Keywords: obstructive sleep apnea continuous positive airway pressure cpap compliance non-benzodiazepine hypnotics
multimodality- adapted dose modification in head and neck cancer radiation therapy ￼

Conditions: Head and Neck Cancer

Summary: this is a prospective trial evaluating dose escalation using an sbrt boost to poor- responding tumors by interim functional imaging (pet/ct and fmri) to improve the local control of hncscc.


Eligibility criteria:
inclusion criteria: * more than or equal to 18 years old. ecog performance scale (0-2). histological confirmation of scc of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx. clinical stage ii-ivb (ajcc, 8th edition). multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (ccrt). informed consent obtained, signed and dated before specific protocol procedures. exclusion criteria: * stage i/ii glottic cancer. patients who underwent surgery for the primary tumor location. distant metastases. inability to undergo pet-ct or mri. prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.
everolimus on ckd progression in adpkd patients

Conditions: Polycystic Kidney Diseases

Summary: the study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of ckd in adpkd patients.

considering the inhibitor activity of everolimus on mtor, our hypothesis is to evaluate its possible utility on the progression of ckd in adpkd patients by reducing the rate of increase of renal cysts.

Eligibility criteria:
inclusion criteria: 1. subjects over 18 years of both genders 2. clinical diagnosis of autosomal dominant polycystic kidney disease (adpkd) 3. gfr, according to mdrd formula, between 30 and 90 ml/min/1.73 mq 4. previous follow up of two years, with a creatinine evaluation at least once a year 5. gfr reduction of at least 2.5 ml/min/year (according to mdrd formula) exclusion criteria: 1. pregnancy, lactating, males and females without adequate contraception 2. leucopenia (\< 3,000 leucocytes/mm3) or thrombocytopenia (\< 100,000 platelets/mm3) 3. dyslipidemia (cholesterol or triglycerides \> 260 mg/dl with treatment) 4. urinary tract infection 5. patients who cannot undergoing nmr

Keywords: adpkd ckd renal disease progression everolimus
exploratory clinical study to evaluation of the safety and immunogenicity of bivalent vaccine v-01d-351

Conditions: COVID-19 Pandemic

Summary: it is a single center, randomized, open-labeled, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine v-01d-351 as a booster.


Eligibility criteria:
inclusion criteria: * adults aged 18 years and older at time of consent, male or female; * normal body temperature; * meet either of the following conditions: 1. received completed primary immunization of 2 doses of coronavac 6-15 months ago; 2. received completed 3 doses of coronavac 5-9 months ago; * female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment; * be able and willing to complete the study during the entire study and follow-up period; * participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol. exclusion criteria: * serious chronic diseases or uncontrolled diseases; * uncontrolled neurological disorders, epilepsy; * received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks; * patients with congenital or acquired immunodeficiency; * history of severe allergy or be allergic to any components of the test vaccines; * history of hereditary hemorrhagic tendency or coagulation dysfunction; * patients with malignant tumors and other patients have a life expectancy less than 1 year; * refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol; * history of previous covid-19 infection; * pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study; * participants who have participated in other clinical trials within 3 months or are participating in other clinical trials; * those considered by the investigator as inappropriate to participate in the study.
the effectiveness of a systemic mindfulness-based intervention program in a cystic fibrosis clinic

Conditions: Cystic Fibrosis

Summary: hypothesis 1: mindfulness is a feasible tool for use within a cystic fibrosis (cf) clinic hypothesis 2: participants in the mindfulness intervention will show an increased level of quality of life post intervention with the mindfulness course hypothesis 3. levels of mindfulness: participants in the mindfulness intervention will report increased mindfulness levels post-program completion as compared to pre-program completion hypothesis 4. levels of stress: participants in the mindfulness intervention will report lower levels of stress post-program completion as compared with pre-program commencement. hypothesis 5. levels of residual depressive symptoms post-mindfulness intervention program: residual symptoms of depression are a risk factor for relapse of depression. post -program participants of mindfulness will purport fewer residual depressive symptoms compared with pre-program. hypothesis 6. cf is associated with severe neutrophilic inflammation of the airways. as mindfulness intervention has been shown to modulate immune system it may improve physical aspects of cf including markers of inflammation and markers of lung disease (lung function tests and rate of pulmonary exacerbations) and nutritional state.

the study will be an active interventional program for approximately six months in duration. all participants will initially undergo an initial assessment interview. personnel trained and certified in mindfulness-based stress reduction (mbsr) will run mindfulness-based groups in 6-8 weekly 1 1/2 hour sessions (the staff group will comprise of 6 sessions and the parents' and patients' groups will be 8 sessions long). participants will learn and engage in various formal and informal meditation practices during experiential learning of skills, including concentration, mindfulness of thoughts, emotions, feelings and bodily sensations, decentering, and letting go. each group will include both practical exercises and a psycho-educational component. daily homework, an essential aspect of the course, will include meditation practices together with exercises designed to integrate application of awareness skills into daily life. on day 0, participants will complete a battery of questionnaires as well as tests of the physical status of cf disease. this battery will be repeated at 8 weeks, and again at 6 months.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cf clinically and by sweat test and/ or genetic testing and/ or nasal potential difference 2. treatment with one or more chronic medications or regimes; 3. willingness by patient or parent to sign consent form; 4. parents capable of complying with the program requirements including completing self-report questionnaires pre and post intervention completion. exclusion criteria: 1. having significant developmental delay or a mental health diagnosis of psychosis; 2. transplant patients; 3. participation in other interventional studies within 2 weeks of recruitment or during the study period -

Keywords: mindfulness stress reduction
single-dose, 2-way crossover open study to evaluate the food effect on the pk of hcp1201 in healthy volunteers

Conditions: Diabetes Mellitus

Summary: to investigate the effect of food in healthy male volunteers who receive hcp1201 tablet in fed versus fasted condition

an open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of hcp1201 tablet in healthy volunteers

Eligibility criteria:
inclusion criteria: 1. healthy male volunteer, age 20\~55 years 2. the result of body mass index(bmi) is not less than 19 kg/m2 , no more than 27 kg/m2 3. subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial 4. subject who has the ability and willingness to participate the whole period of trial exclusion criteria: 1. presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. 2. glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value. 3. liver enzyme (ast, alt) level exceeds the maximum normal range more than one and a half times. 4. systolic blood pressure: lower than 90mmhg or higher than 150mmhg, diastolic blood pressure: lower than 60mmhg or higher than 100mmhg 5. history of relevant drug allergies or clinically significant hypersensitivity reaction. 6. history of drug abuse or positive drug screening. 7. participation in other drug studies within 60days prior to the drug administration. 8. whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days. 9. subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement) 10. subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin. 11. intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial. 12. subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial. 13. positive screening on hepatitis b surface antigen(hbsag), anti-hepatitis c virus(hcv) or anti-human immunodeficiency virus(hiv). 14. genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication. 15. clinically inappropriate laboratory test result. 16. clinically inappropriate electrocardiogram result. 17. subjects who judged ineligible by the investigator.