Kornimate/medical-research-clean huggingface dataset:
shared decision making to address racial disparities in oral anticoagulation in nvaf

Conditions: Atrial Fibrillation

Summary: the study is a pilot analysis using a decision on the risk and benefits of oral anticoagulation for stroke reduction for patients with non-valvular atrial fibrillation. this study is a feasibility and acceptability analysis but will also measure preliminary effectiveness measures. the investigator hypothesizes that a patient decision support tool will increase decision quality and secondarily increase the use of oral anticoagulation in black patients with non-valvular atrial fibrillation.


Eligibility criteria:
inclusion criteria: * black and white adults greater than or equal to 18 years of age * clinical diagnosis of nvaf * cha2ds2-vasc score greater than or equal to 2 * new patient visit for initiation of oral anticoagulation at primary care and cardiology clinics exclusion criteria: * unable to speak english * unable to provide informed consent

Keywords: oral anticoagulation health disparities
a novel patient engagement platform among patients with gastrointestinal malignancies

Conditions: Colon Cancer; Gastric Cancer; Pancreas Cancer; Rectal Cancer; Cholangiocarcinoma; Small Bowel Cancer; Esophageal Cancer

Summary: a randomized control trial to evaluate the feasibility of implementing a patient educational platform (pep) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.

patients will be randomized in a 2:1 ratio. patients in the experimental arm will receive automatically generated personalized educational videos (pev) and questionnaires regarding side effects and quality of life (qol) to either their cell phone or email. the videos will be personalized to each patient based on their demographics, specific medical instructions and treatment plan. data collected regarding side effects and qol in the experimental arm will be used in order to facilitate real time intervention through real time provider alert system. a link to the first pev will be sent before the first chemotherapy cycle, addressing the diagnosis and type of malignancy, chemotherapy protocol, common side effects and their management. side effects questionnaire will be sent every week while qol questionnaire will be sent every 6 weeks. patients will be followed from recruitment through three weeks after completion of the planned treatment protocol. if treatment is discontinued prior to completion of the protocol, follow-up will end three weeks after the last administered treatment.

Eligibility criteria:
inclusion criteria: 1. individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the institute of oncology at the sheba medical center 2. individuals planned to receive one of the following cytotoxic chemotherapy protocols: 1. folfox - a combination of 5-fluoruracil, leucovorin and oxaliplatin. 2. folfoiri - a combination of 5-fluoruracil, leucovorin and irinotecan. 3. folfirinox - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan. 4. de gramont - 5-fluoruracil and leucovorin. 3. ability to read and comprehend hebrew language text. 4. ability to see computer or cell phone screen (i.e., no visual impairment). exclusion criteria: 1. eastern conference oncology group (ecog) performance status greater than 2. 2. cognitive deficits that would preclude understanding of consent form and/or questionnaires. 3. inability to read and comprehend hebrew language text. 4. current participation in a therapeutic clinical trial.

Keywords: patient reported outcome quality of life personalized videos
efficacy and toxicity of docetaxel as a radiosenstizer in head and neck cancer

Conditions: Head and Neck Cancer

Summary: head and neck cancer (hnc) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. the overall incidence of hnc continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries. approximately 90% of hncs are squamous cell carcinoma . the major risk factors of head and neck squamous cell carcinoma (hnscc) are tobacco and heavy alcohol use and human papillomavirus infection . there has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related hnscc . while increase in global incidence of human papillomavirus (hpv)-associated or positive (+) hnscc head and neck squamous cell carcinoma (hnscc) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for hnscc remains poor, with a five-year survival rate of around 50%. chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin although cisplatin-based chemoradiotherapy (crt) is the standard of care for locally advanced head and neck squamous cell carcinoma (lahnscc), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group. the addition of docetaxel to radiation improved dfs and os in cisplatin-ineligible patients with lahnscc.

history: age, gender, comorbidities and risk factors. baseline evaluation of the patients: ct or mri head and neck endoscopy and biopsy will be taken. laboratory: cbc, renal functions and liver functions nutritional assessment audiogram as baseline assessment dental assessment our patients will receive docetaxel (15 mg per meter squared) once weekly concurrently with radiotherapy. follow up of the patient during the course of treatment including evaluation of the patients weekly to assess the adverse events in the form of skin toxicity, mucositis, neutropenia and renal function affection. follow up after finishing the course of treatment. after 6 to 8 weeks the patient will be evaluated with ct or mri head and neck and endoscopy then every three month we will evaluate the patient as regarding the quality of life and late toxicity up to 2 years

Eligibility criteria:
inclusion criteria: * patients above 18 years * pathologically proven of squamous cell carcinoma * patients with locally advanced disease (t3, t4)(n positive) * patients eligible for radiotherapy exclusion criteria: * patients with metastatic disease * patients with second primary cancer * patients ineligible for radiotherapy
study of pirtobrutinib (loxo-305) in participants with impaired kidney function and healthy participants

Conditions: Healthy; Renal Insufficiency

Summary: the main purpose of this study is to measure how much of pirtobrutinib (loxo-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired kidney function and healthy participants. the side effects and tolerability of pirtobrutinib will also be evaluated. participation could last around 46 days.


Eligibility criteria:
inclusion criteria: * participants with impaired renal function \[estimated glomerular filtration rate (egfr): \< 90 milliliters per minute (ml/min) per 1.73 square meters (m2)\] and healthy participants with normal renal function \[(egfr: ≥ 90 ml/min/1.73 m2)\]. * males and females of non-childbearing potential. * within body mass index (bmi) range 18.5 to 40.0 kilograms per square meter (kg/m²). * participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ecg), or clinical laboratory tests, as determined by the investigator (or designee). * able to comply with all study procedures, including the 8-night stay at the clinical research unit and follow-up phone call. exclusion criteria: * history or presence of any of the following, deemed clinically significant by the investigator (or designee), and/or sponsor: 1. liver disease 2. pancreatitis 3. peptic ulcer disease 4. intestinal malabsorption 5. gastric reduction surgery 6. history or presence of clinically significant cardiovascular disease. * participants with out-of-range, at-rest vital signs. * abnormal laboratory values determined to be clinically significant by the investigator (or designee). * clinically significant abnormality, as determined by the investigator (or designee), from physical examination. * participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (day 1). * use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (day 1) and through end of trial. * history or presence, upon clinical evaluation, of any illness that, in the opinion of the investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk. * donation of blood from 56 days prior to screening, plasma or platelets from 4 weeks prior to screening. * receipt of blood products within 2 months prior to check-in (day -1). * significant history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
molecularly tailored therapy for pancreas cancer

Conditions: Pancreatic Cancer

Summary: patient therapy is tailored according to the molecular profile of the patient's tumor.

this study is for patients with metastatic pancreatic cancer (cancer that has spread to other parts of the body). the purpose of this study is to determine whether molecularly tailored therapy can improve the effectiveness of standard chemotherapy combinations for patients with metastatic pancreatic cancer. a series of special tests will be performed on a sample of tumor, and based on the results subjects will be assigned to one of seven chemotherapy treatments, with each being the combination of two standard chemotherapies. each of these combinations has been safely used in patients with pancreatic or other types of cancer. the purpose of this study is to to determine the ability to personalize therapy in this manner, and to determine how many patients a larger study would need. a second purpose is not to determine if one doublet is better than another. rather, this second purpose is to show that for all patients enrolled in this protocol who have been assigned a doublet based on their tumor's molecular analysis (molecular tailoring), treatment response will be better than would be expected compared to patients who have been treated in the past with no molecular tailoring.

Eligibility criteria:
inclusion criteria: * histologically proven pancreatic adenocarcinoma with measurable disease * biopsy accessible tumor deposits * ecog performance status 0-2 * age \>/= 18 years * subjects with no brain metastases or history of previously treated brain metastases * adequate hepatic, renal, and bone marrow function * partial thromboplastin time must be \</= 1.5 x upper normal limit of institution's normal range and inr \< 1.5 * life expectancy \> 12 weeks * women of childbearing potential must have a negative seum pregnancy test within 14 days prior to initiation of treatment * subject is capable of understanding and complying with parameters as outlines in the protocol and able to sign and date the consents exclusion criteria: * cns metastases which do not meet criteria outlines in inclusion criteria * active severe infection or known chronic infection with hiv or hepatitis b virus * cardiovascular disease * life threatening visceral disease or other severe concurrent disease * women who are pregnant, breastfeeding, or women of childbearing potential not using dual forms of effective contraception * anticipated patient survival under 3 months * patients receiving any other investigational agents * history of allergic reactions attributed to compounds of similar chemical or biological composition to gemcitabine, oxaliplatin, 5-fu, docetaxel or irinotecan * uncontrolled intercurrent illness

Keywords: pancreas cancer metastatic chemotherapy
open label extension of efgartigimod in adults with post-covid-19 pots

Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome

Summary: the ole study aims to investigate the safety, efficacy, pharmacodynamics (pd), pharmacokinetics (pk), and immunogenicity of efgartigimod in participants with post-covid-19 postural orthostatic.

study argx-113-2105 is a long-term, single-arm, open-label, multicenter extension of the argx-113-2104 study, designed to evaluate the long-term safety of efgartigimod iv in adult patients with pc-pots. participants will be enrolled from both active and placebo arms of the argx-113-2104 study and will receive efgartigimod iv 10 mg/kg in the extension study without knowledge of their prior treatment arm. to be eligible to enroll in this study, participants must have completed the 24-week treatment period of the argx-113-2104 study and must not have permanently discontinued the imp in that study.

Eligibility criteria:
inclusion criteria: 1. the participant has completed the argx-113-2104 study without permanent discontinuation of imp and agrees to directly roll over into the extension study without discontinuation of imp. 2. the participant signs the informed consent form, and can comply with ole study (argx-113-2105) protocol requirements. 3. the participant agrees to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies. contraceptive requirements are provided. 4. female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving imp. exclusion criteria: 1. the participant has a clinically significant condition, based on the judgement of the study investigator, eg, laboratory abnormalities, 12-lead ecg readings, concomitant medical disease(s), etc., which may place them at undue risk or confound interpretation of study data. 2. the participant intends to become pregnant or start breastfeeding during the study.

Keywords: tachycardia post-covid postural orthostatic tachycardia syndrome efgartigimod
sumor as adjuvant therapy in treatment-resistant major depression

Conditions: Major Depressive Disorder

Summary: sumor is a food supplement that combines the main coenzymes of the s-adenosyl methionine (same) cycle, namely vitamins b6, b12 and folate, with same and betaine. sumor also contains vitamin c, a molecule that has shown promise in the treatment of depression in experimental models, and selenium, an antioxidant agent whose blood deficiency has been associated with depressive symptoms in some preliminary studies. there are no studies in the literature on the efficacy of this combination in the adjuvant therapy of depression. the purpose of this study is to compare the effects of sumor in co-therapy with an ssri antidepressant versus co-therapy with placebo in patients with treatment-resistant major depressive disorder.


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder according to dsm-5 criteria * treatment-resistant status, assessed by clinical interview, after four weeks after ssri therapy prescription as per nice guidelines (national institute for health and care excellence, 2009) * age between 18 and 65 years * signature of informed consent exclusion criteria: * presence of intellectual disability or illiteracy * diagnosis of a disorder belonging to the spectrum of schizophrenia or other psychotic disorders according to dsm-5 * diagnosis of a disorder belonging to the bipolar spectrum according to dsm-5 * concomitant intake of therapy with other antidepressants, antipsychotics or mood stabilizers at the time of evaluation or in the previous 4 weeks * state of pregnancy
post-treatment surveillance in breast cancer: bringing cer to the alliance

Conditions: Breast Neoplasms

Summary: nearly three million living women have survived breast cancer. physicians rely on clinical practice guidelines to make decisions on follow-up care. among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. it is unclear whether these guidelines represent the best approach for any given patient as they do not account for differences in disease or patient preferences and may not consider recent advances in imaging and treatment options. we seek to develop a new approach to surveillance following breast cancer treatment which will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors.

our project involves three primary goals: 1. use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics. 2. use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer. 3. engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials. methods our methods have been developed based on input from patients and other stakeholders who identified the need for a large-scale observational study. the goal is to produce timely results, and guide the development of an improved approach to surveillance that recognizes individual patient risk factors and allows for design of future prospective studies. this study analyzes recurrence data and treatment side effects on over 22,000 patients involved in past clinical trials on breast cancer care. the project also involves the analysis of existing data (n=15,000 patients) from a national cancer registry (national cancer database) to evaluate whether new imaging technology, beyond mammography, are able to detect recurrence earlier and improve survival. finally, we will engage cancer survivors, health care providers, and researchers to develop new guidance for the care and monitoring of breast cancer survivors, and to guide and prioritize future prospective trials.

Eligibility criteria:
inclusion criteria: * women (all aims) * diagnosis of breast cancer (aims 1 \& 2) * american joint committee on cancer (ajcc) stages i-iii (aim 1) ajcc stages ii-iii (aim 2) * patient, health care provider, and researcher stakeholders (aim 3) exclusion criteria: * none

Keywords: breast cancer breast neoplasms health services research surveillance diagnostic imaging magnetic resonance imaging mammography toxicity adverse effects side effects recurrence
pilot study of skin quality improvement after adipose-drived stem cell transfer in irradiated breasts

Conditions: Breast Neoplasms; Skin Abnormalities

Summary: the aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (svf) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.

10 participants who taken conservative mastectomy will be enrolled 1. process * adipose tissue is obtained from the subject's thigh or abdomen * adipose-drived stromal vascular fraction(svf)cell isolation using automatic centrifuge system * adipose-drived stromal vascular fraction(svf)cell graft into the irradiated breast. 2. duration of study * entire duration: approximate 30weeks * follow-up period: 12 weeks * enrollment period: 12 weeks 3. study design - randomized, prospective, pilot study

Eligibility criteria:
inclusion criteria: * female aged between 40 and 60 * subjects who diagnosed breast ductal carcinoma in situ of surgical staging t1an0, negative resection margin of below 2mm in histopathologic examination * subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy * subjects who understand the study contents and sign the informed consent exclusion criteria: * subjects who have radiodermatitis * subjects who planned breast reconstruction with autogenous tissue (ex.transverse rectus abdominis muscle flap) * subjects who have a history of smoking within 3months recently * subjects who participated in other clinical trial within 30 days recently * pregnant or lactating subjects * subjects who have a active infectious disease * subjects who are not eligible for this study at the discretion of the investigator

Keywords: breast cancer loss of elasticity in irradiated breast skin other reconstructive surgery
research study comparing different tablets with the study medicine semaglutide in healthy men

Conditions: Diabetes Mellitus, Type 2

Summary: this study looks at different tablets with a new study medicine called semaglutide. it is to treat diabetes. the aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. the tablet version of study medicine is a new medicine that cannot be prescribed. semaglutide can be prescribed as injections for the treatment of diabetes in some countries. participants will get 1 tablet per day for 10 days. the tablets should be taken in the morning by mouth together with half a glass of water. after dosing participants have to wait 30 minutes before participants may eat or drink. the study will last up to 70 days. participants will have 17 clinic visits with the study doctor. some of the visits are overnight stays. participants will have blood tests at every visit.


Eligibility criteria:
inclusion criteria: - male, aged 18-64 years (both inclusive) at the time of signing informed consent. - body mass index (bmi) between 20.0 and 29.9 kg/m\^2 (both inclusive). - considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: - glycated haemoglobin (hba1c) greater than or equal to 6.5% (48 mmol/mol) at screening. - use of tobacco and nicotine products, defined as any of the below: a) smoking more than 5 cigarettes or the equivalent per day. b) not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s). - history\* of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. - personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma\*. - history\* or presence of pancreatitis (acute or chronic). \*as declared by subject.
subsus (subglottic secretion at ultrasound score)

Conditions: Ventilator Associated Pneumonia

Summary: to compare the performance of ultrasound in detecting subglottic secretion above the ett tube cuff in comparison to computed tomography (ct) scan.

airway ultrasound will be performed at the bedside prior to ct scan in all intubated patients who fulfiled the criteria. the image of subglottic secretion was then compared to the plain ct cervical. the findings of the ct was examined by a radiologist.

Eligibility criteria:
inclusion criteria: * age more than 18 years old * ett in situ * indicated for ct cervical scan exclusion criteria: * neck subcutaneous emphysema * neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.

Keywords: subglottic secretion airway ultrasound ventilator associated pneumonia