Kornimate/medical-research-clean huggingface dataset:
feasibility of patient-centered home care (pchc) to reduce disparities in high-risk black men (bm) with advanced prostate cancer (cap)

Conditions: Advanced Prostate Adenocarcinoma; Metastatic Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC V8; Stage IVB Prostate Cancer AJCC V8

Summary: this study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in black patients with advanced prostate cancer.

primary objectives: i. to evaluate a highly innovative project evaluating the feasibility of patient-centered home care pchc as a new model of cancer care to reduce disparities and improve health related qol (hrqol) and patient reported-outcomes (pros) in black patients with advanced prostate cancer (cap). (phase i) ii. establish patient-centeredness by exploring patients' choice relative to the place of cap treatment for certain aspects of therapy as well as end-of-life care. iii. establish the acceptance and impact of pchc on pros and hrqol in bm with advanced cap. outline: this is an observational study. participants are assigned to 1 of 2 groups. group 1: participants take part in a focus group or complete questionnaires and may take part in an interview on study. group 2: participants complete questionnaires throughout the study.

Eligibility criteria:
inclusion criteria: * group 1 focus groups: * individuals identifying as black and male who are familiar with the landscape of medical care and cancer group 1 surveys: * are 18 years of age or older * have histologic evidence of prostate adenocarcinoma * are requiring prostate cancer therapy * have an understanding of the protocol and its requirements * are willing to fill in a questionnaire and participate in a focused interview * are able and willing to sign an informed consent group 1 interviews: * enrollment in the survey phase of the protocol group 2: * are 18 years of age or older * have histologic evidence of prostate adenocarcinoma * are requiring active standard hormone-based therapies (degarelix or leuprolide), antibone resorptive agents (zoledronic acid or denosumab), oral anticancer treatments (abiraterone or second-generation androgen receptor blockers) or intravenous chemotherapy (docetaxel) * are receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of advanced care at home program (ach) * have an understanding of the protocol and its requirements * are able and willing to sign an informed consent exclusion criteria: * group 1 focus groups: * individuals who do not identify as black or male or who have had no extensive interaction with the healthcare system group 1 surveys: * do not identify as black men * have not been diagnosed with advanced/metastatic cap * are not requiring active standard anti-cancer therapy group 1 interviews: * not enrolled in the survey phase of the protocol group 2: * do not identify as black men * have not been diagnosed with advanced/metastatic cap * are not requiring active standard anti-cancer therapy
gapp 1 survey: global attitudes of patients and physicians in insulin therapy for diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia, europe and in the united states of america. the aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.


Eligibility criteria:
inclusion criteria: * patients with diabetes: * age 18 years or older * treated with insulin * type 1 or type 2 diabetes * physicians: * in practice for more than 1 year since completing residency * see a minimum number of patients with diabetes per week (primary care physicians 5, specialists 10) * initiate insulin treatment for patients with diabetes
revaccination with pneumovax(tm) 23 in older adults (v110-007)

Conditions: Pneumococcal Infection

Summary: the purpose of this study is to determine that revaccination of pneumococcal vaccine is well tolerated and produces an immune response in older adults.

this study is an extension study (v110-007-10) which met requirements for posting on clinicaltrials.gov. the original study (v110-007-00) was completed in 2004 and did not meet the criteria for registration.

Eligibility criteria:
inclusion criteria: * postmenopausal or negative urine pregnancy test if female * no fever on the day of vaccination exclusion criteria: * history of allergy to vaccine components * history of pneumococcal disease * received any live virus vaccination within 4 weeks prior to study start * received any inactivated vaccination within 7 days prior to study start * received any blood products within 5 months prior to study start * participated in an investigational drug or vaccine study in the past 30 days * received immunosuppressive therapy * patient has an immune deficiency
the validity of novel non-invasive inflammatory markers for monitoring of patients with ulcerative colitis

Conditions: IBD, Non Invasive Markers,IL6,Lactoferrin,Ferritin

Summary: ulcerative colitis (uc) is a disease known for repeated relapses and remissions. so, meticulous follow-up is required to individualize treatment plans according to the status of each patient. the currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up. aim: to evaluate the viability of fecal lactoferrin, serum ferritin, and il6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.

introduction: ulcerative colitis (uc) is a disease known for repeated relapses and remissions. so, meticulous follow-up is required to individualize treatment plans according to the status of each patient. the currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up. aim: to evaluate the viability of fecal lactoferrin, serum ferritin, and il6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission. patients and methods: this is a prospective cohort study will include 160 patients. the study will be amulticenterthat will be held in different egyptian governorates. the patient must be, firstly, confirmed to be an ulcerative colitis patient by complete physical examination, laboratory evaluation by fecal calprotectin and crp. also, colonoscopy will be done for all included patients and they will be classified according to the modified mayo endoscopic score (mmes). biopsies will be taken to confirm the diagnosis with histopathological examination. fecal lactoferrin, s ferritin, and il6 (the investigated markers) will be conducted for patients with confirmed diagnosis with uc. . all investigations, including colonoscopy, will be done once again after 3 months to follow up the included patients. the results of all tests will be correlated to the clinical and endoscopic findings of included patients to detect a cut off values to be used during remission and activity.

Eligibility criteria:
inclusion criteria: - patients who are newly diagnosed to be ulcerative colitis. patients \>18 years old. exclusion criteria: * patients who are \>18 years old. pregnant patients . patients with colonic malignancies.
study of [68ga]fapi-46 pet in patients with pancreatic ductal carcinoma

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma; FAP

Summary: this is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68ga\]fapi-46 to detect fap expressing cells in patients with resectable or borderline resectable pdac. the \[68ga\]fapi-46 pet scans will be acquired after initial staging using institutional standard methods. if the participant is prescribed neoadjuvant therapy, a second \[68ga\]fapi-46 pet scan will be performed within 21 days prior to planned surgical resection. this will be followed by histopathology and ihc analyses and comparison to resected pdac tumor specimens.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed pancreatic ductal adenocarcinoma 2. treatment-naïve 3. staged as resectable or borderline-resectable 4. planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection 5. anatomic imaging (e.g., ct, mri) obtained within ≤ 28 days of consent 6. age ≥ 18 years 7. completed informed consent as determined per the irb of record exclusion criteria: 1. pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential 2. declining to use effective contraceptive methods during the study (for individuals of child-producing potential) 3. need for emergent surgery that would be delayed by participation 4. bacterial, viral, or fungal infections requiring systemic therapy 5. serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or sofie could compromise patient safety and/or protocol objectives. 6. known diagnosis of autoimmune disorders 7. patients receiving any other investigational agent within the past 28 days 8. breastfeeding. note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[68ga\]fapi-46 injection. 9. known hypersensitivity to any excipients used in \[68ga\]fapi-46: trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

Keywords: fibroblast activation protein inhibitor (fapi) pdac
corticosteroid injection verses high energy extracorporeal shock wave therapy for lateral epicondylitis

Conditions: Lateral Epicondylitis; Tennis Elbow

Summary: the purpose of this study is to prospectively compare the pain and functional outcomes of patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid injection or high energy extracorporeal shock wave therapy (eswt).

corticosteroid injections and high energy eswt are standard therapies for lateral epicondylitis at walter reed national military medical center. while corticosteroid injections have been shown to be moderately effective in the short term for the condition, a significant minority of patients remains symptomatic. low energy eswt has mixed results in the orthopaedic literature, but to date no study has specifically examined the effects of high energy eswt. the investigators plan to randomize a total of 80 patients with the diagnosis of lateral epicondylitis to either corticosteroid injection or high energy eswt, and follow them for a total of 12 months. primary outcomes will be disabilities of the arm, shoulder, and hand (dash) score, patient reported tennis elbow evaluation (prtee) score, mayo elbow score, veterans rand-36, and return-to-work status. patients will be surveyed at baseline, 6 weeks, 3 months, and 6 months. all assessments will be done by an independent physician examiner who is blinded to the treatment received.

Eligibility criteria:
inclusion criteria: * all patients presenting to the wrnmmc orthopaedic hand surgery clinic for complaints of lateral elbow pain will be evaluated for inclusion in the study. inclusions criteria will be: * clinical diagnosis of lateral epicondylitis based on primary complaint of lateral elbow pain and either (a) tenderness over the lateral epicondyle with direct palpation, or (b) exacerbation of pain at the lateral elbow with resisted dorsiflexion of the wrist * failure of previous trial of non-operative management of at least 4wks duration (to include rest/light duty, non steroidal anti-inflammatory drugs , physical/occupational therapy, home stretching regimen) exclusion criteria: * age \<18yo * pregnant or planning to become pregnant during study period (based on verbal questioning) * steroid treatment (oral or injectable) within the previous 3mo * diagnosis of ipsilateral compressive neuropathy * allergy to kenalog, lidocaine, or conductive ultrasound gel * diagnosis of inflammatory arthropathy or rheumatoid conditions * diagnosis of fibromyalgia, chronic fatigue syndrome, complex regional pain syndrome, or other chronic widespread pain syndromes
mapracorat ophthalmic suspension, 3% for the treatment of ocular inflammation and pain following cataract surgery

Conditions: Cataract; Inflammation; Surgery

Summary: the objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. participants from the united states and canada will be recruited for this study.


Eligibility criteria:
inclusion criteria: * subjects who are candidates for routine, uncomplicated cataract surgery. * subjects who, in the investigator's opinion, have potential postoperative pinhole snellen visual acuity (va) of at least 20/200 in the study eye. * subjects who have ≥ grade 2 (6 - 15 cells) ac cells in the study eye following cataract surgery (postoperative day 1). exclusion criteria: * subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or confound the result(s) of the study. * any intraocular inflammation in either eye (cells or flare score greater than grade 0 at slit lamp examination) or ocular pain greater than grade 1 in the study eye at the screening visit. * presence of active external ocular disease: infection or inflammation of the study eye. * subjects who have known hypersensitivity or contraindication to the study drug(s) or their components. * subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the disallowed therapy section of the protocol.
tislelizumab combined with apatinib and oxaliplatin plus s1 vs oxaliplatin plus s1 as neoadjuvant therapy for borrmann iv、large borrmann iii type and bulky n positive advanced gastric cancer

Conditions: Immunotherapy Gastrict Cancer

Summary: to evaluate the clinical efficacy and safety of tislelizumab combined with apatinib mesylate, oxaliplatin plus s1 vs oxaliplatin plus s1.


Eligibility criteria:
inclusion criteria: * age: 18-70 years of age. * histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume \>5cm borrmann iii, borrmann iv and bulkyn according to ajcc version 8. * measurable lesions at least should be detected by ct/mri examination in accordance with the recist1.1. * ecog（eastern cooperative oncology group）ps（performance status）:0-1 scores. * no previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed. * preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells. * the expected survival time is more than 6 months. * for women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).if a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy. exclusion criteria: * diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ). * significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. if fecal occult blood was positive at baseline, reexamination could be performed，if it was still positive after reexamination, gastroscopy was required. * prior treatment: anti-pd-1, anti-pd-l1, or anti-pd-l2 drugs or drugs that target another stimulating or co-inhibiting t-cell receptor (e.g., ctla-4, ox-40, cd137). * a history of immunodeficiency, including hiv testing positive. * is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing. * patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally. * her2 positive is known. * patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
impact of a family history of hypertension and physical activity on left ventricular mass

Conditions: Genetic Predisposition; Genetic Hypertension

Summary: this is a retrospective analysis of data collected within two previous studies. the data has been combined and used to investigate the impact of having a family history of hypertension on left ventricular muscle mass with and without controlling for moderate and vigorous intensity physical activity frequency per week. the hypothesis was that in a sample of mostly active participants, no differences in left ventricular mass between family history of hypertension groups would be observed, but the positive family history of hypertension group would have elevated left ventricular mass compared to the negative family history of hypertension group following statistical control of activity frequency.

a positive family history of hypertension (fhh) (+fhh) is associated with elevated left ventricular mass (lvm). regular physical activity (pa) may eliminate differences in lvm between +fhh and negative family history of hypertension (-fhh) adults. purpose: to determine if a +fhh is associated with a greater lvm compared to a -fhh group within a sample of young, mostly active healthy adults with and without statistically controlling for pa. methods: healthy young (18-32yrs) participants self-reported fhh status and habitual moderate and vigorous pa frequency. participants then underwent an echocardiogram.

Eligibility criteria:
inclusion criteria: * generally healthy exclusion criteria: * known hypertension, cardiovascular disease, current pregnancy, current infectious disease, diabetes mellitus, kidney disease, a history of cancer, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions
effect of supplementation with hmb and glutamine in wound healing on bloody areas

Conditions: Wound Healing; Diabetic

Summary: a randomized controlled clinical trial in two groups of supplementation with hmb and glutamine. each group consist in 25 patients with bloody areas, one group will receive and intervention with hmb and glutamine and the other will receive a placebo with calcium caseinate.

a fundamental part of the integral management of wound healing in patients with bloody areas is nutrition, since it involves biochemical events that depend on the substrates it provides. wound healing is a phase that demands higher needs of energy-protein than the requirement. problem statement: poor nutrition decreases, through specific phases, normal processes that allow the progression of wound healing. nutrient deficiencies can have negative effects on wound healing by prolonging the inflammatory phase, decreasing fibroblast proliferation, and modifying collagen synthesis. some amino acids are essential for the process, such as glutamine and hydroxymethylbutyrate. objective: to evaluate the effect of glutamine and hydroxymethylbutyrate supplementation over the cells involved in wound healing of bloody areas. hypothesis: glutamine and hydroxymethylbutyrate supplementation promotes a positive effect over the cells involved in wound healing of bloody areas. methodology: a randomized controlled clinical trial, in patients with diagnosis of bloody areas. they will be divided into two groups, the first will receive an intervention with glutamine (14g) and hydroxymethylbutyrate (3g) and a control group will receive a placebo with calcium caseinate (17g) a sample of the affected tissue will be taken before and after the supplementation where histology will be analyzed. remains of tissue will be obteined during surgery wash for histology.

Eligibility criteria:
inclusion criteria: * patients with bloody areas at hospital admission * hospital length stay around 15 days * medical treatment with surgical washing and negative pressure systems * for the groups with diabetes, patients with diagnosis of type 2 diabetes with bloody areas. * patients that accepts and signs the informative consent. exclusion criteria: * patients with cancer or immunodeficiency * patients with hba1c \< 12 * patients with collagen disease * patients with allergy to intervention substances (hmb, glutamine)

Keywords: wound healing, diabetes wound healing
bioequivalence study: 3 mg estradiol valerate (ev) with and without levomefolate calcium

Conditions: Contraception; Ovulation Inhibition

Summary: investigation of the bioequivalence (be) of estradiol valerate (ev) after administration of one film-coated tablet containing 3 mg estradiol valerate and 0.451 mg levomefolate calcium as compared to one film-coated tablet containing 3 mg estradiol valerate investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg estradiol valerate and 0.451 mg levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium


Eligibility criteria:
inclusion criteria: * bmi:\>18 \<30 kg/m² * healthy female volunteers * age 45-75 years * postmenopausal state exclusion criteria: * contraindications for use of combined (estradiol valerate/dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease) * regular intake of medication * clinically relevant findings (ecg, blood pressure, physical and gynaecological examination, laboratory examination) * smoking

Keywords: female contraception contraceptives, oral