Kornimate/medical-research-clean huggingface dataset:
flexiva pulse registry

Conditions: Urinary Calculi; Benign Prostatic Hyperplasia

Summary: to obtain post-market safety and efficacy data for flexivatm pulse high power single-use laser fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (holep).

multi-center, open label, prospective study to document on-going post-market safety and performance of flexiva pulse high power single-use laser fibers. all subjects meeting the enrollment criteria, signing the consent and undergoing the lithotripsy/holep procedure with the study device(s) will be followed: up to 2 months (60 days) post-discharge from final holmium laser lithotripsy procedure for subjects in the lithotripsy cohort or up to 6 months (180 days + 60 days) post discharge from holep procedure for subjects in the benign prostatic hyperplasia (bph) cohort.

Eligibility criteria:
inclusion criteria: for lithotripsy cohort: 1. subject is undergoing treatment for urinary calculi 2. subject is willing and able to return for all follow-up visits for bph cohort: 1. subject is ≥ 40 years of age 2. subject with a diagnosis of benign prostatic hyperplasia (bph) with lower urinary tract symptoms 3. ipss (international prostate symptom score) ≥ 12 4. qmax (peak flow rate) ≤ 15 ml/s 5. subject is willing and able to return for all follow-up visits exclusion criteria: for lithotripsy cohort: 1. subject has uncontrolled bleeding disorders and coagulopathy 2. subject has untreated urinary tract infection (uti) 3. subject requires simultaneous holep procedure for bph cohort: 1. subject has a diagnosis of bladder cancer 2. subject has a diagnosis of prostate cancer 3. subject with prostate-specific antigen (psa) ˃ 10 ng/ml suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy 4. subject has acute prostatitis, a prostate abscess, or neurogenic bladder 5. subject has urethral stricture disorder 6. subject has uncontrolled bleeding disorders and coagulopathy 7. subject has untreated urinary tract infection (uti) 8. subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
biogene bank cohort study for approved research requests

Conditions: Healthy; Chronic Disease

Summary: the biogene bank: is a centralized collection of human blood samples along with de-identified (coded) health information, environmental factors, family disease histories and information from dna. limited to the nslijhs catchment area.

the purpose of the biogene bank cohort is to collect blood and store dna from blood, along with health information to study how genetic variation in the population is associated with particular diseases, treatments and medical outcomes. investigators may study the entire range of diseases and medical problems that exist within the nslijhs, including medical, surgical, psychiatric, pediatric and obstetric conditions. the specimens and medical information will be kept at a central biorepository. this research study does not involve any treatment and individual research results are not provided.

Eligibility criteria:
inclusion criteria: * anyone receiving care at the ns lij health system would be eligible to join the biogene bank cohort. * participants' family members who may or may not have medical records at nslijhs. exclusion criteria: * patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome. * patients unable to provide a blood sample because it would adversely affect their health or who refuse to provide blood sample or share future discarded biological samples. * patients \<10kg in weight

Keywords: biobank genetics dna cohort normal control
safety and efficacy of donafenib in patients with advanced hepatocellular carcinoma

Conditions: HCC

Summary: this phase ib study of donafenib, an oral multikinase inhibitor that targets raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hepatocellular carcinoma (hcc) .

eligibility criteria: * 18 -70 years old; * patients with measurable, histologically proven, inoperable hcc; * child-pugh (cp) score of a; * eastern cooperative oncology group (ecog) performance status score of 2 or less. * patients received prior systemic treatments for hcc before 4 weeks; * patients received operate before 3 months; * patients received tace before 4 weeks; * life expectancy at least 3 months; * adequate hepatic and renal function; * adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter); * prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or aptt≤43s;or tt≤21s. exclusion criteria: * patients had prior treatment with sorafenib; * cns involvement. method: * open-label,randomized,multiceters study; * 2 dose cohorts: 200mg bid and 300mg bid; * patients with advanced hcc(inoperable) and child-pugh (cp) a , randomized,receive continuous donafenib either 200mg bid or 300mg bid in 4 weeks cycles; * sample size:106 patients(53 patients in each dose cohort). endpoints: * safety: toxicities are assessed according to ctcae 3.0; * ttp:tumor response is assessed every two cycles using recisit1.1 criteria; * donafenib pharmacokinetics is measured in plasma samples.

Eligibility criteria:
inclusion criteria: * 18 -70 years old * patients with measurable, histologically proven, inoperable hcc * child-pugh (cp) score of a * eastern cooperative oncology group (ecog) performance status score of 2 or less. * patients received prior systemic treatments for hcc before 4 weeks * patients received operate before 3 months * patients received tace before 4 weeks * life expectancy at least 3 months * adequate hepatic and renal function * adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter) * prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or aptt≤43s;or tt≤21s. exclusion criteria: * patients had prior treatment with sorafenib * cns involvement.

Keywords: donafenib hcc advanced inoperable phase 1b
dpbrn longitudinal study of questionable occlusal caries lesions

Conditions: Dental Caries

Summary: the purpose of this study will allow us to observe and follow the subjects' treatment from dpbrn prevalence of questionable occlusal caries lesions study over a 24 month period.

there have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions. since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.

Eligibility criteria:
inclusion criteria: * patients needed to have at least one permanent tooth with a questionable lesion. this means that subjects were at least 6 years old because that is when the permanent first molar typically erupts. exclusion criteria: * patients under 6 years old * patients 6 years old and older who do not have a questionable lesion

Keywords: assessment questionable caries
the effect of nasal continuous positive airway pressure treatment on ptsd symptoms.

Conditions: Post Traumatic Stress Disorder; Anxiety; Nightmares; Unrefreshed Sleep

Summary: we hypothesize that prevention of sleep disordered breathing among ptsd patients with nasal cpap will result improve their anxiety, insomnia and alcohol craving (among those who use alcohol to control their symptoms).

design: this is a pilot study to study the effect of nasal cpap on the symptoms of ptsd in veterans. recruitment methods: veterans with ptsd will be recruited from the northport vamc ptsd unit. the acos/mental health will refer patients that meet inclusion criteria and do not have an impaired decision making capacity. subjects will be screened for decision-making capacity by their treating psychiatrist as part of their clinical assessment upon admission to the ptsd unit. study methods this will be a prospective, randomized, controlled interventional trial: 1. participants will undergo a routine clinical sleep study at the ptsd unit (using a portable polysomnographic recording unit). or undergo a routine clinical polysomnography to diagnose sleep disordered breathing 2. participants who demonstrate sdb will be randomized into two groups based upon their body mass index 1. group a: bmi \< 30 kg/m2 2. group b: bmi \> 30 kg/m2 the reason for these two arms is to study the effect of nasal cpap upon ptsd symptoms in veterans with a high prevalence of sleep apnea ( bmi above 30 kg/m2) and in veterans with predominantly snoring (bmi below 30 kg/m2). each group will then be randomized into two sub-groups regarding treatment. 1. treatment group receives an automated cpap unit to use during sleep for 6 weeks in conjunction with their usual care in the ptsd unit (psychotherapy). 2. control group receives the usual care that is provided in the ptsd unit for 6 weeks (change in medications will exclude the subject from the study), if any participant in the control group would like to try nasal cpap, then he will be crossed over to use an automated cpap unit during sleep for his second 6 weeks in the ptsd unit together with usual care. 3. all participants will fill out the following questionnaires at baseline and after 6 weeks. (those in the control group who have been crossed-over to nasal cpap will also fill out a set of questionnaire at 12 weeks). 1. ptsd checklist-military version (anxiety) 2. masq anxious arousal subscale (anxiety) 3. insomnia severity index (insomnia) 4. the alcohol craving questionnaire (with an alcohol history during the intake) the changes in patient's reported outcomes will be compared before and after cpap treatment and psychotherapy alone

Eligibility criteria:
inclusion criteria: a. admitted to ptsd unit at nvamc and will remain in the unit for at least 12 weeks after initiation of study participation. b. found to have sdb by polysomnography exclusion criteria: 1. impaired decision-making capacity, as determined by treating psychiatrist. 2. no sleep disordered breathing found by polysomnography 3. unable/unwilling to use the nasal cpap
dual arterial phase liver ct in patients with suspected portal hypertension

Conditions: HCC; Cirrhosis, Liver

Summary: patients with liver cirrhosis is at risk of developing hcc. to diagnose or detect hcc at ct/mri, optimal late arterial phase (lap) acquisition is critical to capture the tumor. for lap acquisition, bolus-tracking is often used at ct. in patients with portal hypertension, however, bolus-tracking occasionally capture early arterial phase which may be related with slow portomesenteric flow. in this study, we obtain dual arterial phase in patients with suspected portal hypertension and determine whether this protocol (dual arterial phase) would provide higher incidence of lap acquisition than single arterial phase acquisition.


Eligibility criteria:
inclusion criteria: * older than 20 years * liver cirrhosis diagnosed with characteristic imaging feature or histology * presence of portal hypertension sign (splenomegaly and varices) * scheduled for liver ct * and signed informed consent exclusion criteria: * relative or absolute contra-indication of contrast-enhanced ct

Keywords: ct
palliative radiotherapy protocol in head and neck cancer

Conditions: Head and Neck Neoplasms; Quality of Life

Summary: phase ii prospective study or palliative radiotherapy of 25 gy in 5 fractions, intensity modulated, for frail patients with incurable head and neck cancer. comprehensive quality of life (qlq-c30, head and neck module, qlq c15 pal) and toxicity data (ctcae v 4.0) collected.

patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 gy in 5 daily fractions over one week. this study was conducted in two academic centers.

Eligibility criteria:
inclusion criteria: * able to give an informed consent * able to complete qol questionnaires * deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy * presence of measurable disease * biopsy proven squamous or salivary cancer of the head and neck region * expected survival of at least 2 months. exclusion criteria: * pregnancy * no previous rt to the neck and no plan to receive concomitant chemotherapy * special histology (lymphoma, small cell cancer, metastasis from a site other than the head and neck region) * unavailable for follow-up

Keywords: radiotherapy palliative care imrt
venus-vitae pivotal study smart-align study

Conditions: Aortic Valve Stenosis

Summary: the purpose is to evaluate the safety, effectiveness and performance of venus-vitae transcatheter heart valve system in patients with severe aortic stenosis.

this trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the venus-vitae transcatheter heart valve system in patients with severe aortic stenosis. clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients with the symptoms of severe aortic stenosis 3. severe aortic stenosis (as, grade 3+), defined as ava ≤ 1 cm2 (avai ≤ 0.6 cm2/m3) or vmax ≥ 4.0 m/s or mpg ≥ 40 mmhg determined by echocardiography 4. patients deemed for cardiac intervention by a heart team 5. patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories. 6. patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements exclusion criteria: a subject meeting any of the following criteria shall be excluded: co-morbidities 1. previous mechanical or biological aortic valve replacement 2. untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention 3. acute myocardial infact within 30 days prior to index procedure 4. untreated clinical significant coronary artery disease requiring revascularization 5. any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months) 6. sever symptomatic carotid artery stenosis 7. stroke or tia within 3 months or modified rankin scale ≥ 4 disability 8. chronic kidney disease (egfr\<30 ml/min/1.73m2) 9. haemotologic disorders: leukopenia (wbc \< 3000 cell/ml), anemia (hgb \< 9 g/dl), thrombocytopenia (plt\< 50,000 cell/ml), or any known blood clotting disorder, deemed clinically significant after consultation with haematooncology specialists 10. severe right heart dysfunction anatomical 11. lvef \< 20% 12. echocardiographic evidence of intracardiac mass, thrombus, or vegetation 13. inappropriate anatomy for femoral introduction and delivery of study device 14. native aortic valve geometry and size unfavorable for study device anchoring general 15. haemodynamics instability requiring inotropic support or intra-aortic balloon pump (iabp) or other hemodynamic support device, or any mechanical heart assistance 16. known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement 17. life expectancy ≤ 1 year due to noncardiac reasons 18. active infection requiring antibiotic therapy including infective endocarditis 19. planned relevant concomitant procedure within 30 days post index procedure 20. pregnant, breastfeeding or intend to become pregnant within 1 year
tongxinluo capsule in ischemic stroke patients（tiss)

Conditions: Ischemic Stroke

Summary: the purpose of this study is to assess the effects in improving life self-care ability of stroke patients after taking tongxinluo capsule(within 72 hours after onset) versus placebos for 90 days.

the study is a randomized, double-blind, placebo controlled, multi-center trial. we aim to enroll a total of 1968 individuals(984 cases in each group) with acute ischemic stroke less than 72 hours after onset. participants will be randomized into tongxinluo capsule treatment group with the capsule administration of 4 granules tid. for 90 days, while the patients in the control group receive placebo capsule. nih stroke score of the subjects is 4-22 at randomization. evaluations of efficacy and safety will be taken at baseline, 7 days, discharge date and 90 days. neuroimaging \[magnetic resonance imaging (mri) scans\] will be obtained at baseline and 90 days after therapy. the primary efficacy endpoint is the proportion of modified rankin scale (mrs) ≤1 at 90 days.

Eligibility criteria:
inclusion criteria: * ischemic stoke within 72 after onset, confirmed by mri or ct. * age 35-75 years, inclusive. * patients with the first attack or patients with stroke history(modified rankin scale score 0-1). * clear signs of localization of nervous system, nihss score 4 to 22. * patient or proxy has signed informed consent. exclusion criteria: * hemorrhage diseases according to head ct or mri, such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, haemorrhage after cerebral infarction. * transient ischemic attack (tia). * severe disturbance of consciousness: 1a of nihss score\>1 point; difficulty in swallowing, unable to take oral capsules; any of 5a, 5b, 6a, 6b of nihss score\>2 point. * convinced of stroke caused by brain tumor, brain trauma, hemopathy, etc. * hemorrhagic tendency patients. * patients with endovascular treatment after the onset of stroke. * patients with dementia, severe parkinson's disease, mental disorders, limb dysfunction caused by other diseases or other conditions that may affect the therapeutic efficacy. * uncontrolled hypertension (≥200 mmhg systolic or ≥110 mmhg diastolic) or hypotension (≤90 mmhg systolic or ≤60mmhg diastolic); severe hyperglycemia(blood glucose ≥400 mg/dl) or hypoglycemia( blood glucose≤50 mg/dl). * severe hepatic insufficiency defined as transaminase values \> 2x upper limit of normal; severe renal insufficiency defined as values serum creatinine\> 1.5x upper limit of normal; cardiac dysfunction or other serious systemic disease with life expectancy ≤3 months. * patients with concurrent malignancy or ongoing anti-tumor therapy. * patients with history of being allergic to the trial medicine. * pregnancy, breastfeeding or potential pregnancy. * within three months or currently participating in another investigational study. * any other condition that in the opinion of the investigator should preclude study participation.

Keywords: ischemic stroke tongxinluo capsule
enhanced recovery after surgery (eras) for complicated appendicitis

Conditions: Appendicitis Acute; Appendicitis Perforated; Appendicitis With Perforation; Appendicitis Suppurative; Appendicitis Gangrenous

Summary: the exploratory objective of this pilot study is to evaluate the feasibility and safety of an enhanced recovery protocol that will allow adult patients to be discharged to home on an oral antibiotic regimen for three days following a laparoscopic appendectomy for complicated appendicitis. feasibility will be determined by high compliance and adherence of patients to the postoperative instructions, while safety will be assessed by the incidence of postoperative infectious complications and requirement for re-admission.


Eligibility criteria:
inclusion criteria: * individuals between the ages of 18 and 65 years of age. * patients undergoing a laparoscopic appendectomy. * diagnosis of complicated appendicitis based on pre-operative imaging or intra-operative assessment. the definition of a complicated appendicitis will include: (a) perforated appendicitis, without generalized peritonitis; (b) gangrenous appendicitis, without generalized peritonitis; (c) suppurative appendicitis; (d) iatrogenic perforation of the appendix. * meet criteria for discharge from the post-anesthesia care unit (pacu). * ability to reliably follow up with the study procedures. exclusion criteria: * age \ 65 years. * pregnancy. * homelessness. * patients who present with generalized peritonitis. * patients with comorbid conditions, including diabetes mellitus, immunosuppressed state for any reason, patients on chronic anticoagulation (excluding aspirin 81 mg). * patients who present with septic shock. * patients who require conversion to an open appendectomy. * patients who present with additional findings on imaging studies or intra-operatively, including ileus or small bowel obstruction. * based on surgeon's clinical judgment for reasons that may not be outlined above. * allergy or intolerance to study medication(s)
to evaluate the response to glucagon during hypoglycemia

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the response to glucagon versus the spontaneous hormonal response to low blood sugar levels in t2dm patients treated with azd1656 and metformin


Eligibility criteria:
inclusion criteria: * type ii diabetes patients, female with non child-bearing potential * t2dm diagnosis confirmed by c-peptide \>0.3nmol/l and no glutamic acid decarboxylate (gad) antibodies at enrolment (screening) * treatment with metformin alone with a total daily dose not less than 1 000 mg. stable glycaemic control indicated by unchanged treatment within 3 months prior to enrolment exclusion criteria: * history of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease * signs of diabetic proliferative retinopathy or diabetic maculopathy, at screening or on an ophthalmological examination within 3 months from start of study * participating in another clinical study during the last 30 days prior to enrolment

Keywords: type ii diabetes counter-regulatory response hypoglycemia
study evaluating conjugated estrogen cream for atrophic vaginitis

Conditions: Atrophic Vaginitis; Atrophy; Vaginitis

Summary: this protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (pvc) given vaginally in postmenopausal women with atrophic vaginitis.


Eligibility criteria:
inclusion criteria: generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse. the subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus. exclusion criteria: women who do not have a clinical diagnosis of atrophic vaginitis.

Keywords: postmenopause vaginitis