Kornimate/medical-research-clean huggingface dataset:
phase 1 study of oral rh324 in advanced non-small cell lung cancer

Conditions: Safety Issues

Summary: phase 1 open label dose ranging study of rh324 in advanced non-small cell lung cancer

this is a phase 1 open label dose ranging study to assess the safety and tolerability of oral rh324 in advanced non-small cell lung cancer

Eligibility criteria:
inclusion criteria: * advanced non-small cell lung cancer * measurable target lesion by response evaluation criteria in solid tumors (recist) 1.1 * failed all standard of care including chemotherapy, targeted therapy, and immunotherapy * adults over 18 years * performance status (eastern cooperative oncology group) less than or equal to 2 * life expectancy greater than 2 months * laboratory values: hemoglobin greater than or equal to 9; neutrophils greater than 1,000; platelets greater than 50,000 liver function tests less than or equal to twice upper limit of normal serum creatinine less than or equal to 2 creatinine clearance greater than or equal to 30 ml per minute hemoglobin a1c less than 7 normal thyroid function * no history of hyperthyroidism * abstinence from alcohol and supplements * not pregnant, lactating and willing to use birth control throughout study * able to provide consent * positive emission tomography/computer tomography part of subjects care plan at baseline exclusion criteria: * prior use of withania somnifera * phenylketonuria * inability to swallow capsules * hypersensitivity to study drug ingredients * unstable medical or surgical condition * history of additional cardiac risk factors * requiring drugs that are "strong" inhibitors of cytochrome p450 * requiring irradiation * requiring intravenous fluids or hyperalimentation * requiring transfusions, dialysis, or other procedures * active infection * human immunodeficiency virus * must exceed washout period of prior treatments * psychiatric, neurological or other reason that precludes subjects ability to participate
the value of toi in evaluating renal function damage in hypertensive emergency patients

Conditions: Hypertensive Emergency

Summary: toi was used to measure heart rate, respiration, blood pressure, heart rate variability and psychological stress. at the same time, the patient's urine protein, creatinine, urea nitrogen and other indicators were detected. according to different renal function, they were divided into observation group and control group, and 100 general inpatients with renal insufficiency were selected as positive control group. the relationship between toi composite index and renal function in hypertensive emergency patients was compared.

toi technique was used to measure the heart rate, respiration, blood pressure, heart rate variability, psychological pressure, etc. at the same time, the urine protein, creatinine, urea nitrogen and other results of these patients were measured. according to the different renal function, they were divided into observation group and control group, and 100 ordinary hospitalized patients with renal insufficiency were selected as positive control group. the relationship between toi composite index and renal function in hypertensive emergency patients was compared. the data management platform provides intelligent management of patients' out-of-hospital follow-up, and the dynamic physiological indicators and psychological assessment data of patients are mastered through the hospital port, so as to provide telemedicine guidance for patients, so as to improve the prognosis of hypertensive emergency patients.

Eligibility criteria:
inclusion criteria: * systolic blood pressure (sbp)\>180mmhg * diastolic blood pressure (dbp)\>120mmhg exclusion criteria: * severe head and facial skin injury * cerebral hemorrhage or severe shock after admission * patients who insist on refusing to participate in this clinical tria * patients who could not participate in the study for other reasons.
cognitive therapy plus dietary intervention for obesity treatment

Conditions: Overweight and Obesity

Summary: this randomized clinical trial was carried out from january 2017 to december 2017 at the facilities of the catholic university of murcia. written informed consent was required from each patient. the protocols of the present clinical trial follow the consort standards. to measure the impact of cognitive training on weight loss in overweight / obese subjects, a double-blind study (de facto masking) was designed. both the participants and the statistical assessors were unaware of the study hypothesis. participants were unaware of treatments and possible assignments between groups, and only those subjects who were randomly assigned to the cognitive training group were informed that such training was part of dietary therapy. the principal investigator of the present study (j.j.h.m.) carried out the randomization, with the assistance of the microsoft excell program, with the help of a macro designed in visual basic® for that purpose. the randomization divided the subjects into two groups, as they were treated with a hypocaloric diet plus 12 nutrition education sessions (control group) or a group that were treated with a hypocaloric diet plus 12 sessions of cognitive training (cognitive group). in order to obtain a similar size in both groups, a randomization in blocks with a 1: 1 allocation ratio was performed. cognitive performance measures were performed before and after training. one week before the beginning of the cognitive and dietary intervention, the participants performed a series of cognitive tests. after 12 weeks of both dietary and cognitive intervention, participants were reexamined to measure performance on neurocognitive tests.


Eligibility criteria:
inclusion criteria: * present a bmi\> 27 kg / m2, and want to be part of the study voluntarily exclusion criteria: * subjects with diabetes mellitus type 2 * subjects with a history of a cardiovascular event (acute myocardial infarction, intermittent claudication, etc.) * subjects with kidney or liver failure or some other significant pathology (cancer) * subjects under pharmacological treatment that could affect body weight (corticoids, thyroxine, etc.) * subjects who were on a diet or had been on a diet at least 6 months before their participation in the study were also excluded.

Keywords: obesity, cognitive therapy, executive function
bcd with or without doxycycline in mayo stage ii-iii light chain amyloidosis patients

Conditions: Amyloidosis; Systemic

Summary: survival of intermediate and high-risk primary light chain amyloidosis (pal) remains poor due to high mortality within 3-6 months of diagnosis. rapidly effective regimens such as bortezomib, cyclophosphamide and dexamethasone (bcd) still failed to overcome the poor prognosis in very advanced pal amyloidosis patients. recently, doxycycline was demonstrated to induce disruption of fibril formation and reduce the number of intact fibrils in transgenic mouse model of pal amyloidosis. furthermore, case-control study suggested that adjuvant oral doxycycline could improve response and survival in cardiac pal amyloidosis, which necessities further confirmation through a randomized trial. therefore, we designed a multi-center randomized open-label controlled study to investigate the efficacy and safety of co-administration of oral doxycycline with bcd regimen in treatment-naïve patients with mayo stage ii-iii pal amyloidosis. the primary outcome progression-free survival, and secondary endpoints including overall survival, hematologic response, organ response and toxicity of doxycycline will be evaluated.


Eligibility criteria:
inclusion criteria: * ≥18 years old adults. * biopsy proved treatment-naïve pal amyloidosis. * mayo 2004 stage ii-iii. * dflc \> 50mg/l. * patient must provide informed consent. exclusion criteria: * co-morbidity of uncontrolled infection. * co-morbidity of grade 2 or 3 atrioventricular block. * co-morbidity of sustained or recurrent nonsustained ventricular tachycardia. * co-morbidity of other active malignancy. * co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia. * grade 2 or higher neuropathy according to national cancer institute common terminology criteria for adverse events version 3.0. * allergic history of doxycycline. * neutrophil \<1×10e9/l，hemoglobin \< 7g/dl，or platelet \< 75×10e9/l. * severely compromised hepatic or renal function: alt or ast \> 2.5 × uln, total bilirubin \> 1.5mg/dl，or egfr \< 60ml/min.

Keywords: primary light chain amyloidosis doxycycline bortezomib prognosis progression-free survival overall survival organ response
deprescribing in patients living with dementia with caregiver and provider nudges

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

Summary: the objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (epct), and explore representativeness of persons living with dementia and care partners identified.

the pcp nudge will consist of: a 'pre-commitment' ehr nudge triggered when a pcp opens a patient encounter (i.e., prompt to first have a discussion and then later deprescribe) and a brief message within the in-basket prior to upcoming visits including information about their patient. the patient living with dementia (plwd)/care partner nudge will include an electronic message delivered prior to upcoming visits (in their primary language recorded in the ehr) that includes a recommendation for the plwd (and care partner, if available) to discuss medications with the pcp at the visit.

Eligibility criteria:
primary care providers will be the primary unit of identification and randomization. primary care providers inclusion criteria: * providers within brigham and women's hospital primary care practices * having prescribed at least one of the high-risk medications of interest eligible patients will be identified through this providers within the health care system. patient inclusion criteria: * at least 65 years of age * prescribed at least 90 pills of one of the high-risk medications of interest in the last 180 days in the ehr system, which most guidelines consider chronic use, and have a diagnosis of dementia in the ehr.
a study of shorter course hormone therapy and radiation for high-risk prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to find out whether combining a shorter than standard course of adt with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.


Eligibility criteria:
inclusion criteria: * pathologically-proven diagnosis of prostate adenocarcinoma * clinical stage t3-4 or gleason score 8-10 or psa \>20 ng/ml °if radiographic t3-t4 is the only high-risk factor, it must be "consistent with" or \>90% probability of having t3-t4 disease determined by the reading radiologist. * decipher genomic score ≤0.6 * willing and able to provide written informed consent and authorization for use and release of health and research study information (hipaa authorization) * age ≥18 * kps ≥70 or ecog 0-2 * estimated life expectancy \>5 years * baseline prostate volume ≤90 cc * baseline ipss ≤20 * no contraindications to adt, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice * patients who have already started adt consisting of bicalutamide 50 mg po daily with leuprolide or an equivalent gnrh analogue are eligible if given for ≤ 60 days prior to registration exclusion criteria: * regional lymph node or metastatic disease * prior pelvic radiation * prior prostate surgery (including turp or cryosurgery) * prior history of inflammatory bowel disease * unable to undergo anesthesia or brachytherapy * active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage i head and neck cancer, or stage i colorectal cancer

Keywords: hypofractionated pelvic radiation brachytherapy boost nccn high-risk prostate cancer low-intermediate risk decipher genomic score androgen deprivation 21-405
influence of sevoflurane and desflurane on postoperative sore throat

Conditions: Hip Arthroplasty

Summary: this investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.


Eligibility criteria:
inclusion criteria: * asa i-iii * patients scheduled for general anesthesia with endotracheal intubation exclusion criteria: * difficult airway * friable teeth * rapid sequence induction * recent sore throat * recent upper respiratory infection * asthma * chronic obstructive pulmonary disease * chronic cough * arrhythmia * coronary disease * heart failure * pregnancy * allergy to sevoflurane * allergy to desflurane * fever after halogenated anesthetics * jaundice after halogenated anesthetics * malignant hyperthremia * allergy to remifentanil * friable teeth * history of head and neck surgery * multiple intubation attempts * regional anesthetic agents * gastric tube * dexamethasone * severe hypovolemia

Keywords: intubation pharyngitis remifentanil
evaluating the effectiveness of paclitaxel-eluting balloons for below-the-knee angioplasty in patients with critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months


Eligibility criteria:
inclusion criteria: * age\>18 years * angiographic stenosis\>50% or occlusion of one below-knee vessel exclusion criteria: * allergy to paclitaxel * contraindication for combined antiplatelet treatment * life expectancy \<1 year * hypersensitivity or contraindication to one of the study drugs * lack of consent * need for amputation

Keywords: critical limb ischemia drug-eluting balloon restenosis
furosemide and albumin for diuresis of edema: a pilot randomized controlled trial

Conditions: Edema; Hypoproteinemia

Summary: critically ill patients usually require intravenous fluids to correct low blood pressure and improve blood flow to vital organs. however, once the patient's blood pressure has improved, these fluids can leak out into various organs, including the lung, kidneys, and skin. excess fluid in these tissues, called edema, has been associated with longer icu stays and higher mortality. thus removing excess fluid is an important goal. the simplest way to treat edema is to use diuretics, such as furosemide, which increase urine output. to further improve urine output, patients are sometimes given albumin, a protein which helps to suck fluid out from the tissues, and keep it in the blood vessel, where it can be filtered in the kidney and removed in the urine. although albumin is often used for this purpose, there is little evidence to support it. a large randomized controlled trial is needed to determine if albumin plus furosemide is truly more effective than furosemide alone in critically ill patients with low levels of blood albumin. we will perform a pilot study to assess the feasibility of such a trial.


Eligibility criteria:
inclusion criteria: * hemodynamically stable for at least 24 hours (absence of persistent \[\>1 h\] hypotension \[systolic blood pressure \<90 mmhg), not currently on vasopressors, less than 2 l crystalloid or colloid boluses, or 2 units red blood cells administered, maintenance fluids excluded * hypoproteinemia (serum albumin \<30 mg/l or total protein \< 60 mg/l) * clinical decision to diurese at least 3 l net fluid balance within the next 72 hours for any reason exclusion criteria: * known pregnancy * patient or surrogate unable or unwilling to consent to blood product administration, including albumin * history of adverse reactions or allergy to either albumin or furosemide * acute kidney injury (rifle criteria "f" or greater) without any improvement in past 24 hours, or otherwise expected to necessitate dialysis within 48 hours in opinion of treating physician * chronic kidney injury requiring dialysis * clinically documented cirrhosis * clinically documented nephrotic syndrome * serum sodium greater than 150 milliequivalent/l or serum potassium less than 2.5 meq/l that connote be treated prior to administration of study treatment * inability to measure urine output and fluid balance * receipt of hyperoncotic albumin within preceding 24 hours * previous enrollment in this trial, or any research studies which may interfere with this study * estimated survival or icu stay less than 72 hours

Keywords: edema hypoproteinemia albumin diuresis critical illness
incidence of complications of brain death

Conditions: Brain Death

Summary: the purpose of the study is to describe the incidence of complications in brain death adult organ donors.

pathophysiological changes following brain death may complicate the care of brain death donors. these complications negatively affects function of donated organs. understanding these complications and its incidence is crucial for their appropriate management. the aim of this retrospective observational study is to evaluate the incidence of complications in adult brain death organ donors. date will be collected from medical records of eligible patients admitted to intensive care unit for suspected brain death in whom brain death was confirmed and who become organ donors.

Eligibility criteria:
inclusion criteria: * age ≥18 years * confirmed brain death * organ donor exclusion criteria: - age under 18 years

Keywords: brain death organ donation
lay health worker outreach in increasing colorectal cancer screening in asian americans

Conditions: Colorectal Carcinoma; Health Status Unknown; Healthy Subject

Summary: this randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in asian americans. training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in asian americans.

primary objectives: i. evaluate the efficacy of lay health worker (lhws) outreach on colorectal cancer (crc) screening among 3 asian american groups (filipinos, hmong, and koreans) in a cluster randomized controlled trial (rct) comparing crc education delivered by lhws (intervention) to a crc brochure and nutrition education (control). ii. examine the processes through which lhws communicate with, connect to, and convince community members from 3 asian american cultures of the importance of crc screening using mixed methods. outline: lay health workers (lhws) are randomized to 1 of 2 groups. group i (crc education): lhws undergo training over 3 days and recruit 15 participants from their social network. participants attend a crc educational session conducted by an lhw over 90 minutes at month 1 and 3. participants receive phone calls from the lhw at months 2 and 4 reminding them about crc screening. group ii (crc brochure): lhws undergo training over 3 days and recruit 15 participants from their social network. participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. after the first meeting, participants receive a brochure on crc screening. participants receive phone calls from the lhw at months 2 and 4 regarding changes in their nutritional behavior. participants may attend an optional post-intervention lhw outreach session on crc screening. after completion of the study, patients are followed up at 2 months.

Eligibility criteria:
inclusion criteria: * lhw: self-identified as filipino, hmong, or korean americans * lhw: age 18 or older * lhw: are fluent in a filipino language (tagalog or ilocano), hmong, korean, or english * lhw: live in the relevant area and intend to stay there for the next 12 months * participants: self-identified as filipino, hmong, or korean americans * participants: speak a language that the lhw can speak such as tagalog, ilocano, hmong, korean, or english * participants: live in relevant area and intend to stay there for at least 12 months * participants: are willing to participate in a study about health behaviors involving nutrition or crc screening exclusion criteria: * personal history of crc * medical problems which may prevent them from attending 2 educational sessions
study of sunitinib in combination with cisplatin and 5-fluorouracil in patients with advanced gastric cancer

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stomach cancer * advanced stomach cancer stage iv * adequate blood chemistry, blood counts and kidney function * willing to participate to study requirements and to sign an informed consent document exclusion criteria: * prior chemotherapy for stomach cancer in its advanced stage * excessive toxicities related to prior therapies * pregnant or breastfeeding patients
a post marketing surveillance to evaluate the safety and efficacy of brilinta

Conditions: Acute Coronary Syndromes

Summary: to identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of brilinta tablet: the occurrence of unrevealed serious adverse events (saes), current status of occurrence of adverse events (aes), the factors that may influence safety and efficacy of the drug.

a post marketing surveillance to evaluate the safety and efficacy of brilinta

Eligibility criteria:
inclusion criteria: * patients with acute coronary syndromes * patients who are taking ticagrelor and asa daily(75-150mg), or patients who are taking ticagrelor only(in the case that the patients have contraindication with asa. contraindication should be recorded in accordance with local pi on crfs) * patients who have signed the data release consent form prior to enrollment in this surveillance exclusion criteria: * patients with hypersensitivity to ingredients of this drug or with moderate or severe hepatic impairment or with medical history of intracranial hemorrhage * patients with pathological hemorrhage at the time of administration * patients being administrated strong cyp3a4 inhibitors

Keywords: unstable angina