Kornimate/medical-research-clean huggingface dataset:
varenicline in-patient study

Conditions: Smoking Cessation

Summary: this investigator initiated research award (iir award #ws981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (part 1) and 4-weeks post-hospitalization (part 2).

the sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. intention to quit smoking will not be required for study participation. using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg bid as tolerated) or placebo during their hospitalization (part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (part 2). abstinence status will be examined at 4 weeks post-hospitalization.

Eligibility criteria:
inclusion criteria: * the sample, 40 women and 40 men, will be hospitalized patients recruited from stanford hospital and clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. intention to quit smoking will not be required for study participation. exclusion criteria: - study exclusion criteria are: dementia or other brain injury precluding ability to participate; alzheimer's disease; parkinson's disease; huntington's disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (mi) with severe cardiac damage; pregnancy or breastfeeding; non-english speaking; complete homelessness; or currently engaged in tobacco treatment. study staff will consult with clinical staff prior to approach for study enrollment. in cases of severe renal impairment (estimated creatinine clearance \<30 ml/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment.

Keywords: varenicline placebo inpatient
diagnostic device risk management of atrial fibrillation and heart failure

Conditions: Atrial Fibrillation; Heart Failure

Summary: the purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. the study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.


Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient (or patient's legally authorized representative) is willing and able to provide written informed consent * patient is willing and able to comply with the protocol, including follow-up visits * documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations) * patient is indicated for the reveal xt insertable cardiac monitor or other commercially-available and substantially equivalent medtronic insertable cardiac monitor * recent hf event within prior 120 days (hf event defined as meeting any one of the following two criteria: 1. admission with primary diagnosis of hf 2. intravenous hf therapy (e.g. iv diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of hf, emergency department, ambulance, observation unit, urgent care, hf/cardiology clinic, patient's home * willing and able to transmit data via carelink exclusion criteria: * patient is pregnant * patient has been participating in another study that may interfere with the identify-hf protocol required procedures * endstage (stage d or new york heart association class iv) heart failure * asymptomatic (stage b or new york heart association class i) heart failure * severe aortic stenosis or insufficiency * existing insertable cardiac monitor implanted for more than 1 year * existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device * severe renal impairment (estimated glomerular filtration rate \<25ml/min) * myocardial infarction within prior 30 days
pet study of breast cancer patients using [68ga]aby-025

Conditions: Breast Cancer

Summary: the study will evaluate \[68ga\]aby-025 for pet imaging of her2 expression in subjects with her2-positive or her2-negative breast cancer.

open-labeled, exploratory, single center study. 1. group 1 (dose-finding) six subjects with her2-positive primary tumor status and four subjects with her2-negative status. \[68ga\]aby-025 pet with low dose (100 μg) of aby-025 peptide is performed, followed by a repeated pet within three weeks using high dose (500 μg) aby-025 peptide (radioactivity maximum 500 mbq). a third \[68ga\]aby-025 pet will be performed in the her2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the aby-025 peptide dose previously determined to be preferable. 2. group 2 ten subjects with her2-positive primary tumor status. \[68ga\]aby-025 pet is performed using the aby-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second \[68ga\]aby-025 pet investigation at signs of progressive disease or else latest after 9 months.

Eligibility criteria:
inclusion criteria: 1. subject is \> 18 years of age 2. diagnosis of invasive breast cancer with metastases 3. availability of results from her2 status previously determined on material from the primary tumor, either 1. her2-positive, defined as a dako herceptest™ score of 3+ or fish positive or 2. her2-negative, defined as a dako herceptest™ score of 0 or 1+ or else; if 2+ then fish negative 4. volumetrically quantifiable metastasis lesions on ct or mri, with at least one lesion \>= 10 mm in smallest diameter and suitable for biopsy 5. ecog performance status of =\< 2 6. life expectancy of at least 12 weeks 7. hematological, liver and renal function test results within the following limits: white blood cell count: \> 2.0 x 10\^9/l haemoglobin: \> 80 g/l platelets: \> 50.0 x 10\^9/l alt, alp, ast: =\< 5.0 times upper limit of normal bilirubin =\< 2.0 times upper limit of normal serum creatinine: within normal limits or else normal clearance 8. a negative pregnancy test (serum beta-human chorionic gonadotropin, beta-hcg) at screening for all female patients of childbearing potential, who must use a medically acceptable form of contraception from study start until at least 30 days after study termination 9. subject is able to participate in the diagnostic investigations to be performed in the study 10. informed consent exclusion criteria: 1. manifest second, non-breast malignancy 2. known hiv positive or chronically active hepatitis b or c 3. administration of other investigational medicinal product within 30 days of screening 4. ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to us national cancer institute's "common terminology criteria for adverse events v4.0 \[ctcae\]" 5. other ongoing severe disease that may influence the patient's ability to participate in the study 6. pregnant or breast-feeding
effect of common bile duct stone clearance using saline irrigation after stone removal: a prospective randomized control trial.

Conditions: Common Bile Duct Calculi

Summary: retained cbd stone after ercp is a common problem in clinical practice. this study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ercp in the reduction of residual cbd stone and the effect on clinical outcome.

this study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ercp in the reduction of residual cbd stone and the effect on clinical outcome. patients with cbd stone who received endoscopic stone removal were included after complete stone clearance was seen on occluded cholangiogram. one arm received saline irrigation of cbd at least 50 ml until clear effluent seen and another arm as control. both group received endoscopic ultrasound to evaluation for residual stone and followed up for complication and outcome.

Eligibility criteria:
inclusion criteria: * patients with common bile duct stone * complete stone removal by endoscopy as seen in occluded cholangiogram exclusion criteria: * unstable vital sign * failed complete stone remval * assciated biliary malignancy or history of bile duct surgery * associated bile duct stricture or choledochal cyst * toxic cholangitis * pregnancy or unable to give informed consent

Keywords: endoscopic retrograde cholangiopancreatography endoscopic ultrasound cholangitis
predictors of patient attitudes and barriers to skin cancer screening

Conditions: Skin Cancer

Summary: this is a cross-sectional survey distributed to a convenience sample of patients in a waiting room of an academic dermatology clinic. the survey assesses patient experiences with full body skin exams and attitudes towards full body skin exams. the survey is designed to help investigators better understand how many patients are not getting full body skin exams, why this may be occurring, and what types of interventions may be enacted to increase the number of patients getting full body skin exams.


Eligibility criteria:
inclusion criteria: * 18 years old or older * english-speaking exclusion criteria: * previously completed the survey

Keywords: number of patients full body skin exam survey preferences
the effect of nasal carbon dioxide (co2) in the treatment of mild headache in people who experience migraines

Conditions: Migraine

Summary: the purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines.

this multi-center, adaptively randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (co2) in the treatment of mild headaches. an estimated 250 patients who meet the eligibility criteria will be enrolled into this study at approximately 15 sites to ensure that about 220 patients are randomized and complete the study.

Eligibility criteria:
inclusion criteria: * able to read and understand informed consent form and voluntarily consent to participate in this study by signing the irb-approved informed consent form * established diagnosis of migraine with or without aura per ichd-ii (patients with a diagnosis of only menstrual migraine are not eligible) * history of 2-8 migraine attacks per month during the 3 months prior to randomization * have a typical migraine which progresses from a distinct mild headache to a moderate or severe migraine * able to recognize a mild headache that could develop into a moderate or severe migraine exclusion criteria: * have less than 48 hours of freedom from headache between attacks of migraine * have 15 or more headache days per month * are females who are pregnant or lactating * use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study * have a concurrent diagnosis of tmd or trigeminal neuralgia requiring treatment * clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril * have participated in another study with nasal co2

Keywords: nasal co2 phase ii adaptive randomized double-blind placebo-controlled multiple-dose multi-center safety efficacy mild headache migraineur
additional effect of intrapulmonary percussive ventilation (ipv) on respiration in people with multiple sclerosis (ms).

Conditions: Multiple Sclerosis

Summary: this study aims to investigate whether intrapulmonary percussive ventilation (ipv) in combination with active breathing exercises using the flow-based incentive spirometer (inspirix) has a positive effect on the respiratory values in people with multiple sclerosis (ms).

the primary research question includes "what is the additional effect of intensive ipv treatment in combination with active breathing exercises on respiratory power (peak expiratory flow, pef) in people with ms?". in a single-center randomized clinical trial, 96 people with ms-related respiratory problems will be allocated to either the intervention group (ipv + active breathing training) or the control group (active breathing training only). interventions will be provided by trained speech- and language therapists, in combination with a multidisciplinary rehabilitation programme of 3 weeks. pre- en posttraining assessment includes measures of respiration, speech and fatigue.

Eligibility criteria:
inclusion criteria: * diagnosis ms * inpatient in the national multiple sclerosis center melsbroek for at least 3 weeks in the period jan-dec 2020 * adequate lip closure * adequate cognitive functioning (mmse\>26/30 \& clinical observation) * peak expiratory flow (pef) with a cut off score of 80% or lower exclusion criteria: * ipv or other breathing treatment of more than 1x/week within 3 months prior to study participation * ms relapse within 3 months prior to study participation * asthma or chronic obstructive pulmonary disease (copd) * infection of lower respiratory tract within 6 weeks prior to study participation * infection of upper respiratory tract within 2 weeks prior to study participation
prospective multicenters clinical cohort study of stratified treatment of chinese children with bl/dlbcl

Conditions: Rituximab; Lymphoma, Non-Hodgkin; Pediatric Cancer

Summary: the trial scccg-bl/dlbcl-2017 is a collaborative prospective, multicenters, non-randomized, observational, cohort clinical study with participating centers of the south china children's cancer group-non-hodgkin lymphoma group(scccg-nhl). the aim of the study is to evaluate efficacy and safety of stratified treatment based on risk factors of childhood and adolescents burkitt lymphoma(bl)/diffuse large b-cell lymphoma(dlbcl) patients in china.

research purposes: 1. to investigate the efficacy and safety of scccg-bl/dlbcl-2017 in children with bl and dlbcl. 2. to investigate the effect of rituximab combined with chemotherapy on the survival rate of children with high-risk bl/dlbcl. 3. to investigate the effect of rituximab on immune function in children with high-risk bl/dlbcl. 4. to explore the correlation between mrd detection and the efficacy and survival of children with bl/dlbcl. 5. to explore the role of pet/ct in evaluating residual lesions in children after bl/dlbcl treatment.

Eligibility criteria:
inclusion criteria: 1. age \< 18 years old 2. pathologically confirmed burkitt lymphoma or diffuse large b-cell lymphoma 3. newly diagnosed patients 4. informed consent of guardian of children patients exclusion criteria: 1. pathological components with follicular lymphoma 2. immunodeficiency second neoplasm
sarcopenia in patients with heart failure

Conditions: Sarcopenia

Summary: sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. in all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. in this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ons) are necessary; ons could have a standard formula or be enriched with specific nutrients. there is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure


Eligibility criteria:
inclusion criteria: * patients with a previous admission due to hf in the previous 12 months * moderate or severe lvef * both sexs * age \>18 years old. exclusion criteria: * mdrd \<15 ml/min * end-stage liver disease.
a study of the effects of gsk189075 on pk profiles of an oral contraceptive pill when given to healthy female volunteers

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

Summary: the purpose of this research study is to demonstrate a lack of effect of multiple doses of gsk189075 on the pk of an oral contraceptive pill in healthy female subjects. to estimate the effects of gsk189075 on hormonal levels and on birth control.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking menstruating female age 18 to 45 years old, inclusive. * able to take a specific oral contraceptive \& kg2107494. * female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test. * female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner. exclusion criteria: * pregnant or a nursing female. * female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the follow-up visit. * have suffered with certain infection within 4 weeks prior to the first dose of study drug

Keywords: healthy female, pharmacokinetics, pharmacodynamics drug interaction,
cytoreductive prostatectomy in treating patients with newly diagnosed, metastatic prostate cancer

Conditions: Metastatic Prostate Carcinoma; Metastatic Prostatic Adenocarcinoma; Prostate Carcinoma Metastatic to the Bone

Summary: this phase i trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. when combined with hormone therapy, robotic assisted radical prostatectomy (rarp) or conventional open retropubic radical prostatectomy (rrp) may prolong survival in patients with prostate cancer that has spread.

primary objectives: i. to determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical t1-3n1m0 or t1-3n0m1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer). secondary objectives: i. time to prostate specific antigen (psa) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation. outline: patients undergo rarp or conventional open rrp. immediately following surgery, patients receive standard systemic androgen deprivation therapy. after completion of study treatment, patients are followed up every 90 days for 3 years.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the prostate * evidence of lymph node or bone metastasis by magnetic resonance imaging (mri)/computed tomography (ct), bone scan, or biopsy (n1mx or nxm1) * give informed consent * clinical stage t3 or less (pelvic mri shows no rectal and ureteral invasion) * cleared by the primary medical doctor for surgery * no prior systemic therapy for metastatic prostate cancer * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * refuses to give informed consent * refuses or is unable to have pelvic mri * clinical stage t4 (pelvic mri shows rectal and/or ureteral invasion) * deemed a poor surgical risk per primary medical doctor * received prior therapeutic intervention for metastatic prostate cancer * known spinal cord compression or brain or liver metastasis * deep vein thrombosis (dvt)/pulmonary embolism (pe) in the past 6 months
delivering a diuretic into the liver artery followed by plugging up the artery to starve out liver cancer cells

Conditions: Unresectable Hepatocellular Carcinoma

Summary: the purpose of this study is to test the safety of bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor tae as part of their regular care. bumetanide is a commonly used medication to reduce the amount of water in the body.


Eligibility criteria:
inclusion criteria: * patients with diagnoses of hcc according to european association for the study of liver disease (easl) criteria for diagnosis (see appendix 1). regional lymphadenopathy will be allowed. * any virus status accepted (e.g. hepatitis c etc.) * any prior liver treatment * patients within unresectable hcc * at least 18 years old * ecog performance status 0 or 1 * radiographically measurable disease per mrecist 1.1 * meets standard of care to undergo embolization exclusion criteria: * women who are pregnant or lactating * documented hypersensitivity to bumetanide or sulfonamides * patients with resectable hcc * high risk for post-embolization hepatic failure: °child's c cirrhosis °\> 80% liver involvement by tumor * contraindication to angiography/embolization including: * patients cannot receive contrast: * severe allergic reaction to contrast despite premedication * poor renal function not on dialysis * other, based on judgment of the investigator * ecog score 2 * main portal vein tumor thrombus * bclc d = patients with distant metastasis

Keywords: bumetanide diuretic transarterial embolization (tae) 17-141