Kornimate/medical-research-clean huggingface dataset:
the sunrise osa trial

Conditions: Obstructive Sleep Apnea

Summary: a prospective, randomised, blinded pilot study comparing the sunrise solution and overnight polygraphy for the diagnosis of osa in adult patients. patients under investigation for osa will use both devices simultaneously for a single overnight sleep study. they will be randomised to receive their treatment decision based on either the sunrise solution or polygraphy. a retrospective check of their diagnosis will be done.


Eligibility criteria:
inclusion criteria: 1. aged ≥18 2. ability and willingness to provide informed consent 3. patient referred for suspected osa 4. bmi \>28 kg/m2 5. epworth sleepiness score \>12 6. reported snoring (criterion may be ignored if patient sleeps alone) 7. patient able to use a smartphone application and having an internet connection at home exclusion criteria: 1. patient already treated for osa 2. patient has psv or hgv driving license 3. unstable cardiac disease 4. supplemental oxygen 5. known secondary sleep pathology e.g. periodic limb movement syndrome, narcolepsy, circadian disorder, obesity hypoventilation syndrome 6. concerns about sleepy driving or any other potentially dangerous symptom from physician or urgent referral from gp when patient has been told to stop driving 7. pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure 8. patient whose beard is too thick to wear the sunrise device, and who does not wish to shave 9. patient with acrylic or painted fingernails, who does not wish to remove acrylic or paint
central blood volume in hypotensive dialysis patients

Conditions: Intradialytic Hypotension

Summary: the purpose of the study is to test whether hypotensive episodes during dialysis - caused by withdrawal of fluid drom the circulation - can be predicted by means of two harmless monitoring techniques.


Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients with central vascular access exclusion criteria: * patients below 18 years of age * patients unable to give informed consent
sir-spheres® 90y microspheres treatment of uveal melanoma metastasized to liver

Conditions: Stage IV Uveal Melanoma

Summary: the purpose of this study is to determine whether radiation provided locally to the liver tumor vasculature environment will demonstrate a response of tumor decline. this radiation may cause the tumor cells to die.


Eligibility criteria:
inclusion criteria: * must have diagnosis of metastatic melanoma liver disease by histological confirmation * one measurable untreated or progressed liver lesion * less than 50% liver involvement * must have ecog performance status of 0-1 * must have adequate renal and bone marrow function as: serum creatinine ≤ 2.0 mg/dl, granulocyte count ≥1000/mm3 and platelet count ≥100,000/mm3 * must have adequate liver function as: total bilirubin \ 3.0 g/dl exclusion criteria: * failure to meet any of the inclusion criteria * solitary liver metastasis that is amenable to surgical removal * previous treatment with isolated hepatic perfusion * systemic chemotherapy within 2 weeks of study entry * significant shunting to the lung (\>20%) as identified on technetium-99m-macro-aggregated albumin nuclear medicine break-through scan * unsuccessful closure of collateral blood flows from the hepatic artery to non-targeted organs such as the gi tract * symptomatic liver failure including ascites and hepatic encephalopathy * metastasis outside of liver requiring systemic treatment within 3 months * untreated brain metastasis * main portal vein occlusion or inadequate collateral flow * uncontrolled hypertension or congestive heart failure * acute myocardial infarction within 6 months * medical complications with implication of less than 6 month survival * uncontrolled severe bleeding tendency or active gi bleed * significant allergic reaction to iodinated contrast * previous radiation that includes the liver in the main radiation field * pregnant or breast-feeding women * biliary obstruction, stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy * children under the age of 18

Keywords: sir-spheres liver metastases selective internal radiation yttrium-90 uveal melanoma ocular melanoma
cognitive impact of pomegranate polyphenols following ischemic stroke

Conditions: Stroke

Summary: the purpose of this study is to determine whether pomegranate supplements improve cognitive functioning following stroke.

research suggests that antioxidants (substances that may slow or prevent cell damage) found in many fruits and vegetables may help improve brain functioning (for example, memory and attention) in healthy individuals and prevent cognitive decline in individuals who have suffered a stroke. the purpose of this research study is to examine whether dietary supplementation with an antioxidant extract can help promote healthy cognitive functioning as a component of recovery after stroke. the procedures include: administering polyphenols via 2 pomx pills, each of which contains polyphenols derived from pomegranates equivalent to the content of approximately 8 ounces of pomegranate juice, or placebo pills (capsules containing no polyphenol ingredients), every day for one week to inpatients who are in the acute post-stroke phase. neuropsychological testing pre- and post-treatment will determine whether cognitive functioning changes. subjects will be randomized into either a placebo or polyphenol group.

Eligibility criteria:
inclusion criteria: * suffered an ischemic stroke and admitted to llumc rehabilitation institute for inpatient care * fluent in english * between the age of 18 and 89 years old exclusion criteria: * less than 6 years of education * global aphasia * pregnant * history of allergy to pomegranates * history of traumatic brain injury * neurodegenerative disease or neurologic condition with known cognitive impact (e.g., alzheimer's disease) * active renal disease * active liver disease * intracerebral hemorrhage in past 6 months * neurosurgery in past month * taking warfarin (coumadin)

Keywords: pomegranate stroke neuropsychology
the efficacy and safety of peg-rhg-csf（pegylated recombinant human granulocyte colony stimulating factor)in patients with breast cancer who were treated with intensive chemotherapy

Conditions: Breastcancer

Summary: the purpose of the study is to evaluate the efficacy and safety of peg-rhg-csf in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.


Eligibility criteria:
inclusion criteria: 1.18-65 years old, gender no limited. 2.breast cancer diagnosed by pathology. 3.did not receive chemotherapy previously and plans to receive 4 cycles intensive ec (epirubicin, cyclophosphamide) treatment. 4.no obvious blood system disease, anc(absolute neutrophil count)≥ 1.5 × 10\^9/l, plt（platelet）≥80×10\^9 /l, hb（hemoglobin）≥75g/l, wbc（white blood cell ）≥3×109/l, and no bleeding tendency. 5.kps (karnofsky performance status) score≥70. 6.expected survival≥3 months. 7.written informed consent are acquired. exclusion criteria: 1. severe or uncontrolled infection. 2. sensitive to the product or other genetically engineered biological products from escherichia coli strains. 3. mental or nervous system disorders. 4. severe heart, lung and central nervous system disorders. 5. pregnant or lactating women. 6. tbil(total bilirubin ), alt（alanine aminotransferase）,ast（glutamic-oxalacetic transaminase） \> 2.5×uln（upper limit of normal）; if it were caused by liver metastases, tbil, alt,ast \>5×uln. 7. cr（creatinine） \>1.5×uln.
antenatal platelet response on aspirin: a pharmacokinetic study through pregnancy

Conditions: Preeclampsia

Summary: longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy

this will be a longitudinal addition to an existing r21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (pk/pd) of aspirin and how individual factors impact aspirin pk/pd in pregnancy.

Eligibility criteria:
inclusion criteria: * \<16 weeks' gestational age * singleton pregnancy * plan to take 81mg aspirin due to high risk history (below), but not yet initiated * ≥1 risk factor: * chronic hypertension * type i or ii diabetes * previous preeclampsia * renal disease * autoimmune disease (sle) or ≥2 risk factor: * nulliparity * ivf pregnancy * black race or socioeconomic disadvantaged * bmi\>30 * prior adverse pregnancy outcome exclusion criteria: * contraindication to aspirin * current or planned use of any other anticoagulation * current need for dialysis * use of aspirin therapy prior to enrollment in the current pregnancy * thrombocytopenia (\<150) * other known platelet disorder/thrombophilia at enrollment
effects of romantic affection on blood chemistry and immune parameters

Conditions: Stress; Hypercholesterolemia

Summary: this trial tests the hypothesis that increasing nonverbal affection in romantic relationships will improve blood lipid parameters (total cholesterol, high and low density lipoproteins, triglycerides), blood glucose, and immune parameters (c-reactive protein and antibodies to latent epstein-barr virus). 52 healthy cohabiting romantic couples took part. in half of the couples, one partner increased the frequency of romantic kissing with the other partner during the six-week trial. the other couples received no such instruction. blood tests performed before and after the trial were used to assess the health outcomes.


Eligibility criteria:
inclusion criteria: * 18+ years of age; * english-speaking; * current co-habitation with romantic partner exclusion criteria: * history of hypercholesterolemia; * current pregnancy; * current use of blood-thinning agents; * greater than moderate anxiety about giving capillary blood; * weight of less than 110 pounds
phosphodiesterase type 5 inhibition to improve endothelial function and vascular remodeling in chronic kidney disease and end stage renal disease patients requiring new arteriovenous fistula

Conditions: Improve Endothelial Function and Decrease Vascular Stenosis

Summary: patients with stage iv and v chronic kidney disease and end stage renal disease requiring hemodialysis at university of alabama at birmingham (uab) dialysis clinics will be recruited from the uab vascular access clinic, which has been the site for recruitment of patients requiring new vascular access for the last 10 years.

the main purpose of this research study is to conduct a research study to determine if sildenafil compared to placebo will improve the vascular health of arteries and veins before arteriovenous fistula creation (shunt) and how quickly your veins and arteries dilate and increase in blood flow after fistula creation. an arteriovenous fistula (shunt) is a connection between the artery and vein in the arm for dialysis use. another purpose of this study is to determine if sildenafil reduces the blood and tissue levels of oxidants prior to fistula creation. oxidants are harmful substances in the body that damage the cells tissues, and organs.

Eligibility criteria:
inclusion criteria: 1. age ≥19 years of age male or female 2. chronic kidney disease stage iv or v patients or end stage renal disease patient requiring arteriovenous fistula surgery exclusion criteria: 1. patient currently on nitrate therapy or any nitric oxide donor in any form 2. patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor 3. patient with resting systolic blood pressure \<90 mm hg and diastolic blood pressure \< 50 mm hg. 4. patient life expectancy \< nine months. 5. patient unable or unwilling to meet study requirements.

Keywords: arteriovenous fistulas (avfs) hemodialysis fistula maturation (hfm) flow-mediated dilation (fmd) nitroglycerin-mediated (nmd) venous plethysmography (vp)
multiple-dose tolerability and pharmacokinetic of ibi362 in chinese patients with t2dm

Conditions: Type 2 Diabetes

Summary: this trial is aimed to investigate the safety, tolerability, pk and pd of multiple subcutaneous injections of ibi362 in chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention

this is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and pk/pd of ibi362 administered as multiple injections in chinese patients with type 2 diabetes. the investigators and subjects will be blinded to the study drug ibi362 and placebo. dulaglutide will be used as an open-label active control group. in this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts. each corhot will be randomized as an 8:4:2 ratio to ibi362 (n = 8), placebo (n = 4), and dulaglutide 1.5 mg (n = 2).

Eligibility criteria:
\* eligibility criteria： inclusion criiteria: 1. male or female 18 to 75 years of age at the time of consent. 2. t2d patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 2 months prior to screening. 3. hba1c 7.5% ≤ 11.0% by local laboratory at screening. 4. body mass index 20 ≤ bmi ≤ 35 kg/m2. exclusion criteria: 1. type 1 diabetes, special types of diabetes, or gestational diabetes. 2. ketoacidosis or lactic acidosis within 6 months prior to screening. 3. history of severe hypoglycaemic episodes within 6 months prior to screening. 4. acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (tia), cerebrovascular accident, acute and chronic heart failure within 6 months before screening. 5. clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (alt and ast) and alkaline phosphatase (alp) \> 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening. 6. the patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.
a two year safety and efficacy study in obese patients (0364-015)(terminated)

Conditions: Obesity

Summary: a study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.


Eligibility criteria:
inclusion criteria: * obese patients with a body mass index between 30 kg/m2 and 43 kg/m2, inclusive (bmi between 27 kg/m2 and 43 kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia, and sleep apnea exclusion criteria: * patients with serious or unstable current or past medical conditions
peptide vaccine focusing on prevention of the recurrence for bladder cancer

Conditions: Bladder Cancer

Summary: the purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after tur-bt

dep domain containing 1(depdc1) and m phase phosphoprotein 1(mphosph1) have been identified using genome-wide expression profile analysis by the use of cdna microarray in our previous studies. the investigators have determined the hla-a\*2402 restricted epitope peptides derived from depdc1, depdc1-9-294, and mphosph1, mphosph1-9-278. these epitopes showed strong ifn-g production when stimulated with the appropriate targets expressed the appropriate protein and hla-a\*2402. furthermore, when vaccinated these peptides, specific ctls were determined after the vaccination. therefore we focused on the prevention of the recurrence of the bladder cancer after surgery using these peptides.

Eligibility criteria:
inclusion criteria disease characteristics 1. bladder cancer without solitary and low grade tumor 2. protein expression of mphosph1 and depdc1 on the tumor patients characteristics 1. patients must be treated completely by transurethral resection of the bladder tumor(tur-bt), and must have no residual tumor after re-tur-bt. 2. patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder. 3. patients must be treated by tur-bt, who are able to treated by intravesical bacillus calmette-guerin (bcg) for adjuvant therapy 4. ecog performance status of 0 to 1 5. age ≥ 20 years, ≤80 years 6. wbc≥ 2,000/mm³, ≤15000/mm³ platelet count ≥ 75000/mm³ ast, alt ≤150 iu/l total bilirubin ≤ 3.0 mg/dl creatinine ≤ 3.0 mg/dl 7. samples of bladder cancer must express mphosph1 or depdc1 8. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) 2. breastfeeding 3. patients willing to childbearing ( refusal or inability to use effective means of contraception) 4. serious infections requiring antibiotics 5. concomitant treatment with steroids or immunosuppressing agent 6. other malignancy difficult to control. 7. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: epitope peptide, ctl, tur-bt, bladder cancer, vaccination bladder cancer after surgery
4d cbct and intrafractional imaging for the determination of the most representative 4d simulation planning technique for lung sbrt technique patients

Conditions: Cancer of Lung

Summary: the researchers plan to investigate two ways of visualizing and planning to account for the respiratory motion which takes place while treating lung tumors with radiation therapy. the researchers will determine if a traditional snapshot (free-breathing) ct or a longer-lasting ct encompassing the breathing cycle better matches a patient's breathing during treatment.

as part of this study the patient will receive the standard of care treatment of stereotactic body radiation therapy (sbrt) approach for treatment of lung cancer. the study will compare whether the quick snapshot or longer-last image is more representative of breathing motion. the standard of care way to verify breathing is to use the cone beam computerized tomography (cbct) before each treatment. for this study the researchers will use two other standard of care ways to verify breathing motion during treatment only during the first and last radiation treatment sessions. during the other radiation treatment sessions the cbct alone will be used. these two other methods are fda approved, but not routinely being used at the mays cancer center. one method is called 4d-cbct and is conducted immediately prior to treatment. this will create an image taken over a longer time of the patient's lungs which will be compared with the images from the ct simulation used to plan the radiation. the other way is called intrafractional cbct and is imaging that is done at the same time as the radiation treatment delivery. this will show the researchers how the tumor is moving while the radiation treatment is taking place. these two methods require a longer treatment time, approximately 10 minutes during the first and last treatments.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * ability to provide informed written consent in either english or spanish. * patients with cancer or presumed cancer involving the lung (primary or secondary) planned to undergo lung sbrt technique or imrt technique with an sbrt setup in 10 or fewer fractions. exclusion criteria: * current pregnancy, as this is a contraindication to receiving radiation therapy. * patients to be treated to multiple targets concurrently. * any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to the prescribed pattern of radiation therapy. * poor lung function, as judged by the prescribing radiation oncologist, sufficiently limiting to make the patient not a candidate for 4d imaging (for example major differences between the 4d and free-breathing ct scan).
to test the relative bioavailability of pf-04191834 when dosed as an immediate release tablet compared with solution following single and multiple dosing

Conditions: Asthma

Summary: to test the relative bioavailability of pf-04191834 when dosed as an immediate release tablet compared with solution following single and multiple dosing.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of approximately 17.5 kg/m2 to 30.5 kg/m2 and a total body weight \> 50 kg (110 lbs). * an informed consent document signed and dated by the subject or a legally acceptable representative. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * subjects who have urinary lte4 levels greater than or equal to 30 pg/mg creatinine at screening following spot urinary collection for cohort 2. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen.