Kornimate/medical-research-clean huggingface dataset:
tgr-1202, a pi3k delta inhibitor, in combination with obinutuzumab and chlorambucil in patients with chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to evaluate the safety and effectiveness of tgr-1202 in combination with obinutuzumab (gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.


Eligibility criteria:
inclusion criteria: * confirmed chronic lymphocytic leukemia (cll) * eastern cooperative oncology group (ecog) score of 0 to 2 * ability to swallow oral medication exclusion criteria: * known hepatitis b virus, hepatitis c virus or hiv infection * primary central nervous system lymphoma or known intracranial involvement * autologous hematologic stem cell transplant within 3 months of study entry or allogeneic hematologic stem cell transplant within 12 months
preeclamptic patients and pentraxin 3 & lipoprotein-associated phospholipase a2

Conditions: Pre-Eclampsia

Summary: in particular, pentraxine 3 (ptx3) molecule was assumed to have a prognostic value in acute myocardial infarction.in patients affected by acute myocardial infarction, early plasma elevation of ptx3 appears to predict a worse outcome in these patients in the longer term. the inflammatory basis of preeclampsia resembles an atherogenic process.it is planned to investigate the role of these two molecules in endothelial dysfunction typical of preeclampsia. the level of circulating ptx3 and lp-pla2 in preeclamptic patients and their serum levels according to the severity of preeclampsia and presence of iugr, and comparison with the control group without preeclampsia and it is planned to investigate the cut-off values and sensitivity and specificity of both molecules together and separately in preeclampsia.


Eligibility criteria:
inclusion criteria: * pregnant women diagnosed with preeclampsia; the blood pressure and proteinuria (at least ≥ 300 mg in urine for 24 hours) will be established before the 20th week of gestation in normotensive pregnancies with an interval of 6 hours. * those who have grand mal convulsions; other causes of convulsions and exclusion of coma were defined as having seizures for the first time after 20 weeks of gestation and 48-72 hours after delivery. * the diagnosis of hellp syndrome will be confirmed by intravascular hemolysis. (abnormal peripheral smear and / or abnormal bilirubin values), high liver enzymes (high serum aspartate transaminase levels \[ast\], alanine transferase \[alt\] and lactate dehydrogenase \[ldh\] üst 2 upper level) and low platelet count (\<100 000 / mm3) * healthy pregnant women without additional disease for the control group exclusion criteria: * maternal diabetes * kidney disease * cardiovascular disease * neurological disease * drug use history * hematological and immunological disease * the presence of any infection * fetal anomaly * in utero dead fetus

Keywords: pentraxin 3 lipoprotein-associated phospholipase a2 preeclampsia risk markers
a study of lobucavir in patients with aids

Conditions: Cytomegalovirus Infections; HIV Infections

Summary: the purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with aids.

patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. weekly clinic visits are required.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * aerosolized pentamidine. * tmp / smx. * isoniazid. * dapsone. * fluconazole. * ketoconazole. * rifabutin. * fluoxetine hcl. * acetaminophen. * antacids. * metamucil. * multivitamins. * other drugs with approval from sponsor. patients must have: * aids. * cd4 count \< 200 cells/mm3. * cytomegalovirus ( cmv ) viruria and virosemenia. * no evidence of intraocular cmv. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness. * inability to take oral medication. * allergy to nucleoside analogs. * diarrheal illness. * poor venous access. * positive test for drugs of abuse. * any other condition that would render patient unsuitable for study. patients with the following prior conditions are excluded: * history of pancreatitis. * recent diarrheal illness. * history of weight loss. * acute serious illness within 4 weeks prior to study entry. prior medication: excluded within 4 weeks prior to study entry: * erythropoietin. * any agent with anti-cmv activity. * other investigational agents. prior treatment: excluded within 4 weeks prior to study entry: * surgery. * blood transfusion. drug abuse.

Keywords: cytomegalovirus infections acquired immunodeficiency syndrome antiviral agents
new strategy study of functional cure of chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: as hbsag clearance is uncommon in chronic hepatitis b (chb) patients on nucleoside analogues (nas) therapy. the purpose of this study is to optimize hbsag clearance in chb patients with sequential treatment of pegylated interferon alpha-2b and nas.

chb patients who had received, and responded to, nas for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.

Eligibility criteria:
inclusion criteria: 1. chb patients who had received nas for more than 12 months. 2. hepatitis b e antigen (hbeag)-negative and anti-hbeag positive. 3. hepatitis b surface antigen (hbsag) positive and \<1500 iu/ml. 4. hepatitis b virus dna not detectable. exclusion criteria: 1. patients with liver cirrhosis, hepatocellular carcinoma or other malignancies. 2. patients with other factors causing liver diseases. 3. pregnant and lactating women. 4. patients with concomitant hiv infection or congenital immune deficiency diseases. 5. patients with diabetes, autoimmune diseases. 6. patients with important organ dysfunctions. 7. patients with serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. ) 8. patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. 9. patients who can't come back to clinic for follow-up on schedule.

Keywords: chronic hepatitis b peginterferon alfa-2b nucleotide analogue
study of imrt radiotherapy concurrent chemothrerapy for anal cancer

Conditions: Anal Cancer

Summary: the purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (imrt) concurrent with chemotherapy for anal squamous carcinoma. all enrolled anal squamous carcinoma patients are intented to receive imrt concurrent with capecitabine + mitomycin ± cetuximab targeted therapy.


Eligibility criteria:
inclusion criteria: * ct/mri diagnosed stage ct1-4n0-3; * histologically confirmed anal squamous carcinoma; * kps \>= 70 * adequate organ function; * no previous radiotherapy or chemotherapy; * no surgery. exclusion criteria: * previous malignant cancer history; * allegic to 5-fu or mmc

Keywords: radiotherapy anal cancer imrt
comparison of bioactive glass and beta-tricalcium phosphate as bone graft substitute

Conditions: Bone Neoplasm

Summary: this study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (bag) and beta-tricalcium phosphate (tcp), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. based on the investigators' previous preclinical research and an ongoing single-center randomized clinical trial on bioactive glass filling, the investigators expect bag filling to be more efficient compared to tcp in promotion of defect healing and functional recovery after surgery.

this study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (bag) and beta-tricalcium phosphate (tcp), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. small metacarpal and phalangeal enchondromas (stratum i) and large long-bone lesions (stratum ii) will be evaluated separately. aside with the head-to-head comparison of the two synthetic bone graft substitutes, autologous bone graft (stratum i) and allogeneic bone graft (stratum ii) will be used as the standard of care controls.

Eligibility criteria:
inclusion criteria: * patients with primary or recurrent benign bone tumor or tumor-like condition that requires operative treatment by means of tumor evacuation and defect filling * pathological fractures of patients in stratum i are treated by means of conservative treatment for three months before tumor surgery exclusion criteria: * history of acute or chronic local infection * history of malignancy (excluding carcinoma basocellular) within past 5 years * a history of local radiotherapy * a known metabolic skeletal disease (such as osteoporosis, paget's disease or osteomalacia) * medication affecting bone turnover (oral bisphosphonates, pth, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids) * any plans to use phenol or other chemical/thermal method of local tumor control * pregnancy * any other condition that in the judgment of the investigator, would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results

Keywords: bone tumors surgery bone graft substitutes bioactive glass bioceramics bone autograft bone allograft
acb versus ia analgesia in knee arthroscopy

Conditions: Postoperative Pain

Summary: reconstruction of the anterior cruciate ligament (acl) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity.

reconstruction of the anterior cruciate ligament (acl) of the knee is a painful procedure, with postoperative analgesia providing patient comfort, early mobilization, and discharge within 24 hours. various methods for postoperative analgesia management are available, such as systemic opioids, epidural local anesthetic, peripheral nerve block and local anesthetic infiltration analgesia. use of systemic opioids can cause adverse effects that may affect functional rehabilitation, such as nausea, vomiting, pruritus, sedation and respiratory depression. hypotension, urinary retention, and pruritus are more common in patients with epidural analgesia. in addition, use of long-acting intrathecal opioids causes adverse effects such as bilateral motor block, tremor and hypotension. systemic and intrathecal methods for postoperative analgesia are gradually being abandoned because of these negative effects. the saphenous nerve is the largest contributor to sensory perception around the knee, while the adductor canal contains the nerve to the vastus medialis, the medial femoral cutaneous nerve, the medial retinacular nerve, articular branches from the posterior division of the obturator nerve and occasionally the anterior branch of the obturator nerve. although adductor canal block (acb) can contribute towards motor blockade of the periarticular musculature, its effect on functional weakness of the quadriceps has been reported to be minimal, compared with femoral nerve block (fnb). intra-articular (ia) local anesthetic agents have been used either alone or in combination with other agent. however, it was observed that use of combination of drug is better than single drug for prevention of postoperative pain, providing synergistic effect and reducing side effects compared to high dose of single drug. dexamethasone is a potent and highly selective glucocorticoid with minimal mineralocorticoid effect. it blocks the nociceptive impulse transmission along the myelinated c fibers. dexamethasone prolongs the duration of regional blocks, when combined with local anesthetics.

Eligibility criteria:
inclusion criteria: * patients undergoing elective arthroscopic reconstruction of the anterior cruciate ligament (acl) under spinal anesthesia, aged from 18 to 65 years old exclusion criteria: * contraindications to peripheral nerve block (e.g. allergy to local anesthetics, coagulopathy, infection in the area) * history of cardiovascular, cerebrovascular, and respiratory diseases * preexisting neuropathies * chronic pain syndrome * opioid dependence * patients with diabetes mellitus, sever hypertension, hepatic or renal dysfunction * pregnancy * not willingness to participate.
pathweigh: pragmatic weight management in primary care

Conditions: Obesity

Summary: the study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. this will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews.

this study will investigate how pathweigh, a weight management tool built into the epic electronic health record, in combination with clinician and staff training on the use of pathweigh as a tool, education on effective weight management practices, and practice facilitation to support implementation can facilitate weight loss and maintenance for primary care patients. the study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. this will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews. this study is being conducted because despite obesity being the leading cause of preventable death in the u.s. and a major risk factor for disease, people with any degree of overweight or obesity are rarely offered anything other than lifestyle advice, rather than more rigorous and evidence-based weight management strategies. poor reimbursement for weight-related visits, competing priorities, lack of appropriate tools, and limited time in visits also prevent more widespread use of weight management interventions. pathweigh helps primary care clinicians and teams prioritize weight management with their patients when appropriate and ensures that they have the tools and knowledge handy to do so effectively. as part of the assessment of the pathweigh intervention, the study will identify predictors of patient weight loss and weight loss maintenance using mediator and moderator analysis. relevant factors (patient demographics, health metrics (e.g. vital signs, anthropometrics, comorbidities), behaviors and goals, provider age, sex, years and % time practicing, and clinic information (e.g. size, location, culture scale)) will be evaluated by including interaction terms between the treatment variable and possible moderating variables in outcome regression models .

Eligibility criteria:
clinician inclusion criteria: * affiliated with a participating primary care practice * provide care for adult patients (\>=18 years old) patient inclusion criteria: * all adult patients (age \>18 years) * bmi \>25 kg/m2 * appointment at a primary care clinic participating in the study patient exclusion criteria: * unable to participate in weight loss treatment due to factors such as cognitive deficits, non-home residence, or limited life expectancy.

Keywords: obesity primary care electronic health record
zydena on cognitive function of alzheimer's disease patients

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine whether zydena (udenafil) has positive effect on cognitive function in patients with alzheimer's disease. this study is a randomized, double blind, placebo-controlled multicenter study.


Eligibility criteria:
inclusion criteria: * signed written informed consent; * male or female subjects 50 to 90 years of age; * diagnosis of probable alzheimer's disease according to national institute of neurological disorders and stroke and the alzheimer's disease and related disorders association (nincds/adrda) criteria; * a mini-mental state examination (mmse) score of ≥10 and ≤26; * global clinical dementia rating ≥ 0.5; * mild to moderate (not severe) white matter hyperintensities on brain mri performed within three years from screening; * good enough hearing and visual function to complete neuropsychological tests * caregivers living with patients or spending 10 or more hours a week with patients; * stable dose of donepezil (5mg to 10mg) for at least 60 days; * if patients have been on memantine, it should be washed out for at least 60 days; * medications including anxiolytics, antipsychotics, and hypnotics may be taken if the dose has been stable for at least two weeks exclusion criteria: * history of stroke within 6 months; * previous diagnosis of severe (more than 80%) intracranial artery stenosis; * history of heart failure, ischemic heart disease (myocardial infarction, unstable angina, and stable angina), hypertrophic cardiomyopathy, and life-threatening arrhythmia; * previous history of coronary artery bypass graft surgery; * severe symptom of orthostatic hypotension (orthostatic syncope or presyncope), especially when patients take alpha-adrenergic blocker (alfuzosin, doxazosin, naftopidil, tamsulosin, terazosin, arotinolol, carvedilol, labetalol, trazodone, typical and atypical antipsychotics); * uncontrolled diabetes mellitus; * proliferative diabetic retinopathy; * severe hypotension (blood pressure less than 90/50mmhg) or severe hypertension (blood pressure more than 170/100mmhg); * hepatic dysfunction (ast or alt more than three times of upper normal limit) or renal dysfunction (serum creatinine more than 2.5mg/dl); * retinitis pigmentosa; * previous history of active peptic ulceration within one year before screening; * hematodyscrasia susceptible to priapism including sickle cell anemia, multiple myeloma, leukemia, and various bleeding disorders; * history of drug abuse; * medication including nitrates/nitric oxide donor (ex: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, and sodium nitroprusside), androgen (ex: testosterone), anti-androgen, and anticoagulants; * current cancer chemotherapy; * usage of pde5i (zydena, viagra®, levitra®, or cialis®) within two weeks before study start; * history of hypersensitive reaction to pde5i (zydena, viagra®, levitra®, or cialis®)
gadolinium-enhanced extracranial mra prior to mechanical thrombectomy is not associated with an improved procedure speed

Conditions: Stroke

Summary: the objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (mra) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics. consecutive patients (912) treated by mechanical thrombectomy (mt) at a large comprehensive stroke center between january 2012 and december 2017 who were screened using pre-intervention mri were included. patient's characteristics and procedural data were collected. analyses were performed to compare mechanical thrombectomy speed, efficacy, complications, and clinical outcomes between patients with and without pre-intervention gadolinium-enhanced extracranial mra.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke exclusion criteria:

Keywords: mechanical thrombectomy magnetic resonance angiography angiogram angiography magnetic resonance imaging revascularization
effect of concomitant use of an antimycotic, an antibiotic, a spermicide or tampons on pharmacokinetics of anastrozole and levonorgestrel released from intra-vaginal ring

Conditions: Endometriosis

Summary: to investigate the pharmacokinetic effect of a vaginally administered antimycotic (miconazole), antibiotic (clindamycin), spermicide (nonoxynol-9) or the concomitant use of tampons during the use of an intravaginal ring releasing anastrozole and levonorgestrel


Eligibility criteria:
inclusion criteria: * healthy pre-menopausal female subject. * age: 18 - 50 years (inclusive) at the first screening visit. for the subject \> 45 years follicle stimulating hormone (fsh) will be investigated at the second screening visit to confirm the pre-menopausal status (fsh \< 40 iu/l in serum). * body mass index (bmi ) above or equal 18, and below or equal 30 kg / m² at the first screening visit. * adequate venous access. * ability to understand and follow study-related instructions * agreement to use adequate non-hormonal contraception. * confirmation of the subject's health insurance coverage prior to the first screening examination/visit. exclusion criteria: * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. * thrombophlebitis, venous / arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction). * presence or history of prodromata of thrombosis (e.g. transient ischemic attack, angina pectoris). * known hypersensitivity to the study medications (active substances or excipients of the preparations). * regular intake of medication other than hormonal contraceptives. * use of systemic or topical medication or substances which oppose the study objectives or which might influence them within 4 weeks before first administration of the study medication, * smoking of more than 10 cigarettes daily; if the subject is a smoker: subject is older than 35 years * suspicion of or known current drug, medicine or alcohol abuse (including anabolics, high-dose vitamins). * abnormal cervical smear * previous ectopic pregnancy.
a lifestyle investigation with spectacles and daily disposable contact lenses in young patients

Conditions: Myopia

Summary: the purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.


Eligibility criteria:
inclusion criteria: * understands rights as a research subject and willing and able to sign a statement of informed consent, or if under 18, parent or guardian understands rights and is willing and able to sign a statement of informed consent. * willing and able to follow the protocol. * currently wearing spectacles full-time (at least five days per week, eight hours per day). * has never worn contact lenses (more than one day) before. * agrees to not participate in other clinical research for the duration of this study. * can attain at least 6/9 in each eye with the study optical correction. * can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group). * willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day. * owns or has regular access to a mobile phone and is familiar with sms text messaging. * has an up-to-date and functional pair of spectacles at time of enrollment. * other protocol-defined inclusion criteria may apply. exclusion criteria: * has an ocular or systemic disorder that would normally contraindicate contact lens wear. * is using any topical medication such as eye drops or ointment. * has had corneal refractive surgery. * has had cataract surgery. * has diabetes. * has taken part in other clinical research within two weeks of starting the study. * other protocol-defined exclusion criteria may apply.