Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of asenapine using an active control in subjects with schizophrenia or schizoaffective disorder (25520)(p05846)

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment. asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. this is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * subject with schizophrenia or schizoaffective disorder. must have completed 12 months treatment under protocol 25517. subject must sign a written informed consent. exclusion criteria: * have an uncontrolled, unstable, clinically significant medical condition.
signaling mechanisms and vascular function in patients with diabetes mellitus

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the purpose of the study is to learn how blood vessel function is altered by diabetes. we are studying an investigational drug, ebselen, to see if it can improve the ability of blood vessels to relax (widen).

a major cause of death and disability in patients with diabetes mellitus is atherosclerosis. endothelial dysfunction is an important, if not primary, factor in atherogenesis. nitric oxide is an important substance made and released by the endothelium. many prior studies in animals and humans have shown that the ability of the blood vessel to dilate is impaired in diabetes. this process of vasodilation is mediated by a substance, nitric oxide, which is thought to be highly susceptible to destruction by oxidant molecules. in previous studies, we found that acute administration of the antioxidant, vitamin c, improves endothelium-dependent vasodilation in blood vessels of patients with type 1 and type 2 diabetes. this suggests that by scavenging oxidants, such as superoxide, vitamin c may reduce the destruction of nitric oxide and thereby preserve endothelial function. additional mechanisms, including activation of a substance called protein kinase c, and oxidant stress from excess soluble peroxides may be present in diabetes and interact with oxidant stress to cause endothelial dysfunction in patients with diabetes. accordingly, we would like to study both of these mechanisms to determine their contribution to endothelial dysfunction.

Eligibility criteria:
inclusion criteria: * subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin exclusion criteria: * any diabetic subject with a hgba1c level of \ 11% * evidence of atherosclerosis * symptoms of angina * symptoms of claudication * symptoms of cerebrovascular ischemia * findings of arterial occlusive disease, as would be suggested by decreased pulses, asymmetric blood pressure, bruits or reduced limb pressure measurements * hypertension defined as a systolic blood pressure \> = 150 mmhg and a diastolic blood pressure \>= 95 mmhg; (allowable blood pressure medications for diabetic subjects include calcium channel blockers, alpha and beta adrenergic blockers, and diuretics) * hypercholesterolemia, defined as total cholesterol levels greater than 75th percentile for age and sex and ldl cholesterol levels \>130mg/dl. * renal insufficiency (serum creatinine \>1.5 mg/dl for men; \>1.2 mg/dl for women) * hepatic dysfunction defined as liver enzyme abnormalities \> two times the upper limit of normal * chronic pulmonary disease * congestive heart failure * pregnancy (or subjects planning to become pregnant); * history of cigarette smoking within the last five years; * history of clinically significant coronary artery or cerebrovascular disease (defined as mi or stroke within 6 months, or presence of unstable angina) * use of any, vasoactive, cardioactive, or non-steroidal anti-inflammatory medications within 24 hours of vascular testing visits
monitoring patients with acute cardiac disease using a wireless, wearable, non-invasive monitor

Conditions: Acute Cardiac Event; Acute Cardiac Failure; Acute Cardiac Pulmonary Edema

Summary: a prospective observational study in patients admitted with an acute cardiac disease, in which the ppg-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.


Eligibility criteria:
inclusion criteria: * men and women aged 18 years and above admitted to the cardiac icu due to an acute cardiac event. exclusion criteria: * pregnant women, subjects under the age of 18 years.

Keywords: acute catdiac events; remote patient monitoring
identification of genetic basis of atrioventricular conduction defects: from congenital forms to degenerative forms

Conditions: Congenital Complete Heart Block; Cardiac Conduction Defect Progressive

Summary: identification of genes involved in congenital atrioventricular block and progressive cardiac conduction disease.

atrioventricular blocks are a heterogenous group of diseases involving children with congenital atrioventricular block (cab) and more frequently elderly patients affected by progressive cardiac conduction disease (pccd). the aim of the study is to uncover the genetic model, likely more complex than previously appreciated, and characterize the gene expression remodelling leading to high degree of conduction defect. the recent technological developments in genomics coupled to the availability of large and highly characterized biobanks of patients have now set the stage: 1. to identify rare genetic variants/new genes contributing to cab and pccd by exome sequencing on familial form suspected to impact strongly the phenotype 2. to identify common genetic variants modulating the risk of developing (severe) pccd by gwas 3. to estimate the prevalence and relevance of genes uncovered by task#1, #2 in large patient sets (pccd and cab) by ngs.

Eligibility criteria:
congenital atrioventricular block inclusion criteria: * patients with idiopathic congenital atrioventricular block diagnosed before the age of 15 years. * non-immune congenital atrioventricular block documented by a maternal serology (negative for anti-nuclear antibodies or anti ro-ssa antibodies and anti la-ssb antibodies) * written consent to participate to the study and written consent of both parents. * parents of children with idiopathic congenital atrioventricular block. congenital atrioventricular block exclusion criteria * positive maternal serology * patients or parents who are unable to sign or who refuse to sign an informed consent progressive cardiac conduction disease inclusion criteria * patients with isolated cardiac conduction disorder with a normal morphology of the heart confirmed by echocardiography. * relatives of patients with isolated cardiac conduction disorder * written consent to participate to the study progressive cardiac conduction disease exclusion criteria * patients with cardiac conduction disorder associated with a structural cardiopathy or due to an identified cause * patients who are unable to sign or who refuse to sign an informed consent

Keywords: genetic congenital atrioventricular block progressive cardiac conduction disease
aquatic verses land exercise to decrease fall risk

Conditions: Osteoporosis

Summary: compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed with osteoporosis

background and purpose: fall prevention through exercise is an ongoing goal of researchers and clinicians. this study compared the effects of aquatic exercise (ae), land exercise (le) and no exercise (ne) on fall risk factors. subjects: seventy-three women, 60 or older, with osteoporosis (op). method: randomized clinical trial comparing balance, posture, strength, mobility, function, falls, and quality of life. results: significant differences (p\ ne), tandem balance (ae \> le) and function (le \> ae). joint pain and falls occurred more often during le. discussion and conclusion: participants experienced significant global improvement with both ae and le. less joint pain, reduced falls and improved balance were found in ae, however le was more effective in improving functional ability at home. clinicians should consider the individual's specific impairments and risk factors when recommending exercise programs on land or in water.

Eligibility criteria:
inclusion criteria: * age 60 or older * diagnosed with osteoporosis * female exclusion criteria: * has not been involved in regular exercise in past 2 months * does not have any medical or neurological condition that would significantly limit activities of daily living, such that involvement in an exercise program would jeopardize safety

Keywords: accidental falls osteoporosis risk factors
rise for health study

Conditions: Lower Urinary Tract Symptoms

Summary: the rise for health study (rise) is an initiative of the prevention of lower urinary tract symptoms (plus) research consortium, which was formed by the niddk in 2015 to develop the science to improve bladder health in women and girls. rise is designed to identify risk and protective factors for bladder health and lower urinary tract symptoms (luts) and to estimate the distributions of bladder health and bladder health knowledge, attitudes, and beliefs in women of all ages across the life course. this will be accomplished by conducting a population-based prospective cohort study. a sample of individuals who live within the study base, i.e., the county containing each plus clinical research center and each adjacent county, will be invited to complete two baseline surveys and then two follow-up surveys one year later. a subset of participants will be invited to attend an in-person evaluation to collect additional clinical information and biologic specimens.


Eligibility criteria:
inclusion criteria: * community dwelling * age ≥18 years * identify or born as female (includes cis- and trans-women, and trans-men) * able to read and understand english or spanish * able to read and provide informed consent exclusion criteria: * physical or mental health conditions that would prohibit self-administration of questionnaires either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis). * residence in a nursing home or other institutionalized living facility.

Keywords: bladder health luts plus rise
fecal microbiota transplantation for liver failure

Conditions: Liver Failure

Summary: to investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and "gut-liver axis immune system" of liver failure, and further optimization of fecal microbiota transplantation technology.


Eligibility criteria:
inclusion criteria: * patients willing to sign informed consent * patients aged 18-65 * according to the diagnosis standard of liver failure in the guide for diagnosis and treatment of liver failure (2018 edition), the eligible patients are included, that is, on the basis of chronic liver disease, the syndrome with acute jaundice deepening and coagulation dysfunction as the manifestation of liver failure caused by various inducements can be combined with complications such as hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, etc and extrahepatic organ failure. the patient's jaundice deepened rapidly, the serum tbil ≥ 10 × uln or the daily rise ≥ 17.1 μ mol / l; there was bleeding, pta ≤ 40% (or inr ≥ 1.5) exclusion criteria: * patients with severe heart failure, copd, cerebrovascular accident, nephrotic syndrome, etc; * patients with gastrointestinal bleeding, pulmonary infection, septicemia, etc * patients with liver cancer, lung cancer, lymphoma and other malignant tumors * patients taking anticoagulants, mental diseases and immune diseases for a long time * pregnant or lactating women.

Keywords: fecal microbiota transplantation gut-liver axis liver failure
the safety and effectiveness of lamivudine plus stavudine or zidovudine in hiv-infected patients who have taken zidovudine

Conditions: HIV Infections

Summary: to compare the magnitude and durability of the reduction in plasma hiv rna in the two treatment groups over the first 12 weeks of treatment. to determine the safety of each of the two treatment groups.

patients will be randomized to either stavudine (d4t) + lamivudine (3tc) + zidovudine placebo or zidovudine (zdv) + lamivudine + stavudine placebo. patients whose plasma hiv rna levels remain \>= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.

Eligibility criteria:
inclusion criteria patients must have: * at least six months of prior cumulative zdv therapy. * qualifying plasma hiv rna count of \>= 4 log10 copies/ml obtained within 2 weeks of randomization. exclusion criteria co-existing condition: patients with any of the following symptoms or conditions are excluded: * presence of newly diagnosed aids defining opportunistic infection requiring acute therapy at time of enrollment. * intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days). * signs and symptoms of bilateral peripheral neuropathy \>= grade 2 at the time of screening. * inability to tolerate oral medication. * any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements. concurrent medication: excluded: * therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential. * therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy. patients with any of the following prior conditions or symptoms are excluded: * history of acute or chronic pancreatitis. * prior history of bilateral peripheral neuropathy. * intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days) within 30 days prior to study entry. prior medication: excluded: * any prior antiretroviral therapy except for ddi, ddc, 3tc or zdv (for zdv, as specified in inclusion criteria). * previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start. * therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir. * any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen. risk behavior: excluded: * active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis. required: at least 6 months of prior cumulative zdv therapy.

Keywords: hiv-1 drug therapy, combination stavudine lamivudine rna, viral anti-hiv agents viral load
a clinical trial comparing cangrelor to clopidogrel standard therapy in subjects who require percutaneous coronary intervention (pci) (champion phoenix)

Conditions: Atherosclerosis; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Summary: the study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (pci).


Eligibility criteria:
inclusion criteria: patients may be included in the study if they meet all of the following criteria: * male or non-pregnant female at least 18 years of age * patients undergoing percutaneous coronary intervention (pci): 1. stable angina (sa) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis 2. non-st-segment elevation acute coronary syndrome (nste-acs) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis 3. st-segment elevation myocardial infarction (stemi) patients (diagnostic angiography not required) * provide written informed consent exclusion criteria: patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization: * receipt of any p2y12 inhibitor at any time in the 7 days preceding randomization * eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization) * abciximab usage within 7 days preceding randomization * receipt of fibrinolytic therapy in the 12 hours preceding randomization * increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (\<1 month) trauma or major surgery (including bypass surgery); currently receiving warfarin; active bleeding
patient decision aid for the treatment of actinic keratosis

Conditions: Actinic Keratoses; Patient Decision Aid

Summary: this study evaluates whether a patient decision aid for the field-directed treatment of actinic keratosis has an effect on shared decision making and patient satisfaction.

actinic keratosis is the most common epithelial precancerous lesion among the caucasian race. with an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice. there are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. treatment options can be divided into: lesion directed therapy en field directed therapy. a patient decision aid for field-directed therapies for actinic keratosis may attribute to better shared-decision making and patient satisfaction which on their part may benefits treatment compliance and health outcomes and may lead to fewer disputes between patients and doctors.

Eligibility criteria:
inclusion criteria: * diagnosis actinic keratosis in maastrichtumc+ or catharinahospital, eindhoven * age \>18 years exclusion criteria: * no knowledge of dutch language

Keywords: actinic keratosis
abdominal wall function and quality of life and before and after incisional hernia repair

Conditions: Hernia, Ventral

Summary: the primary objective of the present study is to investigate a possible correlation between abdominal wall function and subjective measures of qol before and after laparoscopic repair of small- to medium sized incisional hernia. this prospective study includes 25 patients undergoing laparoscopic incisional hernia repair. abdominal wall function is examined by determination of maximal truncal flexion and extension with a fixated pelvis using a goodstrength dynamometer (metitur ltd., jyväskylä, finland). subjective scores of qol (herqles), pain (visual analogue scale) and physical activity (international physical activity questionnaire) are assessed. patients are examined before, one month after and three months after the operation. furthermore, pulmonary function is examined preoperative and three months postoperative by standard spirometry (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in- and expiratory pressure is measured.


Eligibility criteria:
inclusion criteria: * elective laparoscopic repair for one or more incisional hernias in the midline (at least 5 cm caudal to the xiphoid process and at least 5 cm cranial to the pubic bone), using a synthetic mesh * horizontal fascial defect between 3 and 8 cm * age between 25 and 75 years * american association of anesthesiologist score between i and iii * body mass index \< 33 kg/m\^2 exclusion criteria: * severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries * existing stoma * postoperative complications requiring intervention
phase i trial of afatinib and trastuzumab in her2 overexpressing cancer.

Conditions: Breast Neoplasms; Stomach Neoplasms

Summary: the aim of the study is to determine the maximum tolerated dose (mtd) of afatinib in combination with 3-weekly trastuzumab in her2 overexpressing cancer and to assess the efficacy of afatinib given at the mtd dosage, with 3-weekly trastuzumab in her2 overexpressing metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 years and older 2. patients with cancers overexpressing her2 by immunohistochemistry test( ihc) 3+ and/or ihc 2+ with positive gene amplification by fish (confirmation on archived tissue needed) 3. written informed consent that is consistent with ich-gcp guidelines. 4. patients must be eligible for treatment with trastuzumab. 5. patients must have adequate organ function (kidney, liver, bone marrow, cardiac) 6. eastern cooperative oncology group (ecog) = 0 or 1. 7. measurable disease according to recist 1.1 (phase ib). exclusion criteria: 1. active brain metastases. 2. prior treatment with erbb family targeting therapies within the past four weeks before start of therapy or concomitantly with the trial other than trastuzumab and/or lapatinib. 3. patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (phase ib).
hepatic function during and following three days of acetaminophen dosing in alcoholics

Conditions: Alcohol Related Disorders

Summary: the study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of apap for three consecutive days. volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. the primary measures were aminotransferase measures taken at baseline and days 2-5. we hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.


Eligibility criteria:
inclusion criteria any patient, regardless of gender or ethnicity, who was: 1. 18 years or older 2. admitted to one of the two controlled access alcohol detoxification centers with a positive bal at the time of admittance 3. signed a written informed consent form. patients were excluded from the study at baseline if any of the following were present: 1. serum acetaminophen level greater than 20 mcg/ml 2. serum ast or alt levels greater than 200 iu/l 3. inr greater than 1.5 4. if female, positive for beta-subunit of chorionic gonadotropin 5. clinically intoxicated, psychiatrically impaired or unable to give informed consent 6. known hypersensitivity to acetaminophen 7. history of ingesting more than four grams of apap per day for any of the four days preceding study enrollment 8. currently enrolled in another trial or had been enrolled in another trial in the preceding three months.

Keywords: acetaminophen alcohol liver injury