Kornimate/medical-research-clean huggingface dataset:
efficacy of l-ornithine-l-aspartate in cirrhotics with hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: the purpose of this study is to determine whether l-ornithine l-aspartate is effective for the improvement of overt hepatic encephalopathy.

there is no effective treatment available for hepatic encephalopathy at the moment; therefore we aimed to check the efficacy and safety of l-ornithine l-aspartate(lola). it provides critical substrates for ureagenesis and glutamine synthesis, the two primary mechanisms by which the body rids itself of excess ammonia. ornithine is a specific activator of ornithine carbamyl transferase and carbamylphosphate synthetase, and, in addition, is a substrate for ureagenesis. these reactions are carried out mainly in the periportal portion of the hepatic lobules. aspartate and ornithine, after conversion to alfa-ketoglutarate, are substrates for glutamine synthesis, which is performed exclusively by a small population of perivenous hepatocytes, the so-called perivenous scavenger cells. the ammonia lowering effect resulting from the stimulation of these two basic mechanisms of ammonia detoxification has been studied in animals and was confirmed in humans in clinical trials.

Eligibility criteria:
inclusion criteria: * cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis, * patients \>14 years, with he grades 1 to 4 according to west haven criteria, * hyperammonemia (fasting venous blood ammonia level \>60 µmol/l), and * patients with a single reversible precipitating factor of he such as constipation, hypokalemia, urinary tract infection, respiratory tract infection, spontaneous bacterial peritonitis (sbp), dehydration, or none. exclusion criteria: * hepatocellular carcinoma, * severe septicemia, * active gastrointestinal bleeding, * hepatorenal syndrome, * acute superimposed liver injury, * advanced cardiac or pulmonary disease and end stage renal failure, * patients with minimal he * patients taking sedatives, antidepressants, or benzodiazepines and * patients with chronic he on metronidazole or lactulose prior to admission.

Keywords: l-ornithine-l-aspartate, porto-systemic encephalopathy, hepatic encephalopathy, liver cirrhosis, mental state
a study to evaluate pre-emptive treatment for invasive candidiasis in high risk surgical subjects

Conditions: Mycoses

Summary: subjects with intra-abdominal infection requiring surgery and intensive care unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.

subjects will be assessed at the following visits: * baseline (after surgery, prior to randomization) * end of treatment (eot) visit (eot is defined as: requires alternative antifungal, sufficient improvement of surgical condition, confirmed fungal infection or death) * end of study visit (28 days after the eot visit) * long-term follow up visit (90 days after the eot visit)

Eligibility criteria:
inclusion criteria: * intra-abdominal infection requiring surgery and intensive care unit stay * if community acquired intra-abdominal infection, at least 72 hours (but not more than 120 hours) of intensive care unit stay, counted from the end of surgery, and a further expected duration of intensive care unit stay of ≥ 48 hours * if nosocomial intra-abdominal infection, duration of intensive care unit stay ≤ 48 hours, counted from the end of surgery, and a further expected duration of intensive care unit stay of ≥ 48 hours * female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study exclusion criteria: * acute pancreatitis * neutropenia (anc \<1,000/mm3) at the time of randomization * infected intra-peritoneal dialysis * patients undergoing solid organ transplantation * documented invasive candidiasis at the time of randomization * expected survival \< 48 hours * any systemically active anti-fungal within 14 days prior to administration of the study drug * allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients * currently receiving and/or has taken an investigational drug within 28 days prior to randomization * pregnant woman or breast-feeding mother * 'do not resuscitate' order

Keywords: mycoses micafungin intra-abdominal surgery invasive fungal infection intra-abdominal infection
risk assessment of type 2 diabetes in pharmacies

Conditions: Type2 Diabetes

Summary: background: due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. our aim was to explore the capacity of norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health. methods: nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or haemoglobin a1c (hba1c) -group were the participants with a high risk of developing type 2 diabetes also received a hba1c-measurement. two pharmacists at each pharmacy were trained to perform risk assessments and counselling. the pharmacists at the 11 hba1c pharmacies were also trained in how to perform the hba1c- measurement. during six months, pharmacy customers equal or over 45 years old, wishing to participate contacted the pharmacy staff. participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. in the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the hba1c-group, participants with hba1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.

background: due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. our aim was to explore the capacity of norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health. methods: nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or haemoglobin a1c (hba1c) -group were the participants with a high risk of developing type 2 diabetes also received a hba1c-measurement. two pharmacists at each pharmacy were trained to perform risk assessments and counselling. the pharmacists at the 11 hba1c pharmacies were also trained in how to perform the hba1c- measurement. during six months, pharmacy customers equal or above 45 years old, wishing to participate contacted the pharmacy staff. participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. in the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the hba1c-group, participants with hba1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.

Eligibility criteria:
inclusion criteria: - age equal to or above 45 years old (increased from 18 years in the feasibility study), and being able to read and write norwegian/english. exclusion criteria: - known diabetes, pregnancy and blood diseases that may affect measurement of haemoglobin a1c (hba1c).
study to assess the effects and safety of zgn-1061 in overweight and obese participants with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity

Summary: the purpose of this study is to evaluate the efficacy and safety of the study drug zgn-1061 in participants with type 2 diabetes.

participants will be enrolled in 1 of 2 groups. approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of zgn-1061 or placebo (group 1). an additional 40 participants will receive 0.9 or 1.8 mg of zgn-1061 or placebo (group 2).

Eligibility criteria:
inclusion criteria: subjects must meet the following criteria to participate in this study: * be between the ages of 18 and 70 years, inclusive. * overweight or obese with a body mass index of at least 27 kg/m². * have type 2 diabetes with hba1c between 7% and 11%. * for subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor. * for subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery. exclusion criteria: subjects cannot participate in this research study if they meet any of the following: * have taken another study drug or study device within the past 6 months. * are taking certain prescribed medications including narcotics or opiates. * consistent recent use of insulin. * have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study. * have a history of bleeding disorders or risk factors for excessive blood clotting. * have difficulty giving blood. * have a history of drug and/or alcohol abuse.

Keywords: methionine aminopeptidase 2 inhibitor diabetes mellitus, type 2 blood glucose overweight obesity
acupuncture for the treatment of cancer related fatigue

Conditions: Fatigue

Summary: cancer-related fatigue occurs in both adult and pediatric patients undergoing chemotherapy and/or radiation. recently, methods to measure fatigue have improved - however, no non-medication interventions have been studied. ameliorating fatigue may result in an improved quality of life for patients. acupuncture is a safe and well-tolerated procedure and has been used for many indications in pediatric patients. adult studies have suggested improvement in cancer-related fatigue after acupuncture in adults. in this trial, we propose using acupuncture for the treatment in cancer-related fatigue in children and adolescents with central nervous system tumors.


Eligibility criteria:
inclusion criteria: * patients who are ≥ 8 year of age and ≤ 21 years of age who are undergoing chemotherapy and/or radiation therapy for the treatment of any primary or recurrent central nervous system tumor (regardless of diagnosis or disease stage, whether it is malignant or benign, and in any location) at children's memorial hospital. * patients who recently completed therapy (within 60 days of enrollment) will also be eligible. patients must have a minimum baseline fatigue score of 15 on the pedsfacit-f scale (range 0-44). this is not a standard assessment for required clinical care and will only be administered by a research assistant to any patient after consent has been obtained. the assessment will be done during a routine clinic visit. * for patients receiving cytotoxic chemotherapy with a history of myelosuppression or radiation, a hemoglobin concentration of \>8 g/dl measured within 10 days of enrollment and a platelet count of \> 30,000 within 5 days of enrollment is required. * patients must also be able to read and understand english and read a computer screen. * patients with no known contraindications to acupuncture therapy. * patients who are able to attend all scheduled visits for acupuncture. * patients must have a karnofsky performance score of ≥ 50% or a lansky performance score of ≥ 50. * patients who have provided informed consent for the research study (parental consent for patients \< 18 years of age). patients between 12 years and 18 years of age must provide assent in additional to parental consents. exclusion criteria: * patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue. * patients who have received acupuncture in the previous six weeks. * patients with a life expectancy \< 3 months. * patients who are pregnant or lactating. * patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.

Keywords: fatigue
effect of ly450139 on the long term progression of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: alzheimer's disease (ad) is a fatal degenerative disease of the brain for which there is no cure. ad causes brain cells to die. ad is thought to be caused by an excess of beta-amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. at autopsy, ad patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of ad. inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. semagacestat (ly450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid, and brain in animals tested thus far. this study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some participants. the build-up of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. other tests measured the overall function of the brain and brain size in some participants. in this trial, participants who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. in other words, all participants could eventually receive active drug. participation could last approximately 2 years. participants taking approved ad medications were permitted to participate in this study and continue taking these medications during the study. all participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study. preliminary results from this study (h6l-mc-lfan \[lfan\]) and another similar study (h6l-mc-lfbc \[lfbc; nct00762411\]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. study drug was stopped in all studies. studies lfan, lfbc, and open-label h6l-mc-lfbf (lfbf; nct01035138) were amended to continue collecting safety data, including cognitive scores, for at least 7 months. the clinical trial registry (ctr) will reflect results of analyses from the original lfan protocol in addition to those from the amended lfan protocol.


Eligibility criteria:
inclusion criteria: * meets criteria for mild to moderate alzheimer's disease (ad) with mini-mental state examination (mmse) score of 16-26 at visit 1 * modified hachinski ischemia scale score of less than or equal to 4 * geriatric depression scale score of less than or equal to 6 * a magnetic resonance imaging (mri) or computerized tomography (ct) scan in the last 2 years with no findings inconsistent with a diagnosis of ad * if female, must be without menstruation for at least 12 consecutive months or have had both ovaries removed exclusion criteria: * is not capable of swallowing whole oral medication * has serious or unstable illnesses * does not have a reliable caregiver * chronic alcohol or drug abuse within the past 5 years * has ever had active vaccination for ad
effect of intervention on progesterone levels before euploid embryo transfer in pregnancy outcomes.

Conditions: Infertility; Progesterone; Frozen Embryo Transfer; Euploid Embryo Transfer; Pregnancy Outcome; Artificial Cycle; Ongoing Pregnancy

Summary: transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation failure (1), overcoming confounding factors such as embryo ploidy or maternal age. frozen euploid embryo transfer (feet) is routinely performed under standard hormone replacement therapy (hrt) and could be considered the best model for evaluating the impact of the endometrial preparation in clinical pregnancy rate and also in miscarriage rate. recently several authors have paid attention to serum progesterone (p) as a possible factor influencing frozen embryo transfer (fet) outcomes. p plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance. labarta et al. (2) described in blastocyst fet performed under hrt that serum p \<9.2 ng/ml measured on the transfer day is associated to significantly lower ongoing pregnancy rate (or 0.297, 95% ci:0.113-0.779). recently the investigators have analyzed 244 feet performed under hrt in a retrospective study (3). preimplantation genetic testing for aneuploidies (pgt-a) was carried out as previously described (4). embryos that reached the blastocyst stage were biopsied and frozen immediately afterwards using the vitrification method (5). euploid embryos were transferred in a subsequent cycle under hrt. serum p was analyzed the day previous to feet. patients with serum p \ 10.6 ng/ml. the investigators also observed that patients with serum p \>13.1 ng/ml had the lowest miscarriage rate (9.1%) and the highest live birth rate (65.6%). the worst outcomes were observed when serum p was \<8.06 ng /ml (41% live birth rate and 32.4% miscarriage rate). as miscarriage was higher among feet cycles with serum p \<10.6 ng/ml, the investigators hypothesize that altering the progesterone supplementation scheme could potentially reduce miscarriage rates and increase live birth rate. the purpose of this study is to modify the standard progesterone supplementation in feet under hrt (vaginal micronized progesterone 200 mg every 8 hours) (6) according to serum p measured not only on the day prior to transfer but also on beta subunit of human chorionic gonadotropin (β-hcg) analysis day, and to probe if this intervention reduces miscarriage rate and increases pregnancy outcome.


Eligibility criteria:
inclusion criteria: * feet of at least one single embryo * hrt * endometrial thickness \>= 6 mm measured day 4 of progesterone supplementation exclusion criteria: * patients with mosaic embryos. * uterine abnormality. * natural cycle protocol
breath gas analysis for the diagnosis of breast cancer

Conditions: Mamma Carcinoma

Summary: the volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically analyzed by proton-transfer-reaction time of flight mass spectrometry. the goal of the study is to determine typical breath gas components that allow to distinguish patients with mamma carcinoma from women without carcinoma. further, the investigators will test whether these breath gas markers can be used as tumor markers, which change in a typical manner during the progress of the disease. finally the data will be investigated for the presence of marker components, that identify patients who will develop metastasis.


Eligibility criteria:
inclusion criteria: * mamma carcinoma diagnosed by histology (cases) * mamma carcinoma excluded by radiology (controls) * at the time of diagnosis before surgery * at the beginning and during chemotherapy; exclusion criteria: * no informed consent form singed

Keywords: breath gas analysis volatile components in exhaled breath
pf-3512676 (cpg 7909) injection for patients who completed an oncology study using pf-3512676 (cpg 7909)

Conditions: Melanoma; Breast Neoplasms; Carcinoma, Renal Cell; Lymphoma, T-Cell; Carcinoma, Non-Small-Cell Lung

Summary: this protocol allows patients who completed coley oncology studies using pf-3512676 (cpg 7909) injection to continue receiving the treatment until disease progression.


Eligibility criteria:
inclusion criteria: immediate (within 4 weeks) prior completion of a clinical trial of pf-3512676 injection alone or in combination with other anti-neoplastic treatment for malignancy. exclusion criteria: the patient has received any anti-neoplastic therapy since completing a prior trial with pf-3512676 injection, or has participated in another clinical trial following participation in a trial with pf-3512676 injection.

Keywords: cpg 7909 continuation study
definity for ultrasound of intraocular tumors

Conditions: Ocular Melanoma

Summary: the study will test the usefulness of a contrast agent to help image tumors in the eye. in this study, patients with eye melanoma who are going to have their eye removed, will have their eye imaged by ultrasound (sound waves) before and after intravenous injection of microbubbles. the pathology characteristics of the tumor in the removed eye will be compared with the images.

the investigators plan to enroll and image 10 patients with intraocular tumors who are going to undergo enucleation of their eye for the tumor. definity®, a perflutren containing microsphere manufactured by lantheus medical imaging, inc., is commercially available and fda approved for cardiac imaging. it is contraindicated for use in patients with pulmonary hypertension, unstable cardiopulmonary conditions, and cardiac shunts (right-to-left, bi-directional, or transient right-to left). after informed consent is obtained, a cardiologist will examine the patient's history, perform lung and heart auscultation, and obtain a blood pressure in order to ensure the patient has no contraindications to using definity®. if there are no contraindications, routine ocular ultrasonography, both a and b scans, will be performed using an ellex eye cubed ultrasound machine. definity® will be prepared per package instructions and the appropriate dose will be calculated. if necessary, a second 10 microliter/kg dose may be give 30 minutes after the first iv injection. a bubble test (intravenous small amount of definity injected with cardiac echo) will be performed in the cardiology imaging suite, clinical building a, in order to ensure that the patient does not have a right to left shunt. after that, definity® will be administered as a slow iv bolus followed by a normal saline 10cc flush. the ultrasonographer will continue the ocular b scan during administration of definity®. vital signs will be obtained and documented at 30 minutes after administration of the last dose of definity® and longer if needed.

Eligibility criteria:
inclusion criteria: * adults 20 years old or over 18 years old with large uveal melanoma who are going to undergo enucleation exclusion criteria: * patient with right-to-left, bi-direction, or transient right-to-left cardiac shunts * worsening of or clinically unstable congestive heart failure * acute myocardial infarctions or acute coronary syndromes * serious ventricular arrhythmias or high risk for arrhythmias, due to prolongation of the qt-interval (\>60 msec) * respiratory failures marked by signs and symptoms of co2 retention or hypoxemia * severe emphysema, pulmonary emboli, or other conditions that cause pulmonary hypertension due to compromised pulmonary-arterial vasculature * known hypersensitivity to perflutren (if the patient has been exposed to perflutren in the past and had an allergic reaction) * pregnancy or nursing mothers

Keywords: uveal melanoma, ocular melanoma
orwh:scor on sex and gender factors affecting women's incontinence

Conditions: Urinary Incontinence; Diabetes

Summary: this study consists of two studies with overlapping cohorts. one is a follow up epidemiological study of urinary incontinence, the other is a case control study of lower urinary tract dysfunction in women with diabetes. study one: subjects for the study will be a retrospective cohort of 2100 middle-aged and older women from a large health maintenance organization who have participated in the reproductive risk factor for incontinence study at kaiser (rrisk). the rrisk i study assembled a retrospective cohort of long-term female kaiser permanente members to determine the association between specific childbirth events, hysterectomy, hormone use and urinary incontinence later in life. the study also provides descriptive information on urinary incontinence by type, age, ethnicity, severity and age of onset. study two: women with diabetes have a 30-70% increased risk of lower urinary tract dysfunction, including lower urinary tract symptoms, urinary incontinence, and ultimately bladder cystopathy. this sudy investigates the natural history, risk factors, and possible mechanisms of lower urinary tract dysfunction and infection among women with type 2 diabetes as compared to women without diabetes.


Eligibility criteria:
previous participation in the reproductive risk factors for incontinence study at kaiser.

Keywords: healthy