Kornimate/medical-research-clean huggingface dataset:
duration of anti-convulsant therapy for acute symptomatic seizure in acute encephalitis syndrome

Conditions: Seizures

Summary: there are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. the duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. so the investigators plan to conduct this study to decide the optimal duration of anti-epileptic drug in acute symptomatic seizure in central nervous system infections

demography data, seizure details at diagnosis of acute encephalitis syndrome, details of etiology, neuroimaging findings and electroencephalography. a detailed neurological examination will be done in all participants and asked for seizure semiology at admission. seizure details include seizure type, duration, number of seizures, number of days for which seizures were recurring, status epilepticus, encephalopathy in between seizures. after the initial assessment participants would be randomized into 2 groups: group 1: anti-epileptic drug for 4 weeks followed by taper in 10-14days and group 2: anti-epileptic drug for 12 weeks followed by tapering over 10-14days. the primary outcome would be be to study the seizure relapse rate (proportion) after stopping anti-epileptic drugs in participants with acute symptomatic seizure given 4weeks and 12 weeks anti-epileptic drug therapy in the two study groups. clinical status will be assessed at enrollment as defined by pediatric cerebral performance category, pediatric overall performance category and glasgow outcome scale-extended pediatric version (gos-p)

Eligibility criteria:
inclusion criteria: * children with acute encephalitis syndrome with acute symptomatic seizures on single anti-epileptic drug will be enrolled in out patient clinic at 4 weeks of illness exclusion criteria * children with chronic meningitis, brain abscess, intracranial space occupying lesion * children with prior history of seizures, prior focal neurological deficit * children with abnormal development prior to development of seizures * hiv, chronic liver disease, chronic kidney disease, acute hepatic encephalopathy * children on two or more than 2 anti-epileptic drugs * severely affected children (pediatric cerebral performance category scale (pcpc) score, pediatric overall performance category scale with category score of 5) * refusal of consent
initial feasibility study to treat borderline resectable pancreatic cancer with a planar ldr source

Conditions: Pancreatic Cancer

Summary: initial study to evaluate local control and the preferred method of attachment of the civasheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

this is a feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (palladium-103) of standard devices in a novel configuration.this pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. the appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Eligibility criteria:
inclusion criteria: * • subject signed inform consent * age \> 18 years * not pregnant or breast feeding * patient capable of undergoing anesthesia * patient selected to undergo whipple procedure or distal pancreatectomy * patient does not have metastatic disease * patients will have close margins * no prior radiation therapy to the region for separate cancer * confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma * patient received neoadjuvant chemoradiation (4-10 weeks prior to surgery) * chemotherapy was administered for 2-6 cycles with any combination of the following agents: * gemcitabine + nb-paclitaxel * folfirinox * neoadjuvant chemoradiation was administered as imrt or 3dcrt (up to 56 gy), or sbrt (up to 36 gy) with pre-operative external beam dose (nccn) * up to 56 gy (1.8-2.0 gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil exclusion criteria: * not surgical candidate * any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer * an ire candidate (ire is percutaneous irreversible electroporation) * recurrent or previously resected tumors * documented history of alcoholism and or drug abuse * participant in other clinical trials

Keywords: brachytherapy civasheet civatech whipple radiation borderline resectable locally advanced pd-103 intraoperative radiation
nocdurna pass study using registries in denmark, germany and sweden

Conditions: Adverse Drug Event

Summary: a study using medical records to evaluate safety issues for the nocdurna drug using national register data from denmark and sweden, and a health care register covering parts of germany.


Eligibility criteria:
inclusion criteria: * usage of nocdurna recorded as dispensations from drugstores in adults or or usage of drugs for luts. exclusion criteria: * multiple dispensation of nocdurna on the same day or treatment with vasopressin 6 months before study start.

Keywords: nocturia nocdurna post-authorisation safety study
alt-801 in healthy overweight and obese volunteers to study safety and tolerability

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: the purpose of the study is to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of alt-801. this study has 2 parts. part 1 involves a single dose of alt-801 taken as a subcutaneous (sc) injection and will be approximately 36 days in duration. part 2 involves 12 doses of alt-801, once a week for 12 weeks, as a sc injection and will be approximately 116 days in duration. each participant will enroll in only one part.


Eligibility criteria:
inclusion criteria: * male or female healthy volunteers, age 18 to 60 years, inclusive * overweight to obese (bmi 25.0 - 40.0 kg/m2) * mri-pdff≥ 10% (part 2 only) * subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication * ability and willingness to attend the necessary visits to the study center * written informed consent signed prior to entry into the study exclusion criteria: * women who are pregnant or breastfeeding * history of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or hba1c ≥ 6.5% * history of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions: 1. adequately treated non-melanomatous skin carcinoma 2. female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician * mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study * clinically significant laboratory abnormalities including: a. impaired renal function * unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study

Keywords: nash nonalcoholic steatohepatitis
an expanded access program of pegfilgrastim (neulastim) in participants with non-hodgkin's lymphoma (nhl)

Conditions: Non-Hodgkin's Lymphoma

Summary: this study will assess the prophylactic effect of pegfilgrastim (neulastim) on febrile and/or grade iv neutropenia in participants receiving chemotherapy (ct) or immunochemotherapy (ict) as first or second line treatment for nhl. pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of ct or ict in each treatment cycle.


Eligibility criteria:
inclusion criteria: * nhl supported by an immunohistochemical report * eastern cooperative oncology group (ecog) performance status greater than or equal to (\>/=) 2 * total serum bilirubin less than (\<) 2 times upper limit of normal (uln) * absolute neutrophil count (anc) greater than (\>) 2 x10\^9 per liter (/l) exclusion criteria: * bone marrow compromised \> 10 percent (%) * any malignant myeloid condition * active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to ct or ict initiation * known hypersensitivity reactions to escherichia coli derived products * pregnant or nursing participants. women with childbearing potential should use a safe contraceptive method
safety study of 15-valent pneumococcal conjugate vaccine in healthy volunteers aged above 2 months

Conditions: Pneumonia, Pneumococcal

Summary: the purpose of this study is to evaluate safety of 15-valent pneumococcal conjugate vaccine in healthy volunteers aged above 3 months.


Eligibility criteria:
inclusion criteria: * 2 months old (at a minimum of 6 weeks old) and above healthy people. * subject or legal representative who consent and has signed written informed consent. * subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required. * subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine. * subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination. * axillary temperature ≤37.0 ℃. exclusion criteria: * subject with a history of a prior bacterial culture of an aggressive disease caused by s. pneumoniae. * subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination. * subject who are allergic to diphtheria toxins. * children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight \<2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis. * history of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease. * subject who diagnosis of thrombocytopenia or other history of coagulopathy. * known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, guillain barre syndrome. * known or suspected to suffer from: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period. * known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), hiv infection, etc. * received blood products or immunoglobulin within 3 months before enrolling (hepatitis b immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization). * subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.). * in pregnancy or lactation or pregnant women. * ≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities. * any condition that, in the judgment of investigator, may affect trial assessment.
study evaluating bazedoxifene dose-response in japanese patients with postmenopausal osteoporosis.

Conditions: Postmenopausal Osteoporosis

Summary: dose-response in japanese patients with postmenopausal osteoporosis.


Eligibility criteria:
inclusion criteria: * must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture. exclusion criteria: * diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.

Keywords: postmenopausal osteoporosis
ascertainment of emr-based clinical covariates among patients receiving oral and non-insulin injected hypoglycemic therapy

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this study is to identify emr-based clinical covariates and quantify their association with the prescribing of each specific type 2 diabetes (t2dm) medication under investigation. this will include an assessment of how well these covariates are captured through claims data proxies, and their potential to confound comparative research of t2dm medications.

purpose:

Eligibility criteria:
inclusion criteria: * dispensing of an oral or non-insulin injected hypoglycemic medication between may 2011 and june 2012 * diagnosis of type 2 diabetes mellitus * presence of electronic medical records (for the emr-based subset) exclusion criteria: * age \<18 at t2dm medication initiation * missing or ambiguous age or sex information * at least one diagnosis of type 1 diabetes mellitus * less than 6 months enrolment in the database preceding the date of the first dispensing * prior use of the index drug
yoga for abdominal obesity

Conditions: Obesity, Abdominal

Summary: the aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to no specific intervention on weight-related outcomes, well-being, and health behaviour in 60 females with abdominal obesity.


Eligibility criteria:
inclusion criteria: * waist circumference at least 88cm * body mass index at least 25 * sedentary * physical and mental ability to participate in the yoga intervention * willingness to participate in at least 18 of 24 yoga sessions and the whole-day workshop exclusion criteria: * dementia * psychosis * severe hypertension (diastolic blood pressure more than 120mmhg) * type 1 diabetes or insulin-dependent 2 diabetes * coronary artery disease * myocardial infarction * lung embolism * stroke * regular physical activity or yoga practice * pregnancy
extension study of sotatercept in people with pulmonary hypertension (mk-7962-023)

Conditions: Hypertension, Pulmonary

Summary: researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (cpc-ph). this study focuses on cpc-ph that is caused by heart failure with preserved ejection fraction (hfpef). researchers want to know if the study treatment, sotatercept, can treat people with cpc-ph caused by hfpef. this is an extension study, which means people who took part in a certain study on sotatercept for cpc-ph (called a parent study) may be able to join this study. in this extension study, people will take sotatercept and researchers will follow their health for a longer time. the main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: - completed mk-7962-007 (cadence) (visit 9 and end of treatment \[eot\] visit) without discontinuing study intervention and is able to safely enroll into mk-7962-007 (harmonize) exclusion criteria: the main exclusion criteria include but are not limited to the following: * has a diagnosis of pulmonary hypertension (ph) in world health organization (who) group 1, who group 3, who group 4, or who group 5 * has had a study intervention interruption * is pregnant or breastfeeding * has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy) * anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair * has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction) * anticipated or undergone heart transplant or ventricular assist device implantation * has had prior exposure to luspatercept
gabapentin alone and in combination with carvedilol for the treatment of rosacea-associated flushing and erythema:a randomized controlled clinical trial

Conditions: Rosacea; Rosacea Subtype 1 (Erythematotelangiectatic)

Summary: the goal of this clinical trial is to learn if gabapentin works to treat flushing/erythema associated with rosacea. it will also learn about the safety of drug gabapentin. the main questions it aims to answer are: * does drug gabapentin reduce flushing and erythema associated with rosacea? * what medical problems do participants have when taking drug gabapentin? researchers will compare gabapentin to a positive control (minocycline plus hydroxychloroquine, a first-line treatment for rosacea) to see if drug gabapentin works to reduce flushing and erythema associated with rosacea


Eligibility criteria:
inclusion criteria: * initial treatment in our hospital; ② diagnosed by two experienced dermatologists and in accordance with the updated diagnostic criteria of the national rosacea society (nrs) expert committee \[38\], unconscious disorder and no communication disorder; ③ did not receive any other form of treatment within 4 weeks; ④ patients who were followed up for 8 weeks or more and had complete clinical data; ⑤ informed consent was signed before treatment, and the clinical data were agreed to be used for scientific research exclusion criteria: ① received other treatment within 4 weeks of this treatment; ② facial flushing caused by other diseases and local irritation; ③ patients with contraindication to minocycline, hydroxychloroquine, gabapentin and carvedilol; ④ unable to complete follow-up and serum specimen collection; ○5 patients were intolerant to minocycline, hydroxychloroquine and carvedilol; ○6 lactation, pregnancy, liver and kidney dysfunction, psychiatric diseases, cardiovascular and cerebrovascular diseases, systemic lupus erythematosus and other systemic diseases.

Keywords: rosacea
evolution of the profile of infectious endocarditis in france in 2008 (ei2008)

Conditions: Infective Endocarditis

Summary: infective endocarditis (ie) is a rare (30 cases / million / year in france) and serious (20 % of deaths during hospitalization) disease . its epidemiological profile was considerably modified these last years.new predisposing factors appeared, due to increasing number of patients wearing valvular prosthetics. the purpose of this study is to realize in 2008 a new observational study on populational basis to describe and analyze the evolution of the epidemiology of ie in france, compared to previous studies conducted in 1991 and 1999.

it is a prospective observational study based on a population of 25 million inhabitants. the cases are recruited over a one year period, from january 1st till december 31st, 2008, in six regions of france (rhône-alpes, paris et petite couronne, lorraine, franche-comté, marne, languedoc-roussillon) and in the department of ille-et-vilaine. the ie cases are declared by clinicians taking care of the patients, microbiologists and cardiac ultrasonographists.

Eligibility criteria:
inclusion criteria: * major patient * supported in one of the participating centers * the application of diagnostic classification criteria of duke modified by li is carried out after collection of all the data at the output of the patient. will be included in the observatory that patients meeting criteria for definite or possible endocarditis. * affiliated with the french social security regime exclusion criteria: * patients not living in one of the studied regions
study to evaluate the safety and efficacy of nktr-102 in patients with metastatic or locally advanced breast cancer

Conditions: Tumor; Breast Cancer

Summary: this is a multicenter, open-label, two-arm, 2-stage, phase 2 study of nktr-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting. patients will be randomized 1:1 into one of two treatment arms. nktr 102 will be administered at a dose level of 145 mg/m2 in both arms. in arm a, nktr-102 will be given on a q14d schedule. in arm b, nktr-102 will be given on a q21d schedule. approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.


Eligibility criteria:
inclusion criteria: 1. inoperable metastatic or locally advanced breast cancer 2. no more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane exclusion criteria: 1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to day 1 of cycle 1 2. patients who have had any major surgery within 4 weeks prior to day 1 of cycle or minor surgery within 2 weeks prior to day 1 of cycle 1
a clinical cohort study of pneumonia in respiratory intensive care unit

Conditions: Pneumonia

Summary: from 2003 when severe acute respiratory syndromes (sars) appeared，many new types of respiratory viruses emerge in endlessly. therefore, the epidemiology and the clinical character has changed quietly, especially severe pneumonia. this cohort study aim to obtain the contents of severe pneumonia patients in respiratory intensive care unit (ricu). through the clinical data analysis, the investigators could get the information of the pneumonia caused by different reasons, such as morbidity and mortality, risk factors, clinical symptoms and radiographic changes, the respiratory support parameter and so on. the investigators hope the result could guide them do the clinical work of severe pneumonia better in the future.


Eligibility criteria:
inclusion criteria: * admit in ricu because of pneumonia of any causes * anticipated length of hospital stay more than 72h exclusion criteria: * admit in ricu because of other causes except pneumonia * do not agree to join this study * admit in ricu for the second time * anticipated length of hospital stay less than 72h