Kornimate/medical-research-clean huggingface dataset:
a study of risperidone in combination with lorazepam compared with standard therapy for emergency treatment of schizophrenic patients

Conditions: Schizophrenia; Psychotic Disorders; Emergency Treatment

Summary: the purpose of the study is to show that risperidone (an antipsychotic medication) combined with lorazepam (an anti-anxiety medication) is more effective than conventional therapy administered by intramuscular injection for emergency treatment of patients with schizophrenia.

patients with acute schizophrenia are often anxious and uncertain because of the psychotic symptoms they are experiencing. these patients are in need of rapid help and symptom relief. risperidone, a widely used antipsychotic medication, is effective against positive and negative symptoms of schizophrenia, has a rapid onset of action, a low incidence of extrapyramidal symptoms, and, in general, mild adverse events. this is an open-label trial of 2 mg dose of an oral formulation of risperidone in combination with 2 to 2.5 mg of oral lorazepam compared with standard care, which consists of a conventional neuroleptic drug administered via an intramuscular injection, with or without lorazepam. patients requiring emergency care are offered a choice of these two therapies and are monitored for 24 hours after initial treatment. optional follow up may be performed after 2, 3, and 7 days. the primary measure of effectiveness is the success of the treatment 2 hours after the drug is administered, as indicated by the patient being asleep or by showing improvement on the clinical global impression (cgi) improvement subscale. additional effectiveness assessments include an evaluation of hostility and agitation, as assessed by brief psychiatric rating scale (bprs), the degree of sedation, and the ability of the patient to interact with the physician at 1, 2, and 24 hours after the start of treatment. safety assessments include the incidence of adverse events throughout the treatment and follow up periods. the study hypothesis is that oral risperidone combined with lorazepam is more effective than therapy with conventional neuroleptic intramuscular agents, with or without lorazepam, for emergency treatment of patients with schizophrenia. single, oral 2 mg dose of risperidone and a single, oral 2 to 2.5 mg dose of lorazepam; further dosing during the 24 hour period at investigator's discretion. comparator drug of choice (with or without lorazepam) administered intramuscularly according to product labeling.

Eligibility criteria:
inclusion criteria: * psychotic patients with schizophrenia who require rapid intervention * experiencing symptoms of a psychotic disorder * capable of choosing to be treated exclusion criteria: * patients with a known hypersensitivity to the study drugs * have participated in an investigational drug trial within 30 days of study initiation * known to be unresponsive to treatment with risperidone or the comparator drug * known to have benzodiazepine dependence (addiction to this class of anti-anxiety drugs)

Keywords: acute schizophrenia psychosis risperidone lorazepam, antipsychotic agents emergency treatment
retrospective postoperative ards study at vanderbilt university

Conditions: ARDS

Summary: by examining the intraoperative anesthetic characteristics of patients who developed ards postoperatively, we hope to identify variables which have a positive or negative association on the development of ards.

acute respiratory distress syndrome (ards) is a pulmonary disease process that affects post-surgical patients in the intensive care unit and leads to significant patient morbidity and mortality and hospital cost. extensive research has been conducted in the diagnosis and treatment of ards. to date, however, very little research examining the effect of the operative course on the development of ards has been reported. by examining the intraoperative anesthetic characteristics of patients who developed ards postoperatively, we hope to identify variables which have a positive or negative association on the development of ards. once identified, the variables can be confirmed by future studies and encourage change in clinical care to decrease the occurrence of ards in surgical patients.

Eligibility criteria:
inclusion criteria: * ards * post-surgical * ventilator exclusion criteria: * rib fracture * pneumonia * sepsis

Keywords: ards acute respiratory distress syndrome adult respiratory distress syndrome respiratory distress
diagnostic accuracy of ferumoxytol-enhanced mri for detecting lymph node metastases in colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced mri in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer.

this study will investigate the accuracy of ferumoxytol-enhanced mri in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer. this study will be performed in addition to any ongoing routine care and will not serve as a substitute for any imaging tests that would be routinely performed prior to surgery.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older with histologically confirmed colorectal cancer * planned for surgical resection of tumor exclusion criteria: * contraindications for mri * contraindication or known allergy to ferumoxytol or parental iron products (e.g. iron sucrose, iron dextran, etc.) * planned chemotherapy or radiation treatment prior to surgical resection of primary tumor * uncontrolled serious medical illness * unable or unwilling to give informed consent * pregnancy * breastfeeding women * clinically documented or known risk of primary or secondary iron overloading including history of thalassemia, sickle cell anemia, hereditary hemochromatosis or first-degree relative with known hemochromatosis, multiple transfusions for any reason within the past 5 years, or use of over-the-counter ferrous sulfate without the supervision of his/her doctor
phase 1/2 dose confirmation study of flt180a in hemophilia b

Conditions: Hemophilia B

Summary: study of flt180a gene therapy in adults with hemophilia b. up to 9 patients will be enrolled to receive a single dose of flt180a and be followed for 52 weeks. results will confirm the dose for a future phase 3 study.


Eligibility criteria:
key inclusion criteria: * diagnosis of hemophilia b with known severe or moderately severe fix deficiency (≤2% normal circulating fix activity) for which the subject is on continuous, stable and adequate fix prophylaxis * have acceptable laboratory values of a) hemoglobin ≥11g/dl; b) platelets ≥100,000 cells/µl; c) ast, alt and alkaline phosphatase (alp) ≤ upper limit of normal (uln); d) serum albumin \> lower limit of normal (lln); e) total bilirubin ≤1.5 x uln (except if caused by gilbert's disease); f) serum creatinine ≤2.0mg/dl. * level of neutralizing anti-aav-s3 antibodies below the limit of the pre-established clinical cutoff using an in vitro transduction inhibition assay within the 4 weeks prior to flt180a administration * has demonstrated ability to accurately, independently and in a timely manner enter bleed diary data during the lead-in study, as judged by the investigator * at least 150 exposure days to fix concentrates * at least 6 months of satisfactory controlled prospective baseline data for bleeding events and fix consumption data from the flt-01 lead-in study (eclipse) key exclusion criteria: * any history of alcohol or drug dependence * presence of neutralizing anti human fix antibodies (inhibitor; determined by the nijmegen modified bethesda inhibitor assay) at the time of enrolment or a previous history of fix inhibitor * subjects at high risk of thromboembolic events * evidence of advanced liver fibrosis * prior treatment with a gene transfer medicinal product * subjects with active hepatitis b or c * serological evidence of hiv-1, not controlled with anti-viral therapy and as evidenced by cluster of differentiation 4 (cd4)+ counts ≤200 μl * cytomegalovirus (cmv) immunoglobulin g positive subjects who are cmv polymerase chain reaction (pcr) positive at screening * known coagulation disorder other than hemophilia b * high sensitivity (hs) troponin-t ≥14 pg/ml during screening * history of uncontrolled cardiac failure, unstable angina, or myocardial infarction or other acute cardiac conditions requiring clinical management in the past 6 months * planned surgical procedure within the next 12 months requiring prophylactic fix treatment * known active severe infection (including documented coronavirus (covid)-19 infection), or any other significant concurrent, uncontrolled medical condition
research study to determine sensitivity to gentle touch and pressure during an active migraine attack.

Conditions: Migraine

Summary: cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. it is a heightened skin sensitivity during an active migraine attack. migraine attacks in patients who experience allodynia are more difficult to treat. this study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. the results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.


Eligibility criteria:
inclusion criteria: * male and female patients aged 18-65, inclusive * diagnosis of episodic migraine with or without aura. * ability to read and understand an informed consent form and study procedures exclusion criteria: * patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc). * patients who suffer from headache (of any type) 15 or more days per month * patients who are cognitively impaired, as determined by investigator * patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators. * patients who had taken any acute pain medication (e.g. triptans, ergots, nsaids, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing. * patients with skin diseases that may cause abnormal skin sensation. * patients who had been treated with a nerve block in the 4 week period prior to allodynia testing patients who had been treated with botulinum neurotoxin within the 4 month period prior to allodynia testing
a study of the wallflex™ biliary fully-covered stent for the palliative treatment of malignant bile duct obstruction

Conditions: Cholestasis, Extrahepatic

Summary: the overall objective of this study is to assess the functionality of the wallflex™ biliary fully-covered stent as a palliative treatment for malignant bile duct obstruction.


Eligibility criteria:
inclusion criteria: * age 18 or older * clinical symptoms of biliary obstruction * inoperable extrahepatic biliary obstruction by any malignant process * willing and able to comply with the study procedures and provide written informed consent to participate in the study. exclusion criteria: * participation in an investigational study within 90 days prior to date of patient consent * strictures that cannot be dilated enough to pass the delivery system * perforation of any duct within the biliary tree * presence of a metal biliary stent * presence of any esophageal or duodenal stent * patients for whom endoscopic procedures are contraindicated * patients with known sensitivity to any components of the stent or delivery system * patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver * patients with an anticipated life expectancy of \< 3 months

Keywords: malignant cholestasis, extrahepatic biliary obstruction
retrobrace - clinical and functional outcomes 2 years after primary acl repair (internal bracing)

Conditions: Rupture

Summary: the purpose of this study is to quantify 2-year postoperative clinical and functional outcomes including side-to-side differences in gait function, balance, proprioception and muscle strength in patients treated by acl repair with internal brace ligament augmentation.

rupture of the anterior cruciate ligament (acl) is one of the most common injuries. in recent years, arthroscopic techniques have rapidly evolved with advanced tools such as suture anchors, resolvable pins and internal bracing techniques. one of the very latest developments in internal bracing and repair for proximal acl ruptures is the internalbracetm (arthrex inc., naples, florida, usa). the purpose of this study is to quantify 2-year postoperative clinical and functional outcomes including side-to-side differences in gait function, balance, proprioception and muscle strength in patients treated by acl repair with internal brace ligament augmentation.

Eligibility criteria:
inclusion criteria: * 2 years since acl repair and internal brace ligament augmentation exclusion criteria: * revision surgery within 2 years after primary repair (acl, total or partial knee arthroplasty, joint infection, fracture around knee level) * bmi \> 35 kg/m2 * previous injury and surgical procedures of the contralateral knee * neuromuscular disorders affecting lower limb movement * additional pathologies that influence the mobility of the knee joints * inability to provide informed consent

Keywords: acl repair internal brace ligament augmentation acl reconstruction anterior cruciate ligament rupture
safewalker contribution to the rehabilitation of older people after a post-fall syndrome

Conditions: Post-fall Syndrome

Summary: the main objective of this study is to evaluate the feasibility and acceptability of the use of the robot "safewalker" complement classical rehabilitation in a group of elderly patients over 70 years during the rehabilitation of post-fall syndrome.

the post-fall syndrome is an acute functional complications of falls that affects nearly one in five elderly fallers. it combines phobia of the previous vacuum, axial and hypertension astasia abasia. unrecognized and untreated, it progresses to a major regressive syndrome, severe physical, psychological and social implications. only an early rehabilitation for an early resumption of walking, prevents such a development. the main element is to support and encourage the subject to walking. in practice, it was found that the physiotherapist can not be present daily and the duration of its intervention is often short-lived. this study will examine the contribution of a medical device of a walking aid (safewalker the robot) in the rehabilitation and empowerment of seniors with a post-fall syndrome. the safewalker, which is a walking aid device (http://www.safewalker.com), completes the support action exercised by a third person, by reducing support and securing travel. it allows the subject to move alone at will and is a continuity in relation to the management of the physiotherapist, a potential source of motivation. the hypothesis is that the safewalker device can be complementary to the walking rehabilitation in post-fall syndrome.

Eligibility criteria:
inclusion criteria: * patients hospitalized for the treatment of post-fall syndrome exclusion criteria: * demential pathology (mini mental state \<20) * parkinson's disease and other degenerative neurological disorders * stroke sequelae * fractures members in the previous 12 months * lower limb prostheses in place within 6 months prior * psychiatric disease * presence of mucocutaneous lesions perineal * obesity (weight \>120 kg)
prevalence of salivary hypofunction in patients with globus pharyngeus

Conditions: Globus Pharyngeus

Summary: it is well known that 'globus sensation in throat' is caused by the chronic irritation and inflammation of oral, pharyngeal, or laryngeal mucosa, such as laryngopharyngeal reflux and chronic postnasal drip. xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal change of the oral cavity and pharynx. however, no previous studies have documented the prevalence of salivary hypofunction in patients with globus pharyngeus. through this clinical investigation, we hypothesized that the salivary hypofunction might be one of the leading cause of globus pharyngeus.

subjects: patients with symptoms of globus pharyngeus globus symptom scoring: 0(mild) to 5(severe) subjective symptom analysis by "standard table for xerostomia and pharyngoxerosis" subjective physical finding analysis by "standard table for xerostomia and pharyngoxerosis" objective analysis of salivary function by 99m-tc salivary scintigraphy --\> define the prevalence of salivary hypofunction in patients with globus pharyngeus (primary end point) subsequent analysis (secondary end point) 1. group 1: globus patients with objective salivary hypofunction 2. group 2: globus patients with normal salivary function intervention: active management for xerostomia (moisturizing, gargling, humidification, massage of salivary gland, stimulant of salivary secretion, artificial saliva) evaluation of the change of globus symptoms after active management of xerostomia between the group 1 and group 2 (at 1 months, at 3 months after the initiation of intervention)

Eligibility criteria:
inclusion criteria: * subjects with globus pharyngeus symptoms exclusion criteria: * subjects with tumors in oral cavity, oropharynx, nasopharynx, hypopharynx, which may cause globus symptoms * subjects, who do not undergo the endoscopic exam for the upper aerodigestive tract including oral cavity, oropharynx, nasopharynx, hypopharynx. * subjects, who take medications that may have potential effect on the mucosa of the upper aerodigestive tract including oral cavity, oropharynx, nasopharynx, hypopharynx. * subjects with poor medical performance (\<70%)

Keywords: globus pharyngeus xerostomia salivary hypofunction pharyngoxerosis
improvement of hemostasis techniques after median sternotomy

Conditions: Sternal Dehiscence; Sternal Infection; Sternal Pain

Summary: the purpose of this study is to compare 2 different hemostatic agents (bonewax and ostene)to a control group with regards to bleeding, bone healing, pain and infection in a patient group all undergoing median sternotomy.


Eligibility criteria:
inclusion criteria: * men undergoing elective cardiac surgery at the cardiac surgery department of aarhus university hospital, skejby * no clopidogrel-treatment * no osteoporoses * less than 2 co-morbidities in the form of obesity (bmi\>30), copd, chronic steroid use, renal failure, immunosuppression and diabetes exclusion criteria: * profuse sternal bleeding * serious complications to the surgery fx cerebral infarction * re-operation due to bleeding
virtual path planning for image-guided needle interventions

Conditions: Gastrointestinal Diseases; Bone Diseases; Muscular Diseases; Spinal Diseases; Vascular Diseases

Summary: philips healthcare has added a virtual path planner to the current commercially available xperguide software platform and that has the potential to significantly reduce dose during image-guided needle interventions.

the investigational device is used for image guidance by virtually planned path and x-ray data.

Eligibility criteria:
inclusion criteria: * patients at any age who are referred for a clinically indicated xperguide interventional procedure. * the informed consent has been signed by the participant, parent or legal guardian as appropriate. exclusion criteria: -pregnant patients.
conneqt pulse validation study

Conditions: Pregnancy Related; Pre-Eclampsia; Gestational Hypertension

Summary: the purpose of this study is to validate the accuracy of the conneqt pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.

clinical staff will review patient's medical record to determine eligibility. following informed consent, a brief medical history will be collected. serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the conneqt pulse blood pressure monitoring system in a pregnant population according to iso protocol 81060-2.

Eligibility criteria:
all groups: 1. able to provide informed consent 2. pregnant patient, beyond the first trimester (greater than 12 weeks of gestation) 3. 18 years of age, or older normotensive: 1. systolic blood pressure \<140 mmhg (18,66 kpa) and diastolic blood pressure \<90 mmhg (12 kpa) hypertensive: 1. without proteinuria \>300 mg in 24 h; and 2. with systolic blood pressure ≥140 mmhg (18,66 kpa) or diastolic blood pressure ≥ 90 mmhg (12 kpa) pre-eclampsia: 1. with proteinuria \>300 mg in 24 h; and 2. with systolic blood pressure ≥140 mmhg (18,66 kpa) or diastolic blood pressure ≥ 90 mmhg (12,00 kpa)
dhea against vaginal atrophy - safety study of 12 months

Conditions: Vaginal Atrophy

Summary: the purpose of this phase iii trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (dhea) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.


Eligibility criteria:
main inclusion criteria: * postmenopausal women (non-hysterectomized) * women between 40 and 75 years of age. * willing to participate in the study and sign an informed consent. * women who have self-identified symptom(s) of vaginal atrophy. * willing to have endometrial biopsy at screening and end of study (week 52). main exclusion criteria: * undiagnosed abnormal genital bleeding. * hypertension equal to or above 140/90 mm hg. * the administration of any investigational drug within 30 days of screening visit. * endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

Keywords: vulvar/vaginal atrophy atrophic vaginitis dehydroepiandrosterone dhea prasterone vaginorm menopause intrarosa