Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy and safety of armodafinil treatment (150 mg/day) as adjunctive therapy in adults with major depression associated with bipolar i disorder

Conditions: Depression

Summary: the primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar i disorder.


Eligibility criteria:
inclusion criteria: * the patient has a diagnosis of bipolar i disorder according to diagnostic and statistical manual of mental disorders, fourth edition (text revision) (dsm-iv-tr) criteria and is currently experiencing a major depressive episode. * documentation that the patient has had at least 1 previous manic or mixed episode. * the patient has had no more than 6 mood episodes in the last year. * the patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. the current depressive episode must have begun after the patient's current mood stabilizer regime began. * the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). the following criteria must also be met: 1. the mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician. 2. the patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period. 3. the mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit. 4. the dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit. 5. the mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation. 6. the patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine. exclusion criteria: * the patient has any axis i disorder apart from bipolar i disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period. * the patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period. * the patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. * the patient has a history of an eating disorder or obsessive compulsive disorder (ocd) within 6 months of the screening visit or during the screening period.

Keywords: bipolar i disorder
quality of life in patients with hcv related liver cirrhosis before and after direct acting antiviral drugs

Conditions: HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs

Summary: to evaluate the effects of daas on hrql in patients with liver cirrhosis secondary to chronic hcv infection

hepatitis c has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of hcv). it has been widely reported to have a profound negative impact on patient's health-related quality of life (hrql). the reduction of hrql is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). the chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. possibly, also the brain itself is infected by hcv . the egyptian government introduced sofosbuvir as the first daas into egypt through the government funded national treatment program. these agents are highly efficacious with significantly fewer side effects . to date, there is only one study reported about how egyptian hcv patients receiving the new daas perceive their hrql. this study is first one to be done in upper egypt to assess health-related quality of life of hcv patients receiving direct acting antivirals (daas) therapy prior and at the end of therapy

Eligibility criteria:
inclusion criteria: * patients with hepatitis c related liver cirrhosis (diagnosed clinically laboratory and by imaging). * age 18 years or older * eligible for starting daas therapy according to egyptian national guidelines will be enrolled. * follow up of those patients during and after daas therapy (clinically ,laboratory,imaging and with a questionnaire ) to determine hrql. exclusion criteria: * any patient with liver cirrhosis secondary to causes other than chronic hcv infection e. g. auto immune liver disease, pbc * coinfection with other viruses as hbv, hiv. * had significant psychiatric illnesses (diagnosed by psychiatrist)
serp-1 for the treatment of acute coronary syndrome

Conditions: Unstable Angina; Coronary Atherosclerosis; Coronary Restenosis

Summary: males and females aged 18-80 years who present with acs (unstable angina and non st-elevation mi) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mv of presumed new st-segment depression in at least 2 contiguous ecg leads or, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. the primary objective of this study is to evaluate the safety of serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for acute coronary syndrome (acs) requiring early intervention.

a total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of serp-1 injection to placebo control.subjects will receive serp-1 by intravenous (iv) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for acs. serp-1 will be administered as a single iv bolus injection. the initial iv bolus dose is administered immediately preceding the pci procedure with subsequent doses administered 24 and 48 hours later.subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.

Eligibility criteria:
inclusion criteria: * established diagnosis of unstable angina or nstemi with one or more episodes of angina in the 24 hours before hospital admission * scheduled for pci exclusion criteria: * cabg within 6 months * acute st elevation, eligible for thrombolysis on initial examination * coronary lesions with total thrombotic occlusions * current immunosuppressant therapy

Keywords: anti-inflammatory agents unstable plaque acute coronary syndrome
quantifying steatosis in liver transplant donors

Conditions: Non-alcoholic Fatty Liver Disease; Evidence of Liver Transplantation

Summary: non-alcoholic fatty liver disease is the most common chronic liver disease in hong kong. its presence among donors of living donor liver transplants could affect the outcomes of recipients of liver transplantation. by using controlled attenuation parameter (cap) measurements, the investigators aim to investigate the association of cap measurements and severity of fatty liver among liver donors in the recipient outcomes of living donor liver transplantation.

living donor liver transplantation (ldlt) has been increasing worldwide due to the critical shortage of cadaveric donors and the rising number of patients awaiting liver transplantation. the long-term survival rates of ldlt are now comparable to that of deceased donor liver transplantation. currently, two-thirds of all liver transplants performed in hong kong are ldlt. the ultimate goal of ldlt is to guarantee donor safety while optimizing the best possible recipient outcome. donor liver steatosis is a well-known factor which could influence graft function and long-term outcomes of the recipient allograft, and also affects donor hepatic recovery. when needed, pre-operative liver biopsy is often used for the quantitative assessment of donor steatosis, with ldlt not recommended when steatosis exceeds 30%. nonetheless, liver biopsy is limited by its invasive nature, sampling error and intra-observer variations. imaging evaluation for the quantification of steatosis via ultrasonography or computed tomography also has various pitfalls. there is currently no universal consensus on the ideal method in assessing donor steatosis. controlled attenuation parameter (cap) is a novel non-invasive method to quantify hepatic steatosis using ultrasonic attenuations to postulate fat content. it has been demonstrated to have good correlation with the degree of hepatic steatosis in both western and asian populations. the investigators aim to evaluate the application of cap in the donor workup of ldlt and to investigate for its association with post-transplant outcomes.

Eligibility criteria:
inclusion criteria: * age 18-60 ldlt donor who has completed donor workup * consents to study entry exclusion criteria: * concomitant liver disease, including chronic hepatitis b and c infection, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, wilson disease, and increased alcohol intake (30g per week for male, 20g per week for female).

Keywords: nafld ldlt steatosis cap transient elastography
prevalence of pathogens in synovial fluid obtained from emergency department patients

Conditions: Septic Arthritis; Joint Infection

Summary: this is a prospective, observational study of patients presenting to the emergency departments at 9 emergency id net sites. the objectives of the proposed study are to: 1. describe the range and proportion of infectious agents in synovial fluid as detected by standard c\&s and investigational pcr testing, i.e., biofire® film array® bone and joint infection (bji) panel, 2. describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ed), 3. determine the prevalence of septic arthritis in us ed patients presenting with an atraumatic painful swollen joint, and 4. determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis. study coordinators screen the ed log for adult patients presenting with joint pain and whose treating physician ordered an arthrocentesis. after confirming eligibility, study coordinators approach the patient to explain the study, and present the written consent form. if the patient agrees to participate and consent, the study coordinator completes an enrollment data collection using patient and treating physician interview to gather responses. after enrollment, the study coordinator will ensure that approximately 0.3-1.0 ml of leftover synovial fluid is saved and stored in a freezer for shipment to a central laboratory (truman medical center hospital laboratory, kansas city, mo) for testing. approximately 30 days after enrollment, study coordinators complete an electronic medical record (emr) review.


Eligibility criteria:
inclusion criteria: 1. age 18 years and older; 2. diagnostic arthrocentesis in the emergency department (ed) or during hospitalization if admitted from the ed; 3. arthrocentesis and joint culture ordered; and 4. provide written consent in english or spanish exclusion criteria: 1. unable to consent or no legal authorized representative is available; or 2. prisoner or parolee
effect of diltiazem on pharmacokinetics of bms-914392

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose bms-914392 in healthy subjects.

protocol designed to evaluate the potential for a drug-drug interaction

Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * women of childbearing potential (wocbp) and men must be using an acceptable method of contraception to avoid pregnancy exclusion criteria: * current or recent (within 3 months of study drug administration) gastrointestinal disease * current or history of neurological diseases or psychiatric disorders and cardiovascular diseases
biomarkers for length of hospital stay and loss of muscle mass and function in old medical patients

Conditions: Sarcopenia; Muscle Loss; Length of Stay

Summary: as humans age, there is a gradual loss of skeletal muscle mass and strength, termed sarcopenia. the underlying causes of sarcopenia are yet not fully elucidated but are thought to be multifactorial and include increased levels of systemic pro-inflammatory mediators, a decrease in anabolic hormones and changes in the neuromuscular system. furthermore, physical inactivity, chronic diseases, immobilisation and hospitalisation are known to play an important part in the development of sarcopenia. the prevalence of sarcopenia ranges from 20-30% (aged \>70yrs) within the general community. however, the prevalence of sarcopenia in geriatric patients after an acute hospital admission is substantially higher, estimated at ≈50%. furthermore, successive events of hospitalisation have been suggested to contribute to the development of sarcopenia, as even short periods (4-5 days) of skeletal muscle disuse are known to induce muscle atrophy. mean length of hospital stay in geriatric wards due to acute illness or hip-fracture is typically 7 to 11 days during which the level of physical activity is strongly reduced leading to an accelerated loss of muscle mass that many older patients never recover from. notably, a substantial part of the deterioration in functional capacity could be avoided just by counteracting loss of muscle mass during hospitalization. as such, we need to identify sensitive biological, clinical and functional biomarkers predicting loss of muscle mass and function during hospitalization to identify patients at risk of developing sarcopenia. additionally, it is crucial to investigate the association of these biomarkers with hospital length of stay, as hospitalisation has been suggested to contribute to the development of sarcopenia while longer hospital stays may increase patient risk of hospital-acquired infections and place an economic burden on society.


Eligibility criteria:
inclusion criteria: * equal to or over the age of 65 * admitted to the acute ward at bispebjerg hospital exclusion criteria: * age under 65 years * terminal illness * participants who do not understand danish * participants in isolation with airborne or droplet infections
long-term safety study of qge031 in patients with allergic asthma who completed study cqge031b2201

Conditions: Asthma

Summary: this study planned to assess long-term safety of qge031 during 12 months treatment in asthma patients who completed study cqge031b2201.

this study planned to assess long-term safety and tolerability of qge031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study cqge031b2201. the study was terminated early due to the efficacy results from an interim analysis of the phase ii study cqge031b2201.

Eligibility criteria:
key inclusion criteria: * forced expiratory volume in one second ( fev1) \>= 40% predicted * patients who completed cqge031b2201 study key exclusion criteria: * life-threatening asthma attack, intubation, respiratory arrest during or after completion of cqge031b2201 study * new malignancy * ongoing sae from cqge031b2201 that was assessed as related to study drug * patient experienced platelets drop to \< 75,000/ul * patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions * patient is pregnant

Keywords: asthma allergic asthma qge031 open-label ige long-term safety
impact of nirs-guided cardiopulmonary resuscitation after cardiac arrest on resuscitation rate

Conditions: Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation; Cerebral Oxygenation

Summary: sudden cardiac death is one of the main causes of morbidity and mortality worldwide. cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (cpr). the resuscitation guidelines are the current recommendations for cpr and are revised by expert panels such as the "european resuscitation council (erc)". up to now, a parameter for assessing the quality of cpr is missing and further monitoring methods are urgently needed. near-infrared spectroscopy (nirs) is a portable method for measuring regional oxygen levels in the brain. recent clinical trials suggest that cerebral oxygenation measured by nirs may correlate with survival and outcome after cardiac arrest. the investigators propose that nirs technology may not only be suitable to determine or predict the outcome of the patients, but could also be a useful tool to guide the cpr providers to optimize the cpr techniques and guide the individual treatments/interventions. the present study was therefore designed to determine if nirs guided cpr with the aim to optimize nirs values is superior compared to the current standard practice according to published cpr guidelines (return of spontaneous circulation \[rosc\] rate, short and long-term cerebral performance).


Eligibility criteria:
inclusion criteria: * patients with a cardiac arrest from the age of 18 years (in and out-of-hospital cardiac arrest) exclusion criteria: * post-traumatic cardiac arrest * non-fitting nirs sensor (size)

Keywords: near-infrared spectroscopy cardiopulmonary resuscitation cardiac arrest cerebral oximetry
pentosan polysulfate treatment's effectiveness

Conditions: Chronic Interstitial Cystitis

Summary: to examine the relationship between symptoms and quality of life before and after oral pentosan polysulfate (pps) treatment in cases diagnosed with interstitial cystitis/painful bladder syndrome (ic/bps).

demographic characteristics, medical history, clinical conditions, and laboratory and cystoscopic data of patients who applied to our clinic between january 2018 and december 2021 and were diagnosed with ic/bps were retrospectively analyzed. adult male and female patients with ic/bps who received 300 mg/day pps at least six months ago with complaints of pain, urge, frequency, and nocturia not associated with urinary tract infection were included in the study. in addition, pre- and post-treatment symptoms, icsi scores, quality of life (scored between 1-4), and satisfaction were compared.

Eligibility criteria:
inclusion criteria: * chronic interstitial cystitis * bladder pain syndrome exclusion criteria: * acute cystitis * bladder cancer * chronic prostatitis * bladder stone * stress incontinence
uterus transplantation from live donors with robotic assisted surgery - gothenburg ii

Conditions: Infertility, Female

Summary: the study is a follow up of nct01844362. uterus transplantation will be performed from live donors to patients with uterine factor infertility. if will be performed before transplantation. organ procurement from the donor will be performed by robotic assisted laparoscopy. transplantation will be by laparotomy. embryo transfer will be done 10-12 months after transplantation. after birth of 1-3 children the uterus will be removed by hysterectomy,

the study is a follow up of nct01844362. uterus transplantation will be performed from live donors to patients with uterine factor infertility. if will be performed before transplantation. organ procurement from the donor will be performed by robotic assisted laparoscopy. transplantation will be by laparotomy. embryo transfer will be done 10-12 months after transplantation. after birth of 1-3 children the uterus will be removed by hysterectomy.

Eligibility criteria:
inclusion criteria: * age below 38 years * absolute uterine factor infertility * bmi\<30 exclusion criteria: * systemic disease * psychiatric disease

Keywords: infertility, uterus, transplantation
resistance to antibiotics in patients receiving eye injections

Conditions: Age-Related Macular Degeneration; Retinal Vein Occlusion; Diabetic Retinopathy

Summary: the administration of short courses of topical antibiotic drops before and/or after intravitreal injections is a common practice, but increasing evidence suggests this may not lower the risk of infectious endophthalmitis and could increase rates of antimicrobial resistance. the purpose of the present study is to determine the antimicrobial resistance profiles in patients who have received numerous (≥ 20) courses of antibiotics for intravitreal injection compared with untreated controls. this study compares 20 control patients without prior intravitreal injection to 20 patients who have undergone ≥ 20 prior intravitreal injections accompanied by a course of topical antibiotics for two days before and/or after the injection procedure. the lower, inner eyelid and nasal cavity were cultured and evaluated via disk diffusion method for antimicrobial sensitivity.

before administration of anti-vegf therapy (vascular endothelial growth factor) or topical antibiotics, conjunctival and nasopharyngeal swabs are procured with the bacti-swab transport system (thermo fisher scientific, waltham, ma). for conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. for nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds. culture swabs are then plated onto 5% sheep blood plates and incubated at 37°c for 3 days. colonies are isolated and identified with api (analytical profile index) microbial identification kits (biomérieux inc., hazelwood, mo). antibiotic susceptibility is determined using the kirby bauer disc diffusion method. additional data collected includes age, ocular and systemic medical conditions, and the number of intravitreal injections along with anti-vegf agents used. statistical calculations for antibiotic resistance comprises of t-test and and multivariate analysis.

Eligibility criteria:
inclusion criteria: * adult patients (above age 18) diagnosed with age-related macular degeneration and receiving their 1st or 20th (or \>20th) intravitreal injection therapy. exclusion criteria: * those with current use of topical or systemic antibiotics and an active ocular infection or ocular surface disease.

Keywords: drug resistance, microbial
symptom assessment with patient surveys

Conditions: Carcinomas; Squamous Cell Carcinoma; Adenocarcinoma

Summary: the primary purpose of the proposed research is to explore methods of obtaining symptom assessments from pediatric oncology patients and/or their caregivers in hopes of improving the accuracy and thoroughness of these reports. additionally the researchers hope to simply staff efforts in obtaining detailed medical histories from pediatric oncology patients.


Eligibility criteria:
inclusion criteria: * approximately 150 patients ages 0-18 years (75 for each group-intervention and control) will be enrolled. * these patients will be pediatric oncology patients who have received chemotherapy within the prior four weeks and being seen in the oncology clinic for an out-patient visit.