Kornimate/medical-research-clean huggingface dataset:
treatment of nosocomial covid-19

Conditions: Covid19; Nosocomial Infection; SARS-CoV2 Infection

Summary: covid-19 is a respiratory disease caused by a novel coronavirus (sars-cov-2) and causes substantial morbidity and mortality. nosocomial acquisition of sars-cov-2 is a frequent concern across hospital settings in canada and is associated with substantial morbidity and mortality. this clinical trial is initially designed to evaluate the role of monoclonal antibodies against the sars-cov-2 spike protein, for the treatment of hospitalized patients who acquire covid19 via nosocomial infection. new treatments, as they become available, may be integrated, with appropriate adaptation of this document. the trial was initiated with the bamlanivimab product with the options of casirivimab/imdesimab and sotrovimab added as the prevalence of bamlanivimab resistant variants of concerns increased. it is believed that monoclonal antibody treatments are most likely to be effective early in the disease course. the ability to rapidly identify and initiate such treatments in patients with nosocomial acquisition of the infection, combined with the high mortality of 25-30% experienced by this group of patients led us to propose this trial in collaboration with the catco national network. the overall objective of the study is to evaluate the safety and clinical effectiveness of anti-sars-cov-2 monoclonal antibody treatment relative to the control arm, in patients who develop nosocomial sars-cov-2 infection, on need for mechanical ventilation or death. this study is designed as a pragmatic randomized, open-label, controlled clinical trial. subjects will be randomized to receive either standard-of-care (control) or the study medication on a 1:2 basis. bamlanivimab, casirivimab/imdesimab or sotrovimab will be administered intravenously as a one-time infusion after randomization. casirivimab/imdesimab (regn) and sotrovimab will be the default agents based on local availability unless both are unavailable and virus strain known to be native or alpha (b.1.1.7). incidence of infusion-related reactions in the 24 hours post administration.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay, in any specimen prior to randomization. * admitted to a participating centre * is nosocomially acquired infection, as defined by all of: * covid19 diagnosis being made on admission day three or later; * admitted for a reason other than covid19; * within 5 days of covid19 diagnosis based on test collection date or initial development of symptoms, which ever was earliest. exclusion criteria: * plan for palliation within 24 hours * known allergy to study medication or its components (non-medicinal ingredients) * ordinal scale 6 or above * admitted to facility for non-medical reasons including primary psychiatric diagnosis or labour and delivery. * pregnancy or breast feeding * weight less than 40kg

Keywords: bamlanivimab casirivimab imdesimab sotrovimab
blood-brain barrier permeability study in adults with meningitis

Conditions: Blood-Brain Barrier Permeability

Summary: the purpose of the study is to confirm the applicability and usefulness of the novel method of assessment of the permeability of the blood-brain barrier and in monitoring of the treatment of patients with meningitis. the proposed technique is based on evaluation of the kinetics of the indocyanine green (icg) outflow from the brain with the use of near-infrared spectroscopy (nirs). usefulness of the nirs-based method will be analyzed in relation to the reference method, which is contrast-enhanced magnetic resonance imaging (mri).

clinical trials in healthy volunteers and in patients with diagnosed blood-brain barrier disruption: * performing a lumbar puncture as a routine diagnostic procedure in a patient with suspected neuroinfection. biochemical assessment of the degree of the blood-brain barrier disruption based on the albumin ratio. * enrollment of patients diagnosed with neuroinfection to the study and obtaining informed consent. * performing the measurement involving fixation of the nirs probes on the patient's head while intravenously injecting optical contrast agent - icg (5-10 mg in a bolus). the measurement time is about 15 min. monitoring of the patient's condition during the examination using a pulse oximeter monitor. the examination should be performed no later than 12 hours after the lumbar puncture to obtain a reliable correlation of results between the methods. the party responsible for the technical aspect of the investigation will be the sponsor while the party responsible for the medical aspect (including the injection of the contrast agent) will be the principal investigator. * conducting a magnetic resonance test. the mri imaging can be carried out before or after the test by the optical method, but with only a slight time delay (not more than 24h). the gadolinium will be injected at 5 ml/s (20 ml per patient). calculating the cerebral blood flow and the cerebrovascular permeability coefficient and passing the information to the patient's doctor. 3. the assessment of the contrast agent outflow kinetics parameters obtained with use of the optical method 4. the correlation of the results of the of the evaluation of the blood-brain barrier condition by mri, biochemical assessment of the cerebro-spinal fluid and optical method.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * diagnosed with meningitis in the examination of cerebrospinal fluid exclusion criteria: * allergic to any of the contrast agents * a lack of consent to the test * liver failure and kidney failure

Keywords: blood-brain barrier magnetic resonance imaging spectroscopy, near-infrared indocyanine green
fingernails in evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial ibcsg-1-98

Conditions: Breast Cancer; Osteoporosis

Summary: rationale: studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer. purpose: this laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial ibcsg-1-98.

objectives: primary * compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails by raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant hormonal therapy on protocol ibcsg-1-98. * determine the efficacy of nail structure for evaluating bone fragility. secondary * compare fingernail assessments in patients who have had a bone fracture vs those who have not. * determine the natural variation in chemical (raman spectroscopy) properties of 2 fingernails sourced at 1 appointment from the same donor. * evaluate the effect of further drug treatment (after 6 months) on the chemical properties of fingernails. outline: this is a single-blind, multicenter, pilot study. patients are stratified according to treatment on protocol ibcsg-1-98 (tamoxifen vs letrozole) and bone fracture (yes vs no). fingernail clippings are collected at baseline and 6 months later. fingernail clippings are examined by raman spectroscopy. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * enrolled on protocol ibcsg-1-98 * currently receiving (i.e., have not yet completed) 5 years of treatment with tamoxifen or letrozole and expected to receive ≥ 6 months of additional treatment on protocol ibcsg-1-98 * no recurrent breast cancer or second primary cancer * no known bone disease (including osteomalacia or osteogenesis imperfecta) * hormone receptor status * estrogen and/or progesterone receptor positive tumor patient characteristics: * female * postmenopausal * no uncontrolled thyroid or parathyroid disease, cushing's disease, or other pituitary diseases * no malabsorption syndrome or clinically relevant vitamin d deficiency prior concurrent therapy: * see disease characteristics * more than 1 year since prior and no concurrent anticonvulsants * more than 6 months since prior and no concurrent corticosteroids at doses \> the equivalent of 5 mg/day of prednisone for \> 2 weeks total * no prior or concurrent sodium fluoride at daily doses ≥ 5 mg/day for \> 1 month * more than 12 months since prior and no concurrent anabolic steroids * more than 6 months since any prior drug for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin d\]) * concurrent warfarin allowed provided duration of treatment is no more than 4 weeks

Keywords: osteoporosis stage i breast cancer stage ii breast cancer stage iiia breast cancer
burch colposuspension and mid-urethral sling operations

Conditions: Incontinence

Summary: stress urinary incontinence is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons. depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension. the researchers aimed to compare these two types of operations performed on patients. in this way, the superiority and disadvantage of each other in two procedures will be demonstrated.


Eligibility criteria:
inclusion criteria: * a total laparoscopic hysterectomy was planned for benign causes, * patients scheduled for simultaneous operation for incontinence exclusion criteria: * patients previously operated for urinary incontinence * patients whose diagnosis of stress urinary incontinence is uncertain * patients with urinary tract infection
non-interventional post-marketing safety study on the long-term safety of hyqvia (global)

Conditions: Primary Immunodeficiency Diseases (PID)

Summary: the purpose of the proposed study is to acquire additional data (including the assessment of anti-rhuph20 antibodies) on the long-term safety of hyqvia and to assess the prescribed treatment regimens and treatment administration in routine clinical practice.


Eligibility criteria:
inclusion criteria: 1. participant requires immunoglobulin treatment for primary immunodeficiency disease (pidd) 2. participant age is compatible with local package insert requirements 3. participant has been prescribed or has started treatment with hyqvia (immune globulin (human) 10% with rhuph20) 4. participant is willing and able to comply with the requirements of the protocol. 5. female participant of child-bearing potential agrees to inform the investigator if she becomes pregnant, or plans to become pregnant during the course of the study exclusion criteria: 1. participant has known hypersensitivity to any of the components of the medicinal product 2. participant has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during the course of this study 3. participant is a family member or employee of the investigator 4. participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment
enhanced diagnosis of ventricular activation pattern using intracardiac electrograms

Conditions: Arrythmia

Summary: the objective of this study will be to evaluate the ability of iegms (signal recorded from implanted pacing leads) and pseudo ecgs (derived from various iegms) to characterize various electrical conduction patterns. electroanatomic mapping data and 12 lead ecg will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.


Eligibility criteria:
inclusion criteria: * patient with sjm crm device implanted for more than 90 days exclusion criteria: * suspicion of lead dislodgment

Keywords: ablation
early antiviral therapy for critically ill hiv infected patients

Conditions: HIV Infection

Summary: the aim of the study is to verify the effect of haart in critically ill hiv infected patients. the current practice is to begin antiviral therapy after icu discharge, when the condition of the patient is more stable. the investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the icu. the investigators just have retrospective studies in this scenario. after admission to icu, patients are assigned to one of two arms: early haart (within 5 days of icu admission) or conventional therapy (initiation of haart after icu discharge). the following data will be collected: demographic variables, cd4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. the patients will be followed to determine icu mortality, hospital mortality and 6-month mortality.


Eligibility criteria:
inclusion criteria: * hiv infection * cd4 cell count less than 350 cells/mm3 within 3 months prior to study entry or cd4 cell count between 350 cells/mm3 and 500 cells/mm3 if age \> 55 years, coinfection with hbv or hcv, neoplasia, viral load \> 100,000 copies/ml or elevated cardiovascular risk or aids-defining illness exclusion criteria: * regular use of haart * pregnant

Keywords: critically ill patients hiv infection haart mortality
liposomal cytarabine in the treatment of central nervous system resistant or relapsed acute lymphoblastic leukemia in children

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (all) in children and adolescents.

liposomal cytarabine (depocyte) is a new formulation of the drug cytarabine, a drug commonly used in the treatment of all. this formulation of the drug can be given intrathecally (into the spinal fluid), and is released slowly over a longer period, about two weeks. this allows a longer exposure of the drug to the central nervous system, and requires fewer intrathecal injections for the patient.

Eligibility criteria:
inclusion criteria: * age \< 18 years * diagnosis of acute lymphoblastic leukemia (all) * central nervous system involvement with malignant cells present in cerebrospinal fluid * cns involvement may be refractive to prior systemic therapy, a first recurrence after prior systemic and intrathecal therapy or a second recurrence * cns involvement may be an isolated lesion or present with other sites of disease * ecog performance status 0-2 * life expectancy of at least 8 weeks * absence of severe organ dysfunction * informed consent exclusion criteria: * eligibility for aieop studies of first recurrence of all,and receiving therapy in a center participating in the aieop studies * concurrent treatment with experimental therapies * severe neurologic toxicities from previous chemotherapy * severe coagulopathy at time of recurrence * sepsis * intrathecal therapy within 1 week of planned study therapy * total body or head and spine radiation within 8 weeks of enrolment * bone marrow transplant within 8 weeks of start of study therapy.

Keywords: recurrent cns disease intrathecal therapy
functionality and accuracy of the smart system in real-life icu settings

Conditions: Aspiration Pneumonia

Summary: total participants in the "functionality and accuracy of the smart system in real-life icu settings" are 10 participants - in the current jefferson study site there were 8 participants and in the sheba study site (identifier nct03689985) there were 2 participants. this study is conducted in order to validate the functionality and accuracy of the smart™ system in a real-life icu setting. the smart™ feeding tube system is a novel system with nasogastric tube developed by art medical (healthcare) ltd, based on sensor-lined tubes that transmit real-time information to an external console. the smart™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. in addition, the smart™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. the smart™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. furthermore, smart™ feeding tube system can guide operator to correctly re-position the tube. lastly the smart™ feeding tube system is equipped with an anti-reflux mechanism and automatic gastric residual volume (grv).


Eligibility criteria:
inclusion criteria: * males and females 18 years or older * patient has already been admitted to icu * patient requires enteral feeding * patients receiving proton pump inhibitors (ppi) therapy * informed consent by independent physician and next of kin * icu ventilated patients exclusion criteria: * patients with anomalies or diseases of the esophagus and or stomach. * patients with known sensitivities or allergies to any of the feeding tube materials * inability to place patient in semi-fowler's position. * any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder) * pregnancy * recent abdominal surgery (less than 30 days)
near-infrared spectroscopy in myofascial pain syndrome

Conditions: Myofascial Pain Syndrome; Regional Tissue Oxygen Saturation

Summary: myofascial pain syndrome is a regional pain syndrome accompanied by sensorial, motor and autonomic symptoms . myofascial trigger points are most frequently detected in the upper trapezius, levator scapula, and axial postural muscles such as rhomboid major. myofascial pain syndrome is characterized by active myofascial trigger points in the form of focal hyperirritable nodules palpated in the tight band of the muscle . alteration of tissue vascularization could limit or prevent th may cause adhesions, contractures and pain. as a result of decreased blood flow, tissue oxygenation may decrease.

in this study, it will be tried to determine the role of muscle tissue oxygenation in the activity and diagnosis of the disease in myofascial pain syndrome.

Eligibility criteria:
inclusion criteria: * 18-65 years old * myofascial pain syndrome exclusion criteria: * cervical radiculopathy * fibromyalgia * shoulder joint disease, * peripheral and central nervous system disease * polyneuropathy, * inflammatory rheumatic disease, * malignancy
comparison of topical 0.15% gancyclovir gel versus 0.3% hypromellose gel for the treatment of herpes zoster keratitis

Conditions: Herpes Zoster Keratitis

Summary: the purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the treatment of herpes zoster keratitis. half the patients will receive the study drug while the other half of the patients will receive the placebo

patients with herpes zoster keratitis will be enrolled in the study. all patients will receive oral anti-viral medication as a standard-of-care therapy. the patients will be randomized into two groups and given either the study drug or the placebo at the time of enrollment. the patients will come for weekly visits during which slit lamp photograph of the dendrite will be taken. at week 2, if the dendrite has not healed the drug will by unmasked and rescue therapy will be given. the patients will be examined at week 1, 2, and 3 or until resolution occurs.

Eligibility criteria:
inclusion criteria: * age 18 and above * have not been on gancyclovir gel or any other form of topical antiviral therapy for the past month * able and willing to attend subsequent follow-up visits exclusion criteria: * associated retinitis * patients who are allergic to gancyclovir * patients who will require systemic or intra-vitreal gancyclovir therapy * patients who are pregnant or breastfeeding
impact of clinical pharmacy services on medication cost and hospitalization rates in hemodialysis patients

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to evaluate the effects of pharmaceutical care interventions in the ambulatory hemodialysis patients over a one-year period. cost containment occurs through pharmaceutical care interventions designed to identify and ameliorate drug-related problems (drps), improve the cost-effectiveness of therapeutic regimens and prevent hospitalizations.

approximately 350,000 end-stage renal disease (esrd) patients in the united states utilized over $17.9 billion medicare dollars in 1999. the esrd population and cost is projected to double by 2010. esrd patients have a mean of 5 comorbidities per patient and are prescribed a median of eight medications. the average monthly medication cost per patient is approximately $1,200.00. for every dollar spent on medication an additional $1.77 is spent on drug-related problems (drps). dialysis patients are at high risk for drps. it is unknown if continued pharmacist intervention in hemodialysis patients will improve patient care, reduce medication utilization and cost, and prevent hospitalization as seen in other populations. the purpose of this study is to investigate the impact of continued pharmacist intervention in ambulatory hemodialysis patients.

Eligibility criteria:
inclusion criteria: * patients are eligible for inclusion in the study if they have been on hd for greater than three months, greater than 18 years of age, those who plan to be continuously enrollment in therapy at the same dialysis center throughout the duration of the study. informed consent will be obtained on eligible patients. the study is to be approved by the human research review committee prior to initiation. exclusion criteria: * patients will be excluded if they have been on hd for less than three months, decline the opportunity to participate, or are less than 18 years of age.

Keywords: document the number, type, and severity of drps in hd patients. determine the rates and categorization of drps-associated hospitalizations in hd patients. document the number and types of pharmaceutical care interventions. determine the outcomes of pharmaceutical care intervention determine the rate of acceptance of pharmaceutical care interventions . assign significance rank to pharmaceutical determine annual drug cost in hd patients. determine drug cost associated for treatment of each hd patient comorbidity. determine quality of life (qol) using a renal -specific instrument
effects of contact lens wear on children's self-perceptions

Conditions: Myopia

Summary: the purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.

eight to eleven year old children will be randomly assigned to wear spectacles or soft contact lenses. the children's self-perceptions will be measured at baseline and every six months. we will compare the change in self-perception between spectacle and soft contact lens wearers over three years. we will also examine the effect of how much children initially like or dislike to wear glasses on the change in self-perception over three years.

Eligibility criteria:
inclusion criteria: * 1.00 to 6.00 d spherical component myopia, based on cycloplegic autorefraction * 1.00 dc or less astigmatism, based on cycloplegic autorefraction * 20/20 or better best-corrected visual acuity in each eye * global stereoacuity of 250 seconds of arc or better based on randot stereoacuity exclusion criteria: * contact lens wear within the past month * ocular health problems that could affect vision, eye development, or contact lens wear * systemic health problems that could affect understanding of surveys or contact lens wear * participation in other eye or vision studies that prescribed a treatment

Keywords: myopia self-perception contact lenses glasses randomized children self-esteem