Kornimate/medical-research-clean huggingface dataset:
study of lumateperone in the acute treatment of patients with bipolar mania

Conditions: Bipolar Disorder, Manic

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar i disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the diagnostic and statistical manual of mental disorders, fifth edition (dsm 5).

the study will be conducted in 3 phases: * screening period (up to 1 week) during which patient eligibility will be assessed. * double-blind treatment period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio. * safety follow-up period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Eligibility criteria:
inclusion criteria: 1. able to provide written informed consent before the initiation of any study specific procedures; 2. male or female inpatient, between the ages of 18 and 75 years, inclusive; 3. meets the diagnostic and statistical manual of mental disorders, 5th edition (dsm 5) criteria for bipolar i disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and sponsor-approved rater using the modified structured clinical interview for dsm-5, clinical trials version (scid-5-ct); 4. ymrs total score ≥ 20 and a score of at least 4 on two of the following ymrs items: irritability, speech, content, and disruptive/aggressive behavior at screening and baseline; 5. hospitalized voluntarily before screening or admitted to inpatient unit at visit 1 with a primary diagnosis of mania but not \> 14 days before screening. hospital admission must be a result of the current manic episode. exclusion criteria: 1. has a current primary dsm 5 psychiatric diagnosis other than bipolar disorder. these include: 1. schizophrenia, schizoaffective disorder, or other psychotic disorders; 2. dementia or other cognitive disorders; 3. intellectual disability; 4. moderate or severe substance use disorder (excluding for nicotine); 2. experiencing first manic episode; 3. in the opinion of the investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or 1. at screening, the patient scores "yes" on items 4 or 5 in the suicidal ideation section of the columbia-suicide severity rating scale (c-ssrs) within 6 months prior to screening; or 2. at screening, the patient has had 1 or more suicidal attempts within 2 years prior to screening; or 3. at baseline, the patient scores "yes" on items 4 or 5 in the suicidal ideation section of the c-ssrs since the screening visit; or 4. at screening or baseline, scores ≥ 4 on item 10 (suicidal thoughts) on the rater administered montgomery-åsberg depression rating scale (madrs); or 5. considered to be an imminent danger to himself/herself or others.
the rotational insertion technique for proseal laryngeal mask airway

Conditions: General Anesthesia; Elective Surgery

Summary: the purpose of this study is to compare two insertion techniques of large size proseal laryngeal mask airway. we hypothesized that insertion of proseal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.we compared the success rate and incidence of complication of the standard technique with the rotational technique.

proseal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in asian population. first-time insertion success rate was lower and more time was required to achieve an effective airway even in well-trained physician. a number of techniques have been described to improve the insertion success rate. however, these techniques are only recommended to be used as backup when the digital or introducer tool techniques fail. we hypothesized that insertion of proseal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.we compared the success rate and incidence of complication of the standard technique with the rotational technique.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i-ii exclusion criteria: * predicted difficult airway * mouth opening less than 2.5 cm * present sore throat * high risk of aspiration

Keywords: proseal laryngeal mask airway rotational technique success rate postoperative complications
an open-label, intermediate size, expanded access study of bhv-3000 in the acute treatment of migraine

Conditions: Migraine

Summary: the purpose of this protocol is to allow subjects who completed any bhv3000 (rimegepant) clinical study to continue to have access to rimegepant while collecting ongoing safety data. (note: only for patients who participated in a previous bhv-3000/rimegepant clinical trial in the past)


Eligibility criteria:
inclusion criteria: 1.subjects who have completed any bhv3000 (rimegepant) clinical study without significant protocol violations. exclusion criteria: 1. history of basilar migraine or hemiplegic migraine 2. history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease 3. hiv history 4. uncontrolled hypertension or uncontrolled diabetes 5. current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the investigator's opinion, might interfere with study assessments 6. history of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Keywords: migraine prevention, phonophobia, photophobia, nausea
procalcitonin antibiotic consensus trial (proact)

Conditions: Lower Respiratory Tract Infection (LRTI)

Summary: the proact study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in emergency department (ed) patients with lower respiratory tract infection (lrti).

there is a need for improved decision-making for antibiotic prescription in acute suspected infection. infections, particularly in the early stages, can have protean manifestations, often do not manifest with "classic" signs, and clinically overlap with non-infectious conditions. however, the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance. strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology, cardiology, and other fields. these strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care. this approach takes diagnostics to the next level, by demanding a test not only measure well, but also that clinical care be improved by tying the test to a treatment strategy. procalcitonin, a novel biomarker of bacterial infection, may help physicians make more appropriate antibiotic decisions. lower respiratory tract infection (lrti) is an ideal trial population. lrti accounts for a large proportion of antibiotic prescription, and exemplifies the imprecise clinical phenotype of infection.however, key questions of generalizability and safety preclude widespread application.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * a primary clinical diagnosis in the ed of acute lrti (\< 28 days duration) * clinician willing to consider procalcitonin in antibiotic decision-making exclusion criteria: * systemic antibiotics before ed presentation (all prophylactic antibiotic regimens, or received \>1 dose within 72 hours prior to ed presentation) * current vasopressor use * mechanical ventilation (via endotracheal tube) * known severe immunosuppression * accompanying non-respiratory infections * known lung abscess or empyema * chronic dialysis * metastatic cancer * surgery in the past 7 days (excluding minor surgery such as skin biopsy) * incarcerated or homeless * enrolled in proact in the past 30 days

Keywords: procalcitonin (pct) lower respiratory tract infection (lrti) antibiotic exposure antibiotic decision making community acquired pneumonia (cap) chronic obstructive pulmonary disease (copd) exacerbation acute asthma exacerbation acute bronchitis procalcitonin guideline
biological investigations in active surveillance (bias) igar 2008 i 19 in prostate cancer using high field mri (3 tesla), pet, and biomarkers

Conditions: Prostate Cancer

Summary: this study will use high field mri (3 tesla), pet and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.

this study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. this can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. in addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the prostate * registration must occur within 16 weeks of last biopsy * history and physical exam (including dre) within 8 weeks prior to registration * patients must have indolent prostate cancer including all of the following: low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease * patients must have a minimum of six biopsies (sextant) at registration * psa test within 8 weeks registration * creatinine level below 100 umol/l within 8 weeks of registration * patients must have no contraindications to mri scans * no history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy * patients must be reliable for follow up exclusion criteria: * patient does not have histologically-proven adenocarcinoma of the prostate * last biopsy greater than 16 weeks prior to registration * history and physical exam (including dre) greater that 8 weeks prior to registration * patient does not have indolent disease * patient has less than six sextant biopsies at registration * psa test done greater than 8 weeks from registration * creatinine level greater than 100 umol/l within 8 weeks of registration * contraindications to mri scans * history of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy * patients that are not reliable for follow up

Keywords: prostate cancer active surveillance 3 tesla mr biological imaging in prostate cancer tumor gene re-arrangements in prostate cancer
the use of rad001 with docetaxel in the treatment of metastatic, androgen independent prostate cancer

Conditions: Metastatic, Androgen Independent Prostate Cancer; Prostate Cancer

Summary: the purpose of this study is to evaluate the safety and optimal dose of rad001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (phase i). once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus rad001 (phase ii).

* patients will be designated into one of two groups based upon the results of a fdg-pet scan. * a patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with rad001 daily for two weeks. on day 10-14, another fdg-pet scan and serum assessment will be performed. an optional bone marrow biopsy may also be done. on day 15, patients will enter the phase i portion of the trial at the current enrolling dosage or if phase i is completed patients will enter phase ii. * a patient that does not have a positive scan will enter directly into the phase i trial or phase ii depending on which trial is currently enrolling. * phase i trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks. * phase ii trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks. * the maximum duration of the trial is one year of therapy.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate with radiographic evidence of metastatic disease. * willingness to undergo a baseline tumor biopsy. * castrate levels of testosterone (testosterone \< 50 ng/dl) on androgen deprivation therapy (adt) with evidence of progression on adt. gnrh therapy will be continued for those on it at baseline * patient must have suspected tumor in an area that is safe to biopsy. * other prior hormonal interventions or experimental approaches are allowed. these therapies must have been discontinued for a minimum of 28 days with cancer progression. * prior or concurrent use of bisphosphonates is allowed. * one prior non-taxane chemotherapy allowed * ≥ 3 weeks since major surgery; ≥ 4 weeks since radiotherapy; ≥ 8 weeks since prior strontium-89 or samarium 153 * performance status: ecog 0 or 1 * anc \> 1,500/_l; platelets \> 100,000/_l; total bilirubin \< upper limit of normal; ast and alt \< 3 x upper limits of normal; creatinine \< 1.5 x upper limits of normal; total fasting cholesterol \< 350 mg/dl; total triglycerides \< 300 mg/dl exclusion criteria: * ongoing oral steroid use. patients with a history of oral steroid use are eligible as long as the steroids have been discontinued prior to study entry. ongoing topical and/or inhaled steroid use is allowed. * prior taxane chemotherapy * prior mtor inhibitors (rad001, rapamycin, cci-779) * currently active second malignancy other than non-melanoma skin cancer. * ongoing peripheral neuropathy of grade 2

Keywords: prostate cancer rad001 mtor inhibition docetaxel
effects of polynucleotides and hyaluronic acid based subgingival periodontal pockets re-instrumentation

Conditions: Periodontal Pocket

Summary: the purpose of this randomized controlled clinical trial (rct) was to investigate the clinical and biochemical efficacy of a gel containing pdrn and ha used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.

the aim of the present study was to investigate the clinical and biochemical efficacy of a gel containing polynucleotides (pdrn) and hyaluronic acid (ha) used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets. 50 patients were enrolled in a randomized, split-mouth clinical trial. for each patient, two teeth with similar residual pockets with probing depth (pd) ≥ 5 mm were selected to receive re-instrumentation with (test) or without (control) the adjunctive use of a pdrn and ha based gel. differences in changes of pd, gingival recession (rec), clinical attachment level (cal), modified sulcular bleeding index (msbi), plaque index (pli) from baseline to 6, 8, 24, 36 and 48 weeks were analyzed and the frequencies of sites with pd \<4 mm at 48 weeks were compared. furthermore, changes in the dosage of alpha-2-macroglobulin (α2m) and of matrix metalloproteinase-9 (mmp-9) from baseline to 6 weeks were evaluated.

Eligibility criteria:
inclusion criteria: * males and females with ≥ 18 years * stage 3 generalized periodontitis * 3-6 months after step 1 and 2 of periodontal treatment, at least two non-adjacent teeth showing one residual pocket with probing depth (pd) ≥5, without mobility and without furcation involvement. exclusion criteria: * full-mouth plaque score (fmps) and full-mouth bleeding score (fmbs) \>20% * inadequate restorative therapy or malocclusion * uncontrolled systemic disease * immunosuppressive therapy or therapy with corticosteroid or with bisphosphonates * inflammatory and autoimmune diseases of the oral cavity * history of malignancy, radiation therapy or chemotherapy for malignancy in the last 5 years * insulin-dependent diabetes; * smoking (\> 10 cigarettes per day) * drug and alcohol abuse * pregnant or lactating.
clinical impact of automated oxygen administration on confirmed or suspected covid-19 in the emergency department.

Conditions: COVID-19; Hypoxemia; Hyperoxia; Hypoxia

Summary: the aim of this study is to evaluate the impact of the freeo2 system on the quality of the oxygen therapy in confirmed or suspected sars-cov-2 patients in the emergency department.

the aim of this study is to evaluate the impact of the freeo2 system on the quality of the oxygen therapy in confirmed or suspected sars-cov-2 patients in the emergency department. the quality of oxygen therapy is evaluated by the time spent in the spo2 target (+/- 2% spo2 target), time spent in hyperoxemia (\> 5% spo2 target), time spent in hyperoxemia (\<5% spo2 target).

Eligibility criteria:
inclusion criteria: * hypoxemic patients on automated oxygen therapy during their emergency department stay * confirmed or suspected sars-cov-2 patients in the emergency department exclusion criteria: * patient on automated oxygen therapy in the emergency department without accessible data of the freeo2 device.

Keywords: oxygen therapy automated titration
effect of tamsulosin vs prazosin in treatment of female voiding dysfunction

Conditions: Neurogenic Bladder

Summary: the purpose of this study is to determine whether tamsolusin or prazosin are effective in the treatment of female voiding dysfunction(boo)

voiding dysfunction is not uncommon in tabriz.about 20% of patients in female urology clinic of tabriz university of medical sciences sufered from some degrees of voiding dysfunction (due to bladder imparement or bladder outlet obstruction).there is limited information about medical treatment of those patients. on the other hand alpha adrenergic blockers are the first choice medication in benign prostatic hyperplasia. there is some new facts about destribution of alpha adrenergic blockers in female pelvic floor.the purpose of this study is to comparision whether tamsolusin 0.4/daily or prazosin 1 mg/daily are effective in the treatment of female voiding dysfunction(boo)

Eligibility criteria:
inclusion criteria: * healthy females with voiding difficulty with mfr\ 50cc exclusion criteria: * history of pelvic floor surgury during last 3 month * any contraindication for tamsolusin or prazosin

Keywords: female voiding dysfunction tamsolusin prazosin
effect of personalized accelerated pacing in symptomatic patients with non-obstructive hypertrophic cardiomyopathy

Conditions: Non-obstructive Hypertrophic Cardiomyopathy; Hypertrophic Cardiomyopathy

Summary: this will be a two-arm investigator-initiated randomized controlled study of patients with nhcm and lv ejection fraction ≥50% and nyha ii-iii symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (icd) systems. patients will be randomly assigned to either personalized accelerated pacing (using the mypace+ algorithm with mono-fractional exponent) or usual care groups. at baseline and after 3 months of pacing all patients will undergo a cpet, echocardiogram, blood work for nt-probnp levels and complete the kccq-oss and hcmsq, questionnaires. the investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pvo2, biomarkers (i.e. nt-probnp), diastolic parameters and cardiac structure.

this will be a two-arm investigator-initiated randomized controlled study of patients with nhcm and lv ejection fraction≥50% and nyha ii-iii symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (icd) systems. patients will be randomly assigned to either personalized accelerated pacing (using the mypace+ algorithm with mono-fractional exponent) or usual care groups. at baseline and after 3 months of pacing all patients will undergo a cpet, echocardiogram, blood work for nt-probnp levels and complete the kccq-oss and hcmsq, questionnaires. the investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pvo2, biomarkers (i.e. nt-probnp), diastolic parameters and cardiac structure. an interim data safety analysis will be conducted.

Eligibility criteria:
inclusion criteria: * non obstructive hcm: left ventricular outflow tract (lvot) gradient \<30mmhg at rest and with provocation * left ventricular ejection fraction (lvef) ≥50% * new york heart association (nyha ii-iii) symptoms * normal intrinsic conduction system * suitable dual-chamber implantable cardioverter defibrillators (icd) system exclusion criteria: * pregnancy * lvef \<50% * lvot gradient \> 30mmhg at rest or with provocation * prolonged pr \> 250ms * baseline rv-pacing burden of \> 1% more than moderate valvular stenosis or regurgitation * aortic valve replacement in the past one year * significant primary pulmonary disease on home oxygen * uncontrolled hypertension as defined by bp \>160/100 mmhg on two measurements ≥15 minutes apart

Keywords: cardiomyopathy personalized accelerated pacing heart failure with preserved ejection fraction (hfpef)
zometa for the management of tumor-induced hypercalcemia and malignant bone pain in the community

Conditions: Cancer; Hypercalcemia; Pain

Summary: treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. the calgary health region has a unique resource in the home parenteral therapy program (hptp). with the assistance of hptp, patients requiring bisphosphonate treatment for the management of tumor-induced hypercalcemia (tih) or malignant bone pain (mbp) could be treated in the community (ie at home). however, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of tih and mbp need to be identified and evaluated so as to guide future regional decision making.

treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. the calgary health region has a unique resource in the home parenteral therapy program (hptp). with the assistance of hptp, patients requiring bisphosphonate treatment for the management of tih or mbp could be treated in the community (ie at home). however, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of tih and mbp need to be identified and evaluated so as to guide future regional decision making.

Eligibility criteria:
inclusion criteria: if hypercalcemic: * serum corrected ca+++\>= 2.5 mmol/l and symptomatic hypercalcemia * asymptomatic hypercalcemia with corrected ca+++\>= 3.0 mmol/l * moderate to severe intolerable pain (\>=6/10 on numerical rating scale \[nrs\]) despite optimal treatments with a strong opioid such as morphine, hydromorphone, fentanyl, oxycodone or methadone * radiotherapy bone pain related to metastatic bone disease exclusion criteria: * not on a regular bisphosphonate regimen

Keywords: tumor induced hypercalcemia malignant bone pain bisphosphonates cancer palliative zometa palliative patient treatment in community