Kornimate/medical-research-clean huggingface dataset:
kj-tfc-004 drug-drug interaction study

Conditions: Glaucoma; Eye Diseases; Ocular Hypertension

Summary: to assess the pharmacokinetic interaction between dorzolamide and brimonidine in healthy male subjects.

clinical trial to evaluate the influence of drug and drug-drug interactions of brimonidine and dorzolamide co-administration on the pharmacokinetics of brimonidine and pharmacokinetics of dorzolamide in healthy volunteers

Eligibility criteria:
inclusion criteria: * healthy male adults aged between 19 and 50 during screening period * bmi more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg * signed the informed consent form prior to study participation. exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
whether using sequential ph would improve human blastocyst formation

Conditions: Infertility

Summary: any drift in extracellular ph (phe) from the intercellular ph (phi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. this could lead to difficulty in restoring the physiological level of phi. the critical stages that lack robust mechanism of regulating the phi are the denuded oocyte, early stage of fertilization or a thawed embryo. this, in turn, could lead to a significant effect of the perturbations on embryo development. convincing evidence regarding the optimal phe for culturing human embryo is, so far, scanty and mostly anecdotal. the embryo has been reported to have a compensatory mechanism to grow at phe between 7.0-7.4. others have recommended that embryo need a sequential ph to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of ph. however, whether this holds true remains to be examined.


Eligibility criteria:
inclusion criteria: * icsi cycles exclusion criteria: * no exclusion
efficacy of whole-body vibration on balance control, postural stability and mobility after thermal burn injuries.

Conditions: Thermal Burn

Summary: this study will be conducted to investigate the effect of whole-body vibration device on balance control, postural stability and mobility after thermal burn injuries.

40 patients with deep second-degree burn involving the lower limbs and trunk (tbsa: 35-40%), will be randomly assigned either into the experimental group, received whole body vibration (wbv) plus the routine physical therapy program or the control group, received the same routine physical therapy program. all treatment interventions will be applied at a frequency of three sessions per week for 8 weeks. anteroposterior stability (aps), medial lateral stability (mls), time up and go test (tug) test, and berg balance scale will be the outcome measures of the study.

Eligibility criteria:
inclusion criteria: * age ranged between 20 and 45 years, * deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of burn as measured by "rule of nine" method, with complete wound healing or after 6 weeks from the injury. * body mass index of between 17 and 35, with no history of neurological disorders or injuries to the lower extremities. exclusion criteria: * patients with open burn wound, * patients diagnosed with acute rheumatoid arthritis, * joint replacement within the past year, * history of traumatic spine within the past six months, * prosthesis, * recent fracture or bone disease.
cohort b of the pivotal study to evaluate the safety and effectiveness of the novacross™ micro-catheter

Conditions: Coronary Occlusion

Summary: a prospective, multi-center, non-randomized, single arm, open label, supplemental study to evaluate the safety and effectiveness of the novacross™ micro-catheter in facilitating crossing chronic total occlusion (cto) coronary lesions


Eligibility criteria:
inclusion criteria: * adult aged 25-80 * patient understands and has signed the study informed consent form * patient has an angiographic documented chronic total occlusion (i.e. \>3 months occlusion duration) showing distal timi flow 0, with a reference diameter of at least 2 millimeters. * left ventricle ejection fraction \> 25% exclusion criteria: * patient unable to give informed consent. * elevated ck-mb or troponin at baseline * patient is known or suspected not to tolerate the contrast agent * chronic total occlusion is located in aorto-ostial location, svg cto, in-stent occlusion * appearance of a fresh thrombus or intraluminal filling defects * intolerance to aspirin and/or inability to tolerate a second antiplatelet agent (clopidogrel and prasugrel and ticagrelor) * cardiac intervention within 4 weeks of the procedure * severe renal insufficiency with egfr\<30 ml/min/1.72 m2 * congestive heart failure \[new york heart association (nyha) class iii\\iv\] csa class iv * life expectancy \< 2 years due to other illnesses * acute or unstable medical disorder/disease that may cause a risk to patient, including: i. recent myocardial infarction (mi) (within the past two weeks) ii. significant anemia (e.g. hemoglobin \ 180/100 mmhg) v. unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (ptca) or coronary artery bypass graft (cabg)
combination chemotherapy for patients with brain cancer

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus g-csf, in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent.

objectives: i. determine the response rate in patients with refractory or recurrent glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (tax) and topotecan (topo) with granulocyte colony-stimulating factor (g-csf) support. ii. determine survival in these patients. iii. describe the toxicity of tax/topo/g-csf. iv. evaluate tumor p53 expression in relation to response to tax/topo/g-csf. outline: all patients receive paclitaxel, topotecan, and g-csf every 3 weeks for at least 2 courses and until 2 courses beyond maximum response. patients are followed every 3 months for 2 years, then every 6 months for relapse and survival. projected accrual: a total of 35 patients will be entered if there are 1-3 responses in the first 20 patients.

Eligibility criteria:
disease characteristics: biopsy proven glioblastoma multiforme or anaplastic astrocytoma central pathologic review at dartmouth-hitchcock medical center, including assay for tumor p53 expression no anaplastic oligodendroglioma no mixed oligodendroastrocytoma recurrent or progressive disease following radiotherapy documented by ct or mri within 2 weeks of entry patient characteristics: age: 18 and over performance status: karnofsky 60%-100% hematopoietic: wbc at least 3,000 anc at least 1,500 platelets at least 100,000 hepatic: bilirubin no greater than 1.0 mg/dl ast/alt no greater than 2.5 times normal renal: creatinine no greater than 1.5 mg/dl other: no documented sensitivity to e. coli-derived products no major medical or psychiatric illness that would interfere with therapy or compliance with scheduled follow-up no pregnant or nursing women adequate contraception required of fertile patients prior concurrent therapy: no prior taxanes or topoisomerase i inhibitors at least 4 weeks since chemotherapy (6 weeks since nitrosoureas) at least 4 weeks since radiotherapy

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma
brief interventions to create smoke-free home policies in low-income households: texas effectiveness trial

Conditions: Chronic Disease

Summary: the burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. the remarkable progress in creating smoke-free environments in the u.s over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited. the proposed research will systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. during this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a texas 2-1-1 call center. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services. the main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.


Eligibility criteria:
inclusion criteria: * must be 18 years of age or older. * must speak and understand english. * must smoke and live with at least one other non-smoking person or be a non-smoker who lives with a smoker(s). * must not have a total smoking ban in their home. exclusion criteria: * participants who are in immediate crisis * participants who are calling to be transferred to the tiers program * participants who are homeless or facing homelessness

Keywords: secondhand smoke exposure secondhand smoke environmental tobacco smoke smoke-free homes smoke-free homes ban
resuscitative endovascular balloon occlusion of the aorta in non-traumatic out of hospital cardiac arrest

Conditions: Cardiac Arrest

Summary: the primary aim of this trial is to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (reboa) as an adjunct treatment to advanced cardiovascular life support (acls) in patients with out-of-hospital cardiac arrest. out of hospital cardiac arrest (ohca) carries a high mortality rate. the treatment of out-of-hospital cardiac arrest is acls as stated in the guidelines from the norwegian resuscitation council and the european resuscitation guidelines. recently, reboa has been proposed as an adjunct treatment in management of non-traumatic cardiac arrest patients, because thoracic aortic occlusion provides a redistribution of the cardiac output to organs proximal to the occlusion. preclinical studies demonstrate that reboa during cpr provide both increased coronary artery blood flow and perfusion pressure and increased rates of return of spontaneous circulation (rosc). this is the first prospective trial in the world to assess the efficacy of reboa in non-traumatic cardiac arrest. the intervention is shown feasible in the pre-hospital setting. if this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.

this is a prospective, randomised, parallel group, multi-centre, phase ii clinical trial. patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. the control group receives acls according to national guidelines, while the intervention group receives acls according to national guidelines and the reboa procedure as an adjunct treatment. the reboa procedure is performed by a team consisting of a physician (anesteshiologist) and a paramedic, working at a helicopter emergency medical service (hems) base. all operators will be properly educated and tested before they can include patients. if the patients in the intervention group achieves rosc, the balloon will be deflated and post-rosc treatment will be continued as per routine.

Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest * non-traumatic cardiac arrest * less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support * advanced cardiac life support is established and can be continued exclusion criteria: * traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches * accidental hypothermia with temperature \< 32 0c * suspected cerebral hemorrhage as etiology of the arrest * suspected non-traumatic hemorrhage as etiology of the arrest * pregnancy, obvious or suspected * patient included to the study site's e-cpr protocol * other factors as decided by the treatment team (environmental factors, safety factors and others)

Keywords: reboa procedure aortic occlusion resuscitation pre-hospital emergency care
dual psma and fdg pet imaging for patients with advanced prostate cancer

Conditions: Advanced Prostate Cancer

Summary: this study will use prostate specific membrane antigen (psma) and (18)f-fluorodeoxyglucose positron emission tomography (fdg pet) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. this may help with treatment selection and potential response monitoring in the future.


Eligibility criteria:
inclusion criteria: * male, age ≥ 18 years * histologically or cytologically confirmed prostate cancer (adenocarcinoma) * poor risk patients with mcspc at study enrollment * de novo or recurrent high volume mcspc as per conventional imaging (ct chest abdomen pelvis, or mri, plus bone scan) prior to starting adt and arpi * high or low volume mcspc plus psa ≥4.0 after 6-8 months of initiating adt * willing to undergo study pet scans and remain under the care of medical oncology, radiation oncology or urology physician at princess margaret cancer center. * no prior psma or fdg pet imaging within the last 60 days at each specified time point on study * patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility exclusion criteria: * under a randomized-controlled trial with unknown allocation of systemic therapy * inability to undergo or successfully complete psma pet and fdg pet imaging exams * unable to provide written consent by patient and their legal representatives * in the opinion of the treating physician: * conditions which would significantly impair the patient's ability to comply with study procedures and follow up * significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study pet imaging * another active malignancy * patient on dialysis * another radioisotope or investigational systemic agent within 5 half-lives prior to pet imaging

Keywords: prostate specific membrane antigen positron emission tomography
sequential intravesical gemcitabine and docetaxel for rescue therapy in bcg unresponsive non-muscle invasive bladder cancer patients

Conditions: Bladder Cancer; BCG; Gemcitabine; Docetaxel; Intravesical Instillation

Summary: studies in the literature are limited both throughout turkey and in general. for this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to bcg therapy in bladder cancer patients.


Eligibility criteria:
inclusion criteria: - bcg refractory/relapsed/unresponsive or intolerant who do not want or are not suitable for radical cystectomy exclusion criteria: - bcg naive a history of multiple cancers having a radical cystectomy plan

Keywords: bladder cancer bcg intravesical instillation gemcitabine docetaxel
cognitive remediation of schizophrenia in a community mental health setting

Conditions: Experimental Condition TCT; Controlled Condition CG

Summary: the purpose of this study is to investigate the usefulness of neuroscience-guided cognitive training combined with community-based supported employment for people with schizophrenia. the investigators will examine the effectiveness of moving our study of neuroplasticity-based restorative targeted cognitive training out of the laboratory and into the community setting; and the investigators will also investigate its utility in enhancing functional outcome in chronically mentally ill adults who are participating in supported employment.

neurocognitive functioning will be assessed at baseline (study entry), after cognitive training (6 months), and at 12 month follow-up, using the matrics consensus cognitive battery (mccb). the investigators will assess the following six constructs identified by matrics as separable, fundamental dimensions of cognitive impairment in schizophrenia, with a likely sensitivity to intervention \[26\]: 1) speed of processing, 2) attention/vigilance, 3) working memory, 4) verbal learning and memory, 5) visual learning and memory, and 6) reasoning and problem solving (executive functioning). the investigators will also administer the delayed memory trials of hvlt and bvmt, trails b, and d-kefs color-word interference test \[27\], and will make one modification to the mccb in utilizing bacs tower of london \[28\] in place of nab mazes.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder(dsm-iv criteria) * between the ages of 18-65 * english as primary language (learned before age 12) * no major medical or neurological disorder that precludes participation in the study exclusion criteria: * we will not exclude subjects with substance abuse or dependence as we wish to investigate the real-world effectiveness of this cognitive remediation approach when combined with se. as per the clinical policy at community services, however, patients will not be permitted to attend the se program or to participate in the study if they are acutely intoxicated. subjects who miss 5 consecutive days of participation due to intoxication will be dropped and a replacement subject will be recruited.

Keywords: targeted cognitive training (tct) plus evidence-based se computer games (cg) plus evidence-based se
reducing unnecessary antibiotic prescriptions in primary healthcare in saskatchewan by identifying high prescribers

Conditions: Upper Respiratory Tract Infections

Summary: approximately 90% of antibiotics are prescribed in primary healthcare (phc) in canada (public health agency of canada, 2020), making this an important sector for antimicrobial stewardship. upper respiratory tract infections (urtis) represent a common indication in phc for which antibiotics are often prescribed unnecessarily (leis et al, 2020; schwartz et al., 2020). reducing unnecessary antibiotic treatment in this sector is a vital part of contributing to minimizing the global burden of antibiotic resistance. the goal of this research project is to reduce the number of antibiotic prescriptions among family physicians identified as high prescribers in saskatchewan. to achieve this, the investigators will send letters to the top 25th percentile of high prescribers in phc. the letters will contain data indicating the prescribers high antimicrobial usage as well as guidance for reducing unnecessary prescriptions and promoting appropriate lengths of prescriptions for upper respiratory tract infections.


Eligibility criteria:
inclusion criteria: * must be a practicing family physician in saskatchewan * top 25th percentile of antimicrobial prescribers exclusion criteria: * fewer than 12 months of historical prescribing data available

Keywords: audit and feedback antimicrobials primary healthcare
safety evaluation of 3k3a-apc in ischemic stroke

Conditions: Ischemic Stroke

Summary: the purpose of this study was to evaluate the safety, pharmacokinetics (pk) and preliminary efficacy of multiple ascending intravenous doses of 3k3a-apc, a recombinant variant of human activated protein c (apc), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tpa), mechanical thrombectomy or both.

this was a multicenter, prospective, randomized, controlled, double-blinded phase 2 study intended to evaluate the safety, pk and preliminary efficacy of 3k3a-apc following treatment with tpa, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke. approximately 115 subjects were to be randomized, which included the planned 88 subjects in groups of 4 subjects to either 3k3a-apc or placebo (in a 3:1 ratio) and the additional placebo subjects who were enrolled during safety review pauses. this study used a modified version of the continual reassessment method (crm) in order to establish a maximum tolerated dose (mtd). eligible subjects received 3k3a-apc or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurred first. subjects were monitored for safety evaluations through day 7 (or discharge, if earlier) and were expected to be seen on day 7, 14, 30, and 90 for safety and outcome evaluations.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke * able to receive iv tpa, mechanical thrombectomy or both * national institutes of health stroke scale (nihss) score of ≥ 5 * signed informed consent * mechanical thrombectomy subjects only: onset time to arterial puncture time \< 6 hours exclusion criteria: * history of stroke or penetrating head injury within 90 days prior to enrollment * history of previous or current diagnosis of intracranial hemorrhage that represents a potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical thrombectomy * moyamoya disease, cerebral arterio-venous malformation (avm), known unsecured aneurysm requiring intervention during the acute study period * presence of other neurological or non-neurological co-morbidities that may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period * presence of premorbid neurological deficits and functional limitations assessed by a retrospective modified rankin scale (mrs) score of ≥ 2 * mechanical thrombectomy subjects only: baseline non-contrast ct scan revealing a large core occlusion as defined by local protocol * prolonged prothrombin time (pt) or activated partial thromboplastin time (aptt) * severe hypertension or hypotension * glomerular filtration rate (gfr) \<35 ml/min * blood glucose concentration \< 50 mg/dl * prior exposure to any exogenous form of apc

Keywords: ischemic stroke stroke apc 3k3a 3k3a-apc activated protein c rhapsody