Kornimate/medical-research-clean huggingface dataset:
bladder preservation for patients with muscle invasive bladder cancer (mibc) with variant histology

Conditions: Muscle-Invasive Bladder Carcinoma; Tumor

Summary: this is a phase ii, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (mibc) with variant histology who receive neoadjuvant chemotherapy (nac) with or without immunotherapy (io) followed by trimodal therapy (tmt). enrolled patients will undergo at least 3 cycles of nac +/- io (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. these patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone tmt. this study has been designed to test the hypothesis that variant histology tmt can be delivered within 45 days of nac +/- io and is therefore a viable option in patients who are risk of systemic disease spread.

trimodal therapy (tmt) is accepted as an nccn category 1 alternative to radical cystectomy (with neoadjuvant chemotherapy) in patients with ct2n0m0 muscle-invasive urothelial cell bladder cancer (mibc). not all patients with mibc have pure urothelial cell carcinoma; urothelial carcinoma with variant histology (vh) described any morphologic variant of conventional urothelial carcinoma that is believed to be derived from urothelial carcinoma and is typically admixed with conventional urothelial carcinoma in the same tumor. variant histologies described include squamous differentiation, glandular differentiation, micropapillary, sarcomatoid, small cell/neuroendocrine, plasmacytoid and nested variant. this is a rare tumor type and understudied. for patients with variant histologies there is limited data on the use of trimodal therapy. there are a couple single institution retrospective studies and data from the ncdb, but no prospective data.

Eligibility criteria:
inclusion criteria: * documented diagnosis of mibc with variant histology, ct2-t4n0m0, confirmed by turbt and ct c/a/p and/or pet. * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. exclusion criteria: * evidence of diffuse cis on pathology * presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral) * prior radiotherapy to the pelvis * history of systemic therapy for mibs * presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)

Keywords: trimodal therapy (tmt) neoadjuvant chemotherapy muscle-invasive urothelial cell bladder cancer (mibc)
intra artherial therapies in treatment of primary liver diseases: an observational study

Conditions: HCC - Hepatocellular Carcinoma; Cholangiocarcinoma Cancer

Summary: the goal of this observational study is to learn what are the best conditions that will give a positive outcome to men and women that receive a intra arterial therapy (iat) for primary liver cancer. intra arterial therapies are radiologic procedures that block liver cancer blood supply. the researchers will collect the data of participants located in the radiology department in "irccs azienda ospedaliera universitaria" hospital in bologna and will study clinic and radiological traits to understand which is the best case scenario for a optimal treatment response.

this study is non profit, observational, retrospective, prospective and single institution. the researchers will do a retrospective and prospective data collection and analyze the results. they will examine the radiological images (ct scan and rm) to assess the type and size of the cancer, track how the disease responds to treatments, identify possible complications. there are no drugs involved and all the intra arterial therapies are performed within the routine clinical-care path. * for the retrospective phase the researchers will analyze radiological image of the participants that received a intra arterial therapy from the 1st of january 2009. it's expected to enroll around 2000 participants. * for the prospective phase the researchers will enroll for 5 years eligible participants that will receive a intra arterial therapy. participants will go through a follow up every three months for the duration of the whole study. it is expected to enroll around 1300 participants.

Eligibility criteria:
inclusion criteria: * diagnosis of hepatocellular carcinoma (hcc) or intrahepatic cholangiocarcinoma (icca) and clinical indication to receive or have already received one of the following treatments: * trans-arterial embolization (tae), * transarterial chemoembolization (tace), * transarterial radioembolization (tare) * drug-eluting beads chemoembolization (deb-tace) * age over 18 * to give informed consent exclusion criteria: * shunt of gastro intestinal arteries that cannot be embolized * metastasis spread outside of the liver * liver failure
a multi-site intervention to expand hospital based oud treatment provision

Conditions: Opioid Use Disorder

Summary: the investigators implemented a multi-site hospital-based opioid use disorder (oud) treatment intervention across 12 hospitals in colorado to address an oud treatment gap among hospitalized adults with oud.

the investigators implemented a multi-site hospital-based opioid use disorder (oud) treatment intervention across 12 hospitals in colorado to address an oud treatment gap among hospitalized adults with oud. the intervention included nurse driven universal screening for unhealthy substance use with a social work referral for a brief intervention when indicted, electronic health record-embedded protocols to assess for opioid withdrawal and to direct buprenorphine initiation, methadone orders for opioid withdrawal symptoms, and embedded links for post discharge addiction treatment referral. it also included clinician education and nursing education via video conference or in-person lectures. the intervention was supported by the health system chief medical officer and involved subject matters expertise and representation from nursing leaders, social work leaders, and hospital medicine leaders. outcomes assess include a pre/post implementation assessment of 1) change in buprenorphine prescribed in hospital and 2) discharge, 3) change in naloxone prescribed, 4) change in hospital based methadone prescribing, and 5) change in average clinical opioid withdrawal scale (cows) score. investigators also assessed a pre/post survey of hospitalists physicians and advanced practice providers to assess their perception of hospital based oud treatment provision.

Eligibility criteria:
inclusion criteria: * physicians, advanced practice providers, social workers, and nurses who work at any affiliated hospitals exclusion criteria: * none

Keywords: opioid use disorder hospital
prone position with different types of cushions in patients with ards

Conditions: Prone Position; Acute Respiratory Distress Syndrome

Summary: the prone maneuver is a well-established therapy in ards. traditionally, the maneuver is perform with thoraco-abdominal cushions. the goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with moderate to severe ards.

the prone position is a ventilatory therapeutic strategy used in the treatment of patients with moderate to severe acute respiratory distress syndrome (ards) that promotes improved oxygenation with consequent reduction in mortality. despite being safe and effective, it is not without complications, with pressure injuries being one of the main concerns. the use of cushions helps prevent such injuries, but they can interfere with ventilatory mechanics depending on where they are placed. the aim of this study is to assess whether there is a difference in ventilatory mechanics when performing the prone maneuver with a thoraco-abdominal cushion or a modified lateral cushion, based on measurements from electrical impedance tomography (eit), gasometric data, and parameters of mechanical ventilation.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or more, with * moderate or severe acute respiratory distress syndrome (ards), and * indication of prone position exclusion criteria: * contra-indication to the prone position: intracranial pressure \> 30 mmhg or cerebral perfusion pressure \< 60 mmhg; massive haemoptysis needing urgent surgical or radiological treatment; tracheal or thoracic surgery in the last 15 days; facial trauma or surgery in the last 15 days; deep venous thrombosis or pulmonary embolism treated in the last 2 days; unstable bone dislocations of rachis, femur, rib cage, pelvis; mean systolic arterial pressure less than 70 mmhg despite vasopressive therapy and pregnancy * severe acute respiratory distress syndrome (ards) caused b coronavirus disease 2019 (despite meeting the berlin criteria for ards, their ventilatory mechanics are characterized by nearly normal compliance, something rarely seen in patients with ards from other etiologies) * contraindications for the use of electrical impedance tomography (eit) such as presence of a cardiac implantable electronic device * pulmonary transplantation * prone position before enrollment
mobile chess research on emergency medical services for children

Conditions: Asthma

Summary: the primary aims are to test whether an asthma care management system (m-chess) delivered via a smartphone (cellular phone with internet access) can support low income teenagers (ages 12-18) with significant asthma and can improve asthma control and reduce asthma-related emergency or urgent care visits and hospitalizations. secondary aims include whether m-chess increases adherence to asthma control medication and reduces absenteeism from school, work or an event they wanted to attend.

four hundred milwaukee medicaid recipients (ages 12-18), with an asthma-related emergency care visit or hospitalization in the last twelve months, will be recruited through their managed care organization (mco). they will be randomly assigned to one of two study arms and will participate in a 12-month intervention plus a 12-month follow-up period. subjects in the control group will receive a smartphone with internet access \& text messaging service. these devices will provide the ability to collect smartphone use data electronically. the experimental group will also receive the same smartphone devices (with internet access and text messaging service and ability to collect usedata. in addition the experimental group will have access to the mobile chess (m-chess) interface. the m-chess smartphone interface features an interactive, internet based asthma education program, peer support mechanisms and automated reminders for asthma control medicines and data collection.

Eligibility criteria:
inclusion criteria: * adolescents ranging in age from 12-18: * these study candidates will have had an asthma related emergency care visit or hospitalization in the last 12 months and fit the following characteristics: an icd-9 code 493.xx and have filled one or more prescription(s) for an asthma medication (short acting beta agonist, oral corticosteroid, inhaled or nebulized corticosteroid, long-acting beta agonist, xanthine, or leukotriene modifier). * they also must receive medical care from one of the two participating managed care organizations involved in our study. exclusion criteria: * other chronic pulmonary disorders such as cystic fibrosis, abpa, or bronchopulmonary dysplasia. * developmental/cognitive/sensory disabilities.

Keywords: persistent asthma asthma related emergency room visits asthma control, adolescents adherence, asthma control medications
adjusted ventilatory assist (nava-niv) in infants: short-term physiological study

Conditions: Acute Respiratory Failure

Summary: neurally adjusted ventilatory assist (nava) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (eadi), as assessed by trans-esophageal electromyography. to test the hypothesis that nava could provide better patient-ventilator synchrony during niv delivered by nasal-facial mask as compared to conventional flow-triggered psv in infants with acute respiratory failure.

neurally adjusted ventilatory assist (nava) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (eadi), as assessed by trans-esophageal electromyography. because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, nava has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. a high incidence of asynchrony events has been demonstrated to have a significant clinical impact by favouring weaning failure and longer duration of mechanical ventilation. nava has been implemented safely in animals, in healthy volunteers and in critically ill adults and has been shown to improve patient-ventilator synchrony, to limit excessive airway pressure and tidal volume, and to unload the respiratory muscles in tracheally intubated patients. moreover nava was found to be effective in delivering non-invasive ventilation (niv) even when the interface was excessively leaky (75% leak) with reduced positive end-expiratory pressure. with these conditions, nava was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. to date, no data exist on the use of nava in infants during noninvasive ventilation. the aim of this physiological study is to compare patient-ventilator interaction in infants receiving niv by nava and pressure support ventilation (psv).

Eligibility criteria:
inclusion criteria: * infants aging \> 1 month and \< 2 yrs * arf (pao2/fio2 \< 300 mmhg) * accessory muscle recruitment * respiratory rate more than 2 sd related to age * intact neuromuscular pathway to the diaphragm exclusion criteria: * hemodynamic instability * facial surgery * reduction in airway protection * coma * contraindication to insert the nasogastric catheter * heart and lung transplant * increase in pic * refusal of the parents or legal guardian * enrolment in other research protocols

Keywords: nava noninvasive ventilation infants
laboratory smoking of marijuana "blunts"

Conditions: Cannabis

Summary: this is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.


Eligibility criteria:
inclusion criteria: * currently living in baltimore city or baltimore county, md; * able to read, understand, and sign informed consent; * 18-55 years old; * currently smokes marijuana blunts; * designation of medically healthy for research by the study physician; and * willing to abstain from illicit drug use other than marijuana for the duration of the study. exclusion criteria: * bac \> 0.020% as measured by alcohol breathalyzer; * meets dsm-5 criteria for severe current or lifetime cannabis use disorder; * meets dsm-5 criteria for any current axis i disorder, other than current mild or moderate cannabis use disorder; * self-reported current desire to stop marijuana use; * self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation; * has difficulties with blood draws or poor venous access; * history of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit; * among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant; * acute illness which will require participant to be rescheduled

Keywords: cannabis
evaluation on visual outcome of tms

Conditions: Visual Impairment

Summary: the goal of this clinical trial is to learn if transcranial magnetic stimulation (tms) can improve the visual outcomes in patients with visual impairment. the main question it aims to answer is: • does tms improve the visual outcome in patients who suffer from visual impairment? researchers will compare tms to the control group who will not receive effective tms treatment) to see if tms works to improve the visual outcomes of the patients. participants will * undergo tms treatment or no effective tms for consecutive 5 days. * visit the clinic once every 2 weeks for checkups and tests.


Eligibility criteria:
inclusion criteria: * post cataract surgery or clear lens * best-corrected visual acuity less than 0.1logmar exclusion criteria: * diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment; * diagnosed with ocular diseases that affect observation of visual function; * history of epileptic seizures; * long term use of psychotropic drugs； * metal implants in the body.
neoadjuvant toremifene with melatonin or metformin in locally advanced breast cancer

Conditions: Breast Cancer

Summary: this study evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene.

the management of locally advanced breast cancer is complicated issue. neoadjuvant treatment is often needed to downstage locally advanced er positive bc tumors prior to surgery. however, many patients do not achieved objective response on treatment. the ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover, several studies confirm, that this drugs in combination with conventional anti - estrogen treatment may increase objective response. but, this data is still controversial. we hypothesizes that the combinations of melatonin and metformin with conventional anti - estrogen such as toremifene could be more effective than toremifene alone in terms of response rate.

Eligibility criteria:
inclusion criteria: * age \> 18. * obtained inform concent. * morphologically confirmed breast cancer stage iib, iiia, iiib, iiic er positive. * eastern collaborative oncology group performance status scale 0-2. * expected survival \> 6 month. * adequate liver and bone marrow function. exclusion criteria: * systemic treatment for breast cancer. * stage iv disease. * evidence of liver and bone marrow clinically meaningful disfunction. * severe uncontrolled concomitant conditions and diseases. * pregnancy or lactation. * second malignancy. * diabetes mellitus requiring drug therapy. * any condition preventing study participation by investigators opinion.

Keywords: melatonin, metformin, toremifene
safety and feasibility of tmli as conditioning regimen in allogeneic hematopoietic stem-cell transplantation

Conditions: Acute Lymphoblastic Leukemia

Summary: multiple conditioning regimens have been used for the hsct, some of which include radiotherapy. total body irradiation (tbi) has demonstrated to be superior to chemotherapy alone in the phase iii forum trial. however, concerns for long-term toxicity have made tbi less used. total marrow and lymphoid irradiation (tmli) has emerged as a new alternative that can potentially keep the benefits of radiation but reducing toxicity to healthy tissues. the primary objective of this trial is to evaluate the feasibility and safety of tmli as part of conditioning schemes with or without etoposide for hsct in patients between age 16 and 45 years with all in first line or relapsed disease. as secondary endpoint the efficacy will be assessed by minimal residual disease at 60 days post-transplant, as well as other outcome measures such as non-relapse mortality (nrm), relapse free survival (rfs) and overall survival (os).

tmli will be administered as part of the conventional reduced intensity conditioning scheme of our institution: fludarabine 25 mg/m2 + cyclophosphamide 350 mg/m2 on days -6 to -3, for patients with positive measurable residual disease tmli will be added in doses of 12 gy on days -3 to -1 divided into 6 fractions of 2 gy every 12 hours for 3 days, which will be administered through a computed tomography tomotherapy system. infusion of peripheral blood hematopoietic stem cells will be performed on day 0 and after this, prophylaxis for gvhd with post-transplant cyclophosphamide 50 mg/kg will be administered on days +3 and +4, followed by tacrolimus or cyclosporine a plus mycophenolate mofetil regardless of hla matching. the procedure for the donation of hematopoietic cells will be done through a peripheral blood apheresis with previous stimulation with filgrastim at 10 mcg/kg for 4 days according to the standardized procedures of our institution. the leukocyte and platelet count will be monitored by serial complete blood count, and a bone marrow aspiration (bma) and minimal residual disease (mrd) will be performed on day 60 after transplantation.

Eligibility criteria:
inclusion criteria: * diagnosis of all confirmed by flow cytometry. * patients between age 16 and 45 years with all in first remission, refractory, or relapsing * patients who have an identical or haploidentical allogeneic donor by high resolution hla exclusion criteria: * patients who do not meet the age previously mentioned. * patient with comorbidities that rule them out for hsct, with a hematopoietic cell transplantation-specific comorbidity index (hct-ci) greater than 2. * poor performance status or karnofsky less than 70% * transthoracic echocardiogram with alteration in myocardial function with left ventricular ejection fraction (lvef) less than 50% * patients who previously and for another reason have already received radiotherapy or who refuse to receive it
efficacy study of antiseptic preoperative scrubs in prevention of postoperative infections

Conditions: Postoperative Wound Infection

Summary: most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. this trial is to compare the impact of disinfecting the skin with chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. betadine on the rates of infection of clean-contaminated surgical wounds. the study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of chloraprep vs betadine.

this is a prospective, randomized, multicenter clinical trial. all adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.

Eligibility criteria:
inclusion criteria: adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. a clean-contaminated wound is one that is entered under controlled conditions without unusual contamination. - exclusion criteria: patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors. -

Keywords: prevention antiseptic preoperative scrub postoperative wound infection