Kornimate/medical-research-clean huggingface dataset:
safety and biomarker of opb-111077 in subjects with advanced solid tumor

Conditions: Solid Tumor

Summary: this open-label, non-randomized trial will comprise of 2 parts. a dose escalation part will characterize the safety, biomarker and pharmacokinetics of opb-111077 in advanced solid tumor. subsequently, an expansion part will further evaluate the biomarker, safety, pharmacokinetics and antitumor activity of opb-111077 in selected tumor types.

this trial is designed to determine the safety, tolerability, maximum tolerated dose and recommended dose of opb-111077 administered orally 4-days on and 3-days off (3 weeks/cycle) to subjects with advanced solid tumor in the dose escalation part so that biomarkers, efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the expansion part. the dose escalation part employs a 3+3 escalation design as a standard dose escalation design for a small sample size.

Eligibility criteria:
inclusion criteria: 1. pathologically and/or cytologically confirmed advanced solid tumor 2. patients who were refractory to standard therapy or for which there are no standard treatment options available 3. age 20 to 80 years at the time of informed consent 4. patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final imp administration 5. patients informed of the diagnosis of advanced solid tumor who are fully informed about the content of the study by the investigator or subinvestigator using the specified written consent form and other written explanation, and give written consent to participate in the study of their free will 6. patients who are able to take oral medication exclusion criteria: 1. patients with symptomatic brain metastases 2. patients who have not recovered from any prior therapy related toxicity deemed to be clinically significant at study entry, except for the test item defined in inclusion criteria. 3. patients with active infections needing whole body therapy 4. patients with positive hepatitis b surface (hbs) antigen or positive hepatitis c virus (hcv) antibody 5. patients with positive human immunodeficiency virus (hiv) antibody 6. patients with uncontrollable cardiac diseases 7. patients with uncontrollable pain by analgesic drugs 8. patients with a history of organ transplantation 9. patients who have received another imp 10. patients who are pregnant, possibly pregnant, or lactating 11. patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
traumastem® versus surgicel® for the secondary treatment of local bleeding in patients undergoing hepatic resection

Conditions: Liver Hemorrhage

Summary: topical hemostats are agents that stop bleeding by contributing blood to clot. oxidized cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the blood flow and provides a surface to clot more rapidly.it was marketed for the first time in 1945 and widely used for its convenience, biocompatibility, and bactericide from that time. it is currently available in many commercial products, while manufactured using either a regenerated or nonregenerated process. the physicochemical property and hemostatic efficacy of oxidized regenerated cellulose (orcg) and oxidized nonregenerated cellulose (onrcg) has been well documented using in vitro test and animal models, and onrcg was seemingly superior to orcg in terms of hemostasis. however, no clinical study has been performed to verify. therefore, the objective of this prospective randomized study is to assess the hemostatic efficacy of orcg (surgicel®, ethicon) vs onrcg (traumastem®, bioster) for hemostasis of local bleeding in patients undergoing hepatic resection.

representative liver resected surface (prominent bleeding site) was applied the ply of gauze with several seconds of even finger gentle press under aseptic conditions, then it was untouched and observed for 10 min. vascular occlusion of the liver was allowed if necessary, but was open for evaluation of hemostatic efficacy. hemostatic time began to calculate when gauze was applied. time to hemostasis was recorded in seconds and the maximum time to hemostasis was 600 seconds. hemostasis success was achieved based on there was no visible bleeding or minimal ooze from the resection wound.

Eligibility criteria:
inclusion criteria: * inpatient with informed consent * adults aged between 18 to 75 and do not plan to have child within 1 year after the surgery * resection of at least the equivalent tissue volume of 1 anatomical segment of the liver * minor to moderate (oozing/diffuse) bleeding from the incisal area after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, vascular clips, or point electrocautery exclusion criteria: * indication for emergency surgery * participate in other clinical trials in the past 3 months * obvious hematologic disorder (as judged by the investigator from anemia and coagulation dysfunction) * patients with brain disease, abnormal judgment or mental disorder that does not cooperate with the researcher * patients with asthma or allergies * patients with severe cardiac disease, metabolic disease or endocrine disorders * immunodeficient patients (aids) * pregnancy, breastfeeding females * skin infection in the field of the targeted incisional area

Keywords: liver resection liver hemorrhage traumastem surgicel
study of ec0225 for the treatment of refractory or metastatic tumors

Conditions: Cancer

Summary: this is a phase 1 clinical trial evaluating the safety and tolerability of escalating doses of ec0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

this is a phase 1, dose escalation study of ec0225 administered by intravenous bolus (iv) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. ec0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. experimental evidence shows that the target receptor is over-expressed in many human cancers. there are no previous human studies of ec0225; however, lab research (research in test tubes or animals) using ec0225 has shown activity against tumors in animals. this activity in animal models suggests that ec0225 may be useful as chemotherapy against human cancers. the primary objective of this study is to determine the safety and maximum tolerated dose of ec0225 given by intravenous bolus. the efficacy of treatment will also be measured.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * histological or cytological diagnosis of neoplasm * no effective standard therapeutic options * ecog performance status of 0-2 * ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent. * negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mtc-ec20 and ec0225) * adequate bone marrow reserve, renal and hepatic function exclusion criteria: * concurrent malignancies * women who are pregnant or lactating * evidence of symptomatic brain metastases * receiving concomitant anticancer therapy (excluding supportive care) * requires palliative radiotherapy at time of study entry * unable to tolerate conditions for radionuclide imaging * administration of another radiopharmaceutical that would interfere with assessment of 99mtc-ec20

Keywords: cancer phase 1 ec0225 ec20 refractory metastatic experimental
the inspire-asp pna trial

Conditions: Pneumonia

Summary: the inspire-asp pna trial is a cluster-randomized controlled trial of hca hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with pna is infected with a resistant pathogen. note: that enrolled "subjects" represents 59 individual hca hospitals that have been randomized.


Eligibility criteria:
facility inclusion criteria: * hca hospitals admitting adults with pna * facility use of meditech as their electronic health record system facility exclusion criteria: - note: unit of randomization is the hospital, however the cpoe alert intervention will calculate risk estimates for adults age \>=18 admitted to non-icu wards and who are ordered to receive extended-spectrum antibiotics for pna. prisoners were excluded from prompts and analysis.

Keywords: pna cpoe empiric therapy
safemedwaste at-home, environmentally-friendly opioid disposal kit for orthopedic post-operative surgical patients to reduce opioids available for diversion

Conditions: Opioid Use Disorder

Summary: there is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with economic data. safemedwaste, inc. (smw) has developed the patented safemedwaste in-home drug disposal container, that completely destroys opioids within minutes and can be placed in the regular trash, without risk of ground or municipal water contamination. a pilot randomized clinical trial will evaluate the use of safemedwaste in 300 adult patients in outpatient surgery clinics undergoing shoulder and knee surgery.

the trial will evaluate opioid disposal rates and events related to opioid diversion and use disorder in 300 adult patients 18 years of age and older undergoing outpatient knee and shoulder surgery who are prescribed opioids to manage their acute post-surgical pain. patients will be randomized into two arms. during the standard of care post op visits (2-, 6- and 10- weeks), when the treating physician has determined that the patient will no longer need opioids to manage their post-surgical pain, all patients will receive general instructions by video on opioid disposal recorded by one of the orthopedic surgeons. patients in the treatment arm will also be given the safemedwaste opioid disposal system and watch an instructional video on how to use the product. all patients will complete a pre-surgery survey and a post-surgery survey 90 days after surgery. patients will self-report their disposal or non-disposal of the drugs, documented with pictures uploaded to the patient's mychart account. data from the surveys will be statistically analyzed to identify significant factors that influenced patients' behavior vis-à-vis opioid disposal.

Eligibility criteria:
inclusion criteria: * inclusion criteria: * subject is 18 + years of age * subject is opioid naive (within the last 3 months), as evidenced by mychart patient record or response to medical history questions * subject is scheduled to undergo shoulder and/or knee surgery exclusion criteria: * subject has a history of opioid addiction, as evidenced by mychart patient record or response to medical history questions * subject is currently utilizing prescription narcotics for any reason, as evidenced by mychart patient record or response to medical history questions * subject does not have the mental capacity to make their own healthcare decisions * subject is unable to provide written consent

Keywords: opioid use disorder drug disposal at-home drug disposal drug diversion opioid disposal
evaluation of depression and anxiety levels of parents of children with spina bifida

Conditions: Spina Bifida

Summary: studies in the literature have measured the anxiety and depression levels of parents of children with spina bifida. additionally, it has been reported that parents of children with non-neurogenic lower urinary tract dysfunction, such as nocturnal enuresis and overactive bladder, have increased levels of anxiety and depression. in this study, the investigators aim to evaluate, for the first time, the effect of urinary system symptoms and findings in children with spina bifida on the anxiety and depression levels of their parents.

between january 2024 and december 2024, the demographic data of patients with spina bifida under follow-up, as well as the results of dimercaptosuccinic acid (dmsa) static renal scintigraphy, urinary ultrasonography (usg), and voiding cystourethrography (vcug), which indicate upper urinary tract (uut) damage, were recorded. symptom scoring was performed on the primary caregiver of the child, and anxiety and depression scores were calculated. the hospital anxiety and depression scale (hads) and the beck anxiety inventory were used to assess these symptoms in the parents. the presence of renal scarring, hydronephrosis, or vesicoureteral reflux (vur) in the dmsa was considered as uut damage. patients were divided into subgroups based on demographic data, uut damage, history of febrile urinary tract infections (utis), incontinence, and the presence of motor deficits. these groups were then compared in terms of anxiety and depression scores.

Eligibility criteria:
inclusion criteria: - having a child with spina bifida exclusion criteria: - diagnosis of psychiatric illness

Keywords: spina bifida anxiety depression
efficacy and safety of qax576 in patients with eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: this study is designed to investigate the effects of a 12 week course of intravenous qax576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of eoe patients by 75% or greater when compared with baseline.


Eligibility criteria:
inclusion criteria: * males and females aged 18-50 with symptomatic eosinophilic esophagitis * female subjects must be women of non child bearing potential. * elimination diet must have been tried. * treatment for at least two months prior to enrollment on a protocol pump inhibitor . * appropriate contraception must be used by males, (e.g., spermicidal gel plus condom) * must be able to communicate well with the investigator, to understand and comply with the requirements of the study. * understand and sign the written informed consent. exclusion criteria: * have received corticosteroids within 3 months before starting the study for any symptoms. * any other eosinophilic disorders. * history of clinical schistosomiasis, or having travelled within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to southeast and southwest asia, south america and africa. travel to these areas must not be planned for at least 6 months after the last dose. * donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing. * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. * history of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. other protocol-defined inclusion/exclusion criteria may apply

Keywords: esophagitis digestive system diseases esophageal disorder eosinophilic esophagitis
preventing pulmonary complications in surgical patients at risk of covid-19

Conditions: Pulmonary Complications in Surgical Patients; COVID; Severe Acute Respiratory Syndrome

Summary: the aim of this study is to reduce pulmonary complications in adult patients undergoing abdominal or thoracic surgery in covid-19 exposed hospital environments. a trial in low and middle income countries (lmics)

this trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. this will enable rapid feedback of results to clinicians, allowing the standard of care to be modified as the pandemic progresses. regular and frequent monitoring of results will be guided by an experienced, independent dmc. eligible patients will be randomised at the level of the individual in a 1:1 ratio between: a. control (normal practice) b. resp301 6ml mixture of 150mm sodium nitrate, 50mm mannitol and 100mm citric acid, buffered at ph 5.4, three times per day (at least 4 hours apart), for 7 days or until discharge, whichever occurs first

Eligibility criteria:
inclusion criteria: * patients aged 18 years and over. (this criteria must be made country-specific) * planned to undergo abdominal or thoracic elective or emergency inpatient surgery requiring general anaesthesia. * asymptomatic of covid-19, including patients with: those not tested, negative test results, positive test but no symptoms (to be monitored post-surgery for symptoms) * informed patient consent. * able to operate a vibrating mesh nebuliser, as assessed by the recruiting physician exclusion criteria: * procedures under local anaesthesia * known history of adverse reaction/contraindication to trial drug * pregnancy and/or lactating patients (including patients undergoing caesarean section) * history of methaemoglobinaemia * patients receiving any type of prescribed nitric oxide-donating agents (e.g. nitroprusside, isosorbide dinitrate, isosorbide mononitrate, naproxcinod, molsidomine and linsidomine) * unable to tolerate use of a nebuliser and/or deemed unlikely to be able to adhere to protocol in view of investigator

Keywords: surgery pneumonia covid 19 covid sars-cov-2 sars
mesenchymal stem cells for the treatment of covid-19

Conditions: Covid19; Prophylaxis

Summary: this double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from covid-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those patients.

recent preliminary data from wuhan/china have claimed that intravenous injections of mesenchymal stem cells derived from human umbilical chords have resulted in complete recovery of covid-19 infected elderly patients with respiratory failure. this study investigates the efficacy and safety of a single umbilical cord derived stem cell intravenous injection in patients with suspected or confirmed covid-19 infection with fever and respiratory illness. a second arm will test efficacy and safety of a single umbilical cord derived stem cell intravenous injection to healthcare providers at high exposure rates to covid-19 infection.

Eligibility criteria:
inclusion criteria: * age 18 and older * ability to provide informed consent exclusion criteria: * active or recent malignancy (within last 2 years) * inability to provide informed consent * current enrollment in any other covid-19 treatment study

Keywords: stem cell therapy umbilical cord stem cells amniotic stem cells stem cells msc mesenchymal stem cell medicinal signaling cell
salt - success of active versus passive lead fixation of atrial pacing/sensing electrodes

Conditions: Bradycardia

Summary: randomised comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism

this investigation will study and compare 3 types of electrically identical, commercially available fineline ii sterox leads with different fixation mechanisms. this trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and j-shaped) leads, if any. it will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up

Eligibility criteria:
inclusion criteria: * patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. patients must also be able and willing to provide informed consent. exclusion criteria: * patients who previously went through heart surgery should be excluded from the study.
phase 0/1 study of 212pb-ng001 in mcrpc

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the purpose of this study is to evaluate the imaging feasibility and safety of 212pb-ng001.

this is a single site, open label, non-randomized, non-controlled intervention study with an initial microdosing run-in part (phase 0), followed by a conventional dose-escalation phase 1 part.

Eligibility criteria:
key inclusion criteria: * ecog performance status of 0 to 2 * life expectancy \>6 months * histological, pathological, and/or cytological confirmation of prostate cancer * metastatic castration resistant prostate cancer * failure of conventional treatment or such treatment not available/accepted by patient * psma avid mcrpc lesions confirmed by psma pet/ct * adequate hematopoietic, kidney and liver function key exclusion criteria: * concurrent or other cancer diagnosis last two years, except for carcinoma in situ * concomitant diseases not compatible for radioactive therapy * previous psma-targeted radioligand therapy * concurrent serious (as determined by the principal investigator) medical conditions note: other protocol defined inclusion/exclusion criteria apply.
light constraint induced therapy experiment

Conditions: Stroke

Summary: the purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by taub et al.. this study will determine if licite will lead to similar improvements than the original described method.

constraint-induced movement therapy or ci therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. however, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit. the aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by taub et al. (360 minutes of motor training with a physical or occupational therapist). patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. the treatment will last two weeks, five days per week. the evaluations will include clinical measure of motor function and functional mri of the brain. the brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.

Eligibility criteria:
inclusion criteria: * age \> 18 years * first ischemic or hemorrhagic stroke between 2 and 12 months * at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits. * adequate balance while wearing the restraint exclusion criteria: * major cognitive impairment * prior stroke * excessive fatigability * severe aphasia * mal score ≥ 2,5 * specific exclusion criteria for fmri ancillary study

Keywords: 1- constraint induced therapy 2- stroke 3- upper limb 4- rehabilitation 5- motor training 1- first time clinical ischemic or hemorrhagic stroke 2- at least 10° of active wrist extension 3- at least 10° of thumb abduction/ extension 4- at least 10° of extension in at least 2 additional digits 3- adequate balance while wearing the restraint.