Kornimate/medical-research-clean huggingface dataset:
perceptions of trauma and violence informed care

Conditions: Intimate Partner Violence

Summary: the purpose of this study is to adapt, implement and evaluate a trauma and violence informed care intervention designed for black women in middle tennessee.

the primary goal is the adaptation, implementation and evaluation of a trauma and violence informed care (tvic) intervention designed for black women in middle tennessee. in this 5-year rcmi project, the investigators propose 3 aims. aim 1) engage a stakeholder committee of patients, providers, and experts (cope) to adapt a tvic intervention for black women and their healthcare providers at meharry. \[years 1-2\]. aim 2) implement and prospectively evaluate the adapted tvic intervention at the healthcare provider-level, measuring changes in meharry healthcare provider's self-efficacy for tvic implementation and alignment with tic knowledge, attitudes, and practices. \[years 2-3\] aim 3) implement the adapted tvic intervention at the patient-level to provide trauma-informed ipv screening, brief interventions, and referrals to treatment (sbirt), and rigorously evaluate this tvic intervention's impact on the primary outcome of patient-perceived usefulness of intervention and reported linkage to ipv services, and the secondary outcome of changes at the clinic-level relative to climate and culture, through a non-randomized pragmatic trial design. \[year 4-5\].

Eligibility criteria:
inclusion criteria: * meharry or matthew walker comprehensive health center female patients * self-identify as black * self-identify as intimate partner violence survivors * english or spanish language fluency exclusion criteria: * not black female intimate partner violence survivor of meharry or matthew walker comprehensive health center * those without english or spanish language fluency
patient-centered acupuncture for pain (pcap)

Conditions: Cancer Survivors

Summary: the objective of this study is to find out if acupuncture can improve the management of pain in cancer patients when used as part of a treatment plan that includes conventional pain medications. the investigators will enroll 36 cancer patients at abramson cancer center and penn cancer network sites. participants will be enrolled in either the conventional pain management group or integrative pain management group.


Eligibility criteria:
inclusion criteria: * women or men age 18 years or older * primary diagnosis of cancer with history of stage i, ii, or iii cancer * finished primary cancer treatments (surgery, chemotherapy, radiotherapy) * have a karnofsky score of 60 or greater * can understand written english * have worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week * have been taking pain medications daily * have had at least 15 days with pain in the preceding 30 days. exclusion criteria: * women or men with metastatic (stage iv) cancer * unstable and progressive medical conditions as judged by the pis or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks * planned surgical procedures in the next 12 weeks * patients currently in a pain crisis as judged by the pi or designated research nurse that may warrant acute titration of medications or hospitalization * women who are pregnant or breastfeeding * unwillingness to adhere to study related procedures.
adherence with fixed versus unfixed glaucoma therapy

Conditions: Primary Open-angle Glaucoma; Ocular Hypertension; Exfoliation Glaucoma

Summary: a 6-month, parallel, non-interventional trial investigating the level of adherence and the impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed combination therapy once in the evening. all patients participating in this observational study will be monitored for their adherence with the use of medication event monitoring system (mems). at the end of treatment periods treatment satisfaction will be assessed with selected questions from the treatment satisfaction survey-intraocular pressure survey. this study will monitor objectively, for the first time, adherence and intraocular pressure control with fixed versus unfixed therapy. finally it will help us to elucidate the impact of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.


Eligibility criteria:
inclusion criteria: * patient is between 21-80 years old * patient has ocular hypertension or open-angle glaucoma patient receives therapy and is well controlled on fixed or unfixed latanoprost and timolol therapy * untreated iop \>19 mm hg \<33 mm hg at baseline (10:00 hour) * open normal appearing angles * patient had at least a 20% reduction vs untreated baseline on current therapy * patient has early or moderate glaucoma (\< 14 decibel; 0.8 or better cupping) * distance best corrected snellen visual acuity greater than 1/10 exclusion criteria: * contraindication to timolol or prostaglandin therapy * history of lack of response to any medication (\< 10%) * patient does not understand the instructions and will not comply to medications * patient can not attend follow up * patient is a female of childbearing potential, or lactating mother * history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses * sign of ocular infection * a corneal abnormality that may affect iop measurements

Keywords: glaucoma adherence fixed combination therapy
study to evaluate the safety and efficacy of usl261 (intranasal midazolam) in patients with seizure clusters

Conditions: Epilepsy

Summary: the purpose of this study is to examine the safety and effectiveness of usl261 for the outpatient treatment of seizure clusters.

qualifying participants underwent an in-clinic administration (test dose phase \[tdp\]) of two doses of usl261 (intranasal midazolam 5 mg), separated by 10 minutes, in the absence of seizures. eligible participants were then randomized to usl261 versus placebo in an outpatient comparative phase (cp). when the participant had a qualifying seizure cluster episode, as described in an individualized patient management plan, the participant's caregiver administered the double-blind dose. an open-label usl261 dose could be administered after 10 minutes and up to 6 hours after the double-blind dose, if the participant had persistent or recurrent seizures. initial participants could not proceed to cp until an independent data safety monitoring board (dsmb) reviewed safety data from at least the first 25 participants in tdp; the dsmb performed additional safety reviews at pre-set intervals based on enrollment.

Eligibility criteria:
inclusion criteria: * has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes * has an established diagnosis of partial or generalized epilepsy that includes the following: * a documented history of seizure clusters lasting a minimum of 10 minutes * seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any) * a second seizure in the seizure cluster typically occurring within 6 hours from the time of cluster recognition * a seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures * a seizure cluster pattern established \> 3 months before visit 1 * a frequency of ≥ 3 seizure clusters during the year before visit 1 * at least 1 seizure cluster occurring ≤ 4 months before visit 1 * seizure cluster pattern is confirmed by a central reviewer * currently on a stable regimen of anti-epileptic drugs (aeds) with no changes in type of aeds since visit 1 and for ≥ 7 days before visit 2, with or without intermittent use of benzodiazepines at a constant dose * weight is 40 kg to 125 kg, inclusive exclusion criteria: * has a neurological disorder that is likely to progress in the next year * has severe chronic cardio-respiratory disease * has had psychogenic, non-epileptic seizure(s) within the 5 years before visit 1 * has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before visit 1 * has a history of acute narrow-angle glaucoma. * has had active suicidal plan/intent or active suicidal thoughts in the 6 months before visit 1 or a suicide attempt in the past 5 years * currently using a vagal nerve stimulator (vns) unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before visit 1

Keywords: epilepsy seizure clusters acute repetitive seizures rescue treatment artemis
endoscopic papillary large balloon dilatation versus mechanical lithotripsy for large stones

Conditions: Common Bile Duct Stones

Summary: endoscopic sphincterotomy (est) combined with large balloon dilation (lbd) has been increasingly accepted as alternative method for removal of large bile duct stones. however, there were limited studies comparing the efficacy of est in combined with lbd to est with mechanical lithotripsy (ml). the purpose of this study to compare the efficacy and safety of combined est- lbd versus est-ml in the removal of very large bile duct stones.

the large common bile duct stones (cbds) remains a therapeutic challenge in ercps. large cbds are generally refractory to be removed by est and stone extraction balloons and or baskets. traditional rescue therapy was the technique of stone fragmentation using ml. the previous reports have shown that est with ml was successful in the fragmentation of large stones yielding stone clearance rate from 68 t0 79 %. est-lbd has been shown favorable outcome in the treatment of large bile duct stone. a meta-analysis comparing the effectiveness and complications between est-lbd and est in the management of cbds showed that est-lbd was as effective as est for the removal of large or difficult of cbds in terms of stone clearance in the first ercp session of 87.87 % vs. 84.15 % and overall clearance of 97.35 % vs. 96.35 % but est-lbd was associated with fewer complications as well as reduced need for ml compared to est. the efficacy of est-ml versus est-lbd as a therapy for relatively large cbds, a mean stone size \> 20 mm in currently not well defined. the investigators, herein, compared the efficacy and complications between est followed by lbd or ml for the removal of cbds \> 15 mm with a mean stone size \> 20 mm.

Eligibility criteria:
inclusion criteria: -patients with age\>/= 18 years with confirmed or suspected cbds at our institute were enrolled in the study. * informed consent was obtained in every patients prior to the procedure * patients were randomized to lbd or ml if they had cbd stone \>/= 15 mm in shortest dimension or stone' size was disproportionate to the lower bile duct segment with a ratio of largest stone dimension/lower bile duct segment diameter \> 50 % identified by a cholangiogram at ercp. exclusion criteria:-pregnant woman * uncorrectable coagulopathy (inr \>1.5 ), thrombocytopenia( platelet count \< 50,000) * concomitant intrahepatic duct stones * ongoing acute pancreatitis or acute cholecystitis * surgically altered anatomy (i.e. billroth ii or roux-en-y reconstruction) * concomitant pancreatic or biliary malignancy
comparison of the effect of red wine with alcohol on flow-mediated dilation versus red wine without alcohol

Conditions: Healthy; Healthy Diet

Summary: introduction: cardiovascular diseases (cvds) are the leading cause of global mortality, despite being preventable. moderate wine consumption has been associated with one of the preventative approaches due to its benefits on cardiovascular health, including endothelial protection and antioxidant effects, attributed to its chemical composition, such as flavonoids. objective: to assess endothelial function through flow-mediated dilation after the consumption of red wine compared to non-alcoholic wine. methodology: a parallel, randomized, placebo-controlled clinical trial with a blinded evaluator will be conducted with 20 healthy participants, evaluated at two distinct time points. participants will be selected to receive either red wine or non-alcoholic wine and will be crossed over after 7 days to receive the opposite beverage from the initial one. the primary outcome will be the change in flow-mediated dilation of the brachial artery pre- and post-intervention in both groups. the secondary outcomes will include the flow-mediated dilation values, brachial artery diameter after the intervention, and measurements of systolic blood pressure (sbp) and diastolic blood pressure (dbp).


Eligibility criteria:
inclusion criteria: * consume alcohol sporadically exclusion criteria: * continuous medication, including anti-inflammatories * pregnant women

Keywords: wine cardiovascular disease
memantine and antipsychotics use

Conditions: Alzheimer's Disease

Summary: to investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of alzheimer's type, treated with memantine.


Eligibility criteria:
inclusion criteria: * current diagnosis of probable alzheimer's disease consistent with nincds-adrda criteria or with dsm iv tr criteria for dementia of the alzheimer's type. * mri or ct scan supporting the diagnosis of dat without indications of any relevant other cns disorders. * patients treated with any acetylcholinesterase inhibitor (achei) man be included. * the patient should have german as a mother-tongue or at least speak the language fluently. exclusion criteria: * evidence (including ct/mri results) of any clinically significant central nervous system disease other than alzheimer's disease. * modified hachinski ischemia score greater than 4 at screening. * intake of any medication that is contra-indicated in combination with memantine. * treatment with depot antipsychotics. * history of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine or lactose. * known or suspected history of alcoholism or drug abuse within the past 10 years. * previous treatment with memantine or participation in an investigational study with memantine.
efficacy and safety evaluation of easyef® in acute wound (split-thickness skin graft donor site)

Conditions: Skin Graft Scar; Split-Thickness Skin Graft (STSG)

Summary: this study is a prospective study, randomized, using control, open-label, single-center to evaluate the efficacy and safety of easyef® in acute wound (split-thickness skin graft donor site). a total of 10 subjects are randomly allocated. subjects who meet the final inclusion and exclusion criteria are randomized to the test cohorts in a ratio of 1:1:1.

this study was intended to determine the effect of egf on acute wounds such as trauma, surgical wounds and burns. but in this study, skin graft donor site wounds were used because they were the most representative for acute wounds and the depth and extent of the wounds could be controlled. egf is known pharmacologically to accelerate epithelial cell proliferation, fibroblast cells and endothelial cells. giving egf in acute wounds is expected to accelerate wound healing and improve patient quality of life.

Eligibility criteria:
inclusion criteria: * patients who have donor wounds on the vertical (upper and lower) lines of the thigh through skin grafted surgery due to trauma, ulcers, burns, and incisional surgical defects. * the size of the donor follows the standard and the distance between the two skin transplants is at least 2 cm. * patients who are expected to be able to successfully complete or benefit from this examination are based on appropriate medical assessment. * patients is willing to be treated 7 days as inpatient and treated as outpatient for maximum 7 days with homecare nurse visit. * patients is willing to stay near the hospital and visit the hospital after the donor site wound is declared healed by doctor. * patients who decided and agreed in writing to enroll in this study at their own will. * patients aged 18 and up exclusion criteria: * patients with different skin donor site can influence the results of the study. * patients who have other diseases that can interfere with wound healing such as immunosuppressive, metabolic collagen, peripheral vascular obstructive disease (paod), systemic vasculitis, and others. * patients have the talent for keloid formation. * patients have uncontrolled diabetes and diabetes with complications. * patients with liver disease, kidney disease, and other serious diseases that can affect this study. * patients who are deemed difficult to carry out the study by the investigators. * women who are pregnant, lactation or not using reliable methods of contraception and who do not consent to continue contraception for the duration of the trial.

Keywords: egf epidermal growth factor rhegf recombinant human epidermal growth factor acute wound skin graft
single nucleotide polymorphisms (snps) associated with postoperative analgesic failure

Conditions: Pain, Postoperative; Thoracic Surgery, Video-Assisted; Polymorphism, Single Nucleotide

Summary: postoperative pain remains relatively high within 48h for chinese patients who receive video-assisted thoracoscopic surgery. different patients experience different pain intensity. this suggests that there may be genetic variants that make some patients susceptible to analgesic failure. using blood samples from patients, the investigators are going to analyze the relationship between single nucleotide polymorphisms (snps) in genes that are known to be involved in analgesic failure.


Eligibility criteria:
inclusion criteria: * age ≤ 70 and age ≥18 * selective operation lung section with video-assisted thoracic surgery (vats) * iii ≥ american society of anesthesiologists classification (asa classification) ≥i * patients informed and agreed to join the study exclusion criteria: * abnormal function of liver and kidney * allergic- dependence history of alcohol, opioids and local anesthetics * no noncompliance * mental disease history，language communication disorder，cicatricial diathesis * underweight or overweight（bmi\ 30) * patients not suitable for clinical subjects for other reasons * sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24hours before the operation. * history of previous abnormal anaesthesia * women during pregnancy or lactation
retrospective study of acute chest pain in extremely critical condition for more than ten years

Conditions: Acute Myocardial Infarction; Pulmonary Embolism; Aortic Dissection

Summary: acute non-traumatic chest pain is a common kind of symptom in extremely critical condition, with various pathogenesis and different level of risk . chest pain in high risk takes 1/3 of that. it mainly includes acute coronary syndrome (including myocardial infarction and unstable angina pectoris, accounted for over 95% of chest pain in high risk), aortic dissection, pulmonary embolism etc, and is in high lethality and deformity. the investigators do the research : 1. to study the diagnosis and management condition of acute chest pain in extremely critical condition for last ten or more years in qilu hospital,shandong university. 2. to discuss the significance of key accompanying symptoms(for example radiating pain, chest distress, sweating, nausea etc), physical signs and lab examination in early diagnosis and risk stratification of acute chest pain in extremely critical condition. 3. to study the effect factors of thrombus burden in stemi patients, at the same time, creat a a simple, practical and scientific method of blood clots classification.


Eligibility criteria:
inclusion criteria: * inpatients of qilu hospital, whose electronic medical records were searched out by terms of acute myocardial infarction, aortic dissection, pulmonary embolism and unstable angina in international classification of diseases(icd)-10 code from jan.2003 to sep.2015. exclusion criteria: * patients whose medical records are false, omitted or uncompleted because of transference, death et al.

Keywords: retrospective study acute myocardial infarction acute aortic dissection pulmonary embolism unstable angina
anti-cd19/cd22 bispecific car-t cell therapy for cd19-positive all

Conditions: CD19-positive ALL

Summary: the goal of this clinical trial is to study the feasibility and efficacy of anti-cd19/cd22 bispecific chimeric antigen receptors (cars) t cell therapy for cd19-positive acute lymphoblastic leukemia.

primary objectives 1. to determine the feasibility ad safety of anti-cd19/ cd22 car-t cells in treating patients with cd19-positive acute lymphoblastic leukemia. secondary objectives 1. to determine in vivo expression, dynamics and persistency of anti-cd19/cd22 car-t cells. 2. to determine in vivo expression of cd19-positive b cells. 3. to access the complete remission rate (orr) in patients with all with 3 months after cd19/cd22 car-t cells infusion. 4. to investigate the favorable cd19/cd22 car-t cells dose and dosage regimen for the phase ii clinical trial.

Eligibility criteria:
inclusion criteria: 1. 13 years to 70 years, male and female; 2. expected survival \> 12 weeks; 3. clinical performance status of ecog score 0-2; 4. histologically confirmed as cd19-positive lymphoma and who meet one of the following conditions: * patients received at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve cr; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; * disease recurrence after stem cell transplantation. 5. accessible to intravenous injection, and no white blood cell collection contraindications 6. patients who meet the following conditions: * creatinine \< 2.5 mmol/l; * cardiac ejection fraction\>50%, no pericardial effusion and no pleural effusion (echo examination); * baseline oxygen saturation\>92%; * total bilirubin≤1.5xuln; * alt/ast≤2.5x normal. 7. able to understand and sign the informed consent document. exclusion criteria: 1. accompanied by other malignant tumor 2. active hepatitis b, hepatitis c, syphilis, hiv infection 3. suffering severe cardiovascular or respiratory disease 4. any other diseases could affect the outcome of this trial 5. any affairs could affect the safety of the subjects or outcome of this trial 6. pregnant or lactating women, or patients who plan to be pregnancy during or after treatment 7. occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment 8. patients who are accounted by researchers to be not appropriate for this test 9. received car-t treatment or other gene therapies before assignment 10. patients with symptoms of central nervous system 11. subject suffering disease affects the understanding of informed consent or comply with study protocol.