Kornimate/medical-research-clean huggingface dataset:
study of octohydroaminoacridine succinate tablets in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the main purpose of this study is to evaluate the safety and efficacy of octohydroaminoacridine succinate tablets and find the optimal dose in patients with mild to moderate alzheimer's disease.

the purpose of this study is a preliminary assessment of the octohydroaminoacridine succinate tablets in the treatment of mild to moderate alzheimer's disease and explore the efficacy and safety of the best dose. the 288 patients were randomly assigned to four groups: high dose (4mg / time), moderate dose (2mg / time), low dose (1mg / time) and the placebo group, including four weeks of the trial screening period following 16 weeks double-blind treatment.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of probable ad based on dsm-iv and the nincds-adrda criteria. 2. male/female patient aged between 50 and 85. 3. mild to moderate probable ad ：middle school or above: 11 ≤mmse ≤ 25, elementary school: 8 ≤ mmse ≤ 20, illiteracy: 5 ≤ mmse ≤ 16. 4. ct or mri scan excluding another structural brain disease in one year. 5. neurologic examination no significant abnormalities. 6. hachinski ischemic score \< 4；hamilton depression scale ≤10. able to complete the test procedure, audio-visual and physical ability to act to complete the neuropsychological measure. 7. stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week. 8. informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study. exclusion criteria: 1. proven or clinically suspected other type of dementia such as vascular dementia, lewy body dementia, parkinson's disease, frontotemporal dementia, g - jakob disease (spastic pseudo-sclerosis), normal pressure hydrocephalus etc. 2. sudden onset of early dementia or with gait disorders, seizures and behavioral changes. 3. clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs. 4. history of cerebrovascular disease and stroke. 5. serious lack of folic acid and vitb12, syphilis antibody positive or thyroid dysfunction. 6. mechanical intestinal obstruction patient ,resting pulse less than 60,severe liver or renal disease. 7. patients with mechanical intestinal obstruction. 8. history of bone marrow transplantation.mental illness, such as severe depression. 9. cognitive damage caused by alcohol or drug abuse. disable to correctly evaluate the cognitive function. 10. critical condition, disable to make the exact evaluation of the efficacy and safety of new drug. 11. use of any agent for the treatment of dementia within 4 weeks of randomization. 12. be sensitive to achei. 13. be sensitive to two or more foods/drugs. 14. use of another investigational agent within one months of screening.

Keywords: alzheimer's disease octohydroaminoacridine succinate
sivelestat for acute respiratory distress syndrome due to covid-19

Conditions: Respiratory Infection Virus; Respiratory Failure

Summary: a randomized, double-blind, placebo-controlled trial aimed to investigate the safety and efficacy of sivelestat on treating adult patients with covid-19-related acute respiratory distress syndrome (ards)

this study is designed as a randomized, double-blind, placebo-controlled clinical trial, and is planned to be conducted at 3 clinical centers in china from january 1, 2023, to january 31, 2024. during the study period, we intend to enroll a total of 238 eligible patients. these patients will be randomly assigned in a 1:1 ratio to receive either sivelestat sodium or placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days (or to the day of death or icu discharge if it occurs before day 7). both the patients and investigators are blinded to the treatment assignment. subsequent follow-ups will be performed in person at 7,14 and 28 days after randomization. the primary endpoint will be at 7 days post randomization and secondary endpoints will be at 14 and 28 days post randomization. also, endpoint assessors are masked to the treatment allocation. lastly, these endpoint variables will be compared between the treatment groups to investigate the efficacy and safety of sivelestat for covid-19-associated ards

Eligibility criteria:
inclusion criteria: * age ≥18 years old * confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) in sputum, nasopharyngeal swabs, or oropharyngeal swabs * diagnosis of acute respiratory distress syndrome (ards) according to the berlin definition criteria * onset of ards less than 72 hours before randomization * written informed consent exclusion criteria: * ards potentially caused by extra-pulmonary reasons, including non-pulmonary sepsis, pancreatitis, multiple trauma and massive transfusion, etc. * leukopenia (leukocyte count \<4,000/μl/) and/or thrombocytopenia (platelet count \<100,000/μl) * significant hepatic dysfunction, defined as elevated ast and alt ≥ 3 times the normal limits, or total bilirubin ≥ 1.5 mg/dl * severe renal insufficiency with serum creatinine \> 3.0 mg/dl * history of moderate to severe chronic lung disease requiring home-based oxygen therapy, including chronic obstructive pulmonary disease (copd), interstitial lung disease (ild), asthma and bronchiectasis, etc. * pre-existing peripheral nerve injury, spinal cord trauma, or neuromuscular disorder that may impair spontaneous ventilation (e.g., high cervical spinal cord injury, guillain-barré syndrome, and myasthenia gravis, etc.) * current diagnosis of pulmonary embolism * coexisting multi-organ failure, affecting more than 3 systems * combined with burn injury * life expectancy less than 6 months (e.g., due to an an end-stage malignant disease) * moribund and expected to die within 48 hours * known allergy to sivelestat or any of the study drug excipients * pregnancy or lactation, or the possibility of conception * current or recent (last 3 months) participation in any other clinical trial

Keywords: ards covid-19 sivelestat randomized trial
safety and efficacy of aeb071 in metastatic uveal melanoma patients

Conditions: Uveal Melanoma

Summary: this study has two parts, dose escalation and dose expansion. for dose escalation, the primary objective is to estimate the maximum tolerated dose (mtd) of aeb071 in patients with uveal melanoma. for dose expansion, the primary objective is to characterize the safety and tolerability of the mtd of aeb071 in patients with uveal melanoma.


Eligibility criteria:
inclusion criteria: * uveal melanoma with biopsy proven metastatic disease * males and females ≥ 18 years of age * consent to biopsy of tumor * measurable disease according to recist version 1.1 * who performance status of ≤ 1 exclusion criteria: * patients with abnormal laboratory values as defined by the protocol * patients who are receiving treatment with strong inducers or inhibitors of cytochrome p450 3a4 (cyp3a4) that cannot be discontinued prior to study entry * patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol * patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma * patients with impairment of gastrointestinal function or disease * patients with severe systemic infections * patients who are known to be hiv positive and/or have active hepatitis b or c infection * time since last therapy for treatment of underlying malignancy: * cytotoxic chemotherapy: ≤ duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all) * nitrosurea: ≤ 6 weeks * biologic therapy: ≤ 4 weeks * ≤ 5 x pk half-life of a small molecule therapeutic not otherwise defined above * patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery * women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. highly effective contraception as defined in the protocol. * patients with primary central nervous system tumors or brain metastases. * pregnant or nursing (lactating) women. other protocol-defined inclusion/exclusion criteria may apply

Keywords: uveal melanoma phase 1 aeb071 metastatic
safety and efficacy study of eculizumab in shiga-toxin producing escherichia coli hemolytic-uremic syndrome (stec-hus)

Conditions: Shiga-like Toxin-producing Escherichia Coli

Summary: this protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for stec-hus, in the context of the 2011 stec-hus epidemic in germany.


Eligibility criteria:
inclusion criteria: 1. patient must be willing and able to give written informed consent/assent. 2. adults, adolescents, or pediatric (≥2 months and ≥5kg) patients 3. patient has been diagnosed with escherichia coli hemolytic-uremic syndrome (stec-hus) exclusion criteria: 1. known complement regulatory mutation or family history of complement regulatory mutation 2. unresolved systemic meningococcal disease 3. 3. hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Keywords: stec-hus shiga-like toxin-producing escherichia coli hemolytic-uremic syndrome uncontrolled complement activation
tailoring overdose education for black churches

Conditions: Opioid Overdose

Summary: church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. for overdose education and naloxone distribution (oend) to be efficacious in black churches, tailoring may be needed. for this audience, standard oend curricula may need to be adapted to their level of knowledge of substance use disorders (suds), and limited general mental health literacy, and specifically address stigma related to suds and medications for opioid use disorder (moud). finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. the proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., coest) to target black communities of faith. in a pilot randomized controlled trial (rtc) of adapted coest in a stepped-wedge design.


Eligibility criteria:
inclusion criteria: 1. identify as one of the following group members of the black church: clergy; individual with oud and/or stimulant use disorder; family member or friend of an individual with oud; formerly incarcerated. 2. age 18 and older. exclusion criteria: 1. unable to provide informed consent. 2. less than 18 years old. 3. does not identify as belonging to one of the four stakeholder groups.
ventilatory functions and physical intolerance in esrd adolescents: response to program of walking with dogs

Conditions: End Stage Renal Disease; Hemolysis

Summary: adolescents with chronic renal failure going on hemodialysis usually complain many problems including compromised ventilation, early fatigue, early physical intolerance, and bad life quality. incentive spirometer is highly recommended to improve these problems. also, walking program, especially walking with dog, can increase the benefits of incentive spirometer

end stage renal diseased adolescents (numbering forty) will be grouped randomly to two random groups, twenty adolescents in group i or group ii. both groups will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks. group i will additionally walked freely with a dog 30 min three times weekly (in opposite days of hemodialysis). the duration of this trial will be 12 weeks.

Eligibility criteria:
inclusion criteria: * adolescents (forty) with esrd * patents on regular hemodiaysis exclusion criteria: * cardiac insult * respiratory insult * orthopedic problem * liver insult
single center exploratory study to evaluate the use of the rxsight light adjustable lens (lal) and the light delivery device (ldd) to improve visual outcomes

Conditions: Aphakia; Cataract

Summary: the objective of this study is to evaluate, for the visual correction of aphakia, whether the rxsight light adjustable lens (lal) and light delivery device (ldd) can be used to improve visual outcomes after performing adjustments of the lal with the ldd. this is an exploratory study. no primary effectiveness endpoints will be identified.


Eligibility criteria:
inclusion criteria: * must sign a written informed consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the rxlal. * age 30 or older on the day the cataract surgery is performed. * study eye must have cataract causing reduction in best corrected distance visual acuity (bcdva) to a level of 20/32 or worse with or without a glare source. * willing and able to comply with the requirements for study specific procedures and visits. exclusion criteria: * study eye with zonular laxity or dehiscence. * study eye with diabetes with any evidence of retinopathy. * study eye with history of uveitis. * subjects taking systemic medication that may increase sensitivity to uv light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. ldd treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. this is only a partial list of photosensitizing medications. please evaluate all medications that the patient is taking for this effect prior to consideration for implantation. * subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * study eye with history of ocular herpes simplex virus.

Keywords: light adjustable lens intraocular lens lal
effect of hmg-coa reductase inhibitors on the meibomian gland morphology in patients with meibomitis

Conditions: Meibomian Gland Dysfunction; Meibomitis; Dyslipidemias

Summary: this study intends to evaluate the relationship between meibomitis and statin use. meibomitis is the predominant cause of evaporative dry eye. higher cholesterol levels were noted in patients with meibomitis when compared to controls without meibomitis. we would like to investigate the effect of statin use on meibomitis among patients with dyslipidemia.

the purpose of our study is to assess the change of meibomian gland structure in patients during treatment with 3-hydroxy-3-methyl-glutaryl-coenzyme a (hmg-coa) reductase inhibitors using meibography. patients with dyslipidemia with or without hmg-coa reductase inhibitor (statin) treatment were recruited. medical records are collected prospectively from dec. 8th 2016 to dec. 31st 2019. meibomian gland (mg) morphology described by meiboscores, lid margin abnormality scores, meibum quality, and dry eye parameters were compared between the two groups. this study may also provide information about possible treatment options in patients with meibomitis in the future.

Eligibility criteria:
inclusion criteria: * patients with regular hmgcr inhibitor (statin) treatment, and those with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy exclusion criteria: * patients with active eye infection, previous history of chemical or thermal injury to ocular surface, previous operation history of eyelid or conjunctiva, any known allergy or contraindications to statins, history of percutaneous coronary intervention, cerevascular accident, acute coronary syndrome, or rheumatological diseases, fish oil supplements or pregnancy were excluded
breastfeeding education in the time of covid-19

Conditions: Breastfeeding; Breastfeeding, Exclusive; Breastfeeding Jaundice; Educational Problems

Summary: this project will establish that pediatric and family medicine residents who complete a hybrid breastfeeding medicine curriculum that includes an asynchronous unfolding case scenario along with telesimulation with a standardized patient (sp) will provide timely, skilled lactation support more frequently than residents randomized to an asynchronous unfolding case scenario followed by videoconference group discussion regarding care for the breastfeeding dyad.

1. establish that pediatric and family medicine residents who complete a novel breastfeeding medicine curriculum that includes an online unfolding case scenario along with telemedicine simulation with a standardized patient (sp) will provide timely, skilled lactation support more frequently than residents randomized to an online unfolding case scenario followed by traditional didactic breastfeeding case-presentation via videoconference. 2. establish that online learning via unfolding case scenario and telemedicine simulation with a sp will be feasible for family medicine and pediatric residents to complete during their newborn nursery rotation. intern and third year residents completing their newborn nursery rotation at uc davis medical center will be cluster-randomized by rotation month to receipt of breastfeeding education via telesimulation with standardized patient or traditional case-based learning via videoconferencing with pediatric faculty. the primary outcome of this study will be the translation of clinical lactation skills to the care of breastfeeding mothers and newborns. i hypothesize that pediatric and family medicine residents randomized to complete the telesimulation with sp will translate their acquired clinical lactation skills to the care of breastfeeding mothers and newborns at a greater rate than residents who complete a videoconference case-based traditional curriculum discussion with a newborn nursery pediatrician.

Eligibility criteria:
1. inclusion criteria: pediatric and family medicine resident physicians at uc davis medical center 2. exclusion criteria: individuals who are unable to communicate in english, individuals who do not have access to videoconferencing via computer or phone.
influence of u-relax on vaginal health promotion and hpv dna test change from positive to negative

Conditions: Human Papillomavirus; Vaginal Infection

Summary: the purpose of this study is to understand the effect of using oral u-relax on hpv infected women for vaginal environment health promotion, and the hpv dna test index change from positive to negative. long-term infection of hpv is associated with cervical cancer. u-relax contains lactobacillus gr-1 and lactobacillus rc-14 and has been approved of its benefits on treatment of bv, uti, ibd and can improve vaginal environment health. patients with positive result of hpv dna test have no appropriate and aggressive treatment to reduce the risk of cervical cancer. this clinical trial tries to reveal the influence of oral u-relax and patients with hpv dna test positive result.

this study is a prospective, double blind, randomized clinical trial. vaginal health screening and hpv dna test are carried out from 80 patients with positive hpv dna test after conization for 6 months. all these patients will participant this study during the 360-day trial period. all health related conditions will be monitored at the same time.

Eligibility criteria:
inclusion criteria: * female * age over 30 * pap test with negative for intraepithelial lesion or malignancy result * hpv dna index test with positive result after conization for 6 months * not pregnant exclusion criteria: * cervical intraepithelial neoplasia before conization * cervical cancer patient * with gi surgery * gi dysfunction * need for long-term antibiotics treatment

Keywords: oral probiotics hpv dna index test vaginal infection
ctnow: a clinical trials education program for rural cancer patients and oncology providers

Conditions: Cancer; Oncology

Summary: the overall goal of the project is to pilot test ctnow, a multilevel intervention designed to facilitate access and referrals to cancer clinical trials in rural areas through patient and provider education and teleconference resources.


Eligibility criteria:
inclusion criteria: * patients must have been diagnosed with any cancer. * patients who have received treatment, are receiving cancer treatment at the time of enrollment, or estimated to start treatment within 90 days. * patients must be ≥ 18 years of age. patients must be able to read, write, and speak english. study materials and telephone calls are only available in english. patients must be residents of hawaii, kauai, or maui counties. exclusion criteria: * patients must not have previously participated in a cancer clinical trial. those who have participated in a cancer clinical trial are not eligible for the study.
a study on nutrition support in adult patients with severe burns

Conditions: Severe Burn; Enternal Nutrition

Summary: to delineate nutritional support in adults patients with severe burns to investigate associations between nutritional practice and clinical outcomes.


Eligibility criteria:
inclusion criteria: * patients were at least 18 years of age * patients were expected to survive more than 48 hours. exclusion criteria: * irreversible disease
influence of intraoperative analgesia on the postoperative morphine consumption

Conditions: Anesthesia

Summary: unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. we have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. we make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. patients scheduled for abdominal surgery will be divided into two groups: * in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria, * in the other group, patients will receive propofol and remifentanil both automatically administered. assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.


Eligibility criteria:
inclusion criteria: - patients scheduled for an abdominal surgery exclusion criteria: * age less than 18 years, * pregnant women, * allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component, * hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl, * inflammatory bowel disease, * chronic pain, * patients receiving a psychotropic treatment or a a morphine agonist-antagonist, * alcoholic patients and patients taking opiates, * history of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency, * emergency surgery

Keywords: anesthesia analgesia patient-controlled analgesia hyperalgesia