Kornimate/medical-research-clean huggingface dataset:
clinical performance of the automated closed-loop minimum viable prototype

Conditions: Deep Sedation

Summary: the goal of this clinical trial is to evaluate a minimum viable prototype for automated closed-loop administration of propofol in deep sedated patients under invasive mechanical ventilation in the icu. the main question it aims to answer is: • whether the minimum viable prototype for automated closed-loop administration of propofol is effective in keeping patients in deep sedation using the lowest possible dose of propofol participants will undergo deep sedation using the minimum viable prototype for automated closed-loop propofol administration. the usual practice of sedation will be compared with the practice of sedating with the minimum viable prototype to see if the infusion rate of propofol is decreased

the design of the study will consist of each patient being exposed to both forms of administration (matched pair study) during a 12-hour day (8:00 a.m. to 8:00 p.m.) in a randomized manner. specifically, a patient will be given propofol infusion in open-loop mode in the first 5 hours (8:00 a.m. to 1:00 p.m.) and the next 5 hours in closed-loop mode (3:00 p.m. to 8:00 p.m.) with a wash-out period of 2 hours. the order will be randomly determined for each patient. this design will allow the use of the prototype to be evaluated under highly controlled conditions by a trained operator dedicated exclusively to this function.

Eligibility criteria:
inclusion criteria: * indication of deep sedation for more than 48 hours exclusion criteria: * dementia * cranial surgery * hypoxic-ischemic encephalopathy * chronic liver damage child c * history of substance and drug abuse that can alter eeg recordings or the metabolization of drugs (antipsychotics, cocaine, benzodiazepines, opioids) * pregnant women * allergic to propofol * eeg sensor of the bis® covidien cannot be installed
s-1, oxaliplatin, and irinotecan for advanced gastrointestinal cancer

Conditions: Gastrointestinal Neoplasms

Summary: this study will attempt to determine the feasibility of combination of oxaliplatin, irinotecan, and s-1, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.

oxaliplatin or irinotecan has shown a considerable anti-tumor activity, when used in combination with 5-fluorouracil (5-fu) in patients with gastrointestinal (gi) cancer. oxaliplatin, irinotecan, and 5-fu have different mechanisms of actions and do not share the toxicity profiles. since they have a synergistic effect, many clinical trials have been conducted recently to evaluate the efficacy of triplet combination consisting of oxaliplatin, irinotecan, and 5-fu, and demonstrated that the triple combination regimen was effective and resulted in survival benefits with favorable toxicity profiles. s-1 and capecitabine are novel oral fluoropyrimidines and different phase iii trials have shown that these oral agents are at least as active and effective as 5-fu with a superior safety profile. biweekly triple combination of s-1 with oxaliplatin and irinotecan (ois) is an interesting alternative to increase convenience and to simply the treatment delivery. in the present study, we attempt to determine the feasibility of ois combination, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.

Eligibility criteria:
inclusion criteria: * histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract * minimum age of 18 years * ecog performance status 0-2 * life expectancy \>3 months * presence of measurable or evaluable disease by recist * prior adjuvant chemotherapy without s-1, oxaliplatin and irinotecan is allowed if more than 4 weeks elapsed since completion of chemotherapy. * more than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field) * adequate organ functions * patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital exclusion criteria: * patients treated previously with s-1, oxaliplatin, or irinotecan as adjuvant chemotherapy. * patients with cns metastases or carcinomatous leptomeningitis or neurologic disease. * patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding * any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix

Keywords: gastrointestinal neoplasms oxaliplatin irinotecan s-1
randomized trial of gemcitabine/cisplatin versus s-1/cisplatin in advanced biliary cancer

Conditions: Metastatic Biliary Tract Cancer; Locally Advanced Biliary Tract Cancer

Summary: the purpose of this study is to compare the efficacy between gemcitabine/cisplatin and s-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

standard chemotherapy regimen for biliary tract cancer(btc) has not been established due to the difficulty associated with performing clinical trials in this field. gemcitabine or fluoropyrimidines, including 5-fluorouracil and s-1, are routinely used for btc chemotherapy. the european society for medical oncology (esmo) and the national comprehensive cancer network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Eligibility criteria:
inclusion criteria: * age : older than 20 * eastern cooperative oncology group (ecog) performance status 0 -2 * histologically confirmed adenocarcinoma of the biliary tract * metastatic or unresectable biliary cancer * no prior chemotherapy for biliary cancer * a patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral ct or multidetector ct (md ct) * adequate bone marrow, liver, renal function exclusion criteria: * a patient with no measurable disease * a patient who received previous palliative chemotherapy for biliary cancer * a patient who received adjuvant chemotherapy for biliary cancer within 1year * a patient with previous active or passive immunotherapy. * a pregnant or lactating patient

Keywords: gemcitabine cisplatin s-1 bile duct cancer
effect of prophylactic negative pressure versus silver impregnated silicone bandage on c-section infection rates

Conditions: D001458; D011247

Summary: effect of prophylactic negative pressure versus silver impregnated silicone bandage on cesarean section surgical site infection rate

comparison of effect of prophylactic negative pressure versus silver impregnated silicone bandage on cesarean section surgical site infection rate as compared to wound vacuum in high risk women and traditional border dressing in low risk women in adult women having uncomplicated cesarean section.

Eligibility criteria:
inclusion criteria: * adult women, pregnant exclusion criteria: * \<18 years old * surgery complicated by non-routine surgeries (such as appendectomy)

Keywords: infection bandage cesarean section
can ilr reduce the risk of arm lymphedema?

Conditions: Breast Cancer Lymphedema

Summary: breast cancer-related lymphedema (bcrl) is a debilitating, usually lifelong burden for breast cancer survivors. for the breast cancer patients receiving axillary lymph node dissection (alnd), the likelihood of bcrl is about 20%. lymphatico-venous anastomosis (lva) has been accepted as a method of treating extremity lymphedema. a few studies have mentioned the prophylactic effect of lva on bcrl. however, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ilr) with lva could have a clinically significant effect on the reduction of bcrl occurrence.


Eligibility criteria:
inclusion criteria: 1. female patients with unilateral breast cancer 2. going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively exclusion criteria: 1. had received axillary lymph node dissection 2. going to receive bilateral axillary lymph node dissections 3. already have arm lymphedema 4. allergy to the dye used intraoperatively
prefer (pacemaker remote follow-up evaluation and review)

Conditions: Bradycardia; Arrhythmia

Summary: the purpose of the study is to compare remote pacemaker follow-up to current standard of care follow-up. the study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the medtronic carelink® network (remote arm) versus patients who are followed via routine office visits augmented by transtelephonic monitoring (ttm)(control arm).

the clinically actionable events (cae) were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. the defined events are: 1. atrial tachycardia/atrial fibrillation (at/af) episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of at/af per day 2. ventricular pacing that has increased by 30 percent (relative) since the last device interrogation 3. a sensed ventricular response of greater than 100 beats per minute (bpm) during atrial tachyarrhythmia for at least 20 percent of the time since the previous device interrogation 4. runs of non-sustained ventricular tachycardia (nsvt) greater than 5 beats 5. new onset of at/af among patients with no history of at/af 6. loss of atrial capture 7. loss of ventricular capture 8. increase in atrial pacing voltage threshold greater than 1 volt (v) 9. increase in ventricular pacing voltage threshold greater than 1 volt (v) 10. \& 11. significant change in atrial or ventricular lead impedance, defined as any of the following: 1. less than 200 or greater than 2000 ohms (ω) 2. unstable lead impedance deemed to be clinically actionable 3. greater than 50 percent change in lead impedance since last interrogation 12. elective replacement indicator (eri)/battery end of life (eol) indicators

Eligibility criteria:
inclusion criteria: * patient has been previously implanted with a dual-chamber or single-chamber enpulse®, kappa 900®, or adapta® device * patient agrees to complete all required follow-up transmissions and in-office visits * patient is capable of operating the ttm monitor and medtronic carelink monitor exclusion criteria: * patient is an immediate candidate for an implantable cardioverter defibrillator (icd)

Keywords: remote follow up diagnostic bradycardia
multiple dose study to investigate the safety, tolerability, pharmacokinetics, and efficacy of thdbh120 in chinese patients with obesity

Conditions: Obesity

Summary: the aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of thdbh120 injection in participants with obesity. this study includes three multiple-ascending dose cohorts.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years (inclusive), male or female; * body mass index (bmi) ≥ 28 kg/m²; * diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months. exclusion criteria: * type 1 diabetes, type 2 diabetes, gestational diabetes, or other types of diabetes; * history of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema); * presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg; * prolonged qtcf interval on 12-lead ecg at screening (qtcf≥450 ms for males, \>470 ms for females), pr interval \>200 ms, or the presence of long qt syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, wolff-parkinson-white syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia).
trial to address food insecurity in patients with hypertension (smart-fi)

Conditions: Hypertension

Summary: in the us, 47% of adults have hypertension (htn), and htn accounts for more cardiovascular disease (cvd) deaths than any other cvd risk factor. thus, the lack of an adaptive, stepped-care intervention to address fi in patients with htn is a critical problem affecting a large, vulnerable population.

despite advances in prevention and treatment, barriers to adherence are common and htn disparities remain pervasive. populations that have been socially and economically disadvantaged have a greater prevalence of htn, worse blood pressure control, and are at higher risk of developing cvd from htn. food insecurity (fi), the lack of consistent access to nutritionally adequate foods, is an important social need that affects 30 million people in the us, impacts adherence to treatment, and contributes to htn disparities. increasingly, health systems are investing in interventions to address fi as part of routine care, including lower-cost, low intensity (e.g. providing information about community resources) and higher-cost, high intensity (e.g. using community health workers (chws), delivery of medical tailored meals (mtm)) interventions

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years of age) * diagnosis of hypertension (htn) (defined by icd-10 code) or have been prescribed at least one blood pressure medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker) * blood pressures at their primary care office was \>130/80 * experience food insecurity (fi) based on the 2-item hunger vital sign * live in winston-salem or forsyth county exclusion criteria: * unable to speak english or spanish * have severe cognitive impairment or major psychiatric illness that prevents consent and participation * lack of safe, stable residence and ability to store meals * pregnant, breastfeeding, or planning to become pregnant in the next year * advance kidney disease (estimated creatine clearance \< 30 ml/min) * serious medical condition which either limits life expectancy or requires active management * those planning on moving out of the geographic area within 12 months * lack of a telephone

Keywords: food insecurities systolic blood pressure cardiovascular disease
validity of mediastinal blood pool suv ratio

Conditions: Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased Liver

Summary: -validity of blood pool suv ratio in identification of malignancy in case of diseased liver.

pet/ct is the functional imaging tool that can measure increased glucose metabolism in cancer tissues by using flourine 18 fdg which is fda approved and used routinely in identification of malignant lesions , staging and restaging of many malignancy like lymphoma, breast cancer, lung cancer and cancer colon. in clinical routine, suv is often used to determine the glucose metabolism in tumours by 18f-fdg pet/ct. and can be further normalised to suvs in reference regions resulting in a suv ratio (suv ratio).in routine work suv of the lesion is normalised to suv of the liver , but this not used if the liver is diseased like as liver cirrhosis or liver metastases , so suv ratio of lesion to mediastinal blood pool and suv ratio of the lesion to liver will be measured in correlation to pathology to assess validity of suv of mediastinal blood pool.

Eligibility criteria:
inclusion criteria: * this study will include cancer pt who did pet/ct scan who presented to nuclear medicine unit during the period from 2021 until the end of the study. exclusion criteria: * severely ill patient * pt with glucose level above 200
prospective randomized study on the effects of valgus knee brace for knee osteoarthritis in chinese patients

Conditions: Osteoarthritis, Knee

Summary: to investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.

osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age and geriatric population, which poses a huge burden to our in-patient and out-patient orthopaedic services. conservative treatment like physiotherapy and analgesic provide temporary symptomatic relief. surgical treatment like high tibial osteotomy and knee arthroplasty are not without major potential surgical risks and implant-related complications. orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the symptoms and disease progression. small scale biomechanical studies have demonstrated such effects with the use of valgus knee brace (2-4). though prospective clinical outcome studies on chinese patients in our locality are lacking. valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain. using a three-point leverage the unloader brace is to shift the stress away from the arthritic area to the normal portion of the knee, maintains good alignment and stability and thus provides significant pain relief during daily activities. it has been commonly used as a first line management option in other countries. our aim is to perform a prospective randomized study to look at the difference in outcome measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual regime of conservative treatment.

Eligibility criteria:
inclusion criteria: * age between 40-80 * history of symptomatic medial unicompartmental knee osteoarthritis \> 6 months * willingness to wear the knee brace for a minimum of 4 hours per day during daily activities * understanding of the chinese language * ethnic chinese patients exclusion criteria: * symptomatic knee osteoarthritis affecting more than one compartment * clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint * significant knee effusion or soft tissue compromise preventing long-term knee brace use * obesity (bmi\>30) * previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy * peripheral vascular disease of the lower limb
cetuximab + gemox in biliary tract cancer

Conditions: Unresectable; Locally Advanced; Metastatic

Summary: the aim of this prospective single-centre phase ii study is to investigate the therapeutic efficacy and safety of cetuximab in combination with gemcitabine and oxaliplatin (gemox) in the palliative first line treatment of biliary tract cancer (btc) patients.

primary objective(s) the primary objective of the study is to evaluate the best overall response of cetuximab in combination with gemcitabine and oxaliplatin (gemox) as first line treatment in patients with advanced or metastatic biliary tract cancer. secondary objectives the secondary objectives of this study are as follows: * toxicity * secondary resection rate * progression-free survival (pfs) * overall survival (os)

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic cc and gallbladder cancer) * age ≥ 18 years * ecog performance status ≤ 2 * bidimensionally measurable disease per recist criteria * no prior chemotherapy or targeted therapy for advanced disease * adequate bone marrow reserve (neutrophil count \> 1500 /µl, platelet count \> 100,000 /µl) * adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal) * adequate hepatic function (serum bilirubin \<2.5 x the upper limit of normal (uln) and serum transaminase level of ≤ 5 x uln) * written informed consent exclusion criteria: * prior palliative treatment * resectable disease * brain metastases * serious or uncontrolled concurrent medical illness * pregnancy or nursing * history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma * peripheral neuropathy (grade \> 1)
effect of provisional-crown surface coating on biofilm formation

Conditions: Dental Plaque

Summary: auto polymerizing poly methyl methacrylate (pmma), and light initiated resin modified pmmas, are commonly used for fabricating provisional restorations (prs) during prosthetic treatment 1. biofilm accumulated on these prs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. biologic and physical properties of the various materials used as prs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized. one improvement in provisional restorative materials is the use of liquid polish. it is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances.the effect of liquid polish coating or resin bonding coating on biofilm formation on prs was not reported.

auto polymerizing poly methyl methacrylate (pmma), and light initiated resin modified pmmas, are commonly used for fabricating provisional restorations (prs) during prosthetic treatment 1. biofilm accumulated on these prs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. biologic and physical properties of the various materials used as prs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized. one improvement in provisional restorative materials is the use of liquid polish. it is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances. the effect of liquid polish coating or resin bonding coating on biofilm formation on prs was not reported. in this study we intend to measure, in vivo early biofilm formation on pmma prs with and without resin coatings.

Eligibility criteria:
inclusion criteria: * patient in need for pmaa provisional crowns exclusion criteria: * patient took antibiotics three months prior to experiment

Keywords: biofilm adhesion liquid polish bonding resin pmma polymethylmetacrylate provisional crown no antibiotics treatment three months prior to experiment no mouth rinse with oral solutions one month prior to experiment