Kornimate/medical-research-clean huggingface dataset:
dexmedetomidine in the treatment of agitation associated with dementia (tranquility ii)

Conditions: Agitation; Dementia

Summary: a study to determine the safety and efficacy of bxcl501 dosing for episodes of agitation associated with dementia when they occur (given as needed \[prn\]), for a maximum of 28 doses within a 12-week treatment period.

a randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of bxcl501 in male and female subjects (65 years and older) with acute psychomotor agitation. subjects will be dosed prn with a maximum of 28 doses over a 12-week period. once a subject has received 28 doses of bxcl501, they will continue to be followed for the remainder of the 12-week study period. approximately 150 subjects will participate in this study. subjects will receive a single film consisting of bxcl501 40 µg dose or bxcl501 60 µg dose or placebo in a 1:1:1 randomization scheme. subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.

Eligibility criteria:
inclusion criteria: 1. all subjects must have a diagnosis of probable ad based on nia-aa criteria (2018) 2. episodes of psychomotor agitation (e.g., kick, bite, flailing) 3. subjects exhibit behaviors that are congruent with the international psychogeriatric association criterion for agitation representing a change from the subject's usual behavior 4. a score of 15 to 23 on the mini-mental state exam (mmse) 5. subjects who read, understand, and provide written informed consent, or who have a lar to provide consent on their behalf 6. subjects who are deemed to be medically appropriate for study participation by the principal investigator 7. participants who agree to use a medically acceptable and effective birth control method exclusion criteria: 1. subjects with dementia or other memory impairment not due to probable ad. 2. clinical diagnosis of probable ad should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function. 3. subjects with agitation caused by acute intoxication. 4. subjects with significant risk of suicide or homicide per the investigator's assessment. 5. subjects who are medically unstable or in recovery. note: subjects with a remote (\>5 years) history of stroke may be included, regardless of size/location. 6. history of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia. 7. subjects who had a total score of \>13 (ie, high fall risk) on the john hopkins fall risk assessment tool. 8. subjects with laboratory or ecg abnormalities. 9. subjects who have received an investigational drug within 30 days prior to screening. 10. subjects who are currently suffering from substance abuse. patients with a potential cause for delirium (relatively recent onset agitation and dementia)
yeahhh baby! ointment on hip and/or knee pain in men and women

Conditions: Joint Pain

Summary: this study will compare the impact of the yeahhh baby! ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. the hypothesis is that perceived pain will be reduced when subjects use the yeahhh baby! ointment. previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (the western ontario and mcmaster universities arthritis index \[womac\] and visual analog scale \[vas\] for pain).

joint pain is a common ailment among adults in the united states. in 2014, an estimated 14.6 million americans with arthritis suffered from severe joint pain. it is therefore unsurprising that many topical ointments are currently marketed for joint pain relief including bengay®, icy hot®, jointflex®, and aspercreme®. these ointments aim to reduce pain often through a combination of analgesic ingredients include capsaicin, salicylates, menthol, camphor, and lidocaine. bengay® products, for instance, contain one or more of menthol, camphor, salicylates, and lidocaine. icy hot® products contain menthol, while some also include lidocaine. yeahhh baby! ointment is an herbal (botanical: plant-based) treatment for those impacted by joint pain. the product contains a variety of herbal ingredients that have been touted by some within the alternative medicine community as "healing agents." the product started selling in 2016 and is available commercially as an all-natural alternative to other commercially available products. this ointment consists primarily of coconut oil (98%), with magnesium and small amounts of herbal ingredients (tanner's bark, slippery root, sweet weed, velvet plant, walnut hulls, kidney root, green ginger, indian pink, mad dogweed, and nigella seed) thought to reduce inflammation and to promote tissue healing. the present study will compare the impact of the yeahhh baby! ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. the hypothesis is that perceived pain will be reduced when subjects use the yeahhh baby! ointment. previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (the western ontario and mcmaster universities arthritis index \[womac\] and visual analog scale \[vas\] for pain).

Eligibility criteria:
inclusion criteria: * self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30 days * recreationally active (2 or more days per week) * not obese (bmi \< 30kg/m2) exclusion criteria: * tobacco users/smokers * allergic to coconut, walnuts, oak, olives * currently using anti-inflammatory medicines or dietary supplements (and not willing to cease for one-month prior to participation and throughout study)

Keywords: hip knee topical
using a state-wide initiative to disseminate effective behavioral weight loss strategies: study 5

Conditions: Obesity

Summary: the purpose of this study is to examine whether providing additional intervention support to individuals with lower than expected weight loss within the initial stages of an internet-based behavioral weight loss program improves weight loss outcomes at week 12, compared to the internet program alone.


Eligibility criteria:
inclusion criteria: * age 18-70 years * bmi \>=25 kg/m2 * no health problems that make weight loss or unsupervised exercise unsafe * english speaking * access to computer/internet exclusion criteria: * report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire 62 (par-q; items 1-4). * individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written consent to participate from a health care provider * are currently pregnant or intend to become pregnant in the next 12 months * are planning to move outside of the state within the next 4 months
lean body weight-adjusted rocuronium dose and intubation conditions

Conditions: Body Weight Changes; Rocuronium; Intubation Conditions

Summary: in this study, researchers wiil administer rocuronium, based on either the lean body weight or the total body weight in patients with body mass index (bmi) of 18.5 to 34.9 and compared the duration of action of the drug and its effects on tracheal intubation conditions and hemodynamic parameters..

the whole body will be routinely monitored with electrocardiogram, oximetry oximetry, and non-invasive arterial monitoring. for anesthesia induction, intravenous (iv) fentanyl 50-100 µg and propofol 2mg/kg will be ventilated 100% by lightning. after optimal general anesthesia was achieved, the ulnar nerve was adapted and monitored at the wrist with tof-watch® sx (organon, swords co., dublin, ireland). lbw lower content of 0.6 mg/kg rocuronium will be administered. k subgrade similar a dose based on tbw will be administered. the time to duration of rocuronium tof responses will be measured (t1 (seconds)). all consumers will be intubated with a macintosh laryngoscope diameter with endotracheal sold with inner tubes of 7.5 8.0 mm and 7 mm to 7.5 mm. a single air anesthetist will evaluate the intubation target according to the han-raulo intubation scoreboard. anesthesia will be provided with sevoflurane and an additional dose of phenyl. monitoring with tof was continued until the initial fasciculation power (t2=min) of the adductor pollicis decreased to 25% and was approached to an additional rocuronium dose of 0.3mg/kg. all anesthetic agents for operation will be discontinued and extubated when the tof value reaches 90%.

Eligibility criteria:
inclusion criteria: patients who will receive general anesthesia operations that will take less than 6 hours patients to be provided with rocuronium neuromuscular blockade exclusion criteria: renal, hepatic, neuromuscular, and metabolic diseases craniotomies, cardiac, thoracic, and large vessel surgeries those who did not want to participate in the study will be excluded from the study

Keywords: the lean body weight, rocuronium, intubation conditions
study of developing an optimal gemcitabine based regimen to treat elderly patients with advanced non-small cell carcinoma

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: cares for elderly patients with advanced non-small cell lung cancer(nsclc) become one of the common clinical practices oncologist are now facing. so, we need to seek adequate regimens for them. gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. gemcitabine alone have been recommended as first line treatment for elderly nsclc patients, especially in the aspect of tolerability. however, gemcitabine alone is suggested to be suboptimal to control their disease. therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.


Eligibility criteria:
inclusion criteria: * histologically- or cytologically- confirmed non-small-cell lung cancer stage iiib/iv * no prior chemotherapy * existence of measurable disease. the measurable disease should not have been irradiated * life expectancy of more than 3 months * age ≥ 70 years * performance status (ecog):1 or 2 * adequate bone marrow function (absolute neutrophil count \>1500/mm\^3, platelet count\>100000/mm\^3, hemoglobin\>9gr/mm\^3) * adequate liver (bilirubin\<2 times upper limit of normal and sgot/sgpt\<3 times upper limit of normal) and renal function (creatinine\<1.5mg/dl) * informed consent exclusion criteria: * psychiatric illness or social situation that would preclude study compliance. * other concurrent uncontrolled illness. * other invasive malignancy within the past 5 years except nonmelanoma skin cancer * currently/recently taken warfarin, phenprocoumon or phenytoin * hypersensitivity history to any drug

Keywords: carcinoma, non-small-cell lung aged gemcitabine uft
transverse abdominal plane block for caesarean

Conditions: Caesarean Section; Pain

Summary: cesarean sectionis a commonly performed major surgical procedure that results in significant postoperative pain. the objective of this study was to evaluate the effectiveness in the management of post-cesarean pain at the chu souro sanou of bobo-dioulasso


Eligibility criteria:
inclusion criteria: * adult parturients (≥ 18 years old) awaiting caesarean section under spinal anesthesia * asai, asaii exclusion criteria: * lack of informed consent, * parturients with cognitive disorders, * parturients with notion of chronic pain, * allergy to local anesthetics, * morphine allergy * parturients not understanding pain assessment scores

Keywords: caesarean, tap-block, postoperative pain
effect of organic naked oat with whole germ on type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: dietary modification is of great essential for the prevention and treatment of type 2 diabetes mellitus. common oat (avena sativa l.) and its products showed a great potential benefits on ncds including type 2 diabetes mellitus. but data about such effects of naked oat (avena nuda l.) is still unavailable. the investigators aimed to examine the effects of organic naked oat with whole germ (onog) plus diet on patients with type 2 diabetes. after a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes. participants would be randomly assigned to one of the four following groups: usual care group (only basic health advice, no other interventions), diet group (systematic education, structured dietary), 50g-onog plus diet group (all the interventions of diet group plus replacement of 50g onog per day) and 100g-onog plus diet group. a regular follow-up for years would be carried out to predict the long-term effects of onog plus diet intervention on patients with type 2 diabetes. the investigators hypothesized that onog combined with diet would have better effects on glycaemia and insulin resistance control in addition to those yielded by diet or usual care.


Eligibility criteria:
inclusion criteria: * all adults aged 50-65 years old with type 2 diabetes mellitus * stable physical condition * fasting plasma glucose (fpg) concentration ≥7.8mmol/l or 2-h postprandial blood glucose (pg) ≥11.1mmol/l after 75g oral dextrose with an glycated hemoglobin (hba1c)\>7 %, stable medication. exclusion criteria: * pregnancy * breastfeeding * severe renal or hepatic complications * treatment by glucocorticoid * having pancreatic disease or malignancy in recent 3 months * other factors that may limit adherence to interventions or affect conduct of the trial or participation in another supplementary feeding programme.

Keywords: naked oat (avena nuda l.) diabetes mellitus rct
preoperative short course radiotherapy with chemotherapy and camerelizumab in locally advanced rectal cancer

Conditions: Rectal Cancer; Radiotherapy; Immunotherapy

Summary: this is a open-label, single-arm study to investigate the safety and efficacy of consolidative chemotherapy with camrelizumab, an anti-pd-1 antibody drug following short course radiotherapy and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

patients with locally advanced rectal cancer (ct3-4 or n+) are assigned to receive preoperative 5 × 5 gy irradiation over 5 days with consolidation chemotherapy consisting two cycles of capox chemotherapy and camrelizumab, an anti-pd-1 antibody drug for two cycles. subsequent surgical therapy is performed to evaluate the safety and efficacy.

Eligibility criteria:
inclusion criteria: 1. patients who personally provided written consent for participation in the study 2. treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the av before crt 3. primary rectal cancer histopathologically confirmed to be adenocarcinoma 4. clinical stage of t3/t4 or n positive and m0,before crt 5. patients with the ecog performance status of 0 or 1 at the time of enrollment 6. women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy 7. male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug exclusion criteria: 1. patients with recurrent rectal cancer or a history of pelvic radiation 2. patients with a history of inflammatory bowel disease 3. patients with a history of pneumonitis or interstitial lung disease 4. patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 5. patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study 6. patients with a history of thyroid dysfunction 7. patients with a history or finding of cardiovascular risk 8. patients who are positive for any of the following: hiv1 antibody, hiv2 antibody, htlv1 antibody 9. patients who are pregnant or lactating or who may be pregnant 10. patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study
safety/proof of concept study of oral qlt091001 in subjects with leber congenital amaurosis (lca) or retinitis pigmentosa (rp) due to retinal pigment epithelial 65 protein (rpe65) or lecithin:retinol acyltransferase (lrat) mutations

Conditions: LCA (Leber Congenital Amaurosis); RP (Retinitis Pigmentosa)

Summary: the purpose of this study is: * to evaluate the safety of oral qlt091001 * to evaluate whether 7-day treatment with oral qlt091001 can improve visual function in subjects with lca or rp due to rpe65 or lrat mutations * to evaluate duration of visual function improvement (if observed)


Eligibility criteria:
inclusion criteria: * subjects diagnosed with lca or rp (with a mutation in either rpe65 or lrat) * subjects with lca must be 5-65 years of age * subjects with rp must be 18-65 years of age * subjects who have a "best-corrected" visual acuity of 3 letters or better (20/800 snellen equivalent) or viable photoreceptors on oct/faf. exclusion criteria: * subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of day 0. * subjects with any clinically important abnormal physical finding at screening. * subjects who have taken any prescription or investigational oral retinoid medication (e.g., accutane,® soriatane®) within 6 months of day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure. * subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis, or cirrhosis. * subjects who have taken any supplements containing ≥10,000 iu vitamin a within 60 days of screening
mini-invasive balloon aortic valvuloplasty

Conditions: Aortic Valve Stenosis

Summary: the spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. however, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.

consecutive patients with severe aortic stenosis with indication to aortic balloon valvuloplasty will be enrolled. an ad hoc informed consent for the procedure will be obtained from all patients. this is a prospective observational study. the investigators will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation. the aim is to register and monitor the effectiveness and safety of this approach. details regarding management of radial access and pacing with 0.035 wire can be found in the references reported below. the primary endpoint will be the 30-day occurence of minor and major vascular complications according varc 2 classification. the safety endpoint will be the absence of intra- or periprocedural major complications in transradial balloon aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical intervention. the feasibility endpoint will be a procedural success rate ≥90%. the efficacy endpoint will be a reduction of the mean invasive gradient \>30%. at baseline, handgrip strength test will be performed and angiography of the instrumented arm will be performed at the beginning and at the end of the procedure. all patients will be prospectively followed-up for at least 30 days and all adverse events will be recorded. all patients will be assessed also for frailty according the clinical frailty scale (cfs). during the 30-day follow-up visit two independent blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip strength test in in both arms in all patients.

Eligibility criteria:
inclusion criteria: * severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty exclusion criteria: * cardiogenic shock * bilateral absence of radial pulse
naproxen on tooth sensitivity caused by in-office bleaching

Conditions: Toothache; Tooth Bleaching

Summary: this study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.


Eligibility criteria:
inclusion criteria: * at least 18 years old patients of both genders presenting good general/oral health; * all maxillary anterior teeth presenting shade equal or darker than 2m2 at vita bleachguide guide (vita-zahnfabrik, germany); * signed the form accepting to participate of this study. exclusion criteria: * presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth. * undergone tooth-whitening procedures; * pregnant/lactating; * presence of periodontal diseases; * presence of severe tooth discoloration by tetracycline stains or fluorosis; * any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure); * continuous use of drugs with anti-inflammatory actions; * presence of tooth hypersensitivity at baseline measurement; * any known adverse effects caused by naproxen; * non-attendance to any session of evaluation or bleaching.
examination of ventavis (iloprost) inhalation behavior using the i-neb aad system in patients with pulmonary arterial hypertension when switching the iloprost nebulizer solution for inhalation from 10 μg/ml (v10) to 20 μg/ml (v20)

Conditions: Hypertension, Pulmonary

Summary: the aim of this study is to examine inhalation behavior in patients enrolled in the german ventavis patient support program ventaplus when these patients are switched from ventavis (iloprost) 10 μg/ml to ventavis (iloprost) 20 μg/ml formulation.

the ventaswitch study will be a local, prospective and retrospective, observational, case-crossover study. data are collected and downloaded from the i-neb aad (adaptive aerosol delivery) system. two data collection periods are planned: period one; data collection from the last 3 months using ventavis (iloprost) 10 μg/ml (v10) before the index date of switching to ventavis (iloprost) 20 μg/ml (v20) (retrospective part) and period two; data collection for 3 months using v20 from index date (prospective part).

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years at time of signing informed consent. * patients, diagnosed with group 1 pah. * patients must be enrolled in the german ventavis patient support program ventaplus. * patients who either already switched from v10 to v20 therapy or who agreed to do so according to their physician's decision. * patients must have been on v10 therapy for at least 2 weeks. * written informed consent must be obtained. exclusion criteria: - participation in other clinical or interventional study.

Keywords: pulmonary arterial hypertension (pah)