Kornimate/medical-research-clean huggingface dataset:
randomized study of two interventions for liquid aspiration: short-term and long-term effects

Conditions: Pneumonia, Aspiration

Summary: the purpose of this study is to determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with parkinson's disease and/or dementia. liquid aspiration is the most common type of aspiration in older populations, especially those suffering from debilitation, dementia, and depression. pneumonia may develop as a consequence of aspiration and is the fifth leading cause of death in the us among persons age 65 years and over. current treatment involves either use of chin-down position with swallowing or use of thickened liquids in the diet, without any clear evidence supporting the use of one treatment over the other. this is a phase iii inpatient and/or outpatient study in which all participants will be randomly assigned to either the chin-down position or the thickened liquid treatment group based on swallowing function during a modified barium swallow. this study is scheduled to recruit patients for a three-year period; participation by each individual patient spans no more than three months after entry.


Eligibility criteria:
inclusion criteria: * have dementia or parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows. exclusion criteria: * have smoked more than a pack of cigarettes per day in the last year. * drink more than 3 alcoholic beverages per day on a regular basis. * have had any head and neck cancer treatment. * have any head and neck anatomic deformities. * have a history of 20 years or longer of insulin-dependent diabetes. * have other exclusionary neurologic diagnoses. * have had pneumonia within 6 weeks of screening. * currently have a nasogastric tube. * currently have a tracheotomy. * are a resident in non-participating nursing home or assisted living environment. * live alone. * have no regular care provider present at meals. * have no speech-language pathologist to provide a 3-month follow-up.

Keywords: deglutition disorders dementia parkinson disease pneumonia, aspiration
development of a silica microparticle taggant system to measure art adherence

Conditions: Hiv; Medication Adherence; Compliance, Medication

Summary: developing technologies to help measure and provide tools to support medication-taking behaviors (medication adherence) is an important step to ending the human immunodeficiency virus (hiv) epidemic. trutag technologies has pioneered the use of a microparticle system that can be incorporated into the coating of medications may help users both identify the medication they are taking and record adherence events. by using a standard smartphone camera, shining light on trutag-coated medications automatically identifies them to an onboard smartphone app which then indirectly records the adherence event. this study evaluates the real-world usability and feasibility of operating this system among people living with hiv (plwh).

this is an open-label pilot trial of n=15 plwh who are prescribed bictegravir/emtricitabine/tenofovir alafenamide (biktarvy) for antiretroviral therapy (art). participants will receive special trutag-tagged biktarvy and will be asked to scan their trutag biktarvy prior to ingesting it daily over 90 days. a companion smartphone app will record scans as an indirect measure of adherence. included in the app will be a reminder system to nudge individuals to take their biktarvy and a two-way text portal that allows participants to communicate securely with the study team. participants will be screened and enrolled, and will then attend three monthly study visits, where the study team will assess adherence, dispense trutag biktarvy, and understand how the trutag system is operated in the real world. at the final 90-day study visit, the study team will conduct a qualitative interview to explore acceptability and future design iterations of the trutag system.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. living with hiv 3. currently prescribed and taking biktarvy as art for at least 3 months 4. undetectable viral load in prior 6 months 5. owns iphone model 11 or higher (non-se only) exclusion criteria: 1. not english-speaking 2. unwilling to interact with the trutag app
dose response of valsartan on sitting systolic blood pressure in children 6 months - 5 years of age with high blood pressure

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (mssbp) and mean sitting diastolic blood pressure (msdbp) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[ssbp\] ≥ 95th percentile ).


Eligibility criteria:
inclusion criteria: * children aged 6 months - 5 years at visit 1, with a documented history of hypertension * must be able to swallow liquid formulation * must be ≥ 6 kg or ≤ 40 kg at randomization * must have documented history mssbp (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization * if patients enter with uncontrolled bp they can remain on background antihypertensives with an unchanged dosing regimen * if patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy * parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language exclusion criteria: * patients with background arb therapy * patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function) * ast/sgot or alt/sgpt \> 3 times the upper limit of the reference range * glomerular filtration rate \< 30 ml/min/1.73m² * serum potassium \> upper limit of the reference range * mssbp ≥ 25% above the 95th percentile * patients exhibiting clinically significant ecg abnormalities * patients that have coarctation of the aorta with a gradient of ≥ 30 mm hg, or renal artery stenosis other protocol-defined inclusion/exclusion criteria may apply

Keywords: children pediatrics high blood pressure hypertension valsartan
a study evaluating the long term safety and efficacy of vx-659 combination therapy

Conditions: Cystic Fibrosis

Summary: this study will evaluate the long-term safety and tolerability of vx-659 in triple combination (tc) with tezacaftor (tez) and ivacaftor (iva) in subjects with cystic fibrosis (cf) who are homozygous or heterozygous for the f508del mutation.


Eligibility criteria:
inclusion criteria: * completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study. exclusion criteria: * history of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator. * current participation in an investigational drug trial (other than a parent study) other protocol defined inclusion/exclusion criteria may apply.
clinical evaluation to confirm safety and efficacy of sinuplasty in the paranasal sinuses (clear)

Conditions: Chronic Sinusitis

Summary: a multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.

sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. sinusitis is responsible for major healthcare expenditure and loss of workplace productivity. the rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the frontal, maxillary and sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.

Eligibility criteria:
inclusion criteria: 1. age 18 years and greater 2. both male and female patients eligible 3. diagnosis of chronic sinusitis that is not responsive to medical management 4. planned endoscopic sinus surgery (recommended by pi, consented to by patient) exclusion criteria: 1. extensive sinonasal polyps 2. extensive previous sinonasal surgery 3. extensive sinonasal osteoneogenesis 4. cystic fibrosis 5. sampter's triad (aspirin sensitivity, asthma, sinonasal polyposis) 6. sinonasal tumors or obstructive lesions 7. history of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium 8. ciliary dysfunction 9. pregnant females

Keywords: sinusitis rhinitis sinus surgery maxillary ethmoid sphenoid frontal fess sinuplasty
fischer cone biopsy excisor versus loop excision procedure for conization

Conditions: Uterine Cervical Dysplasia

Summary: in a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two electrosurgical excision methods, fischer cone biopsy excison vs. loop excision procedure, will be compared. the primary outcome of the study is dysplasia-free resection margin rate, secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention time, postoperative pain, intra- and postoperative complications, the resected cone volume and users satisfaction.

conization is the method of choice in therapy for cervical dysplasia. beside the risk of preterm delivery, the risk of a local relapse in patients with dysplasia-affected resection margin is high. the goldstandard standard technique in conization for women with cervical dysplasia is the large loop excision of the transformation zone ("lletz"). nevertheless other techniques such as the excision of the abnormal tissue with the so called "fischer cone biopsy excisor" could provide advantages and is yet not enough investigated. the loop excision technique uses a circular electrode, in contrast fischer cone biopsy excision is done by a triangular electrode. it is unknown, whether the use of the circular or the triangular electrode is superior regarding the dysplasia-free resection margin rate and other outcome parameters such as the resected cone volume, postoperative bleeding and postoperative pain. therefore, the investigator designed a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, comparing the two electrosurgical techniques, "lletz-conization" and "fischer cone biopsy excision". the primary outcome of the study is the dysplasia-free resection margin rate independently proved by a pathologist, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 11 step vas scale, time to complete hemostasis measured in seconds, duration of the intervention measured in minutes, resected cone volume, users satisfaction according to a 11 step vas scale and intra- and postoperative complications, defined as necessity to intervene surgically up to 14 days postoperatively. the study population consists of women undergoing conization for histologically proven cervical dysplasia.

Eligibility criteria:
inclusion criteria: * histologically proven cervical dysplasia * colposcopy prior to conization * informed consent * no known hematologic disorder exclusion criteria: * significant language barrier * a personal history of conization * pregnancy * the use of blood thinner * unwillingness to participate

Keywords: conization lletz cervical dysplasia cervical intraepithelial neoplasia fischer cone biopsy excisor loop electrosurgical excision procedure
preoperative warming and perioperative shivering

Conditions: Forced Air Warming Effect on Hypothermia

Summary: shivering is one of the most commonly recognized problem associated with anesthesia, it is believed to be thermoregulatory in origin. studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period. forced air warmers are the most frequently used active warming devices in the peri-operative setting. currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.

inadvertent peri-operative hypothermia (iph) and shivering is one of the most commonly recognized problem during anesthesia which is believed to be thermoregulatory in origin. although shivering is uncomfortable for most patients, it is unlikely that this relatively small increase in total body oxygen consumption in the average shivering patient is associated with increased peri-operative morbidity. it is common for patients to complain that their worst memory from the recovery room is the intense cold sensation and uncontrollable shivering. new guidelines recommend that patients core temperature has to be maintained at \>36°c, postoperatively. studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period. forced air warmers are the most frequently used active warming devices in the peri-operative setting. they are effective at preventing hypothermia induced shivering when used before induction of anesthesia, during anesthesia and surgery, and after emergence in the post-anesthesia care unit. other methods such as warm fluids, opioids, blankets and warm light devices can be used but are less effective as compared to the forced air warming devices. currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.

Eligibility criteria:
inclusion criteria: * all patients going under therapeutic laparoscopic surgery * all patients between 15-70 years irrespective of their gender * asa 1-3 patients * those who have given informed consent exclusion criteria: * any patient undergoing diagnostic laparoscopic surgery * patients below age of 15 yrs * asa 4 or higher patients * patients not giving informed consent

Keywords: shivering hypothermia postoperative temperature forced air warmer
prospective comparison of single-injection serratus anterior plane block with ropivacaine versus local infiltration of anaesthetic after breast surgery

Conditions: Mastectomy; Lymphedema

Summary: to evaluate whether a serratus anterior plane block (sapb) is more effective than a local infiltration anesthesia (lia) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.

to evaluate whether a serratus anterior plane block (sapb) is more effective than a local infiltration anesthesia (lia) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy. primary endpoint: the use of opioid's in the postoperative period. secondary endpoint: numerical pain rating scale (nprs) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. in addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization. there are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the sapb. patients are randomised into each arm after screening.

Eligibility criteria:
inclusion criteria: * age 18-80 years. * provision of signed informed consent prior to any study-specific procedure. * patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy. exclusion criteria: * age \>80 years * history of chronic pain or drug treatment abuse * depression, psychiatric morbidity or mal-adaptive coping behavior * neuropathy * severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain * chronic or acute skin infection of the lateral thorax * hypersensitivity to ropivacaine * severe hepatic or renal disease * refuse to participate to the study * pregnancy
a clinical study of b007 in the treatment of primary membranous nephropathy.

Conditions: Primary Membranous Nephropathy

Summary: to evaluate the efficacy and safety of b007 in the treatment of primary membranous nephropathy


Eligibility criteria:
inclusion criteria: 1. subjects with primary membranous nephropathy pathologically confirmed by renal biopsy; 2. subjects with glomerular filtration rate（egfr） ≥ 45 ml/min/1.73 m2. 3. if taking angiotensin converting enzyme inhibitors/angiotensin ii receptor antagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, a stable dose within 4 weeks before randomization; 4. subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions; 5. subjects whose laboratory test results meet the prescribed standards during the screening period; 6. subjects who have fully understood this study and voluntarily signed the informed consent form； 7. subjects who are able to follow the study protocol as judged by the investigator. exclusion criteria: 1. subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies; 2. subjects identified by the investigator as previously resistant to cd20 monoclonal antibody or cyclosporine; 3. subjects who have received medication prescribed for membranous nephropathy; 4. subjects with concomitant prescribed diseases; 5. subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or b007; 6. subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug; 7. subjects with positive hepatitis b surface antigen; those with positive hepatitis c virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases; 8. subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment; 9. subjects with cd4+ t lymphocyte count \< 400 cells/μl; 10. pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug; 11. for male subjects who have not been sterilized: those who do not consent to the use of barrier contraception during the study period and for at least 12 months after the last administration of the study drug, and who do not consent to the use of other contraceptive methods by their spouses; 12. other conditions unsuitable for participation in this study determined by the investigator.
cognitive function evaluation and rehabilitation by a digital game: mentalplus®

Conditions: Neuropsychological Test

Summary: cognitive dysfunction is a frequent adverse event in the postoperative period, especially in elderly patients. the tests commonly used for the detection of postoperative cognitive dysfunction (pocd) are time-consuming, which limits routine use. consequently, there is a limitation to adopting measures to increase preoperative cognitive reserve and rehabilitation of pocd. that situation incentivizes searching for alternative diagnosis methods to overcome that limitation. digital games have potential neuromodulator effects and have been used as an alternative to psychotherapeutic treatment. however, the tests used to detect postoperative cognitive dysfunction (pocd) are time-consuming, making it difficult to implement routine screening measures. this presents a challenge for increasing preoperative cognitive reserve and rehabilitating pocd. researchers are exploring alternative diagnostic methods, such as digital games, to address this challenge. digital games have potential neuromodulator effects and are an alternative to psychotherapeutic treatments and cognitive rehabilitation. this study aims to validate mentalplus®, a digital game, as a tool for cognitive assessment, pocd evaluation, and pocd rehabilitation-habilitation of mental skills. it is hypothesized that a digital game could replace the usual neuropsychological tests for detecting pocd.

methods: the research subject that will be studied might present some characteristics: over 20 years old, literate, of both genders, and candidate for surgery under general anesthesia in the hospital das clínicas of the faculty of medicine, university of são paulo. reliability mentalplus® analysis will be performed as the first part of the study with healthy volunteers. later, the volunteers assess cognitive functions, like memory, attention, and executive functions, using a usual psychological test battery. compare the psychological test battery results with mentalplus® video game scores. the mentalplus® digital game will be applied to all study phases. a third project will use functional magnetic resonance imaging (fmri) to assess the association between brain response and cognitive training by mentalplus®.

Eligibility criteria:
inclusion criteria: * individuals who accept the invitation will be first submitted to the tics instrument (telephone interview cognitive status), which aims to verify the global cognitive status of the subject evaluated. will be included subjects with tics score \>25. exclusion criteria: * patients who do not meet the tics inclusion criteria will be excluded at this stage and informed that they did not fulfill all the requirements for the study.

Keywords: digital games neuropsychology hypertension
point of care ultrasonography in the management of shock: a pilot study

Conditions: Shock; Hypotension

Summary: this project aims to determine the feasibility of conducting a randomized controlled trial investigating point of care ultrasound guided resuscitation compared with usual care in the management of shock at the critical care trauma centre (cctc) in london health science centre (lhsc).


Eligibility criteria:
inclusion criteria: patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following: 1. lactate greater than or equal to 2.2 mmol/l 2. akin stage i or greater or urine output less than 0.5 cc/hr 3. altered level of consciousness due to shock or requiring invasive mechanical ventilation as a result of shock 4. vasoactive agents required to maintain a mean arterial pressure greater than 65 mmhg. exclusion criteria: 1. pregnant patients 2. participants who have already undergone a pocus study (as defined in the protocol for this study) within the past 48 hours 3. participants who have restrictions on their goals of care at the time of icu admission (including patients refusing blood products). 4. patients post cardiac arrest who are not obeying commands

Keywords: ultrasonography point-of-care ultrasound resuscitation critical care