Kornimate/medical-research-clean huggingface dataset:
effect of policosanol as monotherapy and adjunctive to statin therapy

Conditions: High Cholesterol

Summary: to determine the effects of policosanol on the cholesterol profile.

the primary objectives of this study are to determine the changes in the lipid profile \[ldl-c, hdl-c, triglycerides, total cholesterol\] and the emerging risk factor, lp(a), when policosanol is added to statin therapy. additionally, one more primary objective is to evaluate the safety of the combination regimen.

Eligibility criteria:
inclusion criteria: * ldl \> 100 * male or non-pregnant female. women must be surgically sterile or postmenopausal and not using hormone replacement therapy (hrt) or using a stable, consistent hrt dose with intentions to continue therapy throughout the course of the study * mentally competent to understand study rationale and protocol * speak and read english * currently receiving low to moderate dose statin therapy with plans to continue to the same dose for at least 8 weeks. low to moderate dose statins include the following daily doses: atorvastatin ≤20 mg, fluvastatin ≤40 mg, lovastatin ≤40 mg, pravastatin ≤40 mg, rosuvastatin ≤10 mg, simvastatin ≤ 40 mg exclusion criteria: * ldl \< 100 * sensitivity to policosanol * currently taking a high-dose statin or other lipid-lowering agents (i.e. high-dose niacin formulations \[\>500mg/day\], bile-acid sequestrants, ezetimibe, fibrates and high-dose omega-3 fish oils \[\>900mg of combined epa/dha daily\]) * currently taking medications which have the potential to interact with policosanol (i.e. warfarin, high-dose aspirin) * active liver disease or alt level 2.5 times the upper limit of normal * chronic disease involving hepatic, renal or coronary artery disease * currently experiencing "flu-like" symptoms * currently experiencing any form of acute physical injury * acute psychiatric disorders * immuno-compromised state * currently taking systemic steroidal drugs * currently pregnant or lactating * females of childbearing potential * dependence on alcohol or illicit drugs * participation in any other clinical trial within the last 30 days * displays s/s of acute systemic infection (oral temperature \>100°f, wbc\>12x10³/µl)
clinical trial studying the effects of spironolactone on heart and skeletal muscle function in chronic alcoholics

Conditions: Cardiomyopathy, Alcoholic; Alcoholism

Summary: chronic alcoholics suffer from weak skeletal and cardiac muscle. the investigators have discovered a beneficial effect of spironolactone-treatment in that regard. therefore, a double blind placebo controlled study is conducted, to examine the effects of spironolactone on cardiac and skeletal muscle-function in chronic alcoholics.

our department has done research into skeletal muscle function in patients with liver cirrhosis. post-hoc analyses of one of these studies suggested that treatment with spironolactone had a positive effect on muscle strength and endurance. this effect was probably caused by an increase in concentration of na, k-pumps (sodium-potassium pumps) enabling the muscle cell perform better. to verify this finding we have designed a double-blinded, placebo-controlled, randomized clinical trial with skeletal muscle strength, -endurance, na, k-pump content, cardiac systolic, and diastolic function as primary endpoints. spironolactone is tested against placebo in 40 participants included among our admitted and out-clinic patients. muscle function-tests, muscle biopsy and trans-thoracic echocardiography is performed before and after 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * alcoholism, male gender exclusion criteria: * spironolactone treatment * tense ascites * hepatic encephalopathy * dementia * cancer * severe psychiatric disease * untreated thyroid disease * maltreated diabetes * spironolactone contraindications * kidney failure

Keywords: alcoholism cardiomyopathy skeletal muscle spironolactone na,k-pumps magnesium
a prospective total joint surgery registry to monitor short- and long-term clinical outcomes

Conditions: Osteoarthritis

Summary: the investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (tja). outcomes will be assessed with common, routinely available patient-reported outcomes measures (prom's) such as the hoos jr., oxford score, knee society score, harris hip score, and other patient satisfaction and function assessments in use in orthopedics.

the investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (tja). outcomes will be assessed with common, routinely available patient-reported outcomes measures (prom's) such as the hoos jr., oxford score, knee society score, harris hip score, and other patient satisfaction and function assessments in use in orthopedics. investigators will also record both demographic and clinical data about the subject's history of joint pain, past treatment, medical co-morbidities, and surgical procedure. additionally, gait analysis and standardized physical capacity testing will be included as an option. all patients undergoing hip or knee replacement with the primary investigator will be included for data collection. all procedures and treatment will follow the standard of care, and all prosthetic implants with be fda-approved. data will be used to evaluate the effect on both short and long-term comfort and function of patients diagnosed with hip or knee pain who undergo joint replacement. the main purpose of the study is to provide quality improvement data on the patients in the principal investigator's (pi's) practice currently undergoing joint surgery. this project creates a data repository to store participants' data for this and possible future research.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo tja by the principal investigator exclusion criteria: * age \< 18 * unable to speak and read english * prisoners or any other patients who, in the opinion of the investigator, are unlikely to return for follow-ups or unreliable in completing the assessments
three dimensional changes on nasal septum and alveolar cleft after maxillary expansion

Conditions: Nasal Septum; Deviation, Congenital; Cleft Lip and Palate; Maxillary Hypoplasia

Summary: this study evaluates, by means of cone beam computed tomography (cbct), the alterations in the nasal septum and alveolar cleft volume that occur in cleft lip and palate (clp) patients after rapid maxillary expansion(rme). 40 unilateral clp patients (mean age, 11.1 ± 2.2 years) with transverse maxillary deficiency that underwent to rme will be evaluated in this investigation. cbct images were taken prior to rme (t0) and after the removal of the expander (t1), for adequate secondary bone graft surgical planning. the scans will be used to analyze the effects on the nasal septum, anterior and posterior maxillary basal width (mbw) and alveolar cleft volume.

rapid maxillary expansion (rme) is performed to correct crossbite in clp patients as part of the orthodontic treatment, being able to improve the maxillary transverse dimension, that is an essential condition for alveolar bone grafting. the primary aim of the secondary graft surgery is to restore the function and structure of the maxillary arch at the cleft side, providing support to arch width, minimizing its transverse collapse. however, since rme exert heavy forces to separate the two maxillary helves, it may significantly widen the alveolar cleft defect, possibly compromising bone graft success. moreover, rme has an important impact on the geometry and function of the nasal cavity, providing a lateral displacement of the walls and facilitating the airflow through the upper airways. these effects are very important to clp patients, since they usually present reduced upper airway dimensions, adenoid hypertrophy, sleep disorders, oral breathing, and a marked nasal septal deviation. the nasal septal deviation is one of the major causes of nasal obstruction in non-cleft patients, and often results in blocking of the nasolacrimal ducts, sinusitis, ear infections and mouth breathing. however, nasal septum deviation in clp patients commonly persists even after surgical repair of the cleft, leading to a chronic obstruction of the air passage, until the septorhinoplasty, at the age of 14-18 years. each expander was cemented with a fluoride releasing cement, and the activation regimen was established at 2 turns/day until the tip of the lingual cusps of the maxillary teeth touched the tips of the buccal cusps of the mandibular teeth. after the 3-month retention period, the expander was removed, and a post-expansion cbct scanning (t1) was acquired for adequate secondary bone graft surgical planning.

Eligibility criteria:
inclusion criteria: * the inclusion criteria comprehended the presence of unilateral cleft lip and palate, rapid maxillary expansion as an initial part of the orthodontic treatment, and absence of previous orthodontic treatment. exclusion criteria: * the exclusion criteria were absent maxillary permanent first molars, signs of active periodontal disease, and presence of any additional craniofacial syndrome.

Keywords: nasak septum cleft lip cleft palate palatal expansion technique
su011248 in advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Liver Cancer

Summary: the main purpose of this study is to begin to collect information and try to learn whether su011248 works in treating patients with advanced liver cancer. laboratory studies have shown that su011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further.

* participants will be given a supply of su011248 capsules to be taken orally every morning for 4 weeks. after taking su011248 for 4 weeks, there will be a 2 week rest period when the participant will not take any capsules. this 6-week period is referred to as 1 cycle. * participants will continue to receive su011248 study treatment as long as their disease does not worsen significantly and they are not experiencing any serious side effects. * during cycle 1 of study treatment, the participant will come to the outpatient clinic once a week for blood work, physical examination and dynamic contrast enhanced magnetic resonance imaging (dce-mri), which is done two weeks after they start taking study treatment. * during cycle two and every cycle thereafter, the participant will be asked to come to the outpatient clinic once every two weeks for physical examination, blood work and urine tests. * a ct scan or mri scan to assess the tumor will be performed once during each cycle for the first three cycles, then once every 2 cycles thereafter. acth stimulation test will be done every 2 cycles. a muga scan may be done at anytime at the discretion of the the study doctor.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed hcc and should have metastatic or locally advanced unresectable disease * measurable disease * 0-1 prior systemic chemotherapy regimens for hcc * age 18 years or older * life expectancy of greater than 12 weeks * ecog performance status of 0-1 * adequate organ and marrow function * women of child-bearing potential must have a negative pregnancy test prior to study entry exclusion criteria: * chemotherapy, radiotherapy or major surgery within 4 weeks of study entry * receiving any other investigational agents within past 30 days * known brain metastases * clip score \> 3 * chronic diarrhea or any disorder that will limit adequate absorption of su011248 * prolongation of qtc \> 450 msec in screening electrocardiogram or history of familial long qt syndrome * uncontrolled intercurrent illness * pregnant or lactating women * greater than or equal to 2g of protein/24hr

Keywords: liver cancer hcc
hepatitis c diagnosis to treatment management

Conditions: Hepatitis C

Summary: the objective of this study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis c infection can increase the uptake of hepatitis c treatment. a period of time without alerts will be compared to a period of time with alerts.

the hepatitis c virus (hcv) is one of the most common bloodborne pathogens in the united states. a large proportion of people with hcv infection progress to chronic hcv infection despite the availability of effective treatment; chronic infection can result in cirrhosis, end-stage liver disease, liver cancer, and liver-related death. hcv infection can be cured most of the time with treatment. the objective of this before and after study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis c infection can increase the uptake of hcv treatment. a period of time without alerts will be compared to a period of time with alerts. healthcare providers and clinic staff will not receive alerts during the before period of the study. healthcare providers and clinic staff will receive alerts during the after period of the study.

Eligibility criteria:
inclusion criteria: * 18+ years of age * in care at an aids healthcare foundation healthcare center * active, untreated hcv infection exclusion criteria: * \<18 years of age * patients with active hcv infection who have a current prescription for hcv treatment
endoscopic stenting of gastrointestinal cancer

Conditions: Gastrointestinal Neoplasms; Biliary Tract Neoplasms

Summary: obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.palliative endoscopic treatment with self- expanding metal stents(sems)is an alternative to palliative surgery and other palliative treatment options.the method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. numerous retrospective studies have reported treatment with sems to be safe and effective. prospective studies,and especially studies regarding quality of life improvement are needed. purpose: the purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(sems)in a defined population i norway, especially quality of life changes.

the study is divided into four projects: 1. establish a central register over all patients with malignant gi-obstruction who are treated with sems in the eastern health region in norway .treatment incidence, methods used, treatment effect,complications related to the procedure,need for reinterventions, hospitalisations and survival will be studied. 2. quality of life(qol) studies will be performed before and 14 days after treatment.the eortc qlq c30 and eortcs organospecific modules will be used. 3. gastric emptying before/after stent will be studied. 4. evaluate sems treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"

Eligibility criteria:
inclusion criteria: * palliative sems treatment for malignant gi-obstruction in esophagus,gastroduodenal region, biliary tractus or colon * sems treatment of acute malignant colon obstruction as a bridge to surgery exclusion criteria: * not able to sign informed consent * sems placement in other location last 4 days

Keywords: sems
microbial etiology of ventilator-associated pneumonia in covid-19 infected patients

Conditions: Ventilator Associated Pneumonia

Summary: national multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for vap in patients infected or not by sars-cov-2 and their resistance to antibiotics.


Eligibility criteria:
inclusion criteria: * all patients with microbiologically confirmed vap with pulmonary samples collected from march 15 to april 15 in france. exclusion criteria: * all patients with microbiologically confirmed vap with pulmonary samples collected from march 15 to april 15 in france.
efficacy/safety of pseudoephedrine plus levocetirizine versus placebo in patients with vasomotor rhinitis

Conditions: Vasomotor Rhinitis

Summary: the purpose of this study is to evaluate efficacy and safety of cossac l tablet in the treatment of vasomotor rhinitis

randomized, double-blind, placebo-controlled, phase 3

Eligibility criteria:
inclusion criteria: * diagnosis of vasomotor rhinitis exclusion criteria: * significant concomitant medical condition * use corticosteroids or other allergy medications during the study * considered by investigator as not appropriate to participate in the clinical study with othe reason

Keywords: vasomotor pseudoephedrine levocetirizine
clinical study to assess a dietary supplement on sleep health and quality

Conditions: Sleep Quality; Sleep Health

Summary: the primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. it is a double-blinded placebo-controlled crossover clinical study.


Eligibility criteria:
inclusion criteria: * non-smokers * judged by the investigator to be in general good health on the basis of medical history * willing to wash out of all dietary supplements, essential oils, and non-prescription sleep aids or rx sleep aids for the duration of the study * insomnia severity index score of ≥ 8 * must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study exclusion criteria: * pregnant and/or lactating women * known allergy or adverse reaction to ingredients in the product: tri factor (bovine colostrum and egg yolk extracts), ashwagandha root extract, lavender, pyridoxal-5-phosphate, melatonin, gamma aminobutyric acid (gaba) or magnesium * prescription sedative or psychoactive (including anti-depressant) medication use * diagnosis of a sleep disorder (e.g., sleep apnea, periodic limb movement disorder, etc.) or high clinical probability of another sleep disorder based on sleep history * a clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 4 months (e.g., myocardial infarction, congestive heart failure, cheyne-stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer) * routine consumption of more than 2 alcoholic beverages per day or consumption of caffeine past 2 pm for the duration of the study * illicit drug use * use of prescription stimulants (modafinil, dextroamphetamine, etc.) * use of prescription medications known to affect sleep (antidepressants, anti-anxiety, opioids, alpha-blockers, beta-blockers, corticosteroids, ace inhibitors, angiotensin ii-receptor blockers, cholinesterase inhibitors, allergy medication, asthma medication, glucosamine and chondroitin, statins, anti-smoking or thyroid medication, muscle relaxants, anticonvulsants) * unable to perform tests due to inability to communicate verbally, inability to write and read in english; less than a 10th grade reading level; visual, hearing or upper extremity motor deficit * night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months * unwilling to consume or unable to swallow capsules/tablets * previous exposure to this product in earlier testing phases

Keywords: sleep health sleep quality melatonin lavender essential oil gaba
a study to assess the efficacy and safety of axs-05 in subjects with alzheimer's disease agitation

Conditions: Agitation in Patients with Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation

Summary: this trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of axs-05 compared to placebo for the treatment of agitation associated with alzheimer's disease.

eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with axs-05 or placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease (ad) based on the 2011 national institute on aging-alzheimer association (nia-aa) criteria. * diagnosis of clinically significant agitation resulting from probable ad according to the international psychogeriatric association (ipa) provisional definition of agitation. exclusion criteria: * patient has dementia predominantly of non-alzheimer's type. * unable to comply with study procedures. * medically inappropriate for study participation in the opinion of the investigator.

Keywords: ad agitation axs-05 nmda receptor antagonist dextromethorphan bupropion axsome advance-2
therapeutic drug monitoring study of reduced-dose efavirenz (400 mg) in combo tablet for patients receiving atripla with viral suppression in taiwan

Conditions: HIV Infections

Summary: prospective, therapeutic drug monitoring study of reduced-dose efavirenz (400 mg) plus tenofovir disoproxil fumarate (tdf) and lamivudine in a fixed-dose combination tablet (combo) for patients receiving co-formulated tdf, emtricitabine and efavirenz (atripla) with viral suppression in taiwan

efavirenz (efv) is the most widely used non-nucleoside reverse transcriptase inhibitor (nnrti). the recommended dose of efv is 600 mg daily; however, a phase ii study showed no significant difference in viral suppression rates across the different efv groups (200 mg, 400 mg, and 600 mg) at 24 weeks. the week 96 analysis of encore 1 study confirmed the durable virological non-inferiority of efv 400 mg to the standard 600 mg dose when given as initial therapy with tenofovir disoproxil fumarate (tdf) and emtricitabine (ftc). fewer efv-related adverse events (aes) and fewer treatment discontinuations were also observed in the reduced dose group. the efficacy and safety findings provide robust evidence to redefine the efv dose for hiv treatment.

Eligibility criteria:
inclusion criteria: * patients who are receiving co-formulated tdf/ ftc/ efv (600 mg) and have achieved an undetectable plasma viral load (\<50 copies/ml) for 6 months or longer at screening visit. * having c12 efv of 1 mg/l or greater at screening. * (c12 efv will be determined by using blood sample collected 12 ± 1 hour after previous dosing of co-formulated tdf/ ftc/ efv (600 mg). * no known treatment failure to regimens containing tdf, 3tc or ftc, plus efv. * infected with hiv harboring no known resistance-associated mutations to efv, tdf, 3tc or ftc. * no known allergies to efv, tdf, 3tc or ftc. * aged ≧20 years. * calculated creatinine clearance (clcr) ≥ 50 ml/min (cockcroft-gault formula). * provision of written informed consent. exclusion criteria: * the following laboratory values: * absolute neutrophil count (anc) \<500 cells/μl * hemoglobin \<7.0 g/dl * platelet count \<50,000 cells/μl * serum alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) levels \>5x upper limit of normal (uln) * pregnant women or nursing mothers. * active opportunistic or malignant disease not under adequate control. * use of immunomodulators within 30 days prior to screening visit. * use any of the prohibited medications: bepridil, astemizole, terfenadine, dihydroergotamine, ergometrine, ergotamine, systemic cytotoxic chemotherapy, amodiaquine, pimozide, midazolam, triazolam, cisapride、st john's wort、 elbasvir/grazoprevir and simeprevir.

Keywords: efavirenz hiv infections