Kornimate/medical-research-clean huggingface dataset:
denosumab adherence preference satisfaction study

Conditions: Osteoporosis

Summary: the primary objective is to evaluate the adherence of subjects to subcutaneous (sc) 60 mg denosumab every 6 months (q6m) treatment compared to oral 70 mg alendronate once a week (qw) treatment at the end of treatment period 1 (12 months).


Eligibility criteria:
inclusion criteria: * ambulatory postmenopausal women based on medical history * \> or = 55 years of age at the start of screening * screening bone mineral density (bmd) values (g/cm²), at the lumbar spine or femoral neck or total hip that occur within the specified ranges based on the particular scanner that is used. at least 2 lumbar vertebrae must be evaluable by dual x-ray absorptiometry (dxa), or at least one hip must be evaluable by dxa * provide written informed consent before any study specific procedure is performed. exclusion criteria: * any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures * hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed * current hyper- or hypoparathyroidism * current hypo- or hyper calcemia based on the central laboratory reference ranges for albumin-adjusted serum calcium * rheumatoid arthritis, paget's disease, cushing's disease, hyperprolactinemia, or cirrhosis of the liver * any metabolic bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings * any symptomatic vertebral fracture within 3 months prior to screening * previous participation in clinical trials with denosumab * vitamin d deficiency \[25(oh) vitamin d level \< 20 ng/ml (\<49.9 nmol/l)\] * contraindicated to alendronate therapy; contraindications for alendronate therapy include: 1. abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia. 2. inability to stand or sit upright for at least 30 minutes. 3. hypersensitivity to alendronate (aln) or other constituents of aln tablets. * any known prior bisphosphonate use * currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trail (s), or subject is receiving other investigational agent(s).

Keywords: osteoporosis low bone mineral density alendronate denosumab adherence preference satisfaction postmenopausal women
assessment of coronary artery disease by hybrid pet/ct

Conditions: Coronary Artery Disease

Summary: there have been many advances in the test used to look for heart disease. an example of this newer technology is the multislice ct scan (msct) and positron emission tomography (pet) scans. the use of this type of combined scan may show early coronary artery disease or the degree of damaged heart muscle form a heart attack with a single exam. it may help doctors to know who might benefit from heart surgery or angioplasty to increase the blood flow to the heart. this type of detailed images has previously been available only through cardiac catheterization.

advances in non-invasive multislice ct imaging: multislice ct (msct) and pet imaging are becoming more widely available and more useful in cardiac assessment. msct provides quantification of coronary calcium as well as information about the structures of the coronary vessel walls and atherosclerotic plaques. multiple studies have demonstrated that msct provides information on coronary artery stenosis comparable to that obtained from invasive coronary angiography. pet imaging provides functional data via the measurement of coronary flow reserve (cfr). cfr is a quantitative measure of the increase in coronary blood flow in response to vasodilation; normal coronary flow is able to augment by three- to four-fold; diseased coronary arteries show less ability to increase flow, i.e. less cfr. assessment of cfr yields functional information about the significance of coronary disease and is often used clinically in conjunction with anatomic imaging to identify early atherosclerosis. there is no current data evaluating the incremental value of hybrid pet/ct assessment of cfr and coronary anatomy in relation to spect studies in the clinical setting.

Eligibility criteria:
inclusion criteria: * subject must be 18 years of age or older and able to give informed consent. * scheduled for clinically indicated gated adenoscan spect studies at the university of maryland medical center or baltimore va center * documentation from participant's health care provider indicating no objection to subject's participation in study. exclusion criteria: * hepatic; thyroid or renal disease (creatinine \>1.5 or gfr \< 60ml/min) * women of childbearing age not using medically acceptable form of contraception, pregnant or breast-feeding * contrast allergy * inability to cooperate with imaging

Keywords: coronary artery disease pet ct scan stress test rubidium
levetiracetam in patients being treated for epilepsy

Conditions: Epilepsy

Summary: epilepsy is one of the most common neurological diseases.approximately 53 million people suffering from chronic recurrent epilepsy in 1990 and that number increased about 58 million in 2005. the annual incidence of epilepsy varies considerably in different epidemiological studies, ranging from 11 cases per 100,000 general population to 230 cases per 100,000 people. to date there has been discovered the ideal antiepileptic drugs. the drug, ie, that are safe and effective, it has good daily administration frequency, easily administered from all roads, which has high bioavailability, which is not highly bound to proteins, and not holding inductive or inhibitory effect.

there are broad-spectrum anticonvulsant, which means that a drug can be very effective for a patient, but may or may not regulate and increase the frequency of another crisis. thus there remains now only to choose one among a number of drugs, the most appropriate.this study intends to register within 12 months clinical practice in greek reality as regards the elements of diagnosis and management of patients with epilepsy and those who already are, or are part of treatment with levetiracetam. the aims of this clinical study is to record data on * the diagnosis * the management of epilepsy in daily clinical practice in a sample of greek population * the monitoring of patients entering or already undergoing treatment with levetiracetam. * the assessment of quality of life between visits of the study by using quality of life qolie-31 questionnaire * the economic evaluation of the change in treatment from original to generic levetiracetam this is a data recording study and evaluation of treatment with levetiracetam. the study will take place in 15 antiepileptic centers throughout greece. researchers will have to successively record all incidents of patients (30 per center) with epilepsy, which are new diagnoses or already diagnosed and are treated with levetiracetam.

Eligibility criteria:
inclusion criteria: * outpatients * males and females * age\> 6 years * patients diagnosed with epilepsy or * patients who are diagnosed and treated with antiepileptic treatment levetiracetam * patients who consent to their participation in the study * patients will comply with the requirements and procedures of the study exclusion criteria: * patients who did not consent to their participation in the study * patients who will not comply to the needs and the design process

Keywords: seizures, quality of life
effect of anomia rehabilitation combined with metacognitive training in patients with chronic vascular aphasia

Conditions: Aphasia; Stroke

Summary: the postulate of this study is that rehabilitation combining linguistic and metacognitive training will result in a significant improvement in language performance correlated with changes in functional cerebral connectivity networks. in addition, it could potentiate the generalisation of effects to verbal and non-verbal communication skills, having a direct impact on patients' quality of life. this research is a prospective, randomized controlled, open-label, single-centre study. it is part of the management of patients with aphasia who have suffered a cerebral infarction and aims to evaluate the effect of combined language semantics/metacognition rehabilitation.

vascular aphasia occurs after 20 to 25% of strokes and leads to anomia or word-finding difficulties in many patients. speech therapy, which is the standard treatment, notably employs semantic feature analysis (sfa). sfa aims to teach patients a strategy that helps activate semantic links strongly associated with the target word, thereby facilitating word retrieval. moreover, a growing number of studies suggest combining metacognitive strategy training with language rehabilitation in brain-injured patients, particularly in reading comprehension, communication skills, and anomia, could improve cognitive and language recovery outcomes. in rehabilitation, metacognitive strategy training can be used to enhance and/or compensate for cognitive function deficits. patients are repeatedly exposed to discrepancies between the patients performance evaluations and expectations. findings indicate improvements in trained tasks and transfer effects to similar tasks. while studies have examined the effects of linguistic training on one hand and the impact of metacognitive abilities on the other, to the investigators knowledge, no study has assessed the effect of a combined linguistic and metacognitive training approach in post-stroke aphasic patients on behavioral and imaging variables. this study postulates that rehabilitation combining linguistic and metacognitive training will lead to a significant improvement in language performance, correlated with changes in functional brain connectivity networks. furthermore, it may enhance the generalization of effects to both verbal and non-verbal communication skills, directly impacting patients' quality of life.

Eligibility criteria:
inclusion criteria: * first cerebral infarction * chronic phase (\> 3 months) * patient affiliated to a health insurance scheme * usual french language * severity score measures using the boston diagnostic aphasia examination battery scale corresponding to the mild or moderate level (score greater than or equal to 2) exclusion criteria: * contraindication to undergoing brain mri * cognitive impairment pre-existing stroke (cqi code \> 3.4) (law et al., 1995) * chronic alcohol or drug abuse * unstabilised psychiatric illness * uncorrected sensory deficits * diagnosed as having a progressive general pathology

Keywords: aphasia stroke chronic cognitive rehabilitation sced
zalutumumab in patients with non-curable head and neck cancer

Conditions: Head and Neck Cancer; Squamous Cell Cancer

Summary: the purpose of this study is to investigate if zalutumumab in combination with best supportive care (bsc) is superior to bsc in non-curable patients with head and neck cancer

this is an open parallel group trial. patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with best supportive care (bsc) or bsc. patients randomized to treatment with zalutumumab in combination with bsc will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. after visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration. individual dose titration until the patient develops grade 2 skin rash will be applied. the maximum dose used in study will be 16 mg/kg.

Eligibility criteria:
inclusion criteria: 1. males and females age ≥ 18 years 2. confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy 3. failure to at least one course of standard platinum-based chemotherapy exclusion criteria: 1. three or more chemotherapy regimens other than platinum-based chemotherapy 2. prior treatment with egfr antibodies and/or egfr small molecule inhibitors 3. past or current malignancy other than scchn, except for certain other cancer diseases
inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in nud patients

Conditions: Indigestion

Summary: inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in nud patients

enrolled patients will undergo 24h gastric ph monitoring and subsequently (if gastric ph drops below ph 4 during 24h monitoring) will be randomized to receive placebo (40 mg qd) or esomeprazole (40 mg qd) for 16 weeks of therapy. 24h gastric ph monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy. additionally, in all participants nud symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.

Eligibility criteria:
inclusion criteria: a. males and females of age 18-55. b. a diagnosis of epigastric pain/discomfort (located in the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point categorical scale), which has been present at least 3 times per week for 12 weeks, unrelated to exercise. c. patients may have other symptoms of nud including heartburn, regurgitation, bloating (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea; however, the dominant symptom must be epigastric pain/discomfort. d. capable of and willing to give informed consent and comply with all study requirements. exclusion criteria: a. h. pylori positive serology. b. regular use of nsaids or more than 100 mg of aspirin. c. patients requiring chronic treatment with any medication inducing gi symptoms (e.g., certain antibiotics, codeine, etc.). d. history or presence of endoscopic/radiological evidence of esophagitis. e. history or presence of chronic gastric or duodenal ulcer. f. history or presence of duodenal erosions. g. history or previous upper gi surgery. h. presence of concomitant symptoms of irritable bowel syndrome (ibs) as assessed by three or more of the manning or rome criteria. i. history or presence of other known organic disease that might explain the dyspepsia symptoms (e.g., symptomatic gallstones). j. pregnancy or lactation. k. inadequate contraception. l. regular consumption of greater than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of beer or 16 fluid ounces of wine) per day. m. history of substance abuse. n. unwillingness or expected inability to tolerate absence of antisecretory medications (antacids, h2 receptor antagonists or proton pump inhibitors (ppis) or other gi pharmacotherapy for a period of time of study protocol (16 weeks maximum).

Keywords: epigastric pain non-ulcer dyspepsia (nud)
opioid consumption after orthopaedic surgery

Conditions: Orthopedic Disorder

Summary: this is a randomized controlled study that will involve fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery) within our practice group. consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). the control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative opioid counseling.

over the past two decades in the united states, the opioid epidemic has escalated at a startling rate and prescription opioids are a large contributor to this problem. studies show that there is an excessive amount of opioids being prescribed for orthopedic procedures. an accurate understanding of opioid consumption following common outpatient orthopedic surgery is imperative in order to treat pain appropriately relative to the surgery being performed without leading to excess narcotic prescribing. the purpose of the study is threefold: to better understand typical opioid consumption following common outpatient orthopedic surgeries, to generate prescribing guidelines to optimize opioid prescribing, and to understand the effect of pre-operative opioid counseling on opioid consumption following these procedures. this is a prospective randomized controlled study that will involve eight fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery). consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). the control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative counseling. basic demographic and surgical data will be collected. primary outcomes will be assessed at the post-operative visit. these include the total number of opioid pills consumed, average daily pain scores, and adverse effects. secondary outcomes include the number of days the medication was used, medication refill requests, and patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients indicated to undergo outpatient orthopedic surgery in one of the four areas included in the study (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery). * age eligibility is \> 18 years of age. exclusion criteria: * inpatient procedures. * pediatric patients (age \< 18 years). * known allergy to narcotic medication. * pregnant female patients. * non-english speaking patients * history of chronic pain and/or narcotic use preoperatively.
study of the management of vaginal discharge in west african using single dose treatments

Conditions: Bacterial Vaginosis; Candidiasis; Vaginitis

Summary: this randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of ghana, togo, guinea and mali. it was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers

abstract objective: evaluate whether single-dose treatments are as effective as standard therapy in the syndromic management of vaginal discharge. methods: a randomized controlled effectiveness trial comparing single-dose tinidazole plus fluconazole (tf) to seven days of metronidazole plus three days of vaginal clotrimazole (mc) among 1570 women presenting with vaginal discharge in primary health care institutions of ghana, togo, guinea and mali. participants were randomly allocated to one of the two treatments by research nurses or physicians using pre-coded envelopes. effectiveness was assessed by symptomatic response on day 14. findings: the two treatment regimens had similar effectiveness: complete resolution was seen in 66% (tf) and 64% (mc) and partial resolution in 33% (tf) and 34% (mc) of participants (p=0.26). effectiveness was similar among subgroups with vulvovaginal candidiasis, t. vaginalis vaginitis or bacterial vaginosis. the two treatment regimens had a similar effectiveness among hiv-infected (tf: n=76, 71% complete resolution, 28% partial; mc: n=83, 72% complete, 25% partial, p=0.76) and hiv-uninfected women (tf: n=517, 68% complete, 32% partial; mc: n=466, 65% complete, 33% partial, p=0.20). cervical infections with n. gonorrhoeae, c. trachomatis and m. genitalium were uncommon among women not involved in sex work, were associated with bacterial vaginosis or t. vaginalis vaginitis, and did not alter response to treatment with agents active against vaginal infections. four fifths of women not relieved by single-dose tf had a favourable response when mc was administered as second-line treatment. conclusion: single-dose tf is as effective as multiple-dose mc in the syndromic management of vaginal discharge, even among the hiv-infected. given its low price and easier compliance, tinidazole/fluconazole should be considered as a first-line treatment of the vaginal discharge syndrome.

Eligibility criteria:
inclusion criteria: * women consulting for vaginal discharge * local resident * willingness and ability to consent exclusion criteria: * sex worker consulting for active screening * main complaint of lower abdominal pain * allergy to one of the study drugs

Keywords: bacterial vaginosis vaginal candidiasis trichomoniasis vaginitis ghana togo mali guinea
tace plus pd-1 antibody vs tace alone for unresectable hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of transarterial chemoembolization (tace) combined with programmed cell death protein-1 (pd-1) antibody compared with tace alone in patients with unresectable hepatocellular carcinoma (hcc)

transarterial chemoembolization (tace) is the first-line treatment for patients with unrestable hepatocellular carcinoma (hcc) at intermediate-stage. programmed cell death protein-1 (pd-1) antibody is effective and safe for advanced hcc. no study has compared the efficacy and safety of tace plus pd-1 antibody and tace alone. thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility criteria:
inclusion criteria: * kps≥70; * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl), simultaneously staged as bclc a or bclc b based on barcelona clinic liver cancer staging system. * patients must have at least one tumor lesion that can be accurately measured; * diagnosed as unresectable with consensus by the panel of liver surgery experts; * re commanded treated by tace with consensus by the panel of liver mdt; * no past history of tace, chemotherapy or molecule-targeted treatment; * no cirrhosis or cirrhotic status of child-pugh class a only * meet the following laboratory parameters:(a) platelet count ≥ 75,000/μl; (b)hemoglobin ≥ 8.5 g/dl;(c) total bilirubin ≤ 30mmol/l;(d) serum albumin ≥ 32 g/l;(e) asl and ast ≤ 6 x upper limit of normal;(f) serum creatinine ≤ 1.5 x upper limit of normal;(g) inr \> 2.3 or pt/aptt within normal limits; (h) absolute neutrophil count (anc) \>1,500/mm3; * ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * evidence of bleeding diathesis. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug * serious non-healing wound, ulcer, or bone fracture * known central nervous system tumors including metastatic brain disease * poor compliance that can not comply with the course of treatment and follow up.

Keywords: hepatocellular carcinoma programmed cell death protein-1 antibody transarterial chemoembolization