Kornimate/medical-research-clean huggingface dataset:
imaging a cholinergic biomarker of cognition in parkinson's disease

Conditions: Parkinson's Disease

Summary: this is an imaging study designed to illuminate the function of the cholinergic system and its association with cognitive skills in people with parkinson's disease. the hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. participants will receive a pet and mri scan along with a battery of neurocognitive tests at baseline and again at 18 months follow-up. hormone levels will be measured at baseline.

this is an imaging study designed to illuminate the functioning of the cholinergic system in people with parkinson's disease. some people with parkinson's disease develop trouble with certain aspects of thinking such as memory. studies have shown an association between a decline in thinking skills and dysfunction of the cholinergic system. this study will use the novel pet tracer \[18f\]vat to provide more specific information about how the cholinergic system works by enabling direct measurement of cholinergic terminal density and projections. the hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. this is a longitudinal observational study that involves a screening visit and four study visits over the course of 18 months. the visits consist of neurocognitive assessments and imaging (mri and pet scans) administered at baseline and at 18 months follow-up. hormone levels will also be measured at baseline. this study is open to people with parkinson's disease who have either normal cognition or mild cognitive impairment.

Eligibility criteria:
inclusion criteria: * age 50-80 * diagnosis of parkinson's disease * ability to provide informed consent * ability to speak english * normal cognition or mild cognitive impairment * willingness to go off parkinsonian medication for 12 hours prior to two of the study visits exclusion criteria: * contraindication for mri * abnormal clinical brain mri, specifically with evidence of large-vessel stroke or mass lesion * history of stereotactic or ablative brain surgery * pregnancy * recent participation in other research studies involving radiation such that the annual research radiation dose would exceed fda limit if participating in this study * prior brain injury (eg., tbi) * baseline cognitive impairment due to genetic or developmental disorder * active illicit drug use or alcohol abuse * incapable of staying still for a 2-hour pet or mri study * use of cns-penetrating medications affecting the cholinergic system, including cholinesterase inhibitors and anticholinergics, up to 60 days prior to study participation

Keywords: acetylcholine pet mri
study of the safety and effectiveness of rilonacept for the prevention of gout flares

Conditions: Gout

Summary: this was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. participants participated in this study for approximately 24 weeks. rilonacept was being studied for use in preventing gout attacks in participants who had gout.


Eligibility criteria:
inclusion criteria: * male or female greater than 18 years of age; * previously met the preliminary criteria of the american rheumatism association (ara) for the classification of the acute arthritis of primary gout; * at least 2 gout flares in the year prior to the screening visit. exclusion criteria: * acute gout flare within 2 weeks of the screening visit and during screening; * persistent chronic or active infections; * history of an allergic reaction to allopurinol; * history or presence of cancer within 5 years of the screening visit.
salsalate as an adjunctive treatment for patients with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters. potential subjects will be identified by their clinicians at the freedom trail clinic, or massachusetts general hospital. a total of 15 subjects will be enrolled.

the specific aims include: primary aims: 1. examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the positive and negative syndrome scale (panss) and the scale for assessment of negative symptoms (sans). 2. examine the efficacy of salsalate in improving cognition as measured by the measurement and treatment research to improve cognition in schizophrenia (matrics) composite score. secondary aims: 1. examine salsalate's effects on inflammatory markers such as high sensitivity c-reactive protein (hs-crp), tnf-α and il-6.

Eligibility criteria:
inclusion criteria: * age 18-65 years; * diagnosis of schizophrenia or schizoaffective disorder; * stable dose of the current antipsychotic drug for at least one month; * well established compliance with outpatient treatment per treating clinician's judgment; * able to complete the cognitive assessment battery (must be english speaking); * female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study. exclusion criteria: * inability to provide informed consent; * current substance abuse; * psychiatrically unstable per treating clinician's judgment; * significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases; * currently on immunosuppressant medication including oral steroids; * use of anti-coagulants (heparin, lmwh, warfarin, cilostazol, clopidogrel, dabigatran); * history of chronic infection (including, hiv and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition; * experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other nsaids; * pregnancy or breastfeeding; * pre-existing chronic tinnitus. * known hypersensitivity to salsalate.

Keywords: schizophrenia cognition metabolism antipsychotics psychopathology
single-dose to evaluate the pharmacokinetics of gtx-101 and subcutaneous injectable bupivacaine in healthy subjects

Conditions: Postherpetic Neuralgia

Summary: this is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects. the study will enroll subjects to evaluate the pk of 3 dose strengths (50 mg, 100 mg and 200 mg) of gtx-101 compared to subcutaneous injection in healthy adult subjects. blood samples for pk assessments will be collect at specified time points. safety assessments will also be performed throughout the study.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form (icf) * healthy adult male or female, aged 18 to 55 years, inclusive, at screening * body mass index (bmi) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at screening * have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ecg, as determined by an investigator exclusion criteria: * history of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects * history of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
assessment of safety and efficacy of gabapentin after surface ablation, a case control experimental study

Conditions: Pain After Photorefractive Keratectomy; VAS Will be Used to Assess Pain Postoperative

Summary: the current study aims at assessing the efficacy and safety of oral gabapentin alone versus diclofenac potassium drugs for postoperative analgesia in patients undergoing surface ablation.

to estimate the analgesic effect and pain severity after surface ablation with oral gabapentin intake in comparison with diclofenac potassium, where gabapentin could be a better analgesic medication after surface ablation

Eligibility criteria:
inclusion criteria: * patients over 18 years old * preoperative stable refraction for at least one-year, * normal corneal tomography with expected postoperative flat k reading not less than 38d, and postoperative residual stromal bed not less than 350 μm. exclusion criteria: * patients with preoperative corrected distance visual acuity (cdva) of worse than 20/30 * amblyopic patients, * patients with a history of previous ocular surgeries, * herpetic eye infection, or corneal dystrophies. * patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma * diabetics, * hypertensives, * kidney problems, * breathing problems * adults older than 65 years. * previous allergy or adverse reaction to the used drugs. * history of drug abuse or alcohol abuse problems * history of mood problems, depression suicidal thoughts or behavior
chinese registry of assisted embolization for ruptured wide necked intracranial aneurysm using lvis stent

Conditions: Self Efficacy; Medical Device Complication

Summary: this study aims to investigating the efficacy and safety of low profile visualized intraluminal support (lvis) stents for the treatment of ruptured intracranial saccular aneurysms. the follow-up duration is 1 year.

this study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (lvis) stents combined with coils for the treatment of ruptured intracranial saccular aneurysms. as the protocol, clinical follow-up at 30 days (±7 days) after procedure, dsa or mra follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. the primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up, and modified rankin score (mrs) at 1 year follow-up. the secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. duration of this study is 2 years.

Eligibility criteria:
inclusion criteria: * patients meeting all the following criteria will be enrolled: 1. patients of the age 18-75 years old. 2. patients diagnosed with ruptured intracranial saccular aneurysms via cta, mra or dsa. 3. patients treated with lvis stents combined with coils. 4. patients willing to follow the clinical trial instructions and receive follow-up assessment. 5. patients accepting to participate to the study and sign the consent forms. exclusion criteria: * patients meeting any following criterion will be excluded 1. patients without proper artery approach. 2. patients with avm. 3. patients with a fusiform or dissecting aneurysm. 4. patients with a recurrent aneurysm. 5. patients treated with a lvis stent without coils. 6. patients in poor clinical status, with mrs ≥4. 7. patients with life expectancy less than 12 months. 8. patients participated in other clinical trial, while has not reach the primary endpoint. 9. patients can not accept anti-platelet regimen. 10. patients allergic to contrast agent or intolerable. 11. patients whom the researchers consider should not participate in or continue this clinical trial.
comparison of remimazolam with flumazenil vs. propofol during rfca for atrial fibrillation

Conditions: Recovery

Summary: this prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol total intravenous anesthesia as the main general anesthetics during radiofrequency catheter ablation treatment of atrial fibrillation.

adult patients with atrial fibrillation undergoing radiofrequency catheter ablation under general anesthesia are randomized to receive either remimazolam with flumazenil or propofol total intravenous anesthesia as the main anesthetics. after completion of radiofrequency ablation, each anesthetic is discontinued. the primary outcome of the study is comparison of the time to the first eye opening responding to doctor's command from the discontinuation of each drug between the groups. secondary outcomes includes the time to removal of supraglottic laryngeal mask airway device from discontinuation of each drug, incidence of three consecutive hypotension (systolic blood pressure under 80 mmhg) recordings at 2.5 min-intervals, and intraprocedural vasoactive-inotropic score.

Eligibility criteria:
inclusion criteria: * adult patient, age 20-75 years, scheduled for radiofrequency catheter ablation of atrial fibrillation under general anesthesia exclusion criteria: * patients who are not alert before procedure * hemodynamicaly unstable patients before procedure * patients with history of adverse reaction of allergic reaction to study drugs * patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support * use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h * known galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * severe hepatic or renal dysfunction * alcohol or drug dependence * organic brain disorder * spinal or cerebellar ataxia * acute narrow-angle glaucoma * patients with shock or coma * pregnant or lactating women * patients with hypersensitive to beans or peanut * patients who refuse to participate

Keywords: recovery remimazolam flumazenil propofol radiofrequency catheter ablation
oral estramustine and oral vinorelbine in the treatment of hormone-refractory prostate cancer

Conditions: Prostate Cancer

Summary: purpose: this clinical trail will combine the chemotherapy drugs, estramustine and vinorelbine (navelbine), on an intermittent therapy strategy based on psa response in the treatment of hormone refractory prostate cancer. the investigators will determine the tolerable dose of (oral) vinorelbine in combination with (oral) estramustine, and evaluate the efficacy of this treatment for patients with hormone-refractory prostate cancer.

hormone refractory prostate cancer refers to advanced disease in which a patient no longer responds to conventional hormonal treatment. when hormone therapy is no longer successful, chemotherapy is a treatment option. however, current single-agent treatment has shown to have limited benefit. in this clinical trial, investigators are evaluating the effectiveness of combining two chemotherapy drugs, estramustine and vinorelbine (navelbine), in the treatment of hormone refractory prostate cancer. estramustine has been used in the treatment of prostate cancer for many years. vinorelbine has shown activity in prostate cancer. in addition, the effect of this treatment on the quality of life of patients will be evaluated as measured using the fact-p.

Eligibility criteria:
inclusion: * patients must have a histologic diagnosis of adenocarcinoma of the prostate. (no evidence of brain metastasis or untreated spinal cord compression.) * patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising psa (prostate specific antigen) 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide. * patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated psa). if psa is the only evidence of progressive disease it must be greater than or equal to 4ng/ml. * adequate bone marrow, renal and liver function * ecog (eastern cooperative oncology group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death) * must be at least 18 years of age * must have a life expectancy of greater than or equal to 12 weeks exclusion: * have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow. * evidence of brain metastasis * spinal cord compression * prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years * patients with preexisting neuropathy of greater than or equal to grade 2 * active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption
study of ono-1101 in patients scheduled for multi-slice computed tomography (ct)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of ono-1101 in patients scheduled for multi-slice ct, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.


Eligibility criteria:
inclusion criteria: * ≥ 20 years old * heart rate ≥ 70beats/min and ≤ 90beats/min at entering the ct room and just before dosing organic nitrates. exclusion criteria: * previous allergic reactions to contrast agent * renal failure * asthma
effectiveness of sdf with different post-treatment protocols in arresting dental caries

Conditions: Dental Caries

Summary: to compare the effectiveness of the semi-annual application of 38% sdf with two post-treatment protocols in arresting dental caries in preschool children

methods: the randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. all the tooth surfaces with carious lesions will receive the semi-annual application of 38% sdf solution. after the treatment, children will be allocated to two groups by an independent research assistant. two post-treatment protocols are as follows. group a - children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after sdf treatment. afterwards, no post-treatment protocol is given to children. group b - children are instructed not to eat and drink for at least 30 minutes. clinical examinations after 6-months will be conducted to assess whether the caries is arrested. information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. the analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups. significance: this study will help determine the optimal post-op treatment in sdf treatment. the study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Eligibility criteria:
inclusion criteria: 1. 3-5 year old children attending the first to the third year of kindergarten; 2. free from any systemic conditions and generally healthy; 3. parents sign informed consent; 4. having at least 1 tooth with cavitated dentine carious lesion exclusion criteria: 1. are uncooperative to accept oral examination or treatment; 2. have a significant systematic disease or long-term medications; 3. have abnormal dentition. 4. teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.

Keywords: dental caries preschool children silver diamine fluoride
comparison of two strategies to realize apnea test for the diagnostic of brain in potentiel organ donors.

Conditions: Alternative Method of Apnea Test

Summary: clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. the confirmation of absence of spontaneous breathing is established the apnea test (according to the american academy of neurology's guidelines). however this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (cpap) use. these studies showed that this alternative method (cpap) increased the level of lung harvest but they were not sufficient because these studies were monocentric with little patients,. that why the aim of the present study is to compare the standard strategy and cpap strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.


Eligibility criteria:
inclusion criteria: * age : from 18 to 75 years * neurological signs evoking cerebral ischemia exclusion criteria: * severe hypoxemia (pao2/fio2 \< 200) with controlled ventilation (fio2: 100%) * hypothermia \< 36°c * obesity (bmi ≥ 40) with documented hypopnoea * intractable hypotension despite optimal filling and catecholamine doses \> 1µg.kg.min * patients with contraindication for organs harvesting. * documented chronic respiratory failure * progressive infectious acute respiratory disease * family opposition to subject's participation in the study
intervention with lupin kernel fibre in hypercholesterolemic subjects

Conditions: Hypercholesterolemia

Summary: the objective of the conducted study was to determine the efficacy of lupin kernel fibre-enriched food (lupinus angustifolius boregine) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

dietary fibre is suspected to effect the faecal concentration and excretion of bile acids by binding the bile acids and by increasing the faecal mass. bile acids, especially the secondary bile acids, are potential risk factors for colorectal cancer. a high bile acid-binding ability of fibre could lead to lower blood cholesterol concentrations by interrupting the enterohepatic circulation. there is evidence that the consumption of lupin kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health. a total of 133 subjects were recruited for this study. sixty moderate hypercholesterolemic volunteers (total cholesterol \> 5.2 mmol/l) fulfilled the selection criteria and were randomly assigned three groups. forty-five subjects (mean age of 47 years, 34 women and 20 men) completed the double-blind, randomized crossover trial. the subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. after baseline, each volunteer had to pass all three periods in different order with a two-week wash-out period between each. at the end of each intervention period, subjects consumed a standardized diet for three days. furthermore, a quantitative stool collection took place and fasting blood samples were drawn.

Eligibility criteria:
inclusion criteria: * moderate hypercholesterolemia (total cholesterol \> 5.2 mmol/l) * age 20-75 years exclusion criteria: * intake of lipid-lowering pharmaceuticals * intake of nutritional supplements * allergy against legumes * intolerance against milk protein * pregnancy, lactation * chronic bowel diseases

Keywords: dietary fibre lupin kernel fibre bile acids cholesterol metabolism blood lipids hypercholesterolemia fibre-enriched food moderate hypercholesterolemia