Kornimate/medical-research-clean huggingface dataset:
safety and tolerability ultra-high-caloric food supplements in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the lipcal-als study (nct02306590) has provided preliminary evidence that a high-caloric nutrition might prolong survival in fast-progressing als patients. since increasing the amount of calories of the intervention might possibly increase the beneficial effect, the investigators seek to investigate whether an ultra-high caloric diet (uhcd), featuring the double amount of calories compared to lipcal-als, will be well tolerated by als patients and may serve as an intervention for a potential lipcalii study. for this purpose, the investigators will compare two different uhcds (one fat-rich and one carbohydrate-rich) with regard to safety and tolerability over a time frame of 4 weeks. a third group will receive the original diet from lipcal, and a fourth group will receive no intervention (control group).


Eligibility criteria:
inclusion criteria: * diagnosis of amyotrophic lateral sclerosis (als) according to the revised version of the el escorial criteria (ludolph et al. 2015) * slope of als functional rating scale revised (alsfrs-r) of \>0.25 points per month at baseline visit based on the formula (48 - score at baseline visit) / (time between date of first symptom and baseline visit) * stable on standard therapy riluzole (100 mg/day) for at least 4 weeks * capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (gcp) exclusion criteria: * already taking any dietary supplements * participation in another clinical trial within the preceding 8 weeks * tracheostomy or assisted ventilation of any type which exceeds 23 hours per day * pregnancy or breast-feeding females
randomized comparison of xience and vision coronary stents in the same multivessel patient with chronic kidney disease

Conditions: Chronic Kidney Disease; Multivessel Coronary Artery Disease

Summary: percutaneous coronary intervention (pci) with bare metal stent (bms) in patients with renal insufficiency has shown unsatisfactory results. indeed, drug-eluting stents (des) might reduce the incidence of restenosis and therefore of target lesion revascularization procedures in these patients. we therefore designed a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (xience v) and bare-metal stent (vision) (both 2nd-generation des and bms, respectively), both implanted in the same patient with multivessel disease and renal insufficiency in order to obviate for the multiple and unpredictable characteristics of this high-risk population.


Eligibility criteria:
inclusion criteria: * chronic renal insufficiency (creatinine clearance \ 70%) coronary lesions in two major coronary vessels. exclusion criteria: * age \>85 years * left main coronary artery disease * saphenous vein graft disease * st-elevation mi (\<3 days) * coronary vessel diameter \ 4 mm * contraindication to long-term double antiplatelet therapy * cabg indication by consensus (cardiovascular team) * severe valvular heart disease * informed consent not obtained

Keywords: percutaneous coronary intervention drug-eluting stent chronic kidney disease restenosis
ketamine on acute pain in females and males

Conditions: Mouth and Tooth Diseases; Tooth, Impacted

Summary: the purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars

ketamine is assumed to be a nmda receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. gender differences in ketamine analgesia are not known. this placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars. comparisons: placebo and ketamine in females and males.

Eligibility criteria:
inclusion criteria: * indication for removal of third molar * between 20 and 30 years of age * asa class 1 exclusion criteria: * psychiatric family (father/mother) or own anamnestic history * hypersensitivity towards nsaids or other rescue analgesics * verified or suspected pregnancy * lactating females * surgery lasting over 60 min

Keywords: wisdom tooth teeth third molar
technology-enhanced quitline services to prevent smoking relapse

Conditions: Smoking Cessation

Summary: the purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as alere wellbeing's quit for life program, and help people quit smoking. if successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking.


Eligibility criteria:
inclusion criteria: * 18 years or older * enrolled in free \& clear, inc. services * self-reported abstinence for at least 24 hours at the quit date call * able to read and speak english * personal access to a touch-tone telephone or cellular telephone exclusion criteria: * have not stopped smoking for 24 hours * currently incarcerated * currently participating in any other smoking cessation research * live in same household as another study participant * participated in the alere wellbeing quit for life program within the last 6 months * were previously enrolled in this study even if they repeat the smoking cessation program during the accrual period * hearing impaired enrollees receiving free \& clear services via telecommunications devices for the deaf (tdd) will be excluded from the study as the ivr technology currently does not have this capability

Keywords: smoking cessation quitline counseling
exercise response after revalidation in cancer patients

Conditions: Oncology; Cardiac Toxicity

Summary: this study regarding oncological patients for rehabilitation after specific cancer therapy involves three aims: (1) to evaluate the predictive value of myocardial work parameters on the improvement of exercise performance after rehabilitation, (2) to determine which echocardiographic parameters are more suitable in predicting cardiac dysfunction, and (3) to evaluate the correlation between echocardiographic parameters and fibrosis detected by cardiac magnetic resonance imaging (cmr).

myocardial work (mw) provides an estimation of cardiac function by combining global longitudinal strain (gls) with blood pressure values obtained non-invasively, being less load dependent than standard gls. the investigator hypothesize that myocardial work could be a useful marker for predicting the exercise performance after chemotherapy and/or radiotherapy in oncological patients undergoing rehabilitation. moreover, this study may provide additional information in optimal selection for rehabilitation programs.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with cancer 2. undergoing chemotherapy and/or radiotherapy/hormone therapy 3. age older than 18 years old - maximum age of 90 years old 4. willing to enter revalidation in universitair ziekenhuis brussel 5. signed consent form exclusion criteria: 1. severe aortic stenosis defined as aortic valve aria under 0.6 cm2/m2 2. supraventricular arrhythmias 3. poor image quality for 2d and 3d echocardiography defined as the impossibility to examine of more than 2 adjacent segments 4. resistant hypertension defined as uncontrolled blood pressure values under current european guidelines, systolic blood pressure more than 140 mmhg and/or diastolic blood pressure more than 80 mmhg 5. lung cancer

Keywords: echocardiography revalidation cardiovascular magnetic resonance imaging oncology radiotherapy chemotherapy cardiorespiratory exercise test
intranasal neurostimulation in ameliorating symptoms of neuropathic corneal pain

Conditions: Cornea

Summary: this study is a prospective, interventional, open-label, single arm, non-randomized trial treating 30 patients with peripheral or mixed neuropathic corneal pain at their baseline exam and following 45 days and 90 days of daily use with the truetear™ itn device.

the investigators hypothesize that the stimulation through the ethmoidal nerve in the nasal cavity may have an inhibitory effect on the primary tg interneurons and block the ocular pain signaling to the brain. the investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (ncp) with itn with the following specific aims: specific aims: 1. to elucidate the efficacy of itn in ameliorating pain among neuropathic corneal pain patients. 2. to elucidate the safety, efficacy, longevity of itn in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use. 3. to assess quality of life changes by treating neuropathic corneal pain with itn during a 90-day period with daily use.

Eligibility criteria:
inclusion criteria: 1. age \>22 2. ability to consent to study. 3. symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain. 4. positive in vivo confocal microscopy (ivcm) findings for ncp such as presence of microneuromas and decreased nerve density. 5. fifty percent or more relief of pain or discomfort after instillation of proparacaine eye drops as measured by the visual analogue scale (vas). exclusion criteria: 1. clinically significant acute ocular surface diseases, such as active infectious keratitis or recent ocular surgery in the past 3 months. 2. chronic or recurrent epistaxis, coagulation disorders. 3. nasal or sinus surgery or significant trauma to the nose. 4. severe nasal airway obstruction or vascularized nasal polyps. 5. cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck. 6. chronic or recurrent nosebleeds 7. bleeding disorder 8. known hypersensitivity (allergy) to the hydrogel material 9. disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.

Keywords: intranasal neurostimulation
open-label study of levetiracetam intravenous infusion in children (4-16 years old) with epilepsy

Conditions: Epilepsy

Summary: keppra injection is approved in the us as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. the objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16 years.

the primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (4 to 16 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment. the evaluation period was to be considered as one complete set of 4 pharmacokinetic (pk) samples for a maximum of 4 days; * for children already taking levetiracetam oral tablets or oral solution prior to entering the study, the levetiracetam intravenous (lev iv) dose will be equivalent (mg-for-mg) to their oral dose. the first intravenous (iv) infusion was to be administered 12 hours after the last oral dose of levetiracetam. * for children not taking levetiracetam oral tablets or oral solution prior to entering the study: * if weight \< 50 kg: dose of levetiracetam intravenous (lev iv) dose will be calculated on the basis of their weight at 20 mg/kg/day (i.e. 10 mg/kg twice daily). * if weight ≥ 50 kg: dose of levetiracetam intravenous (lev iv) will be 1000 mg/day (i.e. 500 mg twice daily). however, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (lev iv) dose could be modified after one day. subjects were hospitalized for the duration of the levetiracetam iv treatment.

Eligibility criteria:
inclusion criteria: * male or female between 4 and 16 years of age, inclusive * the subject suffers from epilepsy (except status epilepticus) * the subject is requiring levetiracetam iv treatment in place of oral therapy for a short period of time exclusion criteria: * the subject has difficult venous accessibility * history of status epilepticus during the 3 months prior to visit 1. * the subject is taking felbamate at visit 1 or has been taking it in the past.

Keywords: epilepsy child levetiracetam keppra® infusion intravenous
effects of six months of moderate resistance- versus endurance-training on muscle atp synthesis in first-degree relatives of patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Insulin Resistance

Summary: life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (t2dm). first-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. poor physical fitness is a strong indicator of an increased risk of developing diabetes. long-term endurance exercise training has been shown to increase insulin sensitivity in sedentary young and elderly individuals, first degree relatives of patients with type 2 diabetes, glucose intolerant obese, or type 2 diabetic humans. in type 2 diabetic patients, non-diabetic individuals with igt and sedentary adults after exercise training of different intensity, different duration and different frequency an increase of insulin sensitivity was found. however, despite the vast knowledge concerning beneficial effects physical activity for the prevention of t2dm (and many other chronic metabolic disorders) to date wide ranging strategies have not been realized satisfactory. regardless of age, ethnicity, sex or health status the lack of time is the primary reason for the failure to exercise on a regular basis (or is stated as primary reason). therefore the investigators aimed at investigating whether a controlled endurance/resistance training twice a week over 6 month might be beneficial for healthy, non obese, first degree relatives with t2dm. therefore the investigators measure parameters associated with the prevention of t2dm like insulin sensitivity, flux through fatpase and fck, intramyocellular and hepatocellular lipids.


Eligibility criteria:
inclusion criteria: * first degree relatives of type 2 diabetic patients * age: 18-50 years * bmi \<30 kg/m2 (due to limited mr diameter) * normal routine lab tests (blood cell count, kidney, liver, pancreas, thyroid and neuromuscular function) * availability within the local area throughout the study * ability to understand and sign the consent forms exclusion criteria: * current smoking * present drug treatment * regular exercise training * contraindications for mrs studies: claustrophobia and metalliferous implants * pregnancy * hiv or hepatitis * acute disease 2 weeks previous to the examination * heart disease * hypertension (rr\>140/95) * liver disease * kidney disease * pulmonary disease * thyroid disease

Keywords: type 2 diabetes exercise training atp-synthesis intramyocellular lipids hepatocellular lipids first degree relatives of t2dm patients
pirfenidone in adult hospitalized patients with covid-19

Conditions: COVID-19 Pneumonia

Summary: this center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe covid-19.


Eligibility criteria:
inclusion criteria: * subjects age ≥ 18 willing and able to provide written informed consent * sars-cov-2 infection confirmed by pcr test/antigen dectection or positive serologies * time of illness onset ≥8 days * have findings consistent with interstitial lung disease found on ct scan * willing not use other investigational agents of anti-fibrosis exclusion criteria: * pre-existing severe liver disease * pre-existing severe chronic kidney disease * pre-existing interstitial lung disease * pre-existing severe copd or other structural lung disease * receiving invasive mechanical ventilation * currently pregnant or breast feeding * poor baseline health conditoin * disability to complete lung function test * receiving pirfenidone wthin half-year
the influence of primary hiv-1 drug resistance mutations on immune reconstruction in plwh

Conditions: Hiv; AIDS; CD4 Deficiency; ART; Treatment Resistant Disorders; Treatment-Sensitive HIV Infection

Summary: since the reasons for differential immune reconstitution in hiv-infected patients are still not fully understood, we considered it reasonable to investigate whether the presence of primary hiv drug resistance mutations could be one of the factors of inadequate immune reconstitution. evaluation of unfavorable factors of immune reconstitution can help identify patients at risk of persistently low cd4 cell counts and cd4:cd8 ratios and requiring careful monitoring for progression to aids.

untreated hiv infection leads to progressive and permanent impairment of the immune system, and the successive loss of peripheral blood cd4+ t lymphocytes results in progression to aids. effective antiretroviral therapy (art) can prevent the decline and even cause the restore of the normal level of cd4+ cells. cd4+ count ≥ 500 cells/µl and cd4:cd8 ratio ≥ 1 are considered normal, while patients with persistently lower cd4+ and cd4:cd8 ratios despite art treatment are defined as having an inadequate immune response, which may result in an increased risk progression to aids, and thus higher mortality rates. clinical risk factors for impaired cd4+ regeneration have not been fully established, however, older age, male gender, low cd4+ cell count and low cd4:cd8 ratio at diagnosis are associated with a poorer immune response to art. as well, hiv drug resistance also plays an important role in the process of immune reconstruction. despite the very good results of art, the emergence of drug-resistant mutations in the hiv virus, which may lead to treatment failure, is a cause for concern. the prevalence of hiv-1 drug resistance mutations reported worldwide ranges from 5% to 25%. primary drug resistance of hiv occurs in people who have not previously been treated with art. these people start art treatment with a lower genetic barrier, a higher risk of virological failure and a higher risk of developing resistance to other drugs, which may lead to insufficient immune reconstruction and progression to aids.

Eligibility criteria:
inclusion criteria: * hiv-1 confirmed infection * art naive patients \> 18 years * virological suppression after 6 months of art * available results of hiv genotyping before the start of art exclusion criteria: * hematologic neoplasms * use of chemotherapy, immunosuppressive drugs and other myelotoxic agents * lack of patient's consent to participate in the study

Keywords: hiv cd4 drm drug resistance immune reconstruction
renal and urinary manifestations of chronic inflammatory bowel diseases.

Conditions: IBD - Inflammatory Bowel Disease

Summary: the association between ibd and kidney diseases is more common than previously thought. however, the data is limited and comes from studies with small sample sizes. the proposed study aims to investigate this association in a large population of patients with ibd, assessing risk factors and potential changes in the therapeutic approach to minimize the risk of kidney damage. the primary objective of this study is to characterize the association between ibd and kidney diseases, as well as the progression of intestinal disease and kidney function in patients who have undergone transplantation. the study is monocentric, observational, and both retrospective and prospective.

all patients who agree to participate in the study and sign the informed consent will be asked to allow the collection of their clinical data for database compilation. retrospective data will be evaluated and collected from the medical records of all patients with chronic inflammatory bowel diseases followed at the ssd chronic inflammatory bowel diseases center. for patients with a diagnosis of kidney disease still affiliated with the center, prospective data collection will occur for a period of 3 years from enrollment in the study. no additional study-specific analyses or procedures are planned. * sample size approximately 1500 patients with chronic inflammatory bowel diseases are expected to be enrolled. * statistical analysis all analyses will be performed using stata 13.0 for windows. the characteristics of the enrolled and observed patients will be summarized using descriptive statistics. all variables will be summarized with descriptive statistical analyses. for qualitative variables: relative frequency and 95% confidence intervals; for quantitative variables: mean, standard deviation, and percentiles. to detect possible associations between observed qualitative characteristics, pearson's chi-square test will be used, along with yates' continuity correction or fisher's exact test. analysis of variance (anova) or analysis of covariance (ancova) will be used for quantitative variables. statistical analysis will be conducted using the stats package. differences between groups will be evaluated with student's t-test and uni- and multivariate analyses to identify risk factors.

Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥ 18 years * diagnosis of crohn's disease or ulcerative colitis exclusion criteria: * none
hcc patient preferences in japan

Conditions: Hepatocellular Cancer

Summary: this non-interventional cross-sectional online survey will evaluate preferences among patients with self-reported hcc. the survey will ask patients to express their preferences regarding descriptions of hcc treatments, which will include sorafenib (which will be described as 'oral anti-cancer therapy'), repeated transarterial chemoembolization (tace), and hepatic arterial infusion chemotherapy (haic). please note that all interventions that patients may have received before completing this online survey were given regardless of their participation in this survey. questions also include asking patients to rank various treatment characteristics (e.g., mechanism of action, risk of adverse effects, etc.) relative to each other. the ultimate goal is to better understand patient perceptions of these treatments and to provide evidence to help in patients' and physicians' treatment decision-making in hcc.


Eligibility criteria:
inclusion criteria: the following eligibility criteria will be used: * have a diagnosis of hcc * are \> 20 years of age * reside in japan * are able to read and understand japanese to provide informed consent and complete the survey instrument exclusion criteria: none are currently considered

Keywords: hcc patient preferences
an observational study of mabthera (rituximab) in patients with rheumatoid arthritis and inadequate response or intolerance to a first anti-tnf alpha therapy

Conditions: Rheumatoid Arthritis

Summary: this prospective, multi-center, observational study will evaluate the efficacy and the safety of mabthera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-tnf alpha therapy. participants have commenced mabthera or an alternative anti-tnf alpha treatment as a second biological therapy. data will be collected for 12 months.


Eligibility criteria:
inclusion criteria: * adult participants, \>/=20 years of age * participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-tnf alpha therapy and who have initiated mabthera or an alternative anti-tnf alpha therapy exclusion criteria: * participants whose first anti-tnf alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis * participants who have not signed the informed consent form