Kornimate/medical-research-clean huggingface dataset:
memantine for epileptic encephalopathy

Conditions: Epileptic Encephalopathy, Childhood-Onset

Summary: this study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design.

memantine, a drug approved for alzheimer's dementia, exerts its therapeutic effect through its action as a low to moderate affinity non-competitive (open channel) n-methyl-d-aspartate receptor (nmda-r) antagonist, which binds preferentially to the nmda receptor-operated cation channels. it blocks the effects of persistently elevated levels of glutamate that may lead to neuronal dysfunction. memantine may also have anti-inflammatory effects. memantine has been used off-label in children and adolescents with autism spectrum disorder, to improve the cognitive impairment. epileptic encephalopathy, as well as other forms of epilepsy, may occur as a result of multiple etiologies, including genetic and inflammatory pathologies. ion channels were long considered to be implicated in genetic epilepsy. indeed one of the many possible causes of epilepsy is nmda receptor dysfunction. in the present study, the investigators plan to investigate the potential benefit of memantine as a treatment for epileptic encephalopathy. a double-blind placebo-controlled cross-over design will be used, with participants receiving 6 weeks of memantine and 6 weeks of placebo, with a 2-week washout period in between.

Eligibility criteria:
inclusion criteria: * written informed consent obtained * age 6-18 years (weight ≥ 20 kg) * clinical diagnosis of epileptic encephalopathy * subject with epilepsy and developmental impairment; * epileptic activity itself contributes to severe cognitive and behavioural impairments * patients will typically have already have trialed at least two standard therapies * females of childbearing age: * negative urinary pregnancy test at screening * agree to use effective contraception for the duration of the study exclusion criteria: * inability of a parent or legal guardian to give informed consent for any reason. * known hypersensitivity to memantine hydrochloride * taking concomitant amantadine, ketamine or dextromethorphan, cimetidine, ranitidine, procainamide, quinidine, quinine, hydrochlorothiazide, anticholinergics, l-dopa, anticoagulant, * any degree of renal impairment

Keywords: memantine n-methyl-d-aspartate receptor serum inflammatory seizure
effect of oxygen therapy for patients with precapillary pulmonary hypertension who experience an altitude related adverse health effect (arahe) during 30h exposure to 2500m

Conditions: High Altitude Pulmonary Hypertension; Oxygen Therapy

Summary: to study whether oxygen therapy titrated to maintain oxygenation (spo2) \> 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.

patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. the study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * ph class i (pah) or iv (cteph) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmhg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmhg during baseline measures at the diagnostic right-heart catheterization exclusion criteria: * resting partial pressure of oxygen \<8 kilopascal at zurich at 490 m low altitude * exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study * inability to follow the procedures of the study * other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
effects of vitamin d and fish oil on the kidney in hypertensives

Conditions: Hypertension; Kidney Diseases

Summary: the vitamin d and omega-3 trial (vital; nct01169259) is an ongoing randomized clinical trial in 25,875 us men and women investigating whether taking dietary supplements of vitamin d3 (2000 iu) or omega-3 fatty acids (omacor (r) fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. the vital kidney function in hypertension ancillary study will evaluate the effects of vitamin d or omega-3 fatty acids on kidney function among participants with baseline hypertension.

this ancillary study to the vitamin d and omega-3 trial (vital) will test whether vitamin d3, omega-3 fatty acids, or both prevent the development and progression of kidney disease in participants with hypertension. persons with hypertension are at high risk of kidney disease. vitamin d and omega-3 fatty acids are promising interventions for kidney disease prevention and treatment, based on results of animal-experimental models and early human studies. because these interventions are relatively safe, inexpensive, and widely available, they may offer opportunity to substantially reduce the burden of kidney disease in large populations. this vital ancillary study will test whether vitamin d3 and/or omega-3 fatty acids prevent loss of glomerular filtration rate, over 4 years of therapy. in vital, 25,875 participants have been randomly assigned in a 2x2 factorial design to vitamin d3 (cholecalciferol) 2000 iu daily versus placebo, and to eicosapentaenoic acid 465 mg plus docosahexaenoic acid 375 mg daily versus placebo, and followed for a mean of 5 years to assess effects on cardiovascular disease and cancer events. this ancillary study will identify and recruit a sub-cohort of vital participants with hypertension at baseline and ascertain effects of study interventions on glomerular filtration rate in this group. blood samples will be collected at year 4 simultaneously for measurement of estimated glomerular filtration rate (using serum creatinine and cystatin c) and other relevant biomarkers. this vital ancillary study is designed to determine whether vitamin d3 and/or omega-3 fatty acids have causal and clinically relevant effects on the development and progression of kidney disease in hypertensives.

Eligibility criteria:
inclusion criteria: * participants in vital (nct01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study exclusion criteria: * diagnosis of diabetes mellitus

Keywords: hypertension kidney diseases vitamin d omega 3 fatty acids
effect of probiotic on comorbidity of depression and constipation

Conditions: Comorbidity of Depression and Constipation

Summary: depressive disorder, also known as depression, is a type of mood disorder characterized by persistent low mood. the incidence of depression worldwide is about 6%. the high comorbidity rate between depression and constipation indicated the role of the gut-brain axis in depression. growing evidence suggested that the gut microbiota plays a key role in the development of depression. probiotics can effectively improve constipation and regulate gut microbiota, and showed potential in alleviating depression. this study investigated the effect of formula probiotic (containing lactobacillus paracasei, bifidobacterium animals, bifidobacterium longum, bifidobacterium bifidum, and lactobacillus plantarum) on the comorbidity of depression and constipation.


Eligibility criteria:
inclusion criteria: * normal body mass index ≥ 18.5 until ≤ 29.9 * hamilton rating scale for depression (hamd-17) score not less than 8 * meet the rome iii criteria for functional constipation * agreed to intake study product during the study period * agreed to sign written informed consent exclusion criteria: * use of systemic antibiotics or antimycotics medication in the 30 days prior to the study * investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements * persons with a milk protein allergy, lactose intolerance * pregnant or breastfeeding women * subject had other serious diseases
evaluation of (doravirine / lamivudine / tenofovir disoproxil fumarate) (delstrigo®) as a new strategy for non-occupational post exposure prophylaxis, a prospective open label study

Conditions: Hiv

Summary: subjects who go to emergency room for possible contact to hiv transmission receive delstrigo as post exposition prophylaxis.


Eligibility criteria:
inclusion criteria: * subjects attending emergency room due to potential hiv exposition of either sex: * aged 18 years or more. * who have been exposed to non-occupational hiv and who meet the prerequisites for the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs. * who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required. * individuals able to do follow up correctly. exclusion criteria: * pregnant women or nursing mothers or women trying to conceive during the study period. * patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens. * treatment with drugs that are contraindicated in the study or products that are in the investigational phase. * allergic reactions or intolerance to the compounds of the study treatment regiments
phase ii study of adjuvant sib radiotherapy following narrow-margin hepatectomy in patients with hcc.

Conditions: Hepatocellular Carcinoma; Narrow Margin; Radiotherapy

Summary: this is a single-arm prospective phase ii clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with hcc. eligibility patients will receive imrt or vmat to high risk area of tumor bed and tumor bed. the prescription dose to 95% gtvtb boost was planned at 55-60gy, with ptv 45-50gy, in 23-25 fractions, mainly depending on the dose constraints of oars. the primary endpoint is the 3-year os, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.

surgical resection is the primary treatment for hcc. however, it is associated with a high rate of recurrence and death. based on the results of our retrospective study and phase ii study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(\<1cm) after hepatectomy. the 3-year and 5-year os rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. however, there is no standard for the prescription dose. the high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (sib) technique can optimize the target dose while protecting normal tissues. so, the investigators conducted this single-arm prospective phase ii clinical trial to investigate the efficacy and safety of adjuvant sib radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with hcc.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of hcc after hepatectomy with narrow pathological margins (\< 1 cm) * age \> 18 years * recovery from surgery with an eastern cooperative oncology group performance status score of 0 or 1 * child-push score: a5-a6 * estimated life expectancy \> 3 months * no distant metastasis (m0) * blood routine examination: hb≥80g/l, anc≥1.0x10\^9/l, plt≥50x10\^9/l * hepatic function: alanine transaminase(alt) and aspartate transaminase(ast) ≤1.5 times uln; or alt ≤uln and ast ≤6 times uln exclude possibility of heart disease * renal function: creatinine(cre) and blood urea nitrogen(bun)≤1.5 times uln * voluntary to participate and sign informed consent exclusion criteria: * history of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix * had prior abdominal irradiation * had prior liver transplantation * had serious myocardial disease or renal failure * had moderate or severe ascites with obvious symptoms * duration from surgery ≥ 3 months

Keywords: hepatocellular carcinoma narrow margin adjuvant simultaneously integrated boost radiotherapy
prospective randomized endovascular therapy in multiple sclerosis - premise

Conditions: Multiple Sclerosis

Summary: the departments of neurology and neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of multiple sclerosis (ms).


Eligibility criteria:
inclusion criteria: * age 18-65 years * edss 0-6.5 (0-5.5 in the phase ii of the study) * diagnosis of relapsing ms according to the mcdonald criteria (polman et al., 2005) * 1 relapse within the past 12 months or gad positive lesion on an mri within the past 3 months (only for phase ii of the study) * be on treatment with currently fda approved disease-modifying treatments (excluding tysabri or steroids (within the last 30 days prior to enrollment) * evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see table 1 background and 1.5 section) * normal renal function: creatinine clearance level of \>60 exclusion criteria: * relapse, disease progression and tysabri and steroid treatment in the 30 days preceding study entry * pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.) * severe peripheral chronic venous insufficiency * abnormal renal function * contrast allergy (anaphylaxis) * not accepting to undergo the endovascular treatment * peripheral vascular disease
detection of pathogen and antibiotic resistance genes by targeted next-generation sequencing in icu patients.

Conditions: Infections; Critical Illness; Diagnosis

Summary: it is difficult to determine the pathogens in the early stage of infection in critically ill patients, and empirical use of broad-spectrum antibiotics for a long time is often necessary, leading to antibiotics drug resistance. targeted next generation sequencing (tngs) can provide faster results for pathogen and related antibiotic resistant diagnosis. but it lacks sufficient clinical evidence. evidence regarding the clinical diagnostic accuracy and drug resistance is needed to comprehensively evaluate targeted next generation sequencing (tngs) for diagnosis of patients in icu who and will be critical to inform national policy.

infectious diseases are one of the highest mortality and morbidity diseases in humans. due to the difficulty in identifying the pathogen in the early stage of infection, patients with severe infections often need to empirically use broad-spectrum antimicrobials for a long time. the traditional gold standard of etiological detection - etiological culture, even in sepsis patients, only about 60% of the results are positive. therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment. metagenomic next generation sequencing (mngs), which has emerged in recent years, have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but it is expensive and not able to provide related drug resistant genes. therefore, targeted next generation sequencing (tngs) has been derived, which is characterized by rapid sequencing and genetic testing for drug resistance. the purpose of this study is to evaluate the efficacy of etiological diagnosis and provide patients with more accurate treatment.

Eligibility criteria:
inclusion criteria: * the presence of an infection or clearly excluded the presence of infection. * etiological culture and/or metagenomic next-generation sequencing detection of specimens sent for testing. exclusion criteria: * suspected infection. * participation in other clinical trials in the past 2 months.

Keywords: targeted next-generation sequencing icu infections next-generation sequencing
strategy to avoid excessive oxygen in major burn patients

Conditions: Critical Illness; Wounds and Injury; Disease Attributes; Pathologic Processes

Summary: the objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. although routine, the practice of excessive over-oxygenation may be harmful. an expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (spo2) range of 90-96%, an arterial oxygen (pao2) range of 60-100 mmhg (when applicable), and a fraction of inspired oxygen (fio2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients. specific aim: the purpose of this study is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy. hypotheses: clinical efforts to through a multimodal educational intervention will: 1. improve the proportion of time spent within target normoxemia thresholds (oxygen saturation \[spo2\] 90-96% and/or arterial oxygen \[pao2\] 60-100 mmhg \[when applicable\]) 2. limiting use of excessive supplemental oxygen 3. reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Eligibility criteria:
inclusion criteria: * patients with acute thermal burn injury who meet the criteria for entry into the state or national burn data repository * admission to burn unit within 24 hours of burn injury exclusion criteria: * age \<18 years * prisoners * known pregnancy

Keywords: hypoxia hyperoxia burn critical illness supplemental oxygen oxygenation spo2 pao2 fio2 normoxia hypoxemia hyperoxemia normoxemia
the acceptance of reiki therapy as a complementary and alternative option for the management of chronic pain

Conditions: Pain, Chronic

Summary: for the past few years, the military has been looking for an innovative way to decrease the use of opioids for chronic pain. this has prompted military treatment facilities to begin integrating complementary and/or alternative medicine modalities into their conventional plans of care. reiki, a bio-field energy therapy, is one such modality. the purpose of this prospective repeated measure study is to: 1) introduce the concept reiki therapy to military healthcare beneficiaries experiencing chronic pain, 2) assess pain outcome after receiving six treatments of reiki therapy, and 3) assess participant's impression of reiki therapy as a possible complementary and/or alternative option for the management of chronic pain. thirty military healthcare beneficiaries with the complaint of chronic pain will receive a brief introduction to reiki therapy followed by six 30-minute reiki sessions provided by trained reiki level 1 practitioner. participant's knowledge of reiki will be assessed using pre and post questionnaires; pain will be assessed using the brief pain inventory, defense veterans pain rating scale, dod (department of defense) va (veteran's administration) pain supplementary questionnaire, mcgill pain questionnaire and pain medication diaries; and participant's impression will be assessed using the patient global impression of improvement scale and along with a post study questionnaire. if it is found that reiki therapy helped in decreasing chronic pain outcomes, this treatment modality may be added to landstuhl regional medical (lrmc) pain clinic's pool of complementary and alternative medicine options.


Eligibility criteria:
inclusion criteria: 1. has chronic pain (defined as pain that lasts 3 months or more since first onset). 2. is receiving a stable pain medication regimen (defined as a regimen that has not increased 10% to 20% in the past week prior to enrollment), if on pain medication. 3. is affiliated with at least one of the 13 installations within the kaiserslautern military community area 4. is eligible to receive healthcare at landstuhl regional medical center 5. is 18 years and older 6. can read and speak english 7. is able to commit to 6 treatments (approximately 2-3 weeks) exclusion criteria: 1. have had surgery or a painful procedure in the last 30 days or are being scheduled for any surgeries or painful procedures during the duration of the study 2. already have a working knowledge (e.g., credentialed reiki level i, ii or iii practitioner or reiki master) of reiki or have had reiki therapy in the past

Keywords: reiki chronic pain military
photobiomodulation in treatment of xerostomia in type ii diabetic patients

Conditions: Xerostomia; Diabetes Mellitus

Summary: xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. it leads to difficulties with speech, swallowing and taste alteration. pathological causes of xerostomia are divided into local and systemic factors. local factors include smoking, salivary gland diseases and head and neck radiation therapy. systemic factors include autoimmune diseases as sjögren syndrome and hormonal disorders as diabetes mellitus. photobiomodulation (pbm) previously known as low level laser therapy (lllt) is the application of red and near infra-red light over injuries or lesions to improve wound and soft tissue healing, reduce inflammation and give relief for both acute and chronic pain. it also has grabbed the attention over the last few years as an effective treatment for xerostomia.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus suffering from xerostomia and on oral hypoglycemic drugs. * glycated hemoglobin less than 7%. * duration of diabetes mellitus not less than 4 years and not more than 8 years exclusion criteria: * patients receiving any drugs that cause hyposalivation. * patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus). * patients receiving chemotherapy and radiotherapy. * individuals with skin lesions in the treatment zone to avoid any complications occurring in this area by laser exposure