Kornimate/medical-research-clean huggingface dataset:
tolerability of rebif® (interferon-beta 1-a) therapy in korean patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this is an observational study to assess the tolerability of rebif treatment in korean multiple sclerosis (ms) subjects.

the present observational study is being conducted to assess the safety information from a target of 100 korean subjects with ms treated with rebif. various parameters like subjects' background (age, sex, bmi), ms history, ms status (ms type, expanded disability status score \[edss\] and others), ms treatment concern questionnaire (mstcq), rebif treatment status, concomitant disease modifying agents (dma) therapy and rebif related adverse events will be collected. subjects will be followed for 12 months. proportion of subjects with moderate to severe (grade 3-5) injection site reactions after 3, 6, 12 months of rebif treatment will be determined. secondary outcomes like annual relapse rate, change in edss, changes in mstcq, time to first relapse and incidence of side effects associated with rebif therapy will also be determined and presented descriptively. objectives primary objectives * to assess the tolerability of rebif treatment in korean ms subjects in a non-interventional setting secondary objectives * to evaluate subject's satisfaction, clinical data and disease characteristics of the population of ms subjects undergoing rebif treatment.

Eligibility criteria:
inclusion criteria: * subjects, who are eligible for rebif treatment according to the indication in the national label of rebif in korean subjects with ms. the national labels approved by korean regulatory authority are: 1. subjects with relapsing ms with two or more acute exacerbations in the previous two years 2. subjects with secondary progressive ms with ongoing relapsing activity * subjects who sign the informed consent form. exclusion criteria: * initiation of treatment in pregnancy. * subjects with a history of hypersensitivity to natural or recombinant interferon-ß, or to any excipients. * subjects with current severe depression and/or suicidal ideation.

Keywords: multiple sclerosis interferon-beta 1-a
extension study to evaluate the long-term outcomes of subjects in the cls-ax cls1002-101 study

Conditions: Neovascular Age-related Macular Degeneration

Summary: this is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing cohorts 2, 3, and 4 of the parent study, cls1002-101.

this is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing cohorts 2. 3 and 4 of the parent study, cls1002-101. the parent study is a 12-week, phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of cls-ax administered suprachoroidally in subjects with neovascular age-related macular degeneration (namd) who show stable visual acuity following 3 or more injections with an intravitreal (ivt) anti-vegf therapy in the preceding 5 months. summary analyses will include 12-weeks data from the parent study, cls1002-101, and 12-weeks data from this extension study, cls1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.

Eligibility criteria:
inclusion criteria: * enrolled in and completed the parent study, cls1002-101, as part of cohort 2 or cohort 3 or cohort 4. exclusion criteria: * received prohibited medication in the parent study, cls1002-101. * enrolled in the parent study cls1002-101 as part of cohort 1. * females of childbearing potential who are pregnant and or lactating.

Keywords: amd wet-amd suprachoroidal tyrosine kinase inhibitor namd scs
restart anticoagulation in patients with spontaneous intracerebral hemorrhage and mechanical heart valves

Conditions: Cerebral Hemorrhage

Summary: the investigators retrospectively reviewed the electronic medical records of the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of zhejiang university medical college. medical documents and patient data were reviewed, including patient age, gender, type of mechanical heart valve, replacement time, replacement site, underlying disease, anticoagulant drugs at admission, type of cerebral hemorrhage, treatment mode, time without anticoagulant, length of stay, mortality, etc


Eligibility criteria:
inclusion criteria: * patients with spontaneous cerebral hemorrhage and mechanical valves exclusion criteria: * age\<18y * pregnant patients * death in 24 hours without anticoagulant
probiotics and ozonated olive oil to maintain oral eubiosis in stage i and ii periodontitis patients

Conditions: Periodontal Disease; Periodontal Disease Stage 2

Summary: the goal of this clinical trial is to investigate the clinical benefits of the combined use of ozonized olive oil products (mouthwash and toothpaste) and probiotics on the health status of patients with stage i and ii periodontitis; could include any of the following: * male or female, aged between 18 and 70 years of any race. * diagnosis of stage i or ii periodontitis according to the american academy of periodontology and the european federation of periodontology 2017 classification of periodontal diseases. * good general health. * ability to understand and comprehend the study's instructions and sign the informed consent. the main question it aims to answer is: the single or combined use of ozonized olive oil products (mouthwash and toothpaste) and probiotics could improve the oral health status of patients with stage i and ii periodontitis compared to placebo? participants will proceed to their daily domiciliar oral hygiene maneuvers with the products given by investigators. the toothpaste was used twice daily, morning and evening, followed by rinsing with undiluted mouthwash for one minute. after rinsing, the patient did not rinse further with water and refrained from eating, drinking, and smoking for at least one hour. domiciliary mechanical and drug therapies were continued, without modification, for 30 days. moreover, the patients received a probiotic tablet daily.


Eligibility criteria:
inclusion criteria: * male or female, aged between 18 and 70 years of any race. * diagnosis of stage i or ii periodontitis according to the american academy of periodontology and the european federation of periodontology 2017 classification of periodontal diseases. * good general health. * ability to understand and comprehend the study's instructions and sign the informed consent. exclusion criteria: * pregnancy and breastfeeding. * periodontal or antibiotic therapy in the last two months. * systemic diseases that could influence the severity of periodontal disease or therapeutic success (e.g., down syndrome, hiv, diabetes mellitus). * smoking \> 10 cigarettes per day. * need for antibiotic prophylaxis for dental procedures. * chronic use of anti-inflammatory drugs, calcium channel blockers, antidepressants, and anticonvulsants.

Keywords: periodontitis probiotics oral health ozonated olive oil
a study to see whether stereotactic body radiotherapy (sbrt) can shrink tumours within the liver safely

Conditions: Colonic Neoplasms; Neoplasm Metastasis

Summary: the proposed study will evaluate if "curative intent" sbrt can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mcrc) who do not have surgical options and are no longer responding to systemic therapy

sbrt for oligo-metastatic colorectal cancer

Eligibility criteria:
inclusion criteria: * pathologically confirmed colo-rectal cancer * 1-3 liver metastasis measurable on computed tomography (ct) or magnetic resonance imaging (mri) * surgically resected primary disease * technically/medically inoperable or patient declined surgery * progression or stability after at least 1 line of chemotherapy * adequate marrow function: hb \> 80g/l, platelets \> 100 x 109/l, white blood cell \> 2 x 109/l * eastern cooperative oncology group (ecog) status 0-2 * age \> 18 years * patient must sign study specific informed consent prior to study entry exclusion criteria: * prior liver radiation, or radiation in close proximity to planned treatment sites * prior invasive malignancy * severe, active co-morbidity * active hepatitis or child pugh score b (9) or worse * pregnant or nursing women * extra hepatic disease: any bone/any brain, 2 or more lung metastasis * life expectancy \< 6 mo from any cause * concurrent chemotherapy * response to prior chemotherapy with minimal measurable disease in liver
prophylactic endobronchial tranexamic acid to reduce bleeding in transbronchial cryobiopsy

Conditions: Hemorrhage Lung; Endobronchial Mass

Summary: transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. while these procedures are safe, there is a risk of bleeding from the biopsy site. we are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.

prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. the medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of txa diluted in 10 ml of saline and the procedure would be carried out as usual. the study will be a prospective, single-arm, non-randomized trial location: ascension via christi saint francis. medication: tranexamic acid 500 milligrams per 5 ml ampule (baxter, ndc 43066-008-01) mixed with 10 ml normal saline. patients: a total of 100 patients will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * age ≥18 * signed informed consent * receiving a transbronchial cryobiopsy exclusion criteria: * age below 18 * pregnancy * bleeding diathesis (inr \>1.5 or known hematological problems) * subarachnoid hemorrhage * any active bleeding (any site) * decompensated liver disease * active intravascular clotting * prior vte * on oral contraceptive therapy * platelet count less than 50,000 * use of antiplatelet medication other than low-dose aspirin within 5 days of procedure * use of therapeutic anticoagulation within the last 24 hrs * known severe pulmonary hypertension (pulmonary artery systolic pressure \> 60 mmhg) * chronic renal failure (estimated gfr below 30 ml/min) * allergy or hypersensitivity to tranexamic acid or any of its ingredients * prisoners * comfort care planned or initiated within 72 hours of admission

Keywords: transbronchial biopsy tranexamic acid (txa) hemorrhage prophylaxis
targeting default mode network dysfunction in persons at risk of alzheimer's disease with non-invasive techniques

Conditions: Alzheimer Disease

Summary: default mode network (dmn) dysfunction is a well-established feature of alzheimer's disease (ad) and is already present in preclinical stages and in subjects at risk for ad, thus offering a potential target for early intervention. non-invasive stimulation techniques are candidate approaches to modulate network dysfunction, however interventions specifically targeting subjects at risk for ad are lacking. this project will test a non-invasive intervention to modulate the dmn in cognitively healthy older adults carrying the main genetic risk factor for ad, the apoe e4 allele. the proposal will non-invasively stimulate the dmn in at risk subjects and will assess the neuronal-cognitive effect of this approach with multimodal neuroimaging and neurophysiological techniques.

sixty-four participants will be enrolled (n=32 apoe e4 carriers, 32 non-carriers as reference group) and will undergo rtms stimulation, tms with concurrent electroencephalography (tms-eeg), multimodal imaging (resting-state and task functional mri, and diffusion tensor imaging) and cognitive assessment at baseline, after the intervention (week 1) and after 2 months. participants will be randomized to 2 groups: active dmn stimulation (real-rtms) or placebo (sham-rtms). each subject will undergo a rs-fmri scan before the intervention to derive individualized dmn stimulation targets. rtms will be applied over the left inferior parietal lobule node of the dmn.

Eligibility criteria:
inclusion criteria: * age: 60 years and older * mmse score \> 24 exclusion criteria: * pathological scores in at least two standardized cognitive tests * participation in other interventional studies * known carriers of an autosomal dominant genetic mutation associated to ad * neurological, psychiatric or medical conditions not compatible with the study exclusion criteria for mri and rtms: * metal implants, pace-makers, prosthetic heart valves * claustrophobia * history of epilepsy * pregnancy

Keywords: alzheimer's disease default mode network apoe rtms connectivity
ten fraction adjuvant hypofractionated radiotherapy in node positive breast cancer

Conditions: Breast Cancer

Summary: post-operative loco-regional (lr) hypofractionated radiotherapy (hypo-rt) is an attractive approach in locally advanced breast cancer (labc).

the present is a single arm phase ii study assessing toxicity levels after 34 gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery. both acute (ctcae v4.0) and late (lent/soma) toxicity were collected. all pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the harvard. toxicity was assessed weekly during rt and then at each follow-up examination (1, 3, 6 months and then yearly).

Eligibility criteria:
inclusion criteria: * patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes. * pt1-3 disease pn1-2, ct1-3 disease if neoadjuvant chemotherapy , cn + cytologically and/or histologically assessed; * ecog performance status ≤2; * histologically negative surgical margins * no distant metastases * no prior chest radiotherapy * life expectancy ≥ 5 years * no prior cancer exclusion criteria: * non-epithelial breast cancer (sarcoma, lymphoma etc.) * metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed * pt4 neoplasms or inflammatory breast carcinoma * distant metastasis * concomitant chemotherapy * history of prior controlateral breast tumor

Keywords: hypofractionated rt cosmetic outcome locoregional treatment
timp-2 and igfbp7 for the prediction of the cardiac surgery associated acute kidney injury

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to analyze the new biomarkers (timp-2 and igfbp-7) of tubular renal cell damage for the prediction of the cardiac surgery associated acute kidney injury.


Eligibility criteria:
inclusion criteria: * planned cardiac surgery exclusion criteria: * renal dialysis * minors * emergency * no cardiopulmonary bypass
tachyphylaxis, tolerance, & withdrawal post treatment with igalmi for agitation in schizophrenia or bipolar disorder

Conditions: Bipolar Disorder; Schizophrenia; Agitation,Psychomotor; Schizo Affective Disorder; Schizophreniform Disorders

Summary: this is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.

this is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of igalmi in adult males and females (18 to 65 years old, inclusive) with agitation associated with schizophrenia or bipolar disorder. subjects will be screened for eligibility within 15 days of first dose and no study procedures will occur unless subjects provide written informed consent. subjects will receive single doses of 180 μg of igalmi as needed for the treatment of agitation over a period of 7 days followed by a 3- day follow-up period during which time no igalmi will be administered in an effort to characterize any potential withdrawal. subjects will sublingually self-administer igalmi for an agitation episode that reaches a pre-dose pec total score of 14 or greater, as determined by a trained rater. safety assessments will be conducted before and after each dose. if the subject's agitation is recurrent or persistent, repeat doses of 90 µg may be administered (no more than 2 repeat doses within a 24-hour period) in the absence of any safety concerns or adverse events.

Eligibility criteria:
inclusion criteria: 1. male and female subjects between the ages of 18 to 65 years, inclusive. 2. subjects who have met dsm-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar i or ii disorder. 3. subjects who are currently moderate to severely agitated at least 3 days a week. 4. subjects who read, understand, and provide written informed consent. 5. subjects who are in good general health prior to study participation as determined by a detailed medical history and in the opinion of the principal investigator. 6. subjects who agree to use a medically acceptable and effective birth control method 7. subjects must be willing to remain in-clinic for the duration of the study. exclusion criteria: 1. subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening. 2. use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment. 3. subjects with congenital prolonged qt syndrome. 4. prior treatment with igalmi

Keywords: agitation schizophrenia bipolar dexmedetomidine tachyphylaxis tolerance withdrawal prn treatment open-label pec cgi aces safety tolerability igalmi
managing aftercare for stroke (mas): mas-ii - a longitudinal complex-interventional study in post-rehabilitation stroke patients

Conditions: Stroke

Summary: after discharge from hospital, the current healthcare system in germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. the investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. in this study, the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.


Eligibility criteria:
inclusion criteria: * patients with ischemic stroke * age ≥18 years * at the time of v1 completion of rehabilitation or no rehabilitation planned * informed consent signed by patient or legal representative * stroke patients with a stratified mrs score * within six months after the index event exclusion criteria: * unwillingness to participate in "ambulanzpartner" * unwilling to have pseudonymized data stored, analysed, and anonymously published * patients being committed to psychiatric institutions or prisons

Keywords: stroke aftercare comprehensive care
use of a nutritional supplement to treat diabetic symptoms in hiv-infected adults

Conditions: Insulin Resistance; HIV Infections

Summary: the purpose of this study is to determine the effectiveness of the nutritional supplement chromium picolinate in improving insulin resistance, a symptom of diabetes, in hiv-infected patients. the ultimate goal is to find a simple therapy that can prevent the development of diabetes in individuals with hiv.

insulin resistance occurs when blood glucose levels get too high for the body to respond. certain anti-hiv drugs are associated with increased insulin resistance and may lead to abnormal fat distribution, hypertension, and type 2 diabetes mellitus. the dietary supplement chromium picolinate has been shown to safely improve insulin sensitivity in patients with type 2 diabetes mellitus with no serious side effects. however, the effects of the supplement have not been thoroughly examined in hiv-infected individuals. this study will determine the effectiveness of chromium picolinate in improving insulin resistance in hiv-infected individuals. this study will last 2 months. participants will be randomly assigned to receive either chromium picolinate or placebo once a day for 2 months. participants will have four overnight visits at the research center and two additional daytime visits for safety monitoring. during the overnight visits, participants will undergo a euglycemic hyperinsulinemic clamp, in which a continuous infusion of insulin is given through a vein and glucose levels are monitored through blood samples taken every 5 to 10 minutes. fat tissue biopsies will also be conducted at the overnight study visits. during the safety monitoring visits, blood collection will occur for kidney and liver function tests, cd4 count, and viral load assessment.

Eligibility criteria:
inclusion criteria: * hiv infected * currently taking an anti-hiv drug regimen * insulin resistant:fasting glucose between 5.56 and 7mmol/l and/or two hour post-glucose load between 7.78 and 11.11mmol/l exclusion criteria: * cancer * acute illness that would interfere with the study * hypogonadism * hypothyroidism * untreated hypertension * cd4 count less than 300 cells/mm3 * viral load greater than 35,000 copies/ml * untreated hepatitis c virus infection * pregnancy * diabetes

Keywords: hiv treatment experienced anti-retroviral agents antiretroviral therapy, highly active picolinic acid dietary supplements
safety and effectiveness of fluconazole versus sch 56592 to treat thrush in hiv-positive patients

Conditions: Candidiasis, Oral; HIV Infections

Summary: the purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in hiv-positive patients. fluconazole is a drug that is commonly used to treat thrush. sch 56592 is a new drug that will be compared to fluconazole.

patients receive sch 56592 oral suspension or fluconazole suspension for 14 days. patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are at least 18 years old. * are hiv-positive. * have thrush (oropharyngeal candidiasis). * agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms). * are able to take study medication and return for clinic visits during the study. * are expected to live for at least 2 months. exclusion criteria you will not be eligible for this study if you: * have received protease inhibitors for the first time within 30 days prior to study entry. * have received certain medications. * have certain other types of fungal infections. * have certain types of cancer. * have received sch 56592 within 3 months prior to study entry. * are pregnant or breast-feeding. * cannot take medications by mouth. * are allergic to azole drugs. * have certain medical conditions. * have been in this study before.

Keywords: aids-related opportunistic infections fluconazole administration, oral antifungal agents candidiasis, oral pharyngeal diseases posaconazole