Kornimate/medical-research-clean huggingface dataset:
remote ischemic preconditioning in patients undergoing isolated aortic valve replacement surgery

Conditions: Aortic Valve Disease; Myocardial Ischemia

Summary: the goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (ripc) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a biological prosthesis. neuropsychological evaluation preoperatively and at 30d after surgery will establish if there are any differences in neuropsychological performance between groups. a large array of biochemical markers will be analyzed from plasma samples taken at different time points. additionally skin biopsies from the lower limb will be taken before and after performing ripc on said limb. during the venous cannulation phase a atrial biopsy will be taken. the biochemical markers from plasma and tissue samples will be used to asses brain tissue damage, inflammation and cardiac tissue damage between groups. this will be a single center prospective randomized study with two groups. a intervention group (ripc) and a control group. study size is: 40 patients in total, 20 patients per group.


Eligibility criteria:
inclusion criteria: * non-emergency aortic valve replacement with a biological prosthesis with perfusion and cardiac arrest exclusion criteria: * recent myocardial infarction * carotid stenosis requiring intervention * any other concomitant surgical procedure * increased troponin baseline before surgery * critical ischemia of lower limbs * peripheral arterial disease (aso, media sclerosis) * morbid obesity (incompatible cuff-to-thigh diameter) * severe heart insufficiency * moderate to severe venous insufficiency lower limbs * recent acute stroke \<90d * difference in cardioplegic protocol * diseased aorta in epiaortic ultrasound

Keywords: remote ischemic preconditioning neuroprotection
two radiation dose schedules of sbrt to lung metastases < 5cm in dimension

Conditions: Neoplasm Metastasis; Cancer; Radiation Therapy Complication

Summary: 30 gy single fraction of sbrt for lung metastases will result in comparable oncologic outcomes to 18gy in three fractions (or dosing to a bed \</-100gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.

using two different doses of sbrt, this study will examine the 6-month local disease control rate (ldcr) of the sbrt-treated metastasis to determine the optimum dosing for sbrt in pulmonary metastases. this will allow us to establish baseline sbrt data, from which we will develop a second trial to examine sequencing of immunotherapy with sbrt.

Eligibility criteria:
inclusion criteria: * histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung. * patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc). * patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension * age ≥18 years * ecog performance status \>/= 2 (karnofsky≥60%)). * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients with more than \>/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest. * patients who are receiving any other investigational agents. * patients with active systemic, pulmonary, or pericardial infection. * pregnant or lactating women * patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * chemotherapy concurrent with sbrt is not allowed
the study of transcranial magnetic stimulation in the regulation of spinocerebellar ataxia

Conditions: Spinocerebellar Ataxia

Summary: spinocerebellar ataxia (sca) is a group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. a key pathogenic mechanism of sca is the repeated expansion of cytosine - adenine - guanine (cag) trinucleotides in the coding region of specific genes. these repeated expansions are translated into abnormally large polyglutamine (polyq) tracts in proteins. these polyglutamine (polyq) tracts can cause changes in the excitability of the cerebral cortex in sca patients. quantitative electroencephalogram analysis (qeeg) is a modern type of electroencephalogram analysis that uses complex mathematical algorithms to process, transform, and analyze eeg signals, bringing new technologies for eeg signal feature extraction: specific frequency band and signal complexity analysis, connectivity analysis, and network analysis. it is sensitive to early neurodegenerative lesions. using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in sca patients. currently, the exploration of the quantitative electroencephalogram characteristics of sca patients is still insufficient.


Eligibility criteria:
inclusion criteria: 1. spinocerebellar ataxia patients confirmed through genetic testing 2. patient aged 18-75 3. patients who can walk independently (with the aid of a cane/walker) without assistance from others. 4. the sara score exceeds 3. exclusion criteria: 1. patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.) 2. patients with significantly abnormal clinical indicators identified during screening 3. patients concurrently participating in another clinical study 4. patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders 5. patients with severe heart disease 6. patients who are wheelchair users 7. pregnant woman 8. patients who cannot establish their identity or have limited legal capacity 9. patients with contraindications for rtms, including metallic objects in the head, history of neurosurgery, ferromagnetic bioimplants, metal coatings, history of seizures, autism, current use of protease inhibitors or other medications that may increase the risk of rtms-induced seizures.
tace combined with lenvatinib and mwa in the treatment of locally advanced large hepatocellular carcinoma

Conditions: Liver Tumor

Summary: to explore the objective effectiveness and safety of tace combined with lenvatinib in the treatment of advanced liver cancer. after successful down-stage, radical microwave ablation was further performed.

the purpose of this study is to explore the objective effective rate of tace combined with lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new idea for the radical microwave ablation treatment mode after the decline of locally advanced liver cancer.

Eligibility criteria:
inclusion criteria: * patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months; * number of tumors ≤ 3; * large hepatocellular carcinoma with tumor diameter ≥ 7 cm; * patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus; * although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked; * child pugh grade a or b of liver function; ecog physical fitness score \< 2; * no bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment; * leukocyte count ≥ 3.0 × 109/l； * hemoglobin ≥ 8.5g/dl; * platelet count ≥ 50 × 109/l； * the international normalized ratio of prothrombin time (inr) ≤ 2.3 or prothrombin time (pt) does not exceed the upper limit of normal control for 3 seconds; * serum creatinine was less than 1.5 times of the upper limit of normal; * patients and / or family members agree to join the clinical trial and sign the informed consent form exclusion criteria: * diffuse hepatocellular carcinoma; * portal vein tumor thrombus; * combined with tumor thrombus of hepatic vein and inferior vena cava; * patients with lymph node metastasis and extrahepatic distant metastasis; * the liver function was classified as child pugh c and could not be improved by liver protection treatment; * arteriovenous fistula or arterioportal fistula with ineffective intervention; * uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency; * intractable massive ascites; * ecog physical fitness score \> 2 points; * combined with active infection, especially bile duct inflammation; * serious heart, lung, kidney, brain and other important organ diseases; * note: see attached table 1 for child pugh classification of liver function; see attached table 2 for ecog physical fitness score

Keywords: large hepatocellular carcinoma lenvatinib tace microwave ablation
a long-term extension study of wa22763 and na25220 of subcutaneous roactemra/actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of roactemra/actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis who have completed the 97-week wa22762 or the 96-week na25220 core study. participants will receive roactemra/actemra 162 milligram (mg) subcutaneously weekly (for participants entering from wa22762) or every two weeks (for participants entering from na25220) for 96 weeks, with telephone call follow-up visits at weeks 100 and 104.


Eligibility criteria:
inclusion criteria: * adult participants, \>/= 18 years of age * participants who have completed the 97-week wa22762 or 96-week na25220 core study on subcutaneous or intravenous roactemra/actemra and based on the investigator's judgment may continue to benefit from roactemra/actemra treatment in this study investigating the subcutaneous formulation * oral corticosteroids and non-steroidal anti-inflammatory drugs (nsaids) up to the maximum recommended dose are permitted if on a stable dose regimen for \>/= 4 weeks prior to baseline * permitted non-biological disease-modifying anti-rheumatic drugs (dmards) are allowed * receiving treatment on an outpatient basis * females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception exclusion criteria: * participants who have prematurely withdrawn from the wa22762 or na25220 core studies for any reason * previous treatment with any cell-depleting therapies, including investigational agents or approved therapies * history of severe allergic or anaphylactic reactions to human, humanized or mural monoclonal antibodies * evidence of serious uncontrolled concomitant disease * current liver disease as determined by the principal investigator * history of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (gi) disease such as crohn's disease, ulcerative colitis or other symptomatic lower gi conditions that might predispose to perforations * known active current or history of recurrent infections * any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening * active tuberculosis requiring treatment within the previous 3 years * primary or secondary immunodeficiency (history of or currently active) * pregnant or breast feeding women * body weight \> 150 kilogram (kg) * inadequate renal, hepatic or hematologic function * positive for hepatitis b or hepatitis c
study to compare the efficacy and safety of cc-5013 vs. placebo in subjects with metastatic malignant melanoma.

Conditions: Melanoma; Neoplasm Metastasis

Summary: subjects are randomized to one of two treatment arms. all subjects are screened for eligibility within 28 days prior to randomization. the study consists of a treatment phase and a follow-up phase. subjects are treated in repeating 4 week cycles.


Eligibility criteria:
* understand and voluntarily sign an informed consent form * able to adhere to the study visit schedule and other protocol requirements * metastatic malignant melanoma now stage iv, relapsed or refractory to standard metastatic therapy * women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug * patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Keywords: metastatic melanoma melanoma revimid cc5013
effect of nutritional supplementation on nutritional status & rehospitalization in malnourished elderly patients

Conditions: Malnutrition

Summary: the primary outcome is the mean difference in energy and protein as well as a selection of micronutrients (calcium, vitamin d, and vitamin b12) after 12 weeks of intervention between standard care plus nutritional supplementation vs standard care. the secondary outcomes are body weight, nutritional status, body composition, physical performance, vitamin d level, and nonelective hospitalization the study hypothesize: the hypothesize that outpatients who receive nutrient-dense drinks (ndd) will have increased body weight, better nutritional status, better body composition, higher vitamin d level, better physical performance and reduced non-elective hospitalization than those receiving standard care after 12 weeks of intervention.

1. study design: randomized controlled trial, randomized and controlled intervention trial with 2 treatments in parallel 1. treatment 1: nutrient-dense drinks on top of standard care 2. treatment 2: standard care only (reference) 2. location and time study: geriatric outpatient clinic and internal medicine outpatient clinic in cipto mangunkusumo national hospital jakarta. the study will be conducted on july 2022 to october 2023. 3. study subject: elderly outpatients (aged 60 years old or more) who visit outpatient clinics will be screened for their eligibility as participants of this study. 4. sample size: sample size for each group is 41 participants per group (for two groups a total of 82 participants). to anticipate a dropout of 20% a minimum of 98 participants (rounded to 100 participants in total) is the minimum sample size of our study. 5. data collection : energy and nutrient intake, particularly protein calcium, vitamin d, and vitamin b12, nutritional status based on full form mini nutritional assessment, vitamin d level, lean body mass (using bioelectrical impedance analysis), physical performance will be measured by shor physical performance battery, handgrip strength, medical history, data on the demographic status and clinical data will be retrieved from the medical record and the attending physicians, body weight and anthropometric measurements, intervention: nutrient dense-drink + standard care

Eligibility criteria:
inclusion criteria: * older patients (60-years or older) * malnourished or at risk of malnourished (based on mini nutritional assessment score) exclusion criteria: * impaired kidney function (egfr less than 30 ml/min/1.73 m2) * unwillingness to participate

Keywords: malnutrition geriatric oral nutritional supplement
making alcoholics anonymous easier

Conditions: Alcohol Dependence; Drug Dependence

Summary: this study tests the effectiveness of making alcoholics anonymous easier (maaez), a manual-guided intervention designed to help alcohol and drug dependent clients connect with individuals encountered in aa. an off/on design was used (n=508). maaez effectiveness was determined by comparing abstinence rates of participants recruited during on (maaez intervention) and off (usual care) conditions and by studying the effect of the number of maaez sessions attended. better outcomes were hypothesized for maaez vs. usual care. at 12 months, more clients in the on condition (vs. off) reported past 30-day abstinence from alcohol, drugs, and both alcohol and drugs. abstinence increased for each additional maaez session received. maaez appeared especially effective for those with more prior aa exposure, severe psychiatric problems, and atheists/agnostics. mechanisms of action for maaez (mediators of the maaez effect) include: doing service in aa/na/ca; having a sponsor; having a social network supportive of abstinence; and comfort being in meetings. maaez represents an evidence-based intervention that is easily implemented in existing treatment programs.


Eligibility criteria:
inclusion criteria: * current alcohol or drug dependence diagnosis exclusion criteria: * incapacitating mental or physical health; under age 18

Keywords: 12-step facilitation alcoholics anonymous narcotics anonymous aa self-help
does acupressure decrease post-operative nausea and vomiting (ponv) after the pectus excavatum correction (nuss) procedure?

Conditions: Pectus Excavatum

Summary: post-operative nausea and vomiting (ponv) is not only unpleasant for patients but also can delay hospital discharge and increase cost of stay. in some cases, when severe vomiting occurs, pain scores seem to be increased. the overall incidence of ponv is 30% and increases to 79% in patients at high risk for this post-operative outcome. the nuss procedure is considered to be a procedure with a high risk for the outcome of nausea and vomiting.

the rationale is to do a prospective study in patients who have been diagnosed with pectus excavatum and who are undergoing a nuss procedure (pectus excavatum correction) and to evaluate the effect of acupressure on the post-operative outcome of ponv in these patients. also, to determine whether there are any secondary outcomes related to pain scores and length of hospital stay.

Eligibility criteria:
inclusion criteria: * age 8-40 years old * asa 1-3 * males \& females exclusion criteria: * local infection of the site - p6 * acupuncture treatment within 8 weeks of the preoperative period * coagulopathy is a contraindication for acupuncture but not acupressure

Keywords: ponv nuss procedure acupressure pectus excavatum
phase i study on rivaroxaban granules for oral suspension formulation in children

Conditions: Thrombosis

Summary: to characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability


Eligibility criteria:
inclusion criteria: * children with an age ≥2 months and weight between 3 and \<12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration. * gestational age at birth of at least 37 weeks * oral feeding/ nasogastric/ gastric feeding for at least 10 days * normal pt and aptt within 10 days prior to planned study drug administration * written informed consent provided and, if applicable, child assent provided exclusion criteria: * active bleeding or high risk for bleeding, contraindicating anticoagulant therapy * planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake * an estimate glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * hepatic disease which is associated either with: * coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (alt) \> 5x upper level of normal (uln), or * total bilirubin \> 2x uln with direct bilirubin \> 20% of the total. * platelet count \< 50 x 10\^9/l * hypertension (defined as systolic and/or diastolic blood pressure \>95th percentile for age) * concomitant use of strong inhibitors of both cyp3a4 and p-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed) * concomitant use of strong inducers of cyp3a4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine * inability to cooperate with the study procedures * hypersensitivity to rivaroxaban * participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment * history of gastrointestinal disease or surgery associated with impaired absorption
assessing perceived versus actual knowledge and quality of life in pre-dialysis chronic kidney disease (ckd) patients

Conditions: Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5

Summary: aims: the investigators' primary objective is to assess both perceived and actual disease knowledge in local pre-dialysis chronic kidney disease (ckd) patients. the investigators hypothesize that actual disease knowledge is poorer than perceived. as the secondary objectives, the investigators will also assess the hrqol and examine the association between level of knowledge and hrqol in pre-dialysis ckd patients. the investigators hypothesize that hrqol of pre-dialysis ckd patients is poorer than that of the general population while pre-dialysis ckd patients with greater disease knowledge have a better hrqol than those with poorer knowledge. methodology: a survey was developed to assess both perceived and actual knowledge on five aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of ckd and its complications and renal replacement therapy (rrt) options. for the assessment of hrqol, the following questionnaires will be used - kidney disease quality of life-short form (kdqol-sf) version 1.3, euroqol 5 dimensions (eq-5d), family functioning measure (ffm), and oslo-3 social support scale (oss-3). all study questionnaires will be provided in 3 main languages - english, chinese and malay. a standardized data collection form was developed to retrospectively collect demographic and clinical information from the patients' electronic medical records and patient charts. descriptive statistics will be used to report all results.


Eligibility criteria:
inclusion criteria: * patients at least 21 years of age, * able to read english, chinese or malay, * have stage 3 to 5 ckd as identified from their medical records, but are not receiving dialysis. exclusion criteria: * patients who do not consent, * have already been started on dialysis, * are cognitively impaired as assessed by the recruiter or unable to fill up questionnaires on their own.

Keywords: predialysis