Kornimate/medical-research-clean huggingface dataset:
a trial of adjuvant chemotherapy in nasopharyngeal carcinoma patients with residual epstein-barr virus (ebv) dna following radiotherapy

Conditions: Nasopharyngeal Cancer

Summary: the purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in high risk npc patients with residual ebv dna following primary radiotherapy with or without concurrent cisplatin.

* the standard treatment for nasopharynx cancer is a course of radiotherapy with or without concurrent chemotherapy. this will cure about 80% of patients. for the 20% who developed recurrence or metastases, the prognosis is poor. * elevated ebv-dna in plasma at end of radiotherapy has been shown to predict disease recurrence and may be a marker of subclinical residual disease. * this study aims to test whether adjuvant treatment with 6 cycles of a modern chemotherapy regimen (gemcitabine and cisplatin combination) can improve the survival of these high risk patients of nasopharynx cancer who have elevated ebv-dna after completion of their radiotherapy.

Eligibility criteria:
inclusion criteria: 1. have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice. 2. a histological diagnosis of nasopharyngeal cancer (npc) must have been established at some time and the investigator must review and confirm the diagnosis prior to randomization. 3. loco-regional advanced npc uicc/ajcc stages iib, iii, iva or ivb. 4. no evidence of distant metastases in the staging work up at diagnosis. 5. must have detectable plasma ebv-dna (\> 0 copies/ml) at 6-8 weeks after completion of primary rt or chemo-rt 6. no clinical evidence of persistent loco-regional disease after primary treatment 7. performance status of ecog grade 0 or 1. 8. patients must have adequate organ and marrow function as defined below: leukocytes \>3,000/l; absolute neutrophil count \>1,500/l; platelets \>100,000/l; total bilirubin \ 50 ml/min 9. at least 18 years of age, of either sex. 10. if female, must be either (i) post-menopausal or surgically sterilized, or (ii) use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide for the duration of the study and must be neither pregnant nor breast-feeding. exclusion criteria: 1. hypercalcaemia: calcium \>= 2.7 mmol/l (10.8 mg/dl). 2. second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin). 3. more that 12 weeks after completion of primary radiotherapy. 4. had received prior adjuvant chemotherapy. 5. other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). 6. have serious active infection. 7. patients with peripheral or ototoxicity with a grade of greater than 2. 8. pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.

Keywords: nasopharyngeal cancer adjuvant chemotherapy ebv dna pet ct scan
colorectal pulmonary metastases: pulmonary metastasectomy versus stereotactic ablative radiotherapy

Conditions: Lung Metastases; Colorectal Cancer Metastatic

Summary: copper is an international, multicenter, parallel-arm, phase iii randomized controlled trial comparing two local treatment strategies (sabr or metastasectomy) for patients with an indication for local treatment for limited (max. three) colorectal pulmonary metastases

the study is formally endorsed by the dutch society of lung surgery (nvvl), the dutch society of cardiothoracic surgery (nvt), the dutch society of radiation oncology (nvro). the main objective of the proposed randomized trial is to compare efficacy of sabr to the efficacy of metastasectomy with regards to the primary endpoint (local recurrence free survival at 5 years) in patients with limited colorectal pulmonary metastases. this will determine the most effective local treatment modality. the investigators hypothesize that patients with limited colorectal pulmonary metastases will have non-inferior overall survival after pulmonary metastasectomy compared to sabr, however metastasectomy will result in superior local recurrence free survival at five years when compared to sabr. in addition, the investigators hypothesize that sabr is associated with lower morbidity, comparable quality of life and comparable health care costs compared to metastasectomy. recurrent metastases are preferably treated by the index treatment to which the patient was randomized, local recurrent metastases are preferably treated by means of cross-over between both arms. comparing metastasectomy to sabr for patients with colorectal pulmonary metastases will present the international community the evidence needed to better select patients for local radical treatment, while diminishing uncertainty for patients and care givers.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * eastern cooperative oncology group (ecog)-performance status 0 - 2 * willing to provide informed consent * patients with 1 to 3 lung metastases from colorectal cancer eligible for both a minimally invasive surgical resection and sabr, as assessed by the multidisciplinary tumor board (mdt) * radically treated primary colorectal cancer * patient is able and willing to complete the quality-of-life questionnaires * previous liver metastases are radically treated with curative intent * histologically confirmed malignancy with metastatic disease detected on imaging. biopsy of metastasis is preferred, but not required. exclusion criteria: * previous or present metastases outside liver or lungs * concurrent malignant cancer, or history of other malignant cancers within the past 5 years (excluding prespecified low-risk cancers) * hilar or mediastinal lymph node metastases * poor cardiopulmonary function test * inability to treat all colorectal metastases * surgical resection by means of a bilobectomy or pneumonectomy

Keywords: colorectal pulmonary metastases pulmonary metastasectomy stereotactic radiotherapy randomized controlled trial colorectal cancer metastases
comparison of the sensitive cutaneous block distribution following femoral nerve block using two femoral block techniques

Conditions: Regional Anesthesia; Femoral Nerve Block

Summary: in this study, we will be comparing two approaches to the femoral block. the first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. the second is performed with the ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and injecting. the primary endpoint of the study is the sensitive cutaneous block distribution using both techniques.


Eligibility criteria:
inclusion criteria: * patients scheduled for an elective surgery for which the anesthesiologist planned to do a single shot or continuous femoral nerve block. exclusion criteria: * any contraindication to the femoral nerve block (coagulopathy, infection, pre-existing neuropathy, local anesthetic allergy and refusal of local anesthesia). * refusal to participate in the study * inability to understand or communicate the effect of local anesthesia secondary to the femoral nerve bloc.

Keywords: knee surgery
a study examining torcetrapib/atorvastatin and atorvastatin effects on clinical cv events in patients with heart disease

Conditions: Coronary Disease; Diabetes Mellitus

Summary: the torcetrapib project was terminated on december 2, 2006 due to safety findings. to demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents


Eligibility criteria:
inclusion criteria: * diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant. * subjects with a clinically indicated need for statin (hmg-coa reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on ldl-c and hdl-c including fibrates and nicotinic acid * subjects taking any drugs known to be associated with an increased risk of myositis in combination with hmg-coa reductase inhibitors * subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study
goblet cell degranulation produced by intranasal tear neurostimulator (itn) in dry eye disease

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate goblet cell degranulation following acute use of the intranasal tear neurostimulator in participants with dry eye.


Eligibility criteria:
inclusion criteria: * capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the icf and in this protocol * have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study * the participant should be literate, able to speak english, and able to complete questionnaires independently exclusion criteria: * chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding * nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas * cardiac demand pacemaker, implanted defibrillator or other implanted electronic device * corneal transplant in either or both eyes * current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study * women who are pregnant, planning a pregnancy, or nursing throughout the study

Keywords: dry eye disease
multi-modality mri study on differences in conversion of amci patients with apoeε4 to ad

Conditions: Mild Cognitive Impairment

Summary: this study is to find out the imaging marker and the changing laws of the marker during the course of the disease. the final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of alzheimer's disease.

it is an urgent problem in the field of cognitive neuroscience to tell the conversion progression of amnestic mild cognitive impairment(amci) patients with apolipoproteinε4(apoeε4) to alzheimer's disease(ad). based on our preliminary work, we will study the special group of amci patients with apoeε4 with multi-modality magnetic resonance imaging (resting-state functional mri, structural mri and diffusion tensor imaging) longitudinally. besides, we will also detect the apoe genotype of each sample and enlarge the sample size. according to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of ad and optimize the reliability and validity.

Eligibility criteria:
inclusion criteria: * complaint about memory loss and confirmed by an informant * cognitive impairment in single or multiple domains, adjusted for age and education * normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities * a clinical dementia rating (cdr) score is 0.5 * failure to meet the criteria for dementia * carrying susceptible gene apoeε4 * must be able to accept examination of mri, sight and hearing allow to complete test exclusion criteria: * other diseases that cause cognitive impairment,such as thyroid disease,stroke and so on * people who have severe visual and hearing impairment

Keywords: apoeε4
safety & efficacy study of quetiapine fumarate (seroquel®) vs. placebo in generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to demonstrate that quetiapine sr (seroquel®) is efficacious and safe in the acute treatment of patients with generalized anxiety disorder. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * patient has a documented clinical diagnosis of generalized anxiety disorder. * be able to understand and comply with the requirements of the study. * able to understand and provide written informed consent exclusion criteria: * patients (female) must not be pregnant or lactating * current or past diagnosis of stroke or transient ischemic attack (tia).

Keywords: gad anxiety
microembolic detection in acute ischemic stroke patients with atrial fibrillation and outcome

Conditions: Infarction, Brain; Embolism; Atrial Fibrillation

Summary: this multicenter international prospective cohort study will include patients with ais with a known or newly diagnosed anticoagulant-naïve af. all centers will use the same transcranial doppler machine for one-hour monitoring with bilateral 2-mhz probes within 24 hours of symptom onset. recordings will be analyzed for mes by a blinded central reader. the primary aim is to determine the proportion of patients with mes and the association of mes with functional outcomes assessed by a modified rankin scale (mrs) score at 90 days.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke admitted to the stroke unit, history of af/flutter or a new diagnosis of af at the stroke, and with a possibility to be monitored within 24 hours after symptom onset. exclusion criteria: * use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.

Keywords: infarction embolism atrial fibrillation ultrasound transcranial doppler
comparison of analgesic consumption between perioperative ıv dexamethasone and added to femoral block

Conditions: Postoperative Pain

Summary: the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients

total knee arthroplasty leads to severe postoperative pain. for postoperative pain control after total knee arthroplasty oral -intramuscular opioids ,patient controlled analgesia intravenous or epidural opioids, single -continuous femoral nerve block involving techniques are used. dexamethasone is a glucocorticoid of high potency and frequently used perioperative.dexamethasone to the local anaesthetic solution administered trough in femoral nerve blocks significantly prolonged the analgesic effect of the local anaesthetics used on this blocks.if the analgesic efficacy of systemic treatment with dexamethasone is similar with the use of perineural wich is the safest way should be preferred for systemic use.

Eligibility criteria:
inclusion criteria: * between 18-65 age * knee arthroplasty * no known allergies to drugs * asa 1-2 patients exclusion criteria: * history of diabetes * history of chronic pain treatment * pregnancy * severe bronchopulmonary disease * systemic opioid and steroid use

Keywords: dexamethasone femoral block total knee arthroplasty
a randomized controlled trial comparing medical and medical-surgical treatment in diabetic foot osteomyelitis

Conditions: Diabetic Foot

Summary: osteomyelitis is a frequent complication of diabetic foot ulcer. several therapeutic strategies are used : medical treatment with antibiotics and foot offloading or surgical treatment consisting in the resection of infected bone and a shorter antibiotic course. the medical treatment risk is a longer healing time and a risk of bone infection relapse. the surgical treatment risk is the ulcer relapse because of the modification of the foot structure. these treatments need to be compared in terms of benefit/risk ratio. our hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15% osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean healing time and a 10% osteomyelitis recurrence rate.

the study aim is to compare the rate of therapeutic success of the secondary ostéite with a wound of the foot diabetic, obtained either by a single medical coverage(care), or by a medical surgical coverage(care). the therapeutic success being defined by the association of 1) the absence of local distribution(broadcasting) of the ostéite 2) the healing of the wound 3) in 12 months of the healing the absence of local recurrence of the ostéite

Eligibility criteria:
inclusion criteria: * diabetes * neuropathy and a forefoot ulcer * osteomyelitis on x ray involving one or two contiguous ray * confirmed osteomyelitis on bone biopsy if a metatarsal head is involved * palpable distal pulses exclusion criteria: * glomerular filtration rate \< 30ml/min * whole bone destruction * contra-indication for off loading * asat or alat \> three times normal rate * immunosuppressive drugs * charcot foot on the concerned foot * pregnancy

Keywords: diabetic foot osteomyelitis
biologic association between metabolic magnetic resonance-positron emission tomograph (mr-pet) and tissue measures of glycolysis in brain tumors of infiltrating glioblastoma cells

Conditions: Glioblastoma Multiforme; Glycolytic Index; Epidermal Growth Factor Receptor

Summary: the purpose of this project is to validate a new combined mri and pet imaging technique as a biomarker or measure of glycolysis in brain tumors. to accomplish this, the investigators propose obtaining image-guided measures of tissue ph and biopsied tissue in tumor areas selected for bulk resection surgery. investigators will then correlate the imaging measurements with ph, rna expression, protein expression, and bioenergetics measurements of key glycolytic enzymes.

patients who are scheduled for resection of glioblastoma multiforme (gbm) as part of standard care will be invited to take part in the study. all patients will undergo fdg-pet scan for the study using standard clinical imaging techniques, along with standard brain mri plus up to approximately 15 minutes of investigational mr imaging sequences to permit calculation of \&#34;glycolytic index\&#34; as an experimental gbm imaging biomarker. following ph measurements, the patient's clinical biopsy/tumor resection will take place as planned for clinical care. tissue samples resected during the clinical procedure will be obtained and processed using immunohistochemistry techniques for further assessments, including rna sequencing and bioenergetics analysis. the current study will investigate the central hypothesis that biopsied tumor tissue undergoing high levels of glycolysis via rna expression, protein expression, and bioenergetics analyses can be reliably detected, correlates with direct measure of tissue ph, and is strongly associated with a "glycolytic index" created by combining 18f-fdg pet, amine cest-sage-epi, perfusion mri and diffusion mri. in addition, the investigators will investigate whether metabolic differences identified from this imaging modality may identify infiltrating non-enhancing tumor cells. fdg: 18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose cest: chemical exchange saturation transfer sage: spin and gradient echo epi: echo planar imaging ihc: immuno-histochemical rcbf: regional cerebral blood flow rcbv: relative cerebral volume dsc: dynamic susceptibility contrast adc: apparent diffusion coefficient mct: monocarboxylate transporters

Eligibility criteria:
inclusion criteria: * age \> 18 * patients with newly diagnosed or recurrent glioblastoma clinically indicated for resective surgery exclusion criteria: * patients who cannot obtain an mri or fdg pet scan with contrast * those with ferromagnetic implanted devices that might produce a safety hazard (e.g. infusion pumps, pace makers, aneurysm clips, etc.) will be excluded from the study along with subjects with severe claustrophobia or who have severely compromised renal function (gfr \< 30).
the benefit of add on dlbs1033 for ischemic stroke patient

Conditions: Ischemic Stroke

Summary: stroke is one of the most common non-communicable diseases worldwide. it is the leading cause of morbidity and mortality in many countries. stroke is broadly classified into ischemic and hemorrhagic stroke. ischemic stroke is more common than hemorrhagic stroke. in indonesia, the prevalence of ischemic stroke is 42.9% compare to hemorrhagic stroke 19.9%. ischemic stroke defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. one of the main therapy in ischemic stroke is administration of anti thrombotic agent. dlbs1033 is a bioactive protein fraction isolated from lumbricus rubellus. dlbs1033 possessed quadruple activities that inhibit platelet aggregation, induces fibrinogenolysis, fibrinolysis, and thrombolysis. this is a new proposed medication nowadays. there is still a limited study about dlbs1033. to our knowledge, research concern on the usage of dlbs1033 in stroke patients is very limited in indonesia. this study aimed to measure the benefit of dlbs1033 as add on therapy for ischemic stroke patients. the hypothesis of this study : a. the use of dlbs1033 improve functional status of ischemic stroke patients at hospital discharge. b. the use of dlbs1033 improve functional status 30-days after stroke onset.

this was randomized, controlled, open-label, study from the period of april 2020 - august 2020 at bethesda hospital, yogyakarta, indonesia. there were 180 acute ischemic stroke patients who fulfilled the inclusion and exclusion criteria. each subject recruited from acute stroke intensive care unit had been followed up from the first day they were hospitalized until hospital discharge (died or discharged alive) and 30 days after the onset. ethical approval number 1087/c.16/fk/2019 was obtained from health research ethics committee, faculty of medicine duta wacana christian university yogyakarta. this research has been registered at center for health resources and services research and development indonesia with the ethical approval number of 1087/c.16/fk/2019.

Eligibility criteria:
inclusion criteria: * male or female * adult age (\>18 years old) * diagnosed with acute ischemic stroke for the first time * the onset is \<24 hours * not a referral patient * gcs score of 15 (fully alert) * mild to moderate scores on nihss exclusion criteria: * subjects known to have hypersensitivity to dlbs1033 * participated in other studies for the past 1 month * not competent enough in giving approval and answering questionnaires

Keywords: dlbs1033 standard therapy stroke outcomes lumbrokinase