Kornimate/medical-research-clean huggingface dataset:
individualized elective neck irradiation based on mri in npc patients

Conditions: Nasopharyngeal Carcinoma

Summary: currently, most protocols of nasopharyngeal carcinoma (npc) of various research bodies such as the radiation therapy oncology group require routine elective irradiation to the retropharyngeal area and to levels ii-v lymph nodal areas regardless of the status of nodal metastasis. previous studies had confirmed that the pattern of cervical lymph node (ln) metastasis in npc followed an orderly manner. retropharyngeal lns were the most commonly involved, followed by upper neck levels ii, iii, or va nodes, and finally to the lower neck nodes including level iv and vb nodes; and the incidence of ln skip metastasis is rare, ranging from 0.5% to 7.9%. it was rare for npc patients without neck ln metastases to experience neck failure after elective irradiation to levels ii, iii and va. it was also confirmed that with unilateral ln metastases of higher-level lns usually spread down ipsilateral lns. thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in npc patients with unilateral or bilateral uninvolved neck.

currently, most protocols of nasopharyngeal carcinoma (npc) of various research bodies such as the radiation therapy oncology group require routine elective irradiation to the retropharyngeal area and to levels ii-v lymph nodal areas regardless of the status of nodal metastasis. previous studies had confirmed that the pattern of cervical lymph node (ln) metastasis in npc followed an orderly manner. retropharyngeal lns were the most commonly involved, followed by upper neck levels ii, iii, or va nodes, and finally to the lower neck nodes including level iv and vb nodes; and the incidence of ln skip metastasis is rare, ranging from 0.5% to 7.9%. it was rare for npc patients without neck ln metastases to experience neck failure after elective irradiation to levels ii, iii and va. it was also confirmed that with unilateral ln metastases of higher-level lns usually spread down ipsilateral lns. thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in npc patients with unilateral or bilateral uninvolved neck.

Eligibility criteria:
the eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing npc; with unilateral or bilateral uninvolved neck; aged between 18 and 65 years; karnofsky performance-status score \> 70; adequate haematological function, with a leucocyte count \> 4 × 109/l, haemoglobin \> 90 g/l, and a thrombocyte count \> 100×109/l. the exclusion criteria include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.

Keywords: nasopharyngeal carcinoma elective neck irradiation upper neck irradiation whole neck irradiation
heartbeat sensitivity calibration using the ecg accessory

Conditions: ECG Comparisons in Normal Healthy Subject

Summary: this is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ecg data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (clinical trials of texas). cyberonics will be collecting ecg recordings collected by an investigational device for comparison with conventional ecg recordings. this data will be used to validate a new device under development.

this is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ecg data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (clinical trials of texas). if acceptable data is acquired from one (1) subject the remaining subjects will not be entered into the study. three (3) to six (6) researchers will record data, but all direct contact with the subject will be done by the study coordinator or principal investigator (pi). the purpose of this study is to validate a heartbeat sensitivity calibration process utilizing the cyberonics ecg accessory. the non-invasive, passive collection of ecg signals from a resting healthy subject will be used to validate the use of the ecg accessory with the model 201 programming wand, model 250 vns programming software version 9.0, model 106 generator, and ecg monitor (dre true ecg-12), as well as the associated instructions for use. the data generated from this exercise will be used in future clinical trials utilizing this device.

Eligibility criteria:
inclusion criteria: * 1. patients must be 18 years or older, male, and of any race. * 2. patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements. * 3. patient must be willing and able to complete informed consent and hipaa authorization. exclusion criteria: * 1. subjects with skin abnormalities or conditions that would interfere with ecg electrode patch placement or cause subject discomfort with patch placement. * 2. subjects report history of allergies or sensitivity to adhesive tapes or patches. * 3. subjects with major health condition that in the investigator's judgment would prevent the subject's successful completion of the study.
the effect of music meditation therapy in patients with chronic pain receiving botox

Conditions: Pain

Summary: the purpose of this pilot study is to examine the impact of music meditation therapy session on patients with chronic pain who are receiving botox injections at a pain management center.

this study is a randomized controlled trial (rct) that employs a two-arm parallel-group design. ninety-eight participants scheduled to receive a botox injection will be randomly assigned to receive individual music meditation therapy intervention group or standard care control group before the participant's botox injection. the study team will use an embedded mixed methods study that uses both quantitative and qualitative data. qualitative data play a supporting role and are embedded within a larger rct. the qualitative data will help the investigators better understand the patients' experience of the interventions.

Eligibility criteria:
inclusion criteria: * adult patients of both genders ages 18-60 who have been referred for botox injection for treatment of chronic pain at the rowan som neuromusculoskeletal institute. these patients will have a prior diagnosis made by their physicians necessitating treatment with botox injections. * patients who have previously received a botox injection or patients receiving botox injections for the first time can participate. exclusion criteria: * patients who cannot speak or understand english for informed consent and patient teaching * patients with hearing impairment. * pregnant women, children and/or minors, cognitively impaired patients or the elderly (above 60 years of age).

Keywords: chronic
promoting engagement in the drug resistant tb/hiv care continuum in south africa

Conditions: Patient Non-compliance

Summary: the goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (m/xdr-tb) patients using a mixed methods approach.

tuberculosis (tb) remains the leading cause of morbidity and mortality worldwide among people living with hiv. globally, incidence of multidrug-resistant tuberculosis (mdr-tb) and extensively drug resistant tuberculosis (xdr-tb), the most drug-resistant forms of tb, has approximately doubled over the past fifteen years. nowhere has this increased incidence generated more concern than in south africa where interactions between tb and generalized hiv epidemics are causing 'explosive' tb incidence and case-fatality threatening to undermine the progress reached with antiretroviral therapy (art). medication adherence, a key predictor of outcomes in multi-and extensively drug-resistant tuberculosis (m/xdr-tb) and hiv treatment, is understudied in high burden tb/hiv settings. patient losses during transitions in the care continuum are frequent, increase mortality and limit control of the linked epidemics. demands of m/xdr-tb hiv treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine. this is a prospective observational cohort study for patients newly diagnosed with m/xdr-tb initiating treatment. a mixed method approach will be employed to address the complex research questions of distilling determinants of barriers and facilitators to both tb medications and art; this study will employ complementary qualitative and quantitative methodologies for assessing differential adherence to tb medications and art. a sub-set of patients and health care workers will be approached for participation in focus group discussions.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. mycobacterium tuberculosis (mtb) culture positive with at least isoniazid and rifampicin resistance or molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin or polymerase chain reaction test (genexpert mtb/rif) result showing mtb positive and rif resistance. patients enrolled with only a genexpert mtb/rif result will be withdrawn if their subsequent susceptibility test or molecular drug susceptibility test reveals rifampicin monoresistance. 3. initiating treatment for m/xdr-tb which includes at least 2 new medications 4. have capacity for informed consent 5. hiv positive patients: on antiretroviral therapy (art) or initiating art within the following 4 weeks as per clinician recommendation exclusion criteria: 1. pregnancy 2. prisoners 3. discretion of the investigator of record or clinician

Keywords: adherence hiv mdr/xdr tb health care worker
evaluation of outcome of adult pulmonary langerhans cell histiocytosis based on lung hrct and lung function

Conditions: Pulmonary Langerhans Cell Histiocytosis

Summary: this is a multicenter retrospective study on patients with pulmonary lch who were sequentially evaluated by concomitant lung hrct and lung function testing. the objectives of this study were: 1) to determine the changes over time of lung function parameters in patients with pulmonary lch; 2) to compare the variations of hrct and lung function results during follow-up; 3) to address the respective interest of these investigations for identifying the patients who eventually will experience a progression of their disease.

pulmonary langerhans cell histiocytosis (pulmonary lch) is an uncommon disorder, characterized by the accumulation of cd1a+ langerhans cells (lcs) organized in granulomas that develop in, and destroy the wall of distal bronchioles. in adults the disease occurs predominantly in young smokers from both genders, with a peak incidence at 20-40 yrs of age, although female may be slightly older. high resolution computed tomography (hrct) of the lung has provided a considerable input for the diagnosis of pulmonary lch. we conducted a multicenter retrospective study on patients with pulmonary lch who were sequentially evaluated by concomitant lung hrct and lung function testing. the objectives of this study were: 1) to determine the changes over time of lung function parameters in patients with pulmonary lch; 2) to compare the variations of hrct and lung function results during follow-up; 3) to address the respective interest of these investigations for identifying the patients who eventually will experience a progression of their disease. results of this study may help to improve the management of patients with adult pulmonary lch.

Eligibility criteria:
inclusion criteria: * pulmonary hlp diagnosed between june 1989 and february 2005 exclusion criteria: * followed up for less than 6 months * with less than 2 lung hrct and lung function tests at the same time or within a 2 month period

Keywords: pulmonary langerhans cell histiocytosis
china valve registry study-1

Conditions: Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Valve Diseases

Summary: with the aging of chinese population, degenerative valvular disease is becoming more and more frequent, which has brought a heavy burden to our society. taking aortic stenosis (as) as an example, the incidence of as in population over the age of 65 are about 2%, and in population above the age of 85 can be amounted to 4-8%, in the western country. since the invention of transcatheter aortic valve replacement (tavr),aortic valve disease (avd),including as and aortic regurgitation (ar), has attracted more and more attention. to date, there are few data about the prevalence of avd in china. the characteristics and prognosis of avd in china are still unknown. therefore, the investigators design a prospective, observational cohort study to investigate characteristics, treatments and prognosis of avd in chinese elderly population. the results of the study will provide a basis for the future national health policy for prevention and treatment of avd in the elderly.


Eligibility criteria:
inclusion criteria: * severe as or ar indicated by echocardiography ; * 60 years old or older. exclusion criteria: * having both severe ar and severe as; * having underwent surgical or transcatheter treatment for avd; * non-degenerative avd.
an observational study of avastin (bevacizumab) in first line in patients with metastatic colorectal cancer (avanis)

Conditions: Colorectal Cancer

Summary: this observational study will evaluate the use in clinical practice and the efficacy of avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received prior chemotherapy treatment in the metastatic setting. patients for whom the treating physician has decided to initiate therapy with avastin will be followed for 10 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically confirmed metastatic colorectal cancer without prior chemotherapy in the metastatic setting exclusion criteria: * contraindications for avastin according to the locally approved package insert (version 7 april 2006)
study of khk7580 in subjects with secondary hyperparathyroidism in asia

Conditions: Secondary Hyperparathyroidism

Summary: the purpose of this study is to evaluate the efficacy and the safety of khk7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in china, korea, hong kong and taiwan.


Eligibility criteria:
inclusion criteria: 1. personally submitted written voluntary informed consent to participate in the study 2. aged ≧18 years at the time of consent 3. stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening 4. intact pth level (centrally measured) of \>300 pg/ml at screening 5. corrected serum ca level (centrally measured) of ≧9.0 mg/dl at screening exclusion criteria: 1. treatment with cinacalcet hydrochloride within 2 weeks before screening 2. change in dose or dosing regimen of an activated vitamin d drug or its derivative, phosphate binder, or ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening 3. change in prescribed conditions of dialysis (dialysate ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening 4. treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening 5. parathyroidectomy and/or parathyroid intervention within 24 weeks before screening 6. severe heart disease (e.g., ≧ class ⅲ per new york heart association classification) 7. severe hepatic dysfunction (e.g., treatment with antiviral therapy) 8. uncontrolled hypertension and/or diabetes
a comparative phase iv study evaluating efficacy & safety of magnex(cefoperazone-sulbactam) in intraabdominal infections

Conditions: Infection

Summary: intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. antibiotics used in intra-abdominal infections should aim to cover organisms such as enterobacteriaceae and bacteroides fragilis, which are the commonest organisms known to cause such infections. combinations of a third-generation cephalosporin, an aminoglycoside and metronidazole are often used to treat such infections in surgical settings. an alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination. magnex (cefoperazone- sulbactam) is one such combination, which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections. the combination of ceftazidime, amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of gram-negative and anaerobic organisms found in such conditions.


Eligibility criteria:
inclusion criteria: * male or female subjects aged greater or equal to 12 years * intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening * presence of at least three of the following five indicators consistent with intra-abdominal infections (fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation) * written informed consent obtained exclusion criteria: * rapidly progressive illness or critically ill subjects * pregnant or lactating women, or women of childbearing potential not using an effective method of contraception. * treatment with a presumably effective systemic antimicrobial agent for \>24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator)
five fractions of radiotherapy followed by full dose folfox chemotherapy as preoperative treatment for rectal cancer

Conditions: Rectal Neoplasms

Summary: to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5fu, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.

our principal objectives in this trial will be to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5fu (oral capecitabine if 5fu is unavailable), oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. if we can establish a t stage downstaging rate that is significantly better than 50% and if acute tolerance is acceptable, then we would consider this study as having provided sufficient pilot data to support including this approach as an arm in a multi-institution phase iii trial. the long-term goal is improved overall control of disease by delivering better chemotherapy earlier.

Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the rectum * patient evaluated by surgeon and found to be a potential surgical candidate. since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible. * clinical evidence of t3 or t4 disease. this can be by imaging studies (see or by physical findings (tethering on palpation for t3 lesions or invasion of a neighboring organ for t4 lesions) * karnofsky performance status at \>60 * laboratory criteria: * absolute neutrophil count \>= 1.5 k * platelets \>= 100 k * total bilirubin \<= 2.0; * sgot and alkaline phosphatase \<= 2 x upper limit of normal * creatinine \< 2.0 * hemoglobin \>= 8.0 * informed consent signed * tumor measurable in at least one dimension. this may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies. * estimated longevity at least 12 months * patients with distant metastatic disease will be eligible if they satisfy all other conditions exclusion criteria: * pregnant women, children \< 18 years, or patients unable to give informed consent * patients with a past history of pelvic radiotherapy. * patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer * patients with known allergy/intolerance to 5fu, leucovorin, oxaliplatin, capecitabine * prior chemotherapy for colorectal cancer. * grade \>= 2 peripheral neuropathy * any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5fu (oral capecitabine if 5fu is unavailable), leucovorin, oxaliplatin chemotherapy
co2 (carbon dioxide) - cerebral oxygenation

Conditions: Hypoxia, Brain

Summary: several projects in high altitude research in environments with a low oxygen partial pressure (hypobaric hypoxia) leading to hypoxemia showed, that cerebral perfusion and cerebral performance could be improved by adding c02 (cabon dioxide). the investigators hypothesize that adding 5% c02 to 02 (oxygen) also under normobaric conditions increases the time until a significant cerebral hyopxia is measured by near infrared spectroscopy (nirs) compared to the administration of 95% 02. lf this hypothesis proves to be true, this approach might be used in situations in which individuals are prone to cerebral hypoxia. in bariatric surgery, patients that experience an apnea phase are more prone to (cerebral) hypoxia due to the fact, that they have a higher body mass index (bmi) leading to a reduced functional residual capacity (frc), which serves as the oxygen reserve in the body.

on the day of surgery patients will be randomized. after induction of anesthesia and endotracheal intubation patients will be managed by the study team to perform the intervention and the measurements. according to randomization, investigational medical product (imp) or comparator will be administrated by ventilator 1/ventilator 2. at time point 1 apnea will be performed by disconnecting the ventilator from the endotracheal tube until the nirs value has dropped by 20% from baseline. after that, re-ventilation will be resumed immediately, until parameters have returned to baseline. during apnea time nirs and vital signs will be recorded permanently, blood samples will be drawn at definite time points. application of imp (or comparator) will be performed in this cross-over study design in the same manner after the baseline level is reached again. at the end of the study procedure, after the baseline level of end-expiratory co2 is reached again, patient will be taken over by the clinical anesthesia team and surgeons.

Eligibility criteria:
inclusion criteria: * patients who are designated for bariatric surgery at the university hospital zurich (usz) * informed consent as documented by signature * bmi \>35 kg/m2 exclusion criteria: * severe end-organ damage: chronic obstuctive pulmonary disease (copd) gold (cassification) iii and iv, known hepatic insufficiency or elevated liver enzymes, renal creatinine clearance \<30ml/min * severe cardiovascular disease (nyha classification iii and iv) * known pulmonary hypertension * cerebrovascular disease * pregnancy and lactation * cardiac dysrhythmias * acidosis, chronic pulmonary disease * known or suspected non-compliance, drug or alcohol abuse

Keywords: cerebral hypoxia co2 cerebral perfusion hypoxia