Kornimate/medical-research-clean huggingface dataset:
influence of aromatase inhibition on hepatic- and cardiac function in severe obese men

Conditions: Obesity

Summary: it seems plausible that increased aromatase activity in obese men, as a result of a larger fat mass, is responsible for decreased levels of testosterone. therefore aromatase inhibition increases testosterone levels, which may affect hepatic and cardiac function. in this intervention study two groups of hypogonadal obese men are compared. group a is treated with letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a group with normal testosterone and low oestrogen concentrations. group b is treated with placebo once every two days during four months; this group will retain low testosterone - and high oestrogenic concentrations. the primary objective of the study is to evaluate effects of changed sex steroids in obese men on hepatic and cardiac function.


Eligibility criteria:
inclusion criteria: * obese male subjects * planned for gastric bypass (bmi \> 30 kg/m²) * low testosterone levels * age between 20 and 65 exclusion criteria: * primary hypogonadism or secondary hypogonadism due to genetic causes (kallman syndrome etc.), tumours, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional. * treatment with corticoids, opiates (on a daily basis), androgen- or estrogen analogs or cyp2a6 substrates (dexmedetomidine, ifosfamide, methoxsalen, miconazole, tranylcypromine). * impaired renal function defined as serum-creatine \> 1.5 mg/dl * clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (nyha class iii or iv) at the discretion of the investigator * cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial * palpable prostate nodule or induration, prostate-specific antigen (psa) \> 3 ng/ml, prostatism, untreated sleep apnea syndrome, erythrocytosis (hematocrit \> 50%) or hyperviscosity. (cfr. endocrine society clinical practice guideline by bhasin s et al.) * known or suspected abuse of alcohol or narcotics

Keywords: with disturbed glucose metabolism without disturbed glucose metabolism
steroids, azithromycin, montelukast, and symbicort (sams) for viral respiratory tract infection post allotransplant

Conditions: Respiratory Tract Infections; Bronchiolitis Obliterans; Cryptogenic Organizing Pneumonia; Lung Diseases, Interstitial

Summary: for many patients with blood cancers, stem cell transplantation from a family member or from an unrelated donor remains the only potentially curative option. unfortunately, up to 40% of patients develop chronic lung disease after the transplant, which substantially increases the risk of death in the long-term. currently, patients with transplant-related lung disease are treated with some combination of steroids and other immunosuppressant drugs, but only about 1 out of 5 improve. the importance of our study is that the investigators aim to prevent the development of transplant-related chronic lung disease in the first place. because a strong risk factor for such chronic lung disease is a prior viral respiratory tract infection, the investigators think there is a window of opportunity to intervene. as soon as "cold and flu" symptoms start, the investigators will treat patients with a combination of drugs aimed at eliminating damaging immune responses triggered by the virus. in the absence of such treatment, the investigators believe these lung-damaging immune responses would persist even after the virus disappears. our hope is that preventive treatment might avoid the development of chronic lung disease, and this would substantially increase long-term survival in our transplant patients. this is a pilot study. once feasibility is established, the investigators will seek to expand this study into a definitive clinical trial.


Eligibility criteria:
inclusion criteria: * allogeneic transplant within the prior 1 year * age greater than or equal to 18 years * capable of informed consent * neutrophil engraftment has occurred * this is the first clinically-recognized episode of viral respiratory tract infection after transplant exclusion criteria: * proof or high suspicion for bacterial, fungal or any non-viral microorganism causing pneumonia * cmv, vzv or hsv pneumonia * prior diagnosis of a chronic transplant-related non-infectious pulmonary complication (ex: bo, cop) * treating physician believes the risk of systemic steroids is too great * currently receiving prednisone at or greater than 0.25 mg/kg/day or the equivalent dose of another steroid * currently receiving pentostatin * mycophenolate initiated de novo or increased within the past 4 weeks * use of inhaled corticosteroids within the past 2 weeks for at least 1 week * haploidentical or t-cell depleted graft * lack of pre-transplant pulmonary function tests * evidence of a prior symptomatic viral respiratory tract infection following transplant, whether treated or not * allergy or adverse reaction to any of the study drugs * relapse or progression of the underlying malignancy * palliative care

Keywords: pulmonary disease, chronic obstructive viral respiratory tract infections respiratory syncytial viruses influenza virus a influenza virus b transplantation, allogeneic
vaccine biotherapy of cancer: autologous tumor cells and dendritic cells

Conditions: Metastatic Melanoma

Summary: this protocol was conducted as a single institution trial at hoag cancer center, hoag hospital, newport beach, california. it was a single-arm phase ii trial in which patients with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (dc) and granulocyte macrophage colony-stimulating factor \[gm-csf\]. eligible patients had regionally recurrent and/or distant metastatic cancer.

patients were stratified by whether they had no measurable disease \[nmd\] at the time of treatment (usually because of surgical resection of metastases), or whether they had objectively measurable disease (omd) by physical examination or radiologic scans per response evaluation criteria in solid tumors (recist criteria). key endpoints were the results of delayed type hypersensitivity (dth) skin testing to their own irradiated tumor cells, event-free survival \[death or disease progression\], overall survival, and objective tumor regression in patients who have measurable disease at the time vaccine therapy was initiated. this study was activated in the fall of 2000, and closed to accrual in june 2007.

Eligibility criteria:
inclusion criteria: * recurrent or metastatic melanoma as defined by stage iv disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules * ecog performance status of 0-2 * satisfactory medical condition for treatment in a phase i-ii trial of anticancer therapy * age \> 16 years * venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells. * serum pregnancy test must be negative for women of childbearing potential. exclusion criteria: * active central nervous system metastases * known autoimmune disease or disease process that involves the use of immunosuppressive therapy. * underlying cardiac disease associated with new york heart association class iii or iv function, or unstable angina related to atherosclerotic cardiovascular disease. * ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine \ 3.0 mg/dl, hematocrit \> 25, platelets \> 100,000. * active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.

Keywords: autologous tumor cell vaccine metastatic melanoma sargramostim (gm-csf)
comparison of two technique for assessment of vocal cord movement by c-mac videolaryngoscope vs airway ultrasound.

Conditions: Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid

Summary: this study is planned to compare c-mac video-laryngoscope and airway ultrasound as two novel techniques (causing least discomfort to the patients) for the detection of impaired vocal-cord movement after thyroid surgery.

in this prospective study 100 patients posted for thyroid surgery will be included, after explaining the procedure and written informed consent, all included patients in the study will be assessed for vocal cord mobility by c-mac video laryngoscope (manufactured by karl storz video laryngoscopes) followed by airway ultrasonography (usg). linear transducer (7.5 mhz) will be used for scanning the airway placed at the level of thyroid cartilage with 10-15 degree cephalad tilt so to get proper acoustic window and for optimal visualization of laryngeal structures. c-mac video laryngoscope will be required for virtual visualization of glottis apertures and vocal cord movement. all patients will be scanned pre-operatively by indirect laryngoscopy to see vocal cord mobility as a reference value. immediately after extubation the patient will be scanned for vocal cord mobility by videolaryngoscope by first examiner, after oxygenation and stabilization of haemodynamic, ultrasound of airway will be performed to study the vocal cord movement by the other examiner (blinded to the laryngoscopy finding).visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. according to points the acoustic window scoring for glottis aperture will be graded as fair (score1-2), good(score3-4) and very good(score5-6) findings of both the examiners will be collected by the primary investigator for data collection and analysis.

Eligibility criteria:
inclusion criteria: * patient's undergoing thyroid and parathyroid surgery. exclusion criteria: * patients not extubated.
mr pulmonary angiography to replace ct pulmonary angiography for patients with a suspicion of a pulmonary embolism

Conditions: Pulmonary Embolism; Radiation Exposure

Summary: rational: the first choice of imaging modality for patients with a suspicion of pulmonary embolism is ct pulmonary angiography (ctpa). our goal is to avoid extra cases of cancer due to the carcinogenic effect of ionizing radiation from using ctpa. this carcinogenic effect is greatest in women under 40. in the netherlands, at least 100,000 ctpa's are performed each year, 10% of which are in women under 40 years old, resulting in at least 10 extra tumors induced per year. the goal is to investigate whether mr pulmonary angiography (mrpa) can serve as an alternative to ctpa. if it can replace ctpa, this will result in a significant health benefit. objective: the primary objective is to determine the sensitivity and specificity of mr pulmonary angiography (mrpa) with ct pulmonary angiography (ctpa) as the gold standard. secondary outcomes: to determine the clinical applicability of mrpa in daily practice, negative predictive value, positive predictive value, accuracy of mrpa (compared to ctpa), and agreement in assessment between radiologists. study design: observational-prospective diagnostic study, an additional mrpa will be performed in patients with a suspicion of pulmonary embolism. study population: in patients with clinical suspicion of pulmonary embolism, a standard ctpa is made for exclusion or confirmation of the disease. the study population will consist of 272 patients. primary outcome parameters: determining the sensitivity and specificity of mrpa compared to ctpa (gold standard) in patients with a (clinical) suspicion of pulmonary embolism. secondary outcome parameters: determining the negative predictive value, positive predictive value, accuracy, inter-observer agreement with respect to mrpa, and applicability in daily clinical practice.


Eligibility criteria:
inclusion criteria: * mentally competent * 18 years old exclusion criteria: * regular exclusion criteria for mr examination, * contrast allergy, * hemodynamic instability, * severe respiratory insufficiency * immobile patient. * pregnancy * dialysis patients * covid-19 positive patients
bispectral index value changes during induction and surgical decompression in head injury patients

Conditions: Traumatic Brain Injury

Summary: this study was conducted in two parts: 1. this first part was designed to determine thiopentone dose requirement for induction of anaesthesia with and without the use of bispectral index monitoring - participant and care provider in appropriate study arm blinded. 2. as a secondary outcome, bispectral index monitoring was used to observe changes in neuronal function in intraoperative period as well as haemodynamic changes intraoperatively - participant and care provider blinded.

surgery for traumatic brain injury is an anaesthetic challenge fraught with complications such as brain bulge, excessive bleeding, hypotension etc. as yet there are no anaesthetic regimen guidelines to follow for induction of anaesthesia in neurotrauma surgeries. although the functional effect of anaesthetic agents on neuronal tissue is known quite well, there is lack of studies documenting the effect of these anaesthetic agents on head injured patients. it is also not known whether the requirement of anaesthetic agent in the same as a non head injured patient. this study was designed to assess the requirement of anaesthetic thiopentone in head injured patients and compare the anaesthetic usage with and without bispectral index (bis) monitoring. we also observed the real time change in neuronal function using bispectral index monitoring after craniotomy, i.e. effectively decompression and release of intracranial pressure intraoperatively.

Eligibility criteria:
inclusion criteria: * head injury patients coming for surgery exclusion criteria: * hypotension/arrythmias at time of induction * extra dural hemorrhage * extracranial injuries * scalp lacerations * history of seizures * no consent

Keywords: bispectral index
using the subglottic pressure to predict the dysphagia after partial laryngectomy

Conditions: Laryngeal Cancer; Dysphagia

Summary: recruited patients are divided into two arms depending on laryngeal carcinoma's t1 and t2 stages. two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (ophl). during the pre-and post-operative time, patients performed measurements of swallowing function, including direct subglottic pressure, eating assessment tool-10(eat-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(fees). patients undergo subglottic pressure measurement and swallowing function evaluation three times: 3-7 days, two months, and six months after surgery. patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation.

there were swallowing disorders after partial laryngectomy in most patients with laryngeal carcinoma. at least these patients need several months to recover. few people required surgery of total laryngectomy to maintain normal swallowing function. the swallowing training cannot acquire a valid swallowing function and take the risk of aspiration pneumonia. factors that influenced the swallowing function recovery, for example, the time of nasogastric feeding and tracheostomy tube removal, were affected by age and diabetes. on the other hand, the pharynx size of a ct scan can predict the recovery of swallowing function after laryngectomy. but those are not directly related to swallowing motion, although they are predictors of dysphagia. the investigators will perform the study with swallowing function measures to find predictors relative to swallowing function and evaluate dysphagia's recovery early. subglottic pressure is a protective factor that can reduce aspiration risk. this research will measure the subglottic pressure after laryngectomy and predict or monitor swallowing disorders. specific objectives were to verify the effect of laryngectomy on subglottic pressure.

Eligibility criteria:
inclusion criteria: * age: 18-80 years * surgical treatment by open partial horizontal laryngectomy type i or ii and transoral laser cordectomy for squamous cell carcinoma * availability of clinical data * validity of normal swallowing of thin liquids exclusion criteria: * presence of severe chronic obstructive pulmonary disease, severe heart disease, and psychopathy or mental disease * surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision) * radiotherapy histology * swallowing disorder or trachea aspiration before surgery.

Keywords: partial laryngectomy subglottic pressure laser
do xanthine oxidase inhibitors reduce both left ventricular hypertrophy and endothelial dysfunction in cardiovascular patients with renal dysfunction?

Conditions: Kidney Disease; Left Ventricular Hypertrophy

Summary: cardiovascular related disease is the main cause of death in patients with kidney disease, and "oxidative stress" is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. allopurinol, a drug used safely in the treatment of gout for many years, has been found to dramatically reduce "oxidative stress". it is therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. if it did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney disease patients.


Eligibility criteria:
inclusion criteria: * ckd stage 3 * echo lvh exclusion criteria: * known heart failure * patients already on allopurinol * patients with gout * patients with hepatic disease * contraindications to mri, including severe claustrophobia * current immunosuppressive therapy, chlorpropamide, theophylline, 6- mercaptopurine * malignancy or other life threatening disease * pregnancy or lactating women * patients unable to provide written consent

Keywords: ckd lvh echo lvh chronic stage 3
treatment adherence and influencing factors in children with helicobacter pylori infection during eradication therapy

Conditions: Helicobacter Pylori Infection; Children, Only

Summary: the aim of this study is to describe the current status of treatment adherence in children with helicobacter pylori infection, understand the medication literacy, medication beliefs of the children, knowledge of h. pylori among caregivers, medication beliefs, medication support, and explore the influencing factors of medication adherence.

helicobacter pylori infection usually occurs in childhood and persists into adulthood, and is closely related to the occurrence of chronic gastritis, peptic ulcer, and gastric cancer. however, in recent years, the eradication success rate of helicobacter pylori infection has gradually decreased, while the drug resistance rate has gradually increased, and it is urgent to improve the success rate of first eradication in children. medication compliance is closely related to drug resistance, so it is necessary to investigate medication compliance and its influencing factors during helicobacter pylori eradication in children.children and caregivers who meet the inclusion and exclusion criteria were invited to individually complete questionnaire surveys. part one: children infected with helicobacter pylori and undergoing treatment were invited to complete the questionnaire surveys independently. the children completed the medication literacy questionnaire, medication beliefs specific questionnaire, and medication adherence questionnaire. part two: caregivers of the children completed the survey questionnaires, including a demographic information form, h. pylori knowledge questionnaire, medication beliefs specific questionnaire, and medication support questionnaire.

Eligibility criteria:
children inclusion criteria: * 1.children aged 8-18 years old * 2. whose diagnosis meets the diagnostic criteria for helicobacter pylori infection in the expert consensus on diagnosis and treatment of helicobacter pylori infection in chinese children (2022) * 3. children who receive helicobacter pylori eradication therapy children exclusion criteria: * 1.children are diagnosed with other chronic conditions and take other medications for a long time * 2.unable to communicate with readers in chinese normally caregiver inclusion criteria: * 1.caregivers of children who meet the diagnostic criteria for helicobacter pylori infection in the expert consensus on diagnosis and treatment of helicobacter pylori infection in children in china (2022) * 2.able to communicate normally caregiver exclusion criteria: * 1.not living with children * 2.not familiar with the use of children

Keywords: h.pylori infection medication adherence medication beliefs medication knowledge medication support helicobacter pylori knowledge
study of ngr-htnf as single agent in patients affected by colorectal cancer (crc)

Conditions: Colorectal Cancer (CRC)

Summary: the main objective of the trial is to document the progression free survival (pfs) in advanced or metastatic colorectal cancer patients treated with ngr-htnf as single agent. safety will be established by clinical and laboratory assessment according to nci-ctc criteria.

this is a phase ii, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic colorectal cancer (crc), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using simon's two-stage design method.

Eligibility criteria:
inclusion criteria: * patients \>18 years affected by advanced or metastatic colorectal cancer (crc), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, but not more than three lines of therapy. adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy * ecog performance status 0 - 1 * patients in progression disease at study entry, ct documented * adequate baseline bone marrow, hepatic and renal function, defined as follows: * neutrophils \> 1.5 x 10\^9/l and platelets \> 100 x 10\^9/l * bilirubin \< 1.5 x uln * ast and/or alt \< 2.5 x uln in absence of liver metastases * ast and/or alt \< 5 x uln in presence of liver metastases * serum creatinine \< 1.5 x uln * absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or hemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin") * normal cardiac function and absence of uncontrolled hypertension * patients must give written informed consent to participate in the study exclusion criteria: * more than three lines of chemotherapy (except biological agents) * concurrent anticancer therapy * patients may not receive any other investigational agents while on study * clinical signs of cns involvement * patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * pregnancy or lactation. patients - both males and females - with reproductive potential (i.e.menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

Keywords: ngr-htnf crc