Kornimate/medical-research-clean huggingface dataset:
health assessment, patient treatment satisfaction and quality-of-life in insulin-naive type 2 diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to investigate the impact of insulin glargine versus neutral protamine hagedorn basal insulin on a composite diabetes related quality of life score (drqol). secondary objective: a comparison of combination therapy with insulin glargine versus neutral protamine hagedorn basal insulin from baseline to endpoint in terms of: * glycaemic parameters: 7 blood glucose profiles * incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia * change in lipid status


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ada criteria. * treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea. * no pre-treatment with any insulin in the last 3 months before the study. * glycated haemoglobin a1c (hba1c) value between \> or = 7.0 and \> or = 9.5% * fasting blood glucose (fbg) \> or = 120 mg/dl (6.7 mmol/l). * body mass index \< 40 kg/m. * ability to read and understand german language. * ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis. * women of childbearing potential who will take adequate contraceptive protection. exclusion criteria: * patients with type 1 diabetes mellitus. * any history of ketoacidosis. * pregnancy. * prior treatment with insulin. * treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, glp-1 receptor agonists or with dipeptidyl-peptidase iv (dpp-iv) inhibitors. * history of drug or alcohol abuse. * diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry. * following pancreatectomy. * impaired hepatic function. * impaired renal function. * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. * evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment. * inability to attend follow-up visits. * current treatment because of a mental disorder according to icd 10(f 5 diagnoses). * patients that are in a relationship of dependance with the investigator(s) and/or the sponsor. * systemic corticoids \> 7,5 mg prednisolon equivalent or \<or=7,5 mg prednisolon equivalent for less than 2 months. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
endoscopic strip craniectomy for treatment of sagittal craniosynostosis

Conditions: Craniosynostosis, Sagittal

Summary: * endoscopic strip craniectomy (esc) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault remodeling. esc is frequently performed with or without the use of lateral osteotomies with technical selection being largely based on surgeon preference. * previous studies have shown that there are no statistically significant differences in cranial expansion or complications between the two procedure variants; however, these studies are retrospective in nature and do not account for aesthetic outcomes. * the purpose of this study is to compare the efficacy of esc with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. in addition, we seek to investigate if there are any observable changes in perioperative morbidity between the two procedures.

* this prospective, randomized parallel study seeks to compare the efficacy of esc with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. * both arms of the study will undergo standard care throughout their participation which includes preoperative \& postoperative measurements of cephalic index using the starscanner© (orthomerica products inc.), preoperative \& postoperative photographs, post-operative helmeting, and standard post-operative visits. * additional research-related activities include chart review. primary outcomes include degree of cranial expansion at 1 year post-operatively. * secondary outcomes include aesthetic appearance at 1 year post-operatively (using a 5-point likert scale) and a multitude of intraoperative clinical variables including estimated blood loss, instances of transfusion, instances of dural tear, instances of 30-day readmission, and instances of needing further surgery.

Eligibility criteria:
inclusion criteria: * all patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to texas children's hospital. exclusion criteria: * patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.
vascular function and uterine fibroids

Conditions: Leiomyoma

Summary: the purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. it is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. the investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.

the investigators are inviting women, 25-50 years old, who have not gone through menopause to participate in this study. the investigators are looking for some women with uterine fibroids and some without uterine fibroids based on ultrasound or mri. if the patients have not had a recent ultrasound or mri of the uterus, a physician can provide one. individuals cannot participate if they have high blood pressure, diabetes, or disease in the kidneys, lungs, or blood vessels. also, individuals who smoke, have high cholesterol, or are obese (bmi is higher than 30) cannot participate. certain medications, including high blood pressure medications, beta-blockers and anti-depressants, will also limit potential patient participation. the investigators would be happy to review medications for potential participants. screen day: one of the members of the research team will review the study and the informed consent document with the patient. the patient will have their height, weight, blood pressure, pulse and respirations measured. the patient will also complete three questionnaires. if the patient has not had an ultrasound of the uterus in the last 12 months, a physician will complete one for her. study day: the patient will need to fast overnight (no eating or drinking). the investigators will draw a blood sample and then do a series of tests on the participant's blood vessels. for some of the tests, medication will be given through an iv. the investigators will also test nerve activity in the nerve on the outer aspect of the leg.

Eligibility criteria:
inclusion criteria: * women 25-50 years old * premenopausal exclusion criteria: * postmenopausal * pregnant or currently breastfeeding * using blood pressure medications or anti-depression medications * high blood pressure * diabetes * disease in the kidneys, lungs, or blood vessels * chronic diseases (for example: crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.) * smoker * high cholesterol * bmi higher than 30

Keywords: autonomic nervous system blood pressure blood vessels physiological effects of drugs vascular stiffness
pigtail catheter: a less invasive option for pleural drainage of recurrent hepatic hydrothorax

Conditions: Pleural Effusion

Summary: the effectiveness of pigtail catheter as a less invasive option for pleural drainage in patients with resistant hepatic hydrothorax.

hepatic hydrothorax (hh) is defined as a transudative pleural effusion in patients with liver cirrhosis in the absence of cardiopulmonary disease. the estimated prevalence among patients with liver cirrhosis is approximately 5-6% (baikati et al., 2014). hh is an infrequent but a well-known complication of portal hypertension. trans-diaphragmatic passage of ascitic fluid from peritoneal to the pleural cavity through numerous diaphragmatic defects has been shown to be the predominant mechanism in the formation of hh (kumar\&kumar, 2014). patients with hepatic hydrothoraces often have few options (goto et al., 2011). diuretic-resistant hh could be managed with liver transplantation, transjugular intrahepatic portosystemic shunt (tips) or indwelling pleural catheters. however, tube thoracotomy and pleurodesis failed in most patients (singh et al., 2013). case reports and small case series have reported a high rate of complications associated with chest tube placement for hepatic hydrothorax. the most common reported complications were acute kidney injury, pneumothorax, and empyema. death has been recorded in some cases. chest tube insertion for hepatic hydrothorax carries significant morbidity and mortality, with questionable benefit (orman\&lok, 2009). pigtail catheter insertion is an effective and safe method of draining pleural fluid. its use is safe and recommended for all cases of pleural effusion requiring chest drain except for empyema and other loculated effusions that yielded low success rate (bediwy and amer, 2012).

Eligibility criteria:
inclusion criteria: * patients with cirrhotic liver and recurrent pleural effusion. * pleural fluid should be transudate according to light's criteria: * pleural fluid-to-serum protein ratio less than 0.5 * pleural fluid lactic dehydrogenase (ldh) less than 200 iu * pleural fluid-to-serum ldh ratio and pleural fluid-to-high normal serum ldh ratio less than 0.6 exclusion criteria: * diagnosis of hepatocellular carcinoma or other neoplasm able to shorten life expectancy. * congestive heart failure. * recent (i.e. within the previous 2 weeks) episode of digestive hemorrhage. * exudative pleural effusion. * ascitic fluid or pleural fluid infection * platelet count below 50,000 * prothrombin activity below 50%
an observational study to evaluate the safety and efficacy of cetuximab in combination with platinum-based chemotherapy in the first-line treatment of recurrent or metastatic squamous cell carcinoma of head and neck

Conditions: Carcinoma, Squamous Cell

Summary: the aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of cetuximab (erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (scchn). a total of 100 subjects with scchn will be recruited in 20 centres across india.


Eligibility criteria:
inclusion criteria: * the study inclusion criteria is as per the label for patients with metastatic/recurrent scchn approved by india health authorities, i.e., "cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease." * for each platinum-based chemotherapy, the related product labels approved by india health authorities will also be followed strictly in terms of patient eligibility. exclusion criteria: * patients with known severe (grade 3 or 4; national cancer institute-common toxicity criteria \[nci-ctc\]) hypersensitivity reactions to cetuximab are contraindicated for cetuximab

Keywords: carcinoma, squamous cell erbitux neoplasms, squamous cell
a study of viracept in aids patients with cytomegalovirus retinitis

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give viracept to aids patients who are already being treated for cytomegalovirus (cmv) retinitis.


Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * newly diagnosed or first progression of cmv retinitis. exclusion criteria prior medication: excluded: prior therapy (or less than 2 weeks) with protease inhibitor other than saquinavir.

Keywords: aids-related opportunistic infections placebos antiviral agents cytomegalovirus retinitis treatment outcome nelfinavir
pancreatitis cytosorbents (cytosorb®) inflammatory cytokine removal

Conditions: Pancreatitis, Acute; SIRS

Summary: severe acute pancreatitis (sap) has a mortality of up to 42%. the outcome of sap is related to the development of sirs and consecutive organ failures. due to the lack of a causative therapy except the removal of bile duct stones, therapy is predominantly symptomatic. with regard to a marked inflammatory response ("cytokine storm") during the early phase of sap extracorporeal cytokine removal is a promising therapeutic approach. this prospective case control study investigates the impact of early extracorporeal cytokine adsorption with the cytosorb®-device on haemodynamics (primary endpoint) and several secondary outcomes.

severe acute pancreatitis (sap) has a mortality of up to 42%. the outcome of sap is related to the development of sirs and consecutive organ failures. due to the lack of a causative therapy except the removal of bile duct stones, therapy is predominantly symptomatic. severity and mortality are associated to an early systemic inflammatory response syndrome (sirs) and to septic complications at a later stage of disease. with regard to a marked inflammatory response ("cytokine storm") during the early phase of sap extracorporeal cytokine removal is a promising therapeutic approach. this prospective case control study investigates the impact of early extracorporeal cytokine adsorption with the cytosorb® device on haemodynamics (primary endpoint) and several secondary outcomes. patients with high probability of sap (apache-ii-score ≥10) are eligible for 7 days after the onset of pain. the patients will be treated for 48h with two consecutive 24h sessions of cytokine absorption with the cytosorb®-device. all patients will be under haemodynamic monitoring with transpulmonary thermodilution the primary endpoint is defined as an improvement of the vasopressor dependency index of ≥20% (if no vasoactive drugs are used at baseline, the cardiac power index cardiac power index (cpi) will be used as primary endpoint). the outcome analysis will be based on comparison of the incidence of the primary endpoint in 30 intervention patients compared to 60 matched controls.

Eligibility criteria:
inclusion criteria: * proven acute pancreatitis: * typical pain * at least 3-fold increase in serum lipase * onset of pain within 7 days before inclusion and * apache-ii ≥10 and * ≥1 criterion of "severe sepsis" and * haemodynamic monitoring with transpulmonary thermodilution and * ≥ 1 marker of poor prognosis of acute pancreatitis: * haematocrit \> 44% (men), \>40% (women) * blood glucose \> 125 mg/dl * c-reactive protein (crp) \> 10mg/dl * computed tomography score category c-e * age \>55 years * leukocytes \>16 g/l * glutamate oxaloacetate transferase (got) \>250 u/l * lactate dehydrogenase (ldh) \>350 u/l * calcium \<2,0mmol/l exclusion criteria: * pregnancy * lack of informed consent of patient or representative * pre-existing disease with life expectancy \<3 months

Keywords: severe acute pancreatitis haemodynamic monitoring cytokine removal vasopressor dependency index
xeloxiri as first-line treatment in patients with advanced unresectable pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: this is an open-label, single centre, single-arm phase ii study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma. clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and analyzed in this study. the patients' data will be collected and maintained in the division of medical oncology of the university department of medicine, queen mary hospital, hong kong.


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age, male or female. * histopathologically or cytologically confirmed adenocarcinoma of the pancreas. * ecog performance status 0 to 2. * adequate bone marrow reserve. * absolute neutrophil count \> 1x10\^9/l. * total bilirubin \<3 times the upper limit of the normal range. * life expectancy ≥ 12 weeks. * signed written informed consent form. exclusion criteria: * prior malignant disease other than pancreatic cancer. * patients suitable for surgical or locoregional therapies. * patients who have prior anticancer therapy for pancreatic cancer. * patients unable to swallow oral medications. * any evidence of brain metastasis (unless the patient is \>6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry). * active clinically serious infections (\> grade 2 nci / ctc adverse event version 3.0). * history of allergy to platinum compounds. * patients who have chronic inflammatory bowel disease and/or bowel obstruction. * patients who have severe bone marrow failure. * patients undergoing renal dialysis. * history of hiv infection. * seizure disorder requiring medication (such as steroids or anti-epileptics). * women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception. * substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
retrospective analysis of response markers and adverse events in melanoma patients treated with pembrolizumab

Conditions: Melanoma

Summary: this study is a retrospective cohort study. a database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the netherlands. this database will be used for analysis of response markers and for an evaluation of adverse events.

this study is a retrospective cohort study. a database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the netherlands. this database will be used for analysis of response markers and for an evaluation of adverse events.

Eligibility criteria:
all patients that were eligible for treatment with pembrolizumab in the named patient program in the netherlands.
assessment of diurnal salivary cortisol production in covid-19

Conditions: COVID-19; Adrenal Insufficiency; Adrenal Hyperfunction

Summary: in the year of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) pandemic several studies have focused on the effect of the covid-19 on the adrenal cortex, demonstrating conflicting results. herein, researchers sought to investigate the adrenal response in patients with covid-19by assessing the diurnal rhythm of salivary cortisol and the adrenal androgen dehydroepiandrosterone (dhea), as well as the plasma levels of aldosterone and adrenocorticotropic hormone (acth) in consecutive patients before the possible therapeutic administration of dexamethasone. to elucidate the potential association between the magnitude of individual immune response and the adrenal cortex response we included serum measurements of interleukin - 6 (il-6).

all adult consecutive patients that visited the emergency department of the laiko general hospital of athens from may to july 2021 due to confirmed covid-19 and related symptomatology were eligible for the study. age and gender matched healthy individuals without covid-19 who had never been treated with gcs and fulfilled the exclusion criteria were also recruited from the hospital's personnel and included in the analysis as controls. blood samples were obtained immediately upon admission for the measurements of acth, il-6 and aldosterone, which were performed by electrochemiluminescence assays on the cobas e 801 immunoassay analysers (roche diagnostics gmbh). salivary samples for free cortisol and dheas were obtained during the next day using the salivette (sarstedt, nümbrecht, germany) at different time points 0800, 12.00, 18.00, and 22.00. within 24h after saliva collection the salivettes were centrifuged at 2400 g for 20 min in 4 °c and aliquots were stored at -80 °c and analyzed by an immunochemiluminescence assay in a roche cobas e411 analyzer.

Eligibility criteria:
inclusion criteria: adult patients that visited the emergency department of laiko general hospital of athens, greece from may to july 2021 due to confirmed covid-19 and related symptomatology exclusion criteria: (i) pre-existing hypoadrenalism or concurrent systemic glucocorticoid treatment (ii) patients with chronic kidney disease stage 3b and above, (iii) patients with advanced metastatic disease.

Keywords: sars-cov-2 infection adrenal cortex salivary cortisol salivary dhea aldosterone acth interleukin 6 circadian rythm
quality of life in metastatic breast cancer (mbc) patients in second line monochemotherapy

Conditions: Breast Neoplasms

Summary: post-authorization, prospective follow-up, multi-centre, national study to estimate definitive deterioration in the quality of life in patients with metastatic breast cancer treated with second-line monochemotherapy.

post-authorization, prospective, multi-centre study in metastatic breast cancer patients treated with second-line monochemotherapy. a total of 200 patients are expected to be recruited from 32 spanish sites. in this study the results perceived by patients will be compiled to assess overall quality of life (qol) in mbc patients treated with second-line monochemotherapy, using the eortc qlq-c30 questionnaire (european organization for research and treatment of cancer quality of life questionnaire) and its modules eortc qlq-br23 (eortc breast cancer specific) and eortc qlq-cipn20 (eortc chemotherapy-induced peripheral neuropathy). patients will be evaluated at the time of acceptance to participate in the study after signing the informed consent and will be tracked every three months during treatment with second-line monochemotherapy, coinciding with routine assessments within normal clinical practice. when the patient completes treatment with second-line chemotherapy he/she will enter the post-treatment period, with follow-up at six and 12 months after completion of treatment. also, patients will be followed to assess survival until the end of the study (30 months after enrolment of the last patient in the study). follow-up time has been established based on the median survival of patients with mbc

Eligibility criteria:
inclusion criteria: * patients who give their written informed consent. * patients with metastatic breast cancer who start treatment with second-line monochemotherapy. * patients of both sexes, at least 18 years of age and of any race. * patients with life expectancy longer than or equal to 12 weeks. * patients with histological or cytological diagnosis of her-2/neu negative breast adenocarcinoma. * patients with ability enough to understand the questionnaires. exclusion criteria: * pregnant or lactating women. * patients who have been treated with chemotherapy in the last three weeks * patients who refuse to participate in the study.

Keywords: metastatic breast cancer monotherapy chemotherapy second line treatment her 2 negative