Kornimate/medical-research-clean huggingface dataset:
effects of structured group education on quality of life and glycemic control in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: patients with type 1 diabetes aged 15-65 years without major complications will be randomized either to usual care or to a structured group education program, with 6 four-hour weekly interactive sessions devoted to diabetes management. the principal endpoint will be the variation of hba1c at 12 months from enrolment. secondary endpoints will include quality of life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.

the group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. the intervention is designed for the acquisition of specific skills of self-management. this intervention is provided by a team including physicians, dietitians, and nurses. the control group will receive individual education during routine clinic visits, following usual care, complying with the recommendations of national (italian) guidelines. hba1c will be assessed every three months for all the duration of the study. the principal endpoint will be variation from baseline of hba1c at 12 weeks from the beginning of the intervention.

Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness) * illiteracy
a safety study of mm-121 with cetuximab and irinotecan in patients with advanced cancers

Conditions: Colorectal Cancer; Squamous Cell Head and Neck Cancer; Non-small Cell Lung Cancer; Triple Negative Breast Cancer; Other Tumors With EGFR Dependence

Summary: the purpose of this study was to evaluate the safety and tolerability of escalating doses of the mm-121 plus cetuximab and the mm-121 plus cetuximab plus irinotecan combination.

this study was a phase 1 and pharmacologic dose-escalation trial of mm-121 plus cetuximab plus irinotecan. the study assessed the safety, tolerability, and pharmacokinetics of mm-121, cetuximab and irinotecan.

Eligibility criteria:
inclusion criteria: * no standard options remaining * adequate liver and kidney functions * 18 years of age or above exclusion criteria: * history of any secondary active cancer in the last 3 years. * pregnant or breast feeding * history of severe allergic reactions or contraindications to cetuximab or irinotecan

Keywords: metastatic colorectal cancer kras wild-type squamous cell head and neck cancer non-small cell lung cancer triple negative breast cancer egfr erbb3 mm-121 cetuximab irinotecan
intravenous artesunate and malaria

Conditions: Malaria

Summary: intravenous artesunate is egual to quinine in the treatment of severe malaria

intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time

Eligibility criteria:
inclusion criteria: severe p.falciparum malaria- exclusion criteria: mixed infection pregnant women -

Keywords: severe falciaparum malaria
emotion awareness and skills enhancement program

Conditions: Autism Spectrum Disorder

Summary: this project will address impaired emotion regulation in adolescents with asd (autism spectrum disorder). there are no evidence-based interventions to improve emotion regulation (er) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. the primary objective of this study is to formally evaluate efficacy of ease via a sufficiently powered, two-site randomized-controlled trial (rct).

the current study is to test a new intervention called emotional awareness and skills enhancement (ease). this program was designed to address asd-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. this new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. the goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. the investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the ease program.

Eligibility criteria:
inclusion criteria: 1. ages 12-21 years, inclusive 2. a diagnosis of asd (autism spectrum disorder), as defined by exceeding the asd cutoff on the ados-2 (autism diagnostic observation scale) or adi-r (autism diagnostic interview-revised) in. if the participant has completed the ados in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ados. 3. average verbal intellectual ability (wechsler abbreviated scale of intelligence-2 \[wasi-2\] fsiq \>=75). 4. fluent in the english language 5. problems with regulating emotions based on parent report 6) parent/guardian who will attend sessions and assessments. exclusion criteria: 1. current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview. 2. previous or current diagnosis of a psychotic disorder. 3. receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. this will be assessed using current treatment items on the demographic forms.
safety and efficacy of avp-923 for pseudobulbar affect in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: pseudobulbar affect is a condition characterized by frequent episodes of laughing and crying out of proportion. other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. avp-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. this study will test the safety and efficacy of avp-923 in the treatment of ms patients suffering from pseudobulbar affect.


Eligibility criteria:
inclusion criteria: * 18 to 68 years of age * confirmed diagnosis of multiple sclerosis * clinical history of pseudobulbar affect exclusion criteria: * sensitivity to quinidine or opiate drugs * recent diagnosed within 2 months with multiple sclerosis * patient on anti-depressants * patient with liver or kidney disease * patient with hypotension

Keywords: pseudobulbar affect uncontrolled laughing crying
effect of physical therapy in improving the health of patients with diabetic peripheral neuropathy

Conditions: Diabetic Neuropathies; Peripheral Nervous System Diseases

Summary: people with diabetes can have nerve damage in their extremities (peripheral neuropathy), and this can lead them to being less able to maintain their balance when they are standing, walking or performing complex movement tasks in their day-to-day life. this results in them being more prone to falls, and consequent injuries. the purpose of this study is to determine whether providing strength and balance retraining (in the form of specific physical exercises or activities) can help people with diabetic peripheral neuropathy regain their ability to maintain their balance, increase their confidence in performing balance-based activities and improve their quality of life.

individuals with diabetic peripheral neuropathy (dpn) comprise 16-24% of patients with diabetes mellitus in singapore, and this is set to rise with the increasing prevalence of diabetes. dpn is also associated with the greatest reduction in health related quality of life (hrqol) among all diabetic complications, specifically pcs (physical health component summary) and its sub-components, physical functioning and physical role. however, there is currently no intervention that targets individuals with dpn for improvements in hrqol and functional status. the investigators hypothesise that a targeted intervention providing strength and balance training will improve hrqol and functional status in patients with dpn, which will be sufficiently large relative to increases in cost to make the intervention cost-efficient. the specific aims of the study are to test the effectiveness of a structured strength and balance training intervention in 1) improving the physical health component summary (pcs) measure of health related quality of life, 2) functional status, and 3) assessing cost-utility of the intervention, in individuals with diabetic peripheral neuropathy (dpn).

Eligibility criteria:
inclusion criteria: * individuals aged 40 - 75 * clinical diagnosis of type ii diabetes mellitus * presence of peripheral neuropathy (defined as neurothesiometer reading greater than 25 v and/or positive monofilament test in 2 or more sites in either foot) exclusion criteria: * foot ulceration/ infection/ amputation * medical contraindication for physical activity or physiotherapy * non-diabetic neuropathy * orthopaedic/ surgical/ medical conditions affecting functional mobility and balance not due to diabetes or neuropathy (e.g. stroke, prosthesis use, osteoarthritis) * retinopathy * end-stage renal disease requiring dialysis * congestive heart failure

Keywords: diabetes mellitus diabetes mellitus, type 2 diabetes complications diabetic foot diabetic neuropathies gait balance, postural muscle strength exercise therapy physical therapy modalities endocrine system diseases peripheral nervous system diseases metabolic diseases glucose metabolism diseases quality of life training
optimization of therapeutic drug monitoring of vancomycin in pediatric patients with an implanted port catheter

Conditions: Catheter Related Blood Stream Infections

Summary: the goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.

in this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. to ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously. flushing will be done with sodium chloride 0.9 % solution.

Eligibility criteria:
inclusion criteria: * pediatric patients with a port catheter * treated with systemic vancomycin and/or vancomycin "lock" exclusion criteria: * age \> 18 years * active downgrading of care

Keywords: vancomycin therapeutic drug monitoring catheter related blood stream infections
effects of manual lymphatic drainage and therapeutic ultrasound on breast engorgement

Conditions: Postpartum Complication

Summary: to find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.


Eligibility criteria:
inclusion criteria: * both primiparous or multiparous breastfeeding women * bmi: ≤30-≥25 (14) * immediate puerperium with normal or c - section non-premature childbirth (19) * postnatal lactating mother with symptoms of breast engorgement exclusion criteria: * any breast infection, abscess, mastitis, breast cancer * torn/bleeding or crack nipples * any skin condition like dermatitis, psoriasis etc * non-lactating mothers * having heart pacemaker

Keywords: breast engorgement manual lymphatic drainage therapeutic ultrasound pain self-efficacy post - partum women.
reduction of postoperative pain, nausea and vomiting

Conditions: Post Operative Pain; Nausea and Vomiting

Summary: aim of this prospective study was to assess the quality of postoperative care in a postoperative anaesthesia care unit (pacu) using postoperative pain, nausea and vomiting as well as their reduction as quality markers. so far, only sparse data related to this topic are available and there are currently no established quality markers of a pacu service.


Eligibility criteria:
inclusion criteria: all patients that have been transferred to the postanesthesia care unit postoperatively

Keywords: quality of the anaesthetic care in a pacu reduction of postoperative pain reduction of postoperative nausea and vomiting quality markers
study of pancreatic neuroendocrine tumors and carcinomas in alsace region

Conditions: Pancreatic Neuroendocrine Tumor

Summary: pancreatic neuroendocrine tumors and carcinomas (pnet) see the last year their incidence and prevalence going up. on the basis of their grade of differentiation and proliferation ratio measured ki67 staining, there are divided into 3 grade groups : grade 1 with ki67 between 1 and 3%, grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with ki67 greater than 20%, so undifferentiated carcinomas. pnet is a heterogenous group of tumors with variable prognosis. the aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. the primary endpoint is the description of clinic and pathological parameters of patients from alsace. the secondary endpoints are the identification of prognostic factors in this population


Eligibility criteria:
inclusion criteria: 1. major topic ((≥18 years) 2. subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma 3. subject with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease. 4. subject covered in one of the participating centres between 01/01/2008 and 01/01/2019 5. have a pre-therapeutic biological check-up 6. subject who has not expressed opposition to the use of his or her data for research purposes exclusion criteria: 1. subject who expressed opposition to participate in the study 2. lack of histological data 3. minor subject 4. patient under the protection of justice 5. subject under guardianship or trusteeship

Keywords: pancreatic neuroendocrine tumors neutrophil-to-lymphocyte ratio
effects of sarcopenia on early postoperative outcomes in patients undergoing surgical treatment for gastric cancer

Conditions: Gastric Cancer; Sarcopenia; Malnutrition; Cachexia; Complication

Summary: we aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

among gastrointestinal disease, gastric cancer is a malignancy which is diagnosed predominantly in advanced stages, mostly accompanied with malnutrition when diagnosed, has aggressive behavior with poor oncological outcomes. the only option for curative treatment is surgical resection in this malignancy; however, the surgical procedure itself causes high morbidity and mortality rates. therefore, physicians combine various treatment modalities and risk assessment to decrease complication and mortality rates. sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. for the diagnosis of sarcopenia, using the presence of both low muscle mass and decreased muscle function (strength or performance) is recommended. previous studies showed that colorectal or pancreatic cancer accompanied with sarcopenia has adverse effects on not only for short term and also for long term outcomes. the majority of studies regarding gastric cancer was published from eastern countries owing to their high incidence. there are few studies from western countries which are mostly retrospective and does not meet the diagnostic criteria of sarcopenia. in the western population, there is no high-quality evidence so far regarding the impact of sarcopenia on early outcomes of gastric cancer surgical treatment.

Eligibility criteria:
inclusion criteria: 1. patients undergoing gastric surgery for gastric cancer 2. histologically proven gastric adenocarcinoma 3. patients over 18 years 4. patients who agreed to participate in the study exclusion criteria: 1. patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy) 2. patients received palliative surgery without gastric resection (bypass procedures) 3. patients required thoracotomy/thoracoscopy

Keywords: sarcopenia cancer gastrointestinal
the optimum time for preoxygenation based on body mass index

Conditions: Body Weight; Obesity

Summary: the purpose of this study is to evaluate the relationship between the time needed to raise the oxygen concentration in patient's blood to 90% and his/or her body mass index. the prevalence of obesity in our society continues to rise. no studies have shown the time required for preoxygenation (oxygen given) in relation to body mass index (body weight in kg/height in meter2).

100% oxygen given to patient before induction of anesthesia (asleep) is the standard clinical care. however, studies using various methods have shown differences in terms of the optimal time, technique and number of breaths needed for efficient oxygenation. the only difference to the standard pre-anesthesia care is that we will record the time to raise patient oxygen to 90%. age is recorded to ensure that the subjects fall within our inclusion criteria. the weight (w) in kilograms and height (h) in meters will be used to calculate the body mass index (bmi): bmi = w/h2. alveolar oxygen uptake is dependent on respiratory rate, heart rate, blood pressure, temperature and hemoglobin level. these parameters are measured in order to identify factors that may affect the accuracy of the study. we will record the pulse oximetry value to note the initial oxygen saturation on room air and after the oxygenation. facial hair and mask fit are recorded to assess possible failure of an optimal facemask seal. end-tidal carbon dioxide (fe'co2) is also measured to ensure an adequate facemask seal. anxiety can increase the respiratory rate, heart rate and affect patient compliance with a fitted facemask. all of the aforementioned values are recorded to assess reasons for possible failure of the preoxygenation technique and inaccurate results.

Eligibility criteria:
inclusion criteria: * participants between the ages of 18-50 years with no limitations as to gender or race * participants classified as asa 1 or 2 * participants capable of understanding and signing an informed consent exclusion criteria: * conditions which would affect their oxygenation such as heart disease, lung disease, anemia (hemoglobin less than 12 g/dl) * history of smoking (smoking can affect pulmonary function and oxygen carrying capacity) * acute substance abuse (substance abuse can affect respiratory function). * maxillofacial abnormalities which would interfere with proper face mask seal.

Keywords: pre-oxygenation body mass index end-tidal o2 anesthesia induction
study to evaluate the pk of iv and po omadacycline in children and adolescents with suspected or confirmed bacterial infections

Conditions: Bacterial Infections

Summary: the purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.


Eligibility criteria:
inclusion criteria: * male or female subjects, age 8 to \< 18 (inclusive) who have written and signed parental/legal authorized representative (lar) informed consent and pediatric assent. * currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline. * weight within the 5th and 95th percentile for age and sex. * subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study exclusion criteria: * evidence of a medical condition that may pose a safety risk or impair study participation. * confirmed or suspected sars-cov-2 infection. * has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic. * has received an investigational drug within the past 30 days.
a study of s-1 in combination with gemcitabine as first-line treatment in patients with advanced biliary tract cancer

Conditions: Advanced Biliary Tract Cancer(BTC)

Summary: primary objective: to evaluate disease control rate (dcr) of s-1 in combination with gemcitabine in patients with advanced biliary tract cancer secondary objectives: * to evaluate overall response rate (orr) * to evaluate progression-free survival (pfs) * to evaluate overall survival (os) * to assess the safety profile


Eligibility criteria:
inclusion criteria: * 1.histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of vater); * 2.metastatic or unresectable disease; * 3.no history of chemotherapy or radiotherapy for biliary tract cancer; * 4.presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (ld) ≥20 mm using conventional techniques or ≥10 mm with spiral ct and mri; measurable lymph nodes must be ≥15 mm in the short axis; * 5.adequate hematopoietic function which is defined as below: 1. hemoglobin level ≥ 9 g/dl; 2. absolute neutrophil count (anc) ≥ 1,500/mm3; 3. platelet count ≥ 100,000/mm3; * 6.adequate hepatic function which is defined as below: 1. total bilirubin ≤ 1.5 times upper limit of normal (uln) and \< 2 mg/dl, or total bilirubin \< 3 mg/dl if biliary drainage was performed; 2. alanine aminotransferase (alt) ≤ 3 x uln or alt ≤ 5 x uln in the presence of liver metastasis; * 7.adequate renal function: creatinine clearance rate (ccr) ≥ 60 ml/min ((based upon 24-hour urine collection or calculated by cockroft-gault formula); * 8.age of 20 years or above; * 9.ecog performance status 0-1; * 10.life expectancy of at least 12 weeks; * 11.ability to take oral medication; * 12.ability to understand and willingness to sign a written informed consent document. exclusion criteria: * 1.other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ; * 2.history or known presence of brain metastasis; * 3.presence of grade 2 or above ascites or pleural effusion; * 4.presence of grade 2 or above diarrhea; * 5.presence of mental disease or psychotic manifestation; * 6.active or uncontrolled infection; * 7.significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion; * 8.pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.