Kornimate/medical-research-clean huggingface dataset:
metabolic control and glycemic variability in type 1 diabetes and celiac disease

Conditions: Type 1 Diabetes Mellitis; Celiac Disease

Summary: this is an observational, retrospective study focused on differences of time-in-range and glycemic variability between a cohort of patients with both type 1 diabetes and celiac disease, and a cohort of patients with only type 1 diabetes.

the study design provides for 2 cohorts of pediatric and adolescent patients using the continuous glycemic monitoring sensor. cohort a consists of patients with type 1 diabetes and celiace disease, while cohort b consists of patients with only type 1 diabetes. the primary aim of the study is to assess whether cohort a patients can achieve the same metabolic control and glycemic variability goals (expressed as time-in-range and glycemic variability coefficient) as cohort b patients. the secondary aims are: assessing differences in time-in-range and glycemic variability coefficient between cohort a patients treated with multidaily injections, and those treated with continuous subcutaneous insulin infusion; assessing differences on total daily insulinic intake between cohort a and cohort b.

Eligibility criteria:
inclusion criteria: * patients \< 18 years of age at enrollment; * patients with type 1 diabetes onset since at least 1 year and celiac disease (cohort a); * patients only with type 1 diabetes onset since at least 1 year (cohort b); * using the continuous glycemic monitoring sensor; * being on treatment with continuous subcutaneous insulin infusion or multidaily injections; * obtaining informed consent from parents/legal guardian of pediatric patients. exclusion criteria: * patients with diabetes other than type1 diabetes; * patients not using the glycemic monitoring sensor.

Keywords: type 1 diabetes mellitus celiac disease
observational study of the evaluation of post traumatic stress post stroke

Conditions: Post Traumatic Stress Disorder

Summary: this prospective, observational, multicentre study evaluates the existence of post-traumatic stress disorder following a stroke at 3 and 6 months after the management of the patient. questionnaires will be used to assess the presence of stroke post traumatic disorder. the evaluation of stroke post traumatic disorder would allow to underline the importance of the awareness of the care teams in the the screening of these disorders and to evaluate if the post-traumatic stress disorder checklist scale (pcl5) is an effective screening tool.


Eligibility criteria:
inclusion criteria: * patient age \> 18years old * patient registered with a social security scheme * patient who was given a written information and who gave his/her non-opposition * patient who was hospitalized with a diagnosis of stroke in the neurology department and oriented to the post-stroke consultation (3 months after the hospital discharge) or un the follow-up care and readaptation department of hospital center of dax or mont de marsan exclusion criteria: * patient with a serious disability sequelae (mrs\>3), * patient without enough level of proficiency in the french language, * patient with neurocognitive and neurocognitive disorder diagnosed, * patient with history of significant psychiatric disorders diagnosed, * patient with seve aphasia

Keywords: pcl 5 stroke
role of embolization of thyroid arteries as a treatment for different thyroid disorders

Conditions: Graves Disease; Goiter, Nodular; Goiter Malignant; Goiter Diffuse

Summary: to investigate the safety and efficacy of selective embolization of thyroid arteries (seta) as adjunctive or definitive treatment in different thyroid disorders

in graves disease traditional forms of treatment of the thyroid diseases: pharmacotherapy, radioiodine therapy and surgery can not always be applied. intolerance, side effects of antithyroid drugs, low iodine uptake, high risk of surgery or disagreement with the proposed treatment was the reason for seeking alternative treatment methods. also in cases of large sized thyroid nodule and retrosternal extension, surgery may carries out a lot of comorbidities . with the development of interventional radiology, and gained experience in the use of arterial embolization, this method has become possible to use in treatment of thyroid diseases. the essence of this treatment is to shut down blood flow in major arteries of the thyroid by direct injection of embolizing materials (pva) into the vessel's. . the consequence of acute ischemia is necrosis of the glandular tissue in a field being supplied by this artery. further repair processes and fibrosis lead to a reduction of active thyroid hormone synthesis and restriction of thyroid gland. effects of embolization on angiogenesis, apoptosis and autoimmune reactions contribute to compensation thyroid function and significant reduction a goiter volume in course of graves' disease. preoperative selective embolization of a huge goiter or thyroid cancer improves surgery outcomes, reduces the risk of hemorrhage and damage to surrounding tissue. palliative use of embolization in advanced stages of thyroid cancer reduces symptoms and improves quality of life. little invasive nature of this procedure, the lack of serious undesirable coincidence makes embolization of thyroid arteries an attractive form of a therapy, which may become a therapeutic option in many difficult clinical situations and improve the clinical effectiveness of treatment of thyroid disease

Eligibility criteria:
inclusion criteria: a- diffuse and nodular goiter: b-toxic goiter: c-thyroid cancer: exclusion criteria: a. significant bleeding diathesis. b. contraindication for contrast media (renal impairment or allergy). c. severe atherosclerotic disease prevent arterial catheterization. d. refusal of signing a consent

Keywords: embolization of thyroid arteries
effectivity of postpartum dexamethasone for women with class i hellp syndrome

Conditions: HELLP Syndrome

Summary: corticotherapy accelerates maternal postpartum recovery in women with class i hellp syndrome. the benefit of faster and better recovery would be observed in fewer complications, less utilization of blood products and shorter hospital stay.

patients with class i hellp syndrome will be recruited for use os dexamethasone or placebo in the puerperium. effects such as clinical course (blood pressure and diureses), laboratorial behaviour and complications will be compared. duration of hospitalization will also be accessed.

Eligibility criteria:
inclusion criteria: * postpartum women with class i hellp syndrome exclusion criteria: * chronic users of corticosteroids * patients with chronic conditions affecting the laboratory parameters involved in the hellp syndrome * women who had received antenatal corticosteroids to treat hellp syndrome were excluded

Keywords: hellp syndrome dexamethasone postpartum period class i hellp syndrome
hybrid treatment of type b aortic dissection

Conditions: Aortic Dissection Type B

Summary: authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair.

main hypothesis of this study is that thoracoabdominal aortic repair combined with bare metal stent implantation is better permanent neurological deficits, perioperative bleeding, malperfusion of viscera over conventional thoracoabdominal aortic repair.

Eligibility criteria:
inclusion criteria: * patients with chronic aortic dissection type b * aortic size in descending thoracoabdominal aorta (taa) \> 55 mm exclusion criteria: * concomitant cardiac pathology * concomitant oncology diseases in the last 5 years * acute aortic dissection * aortic size in visceral zone \>45 mm * connectivity tissue diseases

Keywords: thoracic aorta abdominal aorta stents
study to determine the feasibility of sentinel node biopsy in patients with anal cancer

Conditions: Squamous Cell Carcinoma of the Anus

Summary: the purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (slnb), in patients with anal cancer.

slnb is based on the premise that lymphatic dissemination from a tumour occurs in a stepwise fashion, with initial involvement of a primary node, called the sentinel node, before dissemination to the remainder of the lymphatic chain. if the sentinel node is histologically negative, then the remainder of the nodes in the same anatomic region will be at a lower (assumed to be minimal) risk of containing metastases. slnb is part of standard care for patients with malignant melanoma and with breast cancer but has yet to be prospectively evaluated in patients with anal cancer. currently, the standard way to treat patients with anal cancer is to deliver a combination of chemotherapy and radiation to the tumour at the anus together with 'preventative' (prophylactic) radiotherapy to the lymph glands of the groin and pelvis. there is a growing perception for the need to reduce the morbidity of radiotherapy i.e. current regimens over-treat the patient and one approach is to reduce radiotherapy volume and/or dose where there is an absence or very low risk of nodal metastases. this feasibility study is a vital first step in informing the design of a larger study examining the role of slnb in clinical decision-making and outcomes for patients with anal cancer. in this trial eligible patients will attend for lymphoscintigraphy, to locate the lymph node, before sentinel lymph node removal by surgery. detection rate of the sentinel node(s) will be the key outcome for the study.

Eligibility criteria:
inclusion criteria: * patients with squamous cell carcinoma (scc) of the anus (any t size and/or those with recurrent disease) * equivocal lymph node involvement on standard ct staging or magnetic resonance (mr) staging or pet-ct scan, as determined by the anal cancer multidisciplinary team (mdt) * age \>= 18 years * written informed consent provided by the patient exclusion criteria: * patients with unequivocal lymph node involvement on standard ct staging or mr staging, as determined by the anal cancer mdt. * unfit for surgical biopsy * patients undergoing palliative treatment * previous pelvic or inguinal area radiotherapy * other coincident cancers * previous inguinal surgery (e.g. hernia repair) with mesh insertion
efficacy and safety of alpha1-proteinase inhibitor (human), modified process (alpha-1 mp) in subjects with pulmonary emphysema due to alpha1 antitrypsin deficiency (aatd)

Conditions: Pulmonary Emphysema in Alpha-1 PI Deficiency

Summary: this is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of alpha-1 mp versus placebo for 156 weeks (i.e., 3 years) using computed tomography (ct) of the lungs as the main measure of efficacy. the two alpha-1 mp doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by iv infusion for 156 weeks. the study consists of an optional pre-screening phase, screening phase, a 156-week treatment phase, and an end of study visit at week 160.


Eligibility criteria:
inclusion criteria: * have a documented total alpha1-pi serum level \< 11 µm. * have a diagnosis of congenital aatd with an allelic combination of zz, sz, z(null), (null)(null), s(null), or "at-risk" alleles. * at the screening (week -3) visit, have a post-bronchodilator forced expiratory volume in 1 second (fev1) ≥ 30% and \< 80% of predicted and fev1/forced vital capacity (fvc) \< 70% (global initiative for chronic obstructive lung disease \[gold\] stage ii or iii). * have a carbon monoxide diffusing capacity (dlco) ≤ 60% of predicted (corrected for hgb) within the past 2 years or evidence of pulmonary emphysema on ct scan within the past 2 years per the investigator's judgment. * have clinical evidence of pulmonary emphysema per the investigator's judgment. exclusion criteria: * has received alpha1-pi augmentation therapy for more than 1 month within the six months prior to the screening visit. * has received alpha1-pi augmentation therapy within one month of the screening visit. * has had a chronic obstructive pulmonary disease (copd) exacerbation within the 5 weeks prior to the screening visit or during the screening phase. * unable to physically (e.g., unable to fit inside the ct scanner) or mentally (e.g., claustrophobic) undergo a ct scan. * history of lung or liver transplant. * any lung surgery during the past 2 years (excluding lung biopsy). * on the waiting list for lung surgery, including lung transplant. * smoking during the past 12 months or a positive urine cotinine test at screening that is due to smoking. maybe on nicotine replacement, including vapor cigarettes. * history of anaphylaxis or severe systemic response to any plasma-derived alpha1-pi preparation or other blood product(s). * use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 5 weeks prior to the screening visit (inhaled steroids are not considered systemic steroids) or during the screening phase. * use of systemic or aerosolized antibiotics for a copd exacerbation within the 5 weeks prior to the screening visit or during the screening phase. * known selective or severe immunoglobulin a (iga) deficiency.

Keywords: pulmonary emphysema alpha-1 antitrypsin deficiency aatd alpha-1 pi deficiency alpha-1 proteinase inhibitor
money or knowledge? behavioral aspects of malnutrition

Conditions: Malnutrition

Summary: malnutrition accounts for nearly half of child deaths worldwide. children who are well-nourished are better able to learn in school, grow into more physically capable adults, and require less health care during childhood and adulthood. moreover, it is difficult to make up for poor childhood nutrition later in life. i present here the proposal for an intervention that builds on a larger study in ethiopia and will generate insights into the importance of behavioral factors related to persistent malnutrition in low-income settings, allowing for more targeted, cost-effective interventions in the future. existing data from the study region, oromia, ethiopia, suggest that many mothers know how to correctly respond to a hypothetical situation where a young child exhibits poor growth. on the other hand, however, mothers frequently appear unaware about their own children's growth deficiencies. together, these facts suggest that false beliefs about the appropriateness of a child's physical size are a more likely contributor to malnutrition, rather than a weak understanding of how to help a malnourished child. the proposed intervention will provide evidence on the relationship between caregiver beliefs about child nutritional status and the caregiver's behavior, ultimately analyzing how this relationship influences important nutritional choices for young children in a setting with limited resources. the study uses a two-by-two randomized trial; the first treatment is a cash transfer labeled for child food consumption, and the second is the provision of personalized information about the quality of the child's height compared to other children like those of the same age and gender in east africa. together the two treatment arms will provide evidence about the relative importance of behavioral versus resource barriers to improved nutrition. better understanding of the interaction between these key factors is essential in addressing one of the foremost health issues facing developing countries today.


Eligibility criteria:
households for this study were selected from among those who were included in any of the three study groups from a larger study and for whom relevant data had been collected. inclusion criteria: * inclusion in the larger study required the household to have a child who was 6-35 months old for the main study's baseline survey in july-august 2015 (referred to as the index child) and for the household to have land for crop cultivation exclusion criteria: * households that did not meet the inclusion restriction or those who did not have anthropometric data collected during the larger study.
personalizing immune checkpoint inhibitor therapy

Conditions: Lung Cancer Stage IV

Summary: this prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.

overall goal: the long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors. objectives: in this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize * tumor immunogenicity * anti-tumor t-cell response * effect of checkpoint inhibitors on antigen presentation and t-cell response, and * the tumor microenvironment planned enrollment: • ten subjects with lung cancer methods for informed consent: investigators will approach subjects for informed consent

Eligibility criteria:
inclusion criteria: * subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors * availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy * informed consent exclusion criteria: • lack of informed consent
dose escalation trial of cm310 in patients with moderate-to-severe atopic dermatitis (ad)

Conditions: Moderate-to-severe Atopic Dermatitis

Summary: this is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, pk, pd, immunogenicity and preliminary efficacy of subcutaneously cm310 in moderate-severe ad subjects.

the study consists of 3 periods, a up-to-4-week screening period, a 4-week randomized treatment period and a 8-week safety follow-up period.

Eligibility criteria:
inclusion criteria: * diagnosed as ad for at least 12 months before screening, with below requirements: 1)easi score ≥16 at screening and baseline; 2) iga score ≥3 (0-5 points scale) at screening and baseline; 3) ≥10% bsa of ad involvement at screening and baseline; 4) pruritus nrs average score ≥3 at baseline. * inadequate response to topical medications. exclusion criteria: * not enough washing-out period for previous therapy. * concurrent disease/status which may potentially affect the efficacy/safety judgement. * organ dysfunction. * pregnancy. * other.
mild hypothermia and acute kidney injury in liver transplantation

Conditions: Cirrhosis; End Stage Liver Disease; Acute Kidney Injury; Liver Transplant; Complications; Chronic Kidney Diseases; Hepatitis c; Hepatitis B; NASH - Nonalcoholic Steatohepatitis; Alcoholic Cirrhosis; Hepatocellular Carcinoma

Summary: acute kidney injury (aki), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). patients who experience aki after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. in this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. the study will evaluate if mild hypothermia protects from aki during liver transplantation.

this study is a randomized controlled trial of mild hypothermia during liver transplantation to provide protection from aki. participants will be randomized to normothermia (36.5-37.5 °c) versus mild hypothermia (34-35 °c) during a portion of the liver transplant operation. the protocol is based on preliminary data from rodent models showing that hypothermia protects the kidneys from ischemia-reperfusion injury, as well as studies in deceased organ donors showing that cooling improves post-transplant organ function. temperature will be maintained with standard techniques plus a minimally-invasive esophageal cooling device that is approved by the u.s. food and drug administration. the investigators hypothesize that mild hypothermia will reduce the incidence and severity of aki after liver transplantation(ltx). standard surrogates (e.g., change in serum creatinine, need for initiation of dialysis) and biomarkers will be used to assess the severity of kidney injury.

Eligibility criteria:
inclusion criteria: * liver transplantation from a donor after neurologic determination of death exclusion criteria: * liver transplantation from a donor after cardiac death * acute liver failure * living-donor liver transplantation * simultaneous liver-kidney transplantation * preoperative renal replacement therapy * preoperative intubation * portopulmonary hypertension * machine perfusion of liver graft

Keywords: hypothermia ngal - neutrophil gelatinase-associated lipocalin
therapeutic drug monitoring for individualized clozapine therapy

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment

1. the baseline tests (sleeping tendency assessment, clinical symptom and cognitive assessments, clinical laboratory tests, genotyping, exploratory biomarker tests, etc.) are conducted to the schizophrenia patients before initiation of the clozapine dosing. 2. on day 15 and 57, the changes from baseline clinical symptom and cognitive function are assessed after clozapine treatment. also, the occurrence of adverse drug reactions are evaluated. in addition, blood sample collections are performed for the assessment of clozapine and its metabolite levels.

Eligibility criteria:
inclusion criteria: 1. patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia 2. patients who are 19 years or older 3. patient who understands the contents of the clinical research and provide their written informed consent forms exclusion criteria: 1. patients taking a drug that the researcher deems inappropriate before clozapine administration 2. patients who can not use an appropriate contraceptive method during the study period 3. patients whom the researcher deemed inappropriate for clinical research participation

Keywords: genetic polymorphism pharmacodynamic variability personalized pharmacotherapy adverse drug reaction quality of life