Kornimate/medical-research-clean huggingface dataset:
study on the dose-response relationship of pharmacodynamic parameters in patients with hemophilia with inhibitors

Conditions: Hemophilia A With Inhibitor; Hemophilia B With Inhibitor

Summary: randomized, double-blind, single-dose, 5 ways crossover, exploratory clinical trial evaluating four different doses of aryoseven (eptacog alfa, activated) and novoseven on selected pharmacodynamic parameters in patients with hemophilia with inhibitors.

randomized, double-blind, single dose, 5 ways crossover, clinical trial evaluating four different doses (10 µg/kg, 30 µg/kg, 90 µg/kg, and 270 µg/kg) of aryoseven (recombinant human fvii activated or eptacog alfa, activated) and one dose of novoseven (30 µg/kg) on selected pharmacodynamic parameters (pd) \[primary: thrombin generation assay (tga)\] in male adult and adolescent (\>12 years) patients with hemophilia a or b, with an inhibitors titer \>5 bethesda units \[bu\] and not in bleeding status. this will be an exploratory study to evaluate dose-response relationship of pd markers as surrogate efficacy endpoints.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of congenital haemophilia a or b with inhibitors to fviii or fix titer \>5 bethesda units \[bu\] * with \> 2 episodes of bleeding/year requiring treatment with fvii infusions, not in bleeding episode * male adults and adolescents (\>12 years) * patient informed consent has been obtained \[patients to be enrolled must also provide voluntary written informed consent to the protocol prior to screening to be eligible for the study. for adolescents, parent/legal guardian must provide consent and, wherever possible, patient assent will also be obtained. for compromised patients, their designated proxy must provide informed consent\]. * patients willing and able to be hospitalized prior to time of study medication administration for plasma sampling (5 times during the study). exclusion criteria: * any other type of congenital or acquired coagulopathy, such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy. * antibodies against factor vii * ongoing bleeding prophylaxis regimens with aryoseven/novoseven or planned to occur during the trial * platelet count less than 100.000 platelets/mcl (at screening visit) * any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism * hiv positive with current cd4+ count of less than 200/µl * liver cirrhosis * factor viii/ix immune tolerance induction regimen planned to occur during the trial * known hypersensitivity to the study medication * parallel participation in another experimental drug trial. * parallel participation in another marketed drug trial that may affect the primary end-point of the study. * concomitant diseases and/or medications, or any other conditions, that render the patient unsuitable for inclusion into the study in the judgement of the investigator.
impedance sensor evaluated in peripheral artery disease for tissue detection

Conditions: Peripheral Vascular Disease

Summary: the objective of the study is to evaluate the feasibility of the csgs sensor to differentiate tissues involved in peripheral artery disease (pad).

the objective of the study is to evaluate the feasibility of the csgs sensor to differentiate tissues involved in peripheral artery disease (pad) previously the csgs was used in a clinical study in stroke patients (the clot out study) to direct a catheter through blood vessels and to measure electrophysiological parameters in the blood vessels during procedures. in the current study however, a commercially available ce marked guidewire will be used to direct a catheter through blood vessels while the clotild® smart guidewire system will only be used to perform electrophysiological measurements in the blood vessels during peripheral endovascular procedures. it is thus designed for use as an adjunct to conventional angiographic procedures.

Eligibility criteria:
inclusion criteria: * age \> 18 years * subjects with acute and chronic occlusions in the arteries of the lower limbs * patients eligible for endovascular interventional procedures * written informed consent to participate in the study. exclusion criteria: * target vessel aneurysm * target vessel diameter \<2mm * lesions starting at the common iliac artery * any subject that is, according to the discretion of the investigator, not eligible for study participation * known lactating or confirmation of positive pregnancy test according to site specific standard of care

Keywords: pad
using spices and herbs to increase vegetable intake among urban high school students

Conditions: Poor Nutrition

Summary: a two-phase, school-based intervention will be conducted at a high school in baltimore to evaluate whether the addition of spices and herbs to vegetable dishes in the national school lunch program (nslp) can increase vegetable intake among students in an urban and predominantly african-american high school.

the proposed research will be conducted at cristo rey jesuit high school in baltimore, maryland. in this two-phase intervention, the research team will work in phase i with stakeholders throughout the high school community to identify the barriers to vegetable intake in the nslp in this student population and to determine how spices and herbs might help overcome these barriers. the stakeholders with whom we will collaborate will include students, school administration, and cafeteria staff. phase ii will focus on the direct measurement of vegetable intake among students both before and after spices and herbs are added to the vegetables in the nslp. the spiced vegetable recipes that received the most favorable student rankings in the taste tests of phase i will be offered. the vegetable recipes flavored with spices and herbs will meet all nslp requirements for fat, sugar, total calories, and all other guidelines. student vegetable intake will be assessed through two outcomes: 1.) plate waste, and 2.) production waste.

Eligibility criteria:
inclusion criteria: * enrolled student at cristo rey high school * able to read and write english (exclusive to phase 1 participants) exclusion criteria: * does not eat lunch in the cristo rey high school cafeteria * not willing to complete questionnaires (exclusive to phase 1 participants)

Keywords: spices herbs vegetables national school lunch program high school
efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and north america. the aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.


Eligibility criteria:
inclusion criteria: * - informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * - subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. stable is defined as unchanged medication and dose * - hba1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive) * - body mass index equal to or above 20 kg/m\^2 exclusion criteria: * - any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol * - treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. an exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness * - female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice) * - history of chronic pancreatitis or idiopathic acute pancreatitis * - screening calcitonin value equal to or above 50 ng/l * - personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * - diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) * - impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit * - impaired renal function defined as estimated glomerular filtration rate 60 ml/min/1.73 m\^2 per modification of diet in renal disease formula * - any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening * - heart failure, new york heart association class iv * - uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg)
creatine to augment bioenergetics in alzheimer's

Conditions: Alzheimer's Disease

Summary: by doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with alzheimer's disease.

alzheimer's disease is a progressive brain disorder that causes memory and thinking problems. current medications may temporarily help with symptoms but cannot stop the disease from getting worse. as such, new treatments that slow or stop the disease from progressing are needed. there is some evidence from animal studies that taking creatine monohydrate may improve thinking in alzheimer's disease and be good for brain health. however, no studies have looked at creatine monohydrate supplementation in humans with alzheimer's. creatine monohydrate is a dietary supplement regulated by the fda. this is a study that will test if taking creatine monohydrate may be a helpful treatment for people with alzheimer's disease. in this study, investigators will will evaluate: 1. whether persons with alzheimer's disease are able to easily take creatine monohydrate for 8 weeks. 2. whether creatine monohydrate affects thinking function in people with alzheimer's disease. 3. whether creatine monohydrate affects certain biochemicals in the brain and body. 4. whether creatine monohydrate improves muscle size and strength.

Eligibility criteria:
inclusion criteria: * diagnosed cognitive impairment due to alzheimer's disease * agreed cooperation from a study partner * speaks english as primary language * age 60 to 90 * stable medication for ≥30 days * bmi ≥ 20.0kg/m2 exclusion criteria: * insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or recent cardiac event (i.e., heart attack, etc.) * other neurodegenerative disease * ongoing renal disorder or abnormal renal or liver function * unable to undergo mri * clinical trial or investigational drug or therapy participation within 30 days of the screening visit * non-english speakers * inability to perform strength testing * weight \> 350 lbs.
fluoride varnish for childsmile nursery school attenders

Conditions: Dental Caries

Summary: the study will compare the effectiveness of duraphat® fluoride varnish in preventing any further dental decay among 3-4 year old children in nursery schools. it is important to ascertain the additional preventive value that fluoride varnish may provide when applied in conjunction with other preventive measures which form part of a national dental health improvement programme targeting children at risk from dental decay. 1600 children will be recruited into the study for 2 years.

the objective of this study is to compare the effectiveness of duraphat® fluoride varnish plus treatment as usual (tau) with tau only in preventing any further dental decay. thus the study is a clinical trial of treatment as usual (tau) versus tau plus fluoride varnish in the nursery school setting. tau is the core childsmile nursery intervention (supervised daily toothbrushing with fluoride toothpaste, free dental packs of fluoride toothpaste, toothbrushes and advice). children will be screened by asking parents whether or not the child has previously been hospitalised with asthma or diagnosed with any allergies. provided that a child has no contraindications to fluoride varnish then the child can proceed to study inclusion. on the day of the planned application, the dental nurse will carry out a risk assessment to reduce the possibility of children with oral/facial infections being included. after excluding non-eligible children, a baseline dental examination will take place, followed by randomisation into treatment as usual or treatment as usual plus fluoride varnish. this second group will receive up to four fluoride varnish applications at 6 month intervals. after two years, all study children will be offered a final dental examination.

Eligibility criteria:
inclusion criteria: * children attending nurseries which cover significant numbers of children whose home postcode is within the most deprived quintile of postcodes as measured by the scottish index of multiple deprivation (simd) (scottish government 2011). * children in the first year of nursery school (known as the 'ante pre school year'). on average the children will be three years old. * every eligible child in participating nurseries will be invited to join the study, irrespective of the simd ranking of their own postcode. * children with or without pre-existing cavities, as the cavity can be treated through the usual primary care dental service (i.e. as part of 'treatment as usual'). exclusion criteria: * children with contraindications for the duraphat® varnish i.e. hypersensitivity to colophony and/or any other constituents, ulcerative gingivitis, stomatitis, bronchial asthma, history of allergic episodes requiring hospital admission (e.g. asthma). * receipt of fluoride supplements due to a small risk of fluorosis. * abnormalities of the skin around the mouth, lips (e.g. cold sores) and soft tissue lesions.

Keywords: dental prevention caries oral children
erector spinae plane block as a rescue pain therapy in patients undergoing laparoscopic cholecystectomy

Conditions: Regional Anesthesia Morbidity; Cholecystitis, Chronic

Summary: laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases. erector spinae plane block (espb) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due to its safety applicability, and effect on both the visceral and parietal component of pain by providing paravertebral, transforaminal and epidural spread. preoperative application of espb has taken its place as a part of multimodal analgesia in laparoscopic cholecystectomy cases over time and has been shown to reduce postoperative pain scores and opioid consumption and to improve quality of recovery scores. however, there is no data regarding the use of espb in the postoperative period as a rescue therapy.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic cholecystectomy * patients with nrs\>3 scores in the pacu exclusion criteria: * asa \> 2 * violation of standart protocol (anesthesia and analgesia) * application of espb preoperatively * age \> 65 * surgery duration \>90min or \<45min
a trial to investigate different needle features assessed by comparing insulin aspart pharmacokinetic profiles

Conditions: Diabetes

Summary: this trial is conducted in europe. the aim of the trial is to investigate different needle features assessed by comparing insulin aspart pharmacokinetics profiles (the exposure of the trial drug in the body)


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male, age at least 18 years at time of signing informed consent * considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ecg (electrocardiogram), as judged by the investigator * body mass index (bmi) 28-39.9 kg/m\^2 (overweight to obese) * caucasian exclusion criteria: * male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) * non-fasting blood glucose test with blood glucose values above 11.1 millimol per liter (mmol/l) * hba1c (glycosylated haemoglobin) equal to or above 6.5% * known active or in-active skin disease in the injection area or that could affect pain perception * history of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator * use of any prescription or non-prescription medication, including herbal products and nonroutine vitamins, within the last 2 weeks before screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period * known or suspected abuse of alcohol (defined as regular intake of more than 14 units weekly for men where 1 unit equals 300 milliliter (ml) of beer, 100 ml of wine, or 25 ml of distilled spirits) * positive result of an alcohol breath test * known or suspected drug/chemical substance abuse within 1 year from screening
erector spinae plane block with two different volume for open heart surgery

Conditions: Sternotomy Pain

Summary: the erector spine plane block is currently used in many surgeries to provide postoperative analgesia. it has also been used successfully in open-heart surgery for postoperative sternotomy pain. however, an ideal volume that will provide optimum analgesia has not yet been determined. this study aims to compare the effects of esp block administered in two different volumes on poststernotomy pain.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-iii patients undergoing open heart surgery exclusion criteria: * chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
assessing the impact of the early and systematic hormonal replacement after radio-isotopic ablation of graves'hyperthyroïdism on quality of life, efficiency and tolerance

Conditions: Graves Disease (Basedow's Disease)

Summary: the aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of lt4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of lt4 as soon as the first biological signs of hypothyroidism. two hundred patients with graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. the administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 mbq/g thyroid tissue). patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. the primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (thypro). secondary objectives will compare quality of life outcomes at different study visits (using thypro and sf36), fatigue (mfis) and depression (beck), autoimmune parameters (signs of ophthalmopathy, tsh receptor antibodies assessment), efficacy and medico-economic data.


Eligibility criteria:
inclusion criteria: * patient presenting a hyperthyroïdie basedowienne proving a treatment by iodine 131. * patient without or with ophtalmopathie junior defined by a score of ophtalmopathie in 0 or in 1 and a score of clinical activity in 0 (see secondary). * patient whose rate of ft4 and\\or of ft3 is lower than 1,5 times the superior limit of the standards of the laboratory during the balance sheet(assessment) which precedes the treatment by iodine 131 (15j. * patient whose thyroïdien volume estimated by echography is lower than 60 ml. * patient whose treatment by anti-thyroïdiens of synthesis was interrupted at least 5 days before the administration of iodine 131. * 18 years old male or feminine patient or more. exclusion criteria: * patient presenting a thyroïdien nodule suspect of wickedness. * patient presenting disorders not thyroïdiens known to distort the fixation of i131 (congestive heart failure of class iii or iv, renal insufficiency). * patient having received by intravenous way a product of hydrosoluble contrast for radiography in 4 weeks preceding the randomization, or by way intra-thécale or for cholécystographie by a product of contrast iodized in three months preceding the randomization. * patient taking medicines susceptible to disrupt the function thyroïdienne or renal (renal medicines, lithium, amiodarone, in particular). * patient presenting a contraindication to levothyroxine with high dose: décompensée heart disorder, coronaropathie, shady of the unchecked rhythm. * pregnant or breast-feeding women, or patient being able to have children and refusing to follow a reliable contraceptive method during the duration of the study.
cd7 car-t in the treatment of cd7 positive refractory relapsed acute leukemia

Conditions: T-ALL

Summary: patients with acute leukemia derived from t lymphocytes have the characteristics of high expression of cd7 antigen, such as acute t lymphocyte leukemia (t-all).car-t therapy is to genetically modify the patient's t lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. car-t cells are costimulatory molecules that include single-chain antibodies (scfv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif itam), and intracellular signaling regions. the chimeric antigen receptor of cd28 or cd137(4-1bb) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous t cells, so that the modified car-t cells have targeting and specificity recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen


Eligibility criteria:
inclusion criteria: * age 12-65 * sign informed consent * expected survival time ≥ 3 months * cd7 positive refractory and relapsed acute leukemia * karnofsky score≥60 * ecog score ≤ 2 * have not received other immunotherapy within 3 months * the cd7 expression rate on the surface of leukemia cells detected by flow cytometry is greater than 30% exclusion criteria: * uncontrolled active infection * active viral hepatitis b or c * hiv test positive * congenital immunodeficiency patients * pregnant and breastfeeding patients * patients with central nervous system tumors or central nervous system leukemia * the patient and/or family members do not agree to the treatment plan