Kornimate/medical-research-clean huggingface dataset:
comparison of nn1250 versus insulin glargine in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and the united states of america (usa). the aim of this trial is to compare nn1250 (insulin degludec (ideg)) with insulin glargine (iglar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing nn1250 with insulin glargine in subjects with type 2 diabetes. all oral anti-diabetic drug (oad) treatment will be discontinued when trial participant enters the main trial (nn1250-3579) with the exception of metformin and dipeptidyl peptidase-iv (dpp-iv) inhibitor treatment (only in countries where dpp-iv inhibitor treatment is approved for combination treatment together with insulin, otherwise dpp-iv inhibitor treatment is also discontinued). subjects who consent to participate in the extension trial will continue the treatment (nn1250 or insulin glargine + oral antidiabetic drugs (oads)) to which they were randomly allocated in the 52 week main trial. the main period is registered internally at novo nordisk as nn1250-3579 while the extension period is registered as nn1250-3643.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * treatment with oral antidiabetic drugs (oads) for at least three months before trial start at an unchanged dose * hba1c: 7.0-10.0% * body mass index (bmi) no higher than 40.0 kg/m\^2 * for the extension trial only: completion of the 52 week treatment period in trial nn1250-3579 (nct00982644) exclusion criteria: * treatment with exenatide or liraglutide within the last 3 months before trial start * cardiovascular disease within the last 6 months * uncontrolled treated/untreated severe hypertension * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures * cancer and medical history of cancer
dose finding study of ave1642 in patients with advanced or metastatic liver carcinoma

Conditions: Liver Carcinoma

Summary: the primary objective of the study is to select the dose of ave1642 to be administered in patients with liver carcinoma not eligible for local treatment. the secondary objectives of the study are: * to evaluate the safety profile of ave1642 as single agent and the safety profile of combinations with other anti-cancer therapies of interest in liver carcinoma , including detection of immunogenicity. * to evaluate pharmacokinetics and pharmacodynamics profiles of ave1642 as single agent or any pk interactions when given in combination with other anti-cancer therapies. * to assess the preliminary clinical activity in terms of response rate (complete response + partial response), duration of responses, stabilisation rate and duration of stabilisation, according to recist criteria. * to assess the biological activity at the tumor level.

ave1642 will be administered as an iv infusion on day 1 and then every 3 weeks for at least 2 infusions for evaluability requirements. curative and / or prophylactic management of allergic reactions during infusion will be implemented when needed. the duration of the study for one patient will include a period for inclusion of up to 2 weeks, at least 2 cycles of treatment in dose escalation step (one cycle of ave1642 alone and at least one cycle of ave1642 in combination) and at least one cycle of the combination in the extension cohort, followed, when possible, by a minimum of 30-day follow-up after the last drug administration, in order to detect any potential immunogenicity. in the second step, the patients will continue treatment until disease progression, unacceptable toxicity or willingness to stop. the expected enrolment period is 15 months with at least 30 day follow-up after the last patient treated.

Eligibility criteria:
inclusion criteria: * patients not eligible for surgical resection, liver transplantation, local ablation techniques or chemoembolisation and with histologically proven liver carcinoma whenever possible or combination of radiologically documented hypervascular liver tumour and α foeto protein level ≥ 400 ng/ml * signed and dated approved patient informed consent form prior to enrollment into the study exclusion criteria: * ecog performance status \> 2 * inadequate organ function: * neutrophils (anc) \< 1,500/mm3 * hemoglobin \< 10g/dl * platelets \< 100,000/mm3 * total bilirubin \> 1.5 x uln * asat, alat \> 3 x uln * creatininemia \> 1.5 x uln (or ≥ 2.0 mg/dl) * inr \> 1.6 * liver cirrhosis child pugh b or c (score \> 6) * hba1c \> 8% * no measurable or evaluable tumoral lesion * patients not eligible for sorafenib therapy and for whom this therapy cannot be postponed by 3 weeks (during ave1642 single treatment period) in dose escalation part * prior exposure to an anti-igf-1r class compound the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: monoclonal antibody, anti igf1r
carbohydrate restriction and prostate cancer growth

Conditions: Prostate Cancer

Summary: no treatments have been shown to slow prostate cancer progression after radical prostatectomy. we hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. a total of 60 men with a rising prostate-specific antigen (psa) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (\<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. the primary outcome is psa doubling time.


Eligibility criteria:
inclusion criteria: * received prior radical prostatectomy or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination) * psa within the past 3 months is between 0.4 and 20 if prior radical prostatectomy, or between 3 and 20 ng/ml if prior radiation therapy. * psa doubling time (psadt) \>3 months and \<36 months 1. calculated based at least 2 values (at least 0.2) in the prior 2 years with the first and last psa separated by at least 3 months 2. use all values in the last 2 years to calculate psadt 3. psadt calculated while not on androgen deprivation therapy (adt). 4. if prior adt use, then documented either a) normal testosterone or b) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate psadt. * bmi \>=24 kg/m2 * willing to be randomized to a no-diet control or a low-carbohydrate diet * reads, writes, and understands english exclusion criteria: * anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy) * current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program * currently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone (gnrh) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors). testosterone replacement is allowed but treatment should be stable during the entire study. * known distant metastatic disease * already consuming a carbohydrate-restricted or vegetarian diet * unable or unwilling to adhere to a carbohydrate-restricted dietary intervention * weight loss \>5% of body weight in the last 6 months * medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study

Keywords: diet prostate cancer carbohydrate lifestyle
role of high mobility group box 1 as a prognostic biomarker in patients undergoing valvular heart surgery

Conditions: Valvular Heart Disease

Summary: one of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. these myocardial damage and inflammatory response can cause multi-organ failure or even death.

one of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. these myocardial damage and inflammatory response can cause multi-organ failure or even death. high-mobility group protein b1 (hmgb1) is a protein which is encoded by the hmgb1 gene in human. hmgb1 is secreted by immune cells (like macrophages, monocytes and dendritic cells). activated macrophages and monocytes secrete hmgb1 as a cytokine mediator of inflammation. there are many studies suggesting the relationship between hmgb1 and acute coronary syndrome, myocardial ischemic/reperfusion injury, atherosclerosis, heart failure and other cardiac disease as a marker for inflammatory response. however, there are no other study evaluating hmgb1 as a prognostic factor after valvular surgery, so far.

Eligibility criteria:
inclusion criteria: * age ≥ 20 * patients undergoing aortic valve surgery or more than single valve surgery exclusion criteria: * age \< 20 * patients undergoing single mitral valve surgery * history of open heart surgery * emergency surgery * history of steroid medication * infective disease and/or malignant tumor * coronary artery bypass surgery or aortic replacement surgery
mixed methods evaluation of a novel apnoea event detection monitor

Conditions: Respiratory Rate

Summary: this investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea. with 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster. the current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. the respirasense sleep screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed. patients at queen alexandra hospital who are prescribed sleep studies will be invited to participate. the respirasense sleep screener data is only for comparison purposes and will have no effect on their clinical care. if patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * patients due to undergo home monitoring to investigate presence of sleep apnoeic events * patients able to provide informed consent to participate in this investigation exclusion criteria: * patients with known respiratory disorders that are uncontrolled at the time of the sleep study * patients allergic to medical grade skin adhesive * patients on long term, oral steroid use * pregnant women during second and third trimester * patients presently on any sleep disorder therapy * patients with any history of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures * patients with any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
a multicenter cohort study on maternal and infant microecology and new targets for pre-eclampsia screening in china

Conditions: Preeclampsia; Microbiome

Summary: major objective this multicenter, prospective cohort study aims at evaluating the predictive value of microbiome ,proteomics and serum markers in preeclampsia. secondary objective to evaluate the value of microbiome,proteomics and serum markers in assessing pregnancy outcome (complications during pregnancy and delivery, delivery) and neonatal prognosis.

the volunteers will be recruited from the gestational women who come to the hospital before 14 weeks of gestation. after being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. then,urines ,serums and salivas as well as vaginal swabs and feces will be taken from each volunteer at gestational ages 11-14, 22-28, 32-34 weeks and delivery period .in delivery period,we will take placentas, cord bloods, amniotic fluids if it is possible. they will be followed up to two years after the child delivery (6 weeks,6 months,1 years and 2years after the child delivery) and do the same sampling who have preeclampsia during gestation. the salivas, vaginal swabs,placentas, amniotic fluids and feces will be to perform 16s rrna(ribosomal ribonucleic acid) gene sequencing microecology assessment, body fluid samples will be to perform peptidomics by maldi-tof(matrix-assisted laser desorption/ ionization time of flight ) and metabonomics by mass spectrometer, combinations of mean arterial pressure (map), uterine artery pulsatile index , serum placental growth factor (plgf) to estimate the patient-specific risk of pre-eclampsia (pe) .

Eligibility criteria:
inclusion criteria: * aged \>=18 years; * pregnancy woman; * with a singleton pregnancy; * volunteer and receive regular antenatal examinations in the research centers; * volunteer to sign a written informed consent. exclusion criteria: * concurrent with hypertension, diabetes, liver and kidney diseases, hematonosis and other serious diseases of pre-pregnancy women, including patients requiring long-term medication for primary diseases; * with history of preeclampsia; * tumor patients concurrent with serious infection requiring long-term drug treatment; * pregnant women conceiving through in vitro fertilization; * multiple pregnancies; * patients with clear indications of medical pregnancy termination during early pregnancy; * any medical or non-medical conditions deemed inappropriate for study participation according to the investigator.

Keywords: preeclampsia
fiber and insulin sensitivity

Conditions: Obesity; Insulin Resistance

Summary: based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase scfa specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity. the objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.


Eligibility criteria:
inclusion criteria: overweight/obese insulin resistant/prediabetic participants (age 45-70 y, bmi ≥ 28 kg/m2 \< 35 kg/m2) exclusion criteria: * type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/l and 2h glucose ≥ 11.1 mmol/l) * gastroenterological diseases or abdominal surgery; * cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years; * abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day; * plans to lose weight or following of a hypocaloric diet; * regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study; * intensive exercise training more than three hours a week; * use of any medication that influences glucose or fat metabolism and inflammation (i.e. nsaids); * regular use of laxation products; * use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition). * follow a vegetarian diet. * metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body) * the use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck * claustrophobia
combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

Conditions: Port Wine Stain

Summary: port wine stain is a congenital, progressive vascular malformation of skin involving post-capillary venules that occurs in an estimated 4 children per 1,000 live births. approximately 1,200,000 individuals in the united states and twenty-six million people worldwide have port wine stain birthmarks. since most of the malformations occur on the face, port wine stain is a clinically significant problem in the majority of patients. port wine stain should not be considered a cosmetic problem but a disease with potentially devastating psychological and physical complications. personality development is adversely influenced in virtually all patients by the negative reaction of others to a "marked" person. port wine stain are initially flat red macules, but lesions tend to darken progressively to purple, and by middle age, often become raised as a result of the development of vascular nodules. hypertrophy of underlying soft tissue further disfigures the facial features of many patients.

the researcher can use alexandrite and pulsed dye lasers pulses combined delivery to improve port wine stain blanching. the alexandrite and pulsed dye lasers are both approved by the food and drug administration for the treatment of port wine stain. however, the degree of port wine stain blanching seen following either alexandrite or pulsed dye lasers treatment remains variable and unpredictable. treatment of port wine stains can use either alexandrite or pulsed dye alone and with the combined delivery of alexandrite and pulsed dye lasers pulses.

Eligibility criteria:
inclusion criteria: * port wine stain suitable for comparison testing * age \> 12 years and older * minor will be accompanied by parents or guardians during laser treatment * apparent good health as documented by medical history exclusion criteria: * history of photodermatoses or skin cancer * any therapy within the previous two months to the proposed port wine stain treatment sites * current participation in any other investigational drug or device evaluation * concurrent use of known photosensitizing drugs

Keywords: port wine stain progressive malformation of human skin
hddo-1614 intervention trial

Conditions: Osteoporosis

Summary: randomized, open-label, single-dose, 3-period, 6-sequence, 3-way crossover study


Eligibility criteria:
inclusion criteria: * body weight 50kg ≤ / bmi=18\~29kg/㎡ * a person who is determined to be eligible for the test through a physical examination or an interview * those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test exclusion criteria: * patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular * patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials * any person who shows any of the following results in the screening test 1. ast or alt \> 2 times upper limit of normal range 2. total bilirubin \> 2.0mg/dl 3. glomerular filtration rate (egfr) \< 60ml / min/ 1.7㎡ * those who show signs of hypotension (systolic blood pressure ≤ 100mmhg or diastolic blood pressure ≤ 55mmhg) or hypertension (systolic blood pressure ≥ 150mmhg or diastolic blood pressure ≥ 95mmhg) * those who have a history of drug abuse or who have a positive urine drug test
long-term follow-up survey of covid-19 vaccine after vaccination

Conditions: Coronavirus Disease (COVID-19)

Summary: this study is a long-term follow-up survey of japanese people after their second vaccination with the moderna covid-19 vaccine. the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. the main aim of the study is to check for long-term side effects of the covid-19 vaccine. this will be from 28 days to 12 months after the second vaccination of the covid-19 vaccine. the number of visits to the clinic will depend on the clinic's standard practice.


Eligibility criteria:
inclusion criteria: participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study. exclusion criteria: none
safety and efficacy study of lucanthone when used in combination with temozolomide(tmz) and radiation to treat glioblastoma multiforme(gbm)

Conditions: Glioblastoma Multiforme

Summary: the purpose of the study is to determine the effectiveness of an investigational drug called lucanthone, when combined with temozolomide (tmz) and radiation in the treatment of glioblastoma multiforme (gbm).

this is an international, multicenter, randomized, double blind placebo controlled phase ii study to evaluate the safety and efficacy of lucanthone administered as an adjunct to patients receiving primary treatment of gbm with temozolomide and radiation. eligible patients will be randomized to lucanthone or placebo arm in ratio of 1:1. the treatment period will be in two phases ; an initial six weeks of concomitant therapy with temozolomide and radiation, followed by a maintenance phase of six cycles of temozolomide given on days 1 to 5 of a 28- day cycle (+/- 3 days). lucanthone / placebo will be given as an add on in both concomitant and maintenance phases.

Eligibility criteria:
main inclusion criteria: 1. 18 and 70 years of age in india, 18 years and above in us 2. histologically proven gbm who * may or may not have undergone surgery * is scheduled to receive treatment with temozolomide and radiation. 3. karnofsky score ≥ 70%. main exclusion criteria: 1. diagnosis of recurrent brain tumor. 2. received temozolomide previously. 3. absolute neutrophil count ≤ 1.5 x 109/l. 4. screening platelet count \< 100 k/ul. 5. screening bilirubin \> 1.6 mg/dl. 6. screening creatinine \> 2.25 mg/dl in men and 1.8 mg/dl in women. 7. screening alt or ast \> 2.5 times the upper limit of the laboratory reference range. 8. unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study. 9. enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product. 10. receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study. 11. received prior chemotherapy or radiation therapy within four weeks of enrollment.

Keywords: gbm