Kornimate/medical-research-clean huggingface dataset:
crossover trials which assessed consumption of slowly digestible carbohydrates for 21 days on gastric emptying rates

Conditions: Obesity; Diabetes

Summary: to gain a better understanding about the conditioning effect of consumption of slowly digestible carbohydrate on gastric emptying rate, respiratory quotient and metabolic flexibility, this study will focus on monitoring change in gastric emptying with consumption of a single source of slowly digestible carbohydrate (30 g of raw corn starch) for 21 days and compared to a control (21 days of continious consumption of rapidly digesting carbohydrate maltodextrin).

corn starch, a commonly consumed food ingredient, considered gras (generally recognized as safe) cfr 182.70- 182.90 will be used as the test meal treatment fed to non-responding subjects (rapid gastric emptying rate after consumption of slowly digestible carbohydrate) for 1 month. corn starch will be mixed with applesauce (200 g) and a small amount of xanthan gum (amount to be determined) (gras # 121) for palatability and viscosity, respectively. in order to determine whether potential changes in gastric emptying time are induced by consumption of slowly digestible carbohydrates, a control group will be used. the control group will consume a meal composed applesauce (200 g) and xanthan gum with a fast digesting carbohydrate (30 g de -1 maltodextrinpregelatinized starch). the product is commercially available and will be provided by tate and lyle under the brand name of star-dri 1. the general term "maltodextrin" is a non-sweet nutritive polymer that consists of d-glucose units linked primarily by \[alpha\]-1-4 bonds and that has a dextrose equivalent (d.e.) of less than 20. it is regarded as generally recognized as safe (gras) by the u.s. food and drug administration for direct use as a food ingredient (gras, 21cfr184.1444).de-1 maltodextrin is commercially available and will be provided by tate and lyle under the brand name of star-dri 1. maltodextrin is a non-sweet nutritive saccharide polymer that consists of d-glucose units linked primarily by \[alpha\]-1-4 bonds and that has a dextrose equivalent (d.e.) of less than 20. it is regarded as generally recognized as safe (gras) by the food and drug administration for direct use as a food ingredient (gras, 21cfr184.1444). ultimately, this study will help elucidate attributes of carbohydrate-based foods that can promote slow digestion and create a satiety feeling and promote weight management, which can then be implemented to develop foods with superior health benefits.

Eligibility criteria:
inclusion criteria: * normal body mass index (18.5 kg/m² \< bmi \< 25) * healthy eating index score (\<65) exclusion criteria: * gastrointestinal and cardiovascular disease * food allergies or intolerances * pregnancy * smokers
phase ib of abiraterone acetate plus bez235 or bkm120 in castration-resistant prostate cancer (crpc) patients

Conditions: Castration-resistant Prostate Cancer

Summary: this is an open label study of abiraterone acetate in combination with bez235 and abiraterone acetate in combination with bkm120 in crpc patients with abiraterone acetate failure.

a dose-escalation part will first determine the maximum tolerated dose (mtd) and/or recomended dose for expansion (rde) of abiraterone acetate in combination with bez235 and abiraterone acetate in combination with bkm120 in crpc patients with abiraterone acetate failure. subsequently, the mtd and/or rde of each combination will be investigated in two expansion treatment groups of crpc patients who have failed abiraterone acetate therapy.

Eligibility criteria:
inclusion criteria: * adult males ≥ 18 years old * eastern cooperative oncology group performance status ≤ 2 * patient must have a castrate level of testosterone (\<= 50 ng/dl or 1.7 nmol/l). ( castrate status must be maintained by continued gnrh analogues unless patient has undergone surgical orchiectomy). * histologically or cytologically confirmed diagnosis of advanced or metastatic prostate cancer. * advanced or metastatic castration-resistant prostate cancer progression after abiraterone acetate failure * patients should have no more than 2 lines of prior chemotherapies including cytotoxic agents * discontinuation of all anti-androgen, anti-neoplastic or investigational treatment \>= 4 weeks (6 weeks for bicalutamide). exclusion criteria: * previous treatment with pi3k pathway inhibitors (e.g. pi3k, akt, mtor inhibitor), ketoconazole, cyp17 inhibitors (exception of aa), or enzalutamide. * patient has active uncontrolled or symptomatic cns metastases * inadequately controlled hypertension (e.g. systolic blood pressure \>=160 mmhg or diastolic blood pressure \>=95 mmhg) * patient has a qtcf \> 480 msec on the screening ecg (using the qtcf formula), has a short/long qt syndrome, or history of qt prolongation/torsades de pointes * patient has impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of study drugs * patient has a medically documented history of or active major depressive episode, bipolar disorder (i or ii), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others) * patients who experienced dose reductions and/or treatment interruptions due to abiraterone acetate related toxicities (i.e. serious aes, aes, liver toxicities during abiraterone acetate treatment

Keywords: castration-resistant prostate cancer, abiraterone acetate, bez235, bkm120, dose escalation, abiraterone acetate failure
4d-150 in patients with diabetic macular edema

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Summary: phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with diabetic macular edema (dme).

this phase 2 trial is a prospective, multicenter, randomized, active-controlled, double-masked dose-ranging trial to evaluate the safety and efficacy of 4d-150 in adults with dme. the trial will be conducted in two parts: dose confirmation and dose expansion.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * type i or type ii diabetes mellitus with macular thickening secondary to dme involving the center of the fovea; diagnosis of dme must be within 2 years of screening * demonstrate clinical response to on-study aflibercept injection in the study eye. * decreased visual acuity attributable primarily to dme * bcva in the study eye between 25 and 83 etdrs letters, inclusive (\~20/320 and 20/25, respectively) at screening * study eye amenable to ivt injection * sufficient clear ocular media, pupil dilation and fixation in the study eye to permit adequate imaging; ability to perform tests of visual and retinal function and structure; and ability to comply with other protocol-specified procedures * provide written informed consent exclusion criteria: * macular edema in the study eye considered to be secondary to a cause other than dme * systemic anti-vegf treatment (e.g. sunitinib, bevacizumab, pazopanib) within 6 months, or anticipated need for systemic anti-vegf therapy during study participation * systemic corticosteroids (oral, intravenous, intramuscular, intra-articular) or other immunosuppressive medications within 3 months * received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to 4d-150 administration (day 1) * prior gene therapy (ocular or non-ocular) and/or ocular stem cell therapy in either eye * any concurrent ocular condition in the study eye that is likely to require surgical intervention (e.g. cataract surgery) during the 2 year (104 week) study duration note: other inclusion/exclusion criteria apply.

Keywords: retinal gene therapy intravitreal gene therapy dme spectra
evaluation of the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo

Conditions: Chronic Idiopathic Constipation

Summary: the purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with chronic idiopathic constipation (cic).


Eligibility criteria:
inclusion criteria: * either has medically-confirmed diagnosis of chronic constipation (per rome iii), or meets the diagnosis as confirmed using the rome iii constipation module questionnaire during the screening period. * is male or female, 18 or older years of age * should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure exclusion criteria: * has any gastrointestinal (gi) condition, other than constipation, affecting gi motility or defecation * is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting
apatinib in recurrent or refractory intracranial central nervous system malignant tumors

Conditions: Efficacy and Safety

Summary: the patient was given a daily dose of apatinib 500mg (or based on weight). individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy.

the patient was given a daily dose of apatinib 500mg (or based on weight). individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy. brain mri+mrs was examined every 3 months; blood routine, urine routine and liver and kidney function were examined once a week.

Eligibility criteria:
inclusion criteria: * (1) 18 years \ 70 years. (2) karnofsky performance scale (kps) ≥ 60. (2) histologically confirmed diagnosis of gbm world health organization \[who\] grade iv. (3) they were required to have measurable or evaluable disease by magnetic resonance imaging (mri) confirmation and a minimum life expectancy of 8 weeks. (4) definition of relapse: all patients must have progressive disease on mri defined by response assessment in neuro-oncology (rano) criteria after the standard stupp protocol. the time interval for the start of treatment was at least 12 weeks from prior radiotherapy unless there was either histopathologic confirmation of recurrent tumor or new contrast enhancement on mri outside of the radiotherapy treatment field. (5) adequate bone marrow function (leukocyte count ≥ 4000/μl, neutrophil count ≥1500/µl, platelet count ≥100 000/µl, hemoglobin ≥8.0g/dl), adequate renal function (serum creatinine ≤ 150μmol/l, 24 hours urine protein ≤3.4g), and liver function (total bilirubin ≤34μmol/l and aspartate and alanine aminotransferase ≤120u/l). exclusion criteria: * (1) extracranial metastatic disease, (2) gliadel wafer treatment, (3) severe cardiopulmonary insufficiency, (4) status epilepticus, (5) pregnancy, (6) gastrointestinal bleeding, (7) uncontrolled blood pressure with medication (\>140/90 mm hg), (8) swallowing difficulties. (9) hiv positivity with a combination antiretroviral therapy.
therapeutic drug monitoring of secukinumab in psoriasis patients.

Conditions: Psoriasis Vulgaris

Summary: biologics such as secukinumab are currently the most effective treatment option for patients with moderate to severe psoriasis. but they are costly for healthcare systems and still described according to a'one dose fits all' dosing regimen, leading to potential over-and undertreatment. in this study we aim to investigate the predictive value of early serum trough levels of secukinumab and determine the therapeutic window of secukinumab in psoriasis patients.

patients will be included after signing informed consent. after inclusion, patients will continue on standard dosing schedule of secukinumab (i.e. subcutaneous injections once a week for 5 weeks (300 mg) followed by subcutaneous injections every 4 weeks). during each study visit blood will be taken in order to quantify ctroughs and/or anti-drug antibodies towards secukinumab. in addition, psoriasis area and severity index (pasi) and investigator's global assessment (iga) score will be evaluated by a physician. patients complete the dermatology life quality index (dlqi) and european quality of life eq-5d instrument at each visit.

Eligibility criteria:
inclusion criteria: 1. participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. participants must sign an icf indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study exclusion criteria: 1. participants who have currently a predominant nonplaque form of psoriasis 2. participants who are pregnant, nursing or planning a pregnancy 3. participants who are unable or unwilling to undergo multiple venapunctures 4. participants who are treated according to a different dosing schedule than standard dosing of secukinumab

Keywords: therapeutic drug monitoring psoriasis secukinumab
trial comparing conventional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis (survic_study)

Conditions: Decompensated Cirrhosis; Bacterial Infections

Summary: study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.


Eligibility criteria:
inclusion criteria: 1. cirrhotic patients with acute decompensation aged ≥18 years. 2. proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, appendix 1). 3. signed informed consent or consent given by their legal representatives or close relatives. exclusion criteria: 1. bacterial infection lasting for \> 48 hours. 2. infection in a critically ill cirrhotic patient (icu admission). in this population, epidemiological surveillance is standard clinical practice. 3. evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the milan criteria and non-melanocytic skin cancer can be included). 4. pregnant and/or breast-feeding woman. 5. patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
transarterial chemoembolization with lipiodol in the treatment of initial unresectable gastric cancer (gc)

Conditions: Gastric Cancer; Embolization

Summary: this is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable gastric cancer.


Eligibility criteria:
inclusion criteria: 1. pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable r0; 2. age (18-80 years old) and gender are not limited; 3. no extragastric organ transfer; 4. no serious diseases of the heart, liver, lung, kidney and other organs; 5. expected survival time \> 3 months; 6. physical performance status score ecog ≤1 point; 7. females of reproductive age must have a negative pregnancy test; or male and female patients must agree to use effective contraception during treatment and within 1 year thereafter. exclusion criteria: 1. poor coagulation function, inr\>1.5, or ongoing anticoagulation therapy or known bleeding diseases; 2. wbc \<3000/mm3 or platelet count \<50000/mm3; 3. ast and/or alt \> 3 times the upper limit of normal; 4. comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety; 5. the patient has other primary tumors.
bioequivalence study of ins062 and pharmacokinetics and pharmacokinetics study of single injection of hr20014 in healthy subjects

Conditions: Diabetes

Summary: this study was divided into two parts. the aim of this study is to investigate the bioequivalence of ins062 injection andnovorapid ® in healthy subjects(part i), and to investigate the pharmacokinetics and pharmacodynamics of single dose of hr20014 injection and biasp 30 in healthy subjects(part ii).


Eligibility criteria:
inclusion criteria: 1. male subjects aged 18 \~ 45 (including the boundary. value)(part i). subjects aged 18 \~ 45 (including the boundary value), male or female(part ii). 2. subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator 3. body mass index (bmi) between 18.0-26.0 kg/m2 (both inclusive). exclusion criteria: 1. a history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug. 2. have a history of hypertension. 3. severe systemic infectious diseases within 1 month before screening. 4. use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening. 5. presence of any abnormal and clinically significant laboratory tests. 6. 12-lead electrocardiogram (ecg) showed abnormal and clinically significant. 7. known or suspected history of drug abuse or positive urine drug screening test within screening period. 8. those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (the elder shall prevail), who participated in clinical trials are defined as random, prior to screening; 9. women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (wocbp) are reluctant to use appropriate contraception during the trial.
study on antithrombotic prevention in thrombophilia and pregnancy loss

Conditions: Pregnancy Complications

Summary: the occurrence of a spontaneous fetal loss (fl) is a rather frequent event: it has been estimated that up to 15% of pregnancies result in a fetal loss. however, recurrent events, defined as \>2 or \>3 loss, depending on the guidelines used (american college of obstetricians and gynecologists or royal college of obstetricians gynaecologists guidelines), occur in 1 % of all pregnancies and it is noteworthy that recurrent fetal loss ( rfl) in about 30-40% of cases remain unexplained after standard gynaecological, hormonal and karyotype investigations. furthermore, it is important to consider that chromosomal abnormalities are responsible for at least 60% of fl in the first trimester, thus an abnormal karyotype in the fetus should be excluded prior to consider testing women for genetic susceptibility to placental vascular complications (inherited thrombophilia). common inherited conditions, the factor v leiden (fv) and the factor ii g20210a (fii) mutations have been recognized as risk factors for fl. the efficacy of treatment with antithrombotic drugs during pregnancy in women with a history of rfl/ intra uterine fetal death (iufd) and thrombophilia is still debated, due to scarcity of available data. italian guidelines suggest the use of low-molecular-weight heparin (lmwh) in women with fv or fii mutations and previous otherwise unexplained obstetric complications, while guidelines released by rcog suggest that heparin therapy during pregnancy may improve the live birth rate in women with second trimester loss associated with inherited thrombophilias. hence, the idea to propose this prospective observational study comparing clinical data and outcomes in women with common inherited thrombophilias and in women without. during this study the investigators will collect and evaluate clinical data from examinations and visits by patients, eligible for the study as carriers of thrombophilic defects. this observation will begin before pregnancy and continue until the puerperium, allowing us to study all possible factors influencing these conditions. the study will add knowledge for improving feto-maternal prognosis and preventing spontaneous and recurrent fl. plan of the study: multicenter observational study


Eligibility criteria:
inclusion criteria: * recurrent otherwise unexplained fl (defined as \>3, or 2 in the presence of at least 1 normal fetal karyotype) (according to lussana et al.) or * at least 1 intrauterine fetal death (iufd), defined as a loss after 20 weeks of a morphologically normal fetus with/without heterozygous for factor v leiden or heterozygous for fiia20210 (ptm) exclusion criteria: * personal history of venous and/or arterial thromboembolism; * documented hemorrhagic disease; * allergy to lmwh; * uterine abnormalities; * cervical incompetence; * untreated endocrine diseases (diabetes mellitus or thyroid disease); * indication to anticoagulant treatment during pregnancy; * chromosomal abnormalities in parents
assessment of the relationship between severity of chronic venous obstruction and venous claudication

Conditions: Chronic Venous Insufficiency

Summary: assessment of the relationship between severity of chronic venous obstruction and venous claudication

the postthrombotic syndrome (pts) occurs in about 20-50% of patients after a deep venous thrombosis and significantly affects the quality of life of patients. with the patency rates of 73-100% are achieved with endovascular procedures. at 58% of patient ulcer healing was achieved. neglen et al. could a significant demonstrate an improvement in quality of life. aim of the study: to show the influence of the increased inflow to venous objectively review recanalization for patient symptoms and walking performance. therefore, before and after venous interventions, to assess walking performance and pain-free measure the walking distance of the patient on the treadmill and compare it to get a possible identifying relevant and/or significant changes.

Eligibility criteria:
inclusion criteria: 1. patients with an obstruction in the femoral vein communis, v. iliaca externa, v. iliaca communis or v. cava inferior 2. age: 18-80 years old 3. signed informed consent form 4. persons who are legally competent and mentally capable, to follow the instructions of the staff exclusion criteria: 1. patients under 18 years of age. 2. patients who are unable to consent and/or not in are able to appreciate the nature, importance and scope of the study understand and give their consent in writing. 3. persons acting by administrative or judicial order are housed in a facility 4. patients who abuse drugs 5. peripheral arterial disease stage iib, iii and iv -
home pulse oximeter use in patients with covid-19

Conditions: Sars-CoV2; COVID-19; COVID

Summary: the purpose of this study is to investigate the use of home pulse oximetry monitoring in patients with covid-19 to trend disease progression and identify need for hospitalization.

this protocol studies patients with suspected non-severe corona virus disease (covid-19) being discharged to home from an emergency department (ed) or outpatient testing center. patients will be provided a portable fingertip home pulse oximeter that measures peripheral oxygen saturation (spo2). patients will be instructed to check their resting home oxygen saturation three times per day and record these findings. they will be instructed to return to the emergency room for sustained oxygen saturation below 92% or if their symptoms are worsening and they feel they need medical attention. patients will be called once daily by the research team to collect data in real time. patients will be monitored for seven days, and at the end of the seven day period, they will return the pulse oximeter as well as a spreadsheet of their home oximetry readings. the purpose is to see if home pulse oximetry identifies disease progression and need for hospitalization in patients with covid-19. additionally, there will be analysis of trends in home oximetry readings wand predictors of morbidity and mortality.

Eligibility criteria:
inclusion criteria: * patients with suspected covid-19 as defined by the world health organization * age \> 18 exclusion criteria: * pregnancy * prisoners * lack of decision making capacity or cannot provide consent * patients being admitted to the hospital * patients on home oxygen * patients being discharged to a skilled nursing facility

Keywords: oximetry oximeter covid-19