Kornimate/medical-research-clean huggingface dataset:
virtual environment radiotherapy to improve patients' compliance to radiotherapy (rt) in prostate cancer

Conditions: Prostate Carcinoma

Summary: purpose of the study 1. to assess whether offering visual information to patients with prostate cancer prior to receiving rt increases the participant's compliance. 2. to assess whether increased compliance translates into reduced side effects from rt (assessed with a quality of life questionnaire). type of study. this is a randomised control trial which will include 170 patients with the histological diagnosis of prostate cancer in the study arm and 170 patients with the histological diagnosis of prostate cancer in the control/standard arm.

the oncology department at the royal stoke university hospital is a state of the art facility. it has radiotherapy (rt) facilities such as imrt and rapid arc, leading the way in rt planning and delivery. the investigators want to further their expertise and public involvement in rt planning with this proposal. this study follows a pilot study in which patients receiving rt were shown how treatment is planned and given using a 3 dimensional (3d) imaging system. it was noticed that patients with prostate cancer entering the pilot study might have been more compliant (holding water before each treatment session) than those with prostate cancer not entering the study. on this basis, the investigators wish to run this project in which prostate cancer patients will be shown how rt is planned and given using 3d images prior to start rt (study arm, 170 patients) or after completion of rt (control/standard arm, 170 patients). a sample size calculation was performed (see below) in order to distinguish a 10% improvement in retention of bladder volume over the course of treatment. rt planning will be carried out using standard procedures at the oncology department. however, each study patient's ct scan image will be placed in the virtual environment for radiotherapy training (vert) system. the original images will not be altered and will be presented using the established jimage dicom libraries. 3d models will be constructed from the ct images. the system allows moving the 3d images using a mouse. planning ct scans will be taken prior to rt, on the first 3 days, and once weekly during rt to measure bladder volumes (this is standard practice and no patients will have extra ct scans). the investigators will assess whether patients in the study arm were more compliant in holding water when compared to control cases.

Eligibility criteria:
inclusion criteria: * patients with the histological diagnosis of prostate cancer due to receive radical rt. * patients with prostate cancer deemed fit enough to complete a course of radical rt to their prostate area. * patients able to give informed consent. exclusion criteria: * the only exclusion criteria is for participants unable to understand the study aims and therefore unable to give informed consent.
trial of vitamin d to reduce risk and severity of covid-19 and other acute respiratory infections

Conditions: Covid19; Acute Respiratory Tract Infection

Summary: coronavit is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin d status results in reduced risk and/or severity of covid-19 and other acute respiratory infections.


Eligibility criteria:
inclusion criteria: 1. uk resident 2. age ≥16 years 3. gives informed consent to participate exclusion criteria: 1. taking digoxin, alfacalcidol, calcitriol, dihydrotachysterol or paricalcitol 2. known diagnosis of sarcoidosis, primary hyperparathyroidism, renal stones or renal failure requiring dialysis 3. known allergy to any ingredient in the study capsules (vitamin d, olive oil, caramel, gelatine or glycerol) 4. pregnancy
study of the efficacy and safety of alirocumab (regn727/sar236553) in combination with other lipid-modifying treatment (lmt) (odyssey options i)

Conditions: Hypercholesterolemia

Summary: this is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (hefh).


Eligibility criteria:
inclusion criteria: 1. patients with screening (visit 1) ldl-c greater than or equal to 70 mg/dl with documented cvd, not adequately controlled with a daily dose of atorvastatin. or 2. patients with screening (visit 1) ldl-c greater than or equal to 100 mg/dl at high risk for cvd who are not adequately controlled with a daily dose of atorvastatin. exclusion criteria: 1. ldl-c greater than 250 mg/dl 2. ldl-c less than 70 mg/dl at the screening visit in patients with history of documented cvd 3. ldl-c less than 100 mg/dl at the screening visit in patients without history of documented chd or non-chd cvd, but with other risk factors 4. tg greater than 400 mg/dl 5. homozygous fh (clinically or previous genotyping) 6. currently taking a statin that is not atorvastatin 7. currently taking ezetimibe (eze) 8. not on a stable dose of allowable lipid modifying treatments (lmt) (the inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
auto-immune diseases and quality of life

Conditions: Systemic Auto-immune Diseases; Quality of Life

Summary: systemic lupus erythematous (sle), systemic sclerosis (ssc) and inflammatory myopathy (im) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in france. these diseases belong to the group of auto-immune diseases and require specialized follow-up in an expert centre. the repercussions of sle, ssc and im on the everyday life of patients are heavy, and notably linked to skin involvement, to diminished functional capacities and psychological problems. the vast majority of these diseases concern middle-aged, professionally-active individuals, for whom the socio-professional repercussions are major and too often neglected. the aim of this study is to analyse the consequences of auto-immune diseases on quality of life. current quality of life questionnaires are not suitable, and do not reveal the reality of the situation and its different nuances. in this research, the quality of life of patients will be envisaged through their everyday lives. how do these patients construct the social reality of the disease? how do they perceive their health status and their social situation? how do they organize their everyday lives around the disease: work, leisure, relationships with their entourage... ?


Eligibility criteria:
inclusion criteria: * for all patients: * patients aged 18 to 75 years * patients able to understand written and spoken french * patients who have been given oral and written information about the research for patients with sle: - sle defined by american college of rheumatology (acr) 1997 criteria for patients with systemic sclerosis: - ssc according to the leroy or american rheumatism association (ara) criteria for patients with im: - im according to the trojanov criteria exclusion criteria: * refusal to take part in the study * cognitive/psychological status incompatible with interviews
glucocorticoid induced whole body catabolisme

Conditions: Whole Body Catabolisme Induced by Glucocorticoids

Summary: the main purpose of the trial is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid.

long-term treatment with glucocorticoid induces a general state of catabolism and increases insulin resistance. the underlying mechanisms are insufficiently characterized, however glucocorticoid induced changes of growth hormone (gh) and the insulin-like growth factor i (igf-i) appear to be of outmost importance. we wish to investigate the mechanism behind glucocorticoid induced catabolism and insulin resistance. more specific we wish to investigate: * whether glucocorticoid induces igf-i inhibiting substances in serum or interstitial fluid that block the ability of igf-i to phosphorylate its receptor in vitro * whether glucocorticoid inhibits intracellular igf-i and insulin signaling in vitro and in vivo * the mechanisms by which growth hormone counteracts the cg-mediated inhibition of igf-i action

Eligibility criteria:
inclusion criteria: * signed and dated informed consent * healthy subjects * sex: male * age 20-30 years * bmi 19-26 kg/m2 * normal hba1c exclusion criteria: * suspected og known allergy to the trial drug or similar medications. * known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhythmia. * daily drug intake (excluding over-the-counter medicines). * known or previous mental illness * current participation or previous participation in experiments using ionizing radiation for a year prior to inclusion in this study. * participation in a larger x-ray examinations in trial period.

Keywords: protein breakdown insulin resistance glucose intolerance lipolysis
renal function determination in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: we have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin c, because of its nature could improve diagnostic accuracy to determinate the renal function in this population. the investigators hypothesize that glomerular filtration obtained from cystatin-c-derived formulas are more accurate when compared to creatinine-derived formulas with dtpa-tc99 (diethylene-triamine-pentaacetate- technetium-99) as gold standard.

the aim of the study is to determine if the formulas for glomerular filtration are close to the estimation of actual renal function in mexican cirrhotic patients of different etiologies.

Eligibility criteria:
inclusion criteria: * liver cirrhosis * stability in creatinine levels in the previous three months (variation \<0.3 mg/dl) * signed informed consent exclusion criteria: * pregnancy * hepatocellular carcinoma * cerebrovascular events * decompensated heart failure * drugs that modify serum creatinine levels * renal replacement therapy

Keywords: liver cirrhosis glomerular filtration cystatin c
preeclampsia-like syndrome induced by covid-19: is it a real public health issue in pregnancy during the pandemic?

Conditions: Covid-19; Preeclampsia; Pregnancy Related

Summary: by applying polymerase chain reaction (pcr) test for covid-19 to preeclampsia patients who applied to our hospital during the covid-19 pandemic period, we investigated the frequency of covid-19 related preeclampsia-like syndrome in this patient group.

the investigators studied the frequency of covid-19 related preeclampsia-like syndrome by pcr test and lung ultrasound for covid-19 to preeclampsia patients presenting to the instutution during the covid-19 pandemic period. the first consecutive 100 preeclampsia patients presented to our hospital during the pandemic will be involved in our study. the primary outcome measure is to detect covid-19 positivity among the preeclamptic pregnant women..

Eligibility criteria:
inclusion criteria: * first consecutive 100 pregnant women presenting with preeclamptic symptoms and signs between march 15, 2020 and june 1, 2020. exclusion criteria: * the pregnancies with known diagnosis of preeclampsia before covid-19 pandemic * preeclamptic patient without a covid-19 pcr test result * pregnant women who does not want to participate in study or does not want their personal informations to be shared * pregnant women less than 18 years old and more than 40 years old are excluded

Keywords: covıd-19 pregnancy preeclampsia preeclampsia-like syndrome
continuous use of cocs

Conditions: Pregnancy Prevention

Summary: the primary objective is to determine if continuous coc use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day coc regimen.

family health international has recently initiated a usaid funded study to investigate the pregnancy rates, continuation rates, and acceptability of cocs in women taking cocs by the 21/7 cyclic regimen compared with the continuous use of cocs with bleeding-signaled hormone-free intervals. the primary objective is to determine whether continuous coc use leads to higher 12-month continuation rates than use of the standard 28-day coc regimen. secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months between the continuous use group and the 28-day group 2) compare coc continuation rates through 6 months between the continuous use group and the 28-day group 3) compare acceptability of the two coc regimens 4) to compare bleeding and other side effects between the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the continuous use group and the 28-day group

Eligibility criteria:
inclusion criteria: * age 18-30 * currently has menstrual periods every 21-35 days * willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements * has signed the informed consent form * has a negative urine pregnancy test at enrollment exclusion criteria: * has contraindications to coc use (see who mec-3rd edition) * is in any other research study * has been pregnant in the past 3 months * is breastfeeding or has breastfed in the past 3 months * is currently using an iud (women who agree to iud removal are eligible once the iud is removed) * has had an injection of dmpa in the past 6 months * has had an injection of net-en in the past 3 months * has used combined injectables, oral contraceptive pills, implants, or a hormonal iud in the past 2 months * has had any of the following conditions since her last pregnancy, or since menarche if never pregnant: * pelvic infection treated with antibiotics * diagnosis of infertility * endometriosis

Keywords: ae adverse event aids acquired immunodeficiency syndrome alt (sgpt) alanine aminotransferase art antiretroviral therapy ast (sgot) aspartate aminotransferase dcf data collection forms dmc data monitoring committee fda (u.s.) food and drug administration gcp good clinical practice guidelines hb sag hepatitis b surface antigen ich international conference of harmonisation ind investigational new drug application irb institutional review board iu international units mg milligram(s) mm3 cubic millimeter(s) pcr polymerase chain reaction sae serious adverse event µg microgram uln upper limit of the normal range wb western blot
a study of rc48-adc combined with pyrotinib for treatment of local advanced or metastasis nsclc with her2 mutation

Conditions: Non-small Cell Lung Cancer

Summary: this study will evaluate the efficacy, safety and pharmacokinetics of rc48-adc for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with her2 mutation.


Eligibility criteria:
inclusion criteria: * voluntary agreement to provide written informed consent. * predicted survival ≥ 12 weeks. * according to uicc/ajcc 8th edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic nsclc. * is willing and able to provide an adequate archival tumor tissue sample * has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy. * measurable lesion according to recist 1.1. * documented her2 exon 20 insertion mutation. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * adequate organ function. * for female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. male subjects: patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study. * willing and able to follow trial and follow-up procedures. exclusion criteria: * no known egfr, alk, ros1, ret, ntrk, met 14 or braf v600e mutation. * patient has had previous treatment with her2-targeted therapy prior to study participation. * history of major surgery within 4 weeks of planned start of trial treatment. * diagnosed with hbsag, hbcab positive and hbv dna copy positive, or hcvab positive, or hivab positive. * has received a live virus vaccine within 4 weeks of planned start of trial treatment. * nyha class iii heart failure. * suffering from active infection requiring systemic treatment. * uncontrolled hypertension, diabetes, interstitial lung disease, or copd. * treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
treatment of elevated blood pressures in early pregnancy

Conditions: Elevated Blood Pressure; Pregnancy Induced Hypertension

Summary: this is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.

patients will be randomized to treatment of elevated blood pressures (120 or greater systolic or 80 or greater diastolic) versus non-treatment. after randomization to treatment, patient's will be treated with either nifedipine or labetalol (both medications that are standard of care for treatment of elevated blood pressure during pregnancy). the purpose of this study is two-fold: 1) determine if treatment of elevated blood pressures (120 or greater systolic or 80 or greater diastolic) versus non-treatment improves maternal and fetal outcomes and 2) determine if icg directed treatment is optimal as icg will not be used to determine treatment medication (this will be done by secondary analysis after conclusion of the study).

Eligibility criteria:
inclusion criteria: * patients presenting for obstetric care at marshall university (huntington office and teays valley office) between 12 and 16 weeks gestation with a systolic blood pressure of 120 or greater or a diastolic blood pressure of 80 or greater. eligibility for this study will be have blood pressures between 120-139 systolic and 80-89 diastolic. randomization to control, labetalol, or nifedipine will be performed after patient consent. exclusion criteria: * patients already be on medication for hypertension. * patients with the diagnosis of chronic hypertension * patients with a bp of 140 or greater systolic or 90 or greater diastolic (this meets criteria for chronic hypertension in pregnancy). * patients actively using any illicit substance or have history of substance use disorder. * patients who are actively consuming alcohol during pregnancy. * patients with type i or type ii diabetes mellitus. * patients with end stage renal disease. * patients less then 12 weeks gestation or greater than 16 weeks
safety and efficacy of apd356 in the treatment of obesity

Conditions: Obesity

Summary: this is a research study of an investigational drug, apd356, a novel, selective 5-ht2c receptor agonist, in clinical development as a potential treatment for obesity. the purpose of this study is to obtain a preliminary assessment of the safety and efficacy of apd356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy. subjects who are on concomitant medications for control of hypertension or blood lipids may qualify.

this is a double-blind, placebo-controlled, randomized, parallel group study. three different doses of apd356 or placebo will be administered daily for 12 weeks, to obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. approximately 400 subjects will be enrolled.

Eligibility criteria:
inclusion criteria: * healthy male or nonpregnant, nonlactating females aged 18-65 years (inclusive) * body mass index (bmi) of 30-45 kg/m2 * non-smoker * no concomitant medications other than hypertension medications (stable \> 90 days) and/or statins (stable \> 90 days) * no past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency * no more than mild mitral valve regurgitation and absence of aortic valve regurgitation upon screening echocardiogram

Keywords: serotonin 5-ht2c satiety obesity appetite suppressant weight loss overweight
role of fdg-pet ct in the management of muscle invasive bladder cancer

Conditions: Muscle Invasive Bladder Cancer

Summary: bladder cancer is the seventh cause of cancer mortality in france. overall survival is poor, between 45 and 50% at 5 years. optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (mibc). guidelines do not recommend fdg-positron emission tomography (pet) computed tomography (ct), but rather ct for lymph node and metastatic staging, despite its low accuracy. we performed a retrospective analysis of patients undergoing pet ct for localized mibc in two centers, to help define the utility of pet ct in this setting.

background: bladder cancer is the second most frequent genito-urinary cancer, and the seventh cause of cancer mortality in france. overall survival is poor, between 45 and 50% at 5 years. curative treatment of muscle invasive urothelial carcinoma localized to the bladder includes cisplatin-based neoadjuvant chemotherapy, followed by radical cystectomy with lymph nodes dissection. nonetheless, surgery indications depend on pre-operative staging regarding nodes and metastatic involvement. computed tomography (ct) scan is the reference imaging study for loco-regional and metastatic staging. lymph node involvement evaluation is based on morphologic criteria only. its sensitivity lies between 30 and 53% and its specificity between 67 and 91%. yet, optimal node staging is crucial for therapeutic decision. fdg-positron emission tomography (pet) ct, using both morphologic and functional criteria, could help for node staging in muscle invasive bladder cancer assessment, especially by detecting infracentimetric involved lymph nodes. moreover, it could be useful for detecting distant metastasis. objective: to evaluate the accuracy of the pet ct for lymph node staging and to determine the rate of treatment modification according to pet ct results methods: retrospective study based on the medical records of every patient undergoing a pet ct at the time of diagnosis of mibc from 01/2005 to 12/2017 in bordeaux (bergonie institute and university hospital). pet ct could have been done before any treatment (pet 1) and/or after neo-adjuvant chemotherapy and before surgery (pet 2).

Eligibility criteria:
inclusion criteria: * diagnosis of muscle invasive urothelial carcinoma of the bladder (classified at least pt2 on turb) * diagnosis between january 2005 and december 2017 * pet ct done during initial assessment before surgery (at the time of diagnosis and/or after neoadjuvant chemotherapy) * management of cancer at institut bergonié or at bordeaux university hospital * previous treatment for non muscle invasive bladder cancer allowed exclusion criteria: * management of cancer outside of institut bergonié or bordeaux university hospital * no pet ct done during initial assessment (before surgery) * rare pathological type of bladder cancer without urothelial carcinoma (epidermoid carcinoma, neuro-endocrine carcinoma, ...) * extra-vesical urothelial carcinoma

Keywords: bladder cancer pet ct ct scan lymph node staging tnm staging