Kornimate/medical-research-clean huggingface dataset:
medico-economic interest of taking into account circulating tumor cells (ctc) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers

Conditions: Ductal Infiltrating Metastatic Breast Cancer; Hormone-receptors Positive Breast Cancer

Summary: the stic ctc study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (ctc) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. in the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. in the ctc arm, the type of treatment will be decided by ctc count: hormone-therapy if \<5ctc/7.5mll (cellsearch technique) or chemotherapy if =5. the main medical objective is to demonstrate the non-inferiority of the ctc-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in french cancer centers. secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. the medico-economic study will compare cost per progression-free life years gained of the two strategies. the financial impact of centralized (one platform) vs decentralized (several platforms) ctc testing will be evaluated.


Eligibility criteria:
inclusion criteria: * women with metastatic ductal adenocarcinoma breast cancer * 18 years old or more * hormone receptors positive breast cancer (er+ and/or pr+) on the last pathological analysis available. * acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration * ps \<4 * life expectancy \> 3 months * evidence of measurable or evaluable disease (recist 1.1 criteria)in the 28 days before selection * information of the patient and signature of the informed consent form exclusion criteria: * patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted) * her2 positive breast cancer * history of other stage ii or iii cancer in the 5 years. history of other metastatic cancer (whatever the time between the two cancers). * persons deprived of their freedom or under guardianship. * women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.

Keywords: circulating tumor cells breast cancer hormone-receptors positive
testing latest version of nidekrs3000adv

Conditions: Glaucoma

Summary: the investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.


Eligibility criteria:
inclusion criteria: * healthy participants * 18 years old or older exclusion criteria: * those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging * subjects who are unable to maintain retinal fixation on a specified target * subjects unable to achieve sufficient pupil dilation and alignment stability for imaging to take place * subjects with media opacity which preclude high quality imaging will be excluded. * vulnerable subjects * subjects under 18 * pregnant subjects * economically and educationally disadvantaged subjects * decision impaired subjects * homeless subjects
virtual reality (vr) diagnostic tool for attention deficits/hyperactivity disorder (adhd)

Conditions: ADHD; Executive Dysfunction

Summary: attention deficit/ hyperactivity disorder (adhd) is a common neurodevelopmental disorder. the common diagnostic of adhd is based on psychiatric examination and interview. so far, there is not any other diagnostic tool for adhd nowadays. therefore, virtual reality (vr) technology can be used as a stimulus, replacing real stimuli, recreating experiences, which are in the real world would be impossible. consequently, adhd-vr diagnostic tool development should be started to justify the adhd diagnosis in psychiatric out-patient clinical services.

diagnostic test is a very essential in modern medical practices, especially in child and adolescent psychiatry field because the main diagnostic tool is only based on psychiatry interview and observation. using diagnostic tool can help a confirmation towards specific clinical diagnosis, provide more evidence for eliminating one diagnosis versus another, provide more evidence for parents, or to rule out the differential diagnosis. even though psychiatric examination is the main approach on adhd diagnostic procedure, however the laboratory testing or imaging examination is also used especially to rule out the general medical condition or to find out any medical conditions that mimic adhd but not to facilitate the adhd diagnosis per se. nowadays, the expand study in biological psychiatry has found a lot of biological markers in adhd as well; but none is really sensitive and specific for adhd diagnostic test. therefore, there should be another approach for developing diagnostic tool in adhd. vr is one of the best approach bacasue these days, because vr as an adhd diagnostic tool could create and replace real stimuli, recreating experiences, which could not be observed by the clinician at the out-patient clinic.

Eligibility criteria:
inclusion criteria for adhd group: * children with adhd drug naive * parent willing to participate in the study by signing informed consent * children willing to participate the adhd-vr diagnostic tool for at least 30 minutes exclusion criteria: * having untreated chronic physical illnesses * having other mental disorders except adhd inclusion criteria for healthy children group: * do not have any mental disorder * do not have untreated chronic physical illnesses * parent willing to participate in the study by signing informed consent * children willing to participate the adhd-vr diagnostic tool for at least 30 minutes

Keywords: adhd virtual reality, diagnostic tool neuropsychological test indonesia
examination the ability to early diagnose hcc by combining three biomarkers technology developed by wako, and their relevance to cirrhotic of patients with various backgrounds and the israeli population.

Conditions: Fibrosis

Summary: examination the ability to early diagnose hcc by combining three biomarkers technology developed by wako, and their relevance to cirrhotic of patients with various backgrounds and the israeli population. this blood test will serve as an additional diagnostic tool tools currently in use (ultrasound and afp levels) to cirrhotic patients with high risk to develop hepatocellular carcinoma. another group that will be examined for all three biomarkers will be patients which already diagnosed with hepatocellular carcinoma, and have normal afp level in order to examine the correlation between the presence of tumor, the number of them and the tumor size and the three biomarkers concentration in their blood


Eligibility criteria:
inclusion criteria: * patients with chronic liver disease or cirrhotic or with diagnoses hcc with hcv, hbv, nafld, alcohol background exclusion criteria: * patients with chronic liver disease or cirrhotic or with diagnoses hcc with autoimmune background or other background than hcv, hbv, nafld and alcohol.
virtual and physical health assessments and treatment plans

Conditions: Vascular Diseases

Summary: the aim of the current study is to compare virtual clinic visits (i.e., real-time, face-to-face visits conducted over the internet with tablet devices) to actual physical clinic visits. after both types of visits (virtual versus physical) physicians will be asked to classify patients into low, moderate or high risk for a vascular intervention. it is hypothesized that there will be good agreement between classifications made after the virtual visits as compared to those made after physical visits. that is, virtual visit classifications will be as good as those made after physical visits.

patient dissatisfaction can increase because of the complexities associated with navigating modern health care systems. it is easy to speculate that some of this dissatisfaction is associated with travel, wait times and other issues that arise during routine clinic visits. the authors of recent studies have demonstrated that it is possible and feasible to conduct many routine visits remotely. it is our belief that virtual health assessments and treatment plans (vhat) conducted remotely can be as effective, perhaps be more efficient and increase patient satisfaction when compared to regular physical health assessments and treatment plans (phat). physicians want to provide optimal health care; however, in geographically isolated areas such as some locations in west virginia that can be a challenge. it seems reasonable to believe that monitoring patients with telehealth technology, collecting on-going real time data and conducting vhat can provide high quality health care for patients. it can also help to classify health risk, increase patient and medical staff satisfaction, decrease staff time for visits, while at the same time increase the efficiency of the follow-up process. the investigators plan to compare the physician assessments and future treatment plans made using vhat to those made after phat. it is believed that vhat assessments will be in agreement with those made with phat.

Eligibility criteria:
inclusion criteria: -patients referred to and scheduled for an initial visit at our vascular center of excellence (vcoe). exclusion criteria: * patients that are deemed urgent cases by the vcoe, and scheduled within two weeks for the initial clinic visit. * patients who are scheduled to have the placement of an arteriovenous (av) fistula at the time of the initial clinic visit.

Keywords: vascular clinic visit tele-health
lung cancer patients and parent-child interaction experience and process

Conditions: Lung Cancer Patients; Parent-child Interaction

Summary: type of study: the goal of this observational study is to explore the relationship between patients with advanced lung cancer and their parent-child interactions during the treatment process, and to understand the impact of the degree of self-differentiation of parents with advanced lung cancer on the physical and mental health of their children. the main questions it aims to answer are: 1. to explore the post-illness adjustment process of patients with advanced lung cancer and the changes in the parent-child relationship among adolescents. 2. to explore the changes in demographic factors-self-belief, mental health, and self-efficacy among patients with advanced lung cancer-and the parent-child relationship among adolescents. 3. explore the family resilience of patients with advanced lung cancer - family peer relationships, and the interaction between parent-child relationships among adolescents.

this study explores the relationship between late-stage lung cancer patients and their parent-child interactions during the treatment process, and understands the impact of the degree of self-differentiation of parents with late-stage lung cancer on their children's physical and mental health.

Eligibility criteria:
inclusion criteria: 1. patients with advanced lung cancer aged 40 to 64 years (mid-adulthood). 2. there are lung cancer patients in the family who are teenagers aged 10 to 19 years old. 3. those who voluntarily participate in this study. 4. voluntary participants can express themselves orally and in handwriting. exclusion criteria: 1. single lung cancer patients over 65 years old. 2. lung cancer patients under 40 years old. 3. patients diagnosed with early-stage lung cancer. 4. those who have cognitive impairment and are unable to understand the problem. 5. those who are unable to express and respond to questions.
double pet project : a comparison between 11c-acetate and 11c-acetoacetate heart and kidney uptake

Conditions: Ketoses, Metabolic

Summary: the objective of this study is to make a comparison between 11c-acetate and 11c-acetoacetate heart and kidney metabolism

healthy people will have two positron emission tomography scan to perform. one, with a 11c-acetate tracer and the other with 11c-acetoacetate. the results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis

Eligibility criteria:
inclusion criteria: * aged between 18 and 55 * bmi between 18,5 and 28 * healthy * normal value for blood pressure exclusion criteria: * taking drugs that could influence metabolism * diabetes or prediabetes * pregnancy or lactation * participation in a intensive sport program * being on a ketogenic diet * any clinical abnomally in prescreen blood sample

Keywords: ketones heart metabolism kidney metabolism
volasertib in japanese patients with acute myeloid leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: to investigate safety, tolerability, maximum tolerated dose of volasertib in japanese patients with aml


Eligibility criteria:
inclusion criteria: 1. patients with diagnosis of aml (except for acute promyelocytic leukemia, apl) according to the world health organization definition and with one of the following features at screening * relapsed or refractory aml * untreated aml patients not considered to be suitable for standard induction therapy according to investigator's judgement 2. male or female patients of age \>/= 18 years at the time of informed consent 3. eastern cooperative oncology group performance status score 0 - 2 at screening 4. signed written informed consent consistent with japanese good clinical practice. exclusion criteria: 1. patients with apl 2. patients in the third or later relapse 3. prior stem cell transplantation 4. treatment with systemic therapy for the primary disease (including an investigational drug) within 14 days before the first dose of volasertib with the exception of hydroxyurea, or lack of recovery from any acute toxicities or clinically significant adverse events pertinent to the prior systemic therapy 5. treatment with gemtuzumab ozogamicin within 6 weeks before the first dose of volasertib 6. concomitant medication/treatment with anti-leukemic chemotherapy (systemic or intrathecal), radiotherapy, immunotherapy, or any investigational agent while receiving study treatment 7. other malignancy requiring treatment at the time of screening 8. clinical central nervous system (cns) symptoms deemed by the investigator to be related to leukemic cns involvement or requiring treatment
tace-haic vs. haic for potentially resectable hcc

Conditions: Potentially Resection; Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is one of the most commonly malignant tumors around the world. hepatic resection or liver transplantation is the radical method to cure the disease. however, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. therefore, in clinical practice, transarterial chemoembolization (tace) is a preferential and standard treatment of potentially resectable hcc. each trial opened the door to folfox-based system chemotherapy for advanced hcc patients. recently, investigators have showed that hepatic arterial infusion of folfox-based chemotherapy (haic) was safe and efficient for hcc patients. several clinical studies showed that haic bring better tumor response rate that the conditional tace. the combination of tace with haic (tace-haic), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of hcc cells and increase the hepatectomy rate. however, this hasn't been verified in clinical application. to identify a more effective and safety way for treating potentially resectable hcc patients, this study is designed to compare the safety and efficacy between haic and tace-haic for those patients.


Eligibility criteria:
inclusion criteria: * age 18-75 years * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * diagnosed as potentially resectable with consensus by the panel of liver surgeons * stage bclc a/b, without extra-hepatic involvement * no previous anti-hcc treatment * eastern co-operative group performance status 2 or less * liver function: child's a or b (score \< 7) exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * underlying serve cardiac or renal diseases * known or suspected allergy to the investigational agent or any agent given in association with this trial * patients ineligible for hepatic artery embolization
extension study sci-scv-hcv-p2-001: long-term fu in subj who opt for retreatment with peg-inf and rbv after completing treatment in hcv

Conditions: Chronic Hepatitis C

Summary: this is an extension of ongoing study sci-scv-hcv-p2-001 in which subjects will be invited to participate in this extension study if they complete treatment in study sci-scv-hcv-p2-001 and are eligible for retreatment with peg-ifn and rbv.

in this extension study, subjects will be asked to give permission to share their hcv rna viral load test results, obtained from local laboratories, at the different time points and will also be asked to give permission to share their soc dosing information (peg-ifn and rbv). as no scv-07 treatment, procedures, or assessments will be required during this extension study, no related safety information will be collected. the study will last up to 72 weeks after subjects complete treatment on study sci-scv-hcv-p2-001 and begin retreatment with peg-ifn and rbv.

Eligibility criteria:
inclusion criteria: * subjects who satisfy all of the following criteria may be enrolled into the study: subjects must be able to understand and sign an icf approved by the investigator's institutional review board (irb) for this study; must have completed treatment on study sci-scv-hcv-p2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current soc (peg-ifn and rbv). exclusion criteria: * subjects who satisfy any of the following criteria will not be enrolled into the study: subjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-ifn and rbv for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial.

Keywords: hcv genotype 1 relapsers non cirrhotic chronic hepatitis c
moderate-to-vigorous physical activity for glycemic control in patients with gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus; Exercise

Summary: patients with newly diagnosed gestational diabetes will be recruited. the control group with get routine diet and exercise counseling. the intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. all participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. the primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. the hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.


Eligibility criteria:
inclusion criteria: * gestational diabetes mellitus * singelton pregnancy * 18 years old or older * no medical contraindications to exercise exclusion criteria: * multiple gestation * non-english speaking * unable to exercise * preexisting diabetes

Keywords: gdm a1gdm a2gdm
probiotics and low protein diet in advanced chronic kidney disease

Conditions: Renal Failure Chronic

Summary: here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.

prolowckd is a single-centre, double-blind, placebo-controlled, randomised study. at enrolment (t0) participants were prescribed a lpd in addition to their ongoing pharmacological therapy and according to their comorbidities; after 2 months (t2) they were randomized in accordance to a 1:1 ratio to receive probiotics or placebo for other 3 months (t5) in addition to the continuation of lpd. enrolled subjects are invited to assume two doses of probiotic/placebo for 1 month and 1 dose for 2 months. randomization is 1:1 to receive odd- or even envelopes, according to the odd- or even registration number at enrolment. neither the clinician nor the patient knows the content of the odd- and even envelopes. the evaluations will be performed according to the following schedule: at t0 nephrological evaluation and biochemical analysis, dietary counselling, illustration of protocol and signing of the informed consent, administration of the sf36 questionnaire, body composition evaluation by bioimpedentiometry. at t0, t2, t5: blood biochemical parameters: haemoglobin, urea, creatinine, mean urea and creatinine clearance, ckd and mdrd calculation, sodium, potassium, uric acid, calcium, phosphate, pth, acid-base balance, crp, albumin, pc, is, lp-pla2, lps; 24h-urine biochemical parameters: urea, creatinine, sodium, proteins; microbial stools analysis; clinical nephrological and dietitian evaluation.

Eligibility criteria:
inclusion criteria: * age 18-80 years * gfr \< 20 ml/min/sqm * afferent to the outpatient clinic in the nephrology and dialysis unit (azienda ospedaliero universitaria maggiore della carità) drop out or exclusion criteria: * subject refusing to sign the informed consent * administration of prolonged antibacterial therapy * dialysis initiation * death

Keywords: low protein diet chronic kidney disease gut microbiota microbial uremic toxins probiotic bacteria intestinal dysbiosis
31p magnetic resonance spectroscopy fructose study

Conditions: Healthy

Summary: the purpose of this study is to determine the effects of an oral fructose challenge on liver adenosine triphosphate (atp) reserves using 31p magnetic resonance spectroscopy (mrs) as a potential measure measure of liver health.

this study uses 31p spectra acquired from the liver in healthy subjects following a fructose drink to monitor atp levels. this is also related to baseline bmi, liver glycogen and liver lipid levels

Eligibility criteria:
inclusion criteria: * male * age 18 - 30 * bmi 20 - 27 kg/m\^2 * healthy exclusion criteria: * smokers * liver disease or metabolic disorders * metal implants (not suitable for mri)

Keywords: nafld oral fructose challenge 31p mrs liver subjects
phase 1 alks 1140 in healthy adults

Conditions: Central Nervous System Diseases

Summary: to evaluate the safety and tolerability of alks 1140 in healthy adult subjects


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥18 and \<30 kg/m2 exclusion criteria: * clinically significant illness or disease including significant cardiac, gastrointestinal (stomach) * subjects who have known allergic reactions to food or medications * women of childbearing potential * any clinically significant lifetime history of suicidal behavior or ideation (thoughts) * subject had lymphoma, leukemia, or any malignancy within the past 5 years