Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (ro-14) administered subcutaneously increasing single-doses to healthy male volunteers

Conditions: Healthy

Summary: clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (ro-14) administered subcutaneously increasing single-doses to healthy male volunteers


Eligibility criteria:
inclusion criteria: 1. healthy volunteers: male subjects aged between 18 and 45 years 2. body weight: 65-75 kg 3. not meaningful abnormalities in physical examination and in clinical history 4. without evidence of significant organic or psychiatric illness 5. hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory 6. vital signs (blood pressure, heart beat rate and body temperature) and ekg within normal range 7. healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months 8. not give blood in the last 4 weeks. 9. healthy male volunteers who have not received heparin in the past 10. healthy male volunteers who have accepted to participate in the study and have signed the written informed consent exclusion criteria: 1. previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption 2. important consumption of exciting drinks: alcohol consumption \> 30 g/day; coffee, tea, cola \> 5 /day 3. allergy, idiosyncrasy or hypersensitivity to medicines 4. healthy volunteers who are receiving another medication in the past 15 days 5. positive serology of hepatitis b, c or hiv 6. cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events 7. mayor surgery in the last 6 months 8. smoking \> 10 cigarettes / day 9. ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine 10. healthy volunteers with a familiar history evident hemorrhagic episodes

Keywords: pharmacokinetics ultra low molecular weight heparin
high throughput technologies to drive breast cancer patients to specific phase i/ii trials of targeted agents

Conditions: Metastatic Breast Cancer

Summary: high sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (kit mutation, erbb2 amplification, egfr mutations) together with addiction to the given target. more recently, activation of "alternative pathways" (kras mutation, pi3k mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab). from these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen. based on these concepts, numbers of phase i/ii trials enrich their populations in patients presenting specific molecular alterations. high throughput technologies (array cgh, sequencing, gene expression array) identify deregulated genes. in addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). in a pilot study that included 135 patients, we recently performed a combination of array cgh and hot spot mutation array in order to drive patients into phase i/ii clinical trials. this study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify "targetable" genomic alterations in around 40% of samples. in the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase i/ii trials.


Eligibility criteria:
inclusion criteria: * men and women with histologically diagnosed breast cancer * metastatic relapse or stage iv breast cancer at diagnosis * metastases amenable to biopsy * age \<70 years old * ps 0/1 * no restriction regarding the number of previous chemotherapy or endocrine therapies exclusion criteria: * age \<18 * life expectancy \<3 months * symptomatic or progressing brain metastases * progressive patients at the time of biopsy * lvef \<50% (muga or ultrasonography) * inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: * absolute neutrophil count \< 1.5 x 109/l * platelet count \< 100 x 109/l * haemoglobin \< 90 g/l * asat/alat \> 2.5 times the upper limit of normal (uln) if no demonstrable liver metastases or \> 5 times uln in the presence of liver metastases * total bilirubin \> 1.5 times uln * creatinine \>1.5 times uln * corrected calcium \> uln * phosphate \> uln * abnormal blood coagulation that contra-indicates biopsy * patients deprived of liberty or placed under the authority of a tutor
safety and efficacy study to compare continuous infusion of interferon with standard of care for chronic hepatitis c

Conditions: Hepatitis C

Summary: the purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis c infection as compared to patients who receive standard treatment.

the study will include patients who are diagnosed with chronic hepatitis c genotype 1 infection and who have received no previous interferon or other anti-hcv treatment.

Eligibility criteria:
inclusion criteria: * signed patient consent form * genotype 1 chronic hcv with detectable hcv rna * no previous treatment for hcv infection * hepatitis b and human immunodeficiency virus negative at screening visit * able and willing to follow contraception requirements * screening laboratory values, test, and physical exam within acceptable ranges * weight between 40 kg and 125 kg * proficiency in the use of the external pump infusion system exclusion criteria: * current or planned enrollment in another investigational device or drug study * anticipated inability to complete all clinic visits and comply with study procedures * history of, or any current medical condition, which could impact the safety of the subject during the study * autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than hcv * alcoholism or substance abuse with \<6 documented months of sobriety * known allergy or sensitivity to interferons or ribavirin * any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study

Keywords: hepatitis c hcv genotype sustained virological response rapid virological response interferon
anti-infectious therapy of periodontitis - comparison of different clinical strategies

Conditions: Periodontitis

Summary: it is the aim of the study to evaluate the efficiency of "one stage full mouth disinfection" according to the original protocol (quirynen et al. 1995) in comparison to other approaches considering different scaling strategies and different disinfection concepts. therefore, a multicenter randomized control treatment will be performed. in total, 204 patients with chronic periodontitis shall be allocated to the following treatment concepts. group a: quadrant scaling with weekly intervals (q-srp; n = 51); group b: full mouth scaling (fms; n = 51); group c: full mouth disinfection (fmd; n = 51); group d: full mouth disinfection with subgingival glycine air polishing using erythritol powder (fmdp; n = 51). evaluation of periodontopathic parameters and periodontal pathogens at baseline, 3 months and 6 months shall give evidence about the benefits of concept and the single components of fmd.


Eligibility criteria:
inclusion criteria: * patients with generalized moderate to severe chronic periodontitis * presence of at least 18 teeth * with at least 2 multi-rooted and / or 2 single-rooted teeth in the first quadrant with at least 6 sites with periodontal probing depth of ≥ 6 mm * radiographic bone loss of at least 25% of the root length exclusion criteria: * subgingival scaling and root planing within the last 12 months * antimicrobial rinsing or intake of systemic antibiotics within the last 4 months * systemic diseases with known interactions to periodontal disease or known need for antibiotic prophylaxis * known intolerance / allergies to chlorhexidine * pregnancy

Keywords: periodontitis full mouth scaling air abrasion scaling
accuracy of the livervision® semi-automated liver volumetry software

Conditions: Liver Diseases; Liver Cancer

Summary: the livervision® software was designed to provide three-dimensional (3d) visualisation of the liver using computed tomography (ct) scans. it provides semi-automated volumetry measurements, vascular structure and territory tools.

liver volumetry has been widely used in liver surgery and living donor liver transplantation to estimate the future liver remnant or the required liver volume for the recipient, respectively. liver volumetry is typically performed using ct imaging with specially designed software. such manual measurements are time consuming and there is an ongoing debate whether the they reflect the actual liver volume when performed by radiologists or surgeons as well as according to the different software currently available in the market.

Eligibility criteria:
inclusion criteria: * adults (18 years or older) * living liver donors. exclusion criteria: * recipients

Keywords: livervision liver volumetry semi-automated living donor liver transplantation surgery
evaluation of the healthy apple program in san francisco

Conditions: Childhood Obesity

Summary: this randomized controlled trial uses administrative public health screening data to test whether the healthy apple program (hap), designed to support local implementation of national let's move! child care guidelines in san francisco (sf), improves child care center nutrition and physical activity practices and child weight change.

in the usa, first lady michelle obama started a nationwide child care initiative called 'let's move! child care' which aims to improve nutrition and physical activity practices in child care centers to promote healthy weight for children ages 0-5y. the san francisco child care wellness collaborative, including the san francisco department of public health (sfdph) and sf children's council, developed a citywide healthy apple program (hap) to support local implementation of the let's move! initiative. the san francisco department of public health (sfdh) has an existing child care health program (cchp) which provides nurse consultation and health education materials for child care centers and annual health screenings for children. the aim of this analysis is to see whether child care centers offered the hap in addition to usual cchp services can improve child care center nutrition and physical activity practices and child weight change better than usual cchp services alone.

Eligibility criteria:
inclusion criteria: * child care center received nutrition screening services from the sfdph child care health program in 2011-2012. exclusion criteria: * child care center declines cchp services in 2012-2015. * child care center is ineligible for cchp services (based on funding source) * child care center is closed or not serving children * child or family decline the voluntary services

Keywords: water physical activity child care weight change
md2me - texting to promote chronic disease management

Conditions: Cystic Fibrosis; Inflammatory Bowel Disease; Type 1 Diabetes; Chronic Disease Management

Summary: ucsd researchers are conducting a study aimed to develop and evaluate a chronic disease self management web and text message based program on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions. we hypothesize that users of the program will demonstrate greater gains between baseline and 8 month measures of health related self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care comparison group.

the md2me study (or also known as tahlc), sponsored by the national institutes of health is a 2-year randomized controlled trial to develop and test a text message and internet based intervention among adolescents and young adults with cystic fibrosis, type 1 diabetes, or inflammatory bowel disease. adolescents and young adults have been a difficult population to engage in healthcare. it is estimated that 1 in 5 adolescents do not get the healthcare they need. interventions must address how the healthcare system can engage adolescents with chronic disease and provide opportunities to discuss health-related matters and improve disease outcomes. this study will help fill multiple gaps in the literature by exploring the utility of a push and pull sms texting-based application for chronic disease management among youth. based on social cognitive theory, the intervention will use accessible technology to promote disease management among adolescents with chronic disease as they transition to adult care. the popularity and usage of sms already demonstrated by adolescents suggests notable promise for the sms-based tahlc program to promote chronic disease self-management and healthcare engagement with substantial positive impacts on health among youth with chronic disease.

Eligibility criteria:
inclusion criteria: * ages 14 - 22 years * have cystic fibrosis, type 1 diabetes, or inflammatory bowel disease for at least 6 months * have access to the internet * speak english * has a parent that speaks english or spanish (if primary participant is under 18) * willingness to attend assessment visits exclusion criteria: * pregnant or have children * have a history of substance abuse or other psychiatric disorder that would impair compliance with study protocol

Keywords: cystic fibrosis inflammatory bowel disease type 1 diabetes chronic disease management sms text messages internet healthcare interactions
robotic therapy early after stroke events

Conditions: Stroke

Summary: weakness and impairment of the upper limb is a common contributing factor to post stroke disability. specially designed robotic systems have been developed to try to improve this. the investigators already know that their use helps improve limb function after stroke when it has been present for many months. the investigators do not know whether they can help early after stroke and enhance recovery of limb function, and perhaps prevent weakness becoming chronic. the investigators plan a randomised controlled blinded study to explore the benefits of robot assisted therapy early after stroke in 80 stroke survivors. participants will be randomised by 7 days after stroke to standard care or to robotic therapy (40 participants per study group). standard of care will be rehabilitation therapy according to local guidelines delivered by nhs multidisciplinary team. robotic therapy sessions lasts approximately one hour and consists of a series of tasks in first the unimpaired then impaired limb. the robotic-assisted therapy will consist of a series of taks including circle-drawing, reaching targets and holding/moving against moderate resistance. twelve sessions of therapy within the first 4 weeks after randomisation will be delivered. this study will take 3 years to complete.


Eligibility criteria:
inclusion criteria: 1. aged \> 18 years 2. confirmed diagnosis of stroke 3. randomisation by seven days 4. upper limb impairment, defined as a measurable upper limb impairment on the nihss and a baseline upper limb fuglmeyer score of \<50 at randomisation 5. able to comply with the requirements of the protocol exclusion criteria: 1. other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation. 2. diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness. 3. participation in other stroke rehabilitation trial.
validation and evaluation of a newly developed mobile diet app

Conditions: Chronic Kidney Diseases; Chronic Kidney Disease stage3; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5; Chronic Kidney Disease Requiring Chronic Dialysis

Summary: a 12-week, prospective, multicenter, open-label pilot randomized controlled trial (rct) will be carried out to determine the feasibility, acceptability and potential clinical efficacy of a newly developed mobile diet app among ckd populations at different stages in malaysia. participants will be randomly assigned into either (i) intervention group (mobile diet app) or (ii) control group (dietary counseling using conventional pamphlet).

general objective: to evaluate a newly developed mobile diet app in enhancing dietary adherence for patients with chronic kidney disease. specific objectives: 1. to validate the newly developed mobile diet app for patient with chronic kidney disease. 2. to determine the feasibility and acceptability of this newly developed mobile diet app among patients with chronic kidney disease. 3. to evaluate the preliminary efficacy of the newly developed mobile diet app in enhancing dietary adherence in patients with chronic kidney disease

Eligibility criteria:
inclusion criteria: 1. clinically diagnosed ckd / egfr \< 60 ml/min/1.73m2 for ≥ 3 months (only applicable to pre-dialysis patients. 2. undergone maintenance dialysis for at least 3 months (only applicable to dialysis patients) 3. possessing smartphone and is willing to use health app 4. alert and oriented 5. at least 18 years of age exclusion criteria: 1. inability to use the smartphone app (e.g. due to vision problems) 2. hard to comply with home monitoring (e.g. suffering from anxiety or depression) 3. refuse to comply with dietary prescription 4. patients who participate in other study at the same time 5. patients who have participated in another research study involving an investigational product in the past 12 weeks preceding enrollment. 6. planning for kidney transplant over the study duration. 7. female patients who are pregnant, lactating or planning a pregnancy during the course of the trial. 8. participants who are receiving nutritional support (i.e. enteral and intra-venous route). 9. participants who are currently receiving active treatment for cancer

Keywords: mynutrikidney
automated quantification of coronary artery calcifications on radiotherapy planning cts for cardiovascular risk prediction in breast cancer patients: the bragatston study

Conditions: Breast Cancer; Cardiovascular Diseases

Summary: the aim of the bragatston study is to provide a low cost tool for measuring cac in breast cancer patients, thereby identifying patients at increased risk of cvd. breast cancer patients and doctors can act upon this, by adapting the treatment and/or by adopting cardioprotective interventions. hereby, the burden of cvd in breast cancer survivors can be reduced and better overall survival rates can be achieved.

cardiovascular disease (cvd) is the second most common cause of death in breast cancer patients. certain adjuvant treatments (e.g. anthracyclines, radiotherapy) increase the risk of cvd, in particular in patients with pre-existing cvd risk factors. early identification of these patients enables targeted cardioprotective interventions, and switching to less cardiotoxic treatments. the strongest independent cvd risk factor is the presence and amount of coronary artery calcium (cac). in clinical practice, cac is quantified on cardiac cts. breast cancer patients treated with radiotherapy routinely undergo planning cts. these inferior quality cts may give the opportunity to routinely assess cac. the bragatston study is a multicenter retrospective observational cohort study (umc utrecht, erasmus medical center and radboudumc). the project is divided into three work packages (wp), each wp with a unique aim: wp 1: to develop/optimize and validate the umc utrecht developed automated software to determine the presence and the amount of cac (cac score) on radiotherapy planning ct scans of breast cancer patients. wp 2a: to evaluate the association between cac score measured automatically on planning ct scans and the risk of incident (non-)fatal cardiovascular events in breast cancer patients. wp 2b: to evaluate if the association as defined by work package 2a is modified by type of adjuvant treatment. wp 2c: to evaluate the association between other candidate imaging biomarkers (e.g. calcifications in other structures like the aorta or heart valves, the amount and distribution of body fat, bone characteristics) measured (automatically) on planning ct scans and the risk of incident (non-)fatal (cardiovascular) events in breast cancer patients. wp 3: to assess the added value of cac score measured automatically on planning ct scans over classic cardiovascular risk factors and over treatment characteristics to predict (non-)fatal cardiovascular events in breast cancer patients.

Eligibility criteria:
inclusion criteria: * breast cancer patients treated with radiotherapy in umc utrecht, erasmus medical center or radboudumc between 2004-16 * planning ct scan available * age: ≥18 years * gender: both genders exclusion criteria: * not applicable

Keywords: breast cancer cardiovascular diseases coronary artery calcium prediction risk stratification deep learning technique software development computed tomography scan
role of day +60 wt1 assessment on bone marrow in predicting relapse and mortality after allogeneic stem cell transplantation

Conditions: Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem

Summary: the rationale of this study is to determine if an association exists between wt1 expression and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem cell transplantation. in particular, we want to studied wt1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients.

this is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant units of policlinico agostino gemelli in rome, between june 2018 and july 2020, for whom wt1 level was assessed on bone marrow at day 60 after transplant. the minimum follow up for surviving patients will be 60 days. patients will be classified according to european leukemia net criteria. for each patient a total of 24 ml of bone marrow was collected at day +60 post transplant, whereas the same quantity of bone marrow was collected from healthy donor during bone marrow harvest procedure.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years diagnosis of acute myeloid leukemia patients received allogeneic stem cell transplantation signed informed consent to storage and use biological samples for research scope signed informed consent to privacy exclusion criteria: * patients who had received a previous stem cell transplant hematological disease other than acute myeloid leukemia patient not studied for wt1 level at day +60 after transplant