Kornimate/medical-research-clean huggingface dataset:
cathartic-free dect colonography for detection of colonic polyps

Conditions: Colonic Polyps

Summary: asses the clinical performance of dual-energy ctc for the detection of larger polyps 1 cm or larger without cathartic preparation.

determine the feasibility to differentiate polyps from stool with or without the use of contrast agents and to assess the feasibility and accuracy of dual energy techniques in a pilot patient study. 1.1 formulate algorithms that use dual-energy information to quantitatively measure specific material density of colon polyps in physics based simulation. 1.2 determine optimal scanning parameters on prototype ct equipment. 2.1 measure the material composition density and hounsfield number of polyps with and without simulated contrast enhancement. 2.2 measure the accuracy of dual-energy techniques to differentiate between polyps and stool and if needed using a combination of simulated intravenous enhanced polyps and contrast material tagged stool. 3.0 asses the clinical performance of dual-energy ctc for the detection of larger polyps 1 cm or larger without cathartic preparation.

Eligibility criteria:
inclusion criteria: * participants with a known colorectal polyp or colon carcinoma with pathology, at or greater than 1 cm in size on a colonoscopy that is completed either eight weeks before or after ct colonography study visit. * if receiving iodine oral or iv contrast, must have a creatinine less than 1.4 on record within last 30 days of study visit date. if no creatinine is available, one will be drawn for enrollment criteria purposes. exclusion criteria: * pregnant females. * presence of colostomy or right hemicolectomy. * inflammatory bowel disease (crohn's, chronic ulcerative colitis). * familial polyposis syndrome. * pregnant female. * creatinine at or greater than 1.4 * severe or uncontrolled chronic obstructive pulmonary disease (copd) or chronic obstructive lung disease (cold). * iodine contrast allergy.

Keywords: colonography colonoscopy virtual computed tomographic colonography large intestine colon
clinical effectiveness of obturator externus muscle injection in chronic pelvic pain patients

Conditions: Chronic Pelvic Pain

Summary: obturator externus (oe) muscle has the possibility as a pain generator, considering its anatomical and functional aspects, but this muscle as a possible target for therapeutic intervention is currently understudied in pain practice.


Eligibility criteria:
inclusion criteria: * 1. 20-75 adults/ 2. chronic pelvic pain patients who required the interventional procedures/ 3. patients with a localized tenderness on inferolateral side of the pubic tubercle exclusion criteria: * 1. severe cardiovascular disease /2. coagulation abnormality /3. patient denial

Keywords: obturator externus
prevention of capecitabine induced hand and foot syndrome

Conditions: Cancer

Summary: capecitabine is a common anti cancer drug. one of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. quite often the drug dose is reduced to suboptimal level due to this side effect. there is no way to prevent or an effective way to treat this side effect. the investigators aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

capecitabine is a common anti cancer drug. one of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. quite often the drug dose is reduced to suboptimal level due to this side effect. there is no way to prevent or an effective way to treat this side effect. our aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms. the patients will use socks containing copper-oxide impregnated fibers which are sold in the pharma stores without physician's prescription.(epa numbers 8454-2, 8454-3 from april 30 2009). drug toxicity and skin reaction will be documented.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stage iv cancer - treated with capecitabine exclusion criteria: * any patient who can not sign an informed consent * pregnant women

Keywords: capecitabine hand and foot syndrome socks copper toxicity
prospective evaluation of heartfocus

Conditions: Cardiac Disease

Summary: the study's objective is to evaluate if exams, performed with the heartfocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion. novices will be nurses without prior ultrasound experience who have received dedicated training on cardiac ultrasound and on heartfocus software. ultrasound exams will be limited to the acquisition of 10 reference views

this prospective multicentric international pivotal trial will evaluate the ability of the heartfocus software to support novices for the acquisition of 10 reference views of cardiac ultrasound. the 10 reference views are the following: parasternal long axis, parasternal short axis at the aortic valve, parasternal short axis at the mitral valve parasternal short axis at the papillary muscles apical 5-chamber, apical 4-chamber, apical 3-chamber, apical 2-chamber, subcostal 4-chamber, subcostal inferior vena cava. patients included in the study will be adult patients scheduled for an echocardiogram at one of the two investigating centers. ultrasound exams will be limited to the acquisition 10 reference views. patients will receive 2 additional limited exams, which consist of the acquisition of ultrasound clips for each of the 10 references views: one by a novice, nurses having received a dedicated training of 2 days, with an ultrasound probe and the heartfocus software with the guidance system, one by an expert (experienced sonographer/cardiologist) with the same ultrasound probe and the heartfocus software without the guidance system. a total of 8 novices will perform the acquisition on 30 patients each. in total 240 patients will be included in the study, half in each investigator center. the exams (240 acquired by novices, 240 by experts) will be analyzed by cardiologists to assess their quality. the endpoints are described below.

Eligibility criteria:
inclusion criteria: patient (male or female) over 18 years old, patient having an echocardiography examination scheduled in one of the two investigation centers. patient who has given his non-objection to participate in the research exclusion criteria: patient subject to a measure of legal protection (safeguard of justice, guardianship or curatorship), patient deprived of liberty by judicial or administrative decision, patient being unable to give his non-objection, pregnant or breastfeeding women, patient with cardiac anatomy that does not allow reference electrocardiographic sections to be made (situs inversus, single ventricle, congenital anomalies, etc), patient having benefited from prior echocardiographic exams whose reports mention poor or weak echogenicity, patient having known chest deformity that has already been mentioned in previous reports or has been the subject of investigations (pectum excavatum), patient who has undergone total or partial pneumectomy

Keywords: cardiac disease novices guidance artificial intelligence ejection fraction ultrasound
supraventricular tachycardia collection study

Conditions: Supraventricular Arrhythmias

Summary: to collect supraventricular tachycardia (svt) data for developing and testing sensing and detection algorithms for a subcutaneous implantable cardioverter defibrillator (icd).

the purpose of the svt collect study is to collect supraventricular tachycardia episode data for developing and testing new sensing and detection algorithms for a future subcutaneous icd.

Eligibility criteria:
inclusion criteria: * subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the trial is being conducted * subjects indicated for implantable cardioverter defibrillator (icd)/cardiac resynchronization therapy defibrillator (crt-d) implant or icd/crt-d change-out, or subjects indicated for an icd/crt-d that are undergoing ablation or electrophysiology (ep) study (including non-invasive ep study \[nips\]) * subjects are willing to provide informed consent exclusion criteria: * subjects who are ventricular pacing dependent * subjects with a preexisting dual/triple chamber pacemaker or icd who have a history of atrioventricular (av) block with atrial pacing \< 120 beats per minute (bpm) while awake. * subjects who are unable to tolerate elevated ventricular rates (≥170bpm) * any condition which precludes the subject's ability to comply with the study requirements * enrollment in a concurrent study (without prior study management approval) that may confound the results of this study * subjects who are legally incompetent * subjects meet exclusion criteria required by local laws and regulations (e.g. age, breast feeding, etc).
cranial osteopathy in infantile colic

Conditions: Infantile Colic

Summary: background excessive crying (infantile colic) is one of the most common complaints for which parents seek treatment. these otherwise healthy and well fed infants show no signs of failure to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe. objective to explore the feasibility of running a randomised controlled trial (rct) that investigates the effectiveness of cranial osteopathy in addition to usual national health service (nhs) care in infants with colic. methods pragmatic randomised controlled trial, involving united kingdom (uk) osteopaths in private practice and nhs health visitors. parents of 60 excessively crying infants/infants with colic will be recruited by nhs health visitors. infants will be included into the study if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive crying/infantile colic, and have no co-morbidities. participants will be randomised into the usual nhs care group or the usual nhs care plus cranial osteopathic intervention group. usual nhs care will be provided by health visitors and osteopathic treatment will be carried out by experienced osteopaths in private practice. primary outcome measures are acceptability and feasibility of intervention procedures. furthermore, changes in the frequency and duration of crying will be documented in a daily crying diary. parental quality of life will also be assessed. this pilot investigation will provide useful information in order to further develop and adapt the current interventions and trial procedures with a view to a full-scale randomised controlled trial.


Eligibility criteria:
inclusion criteria: * healthy, diagnosed with excessive crying by nhs health visitors no comorbidities parents are able to adequately communicate in english exclusion criteria: * currently participating in other therapeutic clinical trials currently receive manual therapy treatment
serum ferritin and hepicidin concentration in chronic periodontitis patients with t2dm

Conditions: Periodontitis; Type2 Diabetes

Summary: serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease


Eligibility criteria:
inclusion criteria: * patients with more than 30% of the sites had clinical attachment level (cal) 3-4mm with t2dm * systemically healthy patients with more than 30% of the sites had clinical attachment level (cal) 3-4mm * healthy subjects had clinically healthy gingiva with ≤ 3mm pocket probing depth (ppd), nearly zero plaque index (pi), gingival index (gi), zero cal. exclusion criteria: * (i) pregnancy or lactation, (ii) history of receiving professional periodontal treatment during the past 6 months; (iii) treatment with any type of medications and/ or antibiotics during the past 3 months and (iv) current or former smokers.

Keywords: periodontitis ferritin hepicidin type 2 diabetes mellitus non surgical perioontal therapy
efficacy and safety of gsk3196165 (otilimab) versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological disease-modifying antirheumatic drug (dmards) and/or janus kinase (jak) inhibitors

Conditions: Arthritis, Rheumatoid

Summary: this study (contrast 3 \[202018: nct04134728\]) is a phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of gsk3196165 in combination with conventional (cs) dmard\[s\]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (ra) who have had an inadequate response to biologic (b) dmard\[s\]) and/or jak inhibitors. the study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to gsk3196165 150 milligrams (mg) subcutaneously (sc) weekly,gsk3196165 90 mg sc weekly, sarilumab 200 mg sc every other week or placebo (three arms) respectively, all in combination with background csdmard(s). at week 12, participants in the three placebo arms will switch from placebo to active intervention (either gsk3196165 150 mg sc weekly, gsk3196165 90 mg sc weekly, or sarilumab 200 mg sc every other week). participants who, in investigator's judgement will benefit from extended treatment with gsk3196165, may be included in the long-term extension study (contrast x \[209564: nct04333147\]). any participant who does not transition into study 209564 will undergo a safety follow-up visit at week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at week 22).


Eligibility criteria:
key inclusion criteria: * \>=18 years of age * has had ra for \>=6 months and was not diagnosed before 16 years of age * has active disease, as defined by having both:\* * \>=6/68 tender/painful joints (tender joint count \[tjc\]), and * \>=6/66 swollen joints (swollen joint count \[sjc\]) * has had an inadequate response despite currently taking at least one and at the most two concomitant csdmards for at least 12 weeks, from the following: * methotrexate (mtx) * hydroxychloroquine or chloroquine * sulfasalazine * leflunomide * bucillamine * iguratimod * tacrolimus * has had inadequate response to at least one bdmard at an approved dose and/or at least one jak inhibitors at an approved dose. in both cases this may be with or without combination with a csdmard. * if surgical treatment of a joint has been performed, that joint cannot be counted in the tjc or sjc. key exclusion criteria: * has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections. * has received prior treatment with an antagonist of gm-csf or its receptor. * has known infection with human immunodeficiency virus (hiv) or current acute or chronic hepatitis b and/or hepatitis c.

Keywords: bdmard gsk3196165 rheumatoid arthritis sarilumab otilimab
kidscore d3 clinical study

Conditions: Infertility

Summary: the aim of this study is to demonstrate that the kidscore d3 may be used to identify those embryos on day 3 that are most likely to form blastocysts.

the safety and effectiveness of the kidscore d3 was investigated in a prospective study. the study was performed as a single arm, multicenter clinical study conducted at six sites in the united states. this was a non-interventional clinical study where the kidscore d3 was not used during patient treatment. briefly, the purpose of the study was to collect data to evaluate the safety and effectiveness of the kidscore d3's ability to predict which embryos are most likely to develop to blastocyst stage. this was evaluated by using the kidscore d3 as adjunct information to traditional morphological grading. imaging data was collected on embryos cultured to day 5. embryologists were masked to imaging data and evaluation was only based on morphology and kidscore d3 scores. this study aims at analyzing the utilization of established morphology methods with adjunct outcome of an algorithm (kidscore d3) that provides a score (1 - 5) from timings of morphokinetic events. a double-blinded, multi-center study, designed to evaluate the odds ratios and other measures for outcomes of methodologies used for embryo assessment: day 3 morphology alone and day 3 morphology with kidscore d3 results as adjunct information.

Eligibility criteria:
inclusion criteria: * women undergoing ivf treatment exclusion criteria: * less than 5 actively dividing embryos

Keywords: in vitro fertilization time-lapse assisted reproduction
assessment of orthopedic care of the z-shaped foot in infant

Conditions: Foot Deformities

Summary: real-life, observational, monocentric, ambispective study, carried out in france. the aim of the study is to evaluate the success rate of orthopedic management of the z-foot after at least 9 months of follow-up.

the study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. this collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents. early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.

Eligibility criteria:
inclusion criteria: * child having presented a congenital idiopathic malformation uni- or bilateral of foot in z, defined by the presence of an angular adduction of the mid-forefoot and a dorsolateral hump; * orthopedic treatment with femoropedic plasters and slotted splints in 1st intention, having started at least 9 months before inclusion; * child aged 6 months to 2 years at the start of care; * authorization of the parents or the legal representative of the child to collect personal information about their child. exclusion criteria: * child having presented a secondary z foot; * history of foot surgery; * lack of retrospective data to assess the convexity of the external edge of the foot before orthopedic care; * inability of the parents or the child's legal representative to understand the study protocol.
retransfusion or not of cardiotomy blood

Conditions: Blood Loss, Surgical

Summary: this randomised controlled trial has a non-inferiority design. the aim is to test if the blood loss (volume in ml and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? forty cabg (coronary artery by pass grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).


Eligibility criteria:
inclusion criteria: * elective cabg. exclusion criteria: * anaemia, infection, massive bleeding, cabg off pump.
early prediction of acute kidney injury among patients admitted to surgical icu

Conditions: Acute Kidney Injury; Biomarkers

Summary: early prediction of aki can help to improve patients' outcome through early institution of the appropriate intervention, thus the current study hypothesizes that urine analysis for certain markers may provide an early knowledge about the possibility of oncoming kidney affection secondary to organ and tissue trauma affecting patients admitted to surgical icu. the current study tries to evaluate the value of urinary markers as early predictors of possible development of aki in patients admitted to surgical icu.

all patients will be clinically evaluated for demographic and clinical data. severity of injury and number of surgical interventions will be evaluated using the simplified therapeutic intervention scoring system (tiss-28) and the extent of impact of associated diseases on patients' physiological and body organs' functions will be evaluated using the acute physiology and chronic health evaluation (apache ii) and sequential organ failure assessment (sofa) . higher scores indicate more severe illness and for the tiss-28 score, each therapeutic intervention will be assigned 1 to 4 points, and the points will be summed daily to obtain the overall score and higher score indicates a higher number of therapeutic interventions. diagnosis of aki development of aki within the first 48 hours after icu admission and its staging will be defined according to the acute kidney injury network criteria. each stage will be defined by the extent of change in serum creatinine level (∆scr) as follows: mild if scr was increased by ≥0.3 mg/ml or ∆scr was ≥1.5-2-fold from baseline, moderate if ∆scr was \>2-3-fold from baseline and severe if ∆scr was increase by \>3-fold from baseline . laboratory investigations blood samples will be sent for estimation of serum creatinine (scr) . urine samples will be sent for spot creatinine , ungal, kim1.

Eligibility criteria:
inclusion criteria: * all patients who were admitted to surgical icu will be eligible for evaluation for inclusion and exclusion criteria. exclusion criteria: * patients with manifest kidney disease. * patients had renal surgery * patients maintained on renal replacement therapy * patients had diabetic nephropathy. * patients had liver disease, endocrinopathies. * patients morbid obesity that was defined as body mass index (bmi) \>35 kg/m2 .
behavioral self-regulation

Conditions: Obesity

Summary: the purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.


Eligibility criteria:
inclusion criteria: * body mass index between 27 and 40 * age between 21 and 35 exclusion criteria: * report a history of eating disorder or a current eating disorder * report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician * report major psychiatric diseases or organic brain syndromes * currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months * pregnant, lactating, or less than 6 months post-partum * intend to move out of city within the time frame of the investigation or will miss multiple meetings during the study time frame
evaluation of novel point of care hepatitis b diagnostic assays

Conditions: Hepatitis B

Summary: evaluation of novel point of care hepatitis b diagnostic assays.

this study aims to evaluate the sensitivity of the following novel assays for evaluation of hbv infection and assessment of treatment eligibility; * genexpert hbv dna via fingerstick testing, * dried blood spot based hbv dna * point of care alt.

Eligibility criteria:
inclusion criteria: 1. have voluntarily signed the informed consent form. 2. 18 years of age or older. 3. hbsag positive 4. part a: not currently on antiviral therapy for hbv and hbv dna detectable or part b: stable on hbv antiviral therapy for at least 3 months with hbv dna \< 20 iu/ml exclusion criteria: 1) inability or unwillingness to provide informed consent or abide by the requirements of the study.

Keywords: hepatitis b diagnostics hbv dna alt point of care dried blood spot