Kornimate/medical-research-clean huggingface dataset:
sonovue®-enhanced ultrasound (us) versus unenhanced us for focal liver lesion characterization

Conditions: Liver Neoplasms

Summary: the purpose of this study is to demonstrate the sensitivity and specificity of sonovue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant flls using final diagnosis based on histology or combined imaging (ce-ct and/or ce mri)/clinical data as truth standard.

unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Eligibility criteria:
inclusion criteria: * male/female. * provides written informed consent and is willing to comply with protocol requirements. * is at least 18 years of age. * has at least 1 fll (target lesion) requiring work-up for characterization. target lesions may include those: incidentally detected, in subjects with chronic hepatitis or liver cirrhosis, in subjects with known history of malignancy. * is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the sonovue® administration or * in case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a ce-ct and/or ce-mri of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of sonovue®. exclusion criteria: * has an acoustic window insufficient for adequate ultrasound examination of the liver. * has a fll that cannot be identified with unenhanced ultrasound. * has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion. * is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of sonovue®. * has previously been enrolled in and completed this study. * known right to left cardiac shunt, bidirectional or transient. * has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of sonovue®). * has any contraindication to 1 of the planned imaging procedures (ultrasound, ct or mri), e.g., implants, claustrophobia, inadequate medical conditions etc. * has received an investigational compound within 30 days before admission into this study. * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations. * is determined by the investigator that the subject is clinically unsuitable for the study. * is a pregnant or lactating female. exclude the possibility of pregnancy by: testing on site at the institution serum βhcg within 24 hours prior to the start of sonovue® administration, surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses.
study evaluating the effect of person-centred care for patients admitted for inpatient care at an internal medicine unit

Conditions: Endocrine System Diseases; Gastrointestinal Diseases

Summary: patients admitted to internal medicine care environments have complex care needs and must be treated as persons with resources and responsibilities. person-centred care is defined as care in which the caregiver aims to get to know the patient as a person, and the care comprises a holistic approach to assess patients' needs and resources. there is strong motivation for future health care to transform into an approach that acknowledges and endorses every patient's resources, interests and needs. there is limited existing research on the benefit of implementing person-centred care in internal medicine care environments for all patients regardless of diagnosis or care pathway. little is known about the effects of person-centred inpatient care on patients' satisfaction with care. this study includes adult patients admitted to an internal medicine inpatient unit regardless of reason for admission. the aim of the study is to evaluate effects of person-centred inpatient care on care processes, in terms of satisfaction with care and person-centred content in medical records and to evaluate effects on self-reported health and self-efficacy.


Eligibility criteria:
inclusion criteria: * acute or elective admission with a minimum projected in-hospital stay of 24 hours * age ≥ 18 years * conscious and alert, with no delay in response. exclusion criteria: * cognitive impairment or a judgment by the caregivers that inclusion was not in the best interests of the patient (e.g. end of life care, impaired psychological wellbeing).

Keywords: person-centred care intervention inpatient care satisfaction of care quasi-experimental internal medicine
the effects of tourniquet use in total knee arthroplasty

Conditions: Blood Loss

Summary: tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral tka with two different durations of tourniquet use. investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

fifty participants who underwent staged bilateral tka were recruited in this study. on one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. on the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (dvt) incidence and clinical outcomes were monitored for comparison.

Eligibility criteria:
inclusion criteria: * patients aged 50 years or over * classified as american society of anesthesiologists asa 1-2. exclusion criteria: * coagulopathy, * uncontrolled hypertension, * peripheral vascular disease and * patients with bmi≥35

Keywords: tourniquet total knee arthroplasty blood loss
fibres supplementation in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: design: randomized, double-blind, placebo-controlled study with 4 weeks of treatment with either fiber supplements or placebo. primary outcome: variation in scfa between baseline and week 4. secondary outcomes : variations in gut microbiota, disease activity (das28, raid), immune cells (regulatory t and b cells, th17) and heart-rate variability. population: 29 patients with rheumatoid arthritis treated with only csdmards and a moderate disease activity will be recruited in each arm and 29 controls with mechanic disease (osteoarthritis, tendinitis). collection: blood, feces, disease activity and heart rate variability will be collected at baseline and week 4.


Eligibility criteria:
general inclusion criteria: * aged 18 to 85 * be affiliated to or beneficiary of a french social security scheme * o no desire for pregnancy for the duration of the study (effective contraception for women of reproductive age, for the duration of the study (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device)) exclusion criteria: * lack of written informed consent after a period of reflection * patient involved in other research or research for which the exclusion period has not ended * pregnant or nursing woman * type i or ii diabetes * patient receiving more than 10 mg/d corticosteroids at time of inclusion * patient who received corticosteroid infusions in the month prior to randomization * unusual consumption (\>50% higher than usual consumption) of dietary fibre in the last 72 hours (assessed by food questionnaire) patient with rheumatoid polyarthritis inclusion criteria: * rheumatoid arthritis meeting acr/eular 2010 criteria * with moderate clinical activity: das28-crp 3.2 and 5.1 * patient receiving conventional background treatment at stable doses and should not be modified during 4-week follow-up exclusion criteria: * patient treated by targeted ra treatment in the year prior to inclusion * patient who received antibiotic therapy within 3 months prior to randomization control subjects inclusion criteria: * patient consulting in the rheumatology department for a mechanical pathology: osteoarthritis of the limbs or spine, osteoporosis, tendinopathy, fibromyalgia, algodystrophy or capsulitis. * matched to a gender and age pr topic 5 years exclusion criteria: · patient with autoimmune disease, infection or progressive cancer

Keywords: rheumatoid arthritis dietary fibre gut-microbiota scfas
a double-blind placebo-controlled study to evaluate larazotide acetate for the treatment of celiac disease

Conditions: Celiac Disease

Summary: a randomized, double-blind, placebo-controlled phase 2b study to evaluate the efficacy and safety of larazotide acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

this is a double-blind, placebo-controlled phase 2b study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg tid) of larazotide acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (cd). the diagnosis of cd must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

Eligibility criteria:
inclusion criteria: * male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months * measurable serology at screening * ced gsrs score of ≥ 2.0 prior to randomization * experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache) * willing to maintain current diet gluten-free diet throughout the duration of the study. exclusion criteria: * refractory celiac disease or severe complications of celiac disease (eg, eatl, ulcerative jejunitis, perforation, etc.) * chronic active gi disease other than celiac disease * diabetes (type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study * hemoglobin value \< 8.5 g/dl

Keywords: larazotide acetate
a safety and tolerability study of cp-690,550 in subjects with hepatic impairment and normal hepatic function

Conditions: Hepatic Insufficiency

Summary: this study is designed to evaluate how cp-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. this study will also evaluate the safety and tolerability of cp-690,550.


Eligibility criteria:
inclusion criteria: * healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment. exclusion criteria: * subjects with severe liver impairment * subjects who have weakened immune systems

Keywords: hepatic impairment
tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil (mmf) versus neoral/sirolimus in adult, primary kidney transplantation

Conditions: Adult Primary Kidney Transplantation

Summary: comparison of outcomes/safety/and tolerability of srl/fk/pred vs. fk/mmf/pred vs. srl/neoral®/pred in cadaveric and non-hla identical lrd kidney transplants.


Eligibility criteria:
inclusion criteria: * age \>14 years * weight \> 40 kg * primary renal allograft: cadaveric or mismatched living donor * negative standard cross match for t-cells * women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.) * signed and dated informed consent (parent or legal guardian must provide written consent for patients \<18 years of age) exclusion criteria: * evidence of systemic infection * history of malignancy within 10 years (with the exception of localized skin cancer) * use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase * concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole * known hypersensitivity to sirolimus and its derivatives * patients with a screening/baseline (or within 96 hours of transplant) * total white blood cell count \< 4000/mm3; * platelet count \< 100,000/mm3; * fasting triglycerides \> 400 mg/dl (\> 4.6 mmol/l); * fasting total cholesterol \> 300 mg/dl (\> 7.8 mmol/l); * fasting hdl-cholesterol \< 30 mg/dl; * fasting ldl-cholesterol \> 200mg/dl
evaluation of the effect of an specific oral nutritional supplement on the nutritional status in cancer and malnutrition

Conditions: Malnutrition; Cancer; Nutrition Related Cancer

Summary: effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition

multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: experimental group (experimental nutritional oral supplement); and control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).

Eligibility criteria:
inclusion criteria: * men and women over 18 with a cancer diagnosis (any type). * subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery. * having lost more than 5% of body weight in the last 6 months. * adequate cultural level and understanding for the clinical trial. * signed informed consent. exclusion criteria: * subjects who are participating in other clinical trials. * subjects with morbid obesity. * subjects who will undergo surgery or who will undergo. * subjects with cachexia * subjects with infection of a cause other than of the tumor * subjects with an infectious process * subjects with diabetes mellitus treated with insulin and/or not controlled * subjects with kidney, heart, respiratory or liver disease. * subjects with autoimmune diseases. * subjects with mental illness or decrease function cognitive. * subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study. * patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month. * patients who reject oral supplements. * pregnant or breastfeeding women. * allergic to any component of the formula

Keywords: malnutrition cancer nutrition nutritional oral supplement clinical trial
difference in the frequency of use of lachrymal substitutes in patients with moderate to severe dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. topically administered lubricants are the basis for treatment of this disease. relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.


Eligibility criteria:
inclusion criteria: 1. men and women aged over 18 years 2. signed and dated written informed consent. 3. history of dry eye syndrome for at least 3 months 4. tear break up time (but) ≤ 10 seconds or schirmer i test ≤ 5 mm and ≥ 2mm 5. osdi ≥ 22 6. normal ophthalmic findings except dry eye syndrome 7. no administration of topical lubricants 24 hours before the screening examination exclusion criteria: 1. presence of an ocular pathology judged by the investigator as incompatible with the study. 2. any other clinical relevant ocular abnormality except des. 3. history of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green 4. history of known clinically relevant allergy 5. medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, hematological disease; severe psychiatric illness, etc.). 6. history of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (day 0). 7. pregnancy, lactation. 8. pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized. 9. participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses). 10. subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment. 11. participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
early reversal of defunctioning stoma trial

Conditions: Rectal Cancer

Summary: in this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; tme) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. if inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. this trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. the present trial will include 20 consecutive patients who accept participation.

Eligibility criteria:
inclusion criteria: * written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6. exclusion criteria: * written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.

Keywords: defunctioning stoma low anterior resection tme surgery early stoma reversal
whole-exome sequencing (wes) of intraductal neoplasms of the bile duct (ipnb)

Conditions: Bile Duct Neoplasms; Intraductal Papillary Mucinous Neoplasm

Summary: intraductal papillary neoplasm of the bile duct (ipnb) is a distinct type of biliary tumor characterised with delicate fibrovascular stalks (papillary of villous) covered at biliary epithelium. the typical pathologic feature is dramatical dilation of affected bile ducts due to obstruction by mucin production. ipnb has a better prognosis than bile duct carcinoma, but the current proposed entity contains multiple definitions or categories, thus confused in pathology. although mutations of several genes on ipnbs (such as gnas, kras, apc, ctnnb1, and rnf43) identified in previous studies, there is still an unification at gene expression signature. this research trial will use whole exome sequencing and subsequent bioinformatic analysis in finding causative mutations in deoxyribonucleic acid (dna) samples from ipnbs patients.

using production-scale platform, this study will carry out whole exome sequencing from archival (ffpe) material to identification and classification of significantly mutated genes, determine the somatic genomic alterations that may be relevant to the development or treatment of cancer, establish classification of ipnbs gene mutation signature. next, analysis of gene mutation signature and ipnbs clinicopathologic outcomes, including the association between pathologic type, long-term oncological outcomes and gene mutation signature. last, the determination of involved signal pathways at ipnb patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ipnbs * ecog performance status of 0, 1, or 2 * adequate liver function, bilirubin \< 1.5 times uln, alt or ast \< 2.5 times uln * adequate renal function: creatinine \< 1.8 * must be at least 18 exclusion criteria: * diagnosis of hepatic mucinous cystadenoma (mcn) * complicated with other malignancy * pregnancy

Keywords: whole-exome sequencing intraductal papillary neoplasms of the bile duct mutation characteristics
study to evaluate viralym-m (alvr105) for the treatment of virus-associated hemorrhagic cystitis (hc)

Conditions: BK Virus Infection; Hemorrhagic Cystitis

Summary: study to evaluate viralym-m (alvr105) for the treatment of virus-associated hemorrhagic cystitis (hc).

the study hypothesis is that the administration of posoleucel (alvr105) to patients with virus-associated hc will demonstrate superiority for the time to resolution of hc (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. the primary hypothesis will be tested in patients with bk virus (bkv) viruria to demonstrate superiority over placebo in this population (bk intent-to-treat \[itt\] population). a supplementary analysis will be conducted in all patients with any virus-associated hc (cytomegalovirus \[cmv\], human herpesvirus 6 \[hhv-6\], epstein-barr virus \[ebv\], jc virus \[jcv\], and/or adenovirus \[adv\]) in order to evaluate efficacy in this broader population (itt population).

Eligibility criteria:
key inclusion criteria participants must meet all of the following criteria in order to be eligible to participate in the study: * male or female ≥1 year of age. * had an allogeneic hematopoietic cell transplant (hct) performed ≥21 days and ≤1 year prior to randomization. * myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count \>10,000/mm³ at the time of randomization. * diagnosed with hc based on the following criteria (all 3 criteria must be met): 1. clinical signs and/or symptoms of cystitis. 2. grade ≥3 hematuria, defined as macroscopic hematuria with visible clots. 3. viruria with ≥1 target virus (ie, bkv, jcv, adv, cmv, ebv, and/or hhv-6). * at least 1 identified, suitably matched posoleucel (alvr105) cell line for infusion is available. key exclusion criteria participants who meet any of the following criteria will be excluded from participation in the study: * ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose \>0.5 mg/kg/day or equivalent). * therapy with antithymocyte globulin, alemtuzumab (campath-1h), or other immunosuppressive t cell-targeted monoclonal antibodies ≤28 days before randomization. * evidence of active grade \>2 acute graft versus host disease (gvhd). * uncontrolled or progressive bacterial or fungal infections. * uncontrolled or progressive viral infections not targeted by posoleucel (alvr105). * uncontrolled or progressive ebv-associated post-transplant lymphoproliferative disorder. * known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy. * pregnant or lactating or planning to become pregnant. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: allogeneic hematopoietic cell transplant alvr105 posoleucel