Kornimate/medical-research-clean huggingface dataset:
effect of an oral supplement containing omega-3 and omega-6 on dry eye symptoms

Conditions: Dry Eye

Summary: this study will investigate the effectiveness of two oral supplements on the ocular signs and symptoms in symptomatic dry eye patients. eligible participants will be given one of two oral supplements to take once a day for up to three months.


Eligibility criteria:
inclusion criteria: 1. is over 19 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and anticipated to be able to comply with the daily intake of liquid oil supplements (one teaspoon per day for three months); 4. is willing and able to follow instructions and maintain the appointment schedule; 5. exhibit moderate ocular dryness symptoms, defined as: 1. a score of ≥23 on the ocular surface disease index (osdi, (allergan inc., irvine, ca)) questionnaire; 2. currently uses, or feels the need to use eye drops to relieve symptoms of dryness. exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. currently wears, or has worn contact lenses in the past 3 months; 4. has sensitivity or an allergy to products that contain fish, soy, coconut oil or olive oil; 5. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 6. is using any systemic or topical medications (including topical corticosteroids/nsaids or glaucoma medications) that in the opinion of the investigator may affect a study outcome variable; 7. is currently taking, or has used, any omega-3 or omega-6 supplements in the last three months; 8. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 9. is pregnant, lactating or planning a pregnancy at the time of enrolment; 10. is aphakic; 11. has undergone refractive error surgery; 12. is an employee of the centre for contact lens research; 13. has taken part in another (pharmaceutical) research study within the last 30 days;
packed red blood cell transfusion during cardiac arrest

Conditions: Cardiac Arrest

Summary: the purpose of this pilot interventional study is to collect preliminary data on administering packed red blood cell (prbc) during cardiac arrest (ca). the primary objective is to assess the feasibility of prbc transfusion during cardiac ca to help optimize the methods required to augment cerebral and other vital organ oxygen delivery during cardiopulmonary resuscitation (cpr). the secondary objectives are to assess the effect of prbc transfusion during prolonged cardiac arrests on cerebral oxygenation, end tidal carbon dioxide (etco2), return of spontaneous circulation (rosc), survival to discharge, biomarkers of neural injury and inflammation, and neurological outcomes at hospital discharge, 30 days post-ca, and 90 days post-ca.


Eligibility criteria:
inclusion criteria: * adult patients, age ≥18 and \<85 years * experience prolonged, non-trauma-related in-hospital cardiac arrest, defined by cessation of heartbeat and respiration requiring cpr for at least 10 minutes exclusion criteria: * age \<18 years old * age \> 85 years old * patients with dnr/dni orders (do not resuscitate/do not intubate) * patients admitted to the hospital with a cardiac arrest arising from trauma * patients who achieve return of spontaneous circulation within 10 minutes of cpr * inability to start study product administration within 20 minutes of cardiac arrest onset * prisoners * women who are known to be pregnant * patients with a history of rbc antibodies or positive antibody screen prior to enrollment in the study, unless previously cross-matched units are available for transfusion. * patients with ultrasound evidence of right ventricular dilatation at time of ca * patients with known prior objection to receipt of blood products. * patients for whom administration of additional fluid volume is contraindicated (as determined by physician responsible for care) * physician objection based on concern that intervention would interfere with patient care plan
theranostics in soft tissue sarcoma using a vascular disruption approach

Conditions: Soft Tissue Sarcoma

Summary: to test the feasibility of theranostic targeting the psma receptor in sts patients by ga-68-psma-11 pet/ct and lu-177-itg-psma-1 treat-ment with special emphasis on vascular disruption using a translational approach.


Eligibility criteria:
inclusion criteria: * female or male ≥ 18 years old at the time of informed consent * patients with proven soft tissue sarcoma * patients need to pass the sarcoma tumor board and the molecular tumor board at chuv and no approved therapeutic alternative is available * progression of the disease by recist v1.1 after standard therapies according to the treat-ing oncologists * informed consent as documented by signed informed consent form exclusion criteria: * patients under active anti-sarcoma treatment other than the study product (lu-177-itg-psma-1) * female participants who are pregnant or breast feeding * female participants with intention to become pregnant during the course of the study * lack of safe contraception, defined as: female participants of childbearing potential, not us-ing and not willing to continue using a medically reliable method of contraception for the en-tire study duration until 6 months after last lu-177-itg-psma-1 treatment, such as oral, in-jectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. male patients of reproductive potential, not using and not willing to use a medically reliable method of contraception for the entire study duration until 6 months after last lu-177-itg-psma-1 treatment, such as barrier method or sexual abstinence or who are not using any other method considered sufficiently reliable by the investigator in individual cases. the par-ticipant must inform their female partners about the participation in this trial and they must use additional effective contraception (e.g., hormonal) during the trial until 6 months after the last lu-177-itg-psma-1 treatment. * previous enrolment into the current study * history of any disease or relevant physical condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment * insufficient knowledge of project language, inability to give consent or to follow procedures, incapacity to follow radiation safety procedures, required by the study * enrolment of the investigator, his/her family members, employees and other dependent per-sons * the patient makes use of his/her "right not to know" and refuses to be informed about inci-dental findings * absence of psma accumulation in at least 50% of tumours on ga-68-psma-11 pet/ct * grade iv renal impairment and above (calculated gfr \< 30 ml/min/1.73 m2) * blood count disturbance: platelets \ 2 times the upper limit of the norm asat/alat \> 3 times the upper limit without the presence of liver metastases asat/alat \> 5 times the upper limit in the presence of liver metastases • hypersensitivity to any of the ingredients of the injectable product
study of factors and mechanisms influencing the effects of treatments in crohn's disease

Conditions: Crohn Disease

Summary: the course of crohn's disease (cd) varies considerably between patients, but reliable prognostic markers are not available in clinical practice. even though several parameters have been associated with prognosis in cd-including clinical features, serology and genetic variants-none are sufficient to guide therapy in clinical practice. trying to find out the mechanisms influencing the effectiveness of treatments and develop a personalized therapy is an urgent problem in the era of biologics as the investigators now have a growing armamentarium of ibd therapies. several scientists found that the levels of t cells subsets ratio and inflammation cytokines were significantly increased in the intestinal mucosa and serum in active ibd patients, whereas mucosal innate lymph cells had specific effects in inflammation. however the studies about the differences of lymph cell levels between subgroups of ibd patients and their relationships with effectiveness of treatments are relatively rare. based on above, the investigators plan to recruit patients diagnosed and suspicious of crohn's disease and a group of diseases in differential diagnosis of cd to keep track of their disease characteristics, therapy and response, collect their blood sample at specific points of time, to investigate the mechanisms of heterogeneity of therapy effectiveness.


Eligibility criteria:
inclusion criteria: * newly diagnosed or previously diagnosed of crohn's disease according to 2010 wgo criteria for crohn's disease * aged 14-80 years old. exclusion criteria: * history of malignancy * pregnant/breastfeeding at screening * other serious medical or psychiatric illness. * unable to comply with protocol requirements
clinical outcome study of high-dose meropenem in sepsis and septic shock patients

Conditions: Sepsis; Septic Shock; Critical Illness; Carbapenem; Pharmacokinetic; Pharmacodynamic; Clinical Outcome; Organ Failure, Multiple; Morality

Summary: sepsis and septic shock patients are considered to have a high risk of complications and death. appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. however, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. in addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. the purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock


Eligibility criteria:
inclusion criteria: * adults (18 years and older) with sepsis and/or septic shock according to sepsis-3 criteria and receive meropenem within 1 hour after diagnosis * informed consent signed by patient or their legally authorized representative exclusion criteria: * subjects with infective endocarditis * subjects with central nervous system infection * subjects who requires surgical condition within 72 hours after randomization * subjects on extracorporeal membrane oxygenation (ecmo) within 3 days after randomization * subjects with active seizure * history of receiving meropenem within 1 week prior to randomization * pregnancy women and lactation * known allergy to meropenem * not complete a 72-hour course of empirical meropenem treatment
clinical performance of a glass hybrid restorative in nccl's of patients with bruxism

Conditions: Bruxism; Noncarious Cervical Lesions

Summary: this is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in non-carious servical lesions in patients with bruxism. the lesions were restored with glass hybrid restorative (equia forte) or nano ceramic composite resin (ceram-x one). restorations were evaluated after 24 months according to usphs criteria and the data were evaluated.

the aim of this study was to evaluate the clinical performance of a glass-hybrid-restorative compared with a nano ceramic composite resin in non-carious cervical lesions (nccls) of patients with bruxism. for this purpose, twenty-five patients having nccls and bruxism enrolled to the present study. before treatment, the dimensions of the nccls were measured in depth, gingival-incisal height and mesio-distal width using a cpi probe. degree of tooth wear (twi) and gingival conditions (gi) are also recorded. a total of 148 nccls were randomly restored with a a glass-hybrid-restorative system (equia forte fil, gc, tokyo, japan) or a nano ceramic composite resin (ceram.x one universal, dentsply, detrey, konstanz, germany) and restorations were evaluated at baseline and after 6,12 and 24 months according to the modified-usphs criteria. data were analyzed with chi- square, fisher's exact test, mann whitney-u and cochran's q tests (p \< 0.05).

Eligibility criteria:
inclusion criteria: * non-hospitalized, healthy patients that were seeking dental treatmen * occlusally contacted teeth exclusion criteria: * patients having intensive medical history * chronic periodontitis, * high caries activity, * extremely poor oral hygiene, * teeth with restorations, * mobility due to periodontal disease * in contacted with removable prosthetic construction were excluded from the study

Keywords: glass hybrids bruxism non carious cervical lesions
testing tissue sodium stores in capd patients-aims 1 & 2

Conditions: End Stage Renal Disease

Summary: the investigators' overarching goal is to improve long-term outcomes for end stage renal disease (esrd) patients. in this study we focus specifically on patients receiving peritoneal dialysis (pd). volume regulation in pd patients is related to hypertension, heart failure, nutritional status, and survival. salt (nacl) is the body's ion transport target to normally regulate volume via the kidneys; however, in hemodialysis (hd) patients the dialyser or in pd patients the peritoneal membrane, must serve that purpose. determining volume status in pd patients is not easy and monitoring sodium (na+) is more difficult still. the investigators have developed a novel, noninvasive approach to this problem involving 23na+ magnetic resonance imaging (na-mri). na+ is stored bound to proteoglycans in mostly the skin. our technique measures na+ in skin and skeletal muscle. in this study, we propose to apply this novel technique to pd patients. aim 1. to determine na+ stores in pd patients, to compare na+ stores to normal controls using na-mri technique, and to correlate na+ stores by na-mri with multifrequency bioimpedance measurements and cross-sectional clinical data. hypothesis: na+ stores are increased in pd patients compared to normal controls; they are increased in pd patients with volume expansion and in those patients with high soluble vascular endothelial growth factor receptor-3 (sflt-4) levels. aim 2. to determine the utility of na-mri as an assessment of preserving residual renal function in pd patients. hypothesis: extracellular volume expansion as measured by multifrequency bioimpedance was found to have no utility in predicting preservation of residual renal function in pd patients. the investigators hypothesize that na+ stores as determined by 23na-mri will fulfill that function and will be inversely, rather than directly, related.


Eligibility criteria:
inclusion criteria: both subject groups: * age 18 to 80 years; * bmi \< 40; * ability to give informed consent; * life expectancy greater than 6 months. pd subjects: * on peritoneal dialysis for greater than 3 months; * using glucose lactate-buffered pd solutions with consistent glucose exposure; * stable peritoneal prescription (kt/v \> 1.7 or tccr \> 50 ml/week/1.73 m2). control subjects: * estimated glomerular filtration rate (gfr) ≥ 60 ml/min/1.73m2; * no proteinuria. exclusion criteria (both subject groups): * pregnancy; * intolerance to study protocols; * severe, unstable, active, or chronic inflammatory disease (congestive heart failure-ny class iv, active infection, active connective tissue disorder, active cancer or cancer history in the prior 5 years, hiv, liver disease, including active chronic hepatitis b or c); * active inflammatory conditions \[systemic lupus erythematosus (sle), rheumatoid arthritis (ra), minimal change disease (mcd)\]; * patients prescribed or being treated with spironolactone; * history of cirrhosis; * poor compliance with dialysis prescription.

Keywords: na+ mri salt stores
the effect of three prosthesis designs in total knee arthroplasty

Conditions: Gonarthrosis; Primary; Degenerative Joint Disease of Knee

Summary: the purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

total knee arthroplasty (tka) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. in 2015, 6093 patients received primary tka in norway. despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (pcl). prostheses for tka have evolved into designs that either preserve or sacrifice the pcl. in patients with a functional pcl, the decision of which design is selected depends largely on the favor and training of the surgeon. to further improve tka patient outcomes, a better understanding of the role of these differing pcl treatments is needed. thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 tka implant designs (2 pcl-sacrificing and 1 pcl-retaining). we will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. this study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis * non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (hka) radiographs * intact pcl (assessed preoperatively and verified during surgery) * age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic rsa) * body mass index ≤ 35 kg/m2 * asa (american society of anaesthesiologists) score i or ii * only patients with koos scores above 80 on the symptoms, adl (activities of daily living) and pain subscales will be included in the kinematic analysis exclusion criteria: * prior acl (anterior cruciate ligament) surgery * impaired collateral ligaments * secondary osteoarthritis of the knee * previous osteotomy * rheumatic disease * flexion less than 90 degrees * flexion contracture over 10 degrees * peripheral neuropathy * malignancy * patients who do not speak norwegian

Keywords: cruciate retaining anterior stabilized posterior stabilized posterior cruciate ligament degenerative knee joint disease knee injury and osteoarthritis outcome score kinematic radiostereometry
laminaria and misoprostol before operative hysteroscopy

Conditions: Cervical Spasm

Summary: laminaria and misoprostol before operative hysteroscopy

the use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

Eligibility criteria:
inclusion criteria: nullipara * need hystroscopic intervention exclusion criteria: previous pregnancy cervical lesion contraindication to misoprostol -
diabetes and cognitive functions in middle age

Conditions: Diabetes Mellitus, Type 2; Cognitive Impairment; Hyperglycemia; Hypoglycemia; Mood

Summary: this study will examine the effects of type ii diabetes on cognitive functions and mood in middle-aged patients. in addition, the association between cognitive functions and glycemic controls is studied in patients. sixty patients and sixty healthy controls will be recruited and assessed by a multiprofessional team (neuropsychologist, physician).

sixty patients with type 2 diabetes will be recruited from the tampere diabetes outpatient clinic. inclusion criteria for the patients are type 2 diabetes diagnosis, diabetes medication and age 35-65. exclusion criteria are type 1 diabetes, hypothyreosis, neurological or psychiatric disorder, substance abuse and serious diabetes complications. sixty healthy control persons are recruited from the personnel and occupational health care. exclusion criteria for controls are type 1 or 2 diabetes, hypothyreosis, neurological or psychiatric disease and substance abuse. a comprehensive neuropsychological assessment is made to all participants.the assessment consists of standardized neuropsychological tests, questionnaires and interview. domains assessed include attention, executive functions, memory, information processing speed, general cognitive functioning, depressive symptoms, anxiety and fatigue. medical information (such as glycated hemoglobin and blood pressure) from the patients is gathered from the medical records. corresponding information from the control participants is gathered with medical examinations including laboratory tests. informed consent is taken from all participants. this study will examine the difference in cognitive functions between healthy controls and middle-aged patients with type 2 diabetes. there is evidence from previous studies that type 2 diabetes is related to an increased risk of dementia, but the association between diabetes and cognition at younger ages is less studies. the difference in mood and fatigue is also studied between the groups. in addition, the association between glycated hemoglobin level and cognitive functions is examined in patients, as poor glycemic control has been implicated to impact on cognitive decline in previous studies. finally, the association between history of hypoglycemic episodes and cognition is studied.

Eligibility criteria:
inclusion criteria: * type ii diabetes, age between 35-65 years exclusion criteria: * hypothyreosis, previous neurological diseases
non-invasive negative pressure treatment for pectus excavatum

Conditions: Pectus Excavatum

Summary: the purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device vacuum bellfor is effective for the pectus excavatum treatment


Eligibility criteria:
inclusion criteria: * absence of co-morbidities that may interfere with proper placement or function of the apparatus * test negative for pregnancy in women of childbearing age exclusion criteria: * skeletal diseases like osteogenesis imperfecta or osteoporosis * clotting disorders such as hemophilia or thrombopathia * skin diseases or infections of the anterior chest wall * angiopathies or vascular fragility * obesity important with bmi greater than 30 * precarious commitment to the prolonged use of the device protocol

Keywords: chest wall; chest, funnel; pectus excavatum; congenital abnormality