Kornimate/medical-research-clean huggingface dataset:
personalized glucose predictive and therapy advisory system - diadvisor 2

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Summary: the primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.

during this study, we would like to assess the efficacy in keeping blood glucose in a safe range (70-180 mg/dl) of the second generation of a glucose predictive and therapy advisory system in diabetic patients treated by basal-bolus insulin regimens using pumps or multiple daily injections. we want to compare the time spent in safe range while using the predictor and advisor outputs and when the patient is not using them. this is a randomized controlled crossover trial. patient will come for two admissions of 3 days, one with the diadvisor system fully activated, and one with the prediction and advice features disabled.

Eligibility criteria:
inclusion criteria: 1. patient must be aged between 18 (inclusive) and 70 years old 2. patients diagnosed with type 1 or type 2 diabetes according to who criteria for at least one year prior to study entry 3. patient treated by a basal-bolus insulin therapy using an external pump or multiple-daily injections. the insulin regimen has to be stable for the previous six months. nph insulin use will not be acceptable. 4. patient should have stable diabetes with a hba1c between ≥ 7.5 % and \< 10.5 % with no keto-acidosis for the previous 6 months. 5. patient must have a body mass index (bmi) lower than 35 kg/m² 6. patient must be willing to undergo all study procedures 7. patient must be affiliated or beneficiary of a social medical insurance 8. patient has signed informed consent form prior to study entry exclusion criteria: 1. patient is pregnant, or breast feeding during the period of the study 2. patient has impaired renal function with a creatinine blood concentration over 150 μmol/l 3. patient has a liver disease (alat, asat \> 2 x upper limit of normal range) 4. patient is treated by sulfamides, glp-1 analogues, dpp-iv inhibitors or glitazones 5. alcohol or drug addiction, as identified by investigator during screening visit 6. allergy to sensors or one of their components 7. manifest psychological disorders 8. patient health status is not compatible with physical exercise 9. patient is actively enrolled in another clinical trial or was part of study within 30 days 10. persons deprived of freedom, adults protected by law or vulnerable persons

Keywords: diabetes diadvisor type 1 diabetes type 2 diabetes glucose prediction cgm prediction algorithm therapy advices
study to evaluate adverse events, change in disease activity, movement of oral abbv-623 and abbv-992 tablets in the body of adult participants with b-cell cancers

Conditions: B-cell Lymphoma

Summary: b-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). the main objective of this study is to evaluate the safety and efficacy of abbv-623 and abbv-992 given alone and in combination in treating b-cell cancers. adverse events, change in disease activity and how the drug moves through the body of adult participants with b-cell cancers will be evaluated. abbv-623 and abbv-992 are investigational drugs being developed for the treatment of b-cell cancer. study doctors assign participants to one of six groups, called treatment arms. approximately 105 adult participants with a diagnosis of b-cell cancer will be enrolled in the study at approximately 50 sites worldwide. participants in the combination expansion treatment arms will receive oral tablets of abbv-623 and/or abbv-992 once daily for 24 months. all other arms are treated until progression. participants will attend regular visits during the study at a hospital or clinic. the effect of treatment will be evaluated by medical assessments and blood tests. adverse events will be collected and assessed throughout the clinical trial.


Eligibility criteria:
inclusion criteria: * participants must have documented diagnosis for one of the following b-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll), mantle cell lymphoma (mcl), marginal zone lymphoma (mzl), waldenström's macroglobulinemia (wm), diffuse large b-cell lymphoma (dlbcl), and follicular lymphoma (fl), with measurable disease requiring treatment. * participants have relapsed or refractory to at least 2 prior systemic therapies. * combination dose expansion only: participants with documented diagnosis of cll/sll with measurable disease requiring treatment per by international workshop on chronic lymphocytic leukemia (iwcll) criteria. * eastern cooperative oncology group performance status of 0 or 1. * cll/sll, mcl, wm, mzl only: prior bruton's tyrosine kinase inhibitor (btki) exposure will be allowed if participant did not progress on active treatment and there is no evidence of resistance mutations. * renal, liver and hematological function lab values as determined in the protocol. * for participants with prior btk inhibitor exposure, no evidence of mutations which confer resistance to covalent btk inhibitors. exclusion criteria: * participants with indolent forms of non-hodgkin lymphoma (nhl) that require immediate cytoreduction. * participants with prior b-cell lymphoma 2 (bcl2) inhibitor (bcl2i) exposure (except for participants in the abbv-992 monotherapy cohort).

Keywords: abbv-623 abbv-992 b-cell lymphoma cancer chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll) mantle cell lymphoma (mcl) marginal zone lymphoma (mzl) waldenström's macroglobulinemia (wm) diffuse large b-cell lymphoma follicular lymphoma
ultrasound liver intraoperative imaging with sonovue®

Conditions: Liver Metastases From Colorectal Primary Cancer

Summary: hypothesis: use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases. this study is a two-stage phase ii multicenter study (simon's two-stage).

hypothesis: use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases. this study is a two-stage phase ii multicenter study (simon's two-stage).

Eligibility criteria:
inclusion criteria: 1. patient with histological proven colorectal cancer. 2. operable liver metastases according to preoperative imagery. operability is the possibility of treatment by resection and/or local destruction (radiofrequency, cryotherapy...). 3. patient treated or not with preoperative chemotherapy. 4. with or without extra-hepatic metastases 5. age ≥ 18 years. 6. radiological assessment by ct and mri liver and positron emission tomography scan (petscan) within six weeks before surgery. 7. patient affiliated to the social security system. 8. signed informed consent. exclusion criteria: 1. known hypersensitivity to sulfur hexafluoride or another component of sonovue®. 2. patients with recent acute coronary syndrome or suffering from unstable ischemic heart disease, especially: evolving myocardial infarction, unstable angina during the last 7 days, recent coronary intervention or another factor suggesting clinical instability, acute heart failure, class iii or iv heart failure, severe arrhythmias. 3. patients with right-to-left shunt, severe pulmonary arterial hypertension, uncontrolled systemic hypertension, as patients suffering from respiratory distress syndrome. 4. pregnant and lactating women. 5. patients with contraindication for a ct scan, a mri or a positron emission tomography (pet) with contrast. 6. patients with indication of two step liver surgery. 7. patients already included in the study. 8. patient who couldn't be treated or followed up according to study criteria for psychological, social, family or geographical reasons. patient deprived of liberty or under guardianship.

Keywords: liver metastases colorectal primary cancer contrast-enhanced ultrasound sonovue®
the importance of patient education - a randomised controlled trial

Conditions: Osteoporosis; Quality of Life; Level of Adherence; Behavior

Summary: modification of individual life style factors and fall prevention programmes may have significant positive effects on fracture incidence. also, a large number of studies have demonstrated that pharmacological therapy of osteoporosis is effective; however non-adherence to such therapy is a well recognized problem. few studies, however, have examined the effect of particular patient education programmes on knowledge and adherence to therapy. we hypothesised that a group-based, multi-disciplinary, education programme increases the total quality of treatment for patients with osteoporosis, patients' knowledge on osteoporosis and adherence with pharmacological therapy ect. a total of 300 patients, recently diagnosed with osteoporosis and started on specific treatment, were randomised to either the "school" or "control" group. in the school-group, patients attended four classes with 8-12 participants during four weeks (a total of 12 hours). teaching was performed by nurses, physiotherapists, dieticians, and doctors and was based on dialogs and situated learning. the classes covered "facts on osteoporosis", "fractures and pain", "diet", "preventive measures", "balance and exercise", and "medical treatment". teaching was designed to increase empowerment. the control group were offered the department's standard treatment including follow-up visits. all 300 patients received questionnaires regarding "knowledge about osteoporosis", "level of adherence", "quality of life", "dietary calcium intake", "level of physical activity", "falls events" registered every month by postcard, at inclusion and after 3, 12, and 24 month. bmd was examined by dxa-scan at inclusion and after 12 and 24 month. the last patient will answer the questionnaires first of may 2007.


Eligibility criteria:
inclusion criteria: * men and female age 45-80, * diagnosed with osteoporosis and started medical treatment exclusion criteria: * severe illness, * cognitive dysfunction, * not able to speak or read danish

Keywords: group based patient education, multidisciplinary, physical activity, adherence to treatment, quality of life
study evaluating the efficacy and safety of obeticholic acid in subjects with compensated cirrhosis due to nonalcoholic steatohepatitis

Conditions: Compensated Cirrhosis; Nonalcoholic Steatohepatitis

Summary: the primary objective of this study is to evaluate whether obeticholic acid (oca; int-747) can lead to histological improvement in fibrosis with no worsening of nash in adults with compensated cirrhosis due to nash.


Eligibility criteria:
key inclusion criteria: 1. subjects with a confirmed diagnosis of nash and a fibrosis score of 4 based upon the nash crn scoring system determined by central reading key exclusion criteria: 1. current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (he), or variceal bleeding 2. current or past history of cp score ≥7 points 3. model for end-stage liver disease (meld) score \> 12 4. alt ≥ 5 x uln 5. calculated creatinine clearance \<60ml/min using cockcroft-gault method 6. hemoglobin a1c (hba1c) ≥ 9.5 % 7. evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis b, hepatitis c, pbc, psc, autoimmune hepatitis, wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (hcc) 8. history of liver transplant, or current placement on a liver transplant list

Keywords: compensated cirrhosis nonalcoholic steatohepatitis fatty liver disease nash
translation of stroke specific quality of life questionnaire into local languages of pakistan

Conditions: Stroke

Summary: the aim of the present study is to translate the stroke specific quality of life questionnaire into local languages of pakistan along with validation of the translated versions by evaluating their validity and reliability in the people of pakistan, speaking respective languages and suffering from a stroke. no such study has been previously conducted in the pakistan region which translates the specific questionnaire and follows the proper cross-culture adaptation protocol.

the stroke-specific quality of life scale is regarded as one of the most extensive and more commonly utilized patient-centred and self-reported measure of outcomes in the stroke population. the ss-qol scale is a health-related outcome measure that comprises 49 items in 12 areas of vision, mobility, thinking, social roles, self-care, language, personality, family roles, work/productivity, upper limb function, mood and energy. it covers a more extensive inclusion of capacities ordinarily influenced by stroke. the stroke specific quality of life questionnaire, originally developed in english, has been translated into many languages to assess for its validity and reliability ever since, but not any of the pakistani native versions are made or tested. previous studies have shown that the translation of the scale would end up giving a standard measure to be utilized in clinical practices and research studies while sanctioning clinicians and specialists to share information and have an insight into patient's health-related concerns post-stroke. thus, it is imperative to translate this questionnaire into psychometrically sound versions of indigenous pakistani languages such as urdu, punjabi, sindhi, balochi and pashto. this may promote an easy understanding of the local population in pakistan where the languages are spoken and will provide a valid measure of stroke-specific health outcomes to be clinically utilized by practitioners and researchers across the country.

Eligibility criteria:
inclusion criteria: * patients post-stroke (sub-acute/chronic stage) * participants belonging to urdu, punjabi, sindhi, balochi and pashto speaking class * patients should be capable to complete the questionnaire without any help. exclusion criteria: * healthy population * patients at the acute stage of stroke/ tia. * individuals diagnosed with conditions other than stroke. * individuals with language/ memory problems. * individuals with disability due to any structural/congenital cause.

Keywords: stroke ssqol stroke specific quality of life tool translation validity reliability
evaluation of pd 0348292 for preventing blood clots in the lungs or deep leg veins of patients after knee surgery

Conditions: Venous Thrombosis

Summary: to study the safety and effectiveness of several doses of pd 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery


Eligibility criteria:
inclusion criteria: * adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy. exclusion criteria: * history of deep vein thrombosis or pulmonary embolism, suspected postthrombotic state, bleeding or clotting disorders, or cardiovascular, renal or liver disease within the past year
study of nitazoxanide combined with peginterferon compared to peginterferon monotherapy in the treatment of hepatitis c

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis c.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * chronic hepatitis c infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-hcv-antibodies and a positive quantitative rt-pcr amplification of hcv rna. * chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis. * hcv genotype 4. * patients that have not previously received peginterferon. exclusion criteria: * patients unable to take oral medications. * use of ribavirin within 30 days prior to enrollment. * females who are either pregnant, breast-feeding or not using birth control and are sexually active. * any investigational drug therapy within 30 days prior to enrollment other than through romark study number rm01-3027. * patients with other causes of liver disease. * transplant recipients receiving immune suppression therapy. * patient co-infected with human immunodeficiency virus, hepatitis a virus, hepatitis b virus, or hepatitis d virus based on enzyme immunoassay. * patients with decompensated cirrhosis, thrombocytopenia (platelet count \ 6. * patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of \>20 grams per day. * patients who are clinically unstable. * patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. * history of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets or peginterferon alfa-2b solution for injection.
early goal directed therapy in sepsis by emergency medical services

Conditions: Sepsis

Summary: the goal is to evaluate the best way for paramedics and hospitals to work together to treat septic patients as quickly as possible. the investigators think that the best thing to do for septic patients is to identify and treat them as early as possible. this research will test this. the investigators think that if paramedics identify septic patients and begin treatment with fluids in the ambulance, then the patient will do better in the long run. the paramedic will also tell the hospital that a septic patient will be there soon. the caregivers can prepare and be ready to provide care as soon as the patient arrives. with this research, the investigators would like to see if these steps help patient outcomes.


Eligibility criteria:
inclusion criteria: * older than 17 years of age * suspected to having an infection * meets 2 of 3 systemic inflammatory response criteria: heart rate \> 90 beats per minute, respiratory rate \>20 breaths per minute, temperature \>38°c or \<36°c exclusion criteria: * transfer from another hospital * patients, coming from a rehabilitation/nursing facility where antibiotics were given prior to transfer * pregnant patients * prisoners.

Keywords: emergency medical services lactic acid sepsis
amount of lactose causing symptoms in lactose intolerant people

Conditions: Lactose Intolerance

Summary: the hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. these failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs. this study will identify the threshold at which symptoms of lactose intolerance develop, to provide appropriate advice and treatment in the management of patients.


Eligibility criteria:
inclusion criteria: * confirmed lactose intolerance demonstrated with a lactose intolerance test. * adherence to a lactose free diet for at least four days before the start of the study. exclusion criteria: * failure to adhere to a lactose free diet. * people who are on lactose containing medications. * pregnancy. * unwillingness to comply with study outline.

Keywords: lactose intolerance lactose threshold
asthma in the elderly: the role of exhaled nitric oxide measurements

Conditions: Asthma

Summary: this study will investigate the importance of exhaled nitric oxide measurements in subjects with asthma age 65 and older. this group of patients has been ignored in most previous asthma studies.


Eligibility criteria:
inclusion criteria: * subjects with asthma over the age of 65 followed in our practice, non-smokers and able to give informed consent to participate in the study exclusion criteria: * smokers, subjects of diminished mental capacity

Keywords: asthma in subjects over the age of 65
facial skin clinical and microbial profiling from oral probiotic supplementation

Conditions: Healthy; Skin Manifestations

Summary: the goal of this double-blind randomized clinical trial is to investigate the effects on the skin from oral intake of probiotic supplements in healthy adult men and women. the main questions it aims to answer are: • will probiotic supplementation result in beneficial changes to different skin parameters? • will probiotic supplementation result in alterations in the skin microbiome? participants will consume the study product daily for 8 weeks and come in for skin measurements at baseline and after 8 weeks.


Eligibility criteria:
inclusion criteria: * healthy volunteers * fully informed with the study specifications. * signed consent form prior to commencing the study. * motivated for participation in the study, and available over the full test period. * healthy skin on the face (i.e., absence of psoriasis, eczemas, erythema, oedema, scars, wounds, lesions, or any other type of inflammatory or autoimmune skin condition). * healthy gut (i.e., absence of irritable bowel diseases (ibd), irritable bowel syndrome (ibs), or any other type of inflammatory or autoimmune gut condition). * no supplementation with probiotic, prebiotic or synbiotic products 2 weeks prior and/or during the whole study period. * no supplementation with niacin (vitamin b3) 2 weeks prior and/or during the whole study period. * no significant change in skin care routine (such as injectable cosmetics, skin tanning, etc.) throughout the whole study period. * no significant change in the diet throughout the whole study period. exclusion criteria: * not fulfilling the inclusion criteria. * pregnant or lactating 3 months prior to study commencement or during the study. * women post menopause. * use of antibiotics at least 4 weeks prior and/or during the whole study period. * sun-tanned facial skin. * participating in another clinical study that could interfere with the present research. * presented health problems or specific medications that could adversely affect the study outcome. * presented any cutaneous hypersensitivity or allergy to cosmetic products. * major surgery on the face one year prior to study commencement. * applied any cleansing, topical or moisturizing product (including all make-up products) to the measurement area the morning of assessments at oriflame cosmetic ab. * exposure to artificial uv light and/or to the sun during the study. * special diets (vegan, low carbohydrate, weight loss diet, etc.). * significant change in weight one month before or during the study period.
effects of physiotherapy in hemodynamics and childrens respiratory mechanics

Conditions: Respiratory Insufficiency; Children

Summary: the hypothesis of this study is that respiratory physiotherapy can promote improvement in respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is more effective in improving respiratory mechanics in childrens and does not alter the hemodynamic proved safe


Eligibility criteria:
inclusion criteria: * children aged between one and 60 months * diagnosed with respiratory failure * undergoing mechanical ventilation exclusion criteria: * had traumatic brain injury * severe thrombocytopenia (\<20,000 pl/mm³) * hypovolemia and cyanogenic congenital heart defects * pneumothorax, hemothorax and/or pleural effusion without previous drainage

Keywords: respiratory insufficiency physiotherapy techniques respiratory mechanics