Kornimate/medical-research-clean huggingface dataset:
lactobacillus johnsonii in children and adolescents with t1d

Conditions: Type 1 Diabetes (T1D)

Summary: while genetics demonstrated a major risk factor for the development of type 1 diabetes (t1d), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. the probiotic lactobacillus johnsonii n6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the t1d population thereby preserving beta cell function.


Eligibility criteria:
inclusion criteria: * have confirmed t1d by physician diagnosis * have normal values at screening for complete blood count (cbc) and complete metabolic profiles (with the exception of fasting glucose and hba1c) * are able to swallow a capsule * are willing to complete weekly online questionnaires * are willing to consume a probiotic * are willing to provide stool samples throughout the study * are willing to provide blood samples throughout the study * are willing to take three stimulated c-peptide tests * are able to access a computer with internet throughout the study exclusion criteria: * being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, crohn's disease, ulcerative colitis, etc.) * being treated for chronic kidney disease * have had or are currently being treated for other immune-compromising diseases or conditions (hiv, aids, hepatitis, cancer, leukemia, organ transplant, lupus, digeorge syndrome, selective deficiency of iga, bruton's disease etc.) * have an underlying structural heart disease * currently live with an immunocompromised person * are currently taking medications for constipation and/or diarrhea * have taken antibiotics within the past 2 weeks prior to randomization * are currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start * are a current smoker * are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months * have a known allergy to milk or milk protein.

Keywords: probiotics genetics
ventriculostomy in subarachnoid hemorrhage (sah): intracranial pressure (icp) open or not?

Conditions: Subarachnoid Hemorrhage

Summary: the purpose of this study is to explore two currently accepted methods of intracranial pressure (icp) management through cerebral spinal fluid (crf) drainage for patients diagnosed with subarachnoid hemorrhage (sah). this is a randomized observational study of two physician-prescribed approaches to managing icp monitoring and csf drainage for sah patients. the study will enroll only those patients who have icp monitoring. because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

patients diagnosed with subarachnoid hemorrhage (sah) who require intracranial pressure (icp) management through cerebral spinal fluid (crf) drainage will be eligible for this study. subjects will be randomized to receive one of two currently accepted methods of icp management. the first is icp monitoring with intermittent csf drainage and the second is through continuous csf drainage at set pressure thresholds.

Eligibility criteria:
inclusion criteria: * admitted to duke university nccu * adult (18 years of age or older) * primary diagnosis is subarachnoid hemorrhage * intraventricular catheter in situ exclusion criteria: * glasgow coma score = 3 * hunt and hess score = 5 * prisoners * ventriculostomy \> 72 hours

Keywords: cerebral spinal fluid ventriculostomy subarachnoid hemorrhage vasospasm human subjects
rosa robot used in total knee replacement post market study

Conditions: Knee Pain; Chronic Osteoarthritis; Avascular Necrosis of the Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities; Rheumatoid Arthritis

Summary: this is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. this clinical study will include persona, nexgen, and vanguard product families using the rosa total knee robotic system or conventional instrumentation. the primary objective of this study is to collect and compare clinical and surgical data using the commercially available rosa total knee robotic instrumentation and conventional instrumentation.

the primary objective of this study is to collect and compare clinical outcomes data using the commercially available rosa total knee robotic instrumentation and conventional instrumentation.the assessments will include:planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Eligibility criteria:
inclusion criteria: * patient is a minimum of 18 years of age * independent of study participation, patient is a candidate for commercially available persona, nexgen, and vanguard knee components implanted in accordance with product labeling * patient has participated in this study-related informed consent process * patient is willing and able to provide written informed consent by signing and dating the irb or ec approved informed consent form * patient is willing and able to complete scheduled study procedures and follow-up evaluations exclusion criteria: * patient is currently participating in any other surgical intervention studies or pain management studies * patient has underwent contralateral uka or tka within the last 18 months * hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) * hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation) * patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) * patient has previously received partial or total knee arthroplasty for the ipsilateral knee
poststroke fatigue - developing and testing a program to reduce and cope with fatigue

Conditions: Cardiovascular Disease; Stroke

Summary: fatigue is a common complaint after stroke, reported by 39-72% of patients. poststroke fatigue is related to poor neurological recovery, low level of activities of daily living, decreased quality of life and may possibly affect the ability to return to work. little is known about strategies addressing post-stroke fatigue and their effectiveness. aim: to develop, test and evaluate a health promotion program based on strategies addressing poststroke fatigue.

fatigue is a common complaint after stroke, reported by 39-72% of patients. it has been shown that poststroke fatigue may be related to poor neurological recovery, low level of activities of daily living and decreased quality of life. however, little is known about strategies to address poststroke fatigue and the effectiveness of such strategies. objective the aim of the study is to develop a program based on strategies to address poststroke fatigue and to test and evaluate the program. material and methods intervention mapping is the overall approach of the study. it describes a protocol for the development of theory- and evidence-based health promotion programmes. step 1) the program is developed based on a needs assessment. existing knowledge about physical, psychosocial and environmental factors associated with poststroke fatigue is mapped in a literature review. step 2) the program will be tested in a pilot study (controlled trial). in addition to conventional treatment, the patients in the intervention group will participate in the program for a period of 12 weeks. the control group will receive conventional treatment only. step 3) evaluation of the program: primary outcome measure will be fatigue, measured on the multidimensional fatigue inventory-20. secondary outcome measures will be identified during the development of the program. patients will be tested at baseline, after 3 months and after 6 months. the effect size in the pilot study will be assessed and will be used in order to estimate the required sample size for a large-scale randomized controlled trial on formally testing the efficacy of the program.

Eligibility criteria:
inclusion criteria: * patients with first ever stroke * \> 18 year * living in the area of aarhus(intervention group) and patients living in the area of holstebro (control group). * multidimensional fatigue inventory-20/generel fatigue \> 12. * the patient must be able to give informed consent * walking without person support. * walking aids is accepted. exclusion criteria: * neurological problems related to acute stroke(severe aphasia, decreased level of conscience or decreased attention) * other neurologic or psychiatric deseases (including dementia, non treated depression, misuse of alcohol eller medicin) * severe co-morbidity (including cancer, blindness or deathness) * not-danish speaking.

Keywords: poststroke fatigue health promotion patient education
a study evaluating gs-9620 in virologically suppressed subjects with chronic hepatitis b virus infection

Conditions: Hepatitis B

Summary: dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). dose escalation or repetition will be governed by pre-specified safety and activity rules. subjects will be confined on days 1-3 and/or days 8-10. follow-up visits are required periodically through day 43. subjects with sustained reductions in hbsag will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments


Eligibility criteria:
inclusion criteria: * chronic hbv infection for ≥ 6 months * currently on treatment with at least 1 hbv approved oral drug (i.e. lamivudine, telbivudine, entecavir, adefovir, tenofovir) ≥ 3 months prior to screening * hbsag ≥ 250 iu/ml * hbv dna at below the level of quantitation (blq; to be confirmed at screening) * absence of extensive bridging fibrosis (metavir 3 or greater)or cirrhosis * creatinine clearance ≥ 70 ml/min exclusion criteria: * co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv), or hiv * history of gilberts disease * laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (tsh), or other evidence of hepatic decompensation * diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed * evidence of hepatocellular carcinoma

Keywords: hepatitis hepatitis b hepatitis b virus hbv gs-9620 toll-like receptor (tlr)-7 agonist
medical abortion with single daily dose of misoprostol

Conditions: Miscarriage

Summary: medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.


Eligibility criteria:
inclusion criteria: * maternal age more than 18 years old (age of legal consent). * gestational age less than 13 weeks. * hemoglobin \>10 g/dl. * bmi between 25 kg/m2 and 35 kg/m2. * missed abortion. * living fetus with multiple congenital malformations incompatible with life. exclusion criteria: * maternal age less than 18 years old. * gestational age more than 12 weeks. * hemoglobin \<10 g/dl. * anencephaly. * fibroid uterus. * bmi less than 25kg/m2 and more than 35kg/m2. * coagulopathy. * history or evidence of adrenal pathology. * previous attempts for induction of abortion in the current pregnancy. * allergy to misoprostol or letrozole. * medical disorder that contraindicate induction of abortion (e.g. heart failure).
ultrasonic measurement of the optic nerve sheath diameter predicting outcome after cardiac arrest

Conditions: Post-Anoxic Coma

Summary: rationale: an important proportion of patients with return of spontaneous circulation (rosc) after cardiac arrest remain comatose as a result of post anoxic encephalopathy (pae). specific treatments to promote cerebral recovery are lacking. early identification of patients without potential of recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and families. intensivists currently use a combination of diagnostic measures, including brainstem reflexes, motor response, status myoclonus, ssep measurements and (increasingly) the eeg. however, together all these measure identify only 20-50% of the patients with severe pae precluding cerebral recovery. at the moment, there is a high demand for bedside measurements that contribute to the neurological prognostication of comatose patients after cardiac arrest. non-invasive bedside measurements of the optic nerve sheath diameter (onsd) using ultrasound hold potential to improve outcome prediction. objective: to estimate the value and feasibility of repetitive measurements of the onsd in comatose patients after cardiac arrest. study design: prospective cohort study study population: 160 subsequent comatose adult patients after cardiac arrest, admitted to the icu of rijnstate hospital intervention: in addition to standard treatments, patients will undergo ultrasonic measurements of the onsd during the first 3 days after cardiac arrest. survivors will be followed upon hospital discharge. onsd measurements will be followed over time and related tot neurological outcome. main study parameters/endpoints: the primary outcome measure is neurological outcome, defined using the cerebral performance category (cpc) score at 6 months. cpc 1-2 indicates favourable neurological outcome, and cpc 3-5 indicates unfavourable neurological outcome.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * cardiac arrest * admitted to the icu with glasgow coma scale ≤ 8 exclusion criteria: * pregnancy * traumatic head injury * eye surgery in medical history, including cataract surgery * pre-existing dependency in daily living (cpc 3 or 4) * any known progressive brain illness, such as a brain tumour or neurodegenerative disease
general practitioners (gp) involvement in colorectal cancer (crc) screening

Conditions: Colorectal Cancer

Summary: screening for colorectal cancer (crc) is widely recommended because of compelling evidence that it reduces mortality from crc and that it's cost-effective. in france, there is a national crc screening programme inviting people aged 50-74 years by mail to consult their general practitioner (gp) for a free on charge faecal occult blood test deliverance every two years. participation is a key factor for the screening programs success. high levels of screening uptake and the continued participation to regular screening must be achieved and maintained in the targeted population if the enormous potential of crc screening is to be realised. screening rates of various international programs vary widely (20-52%) and the participation is insufficient in the most settings. therefore, a better understanding of facilitating and hindering factors of patient participation can guide interventions to improve crc screening rates. they include patients and physicians' factors. one issue is about gps practice. gp involvement has been shown to improve the participation in the crc screening. this study aims to assess the effectiveness of an intervention targeting gps to increase patient participation in the crc screening. volunteer gps will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. the intervention consists in providing every four months to the experimental group a list of their patients who are eligible but did not proceed yet to the screening. in both groups, patient participation in the screening will be measured at the end of the study.


Eligibility criteria:
inclusion criteria: 1. general practitioner (gp) * exercising in the val de marne (french department of the suburb of paris) * volunteered to participate at the study 2. patient * living in the val de marne (french department of the suburb of paris) * having declared a 'preferred gp' exercising in the val de marne to the main statutory health insurance scheme ("régime général") * being eligible for colorectal cancer screening (aged 50 to 74 years, not excluded and having not proceed yet to the screening) * having consulted his 'preferred gp', whatever the reason, during the study period exclusion criteria:

Keywords: colorectal cancer screening faecal occult blood test general practitioners involvement patient's participation reminder
cognitive rehabilitation in people with metabolic syndrome and mild cognitive deficits

Conditions: Metabolic Syndrome; Cognitive Deficit

Summary: the goal of this clinical trial is to investigate the possibility of rehabilitation of mild cognitive deficits in people with metabolic syndrome. we aim to implement a cognitive training program on patients with metabolic syndrome and cognitive deficits, and examine its effectiveness both post-intervention (3 months) and after 12 months. researchers will compare two groups, the experimental group that will receive the computerized cognitive training and the control group that will receive no training.


Eligibility criteria:
inclusion criteria: * age 18 years or older * presence of metabolic syndrome according to the criteria of idf (2005) or revised ncep-atp iii (2005) * presence of mild cognitive deficit (-1.5 sd below age and education-adjusted normative mean) in previously administered neuropsychological tests of trail making test (part a \& b), verbal fluency test (animals and letter "x"), logical memory test (immediate and delayed recall) * written informed consent to participate exclusion criteria: * presence of any serious neurological or psychiatric condition

Keywords: metabolic syndrome mild cognitive deficits computerized cognitive rehabilitation
the effect of balance pd solution on the peritoneal membrane in patients on automated peritoneal dialysis

Conditions: Chronic Renal Failure

Summary: to investigate the biocompatibility of the peritoneal dialysis (pd) solution balance in comparison to the conventional pd solution in apd(automated peritoneal dialysis) patients using the apd cycler sleep•safe.

equivalence of the investigational pd solution balance regarding fluid status compared to the conventional pd solution. effects of balance on inflammation and systemic advanced glycation end products formation. effects of balance on peritoneal and total urea clearance, on peritoneal and total creatinine clearance and on ultrafiltration, on residual diuresis and on cholesterol levels. safety of the investigational pd solution balance and the conventional pd solution as a control drug. the mesothelial cell mass assessed by cancer antigen 125 is affected by the use of the type of pd solution in apd patients using sleep•safe. treating patients with the pd solution balance leads to not more than 1 litre difference in hydration in comparison to the conventional pd solution which is considered as clinically not relevant regarding blood pressure.

Eligibility criteria:
inclusion criteria: * apd patient ≥ 18 years * prevalent patient with at least 3 months experience on apd prior to inclusion * patient is trained on and being treated with the sleep•safe apd cycler * patient treated on apd exclusively with registered conventional pd solutions capd 2, capd 3, capd 4, capd 17, capd 18 or capd 19 for at least 8 weeks prior to inclusion * patient is on stable diuretic treatment e.g no change in diuretic treatment within the last 30 days prior to inclusion * informed consent signed and dated by study patient and investigator/authorised physician * ability to understand the nature and requirements of the study exclusion criteria: * peritonitis treatment £ 4 weeks preceding inclusion * apd patients treated with ipd modality (intermittent peritoneal dialysis) * malignant disease without remission * patients with artificial joints, amputations, stents, or pacemaker * patients with congestive heart failure or coronary artery disease nyha (new york heart association) iii and higher * active hbv (hepatitis b virus)or hcv(hepatitis c virus)infection- hiv positive * participation in an interventional clinical study during the preceding 30 days * any condition which could interfere with the patient's ability to comply with the study

Keywords: peritoneal dialysis biocompatible dialysis solution hydration status residual renal function body composition monitor bioimpedance spectroscopy cancer antigen 125
probiotics in newly recognized type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: they are major genera of bacteria that make up the colon flora in human, constitute intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal barrier and modulate local and systemic immune responses. changes in gut microbiota can influence the immune system by increasing gut permeability, intestinal inflammation, and impaired oral tolerance in type 1 diabetes.taken together, the data imply that bacteriotherapy may potentially be used as a tool to modulate the immune system for preventing islet destruction. supplementation of lactobacillus rhamnosus gg and bifidobacterium lactis bb12 improved blood glucose control in normoglycaemic pregnant women and reduced the frequency of gestational diabetes mellitus aim of the study: the effect of lactobacillus rhamnosus gg and bifidobacterium lactis bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomized, double blind, placebo-controlled trial. primary end point: area under the curve (auc) of c-peptide level during during fasting and at 30,60,90,120 min following the start of the meal intervention: included patients will be randomly assigned to receive a combination of lactobacillus rhamnosus gg and bifidobacterium lactis bb12 (probiotics group ) or placebo (placebo group ) during six months. the expected results: beneficial effect of lactobacillus rhamnosus gg and bifidobacterium lactis bb12 on beta-cell function shown in the properly performed, methodologically accurate study would create a rationale for its routine use in patients with newly diagnosed type 1 diabetes.

intervention: at the 6-month follow-up visit will be evaluated adherence and occurrence of side effects of the study procedure. the outcome measures will be assessed at the beginning of the study, and at the 6 and 12-month follow-up visit.

Eligibility criteria:
inclusion criteria: * type 1 diabetes confirmed by clinical history and the presence of at least one positive autoantibody: anti-glutamic acid decarboxylase (anti-gad), islet antigen 2 (ia2), islet cell antibody ( ica) * fasting c-peptide level \>/= 0.4 ng/ml * the diagnosis of diabetes during the last 60 days * consent to participate in the study exclusion criteria: * antibiotic-therapy during last 4 weeks * taking of probiotics during last 2 weeks * intestinal infection during last 2 weeks * intestinal chronic diseases

Keywords: probiotics children remission