Kornimate/medical-research-clean huggingface dataset:
influence of probiotics in diabetic cardiopathies with excessive weight

Conditions: Diabetes Mellitus Type 2 in Obese; Anxiety; Cardiopathy

Summary: today in brazil, 6.9% of the population has diabetes mellitus 2 (dm2). in the world, there are about 422 million people with dm2. it is a chronic disease of the endocrine system, accounts for 90 to 95% of cases of dm2 and is characterized by defects in insulin action and secretion. its main cause is linked to obesity and insulin resistance. obesity is a chronic, multifactorial disease - environmental, nutritional and genetic factors - characterized by excessive accumulation of body fat, and is reaching epidemic proportions, more than 100 million children and 600 million adults worldwide. the number of obese people in brazil reaches 17.9% of the population. rates of obesity and dm2 have increased in the last decades, both diseases being associated with inflammation and specific alterations in the intestinal microbiota. thus, studies show that the use of probiotics may be associated with reduced body weight and reduced glucose in the bloodstream. probiotics are living microorganisms that, when administered in suitable dosages, confer benefits to the health of the host. in addition, studies show the relationship of the intestinal microbiota and the emergence of various diseases and demonstrate that probiotics can control inflammatory processes, metabolic dysfunctions, normalization of stress-induced behaviors, regulation of the hypothalamic-pituitary-adrenal axis and neuropsychiatric disorders. thus, the importance of investigating the ingestion of probiotics in relation to anthropometry, biochemical profile and anxiety in diabetic and overweight individuals with cardiopathy are justified. it is a randomized, double-blind, controlled clinical trial. the study will last 3 months and will occur with 74 adult individuals (between 20 and 60 years) of the sus outpatient clinic of the institute of cardiology of porto alegre - rs, of both sexes, with bmi above 25 m² / kg. and less than 40 m² / kg, divided into 2 groups and 37 individuals per group. these patients were: group a (intervention: n = 37): patient received 1 sachet per day of probiotics lactobacillus acidophilus, lactobacillus casei, lactobacillus lactis, bifidobacterium lactis and bifidobacterium bifidum for 90 days and group b (placebo; n = 37): microcrystalline cellulose, lactose, pregelatinized maize starch. probiotics will contain a dose of 109 cfu in each strain. the excipients used will be: microcrystalline cellulose.

probióticos

Eligibility criteria:
inclusion criteria: * age between 20 and 60 years; * bmi greater than 25 m² / kg and less than 40 m² / kg; * dm2. exclusion criteria: * use of antibiotics or medications for weight loss purposes; * use of kefir, yacult; * lactose intolerance; * inflammatory bowel disease; * valvar surgery; * use of laxative in the last 3 months; * patients participating in other clinical studies.
postoperative pain control in children undergoing laparoscopic appendectomy: peripheral nerve block versus local anesthetic

Conditions: Postoperative Pain

Summary: after undergoing a laparoscopic appendectomy, a child may experience some degree of pain in the postoperative period. as a routine part of the procedure, surgeons inject local anesthetic where the laparoscopic ports are placed. this provides some pain relief, but most children will still require additional pain medications after surgery. the purpose of the study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal nerve) will give better pain relief, decreasing pain medication requirements and increasing comfort during the postoperative period.

a study investigator who is not involved in the immediate care of the patient will use a computer generated randomized table as to whether a child undergoing laparoscopic appendectomy will receive local anesthetic infiltration to the laparoscopic port placement sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. all subjects will receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. if the subject is to get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia. the local anesthetic used will be 0.25% bupivacaine without epinephrine for both local infiltration and peripheral nerve blocks. it has been shown that a dose of 0.075 ml/kg is the minimum amount of local anesthetic needed for a successful block. this will be the dose for each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. the infiltration of port sites by surgeons will also be limited to a total of 14 ml. if a subject does not have adequate analgesia in the post anesthesia care unit (pacu), they may receive morphine 0.05 mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per surgeon preference. a blinded observer will observe the subject for pain in the pacu using a validated pain scale, faces pain scale - revised (fps-r). the need for additional pain medications will be noted by an observer in the pacu and followed for the first 24 hours postoperatively. all data will be entered in an excel spreadsheet and the number of doses of rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral nerve blocks versus local anesthetic infiltration.

Eligibility criteria:
inclusion criteria: * all children scheduled for laparoscopic appendectomy between the ages of 6 and 18 * written informed consent from parent of guardian exclusion criteria: * sensitivities to local anesthetics * significant renal, liver, or cardiac disease * appendectomy requiring an open procedure

Keywords: children laparoscopic appendectomy iliohypogastric nerve block rectus sheath nerve block ilioinguinal nerve block
effective fluoride concentration in toothpaste for dental caries prevention

Conditions: Dental Caries

Summary: to identify the effective fluoride concentration in toothpaste for dental caries prevention after 18 months of randomized controlled trial.

in developed countries, well-controlled clinical trials have investigated the effective fluoride level in toothpaste and provided irresistible data in relation to the caries controlling efficacy of tooth pastes. but there has been no such data reported in our part of the world. this indicates the need to determine the effective concentration of fluoride in locally manufactured tooth pastes for accomplishment of the goal of prevention against dental caries. this will be a parallel group, double-blind, randomized controlled trial, over a period of 18 months. the study will be conducted in a randomly selected school of karachi city. participants will be the cohort of regular school children aged 12-14 years. sample size for the present study attained was 330 (165 in both groups), expected attrition rate will be kept as 15%, so the total sample size is 330 + 50 = 380 (190 in each group).

Eligibility criteria:
inclusion criteria: 1. regular school children of 12-15 years 2. presence of at least four molars exclusion criteria: 1. non- consenting cases 2. medically/physically compromised children 3. children under any kind of parallel fluoride regime (systemic or topical) 4. children consuming diet that is different from routine dietary practices 5. children using toothpaste with greater than 1100 ppm and less than 500 ppm of fluoride 6. children found with rampant caries 7. children found with all filled molars 8. children with any oral infection abscess, periodontitis etc 9. dentition with malocclusion 10. children undergoing orthodontic/prosthodontic treatment 11. children with temporo mandibular joint disorder 12. children who missed the baseline examinations 13. loss to any follow-up cases

Keywords: fluoride dental caries prevention
treatment seeking participants with opioid use disorders assessing tolerability of depot injections of buprenorphine

Conditions: Opioid Dependence; Opioid Related Disorders

Summary: this is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.

after completing an up to 2-week screening period, subjects entered an open-label run-in induction phase with suboxone (buprenorphine/naloxone) sublingual film for 3 days followed by a 4- to 11-day suboxone sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the suboxone sublingual film prescribing information. this is a 24-week non-residential study with participants being randomized after meeting randomization criteria. on day 1 and day 29 (± 2 days) participants will receive subcutaneous injections of 300 mg rbp-6000 or placebo. thereafter, participants will receive 4 injections (once every 28 days ± 2 days) of either 300 mg or 100 mg rbp-6000 doses or placebo.

Eligibility criteria:
inclusion criteria: * currently meets diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria for moderate or severe opioid use disorder * by medical history has met dsm-5 criteria for moderate or severe opioid use disorder for the 3 months immediately prior to signing the informed consent form * is seeking medication-assisted treatment for opioid use disorder * is an appropriate candidate for opioid partial-agonist medication-assisted treatment in the opinion of the investigator or medically responsible physician * body mass index (bmi) of ≥ 18.0 to ≤ 35.0 kg/m\^2 exclusion criteria: * current diagnosis other than opioid use disorder requiring chronic opioid treatment * current substance use disorder as defined by dsm-5 criteria with regard to any substances other than opioids, cocaine, cannabis, tobacco, or alcohol. * positive urine drug screen (uds) result at screening for cocaine or cannabis and meets dsm-5 criteria for either moderate or severe cocaine or cannabis use disorder, respectively * meets dsm-5 criteria for moderate or severe alcohol use disorder * received medication-assisted treatment for opioid use disorder (e.g., methadone, buprenorphine) in the 90 days prior to providing written informed consent
an observational study on long-term effectiveness and safety of roactemra/actemra (tocilizumab) in daily practice in patients with rheumatoid arthritis (ichiban)

Conditions: Rheumatoid Arthritis

Summary: this prospective, multi-center observational study will assess the long-term efficacy and safety of roactemra/actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. data will be collected from patients initiated on roactemra/actemra treatment according to label by decision of the treating physician. anticipated time for data collection from each patient will be 2 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * active moderate to severe rheumatoid arthritis * inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists * prescription of roactemra/actemra according to label exclusion criteria: n/a
effective postoperative pain treatment after sternotomy. comparison of the erector spinae plane block vs conventional opioid treatment

Conditions: Pain Reliefe

Summary: comparison of effect between erector spinae plane block and conventional opioid treatment after cardiac surgery

comparison of effect between erector spinae plane block and conventional opioid treatment after cardiac surgery. in group "a" will be erector spinae plane block provided in the thoracic part of the body, under ultrasound control. in the group b will be analgesia provided by pethidine. numerical pain score will be recorded every 2 hours, also usage of analgetics will be recorded in both groups.

Eligibility criteria:
inclusion criteria: * postoperative state after cardiac surgery, serious pain nrs 8-10 exclusion criteria: * disagreement
pinnacle metal-on-metal 522 post-market surveillance study

Conditions: Pinnacle Metal-on-Metal; Revised Pinnacle Metal-on-Metal; Adverse Local Tissue Reaction; Metal Ions; Total Hip Arthroplasty

Summary: the purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the pinnacle acetabular mom system.


Eligibility criteria:
inclusion criteria: 1. able to (or capable of) provide written, voluntary consent to participate in the clinical investigation 2. is willing and able to return for all protocol defined clinic visits 3. subject has a combination of the following implants in the study hip (unless in pre-op cohort): 1. pinnacle acetabular shell with or without gription tm porous coating 2. m-specification cobalt-chrome femoral head or asphere m-specification cobalt-chrome femoral head 3. ultamet metal insert 4. one of the following stems i. s-rom ii. corail iii. tri-lock iv. aml v. summit vi. prodigy vii. c-stem 4. subject has high quality films available for review that were taken within 12 months of the primary surgery of the following views: 1. standing ap-pelvis 2. standing ap-proximal femur (if this view is not available but the ap-pelvis shows the entire implant and greater trochanter, that is also acceptable) 3. lauenstein lateral proximal femur (lateral-femur) exclusion criteria: 1. the subject refuses to allow their medical records to be inspected by the sponsor, representatives of the sponsor, the medical office staff and/or representatives from fda 2. the implanted hip components in the study hip (exclusive of cement), are not all depuy components (unless in pre-op cohort) 3. the primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort) 4. for pre-operative cohort only: the subject has a mom contralateral hip 5. for pre-operative cohort only: the subject is undergoing a revision of the ipsilateral hip

Keywords: adverse local tissue reaction metal ions serum whole blood metal-on-metal total hip arthroplasty
a single center study to characterize the absorption, distribution, metabolism and excretion (adme) of asa404 after a single infusion in patients with solid tumors

Conditions: Advanced Solid Tumors

Summary: this study is designed to characterize the absorption, distribution, metabolism and excretion (adme) of asa404 following a single intravenous administration of 3000 mg (approximately 1800 mg/m2) asa404 containing 60 µci of 14c over a period of 20 minutes in patients with advanced solid tumors. metabolic pathways, route (s) of elimination, distribution characteristics in plasma and blood, and exposure characterization in plasma and blood, and exposure characterization of the parent drug and metabolites will be obtained from the study.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of advanced or metastatic solid tumors for whom either refractory to standard therapy exists, or for whom treatment with an investigational agent alone or in combination with docetaxel, paclitaxel, carboplatin, or paclitaxel plus carboplatin is appropriate; * anc≥ 1.5 x 109/l; * hgb ≥ 9.0 g/l; * plt ≥ 100,000/mm3; * total bilirubin ≤ 1.5; * willing and able to remain in the clinic for at least 4 days exclusion criteria: * patients with cns and/or leptomeningeal disease metastases allowed on the study unless asymptomatic and not requiring corticosteroid therapy. patients having any clinical signs of cns metastases must have a ct or mri of the brain performed to rule out cns metastases in order to be eligible for study participation. patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed; * patients unable to undergo intravenous infusion; * patients with a baseline 12-lead egc qtc of \>450 msec; * radiotherapy in less than two (2) weeks prior to study entry; * a history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced or metastatic cancer refractory core phase extension phase dose escalation standard chemotherapy docetaxel paclitaxel carboplatin safety tolerability
testing mitochondria activity and blood lipid content of multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: background: multiple sclerosis (ms) is a complex and multifactorial neurological disease characterized by infiltration of immune cells and progressive damage to myelin and axons. remyelination, the generation of new myelin in the adult nervous system, is an endogenous repair mechanism that restores function of axons. neurons require considerable energy for their activities, including synaptic neurotransmission, and hence have significant numbers of mitochondria. unlike other cell types that are able to utilize glycolysis as an alternative energy source, glycolysis in fully differentiated neurons is basically suppressed to maintain their antioxidant status. this property makes neurons highly vulnerable to atp deficiency, and may be a factor in the susceptibility of neurons to cell death. mitochondria provide cellular energy by converting oxygen and nutrients into adenosine triphosphate (atp); and reflect local metabolic needs and via oxidative phosphorylation. nervous tissues contain about 70% lipids of their dry weight, and around 40% of these lipids are polyunsaturated fatty acids (pufas). goal: understanding the relationship between blood composition, mitochondria role and clinical status. here, we will examine expression levels of different fatty acids in the blood and monitor mitochondrial transmembrane potential as marker for the mitochondria general function. hypothesis: remyelination efficiency in ms is likely mediated by many factors, besides reducing inflammation. remyelination may not be achieved correctly /sufficient in ms patients due to nutrition low content causing mitochondrial dysfunction and/or due to fatty acid molecules deficit unable to create a new myelin layer.

methods: the study will be authorized by the ziv helsinki committee. informed consent and questionnaire will obtained from all subjects before study entry. we will examine 120 volunteers in a blind fashion, including 60 ms patients diagnosed by a neurologist based on clinical, laboratory and mri findings. patients will be evaluated according to edss score. the control group will include 50 age and gender matched healthy volunteers and 10 more patients with unrelated neurological diseases. inclusion criteria: age 18-60; exclusion criteria: other diseases, pathologies, or immune system disorders. here, we will examine expression of different fatty acids in the serum and in erythrocyte samples; monitor mitochondrial transmembrane potential as marker for the mitochondria general function.

Eligibility criteria:
inclusion criteria: * age 18-60 exclusion criteria: * other diseases, pathologies, or immune system disorders.

Keywords: multiple sclerosis remyelination mitochondria fatty acids
gotnet study, the gothenburg nurse-led tight control study

Conditions: Rheumatoid Arthritis

Summary: purpose: to compare a nurse-led clinic including person-centered care and tight control with "care as usual" in patients with rheumatoid arthritis (ra) and moderate/ high disease activity. project description: study population: patients with ra, 18-80 yrs old, with moderate/ high disease activity score of 28 joints (das28 \> 3.8) and disease duration \> 2 yrs in a 6-month randomized controlled study with a 6 month open follow-up. intervention group (n=60): nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. if disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (dmards and biologics) is modified according to a predefined algorithm. the control group (n=60) is treated according to "care as usual" with visits to physician every 6th month. outcome measures: primary outcome measure is change in diseases activity score (das). secondary outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue, sleep and satisfaction.


Eligibility criteria:
inclusion criteria: * ≥18 and \<80 years of age * signed and dated informed consent form before the start of any specific protocol procedures * fulfill the 1987 acr criteria or the 2010 acr/eular criteria for ra with disease duration of \>2 years * moderate to high disease activity (das28 \>3.8) * ≥2 swollen joints exclusion criteria: * diagnosis of any other inflammatory arthritis * history of chronic infection, recent serious or life-threatening infection within 6 months * concurrent malignancy, a history of malignancy or current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease

Keywords: rheumatoid arthritis person-centered care tight control
early outcomes of mako medial unicompartmental knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: to determine if robotically-assisted uka results in more consistent and improved component positioning and better patient reported outcome scores compared to manual tka and mako tka.

the purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (muka) with the mako surgical robot using the restoris mck partial implant system. the primary end point will be the mean weekly vas pain score during the first four weeks postoperatively. the results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (tka) with the triathlon knee system as well as robotically-assisted total knee arthroplasty with the mako surgical robot using the triathlon knee system

Eligibility criteria:
inclusion criteria: a. unilateral primary medial unicompartmental knee arthroplasty b. age 18 years of age or older c. willing to sign informed consent d. willing to return for all follow-up visits e. smartphone or tablet device capable of running the focusmotion platform exclusion criteria: a. bmi \> 40 b. personal history of dvt or pe c. inflammatory arthritis d. peripheral vascular disease e. opioid use greater than 5 days per week f. nonsteroidal anti-inflammatory allergy g. walking aid for musculoskeletal or neurologic issue other than operative joint h. bilateral medial unicompartmental knee arthroplasty i. patient with an active infection or suspected infection in the operative joint j. the absolute and relative contraindications stated in the fda cleared labeling for the device