Kornimate/medical-research-clean huggingface dataset:
custom cutting block instrument vs regular instrumentation total knee replacement (tkr)

Conditions: Osteoarthritis, Knee

Summary: to determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.

this is a randomized controlled trial. patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. functional and radiographic outcomes will be assessed in a blinded fashion. the smith and nephew legion primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the genesis ii design. all surgeons have used and are familiar with the regular instrumentation. they will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Eligibility criteria:
inclusion criteria: 1. patient is male or female ages 18 and over. 2. patient is having primary total knee replacement 3. patient is willing to sign the informed consent and to come for all study visits. exclusion criteria: 1. deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set. 2. necessity for the use of constrained implants. these types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate. 3. patients undergoing knee replacement revision surgery. theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons. 4. patients scheduled for bilateral knee surgery (simultaneous or staged)

Keywords: total knee replacement
muscle lactate and lactate to pyruvate ratio clearance in septic shock patients

Conditions: Septic Shock

Summary: we conducted this study aiming to assess the performance of muscle lactate and lactate to pyruvate (l/p) ratio clearance in predicting mortality in septic shock patients by using microdialysis.

microcirculatory alterations are frequently observed in patients with sepsis. in vivo microdialysis (md) is a bedside technique that can monitor tissue metabolic changes. we conducted this study aiming to assess the performance of muscle lactate and lactate to pyruvate (l/p) ratio clearance in predicting mortality in septic shock patients by using microdialysis. interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline and every 6 hours for 3 days by using muscle microdialysis. clearances of muscle lactate, and l/p ratio were defined as the percentage change in muscle lactate level or l/p ratio compared to baseline (h0) values. a positive value of clearance means a decrease in the rate of the parameter under study.

Eligibility criteria:
inclusion criteria: * patients fulfilled the criteria of septic shock exclusion criteria: * pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve. * incomplete data
motor imagery and rehabilitation of orthopaedic patients

Conditions: Orthopedic Disorder

Summary: motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. the investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.


Eligibility criteria:
inclusion criteria: * right handed * no contraindication to the fmri exam exclusion criteria: * contraindication to the fmri exam
vk2735 for weight management phase 2

Conditions: Weight Loss

Summary: this is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of vk2735 in adults who are obese (bmi ≥30 kg/m2) or who are overweight (bmi ≥27 kg/m2) with at least one weight-related co-morbid condition. vk2735 or matched placebo will be administered once weekly.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years of age at the time of signing the informed consent 2. body mass index (bmi) ≥30 kg/m2 or ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and bmi \<50 kg/m2 exclusion criteria: 1. history of or current clinically significant medical or psychiatric disorder that, in the opinion of the investigator, does not support study participation 2. self-reported body weight change of 5% or more within 3 months of screening 3. current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational) 4. current or past diagnosis of chronic pancreatitis 5. calcitonin ≥20 ng/l measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened) 6. any glp-1 receptor agonist or glp-1/gip dual agonist within 6 months of screening 7. any prescription or over-the-counter medications intended for weight loss within 6 months of screening

Keywords: overweight obese
dose-escalation study in advanced colon cancer patients

Conditions: Colon Cancer

Summary: this study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of epo906a (patupilone) in patients with pretreated advanced colon cancer.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to recist 2. age ≥ 18 years 3. life expectancy ≥ 12 weeks 4. who performance status of 0-1 5. negative serum pregnancy test 6. adequate hepatic or renal function and hematological parameters exclusion criteria: 1. brain metastases 2. ileostomy or colonostomy 3. history of pelvic radiotherapy 4. grade \> 1 diarrhea at baseline other protocol-defined inclusion/exclusion criteria may apply

Keywords: colon cancer mtd dlt epo906 patupilone
nanosilver fluoride to prevent dental biofilms growth

Conditions: Dental Caries

Summary: this study aims to evaluate the effectiveness of nanosilver fluoride for controlling the growth of s. mutans present in dental plaque of children.

the product will be apllied on cervical vestibular surfaces of incisors and canines healthy, with a total of 8 teeth, 4 upper and 4 below. children will be instructed not to ingest any liquid or food within two hours after application. after a period of 7 days will be carried biofilm colect of cervical dental surfaces of incisors and / or canines upper and lower, with the aid of sterile spatulas. this material will be packaged in pre-weighed microfuge tubes containing 1.5 ml of buffered saline solution (0.9% sodium chloride), and transported under refrigeration immediately to the laboratory where analysis will be performed and the s. mutans colonies will be counted. the biofilm collect and posterior laboratorial analysis will be performed weekly.

Eligibility criteria:
inclusion criteria: * have at least 4 upper teeth and 4 lower teeth deciduous;systemic health satisfactory; did not use antibiotics or nonsteroidal anti-inflammatory within one month before or during the study;do not use any other forms of chemical control of biofilm during the study period;not being a user of orthodontic devices or dentures; exclusion criteria: * presenting oral lesions, supragingival calculus and severe malocclusion.

Keywords: silver nanoparticles antimicrobial activity toxicity biofilm cariostatic agents
the effect of tes on a cognitive training

Conditions: Memory Impairment

Summary: the aim of this study is to investigate the effect of a transcranial electrical stimulation (tes) on a cognitive training in healthy elderly and memory impaired participants. in order to assess these effects different memory and attention tasks will be performed before and after the training as well as after 6 and 12 months.

as other studies have shown, transcranial direct current stimulation (tdcs) can improve the outcome of memory tasks in alzheimer's disease (ad), mild cognitive impairment (mci) and healthy older adults. only few studies have investigated the effect of the combination of tdcs and a simultaneous cognitive training and to the investigators' knowledge there is no comparison of tdcs and transcranial alternating current (tacs) effects during a cognitive training or for different populations. with results from this study existing trainings can be optimised. in total 180 participants are planned to be included in this study. this number is based on a g\*power estimation. according to this estimation the study has to include 153 participants. regarding similar studies the investigators assume a dropout rate of 15% resulting in a total of 180 participants (60 ad patients, 60 mci patients and 60 healthy older adults) this number should make it possible to find the expected mild effects reported in literature. a mixed-effects anova model with the between-subjects factor stimulation (tdcs, tacs, sham) and the within-subjects factor time will be computed.

Eligibility criteria:
inclusion criteria: * able to give their consent to participate in the study * native or fluent german speaker * normal or corrected to normal vision and hearing * ability to visit the study location for 14 appointments exclusion criteria: * acute neurological (other than memory impairment) or psychiatric disorders * seizures * magnetisable implants * high dose of psychotropic drugs * drug or alcohol abuse * participation in another study with investigational drug * tes in the 2 months preceding or during the present study * severe head injuries * skin disease * caffeine 3 hours prior to training

Keywords: cognitive training memory impairment mild cognitive impairment alzheimer's disease tes tacs tdcs
efficacy and safety of acupuncture for degenerative lumbar spinal stenosis

Conditions: Degenerative Lumbar Spinal Stenosis

Summary: degenerative lumbar spinal stenosis (dlss) is a major problem for public health and the primary reason the older seek lumbar spine surgery. acupuncture is safe and maybe effective for dlss but the evidence is poor. therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients. a total of 80 participants meet prior inclusion criteria will be recruited. the participants will be allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group randomly. twenty-four treatments will be provided over 8 weeks. the primary change of modified roland-morris disability questionnaire (rmdq) and secondary outcomes including the change of number rating scale (nrs); the change of self-paced walking test (spwt); the change of swiss spinal stenosis questionnaire (sssq); the expectations that acupuncture might help participants with dlss. all outcomes will be assessed at baseline, and/or after 4, 8, 20 and 32 weeks. statistical analysis will include independent sample t-test, chi-squared test and non-parametric test. the investigators hope the result of this trial will clarify the value of acupuncture for dlss and help clinicians make proper decisions.


Eligibility criteria:
inclusion criteria: participants who meet all of the following conditions will be considered for enrollment. the inclusion criteria are as follows: 1. pain in the low back, buttock, and/or lower extremity with standing, walking and/or spinal extension. (using nrs questionnaire to measure pain symptoms, and pain measured by nrs ≥ 4.) 2. roland-morris score of at least 7. 3. mild-moderate-severe lumbar central canal spinal stenosis identified by mri or ct scan. 4. lower extremity symptoms consistent with neurogenic claudication. 5. age 50 to 80 years old. 6. signed the consent and take part in this trial of his/her willing. exclusion criteria: 1. congenital stenosis of vertebral canal, serious indications of dlss (such as segmental muscular atrophy, bowel and bladder disturbances), spinal nerve root canal stenosis, lumbar spondylolysis, lumbar tuberculosis, lumbar vertebral tumors, and vertebral body compression fracture. 2. spinal instability requiring surgery. 3. severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction. 4. participants who have cognitive impairment that may render the subject unable to give informed consent or provide accurate data. 5. clinical co-morbidities that could interfere with the collection of data concerning pain and function. 6. acupuncture within the past 30 days. 7. administered pain control drugs during the week prior to the baseline assessment (e.g.,non-steroidal anti-inflammatory drugs or herbal anti-inflammatory agents).

Keywords: degenerative lumbar spinal stenosis acupuncture randomized controlled trial
outcomes after epigastric hernia repair in women.

Conditions: Epigastric Hernia

Summary: nationwide cohort study on women undergoing epigastric hernia repair

women have the highest prevalence of epigastric hernia repair. outcomes after epigastric hernia repair are rarely reported independently, although pathology and surgical techniques may be different than for other primary ventral hernias. the aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis. methods nationwide cohort study from the danish hernia database. complete data from women undergoing elective epigastric hernia repair during a 12-year period (2007-2018) was extracted. a 100% follow-up was obtained by combining data from the national civil register. the primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. outcomes for open sutured repair, open mesh repair mesh, and laparoscopic repairs were compared.

Eligibility criteria:
inclusion criteria: * females undergoing epigastric hernia repair in denmark exclusion criteria: * emergency repair umbilical hernias incisional hernias males
arthritis research uk gout treatment trial - phase 2

Conditions: Gout

Summary: the purpose of this study is to determine in community-derived patients with gout the effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects recommended best practice (including patient information concerning gout, its prognosis and its non-pharmacological and drug options).


Eligibility criteria:
inclusion criteria: * diagnosis of gout * at least one acute attack of gout within previous 12 months exclusion criteria: - inability to give informed consent and known terminal or mental illness
efficacy and mechanisms of cbt4cbt for alcohol use disorders

Conditions: Alcohol Use Disorder

Summary: evaluate the efficacy of cbt4cbt and clinician-delivered cbt relative to standard treatment for reducing alcohol use

evaluate the efficacy of computer based training for cognitive behavioral therapy (cbt4cbt) and clinician-delivered cognitive behavioral therapy (cbt) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. our primary hypothesis is that either form of cbt will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via timeline followback interviews.

Eligibility criteria:
inclusion criteria: individuals will be included who: * are 18 years of age or older. * are applying for outpatient alcohol treatment and meet current dsm-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days, * are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up * are willing to provide locator information for follow-up, and * are fluent in english and have a 6th grade or higher reading level. exclusion criteria: individuals will be excluded who: * have an untreated bipolar or schizophrenic disorder, * have a current legal case pending such that incarceration during the 8-week protocol is likely, * have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or * are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by rcs staff at triage).
efficacy and safety of berberine in the treatment of diabetes with dyslipidemia

Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome

Summary: berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human. these findings have not been tested in a clinical trial. this randomized, double blind, placebo controlled and multi-center study has demonstrated that berberine is effective in lowering plasma glucose concentrations, reducing serum hba1c and anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.

berberine, a natural plant alkaloid, has not been well investigated for clinical application in the treatment of diabetes. the present study evaluated the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia. 116 patients with type 2 diabetes and dyslipidemia were assigned in a randomized, double-blind, and placebo-controlled 4-clinical center study to receive berberine (1.0g daily) or placebo for 3 months. the primary efficacy outcomes were changes in plasma glucose and serum lipid levels. the glucose disposal rate (gdr) was measured using a hyperinsulinemic euglycemic clamp to assess insulin resistance in a randomly selected subjects of 54 patients. the baseline characteristics were similar in berberine and placebo groups. after 3 months, fasting and post load plasma glucose levels, hba1c, triglyceride, total cholesterol and ldl-c levels were all significantly reduced in the berberine group compared with the placebo group (p\<0.0001, p\<0.0001, p\<0.0001, p=0.002, p\<0.0001 and p\<0.0001 respectively). the gdr was significantly increased after 3 months of berberine (p=0.037), while no change was found in the placebo group (p=0.86). bmi, systolic blood pressure and serum il-6 levels were all significantly reduced after treatment in berberine group as compared with the placebo group (p=0.016, p=0.041 and p=0.014, respectively). our results show berberine to be effective and safe in the treatment of persons with diabetes and dislipidemia. this agent may be useful in the treatment of patients with type 2 diabetes, and could play a role in treatment of metabolic syndrome.

Eligibility criteria:
inclusion criteria: 1. age of 25 -70 years; 2. newly diagnosed type 2 diabetes according to the 1999 world health organization criteria; 3. dyslipidemia with tg\> 150mg/dl (1.70mmol/l), and/or tc\>200mg/dl (5.16mmol/l), and/or ldl-c\>100mg/dl (2.58mmol/l) according to the national cholesterol education program's adult treatment panel iii (ncep: atpiii) without previous treatment. 4. bmi:19 - 40 kg/m2. exclusion criteria: 1. moderate or severe liver or renal dysfunction, psychiatric disease or severe infection; 2. severe dysfunction of the heart，new york heart association class ³ ⅲ phase; 3. history of acute diabetic complications; 4. pregnancy or planned pregnancy. 5. present or previous use of drugs for treatment of diabetes or dyslipidemia; 6. fasting plasma glucose \>8mmol/l and/or post load plasma glucose level \>17mmol/l after 2-week run-in.

Keywords: berberine type 2 diabetes dyslipidemia
mentalization - based treatment: adolescents with co-morbid depression and personality disorder

Conditions: Depression; Personality Disorder

Summary: mentalisation based treatment (mbt) for young people with co-morbid depression and emerging personality disorder will be more effective in a day/inpatient setting than treatment as usual.

systematic literature review on outcomes with young people with depression and emerging personality disorder showed clear evidence that this group of young people are severely hampered and adult outcomes are strongly linked to both adult pd as well as adult psychiatric disturbance and lower levels of adult functioning. (crawford et al, 2008; kasen et al, 1999; kasen et al, 2007; lewinsohn et al, 1999) this argues very clearly for the need to diagnose young people presenting with co-morbid depression and emerging personality disorder in order to intervene and help these young people's struggles as it will prevent poor prognostic adult outcomes. there were no treatment programs that specifically focussed on the treatment of this co-morbid group in the literature. several studies focussed on the treatment of depression alone and only one rct focussed on the treatment of adolescent personality disorder (chanen et al, 2007). in adult studies mentalization-based treatment programs were found to be effective ( as well as cost effective) in a day hospital setting for adults with personality disorder and depression (bateman, et al, 2007) this study aims to conduct a control trial to test whether mbt will be more effective than tau in this group. all cases will be tested on admission, at discharge and followed up at 2 years post discharge.

Eligibility criteria:
inclusion criteria: * all young people who are admitted to brookside adolescent unit between the ages 12 - 17 presenting with depression and emerging personality disorder will be eligible exclusion criteria: * young people with autistic spectrum disorders or severe learning disabilities.

Keywords: adolescents mbt depression emerging personality disorder
pain and anxiety evaluation in children using different techniques of local anesthesia for dental treatment

Conditions: Pediatric Dentistry; Local Anesthesia; Pain Management

Summary: fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. dental trauma originates in childhood, through experience misconduct. the objective of this study is to evaluate the pain and anxiety related to 4 different modalities of anesthesia in children. will be selected volunteers aged between 5 and 12 years who need restorative dental treatment in posterior teeth in the upper 2 quadrants. all patients will receive 1 modality of anesthesia: conventional anesthesia (control group), computerized anesthesia, dental vibe anesthesia and computerized anesthesia + dentalvibe anesthesia. evaluations will be made with physiological and behavioral criteria. for the physiological evaluation will be measured the blood pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each anesthesia. as criteria for evaluation of anxiety will be applied the methods, corah and modified vpt before anesthesia and modified vpt will be repeated after anesthesia. the pain will be assessed at the end of each anesthesia with visual analogue scale (vas) and wong baker faces. the results will be submitted to parametric and non-parametric statistical analysis, according to the data obtained in the different evaluation criteria.


Eligibility criteria:
inclusion criteria: * children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla. exclusion criteria: * the person responsible does not authorize the participation of the child as a research volunteer. * be using pain modulating drugs. * be using anxiety modulating drugs. * patients with a history of hypersensitivity to local anesthetics. * patients with a history of systemic diseases.