Kornimate/medical-research-clean huggingface dataset:
the impact of dietary restriction of animal protein and fat on osteoarthritis

Conditions: Osteoarthritis

Summary: patients will be randomized into the control or intervention group. based on patient preference, the intervention group will be trained for one hour in either individual or group format on vegan diet. they will also be directed to www.pcrm.org and www.drmarymd.com for low glycemic, animal free, low fat food options and support. the control group will continue their normal omnivorous diet program. twenty-four hour food recalls will be obtained at the start and end of the trial, and once a week for the 6 weeks of the trial by telephone. patients will undergo a final interview at the end of the 6 week study period. the intervention group should strive to obtain 90% of their calories from plants. they will be encouraged to eat freely and not count calories. patients will undergo additional individual consultation as needed to promote compliance and answer specific questions. over the 6 weeks, the patient global improvement of change (pgic) and the 36 item short form health survey (sf-36) will be performed weekly by telephone. patient will perform a visual analog scale (vas) of their pain level randomly daily on their own. c-reactive protein levels will be assessed at the beginning and end of the study at munson medical center laboratories as a secondary measure of diet changes. there have been no published prospective randomized controlled trials assessing whether a vegan diet would benefit osteoarthritis. the specific aim of this study is to determine if a vegan diet will result in subjective reduction in perceived pain and limitations to function in patients with osteoarthritis.


Eligibility criteria:
inclusion criteria: * community dwelling * medical provider diagnosis of osteoarthritis exclusion criteria: * pre-existing vegans or vegetarians * ages less than 18 or greater than 70 * history of an eating disorder * history of diabetes * inability to afford food * lack of control over the food eaten * pregnant or nursing * known food allergies * patients following a medically prescribed diet

Keywords: arthritis pain function diet vegan vegetarian restriction
the frequency of sodium hypochlorite extrusion during endodontic treatments

Conditions: Pain, Acute; Necrotic Pulp

Summary: sodium hypochlorite is a commonly used irrigation agent. however, the solution may extrude beyond the apex of tooth and cause pain during the treatment.the aim of this prospective observational investigation is to determinate the frequency of the extrusion of sodtium hypochlorite in endodontically treated teeth.

sodium hypochlorite (naocl) is a gold standard irrigation solution that has antimicrobial and tissue solvent effect. until now, there is no other alternative that provides its activity characteristics. although it represents many advantages, and it is usually considered safe, some cases of mishap and systematic reviews about case reports of naocl accident especially during endodontic procedures, have been reported in the literature. naocl may lead potentially very damaging injuring results with acute pain, swelling, hemolysis, ulceration, inhibition of neutrophil migration, endothelial and fibroblast cell damage, nerve weakness or damage, trismus and tissue necrosis if it overflows the periapical area. the aim of this prospective observational investigation is to determinate the frequency of the extrusion in endodontically treated teeth. the patients who applied to the clinic for dental treatment will be identified as having root canal treatment indication for at least one tooth. after the detailed medical and dental history will be obtained, the written consent form was taken from the patients who wanted to participate in the study. age, gender, medical history, preoperative pain and pulpal status, having any periapical radiolusency of the related tooth will be recorded and root canal treatment will be performed according to routine procedures. after treatment, the code of tooth according to fdi classification, number of root, apical diameter, volume and concentration of irrigation solution will be recorded. routine treatment follow-up will be performed in patients who has no naocl overflow from the root during procedure. the patients with naocl overflow during the treatment process, appropriate treatment will be planned and followed up until symptoms regress.

Eligibility criteria:
inclusion criteria: * requirement of root canal treatment exclusion criteria: * sodium hypochlorite allergy * immature tooth * root resorption
surgical registry of endocarditis europe

Conditions: Infective Endocarditis; Cardiac Surgery; Outcomes

Summary: this is a prospective, multicentric, european registry of patients with infective endocarditis undergoing cardiac surgery. patient demographics, clinical data and laboratory values will be collected, as well as treatment outcomes at day 30, day 90 and 1-5 years after the intervention.

infective endocarditis (ie) is now a relatively rare but worldwide disease (3-10 ie/100000 population/year) with increasing incidence especially in the western world. ie is still associated with high morbidity and mortality, prolonged hospital stay, high risk of reinfection, significantly worsened prognosis for patients, substantially reduced quality of life, and in any case represents a major financial burden for the respective healthcare systems \[1-11\]. patients who need to undergo cardiac surgery due to infective endocarditis (ie) are heterogeneous and present with a persistently high perioperative morbidity and mortality rate. despite optimal and individualized perioperative management strategies, perioperative complications such as heart failure, systemic inflammatory response, vasoplegia, and sepsis is still the main reason for adverse outcomes following cardiac surgery. the present european, multicenter ie registry (surgical registry of infective endocarditis in europe - surrender) was initiated and established to record and appropriately analyze current surgical treatment options and perioperative adjunctive treatment strategies, as well as short- and long-term patient outcomes.

Eligibility criteria:
inclusion criteria: * patients with infective endocarditis (according to duke criteria) undergoing cardiac surgery * age ≥18 years * written informed consent exclusion criteria: * age \< 18 years * missing declaration of consent * current participation in another interventional trial

Keywords: infective endocarditis registry european surgery prognosis
a dose ranging effect of preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery

Conditions: Surgery; Pain

Summary: pain after ambulatory surgery remains an unsolved problem in the united states and europe. it is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. the concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including non steroidal antiinflammatory drugs (nsaids), acetaminophen, gabapentoids, ketamine, local and regional anesthetic techniques. histamine can have effects on polymodal nociceptors and c-fibers, producing pain which is further increased by neurogenically mediated release of substance p from afferent pain fibers. several non-selective or h1 -selective histamine receptors antagonists have been demonstrated in animal models and clinical pain. chia et al demonstrated that preoperative promethazine had opioid sparing properties without adverse sedative effects in patients undergoing abdominal hysterectomy. diphenhydramine is an anti-histamine drug who has been found to be effective in reducing postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative pain and other important outcomes after ambulatory surgery such as time to meet discharge criteria have not being studied. the mqor 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery. this instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of diphenhydramine. the objective of this study is to determine a dose response effect of preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery. the use of preoperative diphenhydramine can improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery. the research question: does a preoperative dose of diphenhydramine improve postoperative quality of recovery after ambulatory surgery? the hypothesis of this study is that preoperative diphenhydramine will improve postoperative pain, postoperative nausea and vomiting (ponv), sleep which will translate in a better overall quality of recovery.


Eligibility criteria:
inclusion criteria: * age 18-64 years * patients undergoing ambulatory surgery * asa ps i, ii. exclusion criteria: * chronic opioid use * pregnant patient or lactating patients * allergy to diphenhydramine * glaucoma * uncontrolled hypertension * asthma * hyperthyroidism * cardiovascular disease

Keywords: pain anesthesia surgery postoperative
evaluate safety and biological activity of atyr1940 in participants with early onset facioscapulohumeral muscular dystrophy

Conditions: Facioscapulohumeral Muscular Dystrophy (FSHD)

Summary: the purpose of this study is to assess the safety and biological activity of atyr1940 in participants with early onset fshd.

a phase 1b/2 open-label, intraparticipant dose-escalation study aiming to evaluate the safety, tolerability, immunogenicity, biological and pharmacodynamic activity of intravenous atyr1940, administered once weekly for 12 weeks, in early onset fshd participants with signs or symptoms prior to 10 years of age.

Eligibility criteria:
inclusion criteria: * established, genetically confirmed diagnosis of fshd. * onset of fshd signs or symptoms prior to 10 years of age, as documented in the participant's medical record or based on participant or family report. * provide written informed consent or assent * in the investigator's opinion, participant is willing and able to complete all study procedures and comply with the weekly study visit schedule. exclusion criteria: * currently receiving treatment with an immunomodulatory agent including targeted biological therapies within the 3 months before baseline; corticosteroids within 3 months before baseline; or high-dose non-steroidal anti-inflammatory agents within 2 weeks before baseline. * currently receiving curcumin or albuterol; use of a product that putatively enhances muscle growth or activity on a chronic basis within 4 weeks before baseline; statin treatment initiation or significant adjustment to statin regimen within 3 months before baseline (stable, chronic statin use is permissible). * use of an investigational product or device within 30 days before baseline. * evidence of an alternative diagnosis other than fshd or a coexisting myopathy or dystrophy, based on prior muscle biopsy or other available investigations. * history of severe restrictive or obstructive lung disease, or evidence for interstitial lung disease on screening chest radiograph. * history of anti-synthetase syndrome, prior jo-1 ab-positivity, or a positive or equivocally positive jo-1 ab test result during screening. * chronic infection, such as hepatitis b, hepatitis c, or human immunodeficiency virus or a history of tuberculosis. * vaccination within 8 weeks before baseline or vaccination is planned during study participation. * symptomatic cardiomyopathy or severe cardiac arrhythmia, that may, in the investigator's opinion, limit the participant's ability to complete the study protocol. * muscle biopsy within 30 days before baseline.

Keywords: fshd
whey protein supplement in combination with physical exercise and nutrition program

Conditions: Lung Cancer; Gastro-Intestinal Cancer; Breast Cancer; Prostate Cancer; Pleural Mesothelioma; Urothelial Carcinoma; Renal Cell Carcinoma; Ovarian Cancer

Summary: this study evaluates physical performance in cancer outpatients during a multimodal therapy. half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.

the time period of intervention will last 3 month, measurements will be conducted at baseline and 3 month. after 6 month there will be an additional follow-up test point to assess the sustainability of the intervention. the 3-month intervention study consists of a physical exercise program and nutrition counseling in combination with a specially formulated whey protein supplement high in leucine. the standardized training program will be performed twice a week in the physical department of the kantonsspital winterthur (ksw) and once a week in a home based setting. additionally, participants of the intervention group will be aks to consume 15 g of the nutrient supplement powder with approximately 150 ml water. on workout days the supplement should be taken twice a day and on the remaining days once a day. during the three month intervention study participants will take part in a nutrition counseling for at least three times.

Eligibility criteria:
inclusion criteria: * advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma * who performance status ≥ 2 * able to walk independently at least 100 meters * estimated life expectancy of ≥ 6 month exclusion criteria: * patients currently using nutritional supplements with branched chain amino acids * enteral or parenteral nutrition within 1 month * history of ileus within 1 month * psychiatric disorder precluding understanding of information on trials related topics and giving informed consent * milk protein allergy

Keywords: palliative
efficacy of phosphatidylcholine in nafld

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: this study evaluates efficacy of phosphatidylcholine in addition to life style modification and patient health education by clinical pharmacist in the management of non alcoholic fatty liver nafld. all participants with nafld will receive life style intervention and half of them will receive additionally phosphatidylcholine.

as a result of increasing rates of obesity non alcoholic fatty liver (nafld) is the most common liver disorder affecting 17-46% of adults and parallels the prevalence of metabolic syndrome (mets) and its components which also increases the risk of more advanced disease both in adults and in children. its pathogenesis is complex and multifactorial, mainly involving genetic, environmental and metabolic factors. new concepts are constantly appearing in the literature, promising new diagnostic and therapeutic tools. further studies are needed to better characterize not only nafld development but overall nafld progression, in order to better identify nafld patients at higher risk of metabolic, cardiovascular and neoplastic complications. pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven nonalcoholic steatohepatitis (nash) and liver ﬁbrosis. not much therapeutic options for nafld are accepted until today besides correction of obesity with hypocaloric diets and physical exercise and controlling hyperglycemia with diet, insulin, or oral hypoglycemic agents. weight loss generally reduces hepatic steatosis.essential phospholipid (epl) as a nutritional supplement is one of the drugs under discussion with significant positive effects as antioxidative, antifibrotic effects and high biocompatibility on nafld.

Eligibility criteria:
patients were included in the study when the following criteria to were fulfilled : inclusion criteria: * fatty liver upon ultrasonography (us) /computed tomography (ct) /magnetic resonance imaging (mri) with either incidental increased alanine aminotransferase (alt) * the presence of risk factors related to nafld + increased alt * symptomatic liver disease +/- hepatomegaly, +/- increased alt * homeostasis model assessment-insulin resistance homa ir score \> 3 * presence of liver steatosis or stiffness measured by transient elastography * eligible patients had at least one of the following metabolic comorbidities: hypertension, type 2 diabetes mellitus, overweight/obesity (bmi\>27 kg/m2) serum cholesterol of \> 200 mg/d patients were excluded from the study if showing evidence : exclusion criteria: * if showing evidence of alcoholic or chronic liver disease * hepatocellular carcinoma, autoimmune hepatitis * end stage liver disease * treatment with other hepatoprotectants * other concomitant epl within 30 days of study initiation * pregnancy or lactation
comparison of fluoxetine, calcium and placebo for the treatment of moderate to severe premenstrual syndrome (pms)

Conditions: Premenstrual Syndrome

Summary: the purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe pms. second, to compare each active agent to a placebo control. third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.

this is a double blind, randomized, placebo controlled, parallel study that will randomize 60 women at the yale site into treatment. participants will be screened at various collaborating ob-gyn centers for possible pms symptoms, and direct referrals from the community will also be accepted. subject participation length is about 7 months with 6 scheduled study visits. methodology: after successfully completing the screening and qualification phase, participants will be randomized to treatment at visit 1 for 5 cycles of double-blind treatment. participants will be evaluated monthly during the randomization phase for adverse events, concurrent medication, and primary and secondary efficacy variables. .

Eligibility criteria:
inclusion criteria: * female outpatients between the ages of 18 and 48 who are: * menstruating * meet criteria for moderate to severe pms * report pms symptoms for at least 9 our of the 12 months prior to screening; 4) \*are using an adequate method of birth control. exclusion criteria: * any candidate who: * fulfills mini (dsm-iv) criteria for a serious axis 1 disorder * fulfills dsm-iv criteria during the charting phase consistent with a diagnosis of psychotic disorder, bipolar disorder or major depressive disorder * has a severe, co-existing condition that, in the investigator's opinion, renders the patient unsuitable for the study * poses a significant risk of suicide * takes ongoing medication that could treat pms symptoms * has a history of hypersensitivity or adverse reaction to fluoxetine or calcium * is lactating, pregnant or is planning to become pregnant during the course of the study.

Keywords: premenstrual syndrome pms calcium
antiseptic-coated intermittent urinary catheter

Conditions: Neurogenic Bladder; Catheter-Related Infections

Summary: study design is a prospective, randomised, double-blind, and interventional. primary aim of the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary catheters in prevention and reduction of catheter-associated urinary tract infections in children with neurogenic bladder. secondary aim is to assess feasibility of antiseptic-coated intermittent hydrophilic urinary catheters in neurogenic bladder management. octenidine chloride will be used as antiseptic.


Eligibility criteria:
inclusion criteria: * neurogenic bladder * use of intermittent catheterisation for neurogenic bladder management * informed oral and written consent from the child and both parents/legal guardian exclusion criteria: * congenital anomalies of urinary tract or genitals * immunodeficiency * urinary tract fistula

Keywords: intermittent catheterisation antiseptic octenidine chloride children
safety and tolerability study of sns-314 for advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a study to assess the safety and tolerability of sns-314 in advanced solid tumors in humans.

other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).

Eligibility criteria:
inclusion criteria: * advanced solid tumor and that is measurable by a scan exclusion criteria: * uncontrolled or untreated central nervous system metastases * cerebrovascular accident/transient ischemic attack up to 6 months before cycle 1 day 1 * any of the following cardiac conditions: * history of myocardial infarction, acute coronary syndromes up to 12 weeks before cycle 1 day 1 * class iii or iv heart failure up to 6 months before cycle 1 day 1 * baseline heart rate corrected qt interval (qtc)\> 450 msec * history of ventricular arrhythmias up to 6 months before cycle 1 day 1 * use of medications that prolong the qtc interval and are associated with torsades de pointe (tdp) * previous cancer treatment up to 21 days before first dose * any investigational therapy up to 28 days before cycle 1 day 1 * known allergy to cyclodextrins please note: there are additional inclusion/exclusion criteria for this study. please contact the study center for additional information and to determine if all study criteria are met.

Keywords: solid tumors advanced
strategies to promote physical activity

Conditions: Obesity

Summary: getting regular physical activity has many health benefits. current physical activity programs often encourage people to track their physical activity as a way to motivate them to continue being physically active over time. however, not everyone enjoys physical activity, so tracking physical activity may not be very motivating. this research study will evaluate whether a new program-specifically designed to enhance people's enjoyment of physical activity-improves people's attitudes toward physical activity compared to a program that encourages people to track their physical activity with a mobile app.


Eligibility criteria:
inclusion criteria: 1. 25 ≤ bmi ≤ 39 kg/m2 2. systolic blood pressure 120-139 mmhg and/or diastolic blood pressure 80-89 mmhg 3. not currently taking medications for blood pressure exclusion criteria: 1. not free of diagnosed heart disease, diabetes, and cancer 2. medical contraindications to regular, unsupervised physical activity 3. not stable on all medications over the past 3 months 4. not free of binge eating disorder or bulimic compensatory symptoms 5. no regular access to a mobile phone and internet 6. not able to speak and understand english 7. currently pregnant or planning to be within the next year 8. planning to move in the next year 9. not willing to be randomized
short-term clinical feasibility of the new provox vega 22.5 voice prosthesis

Conditions: Total Laryngectomy

Summary: the purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the provox2 and the provox activalve voice prosthesis in 15 laryngectomized patients. factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.


Eligibility criteria:
inclusion criteria: * total laryngectomy * use provox activalve exclusion criteria: * current problems with te puncture

Keywords: laryngectomy larynx cancer