Kornimate/medical-research-clean huggingface dataset:
closed suction drainage in shoulder arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine the limited effectiveness of drains during total shoulder arthroplasty. drains are used during joint arthroplasty procedures to decrease infection rates, swelling,and the number of dressing changes required during a hospital stay. the use of drains has been heavily investigated in the hip and knee replacement literature, but there have been no investigations regarding their use in shoulder replacements, despite frequent use. clinical benefit has not been consistently documented regarding drain usage in hip and knee arthroplasty and the investigators hypothesize that they are of limited utility in total shoulder arthroplasty as well. the investigators will perform a prospective investigation of total shoulder arthroplasty patients- dividing them into two groups- half will receive a drain at the time of surgery and the other half will not be receiving a drain.

the use of closed-suction draining has been well studied in the hip and knee arthroplasty literature. drains have been used with the intention of decreasing infection, ecchymoses, and frequency of dressing changes. some have reported a corresponding decrease in hematocrit for patients receiving post-op drainage leading to increased transfusion needs. given that no clinical benefit has been consistently documented regarding drain usage in knee and hip arthroplasty, they are no longer routinely used in those operations. the use of such drainage systems in shoulder arthroplasty, however, has not been studied and the benefit of drain use in regards to patient outcomes is questionable. as such, the study is a prospective investigation comparing outcomes in two groups of total shoulder arthroplasty patients, those receiving a drain at the time of surgery and those without a drain. the short-term outcome measurements include peri-operative hematocrit and hemoglobin, infection rate, hematoma development, transfusion requirement, ecchymosis and wound complication. long-term outcomes include shoulder functional scores as measured by post-operative visits and any need for revision shoulder surgery.

Eligibility criteria:
inclusion criteria: * patients diagnosed with glenohumeral osteoarthritis undergoing total shoulder arthroplasty exclusion criteria: * patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection

Keywords: shoulder arthroplasty closed suction drainage glenohumeral drainage tube
clinical application of nutrition support package before hepatectomy

Conditions: Liver Neoplasms; Nutrition Therapy; Hepatectomy

Summary: objective:to confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection. study design:prospective, randomized, controlled clinical study. primary end point: incidence of all complications 30 days after surgery.


Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma) * 2. no contraindications for surgery * 3. eastern cooperative oncology group (ecog) score of preoperative physical state \<2 points * 4. preoperative liver function score child-pugh ≤ 6 points: total bilirubin ≤ 3.0 mg / dl, albumin ≥ 28 g / l, aspartate aminotransferase (ast), alanine aminotransferase (alt), alkaline phosphatase (alp) ≤ 5 times the upper limit of normal * 5. voluntarily enter the study and sign the informed consent form, and communicate well with the researcher exclusion criteria: * 1. patients who took fish oil supplements within 3 weeks before the study began * 2. patients with severe nutritional risk: serious nutritional risk should be considered when combining any of the following conditions: weight loss \> 10% within 6 months; digital pain score (nrs) score \> 5 points; bmi \<18.5 kg/m2 (all patients with severe nutritional risk undergo individualized supportive care); * 3. patients with malignant tumors in other parts * 4. patients who are pregnant or lactating * 5. patients with mental and neurological disorders who cannot cooperate with medical staff * 6. patients with severe diabetes or poor glycemic control * 7. patients cannot tolerate nutritional preparations * 8. other circumstances that the researcher considers inappropriate to participate in the study

Keywords: nutrition therapy hepatectomy
a dose finding study of debio 4228 in participants with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the primary purpose of this study is to determine the pharmacokinetics (pk) and pharmacodynamics (pd) of debio 4228.


Eligibility criteria:
inclusion criteria: 1. participant with histologically confirmed diagnosis of prostate cancer, with one of the following: 1. newly diagnosed androgen-sensitive locally advanced or metastatic disease; or 2. localized disease not suitable for local primary intervention with curative intent. 2. participant judged by the study investigator to be candidate for continuous androgen deprivation therapy (adt). 3. baseline morning serum testosterone levels \>150 ng/dl at screening visit. 4. eastern cooperative oncology group (ecog) performance status of 0-2. 5. life expectancy of at least 6 months. 6. adequate bone marrow, hepatic, and renal function at the screening visit. \[note: other protocol and subprotocol-defined criteria apply\] exclusion criteria: 1. previous adt (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and \<6 months treatment-free interval before start of screening. 2. participant requires combination with androgen deprivation therapy with the exception of enzalutamide. 3. history of bilateral orchiectomy, adrenalectomy, or hypophysectomy. 4. received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer. 5. abnormal cardiovascular function or diabetes. 6. use of exogenous testosterone within 6 months before the start of screening. 7. major surgery within 4 weeks before the start of screening. 8. cancer disease within the last two years except for prostate cancer and some skin cancers. \[note: other protocol and subprotocol-defined criteria apply\]
validation of an allergic rhinitis control test in teenagers

Conditions: Allergic Rhinitis

Summary: allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. several tools exist for assessing control of allergic rhinitis, but none has been validated in adolescents or in children. a study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitsis (arct) in patients from 12 years of age. however, this study included only 67 adolescents aged 12 to 17 years old and lacked power. in this new study,the investigators propose, following exactly the same procedure as the pilot study of 2008, to confirme the validation of unmodified adult questionnaire in adolescents 12 to 17 years inclusive.


Eligibility criteria:
inclusion criteria: * patients aged 12 to 17 years old, consulting a practitioner for an allergic rhinitis * parents formulated their study participation agreement by signing the consent form. exclusion criteria: * patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatement.

Keywords: allergic rhinitis
identifying tissue-of-origin in transplant patients and patients with malignancies.

Conditions: Malignancies

Summary: the investigators are developing a method for diagnosing cell death in the body using blood and urine tests. the test is based on two well-known phenomena in biology. first, when cells in the body die, short fragments of their dna, about 150 bases long, find their way into the bloodstream for a short period of time of about fifteen minutes to an hour, before being eliminated in the liver and kidney. the details of this process are not fully known, but it is clear that the phenomenon exists. already today, this phenomenon is widely used clinically for prenatal diagnosis of chromosomal aberrations in the dna of the fetus that is found in large quantities in the mother's blood. liquid biopsies from cancer have already been developed, based on the identification of somatic mutations originating from a cancerous tumor in the free dna found in the serum or plasma. in the case of cancer, liquid biopsies may be a convenient way to monitor the genetic evolution of the tumor, response to treatments, and more. this approach of detecting cell death using free dna in the bloodstream has a severe limitation when it comes to the death of cells whose genome is not different from the genome of the other tissues in the body, and therefore the dna cannot be associated with the tissue of origin based on sequence analysis.

the duration of the sample collection period is estimated to be five years. work in the laboratory will continue for another 3 years. the laboratory work will be carried out in the laboratories of prof. eithan galun at hadassah ein kerem and prof. nir friedman at the hebrew university of givat ram. access will be given to prof. galun and his team. since genetic variation is not tested in this study, there is no fear of revealing the subject's personal genetic information. in this study we use an identified sample, on which identifying details for the participant are indicated, for example: name, social security number or code number that can be given to the sample. the identified information and the information that will be extracted from the sample will be saved in coded excel sheets. in this way, only authorized researchers and research staff will be allowed access. the samples will be preserved as coded identified samples in the laboratory of prof. eithan galun, hadassah ein kerem, jerusalem in a freezer in a locked room with limited access to researchers and the authorized research team only, and also, in the laboratory of prof. nir friedman, the hebrew university of givat ram, jerusalem under similar conditions with access to the research team only. the investigators also ask the liver and kidney transplant recipients to collect a urine sample, with the thought that it might be possible to save a blood test and be satisfied with a urine sample.

Eligibility criteria:
inclusion criteria: kidney and liver transplant recipients patients with malignant tumors exclusion criteria: pregnant women minors incompetent chronic background disease.

Keywords: gene expression dna liver cancer
antimicrobial peptides in periodontitis

Conditions: Periodontal Disease : Chronic Periodontitis

Summary: periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide. etiopathological process involved in initiation and progression of these multifactorial diseases are not well understood, explaining the huge clinical forms variability and the complexity of the currently used classification of periodontal diseases. recently, the implication of antimicrobial peptides (amps) have been suggested as potential track of explanation for periodontal diseases pathogeny. the here presented study explore the level of expression of genes coding those peptides by studying periodontal smears obtained from healthy and periodontitis patients.

this study explore the level of expression of genes coding those peptides by studying messenger rna (mrna) purified from periodontal smears obtained from healthy and periodontitis patients by "masterpure©" protocol.after reverse transcription (rt-pcr), in-silico design of primers and specificity and efficiency calculation, complementary dna (cdna) are quantified by a semi-quantitative method (delta-delta ct) vs a housekeeping gene. wilcoxon-mann \& whitney tests and chi² tests are performed to check the significativity of the results between groups.

Eligibility criteria:
inclusion criteria: * patients suffering of moderate to severe chronic periodontitis as described by the classification armitage-1999, aged 35-65yo exclusion criteria: * pregnant females, patients suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes, cancer) * patients that had received antibiotic treatment in the previous 3 months or who were taking long-term anti-inflammatory drugs; who had received a course of periodontal treatment or orthodontics treatment within the last 6 months; who were heavy smokers (\>5 cig/day)
pharmacokinetic assessment of peramivir in hospitalized adults undergoing continuous renal replacement therapy

Conditions: Influenza; Renal Failure

Summary: pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy crrt - either continuous veno-venous hemofiltration (cvvh) +/- dialysis (cvvhd). crrt is commonly utilized in the hospital setting for patients with acute kidney injury for metabolic correction, slow continuous fluid removal, and to maintain hemodynamic stability. crrt commonly alters drug disposition and clearance, and dosing regimens often need alteration in patients receiving crrt. doses required to generate predictable serum concentrations can be calculated from known patient parameters such as replacement fluid and dialysate flow rate, sieving coefficients, and desired serum concentrations. however, pharmacokinetic studies must be performed in crrt patients to generate drug removal constants or sieving coefficients. of note, the clearance of drugs by conventional hemodialysis cannot be used to extrapolate clearances with crrt secondary to differences in ultrafiltration rates and dialysis membranes. the investigators propose an open label study to obtain peramivir pharmacokinetics in patients undergoing crrt.

this study has been closed. no patients were enrolled as the peramivir eua was rescinded.

Eligibility criteria:
inclusion criteria * patient is hospitalized and undergoing continuous renal replacement therapy (crrt) as a result of the clinical management of the patient (i.e. crrt is not initiated for the purpose of this study). * patient is receiving peramivir for a positive rapid antigen test for influenza or on the basis of clinical suspicion with a high local epidemiological prevalence of h1n1 disease. * patient has a crrt blood flow rate greater than or equal to 100 ml/min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000ml/hr, * the patient is anticipated to require crrt and peramivir treatment for a full 24 hours (i.e. life expectancy is not less than 24 hours). exclusion criteria * the patient has received greater than 5 doses of peramivir. * the subject has a pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study. * the patient is receiving crrt utilizing a pre-membrane dilution method.

Keywords: peramivir cvvh crrt cvvhd influenza sieving coefficient clearance
effect of speech therapy in combination with non-invasive brain stimulation on speech of patients with parkinson's disease

Conditions: Parkinson Disease

Summary: up to 90% of patients with parkinson's disease (pd) have hypokinetic dysarthria (hd) in the early phase of the illness. hd is characterized by a harsh breathy voice quality, reduced variability of pitch and loudness and imprecise articulation. this project investigates the novel combination of speech therapy and home-based non-invasive brain stimulation (tdcs) treatment in order to increase overall positive effects on hd in pd. using a novel multimodal analysis approach based on functional magnetic resonance and acoustic signal processing, we will be able to monitor changes in different domains of speech, as well as associated changes in brain plasticity.

study will investigate the long-term effects of repeated (20) sessions of home-based tdcs as an add-on to well-established remote lsvt (i.e. the gold standard procedure for hd treatment) as compared to lsvt alone (coupled with sham stimulation) in patients with pd in their "on" dopaminergic condition without dyskinesias. a two parallel-group, double-blinded, randomized, sham-stimulation-controlled design will be used. forty pd patients will be randomized into two parallel groups by independent researcher by a computer-generated random number list, 20 subjects in each arm. participants in the real tdcs group and the sham tdcs group will undergo a baseline assessment (v0), a follow-up assessment after four weeks of combined tdcs and lsvt treatments (v1) and another follow-up assessment 8 weeks after the baseline assessment (v2). each visit will consist of eeg, speech tasks recording and speech evaluation by a speech therapist; mr scanning will be done at v0 and v1. both groups will undergo the same speech therapy (lsvt) via telepractice as the gold standard treatment for hd, in combination with real or sham tdcs.

Eligibility criteria:
inclusion criteria: * patients with clinically established pd (postuma et al. 2016) exclusion criteria: * psychiatric disorders, including major depression, hallucinations * any mri-incompatible metal in the body * epilepsy * lack of cooperation * presence of dementia
acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia

Conditions: Tachycardia, Ventricular; Defibrillators, Implantable

Summary: this study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.

this study is a substudy of a planned study involving participants with an implantable cardioverter defibrillator (icd), who will be randomly assigned to either take part in a exercise program for 12 weeks or serve as control and live as usual (clinical trials unique protocol id: 2018/1592). in that study all participants will complete an exercise treadmill test to determine maximum oxygen uptake (vo2 peak). in this study we wish to examine the acute effect of one single bout of high intensity exercise (i.e the vo2 peak test) on the tendency for ventricular arrhythmia. the study will evaluate changes in icd-parameters and the number of premature ventricular contractions the first 24 hours after vo2 peak testing compared to the average number of the 48 hours prior to the test. the study will also examine if the acute effect after vo2 peak testing alters after completing 12 weeks of aerobic interval training or control respectively.

Eligibility criteria:
inclusion criteria: * patients with icd and dilated cardiomyopathy or coronary heart disease as cause for implantation * icd implanted at st olavs hospital, trondheim in case of difficulties with patient inclusion for the study, the criteria might be broadened to include patients with idiopathic ventricular arrhythmia as cause for implantation. exclusion criteria: * inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons * signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill o2 peak test, which after individual assessment is to be found at risk * comorbidity where endurance training at more than moderate intensity is discouraged * severe cardiac valve disease * planned surgery within the next 3 months * inability to give informed consent

Keywords: exercise training
postural and muscle fatigue analysis of endodontic residents

Conditions: Musculoskeletal System Disease; Position Sense Disorders; Symptoms and Signs; Postural; Defect; Endodontic Disease

Summary: musculoskeletal disorders (msds) are a significant occupational health problem for dentists and have been linked to a decline in quality of life, often leading to stress-related illnesses and early retirement. poor posture, poor movement or imbalances in the neck or shoulders can lead to the three most common pain syndromes in dentistry. the objectives of this study were to evaluate the working position adopted during an endodontic procedure and to determine the perception of symptoms of musculoskeletal disorders in first and second year students of the master in advanced endodontics at the european university of madrid (uem), using the standardised nordic kuorinka questionnaire supplemented by a form with socio-demographic variables. this study has a descriptive cross-sectional observational design and included 10 students selected by convenience sampling. a video camera was used to record the procedures from three different angles for a maximum of 5 minutes. the information was processed using microsoft excel spreadsheet software, and the video recordings were assessed using rodgers' muscular fatigue analysis (rmfa) and rapid upper limb assessment (rula).

the unit of analysis for this study consisted of the first and second year students of the master's in endodontics programme at the european university of madrid (uem) who completed the two years of annual clinical practice during the years 2022/24. a total of 10 students were enrolled over the two years of training, treating 30 patients (3 patients per student) in the first year and another 30 patients in the second year (for a total of 22 months). a video camera was used to record the procedures from three different angles for a maximum of 5 minutes (two side views - right and left - and one frontal view) on different patients, following the national institute for occupational safety and health (niosh) protocol for video recording for job analysis and risk assessment. the selected endodontic procedure focused exclusively on upper or lower first molars during the opening and ultrasonic search for the fourth canal in upper first molars or the search for the mesiobuccal canal in lower first molars. the standardised nordic kuorinka musculoskeletal symptom perception questionnaire was used as the measuring instrument. questionnaire data were collected using a spreadsheet program (microsoft excel).

Eligibility criteria:
inclusion criteria: - students of the master's degree in endodontics of the european university of madrid (uem), who have completed the two years of the annual teaching period of clinical practice. exclusion criteria: * subjects previously diagnosed with a musculoskeletal disorder. * subjects who had suffered previous trauma affecting the musculoskeletal system. * pregnant women in their third trimester. * subjects who refused to participate.

Keywords: endodontics musculoskeletal system ergonomics