Kornimate/medical-research-clean huggingface dataset:
antimicrobial stewardship in pediatric surgery

Conditions: Appendicitis

Summary: acute appendicitis is a common surgical emergency in children. non-perforated appendicitis patients do not require antibiotics after appendectomy. although guidelines and recommendations exist to decrease post-operative antibiotic mis-use after appendectomy, surgeons continue to prescribe unwarranted antibiotics. the aim of this study is to determine if an antimicrobial stewardship program in pediatric surgery will decrease the use of un-warranted antibiotics.

many surgeons continue to treat non-perforated or "borderline perforated" appendicitis with postoperative antibiotics despite an evidence-based definition of perforation (in the pediatric surgical literature) and many guidelines and recommendations that specify that no postoperative antibiotics are required. children with perforated appendicitis are also often treated with longer-than-necessary courses of antibiotics. although surgeons may feel that they only prescribe additional doses on occasion, evidence suggests that this behavior occurs in over 50% of children with non-perforated appendicitis. these additional doses contribute to a longer length of stay, excess costs to the health care system, and disrupt patient flow. additionally, the patients are exposed to more antibiotics and their potential for adverse effects (such as incorrect dose, incorrect medication, allergic reaction, antimicrobial resistance or c difficile infection). antimicrobial stewardship programs have been successful in pediatrics and adult general surgery in curbing unwarranted antibiotic use, but have never been evaluated in pediatric general surgery.

Eligibility criteria:
inclusion criteria: * participant (surgeon) is a pediatric surgeon at mcmaster children's hospital and takes care of patients under the age of 18 who undergo appendectomy. * participant (surgeon) is able to read, write and understand english. * participant (surgeon) is able to provide informed consent. exclusion criteria: * participant (surgeon) only has patients who undergo drain insertion, picc line insertion or a secondary operation during the same admission * participant (surgeon) only has patients who do not undergo operation (i.e. "conservative management with interval appendectomy) * participant (surgeon) does not provide informed consent * participant (surgeon) does not understand written and spoken english diagnosis other than appendicitis at time of operation

Keywords: antibiotic, antimicrobial, stewardship, child
optimizing the announcement of advanced or metastatic prostate cancer using animated videos (cartdiag prostate)

Conditions: Prostate Cancer

Summary: in hospitals, the standard prostate cancer announcement system is based on oral and written information. to improve this system, we have developed animated videos that retrace the patient's care path. this is an exploratory, controlled, before-and-after, multicenter study designed to assess the effect of a standard announcement system reinforced by animated videos on patients' level of understanding of prostate cancer diagnosis and treatment. patients' perception of information will be assessed using the eortc qlq-info25 questionnaire.


Eligibility criteria:
inclusion criteria: 1. collection of the patient's non-opposition prior to participation in the study. 2. patient aged ≥ 18 years at inclusion. 3. patient with newly diagnosed advanced or metastatic prostate cancer. 4. patients due to start systemic therapy. 5. patients undergoing consultation. 6. patient affiliated to a social security scheme. 7. patient capable, according to the physician-investigator, of communicating well, understanding and complying with the requirements of the study. 8. patient with a smartphone or computer to review the video at home. exclusion criteria: 1. patient related to any member of the study staff or having a close relationship or conflict of interest with the sponsor. 2. patient to receive only local treatment. 3. patient who does not understand french. 4. clinical follow-up impossible for psychological, family, social or geographical reasons. 5. vulnerable patient: deprived of liberty by judicial or administrative decision, adult subject to legal protection or unable to express non-opposition.

Keywords: prostate cancer advanced or metastatic
a comparison of factors of symptoms generation and evaluation of role of biofeedback in patients with different types of functional esophageal disorders (functional heartburn and functional chest pain)

Conditions: Chest Pain; Heartburn

Summary: there is supposed that patients with functional esophageal disorders such as functional heartburns and functional chest pain have common underlying mechanisms of symptom generation. these include esophageal dysmotility, non-acidic gastro-esophageal reflux, duodeno-gastro-esophageal reflux, esophageal hypersensitivity, and psychological comorbidity. the treatment of these patients is the growing challenge in the primary care medicine and in the gastroenterological practice. it was postulated that functional disorders of the esophagus are the main reason for ppi failure in patients with heartburn. the aim of the study is to evaluate the role of biofeedback in the treatment of patients with functional chest pain and functional heartburns.


Eligibility criteria:
inclusion criteria: 1. men and women ages 18-75. 2. willing to participate and sign an inform consent. 3. having heartburns, acid regurgitations and/or chest pain at least twice a week for at least 3 months. 4. ability to stop anti-acid and anti-pain medications for at least two weeks. exclusion criteria: 1. history of upper gastrointestinal surgery. 2. concomitant diseases that may affect esophageal perception (diabetes mellitus, neuropathy). 3. concomitant medications that may affect esophageal perception (anti-inflammatory, anti-depressants drugs). 4. pregnancy. 5. severe conditions such as cardiac failure, renal failure and other that may be contraindication for upper endoscopy. 6. erosive esophagitis on upper endoscopy or pathological result of ambulatory 24-hour ph monitoring.

Keywords: patients with functional chest pain and functional heartburns
evaluation of cyclosporine microemulsion and tacrolimus on the rate of new onset diabetes mellitus in kidney transplantation recipients

Conditions: Kidney Transplant

Summary: the purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection


Eligibility criteria:
inclusion criteria: - first or second transplant, cadaveric or living donor exclusion criteria: * multi-organ or dual kidney transplants * panel reactive antibodies \>50% other protocol-defined inclusion/exclusion criteria applied

Keywords: kidney transplant, adults, nodm, immunosuppressants
psychological wellbeing in clients in tier 3 weight management service

Conditions: Psychological Distress; Obesity; Disordered Eating; Shame; Body Image

Summary: this study aims to conduct an initial, single case investigation of changes in feelings of shame, overall psychological wellbeing, body image and disordered eating in patients in naturalistic setting, tier 3 weight management service, following cft based, online group intervention that runs for 12 weeks.

tier 3 weight management services are led by multidisciplinary teams (mdts) what usually include physicians, dieticians, nurses, physiotherapist, psychiatrists, and psychologists. in the service where the study is conducted referrals to psychology are often made by a dietician. the psychologist in the service also accepts self referrals from patients either during initial assessment with dieticians or at any point of their journey in the service. the psychology pathway is "opt-in", in other words, only patient who actively express interest, motivation and wish to make use of the additional psych resource and accepted. the participants will be offered the intervention by the group facilitating clinician (who is a part of care team). initially the principal supervisor was meant to facilitate group intervention, but because the principal supervisor is going on maternity leave the group will be facilitated by a qualified substitute clinician. this clinician will offer an assessment of needs to all patients referred for psychological support. the clinician will act as a gatekeeper and will offer cft based group intervention when clinically and ethically appropriate (see the exclusion and inclusion criteria below). taking part in the intervention and signing up for the research will not affect the care patients receive from mdt in the service.

Eligibility criteria:
inclusion criteria: * adults with bmi over 30 who have been referred to tier 3 weight management service. * adults with bmi over 25 with diabetes who have been referred to tier 3 weight management service. exclusion criteria: * group intervention not considered clinically appropriate, following specialist assessment of needs * not being able to commit to 12-week intervention * severe interpersonal difficulties that would be disruptive to other group's participants * moderate to severe learning difficulties * current alcohol or drug abuse.
therapeutic serious game and rehabilitation of stroke patient

Conditions: Stroke; Unilateral Spatial Neglect

Summary: the growing field of new technologies offers new perspectives for neurorehabilitation. serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. the investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. six patients with unilateral spatial neglect after a right hemispheric stroke were recruited. three patients assigned to the experimental group received both serious game training and conventional rehabilitation, and three assigned to the control group received only conventional rehabilitation. the investigators compared the two groups after rehabilitation.


Eligibility criteria:
inclusion criteria: * unilateral spatial neglect syndrome * right cerebral lesion exclusion criteria: * epilepsia * general mental deterioration * psychiatric disorder * no prior history of neurological disease

Keywords: serious game stroke unilateral spatial neglect rehabilitation
safety and efficacy of sdx-3101 for the treatment of chronic rhinosinusitis without nasal polyps (crssnp)

Conditions: Chronic Rhinosinusitis Without Nasal Polyps

Summary: the purpose of this clinical trial is to assess the safety and efficacy of sdx-3101 for treatment of adult patients with chronic rhinosinusitis without nasal polyps (crssnp) by investigating a vibration pattern of sdx-3101 compared to a control

chronic rhinosinusitis (crs) is a common disease (e.g. 11% of adults in the uk report symptoms of crs) leading to substantial health and socioeconomic burden with estimated healthcare costs in the usa of $772/patient/year (2011). crs is characterised by the long-term presence of multiple symptoms including facial pain/pressure in about 80% of crs patients. factors contributing to the pathophysiology of adult crs include allergies, bacterial biofilms, asthma and exposure to various environmental pollutants. computed tomography (ct) scans are often used to identify mucosal thickening and to identify any comorbid factors such as anatomic abnormalities. it is known from the literature that low vibration frequency can improve blood flow, significantly reduce inflammation, and increase the fibroblast activity \[13\]. therefore, syndermix ag created the innovative high-technology, portable medical device sdx-3101 targeting a disease with high unmet medical need. the device offers a drug-free or eventually an add on treatment complying with the maximum demands of safety for the patients potentially avoiding undesirable drug effects or surgery. sdx-3101 is indicated for treatment of crssnp in adults

Eligibility criteria:
inclusion criteria: * adult male or female subjects between 18 and 70 years old * diagnosed history of chronic rhinosinusitis without nasal polyps (crssnp) defined as per epos guidelines. * moderate to severe baseline snot-20 gav score (\> 20) * willingness to stop nasal saline irrigation and drug therapy for crssnp (restart later on possible) exclusion criteria: * subjects with local pathology that would compromise the ability to either administer the device or assess the benefits/risks (e.g. mucocele, antrochoanal polyp, facial trauma, radiation injury, or birth defect) * systemic corticosteroids if not stop for 14 days before study enrolment * subjects suffering from insufficiently controlled asthma * subjects suffering from insufficiently controlled allergic rhinitis (ar) * subjects with prior sinus operations within the last 4 months * subjects with known primary ciliary dyskinesia/cystic fibrosis * subjects with serious underlying medical condition * ongoing oncological treatments * known hypersensitivity to materials in direct contact with the skin * metal or metal-like implant (incl. ceramic) located in the head or neck area. unremovable hearing aids * patients with implanted cardiac pace-maker * women who are pregnant or breast feeding * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
homeopathy for overweight and obesity in mexican adolescents

Conditions: Overweight and Obesity

Summary: this study evaluates the efficacy of a multidisciplinary intervention (diet, exercise, motivational support and homeopathy or placebo) for overweight and obesity in mexican adolescents. half of study participants will receive the multidisciplinary intervention plus calcarea carbonica ostrearum, a homeopathic medicine, while the other half will receive the same multidisciplinary intervention plus placebo.

overweight and obesity in children and adolescents are a major public health issue in mexico. whilst many factors (genetic, cultural, socioeconomic and environmental) contribute to develop obesity during childhood, a multidisciplinary intervention (nutritional, behavioral and exercise) is the best approach to improve weight loss. in mexico, the use of homeopathy for obesity is widespread. although there are some homeopathic medicines used for obese individuals, there is a lack of well-designed clinical trials to demonstrate its efficacy in weight loss. calcarea carbonica ostrearum is a homeopathic mineral medicine. previously, it has been demonstrated that calcarea carbonica has an effect in reducing the percentage of fat in adolescents. therefore, a randomized, placebo-controlled, double-blind, parallel, superiority trial with a 3 month study duration, will be conducted to prove the efficacy and safety of calcarea carbonica ostrearum in reducing weight, body mass index (bmi) and fat percentage, as well as, to prove its effect on the lipid profile, fasting serum glucose, glycosylated hemoglobin and insulin.

Eligibility criteria:
inclusion criteria: * 12 to 19 years old. * at least elementary school. * overweight (bmi ≥ 85th but \<95th percentile based on the centers for disease control and prevention growth chart) or obese (bmi ≥95th percentile). * fasting serum glucose \<126 mg/dl. * glycosylated hemoglobin \<6.5%. * with symptoms that match with calcarea carbonica ostrearum. * willingness to participate, and verbal and written consent. exclusion criteria: * pregnancy or breastfeeding. * cases already undergoing treatment (homeopathic, nutritional or structured physical activity) for obesity within last three months. * currently use of metformin, orlistat, insulin, other antidiabetic medication, contraceptive pills, medications with effects on lipid metabolism \[thiazide and loop diuretics, β and α receptor blockers, antiepileptic drugs (carbamazepine, phenytoin, valproic acid, phenobarbital), antipsychotics (clozapine), protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), tamoxifen, raloxifene, isotretinoin, acitretin, ciclosporin, azathioprine, sirolimus\]. * any condition that prevents physical exercise. * diabetes, hypertension, thyroid diseases, down syndrome, mental retardation.

Keywords: obesity overweight homeopathy calcarea carbonica ostrearum mexico
cervical volume and prediction of preterm labor

Conditions: Preterm Labor; Cervical Volume

Summary: the primary aim of this research is to assess the predictive value of 3d cervical volume and 3d power doppler indices in predicting pregnancies at risk of preterm labor. secondary aim: to compare 2d cervical length and 3d cervical length in coronal view for predicting preterm labour.


Eligibility criteria:
inclusion criteria: 1. age : 18-35 years old 2. singleton pregnancy 3. gestational age : 18-26 ws knowing last menstrual period and history of regular mense. exclusion criteria: 1. multiple gestations (e.g., twins, triplets). 2. history of cervical surgery or cervical cerclage. 3. known uterine anomalies that could affect cervical assessment. 4. contraindications for transvaginal ultrasound, such as active vaginal bleeding or infection. 5. severe fetal anomalies or conditions incompatible with life
abobotulinumtoxina efficacy in post-traumatic headache

Conditions: Post-Traumatic Headache

Summary: this study will evaluate the efficacy of abobotulinumtoxina on veterans with post-traumatic headache

a significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (pth). traumatic brain injury (tbi) is highly prevalent in the operation iraqi freedom/operation enduring freedom (oif/oef) population and consequently there has been a rise in pth in the clinical setting at va hospitals. botulinum toxin type a (bont-a) has been shown to be effective in treating chronic migraine and chronic daily headache. it is therefore reasonable to predict that bont-a may also be effective in treating pth. this study proposes that pth and its associated symptoms may respond positively to bont-a treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache. study design: veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the veterans affairs greater los angeles healthcare system. the study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.

Eligibility criteria:
inclusion criteria: * male or female * age 18-65 * meets international classification headache disorders ii (ichd-ii) criteria for post-traumatic headache * average pain score of greater than 4/10 in severity on the numerical rating system * rancho los amigos cognitive scale score greater than seven. exclusion criteria: * uncontrolled medical condition other than pth * severe additional chronic pain complaint which could not be distinguished from headache pain * pregnancy, breast feeding, * prior treatment with botulinum toxin within one year of enrollment * current substance abuse/dependence * medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, eaton lambert, amyotrophic lateral sclerosis) * poorly controlled psychiatric * initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study * ongoing disability or litigation claim.
extracellular fluid in resistant hypertension

Conditions: Hypertension

Summary: the optimal treatment of drug resistant (defined as bp\> 140/85 despite three anti-hypertensive drugs including a diuretic) is not well defined. this study aims to test the hypothesis that resistant hypertension is caused by excessive expansion of extracellular fluid volume. a secondary objective is to study which of three different antihypertensive drugs would be most useful in drug resistant hypertension.

following recruitment subjects will have ecv measured by 51cr-edta determination of gfr, with brochner-mortensen correction applied. subjects then receive the following drugs, in a randomised fashion, for a period of four weeks each, with bp \& ecv measurement at end of each period: doxazosin gits (cardura xl) 4 mg b.d.; frusemide 40 mg b.d.; amiloride 5 mg b.d.; placebo.

Eligibility criteria:
inclusion criteria: * bp \>140/85 * 3 antihypertensive drugs (ace/arb + calcium channel blocker + thiazide diuretic) exclusion criteria: * pregnancy * breast feeding * unstable heart failure * chronic liver disease * creatinine \>120 mcmol/l * contraindication to (or intolerance of) drug used in study * bp \> 180/110

Keywords: resistant hypertension extracellular fluid volume
to investigate the efficacy and safety of individualized doses of biochaperone insulin lispro in comparison to humalog® u-100 in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: this is a double-blind, randomised, controlled, two period crossover phase ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with biochaperone insulin lispro compared to humalog®. the assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. the meal tolerance test will be performed on day 1-3 and on day 14 of each period. furthermore the study aims at investigating post-prandial glucose (ppg) profiles with biochaperone insulin lispro and humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes). each subject will be randomised to a sequence of two treatments, either biochaperone insulin lispro-humalog® or humalog®-biochaperone insulin lispro, and three different sequences of injection-meal intervals. a blinded to patient continuous monitoring of glucose (cgm) will be performed during the 14 day treatment periods.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months * treated with multiple daily insulin injections (no pump users) ≥ 12 months * current total daily insulin treatment \<1.2 (i)u/kg/day * body mass index (bmi) 18.5-28.0 kg/m² (both inclusive) * hba1c (n-(1-deoxy)-fructosyl-haemoglobin) ≤ 9.0% by local laboratory analysis * fasting c-peptide ≤ 0.30 nmol/l exclusion criteria: * known or suspected hypersensitivity to trial products or related products * type 2 diabetes mellitus * patients using continuous subcutaneous insulin infusion (csii) * previous participation in this trial. participation is defined as randomised * the receipt of any investigational product within 3 months prior to this trial * clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the investigator considering the underlying disease * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator * known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption * unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial