Kornimate/medical-research-clean huggingface dataset:
optimization of peripheral nerve reconstruction: a non-inferiority trial

Conditions: Peripheral Nerve Injury Digital Nerve Hand Left

Summary: 1. to analyse the outcome of different treatment options of peripheral nerve repair with no gap (group 1) and with a critical sized (\>5mm) defect (group 2) in order to optimize peripheral nerve repair 2. to reduce morbidity with the same outcome

patients planned to undergo peripheral nerve repair after traumatic nerve injury with either no gap (group 1) or with a critical sized defect (\>5mm, group 2) of the finger providing written informed consent to this investigation will be randomised in two groups:. group 1: nerve repair with no gap group 1a (standard): epineural suture group 1b (experimental): epineural suture and fibrin wrap group 2: nerve repair with a critical sized (\>5mm) defect group 2a (standard): epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (lacn) group 2b (experimental): epineural suture and fibrin conduit in all groups an epineural suture will be performed (suture enhancement). the outcome of fibrin enwrapment and fibrin conduit will be compared to the standard treatment option to date (direct nerve repair and autologous nerve graft, respectively). randomization will be performed using a computer-base algorithm (www.randomizer.at). ambulatory follow up of patients is carried out by the department of plastic, reconstructive and aesthetic surgery, handsurgery, university hospital basel. the outcome-assessor as well as the patient will be blinded for analysis and the outcome-assessor will have no access to the surgery report. the investigator's aim is to analyse 48 patients within 12 months. since 100 patients undergo peripheral nerve repair annually in the department of plastic, reconstructive and aesthetic surgery, handsurgery at the university hospital basel, patient accrual appears unproblematic. after completion, statistical analysis focusing on the comparison of the different types of surgery concerning the clinical parameters 2-point discrimination (pd), semmes weinstein test, and electroneurography will be conducted. after six months, no difference will be expected between group 1a and 1b or 2a and 2b, respectively. in the investigator's experience there will be no confounders which may influence nerve regeneration. a similar patient satisfaction will be expected between the groups. the investigator expect a higher patient satisfaction in group 2b than in group 2a due to nerve tissue harvest. between group 1a and 1b no difference is expected regarding mhq.

Eligibility criteria:
inclusion criteria: * patients with traumatic peripheral nerve injury of the finger(s) who are to be treated with peripheral nerve repair at the department of plastic, reconstructive and aesthetic surgery, handsurgery, university hospital of basel * written informed consent exclusion criteria: * age \< 18 years * age \> 90 years * pregnancy
acute hamstring strains in danish elite soccer - prevention and rehabilitation

Conditions: Strains

Summary: a common soft tissue injury in sports involving sprinting and jumping is the hamstring strain. not much evidence-based research has been carried out on prevention of hamstring strains. most studies suggest that hamstring strains occur during the later part of the swing phase when the player is sprinting. in this phase the hamstring muscles are working to decelerate knee extension - that is, the muscle develops tension while lengthening. this means that the muscles change from functioning eccentrically to concentrically. we hypothesize that it is during this rapid change from eccentric to concentric function that the muscles are most vulnerable to injuries, and that the injuries can be prevented by increasing the eccentric muscle strength in the hamstring. this randomized clinical trial will examine the effect of a 10-week preseason strength-training program in danish elite soccer. the strength-training program focuses on eccentric hamstring training. 60 elite teams (1200 soccer players) will be cluster-randomized to either ordinary training or ordinary training combined with eccentric hamstring strength training. the training group will start the training program in the pre-season (10 weeks) and continue the training once a week during the following season. suspected hamstrings strains during the season will be examined within 3 days using ultrasound. ultrasound verified hamstring strains will be registered, and players will start a standardized rehabilitation program.


Eligibility criteria:
inclusion criteria: * male soccer player in one of the top 4 divisions i denmark in the 2007/08 season * minimum 18 years old at the time for inclusion exclusion criteria: * current hamstring strain at the time for inclusion * under 18 years old

Keywords: hamstring muscle injury prevention muscles
non-invasive heart failure monitoring using novel acceleration sensors system

Conditions: Heart Failure

Summary: the purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.

pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. these changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure. the research system comprises of patches attached to the patients' thorax that include motion sensors (accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. the signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen.

Eligibility criteria:
inclusion criteria: * acute decompensated hf * decompensated chronic hf in patients with nyha class iii-iv symptoms * age over 20 years * ejection fraction reduced below 35% or doppler evidence of impaired left ventricular diastolic filling exclusion criteria: * inability or unwillingness to follow the study protocol

Keywords: heart failure monitoring
incarcerated right inguinal hernia containing sigmoid colon: an unusual case report

Conditions: Incarcerated Inguinal Hernia

Summary: incarcerated inguinal hernia is an irreducible but the blood supply to the contained part is intact, but developing towards strangulation. here the lumen of the portion of colon occupying a hernia sac is blocked with faeces.

a special data collection sheet designed to collect data regarding the diagnosis, age, sex and treatment from the profile of patient retrospectively. data entry was performed by using microsoft excel and all the data were analysed by spss.

Eligibility criteria:
inclusion criteria: * inguinal hernia that requires emergency operation exclusion criteria: * hernia does not need emergency operation.

Keywords: incarcerated right inguinal hernia, right side, sigmoid colon
effects of inhibition of no-synthesis on renal hemodynamics and sodium excretion in patients with essential hypertension and healthy controls

Conditions: Hypertension

Summary: the study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. the results are compared with a group of healthy subjects.

the study investigates the effects of ng-monomethyl-l-arginine (l-nmma) on: 1. renal hemodynamics (renal plasma flow and glomerular filtration rate) 2. renal sodium excretion 3. lithium clearance and fractional lithium excretion 4. plasma levels of vasoactive hormones 5. blood pressure and heart rate

Eligibility criteria:
inclusion criteria: * essential hypertension (blood pressure \> 140/90) with no signs of secondary hypertension * p-creatinine \< 200 µmol/l exclusion criteria: * anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult * medication except antihypertensives * drug or alcohol abuse * pregnancy

Keywords: hypertension nitric oxide renal hemodynamics
microcurrent stimulation therapy for nonexudative age-related macular degeneration (i-sight)

Conditions: Age-Related Macular Degeneration; Dry Age-related Macular Degeneration; Nonexudative Age-related Macular Degeneration

Summary: evaluate the safety and efficacy of transpalpebral microcurrent stimulation (mcs) therapy for patients with nonexudative (dry) age-related macular degeneration (amd).

the i-lumen(tm) amd device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. the i-lumen amd device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant. up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.

Eligibility criteria:
key inclusion criteria: * age ≥50 years. * non-exudative age-related macular degeneration defined as areds category 3 intermediate amd and/or geographic atrophy * best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and bcva 20/100 or better in the fellow eye key exclusion criteria: * history and/or evidence of exudative age-related macular degeneration in either eye * history and/or evidence of diabetic retinopathy in either eye * current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day) * central chorioretinal atrophy in the study eye * glaucoma in the study eye

Keywords: amd dry amd
use of antibiotic irrigation to decrease wound infections in pediatric perforated appendicitis

Conditions: Perforated Appendicitis

Summary: the proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and iaa in perforated appendicitis compared to suction without irrigation. this will be the first prospective study to compare these two options in pediatric pa.

this study is for pediatric patients who are having an appendectomy and have a perforated appendix. the purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity. arm a patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. arm b patients will not have the antibiotic irrigation but will have their wound suctioned.

Eligibility criteria:
inclusion criteria: 1. male or female, age 18 years or younger 2. scheduled to undergo laparoscopic appendectomy 3. preoperative or intra-operative diagnosis of perforated appendicitis (pa). 4. willingness to undergo treatments, provide written informed consent, and participate in follow-up. exclusion criteria: 1. male or female older than 18 years of age 2. declined to undergo laparoscopic appendectomy 3. not willing to provide written informed consent or undergo randomization of treatment 4. pregnancy
effects of exercise intensity on energy intake, appetite and enjoyment in overweight and obese females

Conditions: Overweight and Obesity

Summary: interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. the benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. however how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known. this study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.


Eligibility criteria:
inclusion criteria: 1. female 2. adult 3. apparently healthy 4. overweight or class i obese 5. eumenorrheic exclusion criteria: 1. diabetes 2. pregnancy 3. cardiovascular disease 4. greater than 1 hour of structured physical activity per week 5. thyroid disease 6. polycystic ovary disease
3d vs 2d-laparoscopy for rectocele and rectal prolapse correction: a prospective, randomized, single center study

Conditions: Rectocele; Female; Rectocele and Incomplete Uterine Prolapse; Rectocele and Complete Uterovaginal Prolapse; Rectal Prolapse

Summary: the aim is to compare proximate and remote results of 3d and conventional 2d laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse. this is a prospective randomized comparative study in parallel groups conducted in single colorectal unit. inclusion criteria: female patients with stage 3 rectocele (3-4 pop-q \[pelvic organ prolapse quantification\] grade) and/or full-thickness rectal prolapse. intervention - laparoscopic ventral rectopexy. the primary outcome is objective cure rate of pelvic prolapse. secondary outcomes include obstructive defecation and incontinence symptoms according to wexner and cleveland clinic scales, and satisfaction according to patient global impression of improvement questionnaire. operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed. the specific point of interest in this study is surgeon's tiredness after the operation assessed with profile of mood states questionnaire.


Eligibility criteria:
inclusion criteria: * stage 3 rectocele (3-4 pop-q grade) and/or full-thickness rectal prolapse * age 18-70 y.o. exclusion criteria: * severe concomitants chronic diseases (american society of anesthesiologists class iii - iv), * ongoing oncological diseases, * ongoing hematological diseases, * ongoing inflammatory diseases of the colon and pelvic organs, * pregnancy
effect of fenugreek on blood sugar and insulin in diabetic humans

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine if bread containing fenugreek reduces blood sugar and insulin compared to identical bread without fenugreek.

trigonella foenum-graecum (fenugreek) has been used in traditional medicine for the treatment of diabetes. fenugreek has been demonstrated to lower blood glucose in response to a glucose load while leaving the levels of serum insulin unaffected in rodents. this effect of lowering blood sugar without changing insulin levels demonstrates improved insulin action. fenugreek has also been shown to decrease glucose absorption by inhibiting intestinal disaccharidases. fenugreek decreases glycohemoglobin in diabetic rodents. an amino acid extracted from fenugreek seeds, 4-hydroxyisoleucine, decreases glucose and insulin in diabetic rodents, improves glucose tolerance and stimulates insulin secretion from isolated pancreatic rodent islets. fenugreek imparts a bitter taste to products into which it is placed, and this property has limited its use in treating diabetes. dr. losso and his associates developed a process that allows incorporation of fenugreek into bread and other bakery goods without imparting a bitter taste, and the success of this process was confirmed in taste testing. this study is designed to evaluate the effect of fenugreek bread made by dr. losso's proprietary process on glucose and insulin.

Eligibility criteria:
inclusion criteria: * healthy male or female with diet controlled diabetes mellitus. * between 18 and 70 years of age. exclusion criteria: * pregnant or nursing. * taking medication for diabetes or a medication like oral cortisone that is known to affect blood sugar or blood insulin. * taking any chronic medication that has not had a stable dose for 1 month or longer. oral contraceptives are accepted.

Keywords: fenugreek trigonella foenum-graecum diabetes mellitus blood sugar insulin glucose
safety evaluation of the lgl102 in obese subjects treated with oms102

Conditions: Obesity; Morbid Obesity

Summary: the main objective of this study is to evaluate the lgl102 implant safety in obese to morbidly obese subjects treated with oms102 system. the effect of the therapy on body weight changes will be also evaluated.


Eligibility criteria:
inclusion criteria: * age of 18 - 60 years old at time of screening * bmi of 35 to 55 at time of screening * history of obesity ≥ 5 years * the subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment * women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods * no significant weight loss (\< 5%) within four months prior to enrollment as documented in the subject's medical record. * successful psychological evaluation following the institution psychological evaluation protocol for bariatric surgery or successful historic assessment performed no more than 6 months prior to enrollment. * glycosylated hemoglobin; hba1c ≤ 7.0 % at visit 2 or historic value performed no more than 3 months prior to enrollment. * if taking anti-depressant medications, they must be stable for at least six months prior to enrollment * willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial * alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial * able to provide voluntary informed consent exclusion criteria: * any prior bariatric surgery * other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator) * diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures * use of anti-psychotic medications * diagnosed with a eating disorder such as bulimia or binge eating * obesity due to an endocrinopathy (e.g. cushing disease) * insulin therapy * gi disease such as hiatal hernia (\> 5cm), gastroparesis, esophageal motility disorders or intractable constipation. * any history of peptic ulcer disease within 5 years prior to enrollment * history of barrett's esophagus * women who are pregnant, lactating or anticipate becoming pregnant within 24 months * arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study. * cardiac history that physician feels should exclude the patient from the study. * use of another investigational device or agent in the 30 days prior to enrollment * a history of life-threatening disease within 5 years prior to enrollment * any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study

Keywords: obesity gastric stimulation morbid obesity
to examine the effects of lapatinib on orally and intravenously administered midazolam in cancer patients

Conditions: Neoplasms, Breast

Summary: to characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed, solid tumor refractory to standard therapy. * tumor for which there is no standard therapy. * able to swallow and retain oral medication. * ecog (eastern cooperative oncology group) performance status 0 to 2. * provided written informed consent. * adequate bone marrow function. * serum creatinine is less than or equal to 1.5 mg/dl. * calculated creatinine clearance is greater than or equal to 60 ml/min based on cockcroft and gault. * total bilirubin is greater than or equal to the upper limit of normal of institutional values. * aspartate and alanine transaminase is less than or equal to 3 times the upper limit of the institutional values. * have a left ventricular ejection fraction (lvef) greater than or equal to 40% based on electrocardiogram (echo) or multiple gated acquisition scan (muga). * resting oxygen saturations of greater than 90%. exclusion criteria: * pregnant or lactating female. * have malabsorption syndrome, a disease affecting gastrointestinal function. * resection of the stomach or small bowel. * evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. * is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations. * have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product. * use of anilinoquinazolines, such as gefitinib \[iressa™\], erlotinib \[tarceva™\]. * immediate or delayed hypersensitivity reaction to midazolam or any component of the formulation, including benzyl alcohol (cross-sensitivity with other benzodiazepines may exist). * has narrow-angle glaucoma which is a contraindication to midazolam use. * has received treatment with any investigational drug in the previous 4 weeks. * received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days, with the exception of mitomycin c within the past 6 weeks. * currently receiving amiodarone or has received amiodarone in the 6 months prior to screening. * is taking regular doses of opiates that in the opinion of the investigator would put the patient at risk of clinically significant respiratory compromise when midazolam is administered. * physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * has class ii to iv heart failure as defined by the new york heart association (nyha) functional classification system. * clinically significant electrocardiogram (ecg) abnormality. * clinically assessed to have inadequate venous access for protocol-related blood draws.

Keywords: midazolam pharmacokinetics lapatinib