Kornimate/medical-research-clean huggingface dataset:
effect of bracing versus no bracing in stable thoracolumbar compression and burst fractures

Conditions: Thoracic Fracture; Lumbar Fracture; Compression Fracture of Thoracic Vertebral Body; Compression Fracture of Lumbar Spine; Burst Fracture of Thoracic Vertebra; Burst Fracture of Lumbar Vertebra

Summary: spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. however, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. being fitted for and acquiring braces are associated with great expense and increased hospital stays. the purpose of this study is to determine wether or not braces are required for good outcome post thoracic or lumbar fracture.

several tens of patient's per year come to the emergency department with thoracolumbar spine compression and burst fractures that are not indicated for surgical fixation. currently, these patients are treated non-operatively through brace wear which is either custom made for the patient or is off-the-shelf pending location of the fracture and surgeon preference. all braces are through the currently contracted orthotics company. as they are non stocked in house, waiting for the brace requires the patients to remain on "strict spine precautions" (flat bed rest in a miami j collar, no pillows behind the head, and logrolls for turning) for anywhere from 24-48 hours. no only is this incredibly uncomfortable for the patient, it is also extending their hospital stay for at least one day and, sometimes, up to three as they wait for the brace and have it adjusted to fit appropriately. the patient's all have to then wait to work with physical therapy and occupational therapy and, finally, have upright spine films taken in the brace. the braces tend to be very uncomfortably and constricting for patient's and significantly inhibit their daily lives. the investigators are proposing that these fractures can be treated without needing bracewear and will have equivalent to superior outcomes than results while wearing the brace.

Eligibility criteria:
inclusion criteria: * any acute, stable thoracic or lumbar compression or burst fracture appropriate for non-operative care exclusion criteria: * neurological deficit, pregnant, incarcerated, non-english speaking, previous spinal surgery, additional lower extremity injury affecting weight bearing, younger than 18 years of age
a two part trial investigating the safety of nn9924 in healthy male subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of nn9924 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * male subjects with good general health as judged by the investigator * body weight of 65.0-95.0 kg (both inclusive) * body mass index (bmi) of 18.5-27.5 kg/m\^2 (both inclusive) exclusion criteria: * known or suspected allergy to trial product or related products * acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the investigator * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the investigator
clinical effect of heart failure management via home monitoring with a focus on atrial fibrillation (effect)

Conditions: Heart Failure (HF); Atrial Fibrillation

Summary: effect is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (af) as well as the early optimization of cardiac resynchronization therapy (crt) via home monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for crt with implantable cardioverter defibrillator (icd) backup and af.

effect is a prospective, randomized multicenter study to assess whether management of atrial fibrillation as well as the early optimization of cardiac resynchronization therapy via home monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for crt with implantable cardioverter defibrillator backup (crt-icd) and paroxysmal or persistent af. 300 patients with a documented history of af will be enrolled and randomized 1:1 to standard patient management or af management and early optimization of crt via home monitoring. the patient outcome regarding days lost due to cardiovascular mortality, cardiovascular hospitalization and inappropriate icd therapy will be documented during an observational period of 1 year. another 300 patients undergoing crt-icd implantation without a history of af will undergo an af evaluation during the first three months of crt. if a patient shows an af episode during this period, he is eligible for study inclusion. if no af episode occurs during af evaluation, the patient be treated as screening failure.

Eligibility criteria:
inclusion criteria: * indication for crt with icd-backup * paroxysmal or persistent af * optimized hf-related medication exclusion criteria: * permanent af * contraindication for anticoagulation * stroke within the last 6 weeks * acute coronary syndrome within the last 2 months * cardiac surgery within the last 2 months * acute myocarditis * severe chronic obstructive pulmonary disease (copd) * planned cardiac surgery or interventional measures within the coming 3 months * dialysis dependency * life expectancy \< 12 months * insufficient gsm (global system for mobile communication)/gprs (general packet radio service)-network coverage * previously implanted unipolar right atrial lead * previously implanted right atrial lead with tip-ring distance \> 11 mm

Keywords: crt therapy of af telecardiology home monitoring cardiovascular hospitalization cardiovascular mortality
effects of a dynamic upper limb orthosis in patients with parkinson's disease

Conditions: Parkinson Disease; Tremor, Limb; Rigidity, Muscle

Summary: this is a randomized controlled clinical trial aimed at parkinson's disease patients. its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity

objective: to assess the effect at 3 and 6 months of the upper limb orthosis, applied for 3 months in the functionality of the affected upper member, manual dexterity, performance of daily living activities and quality of life in parkinson patients. design and setting: a randomized controlled clinical trial of two parallel groups. population: 40 patients with tremor and stiffness due to parkinson´s disease will be included, selected by consecutive sampling at the neurological service and stroke unit of the burgos university hospital (spain) . measurements and intervention: functionality of the affected upper member, manual dexterity, performance of daily living activities and health-related quality of life will be evaluated. all participants will continue to receive the medical treatment indicated to their health status. the intervention group will receive a treatment based on a dynamic orthosis during 3 months. no additional intervention with the participants of the control group will be completed.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease according to "brain bank" criteria * parkinson's disease stage 1 to 3 according to the hoehn and yahr scale exclusion criteria: * moderate cognitive or language impairment * musculoskeletal or dermatological diseases in the upper limb * impossibility of follow-up for 6 months * difficulty to attend to assessment visits * allergy to glove composition

Keywords: parkinson disease tremor rigidity upper limb dynamic orthosis
ligasure small jaw® versus conventional neck dissection in head and neck cancer patients

Conditions: Head and Neck Neoplasms

Summary: the aim of this prospective randomized study was to investigate if the ligasure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.

we compared the differences in perioperative and postoperative variables between ligasure small jaw®-assisted and conventional neck dissection in head and neck cancer patients. patients who were scheduled to undergo neck dissection due to head and neck cancer were eligible for this study. after receiving a detailed explanation, all patients signed an informed consent form before randomization. the study group were treated using the ligasure vessel sealing system (small jaw®; covidien, colorado, usa) for dissection and hemostasis throughout the whole procedures during neck dissection. relevant data included tumor-related variables, perioperative parameters, postoperative drainage status, postoperative subjective pain, and analgesic consumption amount were recorded and analyzed.

Eligibility criteria:
inclusion criteria: * patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer exclusion criteria: * history of coagulation disorders * prior radiation to the neck * prior neck dissection * declined to participate

Keywords: ligasure neck dissection operative duration postoperative drainage postoperative pain
investigation of the effects of local vibration applied to different regions and spinal stabilization exercises

Conditions: Multiple Sclerosis; Ataxia

Summary: the aim of this study is to investigate the effects of local vibration application applied to different regions on postural control in addition to spinal stabilization training in ataxic multiple sclerosis (ms) patients. the study was planned as a single-blind, randomized controlled trial. the patients included in the study will be divided into 3 groups by the closed-envelope randomization method. each treatment will be 8 weeks, 3 days a week. the control group will be given 40 minutes of lumbar spinal stabilization exercises. paraspinal vibration group; in addition to 40 minutes of lumbar spinal stabilization exercises, lv will be applied to the paraspinal muscles for 10 minutes. lv application will be applied to the cervical paraspinal muscles for 5 minutes and to the lumbar paraspinal muscles for 5 minutes, bilaterally, sequentially. gastrosoleus vibration group; in addition to 40 minutes of lumbar spinal stabilization exercises, lv will be applied to the gastrosoleus muscle complex for 10 minutes. lv application will be applied bilaterally, sequentially (5 minutes on the right and left). assessments will be made by a blind assessor. in assessments; demographic information, expanded disability status scale (edss) /extended disability status scale (disease stage), international cooperative ataxia rating scale (ataxia severity), berg balance scale (performance-based balance), trunk impairment scale (trunk control), neurocom balance master static posturography (limits of stability and postural sway), optogait (gait analysis), lumbopelvic muscle endurance tests will be used.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-50 * having been diagnosed with ms by a neurologist * edss score between 3-5 * edss pyramidal system score of 3 or less * not using corticosteroids and/or stopping at least 3 months before starting the study exclusion criteria: * having a history of attacks in the last 3 months * having orthopedic or systemic problems * presence of peripheral vestibular complaints * participating in another exercise program in the last 6 months * being mentally affected (mini-mental test score \< 24) * severe spasticity (mas\>3) * refusal to participate in the study

Keywords: multiple sclerosis ataxia spinal stabilization local vibration postural control
botulinum toxin to improve results in epicanthoplasty

Conditions: Scar; Intercanthal Distance Ratio

Summary: medial epicanthal fold is a common skin fold in the inner part of the eye in more than 50% asia population, giving the illusion of a shorter palpebral fissure length and a wider intercanthal distance. currently, various epicanthoplasty techniques have been well described to correct epicanthus fold. however, hypertrophic scarring after epicanthoplasty remains a clinical challenge, which seems inevitable and may leading to unpleasing supratarsal crease, recurrence of medial epicanthus fold, even obvious scar formation. botulinum toxin type a (btx-a) is widely used for facial rejuvenation and many other medical indications. it is a potent neurotoxin that indirectly blocks neuromuscular transmission and leads to functional denervation of striated muscle for 2 to 6 months after injection. recently, experimental study and clinical trails have revealed that btx-a can inhibit the growth of fibroblasts derived from hypertrophic scars and influenced the expression of transforming growth factor-β1. therefore, we hypothesized that btx-a can improve hypertrophic scarring after epicanthoplasty through release orbicularis oculi muscle tension, inhibit fibroblast growth, and reduce collagen production. the main aim of this trail is to evaluate the efficiency of btx-a injection on improving hypertrophic scaring after epicanthoplasty.


Eligibility criteria:
inclusion criteria: * patients with moderate to severe congenital epicanthus. * patients accept park z epicanthoplasty. * written informed consent given exclusion criteria: * epicanthus caused by trauma, surgical injury. * patients with both epicanthus and blepharopotosis. * patients with blepharophimosis-ptosis-epicanthus inversus syndrome, or only inversus epicanthus * patients underwent botulinum toxin type a periocular injection within 6 months * patients ever have been allergic to botulinum toxin type a or any components of botulinum toxin type a

Keywords: epicanthoplasty botulinum toxins scar intercanthal distance blepharoplasty
sweat gland function in patients with failed back surgery syndrome, treated with spinal cord stimulation

Conditions: Failed Back Surgery Syndrome

Summary: this study is investigating sweat gland function during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years old. * diagnosis of fbss (failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation. * cognitive and language functioning enabling coherent communication between the examiner and the participant. exclusion criteria: * patients with major psychiatric problems.
evaluation of the safety of intraperitoneal laparoscopic radical prostatectomy with or without drainage tube

Conditions: Prostate Cancer

Summary: this is a randomized controlled and non-inferiority trial in comparison of intraperitoneal laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

this trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men with localized prostate cancer. this study aims to determine whether intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

Eligibility criteria:
inclusion criteria: 1. age: more than 18 years old, less than 85 years old; 2. patient who pathologically diagnosed with prostate cancer and plan to undergo radical laparoscopic surgery for prostate cancer; 3. fully understand the clinical trial protocol and sign the informed consent; exclusion criteria: 1. patients with surgical contraindications who cannot accept surgery; 2. patients with non-laparoscopic radical resection of prostate cancer; 3. patients with previous pelvic radiation therapy and complicated abdominal surgery; 4. patients judged by the investigator to be unsuitable to participate in the clinical trial;

Keywords: prostate cancer laparoscopic radical prostatectomy intraperitoneal drainage tube
the effects of mixed grain on blood glucose and insulin in healthy male

Conditions: Healthy People; Diabetes Mellitus, Type 2

Summary: this study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical trial to evaluate the efficacy of mixed grain on blood glucose, insulin and glycemic index(gi) in healthy males.

after a 12-hour fast, oral glucose or meal tolerance test was performed with blood samples drawn at time 0, 15, 30, 45, 90, 120, 150, and 180 min. 1. serum levels of glucose, insulin, and c-peptide were analyzed by biochemical autoanalyzer. the area under the curve (auc) changes in blood glucose were computed by the trapezoidal method. 2. glycemic index(gi): the area under the glucose response curve after consumption of a test food divided by the area under the curve after consumption of a control food containing the same amount of carbohydrate and calculated using 50 g glucose as the reference.

Eligibility criteria:
inclusion criteria: * males, 19\~60years old * bodyweight was more than 50 kg with ideal body weight within ±30% * less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (ogtt) * able to give informed consent exclusion criteria: * major medical illness such as cardiovascular, neurologic, psychiatric, renal, pulmonary and hepatic diseases * history of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery * medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * poor vital sign (systolic blood pressure: below 100 mmhg or above 150 mmhg, diastolic blood pressure: below 65 mmhg or above95 mmhg) * allergic or hypersensitive to any of the ingredients in the test products; treated with any drug within past 2 weeks * participation in any other clinical trials within past 2 months * alcohol consumption above 21 units per week or abnormal screening laboratory test * being judged by the responsible physician of the local study center as unfit to participate in the study

Keywords: mixed grains glycemic index giant embryonic brown rice giant embryonic rice diabetes
enteral vs. oral nutrition after pancreatoduodenectomy

Conditions: Pancreaticoduodenectomy; Malnutrition; Postoperative Complications

Summary: patients suffering from pancreas cancer as well as patients with chronic pancreatitis or requiring pancreas surgery often are in a compromised nutritional status. nutritional support should therefore be started early during the postoperative course to prevent further malnutrition, as it is an important risk factor to develop complications. recently, several studies have shown that early enteral nutrition (een) could shorten length of stay, reduce postoperative infections and mortality, and decrease costs when compared with total parenteral nutrition (tpn) in gastrointestinal cancer surgery. after pancreatoduodenectomy (pd), een has been shown to reduce early and late complications, infections, and readmission rates. it is nevertheless currently not clear if een improves the short-term outcomes after pd compared to oral nutrition. the primary objective of the study is to assess the impact of een on postoperative morbidity after pd, according to the comprehensive complication index. secondary objectives are to assess the impact of een on major postoperative complications, according to clavien classification, specific complications, length of stay, readmission rates, quality of life, metabolic stress and nutritional response after pd.


Eligibility criteria:
inclusion criteria: * patient scheduled for elective open pancreatoduodenectomy. * patient ≥18 years old. * patient at nutritional risk, i.e., with nutrition risk screening (nrs) ≥3. * signed informed consent. exclusion criteria: * patient not able to give informed consent as documented by signature of consent form (e.g., vulnerable patients). * enteral feeding already initiated preoperatively. * language barrier. * inability to follow the procedures of the study, e.g., due to language problems, psychological disorders (i.e., eating disorders and bipolar disorders), or dementia.

Keywords: enteral nutrition oral nutrition pancreatoduodenectomy whipple operation pancreas surgery morbidity
a comparative efficacy and safety study of compound carraghenates cream with mayinglong musk hemorrhoid ointment in the treatment of hemorrhoids

Conditions: Hemorrhoids

Summary: the purpose of this study is to compare the therapeutic effect and safety of compound carraghenates cream with mayinglong musk hemorrhoid (swollen veins in the lower part of the rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of pain.

this is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), controlled clinical trial and comparative study of safety and efficacy of compound carraghenates cream with mayinglong musk hemorrhoid ointment in the treatment of hemorrhoids, especially regarding the relief of pain. participants will be randomly assigned to either of the two treatment groups that are carraghenates cream (titanoreine) group or mayinglong musk hemorrhoid ointment group. the total duration of the study will be 1 week (7 days). in carraghenates cream group, 3-4 gram (g) cream will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days and in the mayinglong musk hemorrhoid ointment group, 2 g ointment will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days. efficacy will be assessed by using numeric rating scale (nrs) and participants' safety will be monitored throughout the trial.

Eligibility criteria:
inclusion criteria: * participants who agree to participate in the current study * participants having painful hemorrhoids (swollen veins in the lower part of the rectum or anus \[external hemorrhoid, mixed hemorrhoid, etc.\]) * participants who did not use other topical drugs to treat their hemorrhoids a day before the inclusion * participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period exclusion criteria: * participants having other anorectal diseases , such as anal fistula , anal cleft , perianal abscess , and anorectal occupied lesions etc * participants having hypersensitive predisposition or hypersensitive to any of components of the study drugs * female participants under pregnancy or during breastfeeding period * participants who fail to accept the scheduled visits or are lost to the visits * participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or mental disorders

Keywords: hemorrhoids carraghenates mayinglong musk titanoreine
investigate the effect of azd1305 on patients with left ventricular dysfunction

Conditions: Left Ventricle Function

Summary: to explore if azd1305 compromises left ventricular performance in patients with left ventricular dysfunction


Eligibility criteria:
inclusion criteria: * male patients and postmenopausal women * mildly/moderately decreased heart function * regular heart rhythm exclusion criteria: * potassium outside normal reference values * child bearing potential * severely decreased heart function

Keywords: azd1305 anti-arrhythmics safety