Kornimate/medical-research-clean huggingface dataset:
a comparative efficacy and safety study between two silver containing dressings in post-op wound healing

Conditions: Surgical Wound

Summary: study objective: the objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of bct silver bandage role in obstetrical and gynecological wound healing is as effective and safe as aquacel® ag. dressing. study devices: * study device: bct silver bandage * comparator device:"convatec"aquacel® ag hydrofiber dressing study design: * randomized, open-label, interventional, comparative, preventive study with blinded evaluator. * all subjects must meet all the inclusion \& exclusion criteria to enter this study in pre-operative phase. * eligible subjects will be enrolled after a scheduled operative procedure. * there is seven visits in this study (one screening eligibility phase up to 7 days before op day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day. * during each scheduled visit, each subject will have colored picture of his wound after dressing been removed, and on visit v6 for wound evaluation by blinded pi. number of subjects: it is expected to recruit ≧150 eligible subjects. study duration: about eighteen month.


Eligibility criteria:
inclusion criteria: * male/female of any race aged between 18 - 70 years old * the subject is willing and able to understand, sign and date the study informed consent, and be able to adhere to the scheduled visits regimen. * the subject is having surgery (cesarean pfannenstiel or open laparotomy incision) within 1 week exclusion criteria: * patients with known allergy or topical hypersensitivity to ionic silver or alginate * any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial * patients undergoing mri (magnetic resonance imaging) examination. * subject residence is outside the study center city * patients was participating in another clinical trial less than 30 days before participation in this trial

Keywords: obstetrics gynecology wound healing
effects of a mechanical needle stimulation pad on chronic low back pain

Conditions: Chronic Low Back Pain; Recurrent Low Back Pain

Summary: the needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. the aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment. patients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. primary outcome measure was pain intensity at week 2; secondary outcome measures included the oswestry disability index (odi), health-related quality of life (sf-36), the fear avoidance beliefs questionnaire (fabq), analgesic medication consumption and safety.

see above

Eligibility criteria:
inclusion criteria: * chronic or recurrent low back pain in the past 12 months * average pain intensity 4 out of 10 points exclusion criteria: * malignant back pain * congenital deformities of the spine * dystonia or other movement disorders * spinal surgery within 12 months prior * pregnancy * dermatological diseases in the areas treated * tendency for hemorrhages * severe mental illness * recent treatment with anticoagulation, corticoid medication, acupuncture
rtms in the treatment of ptsd

Conditions: Post-traumatic Stress Disorder (PTSD)

Summary: the purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rtms) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (ptsd). this research study will determine whether low-frequency (1 hertz \[hz\]) or high-frequency (10 hz) rtms over the right dorsolateral prefrontal cortex (dlpfc) has an effect on symptoms of ptsd compared to sham rtms treatment.


Eligibility criteria:
inclusion criteria: * primary diagnosis of ptsd as determined by a structured interview using the mini international neuropsychiatric interview (mini) * no change in psychotropic medications within 4 weeks before the start of rtms * age \> 19 years and \< 70 years * competency to give informed consent exclusion criteria: * any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rtms coil * implantable devices, including cardiac pacemakers and defibrillators * other contraindications to rtms, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy * psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type i disorder, or organic mental disorders * substance abuse/dependence within the past 3 months * active suicidal risk as judged by the clinician * borderline or antisocial personality disorder * acute medical illness, including cancer * any significant central nervous system disorder, such as brain mass, stroke, etc.

Keywords: post-traumatic stress disorder repetitive transcranial magnetic stimulation civilians neurostimulation dorsolateral prefrontal cortex
linagliptin in post-renal transplantation

Conditions: Transplanted Kidney Complication

Summary: post-renal transplanted patients frequently present hyperglycemia immediately after the procedure. this was a retrospective comparative study performed in post-renal transplanted patients in a single high speciality center with the goal of compare the effect of linagliptin + insulin in post-renal transplanted patients with hyperglycemia interventions were linagliptin 5mg daily plus insulin vs insulin alone during 5 days after renal transplantation with hyperglycemia, and the main outcome were glucose levels, insulin dose and severity of hypoglycemia

this was a retrospective comparative study performed in a single center between 2016 and 2018, included the data collected from 28 hospitalized post-renal transplanted patients that presented hyperglycemia (\>140 mg/dl or or 7.77 mmol/l) immediately after renal transplantation (rt); 14 patients were treated with linagliptin 5mg daily plus a basal bolus insulin scheme prescribed by the endocrinology group at the hospital, and 14 patients treated only with basal bolus insulin scheme were randomly selected from a list of patients treated during the same period of time and by the same endocrinology group. linagliptin dose was 5mg daily and the basal bolus insulin regimen was started and adjusted according to the international guidelines; in general, patients received a starting insulin dose of around 0.5 u/kg/day, given half as basal insulin (nph or glargine) once or twice daily and half as insulin lispro divided into three equal doses before meals. insulin dose was adjusted daily to achieve the goal of fasting glucose between 80-140 mg/dl (4.44-7.77 mmol/l) or random glucose levels below 180 mg/dl (9.99 mmol/l). correctional insulin dose was used before each meal, depending on the glucose measurements, starting at 1 unit for each 40mg above 140 mg/dl (7.77 mmol/l) of glucose. glucose levels were monitored at fasting and before each meal, as well as at bedtime according to standard clinical practice. data regarding fasting and preprandial glucose levels, hypoglycemia, renal function, and immunosuppression therapy were recorded from the patient´s file during the first 5 days after rt; fasting glucose and renal function were also recorded at 1, 6 and 12 months after rt. patients were included if they were between 18-65 years of age and presented fasting hyperglycemia (\>140 mg/dl or 7.77 mmol/l) immediately after rt. ethical and research committee (cei) at the hospital approved the study protocol with the number cei-49-18.

Eligibility criteria:
inclusion criteria: * hyperglycemia (glucose levels above 140 mg/dl) immediately after renal transplantation exclusion criteria: * incomplete records on the patients file * acute complications such as liver failure
prevention of sleep apnea after general anaesthesia with a mad

Conditions: Peri-operative Medicine; Sleep Apnea

Summary: sleep apneic episodes increase after general anaesthesia up to the third postoperative night. a mandibular advancement device, called mad, is a small device that is inserted in the patient's mouth during the night and allows the advancement of the mandible, preventing sleep apneic episodes. the objective of this randomized controlled trial is to determine whether a mad reduces the impact of general anaesthesia on the increase of the sleep apneic episodes in the postoperative period. all patients will have their sleep-related respiratory data measured using a portable respiratory polygraphy recorder (resmed embletta® system). this portable recorder allows a non-invasive recording of nasal airflow through a nasal cannula, oxygen saturation (spo2) via finger pulse oximetry, respiratory efforts through thoracic and abdominal belts, and body position.


Eligibility criteria:
inclusion criteria: - adult patient undergoing any lower limb surgery exclusion criteria: * continuous positive airway pressure (cpap) treatment for obstructive sleep apnoea, * presence of severe respiratory or cardiovascular disease * preoperative consumption of benzodiazepine, * chronic use of opioids \> 30 mg/day morphine equivalent * no tooth * patient known for malignant hyperthermia
predictive model for postoperative complications in hemi-hip arthroplasty

Conditions: Complication; Risk Factor; Elderly Patient; Arthroplasty

Summary: the purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone hemi-hip arthroplasty.

we retrospectively reviewed the medical records and reviewed the major complications and identify risk factors of elderly patients who had undergone hemi-hip arthroplasty for adults aged 60 years or older from january 2011 to december 2015.

Eligibility criteria:
inclusion criteria: * a patient scheduled to undergo spinal anesthesia for hemi-hip arthroplasty exclusion criteria: * 1) patients with acute infectious disease before surgery 2) patients with fractures around the implant 3) patients who underwent reoperation during hospitalization 4) during the study period, duplicate patient who underwent the opposite side of the hip during hospitalization
randomized trial of nasal continuous positive airway pressure or synchronized nasal ventilation in premature infants.

Conditions: Apnea; Infant, Premature; Bronchopulmonary Dysplasia

Summary: very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. assistance with a mechanical respirator is common. however, prolonged use of a respirator can itself cause long-term complications. furthermore, commonly used drugs to improve the regularity of breathing may have long-term consequence only recently recognized. this study will compare two different types of assistance using a nasally applied breathing assist device. the aim is to see which type of assistance is best at avoiding the need for both prolonged respirator use and drugs to regulate breathing.

early extubation of premature infants may limit the deleterious effects of positive pressure ventilation. the primary cause of failure of extubation (and the need for reintubation) is apnea of prematurity. standard treatment for improving extubation success and decreasing apnea of prematurity is with the use of nasal continuous positive airway pressure (ncpap), use of methylxanthines, or both. recent literature suggests that methylxanthines may have significant effect on long-term neurodevelopmental outcome. this primary objective of this study is to investigate the effect of synchronized nasal intermittent positive pressure ventilation (snippv) combined with standard nasal continuous positive airway pressure (ncpap) versus standard ncpap alone, on the need for reintubation and the need of methylxanthine therapy in premature infants. the study period for the primary objective will be the first 7 days immediately after the initial extubation of premature infants with birth weights 500-1250 grams. a secondary objective is to identify any differences in duration of time free of endotracheal intubation and duration of time free of methylxanthine use between the two treatment modalities as measured from the first extubation attempt. the study is a randomized, controlled trial using a new cpap machine (infant flow advance™) that will be able to provide ncpap with and without snippv. because of the mechanics of the snippv mode, blinding of the study is not possible. the study is pragmatic in design allowing the medical staff to make clinical decisions on ventilatory management based on the routinely used criteria thus evaluating the study interventions in the everyday clinical environment. analysis will be on an intention-to-treat basis.

Eligibility criteria:
inclusion criteria: * premature infants with birth weight 500-1250 grams * first attempt at extubation exclusion criteria:(clinical suspicion or documented diagnosis of: * neuromuscular disease * chromosomal abnormality * or any congenital anomalies that would affect ability to be extubated from mechanical ventilation via endotracheal tube (i.e. congenital cardiac anomalies, choanal atresia).

Keywords: xanthines reintubation nasal intermittent ventilation nasal continous positive airway pressure
comparison of us-guided paravertebral and proximal intercostal nerve blocks

Conditions: Pain

Summary: the purpose of this study is to compare the proximal intercostal block to the more medial (classic) ultrasound-guided paravertebral block. the investigators hypothesize that the proximal intercostal block will allow for improved needle visualization, shorter block time, and improved safety profile compared to the classic paravertebral bock.

although previous studies have made advances towards applying ultrasound guidance to the performance of paravertebral blocks (pvb), a technique combining both safety and technical ease remains elusive. the ideal technique (1) permits continuous visualization of the entire needle shaft and tip, (2) avoids aiming the needle tip and injectate directly toward the neuraxis or lung, and (3) is easy to perform. visualization of all structures by ultrasound is essential to minimize the risk of vascular puncture, nerve root or spinal cord injury, and pneumothorax. failure to consistently and quickly identify the transverse process and pleura, as occurs when using older techniques, results in several needle redirections, causing pain and discomfort to patients, and increases the potential risk of pneumothorax. the technical difficulty of applying previously-described us-guided techniques takes an inordinate amount of time and is clinically less practical within a busy surgical practice. in the current study, the investigators describe a novel, modified approach to real-time ultrasound-guided single shot paravertebral blockade, the proximal intercostal block (picb), which utilizes a sagittal paramedian us probe placement to identify the intercostal space and pvs. in this method, instead of placing the probe at a fixed traditional distance of 2.5 cm from the spinous processes, the probe is moved laterally to obtain a comprehensive image, with a clear view of the ribs, internal intercostal membrane, and the parietal pleura. the investigators propose that moving the probe laterally towards the proximal intercostal space allows clearer simultaneous visualization of both pleura and needle as it advances towards the pvs, while achieving comparable injectate spread and, ultimately, similar or better clinical results. such improved visualization will reduce the number of needle passes, increase confidence in the user, decrease block placement time, and improve overall block success. this technique combines the advantages of more lateral approaches (better visualization of structures, in particular the pleura) with the advantage of the more medial approaches (in-plane, closer, and not directed at the neuraxis).

Eligibility criteria:
inclusion criteria: 1. females age 18-85 years old 2. asa 1-3 3. patient scheduled for unilateral or bilateral mastectomy with or without reconstruction exclusion criteria: 1. coagulopathy 2. patient refusal 3. allergy to local anesthetics

Keywords: nerve block anesthesia recovery period pain management
arterial stiffness in type i diabetes mellitus

Conditions: Arterial Stiffness in Youth With Type 1 Diabetes

Summary: using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of 65 children with type i diabetes mellitus. this prospective, crossover study will help determine if there is an acute increase in arterial stiffness in children with type i diabetes mellitus who do not give extra insulin to cover a meal. this will give more support to show why it is so critical to bolus every time they eat and to bolus on time to decrease cardiovascular consequences of poorly controlled diabetes. the hypothesis is that giving insulin before a meal compared to not giving insulin before a meal will be associated with lower arterial stiffness in children with type i diabetes.

the subject will fast overnight (nothing to eat or drink for at least 8 hours). the subject will be asked to drink a mixed meal replacement drink (boost) and will be randomized (like flipping a coin) to bolus insulin for the "meal" or to not bolus insulin using their standard insulin dose. glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. stiffness of the blood vessel of the wrist will be determined using radial tonometry. radial tonometry is safe and does not hurt. a pen like probe is placed on the blood vessel of the wrist. when the machine reads a good wave form the computer will calculate the stiffness of the blood vessel. this test will be done along with the glucose checks; before drinking the meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink. during the next study visit, the subject will repeat the exact same study described above. however, this time they will receive the other insulin assignment they were assigned during the first study (either bolus or no bolus).

Eligibility criteria:
inclusion criteria: * type 1 diabetes based on clinical history * basal-bolus insulin regimen * duration of diabetes greater than 1 year * blood glucose 65-200 mg/dl fasting exclusion criteria: * use of metformin or any other hypoglycemic agents besides insulin * use of anti-hypertensives * caffeine or smoking within the past 24 hours

Keywords: type i diabetes healthy children adolescents young adults
assessment of patterns of patient reported outcomes in adults with congenital heart disease - international study ii

Conditions: Congenital Heart Disease

Summary: this is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (proms) and patient-reported experience measures (prems) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

the research aims of this study are: 1. to further explore differences in a modified selection of patient-reported outcome measures (proms) and (as a new addition in approach-is ii) explore differences in patient-reported experience measures (prems), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("part 1"). 2. to explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("part 2").

Eligibility criteria:
inclusion criteria: * diagnosed with congenital heart disease, defined as: "a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects)" * aged 18 years of age or older at the moment of study inclusion * diagnosed with congenital heart disease before the age of 10 years * follow-up at an achd center or included in a national/regional registry * physical, cognitive, and language abilities to complete self-report questionnaires exclusion criteria: - prior heart transplantation

Keywords: congenital heart disease quality of life patient reported outcomes patient reported experience measures geriatric phenotype
use of human dehydrated umbilical cord allograft in supraspinatus tendon repair

Conditions: Shoulder Injury; Shoulder Sprain; Supraspinatus Tear

Summary: to determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the american shoulder and elbow surgeons (ases) score 12 months post-op.


Eligibility criteria:
inclusion criteria: 1. mri confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair) 2. subject is male or female age 18 or older 3. subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study exclusion criteria: subjects who meet any of the following criteria will be excluded from the study: 1. shoulder pain primarily attributed to any of the following: 1. ligament rupture due to use of fluoroquinolones 2. capsular tear 3. fracture of the humeral head 4. inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis) 5. neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve 6. previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus) 2. known history of poor compliance with medical treatments 3. subject has bilateral supraspinatus tendon tear 4. subject has signs and symptoms of an active infection of the shoulder joint 5. retraction of the supraspinatus tendon exceeding 1.5 cm in length 6. subject has additional injuries requiring further surgical intervention to the ipsilateral arm 7. subject has had previous surgery in the target arm within the past 6 months prior to treatment or plans to have surgery other than rotator cuff repair in the target arm within 180 days of treatment 8. subjects currently receiving radiation therapy or chemotherapy 9. subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment 10. subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment 11. subject has any significant medical condition(s) that, in the opinion of the investigator, would interfere with protocol evaluation and participation 12. allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate 13. workers' compensation patients
the prognostic value of serum biomarkers in ewing's sarcoma

Conditions: Sarcoma, Ewing

Summary: extraction of laboratory data from blood tests prior to surgical and chemotherapy and other histological, clinical and instrumental data related to the patient's history from the digitized medical digitized medical records and analysis of the same. the medical records of 1000 patients from january 1, 2000, until december 31, 2020


Eligibility criteria:
inclusion criteria: * patients with ewing's sarcoma and osteosarcoma with established diagnosis; * patients with age ≥ 2 years; * minimum follow-up duration of 2 years; * medical records, complete blood work and instrumental examinations; regular follow-up. exclusion criteria: * patients with ewing's sarcoma or osteosarcoma who have received medical treatment (surgery radiotherapy or chemotherapy) in other institutions prior to admission to the rizzoli orthopaedic institute.

Keywords: sarcoma; ewing