Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of novolog vs. humalog in insulin pumps in children and adolescents

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in the united states of america (usa). it is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to type 1 diabetes. insulin aspart (novolog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (csii) therapy in the pediatric and adolescent age population. this trial compares the safety and efficacy of insulin aspart (novolog®) and insulin lispro (humalog®) delivered by csii in children and adolescents with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes

Keywords: diabetes, type 1
task-oriented aerobic exercise training in chronic stroke patients

Conditions: Cerebrovascular Accident

Summary: the study is designed to investigate (1) the effects of task-oriented aerobic exercise training on cardiorespiratory fitness, cerebral blood flow, oxygenation, functional performance, and physical activity in patients with chronic stroke. (2) the association between outcomes


Eligibility criteria:
inclusion criteria: * poststroke duration \> 6 months * mmse \> 22 exclusion criteria: * severe cardiovascular disease * depression * dementia * other disease affect the testing of the study

Keywords: physical fitness cerebral circulation walking
efficacy of a sensory comfort room in agitation control

Conditions: Mental Disorders, Severe

Summary: in the initial approach of the study, it was considered that the comfort room would be used by all patients with gct treated in the functional rehabilitation area 1 (arf 1) of the álava psychiatric hospital. however, with the onset of the covid-19 pandemic, the service itself decided to separate the patients into two units, in order to reduce positive contacts. consequently, the use of the comfort room will only be available for one of the two units, which will be considered as the intervention group, while the other unit will be considered as the control group. it is also important to note that the patients in the intervention group unit have a more severe mental state than those in the control group. the control group are older and more psychopathologically stable patients. so already from the initial moment of the study they are two populations with different characteristics. main objective: to determine the effectiveness of the use of a sensory comfort room in the functional rehabilitation area 1 of the hpa. it would be considered effective if mechanical restraints decrease by 5% in the intervention group with respect to the previous year.


Eligibility criteria:
inclusion criteria: * all patients admitted to functional rehabilitation area 1 presenting with questionable, mild or moderate agitation (score less than or equal to 20 on the pec scale) or at the patient's request. * to have freely accepted to participate in the intervention and to have signed the informed consent. an information sheet will also be given to the patient and an information sheet to the tutor (appendixes 1 and 2). experts in easy reading are consulted to adapt this document. exclusion criteria: * severe and extremely severe agitation (score greater than or equal to 21 on the pec scale). immediate previous physical aggression. * declination of the signature of informed consent. * any participant who does not comply with the rules of use of the room will be excluded from the study.
oa optimization program pilot trial

Conditions: Osteo Arthritis Knee; Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis

Summary: total joint replacement is a highly successful treatment option for people affected by severe osteoarthritis (oa), however, the mismatch between resources and demand for this surgery means that many patients face long wait times while enduring worsening pain and disability. the alberta hip and knee program is a centralized intake system for patients referred for total joint replacement assessment. over 3000 patients are assessed annually at the calgary location (alberta hip and knee clinic at gulf canada square) where previously patients waited an average of 43 weeks for a surgical consult then an additional 30 weeks until surgery. given that many elective surgeries in alberta have been cancelled in response to the covid19 pandemic, these wait times have increased significantly, with no clearing of the surgical backlog for the foreseeable future. long wait times for patients can become a spiral of more debility, less mobility, and subsequent weight gain. the current standard of care for patients with obesity awaiting surgery provides little support or guidance beyond general advice about the importance of a healthy weight and remaining active. this waiting period represents an untapped window of opportunity to intervene and help patients with obesity and oa to lessen their disease burden and improve overall health, while addressing patient priorities such as regaining lost function and improving quality of life. many patients with osteoarthritis also have obesity. the best practices in obesity treatment requires a multidisciplinary approach. our aim is to conduct a pilot randomized controlled trial (rct) to evaluate the feasibility of incorporating the multidisciplinary alberta obesity centre program into the clinical care pathway for patients with obesity and oa while they await surgical evaluation at the alberta hip and knee clinic at gulf canada square. the results of this feasibility trial will help inform a larger scale trial that will be powered for clinical and health economics outcomes.


Eligibility criteria:
inclusion criteria: * body mass index (weight in kilograms divided by height in metres squared) greater than 30 * symptomatic osteoarthritis (referred to the alberta hip and knee clinic for assessment for total joint replacement surgery) exclusion criteria: * currently following a specialized or therapeutic diet * pregnant or breastfeeding * diagnosed with type 1 diabetes * unable to read or speak english * unable to use email * unable to use virtual platforms such as zoom
early closure of temporary loop ileostomy after rectal resection for cancer

Conditions: Rectal Cancer

Summary: early closure of temporary loop ileostomy after rectal resection for cancer

the aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer. early closer is defined as postoperative days 8-12 and delayed as later then 3 months. inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma. a ct-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. the patients will be randomized after the "intention-to-treat" principle, before the primary operation. if there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed. primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection. major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered. lars score and eortc qlq-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Eligibility criteria:
inclusion criteria: * all patients aged 18 years or older. * all patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma * written informed consent was obtained from all patients exclusion criteria:

Keywords: ileostomy rectal resection proctectomy stoma closure rectal cancer
real world study of linperlisib for lymphoma treatment

Conditions: Focus on the Lymphoma Including B/T-cell Lymphoma

Summary: this is a multicenter, non-interventional and observational real-world study to evaluate the efficacy and safety of linperlisib in patients with lymphoma.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. clinical diagnosis of lymphoma patients 3. patients signed informed consent, volunteered to join the study, and had the willingness and ability to cooperate with the data collection in this study; 4. the researchers' assessment can use linperlisib treatment exclusion criteria: 1. the nature of the study could not be understood or informed consent was not obtained 2. other ineligible conditions were assessed by the investigator
feasibility testing and pilot study of v-motive protocol software version 1

Conditions: Autism Spectrum Disorder

Summary: this is a project to be funded by a fast-track small business innovative research to build and test the feasibility of a new software prototype called v-motive which will facilitate the combination of two proven autism behavioral interventions: applied behavior analysis therapy (aba) and video modeling (vm). the investigators will conduct a phase i feasibility analysis and phase ii pilot study of the v-motive prototype by observing a community therapy providers' use of the prototype in a therapy setting. investigators will observe the users and record the success or failure of the performance of key functions of the software. investigators will also administer surveys. the study will answer research questions about v-motive's ability to perform its intended function: allowing interventionists to feasibly leverage video modeling within aba therapy with a minimal amount of overhead and labor.

investigators will conduct a within-subject pilot study of 6 tutors and 6 children to answer research questions about v-motive's ability to perform its intended function. the goal is to evaluate the feasibility, usability, and the potential of v-motive to deliver comprehensive, individualized video modeling that is integrated with a child's program. investigators will also use descriptive statistics to provide preliminary insight into the potential impact of the system on a child's performance in their aba therapy. however, these data are not intended to show cause or to show effectiveness. the study will answer the following questions: 1) 3) can v-motive be feasibly used during aba therapy to positively impact a child's performance within 4 weeks? 2) how laborious is it to construct a fully-indexed video repository from therapy footage using v-motive? 3) how accurate is the system in suggesting and cueing up appropriate video for playback on demand?

Eligibility criteria:
inclusion criteria: * children between 4 and 10 years old * clinical diagnosis of autism spectrum disorder * currently receiving applied behavioral analysis therapy * must be developmentally capable of basic imitation behavior exclusion criteria: - none
study of the efficacy, safety & tolerability of serlopitant for pruritus (itch) after burn injury

Conditions: Pruritus; Burns

Summary: study of the efficacy, safety \& tolerability of serlopitant for pruritus (itch) after burn injury


Eligibility criteria:
key inclusion criteria: * male or female, age 18-65 years at consent. * history of serious burn injury * pruritus (itchiness) prior to the initial screening visit and during the screening period * judged to be in good health in the investigator's opinion. key exclusion criteria: * prior treatment with study drug or similar drug * pruritus (itchiness) due to another reason besides burn injury/ healing. * presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject. * history of hypersensitivity to study drug or any of its components. * currently pregnant or male partner of pregnant female. * females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.
complication of pancreatic fistula and bleeding after pancreaticoduodenectomy in treatment periampullary cancer

Conditions: Periampullary Cancer; Pancreatic Fistula; Bleeding

Summary: this multi-site study will be done across hepatobiliary and pancreatic surgery department at cho ray hospital and university and pharmacy center. patients who are diagnosed with periampullary cancer from august 2021 to august 2023 will be underwent pancreaticoduodenectomy. we will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.

the investigator will conduct this study at both site at the same time: cho ray hospital and university and pharmacy center. the investigator will directly consult the patient to participate in the study, collect the preoperative information, intraoperative protocol and postoperative data. the investigator will statically analysis the incident of the morbidity (mainly for pancreatic fistula and bleeding), and invest some risk factors relating to those complications. plan for conducting the study: * the patient diagnosed with periampullary cancer will be consulted with surgical method, operative risks, postoperative complications and agree to participate in the study. the patient signes a consent form to participate in the study. * pancreaticoduodenectomy will be performed according to the uniformity protocol of both hospitals: cho ray hospital and university of medicine and pharmacy center. * post-operative data will be collected and based on the general procedure. data analysis * to determine the incidence of pancreatic fistula and bleeding, survival analysis will be used. * to determine the association of risk factors with pancreatic fistula and bleeding, logistic regression was used, the value with p \< 0.05 will be included in the multivariable regression model to determine the real risk factors. sample size: • the investigator expect approximately 100 patients in the first year in both centers. and the investigator hope at least 110 patients in the whole conducting time. plan for missing data: • the investigator will directly collect the patient information before the operation, observe the operation process and follow-up the postoperative during. investigator will remove any case that missing preoperative information, operative data or post-operative laboratory test.

Eligibility criteria:
inclusion criteria: * patients diagnosed with periampullary cancer meet the following criteria: * possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration. * the postoperative pathology is adenocarcinoma (of the ampulla of vater, common bile duct, duodenum or pancreas) exclusion criteria: * the patient has other organ's cancer beyond periampullary cancer. * patient's medical conditions contraindicate for anesthesia. * the patient does not consent to participate in the study

Keywords: pancreatic surgery
brief interventions for drop-out re-engagement

Conditions: Substance Abuse

Summary: we will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome.

we propose a 5-year stage i behavioral therapy development study to: 1) prospectively evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a manual of single session phone-and office-based interventions to re-engage these individual in treatment.

Eligibility criteria:
inclusion criteria: * admission to outpatient treatment exclusion criteria: * need for hospitalization

Keywords: behavior therapy counseling drug abuse therapy outpatient care therapy compliance clinical trial phase i coping outcomes research satisfaction social psychology patient oriented research
role of corneal nerves in dry eye disease

Conditions: Dry Eye Disease (DED); Dry Eye; Dry Eye Sensation; Corneal Nerve

Summary: this study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms.


Eligibility criteria:
inclusion criteria: * group with ded: diagnosis of ded based on the tfos dews ii report * group without ded: no diagnosis of ded exclusion criteria: * exclusion criteria: * systemic disease that may affect ocular health and innervation * injury or history of operations on the anterior or posterior segment of the eye, which can affect the corneal structure and physiology * regular application of systemic or ocular medication known to affect the tear film except from ded medications * eye drops or makeup on the day of measurement. remarks: contact lens wearers are asked not to wear contact lenses for 1 week before the first appointment. participant with ded medications will be asked to use only conservative-free eye drops on the days of examination
dexilant treatment in gastrointestinal reflux disease (gerd related non cardiac chest pain

Conditions: Chest Pain; Gastrointestinal Reflux Disease

Summary: the purpose of this study is to investigate a new treatment for non-cardiac chest pain (nccp) related to gastrointestinal reflux disease (gerd), called dexilant. the investigators would like to test its effectiveness in treating nccp. the patient will undergo esophageal balloon distention testing (ebdt) before and after taking the new treatment for one month (dexilant). ebdt evaluates the sensation and mechanical properties of the esophagus. a catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ecg and labs will be done throughout the study as a measurement of safety.


Eligibility criteria:
inclusion criteria: 1. aged 18-75 years 2. nerd, or gerd la class a-b (endoscopy) 3. subjects with positive ph testing 4. at least one episode of chest pain a week in the past month 5. previous negative cardiac evaluation (ekg ± stress test ± coronary angiogram) 6. negative esophageal evaluation for a motility disorder (nutcracker esophagus, achalasia) exclusion criteria: 1. subjects requiring narcotics or other pain medications, subjects with known la class c-d, barrett's esophagus or peptic stricture on endoscopy 2. subjects with previous upper gastrointestinal surgery 3. pregnancy 4. subjects with diabetes, neuromuscular disorders, or other severe co-morbidities 5. (cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric). 6. subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm). 7. medications such as baclofen, and prokinetic agents. 8. history of substance abuse

Keywords: gerd nccp chest pain reflux gerd related non-cardiac chest pain
efficacy of an early rehabilitation on decannulation time of patients with severe acquired brain injury

Conditions: Brain Injury; Tracheostomy; Neurological Rehabilitation

Summary: all the patients hospitalized in the neuro-rehabilitation after a severe acquired brain injury carrying a tracheal cannula will be retrospectively analyzed. patients coming from emergency department started a rehabilitative treatment during their hospitalization in icu. patients transferred from an external icu started the rehabilitation in neurorehabilitation department. aim of the study is to evaluate if an early rehabilitation, started since the acute stage of the damage, is able to reduce the decannulation time in this group of patients.


Eligibility criteria:
inclusion criteria: * presence of a tracheostomy at admission in nrehab * patient moved from an icu * gcs≤11 at admission in icu * tracheostomy performed for decreased mental status due to the abi, exclusion criteria: * tracheostomy performed prior to admission to the icu * need for ventilation support.
avodart(dutasteride) post-marketing surveillance(pms)

Conditions: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Summary: an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of avodart administered in korean bph patients according to the prescribing information


Eligibility criteria:
inclusion criteria: * the korean bph patients administrated dutasteride according to the prescribing information exclusion criteria: * women and children and adolescents. * patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
mr-pet for staging and assessment of operability in ovarian cancer - a feasibility study

Conditions: Ovarian Neoplasms

Summary: the importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. we believe that combined magnetic resonance imaging and positron emission tomography (mr-pet) can be of great clinical value in preoperative staging of patients with ovarian cancer.

recently, the academic hospital maastricht invested in an integrated mr-pet system (biograph mmr, siemens healthcare, erlangen, germany), ready to use for routine clinical application. applications of this system are numerous and various types of cancer, including ovarian cancer, could benefit from the possibilities. the whole-body mr-pet system integrates the strengths of mri and pet within a single examination. mri provides anatomic detail in staging local tumor extent due to its high soft tissue resolution and advanced functional techniques such as dwi further enhance both local and distant lesion detection and characterisation. pet imaging complements this structural and functional information with molecular imaging technology useful in staging of adenopathy and metastatic spread. these characteristics contribute to a wide spectrum of possible clinical oncological applications, from primary tumor detection to local and distant staging, selection of patients for neoadjuvant therapy and assessment of response to chemotherapy and finally evaluation of recurrent disease. the importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. we believe that combined magnetic resonance imaging and positron emission tomography (mr-pet) can be of great clinical value in preoperative staging of patients with ovarian cancer. both positron emission tomography (pet), computed tomography (ct) and magnetic resonance imaging (mri) have proved to be useful in ovarian cancer staging but understaging due to difficulties in depicting peritoneal dissemination remains a great problem. in conclusion, the best method for staging ovarian cancer and assessing operability remains to be discovered, hence this study.

Eligibility criteria:
inclusion criteria: * expected figo stage iib-iv epithelial ovarian carcinoma * scheduled for primary debulking or interval debulking surgery * written informed consent exclusion criteria: * patients estimated to have more benefit from chemotherapy * ineligibility to undergo mr-pet examination (non-mr compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, metal splinters etcetera) or claustrophobia) * pregnant or lactating patients. * incapacitated subjects

Keywords: magnetic resonance imaging positron-emission tomography