Kornimate/medical-research-clean huggingface dataset:
silicone sock as treatment of deep heel fissures in people with diabetes

Conditions: Diabetes Complications

Summary: this study evaluates the addition of using a sock of silicone to using a heel cream, in the treatment of heel fissures in people with diabetes, aiming at healing the fissures and preventing them from developing into ulcers. half of the participants will use the silicone sock and a heel cream, the other half will use the cream only.

dry skin and heel fissures are common complications of diabetes and can develop into hard-to-heal ulcers that eventually can make amputation of the foot necessary. patients are advised to use heel creams to heal fissures and prevent them from developing into ulcers. clinical observations have suggested that wearing a silicone sock nighttime can heal fissures, but the additional advantage of using a silicone sock compared to use a heel cream only has not been investigated. participants will be randomized to an intervention group (silicone sock and heel cream) or a control group (heel cream only) and the healing of fissures and development of new ulcers will be compared between the groups.

Eligibility criteria:
inclusion criteria: 1. diabetes diagnosis, and 2. deep heel fissures exclusion criteria: factors associated with increased risk of complications: 1. known allergy or hypersensitivity to silicone or ingredients in cream 2. other skin conditions that make use of sock or cream inappropriate 3. strongly fluctuating foot edema 4. ulcer in part of the foot that the sock is in contact with 5. inability of participant or assisting person to handle the silicone sock correctly including daily cleaning. factors associated with increased risk that complications are not discovered or reported, such as, dementia, language or other communication impairments, intellectual disability or known substance abuse, and there is no other person who can provide adequate support to the participant.

Keywords: diabetic foot diabetic foot disease skin fissures xerosis
sleeve-pex: a randomized trial to reduce reflux after sleeve gastrectomy

Conditions: Gastroesophageal Reflux

Summary: the goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. the main questions it aims to answer are: does gastropexy reduce reflux symptoms? does gastropexy reduce objective evidence of reflux? participants will be randomized to gastropexy or no gastropexy, and researchers will compare these groups to see if reflux (symptoms / objective evidence of) is different in the two groups.

laparoscopic sleeve gastrectomy (lsg) has become the most commonly performed bariatric procedure worldwide. lsg consists of a longitudinal resection of the stomach leaving the intestines intact, thereby lowering the risk for side-effects due to rerouting of the small bowel. however, gastro-esopageal reflux disease (gerd) has been reported to increase after lsg. our hypothesis is that gerd is mainly due to intrathoracic migration of the gastric remnant. the aim of this study is to explore if suturing the gastric remnant to the gastrocolic ligament (gastropexy) will prevent intrathoracic migration and thereby reduce the development of reflux. patients planned for a sleeve gastrectomy will be invited to participate, and participating patients will be randomized to pexi or no pexi. according to power calculations a total of 550 patients will be randomized in the study. follow-up will be at six weeks, one-, two- and five years.

Eligibility criteria:
inclusion criteria: * patients planned for bariatric surgery with primary lsg exclusion criteria: * age below 18 yrs * use of arm for other reasons than reflux * previous antireflux surgery * inability to comprehend and respon to patient related outcome (pro) questionnaire
clinical study between robotic and open surgery in patients with pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma; Minimally Invasive Surgery

Summary: the purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.and the differences in lymph nodes harvest and postoperative survival between two groups.


Eligibility criteria:
inclusion criteria: * diagnosed pancreatic ductal adenocarcinoma * patients and their families volunteered to test and signed informed consent. exclusion criteria: * preoperative exclusion: 1. patients with metastasis (m1) 2. patients with tumor recurrence 3. patients with artery and/or vein invasion and can't perform radical resection and reconstruction 4. patients with poor cardiopulmonary function cannot tolerate surgery; 5. receive neoadjuvant radiotherapy and chemotherapy before surgery; 6. the patient or family member refuses to join the group; 7. pregnant patients * intraoperative exclusion: 1. intraoperative exploration of metastases in other parts besides the primary lesion 2. other organs malignant tumors metastasize to the pancreas * postoperative exclusion: 1. pathology confirmed non-pancreatic ductal adenocarcinoma

Keywords: robotic assisted surgery
in-room pet in proton radiation therapy

Conditions: Brain Tumor; Head and Neck Tumor; Skull Base Tumor

Summary: the investigational part of this study is using a mobile pet/ct scanner to take images of the participants tumor immediately after they are treated with proton radiation. this allows the participant to be treated and imaged on the same bed. the information obtained may improve the accuracy of treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.

for all participants, right after one regular treatment fraction, neuropet or neuropet ii will be wheeled into the patient room. the patient bed will be moved directly into the scan position and a pet scan will be acquired in list-mode for 15 to 20 minutes followed by a ct scan for \~5 minutes. after undergoing their first pet scan, participants will have the option to undergo 1-2 additional scans throughout radiation treatment in the same manner as the first scan.

Eligibility criteria:
inclusion criteria: * adult subjects with brain, head and neck, and skull base tumors receiving external beam proton radiotherapy at the francis h. burr proton therapy center at mgh * age 18 or over * ecog performance status 0, 1 or 2 exclusion criteria: * uncontrolled intercurrent illness that, in the opinion of the investigator, would limit the participant's compliance with study requirements.

Keywords: external beam proton radiotherapy pet
pbfs-guided noninvasive neuromodulation for pre-school children with asd

Conditions: Autism Spectrum Disorder

Summary: this randomized controlled trial aims to evaluate the efficacy and safeness of the pbfs-guided rtms intervention for core symptom relief in pre-school children with autism spectrum disorder (asd).

autism spectrum disorder is a neurodevelopmental disorder, begins early in life. using the personalized brain functional sectors (pbfs) technology, investigators could precisely identify individualized brain function networks based on the functional mri scan. for each participant, two personalised tms intervention targets will be chosen by blinded researcher. one executive function network target is located in the dorsal lateral prefrontal cortex (dlpfc) , and the other social function network target is located in the dorsal medial prefrontal cortex (dmpfc). the participants will be equally randomized to the following four groups, active itbs to the left dmpfc or the left dlpfc, and sham itbs to either the left dmpfc or left dlpfc at a ratio of 2:2:1:1. later analyses will combine the two sham groups as one control group. each participant will receive 1800 pulse active or sham itbs (100% rmt) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between itbs sessions. pre-and post-treatment functional mri data will be collected under sedation.

Eligibility criteria:
inclusion criteria: * 2.5-6 years old * have the diagnosis of autism spectrum disorder * ados-2 score is higher than the asd cut-offs * capacity to follow the study procedures, including fmri scan under sedation, assessment, and rehabilitation training * participant's parents or other legal guardians give informed consent exclusion criteria: * current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder * severe self-injury or suicidal behavior presented in the last 1 year * severe visual, auditory, or motor disability that interferes with any study procedure * current, history or family history of epilepsy * known severe physical diseases, such as congenital heart defect, traumatic brain injury * metal implantations, which are contradicted by mri or tms, such as artificial cardiac pacemakers, stents, cochlear implants * received tms, tcs, fus, or other neuromodulation treatment in the last 3 months * currently participating in other clinical trials

Keywords: tms asd fmri personalized medicine
pilot study for pet/mr imaging of covid-19

Conditions: Brain Diseases; Covid19

Summary: the primary goal of this project is to study the feasibility of a prototype brain-dedicated pet insert for an mr scanner for simultaneous acquisition of pet/mr images of metabolism and perfusion in covid-19 negative and positive/once positive subjects. this study serves as a pilot study for establishing an imaging protocol for combined pet and mr derived functional information as well as mri acquired anatomical information.

this study is a non-randomized non-treatment study. the intention of this work is an assessment of the pet insert technology, and not, for example, to perform a treatment assessment or drug assessment. this work will actively recruit 10 individuals (5 covid-19 negative and 5 covid-19 previously positive in the last 180 days) to perform imaging of the brain with an fda-approved radiotracer.

Eligibility criteria:
inclusion criteria: 1. whole body radiation dose in the last year of less than 5000 mrem determined via subject verbal history reporting 2. must be at least 21 years of age 3. deemed healthy to endure duration of imaging study as confirmed via study pi 4. proof of covid-19 viral or antibody testing within the timeframe of \>20 days but \<=180 days prior to scan. exclusion criteria: 1. history of non-mri compatible surgeries, implants, or activities 2. pregnant or nursing 3. history of allergic reactions to pet radiotracers (via patient verbal report and /or medical record review.
vaginal fluid wash in pre-labour rupture of membranes

Conditions: Disorder of Amniotic Cavity and/or Membrane

Summary: the investigators assess in this study the sensitivity of urea and creatinine and that of nitrazine test in vaginal wash after injecting saline in the vagina of patients with pre-labour rupture of membranes

the aim of this study is to compare the accuracy of measuring the urea and creatinine level versus that of nitrazine test in vaginal wash of pre-labour rupture of membranes patients.each patient with rupture of membranes will be assessed clinically and then if not in labour , patients will be divided into 2 groups, 5ml saline will be injected in the vagina of each patient in every group then the vaginal wash will be collected in a test tube. urea and creatinine group, biochemical tests for urea and creatinine in miu/ml to detect their presence in the wash will be done. in nitrazine group wash will be assessed by nitrazine paper showing bluish discoloration in rupture membranes. sensitivity of each test in diagnosed rupture of membranes will be assessed.which means how many patients in each test show positive results in case of diagnosed case.

Eligibility criteria:
inclusion criteria: * gestational age between 28 and 41 weeks * single intrauterine pregnancy * history of gush of fluid * liquor detected on speculum examination exclusion criteria: * vaginal bleeding * patients in labour * contaminated samples

Keywords: rupture of membranes, nitrazine, urea, creatinine
phase ii clinical trial of clenbuterol in adult patients with pompe disease

Conditions: Pompe Disease (Late-onset)

Summary: the goals of this study are to determine safety and efficacy with regard to motor function of oral clenbuterol in combination with ert in subjects with lopd


Eligibility criteria:
inclusion criteria: 1. diagnosis of pompe disease by blood acid alpha-glucosidase (gaa) assay and gaa gene sequencing, 2. age: 18+ years at enrollment, 3. receiving enzyme replacement therapy (ert) at a stable dose for \>104 weeks, 4. fvc \>15% of expected (supine). 5. subjects are capable of giving written consent. 6. able to walk at least 100 meters on the 6 minute walk test (6mwt) (with assistive devices permitted). exclusion criteria: 1. continuous invasive ventilation (via tracheostomy or endotracheal tube) 2. 6mwt distance \>90% of expected performance (% expected) 3. fvc \>90% of expected (upright). 4. clinically relevant illness within two weeks of enrollment including fever \> 38.2o c, vomiting more than once in 24 hours, seizure, or other symptom deemed contraindicative to new therapy. 5. chronic heart disease (myocardial infarction, arrythmia, cardiomyopathy) 6. tachycardia 7. history of seizure disorder 8. hyperthyroidism 9. pheochromocytoma 10. pregnancy 11. history of diabetes 12. history of hypersensitivity to β2-agonist drugs such as albuterol, levalbuterol (xopenex), bitolterol (tornalate), pirbuterol (maxair), terbutaline, salmeterol (serevent), 13. patients on a non-standard schedule for ert; for example, weekly infusions as opposed to infusions every two weeks. 14. treatment for asthma in the previous 12 months. 15. renal insufficiency (elevated serum creatinine). 16. having started respiratory muscle strength training in the last 6 months prior to study day 1 or having discontinued respiratory muscle strength training in the 6-month period preceding study day 1, or having started respiratory strength training greater than 6 months prior to study day 1 and unwilling to continue for the first year of study participation. 17. received an investigational drug or participated in another interventional study within 90 days of study day 1. 18. anti-rhgaa igg with sustained titer \>1:25.600 for \>6 months at time of enrollment. 19. the use of the following concommitant meds is prohibited during the study: * diuretics (water pill); * digoxin (digitalis, lanoxin); * beta-blockers such as atenolol (tenormin), metoprolol (lopressor), and propranolol (inderal); * tricyclic antidepressants such as amitriptyline (elavil, etrafon), doxepin (sinequan), imipramine (janimine, tofranil), and nortriptyline (pamelor); * monoamine oxidase (mao) inhibitors such as isocarboxazid (marplan), phenelzine (nardil), rasagiline (azilect), selegiline (eldepryl, emsam), or tranylcypromine (parnate); or * other bronchodilators such as albuterol, levalbuterol (xopenex), bitolterol (tornalate), pirbuterol (maxair), terbutaline (brethine, bricanyl), salmeterol (serevent), isoetherine (bronkometer), metaproterenol (alupent, metaprel), or isoproterenol (isuprel mistometer).

Keywords: pompe disease lopd late-onset pompe disease
a study comparing the efficacy and safety of ziprasidone and aripiprazole for the treatment fo schizophrenia or schizoaffective disorder in hospitalized patients

Conditions: Schizophrenia

Summary: the purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder


Eligibility criteria:
inclusion criteria: * hospitalized patients with schizophrenia or schizoaffective disorder * at least a 6th grade reading level * males or females, between 18 and 70 years of age at the time of consent * subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening exclusion criteria: * psychiatric disorder other than schizophrenia or schizoaffective disorder * history of arrhythmia, heart attack, or heart failure
who covid 19 - neurological abnormalities in sars-cov-2 icu patients

Conditions: SARS-CoV-2 Infection; Intensive Care Unit Patient; Neurological Abnormality; Delirium; Encephalopathy

Summary: the sars-cov-2 epidemic is leading to a large number of patients in intensive care units due to severe hypoxemic pneumonia. after an acute phase that may require controlled mechanical ventilation and deep sedation, removal of sedation often reveals a pathological awakening in the vast majority of patients. this encephalopathy state remains, to date and to our knowledge, unexplained. clinical features do not appear to fully correlate with regular delirium. this encephalopathy might be explained by deep and prolonged hypoxemia, a wide use of sedation drugs, systemic inflammation or the hostile icu environment.

this study is intended to investigate neurological abnormalities associated with sars-cov-2 infection. complete daily neurological examinations will be routinely conducted in intensive care unit patients. specific biological analyses will also be performed in these patients by collecting additional blood samples from an arterial or central catheter, every 2 days. these clinical and biological examinations will be continued throughout patient's stay in the intensive care unit.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * covid-19 positive patient (positive rt pcr, nasopharyngeal or tracheal) * patient admitted in an intensive care unit of the department of anesthesia, critical care and perioperative of clermont-ferrand university hospital * patient with an arterial or central catheter to perform blood samples collection exclusion criteria: * patient or family member's refusal to participate * neuropsychiatric history that may interfere with neurological evaluations in the intensive care unit * patient not affiliated with french social security insurance * patient under legal guardianship

Keywords: sars-cov-2 infection intensive care unit patient neurological abnormalities delirium encephalopathy
social media and eating disorder fear

Conditions: Eating Disorder; University Students; Social Media; Eating Behavior; Fear

Summary: the goal of this observational study is to learn about the relationship between social media use and fear of eating disorders in university students. the main question it aims to answer is: is there a relationship between social media use and eating disorder fears in university students? university students will answer a questionnaire face to face, including questions about their social media usage habits, the impact of social media on eating behavior scale, and the fears of eating disorders scale.


Eligibility criteria:
inclusion criteria: * using social media exclusion criteria: * pregnant or lactating individuals

Keywords: social media eating disorder fear
should prosthetic repair of incisional abdominal hernias be drain or not?

Conditions: Postoperative Complications; Hernia

Summary: the purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.

between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia. primary suture of the defect is associated with a recurrence rate between 25 and 50%.mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas. some advocate the use of drains in order to diminish secretions and complications. other claim that drains increase the complication's rate. in the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia. the aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of midline abdominal wall incisional hernia * adults of 20 to 80 years old * asa i to iii * inform consent signed by the patient and investigators exclusion criteria: * incisional hernia less than 2 cm * groin hernia * antibiotic treatment before and during hospital admission * emergency admission for strangulated incisional hernia * immunosuppressing treatment

Keywords: postoperative complications drainage infection seroma hematoma recurrence abdominal wall hernia surgical mesh
reducing prescription opioid misuse: ropes pilot trial

Conditions: Knowledge, Attitudes, Practice

Summary: this is a randomized controlled pilot trial to establish methodological feasibility and determine whether a web-based, continuing dental education intervention regarding opioid prescribing risk mitigation strategies - consistent with ada guidelines - produces pre-to-post changes in knowledge, motivation, and behavioral skills pertaining to the use of risk mitigation strategies when prescribing opioids in dental practice. the current study involves completion of a self-report pre-test (dentists), randomization to complete ropes or attention control intervention, completion of a self-report post-test (immediately following intervention/control completion), and completion of 1-month self-report follow-up assessment.


Eligibility criteria:
inclusion criteria: 1. male or female; any race or ethnicity; age 21-85 years. 2. able to comprehend english. 3. be either a licensed dental practitioner currently practicing or a resident enrolled in the college of dental medicine at the medical university of south carolina or a practicing dentist in the charleston-county area or a licensed dental practitioner currently participating in the national dental practice based research network (ndpbrn). 4. report having ever prescribed an opioid analgesic to a patient 5. must have internet access 6. must have a valid, usable email account 7. must agree to complete all study measurements. exclusion criteria: 1. unable to provide informed consent due to mental or physical limitations. 2. participation in ropes intervention development focus groups.
effect of brivaracetam in photosensitive epileptic subjects

Conditions: Epilepsy

Summary: to assess the effect of brivaracetam on the photoparoxysmal eeg response in photosensitive epileptic subjects


Eligibility criteria:
inclusion criteria: * epileptic subjects with generalized ppr exclusion criteria: * more than 2 concomitant antiepileptic drugs

Keywords: poc photosensitive epileptic brivaracetam ppr aed