Kornimate/medical-research-clean huggingface dataset:
feasibility of permacol use in infected fields

Conditions: Hernia

Summary: this pilot study is to examine the feasibility of using permacol surgical implant in the repair of abdominal wall defects after removal of infected prosthetic mesh


Eligibility criteria:
inclusion criteria: * have given written informed consent * be 18-85 years of age (inclusive) * have prosthetic mesh that is in proximity to an infected wound that has failed conservative management for at least 3 months, with mesh exposure and a draining wound, or that is in proximity to an abscess that requires operative intervention. * have a wound characterized by purulent discharge, positive gram stain or positive culture to document infection * be a candidate for surgical removal of infected mesh placed for repair of ventral/incisional hernias and concomitant abdominal wall reconstruction * have an asa score ≤3 * have a body mass index (bmi) between 16.5 and 40 inclusive * be a candidate for anticipated primary approximation of skin/wound * have a life expectancy of at least 18 months * be willing to allow biopsy of implant if secondary wound opening is performed or spontaneous implant exposure occurs exclusion criteria: * have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree * have an enterocutaneous fistula in proximity to wound/mesh * be a candidate for emergency surgery that would make giving valid informed consent impractical * be currently taking part in another clinical study that conflicts with the current study * have known allergy to porcine collagen products * have active generalized peritonitis or intraperitoneal sepsis * have active necrotizing fasciitis * have active abdominal compartment syndrome * have active untreated metabolic or systemic illness * report unintentional weight loss \>10% of body weight in the previous 90 days * have known collagen metabolism disorder.(e.g., ehlers-danlos syndrome) * have known altered immune response (e.g., hiv or other immunodeficiency disorder)) * have chronic renal failure * have known active malignancy present * have history of systemic chemotherapy within previous 1 year * have lifetime history of radiation to the abdomen, pelvis or thorax * have inguinal or groin hernia as primary diagnosis * be currently pregnant or planning to become pregnant during study period * be unable to give valid informed consent or comply with required follow- up schedule * suffer from mental capacity sufficiently severe to make informed consent unobtainable

Keywords: hernia contaminated field mesh removal infected mesh removal
randomized comparison of sharp versus blunt techniques at cesarean

Conditions: Disruption of Uterine Incision After Cesarean Section

Summary: the purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision


Eligibility criteria:
inclusion criteria: 1. term pregnancy(\> 38 weeks of gestation) 2. required elective cesarean delivery 3. maternal age between 18-40 years exclusion criteria: 1. required emergency cesarean delivery 2. abnormal presentation 3. planned cesarean hysterectomy 4. history of low segment vertical uterine incision 5. history of classical upper segment uterine incision 6. multiple pregnancy 7. cases with a high risk for bleeding(hellp send, preeclampsia, placental insertion anomalies) 8. grand multiparity(parity\>5)

Keywords: unintended extension blunt sharp maternal blood loss
effects of met on ppdh, neck pain and disability after cesarean section

Conditions: Post-Dural Puncture Headache; Cesarean Section Complications

Summary: the goal of this clinical trial is to determine the effect of muscle energy techniques on post dural puncture headache, neck pain and disability after cesarean section. .

caesarean section (cs) is the worldwide process of pregnancy termination that delivers live or dead fetuses with an incision on the abdominal wall and uterine wall. it is performed under neuraxial anesthesia (spinal and epidural anesthesia). post- dural puncture headache (pdph) is a major complication of neuraxial anesthesia which presents as a dull throbbing pain in a frontal-occipital distribution, aggravates on sitting or standing, and is reduced by lying down. this study will be a randomized clinical trial. subjects with ppdh meeting the predetermined inclusion and exclusion criteria will be divided into two groups: i.e. treatment and control group. both groups will receive baseline treatments i.e. (heating pads \& tens). in addition, treatment group will receive post-isometric relaxation of mets. each subject will receive a total of 4 treatment sessions, with 2 treatment sessions per day pre-treatment will be done at day 1 and post-treatment will be done at day 2, using headache disability index (hdi), numeric pain rating scale (nprs) and neck disability index (ndi) as subjective measurements. recorded values will be analysed for any change using spss

Eligibility criteria:
inclusion criteria: * age between 18 to 40 years * both primiparous and multiparous * both elective and emergency lower section cesarean section * headache occurring within 24-72 hours post c-section * headache aggravates on getting in upright position exclusion criteria: * history of trauma/fracture of head and neck region * history of cervical spine surgery * had previous diagnostic lumbar puncture (lp) * any kind of infection, malignancy, inflammation and structural deformity present in head and neck region. * other serious forms of headaches including migraine, cluster, thunderclap, hypnic etc. * cervical radiculopathies and spondylolisthesis

Keywords: post dural puncture headache neck pain cesarean section
school-based assessment of micronutrient interventions in adolescents in burkina faso

Conditions: Anemia

Summary: this purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status, school performance/attendance and development outcomes among adolescents in burkina faso.

this study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in burkina faso. findings from this study will clarify the optimal supplementation strategy (iron and folic acid alone or adding other essential nutrients) and provide a basis for scale up of national micronutrient supplementation programs to benefit the adolescent population as a whole in burkina faso. this will be a cluster randomized study with 3 arms. 42 schools per country will be enrolled (14 schools per arm) to receive either 1) daily multiple micronutrient supplements (mms) and weekly iron and folic acid (ifa) for the first 5 weeks and daily mms for the remainder of the study; or 2) weekly ifa; or 3) to serve as controls. as recommended by the world health organization in settings where continuous supplementation is not possible, supplementation will be intermittent. supplementation will be provided for 3 months, stopped for 3 months over the school summer holidays and resumed for 3 months once students return to school after the holiday. students in intervention schools will receive supplementation and students in control schools will receive the usual care (which does not include supplementation but does include existing curriculum on nutrition and water, sanitation and hygiene \[wash\]). the program will be evaluated comparing effects of weekly ifa and daily mms on anemia status and school attendance/retention.

Eligibility criteria:
inclusion criteria: * adolescents aged 10-17 years * enrolled in secondary school form 1 at study initiation * member of one of the selected classes in a participating school * consent provided by the parent * assent provided by the adolescent * fluency in french exclusion criteria: * no informed consent from parent or assent from adolescent * self-reported pregnancy

Keywords: multiple micronutrient supplementation iron and folic acid nutrition adolescent health
hypofractionated radiotherapy versus conventional radiotherapy in diffuse brainstem glioma in children

Conditions: Pediatric Brain Stem Glioma

Summary: hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. this study is to evaluate the clinical end results of the hypofractionated radiotherapy in dipg compared to the conventional treatment. the non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.

in lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (dipg), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks. this schedule offers a reduction in patient burden, especially preferable in children with a poor compliance and performance status. the non-inferiority of the hypofractionated regimen in its clinical end-results, with the reduction of the overall treatment time to less than its half will decrease the burden for the patient, his/her family and the treating department. this will be considered as added value without compromising the survival or increasing side effects.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol. 2. patients were required to have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs. 3. no performance criteria were required for entry onto the study. 4. the diagnosis of dipg based on a high-quality, gadolinium- enhanced magnetic resonance imaging (mri) scan containing at least t1, t2 mris with gadolinium contrast in three series, as well as diffusion imaging. 5. symptoms \& signs of less than 3 months duration exclusion criteria: 1. children were not eligible if they had received any prior therapy other than steroid 2. the diagnosis of exophytic brainstem glioma

Keywords: dipg hypofractionated radiotherapy radiotherapy median survival
empower@home:connected - feasibility and preliminary effect study

Conditions: Depression; Loneliness; Social Isolation; Depressive Disorder; Mood Disorders; Mental Disorder

Summary: this single-group trial will evaluate the feasibility and preliminary effect of a novel group-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. participants will complete the program remotely in small groups.

depression affects up to 40% of homebound seniors, but most do not receive psychotherapy due to various access barriers. this study focuses on developing community-based solutions to reduce access barriers. in a previously approved project hum00207612, the investigators tested the feasibility of a novel internet-based cognitive behavioral therapy (icbt) program called empower@home. this study will test an adapted version of empower@home called empower@home: connected that is delivered in a group format and also addresses social isolation and loneliness. recruitment methods include 1) referrals from social service agencies, 2) advertisements on social media, local news outlets, and the program website, and 3) research participant registries. the intervention involves attending 9 group sessions. the sessions are facilitated by a mental health professional and involve psychoeducational material, cognitive-behavioral therapy exercises, and socialization. sessions will occur on 9 consecutive weeks and will last approximately 90 minutes. participants will complete a comprehensive baseline assessment and post-test. each assessment will take between 40-60 minutes to complete over the phone. recruitment will occur between january and april 2023, 20-25 participants will be recruited. all participants will receive the intervention.

Eligibility criteria:
inclusion criteria: * \>=60 years * have at least mild depressive symptoms, based on phq-9 \>=8 * are willing to participate exclusion criteria: * probable cognitive impairment based on the blessed orientation, memory, and concentration scale (score \>9). * they do not speak english * have active suicidal ideation, defined as moderate to high risk based on the 6-item columbia-suicide severity rating scale (c-ssrs) * have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months * have severe vision impairment that can not be corrected * have probable substance use disorders as assessed by the 4-item cage screener (\>=2 on the cage and have not been sober for at least one year) * have a self-reported psychotic disorder or bipolar disorder
a study for post-marketing surveillance of nesina® tablet monotherapy or combination therapy in participants with type 2 diabetes (t2dm) in south korea

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate safety by determining the incidence rates of all adverse events (aes) including serious adverse events (saes)/serious adverse drug reactions (adrs), unexpected aes and adrs that are not reflected in the precautions for use, adrs already known, non-serious adrs and other safety related information among participants who have received alogliptin for type 2 diabetes mellitus.

this is a long-term prospective, observational post-marketing surveillance study of alogliptin in participants with t2dm. the study assessed the safety and effectiveness of alogliptin for its approved indication within a real-world setting in south korea. the study will enroll approximately 3000 participants. the data is collected prospectively at the study sites and recorded in electronic case report forms (e-crfs). all the participants are assigned to a single observational cohort: • nesina® tablet the multi-center study is conducted in south korea. data is collected at 13 and 26 weeks after enrollment during standard of care office visits. the overall study was conducted during re-examination period of approximately 5 years and 4 months.

Eligibility criteria:
inclusion criteria: 1. had one of the following treatments with alogliptin for the first time as an adjunct to diet and exercise to improve glycemic control: * monotherapy with alogliptin * combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with metformin or sulfonylurea or thiazolidinedione single therapy * combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with thiazolidinedione and metformin combination therapy * combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with insulin (single therapy or combination with metformin) therapy * combination therapy with metformin in patients who have no prior history of antidiabetic medication and may not achieve adequate glycemic control with monotherapy alogliptin exclusion criteria: 1. had alogliptin treatment outside of the locally approved label in korea 2. had a contraindication for the use of alogliptin (as described in the korean product label)

Keywords: drug therapy
hepatic steatosis and pituitary gland failure, evaluation by nuclear magnetic resonance (nmr) imaging

Conditions: Hepatic Steatosis; Pituitary Gland Failure

Summary: the investigator put forward the hypothesis that liver fat mass in patients with pituitary gland failure is greater than that in a control population. failure of the anterior pituitary and more particularly impaired production of growth hormone (gh) could be the principal mechanism responsible for increased liver fat mass in these patients.


Eligibility criteria:
inclusion criteria: * patients who have provided consent * patients over 18 years * patients with pituitary disease (pituitary adenoma, anterior pituitary failure, craniopharyngioma, empty sella syndrome, hypophysitis, infiltration of the stalk) requiring magnetic resonance imaging (mri) of the pituitary. exclusion criteria: * persons without national health insurance * pacemaker (contra-indication for mri) * alcohol consumption greater than 4 glasses a day * any treatment able to increase liver fat content (glitazones, systemic corticoids, immunosuppressants) are forbidden * presence of metallic implants (contra-indication for mri) * claustrophobia * adult under guardianship * pregnant or breast-feeding women * patients with a liver disease other than non-alcoholic steatosis
estimation of dynamics of humoral and cellular immunity in covid-19 patients

Conditions: Covid19

Summary: the goal of the project: to study the dynamics of the humoral and cellular immunity in patients after pneumonia caused by the sars-cov-2 virus at different time intervals, in order to predict the duration of immune protection

* to form study groups of patients (at least 60 patients in total) who have recovered from pneumonia of varying severity caused by the sars-cov-2 virus (at least 30 patients in each of the groups of patients who have had pneumonia in moderate and severe forms); * to investigate the parameters of cellular immunity (the content of antigen-specific t-cells to the main viral antigens - proteins s, n, m) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the covid-19-associated pneumonia; * to investigate the indicators of humoral immunity (the content of igg to the main viral antigens - proteins s, n, m) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the covid-19-associated pneumonia.

Eligibility criteria:
inclusion criteria: * patients recovered from the covid-19 associated pneumonia (moderate and severe) in 1-3 month interval before inclusion into the trial; exclusion criteria: * cancer; * drug and alcohol addiction; * autoimmune diseases.

Keywords: covid-19
phase iii study of d9421-c 9 mg in patients with active crohn's disease in japan

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the clinical efficacy of d9421-c 9 mg once daily compared to mesalazine 1 g three times a day to patients with mild to moderate active crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the crohn's disease activity index (cdai) by assessment of the remission after 8-week treatment defined by a cdai score of ≤ 150.

a multicentre, double-blind, randomised, parallel-group, phase iii study to assess efficacy and safety of d9421-c 9 mg versus mesalazine 3 g in patients with active crohn's disease (cd) in japan

Eligibility criteria:
inclusion criteria: * 15 years of age or older * main active disease of the ileal, ileocecal region, and/or ascending colon - - if treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation until the study completion or discontinuation * ability to read, write and to fill a diary card and hrql questionnaire having mild to moderate active crohn's disease, defined as cdai score of 180-400 at baseline exclusion criteria: * patient with cd lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper g-i, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease) * patient who need any concomitant treatment for cd that may affect the assessment for efficacy of the study drug * patient who need any medication which is prohibited due to suspected influence to metabolism of the study drug * patient who is judged to be inadequate to participate in this study from the safety point of view patient with well-founded doubt about protocol violation

Keywords: mild to moderate active crohn's disease affecting ileum ileocecal region ascending colon score of 180-400 on the cdai
prescribe to save lives

Conditions: Opioid-Related Disorders; Drug Overdose

Summary: the u.s. is in the midst of an epidemic of opioid overdose deaths. the common use of opioids among persons living with hiv, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. this study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage hiv physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.


Eligibility criteria:
inclusion criteria: clinicians and staff of hiv practice sites that: * receive ryan white funding; * treat adults with hiv; * have 3 or more prescribing clinicians; * have an electronic medical record (emr) with an electronic medication list. exclusion criteria: * sites located in states with fewer than 500 persons living with hiv (plwh) will be excluded
prevention of infections in cardiac surgery

Conditions: Thoracic Surgery; Antibiotic Prophylaxis

Summary: there is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at canadian centers, and as concluded in the three systematic reviews. there also is clinical equipoise on whether the addition of vancomycin to routine cefazolin prophylaxis can further reduce s-ssi rates. a short duration of combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as infections with c. difficile or emergence of resistance, but may also reduce the incidence of s-ssis. the objective of the eventual full scale study is to determine whether adding vancomycin to cefazolin can reduce ssis as well as whether short-term prophylaxis is as effective as long-term prophylaxis. the rationale to conduct the proposed pilot study is to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the adherence to the study protocol at each pilot site, the length of time to fill out the case report forms, and to get reliable estimates of event rates for sample size calculation for the main study


Eligibility criteria:
inclusion criteria: * all adult patients (≥18 years of age) undergoing open-heart surgery (sternotomy, including minimally-invasive surgical techniques). exclusion criteria: * patients on antibiotics at the time of surgery. * previous enrollment in this trial. * known mrsa carriers. beta-lactam allergy (ige-mediated) precluding the use of cefazolin * participant in another study that may interfere with this trial.