Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics and safety of mm36 topical ointment in pediatric subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the pharmacokinetic parameters and safety of topical mm36 (opa-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.

this is a multi-center, open-label study to assess the degree of systemic exposure and safety of mm36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in pediatric subjects with atopic dermatitis.

Eligibility criteria:
inclusion criteria: * subjects 2 to \<18 years of age * diagnosis of atopic dermatitis (ad) * ad affecting ≥ 35% body surface area (bsa) if 2 to \< 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas) exclusion criteria: * active or acute viral skin infection * history of recurrent bacterial infection * malignancy * clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments
bringing the practice of mindfulness into nature - preventing mental fatigue in healthcare professionals.

Conditions: Stress, Psychological; Inflammation; Stress, Physiological

Summary: the purpose of the study is to determine whether a five day mindfulness retreat in nature can increase measures of attention and self-compassion, and reduce stress among bachelor students at danish universities and university colleges. secondary whether the expression of inflammatory markers can be reduced . it is the hypothesis that perceived stress is reduced and the expression of genetic markers of inflammation is reduced after a five day mindfulness retreat.


Eligibility criteria:
inclusion criteria: * bachelor student at a danish university or university college * a score of 16 or above on the perceived stress scale (pss) exclusion criteria: * smoking * psychiatric diagnosis (depression, anxiety, adjustment disorder, ptsd, personality disorder, psychosis). * untreated adhd, autism, abuse and risk of suicide
the efficacy of tranexamic acid in preventing postpartum haemorrhage after caesarean section

Conditions: Postpartum Hemorrhage

Summary: this study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in zimbabwe and globally.

this trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. the study group will receive tranexamic acid (txa) 1g intravenously at the onset of skin incision. there is normal saline placebo for the control group. the study and control groups will both receive the standard care offered at caesarean section including 5 iu of oxytocin intravenously on delivery of the baby. .

Eligibility criteria:
inclusion criteria: women undergoing elective or emergency caesarean section with: * estimated gestational age of 37 weeks or more * live intrauterine foetus * elective or emergency caesarean delivery * signed informed consent exclusion criteria: * history of coagulopathies or conditions predisposing them to thromboembolic phenomena, * seizure history, * autoimmune disease, * placental abruption, * placenta praevia, * abnormally adherent placentae if identified on prenatal ultrasound, * eclampsia or hellp syndrome, * known hypersensitivity to txa, * planned general anaesthesia, * caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin, * poor understanding of english/shona languages, * those who have received anticoagulants in the week before delivery * persons-under-investigation for coronavirus disease (covid-19) and confirmed covid-19 positive women

Keywords: postpartum hemorrhage tranexamic acid caesarean section prevent
micronized dhacm vs. saline in the treatment of osteoarthritis of the knee

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% sodium chloride injection, usp placebo control for the treatment of knee osteoarthritis

each subject will receive 1 injection (micronized dhacm or placebo) and be evaluated for efficacy and safety during a 12-month observation period. a second injection (open-label access to micronized dhacm) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. blinding for the first injection treatment allocation will be maintained until the end of the study. subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.

Eligibility criteria:
inclusion criteria: 1. age ≥ 21 and ≤ 80 years 2. subject has a diagnosis of osteoarthritis (oa) defined as grade 1 to 3 on the kellgren lawrence grading scale 3. subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study 4. subject must have a vas pain scale greater than 45 exclusion criteria: 1. subject has a diagnosis of osteoarthritis (oa) defined as grade 4 on the kellgren lawrence grading scale 2. bmi greater than 40 kg/m\^2 3. subject has active infection at the injection site 4. symptomatic oa of the contralateral knee or of either hip that is not responsive to acetaminophen (tylenol®) and requires other therapy. 5. subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer 6. subject has documented history of gout or pseudo-gout 7. subject has autoimmune disease or a known history of having acquired immunodeficiency syndromes (aids) or hiv 8. subject has received any of the following to the target knee: 1. intra-articular hyaluronic acid (ha) injection within 12 weeks prior to screening 2. steroid or platelet rich plasma (prp) injection within 12 weeks prior to screening 3. has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment 4. history of a total knee arthroplasty 9. subject has used an investigational drug, device or biologic within 12 weeks prior to treatment 10. subject has a history of immunosuppressive or chemotherapy in the last 5 years 11. subject has had prior radiation at the site 12. subject is currently taking anticoagulant therapy (excluding plavix or aspirin) 13. subject is pregnant or plans to become pregnant within 365 days of treatment 14. subject has any significant medical condition that, in the opinion of the investigator, would interfere with protocol evaluation and participation 15. subject is a worker's compensation patient 16. subject is a prisoner
using better model sexual problems in breast cancer

Conditions: Sexuality; Breast Cancer

Summary: breast cancer and its treatments such as mastectomy, chemotherapy, radiotherapy, hormonal therapy cause many side effects such as scar, problems with body perception and sexual problems. sexual concerns lead to significant emotional distress, including sadness/depression, issues related to personal appearance, stigma, and negative impacts on personal relationships, intimacy and sexuality all of which reduce the quality of life. this experimental type of research is conducted within the framework of the better model to evaluate the impact of counselling programme on sexuality issues that patients with breast cancer experience.

methods: the sampling consists of 60 female participants who volunteered to participate in the study. face to face interviews are held with the female participants based on the information forms and female sexual function index (fsfi)", "eortc qlq-br23 quality of life questionnaire", "center for epidemiologic studies depression scale (ces-d)", "body cathexis scale (bcs)" and "better model". counselling programme of the women in the intervention group is held in four sessions one week apart and these women are provided with a counselling booklet accompanied by a cd. the scales are re-applied one month after the last session. in the control group, the women are left under routine hospital control after the scales are applied. the scales are re-applied to the control group after one month.

Eligibility criteria:
inclusion criteria: * who have had primary diagnosis of breast cancer and are at stage 0-i-ii, * who underwent mastectomy, * who are in full remission, receiving no other treatment except hormonal therapy, * who has been receiving hormonal treatment for at least two months and less than 5 years, * age limit is set range from 18 to 45 * who are literate and sexually active, * whose spouses had no sexual health problems, * who don't have psychiatric illness * who are capable of verbal communication and willing to participate in the study exclusion criteria: * who have had other cancer types or at stage iii-iv * who underwent conservative breast surgery * who receive other treatment such as chemotherapy, radiotherapy * above 45 years old * who did not have sexual intercourse within the last month * whose spouses have sexual health problems * who have psychiatric illness * who are not willing to participate in the study * whose contact information could not be accessed

Keywords: breast cancer sexuality better model nursing care
breathe registry - i brazilian registry of heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions.

background: several local registries seek to show an isolated clinical characteristics of patients hospitalized with heart failure (hf) in hospitals and communities in brazil. overall, the analysis of these data suggests that there are important differences in etiology, the factors of decompensation, treatment and prognosis of hf patients in different regions. objectives: to evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions. other specific objectives include describing the in-hospital mortality after admission, to describe the content and the reason for re-admission, to assess adherence to evidence-based guidelines (recommended by guidelines), to measure indicators of quality of care and establish a national registry data to allow for comparison with international records of patients admitted with adhf. methods: observational cross (record) with longitudinal follow-up where patients admitted to public and private hospitals primarily defined in ic will be studied.

Eligibility criteria:
inclusion criteria: * \> 18 years old, * boston criteria \> 7, * patients hospitalized \> 24 hours. exclusion criteria: * myocardial revascularization during last month, * heart failure due to sepsis, * acute coronary syndrome with ventricular dysfunction as reason for current hospitalization

Keywords: heart failure epidemiology evidence-based practice
a multicenter study to evaluate the rox anastomotic coupler system (acs) in patients with severe hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the safety and performance of the rox anastomotic coupler system (acs) in patients with severe hypertension.


Eligibility criteria:
inclusion criteria: * diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination exclusion criteria: * any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Keywords: high blood pressure hypertension resistant hypertension
effects of transcutaneous and percutaneous ptns on idiopathic oab

Conditions: Overactive Bladder; Urge Incontinence; Overactive Detrusor

Summary: the purpose of this study is to determine if transcutaneous tibial nerve stimulation (tens) is as effective as percutaneous tibial nerve stimulation (ptns) as therapeutic option for subjects with idiopathic overactive bladder (oab) who have failed conventional therapy.

both therapies have been proven to be effective, but very few times have been compared. ptns and tens sns have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. only ptns has shown changes in urodynamic data while undergoing therapy. the investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the tens group, if we compare both therapies in a randomized control trial. secondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at tbs scale, while undergoing these therapies.

Eligibility criteria:
inclusion criteria: * female and male * age \>18 years * complaint urge urinary incontinence (3 or more episodes per week) or overactive bladder (8 or more voids per day, and/or 2 or more voids per night) * urodynamic data of overactive detrusor * failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training) * failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication * willing to complete study questionnaires and informed consent study exclusion criteria: * presence of bladder obstruction (prostate or prolapse) * neurogenic bladder overactivity * previous pelvic organ prolapse surgery * unwilling and mentally incompetent to participate in study * pregnancy or planning to become pregnant during the study * presence of urinary fistula * recurrent or current urinary tract infection (5 or more infections in the last 12 months) * bladder stones * bladder cancer or suspected bladder cancer * hematuria * central or peripheral neurologic disorders such as multiple sclerosis, parkinson's disease, spina bifida, or other spinal cord lesion * metal implants such as pacemaker, implantable defibrillator, or metal implants where ptns or tens device needs to be placed (sacrum or ankle/leg). * uncontrolled diabetes and diabetes with peripheral nerve involvement * anticoagulants treatment * current use of anticholinergics or use within the last 4 weeks * current use of botox bladder injections or bladder botox injection within the last year * current use of interstim therapy or currently implanted interstim device or leads * urinary retention or gastric retention * painful bladder syndrome/interstitial cystitis * previous ptns treatment

Keywords: neuromodulation electrical estimulation percutaneous transcutaneous oab
a safety study of ginkgolides meglumine injection in the treatment of ischemic stroke.

Conditions: Ischemic Stroke

Summary: the aim of this study is to evaluate the safety of ginkgolides meglumine injection in the treatment of ischemic stroke with syndrome of intermingled phlegm and blood stasis.

ginkgolides meglumine injection was jointly developed by china pharmaceutical university and jiangsu kanion pharmaceutical co., ltd. its pharmacal ingredients are ginkgo lactones , ginkgo lactone b, ginkgo lactone k, etc; excipients for meglumine, citric acid, sodium chloride. it is used to treat stroke (mild-to-moderate cerebral infarction) in recovery phlegm and syndrome of intermingled phlegm and blood stasis. the aim of this study is to evaluate the safety of ginkgolides meglumine injection in the treatment of ischemic stroke with syndrome of intermingled phlegm and blood stasis.

Eligibility criteria:
inclusion criteria: * patients according to diagnostic standards on western medical ischemic stroke; * patients according to diagnostic standards on chinese medical attack to meridians; * patients according to differentiation standards on syndrome of intermingled phlegm and blood stasis; * 2 weeks to 6 months after attack; * age between 18-80 years; * patients must volunteer to participate in this study and sign the informed consent form. exclusion criteria: * patients accompanying unconsciousness or severe dementia; * alt, ast≥2 times of upper limit of normal; * patients with other severe diseases such as disease in circulatory system, hematopoietic system, digestive system, endocrine system etc; * patients allergic to ginkgo biloba drugs，meglumine and meglumine agents; * patients who are pregnant, lactating or planning for pregnancy; * patients with insanity; * patients who are not suitable for clinical trial under doctors' consideration; * patients with merge bleeding after infarction or patients with hemorrhagic tendency; * patients with lower extremity venous thrombosis; * patients who have participated in other clinical trial within 1 month.

Keywords: ischemic stroke safety ginkgolides meglumine injection
suture contamination rate in adjustable suture strabismus surgery

Conditions: Suture Strabismus Surgery

Summary: 1. to establish the culture positivity rate in adjustable suture strabismus surgery 2. to identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material 3. to compare suture contamination rates with techniques to reduce the suture contamination rate

patients will be randomized into 1 of 2 groups: those who received 1 drop of 5% povidone-iodine instilled directly over the sliding noose at surgery completion (group 1) and those who did not receive povidone-iodine at the end of the surgery (group 2). institutional standard surgical preparation will be performed in all patients with 5% povidone-iodine solution on the periocular skin and eyelid margins, followed by instillation of 1 drop of 5% povidone-iodine into the conjunctival cul-de-sac. all operations will be performed using a sliding noose technique with a polyglactin 6-0 suture (vicryl, ethicon inc). if a patient undergoes surgery on more than 1 muscle in the same eye, a 1-cm section of suture proximal to the knot will be collected from the nonadjustable suture as a control. the control suture will be placed in a tube with 2 ml of trypticase soy broth and agitated for 1 minute. at the end of surgery, patients in group 1 will receive a drop of povidone-iodine. a strip of neomycin sulfate, polymyxin b sulfate, and dexamethasone ophthalmic ointment will be then applied into the lower conjunctival fornix to patients in both groups.

Eligibility criteria:
inclusion criteria: * all strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the bascom palmer eye institute will be invited to participate. exclusion criteria: * patient who has a history of allergy to povidone-iodine. * disorders affecting immune function. * patient who is unwilling to participate in the study

Keywords: adjustable strabismus surgery suture contamination 5%povidone iodine
cardiogenic acute pulmonary edema in subjects over 75 years old: impact of non-invasive ventilation on mortality

Conditions: Cardiogenic Pulmonary Edema

Summary: people aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. cardiogenic acute pulmonary edema (apo) is a very common reason for admission to the emergency room. the effectiveness of non-invasive ventilation (niv) has been demonstrated during the management of pao and would allow, compared to medical treatment alone, a more rapid improvement in clinical and gasometric parameters as well as a reduction in the need for ventilation. orotracheal intubation. on the other hand, the impact of niv on mortality in cardiogenic pao seems poorly defined, with lower levels of scientific evidence regarding a possible benefit in terms of survival, particularly in the elderly population. the objective of this study is to determine whether the use of niv in cardiogenic pao in elderly subjects admitted to the emergency room of strasbourg university hospital would have an impact in terms of mortality up to 6 months compared to medical treatment alone.


Eligibility criteria:
inclusion criteria: * adult subject (\> 75 years old) * admission to the nhc emergency room between january 1, 2021 and october 31, 2021 * diagnosis of cardiogenic pao * indication of niv according to current recommendations * subject not opposing the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed his opposition to the reuse of his data for scientific research purposes. * presence of an absolute contraindication to niv * respiratory distress due to pneumonia or other diagnosis * rt-pcr sars cov 2 positive in emergency

Keywords: cardiogenic pulmonary edema acute pulmonary edema non-invasive ventilation
the lymphoma epidemiology of outcomes (leo) cohort study

Conditions: Non-Hodgkin Lymphoma

Summary: the goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-hodgkin lymphoma (nhl) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. these efforts will identify new approaches to improve the survival and well-being of nhl patients.

newly diagnosed non-hodgkin lymphoma (nhl) patients will be recruited from each center participating in the leo cohort. at time of consent, participants will be asked to completed several questionnaires collecting health history, current medical and quality of life questions. patients will also provide a baseline blood sample that will processed locally and stored centrally for future research use. additionally, consent is given for use of excess clinical tumor tissue for research use.

Eligibility criteria:
inclusion criteria: * newly diagnosed non-hodgkin lymphoma (nhl), within 183 days of enrollment * patients may have been treated as long as initial nhl diagnosis is within 6 months of enrollment * 18 years of age or older exclusion criteria: * lymphoma diagnosis greater than 184 days from date of consent

Keywords: lymphoma cohort non-hodgkin