Kornimate/medical-research-clean huggingface dataset:
a prospective clinical trial of colostomy-replacement combined with bio-mesh placement in the prevention of ssih

Conditions: Stoma Site Incisional Hernia

Summary: the goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (ssih). the main questions it aims to answer are: * whether bio-mesh placement is safe for patients with a high risk of ssih. * whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of ssih. * whether stoma reversal combining bio-mesh placement will trigger other complications. participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. after that, they will be followed up for one year to evaluate the occurrence of ssih and other complications.


Eligibility criteria:
inclusion criteria: * age: 18-75 years old; * patients should have colonic prophylactic stoma and have not received reversal yet; * there are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection; * no serious underlying diseases, can tolerate general anesthesia surgery * preoperative ecog (eastern cooperative oncology group) physical status score 0/1; * preoperative asa (american society of anesthesiologists) grade i-iii; * without vital organs function failure; * all patients and their families signed informed consent before surgery. exclusion criteria: * incapacitated persons; * with a history of other types of hernia; * those who have had hernia mesh implantation before; * those who are allergic to bio-mesh or their components before; * combined with other surgeries; * severe mental illness; * severe respiratory disease; * severe liver and kidney insufficiency; * those who have absolute contraindications to surgery; * suffering from severe bleeding disorders or obvious abnormal coagulation function; * history of unstable angina or myocardial infarction within 6 months; * history of cerebral infarction or cerebral hemorrhage within 6 months; * continuous intravenous application of glucocorticoid within 1 month; * the patient has participated or is participating in other clinical studies (within 6 months).

Keywords: stoma site incisional hernia colon cancer
coaching intervention for caregivers of persons with stroke

Conditions: Caregiver Stress Syndrome; Caregiver Burnout; Stroke, Acute

Summary: caregivers of people with stroke experience strain that can reduce their quality of life. caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. however, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. this proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.

caregiver strain reduces quality of life and can increase the chance of unplanned hospital readmission for the person with stroke. caregivers are routinely engaged during hospital discharge for education and training. however, the critical period after discharge is largely unsupported. the proposed research will integrate occupational therapy and telehealth to provide a post-discharge, caregiver-focused program, the "health coaching-in-context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. the program targets improved caregiver health and reduction in readmissions for stroke survivor. the study aims to examine the effects of the coaching program for caregivers as compared to usual care and evaluate the feasibility of study design. a pilot randomized controlled trial will be conducted with two parallel groups, "health coaching-in-context" and usual care. a sample of up to 40 pairs, including up to 40 stroke survivors and their respective 40 caregivers will be recruited from university hospitals and randomly assigned after consenting. the occupational therapist, unaware of the group assignment, will administer assessments before and after the intervention, and at 4-week follow-up. data will be collected on general information, readmissions, performance, self-efficacy, and quality of life.

Eligibility criteria:
inclusion criteria: * survivor criteria: first-time stroke, discharged from hospital within the past 30 days. * caregiver criteria: informal caregiver primarily responsible for care (family member, friend, or partner), may or may not live in the same household. passes cognition screen, willing to use teleconference using phone, tablet, or computer. * both: 18 to 80 years of age, understand and speak english exclusion criteria: * children * 81 years of age or older * unable to understand and speak english * does not provide consent * caregiver does not pass cognition screen

Keywords: caregiver stroke coaching stress self-efficacy re-admission burden
effects of two different parenteral nutrition regimes on nutrient intakes, growth and plasma electrolytes in very low birth weight infants

Conditions: Nutrition Disorder, Infant

Summary: a single-center retrospective observational study comparing two cohorts of very low birth weight (vlbw, birth weight \< 1500 grams) infants who received parenteral nutrition (pn) either before or after a concentrated pn regime was implemented into clinical use. primary outcome is weight sds at 28 days.

this study is a single-center retrospective observational study comparing two cohorts of very low birth weight (vlbw, birth weight \< 1500 grams) infants who received parenteral nutrition (pn) either before or after a concentrated pn regime was implemented into clinical use. both pn regimes were based on standardized pn solutions with the possibility to complement with additive nutritional products according to individual assessment by the attending physician. to meet recommended macronutrient intakes, in 2012 a concentrated parenteral nutrition regime was implemented into clinical use at the neonatal intensive care unit in umeå university hospital, sweden. however, there is a lack of data on how changes in nutrient intakes affect growth and electrolyte status in preterm infants. recent studies have demonstrated an increased incidence of hypokalaemia, hypophosphatemia and hypercalcaemia in infants who received enhanced parenteral energy and protein intakes. this study is a single-center retrospective observational study comparing two cohorts of very low birth weight (vlbw, birth weight \< 1500 grams) infants who received parenteral nutrition (pn) either before or after a concentrated pn regime was implemented into clinical use. both pn regimes were based on standardized pn solutions with the possibility to complement with additive nutritional products according to individual assessment by the attending physician.

Eligibility criteria:
inclusion criteria: * all infants vlbw infants admitted to the neonatal intensive care unit at umeå university hospital, sweden, within 24 hours after birth and treated there for ≥ 7 days, during 1 february 2010 and 30 september 2013. the infants were divided into two groups: 1. infants born between 1 february 2010 and 18 february 2012, before the concentrated pn regime was implemented (original pn group: n = 81), and 2. infants born between 19 february 2012 and 30 september 2013, after the concentrated pn regime was implemented (concentrated pn group: n = 53). exclusion criteria: * infants with chromosomal or severe congenital anomalies known to affect nutritional intakes and / or growth were excluded from the analyses.

Keywords: preterm
evaluating a pharmacokinetic drug interaction between tadalafil and tamsulosin

Conditions: Erectile Dysfunction; Benign Prostatic Hyperplasia

Summary: we investigate the potential pharmacokinetic drug-drug interaction between tadalafil and tamsulosin in healthy male volunteers who receive tadalafil alone, tamsulosin alone, and both together in a 3 period repeatedly.


Eligibility criteria:
inclusion criteria: 1. healthy male volunteers, age 20 to 55 years. 2. the result of body mass index(bmi) is not less than 19 kg/m2 , no more than 27 kg/m2 3. subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing exclusion criteria: 1. presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. 2. liver enzyme (ast, alt) level exceeds one and a half times more than maximum normal range. 3. systolic blood pressure \<90mmhg or diastolic blood pressure \< 70 mmhg, systolic blood pressure ≥ 140 mmhg or diastolic blood pressure ≥ 90 mmhg(sitting blood pressure) during the screening procedure.
efficacy study of topical application of nifedipine cream to treat vulvar vestibulitis

Conditions: Vulvar Diseases; Vulvar Pain; Vestibulitis; Vestibulodynia; Vulvodynia

Summary: to evaluate the use of topical application of nifedipine cream for the treatment of provoked localized vulvodynia (vestibulitis, vestibulodynia).

30 women aged 18-45 diagnosed with provoked localized vulvodynia will be included. 10 women will use topical nifedipine cream 0.2% 4 times a day for 6 weeks (except for menstrual period). 10 other women will use topical nifedipine cream 0.4% 4 times a day for 6 weeks (except for menstrual period). 10 women will be a control group and will use a placebo cream. the study will be randomized and double blind. participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment. a special detailed questionnaire has been prepared in three languages and will be used to compare dyspareunia and associate variables between the groups. the q-tip tests will be performed and findings will be drawn in each examination. differences between the groups will be examined, and uni- and multi-variate analysis will be performed.

Eligibility criteria:
inclusion criteria: 1. women diagnosed with vestibulitis according to friedrich's criteria: * severe pain with vestibular touch or attempted vaginal entry. * a positive q-tip test: pain produced by touching the vestibule with a cotton tipped applicator. * physical findings limited to varying degree of vestibular erythema. 2. non-pregnant women aged 18-45. 3. women use effective contraception and are not interested in becoming pregnant during the study period. 4. no known nifedipine allergy. 5. no medical diseases. exclusion criteria: 1. women who have undergone vestibulectomy. 2. active vaginal or pelvic infection. 3. a medical disease uch as diabetes, immune suppression.

Keywords: nifedipine treatment vestibulitis placebo
interference screw mectascrew-b postmarket study

Conditions: Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear

Summary: an observational prospective study with the aim to assess the clinical outcomes at 1year after surgery for a specific composite is (medacta mectascrew b) in the reconstructive treatment of ruptured acl or pcl by means of an autograft or allograft.

this is an observational prospective study with the aim toassess the clinical outcomes at 1year after surgery for a specific composite is (medacta mectascrew b) at 12 months following acl or pcl reconstruction. patients with an acl or pcl tear scheduled for surgery at ocm klnik gmbh hospital will be enrolled in the study, after the subscription of informed consent. the injured ligament will be restored with an auto- or allograft that will be fixed with a composite is (mectascrew-b, medacta international sa). data concerning demography, preoperative clinical conditions, surgical details including device implanted, tendon harvesting procedure and complications occurred, postoperative clinical data (as per standard practice at 6 weeks, 6 and/or 12 months) will be prospectively collected, in order to assess the functional outcomes (ikdc objective and subjective) and the knee stability (rom, pivot shift or reverse pivot shift test, anterior or posterior drawer test) of the patients. the treated knee will be also evaluated radiologically by std x-ray according to standard practice to assess swelling, tunnel widening, and resorption problems. the results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms

Eligibility criteria:
inclusion criteria: * both genders * patients older than 18 years * acl or pcl damage requiring primary acl or pcl reconstruction * patient requiring acl or pcl surgery with the use of medacta mectascrew b interference screw, according to manufacturer ifu's, i.e. reconstructive therapy of ruptures to the anterior or posterior cruciate ligament by means of autologous grafts * patients who are willing to participate in the study and have signed informed consent form. exclusion criteria: * patients with contraindications according to ifu's * patients with malignant diseases (at the time of surgery) * patients with proven or suspected infections (at the time of surgery) * patients with functional deficits on the affected extremity (at the time of surgery) * patients with known incompatibility or allergy to products materials (at the time of surgery) * concomitant ligament injury (grade ≥ 3)
supporting the well being of families of young children with autism spectrum disorders

Conditions: Maternal Depression

Summary: the objective of this 2 year research project is to determine whether an evidenced-based empowerment strategy, problem solving education (pse), targeted to mothers of young children with autism spectrum disorders (asds), promotes family well-being by decreasing the burden of maternal depressive symptoms and maternal parenting stress and improving social functioning. we propose a randomized control trial involving 140 mothers who have children \<4 years with confirmed asds. based on the paradigm of the iom report on mental health prevention research that highlights the importance of targeting interventions to at-risk populations who may not meet diagnostic criteria, all mothers of young children with asds will be eligible to participate. consistent with previous studies of cognitive-behavioral interventions, the mother-child pairs will be followed for 9 months. the intervention will be embedded in two settings that provide services to young children with asds - early intervention (ei) programs and specialty developmental assessment clinics. we aim to support families during a critical juncture - when they are confronted with a new diagnosis and are asked to navigate a complex service system on their children's behalf. the hypothesis of this proposal is that strengthening problem solving skills among mothers of young children with asds serve as an important buffer against the negative impact of life stressors, and thereby prevent and attenuate depressive symptoms and parenting stress.


Eligibility criteria:
inclusion criteria: * all mothers of young children \</ 6 with asds * mothers who speak english or spanish exclusion criteria: * mother has psychosis * mother endorses suicidal ideation * mother actively using illicit drugs * mother expected to leave area within 6 months

Keywords: depression, early intervention, behavior disorder, parenting skills, children with special health care needs, developmental disabilities, family support programs
determination of covid-19 related virus in central nervous system

Conditions: COVID-19 Testing; CNS Disease; CNS Infection

Summary: coronavirus disease 2019 (covid-19) is a highly infectious pandemic disease caused by sars-cov-2 virus. central nervous system (cns) complications associated with covid-19 might be secondary sequelae due to exuberant systemic innate-mediated hyper-inflammation, which may impair neurovascular endothelial function, disrupt blood brain barrier (bbb), activates cns innate immune signaling pathways, and induces parainfectious autoimmunity, potentially contributing to the cns manifestations. although the predominant clinical manifestation of sars-cov-2 is characterized by dyspnea, unremitting fever and hypoxemic respiratory failure, neurologic manifestations do occur in most hospitalized sars-cov-2 patients and include non-specific encephalopathy, psychosis, meningitis/encephalitis, myelitis, cerebrovascular events, guillain-barre' syndrome, and cranial or peripheral neuropathies, such as anosmia and ageusia. to date, data about primary cns involvement due to neurotropism and direct neuroinvasion are still lacking.

determination of sars-cov-2 presence in central nervous system

Eligibility criteria:
inclusion criteria: * adult patients * patients candidate for cns surgery * patients who have been tested for nasopharyngeal swab for sars-cov-2 * patients who have been tested for serology test for anti sars-cov-2 immunoglobuling (igg) and immunoglobulinm (igm) antibodies * patients able to sign informed consent exclusion criteria: * patients not meeting inclusion criteria

Keywords: sars-cov-2 cns infection coronavirus brain
effects of compassion training to patients undergoing hsct on biological and psychosocial parameters

Conditions: Hematopoietic Stem Cell Transplant

Summary: the hematopoietic stem cell transplant (hsct) experience is emotionally and physically stressful for cancer patients who undergo this procedure. this study aims to evaluate the effects of cognitively-based compassion training (cbct) on depression and anxiety symptoms, levels of resilience, hope and self-compassion in patients undergoing hsct and their caregivers. as well as assessing the effects of cbct on clinical conditions in patients and cortical activity and heart rate variability in caregivers.

the study hopes to show the positive effects of compassion training in patients and their caregivers. overall aim: this study aims to evaluate the effects of cognitively-based compassion training (cbct) on: depression and anxiety symptoms; levels of hope; resilience; mindfulness; self-compassion and quality of life. the study also aims to demonstrate whether cbct training has any effect on clinical parameters of transplanted patients, as well as whether it has an effect on cortical activity and heart rate variability inpatients and caregivers. specific objectives: 1. develop an adaptation of the cbct protocol for hospitalized patients; 2. to evaluate the effect of cbct on depressive and anxious symptoms in patients and their caregivers; 3. to evaluate the effect of cbct on resilience, quality of life and self-compassion in patients and their caregivers; 4. investigating the cbct training results in altering the cortical activity of patients and caregivers while performing a recall task of recent autobiographical experiences; 5. investigate whether cbct training results in changes in heart rate variability in patients and caregivers; 6. to investigate whether cbct training has any effect on patient's levels of symptoms, such as: pain, nausea, insomnia, among others; 7. to evaluate how correlations between psychosocial factors and biological markers: cortical activity and heart rate variability; 8. evaluate perceptions and impressions of patients and caregivers on the protocol.

Eligibility criteria:
inclusion criteria: * patients referred for hsct attended at albert einstein hospital, as well as their respective caregivers. exclusion criteria: * history of severe psychiatric disorders and neurological diseases.

Keywords: hematopoietic stem cell transplant cancer compassion meditation depression anxiety heart rate variability resilience
urinary incontinence and endocrine factors. a part of lolland-falster health study (lofus).

Conditions: Urinary Incontinence; Diabetes; Thyroid Diseases

Summary: previous studies have shown an increase in the prevalence of urgency and urgency incontinence in women with diabetes. regarding the condition urinary stress incontinence, the literature is diverted. the purpose of the phd project is investigate the prevalence of urinary incontinence and the association to diabetes and thyroid disease in a mainly rual population in lolland and falster. further to investigate if there is any difference in the bladder function in incontinent women with and without diabetes. psychometric validation of the questionnaire used to assess urinary incontinence was also performed.


Eligibility criteria:
inclusion criteria: * woman * 18 years or above * participating i the lolland-falster health study (nct02482896) exclusion criteria: * male * below 18 years * non-participating i the lolland-falster health study
vasculopathy, inflammation and systemic sclerosis

Conditions: Systemic Sclerosis

Summary: it is a study of basic research with mechanistically objectives and including clinical biological samples.

systemic sclerosis (ssc) is a rare and severe disease characterised by a fibrotic process and an incompletely elucidate physiopathology. several shared featured have been identified between ssc and another autoimmune disease, the systemic lupus erythematous (sle) as an interferon-alpha signature, the role of platelets and the polymorphism of ox40 ligand (ox40l). in sle, ox40l has been shown highly linked to the active form of the disease, was increased by the cd40l of platelets and induced the cd8 cytotoxicity while inhibiting the suppressive functions of regulator t lymphocytes. the third main factor of the ssc physiopathology apart from autoimmunity and fibrosis is the vasculopathy with an important role of endothelial cells (ec). they turned out to be half-professional antigen presenting cells and can modulate the adaptive immunity.

Eligibility criteria:
inclusion criteria: * age from 18 to 75. * ssc diagnosed according to the american college of rheumatology (acr) criteria. * with skin manifestations since less than 10 years. * localised sclerosis (lsc) diagnosed, morphea type. exclusion criteria: * age inferior to 18 or upper than 75. * skin manifestations since more than 10 years. * haemostasis diseases (independent from treatments). * stem cell transplant. * immunosuppressive treatments in the last 6 months. * associate autoimmune disease.

Keywords: t lymphocyte ox40/ox40l
ga 6: the blood glucose-lowering effect of glucose-dependent insulinotropic polypeptide

Conditions: Type2 Diabetes

Summary: this study will investigate if the effect of dpp-4 inhibitors is mediated in part by glucose-dependent insulinotropic polypeptide.

a randomized, placebo controlled study. using a gip receptor antagonist, we will investigate the glucose lowering effect of gip during treatment with dpp-4 inhibitors.

Eligibility criteria:
inclusion criteria: * type 2 diabetes, treatment: lifestyle changes or metformin * hba1c \< 75 mmol/mol exclusion criteria: * diagnosed liver disease * egfr \< 60 ml/min/1,73m2 * nyha iii or iv * anemia.