Kornimate/medical-research-clean huggingface dataset:
post-partum perineal pain - chirocaine®

Conditions: Post-partum Perineal Pain; Episiotomy; Vaginal Tear

Summary: the aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic chirocaïne® on perineal pain after episiotomy or first-degree tear. the pain intensity is measured in immediate postpartum period by using a numerical rating scale (nrs) at the following times: h2, h4, h8, h12, h24, h36, h48 during rest, defecation and during activities. the safety of chirocaïne® and the patient satisfaction are also evaluated at each time.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * patients aged 18-45 years * single pregnancy. * vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor. * patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia. * patients affiliated to a national insurance scheme * patients who have given their written consent exclusion criteria: * patient not speaking, reading, writing french. * multiple pregnancy. * breech delivery or instrumental delivery by forceps or spatula. * intact perineum. * no epidural analgesia. * patient who represent contraindication to local anesthetics, severe arterial hypotension. * previous tear requiring sutures.

Keywords: post-partum perineal pain episiotomy first-degree tear
efficacy and safety of evinacumab in adult patients with severe hypertriglyceridemia for the prevention of recurrent acute pancreatitis

Conditions: Hypertriglyceridemia

Summary: the primary objective of the study is to determine the proportion of patients with elevated triglycerides (tg), without familial chylomicronemia syndrome (fcs) due to loss of function (lof) mutations in lipoprotein lipase (lpl), and a history of hypertriglyceridemia (htg)-associated acute pancreatitis (ap) who experience a recurrent episode of ap after treatment with evinacumab versus placebo. the secondary objectives of the study are: * to determine the change in the standard lipid profile after therapy with evinacumab versus placebo * to determine the changes in specialty lipoprotein parameters (apoc3, apob48, apob100, and nuclear magnetic resonance \[nmr\] lipid profile) after therapy with evinacumab versus placebo * to measure the number of ap episodes per patient * to assess the safety and tolerability of evinacumab * to assess the potential immunogenicity of evinacumab * to assess the concentrations of total evinacumab and total angiopoietin-like 3 (angptl3)


Eligibility criteria:
key inclusion criteria: 1. adults without fcs due to lpl loss of function mutations 2. documented history of 1 htg-associated ap episode within 24 months of screening 3. fasting serum tg value \>880 mg/dl (10 mmol/l) or \>500 mg/dl (5.6mmol/l) determined during the screening period as described in the protocol 4. stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study 5. body mass index ≥18.0 and ≤45.0 kg/m2 6. compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study key exclusion criteria: 1. hospitalization for ap within 4 weeks of screening 2. known genetic fcs defined as homozygous or compound heterozygous lof mutations in lpl as defined in the protocol 3. symptomatic gallstone disease within 6 months prior to screening as defined in the protocol 4. use of any medication or nutraceutical known to alter serum lipids which has not been part of a stable therapeutic regimen for at least 8 weeks, and there are no plans to change the regimen during the study 5. presence of any clinically significant, uncontrolled endocrine disease known to influence serum lipids as defined in the protocol 6. has received a covid-19 vaccination within 1-week of planned start medication or for which the planned covid-19 vaccination would not be completed 1-week prior to start of the study note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: severe hypertriglyceridemia (htg) recurrent acute pancreatitis
liposomal daunorubicin in treating patients with hiv-related kaposi's sarcoma

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this clinical trial is studying how well liposomal daunorubicin works in treating patients with hiv-related kaposi's sarcoma.

objectives: primary * determine the effect of liposomal daunorubicin citrate on kaposi's sarcoma-associated herpes virus (kshv) viral gene expression in tumors of patients with hiv-related kaposi's sarcoma. secondary * determine the effect of this drug on kshv viral gene expression in peripheral blood mononuclear cells. * determine the effect of this drug on kshv viral load in plasma. * correlate viral load with viral gene expression and/or tumor regression in these patients. outline: this is a multicenter, pilot study. patients receive liposomal daunorubicin citrate iv days 1 and 15. treatment repeats every 4 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. biopsies are performed at baseline and once during treatment to evaluate kaposi's sarcoma- associated herpes virus (kshv) viral gene expression in tumors and skin tissue using reverse transcriptase-quantitative polymerase chain reaction. blood samples are collected at baseline and periodically during treatment to evaluate kshv viral gene expression in peripheral blood mononuclear cells and viral load in plasma. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed kaposi's sarcoma (ks) involving the following: * skin * lymph nodes (palpable disease only) * oral cavity * must have ≥ 5 measurable, previously nonirradiated, cutaneous lesions that can be used as indicator lesions * must have 2 lesions ≥ 5 x 5 mm that are accessible for 4 mm punch biopsy * serologically confirmed hiv positivity * concurrent antiretroviral therapy required, except for patients who have exhausted all available treatment options * must be on a stable dose for ≥ 4 weeks patient characteristics: * life expectancy ≥ 3 months * no other neoplasia requiring cytotoxic therapy * not pregnant or nursing * fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment prior concurrent therapy: * see disease characteristics * no prior anthracycline therapy * at least 4 weeks since prior antineoplastic treatment for ks, including any of the following: * chemotherapy (6 weeks for nitrosoureas or mitomycin c) * radiotherapy * local therapy * biological therapy * investigational therapy * at least 60 days since prior local therapy of any ks indicator lesion unless lesion has clearly progressed since treatment * no other concurrent investigational drugs, cytotoxic chemotherapy, or ks-specific treatment

Keywords: aids-related kaposi sarcoma recurrent kaposi sarcoma
investigating the effectiveness of pelvicsense(r) on pain and sexual outcomes in provoked vestibulodynia

Conditions: Provoked Vestibulodynia

Summary: this study will examine the effectiveness of the pelvicsense 3-month online program on pain and other outcomes in those with provoked vestibulodynia. this study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. all aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in english, and experience pain due to provoked vestibulodynia for at least 3 months with a physician diagnosis. participants are expected to continue their treatment as usual and this information will be documented throughout the study.


Eligibility criteria:
inclusion criteria: * 18 years or older * fluent in english * have a formal diagnosis of pvd for at least 3 months exclusion criteria: * younger than 18 years of age * nonfluent in english * self-identified diagnosis * pvd duration of less than 3 months
y of central maryland head start asthma implementation

Conditions: Asthma in Children; Implementation; Preschool Children

Summary: despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. head start (hs) serves over one million low income children in the us each year by focusing on early learning, physical health, and family engagement. hs is committed to implementing evidence based programs to promote overall child well-being, and is focused on addressing asthma symptoms due to the deleterious impact on school absences and child development. we have demonstrated the effectiveness of a multi-level staff and family education program (abc asthma) that significantly reduced asthma symptoms and courses of oral corticosteroids. however, these interventions are not successfully integrated within community organizations for long-term sustainability. it is unknown how to best scale up and implement these evidence based asthma interventions into low resource community organizations that serve children at risk. implementation strategies are frequently developed atheoretically and may not be tailored to the setting. the overall purpose of this project is to inform best practices of implementation of an asthma education program by 1) systematically evaluating the use of intervention mapping to develop a tailored implementation strategy in partnership with head start stakeholders, 2) examining both staff and organizational level determinants associated with implementation of abc asthma, and 3) evaluating the success of tailored implementation strategies on implementation outcomes and school absences and other health outcomes. the ymca of central maryland have enthusiastically agreed to implement the maryland abc hs asthma within 40 sites in four communities: baltimore city, baltimore county, anne arundel county, and prince george's county.


Eligibility criteria:
aim 1 inclusion criteria: * aged 18 or older * head start staff member or caregiver of child currently enrolled in head start with asthma * cognitive ability to provide consent * willing to be audio recorded
timing of resistance exercise in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the aims of the current study are 1. to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes. 2. to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes


Eligibility criteria:
inclusion criteria: * physician confirmed type 1 diabetes for at least 1 year * stable insulin therapy for 3 months prior to the study exclusion criteria: * bmi of 45 or higher * bp of 160/100mmhg or higher * autonomic neuropathy * severe proliferative retinopathy * joint or limb injuries preventing weight-bearing activity * autonomic neuropathy * severe proliferative retinopathy * any other medical condition that prevents participants from exercising safely.

Keywords: exercise circadian rhythm glucose control muscle strength
steroids, hyaluronic acid or platelet rich plasma versus placebo for the knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: this study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee joint.

osteoarthritis of the knee joint is a very common disease in middle aged and elderly patients. this study evaluates the efficiency of different commonly used substances for intraarticular, non-operative treatment in early stages of this disease. 120 patients receive an fluoroscopic guided injection in the knee joint: 30 patients get injection with steroids 30 patients get injection with prp 30 patients get injection with hyaluronic acid 30 patients get injection with placebo (iopamiro contrast media) primary outcome: - clinical outcome (pain using numeric rating scale) * magnetic resonance imaging (cartilage defects etc.)

Eligibility criteria:
inclusion criteria: * gonarthritis kellgren 1,2,3 with symptoms * german speaking * informed consent exclusion criteria: -age under 18, gonarthritis, kellgren 4, anticoagulation therapy, known inflammatory disease or infection, cardiovascular disease nyha iv, immunosuppression, contraindication for mri, pregnancy, no informed consent, nsar 3 days before injection, etc.
surgical site infection with 0.05% chlorhexidine (chg) compared to triple antibiotic irrigation

Conditions: Breast Cancer

Summary: the investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% chg (opposite side) in patients undergoing bilateral breast reconstruction. each patient will receive triple antibiotic solution on one breast and the chg on the other breast.

breast reconstruction with tissue expander (te) remains the gold standard of breast restoration after mastectomy. during the first stage of reconstruction, a te is placed under chest muscles and slowly inflated postoperatively over the period of several weeks. after desired volume of te is achieved it is exchanged for permanent breast prosthesis during another surgery (second stage of reconstruction). postoperative wound infection after placement of te can lead to devastating consequences both for patients and a surgeon. frequently, surgical site infection requires additional surgeries and resulting in the removal of te and long term iv antibiotic therapy. therefore, during breast reconstruction procedures all possible measures are implemented to reduce postoperative infection rate. several studies demonstrated that intra-operative irrigation of surgical wounds with antibiotic containing solution before insertion of breast te decreases postoperative infection rate. this approach is currently adopted as a standard of care within plastic surgery clinical community. the investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% chg (opposite side) in patients undergoing bilateral breast reconstruction.

Eligibility criteria:
inclusion criteria: * females between 18 - 81 years of age * and are undergoing bilateral mastectomy * and are candidates for immediate breast reconstruction with tissue expanders. exclusion criteria: * females younger than 18 and older than 81 years of age; * undergoing unilateral mastectomy and reconstruction; * bilateral reconstruction using other techniques, * patients allergic to one or more components of the antibiotic solution; * allergy to chg

Keywords: tissue expander breast reconstruction
study on the effect of exercise intervention combined with physical therapy on chronic ankle instability symptoms

Conditions: Chronic Ankle Instability,CA

Summary: purpose; through experimental observation of exercise intervention (blood flow restriction training combined with low load ankle muscle strength training and balance training) combined with instrument tool therapy (instrument soft tissue release technique, iastm), the intervention effect on ankle function, strength, and joint range of motion of sports dance athletes with ankle instability was observed. method; 45 subjects with unstable, restricted or uncomfortable ankle joints were selected as observation subjects and randomly divided into ankle blood flow restriction training combined with iastm group (n=15), ankle blood flow restriction training alone (n=15), and traditional ankle strength training (n=15). the intervention lasted for 6 weeks, once a week. cumberland ankle instability assessment, faam ankle function assessment score, and ankle range of motion measurement were performed at three time points before intervention, after the first intervention, and after 6 weeks of intervention for three groups. the ankle strength test was only compared and analyzed at two time points before and after intervention.


Eligibility criteria:
inclusion criteria: * age: 18-35 years old * course of illness: suffering from chronic ankle instability symptoms that last for at least 3 months * symptoms: ankle instability, frequent ankle sprains, discomfort during walking or exercise * functional screening: two or more tests tested positive for ankle joint function screening before the experiment * structural examination: no joint structural lesions or congenital ankle deformities, * medical history: have not undergone ankle surgery or have external injuries * health status: no serious heart, lung, nervous system or other systemic diseases * exercise level: able to complete the exercise intervention and evaluation tasks specified in the experiment * agree to participate in the study: has limited exercise ability and is unable to complete the research task exclusion criteria: * under 18 years old or over 35 years old * acute ankle injury or no joint injury * no ankle instability or unwillingness to cooperate with research requirements * failed ankle function screening * structural lesions or congenital ankle deformities present in the ankle joint * have undergone ankle surgery or have obvious injuries or wounds * serious heart, lung, nervous system or other systemic diseases * due to limited athletic ability, unable to complete research tasks * disagree to participate in the study, or inability to understand and comply with the research protocol

Keywords: chronic ankle instability,cai blood flow restriction training，bfrt instrument-assisted soft tissue mobilization，iastm tuina massage
selexipag (act-293987) in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the ac-065a302 (griphon) study is an event-driven phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * male and female patients 18-75 years old, with symptomatic pah * pah belonging to the following subgroups of the updated dana point clinical classification group 1 (idiopathic, or heritable, or drug or toxin induced, or associated (apah) with connective tissue disease, congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or hiv infection) * documented hemodynamic diagnosis of pah by right heart catheterization, performed at any time prior to screening * six minute walk distance (6mwd) between 50 and 450 m at screening within 2 weeks prior to the baseline visit * signed informed consent exclusion criteria: * patients with pulmonary hypertension (ph) in the updated dana point classification groups 2-5, and pah group 1 subgroups that are not covered by the inclusion criteria * patients who have received prostacyclin or its analogs within 1 month before baseline visit, or are scheduled to receive any of these compounds during the trial * patients with moderate or severe obstructive lung disease * patients with moderate or severe restrictive lung disease * patients with moderate or severe hepatic impairment (child-pugh b and c) * patients with documented left ventricular dysfunction * patients with severe renal insufficiency * patients with bmi \<18.5 kg/m2 * patients who are receiving or have been receiving any investigational drugs within 1 month before the baseline visit * acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6mwt * recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training * psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements * life expectancy less than 12 months * females who are lactating or pregnant or plan to become pregnant during the study * known hypersensitivity to any of the excipients of the drug formulations

Keywords: pulmonary arterial hypertension pah
low-protein formula supplements in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: prospective randomized contorl study.comparing clinical outcome between chronic kidney disease who were prescribed 6% low-protein nutrition supplement along with dietatian regular nutrition education and those without oral nutrition supplement.

past studies have shown that supplementation with low-protein nutritional formulas helps to increase compliance with low-protein diet control, but few studies have explored low-protein nutritional formulas supplementing the calories chronic kidney disease patient need, and nutritional supplements rich in ω-3 fatty acids, vitamin d and essential amino acid having effect in chronic renal function and changes in muscle mass, strength, and mobility. the propose of this study that low protein supplement may help maintain renal function or delay deterioration of renal function, or may reduce the risk of malnutrition and further improve muscle strength and mobility or quality of life.

Eligibility criteria:
inclusion criteria: 1. subject is \>65years of age. 2. subject has been diagnosed with chronic kidney disease (ckd) and is classified as being between stages 3 to 5. exclusion criteria: 1. the physician determines that the clinical condition is unstable. 2. lower limb injury or severe edema. 3. food allergies to milk, or fish 4. there is a heart rhythm in the body and a prosthetic device. 5. those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.

Keywords: oral nutrition supplement chronic kidney disease