Kornimate/medical-research-clean huggingface dataset:
choose the best concentration of ropivacaine on tap block for open appendectomy in children

Conditions: Pain, Postoperative; Appendicitis

Summary: blockage of the transverse abdomen (tap) promotes excellent analgesia of the abdominal wall and the parietal peritoneum. the tap block could advange the postoperative pain of appendectomy in children. the world literature doesn´t focus the best ropivacaine´s concentration to improve postoperative pain in appendectomy in children. we propose a randomized trial that compares 3 groups children submitted appendectomy in children between 6 and 16 years. the control group has received no blockade, the other two groups have received tap blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.

blockage of the transverse abdomen (tap) promotes excellent analgesia of the abdominal wall and the parietal peritoneum. the meta-analyzes in adults demonstrate improved of postoperative pain and analgesic´s consumption. there are few studies on tap block in open appendectomies and laparoscopic in pediatrics, they show good results. there is a consensus of the best anesthetic volume for good infiltration of the tap block, but there are still doubts in the literature about the best concentration of local anesthetics of long duration. the main objective of this prospective, randomly distributed and double-blind clinical trial is to evaluate two concentrations of 0.25% and 0.5% ropivacaine with a volume of 0.4 ml / kg in pain control and the analgesic consumption through 24 hours observation in open appendectomy in children between 6 and 16 years. 3 groups were being compared: the control group has received no blockade, the other two groups have received tap blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg. all pacients patients received the same protocols (anesthesia and analgesia). the provided analgesia was dipyrone every 6 hours and ketoprofen every 8 hours, and rescue analgesia was tramadol every 4hours if it were required. the face pain scale was used to evaluate the postoperative pain.

Eligibility criteria:
inclusion criteria: * children between 6 and 16 years who were previously healthy submitted to appendectomy. exclusion criteria: * children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.

Keywords: appendectomy, pediatrics, nerve block, abdominal wall
a gene transfer therapy study to evaluate the safety and efficacy of delandistrogene moxeparvovec (srp-9001) in non-ambulatory and ambulatory participants with duchenne muscular dystrophy (dmd)

Conditions: Duchenne Muscular Dystrophy

Summary: the study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with dmd. this is a randomized, double-blind, placebo-controlled 2-part study. participants will be in the study for approximately 128 weeks. all participants will have the opportunity to receive intravenous (iv) delandistrogene moxeparvovec in either part 1 or part 2.


Eligibility criteria:
inclusion criteria: * definitive diagnosis of dmd based on documented clinical findings and prior genetic testing. * cohort 1 only: non-ambulatory per protocol-specified criteria. * cohort 2 only: ambulatory per protocol-specified criteria and ≥8 to \<18 years of age at the time of screening. * ability to cooperate with motor assessment testing. * stable daily dose of oral corticosteroids for at least 12 weeks prior to screening, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight). * recombinant adeno-associated virus serotype rh74 (raavrh74) antibody titers are not elevated as per protocol-specified requirements. * a pathogenic frameshift mutation or premature stop codon in the dmd gene, except for any deletion mutations in exon 8 and/or 9. exclusion criteria: * exposure to gene therapy, investigational medication, or any treatment designed to increase dystrophin expression within protocol specified time limits. * abnormality in protocol-specified diagnostic evaluations or laboratory tests. * presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the investigator creates unnecessary risk for gene transfer. other inclusion or exclusion criteria could apply.

Keywords: dmd gene-delivery pediatric north star ambulatory assessment (nsaa) performance of upper limb (pul) duchenne
tai-chi and aerobic exercise to improve emotional symptom cluster in late-stage lung cancer patients

Conditions: Advanced Lung Non-Small Cell Carcinoma

Summary: the goal of this randomized controlled trial is to investigate the effects of tai-chi and aerobic exercise on the emotional symptom cluster, and the underlying mechanism of that cluster, in late-stage lung cancer patients. participants will be randomized into one of three groups: 1) tai-chi group, 2) aerobic exercise group, or 3) self-management control group. both the tai-chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). the self-management control group will receive written information regarding the recommended level of physical activity.

late-stage lung cancer patients (n = 318) meeting the inclusion criteria will be recruited and randomized into one of three groups: 1) tai-chi group, 2) aerobic exercise group, or 3) self-management control group. both the tai-chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). the self-management control group will receive written information regarding the recommended level of physical activity. to evaluate the effectiveness of tai-chi and aerobic exercise in alleviating the emotional symptom cluster (primary outcome) and individual symptoms (sleep disturbance, anxiety, depression, fatigue), outcome measures will be conducted at baseline, 8 weeks (mid-point assessment), 16 weeks (post-intervention), and 28 weeks (12-weeks post-intervention). a linear mixed-effects model will be used to study the between-group differences in outcomes. in addition, emotion regulation, mindfulness, and cardiorespiratory fitness will be evaluated at each data collection point, and structural equation modeling will be used for subsequent mediation analysis to determine their mediating role in outcome changes. qualitative interviews will be conducted to understand patients' experience and evaluation of the interventions.

Eligibility criteria:
inclusion criteria: * diagnosed with stage iiib or iv non-small cell lung cancer confirmed by pathology, with no other cancer diagnosis within the previous year; * a current eastern cooperative oncology group performance status of 0-2; * experience of sleep disturbance, anxiety, depression, and fatigue in the past week (rating of 1 or more on a 0-10 numeric rating scale \[nrs\] for each symptom); * able to communicate in cantonese, mandarin, or english; * conscious and alert exclusion criteria: * suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack); * currently participating in any other exercise or mind-body classes; or 3) performing regular exercises, defined as at least 150 minutes of moderate-intensity exercise weekly
clinical evaluation of ultrasonic hydration monitor for infants

Conditions: Diarrhea; Dehydration

Summary: study will verify ability of infant hydration monitor (ihm) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. changes of tissue hydration will be followed during first days of life in newborns and in acute diarrhea in small children during re-hydration therapy. weighting and clinical dehydration symptoms will be used as controls.


Eligibility criteria:
inclusion criteria: * newborns from 1 to 7 days old, * health infants from 1 month to 3 years old, * any ethnicity, * male or female, * infants with diarrhea, * acute gastroenteritis, * diarrhea and/or vomiting, * suspected dehydration exclusion criteria: * congenital heart disease, * renal failure, * chronic liver disease, * chronic lung disease, * inflammatory bowel disease, * immune deficiency, * severe malnutrition, * any external damage to skin of leg, * infants and children whose parents refuse permission to be included

Keywords: dehydration hydration muscle composition diarrhea pediatrics neonatology ultrasound
pharmacological intervention in insulin resistance targeting autonomic nerve activity

Conditions: Insulin Resistance

Summary: the present study on pharmacological intervention in autonomic nervous dysregulation(parasympathetic dysfunction,) regarding insulin resistance, is a concept testing in humans tohelp identify potential new pharmacological target sites in the central nervous system.


Eligibility criteria:
inclusion criteria: * signed written informed consent * bmi of lean and abdominally obese men and women * weight stable exclusion criteria: * ongoing clinically significant diseases * history of repeated syncope * resting pulse\<50 or systolic blood pressure \<100

Keywords: clamp
non-interventional study with novocart® 3d for the treatment of cartilage defects of the knee in pediatric patients

Conditions: Cartilage Disease

Summary: prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of novocart 3d in the treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates.

the present study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of novocart® 3d in the treatment of cartilage defects of the knee in pediatric patients with closed epiphyseal growth plates. in this non-interventional study novocart® 3d, which is marketed in germany under paragraph 4b medicinal products act, will be used in routine clinical practice according to the authorized summary of product characteristics (smpc). as stated in this smpc, novocart® 3d may only be used by physicians who are trained on the product. the treatment with novocart® 3d requires two surgeries. during the first surgery cartilage biopsies will be harvested arthroscopically and sent to tetec ag (tissue engineering technologies ag) for novocart® 3d manufacturing, then novocart® 3d will be transplanted during a second surgery about 3 to 4 weeks later. all patients will be followed up for 5 years post novocart® 3d transplantation and data will be collected at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis. novocart® 3d post treatment rehabilitation should follow the recommendations given in the smpc and during product training. the primary and secondary variables (see below) will be assessed after a follow-up of 24 month post novocart® 3d transplantation (primary analysis). long-term data will be assessed after an additional 3 years follow-up (follow-up analysis). the collected data will be documented using dedicated case report forms (crfs) which are created and printed by tetec ag.

Eligibility criteria:
inclusion criteria: * 13 - 17 years old * medicinal indication for novocart 3d treatment exclusion criteria: • none

Keywords: cartilage defect knee pediatric patients
oral progesterone for prevention of miscarriage in threatened abortion

Conditions: Threatened Abortion

Summary: this study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.


Eligibility criteria:
inclusion criteria: * singleton pregnancy with gestational age 6 - 20 weeks * threatened abortion * confirmed intrauterine pregnancy with a viable fetus by ultrasound exclusion criteria: * history of recurrent miscarriage * having endocervical polyp * having infection such as pneumonia, pyelonephritis, septicemia * having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis * having cancer * having coagulation defect * allergy to dydrogesterone

Keywords: threatened abortion
a two part trial investigating an anti-obesity drug in overweight/obese male and female healthy volunteers

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of nnc 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. selected subjects will continue in a follow-up period of up to 5 years.

due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, nn9161, novo nordisk has decided to terminate further clinical development.

Eligibility criteria:
inclusion criteria: * for trial part 1, the following applies: * informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that would not have been performed during the normal management of the subject * overweight/obese males: body mass index (bmi) between 27.0 to 39.0 kg/m2 * good general health * for trial part 2, the following applies: * informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that would not have been performed during the normal management of the subject. * obese male and female subjects: body mass index (bmi) between 30.0 to 39.0 kg/m2 * good general health. exclusion criteria: * aggressive diet attempts within the last 3 months * current or history of treatment with medications that may cause significant weight gain * history of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour * history of eating disorders * any weight change of 5 kg (11 pounds) in the last 3 months * tobacco use * history of alcoholism or drug/chemical abuse
postpartum screening of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: gestational diabetes mellitus (gdm) complicates 5 to 30 % of pregnancies. gdm is defined as hyperglycemia with onset or first recognition during pregnancy. because it is a forerunner of type 2 diabetes mellitus (t2dm), professional associations recommend t2dm postpartum screening (t2dm-pps) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (ogtt). however, less than a quarter of these women are screened. this recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking... a mother-friendly solution is direly needed. the investigators hypothesize that, in these women, results of an ogtt performed after delivery on the last day of their hospital stay (ogtt-1) will predict results of the recommended ogtt (ogtt-2) at 6 weeks/6 months postpartum. the main aim of our project is to determine the optimal cut-off value for the 2h glucose result during ogtt-1 in order to predict abnormal glucose tolerance status at ogtt-2 (the gold standard), in the same woman.


Eligibility criteria:
inclusion criteria: * women aged between 18 and 45 years; * having a positive diagnosis of gestational diabetes mellitus (iadpsg criteria); * treated with diet or insulin; * have given birth to a child at term; gestational age \> 37 weeks; * have been followed during her pregnancy by a physician who delivers in chus; * have signed the consent form. exclusion criteria: * history of glucose intolerance or diabetes before the pregnancy; * have presented another obstetrical pathology during the pregnancy; * severe gestational high blood pressure with proteinuria; * delayed intrauterine development syndrome; * pregnancy with more than a foetus; * drug addiction; * had complications during the delivery such as: * moderate to severe postpartum bleeding; * surgery in postpartum (curettage, hysterectomy, etc.).

Keywords: postpartum screening type 2 diabetes
zoledronic acid in the prevention of bone loss in postmenopausal women with osteopenia, 45 years of age and older

Conditions: Osteopenia

Summary: osteoporosis prevention is important in patients with osteopenia (low bone density). this study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.


Eligibility criteria:
inclusion criteria: * postmenopausal * greater than or equal to 45 years of age * osteopenia (lumbar spine bone mineral density \[bmd\] t-score between -1.0 and -2.5, and bmd t-score \> -2.5 at the femoral neck) exclusion criteria: * patients with more than one grade 1 vertebral fracture (as per genant method; patients with one grade 1 vertebral fracture are eligible to participate) * patients with any grade 2 or 3 vertebral fracture (as per genant method) * patients with 25-(oh) vitamin d levels less than 15 ng/ml prior to randomization other protocol-defined inclusion/exclusion criteria may apply.

Keywords: postmenopausal osteoporosis osteopenia zoledronic acid osteopenia (osteoporosis prevention)
collagen treatment in facial nerve palsy

Conditions: Facial Nerve Palsy

Summary: to test the effectiveness of a collagen-based treatment for patients complaining of long standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular facilitation protocol (kabat method), compared to a group only undergoing the kabat method.

objective: to test the effectiveness of a collagen-based treatment for patients complaining of long standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular facilitation protocol (kabat method), compared to a group only undergoing the kabat method. methods: patients undergoing both procedures will be compared, after randomization, to matched patients undergoing only kabat procedure after 8 weeks of treatment. the outcomes will be electromyographic findings, validated questionnaires (facial disability index, fdi) and clinical grading (house-brackmann, hb). a correlation analysis will be performed between pre-/post-treatment diﬀerences (δ) in outcome and clinical-demographic measures.

Eligibility criteria:
inclusion criteria: * patients with a medical diagnosis of long-term unilateral peripheral axonotmesis of the facial nerve exclusion criteria: * patients with facial palsy caused by central nerve disease; * patients with a history of recurrent facial palsy; * patients with a facial skin disease hampering the possibility of injecting the drug; - patients with difficulty in moving their face due to previous plastic surgery or facial surgery; * patients with systemic diseases that can affect facial electromyography; * patients deemed inappropriate by the researchers. * patients with a history of hypersensitivity to any collagen solution constituent or showing pregnancy, lactation, neuromuscular junction disorders (myastenia gravis), peripheral motor neuropathies, or active infections will be also excluded.

Keywords: facial nerve palsy kabat method collagen injections electromyography
treatment of acute lymphoblastic leukemia or aggressive lymphoma with relapse in central nervous system with depocyt

Conditions: Adult Acute Lymphocytic Leukemia

Summary: patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented isolated cns relapse or cns relapse combined with other relapse sites should receive therapy with intrathecal depocyte at least once. treatment may be repeated during induction phase each 2 weeks and monthly during maintenance phase. the study aim is to replace the usual 2-3 weekly applications of intrathecal triple therapy with one application of depocyte. primary objective is the response rate after one application of depocyte. further objectives are the compilation of data regarding safety and toxicity


Eligibility criteria:
inclusion criteria: * proven diagnosis of all or very aggressive non-hodgkin-lymphoma (burkitt/burkitt-like) and cns relapse * cns involvement demonstrated by a positive ventricular or lumbar csf cytology or characteristic signs and symptoms of neoplastic meningitis plus an mri or ct scan indicating the presence of meningeal involvement * in combined relapse in cns and other locations: systemic therapy with cns active drugs can be postponed for at least 2 weeks * karnofsky performance score is \> or = 60% * 18 years of age or older * free of uncontrolled infection * recovered from any grade iii / iv toxicities attributable to prior treatment with the exception of hematotoxicity * patient not pregnant or breast feeding and effective methods to prevent pregnancy * free from severe heart, lung, liver or kidney dysfunction * written informed consent exclusion criteria: * failed to respond (as defined by no clearance of the csf) to \> 1 dose of prior i.th. mtx or arac or triple therapy * history of neurotoxicity (grade iii - iv) attributed to i.th. or systemic hd therapy with mtx or arac * prior cns relapse \< 1 month before

Keywords: cns relapse all treatment
a study to evaluate safety of asc40 tablets in patients with moderate to severe acne vulgaris

Conditions: Acne

Summary: this is a multicenter, open-label study designed to determine the long-term safety of asc40 (denifanstat) tablets in patients with moderate to severe acne vulgaris enrolled in the asc40-303 phase iii study. all subjects are eligible for study eligibility screening after enrollment in asc40-303 phase iii study, and all eligible subjects with moderate to severe acne vulgaris will receive asc40 (denifanstat) tablets after signing informed consent. the investigational drug will be administered orally once daily (qd) for up to 40 weeks. there will be a total of 7 visits for screening and follow-up. the tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc.


Eligibility criteria:
inclusion criteria: * participants who have successfully completed a 12-week phase iii study of asc40-303; * have fully understood this research and voluntarily signed the informed consent; * the fertile male and female subjects of reproductive age agreed to use effective contraception from the time they signed the informed consent until 3 months after the final administration of the investigationa drug; * subjects are willing and able to complete the study, understand and comply with the study requirements, comply with the study requirements restrictions and related education, use the investigational drug as prescribed by the physician, and follow up according to the study schedule. exclusion criteria: * discontinue participation in the asc40-303 phase iii study for any reason; * are receiving/planning to receive any systemic acne medications, systemic retinoids, systemic corticosteroids, or any androgen/antiandrogen therapy (e.g., testosterone, spironolactone); * pregnant, nursing, or planning a pregnancy during the study period; * have major complications (including clinically significant abnormalities in clinical laboratory tests), mental disorders, or other factors deemed unsuitable for study participation by the investigator.

Keywords: acne asc40