Kornimate/medical-research-clean huggingface dataset:
investigation of pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of somapacitan in subjects with mild and moderate degrees of hepatic impairment compared to subjects with normal hepatic function.

Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children

Summary: this trial is conducted in europe. the aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics). in this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.


Eligibility criteria:
inclusion criteria: * male or female aged 18-75 years (both inclusive) * body mass index of 18.5-39.9 kg/sqm (both inclusive) * subjects with normal hepatic function or hepatic impairment (mild or moderate) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) for at least 16 days after the last trial product administration * male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration * any blood draw in excess of 25 ml in the past 30 days, or donation of blood or plasma in excess of 400 ml within the 90 days preceding screening * any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
sensorimotor organization in individuals with general joint hypermobility

Conditions: Generalized Joint Hypermobility

Summary: this study is the first to examine the effect of sole sensory training on sensorimotor organization in individuals with geh. individuals with a beighton score of 5 and above were included in the study. within the scope of the study, individuals with general joint hypermobility (geh) were divided into intervention and control groups by the randomization method. the intervention group received sole sensory training in the home environment. both groups were given a foot care brochure. the individuals' sole sensory and balance skills were evaluated before and after the intervention. as a result of the study, the intervention aimed to prevent injuries and disabilities that may occur due to joint laxity by improving sole sensory and balance.


Eligibility criteria:
inclusion criteria: * persons with a beighton score ≥5 without any systemic disease * asymptomatic persons exclusion criteria: * people who have had an upper or lower extremity injury in the last 3 months, * people who have a history of fractures or surgery in the last year, * people who have been pregnant in the last year, * those diagnosed with ehlers-danlos syndrome (eds), hypermobile ehlers-danlos syndrome (heds), or hypermobility spectrum disorders (hsd)

Keywords: joint hypermobility food sense sensorimotor
short-term effect of covid-19 vaccine on blood pressure

Conditions: Covid19; Blood Pressure

Summary: to investigate short-term effect of covid-19 vaccination on blood pressure by conducting 24-hour abpm

safety of coronavirus disease 19 (covid-19) vaccines has been a concern. despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular covid-19 vaccines. one of the mostly known example is vaccine-induced thrombotic thrombocytopenia (vitt). apart from the thrombotic risk of chadox1 ncov-19 vaccine, there has been studies providing the preliminary data on effect of mrna-based covid-19 vaccine on blood pressure. a case series report was published on hypertension in june 2021 on documented stage iii hypertension within minutes of vaccination (mrna vaccines) in a vaccination centre located in switzerland. the study reported 9 subjects experienced a surge in blood pressure to stage iii hypertension after vaccination. yet the study had a few shortcomings. there was not baseline measurement of blood pressure. surge of blood pressure shortly after vaccination could be due to nervousness or white coat effect. thus surge of blood pressure within minutes of vaccination could be not due to vaccination. there was not long-term follow-up on blood pressure measurement after vaccination. further to the case series report, another prospective study in italy investigated effect of mrna vaccine on blood pressure and heart rate. the study was conducted as a survey. there was 5.3% of respondents (6/113) reported rise of home blood pressure of at least 10mmhg after 1st dose vaccination, compared with home blood pressure prior to vaccination. among these subjects, 4 of them required anti-hypertensive medication intensification. yet there remains lack of evidence and detailed description on effect of covid-19 vaccines and blood pressure before and after vaccination. use of ambulatory blood pressure monitoring (abpm) before and after vaccination helps to understand the details on short-term blood pressure changes.

Eligibility criteria:
inclusion criteria: * subjects who will be receiving covid-19 vaccination * subjects who understand chinese to make an informed consent exclusion criteria: * skin condition around the cuff not suitable for long term cuff wearing (e.g. severe dermatitis, wound)
russian extremely severe ulcerative colitis study

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: the purpose of this study is prove the need to selection of a extremely severe ulcerative colitis, to identify predictors of colectomy, which will reduce the optimal time for surgery.

acute severe ulcerative colitis is a life threatening disease,total mortality rate can reach 17%, and the frequency of surgical treatment approximately 40%. standard conservative therapy in these patients is often ineffective and the optimal timing of the surgical treatment has not yet been established. in the russian clinical guidelines for the treatment of ulcerative colitis, the extremely severe ulcerative colitis is added to the classification of the severity. the extremely severe ulcerative colitis is a severe, according to the criteria of truelove, witts and the endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction. conservative treatment of patients with extremely severe ulcerative colitis worsens treatment outcomes only. the authors of the study want to prove that patients with a extremely severe ulcerative colitis need a colectomy in a short time. is there a need for long-term follow-up, conservative treatment of high-risk patients? is it safe to perform early surgical treatment without long-term conservative treatment? this study will allow to answer these questions and help doctors in the treatment of such patients anywhere in russia and not only.

Eligibility criteria:
inclusion criteria: * acute severe colitis according to the truelove and witt's criteria; * extremely severe activity according endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction (lower 31 g/l). exclusion criteria: * pregnancy; * infectious, ischemic colitis; * transformation of diagnosis into crohn's disease; * medical treatment failure before the admission.

Keywords: ulcerative colitis, acute severe ulcerative colitis, predictors of colectomy
oxytocin induction in full term pregnant women with cesarean section of prelabor rupture of membranes

Conditions: Failed Trial of Labor, Unspecified, With Delivery; Failed VBAC (Vaginal Birth After Caesarean); Prelabor Rupture of Membranes; Failed Induction (of Labor) by Oxytocin

Summary: this study is a multi-center, prospective, observational clinical trial study. 528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. in the cesarean section group, full term pregnant women with prelabor rupture of membrane (prom) who are willing to try the trial of labor after cesarean (tolac) and in accordance with the criteria according to the 2016 china vaginal birth after cesarean (vbac) clinical management guidelines will be enrolled and recorded by our homemade registration form of tolac. in the non-cesarean section group, pregnant women after 37 weeks of gestation with prom but without vaginal labor contraindications will be enrolled. whether in the cesarean section group or non-cesarean section group, if spontaneous labor does not occur, and they all will be induced by oxytocin. after 24 hours, their final delivery mode will be recorded. in the following 42 days postpartum, their complications and the neonatal outcome will be followed up.


Eligibility criteria:
inclusion criteria: 1. volunteers sign the informed consent; 2. age: 20-40 years; 3. singleton, a cephalic presentation; 4. no contradiction to vaginal delivery; 5. gestation: 37\~42 weeks; 6. with prelabor rupture of membrane. exclusion criteria: 1. konwn contraindication to vaginal delivery or severe complications; 2. multiple gestation; 3. uterine malformation; 4. severe psychiatric disorder; 5. without family's support.
gut microbiome of patients undergoing antibiotic therapy for orthopedic device-related infection

Conditions: Fractures, Bone; Infection, Bacterial; Joint Infection; Bone Infection

Summary: the microbiome of 80 orthopedic-device related infection (odri) patients treated with antibiotics and 10 healthy controls will be investigated. samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. composition and diversity of the microbiome will be assessed by 16srna sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. for further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.


Eligibility criteria:
inclusion criteria: * the patient is planned to undergo revision surgery due to suspected bone or joint infection. * the patient is at least 18 years old exclusion criteria: * the patient took antibiotics in the previous six weeks of recruitment (a single dose/"shot" of antibiotics during this period is not considered). * the patient suffers from gut-associated morbidities such as morbus crohn or colitis ulcerosa. * the patient suffers from psychiatric disorders/cognitive impairment affecting understanding. * the patient is unable to give consent and follow procedures and/or has insufficient knowledge of the project language.

Keywords: gut microbiome joint infection bone infection antibiotic therapy
the check trial: a comparison of headache treatment in the ed: compazine versus ketamine

Conditions: Headache

Summary: this study compares the efficacy of low dose ketamine versus compazine for the control of headache in patients presenting to the emergency department.

after enrollment, each patient will randomized either to the standard treatment arm to receive prochlorperazine 10 mg iv along with diphenhydramine 25 mg iv, or to the study arm to receive ketamine 0.3 mg/kg along with ondansetron 4 mg iv. the diphenhydramine or ondansetron will be administered first, and immediately afterward the prochlorperazine or ketamine will be administered. the prochlorperazine or ketamine will be diluted in saline so that the total volume is 5 ml, and will be administered over 2 minutes. the diphenhydramine will be diluted in saline so that it is 2 ml (the same volume as the ondansetron). both groups will also receive a 500 ml normal saline bolus after the study medications are administered. the ed pharmacist will be responsible for preparing the medications, using a double-blind protocol. he or she will record which arm the patient was randomized to. only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. emergency providers will be instructed not to administer any rescue medications for at least 30 minutes. the electronic medical record order will read "randomized study medication" (for the ketamine or prochlorperazine) and "randomized add-on medication" (for the ondansetron or diphenhydramine).

Eligibility criteria:
inclusion criteria: * age 18 to 65 years * temperature \< 100.4° f * diastolic blood pressure \<104 mm hg * normal neurological exam and mormal mental status exclusion criteria: * pregnant or breastfeeding. * meningeal signs are present * acute angle closure glaucoma is suspected. * head trauma within the previous two weeks * lumbar puncture within the previous two weeks * thunderclap onset of the headache * weight more than 150 kg or less than 40 kg. * known allergy to one of the study drugs. * history of schizophrenia or bipolar disorder. * history of intracranial hypertension. * is a prisoner * patient declined informed consent * non-english speaking patient. * attending provider excludes patient

Keywords: headache, migraine
the effect of family integrated care on melatonin level in very low birth weight infants

Conditions: Very Low Birth Weight Infant

Summary: this study will explore the effect of family integrated care (ficare) on the level of melatonin and other clinical outcomes in very low birth weight infants (vlbwis) by integrating families into the neonatal intensive care unit (nicu) care team and participating in the daily care of vlbwis, as well as the influence of ficare on parents' outcomes.

this study is a multicenter randomized controlled trial which mainly explores the effect of family integrated care (ficare) on melatonin levels in very low birth weight infants (vlbwis) in neonatal intensive care unit (nicu). the intervention group will use a ficare intervention program, mainly for families who have been fully trained by the nicu professional team and need to stay in the nicu to accompany and care for the vlbwis for not less than 6 hours a day for at least 3 weeks. all non-medical care measures and developmental supportive care will be provided by parents as much as possible. the control group received routine nursing interventions in which all non-medical interventions are led by nicu staff and without parental involvement. the level of melatonin, clinical and parental outcomes in vlbwis are compared between the intervention group and the control group to evaluate the effect of ficare intervention program.

Eligibility criteria:
inclusion criteria: * birth weight \< 1500g; * gestational age \< 32w; * admit within 24 hours of birth; * the parents are conscious and able to cooperate, have certain learning and reading comprehension skills, and are capable of caring for their babies. they are committed to receiving training and caring for their babies for not less than 6 hours a day for at least 21 days; * voluntarily participate in this study and sign informed consent. exclusion criteria * newborns who require palliative care or surgical intervention; * oi (oxygenation index) \<300 ; * newborns with severe congenital malformations;

Keywords: family integrated care melatonin
melanocytic nevi in children under chemotherapy

Conditions: Nevus, Pigmented

Summary: changes in nevus count in 16 children (8m, 8f) aged between 2 and 17 years (median:8 years) suffering from different malignancies were examined every three months during a one-year period after starting chemotherapy. an age and sex matched control group underwent the same skin examinations.at the start of our study, the range of number of nevi in the chemotherapy group was 0-133, in the control group 2-199.

objectives: patients given chemotherapy because of different malignancies have an increased susceptibility to cutaneous tumours and infection and a change of number of nevi during treatment is discussed. we investigated wether total nevi count changes in children undergoing chemotherapy. therefore 16 (8m, 8f) children suffering from leukaemia (11), lymphoma (2), adenosarcoma of the kidney (1), ewing´s sarcoma (1) and neuroblastoma (1) aged between 2 and 17 years (median:8 years), under chemotherapy at the pediatric department of oncology, were examined at the beginning and 9-12 months after starting chemotherapy. as control group age and sex matched children of the local population were used. materials and methods: at the beginning of chemotherapy the nevi were counted on the total body. all nevi were larger in diameter than 1mm and as melanocytic lesion identifiable. clinical and dermoscopic photographs were taken of every nevus. if the patient had more than 50 nevi, only nevi on the face, right arm, upper back and the buttocks were documented. reassessment was repeated every 3 month. conclusion: in our patients under chemotherapy during one year the development of new nevi is similar to sex and age matched children of the general population. during this short period development of nevi seems not to be influenced by chemotherapy.

Eligibility criteria:
inclusion criteria: * patient and/or parents willing to participate in the study * age under 18 study group only: * patient suffering from a malignancy requiring systemic chemotherapy exclusion criteria: * patient and/or parents who decline to participate in the study

Keywords: nevus count children chemotherapy
extension to a pivotal study of sensory stimulation in alzheimer's disease (ole hope study, ca-0015)

Conditions: Alzheimer Disease; Cognitive Impairment; Mild Cognitive Impairment; Dementia, Mild; Dementia Moderate; Dementia Alzheimers; Dementia of Alzheimer Type; AD

Summary: this is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. participants who complete the hope study (ca-0011) will be eligible to consent for screening to enroll in the ole hope study (ca-0015). all participants will be treated with an active sensory stimulation system (gs120) for 60 minutes daily for up to 12 months. there will be no sham treatment group or randomization involved in this study.

this is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. participants who complete the hope study (ca-0011) will be eligible to consent for screening to enroll in the ole hope study (ca-0015). all participants will be treated with an active sensory stimulation system (gs120) for 60 minutes daily for up to 12 months. there will be no sham treatment group or randomization involved in this study. up to approximately 402 participants will complete the hope study and be offered participation in the ole hope study at up to approximately 70 clinical sites. the objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression in the active-active group versus active-sham group for subjects with mild to moderate ad as measured functionally by the alzheimer's disease cooperative study - activities of daily living (adcs-adl) assessment and a combined statistical test (cst) for adcs-adl and the mini-mental state exam (mmse). participants will be treated with the sensory stimulation system (gs120) for 60 minutes daily for up to 12 months with active device settings. each participant will be involved in the study for up to 13 months: approximately 12 months of treatment and 1 month of safety follow-up.the visits in the study include: a screening/enrollment visit (day 0), followed by telephone training on device receipt, a clinic visit at 12 months and a telephone visit at 6 and 13 months.

Eligibility criteria:
inclusion criteria: * randomized and completed 12-months of participation in the hope study (ca-0011) * non-childbearing potential or using adequate birth control * available/consenting study partner exclusion criteria: * insufficient adherence to treatment in the hope study (ca-0011) * living in continuous care nursing home (assisted living permitted) * initiating or ongoing treatment with any of the following during study participation: * immunomodulators or passive immunotherapies for ad (ie, monoclonal antibodies) * memantine (namenda or namzaric) * nootropic drugs except stable acetylcholinesterase inhibitors for more information about the hope study (ca-0011) that participants in this study complete first, please see: https://www.hopestudyforad.com/ or the hope study clinicaltrials.gov posting here: https://clinicaltrials.gov/study/nct05637801

Keywords: gamma stimulation cognito
efficacy and functional outcomes of botulinum toxin a injections to hamstrings in flexed knee gait in cerebral palsy

Conditions: Spastic Diplegic Cerebral Palsy

Summary: the study proposes to determine if injections of btx-a to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.

this study proposes to: (1) to determine if injections of btx-a to the hamstring muscles result in measurable physiologic (body structure and body function) changes not observed with normal saline injections, in children with spastic diplegic cp who walk with a flexed-knee gait pattern; (2) to assess whether physiologic changes translate into functional (activity and participation) improvements; (3) to evaluate family's perception of change in function, activity, participation, and quality of life. this study will demonstrate if btx-a injected into overactive hamstring muscles of children with spastic cerebral palsy (cp) and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the international classification of functioning, disability, and health (icf). it is a multi-center, prospective, randomized, double-blind trial comparing results of injection of btx- a and placebo saline in controls, into overactive hamstring muscles, using multiple outcomes measures. temporal-spatial gait parameters, instrumented 3dga kinematics, passive rom, spasticity measurement with both ashworth and tardieu scales, muscle strength/control, gross motor function measurement (gmfm), pediatric outcomes data collection instrument (podci), gillette functional assessment questionnaire (faq), 6-minute walk test, and goal attainment scale (gas), assessing all icf domains, will be collected at baseline and at 1 month, 3 months, and 6 months post-injection. power analysis demonstrates the need to randomize 250 children (125 with btx-a, 125 with saline), allowing for attrition. nine participating hospitals will contribute patients.

Eligibility criteria:
inclusion criteria: 1. spastic cerebral palsy; 2. bilateral lower extremity involvement; 3. spasticity present in the hamstrings; 4. flexed knee gait \>15 degrees by observation (ogs); 5. age between 3 and 18 years old; ( 6. gmfcs level i to level iv; ( 7. able to walk a minimum of 4 complete steps without resting with and without braces/shoes a minimum of 3 times; 8. able to follow simple commands; 9. cooperative with physicians and therapist; 10. able to tolerate application of equipment to the skin. exclusion criteria: 1. rhizotomy surgery within the last 1 year; 2. lower extremity surgical procedures (soft tissue or bony) within the past 1 year; 3. currently implanted and operating intrathecal baclofen pump (oral baclofen ok); 4. lower extremity btx-a injections within the past 6 months; 5. multilevel btx-a injections; 6. gait trainer reliance; 7. serial casting 3 months prior to or during study protocol.

Keywords: cerebral palsy spasticity diplegia