Kornimate/medical-research-clean huggingface dataset:
phase 1 healthy volunteer burn therapy study

Conditions: Burns

Summary: this is a phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. participants will be healthy male and female adults. the study will consist of a screening period, inpatient dosing and observation period and safety follow-up. participants will receive 1 intravenous dose of the investigational drug or placebo. duration of participation will be approximately 38 days, which includes a maximum of a 30 day screening period and a study period of approximately 8 days.

up to 32 healthy, male and female subjects will be enrolled in this phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study. eligible subjects will be confined to a phase 1 unit for approximately 48 hours and receive a one time iv dose of study medication. they will be required to return for a safety follow-up visit one week later. doses will be studied sequentially starting with the lowest dose of the investigational drug, cnp8. each dose cohort will include a total of 6 subjects dosed with cnp8 and 2 subjects dosed with placebo. a sentinel dosing plan with staggered enrollment will be employed. for each dosing cohort, 2 subjects will be dosed (1 with cnp8 and 1 with placebo) and monitored for serious and/or severe adverse events (aes). if no serious or severe aes occur in 24 hours postdose, the remaining 6 subjects in the cohort will be dosed. safety evaluations, including laboratory tests, vital sign measurements and electrocardiograms, will be performed at several timepoints throughout the study.

Eligibility criteria:
inclusion criteria: * bmi between 18 kg/m2 to 32 kg/m2 and body weight of greater than or equal to 50 kg. * use of highly-effective methods of birth control * willing and able to remain in a clinical research unit for the required study duration and return for the outpatient visit exclusion criteria: * a clinically significant laboratory abnormality or other finding indicative of a clinically-significant exclusionary disease * a history of asymptomatic or mild covid within 30 days of study drug administration * a history of hospitalization with covid within 6 months prior to study drug administration * a history of covid vaccination within 1 month prior to study drug administration
stem cell in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the study will perform uc-mscs transplantation in 2 groups and 1 control group with standard treatment. each group consists of 5 subjects. in the first group uc-mscs will be transplanted via intravenous (iv) route and the second group via intracoronary (ic) route. the iv group will receive 2 million cells/kg for each subject and the dosage of ic group is 50 million cells for each subject. all groups will be observed until 1 year.


Eligibility criteria:
inclusion criteria: * stemi patients within 5 days after symptom onset of a first st-segment elevation myocardial infarction * have undergone successful percutaneous coronary intervention (pci) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the lv anteroseptal, lateral, or inferior wall with lv ejection fraction of \< 45% by echocardiography. * ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf, * willingness to attend all scheduled safety follow-up visits * subjects need to have a specific criteria of having a single vessel disease (ostial or proximal lad vessels) that caused extensive anterior infarction (ef \<45). exclusion criteria: * hemodynamic instability as demonstrated by any of the following, * requirement of intra-aortic balloon pump of left ventricular assist device, * need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmhg, * previous or current concomitant serious illnesses, such as cancer, hematological disorders (hb \ 11x109/l, or platelets \ 2.5 mg/dl, or creatinine clearance \< 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse, * prosthetic valves, * hypertrophic or restrictive cardiomyopathy, * women of child-bearing potential, * inability to comply with the protocol, * currently using implantable electronic defibrillator or pacemaker

Keywords: allogeneic mesenchymal stem cells umbilical cord mesenchymal stem cells intravenous mesenchymal stem cells intracoronary mesenechymal stem cells
role of inhibin a as biomarker for ovarian response for ivf treatment

Conditions: Infertility

Summary: to evaluate the role of inhibin a as bio marker for the number of mature oocytes, compared to estradiol

inhibin a could be an improved biomarker regarding the number of expected mature oocytes compared to estradiol.

Eligibility criteria:
inclusion criteria: patients undergoing ovarian stimulation with gonadotropins in either a gnrh-agonist or gnrh-antagonist for ivf treatment due to primary / secondary infertility. exclusion criteria: patients undergoing a modified natural cycle stimulation protocol (taymour cycle) patients at risk for development of ovarian hyperstimulation syndrome (ohss)
quality of life and surgery in diverticular disease

Conditions: Diverticulitis Colon; Quality of Life; Diverticular Disease of Left Side of Colon

Summary: diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. prevalence and admission rate due to diverticular disease increases. symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. recurrence rates of complicated diverticulitis are estimated to 10-30%. recurrences, chronic complications or persisting pain, here collectively referred to as chronic diverticular disease, may be treated by elective sigmoidectomy. currently, there is no specific criteria for elective surgery, but only a recommendation of a tailored approach depending on the patient's symptoms. it is well established that diverticular disease has a negative impact on quality of life (qol). elective laparoscopic sigmoidectomy may increase qol. in this prospective study, we will prospectively examine qol, patient-related outcomes and peri- and postoperative outcome of elective sigmoidectomy for chronic diverticular disease, and compare it to conservatively treated patients.

design: prospective, multicentre, observational locations: hospitals in central and northern denmark region (6 hospitals). time: recruitment starts in april 2022 and is planned to be completed in 2024. patients: all patients referred to a surgical clinic due to chronic diverticular disease. allocation for surgery or conservative treatment: patients will be treated according to danish national guidelines for treatment of diverticular disease. the study will not influence the treatment of the patient, but only observe and evaluate current daily practice. intervention: patients will be asked to answer questionnaires at inclusion and again after 1 year. patients treated with sigmoidectomy will also be asked to answers questionnaires 3 weeks and 3 months after surgery.

Eligibility criteria:
inclusion criteria: * referred to surgical clinic due to diverticular disease * colonic diverticula verified by ct or endoscopy exclusion criteria: * previous colonic resection other than appendectomy * previous or current colorectal cancer * previous or current disseminated cancer * inflammatory bowel disease * psychiatric disorder influencing the ability to answer questionnaires * inadequate danish
study of oliceridine (trv130) for the treatment of moderate to severe acute pain after bunionectomy

Conditions: Acute Pain

Summary: the primary objective is to evaluate the analgesic efficacy of intravenous (iv) oliceridine administered as needed (prn) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.


Eligibility criteria:
inclusion criteria: * has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * experiences a pain intensity rating of moderate to severe acute pain. * able to provide written informed consent before any study procedure. exclusion criteria: * asa physical status classification system classification of p3 or worse. * has surgical or post-surgical complications. * has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs. * has previously participated in another trv130 clinical study.
the effect of combined aerobic exercise and calorie restriction on mood, cognition, and motor behavior in overweight and obese women

Conditions: Obesity; Metabolic Syndrome

Summary: the benefits of weight-loss programs on mood state and cognitive and motor behavior remain unclear and are largely limited to those of calorie restriction (cr) or physical exercise alone. our aim was to investigate the effect of a combined cr and aerobic exercise program on mood state, cognition-related brain activity, and cognitive and motor behavior in overweight and obese women. twenty-six overweight or obese women were randomized to either a control group (no intervention) or an experimental group (aerobic exercise + 12.5% energy-intake reduction). brain-derived neurotrophic factor (bdnf) levels, mood, prefrontal cortex activity, cognitive performance, and learning of a speed-accuracy task were evaluated before and 6 months after the beginning of the program. confusion and depression increased in the control group (p \< 0.05), whereas tension decreased in the experimental group (p \< 0.05). bdnf level and learning of a speed-accuracy task remained unchanged. although pfc activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (p \< 0.05). an improvement in reaction time during the speed-accuracy task was observed (p \< 0.05). in conclusion, a 6-month combined cr and aerobic exercise intervention improved the psychosocial mental state of overweight and obese women. although it improved motor planning during the speed-accuracy task, it had little impact on cognition and no effect on brain activity and learning of the speed-accuracy task.


Eligibility criteria:
inclusion criteria: * gender: female; * body mass index (bmi) greater than 25 kg/m2; * exhibiting weight stability (body weight change \<2 kg) for at least 2 months prior to enrollment; * sedentary lifestyle (regular exercise 1 h/week). exclusion criteria: * undergoing lactation; * pregnant or postmenopausal; * type 2 diabetes; * cardiovascular disease.

Keywords: brain activity cognitive function diet exercise motor behavior psychosocial state
neocytolysis in the treatment of renal anemia with erythropoieses stimulating agents (esa)

Conditions: Renal Anemia

Summary: the purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with esa with regard to different types of esa.


Eligibility criteria:
inclusion criteria: * signed informed consent * age \> 18 years, dialysis dependent chronic renal failure * hemodialysis three times a week * kt/v \> 1,2 od urr \> 65% * hemoglobin between 11 and 13 g/dl within the last 2 months * hemoglobin change +/- 1g/dl within the last 4 weeks * esa for at least 8 weeks * ferritin \> 300 ng/ml and tsat \> 25% exclusion criteria: * significant bleeding in the last 8 weeks * blood transfusion within the last 8 weeks * hemoglobin disorder * hemolysis * malignant disease * significant inflammation * acute infection * crp \> 30 mg/l * temporary vascular dialysis access * vitamin b12 deficiency * folic acid deficiency * not controlled hyperparathyroidism * not controlled hypertension * epilepsia within thze last 6 months * thrombocyte count \> 500 x 10\^9 /l

Keywords: anemia kidney disease
topical (intra-articular) tranexamic acid and transfusion rates following hip hemiarthroplasty

Conditions: Femoral Neck Fractures

Summary: this study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture exclusion criteria: * history of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure * patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year * patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant * patients with a known allergy to tranexamic acid * patients taking warfarin, dabigatran, rivaroxaban, apixaban, and fresh frozen plasma

Keywords: hip hemiarthroplasty tranexamic acid topical blood transfusion
a study of ro5310074 in patients with psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: this randomized, double-blind. placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ro5310074 in patients with psoriatic arthritis who have or have had an inadequate response to oral disease-modifying antirheumatic drugs (dmards) or non-steroidal anti-rheumatic drugs (nsaids). patients will be randomized in cohorts to receive either 6 intravenous doses of ro5310074 or placebo. anticipated time on study treatment is 12 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, 18 - 75 years of age * diagnosis of psoriatic arthritis (moll and wright or caspar criteria) of \>/= 6 months duration * have \>/= 3 swollen and \>/= 3 tender joints * inadequate response to a current or previous oral dmard or nsaid therapy * current oral dmards must be at stable dose for the appropriate duration (e.g. 14 days for sulfasalazine and 28 days for methotrexate or oral steroids) * nsaids up to maximum recommended dose are permitted if at stable dose for at least 14 days prior to first dose of study drug, but not more than one nsaid simultaneously (except for low-dose aspirin for cardioprotection) * body mass index (bmi) 18 - 42 kg/m2 inclusive exclusion criteria: * previous prolonged treatment with a biologic dmard; use of biologic dmard within 3 months or 5 times its elimination half-live (whichever is longer) prior to first dose of study drug * previous use of b-cell depleting biologic dmards * any previous treatment with alkylating agents such a cyclophosphamide or chlorambucil or with total lymphoid irradiation * history of or current inflammatory joint disease other than psoriatic arthritis; gout or pseudogout that is current or has been active within the past 6 months * positive for hepatitis b, hepatitis c or hiv infection * any acquired or congenital immune deficiency or history of disease known to cause significant alteration in immunologic function * acute clinically significant infection in the 6 weeks prior to administration of study drug, history or presence of chronic infection, or history of recurrent infection as an adult
long-term results of per-oral pyloromyotomy for refractory gastroparesis

Conditions: Gastroparesis

Summary: this is a large multicenter retrospective french cohort conducted in seven french centers that had performed at least five g-poem procedures at the end of 2017. all patients treated by g-poem for refractory gastroparesis since april 30, 2014 (first case of gpoem in france) in these seven centers were included in this study and followed until april 2019. the data were collected retrospectively regarding medical and technical data, and then prospectively for the following data, which were included in a database for each center and combined for analysis. gastric cardinal symptoms index (gcsi) was used to evaluate symptoms and their severity. it applies a likert scale ranging from 0 to 5 (5 being the highest score) for three subscales: satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of two items). the total gcsi score was the mean of the three subscales. a gcsi score ≥ 2.6 is considered moderate gastroparesis and ≥ 3 is considered severe. gastric emptying scintigraphy (ges) was used to confirm delayed gastric emptying, since it is considered the gold standard according to the american society of neurogastroenterology. patients consume a radiolabeled meal, receive imaging at specific time-points to determine gastric retention. the exam is pathological when retention is \> 90% after 1 hour, \> 60% after 2 hours (h2), \> 30% after 3 hours (h3), and \> 10% after 4 hours (h4). all but one center performed the ges according to the us guidelines: that center performed a 3-hour ges with a local validation of a threshold of 30% retention at h3 to define delayed gastric emptying. a %h4 retention \> 30% was defined as severe delayed gastric emptying.


Eligibility criteria:
inclusion criteria: * treatment by g-poem during the study period, * at least a 1-year follow-up, and * gcsi evaluation before and 1 year after g-poem. exclusion criteria: * missing gcsi before and/or 12 months after g-poem, * non-pathological ges before g-poem: delayed gastric emptying was defined as t ½ \> 113 min and %h4 retention \> 10%, and * loss to follow-up or death before 12 months

Keywords: g-poem gastroparesis pop oral endoscopic pyloromyotomy
observational study investigating clinical & anthropometric characteristics of children with achondroplasia.

Conditions: Achondroplasia

Summary: this is a registry study in children with achondroplasia, age 0-10 years, to be conducted at multiple clinical centers in several countries. information collected will include in anthropometric characteristics, related symptoms, tests, \& treatments children's information will be collected in the registry for a maximum of 5 years.


Eligibility criteria:
inclusion criteria: 1. written informed consent is obtained from the children's parent(s) / legal guardian(s) before any study-related activity is carried out 2. the child is able to provide written informed assent, where this is required according to national legislation, before any study related activity is carried out 3. the child has been diagnosed as having achondroplasia documented by clinical diagnosis 4. the child is between 0 years and 10 years of age, inclusive, on the date of consent / assent 5. the investigator has considered the family and prospective participating child being able to comply with the study procedures exclusion criteria: 1. the child has a diagnosis of hypochondroplasia or any short stature condition other than achondroplasia (eg, spondyloepiphyseal dysplasia congenital \[sedc\], pseudoachondroplasia, trisomy 21) 2. the child has any medical condition that may impact growth or where the treatment is known to impact growth, such as but not limited to hypothyroidism or hyperthyroidism, insulin-requiring diabetes mellitus, autoimmune inflammatory disease (including celiac disease, systemic lupus erythematosus \[sle\], juvenile dermatomyositis, scleroderma, and others), autonomic neuropathy, or inflammatory bowel disease 3. treatment in the previous 12 months prior to consent and assent with growth hormone, insulin-like growth factor 1 (igf-1), anabolic steroids, or any other drug expected to affect growth velocity 4. any surgery that affects the growth plate of the long bones that is planned, or has occurred in the past 18 months 5. participation in any interventional study (investigational product or device) for treatment of achondroplasia or short stature 6. has had bone-related surgery impacting assessment of anthropometric measurements or is expected to have it during the study period. children with previous limb-lengthening surgery may enroll if surgery occurred at least 18 months prior to the date of consent/assent and healing is complete without sequelae as determined by the investigator 7. has any condition that in the view of the investigator places the child at high risk of poor compliance with the visit schedule or of not completing the study. 8. any concurrent disease or condition that in the view of the investigator would interfere with study participation
save trial - use of the selution sirolimus eluting balloon for dysfunctional av access treatment indications

Conditions: AV Fistula

Summary: prospective multi-center single-blinded randomized controlled trial (rct) investigating the safety and feasibility of the selution slr™ (sustained limus release) 018 drug eluting balloon (deb) for the treatment of failed av fistula in renal dialysis patients. patients will be randomised to either selution slr or poba.


Eligibility criteria:
inclusion criteria: * age 18-90 years * patient is able and willing to provide written informed consent * a dialysis access that has performed at least 1 successful dialysis session * stenosis \>50% at the outflow vein (by visual estimation) with clinical circuit dysfunction * lesion of ≤7mm in diameter * lesion of up to the 70mm in length exclusion criteria: * life expectancy \<1year * lower extremity avg * infected avg * uncontrolled systemic infection * aneurysm or pseudoaneurysm in proposed target lesion * presence of previous cs or bms * ≥2 lesions present within the circuit * unable to perform protocol prescribed pre-dilation of the lesion * patient is female and is pregnant, or planning to become pregnant during the course of the study.
the effect of vitamin k2 on bone turnover

Conditions: Osteoporosis

Summary: to investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. one month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin. moderate increases of bone resorption and formation markers were observed after 6 months. these changes may contribute to fracture prevention in patients with osteoporosis.


Eligibility criteria:
inclusion criteria: * a diagnosis of osteoporosis was made according to the year 2000 version of the diagnostic criteria for osteoporosis proposed by the japanese society for bone and mineral research. * these criteria state that patients with a lumbar bone mineral density (bmd)\<70% of the young adult mean or patients with pre-existing osteoporotic fractures and a lumbar bmd\<80% of the young adult mean can be diagnosed as having osteoporosis. exclusion criteria: * patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ). * patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, serm, active vitamin d3, or warfarin) were excluded.