Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of botulinum toxin type a as treatment for osteoarthritis knee pain

Conditions: Osteoarthritis

Summary: this study will evaluate the efficacy and safety of a single intra-articular (ia) injection of botulinum toxin type a compared with placebo as treatment for osteoarthritis (oa) knee pain.


Eligibility criteria:
inclusion criteria: * painful osteoarthritis in the study knee * able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study exclusion criteria: * chronic pain conditions other than knee osteoarthritis * presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year * surgery to the study knee within 24 weeks * treatment with hyaluronic acid in the study knee within 24 weeks * treatment with corticosteroids in the study knee within 12 weeks * diagnosis of myasthenia gravis, eaton-lambert syndrome, or amyotrophic lateral sclerosis * previous treatment with botulinum toxin of any serotype for any reason
skin cancer prevention in a pediatric population

Conditions: Skin Cancer

Summary: skin cancer risk is largely determined by sun exposure during childhood. this study determines the effectiveness of a mailed intervention designed to increase sun protection for children age 6-9 years old. the intervention includes newsletters for parents that include risk information tailored to each child. also included are sun protection resources such as a swim shirt, a sun hat, and sunscreen. participants receive the intervention over 3 consecutive years, and data collection includes telephone interviews and skin exams. the study hypothesis is that receipt of the intervention will result in improved sun protection of the child.

about 1 in 90 american children born in the late 1990's will develop malignant melanoma in their lifetimes. sun exposure in childhood appears to be the most important preventable risk factor for this disease. this project will develop a tailored, risk-based, written intervention, which will be mailed to parents of children age 6-9 years in the spring of each year. the tailored intervention will utilize the precaution adoption process model, which has a primary focus on risk perception and suggests that there are seven stages leading to sustained health behavior change. the effectiveness of the intervention will be tested using a randomized controlled trail involving 1000 children recruited from health care facilities and community locations at age 5-6 years and followed for 3 years using telephone interviews to assess sun protection behaviors and skin exams to observe changes in melanocytic nevi, freckling, and tanning.

Eligibility criteria:
inclusion criteria: * child born in 1998, has resided in the denver, colorado area exclusion criteria: * parents unable to respond to telephone survey; child has disabling condition

Keywords: skin cancer prevention precaution adoption process model semi-tailored newsletter pediatric behavioral intervention
effects of prednisolone and pentoxifylline on the regulation of urea synthesis in alcoholic hepatitis

Conditions: Alcoholic Hepatitis

Summary: loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. the liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process. the purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.


Eligibility criteria:
inclusion criteria: * alcoholic hepatitis (alcohol intake (\> 40g/day in 6 months), bilirubin \> 80 μmol/l) exclusion criteria: * severe bacterial infections * other chronical inflammatory diseases * cancer * other catabolic diseases * treatment with prednisolone or pentoxifylline within the last 8 weeks

Keywords: inflammation urea synthesis catabolism nitrogen balance
dual and single switching monopolar rfa using separable clustered electrode for treatment of hcc

Conditions: Hepatocellular Carcinoma

Summary: this study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (dsm) radiofrequency ablation (rfa) with those of conventional single-switching monopolar (ssm) rfa in the treatment of hepatocellular carcinoma (hcc).

recently, dual switching monopolar rfa (dsm-rfa) was developed to enhance further the efficiency of the single switching monopolar rfa (ssm-rfa) in creating ablation zone; yoon et al. reported that dsm-rfa allowed significantly greater rf energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the ssm-rfa in ex vivo and in vivo animal experiments. a retrospective comparative study by choi et al. reported that the dsm-rfa created significantly larger ablation volume than, but seemed to show similar ltp rate to the ssm-rfa. still, whether the physical differences between ssm-rfa and dsm-rfa translate into better clinical outcomes remains an open question. regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between dsm-rfa and the ssm-rfa would be helpful for improving results of rfa. therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of dsm-rfa with those of conventional ssm-rfa in the treatment of hcc.

Eligibility criteria:
inclusion criteria: * diagnosed with hcc (\>= 1.5cm and \< 5cm in maximal diameter) according to aasld guideline or li-rads on mdct or liver mri within 60 days before rfa * no history of previous locoregional treatment exclusion criteria: * more than three hcc nodules * tumors abutting to the central portal vein or hepatic vein with a diameter \> 5 mm * child-pugh class c * tumors with major vascular invasion * extrahepatic metastasis * severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or inr prolongation of more than 50 %)

Keywords: rfa
influence of fampridine on working memory in healthy young subjects

Conditions: Working Memory

Summary: proof of concept study on the acute effects on working memory of 10 mg fampridine sr as well as the effects after repeated administration of 10 mg twice daily (3.5 days). the hypothesis ist that fampridine improves working memory performance.


Eligibility criteria:
inclusion criteria: * male or female * generally healthy * normotensive (bp between 90/60mmhg and 140/90mmhg) * bmi between 19 and 29,9 kg/m2 * aged between 18 and 30 years * fluent german-speaking * ic as documented by signature * at least double vaccination against covid-19 exclusion criteria: * contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to 4-aminopyridine * use of potassium channel blockers within the last 3 months * concomitant treatment with oct 2 inhibitors and substrates (e.g. cimetidine, propranolol) * acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) * acute cerebrovascular condition * history of seizures * risk of lowered seizure threshold (due to e.g. sleep deprivation, withdrawal of alcohol after alcohol abuse) * renal impairment * history of malignant cancers * walking problems (e.g. due to dizziness) * bradycardia \> 50/min during clinical examination * clinically significant concomitant disease states (e.g. hepatic dysfunction, cardiovascular disease, diabetes, asthma) * clinically significant laboratory or ecg abnormality that could be a safety issue in the study * known or suspected non-compliance * drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language or psychological problems of the participant * participation in another study with an investigational drug within the 30 days preceding and during the present study * prior participation (less than two years ago) in a study investigating working memory (notably the n-back task) * enrolment of the investigator, his/her family members, employees and other dependent persons * smoking (\>3 cigarettes per day) * intake of psychoactive drugs (e.g. benzodiazepines, antidepressants, neuroleptics) * pregnancy or breast feeding * experiencing a syncope during basal rmt measuring * metal in the brain, skull or elsewhere in the body (e.g., splinters, fragments, clips, etc.) * implanted neurostimulator (e.g., dbs, epidural/subdural, vns) * cardiac pacemaker or intracardiac lines * medication infusion device * piercings, pivot teeth (retainers are no exclusion criterion) * tattoos (head area) less than 3 months old or older than 20 years * condition after neurosurgery * hearing problems or tinnitus * not able to sit still due to tremor, tics, itching * history of repeated syncope * head trauma diagnosed as concussion or associated with loss of consciousness * diagnosis of epilepsy, or a convulsion or a seizure in the past of the participant or his family * tms in the past showing problems * mri in the past showing problems * surgical procedures to spinal cord * spinal or ventricular derivations
protected pea protein extract and satiety hormone release

Conditions: Obesity; Overweight

Summary: the increasing prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. food ingestion exerts a transient suppressive effect on appetite and further food intake by releasing gastrointestinal hormones. proteins have been shown to be more satiating than carbohydrates and fat. intraduodenal administration (via a naso-duodenal intubation) of pea protein has been shown to reduce food intake and increase satiety hormone levels in humans, in contrast to orally dosed (unprotected) pea protein. in the present study we aim to investigate the effects of human gastric fluid on the degradability of five different protected pea protein products. further, in an ex vivo experiment on freshly obtained human duodenum tissue applying ussing chamber technology; we aim to investigate the intestinal satiety hormone release by the five different prototypes. the prototype that is less degraded by human gastric fluid and is most effective in intestinal satiety hormone release will be used in a future clinical trial.


Eligibility criteria:
inclusion criteria: * healthy men/women * bmi between 18 and 25 kg/m2 * consistently stable body weight for at least 6 months (± 2 kg) exclusion criteria: * type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/l); * gastroenterological diseases or abdominal surgery (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgment of the principle investigator); * cardiovascular diseases, cancer, liver or kidney malfunction, auto-immune diseases, disease with a life expectancy shorter than 5 years; * abuse of products; alcohol (\>20 alcoholic consumptions per week) and drugs * smoking * plans to lose weight or following a hypocaloric diet; * use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing; * regular use of laxation products; * use of antibiotics in the 90 days prior to the start of study. * administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study * known pregnancy, lactation (checked by a pregnancy test before start of study) * blood donation within 3 months before study period * self-admitted hiv-positive state

Keywords: pea protein satiety hormone ussing chamber
fibrocytes in rheumatoid arthritis, asthma and interstitial lung-disease.

Conditions: Interstitial Lung Diseases; Rheumatoid Arthritis; Asthma

Summary: to study fibrocytes in patients with rheumatoid arthritis, interstitial lung disease and severe asthma and healthy controls.

objectives: 1) to demonstrate that circulating cd45+ cd34+ cd11b+ cells can express procollagen 1 and thereby show that these markers can be used to identify circulating fibrocytes. 2) to measure the levels of circulating cd45+, cd34+, cd11b+ cells in patients with ra, fibrotic ilds, severe asthma and in healthy controls (hc). 3) to compare the levels with number of peripheral blood mononuclear cells (pbmc) that differentiate to mature fibrocytes in vitro. method: the cd45+, cd34+, cd11b+ cells from 4 patients were isolated by cell sorting, and stained for procollagen. 30 patients (10 of each ra, fibrotic ilds: ipf or non-specific interstitial pneumonitis (nsip), severe asthma) and 10 hc were included. current medication, disease activity, lung function and radiographic data were collected. in 100 µl of lysed blood cells were enumerated by flowcytometry. further, pbmc were isolated and cultured for 5 days. coverslips from two wells were stained and mature fibrocytes counted and reported as fibrocytes per 106 pbmc originally added to the well.

Eligibility criteria:
inclusion criteria: * 10 patient with rheumatoid arthritis. * 10 patient with rheumatoid arthritis and interstitial lung disease * 10 patients with interstitial lung disease (idiopathic pulmonary fibrosis or nonspecific interstitial pneumonia) * 10 patients with asthma * 10 healthy volunteers exclusion criteria: * unable to sign written informed consent to participate in the study.

Keywords: fibrocytes interstitial lung diseases rheumatoid arthritis asthma
gum arabic as fetal hemoglobin agent in sickle cell anemia

Conditions: Sickle Cell Anemia

Summary: the purpose of this study is to determine whether gum arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.

: high level of fetal haemoglobin (hb f) decreases sickle cell anaemia (sca) severity and leads to improved survival. butyrate proved to increase hbf production in vivo and in vitro studies. nonetheless, its short half-life limited its utilization in clinical practice. gum arabic (ga) is edible, dried, gummy exudate from acacia senegal tree. ga fermentation by colonic bacteria increases serum butyrate concentrations. the investigators hypothesized regular intake of ga will increase serum butyrate level. the latter will induce fetal hemoglobin production and ameliorate patients' symptoms. 47 patients hemoglobin ss aged 5-42 years, on regular follow up in military hospital were recruited from april 2014 to january 2015 patients received dose of g a 30g/day for 12 weeks. hb f, complete blood count and erythropoietin level were measured. the main outcome of interest was the level of hbf after 12 weeks.

Eligibility criteria:
inclusion criteria: 1. over 5 year old 2. less t5han 50 3. diagnosed with homozygous sickle cell anemia by hb electrophoresis exclusion criteria: 1. patients received blood transfusion within the last three months or admitted to the hospital within 2 weeks because of sickle cell anemia -related events or crisis.
namsos anaesthesia children outcome study

Conditions: Emergence Delirium

Summary: behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. persisting behavioral changes may affect emotional and cognitive development. it is known that both type of surgery and anesthetic management affect the occurrence of behavioral disturbances. specifically, differences in occurrence were found after sevoflurane anesthesia and propofol anesthesia, two anesthetics that are generally used in practice. however, evidence is based on methodologically weak studies. the described occurrence of behavioral disturbances in children after anesthesia is not in line with the investigators' clinical experience, and neither are the described differences in occurrence between sevoflurane anesthesia and propofol anesthesia. this study will compare emergence delirium and behavioral changes after discharge from hospital in children who had surgery for removal of their tonsils under sevoflurane anesthesia versus propofol anesthesia.


Eligibility criteria:
inclusion criteria: * adenotomy and/or tonsillotomy and/or tonsillectomy * asa physical status class i or ii exclusion criteria: * unexperienced ear-nose-throat (ent) surgeon (ent surgeon \< 1 year of training, ent surgeon without experience with the use of laryngeal mask as airway during adenotomy/tonsillotomy/tonsillectomy) * preoperative syndromes * asa physical status class \> 2 * missing written consent from parents/guardians

Keywords: pediatric anaesthesia emergence delirium postoperative behavioral changes sevoflurane propofol adenotonsillectomy
register for longitudinal recording of brain function

Conditions: Patients With Brain Masses/Lesions

Summary: the aim of this observational register study is to establish a registry that completely records and compiles the data from routinely performed technical examinations (navigated transcranial magnetic stimulation, intraoperative neuromonitoring and stimulation, mri imaging including tractography and connectome) and clinical tests over time (pre-, intra- and postoperative, under adjuvant therapy, as part of follow-up care) of patients with intracranial masses and lesions.


Eligibility criteria:
inclusion criteria: * intracranial lesion * age ≥ 18 years * written consent to participate in the study exclusion criteria: * age \< 18 years * patients not able to give consent * patients with intracranial ferromagnetic metal implants * patients with implanted electronic devices
correlation between exercise and insulin dose in a camp for pediatric type 1 patients

Conditions: Type1 Diabetes Mellitus; Hypoglycemia; Exercise

Summary: intense exercise is a major challenge to the management of type 1 diabetes. the management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. the investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.

background and aims intense exercise is a major challenge to the management of type 1 diabetes. the management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. few studies confirm this hypothesis but none evaluated the correlation between steps, energy expenditure, sleep time and glycemic control and insulin dosage. methods and materials 60 patients with type 1 diabetes, aged 10 to 12 years, in multiinjection insulin therapy observed for 21 days (one week of camp, one week before and one after it). food program was the same both at home and during the camp. they checked glycemia almost 5 times a day. a wrist accelerometer was used to evaluate sleep, steps and energy expenditure. all data were recorded in a daily diary.

Eligibility criteria:
inclusion criteria: * diabetes onset \> 1 year, multiple injection insulin therapy exclusion criteria: * physical impossibility to movement, food allergy
smc radiation oncology breast cancer cohort study

Conditions: Radiotherapy Side Effect

Summary: the goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy. the main question it aims to answer are: * changes in breast skin * factors related to breast skin changes * patient-reported outcomes * cosmetic outcomes participants will be assessed by multi-dimensional methods before and after radiotherapy: * photographs * fibrometer * questionnaires (breast-q) * ctcae version 4.03 evaluated by treating physicians


Eligibility criteria:
inclusion criteria: * breast cancer treated with curative surgery exclusion criteria: * history of thoracic radiation therapy
a phase ia study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered cug252 in normal healthy volunteers

Conditions: Systemic Lupus Erythematosus

Summary: the intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of cug252 in healthy adult subjects.

this is a phase ia study of cug252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.

Eligibility criteria:
for healthy subject cohorts, inclusion criteria: * non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (bmi) between 18.0 and 32.0 kg/m2 (inclusive), at screening. * healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ecg, and chest x-ray exclusion criteria: * active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment * laboratory test results outside the local reference range and deemed clinically significant * history of chronic medications, immunosuppressant or steroids * history of malignant neoplasm * history of relevant atopy * history of hypersensitivity to biologic agents or any of the excipients in the formulation. * excessive xanthine consumption * history of drug or alcohol addiction or dependence within 1 year * positive of a tuberculosis test or a history of tuberculosis * abnormal blood pressure and/or ecg parameters * any prescribed medications within 28 days or nonprescription drugs within 7 days * previously received aldesleukin or any other il-2 derivative