Kornimate/medical-research-clean huggingface dataset:
long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials - ecztend

Conditions: Atopic Dermatitis

Summary: the purpose of this extension trial is to evaluate the long-term safety of tralokinumab.


Eligibility criteria:
inclusion criteria: * completed the treatment period(s) of one of the parent trials: lp0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or tra-wei-0015-i. * complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator. * able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial). * stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline. exclusion criteria: * any condition that required permanent discontinuation of trial treatment in the parent trial. * more than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (imp) in the parent trial (to be assessed at baseline). * subjects who, during their participation in the parent trial, developed a serious adverse event (sae) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject. * subjects who, during their participation in the parent trial, developed an ae that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject. * treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline. * treatment with topical phosphodiesterase 4 inhibitors or topical jak inhibitors within 2 weeks prior to baseline. * clinically significant infection within 4 weeks prior to baseline. * a helminth parasitic infection within 6 months prior to the date when informed consent is obtained. * tuberculosis requiring treatment within 12 months prior to screening. * known primary immunodeficiency disorder.
effectiveness of microwave ablation of hepatocellular carcinoma as compared to radiofrequency ablation

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to compare microwave ablation using the acculis microwave tissue ablation (mta) system with conventional radiofrequency ablation (rfa) using covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (hcc). the investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation. a randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. the efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. safety of the procedures is also compared between the 2 treatment arms.


Eligibility criteria:
inclusion criteria: * age \>18 years * unresectable hepatocellular carcinoma (hcc) and tumor amendable for local ablation * resectable hcc but patient opts for local ablation * maximum diameter of tumor ≤6cm * maximum number of tumor nodules ≤3 * absence of radiology evidence of major vascular or bile duct invasion * child's a or b liver function * karnofsky performance status ≥70% exclusion criteria: * informed consent not available * pregnant female patients * tumors unfavourable for local ablation (e.g. tumor close to porta hepatis) * hcc with history of rupture * concomitant hepatectomy * patients with chronic renal failure

Keywords: microwave ablation radiofrequency ablation randomised controlled trial
aquamin® as an adjuvant intervention for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine if aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild ulcerative colitis and extend remission in ulcerative colitis in remission.


Eligibility criteria:
inclusion criteria: * ulcerative colitis with confirmed diagnosis by histology and endoscopy and in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) or having a mild disease. * a negative pregnancy test exclusion criteria: * no history or diagnosis of any of the following conditions: crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, kidney disease, including kidney "stones" or hypercalcemia, coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of coumadin or heparin. * ingested certain medications (calcium, vitamin d, fiber supplements and non-steroidal anti-inflammatory drugs - nsaids) within 30 days of study start.

Keywords: remission
an investigation of the mechanism of action of seretide in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is investigating the possible mechanisms of action of an inhaled treatment (seretide), currently used worldwide in millions of patients with copd (chronic obstructive pulmonary disease) and how it improves the symptoms of these patients. previous research has failed to identify the mechanisms at play other than dilation of the airways. the research community has long thought the mechanism to be immune based or anti inflammatory but despite intensive research this has not yet been identified.

we aim to recruit equal numbers of healthy smokers, mild, moderate and severe copd patients (12 patients to be recruited from each group). these patients will never have been prescribed the components present in seretide (salmeterol and flixotide or similar compounds). the patients will have spirometry at the beginning of the study to confirm the presence of copd. healthy smokers will defined as ex or current smokers who match the study population but have normal lung function. patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease will be excluded. the patients will have a total of four study visits, 2 off treatment and 2 while on treatment, over a 56 day study period. at each study visit induced sputum will be performed and blood extracted. the cells fom both of these samples will be analysed for cells type and activation. sputum and serum will be stored for cytokine analysis at a later date. the sputum will be induced using standardised protocols using nebulised saline solution.

Eligibility criteria:
inclusion criteria: * \>35yrs. * \>10 pack years copd as defined as an fev1\<70% and an fev1/fvc ratio of \<70% exclusion criteria: * asthma * lung cancer * bronchiectasis

Keywords: copd emphysema bronchitis
an evaluation of the safety and efficacy of memantine in patients with acute mania associated with bipolar i disorder

Conditions: Bipolar Disorder

Summary: bipolar disorder affects 2.4 million adults in the usa between the ages of 18-65 and has considerable economic impact on our society. bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. the purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar i disorder hospitalized for mania.


Eligibility criteria:
inclusion criteria: * patients must have a documented clinical diagnosis of bipolar i disorder and must be currently experiencing a manic or mixed episode. * patients must be voluntarily hospitalized with a primary diagnosis of mania. exclusion criteria: * rapid cycling bipolar disorder. * suicidal risk. * first manic episode. * ect, clozapine or a depot neuroleptic in the past 3 months. * substance dependence. * known hiv infection. * co-morbid serious, uncontrolled systemic illness.

Keywords: bipolar i disorder mania memantine hcl
the effect of artificial sweeteners (afs) on sweetness sensitivity, preference and brain response in adolescents

Conditions: Insulin Resistance; Obesity

Summary: the purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adolescents using fmri, psychophysical measures, and questionnaires. the investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.

we aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. significant controversy surrounds the possibility that consumption of artificial sweeteners (afs) leads to weight gain. given that the five fda approved afss are found in thousands of foods (yang 2010) this marks a clear and significant gap in knowledge. our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of splenda for just 10 days. these data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. adolescents may be more sensitive to exposure to afs because of changes in metabolism during this period of development. physiologic insulin resistance occurs during adolescence (moran, jacobs et al. 1999); this change in insulin sensitivity may predispose adolescents to greater impairments in sweet taste intensity by altering the relationship between sweet taste and post-ingestive reward, as suggested by the davidson and swithers model (davidson and swithers 2004). therefore, it is imperative that we gain a greater understanding of the physiological consequences of afs use in adolescents, since alterations in sweet taste perception, metabolism and brain reward that occur in response to afs exposure may promote weight gain.

Eligibility criteria:
inclusion criteria: * healthy * fluent in english * right handed * 13-17 years old exclusion criteria: * history of oral nerve damage, presence of known taste or smell disorder, food allergies or sensitivities (for example nuts, lactose, artificial sweeteners), history of cns disease, diabetes, history of dsm-iv major psychiatric disorder, including alcohol and substance abuse, chronic use of medication that may affect taste, conditions that may interefere with gustatory or olfactory perception (colds, seasonal allergies, recent smoking history), aberrant stimulus ratings, contra-indication for fmri, uncomfortable swallowing in supine position, discomfort or anxiety associated with insertion an intravenous catheter, regular artificial sweetener use.
carbetocin versus syntometrine for the third stage of labour

Conditions: Postpartum Haemorrhage

Summary: intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage

postpartum haemorrhage(pph)or excessive bleeding at or after childbirth is a potentially life threatening complication and is one of the major contributors to maternal mortality and morbidity worldwide (lewis 2001).among the various agents that have been studied in addition to the routine oxytocin and syntometrine (which has adverse effects),oxytocin agonist (carbetocin) appears to be the most promising for this indication(chong 2004). carbetocin is a licensed medication for the use of prevention of postpartum haemorrhage in singapore and many other countries. it is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties.the clinical and pharmacological properties of carbetocin are similar to those of naturally occurring oxytocin. like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. in pharmacokinetic studies, intravenous injections of carbetocin produced tetanic uterine contractions within two minutes, lasting six minutes, followed by rhythmic contractions for a further hour.intramuscular injection produced tetanic contractions in less than two minutes, lasting about 11 minutes, and followed by rhythmic contractions for an additional two hours. the prolonged duration of activity after intramuscular compared with the intravenous carbetocin was significant(hunter 1992). in comparison to oxytocin, carbetocin induces a prolonged uterine response when administered postpartum, in terms of both amplitude and frequency of contractions. the potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer duration of action. its relative lack of gastrointestinal and cardiovascular side-effects should also prove advantageous compared to syntometrine and other ergot alkaloids.

Eligibility criteria:
inclusion criteria: 1. any pregnant woman expected to deliver vaginally 2. age more than 21 if not married 3. ability to provide informed consent exclusion criteria: 1. multiple pregnancy 2. patients with other risk factors for postpartum haemorrhage 3. patients planning to have an elective caesarean section 4. history of vascular disease such as coronary artery disease 5. history of hypertension requiring treatment within the last 2 years 6. history of hepatic or renal disease 7. known or suspected coagulopathy 8. history of hypersensitivity to oxytocin or carbetocin 9. any condition where the use of syntometrine/carbetocin is contraindicated
establishment of an artificial larynx after total laryngectomy

Conditions: Carcinomatous Disease

Summary: this study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.


Eligibility criteria:
inclusion criteria: * anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy exclusion criteria: * less than 18 years * contraindications to general anesthesia * any situation considered by the physician operator as an exclusion * pregnant women * lactating women * subglottic or basi-lingual tumor extension more than 1 cm * prior radiotherapy * severe coagulation disorders

Keywords: laryngectomy artificial larynx breathing swallowing upper airway
efficacy and safety of pimavanserin as adjunctive treatment for the negative symptoms of schizophrenia (advance)

Conditions: Schizophrenia

Summary: to evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of the negative symptoms of schizophrenia


Eligibility criteria:
inclusion criteria: 1. adult patients, between 18 and 55 years of age 2. a clinical diagnosis of schizophrenia with a minimum duration of 1 year 3. has predominant negative symptoms according to predefined study criteria 4. the main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below: * aripiprazole * aripiprazole long-acting injectables: * abilify maintena® * aristada® * risperidone * risperidone long-acting injection * olanzapine * lurasidone * cariprazine * brexpiprazole * asenapine exclusion criteria: 1. patient has a psychiatric disorder other than schizophrenia 2. a urine drug screen (uds) result at baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana a. patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation 3. patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program 4. patient has had a myocardial infarction in the last six months 5. patient has a family or personal history or symptoms of long qt syndrome 6. patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
cyp19 genetic polymorphism & aromatase inhibitor(ai)

Conditions: Breast Neoplasms; Arthralgia; Arthritis; Genetic Polymorphism

Summary: the purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(ai) and the cyp19 genetic polymorphisms.


Eligibility criteria:
inclusion criteria: 1. the patient must sign the informed consent. 2. the patient must sign the informed consent of genetic screening test. 3. the patient must be between 18 years old and 80 years old who can make a decision independently. 4. the patient must be post-menopause status. 5. the patient should be the stage 1,2 or 3 of the breast cancer. 6. the test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of ai (aromatase inhibitor). exclusion criteria: 1. the patient is pre-menopause status. 2. the test result of serum fsh level is below 30mu/ml. 3. the test result of the hormone receptor(er \& pr) is negative or unknown. 4. patient's breast cancer stage is 4 which has systemic metastatics.

Keywords: breast neoplasms aromatase inhibitors genetic polymorphisms arthralgia arthritis
genetic determinant of foveolar hypoplasia in parents of albinos children

Conditions: Albinism, Ocular

Summary: fovea plana could be the phenoyipic translation of a genetic anomaly in one of the genes identified in albinisme


Eligibility criteria:
inclusion criteria: * children with albinism * father and mother of children with albinism exclusion criteria: * sign of albinism except fovea plana in father or mother of children with albinism * ophthalmological abnormalities making access to the fundus with oct impossible
altavalve early feasibility study protocol

Conditions: Mitral Regurgitation; Mitral Insufficiency; Mitral Valve Incompetence; Mitral Valve Regurgitation; Mitral Incompetence

Summary: prospective, single-arm, multicenter study to evaluate the safety and performance of the altavalve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.


Eligibility criteria:
inclusion criteria: 1. subjects ≥ 18 years of age. 2. subjects symptomatic new york heart association (nyha) ii-iv. 3. subjects with severe mr as documented by echo. 4. subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., heart team consisting of cardiac surgeon and interventional cardiologist in united states). abbreviated exclusion criteria: 1. inability to understand the study or a history of non-compliance with medical advice. 2. unwilling or unable to sign the informed consent form (icf). 3. history of any cognitive or mental health status that would interfere with study participation. 4. currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)). 5. female subjects who are pregnant or planning to become pregnant within the study period. 6. known hypersensitivity or contraindication to aspirin, heparin, or warfarin without adequate alternative medications. 7. known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated. 8. known hypersensitivity to contrast media that cannot be adequately medicated. 9. evidence of current left ventricular ejection fraction (lvef) ≤30% (where current is defined as the latest lvef measurement completed within 90 days prior to the index procedure). 10. concurrent medical condition with a life expectancy of less than 12 months. 11. prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or mitraclip not interfering with altavalve placement).

Keywords: mitral regurgitation tmvr functional regurgitation degenerative regurgitation transcathether mitral valve replacement primary regurgitation secondary regurgitation
efficacy of nutritional supplements on children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the goal of this clinical trial is to learn if nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. it will also learn about the safety of these nutritional supplements. researchers will compare the combination of nutritional supplements and behavioral intervention, to behavioral intervention alone, to see if nutritional supplements work to treat autism. participants will receive the combination of nutritional supplements and behavioral interventions or solely behavioral interventions for 3 months. and they will visit the clinic at the beginning of the trial (baseline) and after the 3-month intervention period for examinations.

this is an open-label clinical trial aimed at investigating whether nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. participants will be randomly assigned to either the experimental group or the control group. participants in the experimental group will receive the combination of nutritional supplements, including vitamin b1, vitamin b2, folic acid, mecobalamin, vitamin d3, choline, and coenzyme q10, along with the behavioral interventions, for a period of three months. participants in the control group will only undergo behavioral interventions. during the intervention period, the clinical symptoms, metabolomics of bio-specimens, and potential adverse effects will be closely monitored.

Eligibility criteria:
inclusion criteria: * children aged between 2.5 and 6 years old * meeting the asd diagnostic criteria of the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * meeting the asd diagnostic criteria of the diagnostic observational scale for autism, second edition (ados-2） * cars total score ≥ 30 * obtaining informed consent from the legal guardian exclusion criteria: * history of neurological diseases such as epilepsy * history of congenital diseases such as hearing, visual impairment * diagnosed with metabolic disorders such as hypophosphatemic rickets * diagnosed with genetic or chromosomal abnormalities * brain structural abnormalities detected by mri which required surgical intervention * currently participating in other clinical trials * received any new intervention within 8 weeks prior to enrollment