Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of cetirizine tablets versus ketotifen dry syrup in children with perennial allergic rhinitis

Conditions: Rhinitis, Allergic, Perennial

Summary: ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in japan. the objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion; * severity of nasal symptoms was moderate to severe during the observation period; * criteria for allergic etiology of the disease fulfilled, i.e., positive ige antibody test and positive eosinophil count in nasal discharge. exclusion criteria: * history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine; * history of drug hypersensitivity; * history of convulsive disorder; * vasomotor rhinitis or eosinophilic rhinitis; * asthma requiring treatment with adrenocortical hormones; * concomitant diseases which could impede the efficacy evaluation of the study drug; * subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage; * pollen allergy; * malignant neoplasm.

Keywords: cetirizine zyrtec
study to evaluate the use of resources and the costs associated with carcinoid syndrome (cs) in patients with nets in spain

Conditions: Neuroendocrine Tumors

Summary: the objective of this study is to describe the use of resources and the costs associated with controlled or uncontrolled cs in patients with nets in spain.


Eligibility criteria:
inclusion criteria: * patient 18 years of age or older. * patient with a diagnosis of net (g1 or g2) treated with somatostatin analogues (ssas) to manage their symptoms. 1. group a: patient who has had at least one episode of uncontrolled cs, according to medical criteria, since the start of treatment. 2. group b: patient who has not had any episode of uncontrolled cs, according to medical criteria, in the last 12 months. * patient able to read and understand the study questionnaires. * patient who has given written informed consent to participate in the study. exclusion criteria: * patient participating in another clinical study when invited to participate in this study. * patient with another severe malignant disease. * patient who cannot meet the requirements established in the protocol (non-compliant or unfit to fill in the questionnaires). * patient with symptoms or diseases that could be confused with cs or render cs more difficult to evaluate: right cardiomyopathy or diarrhoea of any aetiology other than net.
a prospective study of natural history of pancreatitis

Conditions: Chronic Pancreatitis

Summary: to prospectively define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (cp) of varying etiology. to identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with cp. to quantify the behavioral abnormalities associated with cp. to determine psychological and behavioral correlates of cp disease progression and outcomes.


Eligibility criteria:
inclusion criteria: * subjects with pancreatitis exclusion criteria: * lack of consent, age \<18 years

Keywords: to define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (cp). to identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with cp. to quantify the behavioral abnormalities associated with cp. to determine psychological and behavioral correlates of cp disease progression and outcomes.
trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab administered subcutaneously to haemophilia a subjects

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted globally. the aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia a subjects.


Eligibility criteria:
inclusion criteria: * male subjects diagnosed with haemophilia a without inhibitors present at screening and currently treated on-demand * subjects with a baseline level of factor viii below or equal to 2 % based on medical records * age between 18 and 64 years both inclusive, at the time of signing informed consent * body weight between 50 and 100 kg, both inclusive exclusion criteria: * known or suspected hypersensitivity to trial product or related products * platelet count below 50x10\^9/l at screening * any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator * subjects at increased risk of cardiovascular disease as judged by the investigator
an observational extension study for adult patients treated in study r5459-rt-1944 who receive a kidney transplant

Conditions: Chronic Kidney Disease (CKD)

Summary: the main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the r5459-rt-1944 study (nct05092347). no study drug will be given during this study.


Eligibility criteria:
inclusion criteria: 1. received at least 1 dose of treatment with vonsetamig in study r5459-rt-1944 \[nct05092347\]. 2. received after acceptable crossmatching, a kidney transplant while enrolled in study r5459-rt-1944 3. willing and able to comply with clinic visits and study-related procedures 4. provide informed consent signed by study patient or legally acceptable representative exclusion criteria: 1.there are no exclusion criteria for this study. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: kidney transplant
promoting colorectal cancer screening in rural emergency departments

Conditions: Colorectal Cancer

Summary: this trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (crc) and to promote crc screenings using motivational interviewing (ml) delivered by a lay health advisor (lha) compared to the current standard-of-care (distribution of a brochure describing crc screening services offered by the hospital) on crc screening compliance.

the specific aim of this project is to adapt and pilot a tailored intervention to promote crc screenings in a rural appalachian kentucky emergency department (ed) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ed) that serves a rural appalachian community; and (b) assess the effects of the intervention on barriers to crc screening, stage of readiness to screen and crc screening engagement. the first phase of the project will involve the adaptation and pretesting of the intervention. this phase will take approximately 6 months. the second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. we will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the lha delivered mi intervention to promote crc screening in persons waiting in a rural appalachian emergency department (ed) for non urgent complaints. we will evaluate efficacy by measurement of crc screening status at baseline and three and six months post intervention.

Eligibility criteria:
inclusion criteria: 1. 50+ years of age 2. rural appalachian resident 3. no personal history of colorectal cancer 4. no cognitive impairment 5. ability to speak and understand english 6. has not had one of the following colorectal cancer screening tests-- 1. fecal occult blood test within the past year 2. flexible sigmoidoscopy within the past five years, or 3. colonoscopy within the past ten years exclusion criteria: -
living alone in old age with cognitive impairment

Conditions: Living Alone; Alzheimer Disease; Mild Cognitive Impairment

Summary: the purpose of this study is to better understand the experience of living alone in older age with cognitive impairment. we recruit adults 55+ living alone with cognitive impairment such as alzheimer's disease or mild cognitive impairment. this study investigates the priorities and concerns of older adults living alone with cognitive impairment. participants are interviewed 5 times for one hour in their homes within 3 months at a time that works for them.

the purpose of this study is to better understand the experience of living alone in older age with cognitive impairment. this knowledge is important to design programs that are appropriate. dr. elena portacolone, an assistant professor from the institute of health and aging is the study researcher. study participants are interviewed by elena at a time and place convenient to them, usually their home. interviews are audio recorded and last around one hour. study participants are interviewed five times within 3 months. after the interview, a transcriptionist will type into a computer the recording and will remove personal names. the sound recording will then be destroyed. participants can stop being in the study at any time.

Eligibility criteria:
inclusion criteria: * living alone * medical diagnosis of alzheimer's disease or mild cognitive impairment exclusion criteria: * living in nursing homes, assistive living facilities. * alcohol abuse
ureteral stent placement after ureteroscopy for renal stones: a randomized controlled trial

Conditions: Kidney Calculi

Summary: the rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.

kidney stones affect 9% individuals within the united states, and the prevalence is increasing. over the last few decades, ureteroscopy has become the most commonly performed stone procedure. however the complication rate after ureteroscopy is not insignificant. reducing morbidity after ureteroscopy would improve patient outcomes and reduce health care utilization. a major contributor to patient morbidity after ureteroscopy is the ureteral stent, which is placed at the time of surgery and left in place 1-2 weeks after surgery. the rationale for utilizing stents is to prevent urinary obstruction from edema or stone fragments. on the other hand, stents cause hematuria, pain, and lower urinary tract symptoms. additionally, stent-related symptoms are often misdiagnosed as urinary tract infections leading to unnecessary antibiotic use. the clinical utility of ureteral stents after ureteroscopy has not been well studied, specifically a stone located in the kidney. prior studies on stent-less ureteroscopic procedures have focused on treatment of ureteral stones and not stones located in the kidney, have had restrictive inclusion and exclusion criteria, are primarily from single center institutions, and most being performed \~15 years ago. surgical techniques and device innovations have changed the procedure since that time. to date, there have been only 2 studies that included stone located in the kidney showing no difference in unplanned hospital revisits, however both combined analyses with ureteral stones and selection bias was an issue for both studies. in addition, there is a lack of studies assessing opiate use, impact of quality of life with stent placement, and loss of work related to stent placement

Eligibility criteria:
inclusion criteria: * nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy exclusion criteria: * age \< 18 years * pregnancy status * ureteral stone * preoperative hydronephrosis * indwelling nephrostomy tube * planning bilateral ureteroscopy or subsequent staged ureteroscopy * solitary kidney or egfr \<60 ml/min (ckd stage 3 or greater) * variant anatomy including horseshoe kidney, pelvic kidney, prior urinary tract reconstruction
optical correction and visual functions of adults with amblyopia

Conditions: Amblyopia

Summary: amblyopia is a developmental anomaly resulting from abnormal visual experiences in early life. amblyopia causes reduced visual acuity in the absence of a pathology. adult sensory systems are believed to be structurally invariant beyond early, critical periods of development. however, recent evidence suggest that visual functions in adults with amblyopia can be improved with optical correction alone. this study aims to investigate whether improvements in best corrected visual acuity and other visual functions can result following appropriate optical correction in adults with amblyopia. functional measures relating to vision, binocular vision, and eye movements will be used to assess the efficacy of refractive correction for improving vision. this study will help us better understand the improvements in visual functions following optical correction, as well as the mechanisms underlying neuroplasticity in adults with amblyopia.


Eligibility criteria:
inclusion criteria: * 18-39 (inclusive) years of age * anisometropic amblyopia (difference of ≥0.50d spherical equivalent or ≥1.50d astigmatism between eyes) or mixed mechanism amblyopia (strabismus and anisometropia) * best corrected visual acuity (bcva) in the amblyopic eye of 0.3 logmar to 1.0 logmar (inclusive) * bcva in the non-amblyopic eye of 0.1 logmar or better, and an interocular va difference of 2 logmar lines or more * difference of 1.00d or more between current refractive correction and study prescription * good general health exclusion criteria: * other pathological ocular anomalies known to cause reduced visual acuity * presbyopia (based on amplitude of accommodation) * inability to tolerate prescribed refractive correction in spectacles (e.g., due to aniseikonia) * contraindication to cycloplegic eye drops * currently under amblyopia treatment/therapy * inability to comprehend test instructions and/or provide consent * eccentric fixation * \>-6.00ds of myopia in either eye with spectacles * bilateral amblyopia * presence of amblyopia that is not due to strabismus and/or anisometropia * presence of (current or previous) psychiatric, visual, or neurological disorders

Keywords: amblyopia binocular vision suppression plasticity optical correction
comparing fees to vfss in diagnosing laryngeal penetration and aspiration in infants in the nicu

Conditions: Deglutition Disorders

Summary: the main purpose of the study is to determine whether the fiberoptic endoscopic evaluation of swallowing (fees) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the videofluoroscopic swallowing study (vfss) in bottle-feeding infants in the nicu. a secondary objective is to determine whether fees can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding nicu infants.


Eligibility criteria:
inclusion criteria: * 37 weeks or more postmenstrual age * diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician * inpatient at baylor university medical center nicu exclusion criteria: * not medically stable enough to undergo both fees and vfss as determined by neonatal therapist and/or physician * bilateral complete cleft lip and palate

Keywords: deglutition disorders intensive care units, neonatal
exploratory study of molecular characterization in patients with metastatic germ cell tumours refractory/resistant to platinum treatment

Conditions: Testicular Germ Cell Tumor

Summary: 1. to establish whether circulating tumour dna is detectable in the plasma of patients with platinum refractory/resistant germ cell tumours 2. if ctdna is detectable, perform exploratory analyses to: 1. describe the molecular aberrations in plasma from metastatic gcts with platinum refractory/resistant disease 2. describe aberrations detected in sequential detected in sequential samples form the same individual patient and evaluate whether there are hyposthesis-generating changes that temporarily associate with clinical resistance.

this project will study the plasma of patients who have metastatic gcts with platinum refractory/resistant disease in order to establish if ctdna is detectable and then analyse the molecular aberrations. archival diagnostic tissue will be recalled (this is the tissue used to make the initial diagnosis of testicular cancer). excess tissue acquired from clinically mandated prospective biopsies will be stored and plasma which has been collected at a maximum of 15 time-points per year will be analysed. clinical data will be accessed to make clinically meaningful associations with plasma and tissue molecular aberrations.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed metastatic gct refractory/resistant to platinum treatment * patients who have signed the 'tissues for research' consent form at the royal marsden hospital and have blood samples stored in the rmh biobank. * patients with no prior or current non-testicular invasive malignancy within the last 3 years, other than non-melanoma skin cancer or nccn low risk prostate cancer (pt1 or pt2a gleason ≤ 6, psa ≤ 10 and ≤ 1cc total volume) exclusion criteria: * n/a

Keywords: ctdna
dose ranging study comparing the efficacy, safety and pharmacokinetics of intravenous infusions of abt-874 vs placebo in subjects with active crohn's disease

Conditions: Crohn's Disease

Summary: to compare the efficacy, safety and pharmacokinetics of abt-874 to placebo in subjects who have moderately to severely active crohn's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease for greater than 4 months confirmed by endoscopy or radiologic evaluation. * cdai score of \>= 220 and \<= 450 at week 0. * males and females \>= 18 years and \< 75 years of age at the screening visit. * judged to be in generally good health as determined by the investigator. exclusion criteria: * current diagnosis of the colitis other than crohn's disease. * symptomatic known strictures. * surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study. * ostomy or ileoanal pouch. (subjects with a previous ileo-rectal anastomosis are not excluded). * short bowel syndrome as determined by the investigator. * infection or risk factors for severe infections. * females who are pregnant or considering becoming pregnant during the study, or breast-feeding.

Keywords: crohn's disease
international severe asthma registry: canadian cohort

Conditions: Severe Asthma

Summary: the international severe asthma registry is a global initiative looking to ensure that the care of people with severe asthma will continue to improve by collecting detailed information about the health and treatment of as many people with the disease as possible. the study will gather anonymized longitudinal real-life data for participants with severe asthma for five years. the purpose of the registry is to track the progress of participants and determine how well they are responding to treatment. medical research using data from the registry will give the investigators a better understanding of severe asthma and help the investigators develop and improve the care and treatment for severe asthma participants. the canadian cohort of the registry will collect information from canadian participants with severe asthma across seven different sites.

study staff will collect medical information through reviewing participant medical charts and interviewing participants about their health/asthma. the information collected includes birth date, gender, ethnicity, height/weight, body mass index, medical history (smoking history and exacerbation history), current and past asthma related medications, and any recent test results available pertaining to blood work, lung function, allergen skin prick, and imaging. this information will be collected at the baseline visit, and then once a year at a follow up visit, for five years (total of five visits). participants will be assigned a unique study number to protect the confidentiality of their personal health care information. all study data will be de-identified and then stored in a secure information management system, hosted at the study sponsor, optimum patient care global limited in cambridge, united kingdom. participant identities will always be kept confidential and will not be included in any research that is published. data collected across the canadian sites will be used to find ways to improve asthma treatments in canada, to report on current patterns of managing severe asthma in canada, to identify different sub-groups of severe asthma, and to carry out various medical research to understand asthma better and develop new treatments. research records and health or other source records may be inspected in the presence of the principal investigator or by representatives of the university of british columbia's clinical research ethics board for the purpose of monitoring the research. no information or records that disclose participants' identities will be published without subject consent, nor will any information or records that disclose participants' identities be removed or released without subject consent unless required by law.

Eligibility criteria:
inclusion criteria: * participants 18 years or older * participants receiving treatment according to gina step 5 or uncontrolled in gina step 4 (uncontrolled is defined as having severe asthma symptoms or frequent exacerbations) exclusion criteria: -participants with mild to moderate asthma
discovering patterns in the gut microbiota associated with the risk of stroke and the outcome after a stroke and integration of these data with genomic information to find new drug targets and new treatments to improve neurological evolution and functional status of stroke patients.

Conditions: Ischemic Stroke

Summary: the composition of the intestinal microbiota is associated with the risk of stroke and with post-stroke neurological evolution. at the same time, the genetics and epigenetics of each patient are associated with the composition of the intestinal microbiota. the study of the microbiome in stroke patients will allow finding new therapeutic targets for the treatment of stroke patients. for the study, samples will be collected from those patients with ischemic stroke who come to the hospital while the study is being carried out, taking into account certain criteria: the patients must be over 18 years of age, have suffered an ischemic stroke (demonstrated by resonance or head ct), not have any additional serious illness or unstable medical condition, and not be included in clinical trials with neuroprotective drugs. on the other hand, the control group will be asymptomatic, and will be made up of people who have not previously suffered a stroke or a cardiovascular event and who do not have diseases that affect the digestive tract. the main variables of the study are the risk of stroke and disability after a cerebrovascular accident (measured by mrs at 3rd month). microbiota, genetic and epigenetic variables are also taken into account, such as the presence and levels of bacteria, dysbiosis, genetic polymorphisms and levels of methylation in cpg islands.


Eligibility criteria:
inclusion criteria: * patients with ischemic stroke (demonstrated by resonance or head ct). exclusion criteria: * patients under 18 years of age. * additional serious illness or unstable medical condition. * inclusion in clinical trials with neuroprotective drugs.

Keywords: gut microbiota stroke metagenomics