Kornimate/medical-research-clean huggingface dataset:
feasibility and acceptability of an online act intervention for disorders of gut-brain interaction

Conditions: DGBI; Depression/Anxiety

Summary: the goal of this clinical trial is to assess the acceptability, feasibility, and usability of the iactfordgbi intervention among patients with disorders of gut-brain interaction (dgbi). the main question it aims to answer are: what are the perceptions of patients with dgbi and healthcare practitioners regarding the acceptability, feasibility, and usability of the iactfordgbi intervention? participants will be asked to: complete the iactfordgbi intervention prototype, consisting of self-guided online sessions. participate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years 2. meeting clinical symptom levels for least one dgbi diagnosis (assessed with the rome iv diagnostic questionnaire for functional gastrointestinal disorders in adults (palsson et al., 2016)) 3. clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the montgomery åsberg depression rating scale (svanborg \& åsberg, 1994; (madrs-s; depressive symptoms), or score ≥ 10 on the generalized anxiety disorder scale-7 (gad-7; anxiety symptoms; spitzer et al., 2006) 4. stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention. 5. ability to read and write swedish 6. have access to a device (like computer, tablet or smartphone with) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones). exclusion criteria: 1. currently undergoing any form of psychological intervention. 2. increased risk of suicide (≥4 points on madrs item 9) 3. severe depression (\&amp;gt;34 points on madrs)
time-limited specific oral tolerance induction in children with severe egg allergy

Conditions: - Egg Hypersensitivity

Summary: to evaluate the efficacy of a 6-month specific oral tolerance induction (soti) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe ige-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.

oral immunotherapy consisted in the administration of increasing amounts of raw emulsion egg. the children started with 1 drop of undiluted raw egg emulsion (0.05 ml) flavored with vanilla and cacao, hidden by the parents in the child's breakfast (cow's milk, soymilk, fruit juice or other). the dose was doubled at intervals of about one month in the day hospital. the increases in dose were customized for each subject based on the frequency and severity of side effects, or when an inter-current illness or asthma worsening intervened during the soti. the investigators limited the soti protocol to six months for all patients, irrespective of the dose reached, in order to favor the adherence of families to the study. when objective symptoms seemed more important (grade 2, 3 and 4 reaction), medical treatment was given. subjects were discontinued from the study in case of severe adverse reactions (grade 5 reaction). parents were advised they could telephone investigators 24 hours a day

Eligibility criteria:
inclusion criteria: * at least 1 anaphylactic reaction (grade 3, 4 and 5 according to sampson's grading after accidental exposure to trace amounts of egg or egg-derivative products, requiring emergency treatment, at least 1 year before enrollment * demonstration of egg white specific ige by the skin prick test (spt), end-point spt, raw egg white prick-by-prick (pp) and egg white-specific ige determination * positive double-blind placebo-controlled food challenge (dbpcfc) at a dose of less than 0.9 ml of raw emulsion egg exclusion criteria: * age below 5 years * poorly controlled asthma * parents with a history of unreliable management of complications and treatment.

Keywords: egg allergy,specific oral tolerance induction
efficacy and safety evaluation of octreotide in the treatment of congenital hyperinsulinemia

Conditions: Congenital Hyperinsulinaemic Hypoglycaemia; Octreotide Adverse Reaction

Summary: to analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (chi) in children.

octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.

Eligibility criteria:
inclusion criteria: 1. consistent with the diagnosis of congenital hyperinsulinemia with ineffective diazine; with the maximum dose of diazine at 15mg/kg/d for 5 days, fasting blood glucose/postprandial blood glucose could not be stabilized at the target value of 3.3mmol/l without intravenous glucose infusion. 2. patients treated with octreotide subcutaneous injection. exclusion criteria: 1. before the diagnosis of chi and the treatment related to chi, the child had received total pancreatectomy without octreotide 2. secondary hypoglycemia caused by diseases other than chi 3. patients who refused to take octreotide due to parents or family economic reasons, but not hospital treatment factors. 4. patients who intervene/interfere with octreotide treatment regimen for parental reasons
efficacy of everolimus alone or in combination with pasireotide lar in advanced pnet

Conditions: Islet Cell Tumor

Summary: this study will estimate the treatment effect of everolimus in combination with pasireotide lar relative to everolimus alone on progression-free survival (pfs) in patients with advanced progressive pnet. a planned primary analysis was completed with data cut of 02-apr-2014. the study did not meet its primary objective, which was based on progression-free survival (pfs) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-feb-2015. however, it is important to note that the data did not reveal any new safety concerns. it was decided to stop the study and this decision was shared with the study sites on 31-jul-2014.


Eligibility criteria:
inclusion criteria: * advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor * progressive disease within the last 12 months * measurable disease per recist version 1.0 determined by multiphase mri or triphasic ct exclusion criteria: * patients currently requiring somatostatin analog treatment * prior therapy with mtor inhibitors or pasireotide * patients with more than 2 prior systemic treatment regimens * previous cytotoxic chemotherapy, targeted therapy, somatostatin analogs, or biotherapy within the last 4 weeks other protocol-defined inclusion/exclusion criteria may apply

Keywords: pancreatic neuroendocrine tumors pnet pasireotide everolimus advanced progressive pancreatic neuroendocrine tumor
a clinical safety study of at-100 (rhsp-d) in preterm neonates at high risk for bronchopulmonary dysplasia (bpd)

Conditions: Bronchopulmonary Dysplasia

Summary: the purpose of this study is to determine if an investigational drug, at-100, can reduce the occurrence of bronchopulmonary dysplasia (bpd) in babies born premature, as compared to babies born premature who receive an air-sham alone.


Eligibility criteria:
inclusion criteria 1. preterm neonates born between gestional age (ga): 1. 25 0/7 weeks to 28 6/7 weeks in the initial dose escalation cohorts. 2. 23 0/7 weeks to 28 6/7 weeks in the latter cohort. 2. intubated and on mechanical ventilation. 3. receiving at least 1 dose of standard-of-care-indicated surfactant treatment (curosurf®) after birth, and able to receive the first dose of at-100 or air-sham within 96 hours of birth given at any time point after 15 minutes following any of the subject's curosurf® dose(s). 4. parent or legal guardian is able to provide informed consent. exclusion criteria: 1. weight at time of birth \ 1,800 g. 2. major apparent congenital abnormalities impacting cardio and pulmonary function. 3. active dnr (do not resuscitate) order in place. 4. known pulmonary air leaks (e.g. pneumothorax and pneumomediastinum) at the time of at-100 or air-sham administration. 5. history of allergy or sensitivity to any surfactant or any component of the investigational product (at-100). 6. at-100 or air-sham dosing was set to occur before data safety monitoring committee recommendation to proceed to the next dose-escalation cohort. 7. use of minimally invasive surfactant techniques (e.g., lisa, mist) or insure or if, in the opinion of the care team, the infant is very likely too be extubated shortly after receiving curosurf®. a. subjects extubated and re-intubated after their curosurf® dose(s) are eligible, so long as the subject meets inclusion #3. 8. birth mother: 1. has known active hepatitis b, c, or e diagnosis. 2. has a known illness or exposure that, in the judgement of the investigator, is serious enough to induce an immune deficiency such as human immunodeficiency virus (hiv) and/or is receiving chemotherapy. 3. has known active sexually transmitted infection (sti). 4. has known cytomegalovirus (cmv) active infection. 5. has known history or evidence of alcohol or drug abuse, wit the exception of marijuana/marijuana-based products/thc, based on a positive maternal or infant drug screen as evidenced by the institution's standard-of-care practice. 9. concurrent enrollment in an investigational drug, device, or treatment modulation trial that utilizes treatments outside of standard-of-care. 10. any condition or situation which, in the investigator's judgement, puts the mother or the neonate at significant risk, could confound the trial results, or may interfere significantly with the mother's or neonate's participation in the trial. 11. symptomatic and confirmed covid-19 infection of the mother around the time of birth.

Keywords: bronchopulmonary dysplasia preterm neonate mechanical ventilation respiratory support recombinant human surfactant protein-d (rhsp-d) intratracheal air-sham
association of thyroid autoimmunity and chronic urticaria

Conditions: Skin Itching; Chronic Urticaria

Summary: increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. about 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism.

there is no such report on the association of thyroid autoantibodies and chronic urticaria in taiwan population yet. this study is designed to investigate the prevalence of thyroid autoimmunity associated with chronic urticaria in taiwanese population. in addition, we intend to find out the change in the level of thyroid autoimmunity after the treatment in order to further understand their relationship. we also intend to find out the prognostic parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.

Eligibility criteria:
inclusion criteria: * 18 years old and above * skin itching for more than 6 months exclusion criteria: * pure physical urticaria, infectious diseases, and food or food addictive hypersensitivity, chronic infection

Keywords: urticaria goiter
effects of orthognathic surgery on root resorption and soft tissues

Conditions: Orthodontics; Orthognathic Surgical Procedures

Summary: the aim of this study is to evaluate the three-dimensional tomographic and photographic evaluation of the provision of two different orthognathic surgeries on hard and soft tissues with informative class iii deformity due to maxillary retrognathia and mandibular prognathia.

patients who will undergo non-extraction surgery will be randomized as 'pre-surgery' (sec) and 'early surgery' (ec). maxillary advancement and mandibular recession will be calculated and a total of 24 patients, 12 in each group, will be included in the study. millimetric (length, dehiscence, fenestration) and volumetric measurements and soft tissue anthropometric points will be measured in three-dimensional recordings taken at the beginning of treatment (t0) and after debonding (t1). cone beam computed tomography (cbct) images will be transferred to nnt and 'mimics 18.0' programs for measurements. three-dimensional photographs will be evaluated in the 3dmdvultus program. shapiro-wilk test will be used for normality, 'two independent samples t-test' and 'mann whitney u test' will be used for intra-group and inter-group comparisons.

Eligibility criteria:
inclusion criteria: * they must be over 18 years of age, * skeletal class iii malocclusion and need double jaw orthognathic surgery, * minimum crowding (patients with crowding between 0-3 mm), * complete 3d records before surgery and at the end of treatment, * no decay on their teeth, * good oral hygiene, * healthy periodontal tissues. exclusion criteria: * history of trauma, * congenital anomalies or craniofacial deformities * congenital tooth loss (excluding wisdom teeth)

Keywords: orthognathic surgery surgery first surgery early dehiscence fenestration
capsule endoscopy as an alternative to colonoscopy

Conditions: Colonic Disease

Summary: this is a prospective, multicenter, interventional study assessing ce, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.

study design enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early ce; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from ce (early colonoscopy). study population patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria

Eligibility criteria:
inclusion criteria: * iron deficiency anaemia with or without a colonoscopy performed within the last 5 years * rectal bleeding/haematochezia in patients \>50 years who have undergone a colonoscopy \<5 years ago or \<50 years with no risk factors for crc * chronic constipation/abdominal distension/abdominal pain/diarrhea * suspected crc due to clinical criteria (nice guidelines 2015, updated in 2017) with no ifobt performed * recent change in bowel habits * follow-ups: post-polypectomy syndrome, family history of crc, hereditary syndromes, crc surgery, inflammatory bowel disease exclusion criteria: * study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis * evaluation following fragmented resection (recurrence ruled out) * patients with a positive fit * pregnancy or breast-feeding * any contraindication to crohn's capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices. * allergy or known contraindication to the medications and preparations agents used in the procedure.
qvar therapy in smoking asthmatics

Conditions: Asthma; Smoking

Summary: to evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (ef hfa-bdp) and other inhaled corticosteroid (ics) therapy commonly used in the uk, specifically fluticasone (fp) and non-extrafine (nef) bdp (cfc-bdp and nef hfa-bdp) in a uk primary care asthma population of current smokers.


Eligibility criteria:
inclusion criteria: * aged 16-70 years * current smokers - explicitly coded in patient records or captured in patient questionnaires * evidence of asthma diagnosis and current therapy: ≥2 prescriptions for asthma at different points in time during the baseline year ± a diagnostic code for asthma * on-going asthma therapy: ≥2 prescription for ics during the outcome period (i.e. ≥1 prescription in addition to ipd prescription) * ≥2 years continuous data (i.e. ≥1 year of baseline plus ≥1 year of outcome data) exclusion criteria: patients will be excluded from the analysis if they have: * any chronic respiratory disease other than asthma * are prescribed: * maintenance oral steroid therapy during the baseline year * combination ics/long-acting beta agonist (laba) therapy during baseline year or at ipd * multiple ics prescriptions at ipd or immediately before .

Keywords: primary care particle size beclomethasone dipropionate asthma management maintenance therapy metered-dose inhaler smoking
ketamine assisted psychotherapy for opioid use disorder

Conditions: Opioid-use Disorder

Summary: this pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.

the purpose of this study is to conduct a stage 1 randomized controlled trial to test a potential optimization of the evidence-based mindfulness-oriented recovery enhancement (more) intervention for opioid use disorder (oud). here we will add ketamine to more (more+kap) and test the more+kap intervention versus the standard more intervention in a sample of patients receiving medications for oud (moud; e.g, buprenorphine). the primary aim to is evaluate the extent to which more+kap improves oud treatment relative to more. the secondary aim is to identify the psychobiological mediators of more+kap.

Eligibility criteria:
inclusion criteria: 1. diagnosis of opioid use disorder 2. receiving oud treatment with a buprenorphine formulation exclusion criteria: 1. previous experience with a mindfulness-based intervention program 2. pregnancy 3. any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program 4. prior use of ketamine other than as prescribed by a physician 5. any of the following medical conditions blood vessel disease heart valve disease heart failure class 2 or above heart disease pregnancy/breastfeeding arteriovenous malformation history of intracranial bleeding or stroke history of seizures hypoxia defined by current need for supplemental oxygen liver disease history of allergic reaction to ketamine dementia (moderate-severe) history of psychotic disorder, bipolar disorder, or personality disorder dissociative identity disorder
hiv switch trial in experienced patients with multiple class resistance including nnrti resistance

Conditions: HIV Infections

Summary: this is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including nnrti resistance. the other arv medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the nrti and nnrti, will not be changed. the study will be performed only on two sites

the duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. the reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (mdr) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.

Eligibility criteria:
inclusion criteria: - adult (18 y.o. or more) women and men infected with hiv. * treated with etravirine and at least 2 others arv in the other classes: nrti, pi, insti, ei, for at least 12 months. * virologically controlled (hiv-1 rna \< 50 copies/ml) since at least 6 months. blips (hiv-arn ≥ 50 copies/ml, one time, with return to virologic control at the next visit) are allowed. * presence of at least one major nnrti mutation. * no limitation on the number of previous regimens. * hcv and hbv-infected patients are allowed exclusion criteria: high level of resistance to doravirine according to historical resistance tests. * level of resistance to doravirine superior to that of etravirine * opportunistic or serious active infection or disease * active and untreated malignancy. * current psychiatric or neurocognitive condition judged by the investigator to potentially interfere with study visits and procedures * pregnancy. * active treatment for hepatitis c is forbidden at entry but will be allowed after 3
key specialized monitoring of clinical safety of pudilan xiaoyan oral liquid in the real world

Conditions: Respiratory Infectious Diseases

Summary: to obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by pudilan xiaoyan oral liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.


Eligibility criteria:
inclusion criteria: * (1)upper respiratory tract infection patients using pudilan antiphlogistic oral liquid ; * (2)aged between 18 and 80. exclusion criteria: * lactating women, pregnant women, pregnant planners, psychiatric patients, etc.

Keywords: pudilan xiaoyan oral liquid safety monitoring
a study of ly2951742 (galcanezumab) in participants with cluster headache

Conditions: Episodic Cluster Headache; Chronic Cluster Headache

Summary: the main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study i5q-mc-cgal (nct02397473) or study i5q-mc-cgam (nct02438826).


Eligibility criteria:
inclusion criteria: * participants who participated in and completed either study cgal or study cgam. * investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements. exclusion criteria: * current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of study cgal or study cgam). * current use or any prior exposure to any calcitonin-gene-related peptide (cgrp) antibody, any antibody to the cgrp receptor, or antibody to nerve growth factor (ngf) (with the exception of study cgal or study cgam). * a history of migraine variants that could implicate or could be confused with ischemia. * known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins. * a history or presence of other medical illness that indicates a medical problem that would preclude study participation. * evidence of significant active or unstable psychiatric disease, in the opinion of the investigator. * women who are pregnant or nursing.

Keywords: cluster headache headache brain diseases central nervous system diseases headache disorders headache disorders, primary nervous system diseases neurologic manifestations pain trigeminal autonomic cephalalgias