Kornimate/medical-research-clean huggingface dataset:
evaluating the use of prednisone to decrease pegylated interferon beta-1a side effects

Conditions: Multiple Sclerosis

Summary: some of the most common side effects of the multiple sclerosis drug plegridy (pegylated interferon beta-1a) include flu-like symptoms and injection site reactions. physicians often advise patients to take tylenol or aspirin prior to injection, but in this study the investigators evaluated whether using a low dose of oral steroid in combination with tylenol reduced flu-like symptoms and injection site reactions.

multiple sclerosis (ms) is a chronic neurological disease characterized by demyelination of the brain and spine. currently, there are several treatments designed to decrease the frequency of attacks and delay disease progression. one of these treatments, interferon beta, has shown the potential to decrease relapse rates by approximately 30%, but because the body quickly clears these proteins, patients require more frequent dosing. another interferon therapy called pegylated interferon beta-1a (plegridy) was released and it was shown to last longer in the body than interferon beta-1a. this is why plegridy can be take by an injection into tissue under the skin once every 14 days. however, some of the most common side effects of interferon beta therapy include flu-like symptoms and injection skin reactions, which can often cause patients to want to stop treatment. clinical practitioners often advise patients to take acetaminophen (tylenol) or aspirin before the injection in order to prevent the onset or decrease the severity of flu-like symptoms. a previous study with patients taking interferon beta-1a showed that taking a low dose oral steroid (prednisone) in addiction to a medication like tylenol reduced flu-like symptoms compared to just taking tylenol by itself. because plegridy lasts longer in the body and has more convenient dosing for patients, researchers in this study decided to investigate whether taking prednisone in addition to acetaminophen before the injection would help decrease or prevent the occurrence of flu-like symptoms and injection site reactions in patients taking the therapy.

Eligibility criteria:
inclusion criteria: * diagnosed any form of ms (relapsing remitting, primary progressive, secondary progressive), any edss (expanded stability status scale) score exclusion criteria: * prior allergic reaction to interferon products, congestive heart failure, elevated liver enzymes

Keywords: demyelination relapse rate pegylated interferon beta-1a side effects flu-like symptoms injection site reactions prednisone
a teleintervention in developmental coordination disorder

Conditions: Developmental Coordination Disorder

Summary: the principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of dcd, and ii) parents' utilization of the teleintervention. the study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention.

developmental coordination disorder (dcd) is a neurodevelopmental disorder characterised by difficulties in planning and execution of motor coordination activities like dressing, sports and writing. increasing parents' capacity to manage their children's needs is part of the recommended dcd best practices, as soon as children are suspected to have dcd or early following diagnosis. parents' capacity could be increased through simple, community-based interventions using a consultative approach. using the internet could be an interesting avenue to develop public community-based services and build parents' capacity to manage their child with dcd. the feasibility of recruiting and using the internet to build parents' capacity is however unknown, since no such study have been conducted. this randomized feasibility trail will experiment a teleintervention, characterized by a virtual interaction between a health professional and a user by internet, for children with dcd. the principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of dcd, and ii) parents' utilization of the teleintervention. the study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention. as part of the evaluation of acceptability, the impact of the teleintervention on parental competencies will be explored. at the end of the 3-months randomized feasibility trial, the influence of the number of participants on the utilization of the teleintervention will be explored by providing access to the teleintervention to all participants (control and intervention).

Eligibility criteria:
inclusion criteria: * a dcd medical diagnostic (or dcd medical hypothesis) * must be at or under the 16e percentile for the global score at the movement assessment battery for children-2 (mabc-2) or be at or under the 5e for one of the 3 subscale of the mabc-2. exclusion criteria: * do not have other neurodevelopmental diagnoses, with the exception of attention deficit hyperactivity disorder (adhd) * do not receive rehabilitation services for dcd in the public health care system
online cognitive behavioural therapy for substance use disorder: the impact of peer support

Conditions: Substance Use Disorders

Summary: the purpose of this study is to evaluate the efficacy and cost-effectiveness of breaking free online, in a comparison of outpatients seeking treatment for substance use disorder who receive standard care with group peer support, versus with access to breaking free online, versus with access to breaking free online and individual peer support.

a total of 225 outpatients receiving standard care for substance use disorder from the centre for addiction and mental health will be randomized to receive clinical monitoring (cm) with group peer support, breaking free online only, or breaking free online with individual peer support, in an eight-week trial with a six-month follow-up period. the primary outcome is substance use frequency; secondary outcomes include substance use problems, depression, anxiety, quality of life, treatment engagement, and cost-effectiveness.

Eligibility criteria:
inclusion criteria: 1. 18 years of age and above 2. fluency in english 3. understanding and willingness to comply with study requirements \& provide informed consent 4. current substance use disorder 5. have used alcohol or substances within the past 30 days 6. registration with camh addictions program outpatient services exclusion criteria: 1. current psychosis or mania 2. current psychiatric disorder requiring care more urgently than substance use, including acute intoxication or withdrawal requiring medical attention 3. significant neurological disorder or physical illness likely to interfere with participants 4. any known practical factors that would preclude participation (e.g., extended absences) 5. inability to read at a sixth grade level

Keywords: cognitive behavioral therapy online treatment peer support
acne treatment with active patches which contains azelaic acid, citric acid,salicylic acid and 2% ascorbic acid

Conditions: Acne Vulgaris

Summary: the purpose of this study was to demonstrate the effect of short treatment with active oplon patches on acne.

patients with acne vulgaris were treated overnight with active patches. effect is observed at the end of the treatment and 24 hours later.

Eligibility criteria:
inclusion criteria: * acne vulgaris * over 18 years * signing informed consent exclusion criteria: * active treatment of acne * change in hormonal therapy * antibiotic treatment in a week prior to the experiment * sensitive skin * pregnancy
effect of dapagliflozin on iah in t1dm

Conditions: Diabetes Mellitus, Type 1; Hypoglycemia; Hypoglycemia Unawareness

Summary: approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired awareness of hypoglycaemia (iah) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. iah is usually the end-result of a process of habituation to recurrent hypoglycaemia that is potentially reversible. treatment with sodium glucose cotransporter (sglt)-2 inhibitors (sglt-2i) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. this study will test the hypothesis that treatment with the sglt-2 inhibitor, dapagliflozin, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and iah. in a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 8 weeks with dapagliflozin (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.


Eligibility criteria:
inclusion criteria: * type 1 diabetes, disease duration \>1 year * age \>18 years, \<75 years * bmi 19-40 kg/m\^2 * insulin treatment according to basal-bolus insulin regimen (injections or insulin pump) * impaired awareness of hypoglycemia as assessed by a score of 3 or more on the modified dutch translation of the clarke questionnaire * glycated haemoglobin (hba1c) ≥42 mmol/mol (6%) and ≤75 mmol/mol (9.0%) * ability to provide informed consent exclusion criteria: * treatment with sglt-2 inhibitors * known intolerance to sglt-2 inhibitors * treatment with loop diuretics or other anti-hypertensive agents * treatment with glucose-modifying (other than insulin) or immune-modifying agents (e.g. prednisolon) * treatment with pioglitazone * use of statins * a history of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure) or hypotension * a history of galactose-intolerance, lactase deficiency, glucose-galactose malabsorption * history of diabetic ketoacidosis requiring medical intervention within 1 month before screening * admission to the hospital for hyperglycemia or hypoglycemia within 1 month before screening * frequent episodes of severe hypoglycemia within 1 month before screening * laser coagulation for proliferative retinopathy (past 6 months) * proliferative retinopathy * diabetic nephropathy as reflected by an albumin-creatinin ratio ˃ 30 mmol/mg or an estimated glomerular filtration rate (by mdrd) ˂60ml/min/1.73m2 * history of pancreatitis (acute or chronic) or pancreatic cancer * use of premixed insulin or of long-acting insulin alone * total daily insulin dose requirements \<20 units unless on pump treatment * pregnancy or unwillingness to undertake measures for birth control
analysis of selective cerebrovascular distribution with fdct in the angiosuite

Conditions: Ischemic Stroke; Intracranial Aneurysm; Intracranial Arterial Diseases; Cerebral Hypoxia; Intracranial Vascular Disorder

Summary: the aim of this study is to evaluate the clinical feasibility of the angiographic flat detector ct perfusion imaging (6s pbv) technique. the investigators will examine the specific vessel distribution of patients with steno-occlusive disease, treated with a surgical extracranial-intracranial bypass and assess the cerebral perfusion during test occlusion upon a neurovascular treatment and in intracranial tumor patients referred for potential pre-operative embolization. this study encompasses three scientific objectives: 1. what is the selective contribution of an individual bypass artery to the brain perfusion? 2. is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors? 3. what is the usefulness of performing additive 6s pbv images compared to classical 2d angiography and/or clinical neurological evaluation in case of test occlusion in the evaluation of possible mother vessel occlusion in treatment of complex neurovascular diseases?


Eligibility criteria:
inclusion criteria: * patients referred for diagnostics and surgical (extracranial-intracranial bypass) treatment of steno-occlusive neurovascular disorders. * patients referred for hypervascular intracranial tumor resection * patients referred for angiographic test occlusion as part of treatment of complex neurovascular disorders. exclusion criteria: * pregnant women or women trying to get pregnant * people younger than 18 years old * patients with thyroid disorders and diabetes, especially those using medication with metformin.
photon therapy versus proton therapy in early tonsil cancer.

Conditions: Tonsil Cancer

Summary: in this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage t1-2 (p16-positive or p16-negative) n0-1 (p16-positive)/n0-n2b (p16-negative) according to american joint committee on cancer (ajcc) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. the patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.


Eligibility criteria:
inclusion criteria: 1. the patient must be at least 18 years old. 2. histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the tonsil t1-2 (p16-positive or p16-negative) n0-1 m0 (p16-positive)/n0-n2b m0 (p16-negative) according to ajcc 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent. the treatment may be followed but not preceded by surgery, which would be as a salvage procedure and not part of the planned treatment. an excision of a lymph node, or a tonsillectomy for diagnostic purposes does not exclude the patient from participation. 3. world health organisation/eastern cooperative oncology group (who/ecog) performance status 0-1. 4. the patient must be able to understand the information about the treatment and give a written informed consent. exclusion criteria: 1. patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy 2. concomitant or previous malignancies. exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years. 3. two or more synchronous primary cancers in the head and neck region at time of diagnosis 4. previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator 5. co-existing disease prejudicing survival (expected survival should be \>2 years). 6. psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance 7. when dental fillings with amalgam or metal are present close to the tumour area it must be considered if this may affect radiotherapy before inclusion.

Keywords: tonsil cancer early tonsil cancer radiotherapy photons protons acute side effects late side effects locoregional control disease free survival quality of life health economic
studies of white blood cells derived from hht patients

Conditions: Telangiectasia, Hereditary Hemorrhagic

Summary: hereditary haemorrhagic telangiectasia (hht, also known as osler-weber-rendu syndrome) is an inherited vascular disease that leads to the development of dilated and fragile blood vessels. the study goal is to culture white blood cells that express the proteins mutated in hht and examine in the laboratory to explain aspects of the hht disease phenotype.

hht is a vascular condition but many of the genes that are mutated to cause hht (endoglin, alk-1 and smad4) are also expressed in white blood cells. in this study, investigators will take blood samples from people with hht, culture the white blood cells and study their properties in media prompting different types of differentiation, or infection of cell lines with epstein barr virus to provide cell lines which can be repeatedly studied. rna and proteins will be extracted from these cells for study of white cell responses and association with expression levels of endoglin, alk-1 and smad4. the investigators hypothesize that these cells which express "half-normal" endoglin, alk-1 or smad4 will show differences when compared to normal white blood cells. it is also anticipated that that these findings may help to explain aspects of the hht disease phenotype.

Eligibility criteria:
inclusion criteria: * patients with hht, * hht patients family members exclusion criteria: * unable to provide informed consent

Keywords: telangiectasia
efficacy of fsgm cloud-based remote intervention for insulin-dependent diabetic patients (friend)

Conditions: Type 1 Diabetes Mellitus

Summary: to investigate the efficacy of remote intervention by medical staff based on a cloud system of continuous glucose monitoring data in patients with insulin-dependent diabetes using flash sensor-based glucose monitoring (fsgm).

* previous studies have been reported on the efficacy of cgm or fsgm and education on glucose control in insulin-dependent diabetes patients. * this study aims to investigate whether it is more effective to receive remote intervention by medical staff based on a cloud system, than only to use fsgm and receive general education on fsgm. * trial design : parallel group, allocation ratio 1:1, a superiority study design

Eligibility criteria:
inclusion criteria: * men or women aged 19 to 75 years old * patients with type 1 diabetes * patients on multiple daily insulin-injection or continuous subcutaneous insulin infusion therapy for more than 1 year * patients with hba1c ≥ 7.0% at screening * patients willing to use a fsgm system * patients with informed consent exclusion criteria: * gestational diabetes patients * patients within 1 year of diabetic diagnosis * patients taking drugs for severe cognitive impairment or psychiatric problems * patients who received oral or parenteral corticosteroid therapy for more than 7 consecutive days within 1 month before screening test * patients with severe infection, before and after surgery, and severe trauma * patients on dialysis at the end of renal failure * patients who have a history of substance abuse or alcoholism within 12 weeks through patient history taking, diagnosis records, and past treatment records * pregnant or lactating women * participating in other clinical trials under r\&d other than this clinical trial, or if other clinical trial drugs are administered within 4 weeks before the trial * patients who are using a cgms/fsgm or who have been using it within 12 weeks

Keywords: remote intervention flash sensor-based glucose monitoring type 1 diabetes mellitus insulin-dependent diabetes mellitus
a single-arm trial of roxadustat combined with retinoic acid in the treatment of refractory low-risk mds

Conditions: Myelodysplastic Syndromes

Summary: roxadustat has been approved for low-risk mds clinical trials, but the trial results are not available. for refractory low-risk mds, the effective rate of roxadustat treatment is about 20-30%, and roxadustat combined with retinoic acid may have better efficacy in the treatment of refractory low-risk mds.

patients with low-risk myelodysplastic syndrome who are refractory to the regular treatments have to live on transfusions which lead to poor quality of life (qol) and survival. roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which increases both endogenous epo and iron metabolism, has shown promising results in several phase 3 clinical trials for chronic kidney disease. roxadustat comprehensively improves iron metabolism by upregulating dcytb and dmt1 through the hif pathway, which can promote the iron absorption and utilization. detail mechanisms include upregulating transferrin receptors to increase iron uptake, upregulating transferrin to promote iron transport and downregulating ferritin levels to indirectly improve iron absorption and transportation. patients with refractory low-risk mds were selected and given roxadustat 150mg po qod combined with retinoic acid 20mg po bid.

Eligibility criteria:
inclusion criteria: * low-risk mds unresponsive to first-line therapy exclusion criteria: * myelofibrosis * severe heart and kidney function bu'quan
strong teens for healthy schools change club: a civic engagement approach to improving physical activity and healthy eating environments

Conditions: Cardiovascular Diseases; Nutrition; Physical Activity

Summary: strong teens for healthy schools (sths) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.

the investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the strong teens for healthy schools (sths) program on cardiovascular disease-related outcomes. sths is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (cvd) outcomes among 6th and 7th-grade students. title 1 middle schools in texas (n=20) with \> 40% hispanic and black students will be randomized at baseline to the intervention condition (sths program) or control condition (will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming) (n=20-25 students per school). the investigators hypothesize that students who participate in sths will have reduced mets risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.

Eligibility criteria:
school inclusion criteria: * \> 50 6th and 7th grade students * \> 40% economically disadvantaged students * \> 40% black and hispanic students school exclusion criteria: student inclusion criteria: * 6th or 7th grade student * attend a title 1 middle school that is participating in the sths intervention * read and understand english student exclusion criteria: * participation in a weight loss program in the past 3 months * presence of a condition that prevents participation in physical activity
a study evaluating quality of life for participants with atrial fibrillation (af) following a bleed (equal-af)

Conditions: Atrial Fibrillation

Summary: the purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for af and evaluating their qol through both primary and secondary care settings.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * adult patients (\>= 18 years old) * patients who can understand all study information and literature to provide fully informed consent * atrial fibrillation (af) as the primary diagnosis * having a major or minor bleed up to a maximum of 30 days prior to point of enrolment * receiving oral anticoagulation therapy for af exclusion criteria: * pregnant women * patients with active cancer * patients unable to consent for themselves * patient on concomitant antiplatelet therapy

Keywords: bms-562247 atrial fibrillation oral anticoagulant prospective study quality of life (qol) united kingdom