Kornimate/medical-research-clean huggingface dataset:
isotretinoin in treating young patients with high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors plan better treatment for patients receiving isotretinoin. purpose: this clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.

objectives: primary * to investigate the feasibility of implementing individualized dosing of isotretinoin in patients with high-risk neuroblastoma after course 1 of treatment, based on isotretinoin pharmacokinetics and toxicity. * to minimize the large inter-patient variation in plasma concentrations of isotretinoin. * to ensure that patients are not exposed to potentially sub-optimal plasma concentrations of isotretinoin during long-term treatment, particularly for patients who are not able to swallow isotretinoin capsules. secondary * to obtain preliminary data on the potential impact of isotretinoin therapeutic monitoring on clinical response and toxicity in these patients. outline: this is a multicenter study. patients receive oral isotretinoin twice daily on days 1-14. courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. blood samples are collected at baseline and during courses 1-3 for pharmacokinetic studies and determination of each patient's individual therapeutic-dose level requirement. genotyping to identify genes that metabolize enzymes is conducted via pcr. after completion of study therapy, patients are followed up periodically for up to 3 years.

Eligibility criteria:
disease characteristics: * histologically confirmed high-risk neuroblastoma * concurrent isotretinoin as part of clinical treatment patient characteristics: * not pregnant * fertile patients must use effective contraception * has a single- or double-lumen central venous catheter in place prior concurrent therapy: * see disease characteristics

Keywords: localized unresectable neuroblastoma recurrent neuroblastoma stage 4s neuroblastoma
should we repair ischemic mitral regurgitation?

Conditions: Coronary Disease; Mitral Valve Insufficiency

Summary: the purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.


Eligibility criteria:
inclusion criteria: * stable coronary artery disease * patient accepted for coronary artery bypass surgery * ischemic mitral regurgitation exclusion criteria: * acute coronary syndrome within 30 days * organic valvular heart disease * need for other than cabg and mitral valve repair cardiac surgical procedure
to demonstrate the relative bioavailability of atenolol tablets

Conditions: Hypertension

Summary: to demonstrate the relative bioavailability of atenolol tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
a study to evaluate the safety and pharmacokinetics of ad-228a compared to coadministration of ad-2281 and ad-2282

Conditions: Primary Hypercholesterolaemia

Summary: primary endpoint of this study is to evaluate the pharmacokinetic characteristics of ad-228a in healthy subjects.

the purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of ad-228a compared with coadministration ad-2281 and ad-2282 in healthy subjects.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * the age equal to or greater than 19 in healthy volunteers at the time of screening visit exclusion criteria: * participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * other exclusions applied
childhood trauma, exercise, and cognition

Conditions: Adverse Childhood Experiences

Summary: this study aims to identify and compare the effects of acute and chronic exercise interventions on cognition in middle-aged adults with cognitive complaints and a history of abuse or neglect in childhood. each participant will be enrolled in the study for up to 78 days, in five parts following verification that the participant meets criteria to be included in the study: 1) initial assessment; 2) first acute exercise condition in lab, symptom measures, and neuropsychological testing; 3) second acute exercise condition in lab, symptom measures, and neuropsychological testing; and 4) 9-week exercise intervention or activity as usual outside of lab, with interview, symptom measures, and neuropsychological testing at three-week intervals.


Eligibility criteria:
inclusion criteria: * between 40 and 60 years of age * history of child abuse or neglect * have a complaint about memory, attention, or executive function * native or fluent english speaker * normal or corrected to normal vision and hearing * medically healthy exclusion criteria: * score indicating a history of moderate-intensity activity, hard-intensity activity, or very-hard intensity activity on the stanford brief activity survey * current excessive alcohol or other substance use * eating disorder, bipolar disorder, schizophrenia spectrum disorders, or those judged to be an immediate suicide risk based on having an active plan with intent * autism spectrum disorder, attention-deficit/hyperactivity disorder (adhd), or other neurodevelopmental disorder * neurocognitive disorder, or illnesses or history of neurological events known to cause neurocognitive disorders (e.g., traumatic brain injury, status epilepticus, stroke) * reported chest pain or dizziness during exercise; any endorsed and not controlled medical condition that could make exercise contraindicated, including hypertension; heart disease; heart failure; hear rhythm disorders; heart valve disease; metabolic conditions; chronic obstructive pulmonary disease; pulmonary hypertension; cystic fibrosis; asthma; and bone, joint, or soft tissue problems * pregnancy, major medical disorders such as cancer, or any other condition believed to put a participant at risk
impact of la-ceal halt covid-19 ambassador program on likelihood to vaccinate

Conditions: Covid19; Vaccine Refusal

Summary: the purpose of the study is to assess the effectiveness of the halt covid ambassador educational outreach program on increasing likelihood to vaccinate against covid-19

investigators will use a randomized controlled trial to test the effectiveness of halt covid educational outreach by halt covid ambassadors. halt covid ambassadors will receive training to answer common vaccine questions \& address misconceptions; conduct motivational interviewing; and implement basic behavioral economics and related strategies to remove barriers to vaccination. a random sample of fqhc patients will be identified in ehr data downloads of adult patients seen in the last year and contacted by telephone to gain consent and assess eligibility. a total of 100 individuals will be enrolled into the trial and randomized to intervention (engagement with the halt covid ambassador over a 1 month period via in-person or virtual sessions exploring their own questions and concerns about vaccines) or usual care (no extra engagement). baseline, 1-month, and 2-month follow-up surveys will assess for vaccine likelihood.

Eligibility criteria:
inclusion criteria: * unlikely to vaccinate in next month * age \>=18 years * self-identification as black or african american * ability to understand and speak english * willingness to engage with halt covid ambassador via in-person or virtual sessions exploring questions and concerns about vaccines exclusion criteria: * unable or unwilling to give informed consent

Keywords: community health worker
efficacy of neurofeedback training in adults with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: neurofeedback training (nft) has been frequently investigated as an alternative treatment for adhd mainly in children and adolescents. however, randomized double-blind trials that include a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of nft in adult adhd populations. the inclusion of a sham-neurofeedback group is crucial to monitor and exclude unspecific effects. this study aims to investigate the efficacy of nft as compared to a sham-feedback condition and a cognitive behavioral treatment in adults with persistent adhd. efficacy is assessed on several outcome parameters, such as symptom severity, neuropsychological variables (e.g., attention, memory), and eeg parameters.


Eligibility criteria:
inclusion criteria: * adhd diagnosis * sufficient knowledge of the german language exclusion criteria: * psychiatric disorder(s) lifetime (bipolar disorder, schizophrenia, schizoaffective disorder, borderline personality disorder) * neurological disorder (e.g., epilepsy) * current substance abuse disorder * receives psychotherapy (e.g., cbt) or medication

Keywords: adhd, neurofeedback, cbt
acupuncture efficacy on lipids in tinnitus patients with obesity

Conditions: Tinnitus, Subjective; Obesity; Lipids

Summary: nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood.

for 8 weeks, our study will search effect of acupuncture on tinnitus (chronic subjective type), lipids and weight reduction in obese persons.

Eligibility criteria:
inclusion criteria: * obese patients * tinnitus complaints (chronic subjective form) exclusion criteria: * diabetics * cardiovascular and neurogenic manifestations
implementation of laparoscopy-assisted surgery for colon cancer

Conditions: Colon Cancer

Summary: the purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.

prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes

Eligibility criteria:
inclusion criteria: * age \>17 years * diagnosis of colon cancer either endoscopically, radiologically or histologically proven * no evidence of disseminated disease on ct scan * t1-3 according to preoperative ct scan * written informed consent to participate exclusion criteria: * preoperative diagnosis of locally advanced tumor (t4) * suspicion of pathological lymph nodes outside anticipated resection area * contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns * lack of informed consent
optimizing intervention effects in children and adolescents

Conditions: Childhood Obesity

Summary: childhood obesity is a significant public health concern worldwide. in china, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term. this study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention. the project will be carried out in six primary schools in ningbo city, zhejiang province , those schools are randomly divided into two groups: the intervention group and the usual practice group. the participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. this intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.


Eligibility criteria:
inclusion criteria: * parents agree and support their children's weight loss, and students and parents have informed consent; * students in third grade aged 8 to 10 years old. exclusion criteria: * medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis; * obesity caused by endocrine diseases or side effects of drugs; * abnormal physical development like dwarfism or gigantism; * physical deformity such as severe scoliosis, pectus carinatum, limp, obvious o-leg or x-leg; * inability to participate in school sport activities; * a loss in weight by vomiting or taking drugs during the past 3 months.
aminophylline on perioperative lung mechanics in copd morbidly obese patients undergoing laparoscopic bariatric surgery

Conditions: Aminophylline; Chronic Obstructive Pulmonary Disease; Obese; Laparoscopic Bariatric Surgery; Dexmedetomidine; Lung Mechanics

Summary: the aim of this study is to evaluate the usefulness of adding aminophylline to dexmedetomidine intravenous infusion intraoperatively on oxygenation and lung mechanics in chronic obstructive pulmonary disease (copd) morbidly obese patients undergoing bariatric surgery.

bariatric surgery is considered the most effective treatment for patients suffering from morbid obesity, as it results in maintained loss of weight and clear impact on the comorbidities related to obesity. however, despite the advantages of anesthesia, it can have detrimental effects on the recovery of obese patients who have a high prevalence of respiratory conditions and sleep disorders. obesity is usually related to other respiratory diseases such as asthma, chronic obstructive pulmonary disease (copd). according to a meta-analysis encompassing more than 300,000 adult patients, obesity and asthma were interlinked, and as bmi increased, a higher risk of asthma was noticed. the use of dexmedetomidine infusion in morbid obese patients was assessed by many clinical trials. they revealed that the use of dexmedetomidine has the same analgesic effect as the use of fentanyl with greater hemodynamic stability obtained with the use of dexmedetomidine. dexmedetomidine has the advantage of having no respiratory depressant effect. also, it has an amnestic effect. dexmedetomidine does not affect the sleep pattern and maintains the airway patency. aminophylline is a compound of theophylline with ethylenediamine and most common uses in the airway obstruction such as asthma and copd. primarily for its bronchodilating and central nervous stimulating effects. however, emprical evidence suggests that aminophylline, as an adenosine antagonist, can improve the recovery time from general anesthesia.

Eligibility criteria:
inclusion criteria: * age from 20 to 60 years. * patients scheduled for laparoscopic bariatric surgery not exceeding three hours under general anesthesia. * american society of anesthesiologists (asa) class ii to iii. * patients who had no previous abdominal surgery. * patients with a body mass index (bmi) greater than 40 kg/m2and suffered obstructive lung disease diagnosed by pulmonary function tests (; forced vital capacity (fev1\\fvc) \< 70%). * patients who are psychologically normal. exclusion criteria: * patients who refuse to participate. * those with arrhythmia or receiving anti-arrhythmic medications. * those with significant coexisting diseases (e.g. kidney, heart, liver). * those with known allergy to any of allocated drugs. * those with excessive intraoperative blood loss more than allowable amount to every patient.
safety and efficacy of stem cell transplantation for treatment of liver cirrhosis

Conditions: Other Surgical Procedures

Summary: mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. umbilical cord mesenchyma stem cell with self-and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. in this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures in patients liver cirrhosis will be evaluated.

this study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. all the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of liver cirrhosis; * without hepatic encephalopathy; * no ascites or have easily dissipated ascites; * value of bilirubin is less than 100; * value of albumin is greater than 16 g / l; * prothrombin time is less than 21 seconds; exclusion criteria: * severe cardiovascular disease, and immunocompromised patients; * patients with localized lesions affecting graft infection; * coagulation disorders; * liver nodules more than 2cm or liver cancer

Keywords: umbilical cord mesenchyma stem cell
an observational study of first-line maintenance rituximab (mabthera/rituxan) in participants with follicular non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-hodgkin's lymphoma. participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.


Eligibility criteria:
inclusion criteria: * histological diagnosis of follicular non-hodgkin's lymphoma * complete or partial response to first-line induction therapy with chemotherapy with rituximab * participants about to receive first-line rituximab maintenance treatment for follicular non-hodgkin's lymphoma according to the local label exclusion criteria: * pregnant or lactating women * receipt of an investigational drug within 30 days prior to initiation of observational drug * any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent * central nervous system involvement * hepatitis b or c virus infection or human immunodeficiency virus infection
a research study to look into how well semaglutide medicine works at different doses in people with type 2 diabetes and overweight

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares how three doses of semaglutide work in participants with type 2 diabetes (t2d) and overweight who are taking metformin. the study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). participants will take the study medicine with an injection pen called novopen®4. the injection pen is a medical tool with a needle used to inject the study medicine under the skin. the study will last for about 52 weeks. participants will have 13 clinic visits and 4 phone calls.


Eligibility criteria:
inclusion criteria: * male or female. * aged 18-64 years (both inclusive) at the time of signing informed consent. * diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening. * glycosylated haemoglobin (hba1c) of 7.0 - 10.5 percentage (%) \[53 - 91 millimoles per mole (mmol/mol)\] (both inclusive). * body mass index (bmi) ≥ 27.0 kilograms per meter square (kg/m\^2). * stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations. exclusion criteria: * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * renal impairment measured as estimated glomerular filtration rate (egfr) value of less than (\<) 30 milliliters per minute (ml/min)/1.73 meter square (m\^2) at screening.
follow-up study of aav-mediated gene transfer (ux111; previously known as abo-102) for mps type iiia

Conditions: Mucopolysaccharidosis IIIA; MPS IIIA; Sanfilippo Syndrome; Sanfilippo A

Summary: the main objective of this study is to evaluate the safety/tolerability and efficacy of ux111 (previously known as abo-102) in participants with mucopolysaccharidosis iiia (mps iiia).

this is a multicenter, long-term follow-up study of patients with mps iiia who have participated in a prior clinical trial involving the administration of ux111 (nct02716246 and nct04088734). no investigational product will be provided. at approved sites adjuvant immunomodulatory (im) therapy may be administered to selected participants. the principal investigator and/or caregiver, in consultation with the medical monitor, will determine whether to initiate adjuvant im therapy. not all participants may receive im therapy. this study was previously posted by abeona therapeutics, inc and was transferred to ultragenyx in august 2022.

Eligibility criteria:
inclusion criteria: * participants that have participated in a prior clinical trial in which they received ux111 * parent(s)/legal guardian(s) of participant willing and able to complete the informed consent process and comply with study procedures and visit schedule exclusion criteria: * planned or current participation in another clinical trial that may confound the safety or efficacy evaluation of ux111 during this study * any other situation or medical condition that precludes the participant from undergoing procedures required in this study

Keywords: mps iiia sanfilippo gene therapy
a study to assess the efficacy of early physical therapy intervention following a modified unilateral neck dissection for treatment of head and neck cancer

Conditions: Shoulder Weakness Following Neck Dissection Surgery

Summary: this study will determine whether patients who receive regular physical therapy immediately following a modified neck dissection surgery will report decreased shoulder disability, decreased pain, improved or maintained shoulder range of motion and strength, and improved quality of life than those who receive only home instruction.


Eligibility criteria:
inclusion criteria: * adults age 18-85, able to give informed consent * subject has provided written informed consent * received modified unilateral neck dissection with sparing of the san * not currently using transcutaneous electrical nerve stimulation (tens) as a pain relieving modality * not currently receiving acupuncture as a pain relieving modality * able to participate with treatment group protocol including physical therapy appointment every other week exclusion criteria: * history of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty. * history of cva with hemi paresis * bilateral neck dissection * known severed san

Keywords: spinal accessory nerve palsy, cranial nerve xi, shoulder weakness, neck stiffness, head and neck cancer, neck dissection