Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety, efficacy, and pharmacokinetics of budesonide extended-release tablets in pediatric subjects aged 5 to 17 years with active, mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (pk) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (uc). subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-asa) products.


Eligibility criteria:
inclusion criteria: * established diagnosis of uc is based on: * clinical history * characteristic endoscopic findings * histopathology results from biopsies * age 5 to 17 years, inclusive, at screening. subjects should weigh greater than 13.6 kg at baseline. * active uc of mild or moderate severity, defined as a total mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1. * if on a background oral or rectal 5-asa, the dose and formulation have remained unchanged for at least 6 weeks prior to visit 2 (randomization), baseline and the subject is willing to remain on the same formulation and dose for the duration of the study. exclusion criteria: 1. current or prior diagnosis of crohn's disease or indeterminate colitis. 2. limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge. 3. severe uc, defined as total mayo score \>10. 4. not currently in an active phase or flare, defined as a total mayo score \<4, or mayo score between 4 and 10, but mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy. 5. infectious colitis (based on positive microbiologic tests at screening) or any recent history of infectious colitis (within 30 days prior to screening). 6. prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical). note: prior cholecystectomy is not exclusionary if more than 1 year prior to screening. 7. evidence or history of toxic megacolon or bowel resection.
a study of cadonilimab combined with ak112 as second-line therapy in patients with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: to evaluate the efficacy and safety of cadonilimab combined with ak112 as second-line therapy in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed hcc * age 18-75 years old * ecog ps 0-1 * child pugh a-b7 * patients who progressed on first-line standard system therapy (immunotherapy combined with anti-angiogenesis targeting regimen) or with intolerable toxicity * at least one measurable lesion (recist 1.1) * enough organ and bone marrow function * expected survival time≥12 weeks * sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol exclusion criteria: * severe complications due to primary liver disease * no prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma * malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration * previous treatment with drugs that synergistically inhibit t cell receptors (e.g., ctla-4, ox-40, cd137) * autoimmune immune disease * history of hiv * prognent women * the presence of any serious or uncontrolled systemic disease * medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. the investigator considers that there are other potential risks that are not suitable for participation in the study.

Keywords: cadonilimab (anti pd-1/ctla-4 bispecific antibody) ak112 ( anti vegf/pd-1 bispecific antibody)
a study for the treatment of diabetic peripheral neuropathic pain

Conditions: Diabetic Neuropathies

Summary: the purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. the pain must have been present for at least 6 months and be evaluable in feet, legs, or hands. * participants with hemoglobin a1c (hba1c) less than or equal to 9.0 percent at visit 1. * participants in whom hba1c had been measured 42-70 days before visit 1 and subsequent hba1c levels have been within +/- 1.0 percent of the level at visit 1. * participants with a mean of the 24-hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before visit 2 exclusion criteria: * participants who have undergone renal transplant or who are currently on renal dialysis. * participants who have a history requiring pharmacotherapy within the past year or current history of psychiatric disease, such as mania, bipolar disorder, depression, anxiety disorder, or eating disorder. * participants with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 millimeters of mercury (mmhg) or diastolic blood pressure greater than or equal to 110 mmhg * participants with alanine transaminase (alt) or aspartate transaminase (ast) greater than or equal to 100 units per liter (u/l) at visit 1. * participants unable to discontinue prohibited concomitant drugs or concomitant therapies after visit 1.
18f-gp1 pet-ct to detect bioprosthetic aortic valve thrombosis

Conditions: Thrombosis Cardiac; Aortic Valve Disease

Summary: 18f-gp1 binds with high affinity to the glycoprotein iib/iiia receptors on activated platelets. 18f-gp1 pet-ct has recently demonstrated favourable safety, pharmacokinetic, biodistribution and diagnostic performance for the in vivo identification of venous and arterial thrombemboli.

aortic stenosis is the most common reason for valvular interventions in the developed world, with rates projected to increase as the population ages. aortic valve replacement remains the only recognised treatment available. bioprostheses are far more common than mechanical prostheses, particularly with increasing rates of transcatheter heart valve use. bioprothetic valves are less durable than mechanical valves and are subject to deterioration which may lead to clinical heart failure and the need for re-intervention. long-term results with surgical bioprostheses are well reported, with valve deterioration rates of less than 15% at 10 years. these data, however, rely on re-operation rather than echocardiographic measures, suggesting that the true incidence of structural valve deterioration is underestimated. valve thrombosis is increasingly recognised as a potential contributor to leaflet degeneration and has been detected in participants undergoing both surgical aortic valve replacement and transcatheter aortic valve implantation. the role of valve thrombosis as an early trigger for calcification and subsequent valve degeneration has not been addressed. the true incidence of valve thrombosis and its impact on clinical outcomes is unknown due to the lack of a sufficiently sensitive non-invasive imaging modality to detect early subclinical thrombosis. current observational data suggests rates of 12 to 40%, based on computed tomography findings. there is a clinical need for a more sensitive non-invasive method of detecting valve thrombosis.

Eligibility criteria:
inclusion criteria: * ability to give informed consent * \>1 month post-surgical or transcatheter aortic valve replacement exclusion criteria: * inability to give informed consent * pregnancy or breastfeeding * contraindications to iodinated contrast * contraindications to anticoagulation * use of anticoagulants during the post-operative period prior to screening * extreme claustrophobia * chronic kidney disease (with estimated glomerular filtration rate \<30 ml/min/1.73m2) * metastatic malignancy * inability to tolerate the supine position
integrating pediatric pharmacogenomic testing into the canadian health care system

Conditions: Adverse Drug Reaction (ADR)

Summary: this project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications. we will conduct pilot testing of a pharmacogenomic testing panel and study how the tests and generated test results are utilized and understood by physicians, pharmacists, patients and their families.

the specific objectives are to: 1. implement a pilot pharmacogenomics program to test medication safety and effectiveness of antibiotics, analgesics and mental health medication to enhance prescribing decision-making. 2. develop data collection forms to collect necessary patient information from the prescribing physicians. 3. develop pharmacogenomics reports to return results to physicians, pharmacists, patients and their families. 4. determine how the tests and results are perceived and utilized by physicians, pharmacists, patients and their families.

Eligibility criteria:
inclusion criteria: * participants will be enrolled if they can benefit from pharmacogenomic testing. this means their physician is considering the use of a drug that is part of the panels (analgesics, antibiotics, and mental health medication) or they are already using one. exclusion criteria: * patients who do not speak or understand english.

Keywords: pharmacogenomics pediatrics adverse drug reactions
dose escalation, double-blind treatment with duloxetine hydrochloride once daily dosing for evaluation of safety in major depression

Conditions: Major Depressive Disorder

Summary: the purposes of this study are to determine: the safety of duloxetine and any side effects that might be associated with it. whether duloxetine can help patients with major depression. it is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed. duloxetine might not have any good effects for you.


Eligibility criteria:
inclusion criteria: * you must be at least 18 years old. * you must be diagnosed with major depressive disorder * you must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks. exclusion criteria: * you are a woman and are pregnant or breastfeeding. * you have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. * you have a history of alcohol or drug dependence or abuse within the past 6 months. * you are allergic to the study drug or you have experienced allergic reactions when taking several medications at once. * you have a serious medical illness.

Keywords: sad, blue, lack of energy, depressed, hopelessness, guilt
using thoracic ultrasound to predict pleurodesis success in malignant pleural effusions: a pilot study

Conditions: Malignant Pleural Effusion

Summary: the observational pilot study at the churchill hospital, funded by oxford respiratory trials unit, will assess the feasibility and efficacy of thoracic ultrasound (tus) assessment in patients undergoing talc pleurodesis via intercostal chest drain (icd) for recurrent symptomatic malignant pleural effusions (mpe). participants will undergo tus pre and post pleurodesis on up to four occasions. we hypothesise that a tus scoring system will be able to predict short and long-term pleurodesis success earlier than current conventional medical practice allows. this study may ultimately allow the proposal of a treatment algorithm to manage patients with mpe in a more efficient manner.


Eligibility criteria:
inclusion criteria: * the participant is willing and able to give informed consent for participation in the study. * adult male or female, aged 18 years or above. * diagnosed with a malignant pleural effusion requiring intercostal chest drain insertion and subsequent talc slurry pleurodesis for symptom relief and/or other therapeutic purposes as part of routine clinical care. exclusion criteria: * age less than 18 years. * inability to provide informed consent * known hypersensitivity/allergy to medical talc, or other contraindication to the administration of intrapleural talc, as determined by the responsible clinician. * evidence of significant trapped lung that would prevent pleurodesis being performed, as determined by the clinician responsible for assessing the patient. * expected survival of less than one month due to underlying co-morbidities.
translation and validation of malay version of paindetect questionnaire

Conditions: Neuropathic Pain, Nociceptive Pain

Summary: the translation and cultural adaptation process of the english version of pdq will be performed based on international guidelines. subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (nrs) of pain followed by pdq-m and sf-36 questionnaire. patients' socio-demographic data and clinical characteristics will be reported using frequency for categorical variables and mean with standard deviation for continuous variables. normality will be assessed using shapiro wilk test and histograms for continuous variables. data will be compared between groups using chi-square test (for categorical variables) and t-test or mann-whitney's u test (for continuous variables). suitability of pdq-m data for factor analysis will be verified using the bartlett's test of sphericity and the kaiser-mayer-olkin (kmo) measure of sampling adequacy. parallel analysis will performed to obtain the suitable factors. construct validity will be investigated by exploratory factorial analysis (efa) with varimax rotation. a factor loading of \>0.40 will be used to determine the items for each factor. the internal consistency of the questionnaire will be assessed using cronbach's alpha test. a p value of \<0.05 is taken as statistically significant.


Eligibility criteria:
inclusion criteria: * able to read and understand the malay language * diagnosed to have neuropathic or nociceptive pain by clinician * stable disease condition * pain duration of at least 4 weeks exclusion criteria: * acute illness * poor mental health status that prevents them from understanding or responding to the proposed questions * cultural or language barrier
lumbar plexus catheter versus femoral nerve catheter for postoperative pain after anterior cruciate ligament (acl) repair

Conditions: Postoperative Pain

Summary: randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot femoral block as control group) for postoperative pain control after anterior cruciate ligament repair in children (age 11-21). primary outcome is pain scores for the first 72 hours. secondary outcomes include opioid consumption, incidence of opioid side effects and quality of recovery (previously validated scale). our hypothesis is that lumbar plexus catheter will provide superior pain control and overall quality of recovery compared to femoral nerve catheters.


Eligibility criteria:
inclusion criteria: * asa physical status 1-2 * age 11-21 * undergoing anterior cruciate ligament repair exclusion criteria: * patient refusal * coagulopathy * systemic infection or infection at needle insertion site * allergy to ropivacaine or opioids * taking chronic opioids * unavailable by phone

Keywords: anterior cruciate ligament pain, postoperative peripheral nerve catheter nerve block children undergoing anterior cruciate ligament repair
effectiveness of two oral appliances for managing oral self-biting injuries in patients with als

Conditions: Satisfaction

Summary: this study assesses to determine the most effective type of device on the degree of satisfaction of patients with amyotrophic lateral sclerosis for managing oral self-biting injuries. thirty-one patients with amyotrophic lateral sclerosis will wear two devices, a hard occlusal splint (hos) and a flexible customized mouthguard (fcm), for two weeks each one. the sequence will be randomized to obtain one-half of the participants starting the first week wearing the hos, and the other half wearing the fcm. the participants will rate the degree of satisfaction with the device and the degree of improvement or worsening of oral self-biting injuries in a 10-point scale. they will also rate the degree of change in their quality of life because of changes in their oral self-biting injuries. finally they will rate the compliance and report the adverse effects.

this crossover intervention study aims to assess the most effective type of device on the degree of satisfaction of patients with amyotrophic lateral sclerosis for managing oral self-biting injuries. thirty-one patients with amyotrophic lateral sclerosis diagnosed in the als functional unit at bellvitge university hospital will participate in this randomized crossover trial. two devices will be prepared for each patient, a hard occlusal splint (hos) and a flexible customized mouthguard (fcm). they will wear one type of device for the first two weeks, followed by a week off, and the other type of device for the fourth and fifth week. the sequence will be randomized to obtain one-half of the participants starting the first week wearing the hos, and the other half wearing the fcm. the participants will rate the degree of satisfaction with the device in a 10-point scale, considering 0 extremely dissatisfied and 10 completely satisfied, and the degree of improvement or worsening of oral self-biting injuries, considering 0 an extreme worsening and 10 completely improved. they will also rate the degree of change in their quality of life (nothing, a bit, quite, a lot) because of changes in their oral self-biting injuries. finally they will rate the compliance as the percentage of time the device was used with respect to the recommended time and report the adverse effects (excessive salivation, dry mouth, tooth pain, mucosal irritation, temporomandibular joint (tmj) pain, tmj sounds, bite change, other).

Eligibility criteria:
inclusion criteria: * patients with amyotrophic lateral sclerosis diagnosed in the als functional unit at bellvitge university hospital. exclusion criteria: * patients who cannot be treated due to the advanced evolution of their disease.
the impact of erigo®pro therapy and motor imagery on the balance of stroke patients.

Conditions: Stroke

Summary: the aim of the study is to examine the impact of motor imagery, erigo®pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke.

design: randomized observational study. setting: a hospital rehabilitation department. population: sixty-six post-stroke patients mean, 64.85 ± 18.62 years. methods: 66 stroke patients were randomly assigned to three groups (22 people each) with different therapies (conventional, with the addition of erigo®pro and enriched with motor imagery). the therapy duration was two weeks. patients underwent assessment before and after completion of therapy. the study used the trunk stability test, berg balance scale to assess balance, as well as the riablo device to measure static balance. additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.

Eligibility criteria:
inclusion criteria: 1) patients 6-8 weeks post-stroke, 2) aged 38-85 years, mean, 3) males and females, 4) walking with or without assistance (modified rankin scale = 3), 5) with slight neurological deficits (nihss ≤7). exclusion criteria: 1) stroke up to six weeks after the episode, 2) epilepsy, 3) no possibility to sit and stand, 4) persistent deficit of speech and cognitive functions, lack of attention, 5) visual disturbances, 6) depression, 7) high or very low blood pressure, dizziness, malaise.

Keywords: stroke, motor imaging, erigo®pro tilt table, balance, physiotherapy
pain-less: understanding and alleviating pain for cancer patients in academic and community hospitals

Conditions: Cancer

Summary: this study will increase knowledge of patient preferences for pain treatments, and improve the ability to meet patients pain management needs. this study will assess patient attitudes towards underutilized treatments and identify technologies to increase awareness of such treatments. this study also demonstrate the feasibility of using the penn cancer network in future clinical and cancer control research and better understand how to effectively raise patients awareness of supportive cancer services.


Eligibility criteria:
inclusion criteria: * age 18 or older; have a primary diagnosis of cancer; * have a karnofsky functional score of 60 or greater (i.e. ambulatory); * understand written english; * verbally indicate to the ra/rn that they feel physically well enough to complete a survey at the time of approach; * report experiencing nonzero pain (on a scale of 0-10) in the last seven days exclusion criteria: * an inability to understand the requirements of the survey
effect of body composition on thyroid hormone levels among overweight and obese subjects

Conditions: Obesity

Summary: the study was aimed at investigating the relationship between body composition and thyroid hormone levels in overweight and obese subjects (bmi≥25 kg/m2)

subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. the investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (bp), bioimpedance and a physical assessment of body weight, body mass index (bmi) and waist circumference (wc) as anthropometric parameters.

Eligibility criteria:
inclusion criteria: * overweight or obesity (bmi\> 25 kg/m2) exclusion criteria: * any kind of drug * hypertension * endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), * chronic inflammatory diseases * renal failure * liver failure * angina pectoris * myocardial infarction and heart failure * genetic heart diseases * thrombocytopenias