Kornimate/medical-research-clean huggingface dataset:
prospective group-matched study with belzupacap sarotalocan (bel-sar; au-011) or plaque radiotherapy for primary indeterminate lesions or choroidal melanoma (il/ cm)

Conditions: Choroidal Melanoma; Indeterminate Lesions

Summary: this is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; au-011) and patients who are planned to receive standard of care (soc) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of au-011 and plaque radiotherapy.

up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of il/cm based on the expert judgment of the investigator are planned to be enrolled.

Eligibility criteria:
have per the investigator's expert clinical judgment, a clinical diagnosis of primary indeterminate lesion or choroidal melanoma based on the clinical history, ophthalmic examination, fundus photography and conventional ocular ultrasound.

Keywords: au-011 belzupacap sarotalocan choroidal melanoma plaque radiotherapy matched case control visual acuity bel-sar
mindfulness training in adolescents with type 1 diabetes

Conditions: Anxiety; Type 1 Diabetes; Quality of Life

Summary: creation of an adaptation of a mindfulness-based stress reduction mobile health application specifically designed for adolescents living with type 1 diabetes. aim to determine whether daily mindfulness improves anxiety symptoms in adolescents with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 diabetes for 6 months or longer * anxiety score of 5 or higher on the generalized anxiety disorder 7-item scale * must be able to read and speak english exclusion criteria: * clinical diagnosis of a chronic medical condition requiring intensive daily management
the tranquility 2 trial: a phase 3 clinical trial to assess the efficacy and safety in subjects with dry eye disease

Conditions: Dry Eye

Summary: the tranquility 2 trial: multi-center randomized, double-masked, parallel design, vehicle-controlled phase 3 clinical trial to assess the efficacy and safety of 0.25% reproxalap ophthalmic solution compared to vehicle in subjects with dry eye disease


Eligibility criteria:
inclusion criteria: * 18 years of age (either gender and any race); * reported history of dry eye for at least 6 months prior to visit 1; * reported history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1 exclusion criteria: * clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * contact lens use within 7 days of visit 1 or anticipate using contact lenses during the trial; * eye drop use within 2 hours of visit 1; * previous laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of visit 1; * be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of visit 1 or anticipate such therapy throughout the study period; * planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of visit 1; * temporary punctal plugs during the study that have not been stable within 30 days of visit 1
establishing a diagnostic and therapeutic index in autism spectrum disorder (asd) and fragile x syndrome

Conditions: Autism Spectrum Disorder; Fra(X) Syndrome

Summary: the purpose of this study is to accumulate and quantitatively analyze data on the microbiome, serotonin signaling and genetics, and inflammatory cytokines from patients with autism spectrum disorder and fragile x syndrome. computational analysis of multi-dimensional datasets will be used to establish a "diagnostic and therapeutic index" - an objective set of tools that can help differentiate subtypes of autism spectrum disorder and develop more accurate methods of diagnosis and response to treatment.


Eligibility criteria:
inclusion criteria: * early childhood (pre-diagnosis) or existing asd diagnosis (moderate to severe) * existing fxs diagnosis exclusion criteria: * hospitalization * enrolled in another clinical study
neoadjuvant chemotherapy with or without metformin in early breast cancer.

Conditions: Breast Cancer

Summary: metformin is a widely used anti-diabetic drug. several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. several studies are investigating the anti-tumor effect of metformin in early breast cancer. however, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. this study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically proven breast carcinoma. * american society of anesthesiology (asa) score i-ii. * candidate for neoadjuvant chemotherapy as per hospital's protocol. * clinically measurable tumor. * no evidence of distant metastasis. * normal renal and liver functions. * non-diabetics. exclusion criteria: * pregnant or lactating women. * metastatic breast cancer patients. * patients with hepatic impairment. * patients with renal impairment. * diabetics. * patients unwilling to participate or withdrawing from the trial. * psychological/ mental impairment.

Keywords: breast cancer metformin anti-tumor immunity
immune thrombocytopenia in pregnancy

Conditions: Immune Thrombocytopenia; Pregnancy

Summary: the pregnancy may activate flares of certain autoimmune diseases such as lupus. the influence of pregnancy on the evolution of itp was never studied while this pathology affects firstly women old enough to procreate. also, the influence of itp on pregnancy (risk of obstetric complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and never studied in a prospective study. the realization of a prospective study to answer these questions is necessary to allow us to inform better the patients affected by itp and to define better in this context the strategy of supervision of the mother, the foetus and the newborn. the highlighting of risk factors of itp flare or obstetric or neonatal complications will indeed allow the implementation of prevention measures. the conclusions of this study will allow us to adapt national guidelines for itp during pregnancy.


Eligibility criteria:
1. pregnant itp women inclusion criteria * women more than 18 years old * primary itp diagnosis, defined according to international criteria of 2009 consensus conference (isolated thrombocytopenia \<100 g/l) * and pregnancy diagnosis after itp diagnosis * information notice delivered to women with non opposition to participation to the study exclusion criteria * secondary itp (according to 2009 consensus conference) * severe comorbidity making difficult women's following 2. control itp women (non pregnant) inclusion criteria * women more than 18 years old * primary itp diagnosis, defined according to international criteria of 2009 consensus conference (isolated thrombocytopenia \<100 g/l) * non pregnant (\> 12 months of precedent pregnancy) * (matched on age+/- 5 years old: suppress by amendment n°3 20170117), phase and status of itp, and history of splenectomy * information notice delivered to women with non opposition to participation to the study exclusion criteria * secondary itp (according to 2009 consensus conference) * severe comorbidity making difficult women's following 3. de novo itp pregnant women inclusion criteria * women more than 18 years old * pregnant * with a newly diagnosed thrombocytopenia \<50g/l, after elimination of others thrombocytopenia etiologies during pregnancy: gestational thrombocytopenia, preeclampsia, hellp syndrome, .... * information notice delivered to women with non opposition to participation to the study exclusion criteria * secondary itp (according to 2009 consensus conference) * severe comorbidity making difficult women's following * non confirmation of itp diagnosis in post-partum

Keywords: immune thrombocytopenia pregnancy
a 6 month safety study comparing symbicort with inhaled corticosteroid only in asthmatic adults and adolescents

Conditions: Asthma

Summary: the purpose of the study is to evaluate the safety of symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

a 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with symbicort®, a fixed combination of inhaled corticosteroid (ics) (budesonide) and a long acting β2-agonist (laba) (formoterol) as compared to treatment with ics (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

Eligibility criteria:
inclusion criteria: * provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal * male or female, ≥12 years of age * documented clinical diagnosis of asthma for at least 1 year prior to visit 2 * patient must have history of at least 1 asthma exacerbation including one of the following: * requiring treatment with systemic corticosteroids * an asthma-related hospitalization between 4 weeks and 12 months prior to randomization * current asthma therapy: patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an asthma control questionnaire exclusion criteria: * patient has a history of life-threatening asthma. defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support. * patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to visit 2 * patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable) * an asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization * patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of visit 2 that, in the investigator's opinion, will interfere with the patient's lung function * patient must not meet unstable asthma severity criteria as listed in the protocol * peak expiratory flow must not be below 50% o predicted normal * pregnancy, breast-feeding or planned pregnancy during the study

Keywords: symbicort pmdi asthma safety budesonide
mirabegron as medical expulsive therapy (met) for ureteral stones and ureteral stent pain

Conditions: Ureteral Obstruction; Flank Pain

Summary: the study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (met) in patients with a ct (computed tomography) scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.

the study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (met) in patients with a ct scan-proven ureteral stone between 4 to 10 mm undergoing expectant management. subjects will be distributed at a 1:1 ratio between the control and treatment groups. the treatment group will receive mirabegron and the control groups will receive a placebo. both groups will receive analgesics and hydration will be recommended. all subjects will then be followed for 30 days to determine the proportion of subjects with spontaneous passage. patients will record narcotic usage and pain scores during this time. if there is stone persistence in the ureter based on imaging (ct scan of the abdomen and pelvis versus renal ultrasound plus kub), then the patient will undergo ureteroscopy with stent placement. in these patients, treatment will continue while the stent is in place and patients will fill out a validated questionnaire regarding stent pain.

Eligibility criteria:
inclusion criteria: * single unilateral ureteral calculus 4 to 10 mm visible on ct scan within the ureter * serum creatinine within normal range * ability to tolerate oral fluids and oral pain medication * able to make informed medical decisions regarding consent * willingness to follow-up in the urology clinic in approximately 30 day * willing to undergo ureteroscopic extraction should the stone not pass in this time period exclusion criteria: * adults unable to consent * age less than 18 * multiple stones * solitary kidney * horseshoe kidney * on immunosuppressant therapy * on digoxin * uncontrolled hypertension (systolic blood pressure \> 170, diastolic blood pressure \> 110) * history of ureteral surgery or previous endoscopic procedure * allergy to mirabegron * current calcium antagonist or corticosteroid or tamsulosin usage * patients already taking a beta-adrenergic agonist medication * renal insufficiency \[glomerular filtration rate (gfr) less than 60\] * patients with childs b and c liver failure * signs of infection i. temperature greater than 38 degrees celsius ii. urinalysis with any of the following positive: 1. positive nitrites 2. white blood cell count greater than 15/hpf (high powered field) 3. positive urine culture \[defined as a single isolated bacterial species population of greater than 100,000 colony forming units (cfu)\] * patients with chronic pain already undergoing treatment with narcotic medications * pregnant women and nursing mothers * prisoners * no working phone number

Keywords: medical expulsive therapy ureteral stone stent pain
a study of hs-10516 in patients with advanced clear cell renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the aim of the phase ia portion is to identify the maximum tolerated dose or maximum acceptable dose mtd/mad of hs-10516. the phase ib portion will evaluate the preliminary efficacy of hs-10516 in ccrcc.

this is a phase ia/ib open label multicenter study of hs-10516 in chinese patients aged 18 years or older with advanced clear cell renal cell carcinoma who have failed or are unavailable/intolerant to standard of care. hs-10516 as a single agent, is administrated orally once daily. the aim of phase ia, a dose escalation study, is to identify the mtd/mad of hs-10516. the goal of phase ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of hs-10516.

Eligibility criteria:
inclusion criteria: 1. male or female from 18 to 75 year-old 2. histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma whose standard treatment failed or proven unavailable or intolerant 3. has at least one non-cns target lesion per resist v1.1 4. has an eastern cooperative oncology group performance status of 0-1 5. has a life expectancy of ≥ 12 weeks 6. should use adequate contraceptive measures throughout the study 7. females subject must not be pregnant at screening 8. has the ability to understand and willingness to sign a written informed consent before the performance of the study exclusion criteria: 1. received or being received treatment as follows: 1. hypoxia-induced factor inhibitors 2. traditional chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment. 3. cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment 4. colony-stimulating factors (csfs) within 4 weeks before the first dose of study treatment 5. local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment. 6. major surgery within 4 weeks prior to the first dose of study treatment. 2. has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen 3. has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy 4. has another malignancy or a history of another malignancy 5. has inadequate bone marrow reserve or organ dysfunction 6. has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment 7. has severe infections within 4 weeks prior to the first dose of study treatment 8. has digestive system diseases may influencing adme of study drug 9. has a history of severe hypersensitivity reaction, or proven allergic to hs-10516 or its metabolics 10. has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision

Keywords: advanced clear cell renal cell carcinoma kidney cancer renal cancer recurrent renal cell carcinoma
uncontrolled donation after circulatory determination of death (udcdd)

Conditions: Uncontrolled Donation After Circulatory Determination of Death

Summary: world-wide, patients waiting for organ transplantation exceed the number of organs available. many european countries have a udcdd program which contribute to 10-15% of the donor pool. in canada, this type of program does not exist. the purpose of this study is to report how many deceased person fulfill the criteria for uncontrolled dcdd in a canadian medical center.

while transplantation has become the definitive treatment for many people suffering end-stage organ failure, demand exceeds supply. for many years, donation after neurological death represented the principal source of organs for transplantation. in the last decade, prevention measures, improvements in neurocritical care, and decompressive craniectomy have led to a significant decrease in the number of non-directed donors (ndds). in such situations, alternative sources for organ donation must be identified. cardiac-arrest patients could provide a solution to this organ shortage. patients who have experienced unexpected in or out of hospital cardiopulmonary arrest could become organ donors. organ donation following uncontrolled cardiocirculatory death is currently practiced in many european countries. however, in canada, it's not yet authorized. yet, each deceased could save up to four lives. the purpose of this study is to determine the organ potential for a cohort of patient who had died from a cardiopulmonary arrest at the chus in 2015 and assess the effect of the implementation of a udcd program on the number of additional donors.

Eligibility criteria:
inclusion criteria: * all patients treated for cardiocirculatory arrest at the ciusss-estrie chus in 2015. exclusion criteria: * patients with a status of no resuscitation * pediatric patients (\<18 years old) * adults \>65 years old

Keywords: unexpected cardiopulmonary arrest potential organ donors
thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease

Conditions: Thyroid Dysfunction; Metabolic Dysfunction-Associated Fatty Liver Disease

Summary: this study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.

one of the most common causes of chronic liver diseases worldwide is metabolic dysfunction-associated fatty liver disease (mafld), which affects about 30% of adults. thyroid hormones are critical in maintaining metabolic homeostasis throughout life and are intimately linked to the liver. dysfunctions of the thyroid gland have been implicated as one of the most important risk factors of mafld due to its important role in the hepatic synthesis of fatty acid and cholesterol. maintaining liver metabolism requires thyroid function to be normal, while thyroid disorders may lead to liver disease progression.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * both sexes. * patients with metabolic dysfunction-associated fatty liver disease (mafld). exclusion criteria: * history of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer, hypothyroidism, and hyperthyroidism). * patients with alcoholic liver disease take more than 40g of alcohol (or four units) per day. * viral hepatitis. * pregnant women.
topical anesthesia versus placebo to decrease pain in rubber band ligation for treatment of internal hemorrhoids

Conditions: Hemorrhoids; Pain

Summary: rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. however, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before. the investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.


Eligibility criteria:
inclusion criteria: * symptomatic grade i - iii hemorrhoidal disease exclusion criteria: * chronic liver disease * use of class 3 antiarrythmics * coagulopathy * grade iv hemorrhoidal disease * inflammatory bowel disease * pregnancy

Keywords: hemorrhoids rubber band ligation pain
outcomes in patients and their closest relatives treated for congenital heart disease with catheter based or surgical techniques

Conditions: Congenital Heart Defects

Summary: this study compares clinical, self- reported and cost outcomes in children and adolescents treated with pulmonary valve implantation, percutaneous versus open surgical technique. since cardiac surgery in children and adolescents affect the whole family, the experience of the patients and their closest relatives are recorded and analysed separately. cost may be an important factor in the choice of technology (1). hence, the present study also aims to compare savings in costs, percutaneous versus open technique, related to the individual, their family and society. 1.2 research questions 1. percutaneous pulmonary valve implantation or open heart surgery; what are the patients' and their closest relatives narrative experiences 2. is there a difference in patient and their closest relatives reported outcomes, measured as health related quality of life, in patients with congenital pulmonary disease before the event, 1, 3, 6 and 12 months after percutaneous intervention versus open heart surgery approach? 3. what is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment? 4. are there savings in costs related to the individual and their family and society between the two techniques?


Eligibility criteria:
inclusion criteria: * secure indication of pulmonary valve dysfunction (stenosis and, or regurgitation) * an indication of surgical correction * body weight according to the recommendation from the producer of the device * moderate to serious dilatation of right ventricle * considerable leak in the tricuspidal valve * information from former surgery; conduit size, gradient of the stenosis measured by ekko/mr/ catheterization, x-ray. * be able to speak and communicate well in norwegian. exclusion criteria: * aggressive endocarditis * not circumferential deposit of calcium * \< 20 kg * not able to understand, speak or communicate well in norwegian

Keywords: quality of life congenital heart disease open heart surgery percutaneous pulmonary valve implantation costs