Kornimate/medical-research-clean huggingface dataset:
the body project: comparing the effectiveness of an in-person and virtually delivered intervention.

Conditions: Eating Disorders

Summary: this present study will compare the efficacy of in-person versus virtually-delivered body project groups. it will also evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint, negative affect, eating disorder symptoms, and the future onset of eating disorders over a 3-month follow-up in this population. it will also evaluate the effectiveness of this body acceptance class's ability to impact social appearance anxiety, body compassion, and self-stigma surrounding attaining help.

dozens of eating disorder prevention programs have been evaluated, but only the 4-hr body project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year follow-up, produced larger reductions in outcomes than credible alternative interventions, been shown to engage the intervention target (valuation of the thin beauty ideal), and produced effects in trials from several independent teams. the proposed study will evaluate the effectiveness of a peer-implemented, virtually delivered, body acceptance class compared to a peer-implemented, in-person delivery of the same class. participation in the intervention will last four weeks. participants will be randomly assigned to the in-person or virtual body acceptance class. assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.

Eligibility criteria:
inclusion criteria: participants had to express body image concerns and all gender identities besides cisgender and transgender men were eligible. exclusion criteria: * cisgender and transgender men were excluded due to the fact that the body project is typically administered with groups of all cisgender women.

Keywords: prevention peer leader feeding and eating disorders
a fih study to assess the safety and tolerability of ns intravenous ns101 infusion

Conditions: Neurodegenerative Diseases

Summary: up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the study. the study will consist of 8 cohorts (cohorts 1 to 8, 1 cohort per dose level). each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug ns101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation. a total of 21 blood samples will be collected in each cohort for pk analysis and a total of 14 blood samples will be collected in each cohort for pd analysis.

the study will consist of 8 cohorts (cohorts 1 to 8, 1 cohort per dose level). each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug ns101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation. for each dose level, the dose to be administered to each subject for a single infusion will be calculated based on subject's body weight, measured on day 1. in each cohort, subjects will receive a single infusion of ns101 or matching placebo under fasting conditions over a period of approximately 60 minutes at the target dose level. a total of 21 blood samples will be collected in each cohort for pk analysis and a total of 14 blood samples will be collected in each cohort for pd analysis. a total of 6 immunogenicity blood samples will be collected for ada and nabs. for each subject in cohort 5 to 8 only, one single csf sample will be collected via lumbar puncture over the study, for pk and pd analysis.

Eligibility criteria:
inclusion criteria: 1. male, non-smokers (no use of tobacco or nicotine products within 6 months prior to screening), ≥18 and ≤55 years of age, with bmi \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males. 2. healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. 3. subject's score on the sheehan suicidality tracking scale (s-sts) at screening must be 0. exclusion criteria: 1. any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c found during medical screening. 2. positive urine drug screen or alcohol breath test at screening or admission. 3. history of asthma, allergic rhinitis or urticaria, anaphylactic reactions, or any other clinically significant allergic reactions to any medication, including biologics, or food, or allergy to any excipient in the formulation.
a safety and effectiveness study of saber®-bupivacaine for pain following shoulder surgery

Conditions: Postoperative Pain

Summary: this is a research study testing saber-bupivacaine (an experimental pain-relieving medication). saber-bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. the purpose of this study is to investigate safety (if there are any side effects) associated with the use of saber-bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.


Eligibility criteria:
inclusion criteria: * patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff. * males and females, 18 to 65 years of age, scheduled for shoulder surgery. * patients must be healthy or have only mild systemic disease. * patients must have ecg wave form within normal limits * patients must have blood pressure within normal range. * male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed. * patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial. exclusion criteria: * patients with previous arthroscopic surgery or open surgery on the study shoulder. * patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months. * patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies. * patients with a below normal calculated creatinine clearance. * patients who are pregnant or lactating. * patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis. * patients, who in the investigator's opinion, have developed opioid tolerance. * patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening. * patients with current or regular use of drugs known to significantly prolong the corrected qt interval * patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine). * patients with known hypersensitivity to opioids. * patients with conditions contraindicated for use of opioids. * patients with known or suspected abuse of opioids or other illicit drugs. * patients with known or suspected alcohol abuse. * participation in another clinical trial at the same time or within 30 days of this trial. * patients who, in the investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason.

Keywords: postoperative pain shoulder surgery opioid
care pathway and associated costs of patients treated with car t-cells based on snds data

Conditions: Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia (ALL)

Summary: this retrospective cohort study, based on the french medico-administrative database (snds), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (car) t cells (cart-cells) (kymriah or yescarta): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (all); and adult patients (18 years of age or older) with dlbcl.


Eligibility criteria:
inclusion criteria: dlbcl population: * patients with hospitalisation for car t-cell administration from 2017 to 2020 and * diagnosed with dlbcl (international classification of diseases \[icd-10 c833\]) when receiving car-t and * being 18 years of age or older. all population: * patients with hospitalisation for car t-cell administration from 2017 to 2020 and * diagnosed with all (icd-10 c910) when receiving car-t and * being 25 years of age or younger. exclusion criteria: dlbcl population: • patients hospitalised with a diagnosis other than dlbcl during the historical period or during the index stay. all population: • patients hospitalised with a diagnosis other than all during the historical period or during the index stay.
a multicenter trial to investigate fesoterodine sustained release in overactive bladder syndrome

Conditions: Overactive Bladder Syndrome

Summary: the trial consisted of a 2 week run-in period, 12 week double-blind treatment period and 2 week safety follow-up period. subjects were randomized to one of 4 treatment arms receiving either fesoterodine (spm 907) 4mg, fesoterodine 8mg, active control (tolterodine sr 4mg) or placebo during the double-blind treatment period. two primary efficacy variables will be assessed for submission in the united states: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. for the submissions in the european union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. all continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. the most important safety variables included the assessment of adverse events, laboratory parameters, changes in ecg, physical exams and measurement of residual urine.


Eligibility criteria:
inclusion criteria: * overactive bladder syndrome exclusion criteria: * less than 8 micturitions in 24 hours
enhancing covid rehabilitation with technology

Conditions: Covid19

Summary: in march 2020, the world health organization (who) declared the novel coronavirus (covid-19) a global pandemic. ontario has confirmed more than 547,000 cases of covid-19 since testing began. for many of these patients, symptoms resolve within 4 weeks of onset. however, it is becoming apparent that a significant number of individuals are experiencing symptoms that persist long after the acute infection, known as long covid. these individuals have a wide constellation of presenting symptoms, often varying from initial presentation. for this study, we will be enrolling individuals receiving care at the ottawa hospital for long covid. this study aims to determine the following four things: 1) will adding electronic case management improve quality of life three months after coming to hospital with long covid; 2) is the electronic case management platform cost effective; 3) is there any factors that predict outcomes at 3 months; 4) to determine how a personalized rehabilitation program supported by a digital platform could be implemented for individuals with long covid. we will enroll individuals from the ottawa hospital who will then be randomly assigned to receive either usual care or usual care plus electronic case management, through a platform called nexj connected wellness. participants will also complete questionnaires every 4 weeks for 3 months. we will be looking at quality of life, mental and physical health, cognitive symptoms, fatigue and pain.


Eligibility criteria:
inclusion criteria participants must: 1. be 18 years of age or older 2. have a confirmed diagnosis of covid-19 with a pcr test at least 12 weeks prior or a confirmed rapid antigen test at least 12-weeks prior or meet ottawa public health guidance for a suspected covid-19 case 3. have at least one ongoing symptom consistent with long covid as measured by the who post covid case report form (crf) 4. have a minimum whodas (36 item) sum score of 15 5. be willing to use email for study activities 6. be able and willing to use a smart phone application for the duration of the trial 7. be able to read and understand english or french. 8. be willing and able to provide informed consent. exclusion criteria participants must not: 1. have any significant functional impairment (for example. advanced dementia, heart or lung disease) as judged by the assessing clinician 2. participate in another long-covid trial where treatment is required in the protocol (pharmacological or behavioural). observational studies will be allowed. 3. have symptoms consistent with long covid that are better explained by an alternative diagnosis

Keywords: long covid post-covid
whether it is more appropriate to spray lugol's solution from cervical esophagus to esophagogastric junction

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the aim of this study is to compare the effectiveness and safety of spraying lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

chromoendoscopy using lugol's solution is effective for the detection of early esophageal squamous neoplasia. however, there is no study to investigate the sequence of lugol's staining during endoscopic procedure. the aim of this study is to compare the effectiveness and safety of spraying lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Eligibility criteria:
inclusion criteria: * high risk patients of early esophageal squamous neoplasias. exclusion criteria: * after esophageal surgery or endoscopic treatment ; * known esophageal radiotherapy or chemotherapy ; * esophageal stenosis; * acute bleeding; * a known allergy to iodine; * coagulopathy (prothrombin time \ 50 seconds); * having food retention; * severe hepatic ,renal, cardiovascular or metabolic dysfunction ; * being pregnant or lactating.

Keywords: lugol's solution staining sequence esophageal squamous cell carcinoma effectiveness safety
intra-articular tranexamic acid in the reduction of blood transfusions in primary total hip and total knee arthroplasty

Conditions: Osteoarthritis

Summary: this is a randomized, double blinded, controlled trial in patients undergoing elective total knee arthroplasty (tka) and total hip arthroplasty (tha). the study group will receive intra-articular tranexamic acid (txa) while the control group will receive normal saline placebo.

the primary purpose of this study is to determine if intra-articular administration of low dose txa following tha and tka results in a clinically relevant reduction in blood loss. the secondary purpose is to determine if there is an increased risk of thromboembolic phenomena with the use of txa following elective tha and tka. the primary outcome metric will be - drop in hemoglobin following surgery; secondary metrics include blood loss, transfusion rate, d-dimers, troponin levels, symptomatic deep venous thrombosis (dvt) and pulmonary embolism (pe), vascular events (myocardial infarction, stroke), major and minor bleeding, and death.

Eligibility criteria:
inclusion criteria: * with osteoarthritis * scheduled for elective primary unilateral thr or tkr * provided informed consent * can read, write and speak english exclusion criteria: * history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease) * pre-operative hg of \<120 g/l * known allergy to tranexamic acid * coagulation disorder * acquired disturbances of color vision * hepatic insufficiency, any history of liver disease * renal insufficiency (on dialysis) * preoperative prophylactic use of antiplatelet or anticoagulant therapy such as clopidogrel, warfarin, dabigatran or rivaroxaban. this does not include low dose aspirin (81mg) * patients with a history of subarachnoid hemorrhage \[20\] * simultaneous bilateral tha or tka * any contra-indication for spinal anesthesia * allergy to celecoxib, which will be the only nonsteroidal anti-inflammatory drugs (nsaid) used in the multi-modal analgesia regime. * retinal vein or retinal artery occlusion * female on oral contraceptive pills and/or premenopausal * concurrently taking hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine and/or nitroglycerin for the duration of the surgery.
responsiveness of lower airways in adult patients (18-60 years) with stable asthma after treatment with ciclesonide and fluticasone propionate (by9010/nl-101)

Conditions: Asthma

Summary: the aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. the study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * history of bronchial asthma * fev1 \> 1.20 l * positive skin prick test * not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit main exclusion criteria: * clinically relevant abnormal laboratory values * concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids * chronic obstructive pulmonary disease (copd) and /or other relevant lung diseases * one asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit * current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit * positive response to saline challenge at baseline visits * positive bronchial hyperresponsiveness

Keywords: asthma amp ciclesonide fluticasone propionate
rshf in colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to study stereotactic radiotherapy with a dose of 40 gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).


Eligibility criteria:
inclusion criteria: * age \> or = 18 years * social insurance * performance index \<2 * life expectancy\> 6 months * adenocarcinoma colorectal (histologically proven) * metastases (inoperable or recurrent after surgery), * hepatic localization and / or lung (up to 3 if one organ metastasis or 3 in total if the two bodies are metastatic). the largest diameter of the metastasis will \< ou = 6cm for the liver, \< or = 6 cm for the lung. if multiple metastases, the sum of their maximum diameter is 6cm \< ou = the liver, \< ou = 6 cm for the lung. * lesion (s) measurable (s) and evaluable (s) * ct less than 3 weeks * patients must have received at least one prior chemotherapy regimen containing 5fu • patients may have received one or more lines of chemotherapy including irinotecan. * bilirubin \<1.5 x uln * ast and alt \<5x uln * neutrophils\> 1.5x109 / l, platelets\> 100x109 / l, hemoglobin\> 9 g / dl * tp, tca normal (only for patients treated with a permanent implant) * informed consent signed. exclusion criteria: * contraindication to the administration of irinotecan. * history of radiotherapy in the thoraco-abdominal-cons indicating further irradiation. * history of other invasive cancer treated in a period of less than 5 years (basal cell carcinoma and non-invasive cervical excepted) * metastatic disease diffuse or more than three metastases in the liver and / or lung during the natural history of disease (excluding any patient is having a complete radiological response on several metastases although 1-3 residual after treatment ( s) medical (at)). * location (s) tumor (s) = ctv to less than 12 mm laterally or less than 15 mm in the cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and left pulmonary arteries and right and left. * pregnancy or breastfeeding. - lack of means or refusal to use effective contraception for men or women of childbearing age. * any other concomitant experimental treatment. * any other concurrent anticancer therapy, immunotherapy or hormonal therapy. * monitoring impossible because of psychological, sociological or because of geographical distance.

Keywords: rshf irinotecan colorectal cancer metastases
a phase i open label study of the safety and tolerability of elotuzumab (bms-901608) administered in combination with either lirilumab (bms-986015) or urelumab (bms-663513) in subjects with multiple myeloma

Conditions: Multiple Myeloma

Summary: to assess the safety and tolerability, characterize the dose limiting toxicities (dlts) and identify the maximally tolerated dose (mtd) of elotuzumab administered in combination with either lirilumab or urelumab in subjects with multiple myeloma.

allocation: * part1: non-randomized * part2: randomized

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects must have histological confirmation of multiple myeloma with measurable disease (per international myeloma working group (imwg) criteria): * relapsed/refractory multiple myeloma, subjects who are post autologous transplant and have achieved very good partial response (vgpr) or complete response (ncr) with minimal residual disease (mrd)
familial analysis of keratoconus risk

Conditions: Keratoconus

Summary: the principal objective of this study is to evaluate the frequency of kc inside family of patients with confirmed kc. it's a familial, epidemiological, prospective, single-center study.

keratoconus is a common bilateral progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. this disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation. currently, keratoconus has not known etiopathogenesis, and it is difficult to detect subclinical forms. several risk factors seem to be implied, environmental and genetic : the risk of keratoconus in case of familial history of keratoconus isn't well known at that time, but seems to be important to consider to promote screening and follow up of patient with a familial history of keratoconus (kc).

Eligibility criteria:
inclusion criteria: case : * patient carrier of keratoconus * more than 7 years * patient who didn't expressed opposition as for computerization and use of data concerning him family of case * to have a first degree family member (father, mother, brother, sister, child) carrier of keratoconus * more than 7 years * patient who didn't expressed opposition as for computerization and use of data concerning him exclusion criteria: * ocular pathology or antecedent of modification of cornea (surgery, traumatism, ocular hypertension, keratitis) which could interfere with topographical analysis * wearing of rigid contact lens for 15 days before exams, or flexible lens for 5 days before exams