Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of dcell® meniscus for partial replacement of the meniscus

Conditions: Knee Injuries

Summary: the safety and performance of dcell® meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.

the dcell® meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of tissue regenix's platform dcell® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. it is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy.

Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy * must be a stable, well aligned knee with ligament laxity of grade ii or less * osteoarthritis \<grade 3 on the kellgren lawrence scale * patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol exclusion criteria: * body mass index (bmi) greater than 35 kg/m2 * treatment with any investigational drug or device within two months prior to screening * patients presenting with abnormal degenerative osteoarthritis of the joint * patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months * patients using anticoagulants * patients on current immuno-suppressive or radiation therapy or having received such therapies within six months of screening * patients with diabetes or cardiovascular disease which precludes elective surgery * patients with documented renal disease or metabolic bone disease

Keywords: meniscus meniscectomy decellularised xenograft
safety and immunogenicity (non-inferiority) of a purified chick embryo cell vaccine vaccine administered in two different schedules (conventional versus abbreviated schedule)

Conditions: Rabies

Summary: this study investigates the safety and immunogenicity (non-inferiority) of a purified chick embryo cell vaccine (pcecv) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in china


Eligibility criteria:
inclusion criteria: * male and female subjects 18-50 years of age who: * are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator; * volunteer for the simulated post-exposure vaccination courses and blood draws; * have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study; * are available for all the visits scheduled in the study. exclusion criteria: * subjects with the below criteria were excluded: * pregnancy or unwillingness to practice acceptable contraception during participation in the study; * a history of rabies immunization; * a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the investigators opinion at the time of enrolment; * fever ≥ 38.0°c (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment; * treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment; * administration of any vaccine within the past 14 days before enrolment; * known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder; * history of allergy to egg protein; * known hypersensitivity to neomycin, tetracycline, amphotericin-b, or any other vaccine component; * treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months; * mental condition rendering the subject unable to understand the nature, scope and consequences of the study; * participation in any other investigational trial within the past 3 months before enrolment; * planned surgery during the study period; * intention to leave the area of the study site before the end of study period; * any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.

Keywords: vaccine prevention rabies rabies disease
impact of a european training program for robotic liver surgery (liverobot)

Conditions: Liver Diseases; Liver Neoplasm; Liver Cancer; Liver Metastases; Biliary Tract Cancer; Biliary Tract Neoplasms; Biliary Tract Diseases

Summary: liverobot is a collaboration of high-volume liver surgical centers in europe (≥60 liver resections per year), supported by the european-african hepato-pancreato-biliary association education committee (e-ahpba), and the european registry of minimally invasive liver surgery (e-mils) aiming to support the step-up implementation and safety of advanced surgical expertise of robotic liver surgery (rls) on a european basis. the liverobot training program aims to promote the safe implementation of rls throughout europe. the data from all patients operated on during a surgeons' participation in the training program will be prospectively gathered allowing for learning curve and outcome analyses.


Eligibility criteria:
center/surgeon eligibility criteria: prior to admission to the liverobot training program surgeons must demonstrate laparoscopic experience with a laparoscopic cholecystectomy with osats score \>3 (reviewed by proctors), participation in the laelive training program or demonstrating more than two-year experience in clinical laparoscopic liver surgery. additionally, a minimal surgical volume is required for participation. annual liver surgery volume (open and minimally invasive combined) per two surgeons should be more 60, aiming to reach more than 40 rls annually. each participating surgeon should individually perform a minimum of more than 15 hepatectomy procedures annually. surgeons shall be excluded from the training program if at any point failing to meet the minimal volume criteria (corrected for covid-19 restrictions). inclusion criteria: * age equal or above 18 years * eligible for elective minimally invasive and open hepatectomy for malignant, pre-malignant or benign disease located in the liver or biliary tract * eligible for both minimally invasive and open surgery according to the operating surgeon * fit to undergo the indicated operation according to both the anaesthesiologist and surgeon exclusion criteria: * pregnancy
an observational study of dry eye prior to laser-assisted in situ keratomileusis (lasik) therapy

Conditions: Dry Eye Syndromes

Summary: this is an observational, study of dry eye in patients at the consultation visit prior to lasik surgery. there is no treatment administered or intervention during the study.


Eligibility criteria:
inclusion criteria: * attending an ophthalmology consultation for lasik exclusion criteria: * none
controlled ovarian stimulation in newly diagnosed breast cancer patients (famhope)

Conditions: Breast Neoplasm Malignant Female

Summary: this is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. the study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

patients enrolled in this study undergo standard or "random start" ovarian stimulation with gonadotropins using antagonist protocol before the beginning of chemotherapy. ovulation is triggered in all patients with a gonadotropin releasing hormone-gnrh agonist. after retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification. primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.

Eligibility criteria:
inclusion criteria: * diagnosis of invasive non-metastatic breast cancer (i.e. stage i to iii); * breast cancer diagnosis ≥18 and ≤ 40 years; * no prior history of gonadotoxic treatments; * fertility preservation counseling for fertility preservation; * written inform consent; * fsh \< 20 ui/l and/or antra-follicular count ≥ 6 (follicles of 2-9 mm) and/or amh ≥ 6 pmol (only applicable for patients who undergo controlled ovarian stimulation for embryo/oocyte cryopreservation). exclusion criteria: * newly diagnosed stage iv breast cancer (i.e. de novo metastatic breast cancer); * prior diagnosis of other malignancies before breast cancer.

Keywords: fertility preservation letrozole ovarian stimulation
efficacy of dehydrated cell and protein concentrate versus corticosteroid

Conditions: Knee Osteoarthritis

Summary: to compare the efficacy of ascent injection versus corticosteroid injection in treating knee osteoarthritis.

to compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (csi) or a dehydrated cell and protein concentrate (dcpc) product, ascent

Eligibility criteria:
inclusion criteria: * age greater than 20 years but less than 75 years old * both male and female (non-pregnant) * valid knee radiograph within 3 months of beginning treatment; * diagnosis of oa of the knee * oa pain in the knee despite conservative measures * average daily vas \>= 3 * off any nsaids for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection * kellgren-lawrence system of grade ii, iii, or iv exclusion criteria: * kellgren-lawrence grade i * tense effusion of the knee * significant valgus/varus deformities * viscosupplementation within 6 months * surgery in the knee within the past 6 months systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening * chronic opioid usage * history of leukemia or lymphoma * history of any autoimmune disorders and disease * immunosuppressive medications * active, suspected, or prior infection to the joint * vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...) * nsaids used within 1 week of the procedure * history of bleeding disorders or inflammatory joint disease * patients who plan on becoming pregnant during study period
a phase 2a safety and efficacy open-label study of pra023 in subjects with moderately to severely active crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to assess the safety and efficacy of pra023 in participants with moderately to severely active crohn's disease. after the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of crohn's disease * moderately to severely active cd as defined by crohn's disease activity index (cdai) score and centrally read endoscopy * must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (tnf), anti-integrin, or anti-interleukin (il)12/23 * able to provide written informed consent and understand and comply with the requirements of the study exclusion criteria: * women of child bearing potential (wocbp) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug * diagnosis of ulcerative colitis (uc) or indeterminate colitis * cd isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement * suspected or diagnosed intra-abdominal or perianal abscess at screening * current stoma or need for colostomy or ileostomy * previous small bowel resection with a combined resected length of \>100 cm or previous colonic resection of \> 2 segments * surgical bowel resection within 3 months before screening * past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed * subjects in the opinion of the investigator are at an unacceptable risk for participation in the study * subjects who meet the protocol criteria for important laboratory exclusion criteria

Keywords: apollo-cd apollo crohn's disease
fluorine-18-alphavbeta6-binding peptide positron emission tomography in metastatic non-small cell lung cancer

Conditions: Lung Cancer; Lung Cancer Metastatic; Brain Metastases; Non Small Cell Lung Cancer

Summary: this study investigates fluorine-18-alphavbeta6-bp (\[18f\]-αvβ6-bp) as a positron emission (pet) imaging agent in non-small cell lung cancer (nsclc) patients with brain metastases. investigators hypothesize that \[18f\]-αvβ6-bp pet/computed tomography (ct) is a sensitive tool for disease assessment in patients with metastatic nsclc, including those with brain metastases.

primary objective: the primary objective of this study is to evaluate the sensitivity and specificity of \[18f\]-αvβ6-bp pet/ct for detecting metastases in patients with nsclc. outline: patients will undergo \[18f\]-αvβ6-bp pet/ct at baseline in addition to standard-of-care \[18f\]-2-fluoro-2-deoxy-d-glucose (fdg) pet/ct body and magnetic resonance imaging (mri) of the brain. patients will then undergo standard-of-care cancer directed therapy. patients will be re-staged 8-12 weeks later at the next standard-of-care imaging time point with \[18f\]-αvβ6-bp pet/ct, \[18f\]-fdg pet/ct, and mri.

Eligibility criteria:
inclusion criteria: 1. men and women age \>18 yrs 2. biopsy proven nsclc with brain metastases (treated or untreated) 3. life-expectancy of ≥3 months in the opinion of the treating physician 4. available archival tumor tissue (excisional, core, or fine needle aspiration (fna) is acceptable). tissue from a metastatic site is preferred when available. 5. able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan 6. ability to understand and willingness to sign a written informed consent document. 7. planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging 8. \[18f\]-fdg pet/ct within 21 days of enrollment 9. mri brain within 21 days of enrollment 10. eastern cooperative oncology group performance status ≤ 2 11. glomerular filtration rate (gfr) ≥ 60 exclusion criteria: 1. pregnant or lactating women 2. prisoners 3. concurrent malignancy of a different histology that could confound imaging interpretation 4. patients who cannot undergo pet/ct scanning because of weight limits(\>350lbs)

Keywords: positron emission tomography
a study of rtms personalized precision treatment of post-stroke depression

Conditions: Post-stroke Depression

Summary: this is a multicenter, randomized trial aims to reveal the efficacy and safety of repetitive transcranial magnetic stimulation (rtms) individualized therapy based on the 'emotional loop destabilization' mechanism of psd .one hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive "personalized" rtms treatment or traditional rtms treatment in addition to routine antidepressant treatments.the data of neuropsychological tests and mri will be collected at 0, 2，4 and 8 weeks after the commencement of the treatment.

this is a multicenter, randomized trial aims to reveal the efficacy and safety of rtms individualized therapy based on the 'emotional loop destabilization' mechanism of psd .one hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive "personalized" rtms treatment or traditional rtms treatment in addition to routine antidepressant treatments. based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, psd) cases were collected and randomized into two groups: "individualized" rtms+ drug treatment group and traditional rtms plus traditional drug treatment group. the main indicators were the effective rate of treatment.based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, psd) cases were collected and randomized into two groups: "individualized" rtms+ drug treatment group and traditional rtms plus traditional drug treatment group. the main indicators were the effective rate of treatment. the primary outcome is the measurement of 24-item hamilton depression rating scale (hamd-24) scores, the secondary outcomes include national institutes of health stroke scale (nihss), activities of daily living scale (adls),self-rating anxiety scale(sas). the record of the adverse reactions and sequelae during treatment and follow-up, with a view to providing a better clinical method for the treatment of psd.

Eligibility criteria:
inclusion criteria （1） first-time ischemic stroke with clinical and mri or ct findings of basal ganglia stroke (icd-10-cm code 293.83\[f06.32\]) (3) right-handedness (4)clear consciousness (5)aged 25-75 years with a recent (less than 24 months) ischemic stroke; exclusion criteria 1. aphasia or severe cognitive impairment, severe hearing impairment; 2. contraindications of mri scan and rtms treatment such as pacemaker implantation; (3)depression caused by psychoactive substances and non addictive substances;（4）prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders; （5）pregnant or breast-feeding women; （6）refusal to sign informed consent of this study

Keywords: repetitive transcranial magnetic stimulation
acthar gel for cutaneous sarcoidosis: an open label trial

Conditions: Sarcoidosis; Cutaneous Sarcoidosis

Summary: acthar gel has efficacy in the treatment of cutaneous sarcoidosis

sarcoidosis is a multisystem granulomatous disease of unknown cause. although sarcoidosis most commonly affects the lung3, it may affect any organ. although corticosteroids are recognized as the drug of choice for sarcoidosis, acth is the only drug that is fda-approved for this disorder. however, there is limited data on the efficacy of acth for this condition. presently, corticosteroids as considered the drug of choice for the treatment of cutaneous sarcoidosis. however, acther gel not only has obvious anti-inflammatory effects by resulting in corticosteroid production, but it may also activate melanocortin receptors. the melanocortin system has powerful anti-inflammatory properties that may be beneficial in the treatment of cutaneous sarcoidosis.

Eligibility criteria:
inclusion criteria: 1. patients must have biopsy-proven sarcoidosis. 2. a) patients with active cutaneous sarcoidosis and two active lesions on stable therapy or no therapy for at least two months and/or b) patients with active cutaneous sarcoidosis and lupus pernio lesions on stable therapy or no therapy for at least two months. a maximum of 5 patients may be enrolled fulfilling criterion b) above. 3. both lesions must have a sasi induration score of \> 1 and a sasi induration + erythema score of \> 2. 4. if two lesions are present, one must be \> 1cm in diameter and the subject must be willing to have it biopsied. the second lesion must be at least 0.5 cm in diameter. 5. if a subject has only lupus pernio facial lesions, one needs to be at least 0.5 cm in diameter. exclusion criteria: 1. previous toxic or allergic reaction to acthar gel 2. the presence of another skin condition in addition to sarcoidosis that would interfere with the assessment of the sarcoidosis skin lesions. 3. uncontrolled hypertension. 4. uncontrolled diabetes. 5. active infection. 6. a medical condition that, in the opinion of the investigator would place the subject at significant risk by administering acthar gel.
approaches for the prioritization of patients in primary care post-covid to reduce health inequities (aftermath)

Conditions: Schizophrenia; Bipolar Disorder

Summary: the covid-19 pandemic significantly impacted primary care across canada. inequities in prevention activities and chronic disease management likely increased but the extent is unknown. pragmatic interventions are required to prioritize patients and improve the quality of primary care post-covid. in aftermath, the investigators will conduct a pragmatic cluster randomized controlled trial (crct) at the largest primary care practice-based research network (pbrn) in ontario, focused on a highly marginalized population: adults living with mental illness and one or more additional chronic diseases. the investigators will test an intervention that builds on the investigators' past work and combines data and supports to primary care providers to improve quality of life, reduce gaps in prevention activities and improve chronic disease management. the investigators' project will result in new evidence on ways to improve access to care and reduce inequities, and inform future efforts to use data beyond covid-19.


Eligibility criteria:
inclusion criteria: a. family physicians: any family physician in the university of toronto practice-based research network (utopian) with 10+ community-dwelling patients living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (copd, diabetes, hypertension, osteoarthritis, dementia, epilepsy and parkinson's). b. patients: patients from the included family physician practices living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (copd, diabetes, hypertension, osteoarthritis, dementia, epilepsy and parkinson's). exclusion criteria: a. family physicians: none b. patients: patients under 18

Keywords: primary health care primary care schizophrenia bipolar disorder cluster randomized controlled trial community health worker randomized controlled trial
effectiveness of a counseling program for temporomandibular disorders (tmd) treatment

Conditions: Temporomandibular Disorders

Summary: this study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (tmd).

in this study, 51 patients were allocated to one of the research groups. in group i, it was instituted counseling therapy. for group ii was conducted treatment as usual with occlusal splint. patients were followed for returns at 7, 15, 30 and 60 days after baseline. at baseline, all patients were examined and assessed research diagnostic criteria/temporomandibular disorder (rdc/tmd form). in addition, the patients were referred for specific treatment according to the group to which belonged. in each session, patients were also surveyed about pain intensity using a numeric scale. to analyze the impact of pain on quality of life, oral health impact profile (ohip-14) questionnaire was used.

Eligibility criteria:
inclusion criteria: * female individuals * positive diagnosis of tmd according to rdc/tmd * presence of pain in the orofacial region persisting for at least a week of at least moderate intensity, according to the numeric scale of pain exclusion criteria: * tmd treatment for ongoing pain * presence of pulpal or periodontal disease * orthodontic treatment in progress * daily use of analgesics, antidepressants or muscle relaxants * history of radiotherapy to the head and neck, or any adverse systemic condition that may favor presentation of symptoms involved