Kornimate/medical-research-clean huggingface dataset:
to demonstrate equivalence of pharmacokinetics and noninferiority of efficacy for ct-p10 in comparison with rituxan

Conditions: Lymphoma, Follicular

Summary: this study is a phase 3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (part 1), as well as noninferiority in efficacy (part 2), of ct-p10 to rituxan when coadministered with cvp and to assess efficacy and safety in patients with advanced (stage iii-iv) fl. part 1 and part 2 of the study will run in parallel.


Eligibility criteria:
inclusion criteria: 1. patient is male or female older than 18 years. 2. patient has histologically confirmed fl according to the world health organization 2008 classification (jaffe 2009); grades 1 to 3a based on local laboratory review. 3. patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be: * greater than 1.5 cm in the longest dimension or * between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis 4. patient has confirmed cd20+ lymphoma, as assessed by local laboratory review. (tissue obtained within 6 months before day 1 of cycle 1 will be reviewed by a central independent reviewer to detect pathological type.) 5. patient has ann arbor stage iii or iv disease. exclusion criteria: 1. patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine. 2. patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone. 3. patient has evidence of histological transformation to high-grade or diffuse large b-cell lymphoma. 4. patient has known central nervous system involvement. 5. patient has received previous treatment for nhl: * previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy) * all doses of corticoid therapy for treatment of nhl * corticoid therapy during the previous 4 weeks from day 1 of cycle 1 with prednisone \>20 mg per day for the treatment for any purpose

Keywords: advanced follicular lymphoma
chemotherapy-induced necrosis in ewing sarcoma

Conditions: Ewing Sarcoma of Bone

Summary: this is single institution cases series review of histological and clinical data

investigators will retrieve from the database of the rizzoli institute all the cases with a histological diagnosis of ewing sarcoma from 01 jan 1982 to 31 dic 2012

Eligibility criteria:
inclusion criteria: 1. male and female patients surgically treated at rizzoli institute from 01 jan 1982 to 31 dic 2012 2. patients with diagnosis of ewing sarcoma of bone who have had neo-adjuvant chemotherapy 3. diagnosis of ewing sarcoma localized exclusion criteria: 1. metastatic disease at presentation 2. soft tissue origin 3. radiotherapy before surgery
pandirect: self-care tools and telephone coaching for depression and anxiety during pandemics

Conditions: Mental Health Wellness 1; Coaching; Pandemic; Depression, Anxiety; Self-care Tools

Summary: during pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. this is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. since public health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present covid-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints. the study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. it uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. these tools have already been shown by the team to be effective in other contexts in studies direct-sc (effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and candirect (effectiveness of a telephone-supported depression self-care intervention for cancer survivors). the present study, pandirect (assisting family physicians with gaps in mental health care generated by the covid-19 pandemic), aims to answer the following questions: 1. can these tools be used in the community care of mental health problems during pandemics? 2. are they acceptable to patients? 3. using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes? 4. do family practitioners value patient information sent to them at the end of the trial


Eligibility criteria:
inclusion criteria: * 65+ years old * consented to be recontacted (participant in a previous study) exclusion criteria: * moderate to severe cognitive impairment (using bomc a brief cognitive screen) -unable to read in english or french (self-reported); hearing impairment (as judged by research staff); * currently receiving counseling or psychological therapy (as these treatments may conflict with the self-care interventions) * currently living in a long term care or other medicalized facility, * presenting suicidal intent (as identified through the final item of the phq-9 which will be asked at screening).
t cell receptor (tcr) sequencing and transcriptional profiling in adult celiac disease patients undergoing gluten challenge

Conditions: Celiac Disease

Summary: the primary objectives are: * characterize the t cell receptor (tcr) repertoire in duodenal biopsy samples of participants pre- and post-challenge. * compare for each patient the tcr repertoire of duodenal biopsy samples with the peripheral blood tcr repertoire of each study participant * characterize the transcriptome of duodenal biopsy samples and blood from study participants pre- and post-challenge the secondary objectives are: * ex vivo identification and validation of dq-restricted gliadin specific tcrs. * characterize the gluten-challenge induced changes in small intestine histology using standard for celiac disease (ced) histological assessments


Eligibility criteria:
key inclusion criteria: 1. have a body mass index (bmi) ≥17 and ≤40 kg/m2 and a body weight \>45 kg at the screening visit 2. be judged to be in good health as defined in the protocol 3. have well-controlled biopsy-proven ced, compliant with a gfd for ≥6 months preceding screening as defined in the protocol 4. be hla-dq2 and/or hla-dq8 positive as defined in the protocol key exclusion criteria: 1. have a history of gluten triggered acute symptoms (≤24 hours after gluten exposure), and/or severe symptoms (abdominal pain interfering with daily activities, diarrhea with \>5 stools/day), and/or prolonged symptoms (duration \>7 days) 2. have a history of clinically significant endocrine, cardiovascular, hematological, hepatic, immunological (other than ced or autoimmune thyroid disease), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or disease 3. have participated in another investigational trial within 4 weeks before screening 4. have a history of cancer (malignancy) other than nonmelanoma skin cancer 5. have a history of significant multiple and/or severe allergies (e.g., latex allergy) 6. presence of hiv (hiv ab), hepatitis b (hbsag, hbab) or hepatitis c (hcv ab) seropositivity at screening 7. ongoing immunosuppression or receive any treatment that might alter t cell repertoire or phenotype note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: ced hla-dq2 positive hla-dq8 positive
the efficacy and safety of r-epoch and r-chop regimen for patients with aids associated cd20+ diffuse large b lymphoma

Conditions: To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma

Summary: 1. compare the efficacy of r-epoch and r-chop regimen for patients with aids associated cd20+ diffuse large b lymphoma; 2. compare the safety of r-epoch and r-chop regimen for patients with aids associated cd20+ diffuse large b lymphoma.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18-60 years old; 2. confirmed as aids patients and treated with haart; 3. confirmed as cd20+ diffuse large b lymphoma; 4. serum test; negative for hbv, hcv and syphilis; 5. hematology: absolute neutrophil count greater than or equal to 1000/mm(3); platelet count greater than or equal to 50,000/mm(3); hemoglobin greater than 8.0 g/dl; lymphocyte count less than or equal to 4,000/mm(3); 6. chemistry: serum alt/ast less or equal to 5 times the upper limit of normal. serum creatinine less than or equal to 1.6 mg/dl. total bilirubin less than or equal to 1.5 mg/dl; 7. normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram; 8. negative pregnancy test for female; 9. patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment; 10. to be able to understand and sign the informed consent document with legal force. exclusion criteria: 1. with acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system; 2. patients with heart metastases, cns metastases or cerebrospinal fluid malignant cells; 3. women with pregnant or breastfeeding; 4. any form of primary immunodeficiency; 5. concurrent systemic steroid therapy; 6. history of severe immediate hypersensitivity reaction to any of the agents used in this study; 7. history of allogeneic stem cell transplantation.
alopecia secondary to endocrine therapy in postmenopausal women with breast cancer

Conditions: Breast Cancer

Summary: this is a study to determine the prevalence and severity of alopecia (hair loss) experienced by postmenopausal breast cancer patients receiving endocrine therapy including tamoxifen, letrozole (femara), exemestane (aromasin), or anastrozole (arimidex).


Eligibility criteria:
inclusion criteria: * postmenopausal women * diagnosed with hormone-receptor positive breast cancer * commenced adjuvant endocrine therapy ≥ 3 months ago, specifically tamoxifen, anastrozole, exemestane, and/or letrozole * good command of the english language * under the care of a medical oncologist at princess margaret hospital exclusion criteria: * previously received chemotherapy * recurrent and/or metastatic disease * history of endocrine, dermatology, or immune system disorders known to alter hair growth (ie. hypothyroidism and iron deficiency)
application of ucad for diagnosing urothelial carcinoma.

Conditions: Urothelial Carcinoma; Diagnoses Disease; Chromosomal Abnormality; Urine Marking

Summary: chromosomal instability (cin) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. cin is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. analyzing cin of the dna extracted from urothelial cells in urine samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of bladder cancer patients. cin can be assessed using experimental techniques such as bulk dna sequencing, fluorescence in situ hybridization (fish), or conventional karyotyping. however, these techniques are either time-consuming or non-specific. we here intend to study whether a new method named ultrasensitive chromosomal aneuploidy detection (ucad), which is based on low-coverage whole-genome sequencing, can be used to analyze cin thus help diagnosing and treating bladder cancer patients.

cin results from errors in chromosome segregation during mitosis, leading to structural and numerical chromosomal abnormalities. it will generate genomic heterogeneity that acts as a substrate for natural selection. furthermore, it is proved that tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with metastasis, treatment resistance, and decreased overall survival. it is estimated that 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of cin. cin positively correlates with tumor stage and is enriched in relapsed as well as metastatic tumor specimens. due to the ubiquity of cin in cancer cells, it is a potentially non-invasive way to detect cin in the urothelial cells from the urine sample for diagnosing and monitoring bladder cancer patients. ucad is a new method to detecting cin in the dna sample from patients, including extracting dna from urine, analyzing dna by low-coverage whole-genome sequencing, processing the data by bio-information techniques, and finally optimizing the management of bladder cancer patients. the investigators intended to conduct a prospective study by analyzing urine samples from bladder cancer patients and control groups that without any tumor in the urinary system or other organs to compare the specificity and sensitivity of ucad test for diagnosing urothelial carcinoma to other modalities, such as urine cytology or fluorescence in situ hybridization (fish).

Eligibility criteria:
inclusion criteria: * patients diagnosed with urothelial carcinoma and planned to undergo surgery. * participants without any tumor disease and willing to attend the study by providing morning urine. * male or female patients aged \>= 18 years. * participants signed informed consent form. exclusion criteria: * age under 18 years * individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record. * individuals unwilling to participate in this trial.

Keywords: urothelial carcinoma diagnosis chromosomal aneuploidy detection marker urine
global® ap™ total shoulder arthroplasty

Conditions: Osteoarthritis

Summary: this study will evaluate the clinical performance of depuy global® ap™ shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.

the purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a global® ap™ shoulder prosthesis for glenohumeral arthritis.

Eligibility criteria:
inclusion criteria: * patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate. exclusion criteria: * are under 18 years of age or over 70 * diagnosis of avn, inflammatory arthritis, fracture or malunion. * have a hemi-arthroplasty * have destruction of the proximal humerus that precludes rigid fixation of the humeral component * have arthritis with insufficient cuff tissue * have had a failed rotator cuff surgery * have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified * have evidence of active infection * present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - have a known active metastatic or neoplastic disease * are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol * are skeletally immature. * have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products * have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible * are currently participating in another clinical study * are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery * are currently involved in any personal injury litigation, medical legal or worker's compensation claims.

Keywords: osteoarthritis glenohumeral joint glenoid shoulder arthroplasty
an open label comparing the short term efficacy of lacrisert

Conditions: Dry Eye

Summary: to evaluate the short term effects of lacrisert®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.


Eligibility criteria:
inclusion criteria: -has dry eye disease indicated by a staining score of ≥ 4 and speed score of \>6 exclusion criteria: * concurrent involvement in any other clinical trial * anticipated contact lens wear during the study and 14hours prior to day -history of corneal transplant * active ocular infection, uveitis or non-kcs inflammation * history of recurrent herpes keratitis or active disease within the last six months * topical ophthalmic medications during the study * temporary collagen punctal plugs within one week prior to study.
hydrogen breath test an instrument to predict rifaximin-response in irritable bowel syndrome predominant diarrhea

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Summary: the purpose of this study is to learn more about how to improve treatment of patients with diarrhea predominant irritable bowel syndrome (ibs-d) symptoms.included patients will be requested to answer online surveys and will undergo treatment with rifaximin. hydrogen breath testing and biologic samples collection will also be completed during the study.

the study aims to determine whether hydrogen breath testing can be used to identify patients with ibs-d who are more likely to respond to rifaximin. participating patients will complete a one week screening period when brief daily survey will be answered. eligible patients will proceed with the treatment phase of the study, when patients will receive a 14 day course of rifaximin. all included patients will complete glucose and lactulose hydrogen breath tests before and after rifaximin treatment. biological samples (e.g. blood, stool) will be collected at pre-determined time points and patients will answer daily brief survey for the duration of the study. it is anticipated that 210 patients will be screened to reach a goal of enrolling 110 patients for the treatment phase of the study.

Eligibility criteria:
inclusion criteria: * ibs-d (rome iv diagnostic criteria) * diary compliance for at least 5 days and no rescue medications during baseline * appropriate levels of abdominal pain and diarrhea exclusion criteria: * pregnant women or planning on becoming pregnant while in the study, or lactating women while in the study * inflammatory bowel disease, diabetes mellitus, systemic sclerosis, or celiac disease * active gastrointestinal or hematological malignancy which requires ongoing treatment * surgery to the gi tract in the past 3 months * gastrointestinal infection or diverticulitis in the past 3 months * severe hepatic impairment * any use of antibiotics in the past month * current use of probiotics * any history of allergies to rifaximin or its derivatives * any comitant use of p-glycoprotein inhibitors (for example. cyclosporine) * known allergies to glucose or lactulose

Keywords: ibs irritable bowel syndrome
assessing efficacy of psychotherapy intervention with inflammatory bowel disease surgery patients

Conditions: Anxiety Depression

Summary: the purpose of this research study is to understand the effects of therapy in lowering anxiety and improving quality of life in patients with ibd who are undergoing surgery

pre- and post- surgery scores on the state trait anxiety inventory will be used to measure levels of state-based anxiety as the primary outcome. our hypothesis is that patients in the experimental group, will show a decrease in anxiety levels over the course of the four sessions, while the same group in the control group will not change significantly in their anxiety levels. it is hypothesized that this would be due to the psychotherapeutic intervention mitigating the inherent emotional stress and negative behavioral changes associated with surgery. it will be important to differentiate between the inpatient and outpatient groups, as their anxiety levels may inherently be discrepant. for patients with a three-step ileal pouch-anal anastomosis (ipaa), the three sessions subsequent to surgery will be conducted only after the first surgery. this is an exploratory study in which we are investigating the possibility of a range of potential outcomes to the intervention, including overall reduction of anxiety, depression, body image and improvement in quality of life.

Eligibility criteria:
inclusion criteria: * patients age18 years or older. * patients with documented diagnosis of inflammatory bowel disease. * patients with documented need for ibd surgery exclusion criteria: * patients younger than 18 years of age. * patient who has any condition, including physical, psychological, or psychiatric condition, which in the opinion of the investigator, would compromise the safety of the patient or the quality of the data and renders the patient an unsuitable candidate for the study.
effect of a novel reamer-irrigator-aspirator on the incidence of fat embolism

Conditions: Embolism; Femoral Fractures

Summary: the purpose of this study is to determine the effect on the incidence of fat emboli when using a reamer-irrigator aspirator during reamed im nail fixation of femoral shaft fractures

the current practice of reaming the medullary canal for the fixation of femur fractures is recommended, however, there is an associated increase in the level of embolic events which confers morbidity and, occasionally, mortality. the ria is a single device which is able to ream the medullary canal, irrigate the canal and subsequently aspirate the reamed medullary contents in order to get rid of medullary fat and other contents responsible for these adverse embolic events. a novel reamer-irrigator-aspirator (ria) (synthes, inc) will be evaluated in a randomized study, to determine its effect on the incidence of fat emboli events during reamed im nail fixation of consecutive femoral shaft fractures as measured by intra-operative transesophageal echocardiogram and pulmonary function.

Eligibility criteria:
inclusion criteria: * participant aged 16 to 65 years of age * skeletally mature * isolated, closed femoral shaft fracture (participant may also have sustained a distal radius/wrist, distal tibia/ankle, hand, and/or foot fractures for eligible inclusion) * fracture amenable to an antegrade i.m. nail * fracture amenable to insertion of a 12 mm ria * fracture ≤ 48 hrs post injury * participant has a 'thorax' abbreviated injury score (ais) of \< 2 * participant has a 'head \& neck' ais score of \< 2 * provision of informed consent exclusion criteria: * fracture proximal to the lesser trochanter * open fracture * participant has a humeral, tibial, contralateral femoral, spinal,and/or pelvic fracture * pathological fracture * fractures \> 48 hrs post injury * limited life expectancy due to significant medical co-morbidities * previous history of esophageal/gastric surgery * previous history of esophageal/gastric tumor * previous history of esophageal varices * medical contraindication to surgery

Keywords: embolism femur fracture lavage tee reamer im nail