Kornimate/medical-research-clean huggingface dataset:
clinical implementation of a polygenic risk score (prs) for breast cancer

Conditions: Breast Cancer Risk

Summary: this study aims to assess how a polygenic risk score (prs) reported with the results of multi-gene panel testing affects the breast cancer risk management recommendations healthcare providers make to their patients. the prs is a score based on small genetic changes, clinical history, and family history. the prs is used to estimate remaining lifetime risk of developing breast cancer for patients with no personal history of breast cancer and an overall negative result from mgpt.


Eligibility criteria:
inclusion criteria: * female, age ≥ 18 years * willing and able to provide meaningful informed consent * willing and able to complete study procedures as described in this protocol * electing to undergo multi-gene panel testing for hereditary breast cancer for clinical purposes at the time of consent * no personal history of cancer (except non-melanoma skin cancer) and meets nccn guidelines for brca1/2 testing based on family history of breast and/or ovarian cancer * meets ambry criteria for clinical reporting of prs score exclusion criteria: * prior germline brca1/2 testing * not willing to receive prs * personal history of cancer, except non-melanoma skin cancer * personal history of allogenic bone marrow/stem cell transplant

Keywords: breast cancer breast neoplasm genetic testing breast cancer risk cancer risk risk score genetic risk score polygenic risk score personalized risk score
a study to evaluate rituximab in combination with methotrexate in methotrexate-naive patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase iii, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active rheumatoid arthritis (ra) who are naive to methotrexate (mtx) therapy. rheumatoid factor (rf)-positive and rf-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Eligibility criteria:
inclusion criteria: * adult patients 18-80 years of age * ra for ≥ 2 months; * receiving outpatient treatment * patients naive to, and considered to be candidates for, methotrexate treatment exclusion criteria: * rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra * inflammatory joint disease other than ra, or other systemic autoimmune disorder * diagnosis of juvenile rheumatoid arthritis, or ra before the age of 16 * surgery within 12 weeks of study * previous treatment with any approved or investigational biologic agent for ra, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy * concurrent treatment with any biologic agent or dmard other than methotrexate

Keywords: rituxan mtx ra image wa17047
a phase 3b, open-label, safety and efficacy study of rotigotine as add-on therapy with low doses of pramipexole or ropinirole in patients with advanced parkinson's disease

Conditions: Advanced Parkinson's Disease

Summary: this study is to investigate the safety and efficacy of rotigotine add-on therapy with low doses of pramipexole or ropinirole in patients with advanced-stage parkinson's disease (pd) who have insufficient response to l-dopa and low doses dopamine receptor agonists.


Eligibility criteria:
inclusion criteria: * subject is male or female, aged ≥ 30 and \< 80 years at informed consent * subject has idiopathic parkinson's disease, of more than 3 years duration, as defined by the cardinal sign, bradykinesia, and the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any known or suspected cause of parkinsonism * subject has motor fluctuations such as wearing, dyskinesia * subject has experienced nocturias for at least 3 nights within 7 days prior to baseline * subject is taking levodopa (l-dopa, immediate and/or controlled release) in combination with benserazide or carbidopa and has been on a stable dose of l-dopa for at least 28 days prior to baseline (visit 2) * subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least 28 days prior to baseline (visit 2) exclusion criteria: * subject is receiving therapy with tolcapone or budipine * subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to baseline (visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase a (mao-a) inhibitors, methylphenidate, or amphetamine * subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within the 6 months prior to baseline (visit 2) * subject has a known hypersensitivity to any components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or has unresolved contact dermatitis * subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not surgically sterile, or, (ii) not using adequate birth control methods \[including at least one barrier method\] or, (iii) not sexually abstinent, or (iv) not at least 2 years post menopausal) * subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder

Keywords: rotigotine neupro
investigation of stent-grafts in aortic dissection (instead)

Conditions: Aortic Dissection

Summary: the objective of instead is to compare long-term (5 years) outcomes of endograft prosthesis versus medical management in patients with dissection of the thoracic aorta.

patients \> 18 years with type b aortic dissection were randomized to either thoracic aortic endoprosthesis (stent-grafting) or antihypertensive management (medical treatment). only stable patients without spontaneous false lumen thrombosis 14 days after index dissection were considered eligible for study inclusion. long-term outcome measures included all-cause mortality, aorta-specific mortality and a cluster endpoint (reflecting progression of disease, conversion and additional interventions); the analysis is based on 140 randomized cases followed for at least 5 years.

Eligibility criteria:
inclusion criteria: * no contraindication the general anesthesia and ventilation * type b aortic dissection that occurred 2-52 weeks prior to randomization * diameter of the targeted aortic segment \< 6 cm * subject or legal guardian understand the nature of teh study and agrees to its provisions on a written informed consent form * availability for appropriate follow-up visits during the f/u period of 5 years * capability to follow all study requirements exclusion criteria: * pregnancy * thrombocytopenia * ongoing anticoagulation therapy * renal failure and/or creatinine \> 2,4 mg% * complete thrombosis of false lumen * cancer likely to cause death within 1 year * enrollment in another clinical study * unwillingness to cooperate with study procedures or f/u visits

Keywords: dissection aorta surgery
a clinical test for the treatment of multifocal lung cancers using genome sequencing

Conditions: Lung Neoplasms; Carcinoma Non-small-cell Lung

Summary: the investigators are doing this research to see if they can use small tissue samples or fluid to develop a test that will determine if the tissue samples are related or not related to each other. the test will use the patient's dna, which is part of their unique genetic material that carries the instructions for the body's development and function. cancer can result from changes in a person's genetic material that causes cells to divide in an uncontrolled way and, sometimes, to travel to other organs. currently, researchers and doctors know some of the genetic changes that can cause cancer, but they do not know all of the genetic changes that can cause cancer.

a frequent clinical dilemma in lung cancer care is the management of multifocal lung cancers. the management decision is based on determining if multiple cancers represent true independent primary cancers or related metastasis. this determination is critical to the appropriate staging of the cancers and treatment. indeed, this distinction represents the difference between aggressive local therapy with either surgery or radiation therapy for primary early stage lesions, or palliative chemotherapy or best supportive care with appropriate symptom management for advanced stage metastatic disease. no existing pathologic or molecular test is currently capable of making the distinction between multiple independent lung primaries from metastatic disease with accuracy. the recent release of preliminary data from the nlst screening trial, suggesting survival benefit for screening high risk patients with ct scanning, will only increase the number of patients facing these treatment dilemmas. the research team has recently developed a test that allows this distinction with great accuracy. this test allows determination of lineage between two tumors using the identification of large genomic rearrangements using mate pair next generation sequencing (mp). the test has been developed using fresh frozen tissue from resected lung tumors and is currently being validated for a clinical test. the investigators' goal is to develop the test using cytology and small biopsy specimens.

Eligibility criteria:
inclusion criteria: * subject must be \> 18 years of age * presumed or known lung cancer. * undergoing bronchoscopy, ct guided lung biopsy, or lung resection as part of their clinical care at the mayo clinic rochester. * pft's and other clinical determinates that show the subject is capable of tolerating a lung biopsy or resection. * non-pregnant and non-lactating. women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study. * subject must be able to understand and willing to sign an irb-approved informed consent document.

Keywords: multifocal genetic bronchoalveolar carcinoma adenocarcinoma in situ ground glass opacity next generation sequencing
ballooned intercostal drain trial

Conditions: Pleural Effusion; Pneumothorax

Summary: this study is designed to assess whether a new type of chest drain reduces the number of drains that fall out of or are accidentally removed from the chest cavity (usually requiring another drain to be inserted), without causing any increase in discomfort or other side-effects.

chest drains are an essential part of the treatment for patients with fluid or air around the lung, which usually causes breathlessness. draining the fluid or air relieves symptoms and allows investigations to be carried out that can identify a cause for why the fluid or air is there. chest drains are difficult to secure in place, and sometimes fall out despite the best possible care. this study tests a modified drain that has a small balloon near the end which, when inflated inside the chest cavity, should make it much harder for the drain to fall out of the chest. this was tested in a small pilot study, with encouraging results. the current study is comparing a group of patients treated with the new ballooned drain against a group treated with the standard drain, with patients equally but randomly allocated to each group. the chest drain has been through rigorous laboratory testing and has been ce marked for human use. all patients requiring intercostal drainage for clinical reasons will be offered entry into the study, unless, in the view of the treating physician, blunt dissection is required. no other screening assessments will be required, other than the ability to sign the informed consent form.patients who have provided signed informed consent will then proceed to the study protocol. patients will be randomised to undergo either standard ict insertion (usual clinical care) or insertion of the study drain using standard clinical policies and procedures at each participating centre. once a patient has been identified for the trial and has signed the informed consent form, baseline details will be entered into a dedicated web-based programme accessible at all sites, and patients will be allocated 1:1 to either usual care or to the study drain. all subsequent care will be as per best clinical care for all patients in both arms of the study. the only additional assessments over and above usual care will be the collection of pain scores. pain will be rated by the patients on a visual analogue scale (vas) on up to 4 occasions - insertion, 24 and 72 hours post insertion, and at drain removal.

Eligibility criteria:
inclusion criteria: 1. age \>16 years 2. able to give written informed consent 3. requiring intercostal tube drainage for clinical reasons exclusion criteria: 1. inability to provide written informed consent 2. requiring blunt dissection for intercostal tube insertion 3. haemothorax
evaluation of the cr plug (allograft) for the treatment of a cartilage injury in the knee.

Conditions: Knee Injury

Summary: determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

the specific aim in this study is to assess the ability of the cr-plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * skeletally mature * have one symptomatic score international cartilage repair score (icrs) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the medial femoral condyle (mfc) or lateral femoral condyle (lfc). symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling * functional meniscal tissue (defined as 5 mm or more width) * a score of = or greater than 4 on the vas questionnaire exclusion criteria: * associated tibial or patellar articular cartilage defect greater than 2 icrs * osteoarthritis of either knee * mechanical axis malalignment of greater than 5 degrees * patellofemoral incongruity of merchant view * one or more multiple defects greater than 2.5 cm * osteochondritis dissecans (ocd) with depth of bone loss greater than 4 mm * ligament treatments in the affected knee within one yer prior to current study * previous surgical meniscus treatments in the affected knee in the last 6 months * less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment * use of any investigational therapy with in 30 days prior to the first visit * corticosteroid or viscosupplementation within the past 3 months * a score of 3 or less on the vas questionnaire * active gout or pseudogout or systemic inflammatory condition

Keywords: allograft knee injury cartilage injury osteochondral defects in the articular femoral cartilage
quality of preoxygenation in emergency surgery

Conditions: Preoxygenation; Anaesthesia; Emergencies; Surgery

Summary: preoxygenation prior to general anaesthesia prolongs safe apnea time. proper preoxygenation is always a challenge in emergency surgery. the aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.

factors, that are associated with compromised preoxygenation will be determined during our study. pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures. parameters analysed: * preoperative: medical history, physical examination, laboratory findings, anthropometric data * intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)

Eligibility criteria:
inclusion criteria: * written informed consent * patient going for emergency surgery under general anaesthesia * age \> 18 years exclusion criteria: * informed consent refusal * noneligible for preoxygenation before general anaesthesia

Keywords: anaesthesia preoxygenation
high dose radiotherapy for the treatment of rectal cancer

Conditions: Rectal Cancer

Summary: while surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer we retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in sun yat-sen university cancer center from april 1st, 2006 to july 30th, 2017. patients gave up surgery before any treatment would have received one course of high dose radiotherapy (gtv60-70gy/30-35f). patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: gtv 45-50gy/25f, 2nd: gtv 30/15f). the chemotherapy regimens included capox, folfox, or capecitabine at the discretion of the treating physician. after treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. recurrence, early and late toxicity were recorded. analyses were performed using spss software, version 19.0 (spss, chicago, il). local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the kaplan meier method and were compared by log-rank test.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from the anal verge; 2. pelvic radiation with a total dose ≥60gy for the treatment of rectal cancer; 3. refused surgery as the initial treatment; 4. a complete set of clinical information and follow-up data. exclusion criteria: 1. patients with terminal cancer who received palliative treatment; 2. patients received any treatment before admission to sun yat-sen university cancer center; 3. patients with second primary cancer.

Keywords: high dose radiotherapy rectal cancer
prevalence ， associated factors and influences of prenatal mental disorders

Conditions: Mental Disorder During Pregnancy - Baby Not Yet Delivered

Summary: the purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.


Eligibility criteria:
inclusion criteria: * aged at least 18 years of age * 8 to 12 weeks of pregnancy * there is no history of mental illness * had perinatal health care in a women's \& children's health hospital exclusion criteria: * the obvious body disease * having anxiety, phobia, hypochondriasis, obsessive-compulsive disorder or depression before pregnancy * having severe complications during pregnancy * fetal malformation or abortion * can't understand the questionnaire * without informed consent * more than 13 weeks of pregnancy * less than 18 years of age
observational study of iv ibandronate in women with postmenopausal osteoporosis

Conditions: Osteoporosis

Summary: this observational study assess the safety of intravenous ibandronate (bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of iv ibandronate (bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)


Eligibility criteria:
inclusion criteria: * patients had post menopausal osteoporosis * patients had no contraindication for bisphosphonates * patients had been naive for ibandronate therapy * patients who have signed informed consent and are willing to share their data for data analysis exclusion criteria: * is not ibandronate naïve * hypersensitivity to any component of the bisphosphonates ibandronate; * administration of any investigational drug within 30 days preceding the first dose of the study drug.
impact of the "standing patient" pathway on preoperative anxiety.

Conditions: Surgery

Summary: for 25 years, the concept of rapid rehabilitation after surgery or rrac has developed to bring about a global care of the patient by establishing a safe and quality climate. with this concept of rrac or fast track surgery, it is the idea that a patient will recover sooner than he is lying later. "fast care" is based on the principle that any patient is valid before he / be operated and therefore do not need to come to a bed in the operating room. the ambulatory surgery department of the chu of caen welcomes and supports adults and children over 8 years old. the following specialties are covered: dental surgery and stomatology, digestive and visceral surgery, orthopedic surgery, otolaryngological surgery, vascular surgery, gynecological surgery, urological surgery. the ambulatory surgery unit is experimenting with patient support at the operating theater on foot by the service stretcher team since december 2015. it seems that this technique makes it possible to improve the quality of care by respecting the dignity and autonomy; in fact to wander the patient preserves his glasses, his hearing aids, capillary prosthesis ... the patient is an actor and not dependent, he is accompanied and not taken away. the preservation of autonomy improves their feelings, especially in terms of dignity. it also appears to be a technique for participating in the reduction of preoperative anxiety, an important factor for postoperative follow-up. however, studies reporting the benefit of this technique have rather evaluated the feelings of patients. to the best of our knowledge, there are no studies that have evaluated their benefit on anxiety reduction by questionnaires or ad hoc scales. assessing anxiety with appropriate tools seems essential to determine a real impact. we hypothesize that accompanying the patient to the operating room on foot would reduce preoperative anxiety. we have not yet found any studies showing that the "standing patient" pathway had an impact on preoperative anxiety. we propose to carry out a randomized study comparing the anxiety score using the apais scale at the operating room installation between patients benefiting from the "standing patient pathway" versus the patients receiving the care standard, that is to say the stretcher transport to the operating theater. the duration of this study is evaluated at 2 years.


Eligibility criteria:
inclusion criteria: * major patient. * patient hospitalized for surgery. * patient supported in the south block. * patients agreeing to participate in the study. * patient speaking and understanding french. exclusion criteria: * patient with reduced mobility. * patient with a mental disability. * patient suffering from a severe psychiatric pathology. * major patient protected. * patient does not speak or understand french. * refusal of the patient to participate in the study. * patient who has been premedicated