Kornimate/medical-research-clean huggingface dataset:
a study of abemaciclib (ly2835219) plus tamoxifen or abemaciclib alone in women with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (hr+), human epidermal growth factor receptor 2 negative (her2-), metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * have a diagnosis of hr+, her2- breast cancer. * relapsed or progressed following endocrine therapy. * have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting. * have the presence of measureable disease as defined by the response evaluation criteria in solid tumors (recist 1.1). * have a performance status ≤1 on the eastern cooperative oncology group (ecog) scale. * have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least grade 1) except for residual alopecia or peripheral neuropathy. * have adequate organ function. * have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment. * are able to swallow oral medication. exclusion criteria: * have clinical evidence or history of central nervous system metastasis. * have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest. * have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection. * have received treatment with a prior cyclin-dependent kinase (cdk4) and cdk 6 inhibitor. * have a preexisting chronic condition resulting in persistent diarrhea. * have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.
a study to evaluate rucaparib in combination with nivolumab in patients with selected solid tumors (aries)

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; High Grade Serous Carcinoma; Endometrioid Adenocarcinoma

Summary: this is an open label phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination with nivolumab in patients with high-grade serous or endometroid ovarian cancer. patients entering the following cohorts must have brca mutational status confirmed by a central lab: * cohort a1: no brca mutation in tumor; high level of loh (loss of heterozygosity) * cohort a2: brca mutation in tumor


Eligibility criteria:
general inclusion criteria: * ≥ 18 years of age * adequate organ function * life expectancy ≥ 16 weeks * women of childbearing potential must have a negative serum pregnancy test * high-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer * received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease * relapsed/progressive disease (confirmed by radiologic assessment) * willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment. * measurable disease (recist v1.1)- cohort a1 only * ecog performance status of 0 to 1 general exclusion criteria * active second malignancy * central nervous system brain metastases * evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis. * active, known or suspected autoimmune disease (eg, autoimmune hepatitis). * condition requiring systemic treatment with either corticosteroids * prior treatment with a parp inhibitor or immune checkpoint inhibitor. * non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. mixed mullerian tumors/carcinosarcomas are allowed.

Keywords: parp parpi parp inhibitor aries opdivo rucaparib nivolumab pd-1 brca loh co-338 immunotherapy bms-936558 clovis clovis oncology rubraca
testing product messages for colombia

Conditions: Obesity

Summary: purpose: to better understand the impact of different front-of-package labels (fopls) on consumer purchasing intentions and ability to identify unhealthy foods. participants: \~8,000 colombians, recruited from offerwise, that are 18 years or older. procedures (methods): participants will be randomly assigned to view images of food and drink products with either a nutrient warning label, guideline daily amount label, nutriscore label, or no-label control. they will be asked a series of questions about the products and the labels (excluding control group) on them. questions will also include standard demographic and health related variables.

participants will be recruited from offerwise (an online panel research company). following online consent, participants will be randomly assigned to view different labels (explained below) on food and drink packaging. participants will answer self-reported responses to the content (e.g., elaboration, beliefs, perceived healthfulness). after being randomized to one of the four groups and answering questions (e.g. which product is healthier, which product would you buy), the participant will see all three labels and select which is most dissuading from consuming a product high in a nutrient. at the end, the participant will answer demographic questions. participants will be randomized to see either a no-label control or 1 of 3 nutrient labels. the participants will see 5 types of products with the labels (fruit drinks, yogurt, sliced bread, cookies, and breakfast cereal). nutrient labels: 1. guideline daily amount label 2. nutriscore label 3. adapted peruvian nutrient warning label (high in sugar, high in saturated fat, high in salt/sodium)

Eligibility criteria:
inclusion criteria: * 18-64 years old * resident of colombia * offerwise panel member (recruitment platform) exclusion criteria: * \ 64 years old * not a resident of colombia
glial tumors electromagnetic signature study by magnetoencephalography (meg) "conductome"

Conditions: Cerebral Primitive Tumor With Chirurgical Indication

Summary: the purpose of this study is to determine the correlation between functional meg analysis of the tumor and its periphery and the tumor stage and treatment response.

a better tumor grade definition would provide an optimized surgical care, prognosis and therapeutical response evaluation.

Eligibility criteria:
inclusion criteria: * more or equal than 18 years old * patient affiliated to social security or similarly regime * informed consent form signed * supra-tentorial primitive cerebral tumor exclusion criteria: * pregnant women and lactating mothers * ward of court or under guardianship * adult unable to express their consent * person deprived of freedom by judicial or administrative decision * person hospitalized without their consent * person under legal protection * magnetic resonance imaging (mri) contraindication (implanted material non mri-compatible, ferro-magnetic foreign body, claustrophobia) * patients needed emergency medical care for other pathology * severely altered general health (performance status 3 or 4)
radioimmunotherapy (rit) in multiple myeloma using the antibody b-b4 radiolabelled with iode 131

Conditions: Multiple Myeloma

Summary: the first step of this protocol called step pre-treatment study the biodistribution and pharmacokinetics of a tracer dose of radiolabeled antibody. the second step called step therapy study the toxicity and antitumor effects of antibody b-b4 coupled with increasing doses of iodine 131. at least 17 patients will be included for an estimated duration of 2 years to determine the maximum tolerated dose and dose limiting toxicity. the immediate side effects, medium and long terms will be analyzed. after determining the toxic dose limit, patients will be treated at the maximum tolerated dose, for a total of 15 patients at this level, which will measure the objective tumor response to treatment. these patients will be followed for 1 year after injection therapy. écouterlire phonétiquement


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of multiple myeloma (\> 10% plasma cells on a previous myelogram) * secretion of a monoclonal immunoglobulin * no myelodysplasia evaluated by myelogram * disease refractory or relapsed after at least 3 lines of therapy * patients with a dated and signed the consent form * collection of autologous peripheral blood stem cells containing at least 2. 106 cd 34 + cells / kg * age\> 18 years * performance status \<2 (see annex i), life expectancy of more than 3 months * no chemotherapy or radiotherapy within 4 weeks before inclusion * no major surgery within 4 weeks preceding the assessment of inclusion * no bisphosphonates within 2 weeks prior radioimmunotherapy, except for treatment started more than three months ago. * normality of the biological assessment: * creatinine less than or equal to 1.5 times the normal laboratory * liver: less than or equal to 1.5 times the normal laboratory (free and conjugated bilirubin, sgot, sgpt, gamma gt pal) * hemoglobin ≥ 8 g/mm3 * ≥ 3 wbc 000/mm3 * neutrophils ≥ 1 500/mm3 * platelets ≥ 100 000/mm3 exclusion criteria: patients with other cancers except uterine carcinoma in situ or basal cell skin carcinoma * patients with other (s) condition (s) severe (s) to prevent tolerance to study and conduct the study to completion * patient is pregnant or unwilling to take a contraceptive treatment for three months after treatment * collection of peripheral blood stem cells containing less than 2106 cd 34 + cells / kg * patients enrolled in another experimental treatment protocol * patients who already received treatment with radioimmunotherapy * myelodysplasia assessed by myelogram * patient with thyroid * patient unable to sign informed consent écouterlire phonétiquement
safety and antiviral activity of idx184 in combination with pegylated interferon and ribavirin for 12 weeks (mk-2355-005)

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to assess the safety and antiviral activity of idx184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * males and females with documented genotype 1, chronic hepatitis c infection. * must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs. * has not received prior antiviral treatment for hcv. * written informed consent by participant. exclusion criteria: * pregnant or breastfeeding. * co-infected with hepatitis b virus (hbv; hepatitis b surface antigen \[hbsag\] positive) and/or human immunodeficiency virus (hiv).

Keywords: hepatitis c hcv treatment-naive
gynecological health improvement of adult women with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: following the results of the research team's cross-sectional study conducted in 2014 describing insufficient gynecological care, the research team implemented an on-site gynecological consultation in the adult cystic fibrosis (cf) centre in 2015. the study aimed to compare the results of two surveys conducted successively in 2014 and in 2017 on a cohort of women with cf attending the lyon cf adult referral centre. all the women attending the adult cf center in 2017 were asked to complete the same self-report written questionnaire that was completed in 2014 about their contraceptive choices, gynecological follow-up and cervical screening. questions concerning gynecological comorbidities were added to the 2017 questionnaire. this current study aimed to evaluate the impact of the implementation of an on-site gynecological consultation on gynecological health of women with cf, as measured through 3 indicators: the proportion of women with regular gynecological follow-up, cervical screening coverage, and contraceptive coverage. the identification of specific gynecological comorbidities was the other objective of this study.


Eligibility criteria:
inclusion criteria: * women with cystic fibrosis * subjects followed by the cystic fibrosis adult referral centre in lyon, france in 2017 exclusion criteria: * none
pain and music therapy in patients suffering arteritis

Conditions: Arteritis

Summary: it is estimated that 800,000 people in france suffer from peripheral artery disease (pad), of whom 1-2% present the most severe form critical limb ischaemia (cli). in this situation, the patient frequently presents painful non-healing ulcers and focal gangrene. wound care is generally associated with increasing pain. pain relief may be challenging in spite of major analgesics. several studies in this country and elsewhere assessed the usefulness of music for chronic or acute pain relief during care. however, no data are published regarding the interest of music therapy for pain relief during local care in pad patients.


Eligibility criteria:
inclusion criteria: * men and women, aged at least 18 years, affiliated to the health insurance scheme. * patients affected by arteritis of stage 5 or 6 at limoges university hospital in department cardiovascular surgery. * patients requiring a daily repair of bandage, not exceeding fifteen minutes and provoking a pain * initial pain equal to three during local care in the digital scale. * having given their enlightened consent writes exclusion criteria: * bypass and / or angioplasty lower than one week * diabetic neuropathy * patient who is going to undergo a surgery of amputation * patients affected by demented pathologies or by confusion * pregnant or breast-feeding women or without effective contraception * patients being the object of a saving of justice

Keywords: stage 5 arteritis stage 6 arteritis rutherford classification
pieb-pcea vs cei-pcea for abdominal oncological surgery. a randomized prospective clinical trial

Conditions: Pain, Postoperative

Summary: the aim of the study is to compare programmed intermittent bolus application and continuous epidural infusion with regard to additionally applied patient-controlled volume of local anesthesia and quality of analgesia.

usually, patient controlled epidural analgesia (pcea) is performed with a constant background infusion and patient-controlled bolus applications. an alternative approach is to give boluses at a regular rate for basic medication, instead of the continuous background infusion, maintaining the same amount of medication delivered per hour, (programmed intermittent epidural bolus injection; pieb). in both cases, the patient has the option to trigger additional boluses. pieb has been applied successfully in pain relief for lumbar epidural anesthesia in obstetrics, with better quality of analgesia and less total volume of local anesthetic required. it is assumed that the higher pressure in the epidural space with bolus injection results in a better and more uniform spread of the local anesthetic. in this study the pieb-mode will be applied in major gynecological and abdominal surgery. in order to address the possibility that the different types of surgery result in different degrees of postoperative pain, the patients are stratified in three groups and randomized within these groups (wertheim, whipple, major colon surgery).

Eligibility criteria:
inclusion criteria: * abdominal tumors in gynecology and general surgery * enlightenment and written consent to the investigation exclusion criteria: * refusal to participate * pregnancy and breast feeding period * general contraindications for thoracic epidural anesthesia (e.g. coagulation disorders, --anticoagulation according to the guidelines of dgai) * impossibility to place the epidural catheter correctly * known allergy to the drugs used in the study * lack of understanding how to use the patient-controlled system * postoperative follow-up respiratory assistance

Keywords: pcea pieb epidural analgesia
neo-adjuvant temsirolimus in patients with advanced renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: temsirolimus is a drug that is being studied to possibly treat kidney cancer. it works by starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink the cancer. this study will look at the experimental use of temsirolimus, 12 weeks prior to the surgical removal of the entire kidney or a portion of the kidney that is involved by the tumor.

this study will also find out whether or not there are certain biological factors that show up in patients during their treatment with this drug. this will be able to predict how their disease will respond to the therapy (biomarkers), and this will possibly allow anti-cancer therapies to be developed in the future to tailor to a patient's needs.

Eligibility criteria:
inclusion criteria: * at least 18 years old and capable of giving informed consent. * patient has radiological evidence of rcc consisting of: ct scan with stage t2, t3, t3a, t4, or any stage t with n1/2 and/or metastatic disease. * patient is already having a nephrectomy. * adequate cardiac function as assessed by electrocardiogram (ecg). * patient is will to have a kidney biopsy at baseline/screening. * patient has scored a 0 or 1 on the ecog. * patient is negative for hiv, hepatitis b, hepatitis c * if patient is a woman of child-bearing potential, they have to have a negative pregnancy test. exclusion criteria: * patient has stage t1 disease without metastases. * patient has abnormal laboratory values at screening within the following ranges: * absolute neutrophil count ≤1.5 x 10(9)/l; platelet count ≤ 100 x 10(9)/l * leukocyte count ≤ 3 x 10(9)/l; hemoglobin ≤ 80 g/l * serum creatinine ≥ 2.0 x the upper normal limit (unl) * total bilirubin ≤ 1.5 x unl; ast and alt ≤ 3.0 x unl * fasting serum cholesterol ≤ 9.0 mmol/l * fasting serum triglycerides ≤ 5.0 mmol/l * patients with a known hyper-sensitivity to temsirolimus. * other currently active malignancies. * currently taking any medications known to interfere with the metabolism of temsirolimus. * patients receiving anticoagulation with warfarin. * patients with a history of pulmonary hypertension or interstitial lung disease. * unstable angina as judged by the primary investigator, or any recent mi in the last 180 days.
physical therapy vs remote exercise for knee pain due to osteoarthritis (oa)

Conditions: Knee Osteoarthritis; Chronic Pain

Summary: the purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with simpletherapy, participants with clinical indications of knee oa will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years) * living in the tristate area - ct/ny/nj * symptomatic oa (national institute for health and care excellence clinical criteria for oa) * chronic knee pain (\>3 months) as a primary pain complaint * average pain score ≥ 4 on an 11-point numeric rating scale at baseline * access to a device with internet connection * kl stages 1-2-3 exclusion criteria: * prior documented history of cognitive impairment; * history of total knee arthroplasty; * history of: inflammatory arthritis (e.g. rheumatoid arthritis); or any neuropathies affecting the lower limbs, spinal cord injury, spine fractures, advanced heart disease, bleeding issues (i.e. hemophilia), surgery within the last 90 days; fall within 90 days; high risk of fracture; * history of knee injury, within the last 3 months; * currently engaged with other pt or strengthening program; * present unstable/uncontrolled cardiovascular condition * undergoing active chemotherapy for cancer
the application of enhanced recovery after surgery clinical pathway in posterior cervical spine surgery

Conditions: Cervical Spondylotic Myelopathy; Ossification of Posterior Longitudinal Ligament in Cervical Region

Summary: this study intends to establish a multidisciplinary collaborative eras clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics.

enhanced recovery after surgery (eras) is a new model of deep cooperation between surgery，rehabilitation medicine, anesthesiology, nursing and other disciplines in recent years, which enables patients to start rehabilitation training as soon as possible after surgery and improves the comprehensive effect of surgery. posterior cervical surgery is traumatic, and it is significant to enhance postoperative rehabilitation to improve the overall efficacy of patients. currently, there are no clear guidelines supporting the clinical effectiveness of eras in reducing complications, reducing costs, and enhancing recovery after posterior cervical surgery. therefore, this study aims to establish a multidisciplinary eras model for posterior cervical surgery in peking university third hospital and verify its clinical effectiveness. this is a multi-center, multidisciplinary prospective cohort study,in which the orthopedics department was combined with the anesthesiology department, rehabilitation department, nutrition department, operating room and nursing team to establish the eras clinical pathways for posterior cervical spine surgery. clinical pathways include surgical procedure optimization, rehabilitation procedure optimization, anesthesia and nursing procedure optimization. as it is optimized and promoted,the eras clinical pathways will improve the curative effect and prognosis of posterior cervical surgery, so that more patients with cervical spondylosis will benefit.

Eligibility criteria:
inclusion criteria: 1. age 18-70, gender unlimited; 2. diagnostic diagnosis of cervical spondylosis and consistent with the indications of posterior spinal canal extended laminoplasty; 3. basis of serious diseases of centerlessness, brain, lung, kidney or other important organs, preoperative asa score i-ii; 4. agree to participate in the study and sign the informed consent. exclusion criteria: -

Keywords: enhanced recovery after surgery posterior cervical surgery posterior cervical laminoplasty clinical pathway
hypotension prediction index in patients undergoing liver transplantation

Conditions: Intraoperative Hypotension

Summary: a prospective, open-label and single-center study to determine whether the use of acumen hypotension prediction index software predicts the occurrence of hypotension.


Eligibility criteria:
inclusion criteria: * written informed consent * age ≥ 20 years; * scheduled liver transplantation * planned pressure monitoring with an arterial line; * general anesthesia exclusion criteria: * contraindication for invasive blood pressure monitoring * end-staged renal disease * pre-operative map \<65 mmhg * severe heart failure * severe cardiac shunt * severe aortic stenosis * severe atrial fibrillation