Kornimate/medical-research-clean huggingface dataset:
a study to compare nivolumab drug product process d to nivolumab drug product process c in participants with stage iiia/b/c/d or stage iv melanoma after complete resection

Conditions: Melanoma

Summary: the purpose of this study is to compare the drug levels, immunogenicity and safety of nivolumab process d to nivolumab process c after complete resection of stage iiia/b/c/d or stage iv melanoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage iiia/b/c/d or stage iv melanoma * complete resection of stage iii disease that is documented on the surgical and pathology reports or complete resection of stage iv disease with margins negative for disease that is documented on the pathology report * eastern cooperative oncology group (ecog) performance status score of 0 or 1 exclusion criteria: * prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured * any significant acute or chronic medical illness that is uncontrolled * history of ocular/uveal melanoma * active, known or suspected autoimmune disease * systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease. other protocol-defined inclusion/exclusion criteria apply
evaluation of the results of two different methods in management of antero-lateral instability of the knee

Conditions: Anterior Cruciate Ligament Injuries

Summary: this randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (aclr) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (modified lemaire) in management of antero-lateral instability of the knee

patients will undergo an anatomic aclr in a standardized fashion by the same team of surgeons. they are randomly divided into 2 groups either aclr plus all reconstruction or aclr combined with let in a 1:1 ratio. there are multiple graft options for acl-r, but here for the study, the hamstring autograft is harvested following the traditional technique. the graft is measured and bony tunnels are drilled. an anatomical reconstruction technique is used in all cases. in group a: the surgeon will harvest peroneus longus graft, then sutured to the double bundle hamstring graft. the graft diameters are measured and recorded. the graft is pulled through the femoral tunnel and passed through the tibial tunnel. the single portion of the graft is passed freely through the tibial and femoral tunnels until the quintuple graft portion occupies both tunnels. the graft is then pulled, and an interference screw (smith \& nephew endoscopy) is fixed to the femur. the next step is to fix the inferior end of the quintuple graft to the tibia after pre-tensioning. after tibial fixation, the remaining pl is passed through the subcutaneous and all tunnels. the ligament is fixed under traction, mild valgus stress, and 30' of flexion 1.5 cm from the joint line into a midpoint between gerdy's tubercle and the fibular head. in group b: the surgeon will use a triple stg hamstring (6- strands) tendon graft. the graft diameters are measured and recorded. then, let is performed in a standardized fashion as described in the modified lemaire technique. let is fixed with interference screws (smith \& nephew endoscopy). femoral and tibial fixations are performed with bio-absorbable interference screws (smith \& nephew endoscopy).

Eligibility criteria:
inclusion criteria: 1. the acl deficient knee was clinically manifested by physical examination and confirmed by mri. 2. age 18-45 years, skeletally mature patient. 3. a positive pivot shift test of at least grade ii is required (significant anterolateral instability). exclusion criteria: 1. multiple ligament injuries or a polytraumatized patient 2. revision cases. 3. generalized laxity. 4. symptomatic articular cartilage defect requiring treatment; outerbridge \> grade ii. 5. more than three degrees of varus or valgus malalignment
open-label extension study of trofinetide for the treatment of girls and women with rett syndrome

Conditions: Rett Syndrome

Summary: to investigate the safety and tolerability of long-term treatment with oral trofinetide in girls and women with rett syndrome


Eligibility criteria:
inclusion criteria: 1. has completed the week 12/end-of-treatment visit of the antecedent study, study acp-2566-003 2. met all entry criteria for the antecedent study 3. may benefit from long-term treatment with open-label trofinetide in the judgment of the investigator 4. can still swallow the study medication provided as a liquid solution or can take it by gastrostomy tube 5. the subject's caregiver is english-speaking and has sufficient language skills to complete the caregiver assessments 6. subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to baseline exclusion criteria: 1. began treatment with growth hormone during the antecedent study 2. began treatment with igf-1 during the antecedent study 3. began treatment with insulin during the antecedent study 4. has developed a clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study 5. subject is judged by the investigator or the medical monitor to be inappropriate for the study due to aes, medical condition, or noncompliance with investigational product or study procedures in the antecedent study 6. has a clinically significant abnormality in vital signs at baseline 7. has a qtcf interval of \>450 ms on the baseline ecg performed before the first dose of trofinetide is given in the present study 8. has developed a clinically significant ecg finding during the antecedent study additional inclusion/exclusion criteria apply. patients will be evaluated at baseline to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all prespecified entry criteria).
study on prediction of left ventricular remodeling using st2

Conditions: Acute Coronary Syndrome

Summary: patients who underwent percutaneous coronary intervention after diagnosis of acute coronary syndrome should be enrolled in the study and follow - up.

obtain written consent for patients who meet all of the selection criteria and who do not meet the exclusion criteria. acs(acute coronary syndrome) patients with lv systolic dysfunction(lvef\<50%) on tte test who underwent successful pci. at that time, patient proceed with the baseline blood test(st2) in hospital. and then, medical therapy for 3 months later patient proceed with the follow-up blood test(st2) and tte in opd.

Eligibility criteria:
inclusion criteria: * subjects aged 19 or older * patients with acute coronary syndrome who underwent successful percutaneous coronary intervention * patients with left ventricular ejection fraction less than 50% on transthoracic echocardiography * patients who voluntarily agreed to participate in the study exclusion criteria: * failure to obtain timi 3 flow after procedure * if the remaining life span is less than one year * women who are breastfeeding or plan to become pregnant or are planning to become pregnant during the study period
neoadjuvant therapy and contrast-enhanced mammography for early stage breast cancer

Conditions: Breast Cancer; Locally Advanced Breast Cancer; Neoadjuvant Chemotherapy; HER2-positive Breast Cancer; Triple Negative Breast Cancer; TNBC, Triple Negative Breast Cancer

Summary: the purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (cedm+cedbt), with breast magnetic resonance imaging imaging (mri) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. the device used to obtain cedm+cedbt images is called siemens mammomat. this device produces two-dimensional (2d) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (dbt), which produces a three-dimensional (3d) image of the breast in the form of image slices. dbt allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. by looking at both the cedm images and the cedbt images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner. participation may last up to 18 weeks. study procedures for this research are: * undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery. * before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. the chemotherapy port cannot be used to receive the contrast agent * let the research team record information from your medical record related to your condition and the treatment you receive. * give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.


Eligibility criteria:
inclusion criteria: * diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or her2 status * plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery exclusion criteria: * pregnancy * allergy/sensitivity to contrast agent * decreased kidney function * diabetes

Keywords: cedm cedbt contrast-enhanced digital mammography contrast-enhanced digital breast tomosynthesis neoadjuvant chemotherapy
narrow band imaging in diagnosis of colorectal polyps

Conditions: Colorectal Polyp; Colorectal Neoplasms

Summary: optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. nice (nbi international colorectal endoscopic) and wasp (workgroup on serrated polyps and polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.

near-focus (nf) narrow-band imaging (nbi) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (nf) compared with 52x in normal standard focus (sf) with the simple push of a button of the endoscope to be interchangeable between nf and sf. there were few studies comparing diagnostic accuracy between nf and sf in the diagnosis of colorectal polyps. so, our aim of the current study is to compare accuracy of nf nbi compared with sf nbi in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of nf nbi versus sf nbi in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.

Eligibility criteria:
inclusion criteria: * patients who were scheduled for colonoscopy at nkc institute exclusion criteria: * inflammatory bowel disease * polyposis syndrome * colorectal cancer * active gastrointestinal bleeding * pregnant woman * inadequate bowel preparation * contraindication for polyps removal
study to evaluate safety and immunogenicity of sub-unit adjuvanted influenza vaccine administered to elderly subjects, formulation 2010-2011

Conditions: Seasonal Influenza

Summary: this study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects


Eligibility criteria:
key inclusion criteria: * males and females volunteers of 65 years of age or older * mentally competent * willing and able to give written informed consent prior to study entry. * able to comply with all the study requirements. * in general good health key exclusion criteria: * any serious chronic or acute disease * history of any anaphylactic reaction and/or serious allergic reaction following a vaccination * known or suspected impairment/alteration of immune function * bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject * within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine * fever (i.e., axillary temperature ≥38°c) within the last 3 days of intended study vaccination * individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines

Keywords: seasonal influenza vaccine
a post-marketing observational study on risk factors for hepatic encephalopathy in participants with unresectable hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: this study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. the primary objective of this study is assessment of risk factors for hepatic encephalopathy.


Eligibility criteria:
inclusion criteria: * participants with unresectable hepatocellular carcinoma who were administered the lenvatinib mesilate for the first time within the registration period. * have provided informed consent. * underwent case registration by 14 days after the start of administration of drug.

Keywords: hepatocellular carcinoma lenvima post-marketing surveillance len02t lenvatinib mesilate
impairing drugs and alcohol as risk factors for traumatic injuries

Conditions: Trauma Injury

Summary: impairing drugs and alcohol are major risk factors for traumatic injuries. still there is to date little knowledge to what extent these factors affect the epidemiology of trauma. detailed mapping of risk factors improve targeting and efficiency of primary injury prevention. the aim of this project is therefore to facilitate injury prevention through improved data collection and analysis on impairing drugs and alcohol as a contributing and modifiable factor in injury morbidity and mortality. study question: what is the toxicological profile among patients with suspected severe traumatic injury? study design: a prospective population-based and national observational study will analyse toxicology from blood samples of all trauma admission during a 12 month study period.


Eligibility criteria:
inclusion criteria: * admission to any norwegian trauma hospital (n=37) and trauma team activation, during study period exclusion criteria: * age * foreign citizens
hospital insulin protocol aims for glucose control in corticosteroid-induced hyperglycemia

Conditions: Hyperglycemia

Summary: the objective of this study is to determine the best insulin regimen for hospitalized patients who receive high doses of steroids who have high blood glucose.

the overall study objective of this research is to establish the efficacy and assure the safety of achieving glycemic control in hospitalized patients who receive greater than physiologic doses of steroids. this study will compare 2 methods of achieving glycemic control in hospitalized patients who develop steroid-induced hyperglycemia (blood glucose (bg) \>180 mg/dl): 1) a study-specific steroid nph dosing algorithm plus standard recommended care (experimental group) vs. 2) the standard recommended care (methodist hospital complete insulin orders (control group).

Eligibility criteria:
inclusion criteria: * men or women aged ≥18 years who receive steroids in doses greater than physiologic replacement levels of ≥ 10 mg prednisone or its equivalent of dexamethasone or methylprednisolone. * have signed the consent form for the study * have a bg \> 180 mg/dl any time during the first 24 hour of steroid administration that is above physiological replacement ( ≥ 10 mg prednisone or equivalent) * are scheduled to be in hospital ≥ 2 days. exclusion criteria: * unable to read or understand english * history of psychiatric disability affecting informed consent or compliance with drug intake * type 1 diabetes * acute or chronic renal failure (creatinine clearance \< 30 ml/min estimated by method of cockcroft and gault) * patients in hospice care * age \<18 years * previously enrolled in this study. * not appropriate for the steroid protocol in judgment of the principal investigator and/or attending physician.

Keywords: corticosteroid hyperglycemia hospital corticosteroid induced hyperglycemia in the hospital
lemtrada pregnancy registry in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: primary objective: the primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to lemtrada for multiple sclerosis. secondary objective: the secondary goals of this registry is to assess maternal, fetal and infant outcome in women with multiple sclerosis, exposed to lemtrada.

from enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)

Eligibility criteria:
inclusion criteria : * women with multiple sclerosis who were or became pregnant within the period of time between the first infusion of a course of treatment with lemtrada to 4 months after their last infusion for that course. * women able and willing to provide informed consent for study participation and the requirement of the study. informed consent will be obtained at the time of enrollment in accordance with local regulatory requirements. exclusion criteria: - previous enrollment in this study for a previous pregnancy. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
mind programme for women with breast cancer (nationwide coverage)

Conditions: Breast Cancer Female

Summary: the purpose of this research project is to optimize the mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial


Eligibility criteria:
inclusion criteria: 1. age between 18-70; 2. primary diagnosis of bc (stages between i and iii); 3. having a scheduled radiotherapy treatment starting within 2 months, currently undergoing radiotherapy treatment, or having finished radiotherapy treatment no more than 6 months prior, at any hospital in portugal; 4. able to understand and answer to self-report questionnaires in portuguese; 5. having access to a computer or tablet with internet. exclusion criteria: 1. currently undergoing any form of psychological intervention; 2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation; 3. diagnosis of neurological disease.

Keywords: mental health quality of life cost-effectiveness mindfulness compassion focused therapy acceptance and commitment therapy
dual target car-t cells in b-cell lymphoma

Conditions: Lymphoma, B-Cell; Relapse/Recurrence; Refractory Lymphoma; Dual-target CAR-T Cells

Summary: prospectively evaluate the safety and effectiveness of cd19/cd20 dual-target car-t cells in the treatment of relapsed/refractory b-cell lymphoma .

prospectively evaluate the safety and effectiveness of cd19/cd20 dual-target car-t cells in the treatment of relapsed/refractory b-cell lymphoma . strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. the selected patients received cd19/cd20 dual-target car-t cell therapy. after the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.

Eligibility criteria:
inclusion criteria: * subjects must meet the following criteria to participate in this study: 1. 14-75 years old, no gender limit; 2. diagnosed as relapsed/refractory b-cell lymphoma according to the 2020 world health organization (who) diagnostic criteria; 3. ecog behavior status score is 0-2 points; 4. expected survival time ≥ 3 months; 5. no contraindications to peripheral apheresis; 6. flow cytometry/immunohistochemistry confirms that tumor cells express cd20; 7. those who are tolerant to cd19 car-t cell therapy or those with low cd19 expression; 8. no serious heart, lung, liver or kidney disease; 9. ability to understand and willing to sign the informed consent form for this trial. exclusion criteria: * patients with any of the following cannot be included in this study: 1. tumor cells do not express cd20; 2. there is active infection; 3. abnormal liver function (total bilirubin\>1.5×uln, glutamic-pyruvic transaminase\>2.5×uln), abnormal renal function (serum creatinine\>1.5×uln); 4. people with unstable angina or new york heart association class 3/4 congestive heart failure, multiple organ dysfunction; 5. hiv/aids patients; 6. those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d) treatment; 7. those who received radiotherapy within 4 weeks before the start of the study (blood sampling); 8. known or suspected drug abuse or alcohol dependence; 9. people with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures; 10. those who have participated in other clinical trials within 30 days; 11. pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (such as intrauterine device or condom); 12. the investigator judged that it is not suitable to participate in this trial.