Kornimate/medical-research-clean huggingface dataset:
surgical stress markers for postoperative complications: a prospective study

Conditions: Operative Procedures, Complications

Summary: the aim of this study is to evaluate the predictive value of albumine, c-reactive protein (crp), procalcitonin, and lactates in terms of surgical stress and postoperative complications. these biomarkers will be measured from the day before surgery until postoperative day four in patients undergoing major surgery. major surgery was defined as esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures including an organ resection for benign or malignant disease and lasting more than 2 hours.

this prospective study was conducted at the department for visceral surgery at the university hospital of lausanne switzerland (chuv) between february and december 2015 (nct02356484). the study was approved by the institutional review board (no. 367/15), and all patients provided written consent prior to surgery. inclusion criteria were age \>18 years, and elective major abdominal surgery-defined as an operative procedure with anticipated duration ≥2 hours.17 perioperative care closely adhered to recently published enhanced recovery guidelines (http://erassociety.org.loopiadns.com/guidelines/list-of-guidelines). standardised fluid administration was followed by advanced haemodynamic monitoring to avoid intraoperative fluid overload. according to the clinical care pathway, intravenous fluid was typically discontinued the morning after surgery. biological markers serum levels of albumin, crp, pct and lactate (lct) were perioperatively measured in a fasting state, following standardised institutional guidelines. blood samples were drawn the day before surgery, the day of surgery (4-6 hours after the end of the operation) and on the first, second and third postoperative day. as baseline values tend to show large variations especially for albumin,4 10 we considered that a dynamic value (difference between two time-points) might be more informative than a snapshot value. several values based on preoperative and postoperative concentrations were thus calculated for each marker (ie, δ max: maximal difference between the preoperative and postoperative values; δ pod 0: difference of concentration on pod -1 and pod 0; δ pod 1: difference of concentration on pod-1 and pod 1).

Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients undergoing esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery * operation time more than 2 hours * operation including an organ resection for benign or malignant disease exclusion criteria: * immunosuppressive therapy * cognitive impairment or language comprehension problems * absence of the consent form prior to first blood sample
blinatumomab in refractory myasthenia gravis (blina-mg)

Conditions: Myasthaenia Gravis

Summary: the goal of this clinical trial is to evaluating the efficacy and safety of blinatumomab in the treatment of refractory myasthenia gravis and exploring the immunological mechanisms of blinatumomab therapy in refractory myasthenia gravis. the main questions it aims to answer are: will blinatumomab improve the symptoms of participants? what medical problems do participants have when using blinatumomab? participants will: continuous intravenous infusion of blinatumomab for 5 days, pause for one week, and continue continuous intravenous infusion for 5 days visit the clinic once every 1 month for checkups and tests keep a diary of their symptoms


Eligibility criteria:
inclusion criteria: * 18 years old ≤ age ≤ 75 years old * patients with a myasthenia gravis activities of daily living (mg-adl) scale score of 6 or higher, and an ocular muscle score constituting less than 50% of the total score * after receiving an adequate course of at least two conventional immunotherapeutic drugs (including both steroidal and non-steroidal immunosuppressants), the post-intervention status (pis) remains unchanged or worsens; or after receiving an adequate course of at least two conventional immunotherapeutic drugs, the pis improves, but the mg-adl score is still ≥6 points and persists for at least half a year; or after receiving an adequate course of at least two conventional immunotherapeutic drugs, the pis is in remission or improvement, yet during the regular tapering of immunotherapeutic drugs, there are still at least two annual exacerbations of disease symptoms (mg-adl score ≥6 points); or after the occurrence of a crisis, despite multiple immunotherapies such as intravenous immunoglobulin, plasmapheresis, and high-dose intravenous methylprednisolone, and active infection control, the patient still cannot be weaned off the ventilator due to mg-induced respiratory muscle weakness for more than 14 days * positive for anti-achr, and/or anti-musk, and/or anti-lrp4 antibodies. * patient or their legal representative signs an informed consent form in writing exclusion criteria: * pregnant or lactating women * individuals with an allergy to blinatumomab * individuals who have undergone thymectomy within the 12 months prior to baseline or who are planning to have a thymectomy during the 12-week study period * individuals who have received biologic agents targeting cd19 or cd20 within 6 months prior to baseline are eligible for enrollment (subjects with cd19 or cd20 positive b cell counts above the lower limit of normal are allowed to participate) * within the 3 months prior to baseline, use of ecuzumab and tocilizumab * received intravenous immunoglobulin or plasma exchange therapy within 4 weeks prior to baseline * currently participating in other clinical studies
rsa study using two types of uncemented acetabular components and the uncemented ha coated symax stem

Conditions: Osteoarthritis

Summary: the trident tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. in this randomized controlled trial (rct) the tritanium cup will be compared with the trident ha acetabular component in two equal sized groups. the symax ha coated stem will be used as femoral component in both groups. study objectives: * the primary objective is to determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based rsa technique * secondary objectives are on one hand to assess clinical outcome on the other hand assessing patient satisfaction in both groups using harris hip score, oxford hip score, womac, and eq-5d questionnaires * tertiary objective is to assess bone remodeling of the uncemented acetabular components and the ha-coated symax hip stem using qct derived from usinf f18-fluoride pet in a cohort of 12 consecutive patients of this rct a total of 50 patients will be enrolled in this rct divided into two equal groups. patients have to fulfill the inclusion and exclusion criteria. all evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery at 4 weeks, 3 and 6 months and 1 and 2 years.


Eligibility criteria:
inclusion criteria: * patients with a bmi \< 35 * patients requiring uncemented primary tha * primary diagnosis of osteoarthritis exclusion criteria: * patients with acetabular or femoral osteotomy * patients who had a tha on the contralateral side within last 6 months * female patients who are pregnant or planning pregnancy during the course of the study * patients with active or suspected infection * patients with malignancy * patients with a systemic disease that would effect the subject's welfare or overall outcome of the study * patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device * patients with systemic or metabolic disorders leading to progressive bone deterioration * patients with other illnesses which are likely to affect their outcome * patients with known sensitivity to device materials

Keywords: hipreplacement uncemented migration boneremodeling
brain perfusion assessment in the acute phase of migraine aura

Conditions: Emergencies

Summary: the aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.

migraine is a benign and frequent disorder. migraine aura consists in reversible focal neurological symptoms developing gradually during attack. its diagnosis relies mainly on patient's history, clinical examination and exclusion of other possible secondary causes to explain transient neurological signs. thus it can be difficult particularly during first attack or during attack without headache to differentiate migraine aura from transient ischemic stroke. considering the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest. mri with diffusion, swi, flair 2d, arm 3d tof, asl sequences' are routinely performed for the management of acute neurological deficit. arterial spin labeling (asl), as a mr perfusion method, will be used to describe brain perfusion during migraine aura. the study hypothesis is that hyperperfusion occurs in brain territories corresponding to the neurological symptoms during migraine aura.

Eligibility criteria:
inclusion criteria: * age between greater than or equal to 18 * able to undergo mri during migraine aura exclusion criteria: * pregnant females * contraindications towards mri scanning * history of epilepsy, psychiatric disease, or any other neurologic disease (brain tumors, stroke..). * presence of abnormalities on the mri that could explain the neurological deficit. * adults under guardianship or trusteeship

Keywords: migraine perfusion arterial aura brain
study of inv-102 ophthalmic solution in adults with diabetic macular edema associated with non-proliferative diabetic retinopathy

Conditions: Non-center Involved Diabetic Macular Edema; Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy; Diabetic Retinopathy; Center-involved Diabetic Macular Edema; Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy

Summary: phase 2 study to assess the efficacy of topically administered eyedrops of inv-102 during a 12-week dosing period in subjects with non-center involved dme (ncidme) associated with npdr \[part 1\] and during an 8-week dosing period in subjects with center-involved dme (cidme) associated with npdr \[part 2\].


Eligibility criteria:
key inclusion criteria: * male or female subjects ≥ 18 years of age and \< 76 years of age * diagnosed with diabetes (type 1 or 2) with hemoglobin a1c ≤ 12.0% * study eye must have ncidme (part 1) or cidme (part 2) * study eye must be moderate to severe npdr key exclusion criteria: * prior laser treatment for dr in the study eye within 12 months from screening visit
comparison of two nn1250 formulations versus insulin glargine, all in combination with metformin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia and north america. the aim of this trial is to compare two insulin degludec (nn1250, siba) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject.) * insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months) * treatment with one or two oral anti-diabetic drug (oads): metformin, sulphonylurea (su) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (spc) or locally approved pi * hba1c 7.0-11.0 % (both inclusive) * body mass index (bmi) 23-42 kg/m\^2 \[lb/in\^2 x 703\] (both inclusive) exclusion criteria: * metformin contraindication according to local practice * thiazolidinedione (tzd) treatment within previous three months prior to visit 1 * any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation * subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial drug
gene polymorphism of taste receptors and circulating endocannabinoids in normal weight and obese subjects

Conditions: Nutritional Physiological Phenomena

Summary: the study aims at evaluating in normal weight and obese subjects those factors such as taste sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid and energy metabolism in order to design personalized nutritional strategies.


Eligibility criteria:
inclusion criteria: * body mass index (bmi), range for normal weight subjects 17.5-24.95, for obese subjects 29.6-52.20 * no intake of nutritional supplements for at least six months before the trial exclusion criteria: * major diseases (diabetes, kidney disease, etc.), * pregnancy or lactation; * food allergies; * the use of medications that interfere with taste or smell (e.g., steroids, antihistamines, certain antidepressants).
a study of inotuzumab ozogamicin versus investigator's choice of chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.


Eligibility criteria:
inclusion criteria: * cd22 expression * adequate liver and renal functions exclusion criteria: * isolated extramedullary disease * active central nervous system \[cns\] disease
a study of samuraciclib in combination with fulvestrant in metastatic or locally advanced breast cancer in adult participants

Conditions: Metastatic Breast Cancer; Locally Advanced Breast Cancer; Breast Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced hormone receptor (hr) positive and human epidermal growth factor receptor (her)2-negative breast cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of er-positive, her2-negative locally advanced or metastatic breast cancer. * documented objective disease progression while on or within 6 months after the end of the most recent therapy. * received prior ai in combination with a cdk4/6i as the last therapy * known tp53 mutation status. * participants must have measurable disease or bone only disease as defined by response evaluation criteria in solid tumors (recist) version 1.1. * pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (lhrh) agonist at least 4 weeks prior to first dose of study intervention. * eastern cooperative oncology group (ecog) performance status ≤1 with no deterioration over the past 2 weeks. * expected life expectancy of \>12 weeks in the judgement of the treating investigator. exclusion criteria: * inflammatory breast cancer. * participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. * more than 1 line of endocrine treatment for locally advanced or metastatic disease treatment. * inadequate hepatic, renal, and bone marrow function. * clinically significant cardiovascular disease. * any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. * pregnant or breastfeeding women.

Keywords: metastatic breast cancer advanced breast cancer breast cancer hr positive her2-negative
an evaluation of the njspb scf project for opioid-involved high-risk parolees

Conditions: Substance Abuse; Criminal Behavior

Summary: this study entails an evaluation of the new jersey state parole board swift, certain, and fair (scf) supervision program. the purpose of the evaluation is to test whether subjects assigned to scf supervision perform better than those assigned to parole-as-usual (pau).

the swift, certain, and fair (scf) supervision program - including project hope program provides funding to states, units of local government, territories, and federally recognized indian tribes (as determined by the secretary of the interior) in an effort to enhance public safety, foster collaboration, and to improve the outcomes of individuals under the supervision of community corrections. the goals of this program are to develop and enhance scf initiatives and implement the scf model with fidelity, resulting in reduced recidivism and better outcomes for program participants. scf approaches are intended to: (a) improve supervision strategies that reduce recidivism; (b) promote and increase collaboration among agencies and officials who work in community corrections and related fields to enhance swift and certain sanctions; (c) enhance the offenders' perception that the supervision decisions are fair, consistently applied, and consequences are transparent; and (d) improve the outcomes of individuals participating in these initiatives. the grantee will use awarded grant funds to support programming that provides services to up to 75 opioid involved parolees with services to divert them from a return to prison and manage underlying addictions with a combination of behavioral therapy and medication assisted treatments. the program combines sanctions with targeted reentry and treatment services.

Eligibility criteria:
inclusion criteria: * participants must be 18 years of age or older * participants must have a history of opioid use or addiction * participants have a history of parole violations or active parolees who are at risk for violation (this can include anyone who is reentering the active population from prison) * participants reside in or are moving to ocean county; and * participants must have at least 6 months remaining on their parole term exclusion criteria: -
a 48 week study comparing treatment with saquinavir + lopinavir/ritonavir in combination with enfuvirtide haart versus saquinavir + lopinavir/ritonavir + other nucleoside combinations to see the efficacy of these treatments in patients infected with hiv-1

Conditions: HIV Infection

Summary: the main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. resistance information will also be collected.


Eligibility criteria:
inclusion criteria: * cd4 cell count greater than 50 cells/mm\^3 * hiv-1 rna viral load greater than or equal to 5000 copies/ml * patients must be hiv treatment experienced * patients diagnosed with hiv-1 infection exclusion criteria: * female patients must not be able to have children or must be under effective contraceptives * female patients who are pregnant * have taken enfuvirtide and/or t-1249 before * have serious kidney problems * alcohol and/or drug abuse * have had an organ transplant
treatment of hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: to determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.

background: this grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and followed a cooperative study of the treatment of renal hypertension initiated in 1960 to evaluate the relative efficacy of several recognized drug regimens for reduction of blood pressure. six centers (usphs hospitals) and a coordinating center were involved in the trial. design narrative: randomized, double-blind, fixed sample. three hundred and eighty nine eligible patients were assigned to drug therapy consisting of chlorothiazide plus rauwolfia serpentina or to placebo. the study completion date listed in this record was inferred from last publication listed in the citations section of this study record.

Eligibility criteria:
men and women, ages 21-55. mild essential hypertension (diastolic blood pressure over 90 mm hg.
post-dialysis fatigue and recovery time in hemodialysis patients

Conditions: Hemodialysis; Fatigue; Massage

Summary: this study aims to examine the effect of hand massage on patients receiving hd treatment on the severity of post-dialysis fatigue and post-dialysis recovery time.

after obtaining the necessary permissions for the research, informing the patients about the purpose, importance and method of the study by the researcher, and having the volunteer patients read and sign a consent form, the patients were randomly divided into two groups. randomization of the groups was done in a computer environment.

Eligibility criteria:
inclusion criteria: * those who are 18 years or older, * receiving hemodialysis treatment for at least 3 months, * receiving hemodialysis treatment three times a week, * does not have any open wounds in the area to be applied, * no active fistula in the arm to be treated, * does not have a hearing impairment, * sufficient to understand the questions, * open to communication and cooperation, * volunteer and willing for research exclusion criteria: * having an active oncological problem or receiving oncological treatment, * those with health problems that require contact isolation, * the number of dialysis sessions changed during the study, * those who lost their lives while working, * those who had a kidney transplant during the study, * those who want to leave voluntarily at any stage of the study

Keywords: hemodialysis patient fatique hand massage nursing recovery time
colchicine in coronary artery bypass graft (cabg)

Conditions: Elective Coronary Artery Bypass Graft Surgery

Summary: there is evidence that inflammatory processes may play a key role during surgical myocardial reperfusion. the hypothesis of this study is that colchicine, an anti-inflammatory agent, may lead to reduction in periprocedural infarct size, when administered during elective coronary artery bypass graft surgery.


Eligibility criteria:
inclusion criteria: * the study will enroll patients 18 years old or older who are eligible to undergo cabg surgery. exclusion criteria: excluded are patients: * with age \> 80 years old * scheduled for concomitant valve surgery * scheduled for coronary surgery without cardiopulmonary bypass * with peripheral vascular disease aﬀecting the upper limbs * with acute coronary syndrome within the previous 4 weeks * on inotropic or mechanical circulatory support before induction of anaesthesia * with any disorder that could potentially increase preoperative ctni concentrations (eg, percutaneous coronary intervention within the previous 6 weeks) * with active inflammatory diseases, infectious diseases or known malignancy * under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents * with known hypersensitivity-allergy to colchicine * under chronic treatment with colchicine * with severe renal failure (egfr \< 35 ml/min/1.73 m2) * with hepatic failure (child - pugh class b or c)

Keywords: reperfusion damage