Kornimate/medical-research-clean huggingface dataset:
a study of medi-575 in patients with advanced solid malignancies

Conditions: Advanced Solid Malignancies

Summary: the purpose of this study is to evaluate the safety and tolerability of medi-575 in japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).


Eligibility criteria:
inclusion criteria: * having advanced solid malignancy for which no curative or standard therapies exist * karnofsky performance status of ≥60 * patients must have histological confirmed diagnosis of hcc with no standard therapy available (for only expansion part) exclusion criteria: * inadequate bone marrow reserve or organ function * major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of medi-575. patients must have no unhealed wounds or unhealed fractures * history of allergy or reaction to any component of the medi-575 and/or monoclonal antibody

Keywords: cancer tumor hepatocellular carcinoma
neurophysiological diagnosis for icu septic shock patients

Conditions: ICU Acquired Weakness

Summary: patients hospitalized in the intensive care unit (icu) are at risk for developing severe disabilities, physical or cognitive. in particular, icu-acquired weakness is frequent. the causes of this weakness are multiple and the physiopathology is still not fully understood. immobilization in bed and sepsis are known risk factors. icu-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in icu and hospital length of stay. it has also been associated with significant decrease in functional capacity and with higher mortality. an early screening using a specific diagnostic protocol could help improving the management of patients suffering from icu acquired weakness. the aim of this study is to early detect icu acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.


Eligibility criteria:
inclusion criteria: • patients admitted to the icu with a septic shock and ventilated for more than 72 hours. exclusion criteria: * hospitalization for more than 7 days before intubation. * functional disability at admission of ≥4 (requires constant nursing care and attention, bedridden, incontinent) in the modified rankin scale. * lower limb disorders precluding nerve conduction studies (ncv) and electromyography (emg), such as clinical edema of the lower limbs, or fractures, amputation, and plaster casts of the lower limbs. * evidence of altered neuromuscular transmission at repetitive stimulation test either caused by neuromuscular blocking agents or disease. * burn patients admitted to icu. * patient requesting withdrawal of therapies.
study of provider computer alerts designed to improve delivery of hiv care

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether alerts independent of the ambulatory health record are more effective in eliciting physician responses and therefore have greater impact on hiv disease outcomes than traditional static alerts.

this study will compare the effectiveness of standard and enhanced care alerts in hiv infected participants at massachusetts general hospital in boston, massachusetts. participants will be a part of this study for 4 years or until they are no longer followed at massachusetts general hospital. participants will be assigned randomly to one of two arms. participants assigned to arm 1 will receive standard care, involving standard provider alerts which will be posted on the participant's health record. participants assigned to arm 2 will receive enhanced care, involving improved functionality. experimental informatics-based provider alerts and support systems will be used to develop a pilot system designed to optimize delivery of hiv clinical care. all participants will be monitored for new laboratory toxicities, suboptimal follow up, and virologic failure at their normally scheduled appointments.

Eligibility criteria:
inclusion criteria: * hiv infected * followed in the massachusetts general hospital hiv clinic. exclusion criteria:

Keywords: informatics alerts toxicity virologic failure suboptimal follow up
therapy for pediatric hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: with the success of current chemotherapy for hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. the main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.

this study will evaluate the following objectives: primary objectives: 1. to evaluate the efficacy of 4 cycles of vamp chemotherapy alone in patients with favorable risk hodgkin's disease who achieve a complete response after 2 cycles of vamp chemotherapy. 2. to evaluate the efficacy of 4 cycles vamp chemotherapy plus low dose rt in patients with favorable risk hodgkin's disease who achieve a partial response after 2 cycles of vamp chemotherapy. 3. to evaluate the efficacy of 2 alternating cycles of vamp/cop chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field rt in children with intermediate risk hodgkin's disease. 4. to evaluate the efficacy of 12 weeks of stanford v chemotherapy plus low-dose, involved-field rt in children with unfavorable risk hodgkin's disease. secondary objectives: 1. to evaluate patient quality of life during and after treatment from the patient and parent perspective. 2. to compare patient and parental ratings of treatment-related symptoms and patient physical, psychological, social and cognitive functioning before the first treatment (t1 - baseline); after cycle 2 or after 8 weeks of stanford v (t2 - evaluate response); after cycle 4 or after 12 weeks of stanford v and before or on the first day of radiation (as applicable) (t3); at the conclusion of radiation or within a few days following the end of radiation (as applicable) (t4); and at 3 to 6 months after completion of therapy follow-up evaluation (t5).

Eligibility criteria:
inclusion criteria: * eligible patients must have histologically confirmed previously untreated hodgkin's disease (patients receiving limited emergent rt or steroid therapy because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment). * patients must be 21 years of age or younger * ann arbor stages iib-iv * no prior treatment. * no pregnant or lactating women. * signed informed consent * if re-evaluation of a patient's disease shows favorable risk features or intermediate risk features, the patient will be removed from the hod99 study and consented to the respective hod08 or hod05 study. inclusion: treatment of favorable risk features: * ann arbor ia or iia with: 1. non-bulky mediastinal disease (\<33% mediastinal to thoracic ratio on chest x ray) 2. ann arbor stage ia or iia with any of the following features: (1) "e" lesions (s), (2) 3 or more nodal sites involved, (3) bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) inclusion: unfavorable risk features: * stage must be classified as one of the following: 1. ann arbor stage iib, iiib, or any iv

Keywords: lymphoma hodgkin disease
diabetes coaching program for medicare advantage members with type 2 diabetes - impact on a1c

Conditions: Diabetes Mellitus, Type 2

Summary: the diabetes coaching program for medicare advantage members with type 2 diabetes - impact on a1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the digital health partnership on a1c levels for individuals with uncontrolled type 2 diabetes.


Eligibility criteria:
inclusion criteria: * humana medicare advantage member * type 2 diabetes diagnosis * hba1c levels ≥ 8.0% verified by lab test exclusion criteria: * has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease * not fluent in english * humana membership is part of a full or global risk arrangement * enrolled in humana at home care management
comparison of the efficacy of rhomboid intercostal block and erector spinal plane block on myofascial pain syndrome

Conditions: Myofascial Pain Syndrome

Summary: the investigators evaluate the effect of ultrasound guided rhomboid intercostal block and erector spinal plane block on lower cervical and inter scapular myofascial pain

myofascial pain syndrome (mps) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. in this study, the investigators compare the effect of two regional anesthesia block techniques with the ultrasound guidance.

Eligibility criteria:
inclusion criteria: * complaint of myofascial pain * pain that is rated at least 3 on a numerical rating scale (nrs, 0 = no pain, 10 = the worst pain) exclusion criteria: * pregnancy * presence of coagulopathy, or the use of anticoagulants * a history of surgery on the block area * allergic to bupivacaine * decline to participate
spinal cord stimulation for chemotherapy induced peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: spinal cord stimulation using 10 khz stimulation to the thoracic spinal cord will be a safe and effective treatment for cipn, reducing pain in the lower extremities by at least 50%.


Eligibility criteria:
inclusion criteria: * cipn as diagnosed by oncology and/or neurology * receipt of a platinum-based or taxane chemotherapy prior to development of cipn * pain severity greater than 4 out of 10 on a numeric rating scale of pain * pain chronicity greater than 6 months after the cessation of chemotherapy * failure of medical therapy, which must have included duloxetine * age 18 or greater exclusion criteria: * platelet count less than 100k/mm3 * spinal anatomy precluding placement of the scs leads between t6 and t11 * active infection * estimated lifespan less than 1 year * receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months
follow-up of malnutrition screening in usinv

Conditions: Stroke

Summary: this aim of the study is to set up a procedure for screening for undernutrition in the neurovascular intensive care unit. this screening procedure follows a specific work concerning undernutrition in thrombolyzed patients (nct03303820). this work was motivated by the fact that, despite a high frequency of undernutrition in the hospital (at least 30% of patients), undernutrition in neurovascular unit is studied very little. a cohort of thrombolysed patients in 2014 was studied retrospectively. patients malnourished at the entrance had a non-significant, less good recovery of their stroke (+ 1 rankin score point at 3 months in malnourished patients at the entrance).

the main objective of this project is to assess, prospectively, the frequency of undernutrition at the entrance to the neurovascular intensive care unit and to evaluate the implementation of the undernutrition screening procedure.

Eligibility criteria:
inclusion criteria: * patient whose age ≥ 70 years * patient hospitalized in neurovascular intensive care unit following a stroke (infarction or cerebral hematoma) * francophone patient exclusion criteria: * patient hospitalized in neurovascular intensive care unit following a transient ischemic attack * patient whose age ≤ 70 years * patient hospitalized in neurovascular intensive care unit for another reason than neurovascular disease * patient opposing the use of his data
compare effects of intensive versus conventional lipid-lowering therapy in patients with severe atherosclerotic renal artery stenosis undergoing stent placement

Conditions: Renal Artery Obstruction; Stents; Lipids; Glomerular Filtration Rate; Blood Pressure

Summary: although expert consensuses recommend the use of statins in the treatment of atherosclerotic renal artery stenosis, in patients with severe atherosclerotic renal artery stenosis undergoing stent placement, the related investigation focused on renal protection by intensive lipid-lowering therapy is scant , and the optimal target level for lipid reduction remain uncertain. therefore, we hypothesized that intensive lipid lowering could offer more benefits with respect to renal function in the patients with percutaneous renal artery stenting. we conducted the prospective randomized unblinded trial to compare the renal-protective effect of intensive lipid lowering with that of conventional lipid lowering in patients underwent renal artery stenting (75 patients in each study group)


Eligibility criteria:
inclusion criteria: 1. angiographic evidence of severe atherosclerotic renal artery stenosis (diameter reduction≥ 70%) with ≥ 20 mmhg systolic translesional gradient or positive captopril renography in the target kidney; 2. sustained systolic blood pressure ≥ 180 mmhg, and/or diastolic blood pressure ≥ 110 mmhg while not receiving drug therapy or systolic blood pressure ≥ 140 mmhg, and/or diastolic blood pressure ≥ 90mmhg while taking standard triple-drug combination treatment (including one diuretic); 3. estimated glomerular filtration rate≥ 10 ml/min/1.73m2 with longitudinal kidney length ≥ 7 cm supplied by target artery; 4. serum creatinine level\<264umol/l； 5. urine protein≤ 1+ exclusion criteria: 1. allergy to rosuvastatin; 2. myopathy; 3. active liver disease or alanine aminotransferase and/or aspartate aminotransferase levels ≥ three times the upper limit of normality; 4. serious perioperative complications; 5. severe chronic congestive heart failure (new york heart association functional class iv ); 6. patients who should be excluded basing on physician discretion.

Keywords: renal artery obstruction stents glomerular filtration rate
biportal endoscopic discectomy versus microdiscectomy: rct, non-inferiority trial

Conditions: Lumbar Herniated Intervertebral Disc

Summary: this study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine


Eligibility criteria:
inclusion criteria: * patients aged between 20 and 80 * patients who has radiating pain (vas \>=40) on lower extremities with hivd * patients who required one-level discectomy between l1 and s1 * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form exclusion criteria: * revision surgery * over spondylolisthesis gr ii * degenerative lumbar scoliosis (cobb angle \>20) * patients with a history of other spinal diseases (compression fracture, spondylitis, tumor) * women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years * patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study) * patients with mental retardation or whose parents or legal guardians were older or had mental disabilities * other patients viewed as inappropriate by the staff

Keywords: herniated intervertebral disc discectomy microscope biportal endoscopy
mid-term survival and quality of life of elderly patients undergoing open heart surgery

Conditions: Quality of Life

Summary: the purposes of the investigators study is to examine the overall survival and quality of life in elderly patients (\> 75 years) undergoing open heart surgery at hadassah medical center between 2008-2011. all alive patients will be phone interviewed using the 36-item short form health survey. results will be compared to similar health survey results (36-sf)obtained from a group of israeli adults who had no open heart surgery (controlled group). the investigators hypothesize that elderly patients achieve improvement in quality of life after open heart surgery with acceptable operative morbidity and mortality.


Eligibility criteria:
inclusion criteria: * all patients age \> 75 years who discharged alive after surgery exclusion criteria: * death
study of bulevirtide in participants with chronic hepatitis d infection

Conditions: Chronic Hepatitis D Infection

Summary: the main goal of this study is to collect post marketing data from patients with chronic hepatitis d virus (hdv) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.

the study design time perspective is retrospective and prospective for participants who previously participated in myr-reg-02 and are currently receiving blv and prospective for participants who are scheduled to receive blv.

Eligibility criteria:
key inclusion criteria: * individuals who have been diagnosed with chronic hepatitis d virus (hdv) infection for at least 6 months before study enrollment, confirmed by respective documentation in the individuals' medical records. * must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. * must be willing and able to comply with the visit schedule and study requirements. * cohort 1 only: must have participated in study myr-reg-02. * cohort 2 only: individuals scheduled to receive bulevirtide (blv) according to the approved label or for whom the decision to start treatment with blv according to the approved label has been made and treatment initiation is planned. key exclusion criteria: * individuals currently enrolled in blv clinical treatment studies and/or other interventional clinical studies with an investigational agent. * history or current presence of clinically significant illness or any other major medical disorder that may interfere with individual follow-up, assessments, or compliance with the protocol. * coinfection with hepatitis c virus (hcv) or human immunodeficiency virus (hiv) (individuals with hcv antibodies can be enrolled if hcv rna is negative). * solid organ transplantation. * any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or gastrointestinal bleeding (gib)). * presence of hepatocellular carcinoma (hcc) as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to day 1 for individuals with cirrhosis and within 6 months prior to day 1 for individuals without cirrhosis. * pregnant or breastfeeding females. * individuals with a severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection confirmed by a positive polymerase chain reaction test result. * known hypersensitivity or contraindication to blv or formulation excipients. * individuals who are committed to an institution by virtue of a court or official order. * individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed. this includes persons dependent on the sponsor, investigator, or trial site. note: other protocol defined inclusion/exclusion criteria may apply.
early and standard intervention with 120,000 units of procrit (epoetin alfa) every three weeks in patients receiving chemotherapy

Conditions: Anemia

Summary: the purpose of this study is to evaluate the safety and efficacy of procrit (epoetin alfa) when administered at 120,000 units once every three weeks by comparing early dosing (hb 11g/dl-12g/dl) vs. standard dosing (hb\< 11g/dl).

this is a randomized, open-label, multi-center study. eligible patients will be identified during the screening phase. after randomization, the treatment phase will start at the day 1, week 1 visit. the entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. the primary objective of this study is to obtain efficacy and safety data regarding procrit (epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy: 1. early intervention group: procrit (epoetin alfa) treatment started at patient hemoglobin (hb) \>= 11.0 g/dl to \<= 12.0 g/dl and 2. standard intervention group: procrit (epoetin alfa) treatment started once patient hemoglobin drops to \< 11 g/dl or has a hb \<11.0 g/dl at study entry. for safety monitoring, all patients will be followed for adverse events, hemoglobin (hb), hematocrit (hct), blood chemistries and blood pressure measurements throughout the study. all eligible patients with hemoglobin \< 12.0 g/dl will be randomized to receive epoetin alfa injections (120,000 units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. doses may be adjusted depending on the patients hemoglobin levels.

Eligibility criteria:
inclusion criteria: * biopsy confirmed diagnosis of non-myeloid malignancy * baseline hemoglobin (hb) value of \>= 11.0 g/dl and \<= 12.0 g/dl * no blood transfusions in the 28 days prior to the start of treatment phase * must be receiving chemotherapy or will begin receiving chemotherapy at start of treatment * iron transferrin saturation (tsat) \> 20% or if tsat\<20%, serum ferritin must be greater than 100 ng/ml. exclusion criteria: * no myeloid malignancy or known history of myelodysplasia * no planned radiation during the study * prior treatment with epoetin alfa or any other erythropoietic agent (e.g., darbepoetin alfa, gene-activated erythropoietin) within the previous three months * no uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems * no history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders * has not received an experimental drug or device within the past 30 days

Keywords: anemia hemoglobin level