Kornimate/medical-research-clean huggingface dataset:
comparative study of total knee arthroplasty using a customized-patient specific instrument system.

Conditions: Osteoarthritis, Knee; Arthroplasty, Replacement, Knee

Summary: patient-specific instrumentation (psi) has been introduced in total knee arthroplasty (tka) as a new technology for improving accuracy in restoration of the alignment and biomechanics of the lower limb. psi in tka refers to custom-made cutting jigs manufactured according to the patient's anatomic configuration of distal femur and proximal tibia based on preoperative magnetic resonance imaging (mri) or computed tomography (ct) scans. mri- and ct-based psi systems are available from various manufacturers for preoperative planning. mri offers precise visualization of articular cartilage without the risk of radiation exposure, but it is expensive and requires long scan times. in contrast, ct enables accurate identification of the contour of the femur and tibia at short scan times, but it does not provide information on the cartilage thickness and carries the risk of radiation exposure. as a result, there is a possibility of some discrepancy between the thickness of bone resection proposed by mri- or ct-based psi system and the actual thickness of bone cut. although psi has been the focus of study in many recent researches, there has been no clinical study comparing mri-based and ct-based psi systems in preoperative planning. therefore the investigators questioned whether the mri-based psi that reflects the cartilage layer would provide more precision in tka than the ct-based psi. the purpose of this study was to investigate the accuracy of mri-based psi and ct-based psi in predicting bone resection thickness in tka.


Eligibility criteria:
inclusion criteria: * of the patients who had been scheduled for tka for the treatment of primary osteoarthritis only with varus deformity, those who had been waiting 6 weeks for tka using an mri-based or ct-based psi system and had consented to the relatively new technique were enrolled in the study. exclusion criteria: * patients with primary osteoarthritis with valgus deformity, rheumatoid arthritis, hemophilic arthritis, posttraumatic arthritis, other inflammatory arthritis, or a history of previous high tibial osteotomy were excluded from the study.
safety of fcm vs. standard of care in treating iron deficiency anemia in heavy uterine bleeding and post partum patients

Conditions: Anemia

Summary: the objective of this study is to study the safety of fcm in patients with anemia caused by heavy uterine bleeding and the post partum state.


Eligibility criteria:
inclusion criteria: * female with iron deficiency anemia * hg \</= 11 g/dl exclusion criteria: * previous participation in a fcm trial * known hypersensitivity to fcm * history of anemia other that anemia due to heavy uterine bleeding or the post partum state * current history of gi bleeding * received iv iron within the month prior * anticipated need for surgery * malignancy history * ast or alt greater than normal * received an investigational drug within 30 days of screening * pregnant or sexually active females who are not willing ot use an effective form of birth control
a study evaluating the efficacy and safety of adjuvant atezolizumab or placebo and trastuzumab emtansine for participants with her2-positive breast cancer at high risk of recurrence following preoperative therapy

Conditions: Breast Cancer

Summary: this is a phase iii, two-arm, randomized, double-blind placebo-controlled study in participants with her2-positive primary breast cancer who have received preoperative chemotherapy and her2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. as of june 4, 2024, this study is no longer accepting any newly screened participants.


Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast carcinoma * centrally-confirmed human epidermal growth factor receptor 2 (her2)-positive invasive breast cancer * centrally confirmed pd-l1 and hormone receptor status * clinical stage at disease presentation (prior to neoadjuvant therapy): ct4/anyn/m0, any ct/n2-3/m0, or ct1-3/n0-1/m0 (participants with ct1mi/t1a/t1b/n0 are not eligible) * completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional her2-targeted agents are permitted) * \<=12 weeks between primary surgery and randomization * eastern cooperative oncology group (ecog) performance status 0 or 1 * screening left ventricular ejection fraction (lvef) \>= 50% and no decrease in lvef by \>15% from the pre-chemotherapy lvef. if no pre-chemotherapy lvef, screening lvef \>= 55% * life expectancy \>= 6 months * adequate hematologic and end organ function exclusion criteria: * stage iv breast cancer * an overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy * prior treatment with t-dm1, or atezolizumab, or other immune checkpoint inhibitors * history of exposure to various cumulative doses of anthracyclines * history of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage i uterine cancer, or ductal carcinoma in situ (dcis) * current grade \>=2 peripheral neuropathy * history of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis * history of or active autoimmune disease or immune deficiency * treatment with immunostimulatory or immunosuppressive agents * cardiopulmonary dysfunction * any known active liver disease
comparative evaluation of two different post-operative analgesia after hallux valgus correction

Conditions: Pain, Postoperative

Summary: background: recent studies showed the efficiency of several techniques of anesthesia in foot surgery. the new mini-invasive surgical approaches should require less analgesia and rapid motor recovery after surgery. the aim of this study was the evaluation of two different techniques on postoperative analgesia and motor recovery after hallux valgus correction in one-day surgery patients.

the hallux valgus surgery is often characterized by a significant post-operative pain difficult to control with oral analgesics. consequently, large doses of parenteral opioids are often required various nerve blocks (popliteal, saphenous, sciatic) can give excellent post-operative pain control. among loco-regional anesthesia techniques, the sciatic nerve block provides good post-operative pain relief after foot surgery. thus, sciatic nerve block with long-acting local anesthetics (with or without a peri-neural catheter) has been recommended as a primary option. this analgesic approach should cause a difficult discharge in ambulatory and one-day surgery patients, due to the prolonged motor recovery and loss of proprioception and protective pain reflexes. therefore, it would be preferable to use the sciatic nerve block just for intra- operative anesthesia without affecting motor recovery, and to apply multimodal analgesia for post- operative pain management. hallux valgus repair can now be done percutaneously, a minimally invasive technique called ''mini-invasive hallux valgus repair'', consisting in osteotomies through 3 to 5 mm incisions, without internal fixation. this approach requires less dissection and exposure, determining a smaller inflammatory response and theoretically causing less pain. ideal anesthesia for these procedures should provide rapid patient recovery, minimal nursing care requirements in the post- anesthesia care unit and an earlier hospital discharge. it must provide effective analgesia, since the foot surgery is known to induce a moderate-to- severe post-operative pain, that represents one of the major limitations to hospital discharge on the day of surgery and is the main cause of re-admission. the aim of this matched-control study was to evaluate two different techniques of post-operative analgesia after hallux valgus correction in one-day surgery patients.

Eligibility criteria:
inclusion criteria: * hallux valgus deformity * pain * walking difficulty with shoes exclusion criteria: * peripheral circulatory disorders * foot skin lesion * local anesthetic allergy

Keywords: analgesia technique pain control
safety and efficacy study of an ophthalmic solution in patients with age-related cataract

Conditions: Cataract

Summary: the purpose of this study is to determine the safety and efficacy of c-kad ophthalmic solution in improving visual acuity relative to placebo in patients with age-related cataract


Eligibility criteria:
inclusion criteria: * presence of age-related cataract in the study eye * best-corrected visual acuity of 20/25 to 20/50 in the study eye exclusion criteria: * any other clinical condition in the eye that may compromise vision * presence or history of glaucoma * presence or history of diabetes * use of eyedrops * use of steroids
multimodal imagery characterization of cardiac damage and severity after covid-19 infection

Conditions: COVID-19 Virus Disease; Cardiac Complication

Summary: coronavirus disease 2019 (covid-19) is an infection caused by severe acute respiratory syndrome coronavirus (sars-cov-2), which affects multiple organ system particularly the lung and heart. indeed, sars cov-2 has various cardiac manifestations which are associated with higher mortality and morbidity. cardiac involvement, based on elevated levels of myocardial enzymes, have been described in 20 to 30% of covid-19 infection. however, the physiopathological mechanisms of myocardial injury remains unclear. main hypothesis include inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or stress leading to coronary plaque rupture (type i myocardial infarction), supply-demand mismatch and hypoxemia resulting in myocardial damage (type ii myocardial infarction) ... two patterns can be identified : ischemic or non-ischemic pattern including myocarditis, stress induced cardiomyopathy, thrombo-embolic disease. however, the consequences of myocardial damage after confirmed covid-19 infection are unknown at medium to long term prognosis. data are needed to identify myocardial damage and to guide effective therapies and follow-up (use of ace inhibitor, beta-blockers, steroids...? ) in this study, the investigators proposed to collect multimodal cardiac imaging including mri (magnetic resonance imaging) and tte (transthoracic echocardiogram) in order to identify and characterize cardiac injury as ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective therapies if necessary.


Eligibility criteria:
inclusion criteria: * cardiac involvement confirmed : increase troponin level \> 50pg/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed covid-19 infection * absence of severe renal failure (ckd epi \> 30ml/min/1.73m²) * cardic imaging (mri and tte) performed during 4 months from covid-19 infection exclusion criteria: * cardiovascular history (ischemic or valvular disease, dilated cardiomyopathy, cardiac surgery...) * vulnerable patient (pregnancy, adult under legal protection)
qdsa blood flow measurement in patients undergoing tae of the liver

Conditions: Transarterial Embolism; Transarterial Chemoembolization

Summary: the purpose of this research is to evaluate a new technique, quantitative digital subtraction angiography (qdsa), to measure blood flow during liver embolization procedures. liver transarterial embolization is a way of treating liver tumors by blocking blood flow to it. the qdsa technique could help doctors ensure the blood flow to the tumor is decreased by the right amount by calculating blood flow before, during, and after the procedure. up to 20 participants will be enrolled for 1 study visit and data collection for up to 6 months.


Eligibility criteria:
inclusion criteria: * give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule exclusion criteria: * pregnancy or breastfeeding * patients with an acute kidney injury or stage iv or v chronic kidney disease (cr greater than 2.4 or estimated glomerular filtration rate (egfr) less than 30), unless anuric and on dialysis without expected return of renal function. * patients with an iodinated contrast allergy who cannot be adequately premedicated to receive contrast as part of the embolization procedure. * patients with a physical or psychological condition that would impair study participation. * the patient is judged unsuitable for study participation by the investigator for any other reason

Keywords: quantitative digital subtraction angiography (qdsa)
ovarian reserve in intensive care patients

Conditions: Anti-Mullerian Hormone Deficiency

Summary: gastrointestinal, pulmonary, nephrological, cardiac, neurologic and psychological effects in critically ill patients followed in the intensive care unit have been shown in the literature. however, the effects on ovarian reserve in these patients have not been sufficiently investigated and studies investigating this issue are limited in the literature. the synthesis, release frequency and amplitude of reproductive hormones change under stress. in addition, changes in ovarian homeostasis affect ovarian reserve. the aim of this study was to evaluate ovarian reserve in critically ill patients followed up in the intensive care unit.


Eligibility criteria:
inclusion criteria: * 18-35 years of age * female patients followed in the intensive care unit for more than 24 hours for internal or surgical reasons, * women whose ovarian reserve is being evaluated, exclusion criteria: * previous ovarian surgery, endometriosis, endometrioma, * history of chemotherapy, radiotherapy, * ovarian cyst, malignancy and other ovarian pathologies, * women with single ovary, * women receiving hormone therapy, * polycystic ovary syndrome, * surgical intervention within the last 6 months, * history of drug, alcohol, substance use, * women in pregnancy, puerperium, lactation, * history of vaccination within the last 6 months
a bioequivalence study of two different processes of peg-rhgh preparations

Conditions: Pediatric Growth Hormone Deficiency (PGHD)

Summary: the purpose of this study is to investigate whether peg-rhgh with new preparation is bioequivalent to peg-rhgh with present preparation.

the purpose of this study is to investigate whether peg-rhgh with new preparation is bioequivalent to peg-rhgh with present preparation.

Eligibility criteria:
inclusion criteria: * healthy male aged ≥18 years old and≤45 years old; * the body mass index (bmi): 19-26 kg/m2 (inclusive), and body weight ≥50 kg; * normal results of physical examination, vital signs, laboratory tests, 12 lead-ecg, chest x-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above. exclusion criteria: * subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; or a history of allergic diseases (including but not limited to asthma, urticaria, etc.), or allergic constitution (such as known allergy to two or more substances) * subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or suggest potential diseases, such as abnormal laboratory test results of liver and kidney function (alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\] exceeding the upper limit of normal, or total bilirubin exceeding the upper limit of normal; or blood creatinine exceeding the upper limit of normal value); or other diseases (such as a history of mental illness) deemed unsuitable for participation in the trials by the investigators; * subjects with severe infection, severe trauma, or major surgery within 6 months prior to screening; * subjects who have received blood transfusions, had blood donors, or lost blood ≥400 ml within 3 months before screening; or plan to donate blood within 1 month of the end of the trial; * subjects who have positive results of human immunodeficiency virus antibodies (hiv-ab), or hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv-ab), or syphilis specific antibodies (tppa); * subjects who have participated in clinical trials for medication or medical device within 3 months prior to screening;etc.
user evaluation study of syncvision system with software v4.x

Conditions: Coronary Artery Disease

Summary: this is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'conformité européenne' (ce)-mark co-registration software system along-side of a commercially- released ce-mark coronary physiology and x-ray system during routine clinical workflow. the purpose of this study is to collect professional user feedback regarding clinical utility of the syncvision 4.x system.

the prepare ii study will enroll a maximum of 200 patients in up to 5 sites. no follow-up will be performed. the prepare ii study will only collect data during diagnostic angiogram or percutaneous coronary intervention (pci) procedure, when performed as per standard hospital care.

Eligibility criteria:
inclusion criteria: * patients eligible and indicated for cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice * males over the age of 18 years and post-menopausal females * patient is able to give written informed consent prior to using his/her study data for evaluation and documentation exclusion criteria: - patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation

Keywords: coronary catheterization instantaneous wave free ratio (ifr) fractional flow reserve (ffr) automated co-registration
short term outcomes of heavy-weight versus medium-weight synthetic mesh

Conditions: Hernia, Ventral; Hernia Incisional

Summary: this study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.

the abdominal core health quality collaborative was queried for patients undergoing open retromuscular hernia repairs with both heavy weight polypropylene (pp) mesh and medium weight pp mesh in cases where there was clean-contaminated and contaminated surgeries. the short term outcomes were then evaluated including wound infections, readmissions, recurrences of the hernia, and quality of life scores.

Eligibility criteria:
inclusion criteria: * patients undergoing open ventral hernia repairs with synthetic mesh in contaminated and clean contaminated surgery exclusion criteria: * laparoscopic or robotic surgery * clean cases or dirty cases * pregnancy * under age of 18
phase iii study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (nsclc). docetaxel has also shown promising results against elderly patients in phase ii studies. we conducted a randomized phase iii trial to evaluate whether docetaxel provided better overall survival than vinorelbine in elderly patients with advanced nsclc.


Eligibility criteria:
inclusion criteria: chemotherapy- and radiotherapy-naïve patients with histologically or cytologically diagnosis of stage iiib or iv nsclc and who were ≧ 70 years old with measurable or assessable disease were eligible for this trial. they had to have a life expectancy of at least 3 months. additional entry criteria were as follows: (a) a performance status (ps) 0 to 2 on the eastern cooperative oncology group scale; (b) adequate function of bone marrow (leukocyte count ≧ 4,000/μl, absolute neutrophil count ≧ 2,000/μl, hemoglobin concentration ≧ 9.5 g/dl, platelet count ≧ 100,000/μl), kidney (serum creatinine ≦ 1.2 mg/dl), liver (total bilirubin ≦ 1.5 times the institutional upper limits of normal, transaminase of ast and alt ≦ 2.5 times the institutional upper limits of normal). exclusion criteria: patients with symptomatic brain metastasis or apparent dementia were ineligible. patients with active concomitant malignancy, massive pleural effusion or ascites, active infection, severe heart disease, grade 2 or higher ecg abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.-
a study to evaluate the safety, tolerability, and immunogenicity of a combined modified rna vaccine candidate against covid-19 and influenza.

Conditions: Influenza; COVID-19

Summary: the purpose of this study is to understand the safety and effects of a combined influenza and covid-19 vaccine. this combined vaccine is compared to separate vaccines for the protection against influenza and sars-cov-2. influenza and covid-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. giving both influenza and covid-19 vaccines together against influenza and sars-cov-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. around 8550 participants will be assigned into 1 of 8 vaccination groups (group a, b, c, d, e, f, g or h) by chance. cohort 1: approximately 450 participants will be assigned by chance to one of the following: * group a:influenza and covid-19 combination a vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm. * group b: covid-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm. cohort 2: approximately 4500 participants will be assigned by chance to one of the following: * group c: influenza and covid-19 combination b vaccine, given at the same time in one arm and placebo in the opposite arm. * group d: covid-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm. cohort 3: approximately 3600 participants will be assigned by chance to one of the following: * group e: influenza and covid-19 combination b vaccine. * group f: covid-19 vaccine. * group g: licenced influenza vaccine. * group h: investigational influenza vaccine. all participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at visit 1. the participants will be followed for about 6 months. during this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. this will help understand if the study medicine is safe.


Eligibility criteria:
inclusion criteria: * participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at visit 1. * healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. exclusion criteria: * vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza. * vaccination with any investigational or licensed covid-19 vaccine within 6 months (175 days) before study intervention administration. please refer to the study contact for further eligibility details