Kornimate/medical-research-clean huggingface dataset:
phase iii randomized study of cyclophosphamide with or without antithymocyte globulin before bone marrow transplantation in patients with aplastic anemia

Conditions: Aplastic Anemia

Summary: objectives: i. compare outcome, including graft failure, graft versus host disease, and survival of hla-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.

protocol outline: this is a randomized, multicenter study. patients are randomized to receive cyclophosphamide iv over 60 minutes on days -5 to -2 with or without antithymocyte globulin iv over 4 hours. all patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last dose of cyclophosphamide. patients are followed at day 100, at 6 months, and at 1 year posttransplant.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- severe aplastic anemia with the following criteria: hypocellular bone marrow with cellularity less than 20% at least 2 of the following hematologic abnormalities: * neutrophil count no greater than 500/mm3 * platelet count no greater than 20,000/mm3 * reticulocyte count no greater than 50,000/mm3 hla-identical sibling donor available no clonal cytogenetic abnormalities, paroxysmal nocturnal hemoglobinuria, or myelodysplastic syndrome within 3 months of diagnosis of aplastic anemia no congenital or constitutional aplastic anemia or fanconi anemia --patient characteristics-- hepatic: bilirubin less than 3 times upper limit of normal (uln) renal: creatinine less than 2 times uln cardiovascular: normal cardiac function other: * no uncontrolled infection * no severe concurrent disease * hiv negative * fertile patients must use effective contraception

Keywords: hematologic disorders rare disease
efficacy study of the effect of budesonide on emphysema

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to assess the effect of up to 4 years treatment with budesonide on progression of emphysema in patients with chronic obstructive lung disease.


Eligibility criteria:
inclusion criteria: * clinical chronic obstructive pulmonary disease diagnosis * smoker exclusion criteria: * no exacerbation within the last 30 days * no long term use of oral corticosteroids

Keywords: chronic obstructive pulmonary disease
coronary microvascular disease (cmd) registry

Conditions: Coronary Microvascular Dysfunction

Summary: the purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (cmd). this protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes.


Eligibility criteria:
inclusion criteria: * those with coronary microvascular disease
educational intervention for hypertension management

Conditions: Hypertension

Summary: an interventional study is designed and a structured educational session will be conducted regarding the management of blood pressure for the general physicians of karachi, lahore, peshawar, islamabad, multan and quetta. the purpose of designing this study is to observe the effect of hypertension educational intervention for general physicians to improve patient outcomes indirectly. results of this study may provide a basis for developing a hypertension educational program targeted at general physicians.

study procedure 1. screening of general physicians as per inclusion criteria and recruitment of gps by clinical research associate after obtaining informed consent form. 2. gps will be asked to fill hypertension awareness questionnaire at baseline 3. both group of gps with the help of clinical research associate will recruit 5 patients from study site. 4. after obtaining informed consent, patient will be asked to fill hypertension awareness questionnaire at baseline or recruitment day and share pictures of 12-hour blood pressure measurement (from digital bp apparatus) with clinical research associate. 5. randomization of gps will be than in to 2 groups. 6. after randomization, group 1 gps will receive (1 day) face to face education and group 2 gps will receive print version of education material. 7. after gps education intervention, patients will be invited for regular checkup at gps clinic. 8. patient will be again asked to fill hypertension awareness questionnaire after 3 months and share pictures of 12-hour blood pressure measurement (from digital bp apparatus) with clinical research associate. (1st, 2nd \& 3rd month). 9. gps will be asked to fill hypertension awareness questionnaire again after 3 months (post intervention)

Eligibility criteria:
inclusion criteria: * gps who have at least three years of practice experience in the broad disciplines of primary care using the numerical pain rating (npr) scale over the past week ≥ 2 on a 0-10 numerical pain scale. * patients between 18-60 years. * patients with uncontrolled blood pressure according to pakistan hypertension league guidelines * patients with or without angiographically proven coronary, peripheral or cerebral vascular disease. * patients must be able to give informed consent and be able to read and comprehend in the urdu (national language) * patients must have a digital bp apparatus at home. * patients must have a phone with camera and internet. exclusion criteria: * gps who had attended a planned hypertension educational program during the last 6 months. * patients with a recognized psychiatric disorder as per the diagnostic and statistical manual of mental disorders

Keywords: educational intervention hypertension management primary care physician
research on patients with heart transplantation

Conditions: Heart Transplant Rejection

Summary: this trial was a single-center, prospective cohort study.the purpose of this clinical research is to evaluate the accuracy of combining multimodality mr imaging with circulating exosomal mirna expression to diagnose acute rejection in patients with heart transplantation，thus it may be helpful for timely intervention to improve the patient's prognosis.

acute rejection (ar) after heart transplantation remains the major factor limiting long-term survival, and an independent risk factor for chronic allograft vasculopathy. currently, there remains no reliable non-invasive method to detect ar. multimodality magnetic resonance (mr) imaging shows accurate detection of myocardial damage, such as interstitial cell infiltrates, edema, hemorrhage, myocyte damage/necrosis and capillary stenosis or fragmentation. it turned out that the indicators in both mr imaging and circulating exosomal mirna showed difference between patients with and without ar in our initial research work. therefore, we hypothesize that circulating exosomal mirna may play an important role in the activation of signaling pathway in ar after heart transplantation, which can be detected by multimodality mr imaging. all transplant recipients receiving transplantation follow-up care in our center were approached. in the present research we aim to combine multimodality mr imaging with circulating exosomal mirna to explore a new evaluation methodology and platform for early and noninvasive detection of ar after heart transplantation. we attempt to confirm contribution of circulating exosomal mirna to myocardial damage of ar through biopsy-proven allograft rejection and animal heterotopic heart transplantation.

Eligibility criteria:
inclusion criteria: 1. all patients after orthotopic heart transplantation. 2. all patients has signed informed consent. exclusion criteria: 1. patients with early graft failure within 24-48h after transplantation requiring clinical support or intensive care treatment. 2. patients with severe renal failure. 3. patients with any general contraindication to mri.

Keywords: magnetic resonance imaging multimodality heart transplantation exosome
impact of lucentis on psychological morbidity in patients with retinal vein occlusion

Conditions: Venous Retinal Branch Occlusion; Central Retinal Vein Occlusion; Retinal Vein Occlusion; Depression

Summary: this is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam * age 18 years or over * central macular edema on clinical exam as well as imaging with a central thickness of ≥ 250 microns * visual acuity ranging from 20/8000 to 20/40 * media clarity and patient cooperation sufficient to allow adequate testing utilizing oct and fa * no previous treatment that might compromise or confound assessment of the study outcomes * ability to speak and read english exclusion criteria: * acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements * concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise * history of grid/focal laser in the study eye * history of vitreal surgery * previous treatment with triamcinolone acetonide in either eye * previous use of bevacizumab, pegaptanib, or ranibizumab in either eye * evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders * history of cerebrovascular accident within 1 year prior to day 0 * inability to comply with study or follow-up procedures * any cognitive defect as a result of mental disease, previous injury, or disease process that may interfere with interpretation of study results * visual acuity better than 20/40 * pregnancy (positive pregnancy test) or lactation * inadequate contraception in premenopausal women

Keywords: retinal vein occlusion ranibizumab lucentis depression
total knee replacement component alignment using manual versus custom instrumentation

Conditions: Osteoarthritis of Knee

Summary: 1. to determine whether the low-dose, biplanar x-ray imaging (eos) has the same accuracy as computed axial tomography (ct) 2. to validate low-dose, biplanar x-ray imaging (eos) as a tool to evaluate 3-dimensional alignment of total knee replacement implants. 3. to evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative ct

achieving optimal prosthetic alignment of the femoral, tibial and patellar components during total knee replacement (tkr) is of great importance as it contributes to better function, less pain and improved quality of life.tkr requires accuracy in the execution of bone cuts in the correct orientation to the coronal, sagittal and axial planes. malposition potentially leads to increased mechanical stress on the bearing surfaces and inevitably to earlier loosening. computed axial tomography (ct) is the gold standard technique to evaluate implant alignment in the coronal, sagittal and axial planes. as such, ct has imaging has been used to create custom instrumentation with purported likely improvement in surgical outcomes. customized instrumentation created from a preoperative ct has been shown to be safe and effective, with no reported difference in patient outcomes and similar total knee arthroplasty component alignment. however, taking into consideration ct's high levels of radiation, cost expenses and its inability to obtain images of the limb in weight-bearing position, ct scan cannot be used routinely as a postoperative tool to evaluate tkr implant positioning. the imaging system manufactured by eos imaging (formerly biospace med, paris) is a biplanar, low-dose radiation, full body, high resolution, radiological imaging system allowing simultaneous acquisition in the coronal and sagittal planes and in standing position.eos' main benefits are the considerable reduction in radiation dose (up to 1000 times less than for ct and ten times less than the plain radiography) by using a gaseous detector. george charpak, the inventor, was awarded the nobel prize in 1992 for this work. moreover, the eos system can provide 3d images by using the appropriate software algorithms, thus providing a low-radiation alternative to ct.

Eligibility criteria:
inclusion criteria: * radiographically confirmed diagnosis of osteoarthritis (oa) * failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis * age greater than 18 years * desire to proceed with elective tkr * completion of informed consent and signature of written consent form exclusion criteria: * ligamentous instability that may necessitate a constrained tkr implant * retained hardware in the distal femur or proximal tibia of the operative extremity * medical contraindication to undergo preoperative ct, or inability to tolerate preoperative ct
a study to evaluate role of inhaled amikacin to prevent ventilator associated pneumonia in patients with cirrhosis

Conditions: Hepatic Encephalopathy; Cirrhosis; Ventilator Associated Pneumonia (VAP)

Summary: the recent amikinhal trial found that prophylactic inhaled amikacin was effective in lowering the incidence of ventilator-associated pneumonia in icu patients. since aspiration is a common complication of cirrhosis patients with he (7 out of 10 patients develop some type of he) who are hospitalized to the liver icu also have an elevated risk of ventilator associated pneumonia. despite supportive care and appropriate antimicrobial therapy pneumonia is linked to greater mortality in cirrhosis. this poses a significant challenge to physicians. due to the lack of randomized controlled trials (rcts) on the prophylaxis of vap in cirrhosis patients with he, conducting this study is necessary to evaluate the efficacy of inhaled amikacin. the study results may provide evidence -based guidance for therapy in this patient population.


Eligibility criteria:
inclusion criteria: 1. patients admitted to the liver icu with hepatic encephalopathy (grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia. 2. patient is aged ≥18 years. 3. written informed consent of the patient or a proxy. exclusion criteria: 1. suspected or confirmed pneumonia at the day of inclusion. 2. patients with chronic kidney disease on maintenance hemodialysis 3. stage 2 or 3 kidney disease improving global outcome (kdigo) classification aki the day of inclusion. patients undergoing renal replacement therapy or for whom decision has been made to initiate renal replacement therapy can be included whatever the kdigo stage 4. pregnancy or breast-feeding. 5. clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge. 6. patients known to be allergic to aminoglycosides. 7. patients who received intravenous amikacin before 7 days of inclusion in this study.

Keywords: inhaled amikacin prophylaxis ventilator associated pneumonia
genetic analysis of children with cyclic vomiting syndrome (cvs) and migraines

Conditions: Vomiting; Migraines

Summary: the purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (cvs).

the purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (cvs), various phenotypes of cvs (e.g. menstrual, sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine). this information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. this research is being done because many unanswered questions remain regarding children with cvs.

Eligibility criteria:
inclusion criteria: * subjects age 0-21 years old with cvs (different phenotypes). each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. exclusion criteria: * subjects age \> 22 years old vomiting is not due to cvs or other related condition

Keywords: genome wide scan (gws) mitochondrial scan family trios
tumor microenvironmental collagen signature to predict thyroid cancer superior mediastinal lymph node metastasis

Conditions: Thyroid Cancer

Summary: about 7-13% thyroid cancer patients have superior mediastinal lymph node metastasis, but its clinical identification is insufficient. effective and individualized identification strategy need to be studied. multiphoton imaging can accurately detect extracellular matrix collagen fibers by femtosecond laser. quantitative features such as morphology and texture features extracted from the multiphoton images, can be used to predict lymph node metastasis of gastrointestinal cancer. therefore, the investigators speculate that the characteristics of tumor microenvironment (tme) collagen based on multiphoton imaging may be used to predict superior mediastinal lymph node metastasis in thyroid cancer. the aim of this study is to investigate whether the tme collagen signature could predict superior mediastinal lymph nodes metastasis in thyroid cancer. the exposure of this observational cohort study is high tme collagen signature. the main measurement was the area under the receiver operating characteristic (auroc) curves of collagen signature for predicting superior mediastinal lymph node metastasis.

retrospective cohorts were enrolled from the sir run run shaw hospital of zhejiang university school of medicine, the first affiliated hospital of zhengzhou university and nanfang hospital from january 2020 to december 2023. perspective cohort was obtained from all the three centers from january 2024 to july 2024.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed as thyroid cancer * radical surgery of tumor and simultaneous resection of superior mediastinal lymph nodes exclusion criteria: * reoperation * under the age of 18 * combined with thoracopathy, lymphoma or other diseases that may cause mediastinal lymph node enlargement * the superior mediastinal lymph nodes metastasis status was not separately reported * insufficient pathology section quality * pregnancy

Keywords: thyroid cancer collagen lymph nodes metastasis predictive model multiphoton imaging
hypofractionated radiation therapy vs standard treatment in breast cancer.

Conditions: Ductal Breast Carcinoma in Situ; Invasive Breast Cancer; Early-stage Breast Cancer; Stage 0 Breast Cancer; Stage I Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer

Summary: an explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy dcis, t1-t2 n0 m0 (ajcc v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.

primary objective: i. compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery. secondary objectives: i. identify the histological lineage of the tumor. ii. identify the degree of differentiation of tumor cells. iii. identify the presence and type of receptors (estrogen, progesterone, her-2neu) through immunohistochemistry. iv. measure the frequency of progression or recurrence. v. identify the site of progression or recurrence. vi. measure the frequency of toxicity in both groups. vii. classify toxicity according to its severity. viii. classify toxicity according to chronological presentation, acute, subacute, or chronic. ix. measure quality of life in both groups according to the european organization for research and treatment cancer scale, breast cancer-specific quality of life questionnaire, (eortc, qlq-br23). x. measure quality of life in both groups according to the eastern collaborative oncology group (ecog) performance scale. xi. measure 5-year survival. outline: patients are randomized to 1 of 2 arms. arm i: will receive radiotherapy treatment with high hypofractionation, 26 gy in 5 fractions to the whole breast. arm ii: will receive radiotherapy treatment with standard hypofractionation, 42.5 gy in 16 fractions with simultaneous integrated increase of 5.5 gy to the tumor bed in high-risk patients. after completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years

Eligibility criteria:
inclusion criteria: * patients diagnosed by histopathological report of ductal carcinoma in situ (dcis) or invasive breast carcinoma. * treated with breast-conserving surgery and stage pt1-2 pn0 m0. * over 18 years. * patients who sign informed consent for research study. exclusion criteria: * positive nodes. * clinical or pathological stage t3-t4. * history of previous irradiation. * postoperative positive margin.
skin blood flow changes using laser doppler imager for assessment of pain and analgesia in newborn infants

Conditions: Procedural Pain

Summary: the purpose of this study is to assess whether an instrument, the laser doppler imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. the study will also determine whether the use of sucrose (sugar water) when given by mouth has any effect on pain related skin blood flow changes.

during the last 25 years evidence that newborns can experience pain has been increasing. painful procedures (injections, heel lances, and circumcisions) are part of normal routine newborn care. studies have demonstrated that newborns have increased sensitivity to pain when compared with older children and adults. pain assessment and management is an important component in the overall care of the newborn infant and safe, effective analgesics are needed. pain assessment is complicated by the infants' verbal and cognitive limitations. heart rate, blood pressure and oxygen saturation are commonly monitored in the nursery in response to pain, yet these parameters are affected by handling, illness, medications, as well as by pain. skin blood flow has been documented to increase in premature newborns undergoing painful procedures in the newborn intensive care nursery. in the present study, laser doppler imager technology will be used to define changes in skin blood flow response to heel lance and oral sucrose administration in normal newborn infants.

Eligibility criteria:
inclusion criteria: * informed consent from parent or legal guardian. * term, newborn infant, between 1 and 7 days of age. * appropriate for gestational age (weight 5th through 95th percentile). exclusion criteria: * small or large for gestational age (weight\ 95th percentile). * physical or biochemical abnormalities. * history of maternal drug dependence. * apgar score \<7 at 5 minutes. * current use of analgesics.

Keywords: procedural pain in newborn infants newborn infant acute procedural pain skin blood flow changes sucrose analgesia laser doppler imager neonatal infant pain scale