Kornimate/medical-research-clean huggingface dataset:
new york city observational study of mpox immunity

Conditions: Monkeypox; Mpox; HIV

Summary: the goal of this study is to assess the immune response, tolerance, and safety of the low-dose intradermal (forearm) mpox vaccine in people who are hiv+ compared to people who are hiv-, and compared to the standard-dose subcutaneous (upper arm) vaccine. the resulting data will fill knowledge gaps, inform public health practices, and address community concerns about the absence of data for low-dose intradermal mpox vaccinations in people living with hiv.


Eligibility criteria:
inclusion criteria: 1. must be able to understand and sign the informed consent form (icf) 2. ≥18 years of age a. including breastfeeding and pregnant people 3. must have one or the other of criteria a and b, or can have both: 1. planning receipt of (in the next 30 days) or have received the mpox vaccine, and/or 2. people with recent mpox infection who are out of isolation (≥30 days after symptom onset) 4. willingness and ability to participate in all study procedures exclusion criteria: 1. known clinically significant anemia (i.e., hb \< 10 g/dl) 2. contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia 3. any condition that, in the opinion of the investigator, would make study participation unsafe for the individual or would interfere with the objectives of the study

Keywords: vaccine immunity intradermal
calcium reduction by orbital atherectomy in western europe

Conditions: Vascular Calcification* / Diagnostic Imaging; Atherectomies, Coronary; Tomography, Optical Coherence; Coronary Intervention, Percutaneous; Coronary Angiography; Humans; Treatment Outcome; Vascular Calcification* / Therapy; Vascular Calcification

Summary: in calcified lesions, optimal stent placement and expansion may prove to be challenging. lesion preparation is necessary to facilitate optimal stenting in calcified lesions, for which orbital atherectomy can used. therefore the aim of this study is to: 1. show that orbital atherectomy effectuates optimal stent expansion 2. investigate the mechanics of lesion preparation when using orbital atherectomy patients presenting with a significant and severely calcified lesion in need of orbital atherectomy will undergo optical coherence tomography guided orbital atherectomy and stent placement.

the diamondback 360° coronary orbital atherectomy system (oas) (cardiovascular systems inc., st. paul,mn,usa) is a percutaneous device indicated to modify calcified lesion in order to facilitate stent delivery in patients with severely calcified coronary artery disease (cad). as of to date, detailed sequential intravascular imaging data unraveling the exact calcium modifying effect of orbital atherectomy (oa) prior to stent placement in vivo, are lacking. the aim of this, international, multicenter, prospective and observational single arm study is to understand the mechanism of action of oa for the treatment of de novo, severely calcified coronary lesions priot to stent placement using optical coherence tomography (oct) and to assess stent expansion, based on oct derived minimal stent area. the study population consists of patients undergoing percutaneous coronary intervention of a severely calcified coronary lesion in need of oa to enable proper stent placement and expansion. a total of 100 patients will be enrolled. all patients will undergo peri-procedural imaging using oct and the aim is to obtain data for at least 50 patients with oct before and after oa and after stenting.

Eligibility criteria:
inclusion criteria: * de novo significant native coronary artery lesion * the target lesion must have evidence of severe calcification: 1) presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall with calcification length of at least 15 mm and extend partially into the target lesion. 2) or presence of ≥ 270° of calcium or lumen protruding calcified nodules at \>1 cross section by intravascular imaging (oct) * the target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed 40 mm in length exclusion criteria: * left main disease * prior stenting of the target vessel * target lesion has thrombus or dissection * known left ventricular ejection fraction lvef ≤ 25% * diagnosed with chronic renal failure (gfr \< 30 ml/min) * confirmed pregnancy * life expectancy \< 12 months * coronary anatomy that prevents delivery of oct catheter * known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide
utility of renal biomarkers in cirrhosis

Conditions: Cirrhosis; Ascitis

Summary: evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. the investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and pre-renal causes. finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * known or suspected cirrhosis * suspected ascitis * informed consent signed exclusion criteria: * proven multifocal hepatocellular carcinoma * acute gastric hemorrhage (active or \< 2 weeks) * known end-stage renal disease or on dialysis before admission * recipients of kidney or liver transplants * transferred from another institution
cxcr4 targeted pet imaging in apa preoperative localization diagnosis

Conditions: Aldosterone-Producing Adenoma

Summary: the goal of this clinical trial is to evaluate the effectiveness of cxcr4 targeted pet imaging in preoperative localization diagnosis of primary aldosteronism (pa). participants diagnosed with pa will be asked to be scanned by 68ga-pentixafor pet, and then underwent adrenal venous sampling (avs). then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. researchers will compare the sensitivity and specificity between 68ga-pentixafor pet imaging and avs in preoperative localization diagnosis of pa.


Eligibility criteria:
inclusion criteria: * patients with pa, confirmed by an elevated aldosterone/renin ratio (arr) and an intravenous salt loading test. * the patient has provided written informed consent authorisation before participating in the study. * the patient is 18 to 70 years of age at the time of consent. exclusion criteria: * refusal by the patients to undergo 68ga-pentixafor pet/ct, avs, ct, or adrenalectomy. * suspicion of familial hyperaldosteronism type 1 (fh-1) or type 3 (fh-3). * suspicion of adrenocortical carcinoma. * severe comorbidity potentially interfering with treatment or health-related quality of life. * patients need to take drugs that interfere with clinical research. * any medical condition present that in the opinion of the investigator will affect patients clinical status. * pregnancy or lactation. * estimated glomerular filtration rate \<40ml/min/1.73m2. * interfering treatment in between 68ga-pentixafor pet/ct and avs.

Keywords: hypertension hypokalemia adrenal adenoma
prevention of overweight in infancy

Conditions: Obesity; Growth; Sleep

Summary: obesity is one of the biggest threats to health in the 21st century. rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. this rapid early weight gain occurs most often at weaning when eating patterns emerge. infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. we propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in new zealand. this would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications. this is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.

we plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses: 1. that anticipatory guidance and extra education and support in infancy around weaning and decreasing/avoiding television watching will delay the timing of introduction of solid foods, will be associated with more successful introduction of nutrient dense foods with appropriate portion size and decrease small screen exposure leading to a lower number of children with excessive weight velocity in infancy and early childhood. 2. that anticipatory guidance, education and extra support around the early development of infant sleeping patterns will decrease sleep problems, increase infant sleeping time, decrease arousals at night and lower sleep latency which will in turn influence rate of early infant weight gain. 3. that interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain. 4. that intervention 2 will lead to lower rates of maternal depression and increased family well being.

Eligibility criteria:
inclusion criteria: * mothers booked for delivery in dunedin, new zealand exclusion criteria: * women booked after 34 weeks gestation, * identified congenital abnormality likely to affect feeding and/or growth * home address outside of metropolitan dunedin or invercargill, * families who are likely to shift out of metropolitan dunedin or invercargill in the next 2 years. * unable to communicate in english or te reo maori.

Keywords: obesity sleep physical activity breast feeding depression
etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin as 2nd line therapy for non-hodgkin's lymphoma (nhl)

Conditions: Non-Hodgkin's Lymphoma

Summary: oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (eshap). clinical efficacy and toxicity of this eshaox salvage regimen will be evaluated in refractory or relapsed non-hodgkin's lymphoma patients.

patients with aggressive non-hodgkin's lymphoma (nhl) are known to have a malignancy considered curable in many cases. however, diagnosis of refractory or relapsed disease is devastating and the treatment is difficult because regimens of chemotherapy used as salvage therapy are available only in limited numbers. eshap, consisting of etoposide, methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage regimen, and showed its efficacy and feasibility. but it often requires discontinuation of the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also impede further treatment. oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be active in patients with nhl as a single agent. in addition, the substitution of cisplatin by oxaliplatin in the dhap regimen, another commonly used one in relapsed or refractory nhl, showed meaningful anti-tumor activity with favorable toxicity profile. based on preclinical and clinical findings, we will conduct a multi-center phase ii study of eshaox, which substitutes oxaliplatin with cisplatin in the eshap regimen, to evaluate the efficacy and toxicity profile in patients with recurrent or refractory nhl.

Eligibility criteria:
inclusion criteria: * previously histologically confirmed aggressive lymphomas, defined according to who classification (except burkitt's lymphoma, lymphoblastic lymphoma) * failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease * performance status (ecog) ≤3 * age ≤ 75 * treated with at least one chop or chop-derived doxorubicin containing regimen * at least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional ct or ≥ 1 cm by spiral ct or skin lesion (photographs should be taken) or measurable lesion by physical examination * adequate organ functions defined as; anc \> 1,500/ul, platelet \> 75,000/ul, transaminases \< 3 x upper normal values; bilirubin \< 2 mg% * written informed consent approved by institutional review board exclusion criteria: * any other malignancies within the past 5 years except skin basal cell ca or cis of cervix * serious co-morbid diseases * pregnancy or breast-feeding

Keywords: oxaliplatin eshaox refractory relapsed non-hodgkin's lymphoma
a study to evaluate [18f]-fdg pet (fluorodeoxyglucose-positron) in patients with pancreatic cancer (mk-0000-144)

Conditions: Advanced Pancreatic Adenocarcinoma

Summary: this study will determine whether \[18f\]-fluorodeoxyglucose-positron emission tomography (fdg-pet) can be used to screen for the activity of novel pancreatic cancer treatments.


Eligibility criteria:
inclusion criteria: * patient has a diagnosis of stage iv pancreatic adenocarcinoma with distant metastases * patient is scheduled to receive standard chemotherapy containing gemcitabine * patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma * patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution exclusion criteria: * patient has had open abdominal surgery within 6 weeks of the screening visit * patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit * patient has an active infection, inflammation, or unresolved bowel obstruction * patient has poorly controlled diabetes

Keywords: advanced pancreatic adenocarcinoma
hospital stay and respiratory infection

Conditions: Respiratory Infection

Summary: the acute respiratory infection is the fourth most common cause of hospital stay between elderly people. the purpose of this study is to evaluate the repercussion of hospital stay in hospitalized patients with a respiratory infection.

acute respiratory infection is a serious infection that prevents normal breathing function. it refers to any of a number of infectious diseases involving the respiratory tract. health conditions that increase the risk of a respiratory infection include: another lung condition, a heart condition, a kidney or liver condition and a lowered immune system. the hospital stay of this patients is approximately 7-10 days and it is important to study the effects of this stay in the physical and psycho-emotional characteristics of patients.

Eligibility criteria:
inclusion criteria: * diagnosis of respiratory infection * age: more than 50 year. * signed written consent. exclusion criteria: * heart disease and concomitant neurological condition.

Keywords: respiratory infection physical variables
effect of vestibular exercises on post-stroke fatigue

Conditions: Stroke

Summary: the goal of this clinical trial is to search effects of vestibuler exercises on post-stroke fatigue. the main question it aims to answer is: wer are: - do vestibuler excercises decrease post-stroke perceived and physiologic fatigue? researchers will compare the effects of vestibuler exercises to conventional rehabilitation to find out the superior one. participants will: * take a one-hour conventional rehabilitation or vestibuler exercise program three times in a week. * be assessed in terms of fatigue before and after rehabilitation programs.

one of the most common complications after stroke is fatigue. fatigue prolongs the rehabilitation period and delays recovery. although medical treatments, exercise programs and activity modifications are recommended to reduce fatigue after stroke, an effective evidence-based treatment method has not yet been developed. vestibular exercises can improve oculomotor and postural control by trying to provide sensory integration through adaptation and compensatory mechanisms, thus increasing cortical excitability and reducing fatigue.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study being between the ages of 18-65 having had an anterior circulation stroke at least 6 months ago being at least stage 3 according to the functional ambulation classification scoring at least 22 on the montreal cognitive assessment scale exclusion criteria: * having another orthopedic, neurological or other systemic disease that prevents working having severe aphasia having a disease other than stroke that causes primary fatigue using medication that will affect cognitive status using medication that will affect fatigue

Keywords: stroke vestibular exercise fatigue balance gait
analysis of the molecular profile of the mixofibrosarcoma of the extremities

Conditions: Sarcoma,Soft Tissue

Summary: single institution case series review with a histological diagnosis of mixofibrosarcoma of the extremities from 01 jan 1993 to 01 dec 2017. the study will exam all the clinical, radiological, histological and immunohistochemical features of this tumour in all samples and in a limited serie of cases the presence of mutation of 50 genes cancer related.


Eligibility criteria:
inclusion criteria: 1. male and female patients treated at rizzoli institute from 01 jan 1993 to 01 dec 2017 2. diagnosis of mixofibrosarcoma of extremities 3. histological slides/formalin-fixed paraffin-embedded tissue tumor (ffpe) blocks from archive available to perform the histology analysis and molecular analysis 4. enough tumor biobanked material available for molecular analysis 5. presence of the biobank signed informed consent 6. written informed consent prior to any study-specific analysis and/or data collection exclusion criteria: 1) patients with histological diagnosis different from mixofibrosarcoma of extremities

Keywords: mixofibrosarcoma
edaravone dexborneol combining with mechanical thrombectomy in the treatment of acute ischemic stroke

Conditions: Stroke

Summary: edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. the taste trial (treatment of acute ischemic stroke with edaravone dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. however, the taste trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.

this is a prospective, non-randomized clinical trial in multiple stroke centres of china. the total sample size will be 200. patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (mt) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. patients in standard medication treatment group must not receive edaravone dexborneol. other neuroprotective agents are not limited to use.

Eligibility criteria:
inclusion criteria: * patients presenting with anterior circulation acute ischemic stroke * patients aged between 18-80 years. * cta or dsa verified arterial occlusion of ica, m1 or m2. * nihss on admission 4 - 26 * baseline ctp verified infarct core \ 10 ml, hypoperfusion/core \> 1.8 * undergoing mechanical thrombectomy within 24 hours of stroke onset. for wake-up stroke, the onset time is determined as the midpoint of last-seen-well and discovered time exclusion criteria: * patients without recanalization (tici 0,1, 2a) * pre-existing neurological disability (a score greater than 2 on the mrs) * contraindication of edaravone dexborneol
a study of bcma car-t cell therapy for newly diagnosed multiple myeloma

Conditions: Multiple Myeloma; New Diagnosis Tumor

Summary: clinical trial for the safety and efficacy of bcma car-t cell therapy for newly diagnosed multiple myeloma

this is a single arm, open-label, single-center study. this study is indicated for newly diagnosed multiple myeloma. the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. primary objective is to explore the safety and efficacy

Eligibility criteria:
inclusion criteria: * 1.age and gender unlimited; * 2.according to the imwg2014 standard, diagnosis as multiple myeloma; * 3.according to the msmart 3.0 standard, it is defined as a high-risk multiple myeloma; * 4.abnormal plasmocyte bcma expression positive; * 5.echocardiography shows the left ventricular ejection score (lvef) ≥50%; * 6.the subject has no lung activity infection; * 7.expected life time is more than 3 months; * 8.ecog score 0-2 score; * 9.voluntarily participate in the trial and sign the informed consent form. exclusion criteria: * 1.patients with the history of epilepsy or other cns disease; * 2.patients with prolonged qt interval time or severe heart disease; * 3.pregnant or breastfeeding; * 4.active infection with no cure; * 5.patients with active hepatitis b or c infection; * 6.previously treated with any genetic therapy; * 7.the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; * 8.serum creatinine \> 2.5mg/dl or alt / ast \> 3 times uln or bilirubin \> 2.0mg/dl; * 9.those who suffer from other uncontrolled diseases are not suitable to join the study; * 10.hiv infection; * 11.any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Keywords: bcma car-t multiple myeloma new diagnosis