Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of a new serum-free dtap-ipvvero combination vaccine

Conditions: Active Immunization

Summary: the trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two dtap-ipv combination vaccines: a)the investigational vaccine: dtap-ipv containing ipv produced in a vero-cell line (dtap-ipvvero) b)the reference vaccine: dtap-ipv containing ipv produced in monkey kidney cells (dtap-ipvmkc) the dtap-ipv vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with act-hib vaccine administered as a separate injection in the opposite thigh. three blood samples are collected at 6, 16 and 17 months of age. sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.


Eligibility criteria:
inclusion criteria: * the parents were informed about the trial and have signed the consent form * the subject is healthy * the subject has an age of 28 to 49 days at hepatitis b vaccination * the subject had a birth weight of ≥2500 g * the subject has received a hepatitis b vaccination at birth * the parents grant access to the subject's medical records * the parents are likely to comply with instructions exclusion criteria: * the subject suffers from a severe chronic disease * the subject has already been immunized with one or more doses of diphtheria, tetanus, pertussis, poliomyelitis, or hib vaccines * the subject has a known allergy to one of the vaccine components or to any of the constituents of the vaccines, including act-hib® and hepatitis b vaccines * the subject has a history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, or hib infections * the subject has a known congenital or acquired immunodeficiency * the subject is in treatment with or has been in treatment with a product which is likely to modify the immune response (i.e. immunoglobulin, systemic corticosteroids, blood products, other vaccines) * the subject is participating in another clinical trial

Keywords: dtap-ipv clinical trial safety immunogenicity
colon-md: colon cancer longitudinal study

Conditions: Colon Cancer

Summary: the goal of this proposal is to identify how the composition of the gut microbiome and diet interact to impact chemotherapy-induced diarrhea incidence and severity.

in this longitudinal observational study patients will supply samples of their gut microbiome prior to scheduled colonoscopy or surgery along with dietary intake and blood samples; the relative abundance of microbes from those samples along with dietary data will be used to predict the presence or absence and severity of chemotherapy-induced diarrhea. microbiome and diet based predictions from blinded samples will be combined to map the diet-microbiome changes during treatment to the changes in immune markers and risk of chemotherapy-induced diarrhea.

Eligibility criteria:
inclusion criteria: * colon cancer diagnosis * age \>18 and \< or equal to 79. * ability to perform informed consent * folfox treatment expected exclusion criteria: * not pregnant * does not have lynch syndrome or fap diagnosis. * inability to perform inform consent * inability to comply with follow up program * history of prior colon cancer diagnosis * previous treatment with antibiotics in the last month. * previous bowel resection.

Keywords: folfox treatment
real-world clinical study for malignant tumor-induced cachexia

Conditions: Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia; Multicenter Observational Study

Summary: this study is a non-interventional, multicenter observational study, aiming to assess the clinical characteristics and treatment outcomes of malignant tumor cachexia. the study is mainly divided into two cohorts: retrospective cohort: this cohort focuses on patients who have already been diagnosed with cachexia before the initiation of this study. it involves the retrospective collection and analysis of clinical data. prospective cohort: this cohort includes patients who are diagnosed with cachexia after the start of this study. data will be prospectively collected and analyzed during their subsequent diagnosis and treatment process.


Eligibility criteria:
inclusion criteria: * aged 18 years or older (including 18 years). * malignant tumor confirmed by histology or cytology (both malignant solid tumors and malignant hematologic tumors are eligible for enrollment). * meeting the fearon diagnostic criteria for cachexia. * life expectancy of ≥2 months (for the prospective cohort only). * able to sign the informed consent form (waiver of informed consent for the retrospective cohort). exclusion criteria: retrospective cohort: * missing gender information. * missing date of birth or age information. * lack of any treatment or follow-up information after the date of meeting the diagnostic criteria for cachexia. prospective cohort: (patients with any of the following are not eligible for enrollment in this study) * patients who are unable to receive any treatment for any reason. * patients who cannot undergo at least one follow-up. * patients whom the investigator deems unsuitable for participation in this study.
magnetic resonance imaging in myocarditis

Conditions: Myocarditis

Summary: the purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different mr scanners

in patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is performed for definite diagnosis. in addition, patients undergo magnetic resonance imaging at 1.5 tesla and 3.0 tesla within 24 hours. the imaging protocol of both scan include assessment of myocardial edema respectively edema ratio; myocardial hyperemia respectively global relative enhancement (gre); myocardial fibrosis/necrosis respectively myocardial le and t1 and t2 mapping sentences. diagnostic performance of different imaging protocols as compared to the findings of endomyocardial biopsies is calculated. the protocol also includes a follow-up mr can at 3 months.

Eligibility criteria:
inclusion criteria: symptoms such as: * dyspnea or orthopnea or * palpitations or * exercise intolerance or * angina evidence of myocardial involvement: * ventricular dysfunction on echocardiography or * new or persistent ecg changes * elevated troponin t history of viral infection exclusion criteria: * contraindication for magnetic resonance imaging * impaired renal function: glomerular filtration rate ≤ 30 ml/min/m2 * patients presenting with pregnancy * patients without informed consent * participation in another trial.

Keywords: myocarditis, myocardial inflammation, imaging, magnetic resonance
the metabolite identification and material balance study of sp2086

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to investigate the metabolite identification and material balance of sp2086 in healthy adult volunteers.

all subjects were given sp2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Eligibility criteria:
inclusion criteria: * healthy volunteers with a body mass index(bmi) between 19 and 25 kg/m2,and weight ≥50kg. * lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible. * had signed the informed consent himself or herself voluntarily. exclusion criteria: * has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.). * has a history of allergy or intolerance to sp2086 or other dpp-iv. * the subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks. * did not take effective contraceptive measures or planning of the subjects in half a year. * researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.

Keywords: sp2086 metabolite identification material balance
a feasibility study for women receiving anthracycline chemotherapy with or without radiation for her2-neu positive invasive ductal carcinoma

Conditions: Breast Cancer

Summary: the purpose of this project is to assess the feasibility of collecting plasma samples for cardiac biomarker assessment, and to identify if there is an associations between the biomarkers, echocardiographic features and the cardiac pet scan results (in patients receiving radiation therapy). this is the first step in a research program that has an overall goal of being able to predict early-treatment induced cardiotoxicity in patients with breast cancer.


Eligibility criteria:
inclusion criteria: 1. stage i-iii, her2-neu positive invasive ductal carcinoma 2. scheduled to receive adjuvant/neo-adjuvant 5-fluorouracil, epirubicin, cyclophosphamide and docetaxel (fec-d) chemotherapy 3. scheduled to receive adjuvant trastuzumab 4. ecog performance status 0-2 5. adequate baseline imaging on transthoracic echocardiography, and baseline cardiac ejection fraction of ≥ 55%. additionally, breast cancer patients≥45 years of age and scheduled to receive whole breast radiation therapy will receive two cardiac pet scans. exclusion criteria: 1. prior anthracycline chemotherapy 2. history of dilated cardiomyopathy, congestive heart failure, or coronary artery disease 3. life expectancy less than 15 months 4. pregnant or lactating women 5. use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline. 6. previous chest wall/breast or nodal radiation.

Keywords: invasive ductal her2-neu positive
safety and efficiency of γδ t cell against non small lung cancer ( without egfr mutation)

Conditions: Lung Cancer

Summary: in this study, effects of γδt cells on human non small lung cancer ( without egfr mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

non small lung cancer will be removed using tumor reducing surgery such as cryosurgery. pbmc of the patient will be separated from peripheral blood. after making them potential cancer killer γδ t cell and dc-cik, they will be infused to the patients as immunotherapy.

Eligibility criteria:
inclusion criteria: 1. age:18-75 2. karnofsky performance status \>50 3. diagnosis with non small lung tumors based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ will receive cryosurgery, gd tcells/ dc-cik. 5. life expectancy: greater than 3 months 6. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other kinds of cancer 2. history of coagulation disorders or anemia 3. patients with heart disease and diabetes

Keywords: γδ t cell, non small lung cancer, without egfr mutation
stress echocardiography and heart computed tomography (ct) scan in emergency department patients with chest pain

Conditions: Chest Pain; Angina; Angina Pectoris; Coronary Artery Disease

Summary: the purpose of this study is to determine whether stress echocardiography or computed tomography (ct) of the heart is better at diagnosing emergency room chest pain patients to select appropriate candidates for hospitalization and further work-up.


Eligibility criteria:
inclusion criteria: * presentation to the emergency department with chest pain * low-to-intermediate risk of coronary disease per diamond-forrester criteria * free of known coronary artery disease exclusion criteria: * inability to undergo both stress echo or coronary ct for any reason * contraindication to intravenous iodinated contrast * dysrhythmia precluding ekg gating * heart rate greater than 60 with contraindication to beta blockers * administration of beta blockers within the last 12 hours * known severe cardiac valvular disease or pulmonary hypertension * stress echocardiography, coronary ct or catheterization within the last 6 months

Keywords: stress echocardiography coronary ct angiography
the effect of womb recordings on maturation of respiratory control in preterm infants

Conditions: Apnea of Prematurity; Intermittent Hypoxemia; Bradycardia

Summary: the aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.

the aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants. we hypothesize that exposure to appropriately designed womb-like sounds in the neonatal intensive care unit (nicu) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate. this proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. these sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.

Eligibility criteria:
inclusion criteria: * preterm infants 29-33 weeks gestational age at birth * 34 weeks corrected age * off respiratory support \>1.5 lpm exclusion criteria: * on respiratory support \>1.5 lpm * congenital anomalies

Keywords: apnea, intermittent hypoxemia, bradycardia, audio recording
multiparametric mri in evaluating cancer stage and helping treatment planning in patients with prostate cancer

Conditions: Prostate Carcinoma

Summary: this phase ii trial studies how well multiparametric magnetic resonance imaging (mri) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. multiparametric mri may be useful for evaluating the type of cancer in finding aggressive disease.

primary objectives: i. to estimate the diagnostic performance as quantified by the area under the roc curve to detect aggressive prostate cancer. ii. to develop a risk prediction model by incorporating overall pi-rads, psa, gleason score and clinical stage to predict the presence of aggressive prostate cancer. secondary objectives: i. to evaluate the diagnostic performance of the individual pi-rads score of each mri parameter (t2w, dwi and dce), as determined by local imaging review. tertiary objectives: i. all clinical data including magnetic resonance (mr) images will be banked for future exploratory research aims. outline: patients undergo mpmri within 3 months prior to schedule surgery. after completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.

Eligibility criteria:
inclusion criteria: * recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated exclusion criteria: * not suitable to undergo mri or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; mri-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice) * prior surgical and/or non-surgical treatment for prostate cancer * prior hip replacement or other major pelvic surgery
efficacy study of assiut femoral compression device versus manual compression in the achievement of hemostasis

Conditions: Common Femoral Artery Injury; Other Vascular Adverse Event

Summary: this study was performed to evaluate the safety and efficacy of a locally designed assiut femoral compression device (afcd) versus manual compression (mc). femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. their limited adoption reflects concerns of high cost and conflicting data regarding their safety

the intra-arterial sheaths were removed 6 hours after pci in the mc group according to the standard local protocols. however for afcd group, the sheaths were removed 2 hours after pci instead of conventional 6 hours. to standardize compression times, afcd were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure till distal pulse is palpated. each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.

Eligibility criteria:
inclusion criteria: * patients between 18 and 85 years of age, * scheduled to undergo an elective pci via arterial puncture of common femoral artery were eligible for enrollment in the study. * elective pci was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned pci or for a coronary angiogram followed by ad hoc pci. exclusion criteria: patients were excluded from the study if the patient has 1. any procedural complication included: * prolonged chest pain, * transient coronary artery closure, no-flow or slow-flow phenomenon, * hemodynamic instability, * persistent electrocardiographic changes, * side-branch occlusion of \>1.5 mm, or * an angiographically suboptimal result, 2. arterial access other than the right or left femoral artery , 3. vascular perforation, thrombosis during procedure , 4. patients with high risk of puncture site complications as: * bleeding diathesis, * international normalized ratio \>1.5, * recent thrombolysis, * low platelet count, * hematoma at the end of the procedure, * previous iliofemoral artery surgery or any peripheral vascular surgery, * previous femoral artery complication from angiography, and 5. uncontrolled hypertension at time of procedure (\>180/\>110).

Keywords: femoral compression device manual compression arterial hemostasis coronary intervention coronary artery disease
study of indacaterol dosed in the evening in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[fev1\]) over the full 24-h time period


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure * co-operative outpatients with a diagnosis of chronic obstructive pulmonary disease (copd) (moderate to severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2006) and: * smoking history of at least 20 pack years * post-bronchodilator fev1 \< 80% and ≥30% of the predicted normal value * post-bronchodilator fev1/forced vital capacity (fvc) \< 70% exclusion criteria: * pregnant or lactating females * patients who have been hospitalized for a copd exacerbation in the 6 weeks prior to visit 1 or during the run-in period * patients requiring long term oxygen therapy (\>15 h a day) * patient who have had a respiratory tract infection 6 weeks prior to v2 (with further criteria) * patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis * patients with history of asthma (with further criteria) * patients with type i or uncontrolled type ii diabetes. * patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality * any patient with active cancer or a history of cancer with less than 5 years disease free survival time * patient with a history with long qt syndrome or whose qtc interval is prolonged * patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure * patients who have had treatment with an investigational drug (with further criteria) * patients who have had live attenuated vaccination within 30 days prior to visit 2, or during run-in period * patients with known history of non compliance to medication * patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd, bronchodilator, long acting beta agonist, laba
immediate dentoalveolar restoration compared to bio-oss

Conditions: Fresh Sockets With Buccal Resorption

Summary: this randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. a total of 34 patients will be included and followed clinically and radiographically for 18 months. patient centred outcomes will also be evaluated.


Eligibility criteria:
inclusion criteria: * tooth extraction indicated for teeth in anterior area between second premolars exclusion criteria: * diabetes and other systemic conditions that may affect osseointegration

Keywords: immediate dentoalveolar restoration bio-oss immediate dental implant bovine bone