Kornimate/medical-research-clean huggingface dataset:
adch63 me-trap and mva me-trap malaria vaccines evaluation in healthy children in a malaria endemic area

Conditions: Malaria

Summary: infants in malaria-endemic regions of africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. the purpose of this trial is to assess the safety and immunogenicity of mva me-trap and adch63 me-trap candidate vaccines in healthy children in a malaria endemic region. the regimen proposed here has protected non-immune volunteers in oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the gambia. administration of adch63 me-trap and mva me-trap to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the gambian epi.


Eligibility criteria:
inclusion criteria: * healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents. exclusion criteria: * clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. * severe malnutrition. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, kathon, neomycin, betapropiolactone. * history of splenectomy haemoglobin less than 8.0 g/dl, where judged to be clinically significant in the opinion of the investigator * serum creatinine concentration greater than 70 mol/l, where judged to be clinically significant in the opinion of the investigator * serum alt concentration greater than 45 u/l, where judged to be clinically significant in the opinion of the investigator * blood transfusion within one month of enrollment. * history of vaccination with previous experimental malaria vaccines. -administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the imps current participation in another clinical trial, or within 12 weeks of this study. * any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial. * likelihood of travel away from the study area * maternal hiv infection positive malaria antigen test at screening * failure to have received, prior to enrollment, the routine epi vaccinations due according to the gambian epi schedule.

Keywords: immune response
to evaluate the efficacy and safety of jw0201 added on in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: a multicenter, randomized, double-blind, placebo-controlled, parallel, phase ⅲ study to evaluate the efficacy and safety of jw0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with c2202 and c2203

a multicenter, randomized, double-blind, placebo-controlled, parallel, phase ⅲ study

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * type 1 diabetes mellitus * the subject not meet the specified hba1c and fpg
clinical trial to evaluate the efficacy and safety in nasolabial fold after rhytidectomy using non-absorbable mesh

Conditions: Nasolabial Fold

Summary: the aim of this study is to evaluate the efficacy and safety of the investigational device, rpm,non-absorbable polypropylene mesh made by d med, in correction of nasolabial fold. study hypothesis * level of significance: alpha=0.05( two-side) * power of test: (power= 1-beta),power=0.08 * h0: p equals p0 * h1: p unequals p0 * the difference between the changes in the wsrs(wrinkle severity rating scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( p-p0= 0.237)

1. benefits * enhancing self-satisfaction and quality of life by improving skin elasticity and correcting folds in the nasolabial fold area 2. risks * erythema, swelling, pain and redness in the facial area generally resolve in 1 week 3.duration of study * entire duration: approximate 36weeks * follow-up period: 7 weeks * enrollment period: 12 weeks 4. study design * 2 step operation process * first step- insert polypropylene mesh under the skin * second step- pull the polypropylene mesh 3 weeks later

Eligibility criteria:
inclusion criteria: * subjects who had soft tissue sagging around nasolabial fold * female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as wrinkle severity rating scale(wsrs) * subjects who voluntary decided to participate in the study and signed the informed consent exclusion criteria: * subjects who have a skin disease on the face * subjects who have severe facial skin disease * subjects who are constantly taking anti-coagulants including aspirin * subjects who have too thin or thick skin * subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease * subjects who had an allergy to non-absorbable material. * subjects who are taking immune suppressants * general weakness status * pregnant or lactating women * subjects who have an asthma, cancer, aids, cystic fibrosis, immobility cilia syndrome, leukopenia, immunoglobulin deficiency, active infectious disease, serious liver or renal disease, * subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, softform®)on the face * subjects who participated in other clinical trial within 30 days from screening

Keywords: non-absorbable polypropylene mesh wsrs rhytidectomy
chalazion conservative treatment trial

Conditions: Chalazion Unspecified Eye, Unspecified Eyelid; Chalazion Left Eye, Unspecified Eyelid; Chalazion Right Eye, Unspecified Eyelid; Chalazion Both Eyes

Summary: an eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). this leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. the chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. there are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. there have been no clinical trials to compare the efficacy of any of these conservative treatments. we wish to determine the most effective conservative medical treatment for chalazia.


Eligibility criteria:
inclusion criteria * patients age 18 and above * patient with a palpable chalazion on any eyelid * patients with multiple chalazia but only a single one on each lid * normal lid anatomy enabling lid eversion exclusion criteria * patients with chalazia with atypical features (recurring chalazion, abnormal surrounding lid tissue, associated loss of lashes) that may indicate suspicion of malignancy * patients allergic to any agents being used in the study (tobramycin, dexamethasone) * patients who have had previous eyelid surgery to the same eyelid as the chalazion * patients under 18 years of age * patients without palpable lid chalazion * patients with multiple chalazia on one eyelid * patients with concurrent eyelid infection (cellulitis or conjunctivitis) * patients unable to give consent
subanalysis in patients with cardiolaminopathy enrolled to report-ccm registry

Conditions: Laminopathy; Lamin A/C Gene Mutation; Heart Failure

Summary: observational, retrospective registry with acute and chronic endpoints

this registry includes patients who have undergone ccm device implant and due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, with lmna-dcm etiology for to assess the impact on ccm therapy in term of improvemente of qol and reduction hf hospitalizations

Eligibility criteria:
inclusion criteria: * male or non-pregnant female, aged 18 or older; * chronic heart failure with symptomatic left ventricular systolic function (nyha class ii-iva) with or without device already implanted (for example aicd, pace-maker); * appropriate and optimized medical therapy; * patient signed and dated informed consent form at enrollment; * life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis exclusion criteria: * absence of venous access available for implant; * contraindication to the interventional procedure of ccm device implant (for example presence of mechanical tricuspid vale); * pregnant patients

Keywords: heart failure cardiac contyractility modulation quality of life
vitalflow healthy volunteer study

Conditions: Normal Subject / Healthy Volunteers

Summary: find the stimulation threshold of the facial nerve (ganglion geniculate) associated with tolerability and safety in subjects healthy humans.

magnetic stimulation of the facial nerve (geniculate ganglion) in humans can induce changes in cerebral blood flow safely, without generating adverse effects unknown to the technique. our specific objectives: 1. perform tolerability and safety tests of magnetic stimulation on the facial nerve. 2. establish the optimal stimulation threshold associated with tolerability in order to apply it to the final design of the magnetic stimulation (ms) system. 3. measure whether the threshold found shows any increase in cerebral perfusion in the subject with respect to their baseline.

Eligibility criteria:
inclusion criteria: * healthy subjects * normal audiometry chart (evaluated at the time of your inclusion). * normal neurological examination at time of inclusion. exclusion criteria: * subjects with a diagnosis of epilepsy, seizures, facial nerve palsy, migraine or recurrent headaches, glaucoma or neuropathies. * subjects in breastfeeding or in pregnancy. (to be confirmed with test strip). * subjects with acute or acute chronic medical conditions. * age less than 20 years or greater than 40 years. * carotid surgery. * episodes of syncope. * known arteriosclerosis anywhere on the body * metal implants (cochlear implants, pacemakers, metal prostheses). * intracranial abnormalities observed by mri or mra (evaluated at time of inclusion of the subject). * intraocular pressure\> 22mmhg (evaluated at time of inclusion of the subject)

Keywords: facial nerve magnetic stimulation cerebral blood flow
nitroglycerin prevents radial artery occlusion

Conditions: Injury of Radial Artery

Summary: trans-radial approach (tra) has becoming popular and widely adopted over the last decade. however, radial artery occlusion (rao) continues to be one of the limitation of trans-radial access and potentially limits the radial artery as an access site in the future. several strategies have been used to decrease the incidence of rao including the use of anticoagulation, maintenance of patency during hemostasis, or shortening the duration of compression. currently, there is no data whether vasoactive pharmacological therapy such as nitroglycerin administered intra-arterially at the end of the procedure may reduce the incidence of rao. it is hypothesized that the addition of nitroglycerin (nitric oxide donor) at the end of a tra procedure may reduce the incidence of rao.


Eligibility criteria:
inclusion criteria: * sequential patients undergoing trans-radial catheterization in the institution will be consented to be randomized to receive either 500 microgram nitroglycerin (group a) or a placebo (group b) administered intra-arterially through the sheath at the end of the procedure. exclusion criteria: * patients with cardiogenic shock or hemodynamically unstable * unable to tolerate nitrates

Keywords: nitroglycerin radial artery occlusion transradial catheterization
simplification from tenofovir plus lamivudine or emtricitabine plus ritonavir-boosted-protease inhibitor to ritonavir-boosted-atazanavir plus lamivudine in virologically-suppressed-hivinfected adults with osteopenia

Conditions: Human Immunodeficiency Virus

Summary: a 48-week, open label, non comparative prospective trial in stable chronic human immunodeficiency virus-infected patients having achieved complete virological suppression for more than 24 weeks (human immunodeficiency virus-1 rna \<50 c/ml) switching from an antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted protease inhibitor to boosted atazanavir and lamivudine study visits will take place at screening, baseline, weeks 4, 12, 24, and 48.


Eligibility criteria:
inclusion criteria: * human immunodeficiency virus-1-infected subjects with age ≥18 years old * hip or spine t-scores between \ -2.5 by dual-energy x-ray absorptiometry (in the previous 24 weeks) * stable antiretroviral treatment based on tenofovir and lamivudine or emtricitabine and boosted protease inhibitor for at least 24 weeks. * having plasma human immunodeficiency virus-1 rna \<50 copies/ml for at least the previous 24 weeks, including at least two samples. exclusion criteria: * pregnancy, breast-feeding status or plans for pregnancy in the short term * primary genotypic resistance mutations and/or previous virological failures to atazanavir or lamivudine/emtricitabine * chronic hepatitis b infection * patients with indication for therapy for the prevention of bone fractures * 25-oh vitamin d deficiency (\< 10ng/ml) * hypogonadism (low total testosterone according to local reference range) * hypothyroidism (low t4 and increased thyroid stimulating hormone levels according to local reference ranges) * hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges) * having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more) * using anti-resorptive therapy (calcium and vitamin d supplements are encouraged but not mandated) * body mass index lower than 19
real-world study on long-term treatment with yisaipu for fujian ra patients

Conditions: Rheumatoid Arthritis

Summary: through real-world observation, understanding clinical efficacy and safety of treatment with yisaipu (etanercept biosimilar) for ra patients of fujian province for three years

this is a multi-center, prospective, real-world observational study. patients who have completed 6 months of induction therapy (yisaipu 50mg / week ± csdmards) and achieved clinical remission or low disease activity will be observed for 2.5 years. during the maintenance period, through full communication between doctors and patients, yisaipu 50 mg/wk or yisaipu 25 mg/wk will be chosen as maintenance treatment. the clinical efficacy evaluation parameters include das28, haq-di, modified sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of yisaipu due to adverse events. exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of interstitial lung disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.

Eligibility criteria:
inclusion criteria: inclusion criteria: * meet the acr revised ra classification criteria(2010); * disease duration is more than or equal to 6 weeks; * das28-crp\>2.6; * patient is eligible for tnf inhibitors treatment according to the judgment of the attending doctor in clinical practice; * a written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure. exclusion criteria: exclusion criteria: * patient has contraindication(s) to the use of fusion-protein type of tnf inhibitor; * patient is participating in other ongoing drug clinical trials; * patient whose ltbi screening result is positive, or had not received standard anti-tb treatment for tb history, is unwilling to take prophylactic treatment for tb; * patient with hbv infection and positive for hbv replication (not up to active replication) is not willing to receive anti-hbv treatment; * anti-hcv antibody is positive and hcv-rna is positive, and patient is unwilling to start anti-hcv treatment; * other reasons the researchers think the patient is not eligible for participation in the study.

Keywords: clincal remission; low disease activity
eswt on human gingival fibroblasts

Conditions: Periodontal Attachment Loss

Summary: the idea of treating different deformities or diseases in the maxillofacial region with extracorporeal shockwave therapy (eswt) has recently become popular. shockwave therapy was first introduced in germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis. the present study 'application of extracorporeal shock wave therapy on human gingival derived fibroblasts in-vitro study' was done to explore and evaluate the effect of shockwaves. further, these cells were assessed for cell - cell interaction and cell viability. in this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for control group and the remaining 10 samples were considered as test group. extracorporeal shockwave was applied to the test samples. they were further analysed

background: improved understanding of human biology at the molecular level, scientific and technologic advances are emerging aspects in dentistry. the idea of treating different deformities or diseases in the maxillofacial region with extracorporeal shockwave therapy (eswt) has recently become popular. shockwave therapy was first introduced in germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis. aim: the present study 'application of extracorporeal shock wave therapy on human gingival tissue derived fibroblasts in-vitro study' was done to explore and evaluate the effect of shockwaves. further, fibroblast cells were assessed for cell - cell interaction and cell viability. materials and methods: in this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for control group and the remaining 10 samples were considered as test group. extracorporeal shockwave was applied to the test samples. they were further analysed using wound scratch assay which was used to assess cell proliferative rate and scratch closure through live imaging. mtt assay and atp assay was used to determine cell viability after exposure to shockwaves.

Eligibility criteria:
inclusion criteria: * viable human gingival fibroblast * healthy gingival tissue exclusion criteria: * contaminated samples

Keywords: cell culture eswt cell proliferation cell viability
acute regulation of parathyroid hormone by dietary phosphate

Conditions: Secondary Hyperparathyroidism

Summary: patients with end stage renal disease often have secondary hyperparathyroidism due to high phosphorus and low calcium levels in the blood. preliminary animal studies and our initial human study indicate that the parathyroid hormone levels may change quickly based on the ingestion of phosphorus, prior to any change in the blood levels of calcium or phosphorus. this follow-up study will attempt to determine if the effect is independent of an increase in the blood glucose level. if so, this would suggest an as yet unidentified gastrointestinal receptor that mediates parathyroid hormone levels. this may affect the timing of administration and the type of phosphate binder used in treating patients with secondary hyperparathyroidism. the knowledge that parathyroid hormone levels can change acutely may also affect the recommended timing of blood samples

this study is observational and no drugs or other interventions will be used. the population targeted in this study will be adult patients already on chronic hemodialysis with a diagnosis of secondary hyperparathyroidism. experimental design will involve the use of a glucose clamp to maintain a constant, mild increase in blood glucose levels. frequent, scheduled lab tests will be obtained during the period of hyperglycemia to evaluate phosphorous, calcium, and glucose levels and the relationship of any change in their values to changes in the parathyroid hormone level. the primary outcome will be to evaluate for any change in the parathyroid hormone level in the presence of hyperglycemia and to compare these results to that of our initial study

Eligibility criteria:
1. patients 21 years of age or older 2. receiving treatment with hemodialysis for at least 90 days. 3. serum parathyroid hormone level greater than 200 pg/ml 4. serum phosphorus level greater than 4 mg/dl
change in symptom clusters in hnc patients

Conditions: Neoplasms, Head and Neck

Summary: head and neck cancer (hnc) is the sixth most common malignancy worldwide, causing more than 379,000 deaths in 2015 notwithstanding the breakthrough in cancer screening and medical treatment. the primary treatment for hnc is a combination of surgery and radiotherapy, either delivered preoperatively or postoperatively. although these treatments, especially the postoperative radiotherapy can greatly improve the survival of patients, they still have to pay a high price for numerous symptoms induced by radiation. on the other hand, research on symptoms clusters is an emerging field in oncology which aims to understand the complexity of multiple symptoms experienced by cancer patients. a thorough understanding of symptom clusters help informs the development of comprehensive care plans which target a group of symptoms that is likely to coexist, thus easing the total symptom burden in cancer patients.to date, there has been a paucity of evidence regarding symptom clusters of hnc. to address the gap in existing literature, this study described the symptom clusters among hnc patients who were treated with surgery with a combination of postoperative radiotherapy. in addition, a longitudinal approach was employed to examine the change in symptom clusters throughout the treatment course.


Eligibility criteria:
inclusion criteria: * newly diagnosed with hnc, * aged older than 18 years, * without receiving any radiotherapy prior to surgery, * no cognitive impairment and able to communicate in mandarin or taiwanese exclusion criteria: - undergoing any concurrent treatment for cancer.

Keywords: head and neck cancer, symptom cluster, change, radiotherapy
the use of naltrexone hydrochloride to promote healing in patients with resistant non-infectious corneal ulcer

Conditions: Cornea Ulcer

Summary: the opioid growth factor-receptor antagonist-naltrexone hydrochloride (ntx)- has gained much reach interest for applications in ophthalmology, because of its novel mechanism of action for speeding up corneal wound healing in both diabetics and non-diabetics, effective both locally and systemically and its availability as a low molecular weight synthetic drug.

corneal epithelial defects generally heal within 2 days without complications, in some patients with decreased corneal sensitivity, such as patients with severe dry eye, corneal neuropathy, or autoimmune diseases, the corneal epithelium shows a reduced tendency for spontaneous healing resistant corneal ulcers may appear as epithelial defects associated to bowman's layer disruption with associated damage and partial variable loss of superficial corneal stroma larger than 2 mm in diameter that persist more than 2 weeks even treated with conventional treatment . noninfectious corneal ulcers have a similar clinical presentation like that of infectious ulcers but with no known infectious cause . resistant corneal ulcer can lead to serious complications such as infection, inflammation, corneal scarring, opacification, corneal thinning, and perforation . in our study ntx accelerated healing of resistant corneal ulcers that was refractory to conventional treatment with lubricant eye drops and was safe with no complications reported in all treated eyes.

Eligibility criteria:
inclusion criteria: * refractory non infective corneal ulcer exclusion criteria: * infection