Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy of an amino acid based formula in infants

Conditions: Cow's Milk Allergy

Summary: this clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.


Eligibility criteria:
inclusion criteria: * weight loss within the past 4 weeks * infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks * birth weight greater than or equal to 1500 grams * solely enteral fed * infants with at least one persistent allergy symptom * no change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study * signed informed consent exclusion criteria: * history of underlying condition which, in the investigator's opinion, could interfere with normal growth, development, or assessment of the participant * metabolic disease requiring special attention
use of betashot in children and adults with epilepsy

Conditions: Nervous System Disorder

Summary: in brief, this research is a prospective, feasibility study to evaluate the use of betashot- a medium chain triglyceride- based (mct) food for special medical purposes (fsmp) in children and adults diagnosed with epilepsy. mct is a type of dietary fat used in the ketogenic diet.

this study aims to explore the use of betashot in a group of children and adults with epilepsy who are consuming their normal diets, but limiting intakes of foods high in carbohydrate and sugars. the participants will be required to drink betashot to enable the following assessment: 1. tolerance (side effects such as bloating or cramps) 2. acceptability (flavour, texture, taste) 3. compliance (how easy it is to use betashot at the advised quantity, as part of their daily diet)

Eligibility criteria:
inclusion criteria: 1. children aged 3-18 years with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication, either with a diagnosis of dravet syndrome or another early onset epilepsy, the result of a genetic mutation. adults (aged over 18) with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication. 2. participant/parent/guardian to comply with the study protocol and participate in active monitoring of tolerance, acceptability and compliance of betashot via a written record, and to complete questionnaires. exclusion criteria: 1. children \< 3 years of age 2. children and adults free from epilepsy for \> 4 weeks 3. medical conditions that contra-indicate the use of mct 4. inability to comply with the study protocol. 5. currently on a ketogenic diet 6. children and adults who are totally enterally fed. 7. females who are pregnant or planning to become pregnant during the study.
lateral supramalleolar perforator flap reconstruction through branches outside of the ankle tissue defects

Conditions: Ankle Tissue Injury Wound

Summary: the lateral ankle is a common site of tissue defects and the defects in this area are often accompanied by exposure of the fibula and tendons. microsurgical tissue transfer or a pedicled flap is needed to cover those exposures for even a relatively small defect due to the insufficiency of the local cutaneous and muscle flap in this area. koshima et al. and wei et al. began to propose the concept of localized perforator flaps, which were initially applied to free perforator flaps. the main benefits of such localized perforator flaps are described below. 1. it preserves vital blood vessels and the underlying muscles and fascia. 2. complications in the donor area are rare and can be direct or partial sutures. 3. not technically demanding, although we need to find the vessel but not the vessel junction. 4. shorter surgery time. there are many choices of perforator flaps for lateral ankle soft tissue defects, including lateral upper ankle flap, retrograde anterior tibial artery flap, retrograde gastrocnemius flap, etc. among them, the lateral upper ankle flap is one of the flaps commonly used for reconstruction of lateral ankle tissue defects, and the research on the lateral upper peroneal artery perforator flap is limited.

the purpose of this study is to evaluate the clinical application of the peroneal artery perforator flap with or without split-thickness skin grafting for soft tissue reconstruction of the bony defect of the lateral malleolus of the ankle joints. reconstruction using a peroneal artery perforator flap with or without split-thickness skin grafting was performed for 10 men and 5 women patients with defects in the lateral malleolus. the mean age was 53.7 years with the age range between 22 and 89 years, and the mean size of the flaps was 40 cm\^2. the soft tissue defects were caused by a diabetic foot (6 patients), infected bursitis (1 patient), chronic osteomyelitis (2 patients), and trauma (6 patients). three of six diabetes mellitus patients also had peripheral arterial occlusive disease. the flaps were elevated in the form of a perforator flap, and split-thickness skin grafting was performed over the flaps and adjoining raw areas. the pedicled supramalleolar perforator flap is classified into two categories: (a) propeller and (b) rotation flaps. the mean follow-up duration was 30 months postsurgical.

Eligibility criteria:
inclusion criteria: * the subject is aged 20 years old or above (including 20 years old), regardless of gender. * patients with lateral ankle tissue defects exclusion criteria: * the subject is aged under 20 years old. * patients with tissue metabolic disorders, immune dysfunction, and drug abuse. * patients with severe primary diseases or mental illness such as those involving the hematopoietic system, endocrine system, etc. * pregnant and lactating women. * patient who is unwilling or unable to cooperate with the trial process or follow medical advice.
retrospective study of the effectiveness and safety of niacin and steroid eye drops for retinal vein occlusions

Conditions: Central Retinal Vein Occlusion; Branch Retinal Vein Occlusion

Summary: the aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (kenalog) injections. the types of retinal vien occlusion that are being studied include central (cvro), hemi-retinal (hrvo),and branch (brvo) retinal vein occlusion. niacin, (nicotinic acid, not nicotinamide) a b-vitamin, has lipid lowering and vasodilating properties. the combination of niacin and prednisolone acetate steroid eye drops as a non-invasive treatment approach was developed by the principal investigator. the niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. the prednisolone acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the niacin is taking effect.

a spontaneous improvement was noted in some patients who were experiencing deteriorating retinal vein occlusions. a chart review and questioning of the patients revealed that the addition of niacin by the internist seemed to be the factor that was bringing about the vision improvement. the niacin has vasodilating properties, and it is postulated that as the niacin dilates the retinal vessels, it will encourage earlier collateral vessel formation that will bypass the venous obstruction, and restore venous outflow. the prednisolone steroid eye drops will hopefully reduce the macular edema in the eye. this is a retrospective study conducted by chart review of up to 45 patients who have undergone treatment with 1500 mg per day of oral niacin (nicotinic acid) with or without topical steroid eye drops, prednisolone acetate (pred forte) for the treatment of retinal vein occlusion central (crvo), hemi-retinal (hrvo), branch (brvo). the retrospective chart review of patients seen by dr. michael gaynon will go back to 1998 and will continue through the present time. all patients with vision impairment caused by deteriorating retinal vein occlusion, and who were or will be prescribed the niacin with or without pred forte treatment will be included.

Eligibility criteria:
inclusion criteria: * patients must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion. exclusion criteria: * patients with active gout or high levels of uric acid.

Keywords: crvo hrvo brvo
phase 2 study on the pharmacokinetics and safety of rlyb212 in pregnant women at higher risk for hpa-1a alloimmunization

Conditions: Fetal and Neonatal Alloimmune Thrombocytopenia

Summary: the purpose of this phase 2 study is to assess the pharmacokinetics (pk) and safety of rlyb212 in hpa-1b/b pregnant women at higher risk for hpa-1a alloimmunization and fnait.

this study is a single-arm, open-label, multicenter study of rlyb212 in hpa-1b/b pregnant participants at higher risk for the occurrence of hpa-1a alloimmunization and fnait. a laboratory testing paradigm will be applied at screening to identify women at higher risk for hpa-1a alloimmunization. study ipa2202 is comprised of three phases: a two-part screening phase, an antenatal treatment phase, and a postpartum follow-up phase. study duration for each participant is anticipated to be \~44 weeks, inclusive of the screening visits through the week 10 postpartum visit.

Eligibility criteria:
inclusion criteria: pregnant women who present at gestational week 6 or after and confirmed to be: hpa-1b/b (hpa-1a negative), hla-drb3\*01:01 positive, anti-hpa-1a alloantibody negative, carrying an hpa-1a/b (hpa-1a positive) fetus exclusion criteria: * prior history of hpa-1a related fetal and neonatal alloimmune thrombocytopenia * multiple pregnancy (more than 1 fetus) * prior history of platelet transfusion or other blood transfusions * known sensitivity and/or immediate hypersensitivity to any components of rlyb212 or its formulation * any co-morbid medical or obstetric condition(s), laboratory abnormality, concomitant treatment, or other reason that, in the investigator's opinion, could adversely affect the safety of the participant and/or fetus, impair the assessment of study results, or preclude compliance with the study
genomic signatures to predict treatment response

Conditions: Breast Neoplasms

Summary: a genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based chemotherapy as neoadjuvant treatment. the primary aim of this study is to prospectively evaluate the microarray-based, genomic test as a predictor of axillary lymph node response. also, to determine whether the probability of achieving negative axillary nodes, is sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to support omitting axillary dissection.


Eligibility criteria:
inclusion criteria: * clinical status of lymph nodes must be available * sonographical status of lymph nodes must be available * patients must consent to documentation of cancer treatment * histologic diagnosis of invasive breast cancer, clinical stage t1-4, m0 (non-inflammatory t4c) * patients scheduled for neoadjuvant chemotherapy * treatment with a 3-weekly fec or ac regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel. * local her2 status of tumor biopsy must be negative. exclusion criteria: * the patient has a prior history of invasive or metastatic breast cancer. * the patient had prior excisional biopsy of the primary invasive breast cancer. * the patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer. * the patient cannot safely or feasibly undergo biopsy of the primary tumor. * the patient has a diagnosis of stage iv (distant metastatic) breast cancer. * the patient has proven her2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.
the usage of high-resolution magnetic resonance imaging in patients with post-stroke aphasia for predicting the outcome

Conditions: Aphasia

Summary: combined analysis of functional and structural language network changes may be a good model for predicting language outcome.

background \& objectives: language impairment after aphasic stroke is both common and debilitating. however the mechanisms of language recovery after aphasic stroke is not fully understood. investigators plan to detect the changes of functional and structural language networks after aphasic stroke by high-resolution mri.then combined analyse functional and structural language network changes, establishing a prediction model for language outcome. methods: the proposed study is a observational trial that will include 50 patients diagnosed with post stroke aphasia from the neurology clinics at the first affiliated hospital, zhejiang university. aphasia battery of chinese(abc) and functional magnetic resonance imaging (mri) will be performed at acute(\~2weeks),subacute(3 months) and chronic phase(6months). only routine drug therapy will be used. relevance: currently there is little known about the recovery mechanisms of post-stroke aphasia.the proposed study intends to analyse functional and structural language network changes by high resolution mri, which may reveal the potential recovery mechanism underlying post stroke aphasia..

Eligibility criteria:
inclusion criteria: * healthy right-handed native chinese speakers with more than 6-year education are recruited as healthy controls. exclusion criteria: * not right-handed; * any use of psychoactive drugs; * less than 6-year education; * not suitable for mri scan.

Keywords: resting-state dti aphasia stroke
pcp in immunocompromised population in southern china

Conditions: Immunocompromised Patients; Pneumocystis Pneumonia; Diagnosis; Polymerase Chain Reaction

Summary: to evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in southern china.

pneumocystis jirovecii pneumonia (pjp) is a serious opportunistic infection in immunocompromised patients, with a difficult diagnosis, rapid progression and high mortality rate. the pjp mortality rate is high among patients with delayed diagnosis and treatment, and death is due to severe respiratory failure. up to now, data regarding pneumocystis jirovecii infection in immunocompromised patients is limited. in the present prospective study, the investigators aimed to evaluate the sensitivity and specificity of the combined detection system for the diagnosis of pneumocystis infection in immunocompromised population in southern china.

Eligibility criteria:
inclusion criteria: 1. patients with immunocompromised conditions, including but not limited to hiv infection, long-term systemic use of corticosteroids, use of immunosuppressive agents, hematologic malignancies, solid tumors, hematopoietic stem cell transplantation, solid organ transplantation, radiotherapy and/or chemotherapy for malignancies,primary immunodeficiency disease. 2. patients with typical clinical manifestations of pjp such as fever,nonproductive cough, shortness of breath, and progressive hypoxemia. 3. patients with radiological abnormalities suggestive to pjp in bilateral lungs revealed by chest computed tomography (ct). 4. respiratory tract samples were collected for qpcr and/or mngs detection. exclusion criteria: 1. patients who were unable to obtain a respiratory specimen. 2. medical record was incomplete.

Keywords: pneumocystis pneumonia immunocompromised patients polymerase chain reaction treatment
efficacy of topical capsaicin on chronic neck pain

Conditions: Chronic Neck Pain

Summary: the purpose of this study is to determine whether topical capsaicin patch can effectively reduce chronic neck pain.

* design: this is a double-blind, randomized, controlled study. participants: sixty participants with chronic neck pain are recruited and randomly assigned to two groups. * intervention: over an four-week period, the treatment group (n=30) uses capsaicin patch (100 mcg/3cc) at the tender point of neck for 12 hours a day; the control group (n=30) receives hydrogel patch instead of capsaicin patch.

Eligibility criteria:
inclusion criteria: * korean participants with chronic neck pain are enrolled in our study exclusion criteria: * participants with coagulation deficiencies, infections, hypertension, diabetes, heart disease, renal disease, liver disease, cancer, myelopathy, hypersensitivity of drugs, other skeletomuscular disease, allergic response to capsaicin, pregnancy and nursing are excluded

Keywords: neck pain capsaicin dermal patch
assessment of the durability of cardioneuroablation using physiological indices of heart rate reactivity

Conditions: Syncope, Vasovagal, Neurally-Mediated

Summary: cardioneuroablation is a novel treatment option for reflex-mediated syncope. it involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. we aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.


Eligibility criteria:
inclusion criteria: * signed informed consent * sinus rhythm * clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope exclusion criteria: * pregnancy * known atropine hypersensitivity
evaluation of the safety & effectiveness of the bausch & lomb akreos® tl intraocular lens

Conditions: Cataract; Aphakia

Summary: this study is to evaluate the safety and effectiveness of the bausch \& lomb akreos tl (thin lens) intraocular lens (iol) following implantation in adults requiring cataract surgery.


Eligibility criteria:
inclusion criteria: * subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. * subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction. * subjects must require a lens power from 15 to 30 diopters. * subjects must have a visual potential of 20/40 or better in the study eye. exclusion criteria: * subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. * subjects with any inflammation or edema (swelling) of the cornea. * subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension. * subjects with previous retinal detachment. * subjects with diabetic retinopathy (proliferative or non-proliferative). * subjects with rubella, bilateral congenital, traumatic, or complicated cataract. * subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery. * subjects who have already received an akreos tl iol in the fellow eye.
drug-drug interaction study between edp-305, intraconazole and rifampin in healthy volunteers

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a non-randomized, 2-part, open-label, drug-drug interaction (ddi) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of edp-305 in healthy human volunteers.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * female subjects must be of non-childbearing potential. exclusion criteria: * clinically relevant evidence or history of illness or disease. * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * participation in a clinical trial within 30 days prior to the first dose of study drug.

Keywords: drug-drug interaction
the use of an "anal-tape" in patients with fecal incontinence

Conditions: Fecal Incontinence

Summary: fecal incontinence (fi), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. the negative impact on quality of life has been consistently demonstrated. the prevalence of fi is probably underestimated in most studies. currently conservative treatment is only modestly effective and surgical treatment is complex and expensive with less than optimal efficacy. the investigators developed an "anal tape" using a commercially available elastic band with a special adhesive that is approved for use in the skin. a special design of the tape can be applied to the skin surrounding the anus providing support and additional pressure forces to the anal sphincter. this is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and safety of this device in patients with fi. the primary endpoint will be improvement in quality of life.


Eligibility criteria:
inclusion criteria: * \>18 years old * fecal incontinence for more than 6 months * willing to participate * understand the study procedures * is able to apply and remove the "anal tape" without significant assistance of others. * have done sigmoidsocopy or colonoscopy and anal manometry within five year of screening visit exclusion criteria: * advanced full thickness rectal prolapse. * injured, inflamed or any significant disease in the peri-anal skin. * allergy to any component of the device, either known or developed during testing in the screening visit. * moderate to severe proctitis of any etiology.