Kornimate/medical-research-clean huggingface dataset:
granulocyte-colony stimulating factor (g-csf) as optimizing therapy for pediatric liver transplantation

Conditions: Liver Cirrhosis; Severe Malnutrition; PELD; Undernutrition

Summary: this study compares the effect of human recombinant granulocyte-colony stimulating factor (g-csf) in pediatric patients with liver cirrhosis with a control group. the study aims to observe improvement of (pediatric end-stage liver disease) peld score and nutritional status prior to liver transplantation procedure. in addition to the intervention, standard treatments for liver cirrhosis are also given for both groups. g-csf is administered for 12 times. condition of disease: pediatric patient aged 3 months to 12 years old liver cirrhosis undernourished / severe malnutrition peld score 10-25 intervention: drug: recombinant human g-csf phase: phase 3

this open-label randomized control trial conducted in cipto mangunkusumo hospital, jakarta, indonesia, aimed to determine the effect of g-csf to improve peld score and nutritional status of pediatric patients with liver cirrhosis prior to liver transplantation. a total of 52 pediatric patients with liver cirrhosis, malnutrition and peld score between 10-25 will be collected and divided into intervention group and control group. the intervention group will be given a subcutaneous injection of g-csf 5μg/kg/day for 5 days consecutively, followed by a single dose every 3 days up to 12 times throughout the trial. additionally, both the intervention and control group receive standard liver cirrhosis treatment. randomization is done using block randomization. the patients will be clinically monitored and evaluated for anthropometric changes (body weight, mid-arm circumference, mid-arm muscle circumference, and triceps skinfold thickness), complete blood count, absolute neutrophil count, liver function tests, cytokines (il-10, tnf-α), procalcitonin, hepatocyte growth factor (hgf), cd34+ cell count and peld score (albumin, bilirubin, prothrombin and international normalized ratio values). data analysis will be performed using ibm spss statistics version 20.0.0.

Eligibility criteria:
inclusion criteria: * age between 3 months to 12 years old * conscious state * without the presence of fever (temperature: \<37,5°c) * decompensated liver cirrhosis * liver cirrhosis due to various etiology * undernourished or severe malnutrition * peld score between 10-25 exclusion criteria: * malignancy (liver origin or other types) * history of undergoing any organ transplantation procedure * acute liver failure * failure of any organ other than the liver * encephalopathy * severe infection such as bacterial peritonitis and pneumonia
optimizing vibrational therapy to improve gait and balance in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this research study is to test the safety, tolerability, and the effect of vibration (delivered by an experimental device called pdvibe2) on freezing of gait (fog) in persons with parkinson's disease (pd). the pdvibe2 was developed by resonate forward, llc (rf). this pdvibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with pd while wearing the device.

enrolled patients with parkinson's disease, hoehn and yahr stage 2, will be randomized to receive either vibration or no vibration and then will be crossed over to receive the opposite intervention. the study will consist of two treatment periods of two days followed by a washout period of 2 weeks. each treatment period will consist of four treatments within 2 days, no more than 2 sessions in one day. patients will participate in an additional day for screening and another for follow-up (6 days total). all visits will occur at the virginia commonwealth university parkinson's movement and disorders center in richmond, va. participants will be asked to walk for a brief period of time while wearing the pdvibe2. the pdvibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. participants will be asked to provide feedback on the device, the therapy session, and how they are feeling.

Eligibility criteria:
inclusion criteria: * age 21 years or older * pd diagnosed by a movement disorder specialist for 3 months or longer prior to recruitment * pd medication regimen is stable over the last 3 months with no changes * hoehn \& yahr stage 2 (n = 13) * able to walk independently or with a simple assistive device (e.g., cane, walker) * observed by the research team to have pd related gait disturbance such as fog, shortened or irregular stride lengths, irregular step cadence, slowed speed while on their regular treatment regimen. exclusion criteria: * diagnosed with a known parkinson plus syndrome * were previously exposed to vibration treatment for gait and balance * presence of dementia (montreal cognitive assessment \< 21) * additional disorders (not related to pd)impairing gait, stance, balance or coordination (e.g. stroke, leg amputations, or multiple sclerosis) * history of implantable cardiac device or any other implanted electronic device except a deep brain stimulator (dbs) * use of braces/orthotics that assist with walking * are currently in physical therapy (pt) treatment for balance or gait * peripheral neuropathy by exam * any condition that, in the opinion of the pis, would compromise participant safety, data integrity, or data interpretation. * children under the age of 18 * prisoners * women who are pregnant or may become pregnant during the course of this study since the safety of this device for an unborn child is unknown.

Keywords: gait balance
reversal of botulinum neurotoxin injection related dysphonia with pyridostigmine

Conditions: Dysphonia, Spastic; Dysphonia; Laryngeal Dystonia

Summary: the purpose of this study is to evaluate the effects of pyridostigmine (mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (bont) injections, which is a standard treatment for spasmodic dysphonia. pyridostigmine (mestinon) has been used for treatment of bont overdose, and it is our hope that it will be beneficial in the management of post bont breathy phase.

the study will enroll 10 subjects and will involve 1 clinic visit with two sessions over 2 hours. participants' voices will then be analyzed via sentence/passage reading, sustained vowel holding, maximum phonation time, as well as subjective ratings of effort. during the second clinic visit, participants will then be administered one 60mg tablet of pyridostigmine (mestinon) orally, and asked to return to the clinic in 2 hours, when mestinon has reached peak plasma concentration. upon returning, participants will repeat the vocal analysis and results will be evaluated for any change in outcome. patients who are pregnant, lactating, or have kidney or heart disease should not participate.

Eligibility criteria:
inclusion criteria: * males and females aged 21-100 * scheduled for botulinum neurotoxin (bont) treatment for spasmodic dysphonia (sd) exclusion criteria: * subjects who are pregnant or lactating * subjects with compromised renal or cardiac function * subjects with spasmodic dysphonia with superimposed vocal tremor

Keywords: pyridostigmine dysphonia spasmodic dysphonia mestinon botulinum neurotoxin
a study to assess covid-19 vaccination immune response in multiple sclerosis patients treated with ofatumumab

Conditions: Multiple Sclerosis

Summary: this was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.


Eligibility criteria:
inclusion criteria: * aged at least 18 years of age upon receipt of first covid-19 vaccination. * fully vaccinated with any fda-authorized covid-19 vaccination. * diagnosed with ms. * receiving ofatumumab at the time of either (or both) of the following: 1. initial covid-19 vaccination. 2. booster vaccination. * had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following: 1. full covid-19 vaccination course. 2. booster vaccine (among patients receiving ofatumumab at the time of the booster). exclusion criteria: * received treatment with monoclonal antibodies to treat or prevent covid-19 at any time between the first covid-19 vaccination to within 6 months of the last covid-19 vaccination (booster-inclusive).
painless local infiltration anesthesia

Conditions: Varicose Veins; Pain; Surgery; Anesthesia

Summary: the purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2% mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local infiltration anesthesia, during ambulatory phlebectomy procedures.

the use of local anesthesia by infiltration (lia), usually prepared with 1% lidocaine or mepivacaine 2%, in combination with epinephrine and diluted with saline solution, it's commonly performed in ambulatory phlebectomy procedures. although this kind of anesthesia is among the most effective and safe available, the infiltration of local anesthetic is accompanied by pain in the majority of patients. this can be particularly important in ambulatory phlebectomy procedures, where large areas need to be anesthetized. numerous methods have been proposed to alleviate the pain associated with lia, such as reducing the rate of administration or warming the anesthetic solution. sodium bicarbonate added in small concentrations, can also be effective in reducing significantly the pain associated with lia. a recent trial has confirmed the viability and effectiveness of a solution of lidocaine 1% diluted in sodium bicarbonate 1.4%, in varicose vein surgery. the purpose of this study is to evaluate the effectiveness in alleviating the pain associated with lia, of a solution of mepivacaine 2%+epinephrine diluted with sodium bicarbonate 1.4%, compared with an analogous solution diluted with normal saline.

Eligibility criteria:
inclusion criteria: * patients undergoing ambulatory phlebectomy exclusion criteria: * allergy to amide anesthetics * sinoatrial node disease or any degree of atrio-ventricular block * acute diseases * chronic kidney or liver disease * treatment with drugs that alter pain sensitivity (e.g. analgesics) * treatment with monoamine oxidase inhibitors or tricyclic antidepressants * major psychiatric disorders according to dsm iv-tr diagnostic criteria * alcohol abuse actual or recent as described in dsm iv-tr

Keywords: varicose veins phlebectomy local anesthesia
enbrel® in psoriatic arthritis

Conditions: Psoriasis

Summary: this study is testing the effect of etanercept in treating both the skin and joint symptoms of psoriatic arthritis patients. enbrel®, also known as etanercept, has already been approved by the federal food drug administration for the treatment of psoriatic arthritis. it is taken as an injection under the skin. participants in the trial will be offered etanercept free of charge to be self-injected once weekly for 24 weeks. during that period they will have 5 appointments at the study center and will also be asked to complete assessments of their health.


Eligibility criteria:
individuals may be eligible to enroll in this study if they suffer from psoriasis (covering at least 10% of the body), and: - have had two or more swollen, tender or painful joints for at least 3 months or: - have lower back pain which your physician has diagnosed as sacroiliitis or spondylitis in one or more joints or: - have been diagnosed with active psoriatic arthritis

Keywords: psoriasis arthritis enbrel® etanercept
therapeutic effect of methalazine on 27 cases of suppurative hidradenitis

Conditions: Hidradenitis Suppurativa

Summary: background: hidradenitis suppurativa (hs) is a chronic inflammatory relapsing disease involving the axillae, breast ,groin and anogenital regions. the therapies of the disease are diverse, including medication and surgery. however, responses to treatments are variable and relapse is common, with no single agent being consistently effective. objective: to evaluate the efficacy and safety of oral mesalazine treatment for hidradenitis suppurativa . methods: investigators reported a series of cases of patients who received oral mesalazine(1g qid) for hidradenitis suppurativa in our institution between may 2020 and september 2023. a total of 27 patients, 22 in the mild to moderate group and 5 in the severe group, were included in this study.


Eligibility criteria:
inclusion criteria: * recurrent painful or suppurative lesions * typical clinical manifestations: the distribution of apocrine sweat glands is deep in painful nodules, abscesses, sinuses, scars; exclusion criteria: * severe neurological and psychiatric diseases * tumor diseases * pregnant women in lactation period
(viii): the eight study and immunologic response sub-study

Conditions: Vaccine Reaction

Summary: the study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ecg, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. in the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and t-cell responses.


Eligibility criteria:
inclusion criteria: * is 18 years of age or older. * is able to speak and read english. * plan to receive either the moderna or pfizer vaccine (mrna vaccine). * no known prior covid-19 infection. exclusion criteria: * known allergy to the adhesive used on the vitalpatch.
the construction of precision medicine in chinese medicine

Conditions: Hypertension

Summary: "precise medicine" is also called "personal medicine". with the development of big data database, genetic testing and artificial intelligence, the concept of precision medicine has been applied to the diagnosis, treatment and prevention of different diseases. traditional chinese medicine (tcm) has traditionally emphasis on personalized medicine, according to each person's body constitution, through discriminatory treatment and personalized treatment methods. chinese medicine doctors collect patients' information to distinguish the type of tcm pattern, and then according to the different types of diagnosis of traditional chinese medicine to decide of using herbs, acupuncture, massage and other treatment strategies. however, lacking of objective data of traditional chinese medicine, the current research on precision medicine in chinese medicine is still limited. the aim of this study is to establish a big database of traditional chinese precision medicine, and use the patients with hypertension as the population to conduct research on precision medicine in chinese medicine.this study will combine the tcm body constitutional questionnaire, tongue diagnosis, pulse diagnosis, chinese medicine immunoassay and genetic testing. in addition, the information providing by the medical electronic medical record system of china medical university hospital will be connected, which include modern medical diagnosis, treatment, blood and biochemical analysis and imaging. we will combine the big data analysis and artificial intelligence interpretation technology to explore the correlation between different tcm syndrome types and gene variations in patients with hypertension and establish a database of tcm precision medicine. we will also conduct the education training and symposium to train tcm precision medical talents and promote public understanding of tcm precision medicine. this project will establish a database of traditional chinese medicine precision medicine to provide the correlation between different tcm pattern types of patients with hypertension, the reaction to different herbal medicine, and gene mutation, and provide reference for tcm clinicians.


Eligibility criteria:
inclusion criteria: 1. primary hypertension 2. older than 20 year-old exclusion criteria: 1. past history of cancer 2. hemodialysis 3. hypertension caused by renal diseases or endocrine disorders 4. pregnancy 5. patients can not received investigation of body constitution, tcm tongue examination and pulse examination

Keywords: traditional chinese precision medicine chinese medicine immunoassay body constitution genetic variation
diamond af post-approval study

Conditions: Paroxysmal Atrial Fibrillation

Summary: the diamond af post approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial

the diamond af pas is a prospective, global, multi-center, non-randomized, single-arm observational trial. this post approval study is a condition of the pre-market approval order (p200028/s002) by the u.s. food and drug administration." the purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the diamondtemp™ ablation system. to assess clinical performance and safety of the diamondtemp™ ablation system, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. additionally, study objectives will characterize the ablation procedure, change in qol through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (ae) through 36 months.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of recurrent symptomatic paroxysmal af 2. failure or intolerance of at least one class i or iii antiarrhythmic drug (including sotalol) 3. patient is ≥ 18 years of age 4. planned procedure for the treatment of af using commercially available diamondtemp™ ablation system 5. patient is willing and able to provide written informed consent 6. patient is willing and able to comply with study requirements exclusion criteria: 1. prior persistent af (continuous af that is sustained \>7 days) 2. patient with life expectancy that makes it unlikely 36 months of follow-up will be completed. 3. current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by medtronic 4. patients with contraindications to a holter monitor 5. unwilling or unable to comply fully with study procedures and follow-up
pelvic vein quantitative flow characterization using 2d and 4d flow mri

Conditions: May-Thurner Syndrome; Iliac Venous Compression

Summary: the purpose of the study is to quantitatively characterize the flow in the pelvic venous structures using 2d and 4d flow mri with the objective of establishing physiologic and pathologic parameters for downstream computational fluid dynamics analysis. arm 1: to establish the baseline flow characteristics of the iliac veins in patients with no imaging evidence of iliac venous disease. arm 2: to assess the flow characteristics of the iliac veins in patients with left iliac vein compression syndrome (a.k.a. may-thurner syndrome). arm 3: to assess the flow characteristics of the iliac veins in patients status post iliac stent placement.


Eligibility criteria:
arm 1: inclusion criteria: • no self-reported history of pelvic or iliac venous disease or associated symptoms exclusion criteria: * history of pelvic or iliac venous disease or intervention * contraindication to mri examination * prisoners * subjects ≤ 18 years of age * pregnant women * adults unable to provide informed consent arm 2: inclusion criteria: • clinical symptoms or imaging findings compatible with left iliac vein compression syndrome exclusion criteria: * history of pelvic or iliac venous intervention * contraindication to mri examination * prisoners * subjects ≤ 18 years of age * pregnant women * adults unable to provide informed consent arm 3: inclusion criteria: • history of left iliac vein stent placement exclusion criteria: * contraindication to mri examination * prisoners * subjects ≤ 18 years of age * pregnant women * adults unable to provide informed consent

Keywords: may-thurner syndrome iliac venous disease
comparative effectiveness of targeted therapy in ra patients

Conditions: Rheumatoid Arthritis

Summary: the objective of a multicenter prospective observational study is to compare effectiveness and safety of biologic disease-modifying antirheumatic drugs and small molecular inhibitors in patients with moderately to severely active rheumatoid arthritis patients who have had an inadequate response or intolerace to methotrexate.

this study is a multicenter prospective observational study to show non-inferiority of clinical efficacy for small molecular inhibitors after 48 week of treatment to biologic disease modifying anti-rheumatic drugs (bdmards) in patients having moderately to severely active ra and who have been intolerant to conventional synthetic disease modifying anti-rheumatic drugs (csdmards) including methotrexate. primary end point is a percentage of participants of achieving low disease activity according to disease activity score in 28 joints-erythrocyte sedientation rate (das28-esr) at weeks 24. a total of 506 ra patients will be included, and allocated in ratio of 1:1 to bdmard group and small molecule inhibitor group. group allocation is determined by shared-decision making, so that the number of participants could be re-assessed according to recruitment status of participatns.

Eligibility criteria:
inclusion criteria: patients are included in this study if they are: * 19 years or olders * patients who satisfy the 1987 american college of rheumatology (acr) or 2010 american college of rheumatology/european league against rheumatism (acr/eular) classification criteria for ra * patients having moderately to severely active ra who are intolerant to csdmards including methotrexate and those who have never been exposed to bdmards or small molecular inhibitors before * patients who provide written consent to participate in this study exclusion criteria: * patients who are contraindicated to bdmards or small molecule inhibitor * patients who have plans for pregnancy or elective surgery * patients who had ever diagnosed with any malignancy or are treated for malginancy * patients who cannot voluntarily provie a written consent to participate in this study * patients who did not provide a written consent to participate in this study

Keywords: arthritis arthritis, rheumatoid joint diseases musculoskeletal diseases