Kornimate/medical-research-clean huggingface dataset:
phase iv clinical trial of nimotuzumab in the treatment of nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.

this clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs. subjects who meet the inclusion/exclusion criteria are administered of nimotuzumab based on medication instructions or adjusted by clinicians according to the treatment. in case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of nimotuzumab is stopped.

Eligibility criteria:
inclusion criteria: 1. patients with histologically or cytologically confirmed nasopharyngeal carcinoma 2. sex and age without limiting 3. treatment without limiting 4. subjects with reproductive potential (males and females) willing to use reliable means of contraception 5. able and willing to give written informed consent and comply with the requirements of the study protocol exclusion criteria: 1. patients with severe allergies or idiosyncratic constitution 2. women who are pregnant (determined by urine pregnancy test)or breast feeding 3. any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view
phase 2 study of kls-0611 in patients with dry eye syndromes

Conditions: Dry Eye Syndromes

Summary: to evaluate the efficacy and safety of kls-0611 compared to placebo in patients with dry eye syndromes.


Eligibility criteria:
inclusion criteria: * corneal and conjunctival damage * insufficiency of lacrimal secretion * ocular symptom exclusion criteria: * severe ophthalmic disorder * punctual plugs or surgery for occlusion of the lacrimal puncta

Keywords: dry eye syndromes corneal diseases conjunctival diseases
comparison of nebulizers vs metered-dose inhalers with spacer device for treatment of childhood wheeze

Conditions: Childhood Asthma With Acute Exacerbation

Summary: the goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. the main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze children will be divided in two groups using block randomization method. children in group a will be nebulizer group, treatment will consist of 3 puffs of a placebo mdi with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 ml of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 l/min. for patients in group b spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol mdi with a spacer, followed by 3 ml of nebulized isotonic sodium chloride solution. all treatments will be given at 20-minute intervals. for administration of the mdi, the investigator will dispense i puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. this process will b-e repeated for a total of 3 puffs per treatment. all patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.


Eligibility criteria:
inclusion criteria: patients aged 6 to 24 months * patients of both gender * patients presenting to emergency department with bilateral wheeze exclusion criteria: patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia). * patients with history of congenital heart disease. * patients with history of intubation for longer than 1 week during the neonatal period. * patients having symptoms consistent with croup. * patients with signs of impending respiratory failure i.e pulmonary index score of 12.
a safety study of the auditory brainstem implant for pediatric profoundly deaf patients

Conditions: Profound Bilateral Deafness Due to; Bilateral Cochlear Aplasia; Bilateral Cochlear Nerve Deficiency; Bilateral Cochlear Ossification Secondary to Meningitis

Summary: current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. an auditory brainstem implant (abi) places an electrode close to the auditory nucleus in the brainstem. children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an abi and followed for 1 year for safety and a total of 3 years for preliminary efficacy. this is a feasibility study to determine the safety of the abi.


Eligibility criteria:
inclusion criteria: * bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis * if previously received a cochlear implant, must demonstrate lack of benefit from that device exclusion criteria: * medical contraindication to craniotomy/intracranial surgery * severe cognitive or developmental delays

Keywords: deafness congenital pediatric device
a pilot trial to determine the efficacy of vsl#3 for reducing colonization by vre

Conditions: Anti-biotic Resistance

Summary: the purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, vsl#3 versus oral placebo for reducing colonization by vre.

healthcare-associated infections are an important threat to patient safety. currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the united states, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as vancomycin-resistant enterococcus (vre), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential. eradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. no effective means of eradicating vre intestinal colonization exist. probiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as vre.

Eligibility criteria:
inclusion criteria: * subjects will be male or female * 18 years of age or older * may or may not be hospitalized * able to take oral medications * have been found to be colonized with vre or at high risk of being colonized by vre and are not taking antibiotics exclusion criteria: * people on antibiotics will not be eligible to participate

Keywords: infection probiotics
groceries plus multi-component lifestyle intervention for adults with hypertension and type 2 diabetes

Conditions: Hypertension; Type 2 Diabetes Mellitus (T2DM)

Summary: people with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. research studies suggest that these nutrients can lower blood pressure and blood sugar. this study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. the dash-life research study will recruit adults with hypertension and type 2 diabetes who live in baltimore metro areas that don't have many stores selling healthy foods. the dash-life research study is 6 months long. participants will be randomly assigned to one of two groups: 1) self-shopping dash (s-dash) diet advice group, or 2) coaching dash (c-dash) diet advice group.


Eligibility criteria:
inclusion criteria: * age 18 years or older * diabetes mellitus type 2 defined by: self-reported type 2 diabetes diagnosis, or hba1c\>=6.5%, or treatment of diabetes with diabetes medications(s) * baseline systolic bp 120-159 mmhg (with or without medications.) * serum potassium level \>3.0 and \<5 mmol/l, * estimated glomerular filtration rate (egfr) \>=45 ml/min/1.73m2. * willing and able to complete required procedures in english. * living in healthy food priority area in baltimore; the us department of agriculture (usda) defined low income, low access areas, or census blocks with area deprivation index (adi) 60 and above (state decile\>=6.) exclusion criteria: * hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months * cardiovascular event within 6 months * on diabetes or weight loss medications such as glucagon-like peptide 1 (glp-1), glp-1/glucose-dependent insulin-releasing peptide (gip), insulin, or any combination of these medications * hba1c ≥ 10% * type 1 diabetes * baseline systolic bp \< 100 mmhg * weight \>400 lbs due to the maximum weight on study scale * chronic disease that might interfere with trial participation * current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures * current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets) * unwillingness or inability to adopt a dash-like diet * planning to leave area in the next 6 months

Keywords: hypertension type 2 diabetes diet
a comprehensive disease management program for medically-complex substance users

Conditions: Substance-related Disorder

Summary: disease management (dm) programs are being increasingly utilized by health plans to coordinate care, improve quality of care, and control costs in chronically ill individuals. dm programs for specific medical conditions, such as diabetes mellitus, congestive heart failure, and asthma, have demonstrated improvements in health outcomes and a number of studies have found economic benefits to these programs as well. there are fewer data evaluating multi-disease dm programs, and results have been mixed. additionally, data on such programs specifically targeting substance-using populations are limited, although they are promising. prior utilization and hospitalization data from johns hopkins hospital, johns hopkins health care, and priority partners managed care organization (ppmco) suggest that a substantial portion of high-utilizing, high-cost, medically complex patients have a substance use diagnosis. the investigators hypothesize that a comprehensive dm program for medically-complex substance users with a history of hospitalization, consisting of intensive nurse case management along with behavioral incentives to reinforce engagement in primary care, can decrease inpatient days and costs, as well as improve outcomes for substance use, depression, and physical and mental functioning. the investigators will compare the case management/behavioral incentives intervention to usual care among a group of medically-complex, substance-using, ppmco enrollees. usual care will include access to all existing priority partners care management programs, and usual the investigators believe that this research will make an important contribution to the development of models of chronic care that improve health and promote the best use of health care resources. additionally, the investigators believe this project will promote the study and development of systems to improve the health of substance-using adults, an underserved and often marginalized group.


Eligibility criteria:
inclusion criteria: * age over 18 * continuous enrollment in priority partners mco for past 12 months * primary care site east baltimore medical center (ebmc) * ppmco substance abuse flag other than nicotine only within past 24 months exclusion criteria: * currently enrolled in ppmco care management

Keywords: disease management substance use disorders behavioral incentives
application of electrical impedance myography (eim) as a potential biomarker of idiopathic inflammatory myopathies

Conditions: Idiopathic Inflammatory Myopathies

Summary: 1. to assess changes in impedance parameters in idiopathic inflammatory myopathies (iims). 2. to assess whether eim parameters are reflective of disease severity, based on clinical outcome measures of iims.

1. to assess changes in impedance parameters in idiopathic inflammatory myopathies (iims) there are structural and compositional changes in muscles, such as edema, adipose infiltration, and/or atrophy, in iims. electrical impedance myography (eim) is sensitive to such changes. eim parameters will be different when compared to healthy controls in iims. 2. to assess whether eim parameters are reflective of disease severity, based on clinical outcome measures of iims. clinical outcome measures reflect on disease severity which is an indirect measure of muscle involvement in iims. if eim parameters correlate with clinical outcome measure, it would indirectly prove that eim can reflect disease severity in iims

Eligibility criteria:
inclusion criteria: * duration of weakness \>12 months. * ages 18 to 80 years old. * serum ck level no greater than 15 times the upper limit of normal. * quadriceps weakness \>hip flexor weakness and/or finger flexor weakness \>shoulder abduction weakness. * one or more of the following pathological findings: * endomysial inflammatory infiltrate. * rimmed vacuoles. * protein accumulation or 15-18 mm filaments. dm/pm inclusion criteria: * ages 18 to 80 * symmetric proximal weakness * elevated ck * emg suggestive of myopathy with evidence of muscle membrane irritation * muscle biopsy suggestive of inflammatory myositis (degeneration, regeneration, necrosis, and interstitial mononuclear infiltrates) * typical skin rashes of dm (heliotrope rash or gottron sign) key inclusion criteria for the control group: * no active neuromuscular disorders or known history of neuromuscular disorders. * no sign or symptoms of muscle weakness. * no family history of muscular dystrophies or als. * ages 18 to 80 exclusion criteria: * patients with decompensated congestive heart failure * patients with chronic kidney disease on hemodialysis * patients with active cancer on chemotherapy or radiotherapy * patients with severe disease who are already wheel chair bound
a european registry study to prospectively observe treatment patterns and outcomes in participants with human epidermal growth factor receptor 2 (her2)-positive unresectable locally advanced (la) or metastatic breast cancer (mbc) (samantha)

Conditions: Breast Cancer

Summary: this disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with her2-positive unresectable la/mbc. diagnosis of unresectable la or mbc can be up to 6 months old prior to registry enrollment.


Eligibility criteria:
inclusion criteria: - initially diagnosed with her2-positive unresectable la/mbc no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time exclusion criteria: - not applicable
pvc response ''atrial pace'' inducing atrial tachycardias

Conditions: Atrial Tachycardia

Summary: premature ventricular contractions (pvc) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia. in response certain abbott (former st jude medical) pacemakers have a specific pvc response algorithm ''atrial pace''. in this algorithm the pvarp (post ventricular atrial refractory period) is extended to 480ms but the initial 150ms of the pvarp is deemed absolute. if atrial sensed event occurs after absolute pvarp the pvarp terminates and atrial pace follows after 330ms alert period. two case reports exists where patients atrial tachycardia were suspected to be induced by this algorithm. in helsinki university hospital an index patient with multiple atrial tachycardia episodes was recognized in late 2020 where the cause of the tachycardias was suspected to be the pvc response algorithm ''atrial pace''. after programming the algorithm from atrial pace to off mode the patient had none atrial tachycardias during 2021. after investigating all the patients with physiological icd (implantable cardioverter defibrillator) or crt-d (cardiac resynchronization therapy) device and analyzing remote monitoring transmissions from the year 2020 we found 25 patients with similar atrial tachycardia episodes possibly induced by the pvc response ''atrial pace''.

the device of the subjects participating to the study is interrogated and the pvc response algorithm is switched from ''atrial pace'' to ''off'' mode. subjects are also requested to fulfill the eq-5d-3l and icd8 questionaries before the change in the device programming and after the 12 months surveillance.

Eligibility criteria:
inclusion criteria: * st jude medical or abbott physiological icd or crt-d device * pvc response setting ''atrial pace'' * atrial tachycardia episode duration \> 30s preceded by ventricular extrasystole and atrial pace in year 2020 or 2021 exclusion criteria: * permanent atrial fibrillation, duration ≥ 6 months before the enrollment to the study * pvc response has been switched off before enrollment

Keywords: premature ventricular complex pacemaker arrythmia
mesenchymal stem cells for treatment of amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of als.

a single patient safety study for harvesting, expanding ex vivo and injecting autologous mesenchymal stem cells (msc's) into the subarachnoid space of a patient with amyotrophic lateral sclerosis (als). cells will be isolated from adipose tissue by subcutaneous biopsy and expanded using an fda-approved protocol. they will then be injected by lumbar puncture into the cerebrospinal fluid. injection will be completed in the in- patient clinical research unit (cru). the patient will be followed for two years.

Eligibility criteria:
inclusion criteria: * age greater than 18 years, if female, must be menopausal or had hysterectomy * resident and citizen of the united states * history of a chronic onset of a progressive motor weakness * able to comply with protocol requirements * can provide written consent exclusion criteria: * does not have renal disease (creatine \> 2.0) * does not have active systemic disease * does not have any clinically significant abnormalities on prestudy laboratory evaluation * does not have any clinically significant medical condition (e.g.,within 6 months of baseline, had a myocardial infarct, angina pectoris, and/or congestive heart failure), that in the opinion of the investigator, would compromise the safety of the patient * does not have a history of cancer including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion,or re-occurrence within 3 years of baseline). * has not used an investigational drug within 30 days of baseline visit * does not have a tracheostomy * does not have a beck's depression inventory score \>16
the jiaxing birth cohort in china

Conditions: Childhood Obesity; Anemia; Pregnancy Complications; Pregnancy; Hypertension; Feeding Behavior

Summary: the jiaxing birth cohort (jbc) is the largest prospective cohort study to explore prenatal risk factors, early life feeding practice and growth pattern/ adiposity in chinese children.between 1999 and 2013, 338 413 mother-child pairs were recruited in jiaxing area in south-east china.children of the recruited women were followed up at 1-2, 3, 6, 9 and 12 months of age, and subsequently followed up every 6 months to 36 months of age (toddler stage), and every year to 6-7 years of age before they went to school (pre-school stage). follow-up rate was 70.8% at the toddler stage and 68.9% at the pre-school stage up to june 2013.


Eligibility criteria:
inclusion criteria: 1. pregnant women came to clinic visit at one of the local hospitals during pregnancy at jiaxing area 2. pregnant women were followed up during pregnancy and their children were born alive at local hospital or clinics exclusion criteria: 1. those who did not want to participant 2. the infant was dead at the birth 3. those pregnant mothers who dropped out during follow-up at pregnancy or moved out of the jiaxing area
safety evaluation of sericin-chitosan cream in healthy volunteers

Conditions: Pressure Sore; Safety Issues

Summary: a prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.

a prospective, randomized, active-controlled clinical trial was conducted to initially evaluate safety of sericin-chitosan cream in comparison with a commercially available cream containing dimethicone for pressure sore treatment in healthy volunteers. the results of this study provided preliminary safety profile of sericin-chitosan cream before conducting the further clinical trial in specific population (pateints with early-stage pressure sore).

Eligibility criteria:
inclusion criteria: * healthy volunteers at the age of 20 - 65 years * voluntarily sign inform consent exclusion criteria: * diagnosed with chronic skin conditions (e g. eczema and psoriasis) and immunocompromised diseases * allergic to silk sericin and chitosan, and dimethicone * received immunosuppressive therapy, antihistamine, and corticosteroid drugs two weeks before study enrollment.
dc vaccine combined with cik cells in patients with renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the aim of this phase i/ii study is to evaluate the safety and efficacy of dendritic cells (dc) vaccine combined with cytokine-induced killer (cik) cells in patients with renal cell carcinoma. experimental recombinant adenovirus-transfected dc, which engineered to express muc1 and survivin are used for dc-based immunotherapy. based on the results of our previously performed preclinical study with dc vaccine combined with cik cells, the investigators plan to perform the clinical trial.


Eligibility criteria:
inclusion criteria: * age \>18 years at time of consent * histopathologically confirmed diagnosis of renal cell carcinoma * received standardized treatment of renal cell carcinoma * interval between the last standardized treatment and dc/cik treatment ≥ 4weeks * kps (karnofsky performance scale) \>60 * patient's written informed consent * predicted survival \>3 months * no severe viral or bacterial infections exclusion criteria: * receiving chemotherapy, radiotherapy or other therapy * patients with other malignancies and infectious diseases * pregnant and breast-feeding patient * currently participating in another clinical trial * unfit for participating in this clinical trial in investigators' opinions