Kornimate/medical-research-clean huggingface dataset:
vdot for newly diagnosed pediatric asthma

Conditions: Asthma in Children

Summary: the goal of this research study is to compare the impact of video directly observed therapy on inhaler technique accuracy with participants receiving video directly observed therapy vs. participants receiving standard asthma care. participants will be randomized between the two groups. we will follow up and compare the two groups to see if they have improved asthma control as measured by symptom-free days (sfd), higher inhaler technique at 3-month follow up, higher checklist scores on a standardized inhaler technique checklist, higher proportion of days covered (pdc) of their inhaled asthma controller medication, and have fewer acute care visits for asthma.

emocha® was originally developed by researchers at the johns hopkins university school of medicine, the hipaa-compliant platform was commercialized in 2014. emocha® platform uses virtual communication tools (e.g. asynchronous video technology and secure 2-way messaging) to support and encourage adherence through timely feedback and positive reinforcement: helping users develop healthy behaviors and maintain high levels of medication adherence. the company leverages a public health practice called directly observed therapy (dot). dot is a center for disease control (cdc)-endorsed model of care that has been used by public health departments for decades to contain deadly infectious diseases. our overarching hypothesis is that compared to standard asthma medication education, vdot will improve accuracy of inhaler technique (primary aim) and improve clinical outcomes such as medication adherence and asthma symptoms among children newly referred to asthma specialty clinic or those with a new inhaled asthma medication inhaler type.

Eligibility criteria:
inclusion criteria: 1. age ≥ 6 and ≤ 11 years old 2. physician diagnosed persistent asthma (any severity) and verified by review of electronic medical record 3. new patient with a new prescription for inhaled preventive asthma medication referred to an asthma subspecialty clinic at arkansas children's or established patient in the asthma, allergy or pulmonary subspecialty clinic with a new prescription for inhaled preventive asthma medication. 4. regular access to wi-fi exclusion criteria: 1. significant underlying respiratory disease other than asthma such as cystic fibrosis 2. significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the ability to communicate via interactive video 3. current smoker 4. caregiver/patient does not have access to a smartphone compatible with the emocha® smartphone application 5. caregiver and patient speaks and understands english as their primary language.
efficacy and safety of pemigatinib in participants with solid tumors with fgfr mutations or translocations (fight-208)

Conditions: Advanced or Metastatic Solid Tumors; FGFR Mutations; FGFR Translocations

Summary: the purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating fgfr mutations or translocations.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (stage iiib or iv) or is surgically unresectable. * radiographically measurable disease (per recist v1.1 or rano for primary brain tumors). * documentation of an fgfr1-3 gene mutation or translocation. * objective disease progression after at least 1 prior therapy. * not eligible or able to participate in any other incyte-sponsored clinical trial. exclusion criteria: * advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma. * prior receipt of a selective fgfr inhibitor. * current evidence of clinically significant corneal or retinal disorder. * history of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.

Keywords: advanced solid tumor metastatic solid tumor fgfr inhibitor fgfr mutation fgfr translocation
identification of gene polymorphism in patients with sick sinus syndrome in chinese population in taiwan

Conditions: Sinus Arrhythmia

Summary: background: sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. however, the influence of gene polymorphisms on sinus node dysfunction was not well studied. methods: a group of 100 patients with documented sinus node dysfunction and 100 age- and sex- matched healthy control patients will be enrolled into this study. gene polymorphism study includes the angiotensin-i converting enzyme gene, angiotensin ii type 1 receptor gene, hcn1-4, scn5a, kcne and other possible gene polymorphisms which are related to sinus node function based on previous reports. genetic polymorphisms are identified with polymerase chain reaction-based restriction analysis. comparison of multiple haplotype analysis and single-locus analysis will be analyzed between the cases and controls. estimated results: some genetic polymorphisms of these genes which are related to sinus node function or rennin-angiotensin system will show association with sinus node dysfunction. in multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant difference between cases and controls. in single locus analysis, some genetic polymorphisms may be associated with sinus node dysfunction. estimated conclusion and clinical implication: this study will demonstrate the genetic polymorphisms in ras genes or some other genes associated with sinus node dysfunction. these results will support the roles of these genetic polymorphisms in determining the risk of sinus node dysfunction among the chinese population in taiwan.


Eligibility criteria:
inclusion criteria: 1. heart rate was less than 40/min or long pause more than 3 seconds in series ekg or 24-hour ekg. 2. sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study. exclusion criteria: 1. severe systemic disease. 2. acute coronary syndrome. 3. bradycardia with reversible cause.
study of amv564 in subjects with advanced solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors

Summary: this phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of amv564 alone and in combination with pembrolizumab in patients with advanced solid tumors.

amv564-301 is a phase 1, open-label, multicenter dose-escalation with expansion trial in patients with locally advanced or metastatic solid tumors. in the dose-escalation portion of the study, cohorts of patients will receive amv564 alone or in combination with pembrolizumab at increasing dose levels to determine the maximum tolerated dose (mtd) and/or the recommended dose for expansion. in the expansion portion of the study, one or more cohorts of patients will receive amv564 at the mtd or recommended dose to further evaluate safety, tolerability, and clinical activity.

Eligibility criteria:
key inclusion criteria: * 18 years of age or older * eastern cooperative oncology group (ecog) performance status ≤ 2 * histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists * measurable disease per response evaluation criteria in solid tumors (recist) v1.1 or per other criteria best suited for the specific tumor type being evaluated * willing to complete all scheduled visits and assessments at the institution administering therapy key exclusion criteria: * treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of amv564 * major trauma or major surgery within 4 weeks prior to first dose of amv564 * prior treatment with chimeric antigen receptor (car) t-cell therapy or t-cell engager therapy * chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of amv564 * adverse events from prior anti-cancer therapy that have not resolved to grade ≤ 1 except for alopecia * known, central nervous system (cns) disease involvement, or prior history of national cancer institute common toxicity criteria for adverse events (nci ctcae) grade ≥ 3 drug-related cns toxicity

Keywords: immunotherapy anti-cd33 t-cell engager
study of tongue strengthening for swallowing problems

Conditions: Dysphagia

Summary: this study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. one hundred male and female patients will take part in this study from eight participating facilities around the country.


Eligibility criteria:
inclusion criteria: * referral by a physician for swallowing evaluation because of suspected dysphagia * complaint of difficulty swallowing * aspiration or penetration of the laryngeal vestibule with liquids or semisolids or post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating slp during a standard clinical videofluoroscopic swallowing study * between the ages of 21 and 95 * ability to perform the exercise protocol independently or with the assistance of a caregiver * physician approval of medical stability to participate * decision-making capacity to provide informed consent (confirmed through discussion between the participating slp and the subject's primary physician) exclusion criteria: * degenerative neuromuscular disease * poorly controlled psychosis * patient unable to complete the exercise program * allergy to barium (used in videofluoroscopic swallowing assessment)

Keywords: deglutition exercise
measurement of digital colposcopy for fluorescence spectroscopy of cervical intraepithelial neoplasia

Conditions: Cervical Cancer

Summary: the overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy. other objectives: * to measure digital fluorescence and reflectance images in vivo of sites in the human cervix. * to evaluate the effect of acetic acid in the image contrast obtained. * compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.

dcf may provide a better way to detect or treat lesions of the cervix. women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (a colposcopy is an exam of the vagina and cervix using a magnifying lens). dcf will be done during the routine colposcopy in the outpatient clinic. a digital colposcope (dc) device will be used to take a sequence of images of the cervix and vagina. (a dc is a digital camera connected to the colposcope with a specialized light source. it will shine light on the cervix and acquire a sequence images). the images will tell doctors about the cells and structure of the tissue. after the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken. small samples of areas of abnormal tissue will be removed during colposcopy. taking these tissue samples is a routine part of this type of exam. if patients are having colposcopy and loop electrosurgical excision procedure (leep treatment, one sample of normal tissue will be taken. (the cervix will be numbed for this procedure.) dcf images will be compared with lab findings from these samples. before dcf is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing. this is an investigational study. about 114 women will take part in this study. about 22 will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: * women 18 and older with an abnormal pap exclusion criteria: * pregnant individuals will be excluded from this study

Keywords: digital colposcopy for fluorescence dcf fluorescence spectroscopy digital colposcopy dc cervical intraepithelial neoplasia cervical cancer cervix vagina lesions of the cervix precancerous lesions
the percutaneous transmural arterial bypass -1 study (post approval registry)

Conditions: Peripheral Arterial Disease; Symptomatic Femoropopliteal Lesions

Summary: the purpose of this post-market surveillance study will be to evaluate the real-world use of the detour system in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.

a maximum of 450 subjects will be enrolled with a target study population of at least 200 evaluable female and 200 evaluable male participants at the 12-month post-procedure follow-up visit. a maximum of 200 us sites. sites will be selected that participate or will participate in the vqi pvi registry. follow up visits/assessments will be completed at 1, 12, 24-, 36-, 48-, and 60-months post-procedure. study enrollment is expected to conclude over 4 years. follow up data at 1 year is expected to conclude in 5 years from enrollment, with 5-year follow up expected to conclude in 9 years from enrollment.

Eligibility criteria:
inclusion criteria: participants should be a candidate for the detour system as assessed by the treating physician after review of the clinical and anatomic indications for use. - exclusion criteria: there are no exclusion criteria. all cases entered in the registry at participating institutions will be included up through the targeted goals per the enrollment plan. -
study on the tolerance and efficacy of a new anti regurgitation formula

Conditions: Gastroesophageal Reflux

Summary: the aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.


Eligibility criteria:
inclusion criteria: infants : * aged ≤ 5 months old * fully formula fed * with at least 5 episodes of regurgitation per day exclusion criteria: * breast fed infants * infants presenting symptoms of a complicated gastroesophageal reflux * infants presenting intestinal disorders
evaluation of raltegravir plus maraviroc therapy in controlled hiv patients presenting with lipohypertrophy

Conditions: Human Immunodeficiency Virus; Lipohypertrophy

Summary: evaluation of antiretroviral therapy combining raltegravir and maraviroc in patients with virological success, presenting with clinical lipohypertrophy.

assess the ability to maintain the plasma hiv viral load below the threshold needed for detection (\< 50 copies/ml) at 24 weeks of raltegravir/maraviroc therapy without nrtis and pis, in patients with virological success and presenting with clinical lipohypertrophy.

Eligibility criteria:
inclusion criteria: * patients infected with hiv-1 type b or crf02. * ≥ 18 years old * patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months. * patients whose plasma viral load has been undetectable (below 200 copies/ml) over the last 24 months, and \< 50 copies/ml for at least 12 months. * patients with an r5\* tropic virus, as determined through dna and with cd4 nadir ≥ 100/mm3 * patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump). * patients who have never been treated with raltegravir. * patients who have never been treated with maraviroc. * efficient contraception for women * free and informed written consent, signed by the patient and the investigator. * patients with health insurance. \* to increase the certainty of selecting patients with an r5 virus, the hiv-1 tropism will be determined by the genotype method and interpreted with the geno2pheno\[coreceptor\] algorithm and a false positive rate threshold for x4 virus at 20%, rather than the usual 10%. exclusion criteria: * x4, x4/5 or undetermined tropism of the hiv virus. * hiv-2 or coinfection hiv-1/hiv-2. * chronic viral hepatitis b. * chronic viral hepatitis c requiring specific treatment over the first 24 weeks. * treatment with growth hormones. * hypolipemic or diabetes treatment, begun within the last 3 months. * pregnant or breastfeeding women. * haemoglobin \< 7g/dl, neutrophils \< 500/mm3, platelets \< 50 000/mm3, creatinine clearance \< 50 ml/min, alkaline phosphatases, asat, alat or bilirubin ≥ 3 times the upper limit of the normal range (n). * antiretroviral treatment associated to enzymatic inducer. * chronic alcohol consumption. * subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship. * subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.

Keywords: hiv lipohypertrophy
cardiac computarized tomography in infective endocarditis

Conditions: Infective Endocarditis

Summary: the diagnosis of infective endocarditis is based on the results of blood culture and findings on transeosophageal echocardiography. cardiac computarized tomography is a new modality, mainly used for the imaging of coronary arteries. its use in the diagnosis of infective endocarditis is not well known.the purpose of this study is to establish the use of cardiac ct in infective endocarditis.


Eligibility criteria:
inclusion criteria: * patients diagnosed with infective endocarditis exclusion criteria: * allergy to contrast agent
mapping health-related quality of life in pregnant women with thyroid disease.

Conditions: Thyroid Diseases; Pregnancy Related; Quality of Life

Summary: natural thyroid function changes during pregnancy. in up to tens of percent of pregnant women, these changes can lead to pathological fluctuations in hormone and antibody production. although the effects on pregnancy and child development are well described, none has determined their influence on mother's emotional well-being and the quality of life. at present, universal thyroid screening in pregnancy in the czech republic is not covered by health insurance. the aim of the project is to change this situation by providing quality of life estimate for the cost-effectiveness model. this is a project of three specialized institutions aimed at mapping various aspects of the quality of life of pregnant women and describing the impact of thyroid disease on their lives. the project is a parallel study to a larger project early screening for thyreopathy in pregnancy (cz.03.2.63/0.0/0.0/15_039/0009643) supported by the european fund operational programme employment through the national screening centre. the data will be collected through online questionnaire from women enrolled in the early screening for thyreopathy in pregnancy (cz.03.2.63/0.0/0.0/15_039/0009643) who were screened for tsh, tpoab and ft4.


Eligibility criteria:
inclusion criteria: * pregnant women * screened for laboratory signs of thyreopathy anytime during pregnancy * willing/able to participate in online survey exclusion criteria: * women whose laboratory results were not available or inconclusive * already participated in this survey by filling the online questionnaire * not able to complete the entire questionnaire

Keywords: quality of life eq5d thypro-39 pregnancy thyroid disease thyrotropin thyroxine thyroid autoantibodies
investigation of a new trial drug (fe200486) in prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of this trial was to find an optimal dose for a new trial drug - degarelix (fe200486) - in the treatment of prostate cancer. furthermore the safety of the drug was studied. patients participating were treated with fe200486 on one occasion. thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

degarelix was not fda regulated at the time of the trial. after completion of the trial degarelix has been approved by the fda and is thus an fda regulated intervention.

Eligibility criteria:
inclusion criteria: * written informed consent obtained before any trial related procedures * male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy * ecog score to be equal to or above 2 * testosterone level within age-specific normal range * psa value equal to or above 2 ng/ml * life expectancy of at least 6 months exclusion criteria: * previous or current hormonal treatment of prostate cancer * recent or current treatment with any drugs modifying the testosterone level * candidate for curative treatment such as prostatectomy or radiotherapy * history of severe asthma, anaphylactic reactions or quincke's oedema * hypersensitivity towards any component of fe200486 * cancer disease within the last ten years except for prostate cancer and some skin cancers * signs of liver impairment shown as elevated serum alt or serum bilirubin * other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results * presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. in addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator * mental incapacity or language barrier * having received an investigational product within the last 12 weeks preceding the trial * previous participation in this trial