Kornimate/medical-research-clean huggingface dataset:
om202jp clinical study of knp2002

Conditions: Common Wart

Summary: the goal of this clinical trial is to evaluate safety and efficacy of knp2002 in patients with common warts aged 15 to 50 years old.


Eligibility criteria:
inclusion criteria: * subjects aged 15 to 49 years old * subjects with common warts on the upper or lower limb * subjects who agree to contraception from obtaining consent to 4 weeks after the end of administration * subjects who have given their voluntary written consent to participate in this clinical trial exclusion criteria: * subjects with 5 or more warts on the upper or lower limbs * subjects who are scheduled to undergo treatment such as physical therapy or chemotherapy for warts * subjects with a history of allergy to topical skin preparations * subjects with a history of malignant tumor within 5 years before administration of study drug * subjects with any of the following diseases: malignant tumor; serious heart disease; poorly controlled diabetes/hypertension * women who are pregnant, may become pregnant, or are breastfeeding

Keywords: common wart
cd4-zeta gene modified t cells with and without exogenous interleukin-2 (il-2) in hiv patients

Conditions: HIV-1 Infections

Summary: the purpose of this study is to find out the safety and activity of an experimental anti-hiv treatment using autologous cd4-zeta gene-changed t cells and/or il-2 (recombinant interleukin2).

the purpose of this study is to find out the safety and activity of an experimental anti-hiv treatment using autologous cd4-zeta gene-changed t cells and/or il-2 (recombinant interleukin2). the treatments that the investigators are studying try to improve the immune system by changing some of your t cells so they can find and destroy hiv infected cells (hiv is usually able to hide from your t cells). in this study, the investigators are also trying to find out if giving you more il-2 at the same time as gene changed t cells will help the t cells to live longer or fight hiv better.

Eligibility criteria:
inclusion criteria: * dod beneficiary with hiv-1 infection * greater than or equal to 200 cd4 cells/mm3 * undetectable viral load, for at least the previous 8 weeks * stable anti-retroviral regimen for greater than or equal to 8 weeks * venous access sufficient for apheresis * karnofsky performance \> 80% exclusion criteria: * inadequate organ function * lifetime history of cd4 count less than 200 cells/mm3 on 2 consecutive measurements over at least an 8 week period * any previous history of gene therapy * recent il-2 therapy or other treatment with an investigational agent * pregnancy * some medications (hydroxyurea, corticosteroids and other immunosuppressants, chemotherapy, etc.)

Keywords: hiv-1
intraventricular rt-pa in patients with intraventricular hemorrhage

Conditions: Cerebral Hemorrhage

Summary: this is a study to evaluate how recombinant tissue plasminogen activator (rt-pa) is utilized in patients with intraventricular hemorrhage (ivh). rt-pa is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.

ivh occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. evidence supports a strong contribution of ivh to morbidity and mortality after cerebral hemorrhage. external ventricular drainage (evd) is required clinical management; however, evd via intraventricular catheter alone fails to prevent much of the morbidity and mortality of ivh. this study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-pa, as a method of removing this blood and altering morbidity and mortality. patients will receive intraventricular injections of rt-pa or placebo every 12 hours. they will be followed prospectively with daily head ct scans during the acute-treatment phase and again between days 28 and 32. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * intraventricular hemorrhage (ivh) confirmed by ct scan * more than 12 hours post bleed * hematoma size stable by ct scan * post-ivh catheter ct scan * able to begin study within 24 hours of bleed exclusion criteria: * infratentorial bleed * supratentorial bleed greater than 30 cc * unclipped aneurysm suspected * arteriovenous malformation suspected * any severe, complicating illness (e.g., aids or dnr) * cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis) * active internal bleeding * requirement for heparin doses greater than 10,000 u/day * concurrent coumadin * known allergy to rt-pa * pregnancy

Keywords: intraventricular hemorrhage subarachnoid hemorrhage intracerebral hemorrhage pharmacokinetics recombinant proteins anticoagulants tissue plasminogen activator pharmacology catheters, indwelling cerebral ventricles
endomicroscopy for assessment of mucosal healing

Conditions: Crohn´s Disease; Ulcerative Colitis

Summary: inflammatory bowel disease (ibd) encompasses two major forms of chronic intestinal disorders, crohn's disease and ulcerative colitis (uc). diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. confocal laser endomicroscopy (cle) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure. the main objective of this study is to determine endomicroscopic features of mucosal healing in patients with ibd.


Eligibility criteria:
inclusion criteria: * written informed consent * age 18-85 years * ability of subjects to understand character and individual consequences of clinical trial * subjects undergoing colonoscopy exclusion criteria: * inability to provide written informed consent * severe coagulopathy (prothrombin time \ 50 s) * pregnancy or breast feeding * active gastrointestinal bleeding * residing in institutions (e.g. prison) * known allergy against fluorescein * proctocolectomy
the safety and efficacy of syd-101 in children with myopia

Conditions: Nearsightedness; Near Sightedness; Near-sightedness

Summary: myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in europe, asia and the usa. severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. this study investigates the use of syd-101, an eye solution, in slowing-down the progression of myopia in children.

this will be a 5-arm, multicentered, randomized, double-masked, vehicle-controlled study conducted in 2 parts. part 1 is the primary treatment period of 3 years, during which participants will receive 1 of 3 masked medications. part 2 is the randomized withdrawal period of 1 year, during which participants originally receiving vehicle will receive syd-101, and participants originally receiving syd-101 will receive either vehicle or syd-101.

Eligibility criteria:
inclusion criteria: * myopia of 0.5 d (diopters) to 6.00 d (inclusive) in both eyes. * astigmatism ≤1.50 d in both eyes. * anisometropia ≤1.00 d in both eyes. * if myopia is ≥0.75 d, participant must be wearing single vision eyeglasses or soft, daily-wear, single-vision contact lenses that meet study investigator's criteria. * bcva (best-corrected visual acuity) snellen equivalent of 20/32 or better. exclusion criteria: * participants with a history or current evidence of a medical condition predisposing them to degenerative myopia (e.g. marfan syndrome, stickler syndrome), or a condition that may affect visual function or development (e.g. diabetes mellitus, chromosome anomaly). * current use of a monoamine oxidase inhibitor. * evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis. * past, present or future plans to use orthokeratology (orthok), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression; or the use of atropine, pirenzepine or other anti-muscarinic agent for myopia. * history or evidence of ocular surgery or planned future ocular surgery in either eye. other protocol-defined inclusion/exclusion criteria could apply.

Keywords: children myopia
comparison of transforaminal vs. parasagittal interlaminar epidural injection

Conditions: Spinal Stenosis

Summary: the purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection.

participants were randomly allocated to receive either parasagittal interlaminar or transforaminal esi. investigators obtained clinical data including age, gender, duration of symptoms, predominant symptoms (axial pain vs. leg pain), severity of neurogenic intermittent claudication (nic) and degree of depression. depression was assessed by the korean version of the beck depression inventory (bdi). the bdi is a standardized questionnaire to assess cognitive, affective, and somatic symptoms of depression. all data were obtained before performing esi.data about anterior epidural spreading and presence of concordant pain provocation were obtained during fluoroscopic guided parasagittal interlaminar or transforaminal esi. also total procedure time and amount of radiation exposure were checked. investigators observed the epidural spread pattern after a 2 ml injection of contrast material, confirmed anterior epidural spread with a lateral view, and asked the participants if they had any concordant pain provocation or not. the participants were asked if the pain was in the same distribution as their original pain (concordant) or dissimilar or absent in both quality and location. investigators used the numerical rating scale (nrs) as well as the korean version of the oswestry disability index (odi) to evaluate clinical efficacy in terms of reducing pain and functional improvement at pretreatment and 2 weeks after the esi series. esi was performed twice with a 2 weeks interval before the final treatment outcome evaluation with the nrs and odi. all patients reported average severity of their symptoms over the previous 1 week. a score of 0 on the nrs represents no pain, and a score of 10 represents the worst pain imaginable. the korean version of the odi (0-50) was used to assess functional improvement.

Eligibility criteria:
inclusion criteria: * central spinal stenosis * herniated nucleus pulposus. exclusion criteria: * lateral spinal stenosis * internal disc disruption

Keywords: spinal stenosis epidural steroid injection
immunogenicity and safety study of fluarixtm vaccine in children who have previously been vaccinated with pandemrixtm

Conditions: Influenza

Summary: this study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with gsk biologicals' fluarixtm vaccine in children who have previously been vaccinated with one dose of pandemrixtm at the age of 10-17 years.


Eligibility criteria:
inclusion criteria: * subjects having previously been immunized with only one single dose of pandemrix at the age of 10-17 years inclusive. * subjects having received pandemrix at least six months prior to study enrolment. * subjects who the investigator believes that subject and/or parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol * written informed consent obtained from the subject/ the parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * subjects or parent(s)/lar(s) with access to a consistent means of telephone contact, land line or mobile, but not a pay phone or other multiple-user device exclusion criteria: * active participation in other clinical trials. * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * acute disease and/or fever at the time of enrolment: * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * history of seizures or progressive neurological disease. * subjects having received an h1n1v pandemic vaccine other than pandemrix or having received the 2010/2011 seasonal influenza vaccine. * if the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. * child in care.

Keywords: influenza pandemrix h1n1 fluarix
intravenous iron metabolism in restless legs syndrome

Conditions: Restless Legs

Summary: double-blind, placebo-controlled, entitled: "intravenous iron metabolism in restless legs syndrome

to determine the effects of high-dose infusions of iron on restless legs syndrome (rls) symptoms and brain concentrations of iron.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of restless legs syndrome (rls). * presence of increased periodic leg movements of sleep (plms) before receiving treatment. * patient sleep times are between 9pm and 9am. * patient's rls symptoms would occur daily if you were not on medication. exclusion criteria: * rls secondary to other medical disorders as determined by history and physical/neurological examination. * on a treatment (e.g., psychiatric medication) that might significantly alter rls symptoms or study results and who cannot discontinue medication for the extended period of the study. * history of multiple adverse drug reactions or specifically an allergy to iv iron. * currently experiencing a serious medical condition (chronic organ failure, active inflammation or infection, congestive heart failure, etc.) that might alter iron metabolism, would place them at risk, or interfere with study participation. * an magnetic resonance imaging (mri) is not possible because of medical reasons (pacemaker; loose iron in the tissue) or concern about severe claustrophobia. * any condition that is likely to increase iron loss (chronic bleeding, excluding menstruation; medically necessary phlebotomy) or consumption (pregnancy). * serum ferritin \>300mg/l or percent iron saturation \>50%. this is to exclude subjects with probable hemochromatosis. * significant medical (e.g., inflammatory bowel syndrome; bowel dysmotility syndromes) or surgical (e.g., gastrojejunal bypass, colectomy) gi tract problems; and active chronic inflammatory processes (e.g., active hepatitis, rheumatoid arthritis, systemic lupus erythematosus). this is to exclude conditions which will potentially alter iron metabolism.

Keywords: iv iron restless legs syndrome rls iron
a study of nivolumab and chemotherapy followed by surgery for mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: this study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * karnofsky performance status \> 70% * pathologic diagnosis of malignant pleural mesothelioma. * potentially resectable by pleurectomy/decortication, as assessed by thoracic surgeon * negative serum pregnancy test in women of childbearing potential * female patients of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 5 months after the last administration of nivolumab and at least 6 months after last administration of pemetrexed, whichever is longer * male patients with female partners of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 7 months after the last administration of nivolumab and at least 3 months after the last administration of pemetrexed, whichever is longer * adequate archival or fresh tissue for correlative analysis. archival tissue will be deemed acceptable as long as their was no interval therapy prior to cycle 1 day 1 of protocol therapy. if sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required as long as medically safe and feasible * absolute neutrophil count ≥ 1000/mcl * total bilirubin ≤ 1.5 mg/dl * ast and alt ≤ 3.0 x upper limit of normal * creatinine ≤ 1.5 x upper limit of normal * negative hiv serology blood test exclusion criteria: * prior treatment with chemotherapy or immunotherapy for mesothelioma * autoimmune disease requiring systemic immune modulating treatment during the past two years * pregnant or lactating women * known active hepatitis b or hepatitis c * current use of systemic prednisone at dose ≥ 10 mg daily (or the equivalent dose with another corticosteroid) * serious concurrent medical illness or another active cancer requiring treatment * active pneumonitis

Keywords: nivolumab surgery pemetrexed cisplatin carboplatin 19-272
a study to evaluate the efficacy and safety of recombinant human growth hormone in short stature children due to chronic kidney disease before transplantation

Conditions: Dwarfism

Summary: this study aims to evaluate the efficacy and safety of recombinant human growth hormone injection in short stature children due to chronic kidney disease before transplantation.


Eligibility criteria:
inclusion criteria: * signed informed consent of the subjects or the legal guardian. * subjects and guardian are willing and able to cooperate to complete scheduled visits,treatment plans and laboratory tests and other procedures. * diagnosed as chronic kidney disease. * glomerular filtration rate (gfr) \<75ml/per min/1.73m2. * after the treatment and adjustment of hypertension, anemia, metabolic acidosis, malnutrition, renal osteopathy, hypothyroidism, etc.. * chronological age: ≥2years and ≤14years. * height standard deviation score(htsds) ≤-2sd for chronological age. * bone age: girls≤10 years; boys≤11years. * pre-pubertal (tanner stage i ) patients. * no history of growth hormone treatment. exclusion criteria: * subjects with abnormal liver functions. * subjects positive for anti-hbc, hbsag or hbeag in hepatitis b virus tests. * after adjustment heart function,cardiac ejection fraction(ef) \<50%. * subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient. * subjects with systemic chronic disease or general infection or mental disease. * subjects with diabetes or impaired fasting glucose. * subjects with tumor or potential tumor. * subjects who are using glucocorticoid or immunosuppressant. * other causes for growth retardation. * inability to obtain accurate height measurements. * subjects who took part in other clinical trials within 3 months. * concomitant administration of other treatment that may have an effect on growth within 3 months. * other conditions which are unsuitable for this study in the opinion of the investigator.
increasing adherence to oral appliance therapy for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Adherence, Patient

Summary: obstructive sleep apnea is a chronic condition that has serious health consequences including increased risk of hypertension, type-2 diabetes, heart disease, stroke and reduced life expectancy. this study proposes to use behavioral reinforcement and support to increase adherence to oral appliance therapy for obstructive sleep apnea. the control group in the study will receive routine care. in addition, their oral appliance wear time will be monitored using a sensor built into the appliance. routine care includes an initial 1-hr consult, then delivery of the oral appliance (with sensor) and follow-up appointments at 1 week, 1 month, 3 months, 6 months, and 1 year. the second, experimental group will receive adherence promotion techniques in addition to routine care. these adherence promotion techniques can be categorized into 6 methods. 1- spouse/partner included in a patient counseling session. 2- educational brochure delivery at follow up appointments. 3- electronic reminder/communication system established by patient and provider. 4-follow up communication between primary care physician and orthodontist. 5-celebratory certificate for good adherence with the oral appliance evaluated at 3 month, and 6 month visits. 6-gift card delivery, $25, when patient schedules a follow up with sleep physician. patients will be followed for within the research protocol for 6 months. there are no additional risks involved with the research and the anticipated benefit is to develop methods to increase adherence to treatment for obstructive sleep apnea. this will benefit many patients with obstructive sleep apnea who use oral appliances to control the condition.


Eligibility criteria:
inclusion criteria: * potential participants must have a diagnosis of osa and have been referred for an oral appliance to treat this condition. the participants must have no past experience with oral appliances. patients must be able to read and converse in english. exclusion criteria: * participants who cannot read english will be excluded because all educational material in the study is in english.

Keywords: multifactor intervention oral appliances
social media effect on knowledge dissemination during covid-19 virus outbreak

Conditions: COVID-19

Summary: the recent covid-19 outbreak is very challenging as data are distributed instantly on the data are very rapidly distributed through professional and non professional sources which may impact the management of the disease

the investigators are conducting a survey between the physicians to study the effect and practice of received knowledge disseminated through social media . the survey will be distributed through internet and data will be collected and analyzed

Eligibility criteria:
inclusion criteria: * medical physicians in middle east area exclusion criteria: * none

Keywords: corona virus social media physician knowledge