Kornimate/medical-research-clean huggingface dataset:
a study to assess biomarkers impact on participants response to erlotinib treatment for first-line non-small cell lung cancer with endothelial growth factor receptor (egfr) activating mutations

Conditions: Carcinoma，Non-Small-Cell Lung

Summary: this open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) positive mutations and receiving erlotinib treatment. the anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.


Eligibility criteria:
inclusion criteria: * histological documented adenocarcinoma, locally advanced - stage iiib, metastatic - stage iv or recurrent non-squamous nsclc * activated egfr mutation positive status (exons 19 and 21) for treatment phase * eastern cooperative oncology group (ecog) performance status 0-1 * life expectancy greater than or equal to (≥) 12 weeks * evidence of disease with at least one measurable disease evaluation on response evaluation criteria in solid tumors (recist) * adequate hematological , liver and renal function exclusion criteria: * known hypersensitivity to erlotinib or any of its excipients * squamous non-small cell or small cell tumors or absence of histological report * neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment * prior exposure to inhibitors of egfr * prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease * any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions * radical radiotherapy with curative intent within 28 days prior to enrollment * any active non-controlled systemic disease
efficacy and safety of hsk16149 capsule in chinese patients with diabetic peripheral neuropathic pain who had an inadequate response to pregabalin

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: investigate the efficacy and safety of hsk16149 capsule in chinese patients with diabetic peripheral neuropathic pain (dpnp) who had an inadequate response to pregabalin, following 4 weeks treatment in comparison to pregabalin


Eligibility criteria:
inclusion criteria: 1. signed informed consent; 2. males or females aged 18-75 years of age inclusive; 3. diagnosis of diabetic peripheral neuropathic pain (dpnp) and diabetic peripheral neuropathy (dpn) pain ≥ 6 months; 4. hba1c ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening; 5. have a visual analog scale (vas) pain value ≥60 mm in the past 24 h during screening; 6. dpnp patients are currently receiving continuous treatment with pregabalin for more than 4 weeks who had an inadequate response. exclusion criteria: 1. peripheral neuropathy or pain unrelated to dpn that may confuse the assessment of dpnp. 2. skin conditions in the area affected by neurupathy that could alter sensation. 3. chronic systemic diseases that may affect subjects' participation in the study. 4. severe hematologic, hepatic or renal dysfunction, the subject will be excluded if: 1. neutrophils \< 1.5 × 10\^9/l, or platelet \< 90 × 10\^9/l, or hemoglobin \< 100 g/l; 2. ast/alt \> 2.5 × upper limit of normal (uln), or tbil \> 1.5 × uln; 3. estimation of glomerular filtration rate (egfr) \< 60 ml/min / 1.73 m\^2; 4. creatine kinase \> 2.0 × uln. 5. history of substance abuse or alcohol abuse. 6. acute complications of diabetes in the 6 months prior to screening. 7. any active infections at screening. 8. hbsag or hcv ab positive, or hiv ab positive, or serum tp ab positive. 9. inability or unwillingness to discontinue any other prohibited concomitant medications. 10. history of allergic or medically significant adverse reaction to investigational products or their excipients, duloxetine or related compounds. 11. history of suicidal behavior or attempted suicide. 12. pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of icf signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period. 13. participated in another clinical study within 30 days prior to screening. 14. other conditions of the subjects who are unlikely to comply with the protocol. 15. the investigators determine that there are other conditions that are not suitable for participation in this study.
study to evaluate the pharmacokinetic characteristics of luckyvec 400mg tablet, in healthy subjects

Conditions: Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumors

Summary: the purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the luckyvec 400mg tablet(x 1t) and glivec 100mg(x 4t) when administered a single-dose to healthy volunteers.

healthy volunteers are administrated single-dose over the period i and ii (crossover) of luckyvec 400mg tablet(x 1t) and glivec 100mg(x 4t)as of imatinib 400mg. every time before and after each medication, pk parameters and safety of luckyvec 400mg tablet and glivec 100mg is performed using a blood sample and conducting some tests(laboratory test, v/s, physical examination, etc) respectively.

Eligibility criteria:
inclusion criteria: * between 20 aged and 45 aged in healthy males * bmi: 18\~29.9 kg/m2, (bmi = (체중 \[kg\])/(height \[m\])2) * agreement with written informed consent exclusion criteria: * clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, gastrointestinal system, immune system, skin system, nervous system or mental disease(past history or present) * subject with symptoms of acute disease within 28 days of starting administration of investigational drug * subject with known for history which affect on the adme of drug * clinically significant active chronic disease * inadequate result of laboratory test * ast/alt \> 1.5 x unl * total bilirubin \> 1.5 x unl * positive reaction in the hbs ag, anti-hcv ab, anti-hiv ab, vdrl test * taking etc(ethical the counter)medicine within 14 days * taking otc(over the counter)medicine including oriental medicine within 7 days * clinically significant allergic disease(except for mild allergic rhinitis and dermatits seems to be not need for medication) * subject with known for hypersensitivity reaction to imatinib analog * not able to taking the institutional standard meal * previously make whole blood donation within 60 days or component blood donation within 20 days * previously have blood transfusion within 30 days * previously participated in other trial within 30 days * continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day) * an impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Keywords: imatinib mesylate pharmacokinetics healthy volunteers
oral nutritional optimization in total joint arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.

numerous pre-operative modifiable variables have been extensively investigated for their effect on outcomes in tja. these include metabolic diseases such as diabetes mellitus, obesity, and smoking status. however, nutritional status has not been as thoroughly investigated; to date, no prospective randomized control study has assessed the effect of oral nutritional supplementation for malnourished patients. this study will be a novel investigation into the role for routine serum screening for malnutrition as well as oral nutritional supplementation in tja patients. this study could serve as a stepping stone towards creating a new pathway to highlight at-risk patients and pre-operatively optimizing their outcomes after tja.

Eligibility criteria:
inclusion criteria: 1. patient are current candidates for elective primary total hip and total knee arthroplasty 2. patients ≥55 years of age but ≤ 95 3. patients who meet at least one of the following three laboratory criteria for malnutrition: tserum albumin: ≤3.5 mg/dl pre-albumin: \<15 mg/dl transferrin: \<200 mg/dl exclusion criteria: 1. previous history of septic arthritis 2. allergy to oral supplementation 3. inability to consume oral supplementation 4. protein malabsorption syndromes 5. eating disorders 6. end stage renal and hepatic disease 7. revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty
performance and safety of restylane lidocaine for treatment of depressed facial acne scars

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate performance and safety of restylane lidocaine for treatment of depressed facial acne scars


Eligibility criteria:
inclusion criteria: * intent to undergo treatment of depressed acne scars * presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area * similar type, size and number of scars on both cheeks * men or non-pregnant, non-breast feeding women * fitzpatrick skin type i-iv * signed and dated informed consent to participate in the study exclusion criteria: * presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of \> 4 mm. * active acne with inflammatory component * use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment * use of isotretinoin within 6 months before treatment * post-surgical scars in the treatment area * previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the treatment area * previous tissue augmenting therapy, contouring or revitalisation treatment with calcium hydroxyapatite (caha), or poly l-lactic acid (plla), in the treatment area within 24 months before treatment * previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler such as hyaluronic acid (ha) or collagen in the treatment area within 12 months before treatment * previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy, chemical peeling or dermabrasion in the treatment area within 6 months before treatment * previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area * any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
thrombophilia and migraine, are they related?

Conditions: Migraine; Thrombosis; Thrombophilia

Summary: migraine was described as related to stroke in adults and children as well. complete thrombophilic status was not study in large groups of pediatric patients. the purpose of our study is to assess the prethrombotic profile among children and teenagers diagnosed as suffering from migraine attacks.


Eligibility criteria:
inclusion criteria: * patients diagnosed as suffering from migraine according to the neurologic criteria.

Keywords: migraine thrombosis thrombophilia
awaken prone positioning ventinlation in covid-19 patients

Conditions: COVID-19

Summary: awaken prone positioning (app) ventilation has been widely accepted as a standard regimen in the management of covid-19 patients. physiological studies have proved ventilation/perfusion improvement during app in covid-19, which was associated improved oxygenation. however, the optimal duration for app was not yet demonstrated. in this study, we aimed at the prolonged app to see whether this could improve patients outcomes.


Eligibility criteria:
inclusion criteria: * aged \> 18-yr to 85-yr * severe covid-19 pneumonia (with typical radiographic alternations) and non-intubated patients. * spo2 \<= 93% with ambient air at rest. * pao2/fio2 \<= 300 mmhg exclusion criteria: * definite intolerance to app (e.g. pregnancy, extremity deformity, recent fracture, open thoracic or abdominal surgery, pace-maker implant in recent 48-hr, spine stability, pelvis or facial fractures, predicted difficult airway) * morbidity obesity, bmi \> 40 * consciousness disorder (gcs \< 13), delirium dementia * hemodynamic instability (with norepinephrine \>20 ug/min ) * nyha grade iii or iv * severe hemoptysis * long term home oxygenation of cpap * refuse invasive mechanical ventilation (dni dnr)
the influence of different concentrations of glucose in culture media on in vitro fertilization (ivf) outcome of sibling oocytes

Conditions: Infertility

Summary: the importance of glucose in culture media on fertilization and embryo development is still controversial. although it has been reported that glucose is essential for fertilization process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of glucose in culture media may cause developmental arrest of cleavage stage embryos. the aim of this retrospective study is to examine whether exposure of sibling oocytes to different concentrations of glucose in culture media has any further effect on ivf outcome.

this retrospective study will include data from either standard ivf or intracytoplasmic sperm injection (icsi) cycles, in which sibling oocytes were equally divided and incubated separately in one of the following pairs of culture media: 1. universal ivf medium vs. ism1 medium ( origio, medi-cult) 2. p1 medium vs. ecm medium (irvine). fertilization rate,as well as embryo cleavage rate and morphology will be evaluated.

Eligibility criteria:
inclusion criteria: * sibling oocytes from cycles where at least 4 oocytes were retrieved exclusion criteria: * less than 4 oocytes retrieved * partner has undergone testicular sperm extraction (tese)

Keywords: sibling oocytes glucose culture media
top-down infliximab study in kids with crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (ifx) and azathioprine (aza) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and aza or exclusive enteral nutrition (een) and aza, in moderate-to-severe pediatric crohn's disease (cd) patients.

objective: the purpose of this study is to determine whether a top-down treatment approach, prescribing ifx and aza at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and aza or een and aza, in moderate-to-severe pediatric cd patients. sample size: we will include 100 (2 x 50) patients. with these numbers a difference of 60% and 85% (= 25) can be shown at a power of 80% (2-sided α 0.05). study design: an international open-label randomised controlled trial study population: children (age 3-17 yrs) with new-onset, untreated, cd with moderate-to-severe disease activity (weighted pediatric cd index \[wpcdai\] \>40) intervention: patients will be randomised to either top-down or conventional step-up treatment. treatment arm 1: top-down ifx treatment will consist of a total of 5 ifx infusions of 5 mg/kg (ifx induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks) combined with oral aza 2-3 mg/kg once daily. aza therapy will continue after the last ifx infusion to maintain remission. treatment arm 2: step-up treatment will consist of standard induction treatment by either oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop, or een with polymeric feeding for 6-8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. either of these induction treatments will be combined with oral aza 2-3 mg, once daily, as maintenance treatment. main study parameters/endpoints: clinical remission at 52 weeks without need for additional cd related therapy or surgery. secondary endpoints include clinical response, remission and mucosal healing at week 10 and 52, growth, quality of life and adverse events.

Eligibility criteria:
inclusion criteria: * children (age 3-17 years, both male and female, weight \>10kg) with new-onset, * untreated cd with moderate-to-severe disease activity assessed by a wpcdai \>40 will be eligible for inclusion after a diagnosis of cd was made based on the porto criteria exclusion criteria: patients with the following characteristics will be excluded: * immediate need for surgery, * symptomatic stenosis or stricture in the bowel due to scarring, * active perianal fistulas, * severe co-morbidity, * severe infection such as sepsis or opportunistic infections, * positive stool culture, * positive clostridium difficile assay, * positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy, * those already started with cd specific therapy, * patients with a suspected or * definitive pregnancy

Keywords: crohn's disease pediatric infliximab top-down tiskids
testing a barbershop-based hiv prevention initiative among men

Conditions: HIV Infections

Summary: to test community-based approaches to engage heterosexual men at risk for hiv and specifically to assess the feasibility and acceptability of a barbershop based hiv prevention program.

hptn 111/trim is a cluster randomized study to assess the feasibility and acceptability of a barbershop-based hiv prevention program. eighteen barbershops in kalangala district, uganda will be purposively selected to participate in the study and randomized 2:1 to provide the barbershop-based hiv prevention initiative (intervention) or the standard-of-care (control). individual participants will be enrolled from the barbershops and receive intervention or control services based on their barbershop. the barbershop-based hiv prevention initiative will include barber provided status-neutral hiv education, hiv self-test kits, and information about where to receive hiv prevention services.

Eligibility criteria:
inclusion criteria: persons who identify as a heterosexual male and meet all of the following criteria are eligible for inclusion in this study: 1. age ≥ 16 years a. any participants 16-17 years old will be enrolled following the uganda national council for science and technology (uncst) guidelines for mature and emancipated minors 2. able and willing to provide informed consent 3. behaviorally vulnerable to hiv, based on self-report of at least one of the following in the last three months: 1. had condomless sex with a person of unknown hiv status or a person living with hiv 2. had more than one sexual partner 4. hiv negative per ugandan ministry of health guidelines and the study-specific procedures (ssp) manual 5. is a regular customer at a participating barbershop as defined in the ssp manual exclusion criteria: persons who meet any of the following criteria will be excluded from this study: 1. not planning to stay in the study catchment area in the next 12 months 2. any other condition that in the opinion of the investigator of record (ior)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. participants who report sex with other men will not be excluded from this study so long as they meet the inclusion and exclusion criteria listed above.

Keywords: hiv hiv prevention barbershop uganda kalangala district heterosexual men hiv education hiv self-test kits peer support hiv testing hiv risk reduction counseling sti testing
the evolution of visual acuity measured by electronic tablet / computer of exudative amd patients

Conditions: Macular Degeneration Exudative Eye Bilateral

Summary: this pathology, dmla, whose evolution is chronic, requires regular follow-up and care (ivts) over a long period (several months or even years). increasing the number of patients to be followed and treated poses increasing problems for ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory functional results. moreover, this regular follow-up imposes enormous constraints on patients and their families (some children or patients are still working). studies are beginning to emerge on the reliability of patient follow-up in telemedicine. the use of a measure of visual acuity by patients, electronic tablet (te) or computer (o), and at home, seems a logical step to help us improve the quality of patient follow-up while spacing controls. the aim of our study is thus to demonstrate that the measurement of the va performed by te or o is reliable. indeed, during the follow-up of the patients, in the case where the patient's av decreases, and whatever the reason

our aim is to compare the evolution curves of the visual acuity (av) measured in each patient on electronic tablet (te)/ computer(o) and on the early treatment of diabetic retinopathy study (etdrs) scale, in order to check the reliability of the measurements performed by te / o by comparing them with a well-known reference measure and is routinely practiced routinely in ophthalmology centers. measurement of visual acuity on te / o will be carried out on an etdrs av scale, the size of the letters having been adapted to the reading distance (80 cm by 0.40 cm on the tablet). an etdrs intermediate vision (evi) or meadow vision (teu) score according to the group will be established in the same way. the va measurement will be supervised by a cra trained to the extent of the va, without the orthoptist or ophthalmologist being informed of the results obtained.

Eligibility criteria:
inclusion criteria: * male or female over 50 years of age. * patient monitored and treated in the department by intravitreal injections of anti vegf (aflibercept or ranibizumab) in the indication of treatment. * patient with exudative amd * patient who consented to participate in the study * patient who is able to understand the study and use a te / o * patient with av greater than or equal to 20/100 * patient affiliated to a health exclusion criteria: * patient having expressed his / her refusal on the collection of the medical data of his file at the end of the study * patient treated with non-amd pathology * patient with av less than 20/100 * vulnerable person: protected by the law: guardianship, curatorship. * person participating in another test