Kornimate/medical-research-clean huggingface dataset:
phase i & biological study of etanercept & weekly docetaxel in patients with advanced solid tumors

Conditions: Tumors

Summary: to determine the safety and efficacy of the combination of etanercept and docetaxel in patients with advanced solid tumors for which there is no standard treatment.


Eligibility criteria:
inclusion criteria: * must have pathologically or cytologically confirmed advanced solid malignancy for which there is no standard treatment exists. * solid malignancy that has persisted or recurred following prior therapy or advanced solid malignancy for which docetaxel is considered an acceptable first line treatment option: * non-small cell lung * breast * head and neck * esophageal * stomach * ovarian carcinomas * eastern cooperative oncology group (ecog) performance status of 0-2 * life expectancy of at least 12 weeks. * must have adequate organ function * peripheral neuropathy must be less than grade 2

Keywords: advanced solid tumors
altis® 522 trial - treatment of female stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the aim of this postmarket study is to compare the safety and effectiveness of the altis single incision sling (sis) to an fda cleared transobturator and/or retropubic sling through 36 months.

this study is a prospective, post-market, multi-center, cohort assessment comparing altis sis (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 u.s. and international sites. subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. the study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.

Eligibility criteria:
inclusion criteria: * the subject is female and at least 18 years of age. * the subject is able and willing to complete all procedures and follow-up visits indicated in this protocol. * the subject has confirmed stress urinary incontinence (sui) through cough stress test or urodynamics. * the subject has failed two non-invasive incontinence therapies (such as kegel exercise, behavior modification, pad use, biofeedback, etc.) for \> 6 months. exclusion criteria: * the subject has an active urogenital infection or active skin infection in region of surgery. * the subject has confirmed pelvic organ prolapse (pop) of stage 2 or higher as determined by pop-q prolapse grading. * the subject is having a concomitant pelvic floor procedure. * the subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, parkinson's disease, or similar conditions). * the subject had a prior surgical stress urinary incontinence (sui) treatment. * the subject has undergone radiation or brachy therapy to treat pelvic cancer. * the subject has urge predominant incontinence by mesa assessment. * the subject has an atonic bladder or post void residual (pvr) above 100 cc on ≥ 2 occasions. * the subject is pregnant and/or is planning to get pregnant in the future. * the subject has a contraindication to the surgical procedure or the product instructions for use (ifu). * the subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.

Keywords: stress urinary incontinence altis 522 urinary incontinence
health-related quality of life and comorbidities in danish patients with idiopathic pulmonary fibrosis - a nationwide follow-up

Conditions: Idiopathic Pulmonary Fibrosis

Summary: idiopathic pulmonary fibrosis (ipf) is a progressive lung disease with a high mortality. health-related quality of life (hrql) is impaired in patients with ipf. little is known about the properties of recently developed hrql questionnaires and about the longitudinal changes in hrql, including factors with an impact on hrql. comorbidities have an impact on patients with ipf, but reports differ in incidence and prevalence. the impact of comorbidities on hrql and disease progression has only been studied sparsely. also, the association between biomarkers and disease progression need to be examined further.


Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of ipf 2. signed informed consent exclusion criteria: 1. clinical, radiological or histological findings inconsistent with a diagnosis of ipf 2. inability or unwillingness to adhere to the study 3. active on lung transplantation list
the impact of contrast media used in epidural steroid injections on thyroid function tests

Conditions: Lumbar Radiculopathy; Lumbar Spinal Stenosis; Cervical Radiculopathy; Cervical Stenosis

Summary: this study is aim to disclose the effect of contrast media, which used in epidural steroid injections, on the parameters of thyroid function tests (tfts). the patients who underwent an epidural steroid injection were included. the investigators hypothesized that contrast media owing to contain iodine may impair the values of tfts.

the objective of this study is to reveal the impact of contrast media, whether they change the values of tfts in participants who had been performed any kind of epidural steroid injection such as lumbar, cervical and caudal epidural steroid injection. the inclusion criteria were participants who had normal values of tfts, being between the ages of 18 and 65 and had an epidural steroid injection. patients with impaired parameters of tfts or had thyroid surgery, systemic and/or local infections, malignancy, bleeding diathesis, acute fracture, known allergy to contrast material and/or local anesthetic substances, known history of any psychiatric disorder, and patients with a history of pregnancy were excluded from the study. verbal and written informed consent was obtained from all patients participating in the study. in conjunction with the recording of the demographic data of the patients participating in this study (age, sex, duration of symptoms, etc.), their contrast medium doses and the values of tfts (free t3, free t4 and thyroid-stimulating hormone) were employed before the procedure and 3rd week after the procedure.

Eligibility criteria:
inclusion criteria: * patients who will be performing with an epidural steroid injection * being between the ages of 18 and 65 * having normal values of thyroid function tests exclusion criteria: * patients with a history of thyroid surgery or impaired thyroid function tests * patients with systemic and/or local infections, * malignancy, * bleeding diathesis, * acute fracture, * known allergy to contrast material and/or local anesthetic substances, * known history of any psychiatric disorder * patients with a history of pregnancy

Keywords: thyroid functions epidural steroid injections
post marketing surveillance(pms) study of lorviqua in korea

Conditions: Metastatic ALK+ Non Small Cell Lung Cancer

Summary: the objective of this study is to monitor the usage of lorviqua in real practice within label, including the adverse events associated with lorviqua


Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. use in the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc) 2. evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: patients meeting any of the following criteria will not be included in the study: 1. patients to whom lorviqua® is contraindicated as per the local labeling. a. hypersensitivity to lorviqua® or to any of the excipients of this product b. lorviqua® is contraindicated in patients taking concomitant use of strong cyp3a4/5 inducers c. this medicinal product contains lactose as an excipient. patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose galactose malabsorption should not take this medicinal product. 2. any patients (or a legally acceptable representative) who does not agree that pfizer and companies working with pfizer use his/her information
effects of hypoxia on cognitive performance

Conditions: Hypoxia

Summary: the goal of this clinical trial is to determine the effects of different hypoxia exposures (fio2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. the main questions it aims to answer are: * what is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks? * which hypoxia exposure causes the greatest detriments in cognitive function?

participants will completed four trials in a single-blinded crossover randomised control trial. in the first session, individuals familiarised with the different cognitive tests and hypoxic exposures. in the next four experimental trials (separated by 1 week), participants arrived at the laboratory and rested in a seated for 10 min. the vital signs (i.e., spo2, hr, blood pressure) and lake louise score were recorded prior to mask placed and start with in one of the four conditions: a) pla/nor, b) fio2=15%, c) fio2=13% or fio2=11%. in this hypoxic condition the participant will spend a total of 45 min, of which 30 min was at rest, and the other 15 min was performing the cognitive tasks (i.e., memory test, go/no-go test, eriksen flanker test, anticipation task and reaction time test).

Eligibility criteria:
inclusion criteria: * physically active individuals ( \>150 min/week moderate physical activity or \>75 min/week vigorous physical activity) * non-smokers * individuals without serious and undiagnosed health problems exclusion criteria: * pregnancy and/or breastfeeding * residing at an altitude of more than 1300 m * having been exposed to an altitude of more than 900 m in the last 8 months * having performed a study with hypoxia in the last 8 months * suffering from any of the following diseases/pathologies: diabetes, sleep apnoea, dyslexia, colour blindness, blurred vision, respiratory and/or neuromuscular diseases.

Keywords: cognitive anticipation memory attention reaction time
safety and efficacy of zuretinol acetate in subjects with inherited retinal disease

Conditions: Retinal Disorder

Summary: to evaluate the efficacy of za oral solution in subjects with ird caused by biallelic recessive rpe65 or lrat gene mutations and phenotypically diagnosed as leber's congenital amaurosis (lca) or retinitis pigmentosa (rp).


Eligibility criteria:
inclusion criteria: 1. have read, understood and signed the informed consent form (icf). 2. be aged 6 years or older. 3. have a diagnosis of ird phenotypically diagnosed as lca or rp by an ocular geneticist or ophthalmologist and caused by pathologic biallelic autosomal recessive mutation in rpe65 or lrat as determined by a fully accredited certified central genotyping laboratory. 4. be naïve to gene therapy, surgical implantation of prosthetic retinal chips, or subretinal injections. 5. if previously administered za , have at least \> 3 years since last administration of za. 6. pregnancy testing and contraception before study treatment: women of childbearing potential must not be pregnant or lactating. exclusion criteria: 1. have a presence of concurrent ocular disease that in the opinion of the investigator would put the subject at greater risk during the study or significantly affect study results. 2. have had ocular surgery within 3 months of screening, including cataract or laser procedures. 3. have taken any prescription or investigational oral retinoid medication (e.g., isotretinoin or acitretin) within 6 months of screening; subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure. 4. have taken any supplements containing ≥ 10,000 iu vitamin a within 60 days of screening. 5. have taken any medication that affects bone metabolism within 6 months of screening. 6. have circulating 25-hydroxy vitamin d \< 20 ng/ml. 7. use of medications that may interact with a retinoid, including tetracycline, ketoconazole and methotrexate within 60 days of screening. 8. use of intraocular or periocular corticosteroids within 90 days of screening; use of corticosteroid implants within 3 years of screening; use of systemic corticosteroids unless these are at a steady low dose with low dose level in effect prior to or at screening; or use of intraocular or periocular anti-vascular endothelial growth factor agents within 2 months of screening. 9. have a known and documented allergy to soy.
reassessment of the nutritional status in thai orphans living with hiv in a family style community

Conditions: HIV Infection; HIV Infections

Summary: to reassess nutritional status of hiv-infected thai children living in the family style community after receiving nutrition support program for 6 months.

the first assessment indicated that improving dietary intake, either energy or micronutrient intakes, to meet the recommended for hiv-infected children (clhiv) would be able to improve growth of these children. we implemented the nutrition support program through the two strategies aiming to increase dietary intake for all children to meet the current world health organization (who) recommendations which the recommended energy requirements are increased by10% for asymptomatic clhiv and increased by 20 to 50% for children who require catch up growth or experiencing opportunistic infections. the nutrition support program composed two strategies. firstly is providing nutrition education to caregivers and also children. secondly, revision food menus by caregivers with assisting from the nutritionists of the project. after this program have been implemented for 6 months, reassessment is needed to evaluate the changes of nutritional status and health outcomes in this children aiming to further providing support and applying to other settings.

Eligibility criteria:
inclusion criteria: * children age 4-15 years old * confirmed hiv-1 diagnosis * reside at the community * the guardian must be able and willing to provide written informed consent. oral consent in the presence of witness is acceptable in the case of illiteracy exclusion criteria: * non-hiv infected children * age 0-3 years

Keywords: nutritional status thai hiv-infected children
evaluation of the efficacy of a new specific infant formula in case of functional constipation

Conditions: Functional Constipation

Summary: this study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.

the study comprises a selection period of 1 week where the eligibility of the infant to participate in the study will be evaluated. once his/her participation is confirmed, the tested formula will be compared to a standard formula during a 2-month study period followed by an optional follow-up period of 2 months where only the tested formula will be used.

Eligibility criteria:
selection criteria: infants presenting with constipation according to modified rome iv criteria, i.e. they must present with 1 month the following: * infants without spontaneous stools or with at least one painful or hard spontaneous bowel movement per week and * at least one of the following: * two and fewer spontaneous defecations per week * history of excessive stool retention * history of large-diameter stools non-selection criteria (non-exhaustive list): * preterm birth (\<34 weeks of gestational age) * exclusively or partially breastfed infants within 3 days prior to visit v-1 * infants with organic causes of constipation (e.g. coeliac disease, paediatric intestinal pseudo-obstruction, hypothyroidism, spina bifida, anorectal malformation or hirschsprung's disease) or constipation secondary to endocrine, metabolic, neurologic or autoimmune disorders, surgery or drugs. * infants on laxative treatment * infants taking drugs that are known to affect gastrointestinal motility as well as any probiotic supplements * infants treated with antibiotics * infants with a known allergy to one of the formula ingredients (e.g. cow's milk proteins...) * infants with anaemia who have been prescribed an oral iron supplement as treatment * infants participating in another trial * infants presenting with any other situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the infant inclusion criteria: * infants having completed the selection period and still compliant with non-selection criteria * infants being constipated according to modified rome iv criteria based on information recorded in parents' diary during the week preceding visit v0 (inclusion visit)

Keywords: constipation infants infant formula nutrition defecation prebiotic probiotics
non-invasive ventilation with neurally adjusted ventilatory assist versus nasal continuous airway pressure in premature infants

Conditions: Respiratory Distress Syndrome (RDS) of Neonate

Summary: the purpose of this study is to compare if a new noninvasive ventilation mode (niv nava) is better in noninvasive ventilation of premature infants than currently used nasal continuous airway pressure (ncpap), and if niv nava gives real benefits for patients or not. the investigators study hypothesis is that with niv nava the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.


Eligibility criteria:
inclusion criteria: * postconceptional age 28+0 - 36+6 * need of ncpap treatment and inspired oxygen for at least 60 minutes exclusion criteria: * severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy * any condition which prevents insertion of naso/orogastric tube

Keywords: niv nava non-invasive ventilation
intradialytic exercise and remote ischaemic preconditioning: a cardioprotective role ?

Conditions: Hemodialysis

Summary: the aim of this clinical trial is to evaluate whether intermittent exercise and remote ischaemic preconditioning (ripc) during haemodialysis (hd) can provide cardioprotection in adult patients (aged 20-79 years) undergoing hd for at least 3 months. the main questions to be answered are does intermittent exercise or ripc reduce myocardial stunning during hd? do these interventions have a beneficial effect on haemorheology, arrhythmias, systemic inflammation and hd efficiency? the investigators will compare three hd sessions: no intervention (hd-cont), with moderate-intensity intermittent exercise (hd-ex), and with ripc using cuff inflation (hd-ripc) to see if hd6ex and hd-ripc approaches offer enhanced cardioprotection. participants will: undergo three randomised hd sessions. participate in 5 blocks of moderate-intensity exercise or ripc during the hd sessions. have cardiac function and biomarkers assessed before, during and after hd.


Eligibility criteria:
inclusion criteria: * patients aged between 20 and 79 years. * patients on hemodialysis for more than 3 months. * no engagement in regular exercise outside of dialysis. * no prior exposure to intradialytic exercise within the past six months. * no medical contraindications to physical activity. * life expectancy greater than 6 months. * patients with relative good echogenicity exclusion criteria * patient is participating in another category i interventional study, or has participated in another interventional study within the past 3 months * the patient is in an exclusion period determined by a previous study * the patient is under legal protection or under guardianship or curatorship it turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent * pregnant, parturient or breastfeeding patient * patients with unstable coronary artery disease. * patients with peripheral artery disease (stage iii or iv) in the lower limbs. * patients with limb amputation. * patients with musculoskeletal disorders impairing exercise. * presence of a pacemaker, cardiac stimulation device, or implantable cardioverter defibrillator (icd). * history of heart transplant. * patients with uncontrolled hypertension. * refractory anemia.

Keywords: hemodialysis myocardial function exercise remote ischemic preconditioning myocardial stunning cardioprotection
foot positions affect basketball players with flatfoot

Conditions: Balance; Proprioception; Jumping Performance; EMG

Summary: this study investigated the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with ff.

objective: to investigate the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with ff. methods: eighty-four basketball players with chronic ankle instability were distributed to three groups (28 with flexible ff, 28 with rigid ff, and 28 without ff). the outcome measures will include static and dynamic balance, knee and ankle proprioception, vertical jump, and electromyography (emg) of ankle muscles (including gastrocnemius (ge), soleus (sol), tibialis anterior (ta), and peroneus longus (pl) muscles)

Eligibility criteria:
inclusion criteria: * the presence of flatfoot in the dominant leg. * the presence of chonic ankle instability exclusion criteria: * the exclusion criteria were the existence of limited hallux dorsiflexion * previous hip, pelvis, knee, or foot surgeries within the last year; obesity or pregnancy; leg-length discrepancies; * had any vestibular disorder neurological disorder, brain concussion within the last 3 months that may cause balance impairment; or administering any drugs that could disturb alertness or balance

Keywords: basket ball players balance flatfoot electromyography propioception
combined prf of the pudendal nerve with ganglion impar block effectively alleviates pudendal neuralgia

Conditions: Pudendal Neuralgia; Pulsed Radiofrequency

Summary: patients with pudendal neuralgia suffer from long-term pain, which severely affects their quality of life. due to unclear etiology, there is a lack of specific treatment methods. the aim of this study is to evaluate the efficacy of combined pulsed radiofrequency with ganglion impar block therapy helps evaluate the effectiveness of this treatment method for pudendal neuralgia, comparing it with traditional treatments or single interventions, and providing guidance for clinical practice.

we plan to enroll patients with pudendal neuralgia .pre-treatment, we collected data including pain assessment, anxiety, depression, catastrophizing, and pain sensitivity scales. treatment involved ultrasound-guided pudendal nerve pulsed radiofrequency and x-ray-guided ganglion impar block. the patient global impression of change (pgic) and numeric rating scale (nrs) were used as the main observation indicators to evaluate the treatment effect at 1, 2, 3, and 6 months postoperatively, followed by correlation analysis with the scores of relevant scales.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years old; 2. diagnosis of pudendal neuralgia meets the nantes criteria. essential criteria include the following：1）pain in the territory of the pudendal nerve；2） pain is predominantly experienced while sitting；3) the pain does not wake the patient at night；4）pain with no objective sensory impairment；5）pain relieved by diagnostic pudendal nerve block； 3. received conservative treatment for more than 3 months, and either had poor response to conservative treatment or intolerable medication side effects. 4. capable of signing informed consent form. exclusion criteria: 1. pain caused by pelvic malignant diseases or autoimmune diseases; 2. pain caused by pelvic surgery; 3. taking anticoagulant drugs or having abnormal coagulation function; 4. pregnancy; 5. systemic infectious diseases; 6. inability to complete scale assessments.