Kornimate/medical-research-clean huggingface dataset:
ranibizumab for the inhibition of neovascularization in pterygia

Conditions: Pterygium

Summary: the primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.

as a secondary objective, this study also aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection in patients undergoing pterygium excision and to determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.

Eligibility criteria:
inclusion criteria: * subjects will be eligible if the following criteria are met: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 18 years * patient related considerations: all patients of both genders will be considered for enrollment. * disease related considerations: * patients with pterygia will be considered for enrollment if the pterygium meets standard pterygium excision criteria including encroachment into the visual axis * severe induced astigmatism * foreign body sensation unresponsive to medical therapy. exclusion criteria: subjects who meet any of the following criteria will be excluded from this study: * pregnancy (positive pregnancy test) * women seeking to become pregnant * lactating women * prior enrollment in the study * prior glaucoma surgery in the region of the pterygium * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * participation in another simultaneous medical investigation or trial

Keywords: ranibizumab pterygium
2010/2011 trivalent influenza vaccination

Conditions: Influenza

Summary: intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.

this is a prospective, randomized, single centre trial in the queen mary hospital. we aim to recruit 400 subjects \[with a minimum of 50 subjects per group\] who would be qualified for the hospital authority (ha)/ centre for health protection (chp) mass vaccination program for 2010/2011 tiv. these patients include all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness (or healthcare workers). subjects will be randomly assigned into 4 groups: group 1 (id1) to receive a single low-dose intradermal injection of 2010/2011 tiv, with a microneedle device. group 2 (id2) to receive a single higher low-dose intradermal injection of 2010/2011 tiv with a microneedle device. group 3 (im15) to receive a single full-dose (15ug) standard 2010/2011 tiv delivered intramuscularly by conventional needle. group 4 (int) to receive a single low-dose intradermal injection of 2010/2011 tiv, with intanza® needle. the 2010/2011 tiv used will be fluzone®, sanofi-pasteur for group 3 and intanza®, sanofi-pasteur for group 1,2 and 4.

Eligibility criteria:
inclusion criteria: * all participants qualified for the ha/ chp mass vaccination program for tiv 2010/2011 seasonal influenza as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above that are either healthcare workers or that have a chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure. * all patients give written informed consent. * subjects must be available to complete the study and comply with study procedures. exclusion criteria: * clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers. * history or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study * have a known allergy to eggs or other components of the study vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients. * have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months. * have an active neoplastic disease or a history of any hematologic malignancy. * have known active human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection or autoimmune hepatitis and cirrhosis. * history of progressive or severe neurological disorders or guillain-barré syndrome.
a clinical study of shr8554 injection for the treatment of pain after abdominal surgery.

Conditions: Pain

Summary: the primary objective is to evaluate the analgesic efficacy of iv shr8554 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring elective general anesthesia abdominal surgery 3. conform to the asa physical status classification exclusion criteria: 1. subjects with a history of difficult airway 2. subjects with a history of reflux esophagitis 3. subjects with a history of mental illness 4. subjects with poor blood pressure control 5. transcutaneous oxygen saturation (spo2) \<90% 6. random blood glucose ≥11.1mmol/l 7. subjects with abnormal liver function 8. allergies to opioids and other medications that may be used during the trial 9. pregnant or nursing women
efficacy of amodiaquine-artesunate in children aged 6-59 months with uncomplicated p. falciparum malaria

Conditions: Malaria

Summary: we will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (ipti)trial in the same area in order to correlate preventive efficacy seen in ipti with efficacy for treatment of symptomatic malaria for each regimen.

we propose to conduct an amodiaquine-artesunate efficacy trial at bondo district hospital in kenya. the results will enable us to better interpret the results of the main ipti trial. we will assess the efficacy of a three day course of amodiaquine plus three days of artesunate (aq3/as3) for the treatment of symptomatic, uncomplicated p. falciparum infections. study subjects are febrile children, 6-59 months old, with laboratory-confirmed uncomplicated p. falciparum infections. clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. children will be followed closely for signs of drug failure or recrudescence, and any children failing therapy will be treated with coartem or, if severe, with quinine. we will also perform drug resistance testing on parasite samples from children with treatment failure. the results of this efficacy trial will allow us to assist policymakers in deciding what drugs should be used for ipti, should it be adopted into national policy.

Eligibility criteria:
inclusion criteria: * age 6-59 months * axillary temperature ≥ 37.5º c, or history of fever in previous 24 hours * weight ≥ 5.0 kg * slide-confirmed infection with p. falciparum * parasitemia 2000-200,000 asexual forms per μl * ability and willingness to attend stipulated follow-up visits exclusion criteria: * signs or symptoms of severe disease * weight-for-age ≤ 3rd percentile on kenya growth charts * slide confirmed infection with any other plasmodium spp., besides falciparum * severe anemia, defined as hb \< 7 g/dl * known hypersensitivity to any of the drugs being tested * enrolled in ipti trial * known chronic disease

Keywords: malaria efficacy intermittent preventive therapy in infants drug resistance
performances of a fast test for the detection of helicobacter pylori antigens in child stool

Conditions: Helicobacter Pylori Infection

Summary: the diagnostic tests used to detect helicobacter pylori (h. pylori) infection are either direct and invasive, as in culture, histology and the rapid urease test (rut) or noninvasive, such as serology, the 13c-urea breathe test or the stool antigen test. however, there is no single reference method to detect the h. pylori infection reliably and accurately. the specificity of gastric biopsy cultures is 100%, but the sensitivity is lower. histology and rut provide excellent diagnostic accuracy, but the detection of h. pylori is decreased in cases of bleeding peptic ulcers or gastric atrophy. therefore, it is recommended that at least two tests should agree when defining the h. pylori infection in children. quantitative real-time polymerase chain reaction (qpcr)-based methods have been shown to be the most reliable for h. pylori detection in adults and in children. in children, the reference method for h. pylori infection detection is invasive, namely upper digestive endoscopy with gastric biopsy for histology, culture, rut and qpcr. a noninvasive alternative to detect h. pylori antigen in stools could use a quick one-step immuno-chromatographic technique. the aim of this study was to assess the performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test (alere inc, jouy-en-josas, france) for the detection of h. pylori infection in children.


Eligibility criteria:
inclusion criteria: * children \<18 years old * all children undergoing a high digestive endoscopy with per-endoscopic gastric biopsies. * informed consent of parents and children exclusion criteria: * children having received an antibiotic treatment 4 weeks before inclusion * children having received proton pump inhibitors 2 weeks before inclusion * children having received bismuth salts 2 weeks before inclusion
safety and immunogenicity of the butantan institute influenza vaccine compared to sanofi pasteur influenza vaccine

Conditions: Influenza

Summary: the overall aim of this study is to evaluate the safety and immunogenicity of butantan institute trivalent seasonal influenza vaccine in comparison with the sanofi trivalent seasonal influenza vaccine.

to detemine whether immunogenicity elicited by a single-dose butantan institute trivalent seasonal influenza vaccine is not inferior to that elicited by a single dose of sanofi trivalent seasonal influenza vaccine in adult and elderly populations measured by hi gmt for the three vaccine components 21 days post-immunization. to describe the safety profile of butantan institute trivalent seasonal influenza vaccine and sanofi trivalent seasonal influenza vaccine after a single dose in adult and elderly populations.

Eligibility criteria:
inclusion criteria: * adult, male or female, age 18 to 69 years (inclusive) at the time of enrollment; * provide written informed consent; * agrees to complete all study visits, procedures and contacts; exclusion criteria: * chronic medical conditions such as psychiatric conditions, diabetes, hypertension or any other conditions that might place the subjects at high risk of adverse events. study clinicians will use clinical judgment on a case-by-case basis to assess safety risks under this criterion; * clinically significant abnormalities on physical examination; * use of immunosuppressive medications such as systemic corticosteroids or chemotherapeutics, or immunosuppressive illness. it will be considered immunosuppressive dose of systemic corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days; * women who report being pregnant or have plans to become pregnant during the study period; * participation in research involving another investigational product within 30 days before planned date of first vaccination or anytime through the last study safety visit; * acute febrile illness (axilar temperature ≥ 37.8°c); * hypersensitivity to egg or chicken proteins; * history of guillain-barre syndrome; * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination; * unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the previous 12 weeks); * alcohol abuse or drug addiction; * any vaccination within the previous 4 weeks; * seasonal influenza vaccination in the previous 6 months.

Keywords: vaccine immunization safety immunogenicity
relationship between kinesthetic perception, motor competence, physical fitness and emotional intelligence in children

Conditions: Children

Summary: the benefits of an active lifestyle and physical fitness extend to physical, mental, and social aspects of well-being, including improved cardiopulmonary health, concentration, and self-confidence. the world health organization recommends 60 minutes of daily activity to combat childhood obesity, which is influenced by factors like lack of exercise, poor diet, and sedentary behaviors. obesity negatively impacts children's kinesthetic perception, motor skills, and emotional resilience, crucial for their nervous system development. this study aims to explore the relationship between these factors in obese school-age children.

the data will be collected by both subjective and objective assessments. the data collection will be organized at the premises of the participating schools during the time allocated for physical education and breaks. consent will be taken from each participant before any assessment. the data will be collected included anthroprometric and demographics included sex, age, class/grade level, height, weight, bmi (calculated as the weight divided by the square of height). measurement tools such as, pmsc will be used to assess motor competence and physical fitness in young children. it is a performance based tool, pmsc will assess children's fundamental locomotion skills such as catching, running, kicking, jumping forward, skipping and hitting ball with one hand. each question will be scored as 'good' or 'not as good'. kinesthetic perception will be assessed by nelson hand reaction time. it is a performance based activity. it will test the subject's kinesthetic perception visually, auditory senses and tactile senses. emotional intelligence will be assessed using panas tool.

Eligibility criteria:
inclusion criteria: * age of the participants 10 to 15 years * male and female will be included. * obese class 1, class 2, class 3 exclusion criteria: * children who have high risk level and poor safety as it pertains to physical activity. * children with disabilities that are limited in their ability to understand the testing instructions or the performance of the activities (e.g., cognitive impairments, gross motor impairments etc.). •. children with any kind of disability and congenital deformity

Keywords: kinesthetic perception, motor competence
a study to evaluate tarceva in patients with advanced non-small cell lung cancer (nsclc)

Conditions: Lung Cancer; Non-small-cell Lung Carcinoma

Summary: this is a phase iiib, multicenter, open-label trial of daily oral tarceva in patients with advanced (inoperable stage iiib or iv) nsclc who have progressed following standard chemotherapy treatment.


Eligibility criteria:
inclusion criteria: * written (signed) informed consent(s) * inoperable and incurable, locally advanced, recurrent or metastatic nsclc * relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients) * age \>=18 years * ecog performance status of 0 to 3 * recovered from the toxic effects of prior therapy * able to comply with study and follow-up procedures * able to take oral medication * use of an effective means of contraception (for patients with reproductive potential) * granulocyte count \>=1.0 x 10\^9/l * platelet count \>=75 x 10\^9/l * serum bilirubin \<1.5 x upper limit of normal (uln) * sgot (ast) \<2 x uln unless elevation is clearly due to liver metastases; then sgot (ast) must be \<5 x uln * serum creatinine \<=1.5 mg/dl exclusion criteria: * any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease) * prior therapy with any systemic her1/egfr small molecule inhibitor, including gefitinib (iressa), erlotinib (tarceva), or other investigational agents in this class * history of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of \>=90% * known central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable * nursing mothers or pregnant females

Keywords: advanced non-small cell lung cancer
validity and reliability of the turkish st. marks incontinence score

Conditions: Fecal Incontinence; Pelvic Floor Disorders

Summary: for the turkish validity and reliability study of st.mark's (vaizey) incontinence score, which consists of 7 questions, it will be applied to 65 people diagnosed with anal incontinence after it is translated by translation-retranslation method.


Eligibility criteria:
inclusion criteria: * people with the complatint of anal incontinence * being volunteered to participate exclusion criteria: - having difficulties in understanding and speaking turkish
clinical use and safety of the fentanyl transdermal therapeutic system (tts) in the management of pain in patients with cancer

Conditions: Pain; Cancer

Summary: the purpose of this study is to establish the clinical utility and safety of fentanyl tts (a transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in patients with cancer.

this is a single-arm, non-randomized, open-label, multi-center trial to assess the safety and clinical utility of the fentanyl transdermal therapeutic system (tts) for the treatment of pain in patients with cancer. patients requiring narcotics for pain management are converted from conventional analgesics to oral morphine, and titrated to a stable dose prior to the initiation of fentanyl tts. the stabilized morphine dose provides the basis for the calculation of the equi-analgesic dose of fentanyl tts based on established analgesic potency ratios. patients replace the fentanyl tts patch every 3 days. immediate-release morphine is available as rescue medication for breakthrough pain. the adequacy of analgesia, use of morphine rescue medication, and routine safety evaluations are obtained at scheduled intervals throughout the trial. fentanyl patch

Eligibility criteria:
inclusion criteria: * patients currently taking narcotic analgesics for relief of cancer pain * able to communicate effectively * living with a constant caretaker * who have achieved a stabilized morphine dose that provides adequate pain control exclusion criteria: * patients with a life expectancy of less than 30 days * having history of carbon dioxide (co2) retention or other cardiac, respiratory or nervous system disease (precludes participation because of the potential for respiratory depression) * has severe renal or hepatic insufficiency, active skin disease, a history of allergic reactions to narcotics, or a history of narcotic abuse prior to treatment with narcotics for cancer-related pain * has a mental or psychiatric disease * if female of child-bearing potential, currently pregnant or not practicing an acceptable method contraception

Keywords: patch pain fentanyl narcotic cancer
cisplatin and pemetrexed with radiation followed by lobectomy

Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung; Nonsmall Cell Lung Cancer Stage III

Summary: this study is open to patients that have been diagnosed with non-squamous stage iii non small cell lung cancer (nsclc) and will have surgery to remove the tumor. the purpose of this study is to: * test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. chemotherapeutic drugs selectively destroy diseased cancer cells and tissues. * test the safety of different dose levels of radiation when given with each combination of chemotherapy; * determine what side effects are associated with combining radiation with these two chemotherapy combinations.


Eligibility criteria:
inclusion criteria: * histologically and cytologically confirmed non-squamous nsclc. * resectable t3, and or n2 disease (t3n1, and resectable t1-3n2 multi-station non-bulky with no nodal station being more than 2 cm on preoperative workup, t4n0-1 * resectable t3 includes patients with a satellite lesion in the same lobe as the primary. * male or female, aged \> or = 18 years and be able to give informed consent. * tumor should be technically operable with a lobectomy, bilobectomy or a sleeve resection. * patient should be medically operable * ecog performance status 0 or 1. * adequate bone marrow, hepatic and renal function assessed within 28 days * signed informed consent. * women of childbearing potential should have negative pregnancy test prior to enrollment to study. * men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter. * the ability to interrupt nsaids 2 days before (5 days for long-acting nsaids), the day of, and 2 days following administration of pemetrexed. * the ability to take folic acid, vitamin b12, and dexamethasone according to protocol. * patients must have a negative mri or ct scan of the brain. exclusion criteria: * patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * patients may not be receiving any other investigational agents. * history of allergic reactions attributed to compounds or other agents used in study. * pregnant or lactating women. * male patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial. * patients with concurrent serious infections. * patients with an unstable or serious concurrent medical condition are excluded. * presence of third space fluid which cannot be controlled by drainage. * weight loss \> 10 percent from baseline weight. * hiv-positive patients on combination antiretroviral therapy are ineligible * patients with hypercalcemia will be excluded. * patients who require a pneumonectomy will be excluded.

Keywords: resectable
examination of pregnant women in third trimester by ultrasound to detect any congenital anomalies

Conditions: Congenital Anomaly

Summary: this study aims to help the physicians to evaluate the practice of routine third trimestric fetal scan whether it should be routinely performed to all cases including those with low risk singleton pregnancies.

the third-trimester ultrasound scan ,traditionally performed at 32-34weeks, can assess fetal viability , presentation, anatomy , growth, amniotic fluid volume, placental location and fetoplacental doppler. there are multiple other indications that can trigger a third-trimester scan, including antepartum bleeding , reduced fetal movements, preterm rupture of the membranes and suspected abnormalities of fetal growth based on physical examination. in addition, ultrasound may be used to guide other procedures in the third trimester, such as external cephalic version. however, as yet, there is no convincing evidence that routine universal third-trimester ultrasound examination in a low-risk population improves either perinatal or maternal outcome especially in low socioeconomic countries with limited resources

Eligibility criteria:
inclusion criteria: * singleton healthy pregnancy at second and third trimesters of pregnancy. * fetuses were considered normal based on second trimestric fetal scan in our feto-maternal unit exclusion criteria: * exclusion criteria were patients with multiple gestations, maternal medical complications as preeclampsia, dm ,cardiac or renal diseases , or fetal abnormalities