Kornimate/medical-research-clean huggingface dataset:
a study to assess the immunogenicity and safety of csl's 2013/2014 formulation of enzira® vaccine in healthy volunteers

Conditions: Influenza, Human

Summary: this is a study to assess the immune (antibody) response and safety of the 2013/2014 formulation of enzira® vaccine in healthy adult volunteers aged 18 years or older.


Eligibility criteria:
inclusion criteria: * males or females aged 18 years or older at the time of vaccination. * females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine. exclusion criteria: * known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine. * clinical signs of an active infection. * a clinically significant medical condition. * vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * females who are pregnant or lactating.
neoadjuvant immunochemotherapy for lung cancer

Conditions: Lung Cancer

Summary: we retrospectively analyzed lung cancer patients who had naict and surgery in the department of thoracic surgery, zhongshan hospital. naict was defined as chemotherapy that included at one application of pd-1 inhibitor.


Eligibility criteria:
inclusion criteria: 1. lung surgery was performed in the department of thoracic surgery at zhongshan hospital; 2. at least one cycle of neoadjuvant treatment containing the immune drug pd-1 immunosuppressant was performed before surgery; 3. malignancy was present and confirmed in the pathology before treatment and after surgery; 4. the lung lesion was the primary lesion. exclusion criteria: 1. no lung surgery was performed until 2022.11; 2. no preoperative neoadjuvant therapy was performed or recorded; 3. neoadjuvant therapy did not include immune drugs; 4. previous history of malignancy (including surgery and adjuvant therapy); 5. previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. other conditions inappropriate for enrollment by the investigator.

Keywords: neoadjuvant therapy
perindopril amlodipine for the treatment of hypertension

Conditions: Essential Hypertension

Summary: the purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.


Eligibility criteria:
inclusion criteria: * essential hypertension * for female subjects, a negative serum pregnancy test * ability to provide written informed consent exclusion criteria: * night shift workers whose work hours include midnight to 4:00 a.m. * secondary hypertension * an arm size that precludes the use of the digital blood pressure monitor cuff (arm size \> 42 cm) * renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects * female subjects who are pregnant, planning to become pregnant * history of malignancy within 5 years * primary aldosteronism * heart failure (nyha functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve * significant cardiac arrhythmias, mi, stroke, cabg, ptca, unstable angina * known hypersensitivity to any component of the study drugs other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension essential hypertension
multicomponent cognitive behavioral therapy(cbt) for posttraumatic stress disorder (ptsd) and substance abuse

Conditions: Posttraumatic Stress Disorder; Substance Abuse

Summary: purpose: to conduct a pilot study of a cognitive-behavioral treatment (cbt) for ptsd and substance abuse among persons with serious mental illness (smi) treated in a community setting. participants: participants will be 50 volunteer adult individuals with ptsd and substance use disorders (sud), and smi who are receiving services at the freedom house recovery center, served through the orange person chatham (opc) area program. procedures (methods): participants will be randomly assigned to one of two conditions: 1) the cbt intervention plus treatment as usual; or, 2) treatment as usual.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * currently receiving services at freedom house * meet dsm-iv criteria for ptsd * meet criteria for substance use disorder * able to understand and provide informed consent exclusion criteria: • psychiatric hospitalization or suicide attempt in the past two months
bump on the ball: impact of a prenatal exercise & education program on birth outcomes & maternal quality of life

Conditions: Pregnancy

Summary: operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to maternal exhaustion, which leads to an inability to push effectively; 40% of operative vaginal deliveries at prentice are for maternal exhaustion. the risk of severe birth trauma is increased three to four fold with operative delivery. this randomized, controlled trial will compare rates of operative vaginal delivery and severe birth trauma in two groups of women: (1) an intervention group who will participate in the antepartum total control® fitness and education program modified for pregnancy; and (2) a control group. women will be recruited and followed from the second trimester until 6 weeks postpartum; all will complete validated questionnaires regarding their (1) level of worry and knowledge about their birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4) satisfaction with their birthing experience and (5) level of depressive symptoms at various time points during and after their pregnancy. obstetrical data will also be collected.

this will be a randomized controlled trial of primiparous women with singleton pregnancies who plan on delivering at prentice women's hospital. women will be recruited during their first trimester by their obstetrician as well as through standardized northwestern memorial hospital flyers and ads. demographic and delivery information will be obtained from the northwestern enterprise data warehouse (edw), as well as by the attending midwife or physician at the time of delivery using a standardized delivery information form. women will also be asked about their other physical activities (including other forms of daily/weekly exercise) as well as whether or not they are participating in other birthing classes at the time of their first total control class (intervention group) or 2nd trimester visit with their providers (controls). all women will wear pedometers to track daily general activity.

Eligibility criteria:
inclusion criteria: * singleton, primiparous pregnancy * delivering at prentice women's hospital * able to participate based on parmedx for pregnancy criteria exclusion criteria: * non-english or spanish speaking * age less than 18 years * known condition requiring cesarean section * currently enrolled in any kind of physical therapy * unable to complete the program secondary to medical limitations

Keywords: prenatal exercise prenatal education pregnancy exercise and birth outcomes education and birth outcomes maternal quality of life birth satisfaction
absorption, distribution, metabolism and excretion (adme) study of tki258 in patients with advanced solid malignancies

Conditions: Advanced Solid Malignancies

Summary: this is a phase l study to examine absorption, distribution, metabolism and excretion of tki258. there are 2 cohorts. cohort 1 (4 patients) will receive single radio-labeled 500mg dose of tki258 followed after 15 days by daily dosing of 400mg tki258. cohort 2 (9 patients) will receive 400mg tki258.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years 2. patients with histologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available. 3. who performance status ≤ 2 4. all previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have been resolved 5. written informed consent to participate in the study exclusion criteria: 1. primary brain tumors or symptomatic leptomeningeal metastases 2. clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start 3. fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection pregnant or lactating women (all women of childbearing potential must have a negative pregnancy test (\> 5 miu/ml) before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). female patients must use adequate contraceptive protection 4. centrally located or squamous cell carcinoma of the lung 5. proteinuria \> 1+ on dipstick testing 6. history of gastrointestinal malabsorption surgery involving intestinal anastomosis within four weeks of study start. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: adme tki258 rtks inhibitor pdgrf inhibitor vegfer inhibitor
effect of topical azithromycin on tear film thickness in patients with meibomian gland dysfunction

Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction

Summary: meibomian gland dysfunction (mgd) is among the leading causes for dry eye syndrome (des), affecting millions of people worldwide. we have shown in a previous study that tear film thickness (tft) is reduced in patients with des and that this reduction correlates with tear break up time (but) as well as with the severity of subjective symptoms. even though systemic tetracyclines as well as topical azithromycin can be used for the treatment of mgd, it seems that topical azithromycin is more effective than tetracyclines and also has the advantage of better tolerability. the hypothesis of the present study is that topical treatment with azithromycin leads to a more pronounced increase in tft compared to oral doxycycline in patients with des caused by mgd. the objective of this study is to compare the effect of treatment with topical azithromycin or oral doxycycline on tear film thickness in patients with des caused by mgd.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * signs of meibomian gland plugging or expressibility of the meibomian glands. * des most likely caused by mgd, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce des, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator * signed and dated written informed consent. * history of dry eye syndrome for at least 3 months * normal ophthalmic findings except dry eye syndrome and mgd, ametropia \< 6 dpts * but ≤ 10 seconds exclusion criteria: * participation in a clinical trial in the 3 weeks before the screening visit * symptoms of a clinically relevant illness in the 3 weeks before the first study day * presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator * sjögren's syndrome * stevens-johnson syndrome * presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator * treatment with corticosteroids in the 4 weeks preceding the study * wearing of contact lenses * topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants ocular infection * ocular surgery in the 6 months preceding the study * pregnancy, planned pregnancy or lactating * contraindication against the use of topical azithromycin or oral doxycycline
conventional vaccine and intradermal vaccine among hiv-infected young subjects

Conditions: Human Influenza

Summary: several studies have shown poor immune response to conventional influenza vaccines in hiv-infected individuals. this study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in hiv-infected adults.

during the 2011/2012 pre-influenza season, three vaccines were used in hiv-infected adults (18 to 60 years): inactivated intramuscular vaccine (agripal), reduced-content intradermal vaccine (idflu9μg) and standard-content intradermal vaccine (idflu15μg). serum hemagglutination-inhibiting (hi) antibodies and inf-γ elispot assay were measured at the time of vaccination and 1 month after vaccination. adverse events were recorded for 7 days.

Eligibility criteria:
inclusion criteria: * hiv-infected individuals who were not immunized with 2011/2012 influenza vaccine exclusion criteria: * known allergy to egg * presentation of any febrile illness ≥37.5°c on the day of vaccination * any history of hypersensitivity reaction to previous influenza vaccination * any other vaccinations within the past one month * use of immunosuppressive agent * recipient of blood product or immunoglobulins during the previous three months * any other conditions that might interfere with the study results
intravitreal bevasizumab versus intravitreal triamcinolone in central retinal vein occlusion (crvo)

Conditions: Central Retinal Vein Occlusion

Summary: this randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute central retinal vein occlusion. the outcomes are visual acuity and central macular thickness. the follow-up time is 6 months.


Eligibility criteria:
inclusion criteria: * recent onset (less than 3 months) central retinal vein occlusion exclusion criteria: * any previous intervention
mini-invasive approaches to aortic surgery

Conditions: Surgery; Surgical Injury; Surgical Procedure, Unspecified; Surgical Incision; Aortic Surgery

Summary: there are many different types of mini-invasive approaches to aortic surgery. ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.


Eligibility criteria:
inclusion criteria: - indication for aortic and/or aortic valve surgery exclusion criteria: - none

Keywords: miniinvasive surgery aortic surgery minithoracotomy ministernotomy outcomes surgical complications
detection of peritoneal metastases by diagnostic laparoscopy in patients with locally advanced cervical carcinoma

Conditions: Cervical Cancer

Summary: the study hypothesizes that specific subgroups of lacc patients, (ajcc stage t3/t4, grade 3 tumors, and para-aortic lymph node involvement), have a higher prevalence of peritoneal metastasis. this peritoneal spread may serve as a prognostic factor, and diagnostic laparoscopy could improve staging accuracy, thereby guiding personalized treatment strategies and improving oncological outcomes.

cervical cancer is the most prevalent gynecologic malignancy worldwide, with poor prognosis particularly in patients diagnosed with locally advanced cervical cancer (lacc; figo stage ib3-iva). although peritoneal metastasis is not included in figo staging, it is considered as a distant metastasis. several studies have reported peritoneal disease in about 20% of lacc patients undergoing diagnostic laparoscopy, suggesting a potential role for laparoscopy in staging. however, the benefit of laparoscopy in surgical staging is controversial and the impact of peritoneal involvement on prognosis remains unclear. this is a prospective, observational, single-center study. the primary objective is to assess the prevalence of peritoneal metastasis in specific subgroups of lacc patients (ajcc stage t3/t4, grade 3 cervical cancer, figo stage iiic2) using diagnostic laparoscopy. secondary objectives include evaluating 3-year disease-free survival (dfs), overall survival (os), and treatment response rates to exclusive chemoradiotherapy (if pelvic peritoneal involvement, figo iva) and chemo-immunotherapy (if upper abdominal peritoneal involvement, figo ivb) in patients with peritoneal metastasis.

Eligibility criteria:
inclusion criteria: * cervical cancer ajcc stage t3/t4 and/or * cervical cancer figo stage ib3 and iia2-iva grade 3 and/or * cervical cancer figo stage iiic2 (para-aortic lymph node metastasis). lymph node will be considered pathologic when the short axis diameter is \> 10 mm at mri scan and/or suv max \>2.5 at pet/ct-scan. * all cervical histology sub-types will be included * stage assessment according to local multidisciplinary board * age \>18 years * signature informed consent or substitute declaration on the consent form where applicable. exclusion criteria: * patients with previous diagnosis of other cancers * performance status ecog \>2 * pregnant women * contraindications to diagnostic laparoscopy * recurrent cervical cancer

Keywords: cervical cancer minimally invasive surgery in cervical cancer peritoneal metastases
an algorithmic approach to preoxygenation

Conditions: Preoxygenation; Anaesthesia Induction; Non-invasive Positive Pressure Ventilation

Summary: the aim of this randomized controlled trial is to evaluate an algorithmic approach to gradually adding pressure-supported ventilation and end-tidal positive pressure when conventional tidal volume breathing is insufficient for adequate preoxygenation. the main question it aims to answer is: * will the proportion of patients receiving preoxygenation increase? * will the duration of preoxygenation decrease? participants will; * 200 patients who were planned to undergo general anesthesia for elective surgeries * aged between 18 and 65 years * asa 1-2 physical status * eto2 \<90% at the end of the 3rd minute with spontaneous tidal volume breathing

the patients were randomly assigned to one of two groups (group tvb and group psv) according to a computer-generated randomisation table. in the patients included in group tvb, the tidal volume breathing was maintained for a further two minutes. group psv received inspiratory pressure support of 6 cm h2o for +1 min. at the end of four minutes, patients whose eto₂ value had not reached a minimum of 90% were randomly divided once more into two groups. one group continued with psv, while the other was administered 4 cm h₂o peep in addition to psv (group psv+peep). when adequate preoxygenation was achieved, the duration of preoxygenation, spo2, end-tidal carbon dioxide (etco2), arterial blood pressures and heart rate values were recorded. any adverse effects such as discomfort or gastric distension were noted.

Eligibility criteria:
inclusion criteria: * elective surgeries general anaesthesia was planned for a patient aged 18-65 years with asa 1-2 physical condition. exclusion criteria: * haemodynamically unstable, preoperative oxygen support such as increased intracranial or intraocular pressure, to be operated on by thoracic surgery have conditions in which positive pressure ventilation may be indirectly harmful, bmi≥35 kg/m2, pregnant, undergoing emergency surgery and causing leakage in mask ventilation bearded male patients were not included in the study.

Keywords: anaesthesia preoxygenation tidal volume psv peep
a trial to evaluate the safety and tolerability of namilumab (mt203) in patients with mild to moderate rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this trial is primarily to investigate the safety and tolerability of repeated subcutaneous injections of mt203 in patients with mild to moderate rheumatoid arthritis. furthermore, the amount of mt203 in the blood will be measured and it will be investigated how the body responds to mt203 treatment and if mt203 is effective in the treatment of rheumatoid arthritis.

the trial medication will be administered at 2 dose levels as subcutaneous injections. each patient will receive three injections in total. the trial duration consists of a screening period (28 - 2 days prior to the first injection) and a treatment and observation period (4 months). the trial requires approximately 20 visits at the study site.

Eligibility criteria:
inclusion criteria: 1. out-patients with active rheumatoid arthritis (ra), according to the acr 1987 revised criteria, with low to moderate disease activity (das28-esr ≥ 2.6 and ≤ 5.1) 2. patients must be on stable doses of methotrexate (mtx) ≥ 7.5 and ≤ 25 mg/week for at least 12 weeks before the first injection, with appropriate folic acid supplementation 3. age ≥ 18 years at screening 4. body weight at least 50 kg at screening; bmi: ≥ 18.0 and ≤ 30.0 kg/m2 at screening 5. negative tuberculosis test at screening 6. heterosexually active male and female patients of childbearing potential are obliged to follow whatever contraceptive and / or breastfeeding restrictions may be required for their concomitant medication(s), including methotrexate. in addition, heterosexually active male and female patients of childbearing potential are required to use effective double-method contraception (one hormonal contraceptive or intrauterine device and one other additional contraceptive method) for 1 month before the first administration of the imp, during the course of the trial, and for 6 month after the last injection of mt203. no special requirements are made for female patients proven to be post-menopausal (at least 2 years after last menstrual period and fsh ≥ 40iu/l), surgically sterilized or hysterectomized. likewise no special requirements for heterosexually active male who are surgical sterilized. pregnant or lactating female patients have to be excluded. exclusion criteria: 1. participation in another clinical trial or previous dosing in this trial 2. use of specified medications within certain timeframes or use of certain comedications 3. history or presence of specified diseases 4. drug abuse 5. certain laboratory parameters outside a specified range 6. donation of blood 7. relevant decrease in lung function 8. infections, frequent or chronic infections, herpes zoster 9. females: positive pregnancy test 10. presence of history of tuberculosis 11. history of malignancy

Keywords: rheumatoid arthritis mt203 human igg1 monoclonal antibody gm-csf monoclonal antibody
galig gene expression in parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is the most frequent neurodegenerative disorder after alzheimer's disease. it is characterized by motor symptoms (rigidity, tremor, slowness of movements), and non-motor symptoms (neuropsychological, psychiatric, pain ...). neuronal death initiates in the brainstem and extends progressively through the entire cortex. the processes leading to cell death are poorly understood. pathological cells exhibit abnormal deposits, called lewy bodies, which contain numerous proteins. a major constituent of these protein deposits is alpha-synuclein. it has recently been demonstrated, in the laboratory of molecular biophysics of the cnrs (scientific research national center) in orleans, that α-synuclein interacts with cytogaligin, a protein produced by the proapoptotic galig gene. cytogaligin could thus be a factor regulating α-synuclein activity or aggregation. it is postulated that the level of expression of the galig gene is different in parkinson's disease patients compared with control subjects.


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease according to the criteria of the ukpdbb (uk parkinson's disease brain bank). exclusion criteria: * insane patient arriving without a third party. * patient with parkinson's disease arising from another etiology.

Keywords: parkinson alpha-synuclein galig quantitative pcr (polymerase chain reaction)