Kornimate/medical-research-clean huggingface dataset:
a study to evaluate lenti-hpv-07 immunotherapy against hpv+ cervical or oropharyngeal cancer

Conditions: HPV-Related Cervical Carcinoma; HPV Positive Oropharyngeal Squamous Cell Carcinoma

Summary: the goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called lenti-hpv-07 in patients with a cancer induced by human papilloma virus (hpv). the main questions aim to answer are: * is lenti-hpv-07 safe? * does lenti-hpv-07 induce an immune response? participants will be assigned to a group based on their cancer type * either study drug group a: recurrent and/or metastatic cancer * or study drug group b: newly diagnosed with locally advanced cancer after they finish the study treatment, they will be followed for up to 1 year. follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.


Eligibility criteria:
inclusion criteria: * histologically confirmed invasive hpv-related oropharyngeal or cervical cancer * ecog performance status of 0 or 1 * adequate hepatic, renal, pulmonary, and bone marrow/hematological function exclusion criteria: - with seropositivity for hiv, active hepatitis c virus (hcv) infection, or hepatitis b (hbv) infection

Keywords: hpv16 cervical cancer oropharyngeal cancer immuno-oncotherapy head and neck cancers t-cell vaccine lentiviral vector anti-tumor immunity early e- and e7 antigens hpv18 human papillomavirus
incidence of sub-clinical cystoid macular edema after cataract surgery

Conditions: Cataract; Glaucoma

Summary: cystoid macular edema (cme) can limit visual acuity after cataract surgery. little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (flacs), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+migs) procedures.

subclinical cystoid macular edema (cme) can limit visual acuity after cataract surgery. little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (flacs), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+migs) procedures. the investigators hypothesize that cme incidence will be in the following order: flacs \< phaco \< phaco+migs due to the increase of inflammation with the different surgical procedures. the study is designed as a single centre, prospective study. the study includes patients with a diagnosis of cataract or cataract and glaucoma who will undergo one of the three above mentioned sürgical procedures at the department of ophthalmology at the universityhospital zurich (usz), zurich, switzerland. cme will be assessed by optical coherence tomography of the macular with heidelberg spectralis sd-oct of the macular at: baseline (i.e. preoperative), 1 week, 1 month, 3 months, and 6 months post-surgery. furthermore, a swept source optical coherence tomography angiography (oct-a) using zeiss plex elite 9000 will be performed at: baseline (i.e. preoperative), 1 week, 1 month, and 6 months post-surgery to image the retinal vessels.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of cataract or * patients with a diagnosis of cataract and open angle glaucoma * signed lnformed consent * patients at the age of 18 or older exclusion criteria: * loss of follow up, i.e. not available during the post-operation follow-up inteval. * previous known of cme, macular pathology (e.g., diabetes, exudative age-related macular degeneration, status post retinal vein occlusion) or posterior uveitis. * patient unable to understand the study due to cognitive or linguistic incapacity.

Keywords: cataract glaucoma cystroid macular edema
phase ii neoadjuvant er+/pgr + arimidex +/- iressa study

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving anastrozole or anastrozole/zd1839 combination.


Eligibility criteria:
inclusion criteria: * measurable (stage i-iiib) non meta static non inflammatory breast cancer * patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. postmenopausal patients are defined as: * natural menopause with last menses \> 1 year ago, * radiation induced oophorectomy with last menses \> 1 year ago, * serum fsh and lh levels clearly in the postmenopausal range for the institution. * bilateral oophorectomy exclusion criteria: * other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities, * hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
safety and efficacy of selonsertib in adults with compensated cirrhosis due to nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis

Summary: the primary objective of this study is to evaluate whether selonsertib (sel; gs-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to nash.


Eligibility criteria:
key inclusion criteria: * liver biopsy consistent with nash and cirrhosis (f4 fibrosis) according to the nash clinical research network (crn) classification, in the opinion of the central reader * has the following laboratory parameters at the screening visit, as determined by the central laboratory: * alanine aminotransferase (alt) ≤ 8 x upper limit of normal (uln) * creatinine clearance (clcr) ≥ 30 milliliter/minute (ml/min), as calculated by the cockcroft-gault equation * hba1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if hba1c is unable to be resulted) * international normalised ratio (inr) ≤ 1.4, unless due to therapeutic anti-coagulation * platelet count ≥ 100,000/μl key exclusion criteria: * prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (he), or variceal bleeding * child-pugh (cp) score \> 7, as determined at screening, unless due to therapeutic anti-coagulation * model for end-stage liver disease (meld) score \> 12, as determined at screening, unless due to therapeutic anti-coagulation * other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis b, hepatitis c, autoimmune disorders, drug-induced hepatotoxicity, wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology. * history of liver transplantation * current or history of hepatocellular carcinoma (hcc) note: other protocol defined inclusion/exclusion criteria may apply.
study on ocular blood flow and the orbital cerebrospinal fluid pressure in glaucoma

Conditions: Open Angle Glaucoma; Normal Tension Glaucoma

Summary: ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when compared to otherwise healthy individuals. numerous doppler studies have shown a decrease in flow velocities in the retrobulbar arteries in what appears to be related to the degree of the glaucomatous disease. the anatomic pathway of the several arteries into the eye is intricately complicate, with at least one of them (the central retina artery) penetrating the optic nerve before entering the eye and supplying the innermost structures of the globe. as the optic nerve is surrounded by a layer of cerebrospinal fluid (csf) which is in continuity with the rest of the central nervous system, this central retinal artery has also to cross this csf containing compartment. because of the intrinsic pressure this csf - corresponding to the intracranial pressure at the orbital level - the possibility exists that this pressure around the optic disc could affect the blood flow of the arteries that go through it. the investigators will try to detect if a correlation exists between the optic nerve sheath diameter and the blood flow in the retrobulbar vessels of glaucoma patients.

1. visual field testing will be performed. 2. structural analysis of the retinal nerve fiber layer (through confocal microscopy)will be performed. 3. color doppler imaging of the retrobulbar vessels will be performed. peak and end diastolic velocities, resistivity index will be calculated from the doppler waveform. 4. b-scan ultrasound of the optic nerve sheath diameter will be performed. the measure will take place at 3mm behind the globe.

Eligibility criteria:
inclusion criteria: * individuals over 18 years old * willing to sign an informed consent and able to comply with the requirements of the study * having no other ocular diseases besides glaucoma exclusion criteria: * history of ocular trauma * intraocular surgery (except for cataract surgery) * eye disease (except glaucoma) * systemic diseases with ocular involvement like diabetes
prospective research in infants with mild encephalopathy

Conditions: Hypoxic-Ischemic Encephalopathy; Brain Injury; Neonatal Seizure

Summary: a multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (ne) who are not qualified for therapeutic hypothermia. the intervention includes: neurologic examination by using modified sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aeeg) at 6 ± 3 hrs of age, brain mri at before discharge home to 30 days of age and follow-up at 18-22 months of age. primary outcome is the percentage of mild ne infants with evidence of brain injury defined by the presence of at least 1 abnormality of brain mri, aeeg or neurologic examination in the neonatal period. secondary outcome is the percentage of brain mri, aeeg and neurological exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home, death and long-term outcome.

globally, an estimated 1.8 to 7.7 infants per 1000 live term births suffer from perinatal asphyxia, which remains an important cause of neonatal encephalopathy (ne) and neurodevelopmental impairment. over the last six years, several randomized control trials have demonstrated that prolonged and moderate therapeutic hypothermia (th) reduces the rate of death or disability at 18 months of age among infants who survived. in these trials, infants were eligible if there was evidence of perinatal hypoxia-ischemia and a moderate or severe degree of encephalopathy on neurological evaluation performed at ≤ 6 hrs of age. however, it has been recognized that the level of ne may change over time. preliminary and unpublished observations from our group indicated that some infants who were not classified as moderate or severe ne had neurological abnormalities at discharge or evidence of brain injury on mri performed during the neonatal period. unfortunately, precise data on the outcomes of this specific population is not clear. since th is not offered to this population, the outcomes of infants that do not qualify for th based on neurological evaluation performed ≤ 6 hrs of life requires a more precise investigation.

Eligibility criteria:
inclusion criteria: * infants with birth weight \> or = 1800g and gestational age \> or = 36 weeks and * admission to neonatal intensive care unit (nicu) for possible hypothermia at \< or = 6hr of life exclusion criteria: * infants with normal neurological evaluation * major congenital abnormalities * refusal of informed consent * infants who receive passive or active cooling prior to the nicu admission * infants that develop seizures or moderate/severe ne within the first 24 hr of life and are initiated on therapeutic hypothermia after 6 hr of life.

Keywords: hypoxic ischemic encephalopathy
the prediction using diffusion mri of the response evaluation in brpc in nat.

Conditions: Pancreatic Cancer

Summary: to investigate the correlation between pretreatment adc value of diffusion mri and pathologic response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant therapy.

aim: the prediction using diffusion-weighted mri of the response evaluation in borderline resectable pancreatic cancer. study design: single institution. single arm. prospective phase ii study. number of case: 28 patients: the prediction using dmri of the response evaluation in borderline resectable pancreatic carcinoma (brpc) in neoadjuvant therapy. disease: pancreatic carcinoma method: to investigate the correlation between pretreatment adc value of diffusion mri and pathologic response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant therapy. the correlation between pretreatment adc value of diffusion mri and pathologic response evaluated by evans grade in patients with borderline resectable pancreatic carcinoma (brpc) who undergo neoadjuvant therapy. 1. the correlation between pretreatment adc value at the abutment site of brpc and the rate of tumor cell destruction. 2. the correlation between posttreatment adc value at the abutment site of brpc and the rate of tumor cell destruction. 3. the correlation between the ratio of posttreatment/pretreatment adc value at the abutment site of brpc and the rate of tumor cell destruction. 4. the correlation between pretreatment adc value of brpc tumor in a largest diameter and the rate of tumor cell destruction. 5. the correlation between the ratio of posttreatment/pretreatment adc value of brpc tumor in a largest diameter and the rate of tumor cell destruction. 6. adc cut-off value which predict more than 50% and less than 10% in tumor cell destruction rate. 7. the correlation between the ratio of posttreatment/pretreatment adc value of brpc tumor in a largest diameter and the ratio of posttreatment/pretreatment suv max. 8. adc cut-off value and suv max cut-off value which predict survival time after surgery more than 2 years and less than 2 years. 9. the comparison of the accuracy of prediction for pathological diagnosis at abutment site between the ratio of posttreatment/pretreatment adc value and ct scan. 10. three correlation between high adc value/low adc value/the ratio of posttreatment/pretreatment adc value and survival time after surgery. 11. three correlation between high adc value/low adc value/the ratio of posttreatment/pretreatment adc value and decreasing rate of ca19-9 value. 12. the correlation between tumor's limb sign in diffusion mri and the rate of tumor cell destruction more than 10%.

Eligibility criteria:
the patients with borderline resectable pancreatic cancer who is expexted to undergo neoadjuvant therapy and subsequent radical surgery.
use of short text messages to promote medication adherence in hypertensive patients

Conditions: Hypertension; Adherence, Treatment

Summary: objective: to evaluate the effect of intervention by sending short text messages with a reminder of the time of medication use, compared to sending educational messages, on adherence to drug treatment in patients with hypertension. methodology: prospective, randomized, controlled, double-blind, parallel group study that will be performed in patients with hypertension seen at a community pharmacy in brazil. the following groups will be compared: a) intervention group 1: 70 hypertensive patients registered for access to medication associated with usual care, in addition to text messages via mobile phone with educational information b) intervention group 2: 70 hypertensive patients registered for access to medications that will additionally receive text messages at the times indicated in the prescription for use of each indicated medication, in addition to educational information. after the washout period, the groups will have the active interventions changed for an additional 90 days. the proportion of adherent and non-adherent patients with and without controlled bp in both groups will be compared after the periods of application of the different interventions.


Eligibility criteria:
inclusion criteria: hypertension diagnosis, age, availability of mobile phone with short message texts access and ability to read and access short message texts - exclusion criteria: visual, hearing or mental disabilities that disables receiving short message texts , being pregnant, recently delivered or breastfeeding -

Keywords: hypertension primary health care
eye gaze strategies during facial emotion recognition in neurodegenerative diseases: links with neuropsychiatric disorders (eye-tom study)

Conditions: Alzheimer's Dementia; Parkinson Disease(PD); Fronto-Temporal Dementia

Summary: it is commonly admitted that social cognition impairment, like deficit in facial emotion recognition or misinterpretation of others' intentions (theory of mind), are associated with social behavior disorders. this kind of disorders are observed in fronto-temporal dementia (ftd), alzheimer's dementia (ad) and parkinson's disease (pd), with severe deficits in ftd and lighter deficits in ad and pd. one explanation might be that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others. this study aims to test this hypothesis and further to analyse whether different patterns emerge from these pathologies.


Eligibility criteria:
inclusion criteria: * hospitalized or coming to perform a consultation, for whom an eye-tracking examination is indicated as part of routine care. * sufficient written and oral expression in french. * written informed consent signed by the patient. * for the control group: no cognitive impairment (non pathological mmse (according to age, gender and socio-cultural level), no neurological history, and no psychiatric history (especially anxiety and depressive disorders). * for the ftd group: patient diagnosed according to revised rascovsky et al. 2011., no neurological history (excepted diagnosed ftd), and no psychiatric history (excepted those related to diagnosed ftd). * for the ad group: patient diagnosed according to dsm-iv-tr criteria, no neurological history (excepted diagnosed ad), and no psychiatric history (excepted those related to diagnosed ad). * for the pd group: patient diagnosed according to ninds criteria, no neurological history (excepted diagnosed pd), and no psychiatric history (excepted those related to diagnosed pd). exclusion criteria: * general anaesthesia within 3 months. * ophthalmological problems preventing a video-oculography examination. * oculomotor disorders such as "fixation disorders" or "ocular tracking disorders". * cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia. * history of stroke. * history of alcohol or drug abuse.

Keywords: eye-tracking neuropsychological evaluations
comparative clinical efficacy between multi-layer bandage pressure therapy and gradient pressure elastic stocking treatment after endovenous radiofrequency ablation

Conditions: Vascular Diseases, Peripheral; Venous Insufficiency of Leg; Varicose Veins of Lower Limb

Summary: objective: to assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (rfa) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.

postoperative compression of varicose veins can achieve compression hemostasis, early getting out of bed, reducing edema, preventing phlebitis, ensuring closure effect, reducing soreness and pain, and preventing thrombosis. compression therapy is a continuation of minimally invasive treatment of varicose veins, and postoperative compression therapy is continued for at least 1 month, and grade ii compression therapy may be considered.the application of postoperative compression to the treated limb after radiofrequency ablation of the great saphenous vein has been a topic of controversy. the basic principle of using postoperative compression is to reduce the risk of bleeding, hematoma formation, pain, swelling, and thrombus formation. however, many patients find wearing gradient pressure elastic stockings cumbersome and uncomfortable, as the silicone grips around the stockings can cause skin itching and discomfort. moreover, there is a lack of strong evidence supporting this treatment. the purpose of this study was to investigate the effectiveness of continuous 48-hour use of gradient pressure elastic stockings for compression of the affected limb after endovenous radiofrequency ablation.

Eligibility criteria:
inclusion criteria: * age \>18 years and \<80 years, and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up. * c2 - c5 varicose veins / cvi symptomatic primary gsv, ssv, or aasv incompetence, with reflux \>0.5 seconds on color duplex, eligible for patients undergoing radiofrequency ablation. * color replica ultrasound or venography of the lower extremity veins shows saphenous varicose veins without evidence of deep venous stenosis, filling defects, or ultrasound abnormalities. * no contraindications to the wearing of compression stockings (e.g., arterial insufficiency, skin allergies) exclusion criteria: * severe deep vein valve insufficiency or acute deep vein thrombosis of the lower extremities * previous history of high ligation and dissection of the saphenous vein, recurrence of collateral branches of the deep vein * superficial vein thrombosis is present at the treatment site, with local redness, swelling, warmth, pain, and significant signs of inflammation

Keywords: gradient pressure elastic stockings varicose veins radiofrequency ablation compression therapy
outcomes in cf patients accessing their registry health records

Conditions: Cystic Fibrosis

Summary: a multifactorial, parallel group, randomised control study in cystic fibrosis (cf) patients aged 13-30 years over an 18 month period. patients will be offered read-only access to their cf registry electronic health record (cf view), or educational videos on cf (videos), or videos and cf view, or usual standard of care. the study aims are to examine the effect of patient access to c view on a range of clinical outcomes, health service usage, health literacy and patient reported outcomes.


Eligibility criteria:
inclusion criteria: * diagnosed with cf * registered with their national cf patient registry * fev1pp ≥40 * aged 13-30 years exclusion criteria: * organ transplantation * fev1pp \<40
dietary and exercise interventions in preventing cardiovascular disease in younger survivors of leukemia, lymphoma, or brain tumors

Conditions: Childhood Brain Tumor; Childhood Hodgkin Lymphoma; Childhood Non-Hodgkin Lymphoma; Malignant Childhood Neoplasm

Summary: this clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer.

participants receive personalized exercise plan and prescription tailored to individual needs and current level of activity and fitness, and they also receive 2 one-hour individual exercise training sessions consisting of 20-30 minutes cardiovascular activity and strength training. participants receive nutritional education consisting of energy balance, appropriate portion sizes, calorie count, and basic nutrition skills such as label reading every 2 weeks for 12 weeks. after completion of study treatment, patients are followed for up to 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of pediatric cancer * patients 3 months to 1 year after completion of therapy exclusion criteria: * patients who are already on antihypertensive or insulin or cholesterol lowering medication * patients who have not been evaluated for exercise tolerance and cleared by their physician for participation * inability to understand program instructions due to language barrier or mental disability * unable to participate in the outlined exercise program due to a physical disability

Keywords: hodgkin's lymphoma brain and nervous system non-hodgkin's lymphoma leukemia, not otherwise specified