Kornimate/medical-research-clean huggingface dataset:
standardized long term follow-up of patients after endovascular embolization of a brain aneurysm

Conditions: Aneurysm

Summary: the time-frame and the follow-up elements after embolization of brain aneurysm are not standardized. therefore, few reliable follow-up data are available for these patients. this study aims at collecting standardized long term data for these patients, in order to assess the occurence of aneurysm recanalization and particularly those requiring another intervention on the aneurysm.

an intracranial aneurysm is a localised dilatation in the wall of an intracranial artery, creating a zone of fragility where the main risk is rupture (meningeal haemorrhage). intracranial aneurysms are the 1st vascular pathology treated in the nri department at the rothschild foundation (for). since 2002, between 150 and 250 patients have been treated each year using the embolisation technique (filling the aneurysm sac with coils). over the last thirteen years, this represents the largest cohort in france, with more than 2,000 patients selectively treated for one or more intracranial aneurysms, i.e. more than 2,500 aneurysms. treatment consists of excluding the aneurysmal cavity from the bloodstream, usually by "plugging" it with platinum metal coils. after treatment by embolisation of the aneurysm, recanalisation (recirculation of blood in the aneurysm, exposing the patient to a new risk of haemorrhage due to aneurysmal rupture) of the cavity may occur after a few months or years (approximately in 7% of cases). in addition, new aneurysms may develop during the patient's lifetime, often several years later. another type of aneurysm treatment is also possible: surgical treatment, which consists of clipping the neck of the aneurysm. whichever type of treatment is used, patients are monitored according to a protocol for the first year following treatment, with visits at 6 months and 1 year: an mri is performed 6 months after embolisation. an arteriogram was performed at one year, and a consultation was held for clinical evaluation. a retrospective assessment of follow-up data (study of 2009-2013 files) showed that the date of this consultation varied considerably and that the schedule of follow-up visits over the first 10 years was not standardised, which means that reliable follow-up data are not available for these patients. the occurrence of recanalisation led us to propose standardised longer-term follow-up, with imaging (mri and/or arteriography) 3 years after the operation. in our clinical experience, this follow-up schedule (at 3-6 months, 1 year and then 3 years) makes it possible to detect recanalisation requiring re-treatment. the aim of this research is to obtain standardised, longer-term follow-up data for a large series of patients who have undergone embolisation or surgical treatment of an intracranial aneurysm.

Eligibility criteria:
inclusion criteria: * curative embolization of a brain aneurysm * age \>18 years old exclusion criteria: * none
evaluation of efficacy and safety of sdn-037

Conditions: Inflammation and Pain Associated With Ocular Surgery

Summary: the efficacy and safety of sdn-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.


Eligibility criteria:
inclusion criteria: 1. be at least 2 years of age on the date of assent or 18 years of age at the date of consent 2. be able and willing to follow study instructions and complete all required visits 3. females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test 4. able to self-instill the ip or have a caregiver available to instil all doses of the ip exclusion criteria: 1. any known allergy or hypersensitivity to difluprednate therapy 2. an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye 3. any active corneal pathology noted in the study eye 4. currently suffering from alcohol and/or drug abuse
a study of coformulated favezelimab/pembrolizumab (mk-4280a) versus physician's choice chemotherapy in pd-(l)1-refractory, relapsed or refractory classical hodgkin lymphoma (mk-4280a-008)

Conditions: Hodgkin Lymphoma

Summary: researchers are looking for a way to treat classical hodgkin lymphoma (chl) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (mk-4280a) live longer without the cancer getting worse compared to those who receive chemotherapy.


Eligibility criteria:
inclusion criteria: * has histologically confirmed diagnosis of classical hodgkin lymphoma (chl) that is 2-fluorodeoxyglucose-avid (fdg-avid). * has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve cr or pr to most recent therapy) chl and exhausted all available treatment options with known clinical benefit. * has progressed on treatment with an anti-pd-(l)1 monoclonal antibody (mab) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. * submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated. exclusion criteria: * diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy. * history of central nervous system (cns) metastases or active cns involvement. * has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy. * history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * has an active infection requiring systemic treatment. * history of hemophagocytic lymphohisticytosis. * has an active seizure disorder that is not well controlled. * has clinically significant (ie, active) cardiovascular disease. * received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids. * has not adequately recovered from major surgical procedure. * known additional malignancy that is progressing or has required active treatment within the past 3 years. * history of human immunodeficiency virus (hiv). * has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.

Keywords: programmed cell death-1 (pd1, pd-1) programmed cell death 1 ligand 1 (pdl1, pd-l1) programmed cell death 1 ligand 2 (pdl2, pd-l2)
prevalence of nasopharyngeal carriage of streptococcus pneumoniae in healthy children of 12-18 months in 6 cities, china

Conditions: Streptococcus Pneumoniae Infections

Summary: this study is to observe the carriage rate of streptococcus pneumoniae (s.p.), haemophilus influenzae type b (hib) and moraxella catarrhalis (m.cat.) in healthy chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in chinese young children. the antibiotic resistance of all isolates and the serotypes distribution of s.p. isolates will also be tested. potential risk factors for nasopharyngeal carriage will be collected.


Eligibility criteria:
inclusion criteria * healthy children aged 12-18 months exclusion criteria * use of antibiotics up to 15 days prior to study inclusion * malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible * children with chronic infectious (chronic otitis media or chronic sinusitis prior to study inclusion. * received any pneumococcal vaccine in the past. * children who have already provided a np sample in the same study period. * any relevant hemorrhagic disorder. * any febrile process (fever ≥ 38°c) at time of screening.
derivation and validation of a prognostic model for septic patients at hospital admission

Conditions: Sepsis

Summary: the aim of the present study is to develop a prognostic tool to assess the risk of dead and major complications in patient admitted to hospital for infection. a detailed database of clinical, biochemical and microbiological data is recorded and each item is analyzed and compared with clinical outcomes to develop a prognostic score.


Eligibility criteria:
inclusion criteria: * al least 18 years old * admission to hospital for any infection for more than 72 hours exclusion criteria: * pregnancy

Keywords: sepsis score
high dose baya1040 cr: a long term extension study

Conditions: Hypertension

Summary: this is a clinical study evaluating the safety and efficacy of long term administration of oral baya1040 cr 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of study 13176.


Eligibility criteria:
inclusion criteria: * patients who complete the 8 week double blind treatment phase of study 13176 and for whom the test drug is tolerable exclusion criteria: * patients with expected difficulties for the continuous 1 year follow up

Keywords: baya1040 cr nifedipine essential hypertension japanese patients phase iii extension study
cardiopulmonary bypass (cpb) pumps and blood activation

Conditions: Cardiopulmonary Bypass; Coronary Artery Disease

Summary: blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. the goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.


Eligibility criteria:
inclusion criteria: * men undergoing coronary artery bypass grafting using cardiopulmonary bypass * aspirin therapy exclusion criteria: * redo surgery * acute coronary syndrome requiring urgent surgery * oral anticoagulant therapy * organ dysfunction or chronic inflammatory disease * surgery other than coronary artery bypass grafting
doppler and afv for outcome prediction ın fgr

Conditions: Fetal Growth Retardation

Summary: the investigator contrived a prospective study of aucr to compare its association to adverse perinatal outcomes with other established doppler parameters, such as cpr and ucr within a population of suspected fgr fetuses at term.


Eligibility criteria:
inclusion criteria: * si̇ngleton pregnanci̇es wi̇th fgr fetuses * after 37th gestati̇onal weeks exclusion criteria: * si̇ngle or muti̇pl fetal anomali̇es * evi̇dence of i̇ntrauteri̇ne enfecti̇on
plaque psoriasis efficacy and safety with secukinumab

Conditions: Plaque Psoriasis

Summary: to demonstrate in the patient pool of pasi 90 responders at week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a pasi 90 response rate at week 52.


Eligibility criteria:
main inclusion criteria: 1. chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening and candidate for systemic therapy. 2. moderate to severe psoriasis at baseline as evidenced by: * pasi ≥ 10 and * iga mod 2011 score of 3 or higher (based on a scale of 0 to 4) and * bsa affected by plaque-type psoriasis of ≥ 10%. main exclusion criteria: 1. history of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (tnf) alpha, anti interleukin (il)12/23, or any anti-il 17a or il 17a receptor (il 17ar) antibody. 2. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 3. forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis). 4. drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium). 5. ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (uv) therapy). 6. ongoing use of other non-psoriasis prohibited treatments. washout periods detailed in the protocol have to be adhered to. all other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug. 7. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hcg) laboratory test (\> 5 miu/ml). 8. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug. 9. active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. 10. underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.

Keywords: plaque, psoriasis
preeclampsia and circulating biomarkers

Conditions: Postpartum CVD Risk in Women With Previous Preeclampsia.

Summary: in order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year follow-up study comparing 32 exposed (women with a history of pregnancy complicated by preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy). participants will be recruited from a well-characterised cohort, previously assembled during their pregnancies, at the department of obstetrics at randers regional hospital in 2001-2004. blood and urine samples, collected during their pregnancies, are stored in a biobank, thus rendering the possibility of longitudinal assessment.


Eligibility criteria:
inclusion criteria: * participation in previous study 2001-2005. exclusion criteria: * current pregnancy or breastfeeding

Keywords: preeclampsia cardiovascular disease (cvd) risk
treatment of thrombosed haemorrhoids in pregnancy

Conditions: Haemorrhoidal Crisis; Pregnancy Related

Summary: thrombosis of the external hemorrhoids (teh) is one of the most frequent complain during pregnancy, particularly during the third trimester. the paucity of the medical literature on this topic has recently been underlined in the european guidelines for hemorrhoid treatment . the aim of this prospective study is to compare the efficacy and safety of conservative versus surgical treatment of teh in pregnant women

thrombosis of external haemorrhoids (teh) is a quite frequent acute condition that affects women during the pregnancy arousing great concern and impacting quality of life. teh may present as an acute hemorrhoidal crisis with severe pain and bleeding. up to 21.8 % of pregnant females complaining of dyschezia present with a thrombosed external haemorrhoid and during last three months, 7.8 % of pregnant females experience a teh. systemic changes in women body can be related to the onset of teh and even if haemorrhoidal thrombosis does not represent a life-threatening condition during the pregnancy, on the other hand the pain can deteriorate the emotional and physical status arousing worries which affect the health system with high costs due to several accesses to the hospital. treatment of teh is mainly directed to the relief of symptoms, especially pain control. nowadays conservative and surgical management of teh during the pregnancy have been demonstrated both effective and safe. nevertheless, a conservative approach is more accepted as the patient's ability to tolerate the symptoms of her condition would dictate the need for surgery. in the common practice most patients prefer to be treated conservatively experiencing resolution of their symptoms. on the other hand excision of thrombosed external haemorrhoids results in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals. during the pregnancy the administration of conservative medications is quite limited due to the possible side effect of such drugs on the fetus. the aim of this prospective study is to evaluate and compare the efficacy and safety of conservative and surgical treatment in patients affected by teh during pregnancy. with regard to surgical management, thrombectomy and local excision of external haemorrhoids were compared.

Eligibility criteria:
inclusion criteria: * pregnancy * thrombosed external haemorrhoids * written consent exclusion criteria: * inflammatory bowel disease * cancer * age lower than 18 years old
post-operative sensitivity in composite restorations

Conditions: Class II Dental Caries; Sensitivity, Tooth

Summary: participants will be divided into groups. in group a, composite restoration done using oblique incremental technique. in group b, bulk-fill technique was used. vas scoring to evaluate the primary outcome at one day, one week and two weeks.

after the approval from ethical research committee, a written informed consent taken. participants were briefed about the intervention with its associated merits and demerits. the restorative procedures were accomplished under rubber dam isolation using adequate local anesthesia. the principles of minimally intervention and adhesive dentistry were employed. participants were allocated into two groups. in group a, restorative interventive was performed using oblique incremental placement while in group b, bulk-fill technique was used. post-operative sensitivity was recorded at one day, one week and two week follow up using a visual analogue scale.

Eligibility criteria:
inclusion criteria: * minimum 18 years of age with good general health * vital and periodontally stable teeth * class-ii primary carious lesions with a cavity depth of 3 to 5 mm * established contact with adjacent and opposing natural or prosthetic teeth * prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining) exclusion criteria: * teeth with a history of spontaneous pain * compromised oral health status * patients with parafunctional habits or temporomandibular disorders * previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis * participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 weeks
nopark open label extension study

Conditions: Safety Issues

Summary: this protocol describes the nopark open label extension study. the nopark open label extension study is an optional extension of the clinical phase ii nopark study. participants who have been included in the nopark study will upon completing their participation in the nopark study (i.e., after 52 weeks) be offered to receive the study drug nicotinamide riboside (nr) 1200 mg p.o. per day, until the nopark trial is completed, and the data analyzed with a conclusion of the primary outcome. individuals enrolled into the nopark open label extension study will be followed with yearly visits. the goal of the nopark open label extension study is to monitor long term safety and study long term neuroprotective and other biological effects of nr use.

the primary objective of the nopark open label extension study is to monitor nr use for long term safety. the secondary objective of the nopark open label study is to monitor long term nr use among pd patients and observe the clinical progression of pd. the nopark open label extension study is an open label study, where subjects enrolled in the nopark study (clinicaltrials.gov: nct03816020), upon completion of the study, will be offered the nr study drug for continuous use, until the nopark study is completed and the primary end-point assessed (31/12/2025). the dose of nr is 1200mg nr daily, divided into 600mg twice daily. the reason for the slightly higher dose compared to nopark (i.e., 200mg higher) is the fact that the active compound is now available in capsules of 300mg which cannot be divided. from a clinical and scientific perspective, given current knowledge of safety and efficacy of nr in pd, a dose of 1200 mg is both safe and of a higher potential benefit to patients. the study is multi-site, identical to nopark. the primary endpoint of the study, which is safety, will be analyzed using descriptive statistics. the secondary endpoint, which is if long-term nr use delays pd progression will be analyzed using the clinical mds-updrs score. exploratory objectives will assess pd progression relative to the general pd-population and whether long-term nr use affects methylation metabolism. stratification of analyses is dependent on the duration of administered nr, sex and age. exploratory stratification will be done based on results from biological data analysis based on data from nopark or blood samples collected in the nopark open label extension study.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form stated willingness to comply with all study procedures and availability for the duration of the study participated in the nopark study exclusion criteria: * current use of vitamin b3 supplementation or nr supplementation - other than in relation to the nopark study known allergic reactions to components of the nr physical or psychiatric illness that makes them unavailable for follow-up and participation.

Keywords: parkinson's disease nicotinamide riboside open label
virtual colonoscopy (vc) for primary colorectal screening

Conditions: Colorectal Polyps

Summary: this study involves a primary vc screening for colorectal polyps. the research hypothesis is that vc screening, including surveillance of sub-cm polyps, is a safe and effective approach.

the purpose of this study is to use virtual colonoscopy screening to learn more about what happens to small colon polyps (less than 10 mm) over time. from this, we can find out whether it's safer to remove all colon polyps right away or leave the small ones in place and remove only those that grow to 10 mm or more.

Eligibility criteria:
inclusion criteria: * medium-sized colorectal polyps (6-9 mm) exclusion criteria: * no medium-sized colorectal polyps (6-9 mm)

Keywords: colorectal polyps