Kornimate/medical-research-clean huggingface dataset:
a multi-centre, prospective, non-interventional study to intensively monitor the safety of osimertinib in clinical practice among chinese nsclc patients

Conditions: Non-small Cell Lung Cancer

Summary: this is a multi-center, prospective, non-interventional study. the study will enroll about 1700 chinese patients diagnosed as nsclc and treated with osimertinib at least one dose. the objective of this non-interventional study is to monitor the safety profile of osimertinib in chinese nsclc patients in real world clinical practice.

this is a multi-center, prospective, non-interventional study. the study will enroll about 1700 chinese patients diagnosed as nsclc and treated with osimertinib at least one dose. the investigator in an observational study cannot intervene in the treatment. the prescribing doctor is in charge of prescribing or discontinuation of osimertinib. it is planned that all eligible patients who received at least one dose of osimertinib at the participating sites will be enrolled until 1700 patients has been recruited. the recruited patients will be followed up according to standard clinical practice. they will be tracked up to 30 days after discontinuation of osimertinib treatment, or 12 months after study enrolment, whichever comes earlier. for patients who accrued sae, the sae will be followed up until the outcome is defined, or the study is terminated, whichever comes earlier. the study would be terminated 12 months after the last patient is enrolled. the objective of this non-interventional study is to monitor the safety profile of osimertinib in chinese nsclc patients in real world clinical practice. the primary endpoint of this study is the incidence of all adverse drug reactions (adrs). the second endpoints include the severity for aes, the incidence of all aes, aesis, saes, the incidence of aes for elderly population (age ≥ 65 years old), and aes leading to osimertinib-associated interruption, dose reduction, discontinuation, and death

Eligibility criteria:
inclusion criteria: * provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures * patients histologically or cytologically diagnosed as nsclc * eligible for osimertinib treatment per the judgement of the treating physician in clinical practice * received at least one dose of osimertinib exclusion criteria: • enrollment in other on-going studies, which prohibit any participation in this non-interventional study

Keywords: osimertinib tagrisso nsclc non-small cell lung cancer safety
spectral-domain optical coherence tomography findings in retinal vessel occlusion

Conditions: Retinal Ischemia

Summary: retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in artery occlusions. intracellular edema may develop and decrease transparency of those layers, showing retinal edema. in spectral domain optical coherence tomography (sd-oct) retinal reflectivity changes as a result of retinal edema. the investigators examine the reflectivity changes of different retinal layers between healthy eyes and eyes with retinal artery occlusion and ischemic or non-ischemic vein occlusions. aim of the study is to evaluate whether those changes can be used to measure the level of ischemia in the inner retina.

several studies tried to classify retinal ischemia due to retinal artery or vein occlusion into different grades. in some cases prognosis is dependent on grade of severity, especially in cases of retinal vein occlusion. state of the art to diagnose the severity of retinal ischemia is lfuorescein angiography. however, this technique is invasive and might cause problems like anaphylactic shock. optical coherence tomography is a non-invasive technique, but up to now there is no standardized method to quantify the grade of severity of retinal ischemia in such conditions like retinal vessel occlusion. the study hope to find criteria by which such a classification can be constructed.

Eligibility criteria:
inclusion criteria: * acute retinal vessel occlusion on one eye * healthy contralateral eye * examined with spectral domain optical coherence tomography exclusion criteria: * retinal occlusion older than 1 week * oct image not obtainable/missing
recombinant adenoviral human p53 gene in treatment of malignant pleural effusion

Conditions: Malignant Pleural Effusion

Summary: objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 gene (rad-p53) in treatment of malignant pleural effusion, compared to cisplatin. this is a phase 2, double blinded, randomized, active controlled study.

objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 gene (rad-p53) in treatment of malignant pleural effusion, compared to cisplatin. study design: phase 2, double blinded, randomized, active controlled.ninety patients with malignant pleural effusion, who meet the study inclusion criteria and none of exclusion criteria, will be randomized into 3 treatment groups: rad-p53, cisplatin, and rad-p53 combined with cisplatin. the study endpoints are objective response rate, karnofsky score, effusion-free survival, and safety.

Eligibility criteria:
inclusion criteria: 1. histopathologically diagnosed original cancer with malignant pleural effusion; 2. 18 years or older; 3. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form. 4. signed the informed consent form exclusion criteria: 1. serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/l; 2. have serious heart, lung function abnormalities or severe diabetes patients; 3. active infection; 4. severe atherosclerosis; 5. aids patients; 6. serious thrombotic or embolic events within 6 months; 7. renal insufficiency requiring hemodialysis or peritoneal dialysis; 8. pregnant or lactating women; 9. mental disorder or disease.

Keywords: malignant pleural effusion, p53 gene therapy, cisplatin
follow-up study after bankart repair using mg-1

Conditions: Shoulder Dislocation

Summary: long term follow-up of patients those who underwent arthroscopic bankart repair using mg-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.


Eligibility criteria:
inclusion criteria: * patient who was enrolled to the clinical trial of mg-1 at funabashi orthopaedic hospital and who don't withdraw the consent * patient who understand the contents of the study and from whom a written consent can be obtained exclusion criteria: * patient with dementia * patient who cannot undergo ct examination * patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial * patient who is pregnant or lactating * patient judged to be inappropriate for the study by the (sub)investigator

Keywords: arthroscopic bankart repair bone hole ossification suture anchor shoulder dislocation
high-resolution multi-parametric magnetic resonance imaging for focal epilepsy

Conditions: Epilepsies, Partial

Summary: patients with focal epilepsy often have diagnostic difficulties as their culprit for seizures are difficult to be picked up using conventional imaging. the current study is to investigate the utility of advanced mri sequences on detection of subtle lesions accountable for focal epilepsy.

focal epilepsy refers to having seizures arising from a specific part of the brain. in these patients, workup in magnetic resonance imaging is often necessary as patients with structural lesions have a much higher rate of seizures, ranging from 10% to 26% at 1 year and from 29% to 48% at 5 years. however, there is also a subgroup of patients who has epilepsy not adequately controlled by anti-epileptics with unrevealing first mri study, a dedicated mri protocol may reveal positive lesion in 30-65% of the cases. in these patients, several tricks can be applied to increase the detection rate. first, the used of a high-resolution mri on a high-field scanner could be helpful, which can be increased the sensitivity up to 90%. the use of 7t-mri in further picking up subtle lesions in patients presenting with epilepsy has been investigated, further affirming the role of high resolution mri imaging. secondly, the use of dedicated sequences, such as t1-weighted inversion recovery sequences which allow better distinction of grey and white matter, could also reveal subtle lesions such as polymicrogyria or type 1 focal cortical dysplasia. this study is therefore aimed to apply the findings to the local settings, and specifically to investigate if t1-weighted inversion recovery sequences provides additional benefit in picking up more subtle lesions in patients who had an initial first negative mri.

Eligibility criteria:
inclusion criteria: * consecutive patients with drug-resistant focal epilepsy fulfilling the following criteria - 1. diagnosis of focal epilepsy with a probable site identified, as defined by concordant results from any two of the following: * clinical seminology compatible with focal epilepsy. * electroencephalography pointing towards a specific site for focal epilepsy. * positive ictal brain scintigraphy with spect-ct correlation. and 2. previous mri (at least one study with protocol tailored for epilepsy) which did not reveal accountable focal lesion. and 3. able to consent for mri examination (if patient under age of 18, consent for mri will be obtained from guardian). patients will be provided information leaflets to read on, and written consent before taking part in this study and mri examination. exclusion criteria: * patients who are contraindicated to magnetic resonance imaging (such as due to underlying mri incompatible metallic implants) * patients who cannot cooperate for mri scanning. * patients show are unable to provide informed consent.
mixed venous oxygen saturation from central venous line, venous side of heart lung machine and the pulmonary artery

Conditions: Heart Defects, Congenital

Summary: this study was designed to examine if venous saturations from the central venous line and from the venous side of the heart lung machine are interchangeable or not with mixed venous saturation from the pulmonary artery in children undergoing open heart surgery for correction of various congenital heart defects.

forty children aged from 1-15 years undergoing correction for different congenital heart procedures with cardiopulmonary bypass \[cpb\] were included in this study. simultaneous samples were taken from the central venous line, pulmonary artery, and from venous side of the heart lung machine. samples were taken after 10 minutes on full cpb and at the end of surgery before end of cpb. bland and altman plots were used to study the agreement between venous saturations.

Eligibility criteria:
inclusion criteria: * children in the age from 1-15 years undergoing correction for congenital heart defects with cardiopulmonary bypass exclusion criteria: * any chest renal or hepatic problems

Keywords: mixed venous saturation open heart surgery children
heal-hf: a cardiac resynchronization therapy (crt) outcomes study

Conditions: Heart Failure, Congestive

Summary: the literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (crt) device for symptomatic congestive heart failure (chf) do not have a clinical benefit from the device. the heal-hf protocol will compare the outcomes of conventionally placed crt devices with magnetically placed crt devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular (lv) lead.

baseline information will be obtained including qol, 6-minute walk, and echo measurements. the patient will be randomized to receive a conventionally-placed lv lead or randomized to receive a magnetically-placed lv lead. the magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing. patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in hf symptoms. adverse events will also be recorded during the follow-up period.

Eligibility criteria:
inclusion criteria: * ischemic cardiomyopathy * ejection fraction (ef) \<= 35% * qrs duration \>= 120 msec * standard heart failure (hf) oral medications for at least 1 month * evidence of mechanical dyssynchrony * nyha class iii or iv exclusion criteria: * persistent or chronic atrial fibrillation (af) * hemodynamically unstable or uncontrolled arrhythmias * unstable angina * aortic valve (av) insufficiency or stenosis * mitral valve (mv) regurgitation \> 2+ * active infection * contraindications for heparin * dependence on atrial pacing

Keywords: heart failure resynchronization crt bi-v pacemaker lv lead placement hemodynamic assessment crt outcomes
effectiveness of 5-week digital respiratory practice in children with duchenne and becker muscular dystrophies.

Conditions: Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Muscular Dystrophy

Summary: the purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with duchenne muscular dystrophy and becker muscular dystrophy.

it will be done 4 times a week for a period of 5 weeks, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. an intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery. it is advisable during intervention program to have a playful environment stimulated for the children, and that the intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as with a weekly follow-up using whatsapp as forms of communication, or a telephone call to ensure correct follow-up of the intervention program. it is essential that to carry out the intervention, videos obtained from youtube, own videos prepared to explain the exercises in a playful way applied to children, and even other applications such as spotify to work with music, will be used, being offered in case of zoom calls may be necessary to help optimally resolve doubts that arise when carrying out the program by video call. at the end of the respiratory digital physiotherapy program, variables will be evaluated by the principal examiner.

Eligibility criteria:
inclusion criteria: * participants with duchenne muscular dystrophy and patients with becker muscular dystrophy will be chosen. * aged between 5 and 20 years. * child who could walk and follow the intervention program, and were diagnosed according to the international classification of diseases, 10 revision. code (g71-01); and who had an nssa score greater than 20. exclusion criteria: * patients who present associated heart disease. * patients who presentor fractures, a heart rate greater than 120 beats per minute, or an oxygen saturation less than 89% will be excluded. * participants who do not have the capacity to have internet at home to perform the intervention, as well as all patients whose caregivers did not agree to sign the informed consent.

Keywords: duchenne muscular dystrophy becker muscular dystrophy breathing exercises inspiratory muscle training pulmonary rehabilitation expiratory muscle training
the use of five-strand hamstring autograft to increase the graft size in anterior cruciate ligament reconstruction - a prospective randomized controlled trial

Conditions: Anterior Cruciate Ligament Injuries

Summary: anterior cruciate ligament (acl) reconstruction is one of most commonly performed orthopaedic surgeries. several options for graft choice are available and autologous single bundle hamstring graft is most commonly used. variability exists among patients in terms of hamstring size, and therefore the graft diameter. recently there has been an increasing amount of literature correlating the hamstring graft diameter with the graft failure rate \[1-4\]. they concluded that graft exceeding 8mm in diameter is associated with a significant lower risk of graft failure. there has been study showing that asian patients were indeed 'different' from the caucasians. ho et al published his findings on singaporean patients showing that the median graft diameters for female and male patients were 7mm and 8mm respectively \[5\]. a retrospective review our patients undergoing acl reconstruction in our department over the past 10 years has shown that the mean graft diameter was 7.8mm (range, 5.5-10mm). the conventional way of four-strand hamstring autograft is done by doubling both the semitendinosus and gracilis tendons to provide a quadrupled graft. several techniques have been described to increase the size of the hamstring graft. one of those is the -strand hamstring graft, in which the longer semitendinosus tendon is tripled with the shorter gracilis tendon doubled to produce a 5-strand configuration. we hypothesized that the 5-strand hamstring graft would provide a graft of significantly larger diameter than the conventional quadrupled autograft.


Eligibility criteria:
inclusion criteria: * age 18-50 * symptoms and physical examinations consistent with acl deficiency and magnetic resonance imaging indicating acl injury exclusion criteria: * previous surgeries in the operated knee * revision acl reconstruction * contralateral acl injury * concomitant posterior cruciate ligament / collateral ligament surgeries in the operated knee
study to evaluate efficacy and tolerability of micardis®/micardis® plus in patients with hypertension

Conditions: Hypertension

Summary: study to evaluate efficacy and tolerability of micardis®/micardis® plus under usual daily-practice prescribing conditions in hypertensive patients


Eligibility criteria:
inclusion criteria: * males and females for whom a medical antihypertensive therapy is indicated * age \>= 18 years exclusion criteria: * age \< 18 years
study of ataluren in ≥2 to <5 year-old male participants with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this is a phase 2, multiple-dose, open-label study evaluating the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of ataluren in participants aged ≥2 to \<5 years old with duchenne muscular dystrophy (dmd) caused by a nonsense mutation in the dystrophin gene.

in nonsense mutation dmd (nmdmd), early start of treatment is important and necessary and, therefore, it is relevant to understand the correct and tolerable dose in this age group, particularly since ataluren is dosed by weight. this study included a 4-week screening period, a 52-week treatment period (the first 4 weeks of which included pk parameters), and a 4-week follow-up period for participants who completed the treatment period (60 weeks total duration). the objective of the extension period (treatment period after pk parameters have been completed) was to assess the long-term safety of chronic administration of ataluren in this participant population.

Eligibility criteria:
inclusion criteria: * males ≥2 to \<5 years of age * body weight ≥12 kg * diagnosis of dmd * nonsense mutation in at least 1 allele of the dystrophin gene exclusion criteria: * participation in any other drug or device clinical investigation * ongoing use of prohibited concomitant medications
abiocor implantable replacement heart

Conditions: Severe Biventricular End Stage Heart Disease

Summary: abiocor is a post market approval study for an implantable replacement heart. this post approval study is currently on hold.


Eligibility criteria:
inclusion criteria: * patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by lvad destination therapy, and are not weanable from biventricular support if on such support. exclusion criteria: * patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.

Keywords: end stage heart disease
management of acute dislocation of emergency in the university hospital of strasbourg shoulder: retrospective evaluation of practices and proposal of a clinical path

Conditions: Shoulder Dislocation

Summary: the analysis of professional practices in the emergency department of the strasbourg chru in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. thus, the objectives are twofold: first standardize care in emergency rooms and try to improve the weak points of this care.the investigators will concentrate thier observation work on the medicinal analgesic methods proposed to these patients in order to minimize the pain induced by the external reduction maneuvers performed, in the majority of cases, in the emergencies. this work will ultimately have a real clinical impact on the management of these traumatized patients


Eligibility criteria:
inclusion criteria: * adult patient consulting for acute shoulder dislocation exclusion criteria: * patient refusing to participate in the study
long-term immune persistence of glaxosmithkline biologicals' inactivated hepatitis a vaccine, injected according to 0, 6-month schedule

Conditions: Hepatitis A

Summary: the aim of this study is to evaluate the long-term persistence of hepatitis a antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis a vaccine.

this is a long-term follow-up study at years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with gsk biologicals' hepatitis a vaccine (two-dose schedule). to evaluate the long-term antibody persistence, volunteers will donate a blood sample at years 11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis a (anti-hav) antibody concentrations if a subject has become seronegative for anti-hav antibodies during any of the long-term blood sampling time point (i.e. years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she will be offered an additional vaccine dose. a blood sample will be taken on the day of the additional vaccination, 14 days and one month after additional vaccination to evaluate the immune response following this vaccination. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007 and to include an extended follow up period up to year 20 after primary vaccination. the study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030, 111031, 111032).

Eligibility criteria:
inclusion criteria: * subjects who had received at least one dose of the study vaccine in the primary study * written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Keywords: havrix™ hepatitis a