Kornimate/medical-research-clean huggingface dataset:
extension study up to 3 years for secukinumab in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this study was designed as a 3-year extension to the phase iii core study cain457f2306. it aimed to provide continuous treatment with secukinumab in pre-filled syringes (pfs) for subjects who completed the core study cain457f2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. at week 104 of the study cain457f2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. the regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.


Eligibility criteria:
inclusion criteria * subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed * subjects must have participated in core study cain457f2306, and must have completed the entire treatment period * subjects must be deemed by the investigator to benefit from continued secukinumab therapy exclusion criteria * any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab * any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms * pregnant or nursing (lactating) women * women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in eu) other protocol-defined inclusion/exclusion criteria may apply

Keywords: extension study, psoriatic arthritis, pre-filled syringe
osimertinib for nsclc with uncommon egfr mutations

Conditions: Carcinoma, Non-Small-Cell Lung; Genes, erbB-1

Summary: this is a multi-center, retrospective study of ucegfrmut (exon 20 insertions excluded) metastatic nsclc osimertinib-treated as first egfr inhibitor. recist and rano-bm brain objective response rate (orr) were evaluated by investigators. mpfs, mos and mdor were calculated from osimertinib initiation. mutations found at resistance were collected.

the epidermal growth factor receptor ( egfr) is the most common targetable driver in non-small cell lung cancer (nsclc). approximately 90% of the egfr mutations include an exon 19 deletion and a l858r point mutation at exon 21. less common mutations include, among others, g719x in exon 18, l861q in exon 21, exon 20 insertions, s768i in exon 20, and t790m in exon 20. osimertinib is an egfr tki that has been developed as non-competitive inhibitor targeting a range of egfr mutant molecules, currently regarded as the first-line treatment of choice to egfr mutant (egfrm) patients. inhibition of the less common egfr mutant by osimertinib has been demonstrated. real-world data showed lower response rate (rr) and progression free survival (pfs) in patients harboring uncommon egfr mutations compared to the ones with common mutations treated with egfr tkis. osimertinib as treatment for patients with rare mutations has been assessed in a single arm phase ii study in korea. rr was 50%, pfs was 8.2 months, mos was not reached. osimertinib activity in patients with uncommon mutations was assessed also in a retrospective us study, time on treatment ranged from 7.7 months to 19.3 months. this is a multi-centric, retrospective, real-world study. study goal is to collect high quality data regarding the efficacy of osimertinib in tki naive nsclc patients with uncommon egfr mutations. the primary endpoints are progression-free survival and overall survival, from osimertinib start. secondary endpoints would be recist response, adverse events, time on treatment and time to cns progression, cns response and mechanisms of resistance if tested. the study includes researchers from belgium, denmark, israel, switzerland, netherlands, germany, france, italy and usa. data collection will be conducted at each participating site, following ethics approval. no patient identifying information will leave each of the participating centers. data will be collected centrally by the lead investigators and analyzed for the entire study cohort and for subgroups if deemed appropriate.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. nsclc by histologic or cytologic diagnosis 3. stage iv or stage iii not amendable to curative treatment (i.e., advanced disease) 4. uncommon mutation of egfr (exon 20 insertion excluded) 5. treated with osimertinib for advanced disease as first tki 6. osimertinib initiated not later than end of january 2021 exclusion criteria: 1. lack of any follow-up data 2. lack of consent for data collection or ethics committee approval for the waiver of informed consent (i.e. for deceased patients)
care outcomes in preterm infants following the implementation of family-centered interventions

Conditions: Prematurity

Summary: the proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.the interventions are 1) the close collaboration with parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to single-family room architecture.

the close collaboration with parents training targeted to the health care team of neonatal intensive care units to facilitate parental involvement in infant care and to support parenting. the training program involves a structured education process, where trained mentors educate staff in neonatal units. the duration of the training program is 18 months per unit. the training program has been implemented in eleven neonatal units in finland since 2009; another 12 units haver not gone through the training. the other intervention, single-family room architecture, provides facilities for parents to stay in the room of their infant throughout there 24 hour day. this intervention has been carried out in four neonatal units in finland since 2014; in one by restructuring the existing unit, and in three by building a new unit/hospital. in this study, the investigators are going to use national, population-based registers (the medical birth register, the small preterm infant register and the hospital discharge register) governed by the finnish national institute for health and welfare. these registers have been widely used for observational studies, and contain data on all newborn infants in the country. there are currently 23 neonatal units in finland. three units have undergone both interventions, nine units have undergone one intervention, and 12 units have undergone neither. preterm infants (born before 35 gestational weeks) discharged from any unit will be divided into those who have been cared for all, part or no time in a hospital with an intervention, separately for each intervention. the outcome measures of interest will be related to health care utilization such as the length of stay and unscheduled outpatient visits, and to clinical outcomes such as postnatal growth parameters.

Eligibility criteria:
inclusion criteria: * preterm infants (gestational age \<35 weeks) born in finland between 2006 and 2020 exclusion criteria: * missing data on key variables (gestational age, place of birth, length of stay)

Keywords: infant, preterm length of stay neonatal intensive care postnatal growth
effects of hip abductor and external rotator strength training in patients with patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: the first purpose was to compare the difference between leg press exercise(lpe) and additional hip abductor and external rotator muscle strength training to leg press exercise(lpe+hae) in muscle strength, hip kinematics during step down, pain severity and function for patients diagnosed with patellofemoral pain syndrome. the second one was to discover the relationship between the change in muscle strength performance and the difference of hip joint kinematics post treatment.


Eligibility criteria:
inclusion criteria: * patellofemoral pain syndrome ( bilateral or unilateral) * special tests: crepitus during compression test, patellar grind test (clarke's sign), pain during compression test, palpation ( at least 2 ) * below 50 years old * pain :after long sitting, up/down stair, squat, kneeling, running \& jumping ( at least 2 ) * pain duration at least 1 month * at least 1 item of pss score more than 3 cm exclusion criteria: * knee operation * central or peripheral neurological deficits * obvious knee joint or lower extremity malalignment * people involved in competitive sports * pss sub-scale pain experienced last week more than 8cm * have been taking anti-inflammatory drugs , received anti-inflammatory injection or received other therapy for past 3 months
physiological studies in the prone position in patients with ards

Conditions: Acute Respiratory Distress Syndrome; Mechanical Ventilation; Prone Positioning

Summary: the purpose of this study is to observe the changes of physiological indicators such as ventilation and oxygenation in the prone position of ards patients, to observe the change trend of each patient's indicators, and to observe whether different trends of indicators predict different prognosis of patients.

pp has been shown to effectively improve the prognosis of patients with severe ards, but not all patients with ards can benefit from pp, and the implementation of the pp has a certain clinical risks and side effects, we lack a convenient predictors to guide doctors to determine whether patients should implement the pp. clinical usually observe the p/f improved as whether pp treatment effective reference, but there are literature points out that the rising p/f after pp can not predict the better prognosis. one of the mechanisms for ards patients benefit from pp is proved to be improve v/q, the change of the v/q may determine whether the pp treatment effectively is an important indicator. pao2:fio2 ratio was usually used to evaluate the effect of pp, but some studies did not support this conclusion. pp has been shown to change ventilation-perfusion ratio, dead space may be better physiological indicators, simplify dead space ratio and ventilatory ratio can be easily accessed at bedside and is associated with mortality of patients with ards. the purpose of this study is to observe the predictive value of p/f, vd-etco2/vt, and vr on the treatment effect of ards undergoing pp.

Eligibility criteria:
inclusion criteria: 1. intubated patients 2. undergoing mechanical ventilation 3. moderate to severe ards 4. undergoing prone positioning 5. age≥18 years old exclusion criteria: 1. pregnant 2. cardiac structural shunt 3. extracorporeal membrane oxygenation performed 4. undergo extracorporeal co2 removal 5. pulmonary embolism 6. other situation that may affect the accuracy of petco2 monitoring 7. prone positioning session less than 10 hours

Keywords: prone positioning ards dead space ratio ventilatory ratio ventilation/perfusion
quality control of ce-certified phonak hearing aids - 2016_06

Conditions: Hearing Loss

Summary: a methodical evaluation of new ce-labelled phonak hearing systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. the aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding phonak hearing systems and to equivalent competitor devices.

phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the phonak hearing systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). this will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * central hearing disorders
fit for surgery. multimodal prehabilitation in colorectal cancer patients

Conditions: Colon Cancer; Rectal Cancer; Frailty

Summary: randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.

fit for surgery is a randomized clinical trial of multimodal prehabilitation prior to colon or rectal cancer surgery. participants will either receive the study is a part of the prehab study which is performed in collaboration with international centers. the full protocol are published bmc cancer. 2019 jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

Eligibility criteria:
inclusion criteria: * undergoing elective colorectal cancer surgery * who performance status i and ii * signed consent exclusion criteria: * known metastatic disease * unable to perform baseline test or basic training e.g. paralytic or completely immobilized patients, orthopedic impairments. * asa 4 or 5 (american society of anesthesiologist classification) * neoadjuvant chemo- or radiation therapy * renal failure iii b or higher * illiteracy or unable to write or understand danish * cognitive disabilities, which affects adherence e.g. severe dementia (mmse score ≤17). * withdrawal of consent.

Keywords: prehabilitation colon cancer who performance status rectal cancer exercise nutritional supplement
volume-outcome relationship in rectal cancer surgery

Conditions: Rectal Cancer; Anastomotic Leak Rectum

Summary: hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. however, no linear relation between volume and outcome has been demonstrated. aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (arr).


Eligibility criteria:
inclusion criteria: * diagnosis of a cancer located in the rectum, defined according to the international definition by d'souza et al., * elective setting * anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy). exclusion criteria: * age below age of 18, * inflammatory bowel disease, * acquired or congenital immunodeficiency, * preoperative infection, * pregnancy, * asa iv, * presence of synchronous cancers, * abdominoperineal resection (apr), * failure to perform rectal resection and primary anastomosis, * emergency setting.
pilot study for thyroid surgery by preoperative video support and personalized and secure web platform

Conditions: Thyroid

Summary: the medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient. there are different reasons for the quantity and quality of medical information retained by the patient. an internet platform with personalized and secure access has been developed. this platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time. the investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

the objective is to assess the impact of additional, personalized and accessible preoperative medical information via a secure internet platform on the anxiety level of patients before their surgery. for this, patients agreeing to participate in the study will be randomized (drawn at random) during the inclusion visit and divided into one of the following two groups: * the control group: patients included in this group will receive the usual medical information as part of the surgery performed; * the experimental group: the patients included in this group will have, in addition to the usual medical information, personalized and secure access to a platform so that they can have additional information on the surgery performed.

Eligibility criteria:
inclusion criteria: * age between 18 and 75, * indication of lobo-isthmectomy or total thyroidectomy * compliance for the completion of self-questionnaires * person affiliated or beneficiary of a social security scheme. * free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). exclusion criteria: * difficulty understanding the french language * lack of internet access * persons placed under the protection of justice, * person under guardianship or curatorship * person participating in another research including an exclusion period still in progress, * subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant * pregnant / lactating woman

Keywords: preoperative procedure instructional films and video
autologous stem cell transplant (asct) for autoimmune diseases

Conditions: Systemic Lupus Erythematosus; Systemic Sclerosis

Summary: a subset of autoimmune diseases (ads) in children and young adults are life-threatening and unresponsive to conventional treatments. in these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (asct) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for "immune reset." this strategy has been used in adults across a myriad of indications with evidence for efficacy. this study proposes a pilot study to evaluate this therapeutic strategy in children and young adults with systemic sclerosis (ssc) and systemic lupus erythematosis (sle), two potentially life threatening autoimmune diseases that may response to this therapeutic approach.


Eligibility criteria:
inclusion criteria: 1. age 8 ≤ 25 years at time of enrollment. 2. severe systemic sclerosis or systemic lupus erythematosus based on specific criteria 3. adequate organ function status 4. no active, untreated infections. exclusion criteria: 1. previous hematopoietic stem cell transplant (hsct) or solid organ transplant 2. pregnancy 3. ongoing participation in a clinical trial testing an investigational drug or ongoing receipt of disallowed disease modifying anti-rheumatic drugs (dmard) 4. severe comorbidity that jeopardizes the ability of the subject to tolerate therapy
dose-response study of recombinant factor viii manufactured protein-free (rahf-pfm) in patients with hemophilia a

Conditions: Hemophilia A

Summary: the purpose of this study is to determine the effect of 3 doses of advate rahf-pfm on initial recovery (% increase \[iu/dl\] per iu/kg infused) and major single-infusion pharmacokinetic parameters. the 3 doses are 15, 30, and 50 iu/kg. prior to each infusion, subjects will not have received treatment with a factor viii concentrate for at least 3 days. blood samples will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. a washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. during participation, subjects will maintain their preexisting treatment regimens with advate rahf-pfm or other factor viii concentrate. a secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von willebrand factor ristocetin cofactor activity and von willebrand factor antigen at baseline.


Eligibility criteria:
inclusion criteria: * the subject has severe hemophilia a as defined by a baseline factor viii activity \<1% of normal; tested at screening. (a minimum washout period of 3 days is required before the blood sample can be drawn to determine baseline factor viii levels.) * the subject has a documented history of at least 150 exposure days to factor viii concentrates (either plasma-derived or recombinant). * the subject is within 12 to 65 years of age. * the subject has a karnofsky performance score \>60. * the subject is human immunodeficiency virus negative (hiv-) or hiv+ with cd4 count \>=400 cells/mm3 (cd4 count determined at screening, if necessary). * the subject or subject´s legally authorized representative has provided written informed consent. exclusion criteria: * the subject has a known hypersensitivity to mouse or hamster proteins or to factor viii concentrates. * the subject has a history of factor viii inhibitors with titer \>=0.8 bu (bethesda assay) or \>=0.4 bu (nijmegen modification of the bethesda assay) any time prior to screening. * the subject has a detectable factor viii inhibitor at screening, \>=0.4 bu (nijmegen modification of the bethesda assay), in the baxter central laboratory. * the subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: international normalized ratio (inr) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices. * the subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia a (e.g. qualitative platelet defect or von willebrand´s disease). * the subject has participated in another investigational study within 30 days of enrollment. * the subject´s clinical condition may require a major or moderate surgery (estimated blood loss \>500 ml) during the period of participation in the study.