Kornimate/medical-research-clean huggingface dataset:
ilit: follow-up of rhinitis quality of life

Conditions: Allergic Rhinitis Due to Grass Pollen

Summary: re-evaluation of patients treated with intralymphatic immunotherapy (ilit) in terms of quality of life and therapeutic efficacy and comparison with subcutaneous immunotherapy (scit) 15 years post immunotherapy

in switzerland, around 20% of the population suffers from hay fever. the allergy usually begins in childhood and can worsen or improve as the child grows. the quality of life of those affected suffers greatly. since the allergens are seasonally found in the air, patients cannot really avoid the source of the allergy. on the one hand, allergic rhinitis can be treated pharmacologically. on the other hand allergen-specific immunotherapy (ait) (=desensitization), can be considered. ait can greatly reduce the symptoms and restore the patient's quality of life. it is the only treatment method that can offer long-term therapeutic success without the need for regular medication. subcutaneous immunotherapy (scit) is the traditional method in which the allergen is administered subcutaneously over a period of three to four years with alternating treatment intervals. the chances of success are good, but the drop-out rate is comparatively high due to the long treatment period (at least 3 and up to 5 years). in contrast, intralymphatic immunotherapy (ilit) requires only three sessions over a period of three to four months. the allergen is administered by ultrasound directly into a lymph node. the results are equally good (compared to scit), but the treatment time is much shorter. in the following project, the quality of life of the people who participated in the first ever ilit study (clinicaltrials.gov identifier: nct00470457) will be evaluated. the aim is to have a meaningful result on the duration of the therapeutic effect, as judged by the patients themselves. to develop a meaningful result, a questionnaire was designed for patients to fill out at baseline (prior to pollen season). this shold allow assessmen of how each individual's quality of life has evolved since treatment. the study subjects will also receive a standardised (european) questionnaire. this questionnaire refers to the quality of life and symptoms of the last seven days and is filled out at baseline (prior to season) and in season (mai-june). the data will be analysed and presented to the scientific and clinical audience as soon as possible.

Eligibility criteria:
inclusion criteria: * receiving ilit or scit treatment at the usz. * indication: hay fever (type i sensitisation to grass pollen) * adult male and female patients * written/digital informed consent of the participating person * complete return of both questionnaires exclusion criteria: * discontinuation of immunotherapy * incomplete data set * pathological barrier (e.g. dementia) * language barrier (not understanding the german language)
acute psychological sleep stabilisation for patients hospitalised with depression

Conditions: Insomnia; Depression

Summary: disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited. the overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (cbt-i) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the stockholm region. the main hypothesis for the study is that acute psychological sleep stabilization (aps) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that aps also leads to reduced depressive symptoms and earlier discharge. the project includes a pilot study, which will be followed by a randomized, controlled trial of aps compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. aps will be performed by existing staff in the department with the support of a psychologist.


Eligibility criteria:
inclusion criteria: * admitted to the psychiatric inpatient care (psykiatri sydväst) * depressive symptoms / confirmed depressive episode (uni- or bipolar) * reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase * knowledge of swedish or english that is deemed sufficient to undergo the treatment * consent to be included in the study and is judged to have understood what the study entails (care according to the compulsory psychiatric care act is not in itself an exclusion criterion) exclusion criteria: * dementia * intellectual disability * severe somatic comorbidity with life expectancy \<6 months * ongoing mania / mixed-state * complex problems that make aps impossible or inappropriate * expected discharge within 3 days

Keywords: cbt psychiatry inpatient care sleep
open-label, safety, and efficacy study of dexmedetomidine in preterm subjects ages ≥28 weeks to <36 weeks gestational age

Conditions: Anesthesia

Summary: the primary objective of this study is to characterize the safety, and efficacy of dexmedetomidine (dex) administered as an intravenous (iv) loading dose followed by a continuous iv infusion in preterm subjects, ages ≥ 28 weeks through \< 36 weeks gestational age.


Eligibility criteria:
inclusion criteria: 1. initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require at least 6 hours of continuous iv sedation. 2. age: subjects must fit the following age range at screening: preterm subjects ≥28 weeks through \<36 weeks, gestational age; note: gestational age (in weeks) will be calculated as follows: the time elapsed between the first day of the last menstrual period and the day of enrollment. 3. weight: subject's weight at the time of enrollment must be \>1000 g. 4. subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the institutional review board (irb)/independent ethics committee (iec). exclusion criteria: 1. neonate subjects with neurological conditions that prohibit an evaluation of sedation such as: * diminished consciousness from increased intracranial pressure. * the presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the n-pass unreliable. * subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (nmb) agents. 2. subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ. note: if subject's status-post cardio pulmonary bypass (cpb) was managed without pacing wires in situ, the subject must not be suspected to be in second degree or third degree heart block at the time of dex administration. 3. hr \< 120 bpm prior to the initiation of dex. 4. exposure to any investigational drug within 30 days prior to dex administration. 5. previous exposure to dex as part of an investigational study. 6. in subjects that are ex-utero for less than 72 hours, a maternal history of poly-substance drug abuse, based upon the investigator's clinical judgment. 7. at the discretion of the investigator, subjects in whom the risk of dex treatment is expected to exceed its benefits. 8. subjects who have a known allergy or contraindication to fentanyl, morphine, mdz, dex, or other α-2 agonists. 9. requirement for medications other than dex, mdz, morphine, or fentanyl for sedation and pain control. 10. screening alt levels \>115 u/l.
anti-ox40 antibody in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to test the safety of the anti-ox40 antibody, medi6469, given prior to surgery in patients with advanced head and neck squamous cell carcinoma.

this phase ib clinical trial uses medi6469 at various dose intervals prior to definitive surgical resection of patients with stage iii and iv oral head and neck squamous cell carcinoma (ohnscc) with the primary objective of determining the safety and feasibility of preoperative medi6469 administration. in addition, tumor tissue and peripheral blood will be obtained for exploratory immunologic end points including measurements of tumor infiltrating immune cell populations based on flow cytometry and immunohistochemistry as well as circulating immunological parameters that may correlate with changes induced by medi6469 administration.

Eligibility criteria:
inclusion criteria: * patients with treatment naive, resectable, stage iii or iv squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for definitive surgical resection followed by standard risk adapted adjuvant therapy. * histologic or cytologic diagnosis of a primary ohnscc with no radiological evidence of metastatic disease is acceptable. patients with bone or cartilage invasion and any t or n stage are acceptable. * patients with oral cavity primaries will be managed using conventional transoral or transcervical techniques; oropharynx or hypopharynx tumor will be managed with transoral robotic surgery; and larynx tumors (t3/t4 with thyroid cartilage invasion) will be managed by either total laryngectomy or larynx preservation surgery. * eastern cooperative oncology group (ecog) performance status 0, 1, or 2 * laboratory values (performed within 28 days prior to enrollment) within protocol defined range * ability to give informed consent and comply with the protocol. patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy. * no active gastrointestinal bleeding. * anticipated lifespan greater than 12 weeks. exclusion criteria: * locoregionally unresectable or metastatic disease (stage ivb) * active infection. * active autoimmune disease including patients with inflammatory bowel disease as determined by an autoimmune questionnaire. * previous treatment with mouse monoclonal antibodies * need for chronic maintenance oral steroids \> 5mg prednisone daily equivalent. * any medical or psychiatric condition that in the opinion of the investigator would preclude compliance with study procedures.

Keywords: head and neck cancer anti-ox40 antibody medi6469 immunotherapy
retigabine efficacy and safety trial for partial onset refractory seizures in epilepsy

Conditions: Seizures

Summary: this phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (aeds).

this phase 3 study is being conducted in europe, israel, australia, and south africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (aeds). the primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. the proportion of responders (greater than or equal to 50% reduction in seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization * 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase * currently treated with up to three established aeds * vagal nerve stimulator may be included exclusion criteria: * existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study * clinically significant abnormalities on physical exam, vital signs, ecg, or liver function tests * impaired renal function (creatinine clearance less than 50 ml/minute) * evidence of progressive central nervous disease, lesion, or encephalopathy * history of primary generalized seizures * history of clustering or flurries or status epilepticus within 12 months of study entry

Keywords: partial seizures complex partial seizures epilepsy potassium channels anticonvulsant
abiomed impella rt-daq - observational study

Conditions: Cardiogenic Shock

Summary: abiomed impella-rt-daq - impella real time data acquisition

the objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and impella using a network module, which can replace invasive hemodynamic monitoring in the future.

Eligibility criteria:
inclusion criteria: 1. ongoing or planned intensive care management with impella support 2. presence or planned placement of a cardiac output measurement 1. preferentially pulmonary catheter (including cardiac output (co) preferred as continuous measurement) 2. other means of discontinuous co measurement incl. echocardiography, other thermodilution methods exclusion criteria: 1. age \< 18 years 2. pregnancy 3. anticipated support duration \<24 h
open label study of octreotide implant in patients with acromegaly

Conditions: Acromegaly

Summary: to evaluate the pharmacokinetic (pk) and pharmacodynamic (pd) response of a hydrated and non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of treatment.

an open-label, randomized, multi-center, parallel-group, phase i/ii study conducted in 30 male and female patients with acromegaly. eligible patients received 1 implant, either hydrated or non-hydrated, within 7 days of their screening visit. the octreotide implant was inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia. blood samples for the determination of insulin-like growth factor 1 (igf-1), growth hormone (gh), and octreotide serum concentrations were collected at predetermined timepoints within the first 6 weeks after implantation.

Eligibility criteria:
inclusion criteria: * male and female patients with acromegaly * must be at least 18 years old * confirmed diagnosis of a growth hormone -secreting tumor * must be either a full or partial responder to octreotide demonstrated by historical laboratory values exclusion criteria: * women who are pregnant, lactating or of child-bearing potential who are not practicing a medically acceptable method of birth control * patients with liver disease * patients with symptomatic cholelithiasis * patients receiving radiotherapy for their pituitary tumor at any time before screening

Keywords: s-lar octreotide implant
registry of celution device for processing adrcs and healing in muscle and ligament sports injuries

Conditions: Muscle Tear

Summary: this registry study will compile information about patients who are scheduled to receive or have received adipose derived regenerative cells (adrcs) prepared by celution device to treat muscle and ligament sports injuries.


Eligibility criteria:
inclusion criteria: * males or females \> 18 of age * patients with sports related muscle tear (≥5%) with or without ligament injury as confirmed by ultrasound or mri with onset of injury in preceding year * pain in the affected area at rest and/or movement * weakness or inability to use affected muscle exclusion criteria: * muscle tear \<5% or unrepaired complete tears or ruptures on ultrasound or mri * known spine or disc disease or symptomatic impingement of nerve root * known neuromuscular disease (e.g., amyotrophic lateral sclerosis, muscular dystrophy) * history of documented nerve damage in the affected limb * tears involving open wounds * tears requiring surgical repair * pregnant or lactating status. pregnancy as determined by a positive pregnancy test at screening or baseline
a study of elx-02 in patients with alport syndrome

Conditions: Alport Syndrome

Summary: this is a phase 2 open label pilot study to evaluate the safety and efficacy of subcutaneously administered elx-02 in patients with x-linked or autosomal recessive alport syndrome with col4a5 and col4a3/4 nonsense mutation. in total, up to 8 participants, with a minimum of 3 adults, will be enrolled in the trial. the study will be comprised of the following periods for each participant: * a screening period of up to 6 weeks (42 days) * a total treatment period of 8 weeks (60 days) * a safety/efficacy follow-up period of 12 weeks (90 days) after the last treatment the treatment period will be a treatment of elx-02 0.75 mg/kg sc qd for 8 weeks.


Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of x-linked or autosomal recessive alport syndrome with a documented nonsense mutation of col4a5 in a male or nonsense mutation of col4a3 or col4a4 (male or female) * the nonsense mutation should be uag or uga * egfr\>60 ml/min/1.73 m2 (based on ckd-epi for ages ≥18 and schwartz formula for participants \<18) * urinary protein based on two spot urine collections \[urine protein/creatinine ratio (upcr) ≥ 500 mg/g\] * stable regimen of acei/arb for at least 4 weeks before screening (unless there is a contraindication) exclusion criteria: * history of any organ transplantation * mutation consistent with autosomal dominant alport syndrome * liver disease characterized by cirrhosis or portal hypertension. participants with alanine aminotransferase (alt), aspartate aminotransferase (ast), and/or a total bilirubin 3.0 times the upper limit of normal (uln) will be excluded * history of congestive heart failure diagnosed clinically or with documented left ventricular ejection fraction (lvef) ≤ 40% * history of dialysis

Keywords: aminoglycoside nonsense mutation translational read through
preventing job loss using acceptance and commitment therapy in vocational rehabilitation

Conditions: Multiple Sclerosis

Summary: about 60-70% of people with multiple sclerosis (pwms) lose employment within 10 years of the diagnosis. this can be due to complex personal and work-based factors including psychological factors. ms-proactive aims to test an online self-help therapy to support pwms to stay in work called 'ready for ms'. this is a type of acceptance and commitment therapy. it is a way to provide treatment in a flexible way without people having to go to see a psychologist. the aim of the treatment is to improve self-efficacy which has been shown to be a significant factor for helping pwms who want to work to stay in work. the research team will initially develop an online version of ready for ms. we will ask 4 pwms to test the online'ready for ms' and provide feedback and advice on any necessary changes. we will then recruit and randomise 88 pwms in leeds and london who are at risk of job loss. participants in the active treatment group will use the online treatment in addition to their usual care; the control group will receive their usual care. the participants will complete questionnaires at the start of the study, at 8 weeks and 6 months measuring time off work and work instability (to measure risk of job loss), self-efficacy, mood, quality of life, fatigue and the impact of ms. the questionnaire data will be analysed to test the effectiveness of the treatment. the research team will also interview 4 pwms at each site at the start of the study, at 8 weeks and 6 months to find out about their experience of using ready for ms in more detail. this will help to inform the use of ready for ms in a larger trial in the future.


Eligibility criteria:
inclusion criteria: * employed people with a confirmed diagnosis of multiple sclerosis. paid employment including full-time or part-time work and self-employed. age 18 years and over access to a computer or tablet for the on-line sessions. ability to complete questionnaires at three time points. exclusion criteria: * unpaid employment eg voluntary work. pwms who are planning to retire or fully leave employment in the time period of the rct. on sick leave or maternity leave at the time of recruitment. significant cognitive impairment.
star excursion balance for patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: patellofemoral pain syndrome (pfps) is a common and painful musculoskeletal condition that affects physically active young adults and causes pain front of the knee. patients with pfps has bilateral impairment in proprioception, as well as more in the affected knee than the normal; also the decrease of muscular strength, range of motion, and neuromuscular control are known to result with impaired static and dynamic balance.this study aimed to investigate the efficacy of a-four week ydt balance exercises on pain, quality of life and functional state in patients with pfps with impaired balance.

patellofemoral pain syndrome (pfps) is a common and painful musculoskeletal condition that affects physically active young adults and causes pain front of the knee. patients with pfps has bilateral impairment in proprioception, as well as more in the affected knee than the normal; also the decrease of muscular strength, range of motion, and neuromuscular control are known to result with impaired static and dynamic balance. we aimed to investigate the efficacy of a-four week ydt balance exercises on pain, quality of life and functional state in patients with pfps with impaired balance. patients with pfps diagnosed will included in the study. participants will randomized into the ydt exercise group (n = 24), the kat 2000 exercise group (n = 24) and the combined exercise group (n = 24). before the study, all groups of patients will given exercises such as quadriceps, vastus medialis oblique (vmo), hip abductor, extensor and external rotator strengthening exercises. all patient groups received balance training for four weeks, three days a week. pain intensity will be measure on visual analog scale (vas). functional capacity will be evaluated by using the western ontario mcmaster osteoarthritis index (womac) and kujala patellofemoral score (kps). static balance performance will be evaluated by using kinesthetic ability trainer 2000 (kat 2000) and dynamic balance performance will be evaluated by using berg balance scale (bbs) and kat 2000. the quality of life will assessed using nottingham health profile (nhp).

Eligibility criteria:
inclusion criteria: * between 20 -50 years * retropatellar pain * positive clark test, j finding, increased q angle, positive patellar compression and comphrension test * mild or moderate berg balance scale scores * body mass index \<30 * mini mental state test score \>24 exclusion criteria: * effusion on patellefemoral site * severe neurologic disease * trauma history * lower extremity surgery history * lower extremity fracture history * severe vitamin b12 deficiency * another disease led to balance deficit

Keywords: balance patellofemoral pain syndrome star excursion balance test kinesthetic ability trainer 2000