Kornimate/medical-research-clean huggingface dataset:
effectiveness of care in certified cancer centres in germany

Conditions: Colorectal Cancer; Breast Cancer; Ovarian Cancer; Cervix Cancer; Endometrial Cancer; Bronchial Cancer; Prostate Cancer; Head and Neck Tumor; CNS Tumor; Pancreatic Cancer

Summary: assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries.

cancer constitutes the second most frequent cause of death in germany. to maintain a high quality of treatment, the national cancer plan aims at a unified certification of cancer centres. the project "wirksamkeit der versorgung in onkologischen zentren" (wizen) investigates effects of treatments in certified cancer centres across large populations and different cancer entities in comparison to hospitals that do not hold a certificate. wizen is a retrospective comparative cohort study that analyzes incident cases of eight types of cancer diagnosed within 2009-2017 based on nationwide health insurance data provided by wido (the aok research institute) and data from regional clinical cancer registries (ccr) for the period 2006-2017. these eight types of cancer are colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors and neuro-oncological tumors.

Eligibility criteria:
inclusion criteria: * first hospitalization due to diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2009-2017 \[wido\] * hospitalization due to primary diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 \[ccr\] exclusion criteria: * prevalent diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 * exception: outpatient cancer diagnosis up to 12 months prior to first hospitalization is not regarded as prevalent

Keywords: quality of treatment institution of treatment certification cancer centres quality of care treatment outcome health services research
pharmacokinetic and comparative bioavailability study of codeine sulfate under fasted conditions

Conditions: Pain

Summary: the objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of roxane laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to codeine sulfate or any comparable or similar product.
the dancerex proof-of-concept study for chronic neurological disorders

Conditions: Sclerosis, Multiple; Neurocognitive Impairment, Mild; Neurocognitive Dysfunction

Summary: the goal of this clinical trial is to test a new digital therapeutic solution which combines a holistic, multidimensional rehabilitation program based on dance and music with an innovative motivational system (dancerex-dtx) in chronic neurological disorders (multiple sclerosis and pre-mild cognitive impairment - mci/ mci at risk of alzheimer's disease). the main questions it aims to answer are 1\] efficacy of the digital therapeutic solution in terms of adherence, clinical/functional measures, quality of life and surrogate measures; 2\] usability and acceptability of the system. participants will be randomized (with an allocation ratio of 2:2:1) into the experimental group (dancerex - 24 sessions of multidimensional dance-based program integrated with an innovative motivational system), active comparator group (24 sessions of multidimensional dance-based program) and placebo group (24 sessions of educational program). researchers will compare the experimental group to the other two groups to see if a digital therapeutic solution integrating a multidimensional dance-based program and motivational system is effective in increasing adherence to rehabilitation treatment.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 85 years (adult and older adult); 2. education equal to or more than five years 3. agreement to participate with the signature of the informed consent form; 4. clinical diagnosis of multiple sclerosis (ms) according to the 2017 revised criteria of mc donald - expanded disability status scale (edss) score equal or less than 4.5, r-r disease course, freedom from relapses, and steroid treatment for at least one month, or clinical diagnosis of pre-mild cognitive impairment - mci (subjective memory complaints and/or subjective cognitive complaints)/mci at risk of alzheimer's disease with the clinical dementia rating (cdr) scale equal or less than 0.5 5. normal score to a screening test for cognitive impairment (montreal cognitive assessment test - moca test \> 15.5 santangelo et al., 2015) exclusion criteria: 1. presence of comorbidities that prevent patients from undertaking a safe home program (e.g., balance problems, history of falls in the past 6 months, use of assistive devices for deambulation) 2. presence of overt hearing/visual impairment 3. for the mci group, the absence of a caregiver/study partner able to support the participant; 4. no living in one's own home; 5. for the ms group, score in cerebellum function at edss greater than 3

Keywords: rehabilitation multiple sclerosis dementia digital therapeutics neurocognitive dysfunction mri neuroinflammation telerehabilitation
electrical stimulation of denervated muscles after spinal cord injury

Conditions: Spinal Cord Injury

Summary: in this study the following hypotheses will be tested: electrical stimulation of the gluteal muscle (buttocks) leads to 1. an increase in the thickness of the gluteal muscle 2. a decrease in the thickness of the fat of the buttock area 3. a change in the distribution of the middle and maximal seating pressure to a more consistent pressure 4. an increase in well-being of the patients.


Eligibility criteria:
inclusion criteria: * duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury * level of lesion: t 10 to l 5, ais a, classified by the american spinal injury association (aisa) exclusion criteria: * acute decubitus in the stimulated area * arteriosclerosis * less than three months after flap surgery or after decubitus in the stimulated area * infections or skin eczema in the stimulated area

Keywords: spinal cord injury denervation electrical stimulation
topical steroids and cyclosporin-a for covid-19 keratoconjunctivitis

Conditions: Keratonjunctivitis

Summary: to explore the feasibility of combined topical corticosteroid and topical cyclosporine-a in covid-19 patients with acute keratoconjunctivitis.

covid-19 patients presenting with acute keratoconjunctivitis will be treated with topical 1% prednisolone acetate fourtimes daily for 7 days as initial treatment, non-preserved artificial tears four times daily and cyclosporin a 0.5% four times daily . twelve patients with covid-19 keratoconjunctivitis will be enrolled in this open-label study. symptoms and findings of the patients before and after treatment were recorded.

Eligibility criteria:
inclusion criteria: * covid-19 patients with keratoconjunctivitis exclusion criteria: * associated ocular pathology or disease * other causes of keratoconjunctivitis for example allergic or herpetic
study evaluating neratinib in combination with temsirolimus in subjects with solid tumors

Conditions: Neoplasms; Malignant Carcinoma

Summary: the primary purpose of this study is to identify the maximum tolerated dose(s) (mtd) of neratinib in combination with temsirolimus in subjects with solid tumors. this study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (pk) parameters of the combination.


Eligibility criteria:
inclusion criteria: * pathologic diagnosis of advanced or metastatic solid tumor. * measurable disease per response criteria in solid tumors (recist criteria). * incurable cancer, with disease progression following at least 1 conventional or standard therapy for locally advanced or metastatic disease. * negative pregnancy test for women of child bearing potential. exclusion criteria: * chronic treatment with corticosteroids. * primary central nervous system (cns) tumors and active metastases. * presence of clinically significant or uncontrolled cardiac disease. * significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom. * symptomatic or prior history of non-infectious interstitial pneumonitis.

Keywords: neratinib solid tumors phase 1 dose finding study hki-272 nerlynx temsirolimus pb-272
social media use in adolescent diabetes care

Conditions: Type 1 Diabetes

Summary: the goal of this clinical trial is to evaluate the feasibility of a social media intervention to support diabetes management in adolescents with type 1 diabetes. adolescent participants will be randomized to receive diabetes education and peer support over instagram or to usual outpatient diabetes care. researchers will assess whether the social media intervention is feasible. in addition, the study team will also explore and compare changes in glucose levels and person-reported outcomes between the two groups.

the majority of adolescents with type 1 diabetes do not meet recommended glycemic targets, placing them at risk for acute and chronic diabetes-related complications. strategies that improve adolescent diabetes self-management are needed. social media offers new opportunities to provide diabetes education and peer support through communication in a digital environment. as part of a randomized controlled trial, adolescent participants will be randomized to receive diabetes education and peer support over instagram in addition to usual care or to standard outpatient diabetes care.

Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes ≥12 months * most recent hemoglobin a1c (hba1c) level is \> 7.0% * currently use dexcom continuous glucose monitoring (cgm) system * speak english fluently * cognitively able to participate in program on instagram and complete surveys * have access to a personal instagram account * found to be eligible on the social media preference screener exclusion criteria: * patient is a ward of the state * patient is pregnant as diabetes standard of care is different during pregnancy (i.e., different glycemic targets and frequency of clinic visits) * severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
clinical comparison of two multifocal contact lenses made of silicone hydrogel materials

Conditions: Myopia; Presbyopia

Summary: the purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.


Eligibility criteria:
inclusion criteria: * at least 35 years of age. * spectacle add of +0.50 to +2.50 diopters (inclusive). * currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day. * able to be fit in both eyes with soft multifocal lenses in available powers. * other protocol-defined inclusion criteria may apply. exclusion criteria: * eye injury or surgery within 12 weeks of enrollment in trial. * currently enrolled in any clinical trial. * astigmatism of 1.00 diopter or more. * currently wearing excluded brands of multifocal lenses, as specified by protocol. * other protocol-defined exclusion criteria may apply.

Keywords: myopia presbyopia
trazodone and its augmentation with pregabalin in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.


Eligibility criteria:
inclusion criteria: * patients diagnosed of fibromyalgia according to the american college of rheumatology criteria * written, informed consent * able to understand and comply with the requirements of the study exclusion criteria: * pregnancy or breastfeeding * unwillingness to discontinue other prescribed medications before entering in the study * patients who had previously received trazodone without improvement or who did not tolerate the drug * patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase ii of the study)

Keywords: fibromyalgia trazodone pregabalin fibromyalgia impact questionnaire (fiq) pittsburgh sleep quality inventory (psqi) brief pain inventory (bpi)
study to evaluate the product performance of a new silicone hydrogel contact lens

Conditions: Corneal Deformity

Summary: this will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the ultra contract lens.


Eligibility criteria:
inclusion criteria: * be between 18 and 40 years of age (inclusive) * not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months) * able to read, comprehend and sign an informed consent * willing to comply with the wear and study visit schedule * monocular best-corrected distance visual acuity \>/-20/25 in each eye exclusion criteria: * any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear * systemic or ocular allergies, which might interfere with contact lens wear * systemic disease or condition, which might interfere with contact lens wear * use of prescription sleep aids or alcohol within 24 hours of study appointment * inability to wear contact lenses * under 18 years of age
support for physical activity in everyday life with parkinson's disease

Conditions: Parkinson Disease; Physical Activity; eHealth; Gait Disorders, Neurologic

Summary: this study aims to determine the effects of a motor-cognitive exercise intervention, delivered in the home environment using ehealth methods, among people with parkinson's disease. the intervention will support and motivate motor training, combined with cognitive training, aimed at attentional and executive functions, among people at mild-moderate disease stages. the main hypothesis is that unsupervised motor-cognitive training in the home environment using ehealth will lead to improvements in gait performance, increased physical activity levels and improved perceived health.

this randomised controlled trial will investigate the efficacy of a motor-cognitive exercise program in the home environment, over a 10-week period, on physical function, and motor-cognitive dual task function as well as physical activity behavior in everyday life. participants will be recruited through stockholms sjukhem foundation, karolinska university and via announcements in relevant forums like for instance the swedish parkinson association. consenting participants will be randomized to the ehealth intervention group or the control group condition. block randomization will be achieved using a computerized random sequence generator. blinded assessors will perform the pre- and post-intervention testing of physical performance. the ultimate aim of this project is to provide people with pd with continual long-term and evidence-based rehabilitation in their everyday lives using mobile health technology, to support their self- management and increase their quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson´s disease * hoehn \& yahr (parkinsons progression scale) 2-3 * ≥ 50 years of age * able to ambulate indoors without mobility aid * able to walk continually with/without a walking aid for at least 6 minutes exclusion criteria: * cognitive impairment affecting the ability to understand or follow verbal or written instructions (montreal cognitive assessment ≤ 21 points * major problems with freezing and/or two or more falls in the month previous to inclusion * other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise * impaired vision and/or impaired communication which hinders participation * no internet connection in the home
frontal cortex and gait freezing in parkinson's disease: rehabilitation impact

Conditions: Parkinson's Disease

Summary: this project will relate our new quantification of freezing of gait (fog) in parkinson's disease, using body worn inertial sensors (aim i), with abnormalities in state-of-the-art, resting state, functional brain connectivity (aim ii), and determine the number of subjects needed for a future, randomized clinical trial to test the efficacy of our novel, agility boot camp (abc) rehabilitation intervention for fog (aim iii). the technological approaches to these aims are cutting edge and will allow us to develop sensitive behavioral and brain biomarkers for gait disorders in parkinson's disease (pd) for use in future clinical trials.


Eligibility criteria:
inclusion criteria: * aged 50-90 years old. * no musculoskeletal or peripheral or central nervous system disorders (other than idiopathic parkinson disease, ipd) that could significantly affect balance or gait . * capable of following directions. * ipd subjects: united kingdom brain bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. unilateral onset, response to levodopa. exclusion criteria: * inability to stand or walk for 2 min without an assistive device * recent changes in medication * excessive use of alcohol or recreational drugs, * contraindications to mri scans (eg, claustrophobia, metal in body) * intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) a medical condition that contraindicates exercise participation. * idiopathic pd subjects: same as above and deep brain stimulation electrodes. significant tremor that would interfere with mri scan. control subjects: * will be matched for age and gender to ipd group.

Keywords: freezing of gait (fog) balance gait exercise
association of 5-ht3 receptor gene polymorphism with the efficiency of ondansetron for postoperative nausea and vomiting

Conditions: Post Operative Nausea and Vomiting

Summary: postoperative nausea and vomiting (ponv) is a common and distressing complication in patients undergoing general anesthesia. however, although 5-hydroxytryptamine type 3 (5-ht3) receptor antagonists have significantly reduced ponv, it is reported that over 35% of patients treated with ondansetron experience ponv. though the cause of failure in ondansetron treatment is not clear, the investigators assumed that polymorphism in the 5-ht3 receptor gene would contribute to such inter-individual variation. in this study, the investigators examine whether the polymorphisms of 5-ht3 receptor gene affect the efficacy of ondansetron to prevent ponv in patients undergoing general anesthesia for laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * adult patients (20-90 years of age) scheduled for undergoing laparoscopic surgery undergoing general anesthesia exclusion criteria: * patients with previous history of drug allergy, * administration of antiemetic drugs within 24 hours, * nausea/vomiting within 24 hours and liver or kidney disease

Keywords: ondanstron gene polymorphism postoperative nausea and vomiting laparoscopic surgery under general anesthesia
a novel shape memory alloy-based orthosis for proximal interphalangeal joint stiffness

Conditions: Finger Proximal Interphalangeal Joint Contracture

Summary: the goal of this clinical trial is to evaluate the applicability, effectiveness, and usability of a shape memory alloy-based orthosis for patients with finger proximal interphalangeal joint stiffness. this cutting-edge design incorporates shape memory alloy into the device for improving proximal interphalangeal joint stiffness and, secondarily, enhancing the ability to perform activities. half of the participants will be assigned to experimental group, receiving a shape memory alloy-based orthosis for home program. the other half will be assigned to control group, receiving a conventional stretching program. three evaluations, examining range of motion and hand functional performance, will be conducted before intervention, 4 weeks and 8 weeks after baseline by the researchers.


Eligibility criteria:
inclusion criteria: * 18-79 years old * exhibit limitations in passive range of motion of the proximal interphalangeal joint, with extension less than 0 degrees or flexion less than 90 degrees. * beyond the acute phase of the hand condition, and it has been more than 8 weeks post-surgery (or post-injury). exclusion criteria: * concurrently use other types of splints for pip joint stiffness. * present with abnormal muscle tone, paralysis, or rigidity associated with central or peripheral nervous system dysfunction. * suffer from complex regional pain syndrome or progressive degenerative disease affecting finger joints, such as rheumatoid arthritis. * have an active infection or arthritis in their fingers. * unable to follow instructions.

Keywords: shape memory alloy finger stiffness joint contracture joint range of motion hand injury
quantum molecular resonance electrotherapy in severe dry eye disease

Conditions: Dry Eye

Summary: to evaluate the efficacy and safety of quantum molecular resonance (qmr) treatment in patients with severe dry eye disease (ded), as well as its effects on aqueous-deficient (adde), evaporative (ede) and mixed (mde) dry eye.

to evaluate the efficacy and safety of quantum molecular resonance (qmr) treatment in patients with severe dry eye disease (ded), as well as its effects on aqueous-deficient (adde), evaporative (ede) and mixed (mde) dry eye. in this prospective, interventional study, 81 patients will be randomly allocated to received 4 treatment sessions of qmr at one-week intervals (rexon-eye ® , resono ophthalmic, trieste, italy) (qrm group) or tear substitute 4 times daily, containing 0.15% sodium hyaluronate and 3% trehalose (thealoz duo ® , thea pharma, france) (sh-th group). outcomes measures will include ocular surface disease index (osdi) questionnaire, tear meniscus height (tmh), tear breakup time (tbut), non-invasive breakup time (nibut), corneal fluorescein staining (cfs), lipid layer thickness (llt), tear film osmolarity (osm) and meibomian gland dysfunction (mgd) grade at baseline, 1-month and 3-months follow-up.

Eligibility criteria:
inclusion criteria: -\> 18 years old with a self-reported history of ded * osdi score ≥ 33 points * tbut less than 10 seconds. exclusion criteria: * skin pathologies that prevent qrm treatment * corneal infection and corneal dystrophies * active ocular allergies * intraocular surgery or laser ocular surgery

Keywords: cornea dry eye