Kornimate/medical-research-clean huggingface dataset:
evaluation of physiological responses at the anterior surface of two (hydrophobic acrylic) intraocular lens models

Conditions: Age Related Cataracts

Summary: on the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a vivinex xy1a , hoya surgical optics gmbh and the second eye to be operated receives an xy1, hoya surgical optics gmbh. a complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract for which phacoemulsification extraction and posterior iol implantation is planned * age 40 and older * astigmatism of at least 0.75diopters in one eye * normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant exclusion criteria: * diabetes mellitus * pseudoexfoliation syndrome * systemical anticoagulation * antiphlogistic therapy * antiglaucomatosa * uncontrolled systemic or ocular disease * preceding ocular surgery or trauma * intraoperative complications * pregnancy/nursing * concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
pan european collaboration on antipsychotic naive schizophrenia (pecans)

Conditions: Schizophrenia

Summary: the investigators want to relate disturbances in first-episode schizophrenic patients in (dopaminergic) d2 receptors, brain structure, brain function, and information processing to each other and to psychopathology. additionally, the investigators want to examine the influence of d2 receptor blockade on these disturbances. the investigators expect disturbances in the dopaminergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and investigators expect d2 receptor blockade to reverse some of the functional and cognitive impairments.

the study is designed as a 6 week case-control follow-up study of 70 an fe pt. with scz and 70 controls matched with regard to age, gender, and parental socio-economic status. all subjects will be examined with a diagnostic interview (scan, schedule for clinical assessment in neuropsychiatry), medical and family history, and physical examination before inclusion. at baseline all subjects will be examined with single photon emission computed tomography (spect), mri, fmri, psychophysiology, neurocognition. in addition, they will be screened for drugs, genetic testing, and ecg. patients will further be examined with clinical validated rating scales to measure psychopathology, subjective well-being, and side-effects. after a period of 6 weeks all assessments are repeated. during that period patients will be treated with amisulpride, while healthy controls will receive no treatment at all. efficacy of antipsychotic treatment will be evaluated after this initial period of 6 weeks. based on this evaluation it will be decided to either continue the current (amisulpride) antipsychotic treatment, or to switch to aripiprazole. efficacy of aripiprazole is evaluated on a monthly basis, if the patient does not respond well enough, than the treatment will be adapted individually. regardless of treatment, all subjects will be re-assessed in the same test battery as mentioned above, except for spect and fmri, after a period of 6, 12, and 24 months. the developement in specific disturbances and the relationship between these will be analysed.

Eligibility criteria:
inclusion criteria: for patients: meeting diagnostic criteria for schizophrenia according to icd 10 or dsm iv antipsychotic naive the controls will be matched to the patients according to gender age and parental socio-economic status. - exclusion criteria: patients: mental retardation, other chronic diseases, use of antidepressive medicine during the last month,being pregnant, on going substance abuse controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives,on going drug abuse, mental retardation -

Keywords: dopamine first episode reward cognition mri fmri ppi p300 p50 gating endophenotypes
neuromuscular electrical stimulation in patients with covid19 associated pneumonia

Conditions: COVID-19 Pneumonia

Summary: neuromuscular electrical stimulation (nmes) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (icu). aim of this study is to evaluate the nmes effect on physical function of covid-19 patients.

this prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. patients are randomized to a control group (routine physical therapy for 3 weeks) or a nmes group (routine physical therapy plus nmes of quadriceps and gastrocnemius muscles for 3 weeks). the primary outcome is physical performance assessed through the short physical performance battery (sppb). secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. the spbb and walking performance will be assessed once (after the 3-week intervention period), while all other outcomes will be assessed twice (before and after the intervention). nmes is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. therefore, proving the effectiveness of nmes therapy for physical and muscle function in covid-19 patients could support its systematic incorporation in post-icu rehabilitation protocols of patients presenting with post-intensive care syndrome.

Eligibility criteria:
inclusion criteria: * age above 18 years * respiratory (pao2/fio2 ratio \> 180 mmhg) and hemodynamic stability for at least two days after withdrawal of mechanical ventilation and neuromuscular blocking agents exclusion criteria: * pregnancy * known or suspected malignancy in the lower limbs * body mass index equal or greater than 35 kg/m2 * conditions preventing nmes treatment (e.g., deep vein thrombosis, skin lesions, rhabdomyolysis) * conditions preventing the outcome assessment (e.g., amputation or inability to transfer independently from bed to chair before hospital admission) * presence of an implanted cardiac pacemaker or defibrillator

Keywords: covid-19 fatigue muscle thickness neuromuscular electrical stimulation post-intensive care syndrome quadriceps muscle short physical performance battery
roles of prophylactic subcutaneous drain in preventing surgical site infection in surgical wound after abdominal surgery

Conditions: Surgical Site Infection

Summary: surgical site infections (ssi) pose a common challenge in the field of surgery. current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of ssi in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4). the objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.

this study is a randomized, controlled and open study, where participants who undergo abdominal surgery will be randomly allocated into two groups: (i) patients whose wounds are inserted with subcutaneous negative pressure drain and (ii) patients whose wounds are not inserted with subcutaneous negative pressure drain. the participants in this study will know the details about the presence of their drain placement after the operation. if the patient was assigned to the drain group, the drain will be placed for five days or until there are no content observed in the drain. the primary outcome of this study is the occurrence of ssi, which will be tracked up to 30 days post-operation. the patient in both groups will also be evaluated by the surgeons at day 3, 5, 7, 14 and 30 post-operation for signs and complications of ssi. in situation where the patients are discharged prior to the date of evaluation, the patients will be scheduled for evaluation during the follow-up visits. if ssi is detected in the drain group prior to removal, the drain will be removed and the patient will be treated with wet dressing combined with antibiotics. complications of ssi will also be noted. patient's data on demographic, medical history, clinical presentation, details of operation, and other laboratory findings will also be collected to investigate for risk factors for development of ssi between each group.

Eligibility criteria:
inclusion criteria: * age equal or over 18 years old * admitted to queen savang vadhana memorial hospital * receive abdominal surgery and were classified as class 3 or 4 wound exclusion criteria: * patients who undergo operation for ostomy * patients who do not receive appropriate antibiotics * patients who undergo operation before full recover of prior operation * patients who undergo laparoscopic operation * pregnant women * patients who had history of prior radiation therapy at abdomen * patient with immunocompromised status * patient with chronic skin disease
blocking extracellular galectin-3 in patients with osteoarthritis

Conditions: Osteoarthritis

Summary: the proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with mcp to placebo for the treatment of knee osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. knee pain in at least one knee for more than half the days in the month prior to screening 2. x-rays showing evidence of knee osteoarthritis by kellgren and lawrence score two or three, with definite osteophytes and possible or definite joint space narrowing, consistent with mild to moderate knee osteoarthritis. if both knees are affected, patients would choose the more severe knee for outcomes assessments. 3. willingness to maintain stable analgesic regimen throughout the study period exclusion criteria: 1. diagnosis of fibromyalgia 2. presence of an underlying inflammatory disease in the affected knee, including rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, or other inflammatory disease. 3. patients who cannot give consent will be excluded, as will patients who cannot speak, read and understand english, as we will not have translated documents, consent forms, and surveys for them. 4. while this supplement is considered very safe and low risk, patients with underlying significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10, or platelets less than 100), or with impaired renal function (glomerular filtration rate less than 60) or elevated liver enzymes will be excluded as well.
study to evaluate the safety, pharmacokinetics, tissue distribution, metabolism and dosimetry of two prostate cancer imaging agents

Conditions: Prostate Cancer

Summary: this is a single blinded, randomized, cross-over design. up to 12 patients will be randomly administered a single 10.0 mci dose of 123i-mip-1072 or 123i-mip-1095 (study drugs). the second (alternate) study drug will be administered approximately 14 days after the first. a final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug.


Eligibility criteria:
inclusion criteria: * have a prior histological diagnosis of prostate cancer. * have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, ct scan or mri plus: 1. psa\> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or 2. psa\> 20 if intact prostate * have platelet count of \> 50,000/mm3 * have neutrophil count of \> 1,000/mm3 * provide written informed consent and willing to comply with protocol requirements * greater than or equal to 18 years of age * can be on hormonal therapy if dose stable for \> 90 days exclusion criteria: * karnofsky performance status of \<60 * inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and pk blood sampling, respectively) * patient received a permanent prostate brachytherapy implant within the last 3 months (for pd-103 implants) or 12 months (for i-125 implants). * patient received external beam therapy or chemotherapy within the last 30 days * administered a radioisotope within 5 physical half lives prior to study enrollment * serum creatinine \> 3.5 mg/dl * total bilirubin \> 2.5 times the upper limit of normal * liver transaminases greater than 5x the upper limit of normal * received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study * have any medical condition or other circumstances which, in the opinion of the investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations * is determined by the investigator that the patient is clinically unsuitable for the study * have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.

Keywords: prostate cancer imaging
tonic versus burst dr(tm) epidural motor cortex stimulation for neuropathic pain

Conditions: Neuropathic Pain

Summary: epidural stimulation of the primary motor cortex (pmc) is indicated for the relief of neuropathic pain refractory to pharmacological treatment.

the main objective of this study is to compare the analgesic effect of two distinct waveforms (i.e. tonic versus burst dr(tm)) delivered by an epidural stimulator of the (primary) motor cortex in patients suffering from neuropathic pain resistant to the best pharmacological treatment.

Eligibility criteria:
inclusion criteria: * patients suffering from neuropathic pain refractory to best pharmacological treatment, operated on for mcs with an internal pulse generator (ipg) capable of delivering both tonic and burst dr(tm) stimulation waveforms. exclusion criteria: * patients under 18 years old ; pregnancy

Keywords: motor cortex stimulation neuropathic pain burst dr(tm) waveform
visuospatial and affective abilities in parkinson disease

Conditions: Parkinson Disease; Alexithymia; Visuospatial/Perceptual Abilities

Summary: the aim of the study is to investigate whether prismatic adaptation (ap), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with parkinson disease. furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fnirs) and high-density electroencephalography (hd-eeg).


Eligibility criteria:
inclusion criteria: * over 18 years old; * right-handed; * diagnosis of idiopathic parkinson's disease according to the uk brain bank criteria (lyon and pahwa, 2011); * hoehn and yahr stadium (hoehn and yahr, 1996) \<2,5; * stable pharmacological treatment (dopaminergic therapy: dopamine agonists and levo-dopa) in the last 6 weeks. exclusion criteria: * - sensory-motor deficits that can hinder neuropsychological assessment; * visual system disorders (blindness, glaucoma); * atypical parkinsonisms; * pd with dementia according to the criteria of the diagnostic and statistical manual of mental disorders (dsm-iv) (american psychiatric association).
cortical priming to optimize gait rehabilitation post stroke

Conditions: Stroke

Summary: over four million stroke survivors currently living in the united states are unable to walk independently in the community. to increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. this project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.


Eligibility criteria:
inclusion criteria: * age 50 - 80 years * first ever monohemispheric stroke \> 6 months since onset * residual hemiparetic gait deficits * able to walk without an ankle orthotic for 5 minutes at self-paced speed. handheld assistive device is acceptable. exclusion criteria: * severe osteoporosis * contracture-limiting range of motion of lower limb * uncontrolled anti-spasticity medications during the study period * cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema) * unhealed decubiti, persistent infection * significant cognitive or communication impairment (mmse \<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the tracking task. * lesions pertaining to the brainstem and cerebellum

Keywords: gait brain stimulation tdcs walking
use of probiotics to prevent influenza

Conditions: Influenza

Summary: the goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection.

the goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection. the investigators will determine whether it is feasible to enroll residents and randomize them to a daily course of probiotics or placebo and monitor for influenza and other respiratory tract infections. in addition, the investigators will asses the feasibility of obtaining a nasal specimen for evaluation of the upper respiratory microbiome, measure antimicrobials, and deterioration in functional status. all aspects of the proposed trial will be assessed, including enrollment, randomization, respiratory infection surveillance, methods for outcome assessment, and event rates. the investigators will test the use of our data collection forms and data management strategy and will generate date to derive an appropriate sample size.

Eligibility criteria:
inclusion criteria: * nursing home residents, 65 years of age or older, in the hamilton on area exclusion criteria: * residents who are immunosuppressed (steroids or other immunosuppressives), have a hematologic malignancy, structural heart disease, gastroesophageal or intestinal injury and those are at increased risk of an endovascular infection will be excluded
from rotator cuff repair to reverse shoulder arthroplasty - clinical and radiological results

Conditions: Rotator Cuff Tears; Rotator Cuff Tear Arthropathy; Rotator Cuff Injuries

Summary: in the planned study the investigators will invite 733 participants 10 years after arthroscopic rotator cuff repair to a follow up examination. shoulder pain is a common problem in the norwegian population. rotator cuff tear is a major cause of shoulder pain with a reported prevalence of up to 51% in patients 60-80 years of age. arthroscopic rotator cuff repair is performed in an increasing proportion of these patients. good results in shoulder function has been reported, although there is a lack in published good quality studies and long term follow up of these patients. there is also a lack of evidence regarding the association between radiologically-verified re-tear and clinical outcome. in this project, the investigators address these critical gaps in knowledge and aim to investigate the factors influencing the clinical outcome after rotator cuff surgery and re-tear in a large prospective cohort study. the investigators will investigate how many participants suffering from poor outcome and develop cuff arthropathy in need of reverse shoulder arthroplasty after 10 years.

10 years after surgery: a cohort study of 733 participants with rotator cuff tear operated arthroscopically at lovisenberg diaconal hospital during 2010-2014. the investigators will ask the participants included at the time of surgery to participate in a ten-year follow-up. the investigators will ask them to submit validated patient reported outcome measurements (proms): western ontario rotator cuff index, eq-5d-5l, subjective shoulder value. the investigators will also evaluate the radiological result and signs of cuff arthropathy on x-ray according to hamada-fukuda and seebauer classification. the main objective is to quantify the relative importance of preoperative and perioperative prognostic factors on functional outcomes ten years after rotator cuff repair. the secondary objective is to identify and quantify patients who need shoulder replacement surgery ten years after rotator cuff surgery as a measure of failure.

Eligibility criteria:
inclusion criteria: * operated at lovisenberg diaconal hospital in the time period 2010-2014 with an arthroscopic rotator cuff repair * included in the rotator cuff registry at lovisenberg diaconal hospital * able to read and write norwegian exclusion criteria: * lack of competence to consent * not able to submit patient reported outcome measurements in any way and not able to undergo x-ray * patient is unwilling to participate

Keywords: prom rotator cuff repair rotator cuff tear cuff arthropathy