Kornimate/medical-research-clean huggingface dataset:
clinical comparison of two daily disposable contact lenses - pilot study 3

Conditions: Myopia; Ametropia

Summary: the purpose of this study is to evaluate the overall performance of precision1™ contact lenses when compared to infuse™ contact lenses.

the expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an informed consent form that been approved by an institutional review board. * successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * current/previous precision1 or infuse contact lens wearer. * any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator. * routinely sleeps in contact lenses. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
sphenopalatine ganglion block and pain management in neurosurgery

Conditions: Post Operative Pain; Craniofacial Pain

Summary: post craniotomy pain is defined as headache developed up to 7 days from a craniotomy, not otherwise explained. a moderate to severe pain affects from 60 to 84% of patients. sphenopalatine ganglion block has been successfully used in patients with chronic or acute headache, facial pain and for transsphenoidal pituitary and endoscopic sinus surgeries. there are evidences that sphenopalatine ganglion block reduces vegetative responses to skull pin closure. this study aim to investigate feasibility and efficacy of sphenopalatine ganglion block in reducing pain after a neurosurgical supratentorial craniotomy.


Eligibility criteria:
inclusion criteria: * supratentorial craniotomy exclusion criteria: * prior craniofacial pain syndrome * drug assumption: pain-killers (chronic), antiepileptic

Keywords: sphenopalatine ganglion block post-craniotomy pain
discovisc comparative evaluation

Conditions: Cataracts

Summary: a comparison of the ability of discovisc to that of other opthalmic viscosurgical devices (ovds) (duovisc®, biovisc®, healon5®, or amvisc plus) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.


Eligibility criteria:
inclusion criteria: * unilateral operable cataracts exclusion criteria: * preoperative endothelial cell count (ecc) ≤1500 cells/mm2 * intraocular pressure (iop) \> 21 * history of ocular inflammation * systemic or ocular diseases affecting corneal endothelium

Keywords: discovisc ovd ophthalmic viscosurgical device
zilver ptx drug-eluting peripheral stent study

Conditions: Peripheral Arterial Disease

Summary: this randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer zilver ptx stents (≥ 100 mm) compared to shorter zilver ptx stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.


Eligibility criteria:
inclusion criteria: * one de novo or restenosed artherosclerotic lesion with \> 50% diameter stenosis * reference vessel diameter of 4 - 9 mm * rutherford category ≥ 2 * resting ankle brachial index \< 0.9 exclusion criteria: * prior stent in the study vessel * significant stenosis (\> 50%) or occlusion of inflow tract not successfully treated before the study procedure * lacks at least one patent runoff vessel * lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

Keywords: pad
angiographic comparison in an observational study of cadence (the ambience study)

Conditions: Coronary Artery Disease

Summary: this is a prospective, multi-center study to capture information on sensitivity and specificity of cadence using coronary angiogram as the gold standard, on subjects who are already scheduled for coronary angiography.

cadence is an ecg and acoustic tool to assess coronary artery disease. this study's goal is to collect patient cadence information and compare it to the results of angiogram to determine performance: sensitivity and specificity. the cadence is not used to direct patient care. this is observational only.

Eligibility criteria:
inclusion criteria: * age \>40 years * clinical indication for coronary angiogram * willing and able to give informed consent exclusion criteria: * body mass index (bmi) \ 40 * prior bypass surgery or coronary stenting * presence of pacemaker/defibrillator * presence of artificial valve * presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta * presence of murmurs, including valve lesions, ventricular septal defects and arteriovenous fistulae * presence of moderate-severe valve disease * left ventricular assist device (lvad) * presence of scars on the site thorax areas * participation in trial within 30 days prior to collecting cadence data except participation in registry studies. * asthma or chronic obstructive pulmonary disease (copd) with active wheezing * inability to lie in supine position * heart transplant
automatic stop orders for urinary catheters

Conditions: Urinary Tract Infections

Summary: urinary tract infections are the most common type of hospital-acquired infection. the majority of these infections result from the use of indwelling urinary catheters. often caregivers leave them in unnecessarily. the purpose of this study is to assess the effectiveness of an automatic stop order (automatic removal or urinary catheters when they no longer needed) in reducing urinary infections.

we will randomize patients with urinary catheters to either automatic stop orders or to usual care. the primary outcome will be urinary tract infection. secondary outcomes will include days of indwelling urinary catheterization, symptomatic urinary tract infection, isolation of antimicrobial-resistant bacteria from catheterized urine, antimicrobial use, bacteremia (blood-stream) infection secondary to urinary tract infection, and cost. we hypothesize that use of the automatic stop order will significantly reduce hospital-acquired urinary tract infection.

Eligibility criteria:
inclusion criteria: * urinary catheter for less than 48hrs exclusion criteria: * patient with symptomatic urinary tract infection * latex allergy

Keywords: urinary infections, catheters, bacteriuria, trial
stryker triathlon® cruciate substituting vs. posterior stabilized outcomes study

Conditions: Osteoarthritis, Knee

Summary: this study compares the clinical and radiographic outcomes obtained with the use of the stryker triathalon® cruciate substituting (cs) and posterior stabilized (ps) tibial inserts.


Eligibility criteria:
inclusion criteria: * adults ages 20-80 years old * body mass index \<40 * undergoing primary total knee arthroplasty for osteoarthritis of the knee exclusion criteria: * inflammatory arthritis * revisions other criteria may apply

Keywords: osteoarthritis total knee replacement tka knee ps cs
prospective registry study of endovascular treatment for acute ischemic stroke patients

Conditions: Endovascular Treatment

Summary: to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

prospective registry study of endovascular treatment for acute ischemic stroke patients is an academic,independent, pragmatic , prospective, multicenter, observational registry study. the acute ischemic stroke patients undergone endovascular therapy will be enrolled in stroke centers. baseline information and clinical follow-up information at 90 days of stroke onset are collected. data collected include demographics, comorbidities, pathogenesis, blood pressures, stroke severity on admission, time intervals, reperfusion condition, and functional outcome, et al. the study aims to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke; 2. brain imaging confirmed intracranial large vessel occlusion: intracranial internal carotid artery (ica), middle cerebral artery (mca m1/m2), anterior cerebral artery (aca a1/a2), basilar artery (ba), vertebral artery (va v4), and posterior cerebral artery (pca p1); 3. initiation of any type of endovascular treatment, including mechanical thrombectomy, aspiration, angioplasty, and stenting; 4. informed consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent exclusion criteria: 1. acute intracranial haemorrhage 2. no evidence of large vessel occlusion on digital subtraction angiography. 3. patient bedridden or presenting from a nursing home 4. foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) -

Keywords: acute ischemic stroke endovascular treatment
clinical and radiological results of long term tibial and femoral osteotomy in knee ostheoarthritis with concomitant lower limb malalignement

Conditions: Knee Osteoarthritis; Malalignment, Bone

Summary: the present study aims to evaluate the long-term and medium-term outcomes of different knee osteotomy techniques in the treatment of knee osteoarthritis in patients with lower limb malalignment. this evaluation is necessary in the current context of research on the treatment and prevention of knee osteoarthritis through treatments that do not involve or allow for the postponement of prosthetic replacement. among the biological treatments performed in orthopedic clinical practice, osteotomy is one of the most promising. however, further long-term evaluations are needed to more clearly determine the indications and potential of this type of intervention, considering the various surgical procedures described for performing it.


Eligibility criteria:
inclusion criteria: 1. patients undergoing corrective knee osteotomy and any associated procedures such as meniscal repair/resection/replacement, ligament reconstruction, chondral treatment, or regenerative infiltrative treatment; 2. patients aged between 18 and 70 years at the time of surgical intervention; 3. patients with isolated compartmental osteoarthritis; 4. patients with a varus or valgus knee alignment defect of at least 3° compared to mechanical neutrality. exclusion criteria: 1. patients with advanced multicompartimental osteoarthritis; 2. patients who are no longer reachable; 3. women of childbearing age who cannot exclude pregnancy; 4. patients unable to give informed consent or patients unwilling to sign the informed consent form.
effects of resistance training on physical activity in daily life and functional capacity in hemodialysis patients

Conditions: Renal Insufficiency, Chronic

Summary: the purpose of this study is to determine whether a supervised resistance exercise training during hemodialysis is effective to increase physical activity in daily life in patients with end stage renal disease.

the patients will be randomized into two groups: intervention and control groups. patients in the intervention group will receive a supervised resistance exercise training, during hemodialysis, three times/week for 12 weeks, and patients allocate to the control group will received a passive stretching program during the same timeframe.

Eligibility criteria:
inclusion criteria: * patients with end stage renal disease on hemodialysis for at least three months * sedentary for at least six months exclusion criteria: * presence of physical limitations that prevent the implementation of physical tests * presence of severe comorbidity and unstable (unstable angina, decompensated heart failure, myocardial infarction history of the past six months, cardiac arrhythmias, uncontrolled hypertension with systolic blood pressure ≥ 200 mmhg and / or diastolic blood pressure ≥ 120 mmhg, diabetes decompensated, severe lung disease, acute systemic infection as well as neurological disorders, musculoskeletal and osteoarticular or other disabling conditions according to the clinical judgment) * hospitalization in the three months prior to study entry
evaluate protein c levels in severe sepsis patients on drotrecogin alfa (activated)

Conditions: Severe Sepsis

Summary: in this trial, patients with severe sepsis and low protein c levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. after the drug administration is complete, the protein c levels from the patients receiving the normal, approved dose will be compared to protein c levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein c levels improve faster if given higher dose and/or longer administration time. note: the protocol was amended to remove the option of shorter infusion durations.


Eligibility criteria:
inclusion criteria: * must be 18 years or older * must have a suspected or proven infection * must have two or more sepsis-associated organ dysfunctions exclusion criteria: * documented multiple organ dysfunction greater than 24 hours prior to start of study drug * actual body weight less than 30 kg or more than 135 kg * platelet count less than 30,000/mm\^3 * active internal bleeding or at increased risk of bleeding * not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition
effects of a computerized cognitive stimulation intervention adapted to the level of cognitive reserve

Conditions: Mild Cognitive Impairment; Cognitive Dysfunction

Summary: normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for mild cognitive impairment (mci). older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. in this regard, cognitive stimulation (cs) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (cr) acquired throughout life and the baseline level of cognitive functioning. the general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from occupational therapy based on the level of cognitive reserve in older adults in primary care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. the intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. the main result expected to be achieved is the improvement of higher brain functions. as secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. the investigators think that these results can positively impact the creation of adapted, meaningful and stimulating cs programs in older adults to prevent mci and experience healthier ageing.


Eligibility criteria:
inclusion criteria: * age: ≥ 60 years. * with score in lobo's mini-cognitive examination (mec-35) (lobo, a., escolar, v., ezquerra, j., \& seva díaz, 1979) between: 28-35 points (friedman et al., 2012; vinyoles bargalló et al., 2002). * non-institutionalized persons, belonging to the health centers where the study was conducted. * with a minimum educational level (knowing how to read and write). * who do not present hearing, visual or communication difficulties that would prevent them from completing the cognitive training. exclusion criteria: * people with mild cognitive impairment or alzheimer's disease (ad). * people with significant functional impairment. * people who have received any type of professionalized cognitive stimulation therapy in the last year. * people with significant psychiatric conditions, such as major depressive disorder or schizophrenia. * people who are taking medications that may adversely affect cognitive function, such as anticholinergics, tranquilizers and anticonvulsants.
effects of instrument assisted soft tissue mobilization in patients with chronic mechanical low back pain

Conditions: Low Back Pain

Summary: this study is a randomized control trial in which participants aged 18-50 years having diagnosed chronic mechanical low back pain will be recruited into two groups. group a will be receiving myofascial release using stripping technique whereas, group b will be receiving instrument assisted soft tissue mobilization using long bar tool. afterwards, post-treatment stretching would be performed in both the groups. final assessment of pain, range of motion and disability will be done on last treatment session.

low back pain is a major cause of disability worldwide, affecting both genders equally at some point in their lives. 95% of low back pain is mechanical in origin which is the pain originating from spine, intervertebral discs and surrounding soft tissue structures. a total of 50 participants will be divided into two groups by coin toss method, based on the eligibility criteria. baseline assessment of pain using nprs, range of motion using gravity-based inclinometer and disability using oswestry disability index will be done on 1st session for both the groups. group a will be receiving moist heat for 10 minutes followed by myofascial release and post-treatment stretching. whereas, on the other hand, group b will be receiving moist heat for 10 minutes followed by instrument assisted soft tissue mobilization using graston g6 long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees over lumbar area followed by post-treatment stretching. total treatment plan will be of 3 weeks, consisting of total 9 sessions, 3 sessions on alternate days. final assessment will be done for pain, range of motion and disability on last session at 3rd week. gentle icing would be recommended in case of itching and bruising over the treated area.

Eligibility criteria:
inclusion criteria: * individuals aged 18-50 years with diagnosed chronic mechanical low back pain. * males and females both. * participants having symptoms of duration more than 3 months. * numeric pain rating scale (nprs) score of 5 or more. exclusion criteria: * patient with a history of recent spinal surgery and related trauma. * participants with a history of pregnancy. * participants with a history of infection, tumor and spinal fracture. * participants with diagnosed psychiatric disorder.
alimta (pemetrexed) alone or in combination with cisplatin for patients with malignant mesothelioma.

Conditions: Mesothelioma

Summary: this study is to evaluate the effects (good and bad) of alimta and cisplatin or alimta alone on you and your malignant pleural mesothelioma as well as make alimta available to patients who qualify for treatment.


Eligibility criteria:
inclusion criteria: * have a proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery * prior chemotherapy for your disease is allowed * measurable lesion is not required * have a adequate performance status * sign an informed consent form exclusion criteria: * you are excluded from this trial if you have received any investigational agent within 4 week before enrolling in this study * you are excluded from this trial if you have received radiation within the previous 2 weeks * you are excluded from this trial if you are a candidates for curative surgery
effect of oral txa on buttock bruising post cch injections in adult females

Conditions: Cellulite

Summary: this is an open-label, randomized, multiple dose iir study to evaluate the effect of lysteda™ on bruising following qwo™ injections to the buttocks in female subjects presenting with moderate to severe cellulite. following determination of eligibility based on inclusion/exclusion assessment, the subjects will be randomized to either cohort a, cohort b, or cohort c, based on order of enrollment. each cohort will receive 3 qwo™ treatments spaced 21 days apart, with 1300 mg of lysteda™ tid po at one, two, or all three treatments of qwo™. cohort a will be given tranexamic acid at the first treatment, cohort b at the first and second treatment, and cohort c at all three treatments. all buttock cch injections will follow the on-label injection protocol. subjects will participate in the study for 65 days total, with an additional screening period of 14 days. there will be a total of 11 visits (screening, day 1, day 4, day 14, day 22, day 26, day 36, day 43, day 47, day 57, day 65).


Eligibility criteria:
inclusion . * female \> 18 and \< 55 years of age. * at the screening visit, have buttocks with moderate to severe cellulite based on the cr-pcss. * be willing and able to comply with all protocol required visits and assessments. * be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study. * is willing to refrain from exercise for 24 hours following each treatment. * be adequately informed and understand the nature and risks of the study. exclusion. * has a history of hypersensitivity or allergy to collagenase of any other excipient of cch. * at the screening visit, has none, almost none, or mild cellulite. * at the screening visit, per the investigator, has cellulite that would require less than 6 injections per buttock, or more than 12 injections per buttock. * is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study, or 28 days after the last treatment. * is currently undergoing hormone replacement therapy or has undergone hormone replacement therapy in the past 6 months. * has a coagulation disorder which requires anticoagulant or antiplatelet medication during the study, or has taken anticoagulant or antiplatelet medication within 14 days before injections. * is currently taking oral contraceptive pills. * is currently a smoker, or has smoked within the last year prior to screening. * has a history of scarring due to keloids or abnormal wound healing. * has received previous treatment with cch for cellulite, or any other cellulite treatment. * subject has any history of anemia or taking iron pills.
suboccipital inhibition in tension headache

Conditions: Tension Headache

Summary: the researchers will carry out a randomized experimental study. participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. participants in the control group will only receive the conventional treatment. the existence of significant differences in both groups will be analyzed.

conventional therapy will consist of microwaves, interference currents, and manual therapy.

Eligibility criteria:
inclusion criteria: * pathology tension headache associated with cervicalgia exclusion criteria: * pathology of nervous system

Keywords: tension headache suboccipital inhibition