Kornimate/medical-research-clean huggingface dataset:
thin-flap laser in situ keratomileusis associated dry eye

Conditions: Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters

Summary: laser in situ keratomileusis (lasik) eye surgery continues to be the most common refractive procedure used to correct different forms of ametropia. although the introduction of femtosecond technology has markedly reduced the incidence of intraoperative flap complications and allowed a better control on flap parameters, dry eye remains one of the most challenging postoperative complications.

the pathophysiology of post lasik dry eye is not clear; however, many mechanisms have been suggested including inflammation, loss of conjunctival goblet cells during suction, exacerbation of a preexisting dry eye, abnormal interaction between the lid margins and the ocular surface. intact corneal sensation is crucial for proper tear production and distribution on the ocular surface as well as maintaining the normal dynamics of eyelid blinking. disruption of corneal nerves in lasik decreases the release of neurotrophic factors necessary for the normal function of the corneal epithelium as well as the integrity of the lacrimal functional unit, a condition referred to as lasik induced neurotrophic epitheliopathy (line) that largely contributes to the development of post- lasik dry eye . many studies evaluated the incidence of post-refractive dry eye after lasik compared to flapless laser vision correction (lvc) procedures such as prk and small incision lenticule extraction (smile). the aim of this study is to assess and compare different dry eye parameters following lasik with planned thin flaps created by femtosecond laser (fs) and mechanical microkeratome (mk).

Eligibility criteria:
inclusion criteria: 1. candidates for laser vision correction (lvc). 2. eyes with spherical equivalent (se) up to - 10 diopters (d), 3. corneal thickness at thinnest location of ≥ 500 um and estimated postoperative residual stromal bed of at least 300 um exclusion criteria: 1. patients with symptoms or signs of dry eye (tbut \ 13), 2. posterior blepharitis, contact lens wearers , 3. ocular surface disease , 4. systemic diseases contraindicating lasik and previous ocular surgery.

Keywords: dry eye femtolaser laser in situ keratomileusis
take-home functional electrical stimulation for mdd

Conditions: MDD

Summary: the purpose of this study is to learn whether functional electrical stimulation (fes) of the facial muscles is effective in treating major depressive disorder (mdd) and to develop a model for take-home delivery.

a potential novel intervention for major depressive disorder (mdd) is bilateral functional electrical stimulation (fes) of the facial muscles. the portable fes stimulator delivers electrical current to excitable tissues. based on the preliminary work, fes can elevate mood in healthy subjects and reduce anxiety symptoms in mdd patients. the proposed study will develop a viable prototype for a "take-home" fes device and evaluate the feasibility, tolerability, and safety of fes for participants with mdd. this is a single-site, pilot, double-blind, randomized, sham-controlled clinical trial. the trial will evaluate the feasibility, tolerability, and safety of 20 fes sessions (over 4 weeks) for mdd. additionally, data on the preliminary therapeutic effects of 20 fes sessions for the symptoms of mdd and associated anxiety, quality of life, and sleep will be collected. eligible participants enrolled in this clinical trial will have a total of 28 visits. there will be 1 screening visit which will take place over the phone, 3 on-site visits (including 1 mask development visit, 1 mask delivery visit, and the last follow-up visit), and 24 online visits (to take place over videoconference on the zoom platform); one baseline visit, 20 days of the fes treatment sessions, and three post-stimulation visits.

Eligibility criteria:
inclusion criteria: 1. meet the dsm-5 criteria for unipolar mdd with a current major depressive episode (mde) without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), as determined by a physician and validated by a mini done by a trained research assistant 2. no change in the medication regimen or other forms of treatments (e.g., psychotherapy) for at least 4 weeks (28 days) prior to beginning the study, during the 20-session treatment period, and the 4-week post-treatment observation period. this will be established through self-report, in combination with the antidepressant treatment history form (athf) form filled out by the participant. 3. men and non-pregnant women aged \> 18 years exclusion criteria: * 1. paralysis of facial nerves 2. metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device 3. current fibromyalgia or currently receiving or have received repetitive transcranial magnetic stimulation (rtms) within the last month (28 days) before screening 4. past or current symptoms of mania, hypomania, mixed episodes, psychotic disorders, active substance abuse, or dependence (excluding nicotine and caffeine) which will be confirmed on the mini done by a trained research assistant 5. current suicidal intent or plan as demonstrated by a score of ≥ 2 on madrs item 10

Keywords: major depressive disorder take-home treatment functional electrical stimulation
"remind-to-move" for promoting upper extremity recovery in patients with stroke after subacute discharge

Conditions: Stroke; Upper Extremity Hemiplegia

Summary: this is a multi-centered randomized controlled trial to investigate the effects of "remind-to-move" (rtm) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals.

this is a proof-of-principle study to investigate the effects of "remind-to-move" (rtm) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals. a multi-center, parallel-group, randomized controlled trial with blinded assessment was carried out in four hospitals. eighty-four eligible participants who had suffered from stroke with less than 6 months and could slightly move their arms were randomly allocated to either an experimental, sham, or control group stratified by hemiplegic arm functional levels. patients in the experimental group were treated by rtm using wearable devices, 3 consecutive hours daily, for 4 weeks. the sham group used sham devices. the control group received the usual care. a masked assessor evaluated the participants at 0, 4th, 8th and 12th weeks. outcome measures included arm function tests, motor activity log, movement amount and percentage recorded by wearable devices. all patients allocated to treatment were included in intention-to-treat analysis.

Eligibility criteria:
inclusion criteria: 1. frst-time ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging or x-ray computed tomography 2. unilateral hemispherical involvement 3. aged 18 or above 4. time since onset less than 6 months 5. functional test for hemiplegic upper extremity hong kong version (fthue-hk) ≥ 3 (maximum 7) 6. able to understand verbal instruction and follow one-step commands 7. modified ashworth scale (mas) ≤ 2 8. mini-mental state examination (mmse) ≥ 19 9. no complaint of excessive pain or swelling over hemiplegic arm 10. sensation on the affected wrist intact or with mild impairment only (national institute of health stroke scale=0 or 1). exclusion criteria: 1. participating in any experimental or drug study 2. unable to give consent to participate 3. of inadequate balance as indicated by the inability to stand for at least 2 minutes with or without arm support 4. having history of botulinum toxin injection in 3 months.
effect of gm1 in prevention of oxaliplatin induced neurotoxicity in stage ii/iii colorectal cancer

Conditions: Colorectal Cancer; Chemotherapy-induced Neutropenia

Summary: the primary objective of this study is to assess the efficacy of monosialotetrahexosylganglioside (gm1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

oxaliplatin is a key agent in the treatment of colorectal cancer. however, peripheral neuropathy markedly limits the use of oxaliplatin. many drugs have been tried to decrease the development of oxaliplatin induced peripheral neurotoxicity, however, the results remain disappointing. this multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of monosialotetrahexosylganglioside (gm1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: * age: 18-75 years old, male or female * histologically confirmed diagnosis of colorectal adenocarcinoma with a phase ii or iii disease, within 2 months from radical resection, and intends to receive 6 months of adjuvant chemotherapy with mfolofx6 or xelox, without adjuvant radiation indications * no prior any level of peripheral nerve system disease * patients have not received any other possible neurotoxic-reaction-causing drugs (such as oxaliplatin, cisplatin and paclitaxel drugs etc) * with the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire * with normal functions of major organs * no contraindication to chemotherapy * life expectancy ≥ 3 months * patients have provided a signed informed consent form exclusion criteria: * patients who received radical resection, but are expected not be able to complete 6 months of adjuvant chemotherapy * patients who receive palliative chemotherapy * patients who need adjuvant or palliative radiotherapy during chemotherapy * be allergic to gm1 * hereditary abnormal metabolism of glucose and lipid * doctors believe that patients are not suitable for receiving gm1 treatment * with confirmed history of neurological or psychiatric disorders, including epilepsy and dementia * with concomitant diseases that will seriously harm the patients' safety or impact the completion of the study * patients (male or female) have fertility possibility but not willing or not to take effective contraceptive measures
sirolimus with tacrolimus for graft-vs-host disease prophylaxis after un-related stem cell transplantation

Conditions: Acute Myelogenous Leukemia; Graft Versus Host Disease; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndromes; Non-Hodgkin's Lymphoma; Hodgkin's Disease

Summary: the purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (gvhd) in patients following stem cell transplant from an unrelated donor. this trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of gvhd.

* therapy to prevent gvhd will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily starting 3 days before stem cell infusion. this will take place in the hospital where the patient will remain for the duration of the transplant. * sirolimus will continue for approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in gvhd. * patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. if gvhd is present, tapering schedule will be slower and based on the patient's clinical condition. * tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus. * during the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.

Eligibility criteria:
inclusion criteria: * acute myelogenous leukemia(aml) in first or subsequent remission, in untreated first relapse or any treated relapse. * acute lymphoblastic leukemia(all) in first or subsequent remission, in untreated first relapse or any treated relapse. * chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase. * myelodysplastic syndromes or myeloproliferative diseases * non-hodgkin's lymphoma or hodgkin's disease in second or greater complete remission, in partial remission, or induction failure. * chronic lymphocytic leukemia, rai stage 2-4, which has progressed after initial therapy. * matched unrelated donor. * age 18-55 years at the time of stem cell transplantation * ecog performance status 0-2 * life expectancy of 100 days without stem cell transplantation * total bilirubin \< 2.0 mg/dl * ast \< 90 iu * serum creatinine \< 2.0 mg/dl * ejection fraction \> 40% by echocardiogram or gated nuclear medicine study. exclusion criteria: * uncontrolled infection * forced vital capacity or dlco \< 50% predicted for age * uncontrolled hypertension * prior hematopoietic stem cell transplant * evidence of hiv infection or active hepatitis b or c infection * cholesterol \> 300 mg/dl * relapsed aggressive burkitt's or burkitt's-like lymphoma

Keywords: graft versus host disease gvhd sirolimus tacrolimus stem cell transplant
lung ultrasound in bronchiolitis

Conditions: Bronchiolitis

Summary: prospective assessment of lung ultrasound score in children with different severities of bronchiolitis


Eligibility criteria:
inclusion criteria: * children with bronchiolitis exclusion criteria: * children with bronchiolitis and comorbidities
does the sara combilizer®, an early mobilization aid, reduce the time taken to first mobilise ventilated patients in intensive care?

Conditions: Critical Illness

Summary: this study investigates the impact of introducing an early mobilisation device called the sara combilizer on time taken to mobilise in critical care. the investigators will collect baseline data on time taken to mobilise for a period of 4 months, then following a training programme and introduction of the device for a further 4 months

early mobility within the icu is associated with a number of positive outcomes including reductions in icu and hospital length of stay and better functional recovery. the exact definition of 'early' mobility is still not defined, with the actual ability to mobilize limited by a number of perceived factors. the sara combilizer is a combined tilt table and stretcher chair, which allows passive transfer of patients out of bed. it is theorized the passive and safe nature of transfer may facilitate earlier mobilisation of patients within critical care. this study aimed to assess whether the introduction of the sara combilizer reduced time taken to first mobilize for patients mechanically ventilated for at least 5 days and at risk of icu acquired weakness. patients admitted to a large uk critical care unit during the trial period and ventilated for ≥ 5 days were included in the study. baseline data was collected prospectively for a period of 4 months. the sara combilizer was then introduced for a 1 month training and familiarization period, followed by a further 4 months prospective data collection.

Eligibility criteria:
inclusion criteria: * all adult patients (\>18 years) admitted to critical care and ventilated for 5 days or more exclusion criteria: * patients with contraindications to mobilise (e.g. pelvic / spinal fractures) * poor prior level of mobility (\<10yards) * neuromuscular disease (e.g. guillain barre or motor neurone disease) * mechanical ventilation \> 48 hours at another facility prior to admission * expected withdrawal of treatment within 24 next hours * patients who have already commenced mobilisation in the 1st 5 days of admission * obese patients who exceed the weight limit of the product (200 kg) * patients over 6ft5 due to restrictions of the product * severe neurological injury * lower limb amputations

Keywords: physiotherapy rehabilitation critical care seating
early treatment with evolocumab in patients with st-elevation myocardial infarction

Conditions: ST-elevation Myocardial Infarction

Summary: this is a prospective, multi-centre, open label, randomised study of phase ii that enrolls patients hospitalized with a diagnosis of st-elevation myocardial infarction (stemi), comparing evolocumab versus standard of care.

primary objective of the study is to assess whether early evolocumab administration reduces infarct size in patients with stemi undergoing primary pci. at least 150 patients will be enrolled to investigate the efficacy and safety of evolocumab administration in the acute phase of stemi. patients will be followed for 1 year after the enrollment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * chest pain or equivalent lasting \> 20 minutes * st elevation myocardial infarction scheduled for primary pci * signed written informed consent exclusion criteria: * previous myocardial infarction * previous percutaneous or surgical myocardial revascularization * ongoing treatment with any statin or ezetimibe * history of congestive heart failure * cardiogenic shock at presentation * known pregnancy * women of childbearing age * known major active infection or major hematologic, renal, hepatic, or endocrine dysfunction * malignancy (except non-melanoma skin cancer, cervical in situ carcinoma, breast ductal carcinoma in situ, stage 1 prostate carcinoma) within the last 10 years * patients with hypersensitivity to the active substance (evolocumab) or to any of its excipients * inability to attend the scheduled clinical evaluation and laboratory tests * inability to undergo the pharmacological treatment or other procedures of the study * currently enrolled in another investigational drug study, or \< 30 days/\<5 half-life since ending another investigational drug study(s).

Keywords: myocardial infarction percutaneous coronary intervention evolocumab cardiac magnetic resonance
using neuroimaging to investigate major depressive disorder

Conditions: Major Depressive Disorder; Depression; Anxiety

Summary: the purpose of this neuroimaging study is to investigate the brain correlates of major depressive disorder with anxiety symptoms as well as potentially identify predictors of treatment outcome.

the purpose of this study is to test whether the structural and functional connectivity between the dorso-lateral prefrontal cortex (dlpfc) and amygdala will decline as symptoms of co-morbid anxiety (anxiety factor score) increase in patients with mdd. this decrease in connectivity will also account for decrease in treatment response. the structural connectivity will be assessed using diffusion tensor imaging (dti) and the functional connectivity will be assessed using resting state bold fmri.we propose to use the fmri and dti to identify biological markers that are associated with treatment response in a cohort of patients with a spectrum of anxiety factor scores.

Eligibility criteria:
inclusion criteria: * competent to give informed consent * diagnosis of major depressive disorder * males and females * ages 18-50 years old * all races and ethnicities * able to read, speak, and understand english\* exclusion criteria: * history of psychiatric illness except major depressive disorder, generalized anxiety disorder, social phobia, or specific phobia * alcohol or substance abuse within the last 6 months or alcohol or substance dependence within the last year * diagnosis of an organic brain disease * serious unstable medical illness * history of serious head injury * unsafe or unable to have an mri or previous inability to tolerate mri * pregnancy or breast feeding

Keywords: major depressive disorder depression anxiety
effect of emdogain® on soft tissue wound healing

Conditions: Periodontal Inflammation; Crown Lengthening

Summary: the goal of this randomized, controlled, single-center study is to compare the effects of emdogain®, a regenerative biomaterial, on post-operative pain, wound healing and inflammation of treated sites after surgical crown lengthening. the main question it aims to answer is: does the use of emdogain® in conjunction with crown lengthening surgery improve post-operative soft-tissue healing, decrease inflammation and reduce patient perception of pain compared to crown lengthening without addition of emdogain®? the treatment group will receive emdogain® during surgery, and the control group will undergo standard crown lengthening without emdogain®.

this randomized, controlled, single-center study intends to investigate the effects of emdogain® on wound healing, postoperative pain and inflammation of treated sites after crown lengthening procedures on a single site, and to compare the results of this therapy with those of standard crown lengthening treatment on a single site. we have hypothesized that the use of emdogain® in conjunction with crown lengthening surgery improves post-operative soft-tissue healing, decreases inflammation and reduces patient perception of pain compared to crown lengthening without addition of emdogain®. patients were recruited from the graduate periodontology clinic at the faculty of dentistry, university of toronto. these patients were referred to the department by dental students in the faculty as well as dentists and dental specialists within the community for crown lengthening surgery, and were subsequently screened for eligibility to participate in the study. after confirmation of eligibility and completion of recruitment, patients were randomized, using a computer-generated randomization table, into the following groups: * treatment/experimental group: patients undergoing surgical crown lengthening of a single site with application of prefgel® + emdogain® * control group: patients undergoing surgical crown lengthening of a single site with application of prefgel® only

Eligibility criteria:
inclusion criteria: patients who: * were capable and willing to provide consent and complete treatment as well as follow-up appointments * were over the age of 18 years old * required surgical crown lengthening for functional reasons as outlined in background * had no contraindications to surgery (these include periodontal contraindications to crown lengthening such as poor crown-to-root ratio, furcation exposure or esthetic concerns) exclusion criteria: * patients who were unable to provide informed consent * pregnant women * women receiving estrogen therapy * patients who had received systemic antibiotics within the past 6 months * patients with severe systemic disease (asa 3+) including: poorly controlled diabetes, blood dyscrasias, liver disease, immunosuppressive disorders, malignancy or who have had previous radiotherapy * patients with untreated, active periodontal disease
tailored pca based on preoperative pain sensitivity

Conditions: Analgesia, Patient-Controlled

Summary: opioids via intravenous patient-controlled analgesia (iv pca) are widely used for postoperative pain control. however, effective pain control with minimized side effects of analgesic agents is still challenging. several studies reported that preoperative pain sensitivity measured by quantitative sensory test could predict postoperative pain. therefore, the investigators planned this trial to evaluate the effectiveness of tailored patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain threshold in patients undergoing gynecological surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective gynecological surgery under general anesthesia * patients scheduled to use iv pca for postoperative analgesia * patients with american society of anesthesiologists (asa) physical status classification i, ii, iii exclusion criteria: * contraindication to fentanyl use * inability to communication * age less than 18 years, or more than 80 years * body weight less than 40kg, or more than 90kg * morbid cardiovascular disease * pregnancy

Keywords: fentanyl pain threshold predicted