Kornimate/medical-research-clean huggingface dataset:
foldable capsular scleral buckling versus vitrectomy in medium-complex rhegmatogenous retinal detachment treatment

Conditions: Rhegmatogenous Retinal Detachment

Summary: the objective of the study is to evaluate: 1. safety and efficacy of a novel foldable capsular scleral buckle (fcsb) in scleral buckling for primary rhegmatogenous retinal detachment (rrd) of medium complexity. 2. comparison between fcsb and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary rrd of medium complexity.

pars plana vitrectomy (ppv) and scleral buckling (sb) are major choices in treating rhegmatogenous retinal detachment (rrd) of medium complexity. ppv is more prevailed since it improved internal search for breaks and elimination of vitreous traction. sb has unmatched advantages over ppv such as earlier rehabilitation, free from prolonged positioning, less complicated cataract or glaucoma. the novel foldable capsular scleral buckle (fcsb) can create a big bulge by pressing on the sclera and seal the break in bullous rrd without scleral drainage. in the study, differences of anatomic and functional results between ppv and fcsb in treating primary rrd of medium complexity are evaluated.

Eligibility criteria:
inclusion criteria: one or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction) exclusion criteria 1. simple rhegmatogenous retinal detachment which can be treated with a single silicon sponge or silicone band (e.g. single holes, no traction, limit retinal detachment) 2. complicated rrd, including macular hole within the arcade, pvr c or d, severe cataract, severe vitreous hemorrhage, unclear macular hole, 3. combined with other eye diseases that affect vision prognosis. 4. history of other eye surgeries including cataract surgery. 5. presence of systemic diseases that may affect postoperative observation and follow-up.
the effect of healthy eating index on maternal thyroid volume in hyperemesis gravidarum

Conditions: Healthy Diet; Thyroid Hypertrophy; Pregnancy Emesis

Summary: the relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.

in pregnant women(11-14 week) admitted to our hospital between the ages of 15-49; after the healthy eating index scores were made face to face by the dietician, it was planned to measure the maternal thyroid volume by the radiologist.our hypothesis in our study is to determine whether healthy eating index has effects on thyroid volume and blood parameters.

Eligibility criteria:
inclusion criteria: * 15-49 years old pregnant women * 11-14 gestational week of pregnancy * do not use medication, * have no history of illness, * who participated in face-to-face meetings with a dietician, * who want to be included in the study, * no smoking or alcohol consumption * patients with a bmi between 15-25 exclusion criteria: * pregnant women who are not between 15-49 years old, * patients with chronic disease such as heart disease, diabetes, * patients who do not agree to meet with a dietician, patients who do not agree to be included in the study, * smoking and alcohol use --morbid-obese patients (bmi greater than 25)

Keywords: thyroid volume , healty eating index , pregnancy
the effect of remifentanil on established capsaicin-induced hyperalgesia in human volunteers

Conditions: Hyperalgesia

Summary: treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. an injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (ltp), i.e., a change in the synaptic interaction between neurons. opioids are the gold standard for the symptomatic therapy of moderate to severe pain. now, in animal studies the investigators have discovered previously unrecognized effects of opioids. intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. the investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.


Eligibility criteria:
inclusion criteria: * body mass index between 15th and 85th percentile * normal findings in the medical history and physical examination * drug free for 1 week prior to the study day exclusion criteria: * regular use of medication especially analgesics * abuse of alcoholic beverages, drug abuse * history of asthma * participation in a clinical trial in the 2 weeks preceding the study * symptoms of a clinically relevant illness in the 2 weeks before the first study day * resting systolic blood pressure \> 135 mmhg or diastolic blood pressure \> 85 mmhg * acute skin diseases like sunburn on the relevant areas or skin lesions * pregnancy or breast feeding

Keywords: capsaicin remifentanil hyperalgesia
dysphagia in cardiac surgical patients_

Conditions: Cardiovascular Diseases

Summary: the proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (vfmi) in individuals undergoing cardiovascular surgical procedures. it also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

swallowing impairment and vfmi are common, yet often overlooked, complications of cardiovascular surgical procedures. the true incidence of both dysphagia and vfmi in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patients undergoing cardiovascular surgery. the study is therefore aimed to determine the incidence of dysphagia and vfmi in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. in addition, the study is also aimed to assess the relative impact of vfmi and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status. we will identify risk factors for postoperative dysphagia and vfmi in cardiovascular patients to build a practical electronic risk-stratification tool. we also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. all participants will undergo two research visits (one preoperatively and one postoperatively) where they will undergo an instrumental swallowing test and complete several patient report outcomes and clinical tests. if they are found to have dysphagia after surgery, they will be offered no-cost follow up swallow tests at months 1 and 6. finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Eligibility criteria:
inclusion criteria: 1) individuals over 18 years of age, 2) undergoing a cardiovascular procedure at the university of florida heart and vascular hospital, 3) confirmed negative covid-19 test result, 4) no allergies to barium, 5) not pregnant (female participants), and 6) willing to participate in research exams. exclusion criteria: 1) individuals under the age of 18, 2) patients with a confirmed positive covid-19 test result, 3) participants with allergies to barium, 4) pregnant women, or 5) unwilling to participate in research exams.

Keywords: dysphagia extubation vocal fold mobility impairment peak cough flow (pcf)
freezing of gait correction and fall prevention: developing a real-time somatosensory stimulation system

Conditions: Parkinson Disease

Summary: background and purpose: freezing of gait (fog) is one of the most disabling motor symptoms in people with parkinson's disease (pd), and closely associates with postural instability and fall. previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (sss), which monitors gait real-time and provide somatosensory stimulation once fog episodes detected. and the investigators test the effects of this sss device on fog, fall, and walking function. methods: the first-year study is to build and validate this wearable sss device. the customized device has sensor part and stimulator part; the former is an inertial sensor module to detect fog episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. to validate the device, patients with fog are recruited and conduct fog-provoking tasks during their medication "off" or "late on" state in a laboratory setting. the investigators test if the sss device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. the second-year study is to test if the sss device stands a long-term, daily wearing basis, and to evaluate its effect on fog, fall, and walking function. the investigators recruit pd patients with fog, and randomly assign them into the experimental and control groups. both groups wear the sss device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. the stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. the effect of the sss device is evaluated by the outcomes including fog severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase. clinical relevance: this project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve fog and fall in people with pd. the results of this projects might also provide an objective, long-term assessment tool to measure the fog phenomenon for clinical and research fields.


Eligibility criteria:
inclusion criteria: * idiopathic parkinsonian with hoehn-yahr score between 2 to 4 * suffering freezing-of-gait in the recent week * able to walk unassisted over 30 meters in medication off period exclusion criteria: * non-idiopathic parkinsonian * comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility * impaired cognitive function * abnormal plantar sensory function * abnormal coagulation function

Keywords: freezing of gait parkinson's disease somatosensory stimulation fall prevention
effect of vitamin d on hospitalized adults with covid-19 infection

Conditions: Covid19

Summary: the objective of the study is to evaluate the clinical efficacy and safety of vitamin d supplementation in hospitalized patients with covid-19.

phase iv, interventional, randomised, double blind, placebo-controlled and parallel study to evaluate the clinical efficacy and safety of vitamin d supplementation in hospitalized patients with covid-19. patients will participate in the study for a maximum of 9 weeks, which includes an up to 6-week treatment period and a maximum of 3-week follow-up period. a total of 100 (50 in each group) patients will be randomized in the study and will either receive the test treatment or the placebo treatment.

Eligibility criteria:
inclusion criteria: * male and female over 18 years old (18 years inclusive). * has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization. * expected to survive for at least 96 hours after study entry. * if patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence). * subject or legally authorized representative understands and agrees to comply with planned study procedures. * subject or legally authorized representative provides informed consent prior to initiation of any study procedures. exclusion criteria: * women currently pregnant or breast-feeding. * patients presenting acute impairment of renal function or nephrolithiasis. * patients presenting hypercalcaemia and/or hypercalciuria * patients presenting pseudohypoparathyroidism * use of any vitamin d supplementation alone or in association at screening visit; * use of any prohibited medication as detailed in the concomitant medication section * patients with any sensitivity or allergy to any of the products used within this clinical trial. * presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
a study to evaluate the safety and efficacy of eye secret uv aspheric silicone soft (hydrophilic) 1day color contact lens

Conditions: Myopia

Summary: this was a prospective, randomized, open label, parallel, active-controlled clinical study to assess the safety and efficacy of silicone color contact lens for vision correction.


Eligibility criteria:
inclusion criteria: 1. age from 20 to 65. 2. subject with -1.00 to -10.00 d myopia, less than 1.00 d astigmatism. 3. subjects must be correctable through spherocylindrical refraction and with soft contact lenses to 0 log mar (distance) or better in each eye. 4. willing to comply with all study procedures and be available for the study duration. 5. provide signed and dated informed consent form. exclusion criteria: 1. subjects have a history of allergies that contraindicate contact lens wear. 2. subjects have other active ocular or systemic diseases such as, but not limited to anterior uveitis (past or present), glaucoma, sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or diabetes. 3. subjects have medications that would contraindicate contact lens wear. 4. currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months. 5. current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 6. any active participation in any contact lens or lens care product clinical trial within seven days prior to this study. 7. the presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. 8. subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. 9. subject has a history of papillary conjunctivitis that has interfered with contact lens wear. 10. subject has a history of herpetic keratitis retinal detachment or irregular cornea. 11. subject has a history of recurrent eye or eyelid infections, adverse effects associated with your contact lens wear, intolerance or unusual response to your contact lens wear. 12. the subject has over grade ii corneal and conjunctival staining (oxford scheme) if who has a history of dry eye. 13. subject had any corneal surgery (e.g., refractive surgery).
efficacy and safety of tongluo-kaibi tablet in patients with fibromyalgia syndrome

Conditions: Fibromyalgia Syndrome

Summary: this study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. the aim of the study is to evaluate efficacy and safety of tongluo-kaibi tablets in patients with fibromyalgia syndrome.


Eligibility criteria:
inclusion criteria: * those who meet the classification criteria for fibromyalgia formulated by the american rheumatology association in 2016. * pain vas score ≥ 4 points. * the variety and dosage of the medication used to treat the disease should be stable for at least 2 weeks. exclusion criteria: * severe cardiovascular and cerebrovascular diseases. * malignant tumors, hematological diseases, inflammatory arthritis, or other serious or progressive systemic diseases. * alt and ast are more than 2 times the upper limit of normal. * cr is more than 1.2 times the upper limit of normal. * allergic constitution or allergic to experimental drugs tongluo-kaibi tablet, pregabalin capsules, excipients or similar ingredients. * pregnant, lactating or recently planned pregnancy.

Keywords: tongluo-kaibi tablet traditional chinese medicine fibromyalgia syndrome
comparing harmonic ultrasonic scalpel to small jaw bipolar device in thyroid surgery

Conditions: Thyroid Diseases

Summary: energy devices are used routinely during thyroid surgery to aid surgical dissection and to stop bleeding. the newer generation energy devices have several advantages over older machines. the two most commonly used newer generation energy devices are the harmonic scalpel and the small jaw bipolar device. currently there has been no randomized controlled trial that compares both devices side to side. we aim to compare the effectiveness of these two newer generation energy devices in thyroid surgery.

energy devices are used routinely during thyroid surgery to aid surgical dissection and haemostasis. the newer generation energy devices have several advantages over older machines. first, the newer devices deliver more focussed thermal application and thus are less likely to cause collateral injury to surrounding healthy tissue. this is particularly relevant in thyroid surgery because the thyroid gland is in close proximity to vital nerves that control our airway and glands that regulate calcium metabolism. secondly, the newer energy devices have multifunctional properties and are capable of sealing, blunt dissection, grasping and dividing tissue. this is advantageous in thyroid surgery as the operating field has many narrow areas within and the potential reduction in the exchange of instruments facilitates surgery. currently, two of these newer generation energy devices are available for use in singapore general hospital and national cancer centre singapore. both devices are similarly priced; one is based on an ultrasonic vibrating blade (ucsd) to cut and coagulate tissue while the other uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissue (ebvs). to date, clinical studies comparing both devices have only been done on animal models and focus on sealing times in animal blood vessels. we aim to compare the effectiveness of these two newer generation energy devices in thyroid surgery by looking at the incidence of post surgical complications, post operative drainage as well as the ease of use as reflected in the operating time.

Eligibility criteria:
inclusion criteria: * age 21-75 * histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled my medication * undergoing thyroid surgery exclusion criteria: * previous neck radiotherapy * previous neck surgery * patients with advanced disease that would require radical or modified neck dissection * patients with lobe larger than 10 cm or nodule larger than 8 cm which requires extensive dissection that may confound the study * patients with connective tissue diseases or chronic diseases on long-term medications that may interfere with wound healing such as steroids. * patients with bleeding diatheses.
antegrade cerebral perfusion and retrograde inferior vena caval perfusion for total aortic arch replacement

Conditions: Type A Aortic Dissection; Circulatory Arrest; Hypothermia

Summary: this study is designed as a multicenter, randomized, assessor- blinded clinical trial.the primary aim of this trial is to assess whether retrograde inferior venal caval perfusion combined selective antegrade cerebral perfusion(acp)under mild hypothermia, compared with moderate hypothermia combined with selective acp alone, improves the outcome for the patients undergoing total aortic arch replacement.


Eligibility criteria:
inclusion criteria: 1. patient aged 18 yr-65yr 2. patient underwent total aortic arch replacement exclusion criteria: 1. inability to understand/give informed consent, 2. participation in another clinical trial that interferes with the primary or secondary outcomes of this trial. 3. inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion
social media alcohol intervention

Conditions: Drinking Behavior; Risky Drinking

Summary: social media provides frequent interaction with online social networks, increasing exposure to peer influences, which could affect alcohol use in negative or positive ways. the proposed study will recruit adolescents and emerging adults using social media ads, and conduct online screening, enrolling 975 risky drinkers in a randomized controlled trial comparing three conditions: 8-week social media intervention + incentives, 8-week social media intervention only, and an e-news attention control condition. these innovative design features will provide the critical next step in harnessing social media to reduce alcohol misuse, which could have enormous public health impact by altering the alcohol use trajectories of youth.

the proposed study will recruit adolescents and emerging adults (ages 16-24) using social media ads and conduct online screening, enrolling 975 risky drinkers (i.e., using audit-c screener) in a randomized controlled trial (rct) comparing three conditions: 1) social media intervention + incentives (n=325), 2) social media intervention only (n=325), and 3) attention control e-news condition (n=325), with post baseline follow-up assessments at 3, 6, and 12 months. interventions will include access for 8 weeks to unique, secret group pages facilitated by e-coaches (supervised by therapists), with dynamic content emphasizing reducing alcohol use/misuse as well as concomitant risk behaviors (other drug use based on co-ingestion and common motives for use).

Eligibility criteria:
inclusion criteria: individuals will be eligible to participate if they are between the ages of 16 and 24 years and they have a facebook account. additionally, individuals will be eligible if they: * have a past 3-month audit-c score (see below) indicating that they meet criteria for at-risk drinking/alcohol misuse. * ages 16-17: ≥3 females and ≥4 males * ages 18-24: ≥4 females and ≥5 males exclusion criteria: * do not live in an area that the study is currently seeking participants from (i.e.- zip code not in area of active recruitment). * under 16 years of age or over 24 years of age * not facebook account holder * inability to give informed, voluntary consent

Keywords: alcohol teens young adults social media
effects of a task oriented intervention with two goal-setting approaches

Conditions: Movement Disorder; Learning Disability; Autism Spectrum Disorder; Children

Summary: a randomized trial investigating if effects of a goal-directed task oriented intervention is influenced by who takes the decision and establishes the goal (the child or the parent) and whether establishing a goal per se influence performance and goal-achievement. the main hypothesis are that children's participation in the goal-setting process would positively influence goal achievement, children's self-identified goals would be achievable and that both groups would achieve goals that were the target of a goal-directed intervention.


Eligibility criteria:
inclusion criteria: * enrollment in pediatric rehabilitation, age between 5-12 years and any type of disability but functioning at or above a 5 year old level in receptive language. exclusion criteria: * involvement in another block of intensive intervention during the 5-month study period