Kornimate/medical-research-clean huggingface dataset:
remote device interrogation in the emergency department

Conditions: Heart Disease; Cardiovascular Disease; Heart Failure; Arrhythmias, Cardiac

Summary: a prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with st. jude medical remote care compatible devices interrogated by the unpaired merlin@home transmitter in the emergency department (ed). two sites will enroll up to 100 patients total. expected duration of the study is 6 months. once enrolled the patient will participate in the study for the duration of the emergency department stay, until discharged or admitted to the hospital.


Eligibility criteria:
inclusion criteria: 1. present to emergency department with an implanted pacemaker or defibrillator. 2. are 18 years of age or older, or of legal age to give informed consent specific to state law. 3. are willing and able to provide informed consent for study participation. exclusion criteria: * none

Keywords: remote monitoring remote care cardiac resynchronization therapy pacemaker implantable cardioverter defibrillator
a phase 3 randomized, masked, controlled trial to evaluate efficacy and safety of belzupacap sarotalocan (au-011) treatment compared to sham control in subjects with primary indeterminate lesions or small choroidal melanoma

Conditions: Choroidal Melanoma; Indeterminate Lesions; Uveal Melanoma; Ocular Melanoma

Summary: the primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (il) or small choroidal melanoma (cm).

this is a randomized, sham-controlled, subject-, assessor-, and sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (sc) administration in subjects with primary il/cm. bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (scs) microinjector and activation of bel-sar by a laser photoactivation device.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (il/cm) * have no evidence of metastatic disease confirmed by imaging * be treatment naive for il/cm (subjects who received pdt may be eligible) exclusion criteria: * have known contraindications or sensitivities to the study drug or laser * active ocular infection or disease

Keywords: uveal melanoma eye cancer ocular melanoma choroidal melanoma
a sports injury prevention program to reduce subsequent injuries after concussion

Conditions: Brain Concussion; Musculoskeletal Injury; Locomotion; Postural Balance

Summary: the long-term goal of this research is to implement methods that healthcare providers can use across diverse clinical settings to (1) identify athletes at risk for (musculoskeletal) msk injury when cleared to return to play (rtp) after a concussion and (2) develop practical ways to reduce msk injury risk following concussion rtp. the rationale is that once post-concussion msk injury risk factors are known and prevention strategies tested, concussion rtp protocols will evolve to include injury risk reduction programs.

aims: i. to determine the effect of a sports injury prevention program on msk injuries initiated at concussion rtp and continued throughout the subsequent athletic season. ii. to examine the effect of a neuromuscular training (nmt) program on clinical and instrumented postural control measures before and after the intervention. the proposed study will use an intervention-based paradigm to further understand msk injury risk after concussion rtp and to identify potential methods to reduce this risk. common data element (cde) and instrumented postural control data will be linked to objectively classify the clinical and functional underpinnings of concussion recovery and subsequent msk injury among those engaged in an injury prevention program compared to those who are not. these are important elements to investigate because: 1) few studies have explored the mechanisms for msk injury incidence after concussion using a multimodal and objective approach and 2) no investigations have examined interventions to improve long-term concussion outcomes initiated at rtp.

Eligibility criteria:
inclusion criteria: * eligible participants will be those diagnosed with a concussion, defined as a brain injury caused by a direct blow to the head, face, neck or elsewhere on the body, resulting in the rapid onset of impairment of neurological function and diagnosed by children's hospital colorado sports medicine physicians. * being between 12-18 years of age * the ability to complete initial testing within 14 days of the injury * a post-concussion symptom scale (pcss) score of greater than 9 at the time of enrollment. exclusion criteria: * active lower extremity injury affecting balance * pre-existing neurological disorder (bipolar disorder, schizophrenia, etc.) * previous concussion sustained within the past year * prisoners, pregnant females, individuals with limited decision-making capacity * pre-existing learning disability * structural brain injury (confirmed with neuroimaging) * a high velocity injury mechanism (e.g motor vehicle accident). * less than one month remaining in the current athletic season.
effect of treatments on pain and quality of life in individual with burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: burning mouth syndrome (bms) is characterized by a burning sensation on the tongue or other areas of the mouth, often bilateral but occasionally unilateral. it is more prevalent in postmenopausal women. no specific ethnic or socioeconomic predisposition has been identified. the etiology and pathophysiology of bms remain unknown. various treatment approaches have been proposed, yielding conflicting outcomes and underscoring the need for further investigation. patients with bms appear to respond well to long-term therapy involving systemic antidepressants and anxiolytics. the most promising therapeutic effects have been observed with clonazepam, which leads to a significant reduction in pain when applied topically or systemically. capsaicin, an herbal remedy, also presents as an alternative treatment option, showing positive results in alleviating bms symptoms when compared to a placebo. photobiomodulation represents another non-pharmacological treatment possibility. it's analgesic action is possibly attributed to the inhibition of pain mediators. alpha-lipoic acid (ala) is dietary supplement employed in bms treatment. it serves as a potent antioxidant naturally produced within the body, contributing to the mitigation of skin aging and reinforcing the effects of other biological antioxidants. based on these findings, attempts have been made to demonstrate ala's effectiveness in bms management, concluding that ala may offer benefits in this context. therefore, the objective of this study is to investigate, in adults with bms, the impact of different therapeutic approaches on frequency, intensity, and location of pain, as well as on on quality of life.


Eligibility criteria:
inclusion criteria: * burning mouth syndrome; * oral pain that recurs daily for \> 2 hours per day for \> 3 months; * pain with burning quality and felt superficially in the oral mucosa; * oral mucosa appears normal * oral clinical examination, including sensory tests, is normal; exclusion criteria: * pregnancy; * oral mucosal lesions; * systemic diseases such as diabetes, anemia, deficiency of vitamin b1, b2, b6, b12, fe, zinc, and folic acid; * gastroesophageal reflux; * previous head and neck radiotherapy; * sjogren's disease; * allergies; * candidiasis; * unstimulated saliva flow \< 0.25 ml/min and stimulated flow \< 1.0 ml/min will be excluded;
long-term safety and effectiveness of growtropin®-ii treatment in children with short stature

Conditions: Growth Hormone Deficiency; Idiopathic Short Stature; Turner Syndrome; Small for Gestational Age

Summary: this study evaluates long-term safety and effectiveness of growtropin®-ii treatment in children with short stature.


Eligibility criteria:
inclusion criteria: * children with short stature by growth hormone deficiency(ghd) or idiopathic short stature (iss) or turner's syndrome(ts) or small for gestational age(sga) * children who has official height record at least 6 months prior exclusion criteria: * children with epiphyseal closure
minimizing complications in scoliosis surgery in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: background: posterior spinal fusion (psf) in children with cerebral palsy (cp) carries a high risk of complications and mortality. complication rates have been reported as high as 45%, and infection rates typically reported at 15%. efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. the purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population. methods: this is a prospective, matched cohort analysis with a consecutive series of patients with cp who underwent psf, with two attending surgeons, in 2012. these are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, pa, or rn-fa. the groups are compared using paired student t-tests and chi square tests (significance set a p\<0.05).


Eligibility criteria:
inclusion criteria: * cerebral palsy * neuromuscular scoliosis requiring posterior spinal fusion (\>50 degree cobb) * psf from 2008-2012 at phoenix children's hospital * gmfcs iv or v exclusion criteria: * diagnosis other than cp * gmfcs i-iii * previous spine deformity surgery
the effect of continuous sipping of a glucose solution on markers of oxidation in men and women

Conditions: Cardiovascular Disease; Diabetes

Summary: the objective of this study is to determine the effect of reducing the rate of glucose absorption on oxidative stress after eating and to compare it with the effects of vitamin c. the hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress to a similar extent as 1g vitamin c.

recently, much attention has been paid to evidence that abnormalities of the postprandial state (hyperglycemia) are important contributing factors to the development of chronic disease. this attention has increased interest in the role low glycemic index (gi) foods could potentially play in preventing postprandial oxidative burst/stress. gi is a means by which to categorize carbohydrate according to their postprandial glycemic response. low gi foods promote slow intestinal absorption, prolonged and less pronounced postprandial glycemia, may decrease risk of chronic disease, as well as provide metabolic benefit to people living with glucose abnormalities as well as those with normal glucose. few studies have been conducted looking at the potential relationship between gi and oxidation and are limited by dietary/lifestyle confounders. the proposed study has been developed to eliminate these confounders. hypotheses (3): 1. sipping glucose slowly over 3h will result in less oxidative stress than ingesting the same amount of glucose as a bolus over 5min. 2. sipping glucose will reduce oxidative stress to the same extent as 1g of oral vitamin c. 3. the effect of sipping glucose on oxidative stress will occur sooner than that of vitamin c.

Eligibility criteria:
inclusion criteria: * healthy males or females * 18 to 75 years exclusion criteria: * diabetes * recent hospitalization
a study in healthy subjects of single doses of pf-05230901 injected under the skin

Conditions: Cachexia

Summary: this study will examine whether a single dose of pf-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. an additional objective is to measure the blood concentrations of pf-05230901. each dose will be tested in a different group of subjects starting from the lowest dose.


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * history of seizures, including childhood seizures. * history of movement disorders or related neurological conditions. * history of head trauma associated with loss of consciousness.

Keywords: first-in-human (fih) single ascending dose (sad) study tam-163 pf-05230901 cachexia
pilot study of negative pressure sleep therapy system to treat obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this is a pilot study to investigate the efficacy and safety of the negative pressure sleep therapy system for the treatment of obstructive sleep apnea.

this is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the negative pressure sleep therapy system for the treatment of obstructive sleep apnea.

Eligibility criteria:
inclusion criteria: * diagnosis of osa, based on ahi 10\~60 (as assessed per baseline psg). * subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form. * bmi ≦ 28. exclusion criteria: * poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed. * oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (tmj) conditions, or any oral or dental condition that the investigator believes could be exacerbated by the sleep therapy system. * history of any osa surgical treatment including uvulopalatopharyngoplasty surgery (uppp), maxillomandibular advancement surgery (mma), radio frequency (rf) ablation treatment, palatal stent devices, etc. * history of allergic reaction to silicone. * any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than osa, including insomnia, and central sleep apnea. * currently working nights, rotating night shifts, planned travel across four or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices. * current use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study. * potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including new york heart association (nyha) class iii or iv heart failure, cad with angina or myocardial infarction (mi)/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the study. * female subjects who are pregnant or intend to become pregnant during the study period.

Keywords: osa, oral pressure therapy (opt)
dry eye disease with isotretinoin isotretinoin

Conditions: Acne Vulgaris

Summary: the study aims to explore the effects of isotretinoin therapy on the dry eye parameters in acne vulgaris patients \& determine if it is dose-dependent or not.

to measure the tear film, the eye lid thickness, the meibomian gland function and to do objective tests for comparison

Eligibility criteria:
inclusion criteria: * moderate to severe acne on isotretinoin exclusion criteria: * occular diseases causing dry eye * pregnant females
the fontan education study: a randomized control trial

Conditions: Heart Defects, Congenital

Summary: the fontan education study is a cluster randomized controlled trial evaluating the impact of a novel education program in combination with usual care, versus usual care alone, on preparing parents of children undergoing fontan surgery for the challenges of the postoperative course.


Eligibility criteria:
inclusion criteria: * children who are planned to undergo fontan surgery within 4-6 weeks and their parent(s)/guardian(s) exclusion criteria: * parents with \< grade 6 level of english reading.
thoracic paravertebral block using ropivacaine and dexmedetomidine

Conditions: Pain, Postoperative

Summary: the hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy.

the investigators aim to recruit 60 patients undergoing video-assisted pneumonectomy. all patients asa physical status i-ii grade, aged within 20-70 years, are randomly allocated into two groups: 75mg/20ml ropivacaine only group (group r, n=30) and 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine (group rd, n=30). at the end of surgery, the investigators perform four points thoracic paravertebral block guided by ultrasound combined with nerve stimulator at t3-4, t4-5, t5-6, t6-7 of surgical side where 5ml solution is injected to each point. the characteristics of patients are analyzed to confirm whether they are comparable in both groups. pain was assessed according to a numerical rating scale (nrs) (0 = no pain; 10 = worst pain imaginable). patients were asked to evaluate the maximal degree of pain. pain scores were recorded in post anesthesia care unit(pacu), and1, 2,4, 8, 12, 24, 36 and 48 hours after surgery. the study endpoints are evaluated by an anesthesiologist who does not know the group allocation. the postoperative rescue analgesic administration, adverse outcomes and patient satisfaction are also recorded. all data were processed in spss 18.0 (spss inc., chicago, il usa). normality was tested by the kolmogorov-smirnov analysis. comparisons of continuous outcomes among groups were examined using kruskal-wallis test. chi-square analysis or fisher's exact test was used to assess categorical outcomes between groups. a p-value\<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * asa physical status i-ii grade * undergoing elective video-assisted pneumonectomy under general anesthesia. * participants aged from 30-70 years old. exclusion criteria: * refusal for paravertebral block * inability to obtain informed consent * coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 * pregnancy * infections at the site of injection for the paravertebral block * allergy to local anesthetics or alpha-2 adrenergic agonists * heart block or bradycardia (heart rate \< 60 beat per minute) * clinically significant cardiovascular, pulmonary, renal, or hepatic diseases

Keywords: thoracic paravertebral block dexmedetomidine video-assisted pneumonectomy ropivacaine pain, postoperative
psychoeducational intervention for patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Cirrhosis

Summary: this study aims to refine and pilot test harmony, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (hcc).

there are two parts of this study. study part 1 is an open pilot study to refine harmony prior to larger-scale testing in a randomized controlled trial (rct) setting. study part 1 is purely descriptive, as the investigators will use the data to refine harmony before proceeding to study part 2. study part 2 is a pilot rct to assess the feasibility and acceptability of conducting a randomized trial of harmony versus enhanced usual care. participants will complete a baseline survey and then be randomized to harmony versus enhanced usual care (a supportive care resource guide). this record reflects the clinical trial component (study part 2), as feasibility and acceptability outcomes will be collected for this phase only.

Eligibility criteria:
inclusion criteria: * age ≥18 years * new diagnosis of hcc within the last three months * clinical, radiographic, and/or pathologic diagnosis of concomitant cirrhosis * ability to complete study procedures english exclusion criteria: * significant uncontrolled hepatic encephalopathy * cognitive impairment, or psychiatric disorder which will interfere with study participation * patients near the end of life for whom hospice is recommended
childhood cancer survivors' affective response to exercise

Conditions: ALL, Childhood; Acute Lymphoblastic Leukemia

Summary: the primary objective of this study is to assess the feasibility of administering the personalized single-category implicit association test (psc-iat) to young adult survivors of childhood cancer. participants will perform a total of three trials of a cognitive task before and after their scheduled sjlife cardiovascular stress testing. participants will then be asked to participate in a qualitative interview about the cognitive task tool and body sensations and emotions experienced during exercise.

researchers at st. jude children's research hospital want to learn about the measurement of implicit association bias towards or against exercise in childhood cancer survivors. additionally, researchers want to learn more about the physical and emotional experience of exercise from our survivors. the plan for this study is to administer single category implicit association tests (psc-iat's) to participants during on campus sjlife testing and use this data to determine the feasibility of this tool's use in survivors of childhood cancer without cognitive impairment. this study will also administer the behavioral regulations in exercise questionnaire (breq-2)37 to participants as a construct validity check to the psc-iat. the procedures include psc-iat and breq-2 tests (before and after strenuous exercise as part of the sjlife protocol) and a qualitative interview. these will be in addition to standard components of the sjlife on-campus visit.

Eligibility criteria:
inclusion criteria: * participants enrolled in st. jude lifetime cohort (sjlife) aged 18-39 years at completion of on campus visit * primary diagnosis of acute lymphoblastic leukemia (all) * no cranial radiation therapy (crt) as part of treatment for all * identify as physically inactive (do not meet centers for disease control and prevention (cdc) guidelines of 150 minutes of moderate physical activity per week or 75 minutes of vigorous physical activity per week) * women who are not currently pregnant exclusion criteria: * individuals who cannot speak, read, and/or understand english. * individuals with an estimated iq of \<70 and/or per pi discretion * individuals with any contraindication to stress testing (i.e. cardiovascular complications) * women who are currently pregnant