Kornimate/medical-research-clean huggingface dataset:
a retrospective, natural history study in children with cln2

Conditions: Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)

Summary: this is a multi center, retrospective, chart review study to document the evolution of ocular disease progression in pediatric patients with cln2.

cln2 is a rare disease with limited available ocular natural history data. while current standard of care slows motor degeneration, it is not known to treat the ocular manifestations of disease. this study is planned to document, through retrospective data collection, ocular disease progression in children with a clinical presentation consistent with cln2. no investigational product is administered in this retrospective, chart review study.

Eligibility criteria:
inclusion criteria: a participant is eligible to be included in the study only if all of the following criteria apply: 1. the participant's legal guardian(s) is(are) willing and able to provide them written, signed informed consent. 2. the participant has a documented diagnosis of cln2 disease due to tpp1 deficiency, or has a relative clinically diagnosed with cln2 disease who has the same cln2 mutations as the participant 3. the participant has had one or more eye examinations by an eye care specialist at any time since birth. exclusion criteria: no exclusion criteria apply to this study.

Keywords: cln2, batten disease
the flash study: a study of roflumilast versus placebo in patients with asthma (by217/m2-023)

Conditions: Asthma

Summary: the purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.


Eligibility criteria:
main inclusion criteria: * diagnosis of persistent chronic bronchial asthma * baseline lung function within specified parameters * no change in asthma treatment during the last 4 weeks prior to start of baseline period * stable clinical state * except for asthma, in good health * non-smokers or ex-smokers main exclusion criteria: * poorly controlled asthma * diagnosis of chronic pulmonary disease and/or other relevant lung diseases * patients using continuously (more than 3 days per week) \> 8 puffs/day rescue medication

Keywords: roflumilast asthma
evaluating the effectiveness of using a home laser device to treat patients with knee osteoarthritis

Conditions: Osteoarthritis Of Knee

Summary: osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. it is the leading cause of disability in the elderly. photobiomodulation (pbm), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (koa). the purpose of the current study is to determine if a near-infrared pbm device (b-cure laser), applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with koa.

this is a prospective double blind randomized sham-controlled clinical trial. eligible participants with koa will be randomly allocated to receive active or sham devices for self-treatment at home in addition to standard care. patients will be invited to the clinic for 3 visits: baseline, 1 month, and 3 months. evaluations will include physical examination, range of motion, and patient reported outcomes including subjective pain level by visual analogue scale (vas), western ontario and mcmaster universities osteoarthritis index (womac), and quality of life questionnaire (sf-12). participants will document treatments and analgesic-drug use in a diary. the study hypothesis is that b-cure laser treatments, applied at home by the patient, can reduce pain and improve functionality compared to standard care alone.

Eligibility criteria:
inclusion criteria: 1. diagnoses of knee osteoarthritis by american college of rheumatology (acr) 2. kellgren \& lawrence classification 1-3 3. knee pain on movement 40 to 90 mm visual analog scale 4. knee pain and related functional reduction for at least 1 month exclusion criteria: 1. pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control 2. other causes of knee-related pain (e.g. hip oa, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations. 3. knee surgery for koa 4. intra-articular steroid injection and/or oral steroid treatment within the last six months 5. rheumatoid arthritis 6. symptomatic oa in other joints (i.e. hip, hand) 7. use of narcotics on the day of evaluation 8. active malignancy 9. uncontrolled diabetes mellitus 10. neurological conditions: sciatica, neuropathy, multiple sclerosis 11. other chronic pain conditions that may affect results: fibromyalgia, back pain, hip pain 12. has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain 13. has known dermatological sensitivity to light 14. enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.

Keywords: osteoarthritis knee osteoarthritis
kidney damage in patients with moderate fall in egfr

Conditions: Coronary Artery Stenosis

Summary: to compare iopamidol injection 370 and iodixanol 320 in evaluating neutrophil gelatinase-associated lipocalin (ngal) in patients with moderate fall in egfr

this is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (pci). all patients enrolled must have egfr greater than or equal to 30 ml/min and less than or equal to 59 ml/min. statistical summaries will be presented to analyze the various lab tests results for the two groups.

Eligibility criteria:
inclusion criteria: * at least 18 years of age and provides informed consent * scheduled to undergo percutaneous coronary intervention * documented pre-dose estimated glomerular filtration rate (egfr) of greater than or equal to 30 ml/min/1.73 m squared and less than or equal to 59 ml/min/1.73 m squared exclusion criteria: * pregnant or lactating females * severe congestive heart failure * history of hyperthyroidism; * unstable renal function * emergency pci * history of hypersensitivity to iodinated contrast agents * receiving diuretics to prevent acute renal injury
a multi-center, prospective, observational study of patients being treated with orgovyx

Conditions: Prostate Cancer

Summary: this is a multi-center, prospective, observational study of patients being treated with orgovyx. the goal of this study is to generate real-world evidence about the safety and effectiveness of orgovyx in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of orgovyx.

this prospective observational cohort study will be conducted in patients who are initiating treatment or have initiated treatment with orgovyx within the 1 month prior to the time of study enrollment and who remain on treatment at the time of enrollment. the decision to initiate treatment with orgovyx should be made prior to study enrollment. the study is designed to better understand the actual experience of patients with prostate cancer treated with orgovyx by collecting data on treatment patterns, adherence, and selective safety data. additionally, a better understanding of the trajectory of patients with prostate cancer following cessation of orgovyx therapy will be gained by observing the clinical course of the disease, health outcomes, and health-related quality-of-life (hrqol) in these patients.

Eligibility criteria:
inclusion criteria: * patients who are diagnosed with prostate cancer and initiating treatment with orgovyx at the time of enrollment or within 1 month prior to enrollment and who remain on treatment at enrollment * patients who are willing and able to complete pro assessments during the study * patients who have reviewed and signed the informed consent form (icf) exclusion criteria: * patients with a history of surgical castration * patients with a medical or psychiatric condition that precludes participation in the opinion of the treating physician * patients whose original treatment plan is intended to be less than a total of 4 months of orgovyx

Keywords: relugolix orgovyx prostate cancer optyx
the influence of feeding source on the gut microbiome and time to full feeds in neonates with congenital gastrointestinal pathologies

Conditions: Gastrointestinal Complication; Intestinal Obstruction; Gastroschisis; Hirschsprung Disease; Omphalocele; Midgut Volvulus

Summary: this study explores the use of an exclusive human milk diet versus standard feeding practices to compare the influence on feeding outcomes and the gut bacteria in infants with intestinal differences.


Eligibility criteria:
inclusion criteria: * infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease. exclusion criteria: 1. infant has already been on feeds 2. infants \<34 weeks gestation 3. parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth but oxy/suboxone/marijuana ok) 4. complicated gastroschisis 5. short gut syndrome 6. additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease but kidney disease ok)
the effects of body mass index on thoracic paravertebral block analgesia

Conditions: Pain, Postoperative; Acute Pain; Thoracic Paravertebral Block; Body Mass Index; Thoracic Surgery, Video-Assisted

Summary: obesity has become one of the world's leading health problems. it is known that obesity causes many diseases and negatively affects the quality of life. for this reason, many conditions that are thought to be effective in obesity and concern the quality of life of patients have been scientifically researched and continue to be investigated. one of them is postoperative pain. although there are studies stating that there is no relationship between body mass index (bmi) and postoperative pain, when the literature data is examined, it is thought that obesity is a risk factor for postoperative pain and changes pain sensitivity and analgesic needs of patients. there are also studies in the literature stating that the level of postoperative pain increases in parallel with each unit increase in bmi. after thoracic surgery, many analgesic methods have been suggested, including thoracic epidural analgesia (tea), thoracic paravertebral block (tpvb), intercostal nerve blocks (icsb), erector spina plane block (espb), serratus anterior plane block (sapb). this study will compare the effects of bmi on postoperative pain in patients undergoing tpvb for postoperative analgesia and thoracoscopic surgery.


Eligibility criteria:
inclusion criteria: * 18 to 80 years old * asa physical status i-ii-iii * bmi 18 to 40 kg/m2 * elective video-assisted thoracoscopic surgery exclusion criteria: * patient refusing the procedure * emergency surgery * chronic opioid or analgesic use * patients who will operate under emergency conditions * patients who will not undergo vats
laser therapy on tension-type cephalea and orofacial pain in post-covid-19 patients

Conditions: Tension-Type Headache; Orofacial Pain; COVID-19

Summary: considering the auxiliary potential effect of photobiomodulation in controlling persistent ctt and tmd-related pain in patients who have been diagnosed with covid-19, and are recovered from the viral infection, we intend to conduct a clinical trial comparing two modalities of therapeutic laser application: local application and transcutaneous application in the radial artery. one of the main advantages of auxiliary techniques in pain control is the decrease of the use of drugs for analgesia, avoiding side effects and tolerance caused by them, and promoting an improvement in the individual's quality of life.

orofacial pain and tensional cephalea were symptoms commonly reported in covid-19 patients, even after recovery, and were considered chronic pain in these cases. the pain control, in these cases, is mostly accomplished with the use of analgesic and anti-inflammatory drugs. however, there are auxiliary treatments that can reduce the amount of pharmacological intake and improve the quality of life of compromised individuals, one of them is photobiomodulation. using lasers for treatments to control inflammation and pain is successfully performed, but the parameters and the ways of application are not yet strongly established. the aim of this research is to evaluate the effect of the application of photobiomodulation with red and infrared lasers applied locally and systemically. for this purpose, individuals who have been diagnosed with covid-19 and have had a tension headache and/or orofacial pain for more than 3 months will be selected by convenience. the participants will be divided into two different groups: g1- photobiomodulation with red and infrared laser with local application on the pain points (808 nm and 660 nm,100 mw, 6j per point) and g2 -photobiomodulation with red laser with transcutaneous application on the radial artery (660 nm, 100mw, 30 minutes). all participants will be treated for a period of 4 weeks, with 8 application sessions. the effects will be measured by means of blood lactate level, brief pain inventory, visual analog scale (vas), and cephalea impact test.

Eligibility criteria:
inclusion criteria: * individuals of both sexes, between the ages of 19 and 65, complaining of persistent orofacial pain or functional-type cephalea, for more than 3 months. * individuals diagnosed with covid-19, confirmed by rt-pcr for sars-cov-2 already recovered, at least 30 days after infection. exclusion criteria: * individuals with diagnoses of neuropathies and headaches other than tension-type headache * physical or intellectual incapacity to answer the survey questionnaires; illiterate; diabetics, pacemakers, and pregnant women. * individuals who report photosensitivity to laser.

Keywords: tension-type headache orofacial pain photobiomodulation covid-19
omega-3 fatty acids (lovaza) for second generation antipsychotic-associated hypertriglyceridemia

Conditions: High Triglycerides; Hypercholesterolemia; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Summary: this is an open-label pilot study of omega-3 fatty acids (lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. the investigators hypotheses are that patients who receive lovaza will experience a significant decrease in triglycerides from baseline. secondary hypotheses include: patients will experience a significant decrease in total cholesterol, and lovaza will be well tolerated.

this is an open-label pilot study of omega-3 fatty acids (lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second generation) antipsychotic medication. eligible subjects include men and women, ages 18-75, who have been taking an atypical antipsychotic for at least three months prior to enrollment. atypical antipsychotics include: clozapine (clozaril), olanzapine (zyprexa), risperidone (risperdal), aripiprazole (abilify), ziprasidone (geodon), quetiapine (seroquel), paliperidone (invega), asenapine (saphris), iloperidone (fanapt), and lurasidone (latuda). eligible subjects must also have serum triglycerides \>200 mg/dl or high cholesterol \>250 mg/dl at baseline.

Eligibility criteria:
inclusion criteria: 1. female or male patients, 18-75 years of age. 2. serum triglycerides \>200 mg/dl or high cholesterol \>250 mg/dl 3. current use of an atypical (second-generation) antipsychotic medication - including clozapine (clozaril), olanzapine (zyprexa), risperidone (risperdal), aripiprazole (abilify), ziprasidone (geodon), quetiapine (seroquel), paliperidone (invega) - for at least three months exclusion criteria: 1. current use of triglyceride or cholesterol-lowering medication other than a statin 2. current use of omega-3 fatty acid supplement 3. intake of fish more than twice per week 4. currently pregnant, or breastfeeding 5. known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies) 6. current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, plavix. etc). 7. consumption of alcohol greater than two drinks per day or active substance abuse 8. any medical condition that would make participation in the study unsafe, as determined by investigator
incidence and predictors of heart failure after acute coronary syndrome: coralys

Conditions: Acute Coronary Syndrome; Heart Failure

Summary: single-cohort retrospective study evaluating the incidence and prognostic markers of heart failure following acute coronary syndrome treated by percutaneous coronary intervention

acute coronary syndrome (acs) is the most common cause of heart failure (hf) world-wide. primary percutaneous coronary intervention (pci) has deeply improved short and long-term survival after acs, but his impact on incidence of downstream heart failure still remains unclear and heart failure after acs represents the major driver of late morbidity, mortality and healthcare cost. many predictors and determinant of heart failure after mi have been evaluated, however, to date, the optimal combination of parameters to predict heart failure after mi needs to be defined and very little is known about the prognostic markers in unstable angina setting the aim of this retrospective study: * to show the incidence of heart failure after acute coronary artery syndrome, and the relation between the type of acs and following incidence of hf. * to clarify which features could be routinely identified as prognostic markers. this study is a multi-center non-randomized, single-cohort retrospective study including consecutive patients with acute coronary syndrome treated by percutaneous coronary intervention between 2017 and 2019, without known previous heart failure (baseline ef \> 40% and no medical therapy with loop diuretics), with at least 12 months of follow-up. it is possible to anticipate that the main findings of the present study will fill fundamental knowledge gaps regarding incidence of heart failure following coronary events. among this, the study could suggest specific clinical and epidemiological features related to the risk of development of hf, leading to a better medical treatment and reducing risk for further hospitalizations.

Eligibility criteria:
inclusion criteria: * • informed consent * age ≥ 18 years * previous acute coronary syndrome with percutaneous coronary revascularization * baseline ef \> 40% * at least 12 months of follow-up exclusion criteria: * • significant valvular heart disease (greater than mild stenosis or moderate regurgitation) before acs * type 1, 3, 4, 5 pulmonary hypertension (14) before acs * constrictive pericarditis before acs * primary or infiltrative cardiomyopathies * heart transplantation * medical therapy with loop diuretics for heart failure before acs * previous hospitalizations for heart failure or clinical sign of heart failure detected outpatient before acs
electrophysiological study of the effects of limb cooling on essential tremor

Conditions: Tremor

Summary: to determine the effects of upper limb forearm cooling on essential tremor upper limb tremor using a more practical method of limb cooling through a forearm cold pack.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of e.t. for at least a year by a movement disorder neurologist * a +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand * ages 18 to 95 years old exclusion criteria: * (+) sensory loss in the upper extremities * dermatologic lesions in upper extremities (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash) * known history of sensitivity to cold (i.e., cold urticaria) * known peripheral vascular disease * raynaud's phenomenon * scleroderma

Keywords: essential tremor cooling temperature patients with essential tremor involving the upper limbs with at least moderate tremor.
effect of training on brain volume in ataxia

Conditions: Spinocerebellar Ataxias

Summary: the primary aim is to show balance training improves dcd individual's ability to compensate for their activity limitations, but does not impact disease progression. the second aim is to demonstrate aerobic exercise improves balance and gait in dcd persons by affecting brain processes and slowing cerebellar atrophy.

individuals with degenerative cerebellar disease (dcd) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. with no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. there is no evidence, however, that balance training impacts dcd at the tissue level. aerobic training, on the other hand, may modify dcd progression as evident from animal data. compared to sedentary controls, aerobically trained dcd rats have enhanced lifespan, motor function, and cerebellar purkinje cell survival. numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins. the effects of aerobic training in humans with dcd are relatively unknown, despite these encouraging animal data. a single study to date has evaluated the benefits of aerobic exercise on dcd in humans, and this was a secondary outcome of the study. although participants performed limited aerobic training during the study, modest functional benefits were still detected. the main objective of this project will be to compare the benefits of aerobic versus balance training in dcd. we hypothesize that both aerobic and balance training will improve function in dcd subjects, but that the mechanisms in which these improvements occur differ. 1) balance training improves dcd individual's ability to compensate for their activity limitations, but does not impact disease progression. 2) aerobic exercise improves balance and gait in dcd persons by impacting the cerebellum

Eligibility criteria:
inclusion criteria: * diagnosed with spinocerebellar ataxia * cerebellar atrophy on mri * prevalence of ataxia on clinical exam * ability to safely ride a stationary exercise bike exclusion criteria: * other neurologic conditions • heart disease * cognitive impairment * medical instability

Keywords: ataxia cerebellum cerebellar degeneration