Kornimate/medical-research-clean huggingface dataset:
long-term outcomes for lumbar spinal stenosis patients treated with x stop®

Conditions: Lumbar Spinal Stenosis

Summary: the long-term outcomes study (ltos) is a multi-center longitudinal cohort study of all patients who received the x-stop device in the pivotal trial, continued access protocol (cap), or cross-over study (cos). it is designed to supplement postmarket safety and effectiveness data to be gathered in a condition of approval (coa) study of a population of patients with moderately impaired physical function who elect to undergo x-stop surgery.

evaluate the long term safety and effectiveness of the x-stop interspinous process decompression system in the patients who received the x-stop under the ide. these patients consist of two cohorts to be evaluated: patients who had moderately impaired physical function prior to x-stop implantation (as determined by a baseline score \>2.0 in the physical function (pf) domain of the zurich claudication questionnaire), and patients who had mildly impaired physical function prior to x-stop surgery(as determined by a baseline score \<=2.0 in the pf domain of the zurich claudication questionnaire (zcq), through the fifth postoperative year. clinical examination will be performed at each office visit to confirm the absence of neurological complications. x-ray films (ap/lateral views) taken during the fifth postoperative year will, be analyzed to confirm a) maintenance of distraction and b) the absence of radiological evidence of device-related complications. secondary endpoints will include mean scores from the sf-36, and incidence rates of adverse events, device failures, and secondary surgeries.

Eligibility criteria:
inclusion criteria: a patient will be admitted into the ltos program if he/she meets all of the following inclusion criteria: 1. completed participation in the pivotal trial, cap, or cos and has the x stop implant(s) intact at the time of ltos enrollment; or is an active cap/cos participant, has the x stop implant(s) intact, and has not completed a 24-month follow-up visit in his/her cap/cos study. 2. is willing and able to provide informed consent 3. is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit. exclusion criteria: a patient will not be admitted into the ltos program if he/she meets any of the following exclusion criteria: 1. participated in the pivotal trial as part of the x stop group, but the device has been removed. 2. participated in the cap or cos programs, but the device has been removed.

Keywords: lumbar spinal stenosis x stop
efficacy of gabapentin for post-covid-19 olfactory dysfunction

Conditions: COVID-19; Olfactory Disorder; Anosmia; Hyposmia; Parosmia

Summary: this study will investigate the efficacy of oral gabapentin in olfactory improvement following covid-19- associated olfactory dysfunction. this is a randomized, double-blinded, placebo-controlled trial.

the drug will be given over a maximum 14 weeks with up to four weeks titrating up, eight weeks maintaining highest tolerable dose, and up to two weeks tapering down. change in olfactory function from baseline to completion of 8-week fixed-dose period will be compared between the two study groups. follow-up assessments will be conducted for both groups 4 weeks after completion of taper down.

Eligibility criteria:
inclusion criteria: * men and women between the ages of 18 and 65 years * residing within the states of missouri or illinois * clinically diagnosed or subjective olfactory dysfunction (anosmia, hyposmia, or parosmia) of 3 months duration or longer diagnosed within 2 weeks of covid-19 infection * upsit score consistent with diminished olfactory function (score ≤ 33 in men and ≤ 34 in women). * willing to respond daily to study surveys, preferably through smartphone with unlimited texting plan * in possession of all 7 household items: soap, burnt candle, peanut butter, herb, garlic, lemon, and coffee exclusion criteria: * clinically diagnosed olfactory dysfunction secondary to genetic abnormalities or congenital dysfunction, trauma, non-covid-19 viral infection, nasal polyps, neurodegenerative disorders * current use of: azelastine, bromperidol, orophenadrine, oxomemazine, kratom, paraldehyde, or thalidomide * history of addiction to alcohol, cocaine, or opioids * impaired renal function, myasthenia gravis, or myoclonus * severe allergy to peanuts * pregnancy or attempting pregnancy during study participation * inability to participate in virtual trial due to lack of access to the internet or unlimited text messaging; inability to comprehend or use english language * availability less than 6 months from time of enrollment * residency in states other than missouri or illinois.
chronic mountain sickness, systemic vascular function

Conditions: Mountain Sickness; Chronic

Summary: diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (copd) or emphysema, represent major medical and socio-economical problems and one of the leading cause of morbidity and mortality in the western countries. recently, is has been shown that cardiovascular (cv) diseases contribute highly to the morbidity and mortality of these patients. furthermore, increasing evidence suggest that systemic vascular dysfunction play a central role in the mediation of the increased cv risk in patients with copd. however the underlying mechanisms of vascular dysfunction in these patients are incompletely understood. chronic mountain sickness (cms) is characterized by chronic hypoxemia related at least in part to hypoventilation; it affects relatively young adults, and may therefore allow to study the effects of chronic hypoxemia. the investigators therefore will assess systemic vascular function and test the hypothesis that increased oxidative stress is responsible for this dysfunction. since polyglobulia is a hallmark of chronic hypoxemia and has been suggested to affect vascular function, the investigators will test the effects of hemodilution on vascular function. then, the investigators will test the effects of acute oxygen application and 1 month antioxidative dietary supplement on vascular function. preliminary data suggest that offspring of cms patients may display pulmonary and systemic vascular dysfunction. antioxidant administration is know to improve vascular function. we will test the acute effect of vitamin c in this setting. finally, since there is considerable inter-individual variability of pulmonary artery pressure among cms patients and the presence of a patent foramen ovale (pfo)is increased in clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the prevalence of pfo in healthy high altitude dwellers and in cms patients and its effects on pulmonary artery pressure at rest and during mild exercise.


Eligibility criteria:
inclusion criteria: * patients with chronic mountain sickness and their offspring exclusion criteria: * smoking * lung disease * arterial hypertension

Keywords: endothelial function chronic hypoxia oxidative stress
implication of metabolic and genomic modifications in elderly subjects

Conditions: Insulin Sensitivity; Aging

Summary: an increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle). in 2006, suvimax 2 study began, based on the monitoring of volunteers who participated in former suvimax study (1994-2003). this study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. the subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") these volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging. the purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.


Eligibility criteria:
inclusion criteria: * volunteers from the cohort aging suvimax 2 * men and women * over 60 years * bmi between 18 and 35 kg/m2 (including terminals) * normal medical check up * blood pressure \< 140/90 mmhg * normal glycemia, lipid profile * sedentary or moderate physical activity (maximum 4 hours per week) exclusion criteria: * biological results or anormal chek-up * medical or surgical history not compatible with study * severe digestive, cardiovascular, renal, liver or tumor disorders history in the 5 last years * infectious or inflammatory disease within 2 months * surgical history within 3 months * bood donation within 2 months * coagulation disease, anticoagulant or antiplatelet agents (aspirin ...) treatment * xylocaïn allergy * claustrophobia * drug that could affect insulin sensitivity (beta blockers, lipid lowering, oral antidiabetics, insulin, , steroids)

Keywords: insulin sensitivity aging lipid metabolism hyperinsulinemic clamp gene expression sirtuins
preoperative anxiety's incidence and related factors in surgical patients

Conditions: Elective Surgery; Intravenous Anesthesia; Preoperative Anxiety

Summary: preoperative anxiety is often described as an uncomfortable, tense unpleasant mood before surgery, an emotional response to a potential challenge or threat to reality. data show that adult patients with preoperative anxiety rate of 30-40%. the main reason for the occurrence of patients for surgery, anesthesia and other factors of fear. preoperative anxiety itself is not a mental illness, but studies have confirmed that the occurrence of preoperative anxiety and postoperative complications were positively correlated, and the existence of preoperative anxiety in patients with conventional postoperative analgesic effect is poor. at present, there are still few studies on the relationship between preoperative anxiety and postoperative complications and analgesia. at the same time, there is a lack of large sample size to study the incidence of preoperative anxiety and its related predictors.

surgical patients often have varying degrees of preoperative anxiety.the aim of this study was to determine the incidence of preoperative anxiety and related predictors, and to evaluate the effect of anxiety on anesthesia and postoperative pain and prognosis. the study also showed that prostaglandin, catecholamines, cortex effects of alcohol and inflammatory cell level on postoperative pain in patients with preoperative anxiety.

Eligibility criteria:
inclusion criteria: * age 18-70 years old * sign that informed consent is willing to participate in the study * education: primary school and above * 1 days after elective general anesthesia surgery * asa score grade i-iii exclusion criteria: * emergency surgery * severe mental illness patients (such as anxiety, depression, schizophrenia, etc.) * taking anti-anxiety or antidepressants (benzodiazepines, tricyclic antidepressants, selective serotonin inhibitors, monoamine oxidase inhibitors, etc.)
evaluation of the efficacy and safety of afq056 in parkinson's patients with l-dopa induced dyskinesias

Conditions: Dyskinesias; Parkinson Disease; Movement Disorders; Parkinsonian Disorders

Summary: this study will assess the efficacy and safety of afq056 in patients that have parkinson's disease l-dopa induced dyskinesias (pd-lid)


Eligibility criteria:
inclusion criteria: * outpatients with parkinson's disease (pd), treated with l-dopa, experiencing dyskinesias for at least three months * outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks exclusion criteria: * surgical treatment for pd * cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) * advanced, severe or unstable disease (other than pd) or evidence of dementia that may interfere with the study outcome evaluations other protocol-defined inclusion/exclusion criteria may apply

Keywords: parkinson disease l-dopa levodopa dyskinesia anti-dyskinesia agents
effects of dapagliflozin on the incretin sensitivity of the pancreatic beta cell

Conditions: Diabetes Mellitus, Type 2

Summary: to investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for dapagliflozin arm * normal glucose tolerance (fasting plasma glucose \<100 mgd/l, hba1c \<6.0%) for normal glucose tolerance arm * age 18 to 75 years * bmi \<35 kg/m2 * for type 2 diabetes patients, at least 3 months of treatment period and hba1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea exclusion criteria: * who is allergic to dapagliflozin * type 1 diabetes * patients with history of diabetic ketoacidosis * reduced renal function (egfr \<60ml/min/1.73m2) * taking loop diuretics or dehydrated patient * history of hypotension when taking hypertensive medication * diagnosed with heart failure * diagnosed with cerebral infarction * taking insulin, dpp-4 inhibitor, glp-1 analogue, pioglitazone, alpha-glucosidase inhibitor * above upper limit of normal hematocrit range (male 39-52%, female 36-48%) * pregnant or breastfeeding women * history of recurrent genitourinary infection * ast/alt more than two fold increased above normal upper limit * hemolytic disorder
study to investigate patient preference on dosing in ibandronate and risedronate in korean women with postmenopausal osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: this is a randomized open label, multi-centre study for korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate. eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen. treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa. after taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. there is no washout period.


Eligibility criteria:
inclusion criteria: * women with postmenopausal osteoporosis diagnosed by dxa scanning, defined by t-score of -2.5 sd at spine or femur. * patients who have never received bisphosphonates therapy (bisphosphonates naive) exclusion criteria: * inability to stand or sit in the upright position for at least 60 minutes; * hypersensitivity to any component of risedronate and ibandronate; * administration of any investigational drug within 30 days preceding the first dose of the study drug; * patient has been on hormone (estrogen) replacement therapy or other osteoporosis medication (e.g. serms and calcitonin) within the previous 3 months. * patient has been on systemic corticosteroids therapy for more than 1 month within the past year. * other bone disease except osteoporosis * current medical history of uncontrolled major upper gi disease

Keywords: risedronate ibandronate preference osteoporosis
a pharmacodynamic study with ticagrelor in african american patients

Conditions: Stable Coronary Artery Disease

Summary: the purpose of this study is to assess the pharmacodynamic effect of ticagrelor in african american patients with stable coronary artery disease.

a randomized, open-label, multiple dose, crossover, multiple center study of the antiplatelet effects of ticagrelor versus clopidogrel in african american patients with stable coronary artery disease

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent before initiation of any study-related procedures * male or female patients aged 18 years or older * documented stable cad fulfilling and taking 75-100mg asa daily treatment * females must be post menopausal or surgically sterile self-identified as african american exclusion criteria: * any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, asa dose other than 75 to 100 mg daily) during study period * patients who had acs or stent placed within 12 months of screening patients with a history of moderate or severe hepatic impairment * current smokers, including the use of tobacco containing products in the past 1 month of randomization patients required dialysis

Keywords: stable coronary artery disease, cad
predictors of neuro-cognitive decline and survival in hiv-infected subjects

Conditions: AIDS; Dementia

Summary: patients will be followed every 6 months for a total of 5 visits (month 0, 6, 12, 18 and 24). the first visit is the screening and entry visit which can occur at any time after the subject finishes search 001 study but preferably it should occur approximately 6 months after search 001 study completion. at each visit, patients will undergo the following 1. assessment of function including activity of daily living questionnaire 2. history of medical illnesses, medication history 3. neurological examination: all patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (it is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed). 4. neuropsychological assessment: 5. thai depression inventory. 6. hiv viral load and storage of blood for proviral dna level final outcome assessment based on all available data. if possible, it is intended that these diagnoses will be determined through monthly vtc conference calls with uh investigators. this consensus conference will include the thai investigators, the uh neurologist, the uh neuropsychologist and the uh principal investigators.


Eligibility criteria:
inclusion criteria: * all patients who have completed the search 001 study are eligible to enroll in this search 001.1 study provided that they understand and voluntarily sign the informed consent form. exclusion criteria: * none
effect of antigravity treadmill in knee osteoarthritis (agtreadmill)

Conditions: Knee Osteoarthritis

Summary: to date, the anti-gravity treadmill, as a representative method of lower body positive pressure treadmills, has been rarely reported for knee osteoarthritis rehabilitation. purpose: this study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis.

the study included 40 patients with knee osteoarthritis who were randomly assigned to one of two groups: the antigravity treadmill group (n=20) or the control group (n=20 ). for 12 weeks, the antigravity treadmill group received training on the alter g treadmill (75% weight-bearing, 30 minutes per session, three times per week) combined with traditional physical therapy. during the same period, the control group received only traditional physical therapy. the visual analogue scale, walkway system, and the western ontario and mcmaster universities arthritis index were used to assess pain, spatiotemporal gait parameters, and patient function, respectively. all outcome measures were obtained pretreatment, post-treatment, and 3 months follow-up assessment.

Eligibility criteria:
inclusion criteria: * patients should: (1) be ≥50 years old * patients have been diagnosed with mild to moderate osteoarthritis by a physician and confirmed by radiograph imaging (kellgren \& lawrence grade 1-3) * patients complain of knee pain during the past 30 days when walking, squatting, and/or kneeling (the minimum level 3/10 on visual analogue scale before inclusion) * patients' body mass index greater than 30. exclusion criteria * patients were excluded if they have a history of ankle, knee, or hip injury or medical operation * have used knee injection for their knee osteoarthritis pain within the past year * have a history of other medical conditions that would interfere with walking * received physical therapy during the past 3 months for knee osteoarthritis * had any metabolic, pulmonary, neuromuscular, neurological, and/or autoimmune disease.

Keywords: antigravity treadmill osteoarthritis gait characteristics patient function
health and employment after gastro intestinal surgery - heagis1

Conditions: Esophageal Neoplasms; Stomach Neoplasm; Colonic Neoplasms

Summary: by using the m.a.d.i.t. methodology and the dialogics science, salvo project aims to develop operational guidelines to support oncological target patients in the resumption of their daily post-operative activities. the research will implement an instrument for the purpose of measuring the health need of participants who are admitted to the surgical ward. therefore, targeted interventions will be implemented with participants, and efficacy will be evaluated in order to define treatment guidelines. the principal aim of this study is to create a validated and replicable intervention model for supporting patients who undergone surgery for esophagus and gastro intestinal cancer.

several studies highlight how patients diagnosed with a digestive tract cancer, experience difficulties in returning to work after treatment, leading to socio-economic spill-over effects. a specific 16 questions questionnaire had been developed for this study, the "health and employment after gastro intestinal surgery dialogical questionnaire" (heads-dq). it investigate peculiar patient competences involved after surgery: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities. through this questionnaire patient ability in dealing with after surgery consequences will be evaluated in order to define targeted support, which will be offered by professional psychologists. these interventions efficacy will be evaluated through another administration of the heads-dq.

Eligibility criteria:
inclusion criteria: * \>18 years old; * comprehension of italian language; * esophageal or gastro intestinal cancer diagnosis; * curative surgery for neoplasm; * no metastasis; exclusion criteria: * \<18 years old * non comprehension of italian language; * no esophageal or gastro intestinal cancer diagnosis; * palliative ; * cancer recurrence or metastasis.

Keywords: quality of life work social activities surgery