Kornimate/medical-research-clean huggingface dataset:
efficacy, safety, and tolerability of nerispirdine in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (ms). secondary objectives: * to assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the study investigator * to assess the safety and tolerance of nerispirdine * to evaluate the pharmacokinetics (pk) parameters of nerispirdine

total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period

Eligibility criteria:
inclusion criteria: * clinically definite ms (according to mcdonald criteria), exclusion criteria: * multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit. * subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device, * patients without valid v1, v2, and v4 t25-fw measurements are not eligible for randomization. * female patients who are either pregnant or breastfeeding. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple sclerosis
role of an e-cigarette on smoking displacement in smokers with schizophrenia

Conditions: Schizophrenia and Related Disorders

Summary: it is well established in the scientific literature that people with schizophrenia smoke tobacco cigarettes at rates up to three times that of the general population, relapse more frequently, and die an average of 25 years earlier from cigarette smoking and other life-style attributable illnesses. electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide and new research suggests that e-cigarettes are appealing to smokers with schizophrenia. there is a paucity of research focused on the experience of smokers with schizophrenia who decide to try an e-cigarette. a well-designed prospective-observational study is needed to learn more about the influence of e-cigarette use on cigarette smoking behavior and mental and physical health among smokers with schizophrenia. in response, the investigators have designed a study titled, role of an electronic cigarette on smoking displacement in smokers with schizophrenia: a prospective 3-month pilot study (schizecig).

this is a prospective 3 month pilot study to observe cigarette use behavior among people with a schizophrenia spectrum disorder diagnosis who smoke conventional tobacco cigarettes, do not intend to reduce or quit smoking, and are invited to use an e-cigarette. the investigators are interested to know if e-cigarette use is associated with cigarette smoking displacement. displacement is defined as switching from conventional tobacco cigarettes to e-cigarettes. the investigators will also monitor for physical and mental health, including blood pressure, weight, and scores from the scale for the assessment of negative symptoms (sans) and the scale for the assessment of positive symptoms (saps) as well as any reported adverse events participants' feel are attributed to e-cigarette use and participants' perceptions of the sensory experience associated with e-cigarette use.

Eligibility criteria:
inclusion criteria: clinical diagnosis of a schizophrenia spectrum disorder non-hospitalized persons regular smokers who report smoking 20 or more cigarettes per day who have smoked at least 100 cigarettes in their lifetime, and are not intending to reduce or quit has agreed to try an e-cigarette must be able to provide written informed consent must be able to read, write and communicate in english proficiently must have access to a computer with internet must have the ability to work a computer and navigate the internet easily exclusion criteria: non-smokers persons without a schizophrenia spectrum disorder diagnosis hospitalized persons cardio vascular disease respiratory disease use of smokeless tobacco or any other tobacco products besides cigarettes. use of nicotine replacement therapy or other smoking cessation pharmaco-therapies within the last 3 months pregnancy or breastfeeding

Keywords: schizophrenia smoking e-cigarette
risk of hepatocellular carcinoma in patient with liver cirrhosis

Conditions: Carcinoma, Hepatocellular

Summary: purpose of the study is to determine transcriptomics, metabolomics and proteomics features of liver cirrhotic tissue in patients with hepatocellular carcinoma (hcc) and to find a correlation with the risk of developing hcc and survival.

patients will be enrolled after hepatic ultrasonography control and they will be submitted to hepatic vein pressure gradient and liver biopsy. the study have four research lines: task # 1: transcriptomic characterization of liver tissue. during hepatic vein pressure gradient , liver tissue will be extracted with transjugular catheter equipped with a biopsy device. tissue will be used to extract microrna to define molecular signature. task # 2: proteomic characterization of liver tissue. protein expression changes will be analyze with maldi-tof task # 3: metabolomic features on serum of patient with cirrhosis. metabolomics is defined as the quantitative measurement of the dynamic multiparametric response of living systems to pathophysiological stimulus or genetic modification. principal objective of this activity will be identify metabolites deregulated with metabolomic approach and clarify any new pathways involved in the evolution of cirrhosis to hepatocellular carcinoma. the metabolomic analysis will be performed on sera collected in patients with cirrhosis at baseline. task # 4: transcriptomic characteristics of newly diagnosed hcc. new diagnosis of hepatocellular carcinoma will undergo an eco-assisted liver biopsy. a tissue sample will be dedicated to the extraction of 'rna. patients will then undergo elective treatment according to international guidelines. the course of the disease and the results of therapeutic interventions will be recorded and correlated with the molecular data. molecular signature will be obtain.

Eligibility criteria:
inclusion criteria: * obtaining written informed consent * liver cirrhosis * aged between 18 and 75 years * absence of exclusion criteria exclusion criteria: * hcc * hiv * pregnancy * portal vein thrombosis * liver transplant * patients' refusal to participate in clinical research
impact of obstructive sleep apnea treatment in patients with metabolic syndrome

Conditions: Sleep Apnea; Metabolic Syndrome

Summary: obstructive sleep apnea (osa) is a common condition that may induce hemodynamic and metabolic dysregulation. however, it is not clear if osa is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. this study was designed to evaluate the impact of osa treatment with cpap in consecutive patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * metabolic syndrome (atp iii) * moderate to severe osa exclusion criteria: * smokers * patients under chronic use of medications * neurological diseases * coronary artery disease * acute heart failure * chronic renal failure (gfr \< 30 ml/min) * chronic obstructive pulmonary disease * mild osa and patients with bmi over 40 kg/m2.
effect of anesthesia on quality of recovery in patients undergoing correctional tibial osteotomy - a randomized controlled trial

Conditions: Short Stature; Osteoarthritis

Summary: the effect of total intravenous anesthesia (tiva) versus inhalational anesthesia on the quality of recovery from surgery has been reported in several different types of operations. the quality of recovery 40 (qor-40) questionnaire is designed multi-dimensionally to assess the degree of recovery after anesthesia and surgery, and has been validated in previous studies. the present study aims to compare the quality of recovery with the qor-40 questionnaire, in patients undergoing correctional tibial osteotomy under general anesthesia with either tiva with propofol or inhalational anesthesia with desflurane.


Eligibility criteria:
inclusion criteria: 1. adult patients over the age of 19 scheduled for cosmetic lower limg lengthening for short stature, or correctional tibial osteotomy for osteoarthritis exclusion criteria: 1. patient refusal 2. patients with altered mental status 3. ejection fraction under 55% 4. recent mi, cva, or major cardiovascular surgery 5. 3rd degree av block, 2nd degree av block with p:qrs ration greater than 3:1 6. hemodynamically unstable patients requiring vasopressors or oxygen therapy 7. febrile patients 8. patients with decreased renal function (serum cr \> 0.1 mg/dl) 9. patients with known allergies to propofol 10. pregnant patients

Keywords: total intravenous anesthesia desflurane qor-40 correctional tibial osteotomy
risk of morbidity, mortality and long-term monitoring of antiretroviral treatment in people living with hiv

Conditions: HIV Infections; Antiretroviral Agents

Summary: hiv infection is now a chronic disease in countries where antiretroviral treatments (art) are largely available. long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as new treatments side effects. the main objective of the cohort is to describe and study the evolution of hiv infection in art-treated individuals.

the survival of people living with hiv (plhiv) taking antiretroviral therapy (art) is now close to what is reported in the general population in northern countries. however, plhiv experience an increased risk of morbidities that the anrs co3 aquitaine cohort has largely contributed to describe in the last years. among contributing factors to this excess of morbidity, immune suppression, immune activation, and exposition to cardiovascular and cancer risk factors as well as ageing represent possible intervention targets. long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as art side effects. moreover, the global evaluation of health in plhiv, including psychiatric, neurologic and social determinants and not only biomedical determinants represents one of the public health challenges of the next decade in the field of hiv infection. the aim of the present study is to study the emerging morbidity occurring during the course of hiv infection in people treated with art as well as to describe the tolerance and efficacy of new available art regimens. the follow-up of patients will be performed according to national guidelines. demographic, clinical, biological and therapeutic data will be captured at each patient's hospital contact according to a standardized questionnaire. all events occurring during the course of clinical management will be prospectively registered in the database according to the icd 10th revision. a biobank will be collected from every consenting plhiv at inclusion in the cohort and then every two years.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years old. * confirmed hiv infection * signed informed consent exclusion criteria: * hiv-2 infection

Keywords: hiv cohort studies antiretroviral treatment
the effect of oral vitamin d versus narrow-band uv-b exposure on the lipid profile

Conditions: Vitamin D Deficiency

Summary: participants in this study will be randomized to receive either oral vitamin d pills or ultraviolet light treatment. the investigators will compare how these two methods of raising vitamin d levels will affect cholesterol levels.

potential subjects will be screened for eligibility, including serum 25(oh)d levels \<20ng/ml. eligible subjects will be randomly assigned to receive either: 1) oral vitamin d3, 50,000 units weekly for 8 weeks or 2) narrow-band uvb radiation, 2 treatments/wk for 8 weeks. duration of treatment will be based on skin type. after 8 weeks, 25(oh)d levels will be measured monthly. for participants with levels \<35 ng/ml, additional doses of oral vitamin d3 or uv radiation will be administered. a subset of participants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. vitamin d 25-oh level \< 20 ng/ml exclusion criteria: 1. serum calcium \> 10.5 mg/dl 2. serum phosphorus \> 5.5 mg/dl 3. serum parathyroid hormone (pth) level \< 12 pg/ml 4. ldl cholesterol \> 190 mg/dl 5. history of recent acute infection (within 1 month) 6. glomerular filtration rate(gfr) \< 60 ml/min 7. liver function tests indicative of liver disease (aspartate aminotransferase (ast) or alanine transferase (alt) \> 3x uln) 8. current use of vitamin d \> 400 iu/day 9. current use of any statins, fibrates, niacin, or ezetimibe 10. current use of any medications affecting sensitivity to uv light 11. pregnancy (self-reported) 12. intentional uv exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study 13. history of malignancy not in remission (\> 6 months) 14. history of malignant melanoma 15. participation in an investigational drug study within 30 days of the screening visit 16. any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data. 17. history of any non-melanoma skin cancer
the effect of prucalopride (resolor®) on gastric motor function and gastric sensitivity

Conditions: Gastrointestinal Motility Disorder; Dyspepsia

Summary: functional dyspepsia-postprandial distress syndrome (fd-pds), is characterized by meal-related symptoms such as early satiation and postprandial fullness. disturbances of gastric motor function have been implicated the pathogenesis of pds symptoms, and hence, motility modifying agents are considered for the treatment of pds. prucalopride (resolor®), a highly selective 5-th4 receptor agonist which stimulates gastrointestinal motility throughout the gi tract, is currently approved for the treatment of chronic constipation. the objective of this study was to evaluate the effect of prucalopride on gastric sensorimotor function in healthy volunteers (hv). methods a total of 17 hv (59% females, mean age 29.4±2.7 years) underwent a barostat and intragastric pressure (igp) measurements after treatment with placebo or prucalopride (2 mg) in a single blinded cross-over fashion. isobaric distentions with stepwise increments of 2 mm hg starting from minimal distending pressure (mdp) and scoring of intensities of gastric sensations (0-6: pain) were used to determine gastric compliance and sensitivity. gastric accommodation (ga) was quantified as the difference (delta) in intra-balloon volume 30 min before and 60 min after ingestion of 200 ml of a nutrient drink (nd) (1.5 kcal ml(-1)). ga measured by igp was quantified as the drop of igp from baseline during the intragastric infusion of nd until maximal satiation. during all tests, epigastric symptoms were scored every 5 minutes.


Eligibility criteria:
inclusion criteria: * healthy volunteers, male and females, between 18-60 years old exclusion criteria: subjects that: * they are older than 60 years old. * have severely decreased kidney function. * have severely decreased liver function. * have severe heart disease, for example a history of irregular heartbeats, angina or heart attack. * have severe lung disease. * have severe psychiatric illness or neurological illness. * have any gastrointestinal disease * women that are pregnant or breastfeeding. * have a rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption (resolor tablets contain lactose).

Keywords: gastric accommodation gastric sensitivity gastric compliance nutrient tolerance
a prospective randomized study on the clinical benefits of orthopat drains

Conditions: Spine Deformity

Summary: the examination of the ability of the orthopat® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.

the purpose of this study is to investigate the use of postoperative drains with blood salvage capabilities to determine if they decrease both the volume and rate of allogenic blood transfusion in adult patients undergoing multilevel spine surgery for deformity. in addition, the ability of these drains to decrease the complications that are associated with allogenic blood exposure (postoperative infection, volume overload and transfusion reactions) will also be evaluated.

Eligibility criteria:
inclusion criteria: the patient is at least 18 years of age the patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels the patient has signed a patient informed consent exclusion criteria: the patient is less than 18 years of age the patient has a hematologic disorder of any etiology the patient has received active anticoagulant therapy, including aspirin, plavix, heparin, lovenox or coumadin within one week of admission the patient has a known active infection or malignancy. the patient has a terminal illness with a life expectancy of less than one year. the patient requires immuno-suppressive therapy. the patient is undergoing a combined anterior/posterior fusion. the patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.
imaging of retinochoroidal vasculature in patients being assessed for cardiovascular disease

Conditions: Cardiovascular Diseases; Retina; Change

Summary: this study aims to determine whether changes in retinal vasculature seen on ss-octa can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography.

the study's primary objective is to determine whether measures taken from ss-octa, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of hollenhorst or other plaques, and/or areas of ischemia.

Eligibility criteria:
inclusion criteria: * subjects between 18 and 80 years of age. * no known prior history of retinal disease. * able to participate in a clinical eye examination setting. * able to consent. * subjects receiving standard of care carotid duplex ultrasounds. exclusion criteria: * known ophthalmologic disease (e.g. glaucoma, macular degeneration, ocular injury) other than corrected refractive error. * lack of capacity to provide informed consent. * subjects younger than 18 years of age or older than 80 years of age. * history of stroke or acute loss of vision. * unable to participate in a clinical eye examination setting.

Keywords: retinal vasculature cardiovascular disease swept source optical coherence tomography angiography ss-octa carotid duplex ultrasonography
deb-after-cutting balloon-pta in dialysis fistula stenosis

Conditions: Renal Insufficiency

Summary: the incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, ptfe shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. this therapeutic measure is a dilatation of the stenosis using a standard pta balloon (poba, plain old balloon angioplasty with a primary technical success rate of 50-79% \[2-4\].in turn, in 21-50% of the cases an insufficient pta result is obtained (so-called poba-resistant stenosis). in these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. however, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis. the use of drug-coated balloon (dcb) in non-poba resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. however, the effect of dcb in poba resistant stenoses is unknown. therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in poba resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.


Eligibility criteria:
inclusion criteria: * dialysis fistula dysfunction requiring cutting balloon angioplasty exclusion criteria: * missing informed consent or unable to consent * age \< 18 years * pregnancy

Keywords: dialysis
the effect of weight on vitamin d dose response

Conditions: Obesity; Vitamin D Deficiency

Summary: vitamin d3 is a vitamin that is an essential component of biological regulating systems in humans. sun exposure is the predominant source of vitamin d3. previous research has shown that vitamin d3 deficiency is common worldwide. it is especially common in northern countries with long winters due to inadequate sun exposure during winter. in the us, an estimated 36% to 57% of healthy middle-aged to elderly adults have vitamin d3 deficiency. current research indicates that obesity is associated with a low vitamin d3 level.

obesity is a known risk factor for vitamin d deficiency. adequate levels of vitamin d are important, not only for bone health, but appear to be important for prevention of certain autoimmune diseases, infections and cancers. current fda recommendations for vitamin d intake do not differentiate between lean and obese people. there are no published studies indicating if the 25(oh)d response to a given daily dose of vitamin d is any less in an obese person than a normal weight person. the purpose of this study is to characterize the quantitative relationship between steady state cholecalciferol input and the resulting serum 25 (oh)d concentration in obese subjects. data obtained in this study will be compared to published normative data for non-obese subjects. recommendations will be provided for optimal treatment of vitamin d deficiency in obese men and women.

Eligibility criteria:
inclusion criteria: * men aged 19 to 60 with bmi \> 30.0. * they will have low (\<1,000 iu) usual intake of vitamin d (from milk, multivitamins, supplements, and fortified foods) exclusion criteria: * subjects will not have history of hepatic or renal disease. * subjects will not be taking medications known to affect vitamin d metabolism such as anti-seizure medications and/or corticosteroids. * they will not be on hydrochlorothiazide medications which could cause hypercalcemia. * they will not have diseases causing malabsorption of vitamin d, such as celiac sprue or small bowel surgeries. * pregnancy is also an exclusion criterion.

Keywords: vitamin d