Kornimate/medical-research-clean huggingface dataset:
postmarketing clinical study on ao-128

Conditions: Impaired Glucose Tolerance (IGT)

Summary: the purpose of open-label study is to evaluate the efficacy and safety of ao-128 (voglibose) 0.6 mg/day in patients with impaired glucose tolerance (igt) who had been non-responsive to diet therapy and exercise therapy, and follow up the progress after the end of treatment in patients who was assessed as normoglycemic.

the α-glucosidase inhibitor voglibose was developed by takeda pharmaceutical co. ltd and is one of the most commonly used oral antidiabetic agents in japan. voglibose is used as first-line treatment for improvement of postprandial hyperglycemia in diabetic patients with inadequate response to diet and exercise therapy and as add-on treatment to other oral antidiabetic drugs and insulin. in 2009, voglibose was approved in japan for the management of prediabetes (igt). this study was a single-group, multi-center, open-label study. the study period consisted of a screening period of 1 week or less, a treatment period of 96 weeks or more, and a follow-up period of 48 weeks. however, if a patient was assessed as having type 2 diabetes mellitus or normoglycemia, the treatment period was to be ended, and only those assessed as normoglycemic were to proceed to follow-up. follow-up was also to be terminated if patients were assessed as having igt or type 2 diabetes mellitus during follow-up.

Eligibility criteria:
inclusion criteria: 1. patients on diet therapy and exercise therapy for 3 to 6 months prior to the start of screening, with baseline (fasting ) plasma glucose \< 126 mg/dl and 2-hour plasma glucose of 140 to 199 mg/dl (revised who criteria) during a 75 g oral glucose tolerance test (ogtt) in the screening period 2. patients meeting any of 1 through 4 below: * 1) comorbid hypertension or high normal blood pressure * 2) comorbid dyslipidemia * 3) comorbid obesity * 4) patients with up to a second-degree family history of type 2 diabetes mellitus 3. patients with hba1c \< 6.5% in the screening period 4. male or female patients at least 20 years of age at the time informed consent was obtained 5. treatment category: outpatient exclusion criteria: 1. patients previously diagnosed with diabetes mellitus. 2. patients with apparent impaired glucose metabolism or with a disease or condition potentially involving impaired glucose metabolism. 3. patients with serious hepatic impairment. 4. patients with serious renal impairment. 5. patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other disease. 6. patients with a history of intestinal obstruction or a history of laparotomy within 6 months (24 weeks) before the start of screening.
efficacy of maitland mobilization in shoulder pathology

Conditions: Tendinosis

Summary: the shoulder is a mobile structure which generates a lot of pathologies. one of them is rotator cuff tendinosis. on the other hand, it has been investigated that maitland is effective for reducing pain and for mobility in the cervical and lumbar spine and in joints such as the knee and ankle, however, there are few studies that confirm that it is effective in shoulder pathologies.so here the investigatprs want to study the effectiveness of maitland as an adjunctive treatment for shoulder pathologies, comparing it with conventional physiotherapy treatment, in relation to the reduction of pain and increased mobility. for that the investigators have a randomized clinical trial with two group.

group 1 receives tens, sw, conventional physiotherapy and exercises as treatment. group 2 receives tens, sw, mailtland, and exercises. an assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. the eva ases, dash and sf-36 scales are included and the biomechanics study is used for the range of mobility.

Eligibility criteria:
inclusion criteria: * have a shoulder pathology. * have a restriction at least of two ranges of movement of the shoulder. * sign the consent before starting the study. exclusion criteria: * patients with a history of shoulder or neck surgery. * patients with neurological damage such as stroke or disease of parkinson's, as well as those with rheumatism, osteoporosis, surgical fixation, or malignant tumors. * have a radiating pain in shoulder from a cervical injury. * pregnant patients. * patients who do not sign the consent before starting the study.

Keywords: shoulder maitland tendinosis
the effect of increasing dialysate calcium on t50 in subjects with secondary hyperparathyroidism and eskd

Conditions: Secondary Hyperparathyroidism; End-stage Kidney Disease

Summary: patients with end-stage kidney disease (eskd) have an increased risk of cardiovascular mortality. high parathyroid hormone (pth) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. the main driving factor for secondary hyperparathyroidism is hypocalcaemia caused by low levels of 1,25-dihydroxy vitamin d and pharmacological supplementation with activated vitamin d and oral calcium-containing phosphate-binders are used to control secondary hyperparathyroidism. the amount of calcium used in this context is controversial, as higher calcium load in blood may theoretically increase vascular calcification. conversely, by alleviating the efflux of phosphate and calcium from bone due to secondary hyperparathyroidism, increasing the load of calcium might actually prevent vascular calcification. to study this further, we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate ca from 1.25 mmol/l (standard dialysate concentration) to 1.50 mmol/l in patients with eskd and secondary hyperparathyroidism on maintenance haemodialysis (hd). the overall effect of increased dialysate calcium will be gauged by its effect on serum calcification propensity (t50) and on markers of bone turnover.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * treatment with thrice-weekly maintenance hd for eskd for \> 3 months. * dialysate calcium of 1.25 mmol/l (standard concentration). * plasma ionised calcium \< 1.35 mmol/l (average of last 3 months). * plasma intact pth \> 14 ρmol/l. * plasma total alkaline phosphatase \>90 u/l * negative pregnancy test and use of highly effective and safe contraception. * able to give written informed consent. exclusion criteria: * treatment with peritoneal dialysis. * clinical bone fracture within the last 6 months. * treatment with bisphosphonates, denosumab, romosozumab, or teriparatide within the last 3 months. * other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial. * pregnancy or breastfeeding.
evaluation of clinical decision support system-mpdia for neurodegenerative parkinsonism using mri images

Conditions: Diagnoses Disease

Summary: mpdia is a software that has been pre-learned based on a neurodegenerative parkinsonism diagnosis model using nigrosome 1 mri images, and clinical decision support system for diagnosing neurodegenerative parkinsonism by automatically analyzing nigrosome 1 mri images by assisting the medical team. the specific aims of this study are to evaluate efficacy of mpdia for neurodegenerative parkinsonism compared to the sensitivity and specificity levels of 18f fp-cit pet/ct which is currently used to diagnose neurodegenerative parkinsonism.


Eligibility criteria:
inclusion criteria(normal cohort): * adults over 19 years old * 3t nigrosome 1 mri acquired * 18f fp-cit pet/ct are confirmed to be normal * the person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism inclusion criteria(abnormal cohort): * adults over 19 years old * 3t nigrosome 1 mri acquired * 18f fp-cit pet/ct are confirmed to be abnormal * the person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism exclusion criteria: * patients with other brain diseases except parkinsonism * who have anatomical abnormality in mris etc. * who have other causes of tremor(e.g., thyroid disease) * patients with lesion in basal ganglia(e.g., vascular parkinsonism, hydrocephalus and wilson's disease)

Keywords: neurodegenerative parkinsonism
extinction generalization in exposure therapy

Conditions: Specific Phobia

Summary: patients with anxiety disorders oftentimes express fear responses to more than only one fear-inducing object. the principal aim of this study is to examine whether the beneficial effects of exposure on fear reduction in spider phobia can extend to stimuli which are conceptually similar to spiders (i.e. cockroaches), but have never been presented during the respective treatment.

fear extinction has evolved as the central mechanism underlying exposure-based treatments. findings from conditioning studies indicate that fear reduction following a fear extinction procedure can generalize from the extinction stimulus to other conceptually and perceptually related stimuli. this study is aimed at translating these findings to a clinical application and will hence examine whether the basic principles of extinction generalization are applicable to exposure. patients with spider phobia will either receive two sessions of in-vivo exposure with spiders or no treatment. prior to as well as after treatment, patient's fear of spiders will be assessed using the behavioral approach test (bats) and self-report questionnaires. in addition, bats with cockroaches will be conducted to examine the effects of exposure therapy on extinction generalization.

Eligibility criteria:
inclusion criteria: * spider phobia according to diagnostic and statistical manual of mental disorders (dsm) -iv criteria exclusion criteria: * any neurological or neuropsychiatric condition * current behavioral or pharmacological treatment * any mental disorder that is considered more severe than specific phobia

Keywords: exposure spider phobia generalization extinction
an injury prevention program for professional ballet

Conditions: Accidents Sports; Injury Prevention

Summary: the aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.


Eligibility criteria:
inclusion criteria: * professional ballet dancer * willing to participate and undergo informed consent process exclusion criteria: * pregnant women, non-english speaking subjects, or those who decline participation in the study.

Keywords: injury prevention program; professional ballet
metabolic effects of very low carbohydrate ketogenic diet in subjects with severe obesity

Conditions: Lysosomal Acid Lipase Deficiency; Obesity; Ketogenic Dieting; Ketosis

Summary: the very low carbohydrates diet (vlckd) induces liver steatosis amelioration. lysosomal acid lipase (lal) deficiency plays a role in fats accumulation in liver. to date, no studies have assessed lal activity in morbid obesity. the aim of our study is to evaluate vlckd impact on metabolic/vascular parameters and lal activity in obese patients. a vlckd is administered for 25 days to 52 morbid obese patients (bmi 44.7±8.3 kg/m², age 49±12.5 years); at baseline and after diet we evaluated: bmi, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (fmd). in a subgroup of 20 patients we also tested lysosomal acid lipase (lal)-activity. a group of healthy normal weight subjects (age 43±13, bmi 22.8±2.6 kg/m²) was also included in the study.


Eligibility criteria:
inclusion criteria: * bmi \> 40 kg/m2 or \> 35 kg/m2 with comorbidities exclusion criteria: * type-2 diabetes * kidney, heart or liver failure
using mri scans to evaluate spinal manipulation

Conditions: Lower Back Pain

Summary: lumbar spinal manipulation, or chiropractic adjusting, is thought to separate the surfaces of the spinal joints and thereby relieve lower back pain. this study will use mri scans to evaluate the spinal joints before and after spinal manipulation.

zygapophysial joints, better known as facet or "z" joints, are located on the back (posterior) of the spine on each side of the vertebrae where it overlaps the neighboring vertebrae. z joints provide stability and allow the spine to bend and twist. adhesions in the z joints may develop following hypomobility of vertebrae. these adhesions may be alleviated by separation (gapping) of the z joints. side posture adjusting (spinal manipulation) is thought by many to gap the z joints, yet no measurable differences of the z joints before and after spinal manipulation have ever been published. this study will evaluate gapping of the l3/l4, l4/l5, and l5/s1 z joints by taking measurements directly from mri scans of the z joints before and during positioning for a side posture adjustment, and before and after side posture adjusting. health volunteers will be randomly assigned to one of four groups: 1) neutral position followed by side posture positioning (trunk rotated to the volunteer's right); 2) neutral position followed by side posture spinal adjusting followed by neutral positioning; 3) neutral position followed by side posture spinal adjusting, followed by side posture positioning; and 4) neutral position followed by neutral position (control group). mri scans will be taken with the volunteers in the original neutral position and in the final position (either second neutral position or side posture positioning).

Eligibility criteria:
inclusion criteria: * student at the national university of health sciences * 185 pounds or less for males and 145 pounds or less for females * no previous history of lower back pain lasting more than 2 weeks, or no more than three episodes of back pain of brief duration (1 to 2 weeks) in any given year exclusion criteria: * history of lower back pain * presence of disc degeneration, significant osteoarthritis, scoliosis of greater than 20 degrees (cobb's angle), or other significant pathology seen on x-rays * positive findings on orthopedic or neurologic test * pregnancy * inability of the examining chiropractor to obtain articular releases (audible pop) during lumbar side posture adjustment given at the conclusion of the examination

Keywords: spinal manipulation chiropractic zygapophysial joints
compliance and acceptance of teriparatide injection in severely osteoporotic patients

Conditions: Osteoporosis

Summary: the purposes of this study are to evaluate the acceptance of the subcutaneous drug teriparatide over 6 months of therapy in patients with severe osteoporosis in canada, and to evaluate how often such patients are actually able to use the injection; to obtain additional safety data (side effect data) that will supplement the existing database of adverse events that have been reported to-date in clinical trials by patients treated with teriparatide; to document the prior use of other osteoporosis therapies in this patient population, and ongoing use of other osteoporosis therapies during the study; and to describe the baseline demographics and disease state of these severely osteoporotic patients.the purposes of the study extension are to continue to assess the acceptance of the subcutaneous drug teriparatide over up to 18 months of therapy in patients with severe osteoporosis in canada, and to continue to assess how often such patients are actually able to use the injection; to obtain additional safety data (side effects) that will supplement the existing database of adverse events that have been reported to date in clinical trials by patients treated with teriparatide.


Eligibility criteria:
inclusion criteria: * postmenopausal woman or a man at least 30 years of age (who no longer have bone growth) * in the opinion of the investigator: * the patient must have severe osteoporosis (defined as a low bone mass and a fracture related to osteoporosis), and be at high risk for fracture despite currently available therapies * patients should have failed or been shown to be intolerant to currently commercially available osteoporosis therapies. (failure of therapy: fracture, or significant loss of bone mass) * there should be no other medical causes of the osteoporosis (called idiopathic osteoporosis) except for low estrogen (in women) or low testosterone (in men) * in the opinion of the investigator, the patient can learn to use the pen type injection delivery system and will be able to use it either alone or with appropriate assistance * must be able to understand and sign an approved informed consent document * must be able to come in for follow-up visits for the duration of the study. exclusion criteria: * high blood calcium levels, high parathyroid hormone levels in the blood, high levels of a blood test called alkaline phosphatase that haven't been explained yet. * known or suspected bone diseases other than osteoporosis * any medical condition that might increase a patient's baseline risk for bone tumors (including prior radiation to the skeleton, paget's disease, previous bone tumors). * recent or currently active kidney stone, or major problems with kidney function * serious ongoing medical problems incompatible with the study (as assessed by the investigator)
the italian version of the computer-vision symptom scale questionnaire: translation, validation and reliability.

Conditions: Video Display Terminal Workers; Computer Vision Syndrome

Summary: video display terminal users frequently refer computer-related visual and ocular symptoms, that are the most frequently occurring health problems among such these subjects. the italian law has established an eye examination to assess ocular status (d.lgs 81/08 ex law 626/96) in vdt workers: subjects are evaluated by clinical signs and symptoms. the availability of a validated questionnaire could be very useful to diagnose visual disturbances and to follow them during follow-up examinations in 2014, a spanish group has developed and validated a questionnaire for the assessment of visual and ocular symptoms in vdt workers. aim of the present study is to make available to italian health professionals a new instrument to assess asthenopic symptoms, taking into account the patient's perspective.


Eligibility criteria:
inclusion criteria: * vdt workers as defined by the italian law (\>20 hours a week on pc); in the control group patients no vdt workers. * vdt workers at the foundation or vdt accessing to the general service of the clinic for a routine visit (vdt group) * patients, not working at vdt, accessing to the "general service" of the eye clinic to perform a routine visit will be asked to participate the study (control group) * no ocular surgery in the preceding 6 months * written consent to participate to study procedures and personal data utilization in an encoded form exclusion criteria: * ocular surgery in the preceding 6 months * patients unable to respond to questionnaire
eyto (european youth tackling obesity): a randomized controlled trial in catalonia (spain)

Conditions: Obesity; Life Style

Summary: our hypothesis is that healthy lifestyles improvement by an intervention designed according 8 social marketing benchmark criteria, can reduce overweight or obesity implemented by adolescents on their colleges. the general aim of eyto program is to improve health and well-being among adolescents who live in low socioeconomically communities, through an intervention study designed by selected adolescents with the inclusion of social marketing benchmark criteria.

5 adolescent coordinators (of intervention high-schools) will be trained by experts in social marketing and health promotion. this 5 selected adolescent as coordinators who will be in charge of the design of an 8 social marketing criteria intervention to implement their peers´ lifestyles. the program has over two academic years. the participants will be followed for the duration of 2 academic years, an expected of up to 16 months.

Eligibility criteria:
inclusion criteria: * informed consent signed by parents and/or guardians. * adolescents between 13 and 17 years old. exclusion criteria: - the lack of one or more inclusion criteria.

Keywords: adolescent
prospective study to determine impact of early palliative care consult on quality of life (qol), cancer related symptoms in advanced lung cancer patients: thoracic pilot project

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: the goal of this study is to learn about the quality of life (qol) in participants with advanced lung cancer.

advanced lung cancer (alc) will be assessed for participant outcomes in a sample which is prior initiation of palliative consultation and in a sample after the initiation of early palliative consultation. study goals are: i. to determine the differences in participant outcomes including quality of life (qol); symptom distress \[edmonton symptom assessment scale (esas)\] and caregiver outcomes \[zarit burden interview {zbi}, hospital anxiety and depression scale(hads) and famcare\] at week 12 in advanced lung cancer (alc) patients receiving early palliative care consultation versus those who don't. ii. identify the cellular, molecular, and immune basis for the development of symptoms in patients with alc.

Eligibility criteria:
inclusion criteria: 1. have a diagnoses of advanced nsclc (defined as locally advanced or metastatic) 2. have no clinical evidence of cognitive failure, as evidenced by a memorial delirium assessment score of less than or equal to 7 of 30 ⁭at the time of consent. 3. be at least 18 years of age. 4. be able to understand the description of the project and give written informed consent. 5. plan to receive their cancer treatment at md anderson cancer center. 6. individuals with advanced cancer who are able to identify a primary caregiver who also agrees to participate (in person or by telephone) in the study. a caregiver will be defined as a spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living. exclusion criteria: 1. patients to be excluded from the study will be those unable to complete the baseline assessment forms or to understand the recommendations for participation in this project. 2. patients seen at the thoracic center at ut md anderson cancer center after 8 weeks of the initial diagnosis (first cohort only - patients using the current palliative care referral practices prior to the implementation of the early palliative care program).

Keywords: advanced lung cancer nsclc palliative care