Kornimate/medical-research-clean huggingface dataset:
the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma

Conditions: Chronic Pain Due to Trauma; Spinal Cord Injuries

Summary: study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma


Eligibility criteria:
inclusion criteria: 1. men and women, age 18 - 65 years 2. signed written informed consent 3. patients after complete/non-complete spinal lesion, after surgery 4. patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal) 5. patient willing and able to comply with the study protocol 6. male and females with a highly effective method of birth control plus an additional barrier method exclusion criteria: 1. patients with spinal cord lesion ischemic etiology 2. pregnant women, nursing or childbearing age with a positive pregnancy test input 3. patients unable or unwilling to comply with the study protocol 4. acute pancreatitis in 1 year from the start of the study 5. chronic pancreatitis in the case history 6. active or uncontrolled infectious diseases 7. hypersensitivity to any component of the investigational product 8. active autoimmune disease 9. serious neurological disease with the incidence chronic neuropathic pain
does improving vagal tone increase mitochondrial bioenergetics

Conditions: Functional Gastrointestinal Disorders; Irritable Bowel Syndrome; Dyspepsia; Functional Abdominal Pain Syndrome

Summary: this study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics and inflammation through vagal nerve modulation via non-invasive percutaneous electrical nerve field stimulator in children with functional gastrointestinal disorders.

in understanding the pathophysiology of pediatric functional gastrointestinal disorders (fgid), it has been documented that subjects have decreased vagal tone. vagal tone in turn modulates mitochondrial bioenergetics and plays a role in anti inflammatory effects. further defining these brain-body connections that underlie fgid's could help guide future treatment. the investigators postulate that a 4 week neuro-stimulation with an electro auricular device that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics and decrease in inflammatory markers in this patient group.

Eligibility criteria:
inclusion criteria: * english-speaking and able to verbalize their condition and concerns about nausea, pain and other symptoms * subjects will meet rome iv criteria for functional nausea, irritable bowel syndrome, dyspepsia or functional abdominal pain as determined by a pediatric gastroenterologist * patients must have an intact external ear that is free of infection or severe dermatological conditions, have stable vital signs for their respective age, no history of seizures and no currently implanted electrical device exclusion criteria: * mental retardation or pervasive developmental disorder or epilepsy * psychosis * genetic or chromosomal disorders * pregnancy * subjects who admit to substance abuse during screening * patients with findings of peptic ulcer disease, h.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, or any chronic condition or medication that may cause nausea or pain * patients who are treated with opioids or who had any changes in their medical regimen in the past four weeks prior to study * patients with a history of allergy to adhesives

Keywords: fgid neural stimulation functional abdominal pain dysautonomia
prolonged ex-vivo normothermic machine perfusion for kidney regeneration

Conditions: End Stage Renal Disease

Summary: the investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (pnmp) to preserve and assess high-risk donor kidneys prior to transplantation.

currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. the number of organs available for transplantation is insufficient with a widening gap between supply and demand. nowadays, centers accept older and higher risk donor organs with co-morbidity, often leading to non-function, complications and with half of the patients back on dialysis within 15 years. furthermore, many donor kidneys have to be discarded as too damaged and beyond repair. increasing the quality and therefore transplantability of these high-risk donor organs could significantly increase the donor kidney pool. using prolonged normothermic perfusion of marginal donor organs, the investigators aim to kick start regeneration in the kidney before transplantation, improving function and survival long-term. furthermore, the choice to accept or decline a donor kidney organ is currently based on subjective criteria and causes great uncertainty amongst clinicians. there is a dire need for tools to aid in decision making and reduce this uncertainty. biomarkers predictive of graft regeneration are lacking. samples from perfused kidneys and donor recipients will be collected and analysed to allow the formulation of a kidney fitness index.

Eligibility criteria:
inclusion criteria: * patients undergoing 1st or 2nd kidney transplant * patients undergoing a kidney transplantation from dcd maastricht iii \& v * transplant recipients aged ≥ 18 years * written informed consent exclusion criteria: * patients undergoing 3rd or subsequent kidney transplant * patients undergoing a kidney transplantation from dcd maastricht i, ii \& iv * transplant recipients aged \< 18 years * patients receiving multi-organ transplants * abo/hla incompatible transplants * highly sensitized patients with a panel-reactive antibody (pra) ≥85% * kidneys with cit \> 12 hrs at the point of arrival at transplant centre * kidneys with complex vascular anatomy (≥3 arteries, artery which cannot be can-nulated or attached to the patch holder) * kidneys explanted from a donor on normothermic regional perfusion

Keywords: normothermic machine perfusion renal transplantation kidney transplantation
observational study on the improvement of dry eye syndrome, treatment satisfaction, and intraocular tolerance with diquasol eye drops

Conditions: Dry Eye Syndrome

Summary: this study is to verify the efficacy and safety in the treatment of dry eye syndrome in patients prescribed with diquasol eye drops as a monotherapy, or in combination with hyaluron eye drops, or in combination with hyaluronmax eye drops.

this study is to observe the prescription patterns in routine clinical practice and assess the changes in dry eye symptoms, treatment satisfaction, and intraocular tolerance over a 12-week period in patients prescribed with diquasol eye drops as a monotherapy or in combination with hyaluron eye drops or hyaluronmax eye drops for the treatment of dry eye syndrome.

Eligibility criteria:
inclusion criteria: * adults aged 19 years and older * patients with dry eye syndrome with tbut of 10 or less * individuals scheduled to receive either diquasol eye drops as a monotherapy or a combination therapy of diquasol eye drops with hyaluron eye drops or diquasol eye drops with hyaluronmax eye drops, based on clinical judgment for the treatment of dry eye syndrome * individuals who have voluntarily provided written consent for participation in this study exclusion criteria: * pregnant or lactating women * individuals contraindicated according to the approval conditions of diquasol eye drops, hyaluron eye drops, and hyaluronmax eye drops * cases where the principal investigator or study personnel deem the individual unsuitable for participation in this clinical study
reduced-dose radiotherapy for low-risk stage iii patients with nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: to study the 2-year pfs (progression-free survival) of patients with stage iii nasopharyngeal carcinoma of pretreatment ebv dna\<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.

to explore the 2 year pfs of patients with stage iii nasopharyngeal carcinoma of pretreatment ebv dna\ 0 after induction chemotherapy, the patients will receive a total of 70 gy imrt combined with 3 cycles of cisplatin concurrent chemotherapy. the included patients will be treated with 2 cycles of tpf regimen induction chemotherapy and 60gy imrt combined with cisplatin concurrent chemotherapy. the tpf regimen is consist of paclitaxel liposome 135mg/m2 d1, cisplatin 25mg/m2d1-d3 and 5-fu 3750mg/m2 civ120h, with a total of two cycles. concurrent cisplatin chemotherapy is delivered with dose of 100mg/m2, a total of three cycles. the third cycle of cisplatin concurrent chemotherapy is allowed to be delivered within one week after imrt finished.

Eligibility criteria:
inclusion criteria: 1. pathological diagnosis of npc(who ii or iii). 2. stage iii（8thajcc/uicc staging system) and pretreatment ebvdna\<4000opies/ml. 3. aged 18-70 years。 4. ecog = 0-1。 5. hgb≥90 g/l，wbc≥4×109 /l，plt≥100×109 /l. 6. alt,ast\<2.5 fold of uln；tbil\<2.0×uln。 7. ccr≥60ml/min or cr\<1.5×uln。 8. signed informed consent exclusion criteria: 1. who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. age \ 70years. 3. treatment with palliative intent. 4. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 5. pregnancy or lactation. 6. history of previous radiotherapy (except for non-melanomatous skin cancers outside intended rt treatment volume). 7. prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 8. any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance.

Keywords: nasopharyngeal carcinoma imrt radiation dose induction chemotherapy
study of catheter based renal denervation therapy in hypertension

Conditions: Resistant Hypertension; Renal Denervation; Ambulatory Blood Pressure; Renal Function

Summary: the depart study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation: 1. reduces daytime ambulatory blood pressure, 2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.


Eligibility criteria:
inclusion criteria: * they have a mandatory \> 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion, * a mandatory check list of secondary cause of hypertension has been excluded * they succeed the pill count test. * they have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmhg and/or 85 mmhg, respectively. daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmhg and/or 85 mmhg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3). exclusion criteria: * patients with an egfr \<30ml/min/m² are excluded, * patients with known renal atherosclerotic lesions, * previous procedures in the renal arteries, * known unsuitable anatomy for the procedure, * previous nephrectomy, * contrast agent allergy, * hyperthyroidia.

Keywords: resistant hypertension renal denervation ambulatory blood pressure renal function simplicity catheter sham procedure
effectiveness of school-based weight management program in overweight and obese children between 8-11 years

Conditions: Childhood Obesity; Child Obesity

Summary: obesity, which is an important public health problem of the last century globally, affects not only adults but also children and young people. reducing childhood obesity requires effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical activity and stress management. to reduce childhood obesity, including school-based multi-component behavioral research in turkey it has not been demonstrated to parents. the program, which is planned to be carried out and aims to reduce overweight and obesity in children, is a school-based parenting lifestyle intervention involving multiple behaviors. the program includes family visits, game-based physical activity activities with children, healthy eating recommendations and healthy eating activities with parent participation. the program planned to be implemented was developed to evaluate whether healthy preferences and lifestyle intervention reduce obesity. the aim of this study is to make the positive health behaviors permanent in children, to be a guide for combating childhood obesity and to be useful for future research. to be applied to the research, nutrition consists of 10 sessions, physical activity, including issues such as coping with healthy ways with stress child obesity program (cop), it is thought to overcome this deficiency was needed in turkey.


Eligibility criteria:
inclusion criteria: - overweight or obese children aged 8-11 * volunteers to participate in the research * students who are allowed to participate in the research by their parents exclusion criteria: * children with any physical or mental disability and chronic disease (diabetes, metabolic syndrome, heart disease... etc) * children who have normal weight * children who constantly use the drug that can affect weight management (weight gain and loss) the age group included in the study piaget's development theory coincides with the concrete process period. concrete

Keywords: childhood obesity school based obesity intervention
multimodal circuit exercises for chronic musculoskeletal pain in older adults

Conditions: Musculoskeletal Pain; Chronic Pain

Summary: analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disability in older adults.

this is a randomized parallel study (two arms) with blinded outcome assessments. the participants' recruitment will be done by a non-probabilistic sampling resulting from invitations to basic health units. the sample size estimation indicated 164 participants. participants will be allocated, by means of a randomization process, to one of two groups (82 for each group): experimental group (multimodal circuit exercise) or control group (cycle of multidisciplinary lectures on pain ). the primary outcomes are global chronic pain intensity and global functional disability scores. the secondary outcomes are functional mobility and cardiorespiratory capacity. all analyses will be processed using the rstudio software. the differences will be considered statistically significant when a 2-tailed p-value is less than 5% (p \< 0.05). the statistical analysis will follow the intention to treat. discussion: this study will discuss the effects of multimodal circuit exercise on global chronic pain intensity and global body functional disability scores. the hypothesize is that multimodal exercises will reduce musculoskeletal chronic pain and disability in older adults to the same extent as traditional supervised and structured exercises.

Eligibility criteria:
inclusion criteria: * subjects from both sexes; * aged 60 or higher; * had a history of chronic pain in at least one synovial joint for more than three months. exclusion criteria: * participants with some types of co-morbidities that may interfere with the research parameters, such as a history of stroke, stenosis of the spinal canal, severe heart disease, fibromyalgia, rheumatoid arthritis; * participants who presented a level of pain between 7 and 10 points on the numeric rate scale (nrs) in any body location; * participants being under psychiatric treatment with sensory deficits (visual, auditory and intellectual) * participants performing any supervised and structured exercise at the moment of study enrollment or six months before.

Keywords: exercise therapy multimodal exercise
efficacy and safety of vildagliptin 50mg bid as an add-on therapy to insulin with or without metformin, in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of type2 diabetes mellitus (t2dm) by standard criteria * c-peptide \>0.6 ng/ml (\>0.20 nmol/l). * hba1c ≥7.5 to ≤11% at visit 1 * treatment with stable, once or twice daily doses (maximum dose of \< 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to visit 1. stable is defined as ±10% of the visit 1 dose during the previous 12 weeks * patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to visit 1 * body mass index (bmi) ≥20 to ≤40 kg/m2 at visit exclusion criteria: patients fulfilling any of the following criteria are not eligible for participation in the study * fasting plasma glucose (fpg) ≥240 mg/dl (13.3 mmol/l) at visit 1 * pregnant or lactating women * acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months * current diagnosis of congestive heart failure (nyha iii or iv). * myocardial infarction (mi) within the past 6 months * liver disease such as cirrhosis or chronic active hepatitis other protocol defined inclusion/excusion criteria may apply

Keywords: type 2 diabetes mellitus vildagliptin
effect of berberine on hormonal and metabolic features in obese women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome; Obesity

Summary: berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (pcos) are lacking.the objective of this study is to examine the effect of berberine metabolic and hormonal parameters and insulin resistance in obese patients with pcos.


Eligibility criteria:
inclusion criteria 1. age of women between 18 and 35 years. 2. confirmed diagnosis of pcos according to the modified rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism. 3. body mass index (bmi) equal to or greater than 23 kg/m2. 4. with no desire of children within 6 month. pcos is defined by the modified rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume \>10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. oligomenorrhea is defined as an intermenstrual interval \>35 days and \ 90 days. clinical hyperandrogenism in china mainland is defined as a ferriman-gallwey (fg) score ≥5. exclusion criteria are 1. use of hormonal drugs or other medications including chinese herbal prescriptions in the past 3 months. 2. patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected cushing's syndrome 3. patients with known sever organ dysfunction or mental illness.

Keywords: polycystic ovary syndrome obesity
abscess packing versus wick placement after incision and drainage

Conditions: Superficial Abscess Packing

Summary: abscesses or "boils" are becoming more common every year and are a common reason children come to the emergency department. for the abscess to heal the skin needs to be opened to let the pus come out. often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. it is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. with informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. after treatment in the emergency department the child will be scheduled to follow-up in the pediatric acute wound service (paws) clinic as all other children with this infection are scheduled. at this visit the healing of the wound will be checked by the staff in the clinic and will be scored. with this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.


Eligibility criteria:
inclusion criteria: * well appearing patient * abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back * patients presenting saturday-wednesday exclusion criteria: * fever \>38 degrees celsius * ill appearing patient * underlying immunodeficiency or disorder leading to chronic abscess formation * any reason for admission to hospital beyond the need for sedation at the time of follow-up * thursday-friday

Keywords: superficial abscess packing material wick incision and drainage