Kornimate/medical-research-clean huggingface dataset:
a study assessing saxagliptin treatment in subjects with type 2 diabetes who are not controlled with diet and exercise

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical research study is to learn whether saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

all subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. subjects who complete the short-term period will be eligible to enter the long term extension period. also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * drug naive * hemoglobin a1c (hba1c) ≥6.0% and ≤8.0% * fasting c-peptide ≥1.0 ng/ml * body mass index ≤40 kg/m² exclusion criteria: * recent cardiac or cerebrovascular event * elevated serum creatinine
the validation of the turkish version of the lump questionnaire

Conditions: Globus Pharyngeus; Validation

Summary: purpose of the study is the validity and reliability of the turkish version of the laryngopharyngeal measure of perceived sensation (t-lump) questionnaire, so that it would be used as an assessment tool for turkish globus pharyngeus patients.

globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. the study will assess the construct validity and reliability of the turkish version of laryngopharyngeal measure of perceived sensation (t-lump) questionnaire. the investigators developed the turkish version of this questionnaire (t-lump), according to the cross-cultural adaptation guidelines. two translators translated the lump into turkish and a native english language speaker reverse-translated it into english. the back translation was sent to the original author for proofreading. the final version of the lump questionnaire consisted of 8 basic and understandable questions related with globus pharyngeus symptoms.

Eligibility criteria:
inclusion criteria: * diagnosed with globus pharyngeus in study group * able to speak, read, understand and write in turkish * give a consent form exclusion criteria: * patients with dysphagia or odynophagia * laryngeal organic pathologies * pharyngeal organic pathologies * epiglottic retroversion * malignancy * pregnancy * mental disorders * neurological disorders * major psychiatric disorders * underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy * underwent any surgery last a year * cognitive limitations * give not a consent form

Keywords: globus sensation pharyngeus laryngopharyngeal measure perceived turkish
thoracic and lumbar burst fracture: correlation between structural changes and clinical outcome of treatment

Conditions: Traumatic Burst Fractures of the Thoracic or Lumbar Spine.; Normal Neurological Function

Summary: evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment.

the treatment of burst fractures of the thoracic and lumbar spine is still a subject of much discussion and debate in the literature, especially in patients without neurological deficit. most authors recommend surgical treatment for patients whose fracture shows signs of instability: 50% loss of vertebral body height, kyphosis with more than 30 degrees, involvement of more than 50% of the spinal canal. the authors advocate that this type of treatment uses the shorter hospital stay, early patient mobility, better kyphosis correction, the possibility of spinal canal decompression and prevention of neurological deterioration, as arguments in its favor.however, observational studies in patients without neurological deficit, showed no difference in long-term functional outcomes in patients with this type of injury, regardless of the type of treatment used (surgical or conservative). this study will express the clinical results and morphological changes of the thoracic and lumbar spine, at a minimum follow-up of 24 months, comparing the findings of the patients undergoing surgical treatment with those found in undergoing conservative treatment.

Eligibility criteria:
inclusion criteria: * patients with thoracic or lumbar burst fracture, without neurological lesion treated by the principal investigator of the study and periodically monitored in the service of the researcher, orthopedic hospital of passo fundo, with minimum follow-up of 24 months fracture. exclusion criteria: * patients with neurological deficit or who have left before 24 months the follow-up.

Keywords: vertebra column lumbar toracica fracture burst
study evaluating the efficacy and safety of topical diclofenac spray in osteoarthritis of the knee: trial i

Conditions: Osteoarthritis

Summary: the objective of this study is to evaluate the efficacy and safety of tds-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. the main hypotheses are that tds-943 will be better than placebo and no worse than celecoxib.

this is a multicenter, outpatient, multiple-dose, placebo- and active controlled, double-blind, double-dummy parallel group, randomized (stratified by unilateral vs. bilateral knee oa) trial. the trial will enroll subjects who have been diagnosed with oa of the knee (confirmed by weight-bearing x-ray) and whose condition is in flare at baseline. subjects who qualify to enter the study will be randomized to topical tds-943 40 mg bid, oral celecoxib 200 mg qd, or placebo in a 3:2:2 ratio.

Eligibility criteria:
inclusion criteria: * males or females in generally good health at least 40 years of age * osteoarthritis (oa) of at least one knee, verified by a weight-bearing radiograph * subject has taken an oral nsaid or analgesic at least 3 days during the past 30 days to treat knee oa pain exclusion criteria: * females who are pregnant or lactating or who may become pregnant * hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides, acetaminophen, diclofenac, celecoxib, aspirin, or any other nsaid * history of myocardial infarction, congestive heart failure, stroke, coronary-artery bypass graft surgery, or any other significant cardiovascular disease, or is on any form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)
autologous endothelial progenitor cells transplantation for chronic ischemic stroke

Conditions: Stroke

Summary: stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.stem cell transplantation provides a promising approach for rehabilitation. the main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous endothelial progenitor cells in patients with chronic stroke.

stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.it will brought heavy burden to patients themselves,their family and society.drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.however,in the chronic ischemic stroke,there was few methods to improve the functions.in recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. in this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous endothelial progenitor cells in patients with chronic ischemic stroke. the neurological outcome will be determined after transplantation.

Eligibility criteria:
inclusion criteria: * aged 18-80 chronic ischemia stroke or patients * with stroke history of more than 6 months, less than 60 months * nihss (nih stroke scale) score of 7 or more points * internal carotid artery territory infarction measured by mri * can be hospitalized and signed informed consent * with fewer effect by traditional post-stroke treatments or rehabilitations exclusion criteria: * lacunar infarction * recurrent thrombotic diseases less than 6 months * hemorrhage stroke,brain tumor or mri show the occlusion is not in the middle cerebral artery territory * pregnant women * can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, aids, combine other tumor or special condition * penicillin anaphylaxis or some other drugs allergy * autoimmune disease * inaccessibility for follow up

Keywords: endothelial progenitor cells transplantation stroke
the association between parathyroid hormone and preterm labor

Conditions: Preterm Labor; Parathyroid Diseases

Summary: this observational study aims to test the level of parathyroid hormone in pregnant women. the main question it aims to answer is: n pregnant women, are the levels of serum pth, calcium, magnesium, phosphorus \& albumin similar in both preterm and term births?

* approval from ethical committee will be sought. * patients will be enrolled from ain shams university maternity hospital labor ward and antenatal outpatient clinic. * history, examination and fetal ultrasound will be done to identify eligible patients. history: a full detailed history including personal, menstrual, obstetric, present, past history and family history will be obtained. accurate last menstrual period date will be obtained, and gestational age will be calculated using naegele's rule or first trimester ultrasound to identify preterm patients with gestational age (28-36 weeks). examination: general, abdominal and vaginal examination to identify patients in established labor with regular uterine contractions are at least 3 in 10 min each lasting 40 seconds. progressive cervical dilatation (at least 4 cm). ultrasound: for (viability of fetus, fetal biometry and estimated fetal weight, amniotic fluid, placental localization). thus, two groups of patients will be identified: 1. cases: established preterm labor - gestational age: (28-36 weeks) 2. controls: pregnant women not in labor - gestational age: (28- 36 weeks) * venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and albumin levels. * samples will not be collected from an arm with an intravenous catheter if alternate sites are available. * patient collection site will be appropriately disinfected prior to sample collection. * after collection, samples will be put in a red or yellow tube (serum separating tube) with a serum gel separator. * samples will be gently mixed immediately following collection into tube to ensure proper preservation of the analytes. 180° tube inversion, allowing bubble to travel the length of the tube, followed by return to upright position is one mix. * samples will be delivered to laboratory within 30 to 60 minutes. * data will be collected and recorded in a case report form (age, parity, previous preterm births/ miscarriage, gestational age, measured levels of serum pth, calcium, magnesium, phosphorus \& albumin , mode of delivery, birth weight). * statistical analysis will be done to get results.

Eligibility criteria:
inclusion criteria: * pregnant women aged (18-40). * gestational age (28-36 weeks). exclusion criteria: * known maternal disease as diabetes, hypertension, renal disease, cardiac disease and liver disease. * known hypo or hyperparathyroidism * multiple pregnancy * polyhydramnios * premature rupture of membrane * antepartum hemorrhage * uterine malformations e.g. bicornuate uterus * smoking

Keywords: parathyroid hormone; calcium, magnesium, phosphorus, albumin
polish registry of common carotid artery access for tavi

Conditions: Aortic Valve Stenosis; Ventricular Outflow Obstruction, Left

Summary: transcatheter aortic valve implantation (tavi) is valuable treatment option for patients, who are at the high risk of surgical aortic valve replacement (avr). majority of procedures are performed through femoral arteries, however in some this access cannot be applied. common carotid artery is one of the alternative routes of delivering the device in those patients. established registry aims at collecting the data prospectively to assess outcomes of tavi through common carotid artery.

the study is a prospective multicenter evaluation of transcatheter aortic valve implantations through common carotid artery in polish health centers. duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Eligibility criteria:
inclusion criteria: * qualification for tavi through common carotid artery by decision of the local heart team * patient provided written informed consent

Keywords: tavi common carotid artery
tolerability to hs-20004 with titration administration in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: this study is conducted in china. the aim of this trial is to assess the tolerability to hs-20004 with titration administration in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed for more than 3 months; * hba1c between ≥6.0 and ≤9.0 %, and fpg between ≥7.0 and ≤13.9 mmol/l; * body mass index (bmi) between 18.5 and 30 kg/m\^2 (inclusive) with a total body weight of at least 50 kg; * agree to stop any other drugs for diabetes during washout and study period; exclusion criteria: * treatment of glp-1 analogues, dpp-iv enzyme inhibitors or other analogues before; * history or family history of drug allergy; * smoker or alcohol abuse; * currently use or plan to use systemic corticosteroid; * history of recurrent severe hypoglycemia; * history of proliferative retinopathy or maculopathy which required acute treatment; * impaired hepatic or renal function, or cardiac problem; * uncontrolled active or untreated hypertension; * family history of thyroid cancer or submandibular gland cancer, or past history of pancreatitis, cholelithiasis, or serious unconscious hypoglycemia history; * positive of hepatitis b surface antigen, hepatitis c antibody, hiv antibody or syphilis antibody; * subject has participated in any investigational study within 3 months, or is currently participating in another clinical study; * female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization; subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration; * have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol； * subject was not used for the study as determined by the investigator.
neurodegeneration in newborns after anesthetics

Conditions: Neurodegeneration; General Anesthesia

Summary: the purpose of the study is to quantify biomarkers of neural damage in neonates exposed to varying levels of volatile anesthetic in utero.

this study will enroll 130 pregnant patients undergoing c-section or fetal surgery with exit (ex utero intrapartum treatment) procedures under epidural or general anesthesia with low (0.75 mac) or high (2.5 mac) concentrations of desflurane. patients will be recruited from both the hospital of the university of pennsylvania (100 c section) and children's hospital of philadelphia (30 exit procedure). the standard of care protocol for patients undergoing anesthesia for these cases will be followed throughout the surgery. these include monitoring and management of blood pressure, heart rate and rhythm, ventilation, oxygenation, temperature, and fluid status. management of these parameters will be at the discretion of the clinical team. the choice of the anesthetic technique will also be at the discretion of the clinical team. typical anesthetic management includes the following: c-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine c-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5% exit procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18% 1. after the baby is delivered, and the umbilicus is cut, two ml of blood will be taken from the umbilical vein and artery on the placenta side. a portion of the blood will be used for the blood gas and the remainder will be used for the s100b study assay. 2. 5 ml of blood will be taken from the mother via the existing intravenous catheter. 3. 5 ml of amniotic fluid will be obtained at hysterotomy and will be used for the s100b study assay. all subjects will receive standard of care post operative clinical care and monitoring.

Eligibility criteria:
inclusion criteria: 1. women delivering a child via cesarean section or exit procedure 2. informed consent exclusion criteria: 1. known fetal neurologic defect 2. known maternal neurologic abnormality 3. sensitivity or allergy to medications used in the study 1. c-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine 2. c-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5% 3. exit procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18%

Keywords: neonates biomarkers exit procedure cesarean section
affective dysregulation (ad) in children with adhd treated by guanfacin

Conditions: Affective Dysregulation

Summary: early onset, high prevalence and persistence, as well as developmental comorbidity make affective dysregulation (ad) in childhood one of the most psychosocially impairing and cost-intensive mental conditions. despite continuous research, there is still a substantial need for optimization of individual treatment strategies in order to improve outcomes and to reduce subjective and economic burden. here we want to study the change of psychopathological markers of affective dysregulation (ad) treatment of affective dysregulation (ad) in children with attention deficit hyperactivity disorder (adhd) treated by guanfacine. these children did not respond to methylphenidate treatment. the results will allow the generation of a hypothesis for a randomized clinical trial to investigate the efficacy and safety of guanfacine for the treatment of ad in children.


Eligibility criteria:
inclusion criteria: * male and female patients (aged 6 to 17 years) * clinical diagnosis of adhd (f90.0) or comorbid adhd and oppositional defiant disorder (odd) (f90.1) * patients with adhd who did not respond to stimulants * dadys is an instrument to assess ad and has a domain for disruptive behaviors. inclusion criterion for the study is a score of at least moderate (middle) severity in the dadys parents version this domain * iq must be at least 70 * patients receiving or intended to receive guanfacin * written informed consent by the custodian and the children exclusion criteria: * unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder * current substance abuse
smart-ald - a new lifestyle intervention to improve quality of life in women with x-linked adrenoleukodystrophy (x-ald)

Conditions: X-linked Adrenoleukodystrophy

Summary: x-linked adrenoleukodystrophy (x-ald) is one of the most frequent inborn error of metabolism caused by mutations in the abcd1 gene, which codes for the transporter of saturated very long-chain fatty acids (vlcfa) for peroxisomal degradation, thus causing their toxic accumulation in body fluids and tissues. the clinical spectrum ranges from adrenal insufficiency without neurological symptoms to a rapidly progressive, fatal cerebral demyelinating disease that may occur in childhood as well as later in life. the most frequent phenotype in adulthood is adrenomyeloneuropathy (amn), a slowly progressive myelopathy and peripheral neuropathy, which may also be prevalent in up to 80% of females carrying the x-ald gene defect. since signs and symptoms in females are usually milder and with a later onset, they are frequently underestimated, overlooked or misinterpreted, e.g. as multiple sclerosis. consequently, many women with x-ald do not receive adequate treatment. against this background, the development of new therapeutic interventions with the help of ehealth technology (e.g., counselling and treatment via digital communication tools) is of particular relevance, as it provides cost-effective, regular care even for patients who live remote from leukodystrophy clinics. the aims of this study is to evaluate the effectiveness of a multi-approach intervention ("smart-ald") on physical and mental well-being and quality of life in n=30 x-ald symptomatic heterozygous females compared to a waiting list control group (n=30) using electronic health (ehealth) technology.


Eligibility criteria:
inclusion criteria: * informed consent obtained from the patient or a competent guardian with legal capacity to execute a local institutional review board/independent ethics committee approved consent. * females ≥18 years at the time of consent, with proven x-ald as defined by 1. elevated vlcfa values, or 2. mutation in abcd1 gene * neurological symptoms as defined by adult ald clinical score (aacs) ≥ 2 exclusion criteria: * no informed consent and assent * any medical condition that may interfere with the study, e.g. severe liver, kidney, active infections or major heart diseases (\>new york heart association class ii) * any clinically significant condition with an estimated life-expectancy of \<6 months * current pregnancy

Keywords: adrenoleukodystrophy adrenomyeloneuropathy genetic diseases, x-linked rare white matter disorders female carriers women with x-ald peroxisomal disorders ehealth intervention central nervous system diseases heterozygous carriers quality of life lifestyle intervention