Kornimate/medical-research-clean huggingface dataset:
endothelin-1 as a potential trigger of migraine aura

Conditions: Migraine With Aura

Summary: one third of migraine patients experience aura, i.e. dramatic, transient neurological symptoms, most often in the form of visual disturbances, that usually appear before the onset of migraine headache. the likely underlying mechanism of aura is known as cortical spreading depression, a wave of changes in electrical activity that slowly spreads in the outermost layer of the brain. it is currently not known what causes the aura to initiate in patients or what the relationship is between aura and migraine headache, e.g. if treatment targeted at aura mechanisms will prevent subsequent headache. due to the short-lasting and unpredictable nature of aura, the only possible approach for systematic investigations is to experimentally trigger aura, but currently no method for aura-triggering is available. the overall goal of the proposed project is to reveal the earliest mechanisms of the migraine attack by investigating the initiating factors of aura in the migraine brain. current animal evidence indicates that infusion of endothelin-1 (et-1), a naturally occurring signaling molecule released from blood vessels, is safe and very likely to trigger migraine aura in patients. in this project the investigators aim to study the effects of et-1 on the human brain, to investigate aura-inducing effects of et-1 in patients and to develop a safe and reliable method for the experimental induction of migraine aura using et-1.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years * diagnosis of migraine with typical aura (patient group only) * attacks of migraine with aura at least once per month on average (patient group only) * no history or family history of migraine (healthy subject group only) * use of safe contraception (women of fertile age only) exclusion criteria: * tension-type headache more than one day per month on average * any other primary headache disorder * daily intake of medication * daily smoking during the past 5 years * pregnant or breastfeeding women * hypertension on the experimental day (systolic bp\>150 mmhg or diastolic bp\> 100 mmhg) * history of any cardiovascular disease including cerebrovascular disease * history of diabetes or hypercholesterolemia * ecg changes suggestive of ischemia * contraindications of mri

Keywords: [c10.228.140.546.399.750.250]
a clinical study of a spine fusion system in vertebral body fusion surgery

Conditions: Disc Degenerative Disease; Spondylolisthesis; Spinal Fracture; Spinal Deformity; Spinal Stenosis; Spinal Tumor

Summary: the primary objective of this study is to demonstrate that the efficacy and safety of spine fusion system manufactured in china is no inferior than imported product.

this study is a prospective, multicenter, randomized, comparative, non-inferiority study comparing the change of japanese orthopaedic association score from baseline at postoperative 24 weeks for patients implanted with local made spine fusion system versus imported products.

Eligibility criteria:
inclusion criteria: * 20-70 years old, male or female; * subject being diagnosed as having disc degeneration disease, spondylolisthesis, spinal fracture, deformity(degenerative deformity), spinal stenosis, or spinal tumor, has been treated with conservative treatment without relief or getting worse, who is suitable for surgery according to clinic practice. * subject is a suitable candidate for implanting investigational products described in study protocols according to investigator's assessment; * patient, in the opinion of the clinical investigator, is able to understand this clinical investigation and willing to be available for each required study procedure over the study duration. * subject has been given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to study sponsor. exclusion criteria: * patient has a local or systemic infection. * patient has had one or more previous non-fusion spinal surgery at the involved level(s). * patient without spinal deformity and requires fusion at 3 or more levels. * has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated * has presence of active malignancy * has a medical condition with less than 1 year of life expectancy. * pregnancy or women in lactation period. * is grossly obese, i.e. body mass index≥40. * has a diagnosis, which requires postoperative medication or treatment that interferes with fusion, such as steroids, chemotherapy, radiotherapy, growth factor (for more than 3 months), nonsteroidal antiinflammatory drugs(for more than 3 months), and etc. * has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. uncontrolled diabetes with medication, renal osteodystrophy, or osteogenesis imperfect) * alcoholic (taking more than 40g/day, equals to 100ml 50°chinese liquor), smoking more than 40 cigarettes/day, or drug abuser; * is currently participating in another investigational drug or device study.
game-based digital intervention for depression in adolescents

Conditions: Depression; Anxiety

Summary: the goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. the main question it aims to answer is: can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? the trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy. participants will be asked to engage with the digital intervention platform for a period of two months.


Eligibility criteria:
inclusion criteria: * the mini international neuropsychiatric interview for children and adolescents (mini-kid) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the dsm-5(the diagnostic and statistical manual of mental disorders, fifth edition). * no prior use of antidepressants or antipsychotic medications. * having a hamd (hamilton depression scale) score \>= 8 upon enrollment * demonstrate normal cognitive function. * voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent. * being able to read and typeset chinese. exclusion criteria: * with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning * with concurrent psychiatric disorders (as determined by clinical assessment) * at high risk of suicide
kovanaze vs. articaine in achieving pulpal anesthesia of maxillary teeth - endodontics

Conditions: Caries,Dental; Apical Periodontitis

Summary: the primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between kovanaze nasal mist and articaine needle anesthesia.

in june 2016, an intranasal delivery system of local anesthesia called kovanaze, gained fda approval. \[9\] kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face. with the ability to avoid the traditional painful injection kovanaze offers promise in the field of maxillary anesthesia and this study intends to: 1. compare kovanaze to conventional needle anesthetic for procedures other than fillings and/or involving multiple teeth in adults 2. evaluate patient anxiety, tolerance and acceptability of kovanaze in patients undergoing dental procedures

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists class i or ii * preoperative heart rate of 55 to 100 beats per minute * maximum blood pressure reading of 166/100 mmhg * treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia * adults (\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth exclusion criteria: * inadequately controlled thyroid disease * five or more nosebleeds in the past month * known allergy to any study drug or para-aminobenzoic acid * history of methemoglobinemia * taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol); * taking oxymetazoline-containing products (i.e., afrin) in the last 24 hours.

Keywords: necrotic teeth, root canals
effects of anti-ige antibody omalizumab on patients with chronic sinusitis

Conditions: Chronic Sinusitis

Summary: we propose to study the effects of xolair on patients with chronic sinusitis with or without nasal polyps. because of the similarities between the inflammatory processes found in asthmas and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should respond to xolair, just as asthma.

we propose to study the effects of xolair on patients with chronic sinusitis with or without nasal polyps. since xolair has been shown to be effective in asthmatic subjects with evidence of atopy and elevated ige, we will limit our study to patients with chronic sinusitis and these parameters. the primary objective is to determine if xolair decreases mucosal thickness on ct scan after 6 months of treatment.

Eligibility criteria:
inclusion criteria: * males and females between 18 and 75 years of age * chronic sinusitis as defined by symptoms for greater than 12 weeks despite treatment. * paranasal sinus ct scan showing evidence of chronic sinusitis. * positive skin or rast test to an inhalant allergen. * serum total ige between 30 and 700 international units/ml. * body weight less than 150kg. * impaired quality of life as measured by the rhinosinusitis disability index (rsdi). exclusion criteria: * women of childbearing potential not using the contraception method(s) (birth control pills, depo provera, double barrier) as well as women who are breastfeeding. * known sensitivity to xolair * patients with severe medical conditions that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). * use of any other investigational agent in the last 30 days. * no measurable disability on the rsdi. * immunocompromised patients or patients with ciliary disorders.

Keywords: chronic sinusitis xolair nasal discharge nasal obstruction facial pain hyposmia
hepatitis e virus infection in pediatric transplantation, a prevalence study

Conditions: Transplantation

Summary: hepatitis e virus (hev) is an emerging disease. the genotype 1 and 2 are predominant in asia and africa, and are responsible for recurrent epidemics. genotype 3 is the main genotype found in europe and north america and is responsible for sporadic infections except for travel associated diseases. hev had a principally asymptomatic form. however, it was recently demonstrated that it could lead to a chronic form, especially in immunosuppressed patients. moreover, in liver transplanted patients the infection could mimic a rejection and lead to the loss of the transplant. in other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its well-known complications (ascitis, digestive hemorrhage, liver failure...). there is a lack of information about the prevalence of this disease. in canada the incidence of hev infection was high (15-86% for liver transplanted children with liver tests disturbed). in germany the prevalence was lower: 3,2% in liver \& kidney transplanted children whereas 7,4% in control. it was shown in a retrospective study that in liver (and liver+kidney) transplanted children the prevalence in lyon was around 8,3%. this study will determined in a prospective approach the hev prevalence in kidney, lung, heart and bone marrow transplanted children in lyon.


Eligibility criteria:
inclusion criteria: * \<18 years old * transplantation (heart, kidney, lung or bone marrow) * protocol acceptance by family * social security available exclusion criteria: * protocol rejection by family

Keywords: hepatitis e pediatric transplantation prevalence
treatment of metabolic alkalosis with acetazolamide. effect on the length of mechanical ventilation.

Conditions: Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome; Metabolic Alkalosis

Summary: the purpose of this study is to analyze whether the treatment of metabolic alkalosis with acetazolamide in intubated patients with chronic obstructive pulmonary disease (copd) or with obesity hypoventilation syndrome (ohs) reduces the length of mechanical ventilation (mv).

metabolic alkalosis (ma) may reduce central respiratory drive, cardiac output and worsen oxygenation, leading to a delay in weaning from mv. acetazolamide is a carbonic anhydrase inhibitor that is able to correct ma and to stimulate respiratory drive. there is a paucity of studies on the outcome of patients with ma under mv treated with acetazolamide. the primary objective of our study is to analyze whether the treatment of ma with acetazolamide in intubated patients with copd or with ohs reduces the length of mv, reduces the length of icu stay or icu mortality. complications associated with acetazolamide treatment will be also analyzed. phase iii double-blinded trial, with copd or ohs patients under mv who have ph \> 7,35 and bicarbonate \> 28 meq/l. patients will be randomized to receive 500 mg of acetazolamide or placebo. according to arterial blood gas analysis (abga) values treatment administration will be evaluated daily until extubation.

Eligibility criteria:
inclusion criteria: * patients with copd or obesity hypoventilation syndrome on invasive mechanical ventilation during less than 72 h with metabolic alkalosis, defined as a ph \> 7.35 and actual bicarbonate \> 28 mmol/l, and with potassium plasmatic levels \>= 4 meq/l. exclusion criteria: * postoperative patients. * previous psychiatric disease. * epilepsy. * pregnancy. * hepatic cirrhosis. * sulfonamide or acetazolamide allergy. * plasmatic creatinine \> 2.5 mg/dl or creatinine clearance \< 20 ml/min or continuous renal replacement techniques. * intolerance to enteral feeding. * administration in the previous 72 h of bicarbonate or acetazolamide. * terminal disease.

Keywords: pulmonary disease, chronic obstructive obesity hypoventilation syndrome alkalosis respiration, artificial acetazolamide intensive care adult
mindful self-compassion to assist emerging adults with diabetes transition to adulthood

Conditions: Diabetes Mellitus, Type 1

Summary: the transition from pediatric to adult care is particularly difficult for individuals with type 1 diabetes. it is hypothesized that a mindfulness-based intervention for individuals making this transition will contribute to personal psychological well-being, superior participation in health care, and more tightly controlled blood sugar levels. young adults with type i diabetes will complete an eight-week training program in mindful self-compassion. intervention effectiveness will be assessed with both self-report and physiological measures. assessments will occur at the start of the training program, end of the program, and three-months post-program.

this research will evaluate the consequences of an eight-week mindful self-compassion (msc) intervention on the psychological and physical well-being of 18 to 25 year-old individuals with type 1 diabetes who are at an age of established risk. participants will be randomly assigned to either an immediate intervention group or wait-list control group. all participants will be tested before and after the intervention on a battery of self-report measures designed to assess various aspects of self-care and psychological functioning. blood samples will also be taken before and after the intervention to determine hba1c levels. participants will also receive a followup assessment three-months post-intervention to assess the durability of the effects. we expect msc training to induce positive change in participants' diabetes management and personal well-being.

Eligibility criteria:
inclusion criteria: * adults between the ages of 18 and 25 * obtain care for type 1 diabetes exclusion criteria: * psychologically or medically unable to complete the msc program

Keywords: mindfulness mindful self-compassion self-compassion diabetes self-care
efficacy of medical ozone therapy in patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis b.

total of 189 patients with compensated chronic hepatitis b will be divided equally and randomly into three arms. patients in arm i and ii treated with medical ozone therapy with different medical ozone generators, one was made in tianyi medical instruments limited company and the other in germany. sixty-three patients of arm iii treated with diammonium glycyrrhizinate capsules, common used liver protective herb drug. the term of therapy is 12 weeks. virology response, biochemistry response and hepatitis b viral serological response will be studied at the end of 12 weeks treatment.

Eligibility criteria:
inclusion criteria: 1. male or female, not less than 16 years old； 2. hbsag positive for over 6 months； 3. alt over 2×uln, tbil less than 80µmol/l and serum hbv dna over 10000copies/ml。 exclusion criteria: 1. patient has a history of hemorrhagic or hemolysis disease; 2. patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease; 3. patient is co-infected with hiv or hcv; 4. patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months; 5. patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation; 6. pregnancy; 7. current alcohol or drug abuse; 8. difficulty to draw blood through veins; 9. patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (hcc), or afp over than 100ng/ml; 10. patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance; 11. patient is enrolled in any other clinical trials.

Keywords: medical ozone therapy chronic hepatitis b
fetal intrapartum heart rate fhr/ecg study

Conditions: Abnormality in Fetal Heart Rate or Rhythm

Summary: the objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific fetal heart rate monitoring findings using the device under study.

the purpose of the study is to: 1. evaluate the association between serologic markers of neonatal brain injury and the specific fhr monitoring findings using the investigational device; 2. investigate the relationship between selective serotonin reuptake inhibitor (ssri) antidepressants and the qt interval of the fetal heart. specifically, examine the potential association between maternal ssri use and the fetal qt interval,and; 3. develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle. for this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.

Eligibility criteria:
inclusion criteria: * pregnant women in their third trimester and women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study * 18 years old or older * women with the diagnosis of fetal intrauterine growth restriction may be included. exclusion criteria: * speakers of languages other than english * gestational age less than 24 weeks 0 days
ig-vmat for localized prostate cancer

Conditions: Prostate Cancer

Summary: to determine if hypofractionated ig-vmat (70 gy in 28 fractions over 5.6 weeks) will result in disease-free survival (dfs) that is no worse than dfs following conventionally fractionated ig-vmat (80gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. analysis the local progression, disease-specific survival (dfs), freedom from biochemical recurrence (ffbr), and overall survival (os) of two groups. observe the incidence of gi and gu toxicity.


Eligibility criteria:
inclusion criteria: * age 50-79 * histologically confirmed prostate adenocarcinoma * clinical stage t1-3n0m0 according to the ajcc 6th edition * gleason score must be \>5 * kps \>70 * no radical surgery or cryosurgery for prostate cancer exclusion criteria: * prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (for example, carcinoma in situ of the bladder or oral cavity is permissible) * evidence of distant metastases * previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * previous or concurrent cytotoxic chemotherapy for prostate cancer

Keywords: prostatic neoplasms radiotherapy
uphold versus robotic surgery for pelvic prolapse repair: a decision analytic approach

Conditions: Pelvic Organ Prolapse

Summary: within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the uphold procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy

the cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. given the aging demographics in the u.s., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. the demand for gynecologic services is predicted to increase by more than 45% in the next ten years. prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the us. treatment choice of patients: patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. these are difficult decisions for patients. when it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. thus, the proposed project.

Eligibility criteria:
inclusion criteria: * female * underwent either uphold procedure or robotic surgery for pelvic organ prolapse exclusion criteria: * other vaginal procedure to correct prolapse

Keywords: uphold robotic surgery decision analysis fda decision node outcome node
treatment of pelvic organ prolapse by pivs versus surgeon cut mesh

Conditions: Pelvic Floor Prolapse

Summary: women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. the investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of pivs.


Eligibility criteria:
inclusion criteria: * women who underwent surgery for pelvic floor prolapse exclusion criteria: * women who did not have surgery for pelvic floor prolapse.