Kornimate/medical-research-clean huggingface dataset:
treatment of fibrotic scars with rapid acoustic pulse (rap) device

Conditions: Scars, Hypertrophic

Summary: a multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with soliton's rapid acoustic pulse (rap) device for the improvement in the appearance of fibrotic scars

soliton's rapid acoustic pulse(rap) device is an electrohydraulic (eh) device using soliton's rapid acoustic pulse (rap) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts'

Eligibility criteria:
inclusion criteria: 1. male or female 18 years of age or older at the screening visit. 2. the participant is healthy, as determined by the investigator based on a medical evaluation including medical history. 3. the participant has a fibrotic scar (keloid or hypertrophic scar) that is easily delineated photographically located on the chest, back, trunk, upper arms or upper legs. 4. scar must be located an essentially planar surface. 5. scar size preferably between 2.5 cm2 and 5 cm2. 6. preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm. 7. scar less than 5 years old. 8. participant is willing to forego any other scar treatments until complete with study participation. 9. participant is willing to participate in study and adhere to follow-up schedule. 10. participant is able to read and comprehend english. regardless of the above, the final decision on scar inclusion will rest with the pi. exclusion criteria: 1. participant is sensitive to loud sounds 2. participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months. 3. participant is unwilling to have research photos taken of treatment areas in the presence of sponsor's researchers. 4. participant is unwilling to have rap treatment provided in the presence of sponsor's researchers. 5. participant is pregnant or planning to become pregnant during the duration of the study. 6. metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, knees, elbows, etc.). 7. active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc. 8. medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.). 9. history of coagulopathy(ies) and/or on anticoagulant medication. 10. skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. 11. current smoker. 12. any surgical procedure in the prior 3 months, or planned during the duration of the study. 13. any issue that, at the discretion of the investigator, would interfere with assessment of safety or efficacy or compromise the participant's ability to fulfill study obligations 14. treatment with another investigational device or agent within 30 days before treatment or during the study period
study to evaluate divigel for the treatment of postmenoupausal symptoms

Conditions: Postmenopausal Symptoms

Summary: the purpose of this study is to compare the safety and efficacy of usl-221 to placebo for postmenopausal patients.


Eligibility criteria:
inclusion criteria: * postmenopausal women * have moderate to severe hot flashes * normal pap smear exclusion criteria: * abnormal mammogram * abnormal clinical breast exam * bmi \>35

Keywords: vasomotor symptoms estrogen estradiol hot flashes
immunological biomarkers in patients with acute ischemic stroke

Conditions: Ischemic Stroke

Summary: stroke is accompanied by local inflammatory response and systemic immunosuppression. immunosuppression markers are associated with the occurrence of medical complications (infections), whereas inflammatory markers are associated with worse functional prognosis. this prospective study tries to validate in acute stroke patients the prognostic usefulness of a panel of immune biomarkers that have previously been associated with various clinical outcomes. the identification of beneficial and harmful immune responses in cerebral ischemia will allow the prediction of the clinical course of the patients and will be helpful in designing immunomodulatory therapeutic strategies for acute stroke.

stroke is accompanied by local inflammatory response and systemic immunosuppression. immunosuppression markers are associated with the occurrence of medical complications (infections), whereas inflammatory markers are associated with worse functional prognosis. this prospective study tries to validate in acute stroke patients the prognostic usefulness of a panel of immune biomarkers that have previously been associated with various clinical outcomes. the immune biomarkers will be assessed at admission, at day 1 after admission and at day 90. the assessed immune biomarker panel includes: * serum cortisol levels. * serum interleukin (il)-10 levels. * proportion of circulating b lymphocytes (cd3-cd19+ cells). * monocyte surface expression of tlr4, hla-dr, cd86, and vla-4. * ex - vivo production of tumor necrosis factor (tnf)-α in monocytes after stimulation with lps. * proportion of each of the circulating monocyte subpopulations (cd14highcd16-, cd14highcd16+, and cd14dimcd16+). the identification of beneficial and harmful immune responses in cerebral ischemia will allow the prediction of the clinical course of the patients and will be helpful in designing immunomodulatory therapeutic strategies for acute stroke.

Eligibility criteria:
inclusion criteria: * ischemic stroke\* * stroke onset within 6h\* * treated with systemic or intraarterial thrombolysis\* * minimum severity in the nihss of 3\* * age ≥ 18 * consent by the patient or the legal representative * these items do not apply for healthy subjects. exclusion criteria: * intracranial hemorrhage * signs of infection at admission * use of antibiotics, immunosuppressors or corticosteroids in the previous 3 months * significant disability (mrs\>2) before index stroke

Keywords: ischemic stroke immune biomarkers stroke-associated infection functional outcome prediction
connected health to decrease opioid use in patients with chronic pain

Conditions: Chronic Pain

Summary: the objective of this pilot study to evaluate if behavioral incentives applied at the va medical center can appreciably increase participation in activities that promote mobility, and subsequently reduce pain severity and opioid use.

chronic pain is a highly prevalent and costly condition in the us. an estimated 88.5 million adults suffer from daily pain, resulting in estimated cost of $500- 635 bijlion due to lost productivity, and $261-300 billion in health care expenditures. to manage their chronic pain, 5 to 8 million americans take an opioid medication daily. yet , the risks associated with ongoing opioid prescription , including overdose, abuse and diversion, temper their analgesic effects. opioids are not more effective in the treatment of chronic pain compared with non-opioid approaches. current guidelines have adapted to the evidence, recommending opioid-sparing approaches for treating patients with chronic pain, and tapering for those on higher doses to safer levels of use. tapering opioids, however, requires replacing them with effective non-opioid strategies. improving mobility has been shown to improve pain and decrease medication use among patients chronically prescribed opiates. concurrently, financial incentives and the use of behavioral incentives have been shown to promote mobility. appreciating the gains in health outcomes that can be made with "connected health" approaches, we propose a novel pilot study designed to evaluate if technology enabled care (tec) strategies and financial incentives can improve patient mobility in our chronic pain population, reduce pain and decrease opioid use . our primary aim is to determine if chronic pain patients who receive tec-enhanced treatment with financial incentives demonstrate increased participation in activities that promote mobility (physical therapy, yoga, tai chi) in comparison to patients receiving usual care. secondary outcomes will include whether increased activity participation also reduces pain severity and opioid use, and improves function and increases the number of daily steps taken. the results of this pilot will enable us to determine what strategies are effective at increasing mobility and if these gains translate into reduced pain and decreased opioid use.

Eligibility criteria:
inclusion criteria: * chronic non-malignant pain * high dose opioid therapy * possession of activated cell phone with text messaging capabilities * willingness to comply with study requirements exclusion criteria: * pain of malignant origin * sensory impairments precluding use of text messaging and activity tracker * physical disability precluding improvements in physical activity
the effectiveness of l-ornithine-l-aspartate (lola) on plasma ammonia in cirrhotic patients after tips

Conditions: Decompensated Cirrhosis; Portal Hypertension; Bleeding Varices; Refractory Ascites

Summary: the aim of this study is to evaluate the effectiveness of l-ornithine-l-aspartate (lola) on plasma ammonia in cirrhotic patients after transjugular intrahepatic portosystemic shunt (tips) procedure.

patients with successful tips deployment are randomized to lola arm and blank control arm. plasma ammonia concentrations are measured before tips, day 1, day 4 and day 7 after tips.

Eligibility criteria:
inclusion criteria: * cirrhotic patients with refractory ascites or at least one episode of variceal bleeding * no active bleeding within 5 days before tips * child-pugh score ≤ 11 * signed written informed consent exclusion criteria: * an age \ 65 years * with tips contraindications * using drugs for hepatic encephalopathy such as neomycin, rifaximin, lactulose, lactitol or branched-chain amino acid. * intake of psychostimulants, sedatives, antidepressants, benzodiazepines or benzodiazepine-antagonists * past or present history of hepatic encephalopathy * pregnancy or breast-feeding * hepatic carcinoma and/or other malignancy diseases * sepsis * spontaneous bacterial peritonitis * uncontrollable hypertension * serious cardiac or pulmonary dysfunction * renal failure * portal vein thrombosis * history of organ transplantation * history of hiv (human immunodeficiency viruses) infection

Keywords: transjugular intrahepatic portosystemic shunt tips liver cirrhosis lola l-ornithine-l-aspartate refractory ascites
headache inducing effect of nn414 in migraine patients

Conditions: Headache, Migraine

Summary: to investigate the role of katp channels on the cerebral hemodynamic in migraine patients.


Eligibility criteria:
criteria inclusion criteria: * migraine patients of both sexes. * 18-60 years. * 50-100 kg. * women of childbearing potential must use adequate contraception. exclusion criteria: * headache less than 48 hours before the tests start * daily consumption of drugs of any kind other than oral contraceptives * pregnant or nursing women. * cardiovascular disease of any kind, including cerebrovascular diseases. * diabetes mellitus and other endocrinologic disease
chocolate melatonin for adolescent migraine

Conditions: Migraine

Summary: existing treatments for acute migraine are not effective for all children and adolescents, and can cause side effects. investigator propose a dose-finding study of melatonin for acute migraine treatment in children and adolescents to determine the best dose to bring forward in a future fully-powered efficacy trial.

this pilot randomized trial is a dose-finding study to determine which dose of melatonin is most effective for treating acute migraine in children and adolescents who have episodic migraine. investigator will identify the most effective dose to pull forward into a future fully-powered placebo-controlled efficacy study. if both doses are equally effective, investigator will bring forward the best tolerated dose. if doses are equally well tolerated, investigator will bring forward the lowest effective dose, as this will minimize cost to families should this treatment become widely adopted.

Eligibility criteria:
inclusion criteria: 1. meet ichd criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average. 2. age 3-17 years 3. dissatisfaction with previous acute treatments, for one or more of the following reasons: a) one or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or c) patient/family would prefer a natural supplement for acute treatment over medication treatment 4. if of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin. exclusion criteria: 1. allergy or intolerance to melatonin, or to chocolate. 2. opioid or barbiturate overuse as defined in ichd 3. pregnant/lactating
cardiac murmurs in children: predictive value of cardiac markers

Conditions: Congenital Heart Disease

Summary: heart murmurs are commonly discovered in young children during clinical encounters in general practice. heart murmurs might signal a structural cardiac disease that need to be treated, such as atrial septal defect. thus, children with heart murmurs are routinely referred to comprehensive cardiac examination at a paediatric hospital department featuring echocardiography ('gold standard'). however, the great majority of such murmurs are innocent or physiological; ie., they do not represent a cardiac disorder. the prevalence of such innocent murmurs during routine random auscultation is estimated at 30 %. it would be advantageous if patients with a heart disease to a greater extent could be identified at the general practitioners' office: * healthy children would not be exposed to comprehensive cardiac examination * the burden on the family would subside. * scarce medical resources in highly specialized departments would be better allocated, to the benefit of patients with real heart disease. the primary aim of this study is to establish the predictive value of cardiac markers in children with heart murmurs. secondary aims are a) to do a pilot study of pediatric cardiac ultrasound examination in general practice; b) to establish age-adjusted reference range for cardiac markers in children, and c) to explore aspects of cardiovascular physiology in children. the investigators will include a total of 500 children aged 4 weeks to 10 years who is consecutively referred to the dept. of paediatrics, akershus university hospital, for assessment of heart murmurs. all participants will be subjected to clinical examination, symptom assessment, pulse oximetry, blood sampling (for troponin t, probnp and other biomarkers), ecg recording, and echocardiography. a randomized subgroup of children will also undergo echocardiography performed by a general practitioner who has not received formal training in pediatric cardiology. the value of possible predictors will be assessed through the construction of receiver operating characteristics (roc) curves, and calculation of negative predictive value.


Eligibility criteria:
inclusion criteria: * spontaneously discovered heart murmur at general practitioner's office exclusion criteria: * known cardiac disease * other chronic or acute disorder * medications
study evaluating rhbmp-2/cpm in closed distal radius fractures

Conditions: Radius Fractures

Summary: to evaluate the safety of rhbmp-2/cpm administered to subjects presenting with closed distal radius fractures. the key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study \[rus\]); and 4) rate of fracture displacement. the primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the soc control group.


Eligibility criteria:
inclusion criteria: * adults aged 50 to 80 years of age; alert and oriented to person, place, and time. * acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid process), classified according to ao/asif as either a2 or a3 (extra-articular) or c1 or c2 (intra-articular) fractures. * closed fracture reduction and definitive fracture fixation performed within 7 days after injury by means of external skeletal and/or percutaneous pin fixation. note: fractures that are initially treated by closed reduction and casting, then converted to external or percutaneous pin fixation for definitive fracture fixation within 7 days after injury are eligible for the study. other inclusion applies. exclusion criteria: * other fractures of the ipsilateral upper extremity (except for ulnar styloid fractures) or the contralateral upper extremity (except for previously healed fractures without residual functional deficit). * fracture fixation by other means (eg, plate and screw fixation). * planned treatment for the fracture includes any procedure to promote fracture healing (eg, open reduction internal fixation, bone grafting, non-invasive modalities such as ultrasound, electrical stimulation, etc). note: after 12 weeks have elapsed since administration of the treatment assignment, unanticipated procedures to promote fracture healing are permitted as clinically indicated. other exclusion applies.

Keywords: distal radius fractures
the effect of testosterone replacement on endothelial dysfunction, inflammation and insulin resistance in male hypogonadotrophic hypogonadism

Conditions: Hypogonadotrophic Hypogonadism

Summary: the study searched for answers to two questions 1. what is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance? 2. regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.


Eligibility criteria:
inclusion criteria: * men * treatment naive * hypogonadotrophic hypogonadism exclusion criteria: * previous history of androgen replacement * chronic metabolic disorders

Keywords: hypogonadism endothelial dysfunction inflammation insulin resistance testosterone replacement therapy
impact of stress management training after cardiac transplantation

Conditions: Heart Transplant

Summary: in spite of major medical advances in heart transplant patients, psychiatric comorbidity remains very high in pre-and post-transplant phases. anxiety and depression are especially frequent. they impact significantly morbidity and mortality. especially because they are associated with poor therapeutic adherence and risks of infection and rejection. the inability to make beneficial therapeutic choice can be explained by the negative perception of events, associated with anxio-depressive disorders. this results in an important deterioration in quality of life of patients. the investigators assume that better management of emotions might reduce the stress of waiting situation and its psychopathological and somatic consequences pre-and post-transplant.


Eligibility criteria:
inclusion criteria: * men and women on the cardiac transplantation waiting list * patients aged 18 years and older * signed written informed consent * patients under the social security * patients with a somatic condition allowing travels * patients mastering the french language * class ii or iii nyha patients exclusion criteria: * patients minor or under protection measures * patient who have not signed written informed consent * patients not mastering the french language * patients with psychiatric illness characterized by the axis 1 of dsm iv r * patients receiving a psychotherapy or with a psychiatric care * class iv nyha patients

Keywords: psychotherapeutic intervention stress management cardiac transplantation quality of life
prevention of neural tube defects by inositol in conjunction with folic acid (ponti study)

Conditions: Recurrent Neural Tube Defects

Summary: the aim of the study is to develop a randomised, double blind clinical trial to compare (i) folic acid plus inositol, with (ii) folic acid plus placebo, for prevention of recurrent neural tube defects.

women were eligible to join the ponti pilot study if they had a history of previous ntd-affected pregnancy, were planning to become pregnant again, and were prepared to be randomised to one of the two study arms. both study and control groups received 5 mg folic acid (the standard uk supplement for pregnancies at high risk of ntd); the study group additionally received 1 g inositol, whereas the control group was prescribed a placebo instead of inositol.

Eligibility criteria:
inclusion criteria 1. women with a history of one or more ntd pregnancies (spina bifida, anencephaly or encephalocele) who wished to embark upon a further pregnancy. exclusion criteria 1. women who were unable to give informed consent for any reason (language difficulties, low iq). funding was not available to translate the information leaflets or to employ interpreters for the telephone interviews. it was intended to take appropriate measures to include these groups in a definitive follow-up trial. 2. maternal age outside 18 - 40 years of age. an upper limit of forty years was stipulated because there is increased risk of a pregnancy being affected by chromosomal abnormality which may result in a ntd, but which may not be similarly susceptible to prevention by nutrient supplementation. 3. cases where the previous affected child had abnormalities other than ntd, which might be suggestive of another underlying genetic aetiology, a chromosomal abnormality or fetal valproate syndrome. in these cases the underlying pathology would be different from spontaneous, isolated ntds, and folic acid or inositol would not be expected to influence recurrence risk. 4. women who were epileptic and/or taking anti-epileptic medications including valproate. it was recognised that some anti-epileptic drugs increase the predisposition to ntds and, such ntds might be unresponsive to inositol supplementation. 5. women who did not have a gp or obstetrician in the uk. we needed to be able to monitor the pregnancy, confirm there were no contraindications to inositol supplementation, and seek outcome data. we did not have the facilities to seek this information for cases outside the uk. 6. women would be required to stop participation in the trial if the following criteria were met whilst taking the prescribed drugs; * diagnosed with epilepsy and were therefore required to take anti-epileptics. * failed to conceive within one year of starting the trial. * they no longer wished to conceive .