Kornimate/medical-research-clean huggingface dataset:
mmf versus ctx in the induction treatment of anca associated vasculitis

Conditions: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody

Summary: the purpose of this study is to access the efficacy of mmf compared to ctx in inducing remission and improving renal function in subjects with anca associated vasculitis with renal involvement.

the anca-associated vasculitides can be life threatening. glucocorticoids and cyclophosphamide therapy is effective in about 80% patients. however, the side effects such as bone marrow suppression, infection, cystitis, infertility, myelodysplasia preclude further use of cyclophosphamide in some patients and the relapse rate is high. recent studies have shown that mycophenolic acid(mpa), the active metabolite of mycophenolate mofetil(mmf), could exhibit multifarious effects on endothelial cells, including inhibition of icam-1 expression, neutrophil attachment,il-6 secretion, and the process of angiogenesis, which contribute to the efficacy of mmf in the treatment of vasculitic lesions such as lupus nephritis with vasculitic lesions. this study was a feasibility study to assess the safety and effectiveness of mmf in inducing remission in subjects with anca-associated svv compared with pulse intravenous cyclophosphamide. after enrollment, subjects were followed longitudinally, and formal measurements of disease activity were determined using the birmingham vasculitis activity score (bvas).

Eligibility criteria:
inclusion criteria: 1. a new diagnosis of anca associated vasculitis (eg. mpa or wegener granulomatous, or renal limited vasculitis) proved by histology and serology. 2. renal involvement attributable to active anca associated vasculitis with at least one of the following: * elevated serum creatinine between 150 and 500 umol/l - renal biopsy * demonstrating paucin -immune necrotizing glomerulonephritis * red cell casts * haematuria with \> 30 red blood cells/hpf and proteinuria \> 1g/24h 3. serum anca positive by indirect immunofluorescence (iif) and positivity in the anti-pr3 or anti-mpo by elisa 4. age 18\~65 years exclusion criteria: 1. more than two weeks treatment with cyclophosphamide (cyc) or other cytotoxic drug within previous 6 months or with oral corticosteroids (ocs) for more than 4 weeks 2. co-existence of another multisystem autoimmune disease, e.g. sle 3. serum creatinine \> 500umol/l 4. severe viral infection(hbv, hcv, cmv) within 3 months of first randomization or known hiv infection 5. congenial or acquired immunodeficiency 6. immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence) 7. previous malignancy 8. pregnancy or inadequate contraception if female 9. anti-gbm antibody positivity 10. cerebral infarction due to vasculitis 11. rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour 12. massive gastro-intestinal bleeding 13. heart failure due to pericarditis or myocarditis 14. liver dysfunction measured on at least 2 separate occasions 15. age \ 65y

Keywords: anca vasculitis mycophenolate mofetil cyclophosphamide treatment
noninvasive ventilation after extubation in hypercapnic patients

Conditions: Respiratory Failure

Summary: the purpose of this study is to assess the efficacy of noninvasive ventilation (niv) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

reintubation, which occurs in 6 to 23% within 48 to 72 hours after planned extubation, is a relevant consequence of respiratory failure after extubation. patients with chronic respiratory disorders and invasively mechanically ventilated in intensive care unit, often exhibit hypercapnia, during breathing trial prior extubation. this is associated to increased incidence of extubation failure and mortality. although the need for reintubation may be a marker of increased severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. niv does not seem to be beneficial in avoiding reintubation when these patients have developed respiratory failure. however, a recent randomised study demonstrated that the early use of niv averted respiratory failure after extubation in patients at increased risk. the patients were considered at risk if they had at least one of the following criteria: age \> 65 years, cardiac failure, increased severity assessed by an acute physiologic and chronic health evaluation score \> 12. but, the beneficial effects of niv on survival appear to be restricted to patients with chronic respiratory disorders and hypercapnia during the spontaneous breathing trial. so the beneficial effects of niv should be confirmed in a trial in this specific population. we planned to conduct a study evaluating the efficacy of niv in the prevention of extubation failure and mortality in these patients. if no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to niv group or control group. the clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the icu and hospital mortality, 28-day survival, the complications associated to mechanical ventilation, icu and hospital length of stay.

Eligibility criteria:
inclusion criteria: * patients intubated for 48 hours or more * patients with chronic respiratory disorders * and/or hypercapnic respiratory failure during successful spontaneous breathing trial exclusion criteria: * face or cranial trauma or surgery * home noninvasive ventilation * recent gastric or oesophageal surgery * tracheostomy or other upper airway disorders * upper gastrointestinal bleeding * excess respiratory secretions * lack of collaboration * do not resuscitate order or any decision to limit therapeutic effort in the icu.

Keywords: chronic respiratory disorders hypercapnic respiratory failure noninvasive ventilation
a study to explore the long-term safety and efficacy of fremanezumab (tev-48125) for the prevention of cluster headache

Conditions: Cluster Headache

Summary: this is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (ch). participants who complete the pivotal studies tv48125-cns-30056 (nct02945046) and tv48125-cns-30057 (nct02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (imp) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies \[adas\]), and biomarker analyses. participants will return to the investigational center for a follow-up visit to evaluate adas, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of imp.


Eligibility criteria:
inclusion criteria: * the participant completes either the phase 3 pivotal study for ech (study tv48125-cns-30056) or the phase 3 pivotal study for cch (study tv48125-cns-30057) without important protocol deviations related to participant safety and participant compliance. * prior to 15 june 2018, participants from the ech study and the cch study were enrolled. after 15 june 2018, only participants who participated in the ech study (study tv48125-cns-30056) will be enrolled for active treatment. * in addition, participants who do not complete the pivotal efficacy studies, and participants who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating adas, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the imp. * additional criteria apply, please contact the investigator for more information exclusion criteria: * any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation) * additional criteria apply, please contact the investigator for more information
pembrolizumab in combination with salvage chemotherapy for first-relapsed or refractory classical hodgkin lymphoma

Conditions: Classical Hodgkin Lymphoma

Summary: the aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r chl by introducing the anti-pd-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ice, dhap). synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (hdct).


Eligibility criteria:
inclusion criteria: * histologically confirmed first relapse of chl or primary refractory chl exclusion criteria: * nodular lymphocyte-predominant hodgkin lymphoma or composite lymphoma
efficacy and safety of a purified standardised bee venom preparation

Conditions: Bee Venom Allergy

Summary: the trial is performed to assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy


Eligibility criteria:
inclusion criteria: * history of bee venom allergy, * positive rast for bee venom, * positive skin prick test for bee venom exclusion criteria: * serious chronic diseases

Keywords: bee venom allergy specific immunotherapy
the effect of using perineal warm compress techniques during the second stage of labor on perineal outcomes

Conditions: Heat Therapy; Perineal Tear; Pain; Labor

Summary: the goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women. the main questions may reveal the pain intensity and the perineal outcome of the warm compress which might be helpful to the women during labor and related authority of the hospital. the intervention with warm perineal compression will be done among primiparous mothes during second stage of labor

participants * after full dilatation of the cervix, assign participants in a 1:1 ratio to the study and control groups randomly. * ask women to select one closed envelope containing a card with the group allocation (study or control groups) * provide usual care according to the unit protocol to all the women until the second stage of labor. * provide the participants of the study group with a warm perineal compress during the whole second stage of labor * provide usual care according to the unit protocol to the participants of control group during the whole second stage of labor. the process of applying the warm perineal compress * fill a clean container with warm water (45-59°c) * soak a clean pad in the water, squeeze then place gently on the perineum during each uterine contraction. * maintain the temperature between 38-44°c during its application. * re-soak the pad in warm water between contractions, to maintain warmth and then reapply. * replace the water in the container every 15 minutes until delivery or if the temperature drop below 45°c

Eligibility criteria:
inclusion criteria: low-risk pregnant mothers such as no hypertension, headache, bleeding infection etc - exclusion criteria: pregnancy with any health problems such as preeclampsia, bleeding, obstructed labour, cesarean section -

Keywords: perineal warm compression, tear, pain
nutrition and physical activity counselling

Conditions: Childhood Obesity

Summary: background: childhood obesity imposes a great burden on the healthcare system. given the increased frequency of dental compared to medical visits during childhood, dentists may be in an ideal position to recognize patients at risk of developing obesity. this randomized clinical trial explored the efficacy of a brief nutrition and physical activity counseling for healthy weight 6 to11 year-old children in a university-based pediatric dental clinic. methods: 168 children, 6-11 year old, were allocated to test and control groups and their body mass index (bmi) were recorded. their parents/caregivers completed a questionnaire regarding their child's nutrition, physical activity and screen time. the parents/caregivers of the test group then received a brief counseling session that encouraged an increase in children's physical activity, and a decrease in sugar-sweetened beverages and screen time. data, collected at baseline and follow-up session (within 6-12 months) were analyzed using general linear regression, adjusting for age, gender, socio-demographic characteristics, education, labour force, income and awareness of school nutrition policy (p≤ 0.05).


Eligibility criteria:
inclusion criteria: * healthy * 6 to 11 years old exclusion criteria: * younger or older children * those with systemic diseases (such as diabetes, cardiac problems, dyslipidemia, elevated cholesterol, obstructive sleep apnea, stroke, fatty liver disease, osteoarthritis, orthopedic problems and any forms of cancer) * children and their accompanying parents or caregivers (hereafter, caregivers) unable to communicate in english * if caregivers were unreachable after three attempts by phone

Keywords: pediatric obesity body mass index dentistry
the 3-dimensional printed guide in endodontic microsurgery

Conditions: Endodontic Disease; Endodontic Re-treatment Failure

Summary: in recent years, there was a great interest in employing the surgical guide in dentistry due to the development occurred in the 3d printing which became available widely. cone beam computed tomography (cbct) is necessary and crucial in planning for endodontic surgery, but the procedure still depends on how the surgeon reflect the 3d images on the anatomical structures accurately, which may leave room for error. this study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.

endodontic microsurgery in critical anatomical structures is considered as a serious challenge for the endodontist. major advances have been made to the techniques used in endodontic surgery to make the procedure easier to perform, safer and more predictable. several case reports that used surgical guide in endodontic microsurgery found that the procedure was more accurate in control of depth, diameter and angle of osteotomy. the aim of this study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures. patients will be selected that they are indicated for endodontic surgery. upper and lower teeth will be selected close to critical anatomy such as; maxillary sinus, nasal fossa, mental foramen and mandibular canal. medical and dental history will be obtained from all selected patients. patients will be randomly distributed to either guided micro-surgery group or conventional micro-surgery group. all steps of the surgical procedure will be performed under microscopic magnification. bioceramic putty will be used as a root-end filling material. post-surgical instructions will be given to patients. the time of the surgery will be recorded from the first incision to the last suturing. success and failure will be assessed using radiographic and clinical evaluation at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * patients in good general health. * patients with age ranging between 18-50 years. * posterior/anterior teeth close to critical anatomical structures that indicated for endodontic surgery. * patients' acceptance to participate in the trail. exclusion criteria: * patients with allergy to materials or medications used in the trial. * patients with serious systemic disease incompatible with surgery. * pregnant female patients. * teeth with periapical pathosis associated with vertical root fracture. * non-restorable teeth. * teeth with periodontal probe more than 5 mm.

Keywords: apicoectomy guided endodontic surgery micro-surgery surgical guide 3-dimensional printed critical structures
a study to test if tev-50717 is safe and effective in relieving abnormal involuntary movements in cerebral palsy

Conditions: Cerebral Palsy, Dyskinetic

Summary: study tv50717-cns-30081 is a 55-week study in which participants who have successfully completed the parent study (study tv50717-cns-30080) may be eligible to enroll in this study. the primary objective of this study is to evaluate the safety and tolerability of long-term therapy with tev-50717 in children and adolescents with dcp. the secondary objective of this study is to evaluate the efficacy of long-term therapy with tev-50717 in reducing the severity of dcp.


Eligibility criteria:
inclusion criteria: * participant has completed parent study tv50717-cns-30080. * participant weighs at least 12 kg (26 lb) on day 1 of this study. * participant is able to swallow tev-50717 whole. note- additional criteria apply, please contact the investigator for more information exclusion criteria: * participant has clinically significant depression at screening or day 1 of this study. note: participants receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening or day 1 (whichever comes first) and anticipated to remain stable (dose and frequency) within the study duration. * participant has a history of suicidal intent or related behaviors based on medical or psychiatric history or the c-ssrs at screening visit, if performed, or at the day 1 visit, as applicable according to the participant's age: * intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought * suicidal preparatory acts or behavior. * participant has a history of a previous actual, interrupted, or aborted suicide attempt. * participant has a first-degree relative who has completed suicide. * participant has received any of the following concomitant participant has received any of the following concomitant medications within the specified exclusionary windows from screening or day 1 (whichever comes first) of this study: * within 30 days: tetrabenazine or valbenazine * within 21 days: reserpine * within 14 days: levodopa, dopamine agonists, and monoamine oxidase inhibitors * participant has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or cp since the week 15 visit of study tv50717-cns-30080, or the participant is not in a stable clinical condition. * participants with a history of torsade de pointes, congenital long qt syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure. * participant has a known allergy to any of the components of tev-50717. * participant has participated in an investigational drug or device study other than study tv50717-cns-30080 and received imp/intervention within 30 days or 5 drug half-lives of day 1 of this study, whichever is longer. * participant is pregnant or breastfeeding. note- additional criteria apply, please contact the investigator for more information
triple-a barcelona study

Conditions: Abdominal Aortic Aneurysm

Summary: the triple-a barcelona study (tabs), is a new hospital-based longitudinal study recruiting consecutive individuals with abdominal aortic aneurysm (aaa) in barcelona. individuals that have at least one measurement of the abdominal aortic diameter, either by computed tomography scan or by ultrasound, along with anthropometric, clinical information, and blood samples for most follow-up visits are recruited.

the triple-a barcelona study (tabs) is a prospective longitudinal registry started in 2019. all individuals identified incidentally with aaa, defined as those with dilation in infrarenal abdominal aorta with a diameter greater than 30 mm13 that visit the vascular and endovascular surgery units of hospital de la santa creu i sant pau and hospital del mar (barcelona, spain) from 2020 to the present are invited to participate to the project. patients who did not consent to participation were not considered for enrollment. upon enrollment, participant's medical history was carefully reviewed, and all previous measures of aortic diameter and available clinical information was included retrospectively in the database. all participants have at least one measurement of the abdominal aortic diameter, either by computed tomography scan (ct-scan) or by ultrasound along with anthropometric and clinical information, and blood samples for most follow-up visits. the first measurement was considered as the baseline. all measurements following the baseline measurement were used until aortic repair or rupture, or death. individuals that were excluded from surgery after they exceeded the surgical threshold (due to concomitant pathology, aaa anatomy or patient rejection to surgery) were also considered for inclusion, and their retrospective data, if existing, was recorded. all patients were asked for an informed consent to participate in this study, and to be included in a clinical database. type b dissections that progress to aaa, saccular aneurysms, mycotic aneurysms, visceral aneurysms or thoracic aneurysms were excluded. aortic diameter was assessed using either ultrasound or ct-scan images.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of abdominal aortic aneurysm * infrarenal abdominal aortic diameter greater than 30 mm exclusion criteria: * type b dissections that progress to aaa * saccular aneurysms * mycotic aneurysms * visceral aneurysms * thoracic aneurysms.

Keywords: aneurysm, aorta, risk
safety study of adult mesenchymal stem cells (msc) to treat acute myocardial infarction

Conditions: Myocardial Infarction

Summary: the purpose of the study is to determine whether adult stem cells \[provacel™(pump1)\] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).

cardiovascular disease is the single largest killer of males and females in the united states with an average of 335,000 deaths per year. this year an estimated 700,000 americans will suffer an acute myocardial infarction. the standard of care treatment for acute myocardial infarction (mi) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, beta-blockers, nitrates and ace-inhibitors. management of cardiac risk factors such as tobacco use, hypertension, lipid levels, diabetes, weight control and exercise all work to reduce further atherosclerotic events. yet, many patients go on to develop congestive heart failure (chf). medical management for chf may improve symptoms and slow the progression to failure but does not restore a functioning myocardium. a therapy that could improve the myocardial remodeling process and reduce the incidence or severity of chf following acute mi would provide a significant benefit in an area of unmet medical need. patients will receive standard of care in addition to stem cells or placebo.

Eligibility criteria:
inclusion criteria: * male or female between 21 and 85 years old * first heart attack within 1 to 10 days exclusion criteria: * positive for hiv 1 and 2 * previous heart attack * pacemaker or other device * pregnant or breastfeeding * allergic to cow or pig derived products * previous bone marrow transplant * involved in another clinical trial within the past 30 days * alcohol or recreational drug abuse within the past 6 months * hepatitis positive * major surgical procedure or major trauma within the past 14 days * body weight greater than 300 pounds * autoimmune disease ( e.g. lupus, multiple sclerosis)

Keywords: acute myocardial infarction heart attack cardiovascular disease stem cells congestive heart failure heart attack repair