Kornimate/medical-research-clean huggingface dataset:
cyclooxygenase-2-inhibitor combination treatment for bipolar depression

Conditions: Bipolar Depression

Summary: this project will attempt to enhance and augment the antidepressant efficacy of a commonly used antidepressant in poorly responding bipolar depressed patients.

this is a placebo-controlled study of patients with bipolar i disorder (bpd) utilizing a well-known antidepressant, escitalopram (esc), in combination with the anti-inflammatory agent, celecoxib (cbx). the investigators hypothesize that combination treatment will lead to a qualitatively and quantitatively augmented response and will result in greater numbers of remitters compared to esc monotherapy.

Eligibility criteria:
inclusion criteria: * ages 21 - 65 years old at time of screening visit. both genders and any race will be accepted. * diagnosis of bpd i or ii without significant co-morbid secondary medical or psychiatric diagnoses; no substance abuse or dependence during preceding 12 months * a minimum score of 18 on the first 17 items of the 21-item hamilton depression scale * willingness to washout for a reasonable time (depending on the substance) from: vitamin e and fish oils (\>600 iu/day), non-aspirin nsaids or aspirin (\>81 mg/day, h2 receptor antagonists, ginko biloba, caffeine on morning of blood drawing, and to institute lights-out at 23:00 hours on the nights before blood drawings exclusion criteria: * any abnormal findings on the physical exam, ecg, blood/urine or minor infections * any pre-existing physical pain condition, including fibromyalgia * history of peptic ulcer complicated by perforation, hemorrhage, or obstruction; symptoms of peptic ulcer within 4 weeks of enrollment date * any substance abuse or dependence during the preceding 12 months * clinically significant hypertension, anemia, liver disease, kidney disease, arthritis, diabetes, recurrent migraines, epilepsy, stroke, gum disease, autoimmune disease * current use of lithium * current use of a stimulant * certain steroids including use of hormonal birth control and any systemic or topical corticosteroids (hormone replacement therapy will be allowed) * unwillingness to refrain from h2 receptor antagonists, non-aspirin nsaids, or aspirin (more than 1 mg/day). * use of any anticoagulant agents * use of nicotine-containing substances. subjects who quit smoking more than 3 months prior to assessment may be considered for the study * known sensitivity or allergy to the study medications or a need to receive agents that are contra-indicated in combination with cbx or esc * unwillingness to fast and abstain from caffeine on mornings of blood drawings * a sleep disorder other than insomnia or hypersomnia as a distinct symptom of major depressive disorder (mdd) * inability to commit to the follow-up visits between 8 and 11 am

Keywords: bipolar depression celecoxib escitalopram inflammation
beyond 12 hours reperfusion alternative evaluation trial

Conditions: Myocardial Infarction

Summary: the objective of this international, multicenter, randomized study is to assess whether coronary artery stenting is associated with a reduced infarct size in patients with ami presenting between 12 and 48 hours after onset of symptoms compared to medical treatment alone

between 8.5% and 40% of patients with acute myocardial infarction present late after symptom onset, no longer being eligible for thrombolysis.despite efforts to reduce time to presentation, recent studies have demonstrated that time-to-arrival has not changed.the lack of efficacy of thrombolysis in patients with acute mi presenting \> 12 hours after symptom onset may be a reason why current guidelines oppose reperfusion therapy in this setting.several findings suggest, however,that reperfusion therapy may be beneficial even among these patients. first, recent studies have shown that viable salvageable myocardium exists even after \>12 hours of severe ischemia. second, previous studies have not only demonstrated that pci is better than thrombolysis in patients with acute mi,but also that the time window of efficacy for pci may be wider than that for thrombolysis.third, observational studies suggest that pci is effective even when performed after 12 hours from symptom onset in patients with acute mi. the goal of our trial was to assess whether an invasive strategy based on pci with stenting is associated with reduction of infarct size in patients with acute stemi presenting \> 12 hours after symptom onset compared with a conventional conservative treatment strategy.

Eligibility criteria:
inclusion criteria: * patients fulfilling the criteria of ami and presenting at the hospital between 12 and 48 hours after onset of symptoms. the criteria of ami are fulfilled when at least one episode of typical chest pain lasting ≥ 20 minutes is combined with either unequivocal ecg changes (≥ 0.1 mv of st-segment elevation in ≥ 2 limb leads or ≥ 0.2 mv in ≥ 2 contiguous precordial leads or new pathological q-waves) or ck plus concomitant ck-mb increase above twice the upper normal threshold. all patients have to be informed of the nature of the study and should give their informed consent for participation in the study. exclusion criteria: * age \ 80 years * cardiogenic shock (systolic blood pressure \< 80 mm hg unresponsive to fluids or necessitating the infusion of catecholamines: gusto i criteria) * persistent severe chest pain * prior thrombolysis (for index ami) * malignancies with life expectancy \< 1year * history of bleeding diathesis, coagulopathy * contraindications to the antithrombotic therapy used in conjunction with coronary stenting (clopidogrel and abciximab) * stroke within the past 3 months * major surgery within the past 30 days * platelets \ 700000/mm3, hb \< 10g/dl, white blood cell count \<3000/mm3 * percutaneous coronary intervention within the past 30 days * inability to cooperate with study procedures and/or follow-up * previous enrollment in this trial
spg neurostimulation in cluster patients

Conditions: Chronic Cluster Headache

Summary: we hypothesized that lf stimulation of the spg would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.

we conducted a double-blind, randomized, sham-controlled, crossover study to investigate cluster attack induction following lf (20 hz and 0.2-2.1 amplitude) and sham (amplitude = 0) stimulation in 20 ch patients with implanted spg neurostimulator. in addition, we measured plasma concentrations of pituitary adenylate cyclase-activating polypeptide-38 (pacap38) and vasoactive intestinal peptide (vip), as markers for parasympathetic activation before, during and after spg stimulation. we also investigated if lf spg stimulation induces changes in cardiac autonomic regulation and whether any attacks induced by spg stimulation are associated with such changes.

Eligibility criteria:
inclusion criteria: * chronic cluster patients exclusion criteria: -
a survey to assess participants' and physicians' knowledge, attitudes and behavior when using natpara

Conditions: Hypoparathyroidism

Summary: this main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and prescribing physicians regarding the risks and safe use of natpara. the survey will be done via internet, telephone, or paper and participants will be able to choose the method that is preferred. no study medicines will be provided to patients in this study.


Eligibility criteria:
participant inclusion criteria: • participants who are 18 years of age or older and who have been approved for natpara and a part of the sup program prior to survey implementation are eligible to participate in the survey. * a caregiver may participate in this survey on behalf of a participant who is a part of the sup program and who is eligible but unable to complete the survey. prescribing physician inclusion criteria: • hcps in the united states (us) who can provide a 10-digit npi number and who are certified in the natpara rems by successfully completing the natpara rems program training module for prescribing physicians, including the knowledge assessment, and submitting a natpara rems program prescribing physician enrollment form are eligible for participation in the survey and a part of the sup program. participant and prescribing physician exclusion criteria: * respondents who do not agree to participate in the survey will be excluded. * survey respondents who have been employed or whose immediate family members have been employed by nps, shire, takeda, united biosource llc, (ubc), or the food and drug administration (fda) are not eligible to participate in the survey and will be excluded. * respondents who reported having a conflict of interest will be excluded. * respondents who are not part of the sup program will be excluded. participant exclusion criteria: * participants who do not agree to participate in the survey will be excluded. * participants who have opted out of receiving communications will be excluded.
sitagliptin dose comparison study in patients with type 2 diabetes (mk-0431-077)(completed)

Conditions: Type 2 Diabetes

Summary: a study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes * patient is between the ages of 30-65 years * patient is not on an antihyperglycemic agent (aha) (glycosylated hemoglobin \[a1c\] 7-10% ), or is on oral single aha or low-dose combination therapy (a1c 6.5-9.5%). exclusion criteria: * patient has type 1 diabetes * patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months * patient has taken insulin within the past 3 months
a safety and dose finding trial of c-tb, when given to adult patients recently diagnosed with active tuberculosis

Conditions: Tuberculosis

Summary: the primary objective is to assess the safety of two doses of c-tb (0.01 and 0.1 µg/0.1 ml) when administered intradermally by the mantoux technique to patients in the acute phase of treatment against active tb. the secondary objectives are to assess the immune response of two doses (0.01 and 0.1 µg/0.1 ml) of c-tb from the size of induration and to assess the safety of unpreserved c-tb and c-tb preserved with 0.5% phenol (local reactions).

this clinical trial is a single centre phase ib open dose adjustment study with respect to the dose of c-tb combined with a double blind randomised, split-body comparison of unpreserved c-tb and c-tb preserved with 0.5% phenol (each patient receives the unpreserved version in one arm and the preserved version in the other arm).

Eligibility criteria:
inclusion criteria: the patient: 1. has signed an informed consent 2. is willing and likely to comply with the trial procedures 3. has been diagnosed with active tb and has been in treatment ≤ 60 days at the time of inclusion * has 1 documented positive sputum smear microscopy result * has positive culture * has a positive pcr result for tuberculosis * has a compatible clinical picture of tb with the intention to treat 4. has a positive t-spot assay or a quantiferon®-tb gold in tube test 5. is prepared to grant authorized persons access to their medical records exclusion criteria: the patient: 1. has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products) 2. has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. bcg, mmr, yellow fever, oral typhoid vaccines) 3. has a known congenital or acquired immune deficiency 4. has a disease affecting the lymphoid organs (e.g., hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 5. is infected with hiv 6. has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 7. has a condition where blood drawings pose more than minimal risk for the patient, such as haemophilia, other coagulation disorders, or significantly impaired venous access 8. is actively participating in another clinical trial 9. is pregnant according to urine pregnancy test at inclusion 10. has a condition which in the opinion of the investigator is not suitable for participation in the study

Keywords: tuberculosis esat-6 cfp-10 skin test diagnostic test
clinical situations at high risk of placenta accreta / percreta

Conditions: Placenta Accreta / Percreta

Summary: the purpose of this study is to identify what factors -either individual or related to the type of management received- influence the maternal outcomes in pregnant women at high risk for placenta accreta i.e , women with placenta praevia and previous caesarean. this population-based study conducted in 8 french regions will also provide valid estimation of the incidence of placenta accreta among all parturients and among "at risk "women. finally, a psychological evaluation of these women up to 1 year after delivery will provide information on the impact of these conditions on women, beyond somatic complications.

background: no population-based study has assessed the prevalence of placenta accreta, the predictive value of prenatal diagnostic examinations, the maternal morbidity associated with its management, or its psychological effects. moreover the technical resources necessary for the safest delivery of women at risk have not been clearly identified. objectives: the primary objectives are to identify individual risk factors for maternal morbidity, as well as risk factors related to types of management and healthcare facilities for postpartum hemorrhage (pph). secondary objectives are to 1) determine the prevalence of placenta accreta among women at risk; 2) assess the predictive value of ultrasound and mri for the diagnosis of placenta accreta in this population; 3) evaluate psychological impact and physical complications; 4) report maternal physical complications during the year after delivery. design: population-based prospective observational study of pregnant women with a placenta inserted at a uterine scar setting; a total of 166 centers in 8 french regions, with 260,000 deliveries annually. methods: we expect to include 570 women at risk of placenta accreta in two years, of whom approximately 100 (20%) will have placenta accreta. main outcome measures: the primary outcome measure is severe maternal hemorrhage; secondary outcome measures are maternal morbidity and deaths, predictive value of ultrasound and mri, and psychological evaluations at 1, 6 and 12 months after delivery. conclusion: this study will be the first prospective population-based study to include women at risk of placenta accreta and to investigate incidence, prenatal detection, type of management, morbidity and maternal psychological consequences.

Eligibility criteria:
inclusion criteria: every woman: * delivering in a maternity unit of the 11 participating perinatal networks. * with a placenta praevia and at least one previous cesarean delivery, and / or having a placenta accreta * aged 18 or more exclusion criteria: every woman: * not understanding french. * refusing to participate in the study.

Keywords: placenta accreta previous caesarean placenta praevia severe obstetric haemorrhage population-based study
the role of ketamine in preventing cognitive dysfunctions in postoperative period of cardiac surgery

Conditions: Delirium; Inflammation; Cognitive Disorders; Amnestic; Dementia

Summary: the purpose of this study is to analyze the ketamine with its anti-inflammatory profile would be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since these disorders contribute to an impact on morbidity / mortality in this population.


Eligibility criteria:
inclusion criteria: * patients aged over 50 years. * be submitted to cardiac surgery by sternotomy and with the use of cardiopulmonary bypass (cpb). * american society of anesthesiologists classification 1, 2,3 and 4. exclusion criteria: * patients undergoing reoperation. * patients undergoing heart transplantation. * patients using vasopressor agents and / or ionotropic continuous preoperatively. * patients with prior endotracheal intubation and consequently ventilatory assistance mechanics. * patients with documented psychiatric disorders. * patients with previous cognitive disorders. * patients with a history of alcohol or drug abuse. * patients with a history of cerebrovascular accident (cva) with less than 3 months.

Keywords: ketamine cardiac surgery neurocognitive disorders
traumatic brain injury and stroke long term outcome

Conditions: Traumatic Brain Injury; Stroke

Summary: investigators will determine the long-lasting effects of post-acute rehabilitation after traumatic brain injury and stroke. investigators will also evaluate if the beneficial effects of rehabilitation continue after discharge from a rehabilitative program.

the long-term effects of rehabilitation will be evaluated on 60 patients with traumatic brain injury (tbi) and 60 patients that suffered a cerebrovascular accident (cva) that underwent an comprehensive rehabilitative. these patients will be matched with subjects that received limited or no rehabilitation rehabilitative therapy. thus, the total number of subjects in this study will be 240. subjects will be contacted at least 1 year after discharge and will be lowed up every two-years thereafter for a total period of 10 years. procedures will be performed in-person whenever possible. however, it is highly likely that the majority of participants will be contacted via phone interviews. aim 1: determine if rehabilitation improves vocational status and living status after tbi and cva. aim 2: determine if rehabilitation improves life quality after tbi and cva. aim 3: determine if rehabilitation improves cognitive function after tbi and cva. aim 4: determine if rehabilitative benefits are sustained. aim 5: determine if long-term outcome is dependent on the duration of rehabilitation. aim 6: determine if long-term outcome is dependent on the nature of the rehabilitative treatment by comparing the effects of different types of rehabilitation. these will include the following: residential-multidisciplinary, day-treatment (i.e. full time multidisciplinary outpatient), outpatient (part-time), skilled nursing and no post-acute rehabilitation.

Eligibility criteria:
inclusion criteria: * endured a traumatic brain injury or stroke * subject or caretaker should be fluent in english exclusion criteria: * diagnosis of degenerative neurological disease prior to sustaining stroke or traumatic brain injury * b) a history of major psychosis as defined by diagnostic and statistical manual of mental disorders (dsm-v) prior to sustaining stroke or traumatic brain injury

Keywords: rehabilitation long term outcome
long-term trial of opa-15406 ointment in adult and pediatric patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: to demonstrate the safety of 1% opa-15406 ointment in adult patients with ad and of 0.3% and 1% opa-15406 ointments in pediatric patients with ad administered twice daily for 52 weeks.


Eligibility criteria:
inclusion criteria: * age: at least 2 years (at time of obtaining informed consent) * diagnosis of ad based on the japanese dermatological association's criteria * atopic dermatitis affecting ≥5% of body surface area (bsa, excluding scalp) at the screening and baseline examinations exclusion criteria: - subjects who have an ad or contact dermatitis flare-up defined as a rapid intensification of ad, within 28 days prior to the baseline examination
review of human herpes viruses in burns

Conditions: Human Herpes Virus; Herpes Simplex Virus; Varicella-zoster Virus; Chickenpox; Cytomegalovirus; Burns

Summary: herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to play a pivotal role in morbidity and mortality in burns. thus far, there is no existing systematic review (level of evidence iii or higher) describing the unique role as well as concurrent infections of these viruses in burns. the aim of this review is to point out the clinical differences between these human herpes virus subtypes, to outline established therapy approaches, and to provide evidence for virus related morbidity and mortality in burns.

this systematic review was created according the primsa (preferred reporting items for systematic reviews and meta-analyses) guidelines and checklist. we performed an review of the medical literature to identify all studies that contain hsv, cmv and vzv infections in burns.therefore, systematic review of the medline database by using pubmed and ovid interface was conducted. also the web of science interface was used for systematic literature search. on the pubmed interface, we used the following search terms: ("hsv"\[all fields\] or "herpes"\[all fields\] or "cmv"\[all fields\] or "cytomegalovirus"\[all fields\] or "vzv"\[all fields\] or "varicella-zoster"\[all fields\]) and ("burns"\[mesh terms\] or "burns"\[all fields\] or "burn"\[all fields\] or "thermal trauma"\[all fields\]). for ovid we used: exp burns/ and (exp herpes zoster/ or exp encephalitis, herpes simplex/ or exp herpes simplex/ or exp herpes simples virus vaccines/), exp burns/ and (exp cytomegalovirus/ or exp cytomegalovirus infections/), exp burns/ and (exp chickenpox/ or herpesvirus 3. human/ or exp herpes zoster/). and for web of science we used: (ts=(hsv or herpes or cmv or cytomegalovirus or vzv or varicella-zoster) and ts=(burn or burns or thermal trauma)) and language: (english) and document types: (article); timespan: all years; indexes: sci-expanded, ssci, a\&hci, cpci-s.

Eligibility criteria:
inclusion criteria: * patients who presented with at least 1% tbsa burned * patients who presented with a viral infections during their hospitalization exclusion criteria: * patients who had no burns * patients who had no viral infections during their hospitalization
quality of life in elderly patients after pancreatic cancer surgery

Conditions: Pancreatic Cancer; Surgery; Elderly

Summary: pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. in france, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men. surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. the main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied. the aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. these patients underwent surgery at édouard herriot hospital (hospices civils de lyon) since july 2021, and the assessment will be conducted through telephone questionnaires. it is hypothesised that these patients will be able to maintain their independence in terms of daily activities.


Eligibility criteria:
inclusion criteria: * subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen * operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the édouard herriot hospital since july 2021 * 70 years of age or older at the time of surgery. exclusion criteria: * patients who have expressed their opposition to the study * patients under curatorship, guardianship or legal protection * patient unable to express non-opposition * patient unreachable after 4 attempted calls over 3 consecutive weeks * patient deceased at the time of the telephone call * persons deprived of their liberty by a judicial or administrative decision * persons under compulsory psychiatric care

Keywords: pancreatic cancer pancreatectomy pancreatic surgery independence quality of life elderly people octogenarian geriatric assessment