Kornimate/medical-research-clean huggingface dataset:
the effect of 5-fu and lmw heparin on the rate of retinal redetachment after silicone oil removal in cases of pvr

Conditions: Proliferative Vitreoretinopathy

Summary: to evaluate the effect of combined 5-fu and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (pvr).


Eligibility criteria:
inclusion criteria: * cases with history of vitrectomy and silicone oil injection for management of pvr who undergo silicone oil removal exclusion criteria: * any sign of retinal redetachment before silicone oil removal * any sign of diabetic retinopathy

Keywords: silicone oil pvr retinal redetachment low molecular weight heparin 5-fu
trial of olanzapine in patients with manic or mixed episode of bipolar i disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar i disorder.


Eligibility criteria:
inclusion criteria: * meet the criteria for manic or mixed episodes according to the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) and have a diagnosis of "294.4x bipolar i disorder, most recent episode manic" or "296.6x bipolar i disorder, most recent episode mixed". * have a total score on the young mania rating scale (ymrs) of at least 20 at visit 1 and visit 2. exclusion criteria: * have received an antidepressant or a psychostimulant within 5 days prior to visit 1. * the duration of the current episode is more than 90 days at visit 1. * have a history or a diagnosis of diabetes mellitus. * have received any psychotropic medication within 2 days prior to visit 2 (except for benzodiazepines).

Keywords: manic or mixed episode associated with bipolar i disorder
prevention of preterm birth in singletons using pessary after resolutive threatened preterm labor

Conditions: Preterm Birth

Summary: in france, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases. after 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%. a pessary is a silicone ring encircling the cervix. it was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies. the multicenter pecep trial conducted by goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective. to evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.


Eligibility criteria:
inclusion criteria: * minimal age of 18 years * informed consent * confirmation of dating of pregnancy by first trimester echography. * episode of threatened preterm labour * singleton between 24 and 34 weeks of gestation * cervical length ≤20mm in cervimetry * pulmonary maturation completed * ≤6 contractions by hour after 24 hours of tocolysis. exclusion criteria: * major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * spontaneous rupture of membranes at the time of randomization * cervical cerclage in situ * uterus malformations * antecedent of conisation * active vaginal bleeding, placenta previa * intra-amniotic infection * hydramnios * maternal chronic pathology (hypertension, diabetes) * anomaly of breathing foetal rate

Keywords: preterm birth pessary threatened preterm labor
monitoring adherence using mobile technology

Conditions: Asthma

Summary: this study plans to learn more about how children use their asthma medicines. the investigators would like to see if special electronic monitoring devices that connect to smartphones and computers can help children to better manage their asthma


Eligibility criteria:
inclusion criteria: * age 6-17 years and their parents * either 2 emergency department visits/prednisone bursts in the last 12 months or at least 1 asthma related hospitalization in the last 12 months * requiring daily controller therapy with either inhaled corticosteroids or combination corticosteroids/long acting beta agonist (laba). * patients using metered dose inhaler therapy would be eligible. patients may also be on leukotriene antagonists, * must be made aware that they will have to read and accept to the terms of the user agreement prior to enrollment in the study. if they do not agree they will not be able to continue participation. the user agreement will be read agreed to electronically when they begin using the device, however a paper version will be provided at the time of consent upon request. exclusion criteria: * primary language other than english or spanish * presence of other significant chronic lung disease including cystic fibrosis, interstitial lung disease, tracheostomy status. * patients using diskus therapy. * patients only on leukotriene antagonists.
does type of anesthesia influence inflammation change after breast surgery?

Conditions: Breast Cancer Female

Summary: the neutrophil to lymphocyte ratio (nlr) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the nlr value. such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state. this study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient nlr value between pre- and post-surgery. patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (pec i and serratus plane block) associated with opioid-free general anesthesia (pecs + opioid-free ga) or general anesthesia.


Eligibility criteria:
inclusion criteria: * first diagnosis of histologically confirmed breast cancer * candidate to external quadrantectomy and axillary surgery (biopsy of the sentinel lymph node and possible axillary lymphadenectomy) * able to provide adequate informed consent * with intact cognitive abilities exclusion criteria: * ongoing pregnancy * in therapy or in follow-up for other cancers at the time of the study * concurrent therapy with opioids or other drugs, for chronic pain conditions related to cancer or other diseases * history of documented allergy or previous adverse reaction to local anesthetics * documented history of anesthesiology related problems during previous surgical interventions or history of problems in airway management * unable to comply to study protocol schedule for logistic or other reasons * refusal to participate to the study (absence of signed informed consent)

Keywords: breast cancer pecs neutrophil to lymphocyte ratio quadrantectomy
prehospital non-invasive ventilation for acute exacerbation of chronic obstructive pulmonary disease

Conditions: COPD Exacerbation; COPD Exacerbation Acute; Noninvasive Ventilation; Emergency Medical Services

Summary: the goal of this clinical trial is to test if treatment with prehospital non-invasive ventilation (niv) for patients with acute respiratory failure (arf), due to acute exacerbation of chronic obstructive pulmonary disease (aecopd) based on in-hospital criteria, should be used in the prehospital setting. this is performed with the introduction of prehospital arterial blood gas analyzation. the primary objective is: • to determine if early prehospital applied niv together with standard medical treatment will affect arterial ph at hospital arrival in patients with arf due to aecopd. participants in the intervention will receive non-invasive ventilation together with standard medical treatment. the intervention will be compared to standard medical treatment alone, that may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years. 2. medical history of copd. 3. unable to give informed consent ("inhabil" in danish) based on the criteria below 4. respiratory acidosis with a paco2 of \> 6,0 kpa and a ph of \< 7,30. and one of the following: 5. respiratory rate of \> 25 per minute. 6. hypoxia with a pao2 \< 7 kpa and/or a saturation \< 88% without oxygen administered. exclusion criteria: 1. upper gastrointestinal hemorrhage or vomiting. 2. anatomical abnormality that precludes the use of an oro-nasal interface. 3. suspicion of pneumothorax. 4. cardiac or respiratory arrest. 5. uncontrollable malignant arrhythmia. 6. refractory shock (systolic blood pressure \< 90 mmhg) despite fluids and/or vasoactive drugs given. 7. required orotracheal intubation. 8. suspected upper airway obstruction. 9. no indication for life-prolonging treatment with niv.
comparison of the effectiveness of two medical compression bandage application techniques by measuring interface pressures depending on whether or not the heel is included in patients with open venous ulcers

Conditions: Venous Ulcer

Summary: the importance of wearing medical compression to heal the venous ulcer has already been shown. however, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. the investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .


Eligibility criteria:
inclusion criteria: * patients over 18 years old * patient with at least one venous ulcer progressing for at least 4 weeks * patient coming for a specialized outpatient consultation called "vascular wound" at nantes university hospital * informed consent to participate in the study * social security insurance affiliation exclusion criteria: * patients under guardianship * patient with major cognitive disorders incompatible with follow-up of protocol * pregnancy * patient with an open leg ulcer with a systolic pressure index \< 0.8

Keywords: varicose ulcer compression bandages patient compliance heel methods
comparative study of the outcome of partial and full pulpotomy in irreversible pulpits

Conditions: Carious Exposure of Pulp; Irreversible Pulpitis; Pulpotomy

Summary: this study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. the primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up. the study design will be a double blind randomized clinical trial.

aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis methods: assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm. patients referred to the postgraduate endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. after a written informed consent baseline demographics of patients and teeth will be recorded. pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. post operative baseline radiographs will be taken. primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively. data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests

Eligibility criteria:
inclusion criteria: * mature permanent tooth * deep caries extending more than two thirds of dentine or exposing the pulp * tooth responds positively to cold test * clinical symptoms of irreversible pulpits * tooth is restorable and can be restored with coronal restoration * bleeding normally is confirmed after pulp exposure * hemostasis could be achieved within 8 minutes exclusion criteria: * non restorable teeth * necrotic teeth * hemostasis could not be achieved within 8 minutes

Keywords: irreversible pulpits pulpotomy outcome
study to determine the effect of 14 days dosing with darapladib (sb-480848) on carotid plague composition in patients with planned carotid endarterectomy

Conditions: Atherosclerosis

Summary: the primary objective is to determine lp-pla2 activity in atherosclerotic carotid plaques after 14 (+/-4) days treatment with darapladib, compared to placebo. secondary objectives include determination of the change in lp-pla2 activity in blood, lp-pla2 mass in blood and plaque, specified biomarkers in blood and plaque and their respective correlation's with lp-pla2. in addition, the study aims to characterise the pk/pd of repeat oral doses of sb-480848, and safety and tolerability in this population.


Eligibility criteria:
inclusion criteria: * male or female, \>35 years of age * females of childbearing potential must be using approved contraceptive measures * male patients must be willing to abstain from sexual intercourse or use a form of contraception if engaging in sexual intercourse with a woman who could become pregnant * planned carotid endarterectomy within a timeframe compatible with recruitment for the study and able to comply with the requirements of the study, as deemed by the investigator * written, informed consent to participate exclusion criteria: * recent myocardial infarction (within the previous 4 weeks) * currently taking corticosteroids, warfarin, digoxin or a potent cyp3a4 inhibitor * recent (\<3 months) or ongoing acute infection or significant trauma associated with bruising and/or taking antibiotics. prophylactic antibiotics for surgery are allowed * change in dose of lipid-lowering therapy during the previous 4 weeks from randomisation * history of chronic liver disease (e.g. cirrhosis, hepatitis) or alt or ast ≥1.5 times the upper limit of normal (uln) at screening * diagnosis of systemic lupus erythematosis (sle) or rheumatoid arthritis (ra) * clinically significant anaemia * history of severe renal impairment (serum creatinine \>1.8mg/dl) * unstable angina * history of asthma , anaphylaxis or anaphylactoid reactions, severe allergic responses * abuse of alcohol or drugs within the last 6 months * any factor or clinical disease state that, in the investigator's opinion, would preclude completion of a safe surgical procedure and/or completion of the study * use of an investigational drugs within 30 days or 5 half-lives of their last dose prior to starting the study, whichever is the longest
elriah score: a simple score for hcc risk stratification in chc patients with cirrhosis or advanced liver fibrosis who achieved svr following daa therapy

Conditions: HCC

Summary: aimed to develop a scoring system to assess risk of developing hcc in a large cohort of chronic hepatitis c (chc) patients with advanced hepatic fibrosis (f3) or cirrhosis (f4) with sustained virological response (svr) after receiving direct acting antivirals (daas).

current guidelines recommend biannual surveillance for hepatocellular carcinoma (hcc) in all patients with cirrhosis. however, risk of hcc incidence is not the same for different patients. the study aimed to develop a scoring system to assess risk of developing hcc in a large cohort of chronic hepatitis c (chc) patients with advanced hepatic fibrosis (f3) or cirrhosis (f4) with sustained virological response (svr) after receiving direct acting antivirals (daas).

Eligibility criteria:
inclusion criteria: * no history of previous hcc * svr after daas treatment exclusion criteria: * history of previous hcc
evaluation of integration success and crestal bone preservation biomet 3i's t3 implant system

Conditions: Partial Edentulism; Tooth Disease

Summary: this study evaluates the t3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. the new surface-treated features of the implant may contribute to improved soft and hard tissue healing. the success rate of the t3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.

this prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. implant sites will be randomly assigned to receive either a test (t3 implant) or control (nanotite certain tapered implant) with an 80:20 (test:control) randomization ratio. all implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter. cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.

Eligibility criteria:
inclusion criteria: * patients of either sex and any race greater than 18 years of age * patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla. * patients must be physically able to tolerate conventional surgical and restorative procedures. * patients must agree to be evaluated for each study visit, especially the yearly follow-up visits exclusion criteria: * patients with active infection or severe inflammation in the areas intended for implant placement. * patients with a \> 10 cigarette per day smoking habit. * patients with uncontrolled diabetes mellitus. * patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or paget's disease of bone. * patients with a history of therapeutic radiation to the head * patients in need of bone grafting at the site of the intended study implant for augmentation purposes. * patients who are known to be pregnant at the screening visit. * patients with evidence of severe para-functional habits such as bruxing or clenching.

Keywords: edentulism dental implants clinical study endosseous randomized crestal bone level t3 nanotite certain nanotite certain prevail tapered
clinical hemodynamic study of balloon counterpulsation in advanced heart failure

Conditions: Heart Failure

Summary: the primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (iabp) using pressure-volume loop and 3d-echocardiographic analyses.


Eligibility criteria:
inclusion criteria: * male or females between 18-75 years of age * nyha class iii-iv heart failure at the time of mega deployment * stage c-d systolic heart failure * non-ischemic cardiomyopathy * preserved right ventricular function defined by 2d-echocardiography * clinically indicated left and right heart catheterization and mega-iabp placement * clinically indicated mega-iabp support for 12 hours minimum exclusion criteria: * ischemic cardiomyopathy * active myocardial ischemia or acute coronary syndrome * severe peripheral vascular disease * severe aortic or mitral valve insufficiency * severe aortic or mitral valve stenosis * right ventricular failure * inability to tolerate left and right heart catheterization * severe hemodynamic instability defined as a systolic bp \<80mmhg despite vasopressor/inotropic support * sustained ventricular tachycardia (\>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours * pacemaker dependent rhythm * left ventricular thrombus * rapid atrial fibrillation (hr\>120 bpm) * unable to provide informed consent * pregnancy
prevalence of chronic rhinosinusitis in cystic fibrosis

Conditions: Cystic Fibrosis; Sinusitis

Summary: aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation with pseudomonas aerug. in the upper airways in patients with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of cystic fibrosis exclusion criteria: * current systemic therapy against pseudomonas aeruginosa

Keywords: cystic fibrosis with chronic rhinosinusitis
prognostic tools in patients with acute pulmonary thromboembolism.

Conditions: Pulmonary Embolism

Summary: acute pulmonary embolism (pe) is a serious disease associated with high mortality rates despite advanced therapeutic options. the treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition

acute pulmonary embolism (pe) is a serious disease associated with high mortality rates despite advanced therapeutic options. the treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition. initial risk stratification of patients with pe could be based on clinical indicators. the presence of shock and hypotension is the most important clinical sign of poor prognosis. other clinical variables, associated with poor prognosis are age over 70 years, history of bed rest over five days, cancer, chronic obstructive pulmonary disease, renal failure, heart failure, and tachycardia . echocardiography represents the most useful imaging tool in everyday clinical practice to show right ventricular dysfunction (rvd) because of its noninvasive nature and relative low cost. rvd assessed on echocardiography has been described as one of the strongest predictor of early mortality in pe . currently, computed tomography pulmonary angiography (ctpa) represents the diagnostic gold standard for pe. additionally, ctpa was used to evaluate the prognosis by determining the distribution and severity of vascular obstruction of clots in pulmonary circulation; this is called computed tomography pulmonary artery obstruction index (ct-paoi). ctpa was also suggested as a predictor of rvd . in addition to the clinical findings and the imaging abnormalities, there are several biomarkers and indicators that can be used to predict severity and prognosis in patients with pe. these biomarkers include troponin and brain natriuretic peptide (indicators of rvd and myocardial damage), d-dimer, c-reactive protein, arterial blood gases parameters and complete blood count (cbc) parameters. however, some of these biomarkers have not been widely studied and are not commonly used although they are readily available and cheaper for developing countries.

Eligibility criteria:
inclusion criteria: * adults (≥ 18 years) who will be diagnosed as acute pulmonary embolism based on computed tomography pulmonary angiography (ctpa) and not yet treated. exclusion criteria: 1. age less than 18 years. 2. patients with known hematological disorders. 3. patients with history of recent blood transfusion (within 3 weeks). 4. patients receive anti-platelet and/or anticoagulant medications. 5. patients receive immunosuppressive drugs. 6. patients with known cardiopulmonary diseases other than the pulmonary embolism. 7. patients with known active infectious diseases or immunological diseases