cyrilzakka/clinical-trials huggingface dataset:
Is Optimal Minute Ventilation a Predictor of Weaning in Patients With Prolong Mechanical Ventilation?

1. purpose of study: optimal minute could be the prediction of successful weaning and become the new weaning parameter.
2. study design: inclusion criteria: investigators will perform this study at our respiratory care center. Patients who had been maintained on mechanical ventilator in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had ailed.

   Exclusion criteria: Patients do not have spontaneous breath. Terminal cancer stage and unstable hemodynamics condition.
3. study duration: 2016/01/01\~12/31

Investigators will preform this study at our respiratory care center. Initially, Investigators collected all physiological parameters and baseline characteristics of patients with prolong mechanical ventilator. Investigators use Gold-Galileo ventilator and patients use adaptive support ventilation mode. In adaptive support ventilation, the clinician enters a target minute volume , using a parameter called minute ventilation percentage. The minute ventilation percentage setting be initially set at 100% (the 100%minute ventilation setting), which provides a target minute ventilation of 0.1 L/min/kg of ideal body weight . Investigators observed respiratory frequency of patients, the minute ventilation percentage was increased every 5 min until the mandatory breath began to appear and spontaneous rate is zero. If the minute ventilation percentage had exceeded 250%, but patients do not have mandatory rate appeared, the optimal minute ventilation of the patient is means above 250%. Investigators also measure other weaning parameters. Finally, Investigators analyze the prediction of optimal minute ventilation as a weaning parameter.

Eligibility Criteria:
Inclusion Criteria:

* patients who had been maintained on mechanical ventilation in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had failed.

Exclusion Criteria:

* Patients do not have spontaneous breath. Patients do not use invasive mechanical ventilator. Terminal cancer stage and hemodynamics unstable.
Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.


Eligibility Criteria:
Inclusion Criteria:

* females, adults 18 years of age and older, diagnosed with OAB

Exclusion Criteria:

* bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients
Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.

To access CT Scan as a diagnostic tool for foreign bodies aspiration.

Comparison with gold standard diagnostic tool, the endoscopy

Eligibility Criteria:
Inclusion Criteria:

* age between 6 months and 16 years
* suspicion of a foreign body aspiration
* health care assurance
* information of parents

Exclusion Criteria:

* emergency situation
* certainly of foreign body presence
* delay for CT Scan realization longer than 24 hours
* no speaking French parents
* parents refusal.
Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities

Removing anti nutrient factors using simple cost-effective and sustainable household methods to improve nutritional status of children in communities were plant based complementary foods are the main source of Nutrients is highly recommended. Therefore, the aim of this study is to determine effect of soaking complementary foods on hemoglobin, nutritional and health status of children 6-23 months in agrarian community of bale zone.

Objectives of the intervention

* To determine prevalence and associated factors of nutritional status and anemia among children aged 6-23 months in agrarian community of Bale zone
* To Explore the complementary feeding practice knowledge perception of mother with children aged 6-23 months in agrarian community of Bale zone
* To determine effect of soaking complementary foods flour on nutritional status of children aged 6-23 months in agrarian community of Bale Zone
* To determine effect of soaking complementary foods flour on hemoglobin level of children aged 6-23 months in agrarian community of Bale Zone
* To determine effect of soaking complementary foods flour on frequency of morbidity of children aged 6-23 months in agrarian community of Bale Zone

Target groups The target groups for the intervention will be mothers with their children aged 6-23 months in selected Districts of Bale zone and participated in the baseline study.

Following baseline study, the two districts were assigned to be either an intervention or comparison group randomly. While the intervention community received the Nutrition counselling on promotion of complementary flour soaking, the comparison community was monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention in the target. The intervention will be carried out for a period of six months.

End-line data collection included the following major components:

* Dietary Diversity practice
* Anthropometric measurements
* Hemoglobin test

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agreed mothers with children aged 6-23 month

  * Mothers with children aged 6-23 month who lived at least six months in the selected communities
  * Mothers who have no plan to leave the area within 6 months period

Exclusion Criteria:

* • If the child is seriously ill at the time of data collection

  * Children with severe anemia hemoglobin level \<= 7mg/dl will be excluded
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis

This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.


Eligibility Criteria:
Inclusion Criteria:

* plaque psoriasis for 6 months
* PGA score mild or moderate
* body surface area (BSA) 2-15%

Exclusion Criteria:

* other skin conditions that would interfere with the evaluation of psoriasis
* history of herpes zoster or simplex
* Infected with Mycobacterium tuberculosis
Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy

The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.

Hypothesis:


Eligibility Criteria:
Inclusion Criteria:

* men aged 50 or older
* diagnosed with adenocarcinoma prostate cancer
* will initiate and receive continuous ADT (LHRH or combination of LHRH and anti-androgen for at least 6 months

Exclusion Criteria:

* severe cardiac disease (New York Heart Association class III or greater)
* angina
* severe osteoporosis
* uncontrolled hypertension
* orthostastic blood pressure drop \> 20mm Hg
* moderate to severe aortic stenosis
* acute illness or fever
* uncontrolled atrial or ventricular dysrhythmias
* uncontrolled sinus tachycardia (\> 120 beats per minute)
* uncontrolled congestive heart failure
* third-degree atrio-ventricular heart block
* active pericarditis or myocarditis
* recent embolism, thrombophlebitis
* deep vein thrombosis, resting ST displacement
* uncontrolled diabetes
* uncontrolled pain
* cognitive impairment
* history of falls due to balance impairment or lost of consciousness
* severe neuromusculoskeletal conditions that limit their ability to perform walking exercise
Thrombogenic Factors and Recurrent Coronary Events

To determine if selected circulating blood factors that reflect enhanced thrombogenesis are associated with an increased incidence of recurrent coronary events, including cardiac death or non-fatal myocardial infarction.

DESIGN NARRATIVE:

In this multicenter, collaborative, prospective study, patients hospitalized with a myocardial infarction were enrolled from ten geographically dispersed centers. Five thrombogenic- related blood factors were quantitated, and formed the centerpiece of this study: 1) lipoprotein(a) \[Lp(a)\] - a quantitative genetic factor that contains apolipoprotein B, has a structural homology to plasminogen, interferes with intrinsic thrombolytic activity, and represents a crossover link in the thrombogenesis/atherogenesis hypothesis; 2) soluble fibrin - a system indicator of coagulation activity in the ongoing conversion of fibrinogen to insoluble fibrin strands; 3) plasminogen activator inhibitor-1 (PAI-1) - an important regulator of the fibrinolytic system, it interferes with intrinsic t-PA activity; 4) coagulation Factor VII -high levels lead to increased thrombogenesis and have been associated with an increased risk of ischemic heart disease; and- 5) von Willebrand factor - it binds to platelet glycoproteins, contributes to local thrombus formation, and it is elevated in patients at increased risk of coronary thrombosis.

The primary analysis utilized a time-dependent survivors hip model (Cox regression) to determine the presence or absence of an association between one or more of these factors and subsequent thrombotic-related coronary events. Secondary objectives included: 1) to determine if there was a statistical association between the thrombogenic factors and conventional hematologic/lipid parameters, and to evaluate their interactions regarding coronary events; and 2) to determine if thrombogenic factors had uniform effects on coronary event rates across various subgroups.

Eligibility Criteria:
No eligibility criteria
Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma

Carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (KRDd) can induce profound clinical responses. The investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of KRDd with autologous stem cell transplantation versus patients with 8 cycles of KRDd without autologous stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed and previously untreated multiple myeloma by the International Myeloma Working Group criteria that requires treatment based on: Presence of elevated calcium, renal failure, anemia and/or bone lesions (CRAB) Clonal bone marrow plasma cells ³ 60% Involved/uninvolved serum free light chain ratio ³ 100 \>1 focal lesions on MRI studies (³5 mm in size)
2. Age \> 18 years
3. Functional stage of 0 - 1 measured by the Eastern Cooperative Oncology Group (ECOG) scale.
4. Capacity and willingness to provide a written informed consent.

Exclusion Criteria:

1. POEMS syndrome
2. Systemic amyloidosis
3. Plasma cells leukemia
4. Radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region)
5. Improper liver function: total bilirubin \> 1.5 x upper limit of normal (ULN) or \> 3 x ULN in patients with Gilbert syndrome, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 3.0 x ULN.
6. Non-controlled systematic active infection (viral, bacterial and/or fungic).
7. Patients with known infection by human immunodeficiency virus (HIV).
8. Active infection by hepatitis B.
9. Active infection by hepatitis C.
10. Significant cardiovascular diseases as uncontrolled or symptomatic arrhythmias, congestive heart failure or acute myocardial infarction within 2 months prior to screening, or any New York Heart Association (NYHA) class 3 or 4 heart disease.
11. Diagnosis of previous malignancies for 2 years, with exception of patients with basal or squamous cell carcinoma or "in situ" carcinoma of cervix or breast.
12. History of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies.
13. Pregnant or lactating women.
Premium Monovision Versus Other Types of Monovision and Bilateral Trifocal Implantation.

Primary objective of this study was to compare the efficacy of premium monovision with Restor and Panoptix, against other prevalent monovision techniques and against bilateral Panoptix implantation in a sample of patients following lens-extraction surgery.

Four study groups were formed according to the procedure and the intraocular lens technology that was used: a) Monovision Group (MoG), b) Multifocal Lens Group (MfG), c) Hybrid Monovision Group (HmG), and, d) Premium Monovision Group (PmG). Patients who have undergone one of the above categories of presbyopia correction surgery were selected to compare the effectiveness of these techniques by evaluating the uncorrected near, intermediate and distant visual acuity as well as the degree of subjective patient satisfaction, contrast sensitivity, dysphotopsia symptoms and spectacle independence .

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

* Manifest astigmatism \> 1.00 diopters
* Reports of headaches and/or eyestrain associated with visual activities
* Positive, pathologic ocular cover test (near \& distant) and / or the Mallett's disparity test (near \& distant) and the double Maddox rod test
* Endothelial cell count less than 1900/mm2
* Glaucoma
* intraocular pressure-lowering medications
* Former incisional surgery
* Former diagnosis of corneal disease
* Former diagnosis of fundus disease
* Diabetes
* Autoimmune diseases
* Mental diseases
Superb Microvascular Imaging in Focal Nodular Hyperplasia

Focal nodular hyperplasia (FNH) in liver is the second common benign hepatic tumor. It usually shows hypervascular mass on imaging studies and it is not easy to differentiate with other hypervascular malignant tumor. For diagnosis of FNH, contrast-enhanced ultrasonography (US) has been used to detect 'spoke-wheel sign', which can be typically seen in FNH. However, temporal window of vascular phase using contrast-enhanced US (CEUS) is very short (about 10 sec) and coordination of patient's respiration during US exam is absolutely needed. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for detection of 'spoke-wheel sign' in patients with proven FNH, which enable to detect slow micro vascular flow without using CEUS.

First, to compare the detection rate of 'spoke-wheel sign' between CEUS using sonazoid (Perfluorobutane, GE healthcare) and SMI.

Second, to compare the accuracy of size measurement between gray-scale US and SMI (reference standard: CEUS using sonazoid.)

1. To evaluate the detection rate of 'spoke-wheel sign' on CEUS using sonazoid and SMI (primary outcome).

   Each US findings during exam for patients with FNH were recorded by radiologist. The results were interpreted by consensus using 4 scale bar.

   0. Absence of 'spoke-wheel sign'
   1. Mild suspicious of 'spoke-wheel sign'
   2. Highly suspicious of 'spoke-wheel sign'
   3. Definite "spoke-wheel sign'
2. To evaluated the accuracy of size measurement for FNH on gray-scale US and SMI (reference standard: CEUS using sonazoid).

   To calculate the measurement error between each method and CEUS using sonazoid on US images using measurement of maximum diameter of tumor.
3. Sample size calculation according to the primary outcome.

Expecting the detection rate of "spoke-wheel sign" on SMI, 20% (known detection rate on CEUS using sonazoid, 23.5%), a sample size of 62 patients was required using 95% confidence interval.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with biopsy or imaging proven focal nodular hyperplasia

Exclusion Criteria:

1. Pregnant women
2. Patient's age \> 70
3. Egg allergy
4. Breast-feeding women
Supporting Decisions on Lifestyle Change

This study will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Body Mass Index (BMI) ≥ 30 kg/m2 based on self-report body weight and height, or BMI ≥ 27-29.9 kg/m2 with a weight related comorbidity of hypertension, type 2 diabetes, pre-diabetes, dyslipidemia, or obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease.
* Self-report weight ≤ 375 lbs (the maximum weight that BodyTrace scales can accurately detect is 397 lbs, thus 375 lbs provides a buffer to allow detection of at least 20 lbs weight gain).
* Has a desire to weigh less
* Has valid email address in Electronic Health Record
* Has an appointment scheduled with enrolled PCP about 21-28 days after electronic data pull
* Speaks and reads English
* Has either WiFi internet access at home or a phone or tablet with a data plan.

Exclusion criteria

* Currently enrolled in evidence-based comprehensive weight loss treatment
* Pregnant or planning to become pregnant in the next 6 months
* Currently breastfeeding (or pumping breastmilk) more than 3 times per day.
* Currently undergoing treatment for cancer
* Had cardiovascular event in the past 60 days
* Severe depression symptoms on PHQ-8 (total score ≥20)
* Inpatient psychiatric treatment in the past 6 months
* Eating disorder in past 5 years
* Congestive heart failure resulting in recent (past 6 months) hospitalization or contributing to difficulty breathing or difficulty doing daily activities.
* Dementia diagnosis
* Bariatric surgery in the past year or currently undergoing evaluation for bariatric surgery
* Currently taking doctor-prescribed medication for weight loss
* Inability to stand on body weight scale independently
* Impaired hearing
* Unable to read content on websites without assistance
Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children or children with an increased health risk due to an underlying chronic disease-such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases-aged between 6 and 13 years.
* All subjects must not have received a prior influenza vaccination.
* All subjects must not have had a prior influenza disease.

Exclusion Criteria:

* Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
* Acute illness at the start of the study.
* Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
* Known allergic reactions which might be caused by the ingredients of the vaccine.
* Girls post-menarche: pregnancy or positive pregnancy-test
* Multiple sclerosis or congenital or acquired immunodeficiencies.
Heart Rate Regularization in Atrial Fibrilation and Heart Failure

The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF\>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level\>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.

Permanent atrial fibrillation (AF) causes beat-to-beat heart rate irregularity, which has shown to decrease cardiac output. Observational data suggest that heart rate regularization through atrioventricular (AV) node ablation and pacemaker implantation improves outcomes in heart failure (HF) patients. However, no trials have been conducted to assess its potential benefit in HF and left ventricular ejection fraction (LVEF)\>40%, a population in whom treatment strategies effectively improving outcomes are scarce.

The goal of this trial is to assess the benefit of heart rate regularization through AV node ablation and conduction system pacing (CSP) in patients with permanent AF and HF with preserved or mildly reduced systolic function. The investigators hypothesize that heart rate regularization added to physiological pacing - preventing the deleterious effect of right apical pacing - reduces mortality, HF hospitalisations or worsening HF in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Permanent atrial fibrillation
* At least one episode of hospitalisation due to heart failure in the previous 12 months.
* Left ventricular ejection fraction \> 40%
* Average resting heart rate ≤ 110 beats per minute
* NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
* Age ≥ 18 years
* Capacity to understand the nature of the study, legal ability and willingness to give informed consent.

Exclusion Criteria:

* Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to \< 12 months.
* Acute heart failure at the time of enrollment or systolic blood pressure \< 80 mmHg in the absence of inotropic agents.
* Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
* Severe mitral or aortic valvular heart disease
* Anaemia (Haemoglobin \< 10 g/dl)
* Morbid obesity (BMI ≥ 35)
* Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3)
* Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD)
* Obstructive hypertrophic cardiomyopathy
* Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
* Simultaneous participation in a different trial