cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)

The purpose of this study is to demonstrate that solifenacin post-operatively improves irritative symptoms in men whose obstructive symptoms have been relieved with the GreenLight laser outpatient procedure.

Obstruction of the urinary tract secondary to benign prostatic hyperplasia can result in both obstructive and irritative urinary symptoms. In the last few years, photovaporization of the prostate has emerged as a popular teatment for this problem. This outpatient procedure uses a GeenLight KTP laser manufactured by Laserscope to vaporize the obstructing aspects of the prostatic urethral tissue to create a central cavity. After obstruction is relieved , it is not uncommon for a patient to be left with the irritative symptoms of frequency, urgency and nocturia, either from the procedure itself in the short-term or due to changes that develop in the bladder due to the long-standing obstruction. Clinical experience with this procedure indicates that after the mechanical obstruction of the prostate is relieved, medical therapy with an antimuscarinic agent should be able to alleviate these irritative urinary symptoms without the risk of urinary retention. By adding solifenacin in the early post operative period ( 2-12 weeks)for the subset of patients still experiencing irritative symptoms, further improvements in bladder symptoms my be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Male patients greater than 18 years of age with continued OAB symptoms after successful PVP for BPH.
* Patients may be included if they have previously been treated with FDA approved anticholinergic agents for the treatment of OAB such as Oxybutynin chloride(generic oxybutynin chloride, Ditropan XL, or Oxytrol) Tolterodine tartrate(Detrol or Detrol LA), or trospium chloride(Santura) and are no longer receiving such treatment for a minimun of 14 days prior to study

Exclusion Criteria:

* Previous treatment with darifenacin
* Urinary obstruction as defined as a Qmax \< 12 ml/sec at time of study entry.
* Urinary retention as defined as PVR \> 150 ml
* Neurogenic Bladder
* Prostate Cancer
* Chronic inflammation( i.e. interstitial cystitis)
* Bladder stones
* History of bladder cancer
* Urinary tract infection
* Uncontrolled narrow-angle glaucoma
* Gastric retention
* History of diagnosed gastro-intestinal obstructive disease.
* Severe renal or hepatic impairment
* Concomitant anticholinergic or antispasmodic medications.
* Known or suspected hypersensitivity to Solifenacin, any of its components (lactose monohydrate, corn starch, hydromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 ant titanium dioxide with yellow ferric oxide(5 mg tablet) or red ferric oxide(10 mg tablet, or other anticholinergics.
* Participation in any clinical trial involving an investigational drug, within 30 days prior to enrollment.
* Any clinical condition, which in the opinion of the investigator, would not allow safe completion of the study.
Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail.

Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.


Eligibility Criteria:
Inclusion Criteria:

* Pertrochanteric or subtrochanteric femur fracture
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI

The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).

The study population consists of pacemaker-free patients that are 18 years or older undergoing a TAVI with new onset left bundle branch block. Patient consent is required.

Patients meeting the inclusion criteria will be randomized in a 1:1 ratio to one of the following two groups:

Group 1: electrophysiology-based algorithmic approach

Group 2: standard clinical follow-up with transcutaneous cardiac monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Informed consent to participate
* Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)

Exclusion Criteria:

* Prior pacemaker or implantable cardioverter-defibrillator
* Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)
* Class I or IIA indication for PPM implantation according to management guidelines
Opioid Counseling in Pain Management

The purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.

Prescription opioid abuse has been increasing dramatically in recent years. There is growing concern regarding the unprecedented increase in morbidity and mortality related to the use of opioids.1-2 In 2010 the rates of opioid sales, deaths, as well as associated treatment admissions have increased to more than triple the rates in 1999.1-2 Although policy makers and the media often associate the opioid crisis as a problem of nonmedical opioid abuse, evidence has suggested that opioid addiction occurs in both medical and nonmedical users.2 The Centers for Disease control and Prevention reported and warned that long-term opioid use often starts with treatment of some type of acute pain.3 Prescription opioids have been shown to be favorable in perioperative pain management, however, their effectiveness in chronic pain management is not as clear. Surgeons are among the highest opioid prescribers. Many common elective as well as trauma-related procedures have been reported as possible causes of increased prolonged opioid usage. Recent evidence also suggested that a considerable number of patients who were prescribed opioids struggle to with transitioning to non-opioid pain medications.1-6 Numerous methods have been considered and explored in effort of decreasing the misuse and abuse of prescription opioids. One of the methods being opioid counseling, in which patients are educated on the effects and risks of short-term and long-term opioid usage and physicians recommend and discuss the appropriate opioid usage as well as alternative nonopioid options. It has also been indicated that counseling is more effective if given earlier on in the patient's surgical care rather than through rushed education overview at discharge.1,4-6 Therefore, the purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Elective bilateral reduction mammoplasty to be performed as outpatient
* Able and willing to provide informed consent
* Able and willing to comply with study procedures

Exclusion Criteria:

* Age \< 18 years
* Bilateral reduction mammoplasty planned/performed with any concomitant procedures
* History of preoperative opioid consumption or rehabilitation
* Opioid allergy
* Local anesthetic given during or after procedure
* Unable and/or unwilling to provide informed consent
* Unable and/or unwilling to comply with study procedures
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)

The purpose of this study is to investigate the extent to which diet and exercise may improve PAH through the modulation of insulin sensitivity. The central hypothesis is that dysregulated glucose metabolism elicits a response in PAH patients that can be modified by exercise and diet, thereby leading to improvements in pulmonary vascular disease.

Pulmonary arterial hypertension (PAH) leads to premature death as a consequence of increased pulmonary vascular resistance and right heart failure. PAH-targeted therapies developed over the past 20 years target excessive vasoconstriction. However, the pathobiology of PAH is more complicated, and includes dysregulated vascular cell proliferation, cellular metabolic abnormalities, and inflammation. Even with modern PAH therapies, current outcomes remain poor, with an estimated 3-year survival rate of only 55%. Thus, there is a clear need for more effective therapies, based on better understanding of the pathobiology of the disease.

Insulin resistance has emerged as a potential new mechanism in PAH. Animal models of insulin resistance are associated with PAH, which reverses with the administration of insulin sensitizing drugs. Over the past decade there has been an epidemiologic shift in PAH, where the disease is increasingly observed in older, obese, and diabetic subjects. Low levels of high-density lipoprotein cholesterol in PAH, a feature of insulin resistance, have been observed and found to be a strong independent predictor of PAH mortality. Elevated glycosylated hemoglobin (HbA1c) also correlates with PAH diagnosis and severity. As measured by the OGTT, idiopathic PAH patients have not only insulin resistance, but also an inability to mount an appropriate insulin response to a glucose challenge. These data point to dysfunction in the pancreatic beta cells of PAH patients. It is known that an exercise and low glycemic index diet intervention improves insulin sensitivity in pre-diabetic subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 18-75 years old
* Group 1 PAH, including idiopathic, heritable, drugs and toxin induced, and PAH associated with connective tissue disease, HIV infection and congenital heart disease
* NYHA Class II or III
* ≥ 1 PAH-targeted therapy with a stable dose for ≥ 2 months
* Stable dose of diuretics and rate of supplemental oxygen for the preceding 2 months

Exclusion Criteria:

* Decompensated Right Heart Failure
* NYHA Class IV
* Syncope within the previous 3 months
* Cardiac Arrhythmia (except for controlled atrial fibrillation or flutter)
* Baseline supplemental O2 \> 4 LPM
* Portal Hypertension
* Pulmonary hypertension due to Lung Disease and Hypoxia
* Pulmonary Hypertension due to Left Heart Disease
* Chronic Thromboembolic Pulmonary Hypertension
* Pulmonary Hypertension associated with systemic diseases such as hematological disorders and sarcoidosis
* Type 2 Diabetes
* Evidence of cardiac ischemia on a graded exercise test
Neural Mechanisms With CES in Depression

This study will examine the effect of cranial electrotherapy stimulation (CES) treatment on adults with depression. Scalp based electroencephalogram (EEG) will be utilized to record the brain activity of participants whilst they perform computer based tasks. The aim is to understand if there would be changes in the neural signals following CES.

Patients meeting the inclusion and exclusion criteria and volunteer to participate will be randomly assigned to "Active CES Therapy" and "Sham CES Therapy" groups. Before start of the treatment (active or sham), their medication details or any other form of treatment they are on will be noted down. These patients will be assessed on self-rated Beck Depression Inventory and clinician rated Hamilton Depression Rating Scale. They will be also assessed on neuropsychological functions of attention, executive functions, memory, information processing and emotional processing evaluation using Emotional Test Battery. In addition, 25 patients from each group will undergo EEG recording whilst they perform computer based tasks. These assessments will take place at 4 time points (Pre-treatment, 1 month after treatment, at 3 months, and at 6 months after treatment).

The study will use scalp based electroencephalogram (EEG) to record the brain activity of participants whilst they perform computer based tasks. The aim is to understand if there would be changes in the neural signals following cranial electrotherapy stimulation. Investigators propose to use EEG to investigate if CES therapy will modulate brain responses in a way that leads to better information processing as a mechanism to improve depression. Furthermore, researchers will also investigate changes in EEG based brain connectivity patterns following CES therapy. Therefore, as a mechanism of action for CES therapy could be changes in the functional brain connectivity for efficient information processing. EEG investigation will be helpful to understand this connectivity based mechanism following CES.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 to 65 years of age.
* Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
* Subjects must fulfil ICD-10 criteria for Depressive Episode or Recurrent Depressive Disorders based on clinical assessment and confirmed by short a structured diagnostic interview, MINI.
* Subjects must have an initial score of at least 14 on the BDI at screen and at baseline of study.
* Current depressive episode of at least 4 weeks duration.

Exclusion Criteria:

* Current or past diagnosis of any other major mental disorders (e.g., schizophrenia, bipolar affective disorders)
* Depression with psychotic symptoms
* Dysthymia
* Depression of organic origin
* Substance misuse/ dependence
* Subjects with one or more seizures without a clear and resolved etiology.
* Female subjects who are pregnant.
* Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk
THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT.

This study, which has a quasi-experimental, prospective, and open-label randomized controlled design, was conducted to examine the effect of cold application on the development of phlebitis in patients receiving IV amiodarone infusion treatment.

Study Hypotheses H0-1: There is no difference in the rate of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

H0-2: There is no difference in the grade of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

H0-3: There is no difference in the time of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18, who were planned to receive 300 mg amiodarone in 150 ccs of 5% dextrose + 900 mg amiodarone (maintenance) in 50 ccs of 5% Dextrose in 30 minutes (24 hour-infusion),
* Patients to whom PVC was placed in the upper extremity, and who did not develop phlebitis on the PVC site

Exclusion Criteria:

* Cold allergy/sensitivity or circulatory disorders
* During the study, patients who had a change in the IV amiodarone treatment protocol, whose IV amiodarone treatment was terminated before 24 hours, whose IV amiodarone treatment protocol was started, but PVC had to be replaced for any reason during the 24-hour period
Pre-hospital Ventilation Clinical Study

This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.

This is a prospective, observational study.

ZOLL will develop a methodology to collect and transfer ventilator data from the device to ZOLL to allow for a characterization of ventilator use in the pre-hospital setting. This knowledge and experience will subsequently be used to inform development of a mechanism to allow for automatic data collection and transmission from ZOLL ventilators to a central data repository. These data will be used to provide feedback, reporting, and benchmarking to individual agencies and departments on their ventilator use as well as aggregate use data from all ventilators to allow for comparisons.

Enrollment in this study is expected to take approximately 24 months. No patient outcome data will be collected.Participants are enrolled once data have been downloaded from the ventilator via RescueNet® VentReview software. Participants will not be followed after the assessment of study objectives.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for this study must meet all of the following Inclusion criteria:

  1. Ventilated using ZOLL 731 Series ventilator with Release 5 (or greater) software
  2. Data recorded in ventilator data file

Exclusion Criteria:

* None
Effectiveness and Cost-effectiveness of Lower Limb Prostheses

The goal of this observational study is to investigate the effectiveness of NMPKs versus MPKs in persons with an LLA in the standard healthcare system in the Netherlands taking all levels of the ICF model into account. Our main aim is to assess the effect of MPK use compared to NMPK use on walking distance, as this is one of the most used outcome variables in literature and thus enables comparison with previous studies. Our secondary aim is to investigate the effect of NMPKs versus MPKs on all ICF-levels: body structures and function, activities and participation.

Participants will be seen four times in a year. During these measurement moments they will:

* Perform two physical tests
* Fill out a set of questionnaires
* Wear an activity tracker for one week

In this prospective cohort study the participants made use of two types of prosthetic knees; the CMK and MKP. A baseline measurement (T0) was performed while the participants were using their own CMK. One week later, they received the MPK to start a six week-trial. During this trial, they received 30 minutes of physical therapy twice a week. In the last week of the trial period, the measurements were performed again (T1). After the trial period, participants switched back to their CMK and after four weeks of getting used to that, the functional performance tests were repeated (T2). Nine months after the last measurement, and if the participant received a MPK, the measurements were repeated again (T3).

The measurements consisted of:

Physical tests:

* 6 minute walking test (6MWT)
* Timed up and Go test (TUGtest)

Questionnaires:

* Cost questionnaire
* Activities-Specific Balance Confidence Scale (ABC-NL)
* Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P)
* Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)
* Prosthesis Evaluation Questionnaire (PEQ)

Activity monitor:

* Activ8 professional. Worn for seven consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* At least one year post amputation
* Unilateral transfemoral amputation or knee-disarticulation
* Eligible for a trial on an MPK
* Able to read and write in Dutch
* Use a prosthesis with a socket

Exclusion Criteria:

* Bilateral amputation
* Osseointegration
* Previous experience with an MPK
Comparison of Cardiac Computed Tomography and Vasodilator Stress Magnetic Resonance Imaging Perfusion in Patients With Prior Equivocal Stress Test for Detection of Coronary Artery Disease

Background:

* Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate further expensive testing.
* In patients with known or suspected coronary artery disease, both computed tomography (CT) and magnetic resonance imaging (MRI) have been shown to provide suitable results for detecting the disease. However, both types of scans have limitations in their usefulness, and it is not known whether one is preferable in either accuracy or cost-effectiveness.

Objectives:

- To determine the accuracy and cost-effectiveness of CT and MRI in subjects with a prior inconclusive heart stress test.

Eligibility:

- Patients 18 years of age and older who have had an inconclusive heart stress test within the past 90 days.

Design:

* A blood test will be obtained prior to both heart tests. This will require less than a teaspoon of blood.
* A CT scan will be performed, accompanied by beta blocker medications (to slow heart rate) or nitroglycerin (to enlarge blood vessels) to improve picture quality, as needed.
* An MRI scan will be performed. Scans will be taken before, during, and after the patient receives vasodilators (to increase blood flow to the coronary arteries and detect blockages in heart blood vessels).
* Heart rate and function will be monitored with an electrocardiogram.

Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate further expensive testing. We will do both cardiac computed tomography (CT) and stress cardiac magnetic resonance imaging (MRI) in patients who have an inconclusive noninvasive cardiac stress test. We will test whether MRI predicts significant coronary artery disease in a more cost-effective and accurate manner than CT, or vice versa.

Eligibility Criteria:
* GENERAL INCLUSION CRITERIA:
* 18 years of age and older
* Prior equivocal stress study within the preceding 90 days
* Able to provide informed consent

MEDICAL EXCLUSION CRITERIA:

* Decompensated heart failure (unable to lie flat during MRI or CT)
* Severe kidney disease (MDRD estimated Glomerular Filtration Rate less than 30mL/min/1.73m(2).
* Prior cardiac revascularization with coronary stent or bypass surgery
* Resting tachycardia (HR greater than l00 bpm)
* Pregnant women (when uncertain, subjects will undergo urine or blood testing)
* Lactating women (unless they are willing to discard breast milk for 24 hours after receiving gadolinium)
* Second (Type II) and third degree atrioventricular heart block
* Asthma or chronic pulmonary disease (emphysema) actively treated with bronchodilators or leukotriene antagonists

MRI EXCLUSION CRITERIA:

* Cardiac pacemaker or implantable defibrillator
* Cerebral aneurysm clip
* Neural stimulator (e.g. TENS-Unit)
* Any type of ear implant
* Ocular foreign body (e.g. metal shavings)
* Any implanted device (e.g. insulin pump, drug infusion device)
* Metal shrapnel or bullet
The Clinical Features of Combined Central and Peripheral Demyelination

The investigators conduct this study to clarify the clinical features and to evaluate the prevalence of anti-nodal/paranodal antibodies of patients with combined central and peripheral demyelination (CCPD) .

The investigators will review the clinical manifestation, laboratory test results, electrophysiological examination and neuroimaging findings of patients with CCPD. And we will detect antibodies to aquaporin 4(AQP4), myelin oligodendrocyte glycoprotein (MOG), neurofascin-155 (Nfasc155), neurofascin-186 (Nfasc186), and myelin-associated glycoprotein (MAG) in patients with CCPD.

Eligibility Criteria:
Inclusion Criteria:

1. T2 high-signal intensity lesions in the brain or spinal cord on MRI, or visual-evoked potentials(VEPs) abnormalities.
2. conduction delay, conduction block, temporal dispersion or F-wave abnormalities, suggesting peripheral demyelinating neuropathy regarding nerve conduction studies (NCS).

Exclusion Criteria:

1. infectious diseases(e.g., human T lymphocyte trophic virus type1-associated myelopathy, syphilis, neuroborreliosis, HIV infection or progressive multifocal leukoencephalopathy)
2. pre-existing inflammatory diseases (e.g., sarcoidosis, Behçet's disease, Sjögren's syndrome, vasculitis or other collagen diseases)
3. mitochondrial disease
4. metabolic/toxic diseases (e.g., vitamin deficiency, amyloidosis, chronic alcoholism, diabetes mellitus or subacute myelo-opticoneuropathy due to clioquinol intoxication
5. cervical spondylotic myelopathy
6. syringomyelia
7. spinocerebellar degeneration
8. multiple myeloma, other tumors
9. inherited diseases (e.g., leucodystrophies)
10. cerebrovascular disease
11. non-specific lesions on T2-weighted MRI (e.g., leucoaraiosis).