cyrilzakka/clinical-trials huggingface dataset:
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System

The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date.

The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of

* Death
* Symptomatic embolism (systemic arterial embolism or pulmonary embolism)
* Bacteremia og pocket-infection
* Removal of a CIED due to new infection


Eligibility Criteria:
Inclusion Criteria:

* Culture positive or negative infection of a CIED acording to PI
* Indication for removal of device
* Indictation for reimplantation of new device
* A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered
* stabilization criteria fulfilled i.e. I) negativ blood cultures, II) WBC \< 15 mia/L or reduction of min. 25% and III) CRP \<50 or min. 25% reduction.

Exclusion Criteria:

* Immunoincompetence (active chemotherapy or prednisone treatment \> 20mg/day
* Device-infection within last 6 months (relaps)
* Septic shock
* Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment
ivWatch Model 400: Device Validation for Infiltrated Tissues

A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Pass health screen by clinician
* 18 years or older

Exclusion Criteria:

* Fail health screen
A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children

In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.

Please note that the present study is allocated two study phases, i.e. phase I and phase III.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years) who are scheduled to undergo Gadolinium (Gd)-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view).

Exclusion Criteria:

* Clinically unstable patients (e.g. intensive care unit)
* Renal insufficiency
* Patients undergoing a relevant change in chemotherapy \</= 48 hours prior to and up to 24 hours after the administration of Gadovist.
Parasagittal Vs Cornerpocket Approaches

Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.

Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.

Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .

A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.

The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .

A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach

After approval of research ethics committee of Sohag University hospital, a written consent will be taken from all participants to use their data for research and educational purposes The study will be carried on 80 participants who undergo elective upper limb surgery for a comparative study.

In this study the investigators will use A 22 G Spinal needle , a high frequency linear probe of US and 2 % lidocaine and 0.5% bupivacaine as local anathetics ,Every participant will be informed about advantages and disadvantages of the research and has the right to withdraw at any stage without negative impact on medical service production.

For both types of block:

Wide bored cannula is inserted,Monitoring is applied (pulse,Ecg,Bp) Oxygen mask 5 liters , Participants were positioned supine with the head turned to the non-operative Side ( contralateral side), and a pillow under the head and shoulder with the ipsilateral arm placed adducted by the patient side.

After that we sterilize the skin and apply a local anesthetic (2-3 ml of2% lidocaine).

The total volume of the local anesthetic mixture was 30 ml (10 ml of 2% lidocaine mixed with 20 ml of 0.5% bupivacine ) Then participants will be divided randomly into 2 groups ,each group 40 participants.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years old
* ASA grade I to II
* Elective upper limb surgery

Exclusion Criteria:

* Patient refusal.
* Patient with neurological deficit in the limb of surgery
* Patients with psychiatric disease.
* Coagulopathy.
* Morbid obesity.
* Known allergy to used local anathetics
* Local infection at the block site.
Nitric Oxide and the Autonomic Nervous System

The amount of blood flowing to the different parts of the body is regulated by the autonomic (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is one of the most important of these metabolic factors. If the production of NO is slowed or stopped the amount of blood to the different parts of the body is decreased. There is increasing knowledge that NO mechanisms are impaired in a number of medical conditions. NO function is reduced in patients with risk factors for atherosclerosis (hardening of the arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes mellitus, and is also impaired in smokers. This NO "deficiency" is believed to contribute to the greater cardiovascular risk that marks these patient populations. This study is designed to examine if endothelial nitric oxide is an important control mechanism of blood pressure under normal conditions, and if impairment of nitric oxide contributes to hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects.
* 18 to 85 years.
* Non-smokers or long term smokers for specific aim 6.
* Drug-free.
* Long term hypertension in specific substudy 3, patients with autonomic failure in specific aims 4 and 5, diabetes mellitus in specific aim 5.

Exclusion Criteria:

* Being on any medication other than antihypertensives (for hypertensives), autonomic medications (for autonomic failure \[AF\] patients), insulin or other treatment for diabetes (for diabetic patients).
* Having pulmonary, renal, hematopoietic, hepatic and/or cardiac disease.
Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care

Wheat allergy is increasing in Thailand. Some studies show that cutaneous exposure of allergen may cause allergy and there are many wheat containing skin care products that are over-the-counter. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to wheat and omega-5 gliadin in wheat allergy patients after stop using wheat containing skin care products.

All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by medical history, medical examination included skin status (suspected atopic dermatitis or not). Blood sample was taken for baseline determination of immunoglobulin E antibodies to wheat and to omega-5 gliadin. Transepidermal water loss was examined in case with atopic dermatitis. The primary outcome was the specific immunoglobulin E antibodies to wheat and omega-5 gliadin in case that stop using wheat containing skin care product and case that continue using products.

Eligibility Criteria:
Inclusion Criteria:

* children age 1 to 18 years
* History of IgE-mediated wheat allergy

Exclusion Criteria:

* Parents refused to sign the consent
* severe atopic dermatitis
* on oral immunothery
* severe IgE mediated reaction after using wheat containing skin care product
Digital Wavefront Sensing

A holographic optical coherence tomography (H-OCT) setup is used to detect the wavefront by means of phase reconstruction.

H-OCT will be tested in this study for its suitability for the qualitative investigation of aberrometry. We aim to achieve a digital equivalent for wavefront calculation of the widespread analog procedure commonly used with conventional wavefront-aberrometers. The results will be compared with those from a conventional analog wavefront calculation method.

In the course of this pilot study, 20 eyes of phakic and 10 eyes of pseudophakic subjects with suspected higher order aberrations will be examined using H-OCT.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Men and women aged between 18 and 85 years
3. Normal ophthalmic findings except refractive errors or suspected higher order aberrations
4. Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

1. Hyperopia \> +6 Dpt. and Myopia \< -6 Dpt.
2. Known ophthalmic diseases such as age related macular degeneration, diabetic retinopathy, glaucoma, retinal detachment or previous ocular trauma and surgeries except cataract extraction
3. Participation in a clinical trial in the previous 3 weeks
4. Presence of any abnormalities preventing reliable measurements as judged by the investigator
5. Pregnancy, planned pregnancy or lactating
To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.

This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.


Eligibility Criteria:
Inclusion Criteria:

1. Female postmenopausal subjects aged \>30 to \<75 years
2. At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her

   * vaginal dryness
   * vaginal and/or vulvar irritation/ itching
   * dysuria
   * vaginal pain associated with sexual activity
   * presence of vaginal bleeding associated with sexual activity
3. Have \<5% superficial cells on vaginal smear cytology and vaginal pH \>5.0 at Visit 1
4. Systolic blood pressure \<150mm Hg and diastolic blood pressure \<90mm Hg at Visit 1

Exclusion Criteria:

1. Known hypersensitivity to Estradiol vaginal tablet
2. Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
3. History of undiagnosed vaginal bleeding.
4. History of significant risk factors for endometrial cancer
5. For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.

The analysis population is defined as all the set of de-identified patient results received from the practices who met the inclusion / exclusion criteria. A target recruitment of 2000 subjects with an expected loss of 20% (400 subjects) and an overall event rate of 30% (480 subjects of 1600) will result in 480 cases and 1120 controls, where cases are defined as those patients with NCCN unfavorable intermediate risk or worse disease. With a significance level alpha of 0.05, the number of cases above will result in a statistical power (1-ß=0.2) of at least 80% to show a significant increase in performance of the full assay over clinical variables alone, assuming that performance characteristics are similar to those observed in a retrospective, independent training cohort and that the patients in the SAFELY cohort resemble this same training population.

Eligibility Criteria:
Inclusion Criteria

* Men between 40-80 of age with at least a 10-year life expectancy
* All active surveillance protocols are accepted
* No PSA limits

Category 1:

* Patient is currently on active surveillance with only ONE previous low grade prostate biopsy.
* Patient must already be scheduled for their 1st annual biopsy under their active surveillance protocol within 90 days of enrollment date.

Category 2:

• Patient is recently diagnosed with low grade prostate cancer but has decided against active surveillance and is scheduled for radical prostatectomy within 90 days of enrollment date.

Exclusion Criteria:

Men on watchful waiting i.e. those with less than 10-year life expectancy with no intent for curative therapy

* Men with symptoms or rising PSA who have not been proven to have cancer by tissue biopsy i.e. men with only negative prostate biopsies.
* Patients with a history of a different cancer (except basal cell carcinoma)
Randomized Controlled Trial of Supervision Strategies to Improve Clinician Fidelity to Trauma-focused CBT

The primary goal of this study is to examine the impact of varying supervision strategies on clinician fidelity and client outcomes in a community-based setting. Prior research has established that training approaches that do not include a period of intervention-specific supervision or consultation are ineffective and that implementation efforts that include only an initial period of supervision show an eventual attenuation of gains in knowledge and fidelity in practice. Ongoing supervision may be required for effective and sustained implementation of evidence-based practices (EBPs) in community-based settings. However, supervision is one of the least investigated aspects of training. "Gold standard" elements of supervision from efficacy trials include review of sessions, standardized procedures for monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in community-based settings is unknown.

There are a growing number of national and statewide efforts to increase the reach of EBPs through dissemination and implementation initiatives. There are 18 statewide initiatives to implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those for other EBPs, include a specific focus on supervisors. However, the limited scientific literature provides very little guidance for these efforts. Aims of the current trial include 1) studying supervision with existing implementation supports; particularly presence of gold standard elements; 2) evaluating the effects of varying supervision strategies on fidelity and client outcomes; and 3) testing the mediating effect of treatment fidelity on the relationship between supervision type and client outcomes. We propose a two-phased, within-subjects and between subjects design. In Phase I (9 months), we examined supervision with implementation support. In Phase II (30 months), we will examine two specific supervision conditions, each including varying EBP supervision elements.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 6-17 who are starting Trauma-focused Cognitive Behavioral Therapy (TF-CBT) with one of our enrolled clinicians.They must also have significant Post Traumatic Stress symptoms as measured by a score of 21 or higher on the UCLA PTSD-RI, and live with a parent or guardian who is willing to participate in the study.
* Community-based mental health clinicians who are employed in Regional Support Network agencies (state Medicaid clinics) who have participated in the Washington State Initiative for TF-CBT and are supervised by a participating supervisor, or have completed the TF-CBT web training and been supervised on a case.
* Community-based mental health supervisors trained in the WA State Initiative in TF-CBT and employed at participating clinics in WA.

Exclusion Criteria:

* Non-English speaking child.
Correlation Between Altered Glycometabolic Status and Joint Inflammation in Diabetic Patients With Osteoarthritis Undergoing Knee Arthroplasty

Evaluate the correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee replacement surgery


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients
* Patients with osteoarthritis awaiting knee replacement surgery
* Patients awaiting knee replacement surgery
* Patients who agree to sign informed consent

Exclusion Criteria:

* Patients less than 55 years of age.
* Patients over 85 years of age.
* Patients who are unable to understand and want.
* Patients with severe neurological disorders or with severe disabilities.
* Rheumatoid arthritis patients
* Cancer patients
* Patients suffering from chronic inflammatory bowel syndromes (RCU and Crohn's disease)
* Patients on immunosuppressive therapy
The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke

The purpose of this study is to see whether treating subjects for wrist rehabilitation following stroke with Botox® and robotic therapy is more effective than treatment with robotic therapy alone and no Botox®.

This study will explore new ways to facilitate rehabilitation of wrist function after stroke. One of the challenges of recovery is muscle stiffness or excessive muscle tone that often limits exercise or therapy progress. Taking this into account, the investigators propose treating the wrist and forearm with a combination of a one-time Botox® injection and a 6-week robotic therapy protocol to maximize recovery.

Botox® is a drug that is injected directly into a muscle to temporarily relax the muscle. Botox® is commonly used to decrease muscle tone in tight muscles in the stroke population. Robotics therapy provides highly repetitive mass practice with visual and haptic feedback.

Subjects will be randomized to two groups. Group A will receive the Botox® injection and group B will receive a placebo saline injection. Both groups will receive the same robotics therapy protocol. Subjects and investigators will be blinded to group assignment. The investigators would like to know if there are trends between groups in a variety of outcome measures depending on what intervention they received. The investigators predict that the treatment group will have better results than the control group on the Fugl Meyer, our primary outcome measure. The investigators hope the results of this pilot study will guide development of a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* \> 6 months post-stroke
* Single stroke
* Ashworth Scale of \> 2 but \< 4 for wrist flexors and pronators
* Able to follow multiple step directions
* Completed all active occupational therapy
* Motor strength \> 1/5 at the wrist extension and supination
* Passive ROM of 0-45 degrees at wrist flexion and extension, 0-20 degrees at radial deviation, 0-20 degrees at ulnar deviation, 0-45 degrees at pronation and supination
* No Botox® injection in the wrist/forearm muscles for at least 12 months
* Naïve to robotics study protocol

Exclusion Criteria:

* Joint contracture and wrist or forearm
Effect of Fentanyl on Pain Severity and Duration of Labor

Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain of delivery. It is necessary to be known effect of these drugs on the mother and fetus during labor adverse. Therefore, the purpose of this study was determination of effect of Fentanyl intravenously on pain severity during the active phase of labor.


Eligibility Criteria:
Inclusion Criteria:

* multiparas pregnant women (gravid 2-7),
* term singleton pregnancy,
* cephalic presentation,
* low risk pregnancy with no history of drug tolerance (addiction),
* medical and mental diseases.

Exclusion Criteria:

* Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).