cyrilzakka/clinical-trials huggingface dataset:
Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic cardiomyopathy AND
* Moderate or severe mitral regurgitation AND
* Cardiac resynchronization therapy (CRT) ≥ 3 months prior to enrollment AND
* Maximal Medical Therapy (ACE-Inhibitor, beta blocker, aldosterone antagonist, diuretic, aspirin, statin)

Exclusion Criteria:

* nonischemic cardiomyopathy
* active heart failure
* current ranolazine therapy
* congenital heart disease
* mechanical valve prostheses
* vegetation/endocarditis
* significant pulmonary disease
* peripheral vascular disease
* trivial or mild mitral regurgitation
* creatinine clearance \< 30 mL/min
* liver cirrhosis
* strong inhibitors of CYP3A (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
* strong inducers of CYP3A (including rifampin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort)
* Strong P-glycoprotein inhibitors (including cyclosporine, verapamil, and quinidine)
* Initial QTc interval ≥ 440msec
Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

The main goal of the study is to describe the sublingual microcirculation of children with type 1 diabetes mellitus (T1D) with stable and satisfactory treatment of the disease and to compare it with previously measured parameters of healthy children, NCT05324228.

After recording the basic anthropometric parameters, pressure and pulse, each child who meets the inclusion criteria will have their microcirculation measured using a Sidestream Dark-Field (SDF) probe placed sublingually by one examiner using the SDF method. The measurement will be performed in supine position in a disease-free period, with normal diets, at least 2 hours after the last meal, for girls outside the menses period. Premedication or analgesia will not be used. A total of 3 video clips will be recorded from different parts of the sublingual area with a minimum length of 20 seconds in a row, unless the child needs a short break between measurements. The recorded videos will then be processed offline by one evaluator who is trained and experienced in microcirculation evaluation, three best and most stable parts of each video clip will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus
* informed consent of parents

Exclusion Criteria:

* acute infection
* period of metabolic decompensation and 14 days after it
Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Patients with Retinal Degeneration

The Vision Research and Assessment Institute (VRAI) was established with the purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision.

The mission of the VRAI is to enable the highest quality, standardized efficacy testing of patients with visual impairment.

The VRAI facilitates the development and refinement of existing endpoints specifically for testing patients with Low Vision.

The VRAI is a state-of-the-art research institute specifically for patients with low or very low vision due to diseases of the retina of the eye. The Institute is staffed by highly experienced Low Vision specialists and provides a comfortable, familiar environment for patient testing.

The study is a non-interventional prospective cohort study of up to 40 patients for each disease condition (Retinitis Pigmentosa, Choroideremia, Stargardt Macular Dystrophy, Geographic Atrophy from Age-related Macular Degeneration, X-linked Retinoschisis or other retinal dystrophies ).

Patients are scheduled for an initial visit where they are tested on a series of efficacy tests. Thereafter, patients will be invited to attend for a further visit up to two weeks and then periodically for up to one year. The objectives of the study are to evaluate how well patients use their vision, how the tests relate to activities of daily living, establish clinical meaningfulness, assess the impact of disease progression and the precision and accuracy of each test in the context of their eye condition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bilateral retinitis pigmentosa, choroideremia, Stargardt macular dystrophy, geographic atrophy from age-related macular degeneration, X-linked retinoschisis or other retinal dystrophies confirmed from previous eye examination records
* Best-corrected visual acuity between 20/70 and HM in at least one eye as tested with clinic-based visual acuity method
* Reasonably fluent in English

Exclusion Criteria:

* Cognitive impairment, memory loss or dementia sufficient in severity to preclude informed consent or in the opinion of the investigator would prevent satisfactory completion of some or all of the testing.
* Any circumstance that in the opinion of the investigator, would interfere with participation in, or compliance with the study protocol
* Current pregnancy as reported by patient
Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function

The objective of this study is to gain more knowledge about the association between muscle weakness, spasticity and motor control in children with cerebral palsy, and its relationship to hand function.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed spastic hemiplegic or diplegic cerebral palsy, reduced handfunction.
* Indication for treatment with Botulinum Toxin A
* Score 3 on House Classification of Upper-Extremity Functional Use
* Score 3 or better on Manual Ability Classification System

Exclusion Criteria:

* surgery within the last two years
* Treatment with Botulinum Toxin within the last six months
Pathogen Detection and Community Acquired Pneumonia

Study to compare the number of community-acquired pneumonia (CAP) pathogens detected using current diagnostic tests to the number detected using the BioFire Diagnostics investigational polymerase chain reaction (PCR) platform.

Patients diagnosed in the emergency department with CAP that requires hospitalization provide a sputum sample for culture and sensitivity testing, urine for detection of S. pneumonia and L. pneumophila, an anterior nasal swab for S. aureus PCR, a nasopharyngeal swab for S. pneumonia PCR and the FilmArray LRTI v.2.0 IUO Panel, and blood for procalcitonin testing and, in cases in which the patient is suffering rigors and hypotension, cultures. As part of this study, sputum or sputum equivalent will be acquired for testing using the FilmArray LRTI v.2.0 IUO Panel.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion Criteria:

* Inability to obtain sputum or sputum equivalent
The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter

The goal of this feasibility/pilot study is to investigate whether or not vascular ultrasound can be used to aid the diagnosis of May Thurner Syndrome, in adult patients presenting to the vascular department with unexplained left leg swelling. The main research objective it aims to answer are:

* The diameter variation of the left common iliac vein based on posture, using duplex ultrasound.
* To determine inter- and intra-observer variation of the diameter measurement of the left common iliac vein using duplex ultrasound.

Participants will have an ultrasound scan performed on their abdomen by three different clinical vascular scientists, and will have each scan performed whilst lying supine on an examination couch and again when the couch is tilted to 45 degrees.

Researchers will compare the results of symptomatic patients to asymptomatic patients, to see if there is a difference in the diameter of the left common iliac vein between these two groups.


Eligibility Criteria:
Inclusion Criteria:

* Participant has the capacity to consent
* Participant is required to have a vascular ultrasound scan in the vascular ultrasound department
* Participant is 18 years of age or older at the start of the study.

Exclusion Criteria:

* Previous iliac vein intervention or treatment for iliac vein disease
* Previous diagnosis of iliac vein thrombus
* Pregnancy
* Unable to provide appropriate informed consent
* The participant does not require a vascular ultrasound as part of their routine care
* Under 18 years of age at the start of the study
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 18 years of age at time of screening
2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment
3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
4. Absence of cirrhosis and advanced bridging fibrosis

Exclusion Criteria:

1. Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score \> 2 or an Ishak score \> 3
4. Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
5. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.


Eligibility Criteria:
Inclusion Criteria:

* Subject has undergone primary THA for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.

Exclusion Criteria:

* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated
Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in subjects with active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female; age 18 to 75 years
* Active RA for at least 6 months
* Active disease defined by having equal to or greater than 6 swollen joints and 6 tender joints, based on a 28 joint count
* On stable doses and regimen of allowed RA medications
* Currently receiving at least 10 mg of methotrexate a week. Patients unable to tolerate doses greater than 10 mg may also be eligible for enrollment.

Exclusion Criteria:

* Diagnosis of Felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic disease
* Any surgical procedure within 30 days of Screening or likely to need joint or tendon surgery or other surgical procedure during the study
* Intra-articular or intra-muscular corticosteroids within 60 days prior to dosing
* Previous treatment with any biologic response modifying agent for RA within 90 days or 5 half-lives, whichever is greater, prior to screening
* Previous treatment with rituximab at any time
* Use of corticosteroid therapy equivalent to an average daily dose of \>10 mg of prednisone
* Any Screening laboratory values that are out of allowed reference ranges
* Inability to comply with protocol or study procedures
* Any other significant illness or condition that may adversely affect the subjects participation in the study
Opportunistic Screening in Pharmacies for Atrial Fibrillation in Seniors (>65 Years)

Atrial fibrillation (AF) is the most common arrhythmia in Germany and is associated with an increased risk of thromboembolic stroke. The risk to suffer from AF increases with age. Early detection of AF and anticoagulation seem the most effective way of preventing ischaemic stroke in patients at risk. The guidelines of the European Society of Cardiology recommend opportunistic screening for AF by pulse check at each general practitioner visit for all patients aged 65 years or older.

The objective of this study was to test whether an opportunistic AF screening with a hand-held diagnostic tool in a German pharmacy setting is useful in detecting unknown AF among people in the age of 65 and older. Besides a pulse palpation with a hand-held ECG-stick the screening in the pharmacies also includes a questionnaire related to demographics and medical history of the subject as well as several questions concerning the stroke risk stratification (CHA₂DS₂-VASc). Every subject with a positive test result (indication on AF) is insistently asked to make an appointment with his or her general practitioner. The subject receives an information letter for his or her general practitioner that adverts to the positive screening result and the necessity of further diagnostic Investigation.

In order to assess the incidence of unknown AF as well as accomplish the secondary objectives of this study, two follow-ups by means of telephone interviews are performed. First, all subjects with a positive test result are called 8 weeks after the screening in the pharmacies was conducted. The subject is asked several questions concerning personal data/demographics, the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea and stroke, the bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the Intervention and the mace. 12 months after the screening in the pharmacies was performed, all participating subjects were called. The list of questions is similar to the one that is used during the first telephone interviews after eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* At least 65 years or older
* Signed informed consent
* Signed subject information

Exclusion Criteria:

* Insufficient language skills
* Limited cognitive abilities
* Limited physical abilities (i.e. tremor)
A Handwriting Intervention Program for Children With Tic Disorders

The purpose of this study is to evaluate the effectiveness of a computerized handwriting training protocol (MovAlyzeR), through daily practice of handwriting on an electronic device to improve handwriting skills in children with tic disorders (TD).

Handwriting is a functional skill underlying almost all academic performance of school-aged children, and handwriting impairment is highlighted by the World Health Organization as a barrier to school participation. The available evidence mentioned in the literature suggests handwriting skills are academically crucial, and handwriting deficits may lead to challenges in performing various academic activities both in and outside the classroom.

Given that children with TD are more likely to have handwriting deficits as suggested in a recent study, they are also more likely to have challenges in their academic performance and success as evidenced in the literature.

In the context of education, strong evidence indicated that handwriting has more cognitive and neurological benefits than using a keyboard when taking notes in the classroom. Therefore, reducing tics and improving handwriting skills rather than an adaptation approach using a word processor or computer may be the goal of intervention.

Results of the investigator's previous study showed that children with Tourette Syndrome (TS) or tic disorders (TD) demonstrated handwriting deficits when compared to the general children population, and were consistent with a recent study conducted in France showing that children with TS exhibited handwriting problems. In addition to illegibility issues in handwriting as indicated by the low score on the Test of handwriting skills (THS-R), children with TS or TD also demonstrated writing deficits in the areas of speed of writing and correct letter case formation.

Since handwriting deficit is an area of concern among children with TS or TD, one way to improve these children's handwriting skills is through handwriting practice. NeuroScript, LLC., has developed a software program (MovAlyzeR) that allows children to practice handwriting on an electronic device (such as tablet, laptop, etc). Given that the practice is completed on an electronic device with immediate feedback, this handwriting program may serve as a strong incentive to motivate children practicing handwriting. In order to provide evidence for the educators and therapists on the effectiveness of this software program, it is important to evaluate its effectiveness on improving handwriting skills among children with TS or TD.

Eligibility Criteria:
Inclusion Criteria:

* Tourette syndrome
* Diagnosed tic disorder

Exclusion Criteria:

* Diagnosed anxiety disorder
* Diagnosed learning disability
* Diagnosed dysgraphia
Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer

Men undergoing androgen deprivation therapy for prostate cancer may experience significant side effects including symptoms of intense heat, facial flushing, and sweating. These so-called hot flashes are similar to those experienced by women during menopause. A traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.

Recently, the awareness and use of herbal remedies and over-the-counter preparations for a number of different conditions have increased dramatically. This trial was, therefore, designed to determine if Dong Quai significantly reduces the incidence and severity of hot flashes in men following androgen deprivation therapy for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer treated with some form of androgen deprivation therapy for at least one month. This includes either surgical (bilateral orchidectomy) or medical (LHRH agonist, pure or steroidal antiandrogen or combined) castration;
* Greater than seven vasomotor episodes per week;
* Significantly bothersome symptoms associated with these vasomotor episodes, which produce a desire in the patient to seek treatment to reduce both their incidence and severity;
* Documented informed consent to participate in the trial.

Exclusion Criteria:

* Enrolment in any other clinical trial or study protocol;
* Presence of pain due to prostate cancer;
* Life expectancy less than three months;
* Any severe concomitant condition that would make it undesirable, in the clinician's opinion, or the subject to participate in the trial or would jeopardize compliance with the trial protocol;
* Concomitant anticoagulation therapy or history of bleeding disorder or blood dyscrasia;
* Known hypersensitivity to Dong Quai.