cyrilzakka/clinical-trials huggingface dataset:
High Frame Rate Ultrasound in Heart Disease Assessment

The study will compare standard ultrasound images to high frame rate ultrasound images in patients with heart disease or with a low risk of heart disease to see if a higher frame rate of ultrasound adds to the information obtained from standard ultrasound.

Following informed consent, patients recruited for the study will have an IV cannula inserted and will undergo imaging using 2 ultrasound systems. Standard clinical system (Philips IE33) will be used for 2D and CE imaging, followed by imaging using the Verasonics VantageTM research system (Verasonics Inc., Redmond, WA), using both conventional 2D and HFR modes.

Baseline unenhanced 2D and Doppler images would initially be acquired using Philips IE33 system and Verasonics VatangeTM unenhanced conventional 2D and HFR mode .

Ultrasound contrast agent (Sonovue) will be then injected via the intravenous (iv) cannula and 3 sets rest contrast images will be acquired - using the Phillips IE33, Verasonics and Verasonics VantageTM platform (conventional CE and HFR CE). Both systems will be optimised separately on each patient before and during infusion of contrast agent. When the optimal imaging and destruction parameters are set, there are not modified along the acquisition.

This is followed by dipyridamole infusion and the scans being repeated during stress - 3 sets contrast images will be acquired - using the Philips IE33 and Verasonics VantageTM platform (conventional CE and HFR CE).

Eligibility Criteria:
Inclusion criteria Either

* Ability to give informed consent
* age ≥18years and
* confirmed inducible wall motion / perfusion abnormality on previous stress echocardiogram
* known coronary artery disease - defined by presence of flow-limiting coronary stenosis(\>70% diameter stenosis) on coronary angiography.

OR

• patient who has been assessed as at low risk of having coronary heart disease

Exclusion Criteria:

* Inability to undertake pharmacological stress, ie previously known intolerance to dipyridamole;
* Moderate or Severe aortic or mitral regurgitation or severe mitral stenosis;
* Significant pulmonary disease like severe COPD or pulmonary fibrosis;
* Atrial fibrillation;
* Inability to provide informed consent;
* Pregnancy and lactation;
* Known allergy to Sonovue
* Patients with second and third degree heart block, unless they have a pacemaker fitted
* Systolic BP \< 90
* Known Myasthenia Gravis
* Bronchial asthma
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).

Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients of weight from 7.0 kg.
* For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings.
* For dermatological infections: subjects diagnosed with mild or moderate dermatological infection in terms of clinical symptoms/signs and laboratory findings.
* For otorhinolaryngological infections:subjects with purulent / mucopurulent rhinorrhea and postrhinorrhea, subjects diagnosed with mild or moderate otorhinolaryngological infection in terms of clinical symptoms/signs and laboratory findings
* For dental / oral surgical infections: subjects who have formed obstructive abscess and diagnosed with mild or moderate dental / oral surgical infection
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis

The purpose of this study is to evaluate the safety and efficacy (effectiveness) of Infliximab (Remicade) in patients with Giant Cell Arteritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

The purpose of this study is to see if infliximab is safe and effective in treating GCA. Currently, the only treatment for GCA is prednisone. GCA is a long lasting inflammatory disease. The cause is unknown. It may affect all the arteries, but it focuses on the big vessels such as those around the heart, the vessels in the neck and head, and their major branches. It can lead to vision loss, blindness, stroke, stenosis (narrowing of blood vessels) and aneurysms (a weakening in the lining of the blood vessel wall, which may eventually lead to rupture of the blood vessel). The damage to the arteries is caused by an immune response. A naturally occurring substance in the immune system called "tumor necrosis factor alpha" (TNFa) plays a significant role in this immune response against the blood vessels. This response is thought to cause the long-lasting inflammation (irritation and swelling of the vessels). By blocking the effect of TNFa we think that we may reduce the signs and symptoms associated with GCA. This trial will study patients who are stable on prednisone treatment by evaluating whether infliximab can control their symptoms as the dose of prednisone is reduced. Patients will receive infusions of either 5mg/kg of infliximab or placebo at weeks 0, 2, 6, 14, 22, 30, 38, and 46. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive receive infusions of either 5mg/kg infliximab or placebo infusions at weeks 0, 2, 6, 14, 22, 30, 38, and 46.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis of Giant Cell Arteritis (GCA)
* Patients who have a diagnosis of GCA of = 4 weeks' duration
* Patients who are receiving = 40 mg/day of prednisone/prednisolone Exclusion Criteria:
* Patients must not have a prior diagnosis of GCA \> 4 weeks
* Patients must not have failed to respond to glucocorticosteroid therapy within 5 days of initiation of therapy.
Using Virtual Reality to Train Children in Pedestrian Safety

Pedestrian injuries are among the leading causes of morbidity and mortality in American children ages 7-8, but existing behavior-oriented interventions achieve only modest success. One limitation to existing interventions is that they fail to provide children with the repeated practice needed to develop the complex perceptual and cognitive skills required for safe pedestrian activity.

Virtual reality (VR) offers a highly promising technique to train children in pedestrian safety skills. VR permits repeated unsupervised practice without risk of injury; automated feedback to children on success or failure in crossings; adjustment of traffic density and speed to match children's skill level; and an appealing and fun environment for training. The proposed research is designed to test the efficacy of virtual reality as a tool to train child pedestrians in safe street-crossing behavior.

A randomized controlled trial will be conducted with four equal-sized groups of children ages 7-8 (total N = 240). One group will receive training in an interactive and immersive virtual pedestrian environment. The virtual environment, already developed, has been demonstrated to have face, construct, and convergent validity. The second group will receive pedestrian safety training via video and computer strategies that are most widely used in American schools today. The third group will receive what is judged to be the most efficacious treatment currently available, individualized behavioral training at streetside locations. The fourth and final group will serve as a no-contact control group. All participants in all groups will be exposed to a range of field- and laboratory-based measures of pedestrian skill during baseline and post-intervention visits, as well as during a six-month follow-up assessment. Primary analyses will be conducted through linear mixed models designed to test change over time in the four intervention groups. We hypothesize all children in active learning groups will increase pedestrian safety skills, but the largest increase will be among children in the virtual reality group.


Eligibility Criteria:
Inclusion Criteria:

* 7 and 8 year old children living in Birmingham, Alabama, area

Exclusion Criteria:

* family plans to move within 6 months of recruitment
* visual or perceptual impairment (e.g., blindness) that are uncorrected and would prevent valid participation in protocol
* physical impairment (e.g., use of wheelchair) that would prevent valid participation in protocol
* cognitive impairment (e.g., moderate mental retardation) that would prevent valid participation in protocol
Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services

The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.

This project will examine the implementation and effectiveness of an ASD executive functioning intervention, entitled Unstuck and On Target, adapted for use in community mental health clinics. Minimizing the impact of executive functioning deficits in youth has broad public health implications, including improving the effectiveness of mental health services for youth such as those with autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD). Improved executive functioning also has the potential for improvement in real-world functioning, including daily living skills, mental health, and educational outcomes. Although Unstuck and On Target is an established evidence-based intervention, the effectiveness of this intervention in mental health settings has not been established. Therefore, the primary aim is to collect data on implementation outcomes of the adapted intervention, including feasibility, utility, and therapist fidelity, in mental health settings. The secondary aim is to collect data on the preliminary effectiveness of Unstuck and On Target adapted for mental health settings. This study has the potential to make a significant impact by building local capacity to serve school-age children with executive functioning deficits in routine service settings, and advancing the science on the effectiveness of an established evidence-based practice (Unstuck and On Target) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/setting.

Eligibility Criteria:
Inclusion Criteria for Therapists:

1. Employed as staff or a trainee at participating clinic (publicly-funded mental health program)
2. Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months).
3. Has an eligible client on current caseload (see below).

Inclusion Criteria for Child Participants

1. Child age 5-13 years.
2. Has a current ASD diagnosis on record.
3. English or Spanish speaking.

Exclusion Criteria for Child/ Parent Participants

1. Child does not present with executive functioning deficits.
2. Child does not meet criteria for ASD via case record, on the Autism Diagnostic Observation Scale or exhibit other clinical indicators of ASD
rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets

Evaluation of efficacy and safety of recombinant factor VIIa versus standard therapy in preventing early haematoma growth in spontaneous acute intracerebral haemorrhage in patients treated with oral anticoagulants or antiplatelets agents

Intracerebral hemorrhage (ICH) is the deadliest, most disabling, and least treatable form of stroke. Approximately 40% of patients die within 1 month of ICH onset, and two-thirds of survivors never regain functional independence. Though guidelines for supportive care exist, there is currently no treatment that has been shown in a randomized-controlled trial to definitely improve outcome after ICH. Hematoma volume is a critical determinant of mortality and functional outcome after ICH, and early hematoma growth may be an important cause of early neurological deterioration.

Considerable clinical interest has been given to the relationship between antiplatelet and antithrombotic treatment and ICH.

The reported incidence of major bleeding events in patients undergoing antithrombotic treatment is 5-11/1,000 patients/year, while the overall range of hemorrhages is about 62/1,000 patients/year.In the patients treated with antithrombotic drugs (oral anticoagulants or antiplatelets agent) the incidence rate of ICH has been shown higher than in the general population. Moreover, the mortality rate for both spontaneous and post-traumatic events is higher in antithrombotic treated patients than in controls. \[14,15\] rFVIIa has been successfully used to control ICH in patients with hemophilia or other coagulation disorders, and can arrest intraoperative bleeding and reverse coagulopathies in patients undergoing neurosurgical procedures.\[19\] rFVIIa has also been reported to prevent or minimize refractory bleeding in non-coagulopathic patients.

Eligibility Criteria:
Inclusion Criteria:

* ICH in patient on treatment with one of the following:
* a)oral anticoagulant (INR upper than 1,4 at enrollment
* b) aspirin, whatever dosage
* Male or female subjects, age \> 18 years.
* Informed consent

Exclusion Criteria:

* INR below 1.4 for patients on oral anticoagulants.
* Patients with secondary ICH related to infarction, tumor, cerebrovenous thrombosis, thrombolysis.
* Planned neurosurgical intervention.
* Any history of haemophilia or other congenital or acquired coagulopathy requiring specific antihemorrhagic treatment.
* Acute myocardial ischaemia or acute thrombotic stroke (within one year).
* Septicemia, intravascular disseminated coagulation.
* Pregnancy.
* Limb amputation due to vascular disease or claudication within last 30 days.
* Known or suspected allergy to the trial product or related products.
* Participation in other trials within the previous year.
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.

This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus ≥ 12 months
* Treated with multiple daily insulin injections or CSII ≥ 12 months
* BMI 18.5-28.0 kg/m² (both inclusive)
* HbA1C%≤9%

Exclusion Criteria:

* Type 2 Diabetes Mellitus
* Receipt of any trial product within 60 days prior to this trial
* Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
* Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
* Any systemic treatment with drugs known to interfere with glucose metabolism
* Use of any tobacco or nicotine-contained product within one year prior to screening
Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)

Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.

Patients will be randomized using sealed and numbered envelopes and will be assigned to receive a similar ovarian stimulation regime incorporating either Gonal-F or highly purified Fostimon as the hormonal analog. Ovarian response using either of the two compounds, pregnancy rates and miscarriage rates will be compared to define possible statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* PCOS
* Primary infertility
* No other fertility manifestation

Exclusion Criteria:

* Non PCOS
* Secondary infertility
Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization

The purpose of this study is to evaluate

1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone
2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Objectives: The purpose of this study is to evaluate

1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone
2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and pre-molars will be allocated in this randomized, controlled, single blinded study to one of the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont Repair+Curodont Protect) or control (Fluoride Varnish) group.

Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS) in addition to the Global Impression of Change Questionnaire will also be used for the evaluation of the outcome.

Eligibility Criteria:
Inclusion Criteria:

* Early occlusal carious lesion which does not require an invasive treatment (ICDAS-II scores: 2 and 3)
* Size and form of the lesion: the lesion must both be fully visible and assessable and accessible
* Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
* Written informed consent before participation in the study

Exclusion Criteria:

* Evidence of tooth Erosion
* Fluoride varnish application \< 3 months prior to study treatment
* History of head and neck illnesses (e.g. head/neck cancer)
* Any pathology or concomitant medication affecting salivary flow or dry mouth
* Any metabolic disorders affecting bone turnover
* Concurrent participation in another clinical trial
Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia

This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.

Left bundle branch pacing (LBBP), achieved via trans-septal approach with the pacing tip at the left side of the ventricular septum, has recently initiated and been well practiced in China. LBBP is characterized with relatively ease of implantation (usually \<5 minutes fluoroscopic use time), narrow paced QRS duration (similar to physiological pacing), low and stable pacing threshold (usually around 0.5V @0.5ms, good for device longevity and long-term stability without need of back-up pacing lead), high R wave amplitude for pacing management, and LBBB (left bundle branch block) correction by a low pacing output.

LBBAP (left bundle branch area pacing) can generate a relatively narrow QRSd and fast left ventricular activation. As AV interval is an important pacing parameter relevant to cardiac function. This study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 80 years old
* Patients who are willing to provide Informed Consent
* Patients who received LBBAP for at least 3 months
* Patients' implanted device can provide intracardiac electrograms
* Bradycardia patients with AVB or heart failure patients with LBBB

Exclusion Criteria:

* Patients who are pregnant or have a plan for pregnancy during the study
* Patients with persistent AF
* Patients who have medical conditions that would limit study participation
* Patients who were already enrolled in other clinical trial which would impact his/her participation
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

This study seeks to understand how frailty, a term that describes people who are more vulnerable stressors such as a new medical problem, affects the outcomes and quality of life in adult patients with gynecologic cancer.

PRIMARY OBJECTIVE:

I. Assess the risk factors associated with frailty in newly diagnosed gynecologic cancer participants.

SECONDARY OBJECTIVES:

I. Compare primary quality of life endpoint of "healthy days at home" between non-frail and frail participants (primary quality of life endpoint).

II. Compare other perioperative, oncologic, and quality of life outcomes between non-frail and frail participants.

OUTLINE: This is an observational study.

All new patients being evaluated for a new diagnosis of gynecologic cancer by the University of California, San Francisco (UCSF) Gynecologic Oncology service and the Dana-Farber Cancer Institute will be recruited in both the outpatient or inpatient setting. Study participants will be enrolled at the time of diagnosis and followed for up to one year after undergoing surgery for cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Undergoing evaluation for a newly diagnosed gynecologic malignancy
* Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

* Contraindication to any study-related procedure or assessment
* Does not speak a language for which the consent form and study materials are available