cyrilzakka/clinical-trials huggingface dataset:
Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type 2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment has been mandated to detect myocardial dysfunction because of the risk of heart failure with this treatment. Myocardial deformation imaging is a sensitive means of detecting LV dysfunction, but this technique has not been evaluated in patients treated with trastuzumab. The aim of this study was to investigate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than conventional echocardiographic measures in patients treated with trastuzumab.

The investigators will prospectively evaluate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR) and identify possibility of early detection of LV dysfunction in patients treated with trastuzumab.

Eligibility Criteria:
Inclusion Criteria:

* HER2(+) breast cancer, anticipating Trastuzumab therapy

Exclusion Criteria:

* Refusal to informed consent
* Congenital heart disease
* Significant arrhythmia in EKG
* Regional wall motion abnormality (+) in echocardiography
* Poor sonic window
Application of Simethicone in Esophagogastroscopy

This is a randomized controlled trial to comparing the different simethicone administration strategies for esophagogastroscopy. Recent studies have indicated that the administration of simethicone before endoscopic examination could shorten the procedure time and improve the diagnostic rate of the gastric mucosal lesions. But the time interval between simethicone administration and the examination has not been fully determined. This study will test whether the time of taking simethicone before endoscopy could influence the performance of the procedure in a randomized controlled trial. The results may benefit the current clinical practice.

Esophagogastroscopy can enable the direct examination of the esophageal and gastric mucosal lesions, which has been widely applied in clinical practice. However, during the examination, too much water, foam or residues in the stomach will not only increase the procedure time and the misdiagnosis rate, but also decrease the patients' tolerance, for more efforts should be made to deal with the excessive water, foam or residues in order to obtain a clear view of the mucosa. Simethicone is also called poly-dimethylsiloxane, which can be used to remove the foam and water. Although simethicone has been routinely administrated before the esophagogastroscopy, the optimal strategy of administrating simethicone has not been clearly investigated, especially the time to administrate simethicone. Intaking simethicone too early will result in too excessive water in the stomach, while if the patients take it too late it doesn't take effects. Thus, this is a study to determine whether selecting different simethicone administration strategies could improve the performance of the esophagogastroscopy and minimize the patients' dissatisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old patients
* Who agree to participate in the study
* Patients with the indications for gastroduodenoscopy

Exclusion Criteria:

* Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
* Severe uncontrolled coagulopathy
* Prior history of gastric surgery.
* Pregnancy and lactation
Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain

The aims of this study are to examine the effectiveness of functional range conditioning in patients with chronic non-specific low back pain in terms of improving hip internal rotation and strength of the hip abductors, and reducing pain and disability.

It will be a single blind two-arm randomized controlled trial. Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain will be invited to participate in this study. Subjects who will fulfill the study's criteria and who are willing to participate in this study will be asked to sign an informed consent form. The primary outcome will be the active and passive range of motion (ROM) of the hip internal rotators and it will be measured using digital inclinometer. The secondary outcomes in this study will be the maximum torque of the hip abductors (gluteus medius), concentric at a constant, low-speed, and high-speed. The peak torque and strength will be measured using isokinetic dynamometry, pain intensity will be assessed using a visual analog scale and disability will be assessed using Oswestry disability index. All participants will have their information taken by the principal investigator. Subsequently, participants will randomly be assigned to either the FRC group or the conventional treatment group by the principal investigator. Concealed randomization will be performed by means of a computer-generated table of random numbers. Outcomes will be measured at baseline, week 4 and week 8 for all participants in both groups by an assistant researcher.

Eligibility Criteria:
Inclusion Criteria:

* Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain

Exclusion Criteria:

* Hip, spine and knee pathology.
* Hip and knee replacement.
* Surgery and fracture within the last 6 months.
* Cancer.
* Pregnant women.
* Any medical condition that precluded safe participation in exercise programs such as significant cardiac, pulmonary, neurological disease or mental disorder.
Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment

This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.


Eligibility Criteria:
Inclusion Criteria:

1. patients \> 18 years of age;
2. patients with Chronic limb-threatening ischemia (CLTI);
3. patients with below-the-knee lesions undergoing endovascular treatment;
4. target limbs with certain WIfI stage;
5. patients voluntary and capable of follow-up;
6. informed consent.

Definition of CLTI:

A diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene).

Exclusion Criteria:

1. Contraindication for antiplatelet , anticoagulant or thrombolytic agent;
2. Contrast agent allergy;
3. Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;
4. Complications affecting surgical safety;
5. Major amputation was adopted to the target extremity;
6. The existence of aneurysm in the target vessels;
7. The existence of perforation, dissection or any other injury requiring intervention in the target vessels.
Fetuin-A, a Promising Serum Biomarker for Diagnosis of Non-Alcoholic Fatty Liver Disease

The work investigate the role of fetuin-A in the diagnosis and assessment of the severity of non-alcoholic fatty liver disease (NAFLD).

The prevalence of nonalcoholic fatty liver disease (NAFLD), which has recently become one of the most prevalent chronic liver illnesses, is about 25% worldwide. NAFLD is a progressive liver disease that can cause fibrosis and ultimately cirrhosis, in contrast to simple hepatic steatosis, which is considered to be a benign condition. The sole way to diagnose NAFLD and stage liver fibrosis has historically been a liver biopsy. There are a number of issues with this method, though. A liver biopsy is a painful and invasive diagnostic procedure that carries a risk of consequences.

Fetuin-A, also called the 2-Heremans-Schmid glycoprotein, belongs to the fetuin group of serum-binding proteins and is largely produced by hepatocytes. It is a phosphorylated glycoprotein. Fetuin-A can cause insulin resistance in the target organs, including the liver and skeletal muscle, as it is an endogenous tyrosine kinase inhibitor. A strong correlation between the level of circulating fetuin-A and the onset and progression of NAFLD has been described by accumulating lines of evidence, but the findings have been contradictory.

The investigators want to find out how fetuin-A affects the diagnosis and evaluation of the severity of non-alcoholic fatty liver disease (NAFLD) and to reveal the relationship between fetuin-A and the NAFLD fibrosis score (NFS).

Eligibility Criteria:
Inclusion Criteria:

* patients who were admitted to the university hospitals with inclusion criteria

Exclusion Criteria:

* Patients who are younger than 18 years old,
* Patients with a history of high alcohol consumption (more than 40 g/day for men and 20 g/day for women) over the previous five years,
* Patients who have concurrent hepatitis B and hepatitis C viral infections
* Patients with hepatobiliary malignancy, Wilson's disease, alpha-one antitrypsin deficiency, and autoimmune hepatitis,
* Pregnant women
* Patients who take steatogenic pharmaceuticals including amiodarone, valproic acid, antiretrovirals, methotrexate, and tetracyclines, or NAFLD treatments like vitamin E, metformin, and thiazolidinediones
Testing Different Modes of Cognitive Behavior Therapy

The purpose of this study is to test a novel behavioral treatment - Adapted Cognitive-Behavior Therapy (ACBT) - against standard Cognitive Behavior Therapy (CBT). The goal of the study is to determine if ACBT confers improved outcomes for women with depression and low literacy. Depression is a serious women's health issue. According to the World Health Organization, depression is the leading cause of disability worldwide with females reporting symptoms of depression at almost twice the rate of males. This study will provide pilot data to enable us to determine the effect size needed to detect a between-groups change in depression scores. The overall impact of this study will be empirical support for a novel form of treatment for women with depression, who also may lack adequate literacy, educational, or cognitive ability required to benefit from standard CBT.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. female
3. diagnosis of major depressive disorder (MDD) according to DSM-5 (Diagnostic and Statistical Manual-5) (and no specifiers that pertain to exclusionary criteria (e.g. MDD with psychotic features)
4. able and willing to give informed consent
5. able to communicate in English
6. willingness to be randomized to therapy
7. willing to complete all study assessments
8. at baseline, no plans to move from the Chicago area during the duration of the study

Exclusion Criteria:

1. history of bipolar disorder
2. history of psychosis
3. current substance use disorder of moderate or severe level of severity
4. suicidal intentions or actions within the past three months
5. known neurologic disease (e.g., multiple sclerosis, Parkinson's disease, cerebrovascular accident) and/or cognitive or neurologic impairment (e.g., Alzheimer's disease)
6. current participation in other psychotherapy (not including psychiatric appointments pertaining to medication management)
7. inadequate vision or hearing to interact with study materials
8. being a prisoner, detainee, or being in police custody
9. any current involvement in litigation
SEBBIN Silicone Gel-filled Testicular Implants

This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility Criteria:
Inclusion Criteria:

* The patient is an adult or a child at the time of implant placement with SEBBIN implant.
* The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.
* The patient has been informed of the study, has read the patient information letter and -provided oral consent.

Exclusion Criteria:

* The patient has silicone implants somewhere else than in the scrotal sac.
* The patient was diagnosed with one of the following pathologies:

  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
* The patient has a pathology that could delay healing.
* Custom-designed implants are used for surgery.
Move it, Move ID! Promotion of Physical Activity in Adolescents With Intellectual Disability

The aim of this study is to develop and implement an mHealth intervention focusing on the promotion of physical activity in adolescents with intellectual disability.

Overweight and obesity are globally challenging health problems and major risk factors for a number of chronic diseases, including diabetes, cardiovascular diseases and cancer. Sufficient physical activity (PA) is an important protective factor in the development of overweight and obesity. Adolescents with intellectual disability (ID) report lower levels of PA and higher rates of overweight and obesity in comparison to adolescents without ID. There is a dire need to find ways to promote PA in adolescents with ID for their present and future health. However, while PA promotion in adolescents is a welldeveloped science, there is only a handful of studies dedicated to adolescents with ID. Consequently developing and designing PA promotion interventions specifically tailored to the needs of youth with ID is of the utmost importance. Currently, however, there is a real knowledge gap in terms of fundamental research on crucial intervention mechanisms to promote PA in adolescents with ID, as well as specific behaviour change theories adapted to this population. The aim of the current research project is to co-create and evaluate a theory-based mHealth intervention, which focuses on increasing PA for adolescents with ID.

The underlying framework within the intervention development is the Behaviour Change Wheel, together with a co-creation approach which is a bottom-up approach in which the target group (adolescents with ID in this case) is actively involved in the development of the intervention. The result of this approach is contextually appropriate intervention and intervention strategies.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with mild ID
* Dutch speaking
* Having a smartphone or tablet (or being able to use a test smartphone from the research group)
* Having enough motor skills to engage in PA

Exclusion Criteria:

* Adolescents with moderate, severe or profound ID
One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses

Comparison of different contact lens materials.

This is a 1-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to sign informed consent form
* ages 18 years or older
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* Astigmatic power ≤0.75 D

Exclusion Criteria:

* Eye injury or surgery within 3 months immediately prior to enrolment for this trial
* Pre-existing ocular irritation that would preclude contact lens fitting
* Currently enrolled in an ophthalmic clinical trial
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
* Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* Current extended-wear users (sleep-in overnight)
* Current monovision lens wearers
* Pregnant women and nursing mothers
* Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)
Optimizing the Use of Morphine in Pre-Term Neonates

The purpose of this study is to improve the dosing of morphine in critically ill premature neonates.

The investigators hypothesize that identifying co-variates predictive of variability in morphine disposition and/or response will provide the scientific basis for rationale and individualized morphine dosing schemes in neonates and young infants.

60 preterm neonates ranging in gestational age from 22 to 32 weeks will be recruited from the NICU. Stratification by gestational age will be done to ensure broad representation. The decision to initiate morphine therapy will be based solely on clinical indications. Prior to morphine dosing, a biochemical assessment of hepatic and renal function will be obtained. A 0.05 mg/kg loading dose of morphine will be given by an intravenous infusion over 30-minutes in preterm neonates with a gestational age of less than 29 weeks, followed by a continuous infusion of 0.005 mg/kg/h, whereas a loading dose of 0.1 mg/kg will be given in preterm neonates with a gestational age of 29 weeks or more followed by a continuous infusion of 0.01 mg/kg/h. Pain assessment will be performed at baseline (prior to study medication administration) and at .5, 1, 2, 4, 8, 12 and 24 hours after the dose. At each of these time points infants will be videotaped for two minutes with two cameras. Videotapes will be scored afterward using standard validated pain assessment tools for preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates of both genders and all races
* postnatal age less than 30 days
* an indwelling (peripheral or umbilical) arterial line, and
* a clinical indication for intravenous morphine administration

Exclusion Criteria:

* Neonates with severe asphyxia, grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations, neurological disorders, and those receiving continuous or intermittent neuromuscular blockers.
* clinical or biochemical evidence of hepatic and renal compromise (including systemic hypoperfusion) or
* received drugs that are UGT2B7 substrates (including Lorazepam, ibuprofen, valproic acid, naloxone and other morphine derivatives or propanolol)
BFPET for Regional Myocardial Perfusion Imaging

BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in subjects with known or suspected coronary artery disease (CAD) as compared to standard nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or suspected CAD subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must provide written informed consent prior to any study related procedures;
* Subjects must be ≥ 21 and ≤ 85 years of age;
* Subjects must have known or suspected CAD documented by ≥2 segments of reversible perfusion abnormalities on a SPECT (MPI)study

Exclusion Criteria

* Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
* Blood pressure over 180/100mmHg
* Acute changes in comparison to most recent ECG;
* Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident (CVA), CABG or PCI
* Any pacemaker or defibrillator implanted within the last three months;
* Inability to remain in camera for approximately 60 minutes
* Bronchospasm
* Serum creatinine \> 2 mg/dL;
* Cancer patients who have received chemotherapy or radiation therapy within the past 60 days.
* Any exposure to any investigational drug(s) or medical device(s) within four (4) weeks prior to imaging study;
* Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination.
* NYHA Class III or IV Congestive heart failure;
* Subject has symptomatic hypotension
* Allergic or intolerant to aminophylline, nitroglycerin or metoprolol
* Allergic or intolerant to regadenoson or any of its excipients
* Prior participants in the study.
* Female subjects only: Positive serum and/or urine pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing.

Females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following BFPET administration.
Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects

The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
* Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
* When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.
* Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
* No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

Exclusion Criteria:

* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
* Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
* Positive results from urine drug screen test.
* Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
* Subjects who plan to receive or have had organ transplants.
* Subjects considered by the investigator to have other factors unsuitable for participation in this study.
Pilot Evaluation of Two Multipurpose Solutions in Regards to Corneal Staining

To evaluate corneal staining after contact lens instillation with two different multi purpose solutions.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 yrs or older
* Males or females
* Any race or ethnic background
* CL patients using (multipurpose solutions) MPS
* Patients using Acuvue 2 lenses

Exclusion Criteria:

* Corneal refractive surgery within 6 months of this study.
* Contact lens use on day of examination.
* Corneal ectasia.
* Current use of Restasis