cyrilzakka/clinical-trials huggingface dataset:
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography

This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis

This study will evaluate left ventricular patterns of remodeling and hypertrophy in patients with aortic stenosis, and compare two-dimensional echocardiography measurements (wall thickness) with three-dimensional echocardiography data(left ventricular mass). Along with a second objective to assess Doppler diastolic filling indices associated with the various patterns of left ventricular remodeling.

Previous studies(see reference list) were primarily derived from two-dimensional echo data set(based on wall thickness). Various patterns of left ventricular remodeling have been described in response to increased pressure overload.

Three-dimensional echocardiography is a relatively new technique that is being increasingly used in the Echocardiography Lab in selected patients. This technique holds promise of being more accurate for volume-related measurements than the standard 2-dimensional echocardiography techniques.

Eligibility Criteria:
Inclusion Criteria:

* Subjects more than 18 yrs of age through 90 yrs of age
* Both male and female
* Patients with moderate or severe isolated Aortic Stenosis
* Patients who have been referred for both two-dimensional and three- dimensional echocardiographies.

Exclusion Criteria:

* Poor acoustic windows
* h/o CAD and wall motion abnormality
Analysis on the Infection Risk, Prognosis, and Drug Sensitivity of Klebsiella Pneumoniae.

Nosocomial infections are increasing rapidly both internationally and domestically, especially carbapenem-resistant Klebsiella pneumoniae infections. However, there were still lack of evidence about the risk and prognosis in Taiwan. The choice of drug and related sensitivity test was also limited. We would analyze the infection risk, prognosis, and drug sensitivity of Klebsiella pneumoniae and focus on strategy to manage carbapenem-resistant Klebsiella pneumoniae infections.


Eligibility Criteria:
All adult patients (≥18 years) with K. pneumoniae bloodstream infection were included. Patients were excluded if there was other recognized bacteremia within two weeks before or after the first episode of K. pneumoniae bloodstream infection.
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.


Eligibility Criteria:
Key Inclusion Criteria:

Part A: Completed study drug treatment in parent study or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study

Part B: Completed study drug treatment in Part A or had study drug interruption(s) in Part A but completed study visits up to the last scheduled visit of the treatment period of Part A

Key Exclusion Criteria:

History of study drug intolerance in the parent study

Other protocol defined Inclusion/Exclusion criteria may apply.
Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients

The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.

The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) using the 6-minute walk test (6MWT) after supplementing with higher doses of dietary NO3- compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.

Eligibility Criteria:
Inclusion Criteria:

* Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 \<80% of predicted).

Exclusion Criteria:

* Smoking,
* failure to complete physical testing,
* on-going participation in rehabilitation programs,
* pacemaker or use of nicotine products,
* oxygen mask,
* beta blockers,
* antibacterial mouthwash,
* chewing gum or stomach-neutralizing medicine during the intervention.
Independent Walking Speed and Crossing a City Street

The purpose of this study is to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (\>120 cm/sec).

The ability to adequately perform functional tasks at a level that allows independent community living is key to measuring the success of any physical therapy program. The essential tasks needed to allow independent community living have been well documented in the elderly population. However, these tasks have not been delineated in the pediatric population. The investigators aim to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving in-or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (\>120 cm/sec). One essential task that is necessary in the urban environment is to have the ability to cross a street within the time constraint of a traffic signal. Walking speed becomes increasingly important for those living in urban settings, as the ability to cross the street safely is fundamental for achieving independence. One of the major criticisms of clinic/lab-based measures of gait speed is that relative performance may not be representative of independence within the community. Participants aged 5 to 21 years, will be recruited from the patient population at Blythedale Children's Hospital for a six week trial. Children will be assigned to one of two random groups: one weekly Balance Master sequence training group (in addition to their regularly scheduled therapy sessions) and a group that continue regularly scheduled therapy sessions alone. Gait velocity will be measured by "Walk Across" Functional Assessment using Balance Master long force plate.

Eligibility Criteria:
Inclusion Criteria:

* Ability to ambulate independently at least 25 feet with or without assistance device and/or orthoses.
* Receiving physical therapy services that include ambulation training.

Exclusion Criteria:

* Diagnosis of a progressive disorder.
* Inability to follow directions.
* Uncorrected vision impairment.
* Require additional physical assistance to ascend a ramp and over force plate.
* Refusal to participate.
Functional Assessment Protocol for the Upper Limb for Pediatric Age

During data acquisition a trained therapist placed reflective markers on the skin of the participants in the selected body landmarks. The participants will be asked to perform five trial for each upper limb of a determinate functional task for each session.

Acquired brain injuries (ABIs)and cerebral palsy (CP) can lead to a wide range of impairments, including weakness or paralysis on one side of the body known as hemiplegia. In hemiplegic patients, the rehabilitation of the upper limb skills is crucial, because the recovery has an immediate impact on patient quality of life. Therefore, an accurate upper limb motion analysis may be useful during medical diagnostic-therapeutic process, it is relevant to understand the integrated and synergic motion of the upper limbs for a variety of applications, such as clinical diagnosis, endoprosthesis design, and the evaluation of treatment outcomes. There are many clinical scales used to assess the upper extremity. Most of these use an ordinal-level scoring system, with scores assigned to the patient by the observing physician or therapist. Another way to assess upper limb activity is through kinematics data from 3D motion capture. Kinematics data provide an objective and quantifiable method, as well as allowing the use of several otherwise undetectable metrics: time, velocity, and joint angles. The aim of this study is introducing a new protocol consisting of a marker set, i.e. an innovative and integrated biomechanical model of the human body for the global analysis of upper limb during functional tasks allows for a more detailed evaluation of the motor behavior and its abnormalities to better characterize the functionality of the upper, both on the sagittal, frontal and transversal plane. The development of a new protocol of analysis requires the validation before its definitive and clinical application. More in detail, the validation should be carried out in terms of both comparisons with reference absolute measures and the evaluation of its repeatability with healthy subjects.

Eligibility Criteria:
For healthy group:

Inclusion Criteria:

- absence of functional impairments in the upper limbs

Exclusion Criteria:

* behavioral, visual or auditory problems
* presence of pain in the upper limbs

For pathological group:

Inclusion Criteria:

* Unilateral PCI candidates for CIMT (Constraint Induced Movement Therapy) treatment;
* Acquired brain injury candidates for CIMT or Bimanual treatment;
* Ability to understand and follow test instructions.

Exclusion Criteria:

* behavioral, visual or auditory problems
* presence of pain in the upper limbs
Very Low Calorie Diet Weight Loss

Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.

The overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (VLC) diet.

In order to address the general hypothesis the following specific aims will be addressed:

Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects.

Specific Aim 2: To test the hypothesis that variation in % weight loss to the 2-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

Specific Aim 3: To test the hypothesis that variation in % weight loss to the 4-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

Eligibility Criteria:
Inclusion criteria obese subjects:

Diagnosed with morbid obesity (defined as BMI \> 40 kg/m2 or BMI \> 35 kg/m2 with at least one serious comorbidity (2013 NIH compendium guidelines)) Scheduled for medically supervised Very Low Calorie Diet Age 30 years and older Ability to lay in supine or elevated position for 5 hours Willingness and ability to comply with the protocol Exclusion Criteria Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only) Participation in Weight Loss Management Program within the last 6 months prior the first study day Presence of fever within the last 3 days Untreated metabolic diseases including hepatic or renal disorder unrelated to the primary disease Presence of acute illness or metabolically unstable chronic illness unrelated to the primary disease

· (Possible) pregnancy Any other condition according to the PI or nurse that would interfere with the study or safety of the patient Failure to give informed consent Use of protein or amino acid containing nutritional supplements within 3 days of first test day
The Expanded Access Use of Viltolarsen in Duchenne Muscular Dystrophy With Confirmed Exon 53 Amenable Mutation

This is an open label expanded access program for boys, 3 to 12 years old, for the treatment of Duchenne muscular dystrophy (DMD) with confirmed mutation(s) in the dystrophin gene that is amenable to skipping of exon 53.

This expanded access program is designed to provide access to viltolarsen in patients with DMD with confirmed mutation(s) in the dystrophin gene amenable to skipping of exon 53, who in the opinion and clinical judgement of the treating physician, would benefit from treatment with viltolarsen.

Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 3 and ≤ 12 years of age
* Clinical signs compatible with DMD
* Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 53 to restore the dystrophin messenger ribonucleic acid (mRNA) reading frame
* Able to walk independently without assistive device
* Not able to participate in a Phase 3 trial

Exclusion Criteria:

* Chronic systemic fungal or viral infections
* An acute illness within 4 weeks prior to the first dose of viltolarsen
* Symptomatic cardiomyopathy
* Patient has a previous or ongoing medical condition, medical history, physical findings, or laboratory abnormality that could affect participant safety in the opinion of the treating physician
* Surgery within the 3 months prior to the first anticipated administration of viltolarsen and in the opinion of the treating physician would impact weekly treatment schedule
* Positive test results for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody at screening
* Currently taking any other investigational drug or has taken any other investigational drug within 3 months prior to the first dose of viltolarsen
* Previously enrollment in any viltolarsen study.
* Currently taking any other exon skipping agent or has taken any other exon skipping agent within 2 weeks prior to the first dose of viltolarsen (would need to be discontinued in order to be eligible)
* Any gene therapy for DMD
* Inadequate renal function as defined by a serum cystatin C \> 1.5 x upper limit of normal (ULN). If the value is \> 1.5 x ULN then the measurement can be repeated once. If repeat measurement is still \> 1.5 x ULN then the patient should be excluded.
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance.


Eligibility Criteria:
Inclusion Criteria:

* Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery.
* Subject is able to provide a signed informed consent form.
* Subject will agree to comply with all study-related procedures.
* Subject is not pregnant at this time by confirmation of one of the following:

  * Subject is male
  * Subject not of child bearing age
  * Subject is surgically sterile
  * Subject is not pregnant per negative hCG test
  * Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.

Exclusion Criteria:

* Subject does not meet inclusion criteria.
* Presence of non-viable tissue at the implantation site.
* History of septal perforation.
* History of polyps.
* Presence of concha bullosa.
* Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea.
* Subject is participating in a clinical trial which could affect the healing of the middle turbinate.
* Subject has uncontrolled diabetes.
* Subject is a:

  * smoker
  * severe drug abuser
  * severe alcohol abuser
* Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.
Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)

This is a prospective open comprehensive proof-of-principle pilot study.

This is a prospective open comprehensive proof-of-principle pilot study with patients of mild to moderate Alzheimer's Disease who have been treated with transcranial pulse stimulation (TPS)

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
* MMSE ≥ 10: Mild and moderate Alzheimer's Disease according to AWMF Register, S3 Guidelines of DGN 038/013 and DEGAM 035/021
* At least 3 months of stable antidementia therapy or no antidementia therapy necessary (Patients need to continue their standard treatment within the clinical investigation according to the guidelines as TPS is considered an additional treatment to standard therapy)
* Signed written informed consent
* 18 years ≤ Age ≤ 85 years
* Monthly pregnancy tests for female patients in childbearing age

Exclusion Criteria:

* Non-compliance with the protocol (including CERAD-plus)
* Pregnancy
* Breast-feeding women
* Microbubbles (contrast agents) in application area
* Cerebral pathology unrelated to Alzheimer's disease
* Metallic objects in the head
* Neurosurgical intervention of the brain / Craniotomy
* Cardiac disorders
* History of psychiatric diseases before development of dementia
* Hemophilia or other blood clotting disorders
* Cortisone treatment up to 6 months before first treatment
* Other conditions implying increased risk according to the judgement of the investigator
Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment

Research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.


Eligibility Criteria:
Inclusion Criteria:

* Patients currently residing at Arbor Terrace memory care unit
* Patients diagnosed with dementia

Exclusion Criteria:

* Hospice patients with less than 30 days of life expectancy at the time of enrollment
Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-T.

Patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.Every patient receive at least 2 cycles anthracycline chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Histologically confirmed primary infiltrating adenocarcinoma of the breast

  * Confirmed by core needle biopsy or incisional biopsy or surgery
  * Experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
  * At least 2 cycles same anthracycline based chemotherapy are needed

Exclusion Criteria:

* Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2
* With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart
* Pregnant or nursing
* Other currently active malignancy except nonmelanoma skin cancer
* Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
* Grade 2 or more Cardiac Toxicity (CTC AE3.0)
Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair

Because it avoids direct nerve irritation or entrapment, mesh fixation with tissue adhesive glue seems an optimal option to reduce postoperative pain. Indeed, preliminary results published with different glues all showed promising results with reduced postoperative pain.

This randomized controlled study aimed to compare mesh fixation using N-butyl 2-cyanoacrylate with classical suture fixation in Lichtenstein hernia repair in terms of chronic groin pain, postoperative complications, operative time and recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders aging between 18-65 years with primary unilateral uncomplicated inguinal hernia were included.

Exclusion Criteria:

* Patients with bilateral or sliding inguinal hernia.
* incarcerated or strangulated hernia
* recurrent inguinal hernia
* femoral hernia
* patients unwilling to participate in the trial.
Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.

Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.

Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.

Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years,
* Admitted to ICU within 72 hours,
* Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),
* Having acute hypoxemic respiratory failure with a \[PaO2/FiO2\] ratio between 100 mmHg and 300 mmHg,
* Having given free and informed written consent,
* Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

* Unable to achieve a prone position for mobility reasons,
* Unable to achieve a prone position due to agitation whatever the cause,
* With clinical occlusive syndrome in order to limit the risk of inhalation,
* Having a contraindication to the use of the esophageal catheter,
* Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,
* Having hypercapnia indicating the use of non-invasive ventilation (PaO2\> 50 mmHg),
* Having severe hypoxemia defined by PaO2 / FiO2 \<100mmHg,
* Ongoing pregnancy or breastfeeding,
* Subject to a measure for the protection of justice.