cyrilzakka/clinical-trials huggingface dataset:
Telerobotic Ultrasound for Carotid Imaging - Feasibility Study

In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.

BACKGROUND

Ultrasonography is an inexpensive, noninvasive, radiation-free diagnostic tool that is indispensable in modern medicine. Carotid intima-media thickness (IMT) and carotid atherosclerotic plaque detection have been powerful screening tools for identifying patients at risk for cardiovascular events; including myocardial infarction, cardiac death, and stroke. The need for trained sonographers by the patient side to perform quality ultrasound studies has limited the accessibility to this imaging tool, both in terms of location and time of day. Robotic arms controlled remotely over the internet, by trained sonographers, can potentially provide easier and more ubiquitous access to ultrasonography in and outside traditional medical facilities, including remote villages in underdeveloped countries, disaster areas, battle zones, etc. In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.

HYPOTHESIS:

Telerobotic ultrasound performed by an experienced sonographer over the Internet produces diagnostic images with quality similar to manual conventional imaging.

AIMS:

1. Telerobotic ultrasonography produces diagnostic images of the carotid arteries at a rate that is non-inferior to those obtained using standard manual acquisition.
2. Telerobotic ultrasonography can detect carotid atherosclerotic plaques at a rate that is non-inferior to the gold standard of manual acquisition.

IMPLICATIONS:

Realizing our study aims could mark a new era in ultrasonography. There are wide applications for telerobotic carotid ultrasonography in atherosclerosis screening. Furthermore, establishing the noninferiority of telerobotic carotid ultrasonography acquisition will provide a rationale for further studies in telerobotic ultrasonography, including echocardiography. This in turn has even wider clinical applications such as emergency studies in hospitals during weekends and after-hours. In addition, this could pave the way for use in disaster areas and battle zones where expert sonographers may not be available on-site.

Eligibility Criteria:
Inclusion Criteria for Cohort A

* Healthy volunteer
* \>18 years of age
* Signed informed consent

Exclusion criteria for Cohort A include:

* Prior stroke or transient ischemic attack
* Prior heart attack.
* Prior angioplasty/stent of the heart artries
* Prior bypass surgery of the heart
* Known history of peripheral arterial disease claudication Peripheral arterial revascularization
* known history of carotid artery stenosis

Exclusion criteria for Cohort B include:

* known history of carotid artery stenosis
* known history carotid artery dissection
Gene Therapy in Treating Patients With Ovarian Cancer

Phase I trial to study the effectiveness of gene therapy in treating patients with ovarian cancer that has not responded to previous treatment. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer cells more sensitive to treatment.

OBJECTIVES:

I. Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and paclitaxel-resistant ovarian epithelial cancer.

II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.

III. Document the observed anti-tumor activity of this regimen in these patients.

IV. Evaluate the biological endpoints (e.g., induction of apoptosis, p53 expression) of this regimen in these patients.

OUTLINE: This is a dose escalation study.

Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic ovarian epithelial cancer that is platinum- and paclitaxel resistant as defined by: Disease progression while on first-line regimen containing both a platinum drug and paclitaxel OR Tumor progression within 6 months of completion of platinum-based therapy (either as first- or second-line) or paclitaxel-based therapy (either as first- or second-line)
* Refractory or recurrent ovarian epithelial cancer as defined by: Lesions of any diameter
* Nonmeasurable disease (with CA-125 at least 35)
* Ascites and/or pleural effusions allowed
* No borderline or low malignant potential tumors

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: Zubrod 0-2
* Life expectancy: At least 12 weeks
* WBC at least 3,000/mm3
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 mg/dL PT/PTT normal
* Creatinine no greater than 1.4 mg/dL
* No active, unresolved upper respiratory infections
* Not HIV positive
* At least 5 years since prior malignancy, except nonmelanomatous skin cancer
* Willing and able to undergo placement of Tenckhoff catheter in the peritoneal cavity for sampling of ascites or peritoneal fluid
* No concurrent serious medical illness
* No untreated gastrointestinal obstruction
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* May have failed an unlimited number of prior chemotherapy regimens
* At least 30 days since prior chemotherapy
* No prior radiotherapy to the pelvis or abdomen
* Eligible for laparoscopy
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas:

1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
2. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
3. Post-transplant lymphoproliferative disorder (PTLD)
4. EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL)

The study was terminated prematurely and did not reach its target enrollment.

Eligibility Criteria:
Key Inclusion Criteria:

* EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent.
* For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed
* For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated)
* No available therapies in the opinion of the Investigator
* Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy
* Measurable disease per Cheson 2007
* ECOG performance status 0, 1, 2
* Adequate bone marrow function

Key Exclusion Criteria:

* Presence or history of CNS involvement by lymphoma
* Systemic anticancer therapy or CAR-T within 21 days
* Antibody (anticancer) agents within 28 days
* Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant
* Less than 90 days from prior allogeneic transplant.
* Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1
* Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
* Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).
Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>18 years.
* Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.

Exclusion Criteria:

* A history of surgical or percutaneous coronary revascularization
* Non-revascularized angiographic obstructive coronary artery disease (\>50% diameter reduction).
* Normal invasive coronary angiography or stress imaging less than 1 years ago.
* Inability or unwillingness to provide informed consent.
Stable and Independent Communication Brain-computer Interfaces

People with locked-in syndrome cannot move their limbs or talk because of a motor impairment, but remain conscious and intellectually awake. Restoring the ability to communicate to people with locked-in syndrome will have a positive effect on their quality of life, will enable them to reintegrate into society and increase their capacity to lead productive and fulfilling lives. This study sims to develop a new assisted communication device based on a brain-computer interface, a system that allows the user to control a computer with his brain activity. The investigators will develop this brain-computer system for long-term stability and independent use by using adaptive decoders. The investigators will test the long-term stability and independence of this system with healthy volunteers, people with tetraplegia and people with locked-in syndrome over time periods of several months.


Eligibility Criteria:
Inclusion criteria for healthy persons:

* Older than 18
* Fluent in French, English, German or Italian
* Good visual acuity

Inclusion criteria for people with tetraplegia:

* Older than 18
* Fluent in French, English, German or Italian
* Good visual acuity
* Diagnosed with spinal cord injury, brainstem stroke, spinal stroke, muscular dystrophy or other non-degenerative motor neuron disorders
* Limited or no ability to use both hands - less than grade 4 muscle strength in elbow extension and wrist extension and less than grade 2 strength in finger flexor and abduction on both sides

Inclusion criteria for people with locked-in syndrome:

* Were fluent in French, English, German or Italian before losing the ability to speak
* Enough visual capability to see large letters from a distance of around 50cm according to caretaker's or guardian's opinion

Exclusion criteria for healthy persons:

* Smokers
* Substance or alcohol abuse
* Neurological or psychiatric illness
* History of cranio-facial surgery
* Metallic implants that would prohibit the subject from having a MRI scan
* Medications that may retard motor coordination and cognitive ability (such as sedatives)
* Seizure disorders
* Treated with anti-epileptic medications

Exclusion criteria for people with tetraplegia and locked-in syndrome:

* Disabling neurological illness other than tetraplegia or locked-in syndrome
* Disabling psychiatric illness
* History of cranio-facial surgery
Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma

The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously progressed on first line of chemotherapy with anthracyclines.


Eligibility Criteria:
Inclusion Criteria:

* The patients must have a histological diagnosis of aggressive non-Hodgkin's lymphoma including the following sub-categories of the WHO classification:

  * Diffuse large B-cell lymphoma and its variants (immunoblastic, Burkitt-like, sclerosis of mediastinum, large B-cell MALT, rich in T-cells and anaplastic B-cell lymphoma)
  * Peripheral T-cell lymphoma
  * Anaplastic lymphoma of large T-cells /null cells
* Patients are eligible if they have documented evidence of progression after prior first-line chemotherapy containing anthracyclines associated or not with Rituximab. Patients with refractory disease to first line of treatment are also eligible.
* ECOG PS (performance status) less than or equal to 2
* Presence of bidimensionally measurable disease in accordance with WHO criteria.

Exclusion Criteria:

* Involvement of the CNS.
* Any medical condition which contraindicates the degree of hydration required for the safe use of cisplatin.
* Intermediate degree lymphoma derived from the malignant transformation of a previous low-grade lymphoma.
* Active infection (in the opinion of the investigator).
Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study

The purpose of this study is to determine whether two osteopathic evaluators with less than 5 years experience will be able to determine the same location and nature of the primary lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global osteopathic evaluation approach.

Back pain is one of the leading causes of consultation for rehabilitation. Establishing a diagnosis in the initial patient assessment is essential to choosing a specific treatment plan for that patient, regardless of the type of therapy the patient chooses to pursue. Evidence based medicine is the current gold standard for most manual-therapy professions, and there has been a great deal of research performed in an attempt to give credibility to the one tool that all manual therapy professions share in common: palpation. Few studies have been able to demonstrate an acceptable rate of inter-examiner reliability for palpation. This study will combine a global testing regime, consensus training for evaluators, and access to history of injury with symptomatic subjects to verify the inter-examiner reliability of an osteopathic evaluation on patients with chronic, non-specific low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-60
* Must have a history of non-specific back pain (not due to any known pathology eg. disc herniation or disc degenerative disease) that is currently not irritated and has not been, in the past 8 weeks
* Must be available for 3 consecutive hour

Exclusion Criteria:

* Patients with a known cause for their back pain
* Patients who have had a flare up of symptoms within the last 8 weeks
* Patients who are currently undergoing any rehabilitation or who have received manual treatment in the last 8 weeks.
* Patients who are taking daily medications for pain
* Pregnant women
* Major medical conditions: fractures, degenerative arthritis, inflammatory disorders, ankylosing spondylitis, multiple sclerosis, cancer, paralysis stroke or recent concussion history
* Any other conditions that would prevent the participant from completing the evaluation
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite

Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite

To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).

Eligibility Criteria:
Inclusion Criteria:

* Female ages 18-65 years
* Participant seeking treatment of cellulite in the upper lateral thigh areas
* Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
* Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
* Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
* Participant is willing to participate in study and adhere to follow-up schedule
* Participant is able to read and comprehend English
* Participant has completed Informed Consent Form

Exclusion Criteria:

* Participant is pregnant or planning to become pregnant during the duration of the study
* Participant has a BMI \> 30
* Greater than 10% increase or decrease in body weight within past 6 months
* Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
* Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.)
* Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
* Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
* Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
The Implementation of Novel 'Heavy' Water Techniques for Determining Modulation of Muscle Protein, DNA and Lipid Synthesis Due to Ageing

Maintenance of body's skeletal muscle is key to a healthy older age. However, as we age we lose on average 1-2% of our muscle each year. In order to slow this loss we need to understand fully the mechanisms regulating muscle mass with ageing. In this project we aim to determine these mechanisms using a new novel technique of 'heavy' water ingestion, which will allow us to measure multiple aspects of skeletal muscle mass control during normal everyday activities in young and old individuals over a period of 6 weeks. We will also determine the influence of resistance exercise training during this period in offsetting declines in muscle with ageing using this method


Eligibility Criteria:
Inclusion Criteria:

* Young (18-30y) and old men (65-75y) who are generally healthy and recreationally active

Exclusion Criteria:

* Active cardiovascular disease
* Cerebrovascular disease including previous stroke, aneurysm (large vessel or intracranial)
* Respiratory disease including pulmonary hypertension or COPD
* Hyper/ hypo parathyroidism, hyper/ hypothyroidism, Cushing's disease, diabetes
* Active inflammatory bowel disease
* Renal disease
* Malignancy
* Recent steroid treatment (within 6 mo), or hormone replacement therapy
* Clotting dysfunction
* Musculoskeletal or neurological disorders
* Any disease requiring long-term drug prescriptions, including statins
Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT

The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT.


Eligibility Criteria:
Inclusion Criteria:

* indicated for coronary CT assessment

Exclusion Criteria:

* aortic disease
* pulmonary embolism
* severe arrhythmia
* severe heart failure
* allergy for iodinated contrast agent
The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis

This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.

The life expectancy of patients with Cystic Fibrosis (CF) has greatly increased over time due to improved clinical care. While this is certainly beneficial to CF patients, the overall stability in lung function has made it more difficult to assess the effect of therapeutic interventions. Currently, FEV1 (forced expiratory volume in 1 second) remains the primary outcome measure for most clinical trials, but many CF patients have normal pulmonary function and the annual rate of decline is now less than 2% in large specialized centres. Therefore, additional parameters are needed that are more sensitive parameters to define abnormalities in CF patients and be used in therapeutic trials.

One such promising parameter is the Lung Clearance Index (LCI). The LCI is a test to quantify ventilation inhomogeneity by assessing the washout of an inhaled inert gas. Abnormalities in gas clearance from the lung are largely due to retention of inhaled gases due to mucous obstruction in the lower airways.

Interventions that improve mucus accumulation are expected to improve the LCI. Hypertonic saline has been shown to increase airway surface liquid (ASL), mucociliary clearance and pulmonary function. Therefore, this study will examine the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
* Informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject
* 6-18 years of age at enrolment and able to perform reproducible spirometry
* Clinically stable at enrolment
* FEV1 % predicted ≥ 80 % as calculated by the Wang reference equations
* Ability to comply with medication use, study visits and study procedures

Exclusion Criteria:

* Respiratory culture positive for NTM or B. cepacia complex within past year or screening
* Use of intravenous antibiotics or oral quinolones within 14 days of screening
* Investigational drug use within 30 days of screening
* Physical findings at screening that would compromise the safety of the participant or the quality of the study data