cyrilzakka/clinical-trials huggingface dataset:
MicroRNAs in Patients With Neurofibromatosis Type 1

MicroRNAs are small molecules which have recently been discovered in cells. They are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. Many previous studies have been done evaluating the expression of microRNAs in normal tissues as well as in a wide variety of cancers.

Recently, microRNAs from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to assess the utility of microRNAs in the blood as an early predictor of cancer as well as a marker of response to therapy. No previous studies have been performed evaluating microRNAs in archived tumor tissue and blood of patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility study to evaluate the presence of microRNAs in archived tumor tissue and the blood of patients with NF-1. If the investigators are able to identify circulating microRNAs in this population of pediatric patients, they will build upon this data in proposing a future study.


Eligibility Criteria:
Inclusion Criteria:

* Patients ages 2 years to 21 years.
* Patients with NF-1 being followed in the Neurofibromatosis Clinic.
* Patients have had MRI imaging in the 24 months prior to enrollment on the study.
* Patients may have known concurrent malignancies such as plexiform neurofibroma.
* Patients and/or parents/legal guardians must have signed an informed consent and assent when applicable.

Exclusion Criteria:

* Patients who have had prior tumor-directed therapy (including chemotherapy and/or radiation)
* Patients with a prior or current diagnosis of a malignant peripheral nerve sheath tumor.
* Patients who are considered too ill to participate as determined by their treating physician
* Patients who are pregnant or lactating
Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

Background:

Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years.

After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems.

Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance.

PerBOMs are used with for:

* Setting goals with patients
* Assessing how patients respond to treatment/rehabilitation
* Predicting if patients are likely to use a prosthetic limb in the future

Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments.

Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb.

Methods:

Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks.

Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs.

In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM.

All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences.

This study has been developed with patients and public involvement.


Eligibility Criteria:
Vascular amputee group:

Inclusion criteria

* Undergone major lower limb amputation due to peripheral arterial disease and/or diabetes at any time point
* or
* Planned date for major lower limb amputation within 1 week of consent due to peripheral arterial disease and/or diabetes

Exclusion criteria

* Has/will undergo a minor amputation only
* Amputation due to alternative aetiology
* No plan for amputation to lower limb
* Unable to communicate or write in English
* Lacking capacity to consent to research study
* \>1 weeks or unspecified date for amputation surgery
* \<18 years

Healthcare professional group:

Inclusion criteria

• Healthcare professional currently working with vascular amputees. Healthcare professional defined as qualified professional background e.g. HCPC, NMC or GMC registered or non-qualified professional background e.g. healthcare support worker

Exclusion criteria

* No experience of working with vascular amputee patients
* Unable to speak or write English
Sustain, A.S.P.E.N. HPN Registry 2011

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) developed a Web-based registry for nutrition care launched in early 2011, initially focusing on the home parenteral nutrition (HPN) patient population. The purpose of Sustain is to collect information regarding the patients and populations who require HPN in the United States, measure outcomes associated with HPN, allow institutional benchmarking against the aggregate data, and publish the findings to improve the quality of care for patients receiving HPN. The registry is open to all sites (hospital and home based) who care for new or existing HPN patients.


Eligibility Criteria:
Inclusion Criteria:must receive PN at home -

Exclusion Criteria:patients receiving PN in long-term care or as IDPN

-
Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients

It is very important to evaluate the degree of gastrointestinal dysfunction in critical ill patients. Thus the investigators conducted transabdominal intestine ultrasonography(US) in critical ill patients to evaluated the degree of gastrointestinal dysfunction under the acute gastrointestinal injury (AGI)


Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 years
* Acute Physiology Chronic Health Evaluation II (APACHE II) score \>8

Exclusion Criteria:

* uncontrolled mesenteric vascular disease
* uncontrolled chronic organ dysfunction
* advanced cancer
* any terminal stage disease
A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria
* Active disease at Screening
* Stable dose of methotrexate between 10-25 mg/week oral or parenteral

Exclusion Criteria:

* A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments
* A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

The goal of this randomized controlled trial is to test the effectiveness of non-invasive brain stimulation in treating adults with symptomatic convergence insufficiency compared to vergence/accommodative therapy. The main questions it aims to answer are:

1. Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency?
2. Is non-invasive brain stimulation alone just as effective as office-based vergence/accommodative therapy in treating convergence insufficiency?

The investigators hypothesize that non-invasive brain stimulation will shorten the treatment time from 12 weeks to 8 weeks of office-based vergence/accommodative therapy and that non-invasive brain stimulation alone would be equally effective as office-based vergence/accommodative therapy in improving symptomatic convergence insufficiency.

Participants will be randomized into one of three treatment groups:

1. Non-invasive brain stimulation with office-based vergence/accommodative therapy.
2. Sham stimulation with office-based vergence/accommodative therapy.
3. Non-invasive brain stimulation only.

Researchers will compare baseline measurements of near point of convergence (NPC) and positive fusional vergence (PFV) to post-treatment measurements for each group.


Eligibility Criteria:
Inclusion Criteria:

* Best-corrected visual acuity of \> 20/25 in each eye at distance and near
* Exophoria at near at least 4∆ greater than at far
* Receded near point of convergence of \> 6 cm break
* Insufficient positive fusional vergence at near (\< 15∆ base-out blur or break)
* CISS score of 16 and greater for children or 21 and greater for adults
* Have had a dilated fundus examination within the last 12 months
* Informed consent and willingness to participate in the study and be randomized

Exclusion Criteria:

* Previously treated for convergence insufficiency with home- or office-based vergence/accommodative therapy
* Amblyopia (\> 2-line difference in best-corrected visual acuity between the two eyes)
* Constant strabismus
* History of strabismus surgery
* Convergence insufficiency secondary to acquired brain injury or neurological disorder
* Manifest or latent nystagmus
* Systemic disease known to affect accommodation, vergence, and ocular motility including multiple sclerosis, Graves disease, myasthenia gravis, Parkinson's disease, cerebral palsy, and diabetes
* Developmental disability, attention deficit hyperactivity disorder (ADHD), learning disability or cognitive dysfunction that would interfere with treatment
* Taking medications that can affect normal neurological function including antipsychotics, antiepileptics, and opioids
* Presence of metal or electronic implants in or on the body, including pacemakers
Detection no Invasive of a Silent Myocardial Ischemia

The pathophysiological features of myocardial diabetic subject combined with cardiac autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the sudden onset of a myocardial infarction, or even sudden death.

That is why the investigators want to evaluate the contribution of non-invasive tools to stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map: Technical myocardial speckle tracking in studying strains overall average left ventricular (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress echocardiography with dobutamine (ESD)


Eligibility Criteria:
Inclusion Criteria:

* With at least two cardiovascular risk factors including: hypertension, dyslipidemia, smoking active or interrupted for less than 3 years, family history (relatives of the 1st degree) Accident major CV before 60.
* Or whatever the level of risk factors: peripheral artery disease and / or carotid atherosclerosis, or proteinuria

Exclusion Criteria:

* Valvular heart disease (severe to moderate valvular ) , hypertrophic , dilated , chronic lung
* History of cardiotoxic chemotherapy
* Atrioventricular blocks of degree
* Asthma
* Recent stroke within a month
* Bilateral carotid stenosis tight
* Glaucoma untreated narrow angle
* Subject to exclusion period (determined by a previous study or in progress)
* Inability to give informed about information
* patient under judicial protection
* patient guardianship or curatorship
* Current pregnancy (women of childbearing age )
* Breastfeeding
Novel Topical Treatment of Hand Dermatitis (Eczema)

This study is designed as a prospective, randomized, double-blind right/left comparison of Epikeia coatings to improve hand dermatitis.

Hand dermatitis was chosen for investigation due to high incidence and typical symmetrical involvement that allows for right/left treatment comparisons. Hand dermatitis is also important due to its implication on healthcare workers in particular, where frequent hand washing and chronic occlusion from gloving, provide a route for skin sensitization to natural rubber latex proteins increase the risk of colonization of microorganisms on the skin, and thereby increase the likelihood of contact dermatitis.

This feasibility study will be performed to evaluate the efficacy of PVDF coatings in treating chronic hand dermatitis.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following inclusion criteria:

1. 18 years of age or older;
2. have mild to moderate hand dermatitis, according to Investigator Global Assessment (see below);
3. be generally healthy, as determined by brief medical history;
4. have a negative urine test for pregnancy if female, and use of highly effective method of birth control, such as condoms \& spermacide, implants, injectables, combined oral contraceptives, intrauterine device (IUD's), sexual abstinence, or a vasectomized partner. For subjects using a hormonal contraceptive method, \[i.e., birth control pill (BCP)\], the dose and type of BCP should stay constant 1 month prior to enrollment and throughout the study, and
5. be capable of understanding and signing the consent form.

Exclusion Criteria:

Subjects will be excluded from the study if they:

1. have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;
2. have severe and very severe hand dermatitis according to the Investigator Global Assessment;
3. have severe vesiculation or bullae;
4. have a history of psoriasis, contact urticaria, and/or pustular diseases of the hands;
5. have had therapy of the hands with potent topical corticosteroids within one month of enrollment;
6. have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study
7. have a history of alcoholism or drug abuse;
8. have a history or current evidence of a chronic or infectious skin disease; and
9. are pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria; Pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria.
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults with history of sleeplessness

Exclusion Criteria:

* Allergic to investigational drug
* Any conditions and medications that may interfere with study drug evaluation
T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy

T-wave alternans is an electrocardiographic finding that has been shown to predict the occurrence of future cardiac arrhythmias in patients who have had a heart attack. What is unknown about T-wave alternans testing is when is the best time to perform the test. In most studies, T-wave alternans testing is conducted 4 weeks or more after a heart attack. It is unknown if T-wave alternans testing performed prior to hospital discharge in heart attack patients is reliable. The objective of this project is to determine the diagnostic accuracy of T-wave alternans testing performed prior to hospital discharge and again at 30 days after hospital discharge in patients who have suffered a heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Acute Myocardial Infarction (MI) confirmed by electrocardiographic and or/ enzymatic criteria
* Patients with a left ventricular ejection fraction of 45% or less

Exclusion Criteria:

* Patients with (1) atrial fibrillation, (2) pacemaker rhythm, (3) left bundle branch block, (4) class III-IV heart failure, (5) inability to achieve a target heart rate with exercise or handgrip stress or (6) spontaneous sustained ventricular tachycardia/ventricular fibrillation will be excluded
* Patients with recurrent angina pectoris, MI, coronary revascularization, or any other adverse cardiovascular event in the 30 days following their initial MI will also be excluded
Risk-Guided Cardioprotection with Carvedilol in Breast Cancer Patients Treated with Doxorubicin And/or Trastuzumab

Investigators will evaluate the safety, tolerability, and feasibility of a risk-guided cardioprotective treatment strategy with carvedilol, as compared to usual care, in breast cancer patients undergoing treatment with doxorubicin, trastuzumab, or the combination.

This is a single-center, randomized clinical trial that seeks to determine if a risk guided treatment strategy that initiates carvedilol in high risk breast cancer patients prior to doxorubicin and/or trastuzumab is safe, tolerable, and feasible. Subjects who are identified as having elevated CTX Risk by an internally validated clinical risk score (exceeding a pre-specified risk threshold) will be randomized to individually-dosed, open-label carvedilol or usual care. Investigators will use a stratified randomization according to trastuzumab therapy (yes/no) to ensure balance across treatment regimen. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and standardized time intervals during and after therapy at approximately 3, 6, 9, 12, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Females
* At least 18 years old
* Diagnosed with Stage I-III breast cancer with treatment plan to include therapy with anthracyclines and/or trastuzumab in the adjuvant or neo-adjuvant setting
* Study team is able to obtain all necessary information for calculating Cardiotoxicity Risk Score (including echocardiographic measurement of left ventricular ejection fraction)

Exclusion Criteria:

* Pregnant or breast feeding. Due to unknown risks and potential harm to the unborn fetus a negative pregnancy test within 10 days prior to enrollment is required in women with child-bearing potential. Due to the potential nursing infant harm, women who are currently breast feeding are not eligible for this study.
* Contraindication to carvedilol
* Baseline systolic blood pressure \< 90mmHg (if multiple blood pressures are available in the medical record within 1 month prior to screening, the average SBP will be considered)
* Baseline heart rate \< 55 bpm consistent with severe bradycardia (if multiple resting heart rates are available in the medical record within 1 month prior to screening, the average heart rate will be considered)
* Allergy to carvedilol
* History of bronchial asthma or related bronchospastic conditions
* Known history of sick sinus syndrome
* Severe hepatic impairment, defined as serum bilirubin \> 3.0x ULN, AST or ALT \> 5.0 ULN within 28 days of enrollment
* Second- or third-degree AV block, as determined by electrocardiogram
* Severe bradycardia (unless permanent pacemaker is in place)
* Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy
* Current use of: Bupropion (Wellbutrin), Fluoxetine (Prozac), Paroxetine (Paxil), Quinidine (Quinidex), Duloxetine (Cymbalta), Digoxin
* Current treatment with beta blocker
* Unable to provide consent
Rescue Extracranial Vertebral Stenting in Tandem Occlusions

The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. The investigators reported whether the additional rescue extracranial stenting improved clinical outcome by modified Rankin Scale (mRS) score within 3 months after the procedure

Acute vertebrobasilar artery occlusion is one of the cerebrovascular diseases with high disability and mortality rates. Although mechanical thrombectomy has recently been demonstrated an effective treatment for large vessel occlusions of posterior circulation, the treatment strategies depending on the specific pathophysiology. Tandem occlusion in posterior circulation is less frequently than in anterior one, comprises severe stenosis or occlusion of the extracranial vertebral artery ipsilateral to its intracranial and basilar occlusion. The recent studies showed the benefit of the "distal-to-proximal" approach, there were many tecniques to achieved the successful recanalization. Besides, the use of Dotter technique allowed 8F guiding catheter to cross the extracranial lesions easily and save the procedural time. However, the Diagnosis 5F-Dotter, like the Dilator-Dotter, has not been mentioned in previous studies. Therefore, the aim of the our study was to assess the improvement of outcomes at 3 months posttreatment in patients receiving rescue extracranial vertebral stenting

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Onset to treatment time \< 24 hours
* NIHSS \> 5
* pc-ASPECTS ≥ 5

Exclusion Criteria:

* Premorbid mRS \> 2
* Extensive, bilateral brain-stem infarction on neuroimaging
* Cerebellar mass effect on neuroimaging
* Loss to follow-up
Changes in Renal Perfusion During Hemodialysis in Patients with End-stage Renal Disease

Residual renal function (RRF) characteristically declines after patients with end-stage renal disease (ESRD) initiate dialysis. Although RRF preservation correlates with improved patient\&amp;#39;s quality of life and survival prospects, poor understanding of the pathophysiology underlying RRF decline limits protection strategies.

Hemodialysis (HD) is the primary renal replacement therapy for patients with end-stage renal disease. However, residual renal function (RRF) characteristically declines after these individuals start dialysis. This loss of RRF not only impacts the adequacy of dialysis and control of complications but also affects the patient\&amp;#39;s quality of life and survival prospects. Due to a lack of clear understanding regarding the pathophysiology underlying this decline in RRF, no effective strategies exist for its preservation at present. The objective of this study is to explore the changes in renal perfusion during hemodialysis in patients with end-stage renal disease, and provide a new idea for protection of RRF. This study was an observational study, and no interventions were performed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
* Urine output \&gt; 500ml/day or GFR \&gt; 3ml/min/1.72m2;
* Signed and dated informed consented is obtained.

Exclusion Criteria:

* Presence of vascular access dysfunction (blood flow rate \&lt; 180ml/min);
* Severe heart failure;
* Active infection;
* Infectious disease;
* Patients with severe anemia;
* Patients with polycystic kidney disease;
* Expected dialysis duration \&lt; 6 months;
* Pregnancy or lactation women;
* Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
* Unwillingness to be followed up or poor adherence to treatment;
* Other circumstances that the investigator considers unsuitable for enrolment.