cyrilzakka/clinical-trials huggingface dataset:
COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU
* With or without ventilatory assistance
* Treated or not with hydroxychloroquine 200 mg. every 12 hours
* Indistinct sex
* Older than 18 years
* Signed informed consent

Exclusion Criteria:

* Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab.
* Patients with severe kidney failure who require replacement therapy.
Effects of Photobiomodulation on Changes in Cognitive Function and rCBF in MCI

This pilot study has two goals. The first is to see if the cognitive improves when VA and CA are stimulated in MCI patients, and the second is to do an explanatory data analysis to see if that improves cognitive in relation to the rCBF improvement.

After being informed about the study and potential risks, all patients giving written informed codsent sill undergo a 1 day screening period to determine eligibility for study entry. Subjects who pass the screening test will receive a registration number within 7 days and proceed with the pre-intervention test as follows.

Eligibility Criteria:
Inclusion Criteria:

* The patients with mild cognitive impairment(MCI). The MCI was diagnosed based on medical history and neurological examination
* A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

* Any psychiatric disorders such as schizophrenia that would compromise participation
* Those with central nervous system disease
* Serious cognitive problems(MoCA score 7 or less).
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study

The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.

Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts, and drug-eluting devices might be beneficial in this field as well.

In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.

The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Any venous bypass with stenosis warranting intervention

Exclusion Criteria:

* Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Motivational Enhancement Therapy to Improve Adherence to Aromatase Inhibitors

The proposed research is a randomized controlled investigation of the efficacy of motivational interviewing (MI) to improve adherence to aromatase inhibitors (AI) in a community sample of patients with poor adherence to AIs.

Background: The use of Aromatase Inhibitors (AIs) among breast cancer (BC) patients with hormone receptor-positive disease reduces recurrence by 41% and mortality by 31%. Despite the efficacy of AIs, one-quarter of BC survivors fail to take their AIs as prescribed during the first year with another one-fifth discontinuing later in treatment. There are a variety of reasons for non-adherence, including low motivation, poor patient-provider communication, low self-efficacy, low perceived risk, and the experience of side effects. One promising intervention for improving treatment adherence is motivational interviewing (MI), a broad set of patient-centered techniques designed to enhance motivation for behaviour change. Objectives: To conduct a parallel-group, double-blind, randomized controlled trial (RCT) to evaluate the efficacy of MI at improving 12-month adherence to AIs relative to attention control (AC). The primary outcome is medication adherence measured using pharmacy records and calculated by medication possession ratio (MPR). Secondary outcomes include self-reported adherence, motivation and self-efficacy. Methods: A community sample of BC survivors newly prescribed AIs will be recruited from a local cancer centre pharmacy for a 6-month medication adherence observation period. The investigators chose to recruit new AI users because a significant number (i.e., 20-35%) are expected to discontinue medication within 12-months. MPR will be calculated following the observation period and patients meeting inclusion criteria and deemed non-adherent (MPR \< 80%) will be enrolled in the trial, randomly assigned to MI or AC, and scheduled for a baseline appointment. Recruitment will continue until 128 (64 per group) non-adherent BC survivors are identified. Four MI or AC sessions will be delivered at 3-month intervals (0-,3-,6-,9-months), each lasting 30-45 minutes. A final assessment will occur at 12-months. Baseline and final assessments will be conducted by an assistant who is not affiliated with the trial. Given that the long-term adherence to AIs is poor, a lack of adherence leads to clinically meaningful increases in BC recurrence, morbidity and mortality, and there has been only one published intervention study related to AIs to date, our trial represents a top priority in the prevention and treatment of BC.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking women, prescribed their first aromatase inhibitor medication. Been identified as non-adherent following a 6-month observation run-in period (Phase 1).

Exclusion Criteria:

* Unable to comply with protocols; diagnosis of cognitive impairment; severe psychopathology (e.g., schizophrenia); history of drug abuse; terminal condition with low likelihood of survival; living in a long-term care facility.
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis

This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in participants with systemic sclerosis. Other purposes of the study were to investigate whether STI571 is effective in improving lung functions and other test results called biomarkers. Whether STI571 is well-absorbed in systemic sclerosis participants' gut was also investigated by testing the drug level in the blood (pharmacokinetics).


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are equal to or older than 18 years of age and who have early diffuse cutaneous systemic sclerosis (Disease duration \< 18 months from the first non-Raynaud's symptom)
* Participants with a modified Rodnans Skin Score (MRSS) of at least 20 in the absence of trunk involvement or a MRSS of at least 16 in patients with trunk involvement
* Female patients of childbearing potential practicing two acceptable forms of contraception

Exclusion Criteria:

* SSc patients with a MRSS greater than 35
* Concurrent connective tissue diseases other than systemic sclerosis
* Significant pre-existing heart, liver, lungs, digestive system, blood and other diseases, cancer
* Conditions that might mimic the potential side effects of STI571 (blood conditions, liver damage, chronic diarrhea, edema)
* Concurrent medical therapies (or during last 6 weeks before first dosing) that may potentially influence outcome of the study
* Allergic to the study medication
* Pregnancy
* Breast feeding
Effects of Zolmitriptan on Sensory Transmission After Spinal Cord Injury

After spinal cord injury, patients develop a spastic syndrome that is characterized by hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The neuronal mechanisms behind the development of spasticity remain largely unknown, though animal experiments have shown that changes occur both at the level of the motoneuron and sensory neurons. This project aims to examine the changes that occur in the modulation of sensory afferent transmission after spinal cord injury, and how these changes can contribute to the triggering and initiation of muscle spasms after chronic spinal cord injury in humans.

It is known that after spinal cord injury, the majority of descending sources of monoamines, such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a result, after spinal cord injury these receptors are no longer activated below an injury, resulting in the production of large, long excitatory responses in the motoneuron when sensory are activated. This large sensory activation of the motoneuron can, in turn, activate a long response in the motoneuron to produce an involuntary muscle spasm. The aim of our study is to determine whether, similar to animal experiments, the 5HT1 receptors are responsible for sensory inhibition in spinal cord injured subjects, and whether activating these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition of sensory transmission that is lost after injury, thereby resulting in a decrease in the initiation of involuntary muscle spasms.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have suffered a trauma to the spinal cord at least 1 year prior. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score greater than 1 in the ankle or knee.

Exclusion Criteria:

* If patients have damage to the nervous system other than to the spinal cord
* Pregnant women
* Elderly Patients (\> 65 years)
* Alcoholic Patients
* History of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
* Valvular heart disease or cardiac arrhythmias
* Other significant underlying cardiovascular disease (atherosclerotic disease, congenital heart disease)
* Uncontrolled or severe hypertension
* Hemiplegic, basilar or ophthalmologic migraine
* Hypersensitivity to Zolmitriptan or any component of the formulation
* History of Autonomic Dysreflexia
* Patients taking:
* Ergot-containing drugs
* Other 5HT1 Agonists
* MAO Inhibitors
* Cimetidine and other 1A2 Inhibitors
* Propranolol
* Selective Serotonin and Norepinephrine Reuptake Inhibitors
* Acetaminophen
* Metoclopramide
* Xylometazoline
* Oral Contraceptives
Comparison of Three Methods for Early Detection of Breast Cancer

Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).

The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.

1. Positive predictive value of CEDM in detecting lesions seen on MR
2. Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
3. Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
4. Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Patients, greater than 30 years of age
* In good general health as evidenced by medical history
* BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.

Exclusion Criteria:

* Patients who are less than 30 years of age
* Have known or suspected cardiac shunts
* Have history of hypersensitive allergic reactions to any imaging contrast agents
* Pregnant (a urine pregnancy test will be given at no cost to the patient)
* Are nursing babies
* Poor renal function
* Are unwilling or unable (such as having a pacemaker) to undergo a CEMR
Clinical Outcomes With Ceftolozane-tazobactam for MDR Pseudomonas Infections

This study will describe clinical outcomes in patients who received ceftolozane-tazobactam for a Pseudomonas aeruginosa infection. Primary outcomes include 30-day and in-hospital mortality.

Very little data is available to evaluate the use of ceftolozane-tazobactam in MDR Pseudomonas aeruginosa infections. Additionally, there is currently no standard recommendation for the treatment of MDR Pseudomonas aeruginosa infections, and multiple agents are often used in combination which increases the probability of adverse effects in addition to leading to possibly more resistance and higher costs of care. This is particularly relevant since the primary alternative drugs for MDR Pseusomonas aeruginosa infections are aminoglycosides and polymyxins, two categories of agents with significant adverse effects and suboptimal pharmacokinetics that limit efficacy.

This is a multicenter study designed to collect retrospective data on clinical outcomes of patients treated with ceftolozane-tazobactam in the hospital. The primary outcomes include 30-day and in-hospital mortality. Microbiological and clinical cure will be assessed as secondary outcomes. Microbiological outcomes will be defined as: cure- a repeat culture was negative; failure- repeat cultures were not negative or the patient died before repeat cultures could be obtained; presumed cure- repeat cultures were not taken but clinical cure occurred. Clinical outcomes will be defined as: clinical success- signs and symptoms o the index infection resolved at the end of therapy; clinical failure- signed and symptoms remained at the end of therapy or the patient died; indeterminate- it was not possible to determine the clinical outcome at the end of therapy.

Patient information will be collected from Temple University Hospital as well as 20 other hospital sites. The source population will be all adult patients who received ceftolozane-tazobactam for greater than 24 hours in each of the hospital sites between December 19, 2014 and December 31, 2016. Participating hospital sites will review clinical charts to identify and enroll a target of 5-15 subjects per site. We have a targeted enrollment of 200 subjects. All involved parties will use the Research Electronic Data Capture (RedCap) database based at Temple University for data collection and storage.

We will be utilizing existing electronic data and will have no direct contact with or recruit research subjects. Because this is a study with retrospective data collection, enrolled patients will have received treatment as determined by the treating physicians in accordance with standard of care. To limit bias in the selection of subjects, investigators will be asked to identify and consecutively enroll all eligible patients treated with ceftolozane-tazobactam within the study period.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old
* Cultures positive Pseudomonas aeruginosa from any source
* Received ceftolozane-tazobactam for at least 24 hrs

Exclusion Criteria:

* Protected populations
* Prisoners, pregnant women, children
Motivational Interviewing to Prevent Suicide in High Risk Veterans

The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide.

Veterans who receive health care from the VA are at elevated risk for suicide, and the number of Veterans at high risk may be growing. Although the months following discharge from psychiatric hospitalization are a period of acute risk for Veterans, there is a dearth of empirically supported treatments tailored to psychiatric inpatients and no studies examining treatments for psychiatrically hospitalized Veterans. This randomized controlled trial will test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide. Participants will be recruited from the Acute Psychiatric Inpatient Unit at the Syracuse VA Medical Center. To meet high-risk criteria, Veterans must score over two on the Scale for Suicidal Ideation (SSI), which is prospectively predictive of death by suicide. Participants will complete a screening assessment to confirm eligibility and a baseline assessment of risk factors for suicide. They will be randomized to receive Motivational Interviewing to Address Suicidal Ideation (MI-SI) or a revised version (MI-SI-R) plus treatment as usual (TAU), or TAU alone. The MI-SI groups will receive two sessions of MI-SI during hospitalization and one telephone booster session after discharge. Participants in all conditions will be asked to complete telephone follow-up interviews at 1, 3, and 6 months after discharge. Change in the severity of suicidal ideation will be measured using the SSI.

Eligibility Criteria:
Inclusion Criteria:

* Veteran status,
* admitted to psychiatric inpatient unit,
* age 18 and over,
* English speaking,
* able to understand the study and provide informed consent,
* clinically cleared to participate by unit staff,
* receive health care from a VHA facility in upstate New York
* at increased risk for suicide (Scale for Suicidal Ideation \[SSI\] \> 2)

Exclusion Criteria:

* current psychosis,
* current mania,
* dementia,
* prisoner status,
* being inaccessible
* being discharged from the unit less than 48 hours after being identified by study staff
STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)

This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects with relapsing remitting MS.
* Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
* Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.

This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.

- or patients with rapidly evolving severe RRMS (e.g. \> 2 relapses with disease progression in one year and \> 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).

Key Exclusion Criteria:

* immunocompromised patients
* active infections
* pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
* presence of malignancy (other than localized basal cell carcinoma of the skin).
A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)

This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.

The duration of treatment is a one time dose.

Eligibility Criteria:
Inclusion Criteria:

* Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria:

* Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation

Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients，so that there is the need to continue to look for alternative therapies. Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation and expression of silenced genes including those involved in apoptosis. The approval of decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit disease progression in transplant-eligible patients. To assess the effect of pretransplant decitabine treatment on post transplant outcomes, we recently reviewed our institutional experience with MDS and AML patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 8- 65 years
* Diseases must be myelodysplastic syndrome and acute myelocytic leukemia
* Must need a bone marrow transplant
* Must have the ability to observe the efficacy and events
* Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed

Exclusion Criteria:

* Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
* Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
* Must not have a known or suspected hypersensitivity to decitabine