cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas

This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA) (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.

Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the tumor can look like normal brain tissue. Studies in other countries have shown that in some brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may make it easier for doctors to remove as much tumor as safely as possible from your brain.

This study also hopes to see if 5-ALA can find different cell populations within the tumor that is removed and allow the researchers to better understand brain tumors.

The purpose of this study is to:

* Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see how well 5-ALA can find different cell populations within brain tumors
* Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow under ultraviolet light
* Make sure the 5-ALA identifies tumor and not normal brain
* Make sure 5-ALA does not cause any side effects


Eligibility Criteria:
Inclusion Criteria:

* Patients must have clinically documented primary brain tumor for which resection is clinically indicated. Radiographic findings should be consistent with high grade glioma. Intraoperative frozen section should either be: anaplastic astrocytoma (WHO Grade III astrocytoma) or glioblastoma (WHO Grade IV astrocytoma).
* Patients must be aged greater than 18 years old
* Karnofsky Performance Score \> 70 (Appendix)
* Patients must have normal organ and marrow function as defined below:

  * Leukocytes \> 3,000 /uL
  * Absolute neutrophil count \> 1,500/uL
  * Platelets \> 100,000/uL
  * Total bilirubin within normal institutional limits
  * AST/ALT within normal institutional limits
  * Creatinine within normal institutional limits

Exclusion Criteria:

* Prior craniotomy for resection, deep seated tumors in thalamus and brain stem.
* History of allergic reactions to compounds of similar chemical composition to ALA.
* Personal or family history of porphyrias
* Personal history of hepatitis or other liver diseases.
* Pregnant women are excluded from this study because ALA is of unknown teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA, breastfeeding should be discontinued prior to treatment with ALA.
* Inability to undergo magnetic resonance imaging (i.e. those patients with AICD/pacemakers).
Role Of Angiogenic Factors In The Development Of Hepatorenal Syndrome

This Study will look at the effect of substances called "angiogenic factors"(development of new blood vessels) have on the development of severe liver disease. The results may help to understand the factors involved in the repair and regeneration of liver tissue and to see if different types of liver disease are associated with different types of factors, especially in the severe liver disease called hepatorenal syndrome.

Renal dysfunction in patients who also suffer from end stage liver disease is associated with increased morbidity and mortality comparted to patients suffering from liver disease alone. If frank renal failure develops in a patient with cirrhosis and ascites, the median survival time from onset of renal failure is approximately 2 weeks. Kidney dysfunction may be transient, secondary to pooling of blood in the splanchnic bed and consequent reduction in renal blood flow. In this instance, liver transplantation and restoration of normal circulatory patterns will result in return of normal renal function.

Currently, there is no diagnostic test to differentiate between temporary and permanent renal dysfunction in the presence of end stage liver disease. As a result, the number of combined liver-kidney transplant occuring has steadily increased. Slightly more than 20%(8 of 38) of the liver transplants performed by our service in 2004 have been combined liver-kidney transplants. The double procedure increases the length of anesthesia exposure and surgical time, and the presence of the transplanted kidney may require increased immunosuppression in comparison to a liver-only transplant.

We plan to examine the role of angiogenic factors in the abnormal blood flow patterns known to be associated with hepatorenal syndrome.

Specimen analysis: Circulating levels of cytokines and growth factors will be measured using commercially available ELISAs. Matrix metalloproteins will be measured by quantitative electrophoresis.

Expression of A20 will be determined by extraction of total RNA from whole blood using Trizol and run in standard Northern blot methodology. RNA will by hybridized with \[³²P\]-dATP labeled A20 probes and glyceraldehyde-3-phosphate dehydrogenase(GAPDH) or β-actin probes to correct for uneven loading. Similar RNA extraction will be performed on liver tissue obtained at time of surgery. Microarray analysis will be performed on the extract to identify specific genes that may be involved in the pathogenesis of HRS.

Results of laboratory analyses will be correlated with clinical parameters and attempts will be made to identify specific cytokines or up-regulated genes with particular phases or degree or renal dysfunction in patients with liver disease. Similar analyses will be performed in patients with other types of hepatic disease.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent
* Subjects who present for Liver Transplantation
* Subjects who present for Hepatic resection
* Subjects with Non-Surgical Liver Disease

Exclusion Criteria:

* Absence of Liver Disease
Multifunctional Approach in Cardiac Surgery

Postoperative pain and swallowing disorders are complex, multifactorial phenomenon that frequently occur after cardiac surgery. Preoperative anxiety and the interaction between sex and other sociocultural factors may predict greater sensitivity to postoperative pain, whereas the epidemiology and course of swallowing disorders has not been systematically investigated, along with the interaction between dysphagia, post-operative pain and emotional stress. Cardiac rehabilitation is a multifunctional intervention which may address all these functional domains, improving patients' prognosis.

The aim of the present study is to demonstrate the superiority of a multifunctional approach (OMT, systematic swallowing screening and specific treatment according to good clinical practice associated with psychological counseling) compared to local clinical practice in the management of pain and swallowing disorders.

The TITANIC trial will provide evidence on whether a multifunctional intervention systematically implemented in the cardiac rehabilitation setting will improve the clinical course and prognosis of patients with recent cardiac surgery.

The design is a randomized clinical trial with parallel group design. Patients aged over 18 undergoing elective cardiac surgery and admitted to IRCCS Fondazione Don Gnocchi, Santa Maria Nascente, Milan, for cardiac rehabilitation will be randomized to standard post-acute treatments (cardiovascular training, monitoring and logopedic treatment only in case of swallowing dysfunction) compared with an experimental approach which consists of osteopathic manipulative treatment (OMT) treatments, swallowing screen protocol, psychological assessment and counseling.

This study may help in the identification of a new diagnostic-therapeutic pathway in cardiac surgery patients that allows a reduction in the use of analgesics and anti-inflammatories and increases the early detection of swallowing disorders. Furthermore, by allowing an integrated assessment of emotional needs, it can have a positive effect in reducing the need for post-operative clinical visits and assessments in the medium to long term, improving the patients' quality of life.

Eligibility Criteria:
Inclusion Criteria (all the following must be satisfied):

* patients with recent cardiac surgery (within one month)
* without swallowing disorders already identified before discharge
* with the presence of chest pain (NRS\>2).

Exclusion Criteria:

* patients who are unable to sign informed consent.
* patients with already known psychological/psychiatric disorders.
Beliefs About Mental Health Treatment - Gambling Addiction Study in Colorado

Many people with mental health conditions do not seek treatment, and it is unclear what exactly prevents people from taking up treatment. The goal of this interventional study is to learn about how people think about cognitive behavioral therapy (CBT) for gambling disorders. The main questions it aims to answer are:

* Do people have incorrect beliefs about the net benefits of CBT? If yes, which beliefs are those, and how much do people underestimate or overestimate the benefits?
* Is a small monetary incentive (that participants receive conditional on trying out CBT) helpful in increasing take-up of CBT?

Apart from these questions, the researchers will also study how well CBT works to treat gambling disorders.

Participants will be asked to complete two surveys over four months and might be offered a modest monetary incentive for doing (free) CBT if they are in the treatment group. Researchers will compare that treatment group to a control group. Participants in the control group will have access to free CBT and do the same two surveys as those in the treatment group, but will not receive the monetary incentive.


Eligibility Criteria:
Inclusion Criteria:

* must reside in Colorado
* must be English-speaking

Exclusion Criteria:

* does not reside in Colorado
* is not English-speaking
Lenalidomide Monotherapy in R/R DLBCL

This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of DLBCL
* Relapsed/refractory to at least one previous systemic therapy for DLBCL
* Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
* Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT

Exclusion Criteria:

* CNS involvement by lymphoma
* Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
* Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
* Patients who previously underwent allogeneic SCT
* Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
* Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start
Food and Education Effects on Diabetes Study

Low-income adults are disproportionately affected by diabetes, experiencing greater rates of diabetes, diabetes-related complications, and mortality. Dietary habits play an important role in achieving and maintaining glycemic control to improve health outcomes. However, low-income adults are less likely to adopt the necessary dietary changes to improve glycemic control largely due to poor access to care, limited knowledge and skills to facilitate lifestyle change, and financial and environmental constraints that limit access to healthy foods. Nutrition interventions that target key barriers to healthy dietary habits among low-income adults with diabetes may have a profound impact on improving glycemic control. The provision of home-delivered, medically-tailored meals in addition to individualized medical nutrition therapy is a promising approach to improve dietary habits in socially disadvantaged populations with diabetes. Evidence suggests the provision of medically tailored meals may be beneficial in improving health outcomes and health care costs among socially disadvantaged adults with chronic illnesses, however rigorous studies specifically exploring the benefits of meal provision and medical nutrition therapy among adults with type 2 diabetes are lacking. The investigators aim to conduct a randomized-controlled clinical trial examining the impact of medically-tailored meals and medical nutrition therapy on health-related outcomes and health care costs among low-income adults with type 2 diabetes.

The investigators will recruit 100 individuals age 18 and over with uncontrolled diabetes (defined as a hemoglobin A1c (HbA1c) \>8%) and enrolled in Priority Partners Medicaid insurance. Participants will be randomized to one of two groups: 1) 3 months of home-delivered, medically-tailored meals combined with monthly individual Medical Nutrition Therapy sessions for 6 months or 2) usual care. The investigators will follow participants for up to 12 months to assess for changes in hemoglobin A1c.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Diabetes with a hemoglobin A1c\>8%
* Medicaid beneficiary
* Enrolled in Medicaid Insurance

Exclusion Criteria:

* Medical conditions that are indications for additional dietary requirements (e.g., advanced chronic kidney disease, end-stage renal disease, chronic wounds, or severe alcohol use disorder)
* Swallowing difficulties
* Food allergies
* Non-English speaking
* Language or hearing impairment
* Currently pregnant or breast feeding
* Does not have a refrigerator/freezer in the home to store meals
* Has plans to move out of the meal delivery service area in the next 12 months
A Study of the Effectiveness of Direct Current Stimulation for Alcohol Use Disorders

Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving in drug addiction.

Objective:In this study, the investigators employed real and sham tDCS of the bilateral dorsolateral prefrontal cortex (DLPFC) to test the effect of whether it could reduce cue-induced craving, influence cognitive function in alcoholics and explore its underlying mechanism with functional magnetic resonance imaging (fMRI).

Methods: The investigators perform a randomized sham-controlled study in which 40 inpatient alcoholics will be randomized to receive 10 sessions of 20min sham or 1.5mA tDCS to the bilateral DLPFC (anodal right/cathodal left). The neuroimaging data, craving after exposed to alcohol-associated cues and the cognition task at baseline and after stimulation will be collected.

The investigators hypothesized that tDCS stimulating the DLPFC decreases cue-induced craving and improves cognition, which might be associated with the functional connectivity alterations.


Eligibility Criteria:
Inclusion Criteria:(1)Clinical diagnosis of severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5); (2)Must be able to look and hear; (3) Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score less than 10.

Exclusion Criteria:(1) Clinical diagnosis of substance use disorder other than an alcohol or nicotine use disorder defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)；(2) Severe brain injury, stroke, seizure, epilepsy or other major neurological diseases ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for fMRI scanning.
Comparision of PVC Ablation Techniques

Several reports have shown the utility of PVC ablation with cryo catheters. The aim of this study is to compare the outcomes and safety of Cryo vs. RF for PVCs.

Background: Radiofrequency (RF) catheter ablation (CA) is an effective therapeutic strategy in eliminating refractory idiopathic ventricular outflow tract (OT) ventricular arrhythmias (VA). However, early and late recurrences occur commonly. RFCA has also been reported to be associated with collateral damage and pain. The use of Cryo ablation as a safer alternative energy source been previously described. In several reports Cryo was reported to successfully treat VA originating from the OT in the absence of ablation related pain and collateral damage to adjacent structures such as the coronaries. When comparing outcomes and complications of catheter ablation of VA from the papillary muscles of the left ventricle with either Cryo or RF, Cryo was found to be associated with significantly higher success rates and lower recurrence rates than RFCA.

Aim: To compare the outcomes and safety of Cryo vs. RF for PVCs. Methods: Patients with PVC VA will be randomized in a 1:1 fashion to RFCA or Cryo ablation. All procedures will be done using a 3-dimensional mapping system (EnSite™ NavX™ system, St. Jude Medical). Ablation will be performed at sites with earliest activation or at least pacemap exhibiting QRS morphology match of \>11/12. Endpoint of procedure will be elimination and non inducibility of the clinical VA. All patients will undergo continuous monitoring for at least 12 hours post procedure and 12 lead Holter and exercise testing 1 month post procedure. Successful ablation will be defined as absence of clinical VA or \> 50% reduction in arrhythmia burden on Holter in the absence of anti-arrhythmic medications.

Eligibility Criteria:
Inclusion criteria:

1. Patients referred for PVC ablation.
2. Age ≥ 18 years on a date of consent.

Exclusion criteria:

1. Contraindications for ablation
2. Serious known concomitant disease with a life expectancy of \< 1 year
3. Elderly patients \>80 years of age
4. Pregnancy or nursing
5. Unwilling or unable to give informed consent
Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation

The present study is designed as a observational prospective, multicentre, international. The main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB in a prospective manner.

Consecutive patients programmed for cryoballoon ablation (CBA) for PAF will be prospectively enrolled in our study. After PVI is obtained and proven by entrance- and exit block, the SVC will be mapped for potentials. If the SVC exhibits electrical activity, isolation will be attempted performing a single maximum 180 seconds balloon application. A single 180 seconds application is known to produce a durable lesion. Performing a combined approach (PVI together with SVC isolation) using the same cryoballoon requires no additional vascular access. Therefore no significant raise in complications is to be expected. During a second generation CBA the described rate of complications is to be estimated around 2%. Transient phrenic nerve palsy in 7.2 %, but reversible in virtually all patients within the end of the procedure.

To prevent nervous injury the phrenic nerve (PN) will be tested during ablation of the SVC, in the same fashion as performed systematically during ablation of the right sided pulmonary veins.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Consecutive patients programmed for cryoballoon ablation (CBA) for PAF will be prospectively enrolled in our study

Exclusion Criteria:

1. Age younger than 18 years
2. Severe valve disease (MI or AI \> ¾)
3. Uncontrolled heart failure,
4. Contraindication to general anaesthesia/ deep procedural sedation
5. Left atrial thrombus at the pre-procedural transesophageal echocardiogram (TEE)
Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation

The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.

The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.


Eligibility Criteria:
Inclusion Criteria:

* presence of risk factors for aspiration :
* known or likely swallowing dysfunction,
* altered consciousness,
* cardiac arrest,
* difficult intubation
* witnessed aspiration
* symptoms and signs suggestive of lower respiratory tract pathology
* temperature ≥38.5°C or \<36°C
* leukocyte count ≥10 000/µL or \<1500/µL
* purulent sputum or tracheal aspirate.
* new radiographic infiltrate on chest X-ray
* tracheal intubation and mechanical ventilation since less than 48 hours

Exclusion Criteria:

* pregnant women
* refuse to participate to the study
* no informed consent
* documented bacteremia
* septic shock
* severe immunosuppression: leukocytes\<1000/L or neutrophils\<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4\<50), and chronic corticosteroid use (\>0.5 mg/kg day for at least one month during the last three months).
* moribund patients (SAPS II \>90).
Optimizing Prescribing of Antipsychotics in Long-Term Care

Inappropriate antipsychotic prescribing is a key quality indicator by which clinical outcomes might be monitored and improved in LTC. A multi component intervention to reduce inappropriate antipsychotic prescribing was evaluated in ten Canadian long-term care facilities.

Increasing numbers of older adults are affected by dementia, and many will eventually reside in long-term care (LTC), where antipsychotic use is relatively common. Inappropriate antipsychotic prescribing is a key quality indicator by which clinical outcomes might be monitored and improved in LTC but limited evidence exists on the most effective strategies for reducing inappropriate antipsychotic use.

The objective of the study was to evaluate a multicomponent approach to reduce inappropriate prescribing of antipsychotics in LTC.

A prospective, randomized stepped-wedge, study design was used to evaluate the effect of the intervention in 10 LTC facilities in Canada. The intervention consisted of an educational in-service, provision of evidence-based tools to assess and monitor neuropsychiatric symptoms (NPS) and monthly interprofessional team meetings.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia
* Receiving an antipsychotic medication without a diagnosis of psychosis

Exclusion Criteria:

* Diagnoses of schizophrenia, Huntington's disease
* Presence of active hallucinations and/or delusions
* Individuals at end of live or receiving palliative care