cyrilzakka/clinical-trials huggingface dataset:
Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant

There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.

This is a pilot study to determine the safety of PCV13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by PCV13 vaccination in patients with myeloma when administered before and early after autologous PSCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed multiple myeloma
* Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant

Exclusion Criteria:

* Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine
* HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing
* Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
* Active central nervous system (CNS) malignancy
* Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy.
* History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
* Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation
* Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
* Active or uncontrolled infection
* Diffusing lung capacity oxygenation (DLCO) \<50 %
* Left ventricular ejection fraction (LVEF) \<40%
* Bilirubin \>2
The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving

Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural mechanisms through which CBCST changes drinking behavior, it may be possible to improve its efficacy. CBCST promotes abstinence by teaching "coping skills" for managing alcohol-related thoughts and emotions. In this pilot study, the investigators examine the neural systems that play a role in the learning of coping skills through CBCST, specifically focusing on the role of emotion regulation systems.

The study combines 1) a 12-week clinical trial of CBCST in currently drinking alcohol dependent patients (target N=25) who are seeking treatment to reduce their drinking with 2) functional magnetic resonance imaging (fMRI) experiments that probe neural activity related to the utilization of copings skills taught in CBCST. The fMRI studies will be performed both before and after treatment with CBCST, with the goal of determining 1) the pattern of neural activity that is related to coping skills utilization prior to undergoing CBCST, with particular focus on neural systems known to play a role in emotion regulation; 2) how CBCST changes this pattern of neural activity; and 3) how these changes in neural activity predict changes in alcohol use during CBCST.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Meets DSM-V criteria for current Alcohol Use Disorder
* Currently drinking \>5/4 or more drinks/day for men/women in the last 28 day, on average, at the time of initial screening visit.
* Current goal of moderating or abstaining from drinking alcohol
* Seeking treatment for Alcohol Use Disorder
* Agree to not seek additional treatment, apart from Alcoholics Anonymous
* English-speaking and able to provide informed consent and comply with study procedures
* Willing to abstain from alcohol completely for 24 hours on 3 separate occasions

Exclusion Criteria:

* Any current Moderate or Severe substance use disorder, other than alcohol, nicotine or caffeine use disorders.
* Lifetime history of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder
* A diagnosis of any current psychiatric disorder other than Alcohol Use Disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder) that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
* History of severe alcohol withdrawal (e.g. seizure, delirium tremens, multiple detoxifications or ER visits for alcohol withdrawal)
* Significant risk for suicide or violence
* Legally mandated to receive treatment
* Sufficiently socially unstable as to preclude study participation (e.g. homeless).
* Currently taking any psychotropic medications.
* Significant cognitive impairment
* Neurological or medical conditions that would interfere with MRI scanning (e.g. history of stroke, seizure, brain tumor, brain infection, multiple sclerosis, metal device in body, pregnancy, claustrophobia)
A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML

This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML

This is a Phase 1, open-label, 3 + 3 dose escalation and expansion study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of prior standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML. Escalation to the next higher dose level will depend on demonstrated safety and tolerability at each dose level.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL), or AML

  a. Subjects must have disease that has relapsed or is refractory to 2 or more prior regimens and in need of treatment due to progressive disease
* Presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for AML subjects)
* Adequate hematologic parameters unless clearly due to the disease under study
* Adequate renal and hepatic function, per laboratory reference range at screening

Exclusion Criteria:

* History of pneumonitis of any cause
* For CLL subjects: only known histological transformation to an aggressive lymphoma
* For AML subjects:

  1. Acute promyelocytic leukemia
  2. Peripheral blast count \> 25 × 10 9/L
* Known central nervous system involvement
* Significant cardiovascular disease
* Significant screening ECG abnormalities
* Subjects who require warfarin, anti-cancer therapeutics or investigational agents
* Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of voruciclib therapy
* Prior solid organ transplantation
* Receipt of an allogeneic transplant within 6 months or an autologous transplant within the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD)
* Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor
* Symptomatic/uncontrolled HIV infection/AIDS, or currently taking contraindicated medications for HIV control
* Ongoing immunosuppressive treatment including calcineurin inhibitors at the time of the start of study treatment, including systemic or enteric corticosteroids except as follows:

  1. Prior to the start of study treatment, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
  2. During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed
Expression of Inflammasomes in HCV Patients

Hepatitis C virus has been identified a quarter of a decade ago as a leading cause of chronic viral hepatitis that can lead to cirrhosis and hepatocellular carcinoma. Only a minority of patients can clear the virus spontaneously during acute infection. Elimination of HCV during acute infection correlates with a rapid induction of innate and a delayed induction of adaptive immune responses. The majority of patients is unable to clear the virus and develops viral persistence despite the ongoing innate and adaptive immune response. The virus usually develops several strategies to escape these immune responses.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C virus patients.
* Patients do not start treatment protocol.

Exclusion Criteria:

* Pregnant women.
* Hepato-cellular carcinoma patients.
* Autoimmune disease patients.
* Patients with liver cirrhosis.
* Patients who refuse to participate in the study
Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance

The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.

Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Vietnam Combat Veteran
* Diagnosis of combat-related PTSD
* Stable psychotropic regimen for a minimum of three months
* Experiences recurrent nightmares

Exclusion Criteria:

* Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders
* Schizophrenia and other psychotic disorders
* Substance abuse or dependence within the last six months
* Untreated medical disorders known to impact sleep
Manual Therapy and Rehabilitation on Pain and Physical Functioning for Chronic Knee Pain

This is a research study examining if hands-on therapy and prescribed exercise is an effective way to manage and reduce knee pain. It will also look at physical benefits of this treatment including balance, strength, and flexibility.

Participation will include 2 assessment days and a 12-week treatment cycle. Assessments will be conducted during week 1 and after treatment. The treatment will vary based on the assigned group. This may include 12 in-person manual therapy sessions occurring once per week and or 12-weeks of at-home therapy occurring 5 times per week.

The greatest risk of participation includes possible muscle/joint soreness, injury during at-home exercises, and loss of confidentiality.


Eligibility Criteria:
Inclusion Criteria:

* Adults experiencing non-specific knee pain for 3 or more months. Pain must be 3/10 (VAS) or higher.

Exclusion Criteria:

* Pain due to knee surgery, fracture, tumor, trauma, or those on medication for mood disorder (assessed on case by case basis).
Assessing Eye Tracking Features Following Sports-Related Concussion

This proposal aims to describe the oculometric features present during King-Devick (K-D) testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

This proposal aims to describe the oculometric features present during K-D testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

The main objectives include:

1. Describing the oculometric deficits present in subjects with acute sports-related concussion.
2. Analyzing and quantifying the oculometric changes that occur during subject recovery.
3. Identifying possible oculometric features as potential biomarkers that may lead to reliable, rapid method for recognizing acute concussion.

Eligibility Criteria:
Inclusion criteria:

* Over the age of 8 years, and able to provide informed consent / assent.
* Have documented diagnosis of sports-related concussion within two weeks of the event.
* Currently demonstrating post-concussion symptoms.

Exclusion criteria:

- Alcohol consumption within 48 hours of evaluation.
A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease

A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients will cross over to the treatment not yet received.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 40 to 70 years of age (inclusive) at screening
* Patients with Type 2 diabetes mellitus diagnosed at least 12 weeks before screening and either drug-naïve or treated with stable metformin monotherapy for at least 12 weeks prior to screening
* HbA1c \>/= 7 % and \</= 9% at screening
* Absence of history of coronary artery disease

Exclusion Criteria:

* Diagnosis or history of Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Current treatment with fibrates, thiazolidinediones, or insulin
* Prior intolerance to thiazolidinediones and/or fibrates
* Clinically significant liver disease or impaired liver function
* Know chronic diabetic complications (i.e. retinopathy, neuropathy, nephropathy)
* Symptomatic congestive heart failure classified as NYHA class II-IV
* Diagnosed and/or treated malignancy within the past 5 years, except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
* Contraindications to MRI, or inability to tolerate MRI scanning
VAN Assessment Tool in the Treatment of Acute Ischemic Stroke

To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction

The investigators propose to perform a 6-month pilot study in Northwest Arkansas in collaboration of two EMS providers; Central EMS and AirEvac. These local providers operate in the WRMC catchment area and transport over 90% of patients with a suspected stroke to WRMC comprehensive stroke center. Thus no changes to their standard operations would be implemented. The aim of this pilot study would be to test the accuracy of VAN-screening in the area in patients treated at WRMC - thus only patients who are brought to WRMC as per current protocol would be included in the study.

The investigators would train Central EMS and AirEvac personnel to perform the V.A.N screen, over a 2-month period (estimated June-July 2020) in several sessions at the Central EMS training center at 800 S. School Ave. in Fayetteville. This training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (APNs). The training would consist of a training video, hands-on instruction, and sample scenarios.The investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. The PowerPoint presentation planned for the training session, as well as the post-training quiz, are attached as Appendices to this application. The investigators would expect a rate of 80% correct answers in the post-training quiz. All questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for stroke at WRMC who are transported to the hospital by Central EMS or AirEvac

Exclusion Criteria:

* Stroke patients who arrive directly to the hospital (without the use of EMS services)
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of undifferentiated arthritis
* Clinical synovitis of two or more joints
* At least one but not more than three of the criteria for diagnosis of RA (1987).
* No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
* Duration of disease must be 18 months or less.
* Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria:

* Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
* Active vasculitis of a major organ system.
* Severe or recurrent bacterial infection.
* History of cancer in the last five years except certain skin cancers.
* Herpes zoster that resolved less than 2 months prior to enrollment
0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka

Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.

This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is the proportion of patients "fit to discharge" on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. The study was designed to compare two of our current standard therapies:

1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and
2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis
* Ages 40- 80 years old
* American Society of Anesthesiologists class I-III

Exclusion Criteria:

* Refusal or absolute medical contraindication to peripheral nerve block
* refusal or absolute medical contraindication to spinal anesthesia
* conversion of spinal anesthesia to general anesthesia is obtained
* inability to cooperate
* allergy to any drug used in this study
* daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)
* alcohol dependence or use of any illegal drugs within the last month
* inability to perform the mobilization test and timed up and go (TUG) test pre-operatively
Identification of the Cranberry Juice Compounds That Prevent Urinary Tract Infections

The purpose of this study is to identify the substances in cranberry juice that make it effective in reducing urinary tract infections (UTIs) in women.

Urinary tract infections (UTIs) are a significant health issue, with one fourth of all women experiencing symptoms during their lifetimes. Cranberry juice has been shown to reduce the incidence of UTIs by preventing bacteria from adhering to the bladder. However, the compounds that direct this activity have not been identified. This study will identify and examine UTI-reducing compounds in cranberry juice.

Participants in this study will drink a specified amount of water following an overnight fast. Their urine will be collected 1 to 3 hours after the water is consumed. Several days later, the women will be provided with cranberry juice to replace the water in the regimen. Urine samples will be analyzed for compounds that have antibacterial or antiadhesion activity against the bacteria that cause UTIs.

Eligibility Criteria:
Inclusion Criteria:

* Good overall health

Exclusion Criteria:

* History of urinary tract infections
* Use of cranberry products or antibiotics within 1 week of study start
* Current use of any other medication
* Hypertension
* Diabetes
* Pregnancy
Longitudinal Outcomes in Hepatic Resection

This observational registry of patients undergoing liver surgery collects patients both retrospectively and prospectively. Patients undergoing liver resection for any non-transplant indication will be evaluated for clinical outcomes (such as surgical complications, survival, and disease progression) based on clinical and patient factors (like indication, age, and other treatments for the disease).


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring liver resection

Exclusion Criteria:

* Patients under the age of 18 years
* Patients undergoing liver transplant