cyrilzakka/clinical-trials huggingface dataset:
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg

Background:

The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There is a good chance to further increase the cure rate if the investigators can enhance the HBV-specific immune response when the HBsAg level already comes to a low level.

Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients whose HBsAg already \<=2000 IU/ml.

Patients and methods:

This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine (20μg for \<20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg clearance.

Aims

1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg.
2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients.
3. To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.

Vaccination schedule:

Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those \<= 20 years old and 40μg in those \> 20 years old.

HBsAg and anti-HBs:

qHBsAg will be checked by commercial kits (Elecsys, Roche Diagnostics, Indianapolis, IN) at baseline, right before every dose, and every 3 months following the last dose for one year. ALT, AST, Alpha-fetoprotein, bilirubin and anti-HBs will be checked simultaneously.

Eligibility Criteria:
Inclusion Criteria:

1. Naïve or treated chronic hepatitis B patients with positive HBsAg and negative HBeAg;
2. Quantitative serum HBsAg (qHBsAg) \<2000 IU/ml;
3. No HIV co-infection;
4. No obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy, immunosuppressant);
5. Aged 3 to 80 years;

Exclusion Criteria:

1. Pregnancy
2. Allergic to HBV vaccine or yeast.
3. Hepatic decompensation
Family Telemental Health Intervention for Veterans With Dementia

Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver stress and behavioral problems are often ineffective. Many caregivers do not realize their interactions with PWD contribute to behavioral problems and thus do not ask for help to improve their interpersonal skills. The aim of this project is to develop an assessment of interpersonal skills deficits and a related treatment strategy to assist family caregivers of PWD who are challenged by a lack of interpersonal skills and are not helped by existing family caregiver treatments. This project, will develop and test (1) a video assessment of caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and (2) a family therapy for the interpersonal difficulties clinicians identify in the assessment.

Study temporarily suspended due to COVID risk associated with at risk population of Veterans with Dementia and often older caregivers.

Eligibility Criteria:
Inclusion Criteria:

Either the caregiver or the care-recipient must be a Veteran.

The caregiver must:

* Be the primary unpaid family or friend who helps or supports an individual with dementia
* Be involved in the care of the person with dementia (at least 4 hours of care per day)
* Report that the care-recipient exhibits behavioral problems that are distressing
* Not be currently receiving the REACH VA protocol

Additionally, the care-recipient must:

* Must have a documented diagnosis of dementia
* Have cognitive impairment (MMSE\<23 or SLUMS\<20 or diagnosis of dementia based on chart review)
* Be out of bed and able to respond to a caregiver's instructions or interventions

Exclusion Criteria:

* Caregiver severe cognitive impairment
* Caregiver inability to meet study demands
* Caregiver psychosis
Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age

This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants 6 months to less than 18 years of age at the time of informed consent/assent form was signed
* Participants whose parent/LAR(s) have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them
* Participants with macrocystic LM or mixed cystic LM (≥ 50% macrocystic disease measured by volume) of the Head/Neck/Mediastinum according to the ISSVA 2018 criteria (ISSVA 2018) measured via LM imaging at Screening to confirm, upon central review, the diagnosis of macrocystic or mixed cystic LM
* Participants who may have had surgical or sclerotherapy treatment for their LM, but not within six months of the consent/assent form being signed

Exclusion Criteria:

* Penicillin allergy
* Vascular tumors or combined vascular malformations
* Microcystic LM or mixed cystic LM with predominant microcystic features
* LMs of the orbit (orbital LM) as target cyst

For more information on eligibility criteria, please contact the sponsor.
Chronic Kidney Disease (CKD) Guideline Adherence - A Quality Improvement Study

Chronic kidney disease (CKD) is defined as kidney damage for greater than 3 months or a glomerular filtration rate less than 60 mL/min per 1.73m2 for greater than 3 months. Patients with CKD are at high risk for development of cardiovascular disease and metabolic complications. Guidelines for the care of patients with CKD have been developed by the National Kidney Foundation. Despite the wide availability of these guidelines, adherence is low. The goal of the current study is to evaluate whether a multifactorial intervention, including a CKD registry, will improve CKD guideline adherence. The hypothesis is that providers exposed to a multifactorial clinical intervention including education, academic detailing, and a CKD registry will be more likely to adhere to CKD guidelines than those only exposed to education.


Eligibility Criteria:
Providers:

Inclusion Criteria:

* All primary care providers at the Wade Park Veterans Affairs Medical Center (VAMC) will be eligible for the study

Patients:

Inclusion Criteria:

* Receive primary care from a provider at the Wade Park VAMC
* Have:

  * CKD as defined by an estimated glomerular filtration rate (eGFR) less than 60 on two separate occasions 90 to 730 days apart,
  * diabetes, OR
  * hypertension

Exclusion Criteria:

* End-stage renal disease
* Renal transplant recipients
* Less than 18 years of age on July 1, 2009
* No primary care visit between Jan 1, 2008 and July 1, 2009
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic

Exclusion Criteria:

* First manic episode
* Current manic or mixed episode with \> 2 years duration
* Treated with aripiprazole within the past 3 months
* Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
Comparative Study of Inguinodynia After Inguinal Hernia Repair

To evaluate the postoperative pain and the relapse after the repair of the inguinal hernia by Lichtenstein technique with four different mesh types with different types of fixation in patients undergoing major ambulatory surgery.

Since the widespread use of meshes in the repair of inguinal hernia, recurrence rates have acceptable values, so, today, the focus is on trying to decrease chronic pain after hernioplasty. Chronic postoperative inguinal pain (CPIP) is an important clinical problem, which can significantly influence the quality of life of the patient. Different studies have published CPIP rates from 9.7% to 51.6%.

The reasons for CPIP are unclear; Lesion and entrapment of the nerves, the type of mesh used, and the fixation material of this has been related to the causes of inguinodynia.

CPIP can be divided into neuropathic pain and non-neuropathic pain. According to the International Association for the Study of Pain (IASP), neuropathic pain is caused by the primary lesion or nerve dysfunction, causing burn-like pain that radiates through the area innervated by the injured nerve, intensifying the nerve with light touch. The causes of this type of pain are the entrapment of the nerve by the mesh or sutures or by the formation of neuromas associated with the partial or complete transection of the nerve. The nerves that run through the inguinal region and are therefore susceptible to injury when the anterior approach is the ilioinguinal nerve, the genitofemoral genital branch, and the iliohypogastric nerve.

Neuropathic pain may occur immediately after surgery, but may also occur months or years after surgery.

Non-neuropathic or nociceptive pain is caused by the activation of mediators of inflammation due to the continuous inflammatory reaction that occurs around the mesh. According to Amid, nociceptive pain is caused by the mechanical pressure of the mesh over adjacent tissue, including the vas deferens and nerves. This type of pain is acute and stabbing and is aggravated by intense exercise.

In conclusion, the use of foreign materials in hernia surgery may induce intense inflammation that can result in chronic pain.

The hypothesis of our work is that: "The use of glue-attached meshes (self-adhesive) compared to those fixed with suture present lower rates of post-hernioplasty pain".

Eligibility Criteria:
Inclusion Criteria:

* Age: over 18 years
* Patients undergoing INGUINAL HERNIA surgery on a scheduled basis in surgery without hospitalization.
* Sign informed consent.
* ASA I-II.
* Inguinal hernia.
* Unilateral or bilateral hernia.
* Lichtenstein hernia repair technique

Exclusion Criteria:

* Patients with ASA III-IV.
* Psychiatric disorders.
* Pregnant or breastfeeding.
* Non-acceptance of informed consent.
* No acceptance or inability to follow a follow-up protocol.
* Any hernia repair technique other than Lichtenstein.
* Recurrent inguinal hernia
Screening, Brief Intervention, and Referral to Treatment in Primary Care

This add-on study of providing tobacco, alcohol and other drug screening, brief intervention and referral for treatment to a primary care high risk diabetic population leverages the existing research resources of a funded parent project "Duke University CMS Innovation Award Southeastern Diabetes initiative (PI: Robert M. Califf, MD)" to explore the feasibility of implementing Screening for substance use, Brief Intervention, and Referral to Treatment services in Primary Care (SBIRT-PC) and to examine the effects of substance use status on diabetes health care outcomes. This pilot study also examines the feasibility of the CTN's common data element algorithms of SBIRT for illicit and nonmedical drug use in the primary care setting.

Duke University Translational Medicine Institute has received funds from the Bristol-Myers Squibb Foundation and the Centers for Medicare and Medicaid Services (2012-2016) to augment existing standard of care for patients with diabetes in community-based medical settings in order to achieve goals of better health, better health care, and reduced costs ("Duke University CMS Innovation Award Southeastern Diabetes initiative"; Principal Investigator, Robert M. Califf, MD). Its goals are to (1) improve population-level diabetes management, health outcomes, and quality of life for diagnosed and undiagnosed adults living with type 2 diabetes, (2) reduce disparities in diabetes management, health outcomes and quality of life for adults living with type 2 diabetes, and (3) reduce healthcare costs associated with type 2 diabetes. This already funded diabetes care project provides a cost-effective platform for conducting an add-on project to examine the feasibility of the CTN's clinical decision support algorithms for SBIRT in primary care settings, as the study team can leverage existing organizational and research infrastructure to facilitate the completion of the study. The add-on study is supported by strong rationale, including the fact that primary care settings serve as common points of contact for adults and provide many opportunities to detect drug misuse and to intervene early in low or mild severity (better outcomes), which in turn may reduce substance use, increase awareness and drug-medication interactions, enhance patient medication adherence, and decrease high inpatient costs and repeat emergency department visits.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* Diagnosis of Type 2 diabetes
* Reside in Durham County, NC, or the neighboring areas and receive the majority of their healthcare in the county
* Referral from the primary care clinician or patient's medical home if one has been designated
* Have capacity to make decisions

Exclusion Criteria:

* Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
* Have a terminal illness with a life expectancy of 6 months or less
* Diagnosis of Type 1 diabetes or gestational diabetes
* Currently pregnant
* Unable to comply with study requirement
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.

A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.

This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years; Male or Female.
2. Treatment-naïve patients after Resection of Glioblastoma.
3. Histologically confirmed Glioblastoma.
4. KPS ≥ 60
5. White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
6. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
7. Patients must be able to understand the investigational nature of the study and provide informed consent.

Exclusion Criteria:

1. Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
2. Those with severe autoimmune diseases or immunodeficiency diseases.
3. Those who are expected to take systemic corticosteroids within three months.
4. Those who needs long-term usage of immunosuppressive agents.
5. Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
6. Those who plan to receive any other anti-tumor treatment during the trial.
7. Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
8. Patients with other malignant tumors.
9. Those with active infections, etc.
10. Suspected or confirmed a history of alcohol and drug abuse.
11. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
12. Women who are pregnant or nursing.
13. Women of childbearing age who refuse to contraception.
14. Active participation in another clinical treatment trials.
15. According to the judgment of the investigator, other conditions that the plan cannot be followed.
Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.

PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.

OBJECTIVES:

Primary

* To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy.

Secondary

* To obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients.

OUTLINE: Patients undergo a baseline evaluation in week 1 focusing on basic demographics, health, physical function and quality-of-life assessments. These assessments include the Short Physical Performance Battery (SPPB); the Hand Grip Test of Muscular Strength; the Demographics and Physical Activity History; the Functional Assessment of Cancer Therapy (FACT-Leu); the Distress Thermometer; the Short-form Positive Affect Schedule (PANAS-SF); the Satisfaction with Life Scale (SWL); the FAST-23 Disability Measure; the Center for Epidemiologic Studies Depression Scale Short Form (CES-D); the Self-efficacy for Physical Activity Scale; the Intervention Feedback Form; and the Pre-Post Session Ratings. Some medical data may be obtained from the patient's medical record to assist in these assessments.

Beginning in weeks 2-5, patients undergo a 30-minute orientation to the exercise sessions that will be tailored to individual needs and abilities. Patients undergo a 30- to 45-minute group physical activity session twice a week, and a supervised individual session following the same format as the group session, once a week for 4 weeks. After completion of the physical activity intervention, patients complete an activities packet and repeat the physical function and quality of life assessments in weeks 5-6 and again upon readmission for consolidation therapy in weeks 9-13 .

After completion of study intervention, patients are followed for 4 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed acute myeloid leukemia (AML) by WHO criteria
* Planning to undergo induction or reinduction chemotherapy
* Inpatient status at Wake Forest University Baptist Medical Center
* Must not require intensive care unit support

PATIENT CHARACTERISTICS:

* Able to understand English
* Medical eligibility confirmed with Leukemia Service Attending
* Ambulatory or able to walk with a cane
* No hemodynamic instability
* No acute thrombosis within the past 7 days
* No active ischemia within the past 7 days
* No uncontrolled pain
* Must have \< 3 incorrect responses on the Pfeiffer Mental Status Exam

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Although norepinephrine is commonly used and is the recommended agent for the treatment of hypotension in volume-resuscitated hyperdynamic septic shock, Low doses of vasopressin may be added to norepinephrine to maintain arterial blood pressure in refractory septic shock and to decrease exposure to norepinephrine. The aim of the work is to compare the effect of norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue perfusion in septic shock patients.

Study which was performed on 90 adult of either sex in intensive care unit who developed septic shock.45 patients in each group according to the drugs used, by the single blind technique as the treating physician only is aware of the drugs used.

Group 1: patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min).

Group 2: patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min).

A comparison was done between both groups as regard:Hemodynamics,Tissue perfusion, C-Reactive Protein (mg/L) ,WBC, UREA (mg/dL),CREATININE (mg/dl), NGAL (Neutrophil gelatinase associated Lipocalin) (ng/ml). Comparison was done at baseline, then every 6 hours for 48 h as regard hemodynamics and tissue perfusion, and at base line then, 24 h and 48 h as regard sepsis biomarkers and renal biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of both sex

Exclusion Criteria

* Patients with renal impairment (Creatinine\>2mg/dl)
* Sever Heart Disease (ischemic/valvular)
* Peripheral vascular disease (e.g. Raynaud's phenomenon)
Comparison Across Multiple Types of Sleep Deprivation

This study is designed to assess neurobehavioral performance, as well as genetic and other physiological changes associated with variations in timing and quantity of sleep.

During a 1.5 week inpatient laboratory protocol, subjects will undergo one of four parallel sleep conditions. Subjects will be randomly assigned to each condition group. During their time in the laboratory, biological samples (e.g., blood) will be collected for genetic and other analyses, and sleep quantity and quality will be monitored. Additionally responses on neurobehavioral tests and surveys will be monitored for differences among the groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI 18.5-29.9, with consideration of BMIs 30-34.9.

Exclusion Criteria:

* Medication use, with potential consideration for contraceptives.
* Color blindness
* Recent nightwork, shiftwork, or travel across greater than two time zones
* Pregnant or within 6 months post-partum