cyrilzakka/clinical-trials huggingface dataset:
Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs

This study is designed to define groups of patients (among patients with a heart or kidney graft or a glomerular disease and nephrotic range proteinuria) who would either not profit from a therapy with mycophenolate-mofetil (MMF) or need a higher than conventional dose to respond.

Mainly there are 2 possible explanations for inter-patient differences in responsiveness to MMF therapy:

1. Based on a mutation (in this study single nucleotide polymorphisms-SNPs-) in the inosine monophosphate dehydrogenase 2 (IMPDH 2) transcript as the target enzyme of mycophenolic acid (MPA) pathway, MMF cannot exert its effect.
2. Based on a high enzyme activity of IMPDH 2 a higher MMF dose than in the conventional regimens is needed.

To study the significance of these possible explanations there are 4 objectives in this study:

Objective 1: Since there are no data on SNPs with functional relevance in IMPDH 2 transcript, we will first sequence all 14 exons of this gene in their entirety in 100 gender and age matched healthy individuals.

Objective 2: The functional relevance of a detected SNP will be tested in vitro in a lymphocyte proliferation assay using various MPA concentrations.

Objective 3: These functionally relevant SNPs will be searched in patients with kidney graft in a retrospective as well as prospective manner.

Objective 4: Parallel to the genotyping experiments, IMPDH 2 activity and MPA plasma levels will be measured in all patients recruited in the study prospectively.

An association between these SNPs or various IMPDH 2 activity / MPA plasma levels with MMF responsiveness will be examined.

Objective 5: Strongyloides IgG titers are screened to evaluate the prevalence of helminth carriers in patients with immunosuppressive therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with a de novo kidney graft and age \>18 and \< 75

Exclusion Criteria:

* pregnancy
* panel of antigens reactivity \> 40%
The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU

Postoperative pain is a major concern in routine management of children admitted to pediatric intensive care treatment. There are significant negative physiological and psychological ramifications of postoperative pain such as impairment of cardiac function due to tachycardia, restlessness in an intubated patient requiring increase dosage of sedative and paralytic drugs and reduced patient cooperation in the healing process.

The main body of evidence dealing with gender differences in pain perception and treatment stems from studies in the adult and adolescent population as the gonadal hormones have a central role in the way one experiences pain The hypothesis of this study is that there is a difference in the perception of pain, the amount of analgesia used and the response to pain medication between male and female infants undergoing craniosynostosis repair or untethering of cord.


Eligibility Criteria:
Inclusion Criteria:

All infants 0-1 year old, admitted to PICU after craniosynostosis repair or untethering of cord.

Exclusion Criteria:

1. Contraindication to analgesic medication
2. Infants with neurologic deficits that may hinder the assessment of pain severity such as facial nerve palsy and limb paralysis.
3. Ventilated infants.
Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy

To compare the efficacies of two different interventional techniques (Caudal epidural steroid injection and S1 transforaminal epidural steroid injection) for the treatment of unilateral S1 radiculopathy.

Epidural steroid injections are commonly performed for the treatment of radicular pain resulting from a disc herniation. There are 3 different methods to deliver steroids to epidural area which are caudal, interlaminar and transforaminal routes. Lower lumbar and sacral radiculopathies can be managed with caudal epidural steroid injection which is generally quite easier to perform in comparison to transforaminal injection. Transforaminal epidural injection provides injectate to reach anterior epidural area and is the most target specific technique among others. In the present study investigators aim is to compare the success rates of these two different procedures regarding unilateral S1 radiculopathy. The patients referring to the pain medicine outpatient clinic of a university hospital for unilateral radicular pain and diagnosed S1 radiculopathy were planned to be randomized into these two different intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral radicular pain resulting from a paracentral L5-S1 disc herniation causing S1 nerve root compression.

Exclusion Criteria:

* History of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases
Gallium-68 NODAGA-JR11 PECT/CT in Neuroendocrine Tumors

NODAGA-JR11 is a novel somatostatin receptor antagonist, while Gallium-68 DOTATATE is a typical somatostatin receptor agonist. This study is to evaluate the lesion detection ability of Gallium-68 NODAGA-JR11 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (PET/CT).

The results will be compared between antagonist Gallium-68 NODAGA-JR11 and agonist Gallium-68 DOTATATE in the same group of patients.

Patients with histologically confirmed metastatic, well-differentiated neuroendocrine tumors will be recruited in this study.

Each patient received an intravenous injection of 68Ga-DOTATATE (40ug/150-200MBq) on the first day and 68Ga-NODAGA-JR11 (40ug/150-200MBq) on the second day. Whole-body PET/CT scans were performed at 40-60 min after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.

Eligibility Criteria:
Inclusion Criteria:

* • Written informed consent.

  * Patients of either gender, aged ≥ 18 years.
  * Histologically confirmed diagnosis of Metastatic, well-differentiated neuroendocrine tumor.
  * A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor region within the previous 6 months prior to dosing day is available.
  * At least 1 measurable lesion based on RECIST v1.1.
  * Blood test results as follows (White blood cell: ≥ 3\*10\^9/L, Hemoglobin:

    ≥ 8.0 g/dL, Platelets: ≥ 50x10\^9/L, Alanine aminotransferase / Aspartate aminotransferase / Alkaline phosphatase: ≤ 5 times upper limit od normal (ULN), Bilirubin: ≤ 3 times ULN)
  * Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older.
  * Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min.

Exclusion Criteria:

* • Known hypersensitivity to Gallium-68, to NODAGA, to JR11, to TATE or to any of the excipients of Gallium-68 NODAGA-JR11 or Gallium-68 DOTATATE.

  * Presence of active infection at screening or history of serious infection within the previous 6 weeks.
  * Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within 28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on short-acting Sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug.
  * Any neuroendocrine tumor-specific treatment between antagonist and agonist scans.
  * Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
  * Pregnant or breast-feeding women.
  * Current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of \> 5 years can be included.
  * Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
The Women's Urology Center/WISH Database Project

Comprehensive database from the Women's Urology Center/WISH (Women's Initiative for Pelvic Pain and Sexual Health) program at Beaumont.

This women's health database will help us to identify health issues/concerns, useful therapies and interventions, and identify areas for improvement or further research specific for women's health. It will allow evaluation of outcomes of clinical interventions to enhance the care and treatment of women with pelvic pain and sexual health concerns.

Eligibility Criteria:
Inclusion Criteria:

All Women's Urology Center or WISH patients will be included in this database over time.

Exclusion Criteria:

The only exclusion would be if specified by a patient upon consent to treatment in the Women's Urology Center or WISH program
Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

The purpose of the study is to compare two different types of decision support materials for patients considering treatment for chest pain or chest discomfort from heart disease.

The purpose of the project is to compare the effectiveness of a detailed, video patient decision aid and an online, interactive patient decision aid for treatment of Stable Chest Discomfort. The study will randomly assign eligible participants to receive either the online decision aid or the video decision aid. Participants will complete a survey after reviewing the decision aid that will examine decision quality, use of the intervention, and satisfaction with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 and older
* English speaking
* Current diagnosis of stable angina
* Ability to access online material and willing to provide an email address

Exclusion Criteria:

* Coronary bypass surgery and/or percutaneous coronary intervention within 6 months
* Diagnosis of unstable angina, acute coronary syndrome, STEMI, non STEMI within 6 months
* Scheduled for nonelective catheterization
* Significant cognitive deficit such that participant is unable to consent for self
* Serious comorbidities or other conditions that make revascularization inappropriate
The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia.

Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference, Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG.


Eligibility Criteria:
Inclusion Criteria:

* without history of cardiovascular disease (CVD),
* not taking any medication likely to affect glucose or lipid metabolism (oral hypoglycemic agents and statins)
* free of overt liver, renal and thyroid disease

Exclusion Criteria:

* smoking
* drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response

The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption.

Exclusion Criteria:

* age \<18 years;
* pregnancy,
* known intolerance of vaccine,
* ongoing infection
A Study of LY3164530 in Participants With Cancer

The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.


Eligibility Criteria:
Inclusion Criteria

* Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
* Have adequate organ function.
* Prior Treatments:

  * Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:

    * Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
    * Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
  * Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
* If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug.
* If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.

Exclusion Criteria:

* Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
* Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
* Must not have a serious preexisting medical conditions or concomitant disorders.
* Must not have leukemia.
* Must not have QT interval of \>470 millisecond.
* Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.
Lipids and Neurological Complications in Liver Transplantation

To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol

All patients included in the study will receive the same immuno-suppression protocol based on tacrolimus and mycophenolate mofetil after the induction immuno-suppression during the intra-operative period.

Patients will have a full history taking and full neurological examination 48 hours prior to the designated operative date as a basal record.

the control group will not receive any lipid infusions at all the treatment group will receive the study emulsion (SMOF lipid 20% - Fresenius Kabi) starting 48 hours before the planned surgery day and will continue to receive it for 5 post-operative days by intravenous infusion.

During the post-operative period. patients will be assessed daily by full neurological examination as will as patient complaints (symptoms) related to neurological status for diagnosis of any neurological conditions (complications) that might arise during the study period.

Data will be analysed compared to the basal value in each group and between both control and intervention groups using the appropriate statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* Adult living donor liver transplant recipients of either sex

Exclusion Criteria:

* MELD score \> 30
* Retransplantation
* Budd Chiari syndrome
* Diabetes more than 10 years
PEERS Using Peer Mentors to Deliver Depression Care

Fifteen to twenty percent of older Americans (6 to 8 million people) suffer from depression but more than one-half do not receive any services, a burden disproportionately shared by low-income and minority older adults who receive few or no services. The investigators propose to test a community-based peer model of depression care called PEERS (a peer support program) that provides self-care support for minority and low-income older adults.

Depression is a major burden for minority and low-income older adults who are less likely to use mental health services, and development of new service delivery models is needed to improve the quality of life and address disparities to access for this group. The investigators propose to test the effectiveness of a peer-delivered depression care program that is embedded in the community and linked to the patient's primary care clinic. The investigators will carry out a randomized controlled trial of the PEERS program in which peer mentors who have personal experience of depression meet individually with older adults recruited in the community for 8 weekly meetings focused on relief of depressive symptoms through self-care support and linkages to community resources. This group of low-income and minority older adults in the intervention will be compared to a group that receives non-peer visits that provide social interaction. The PEERS program takes a chronic disease self-management approach and is guided by the conceptual frameworks of social support, peer support, and social learning. The investigators will conduct an analysis of mediation to understand the mechanism of peer support, by measuring factors such as self-efficacy and loneliness that may be responsible for the intervention effect. The investigators' goal is to use peer-delivered depression care to decrease the mental health morbidity of at-risk low-income and minority adults. The potential public health impact is high because the investigators' project seeks to increase access to depression for a vulnerable group of older adults who often do not get care and leverages an existing workforce of peer workers whose services are reimbursed in many states.

Eligibility Criteria:
Inclusion Criteria:

* 50 years and older
* depressive symptoms with Patient Health Questionnaire-9 scores ≥ 5
* belong to an underserved population, defined as annual income less than 200% of the federal poverty level ($24,120) and/or self-identified ethnic minority
* able to communicate in English
* willing to give informed consent.

Exclusion Criteria:

* meet diagnostic criteria for mania or hypomania
* meet diagnostic criteria for psychotic syndrome
* meet diagnostic criteria for substance abuse or dependence
* acutely suicidal
* a score on the Mini-Mental State Examination (MMSE) ≤ 24
* currently taking an antidepressant medication with dosage change in the past 3 months
* receiving active psychotherapy
Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women

With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data.

This record describes a quality improvement program (called "Nurture") piloted by Driscoll Health Plan, which included nutrition education and food purchase support offered to a subset of pregnant women aged 30 years and above and covered by the Medicaid Managed Care Organization (MCO) plan in their "STAR" and "CHIP" programs during October 2022 and July 2023.

Factor Health lab at Dell Medical School at the University of Texas at Austin will do a secondary data analysis to evaluate the impact of DHP's program.

Driscoll Health Plan (DHP) is a non-profit, community-based health insurance plan that provides coverage to South Texas and the Rio Grande Valley communities. Their insurance products include STAR Medicaid, STAR Kids, CHIP, and CHIP Perinatal.

With input from Factor Health lab at Dell Medical School, DHP introduced the Nurture program for its members as a quality improvement initiative, designed to expand members' access to nutrition education and food purchase support to improve health and pregnancy outcomes.

Nurture included up to 8 packages mailed every four weeks until the member reaches the end of pregnancy. Each package included USD $40 in the form of gift cards to a large-chain grocery store, a healthy eating information sheet selected from Brighter Bites (https://brighterbites.org/), a set of three recipes, and nutrition-related Frequently Asked Questions during pregnancy (in four out of the eight packages). Members also received two 30-minute nutritional consultations over the phone.

Members had the flexibility to opt out of the program at any time and discontinue receiving packages. Consultations were optional. If they opted out, they continued to receive the DHP benefits as part of their regular coverage.

Eligibility Criteria:
Inclusion Criteria:

* Member of Driscoll Health Plan
* Pregnant
* Aged 30 or older

Exclusion Criteria:

* Not a member of Driscoll Health Plan
* Not pregnant
* Younger than 30 years of age