cyrilzakka/clinical-trials huggingface dataset:
FDG-PET/CT for Simulation and Radiation Treatment Planning of Early Breast Cancer

The purpose of the study is:

* to assess the potential benefits of 18F-\[FDG\] PET/CT and PET/MRI for operable breast cancer in order to define the size and location of the primary tumor, as well as axillary, supraclavicular and internal mammary lymph nodes.
* to apply the imaging results to the simulation and the radiation treatment planning and partial breast for 3-D radiation treatment and partial breast irradiation with intensity modulated radiation treatment (IMRT).

Pre-operative FDG PET/CT, and in option PET/IRM, are intended for women with histologically confirmed operable clinically node-negative breast cancer, in whom breast conserving and post-operative radiotherapy are planned.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast carcinoma
* Clinical stage T1-2 N0 M0
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* WHO performance index 3
* Premenopausal women without contraception
* Gestation
* Lactating
* Prior surgery or radiotherapy on the same breast
* Unable to understand study participation
* Bilateral breast cancer
* Prior CT thorax-abdomen and breast MRI within 4 months of interview
* Presence of electromechanical implant and/or body ferromagnetic material
* Previous history of renal insufficiency requiring dialysis and/or hospitalisation
* Ureum and/or creatinine within 2 weeks of interview above lab's reference limits
* History of contrast allergy
* Hyperthyroidy
* Claustrophobia.
Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.

The present multiple baseline single case trial will study the efficacy and acceptability of the "Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders" in the treatment of emotional symptomatology and/or emotional disorders in a sample of patients with Post Covid-19 condition.

COVID-19 disease has caused one of the largest pandemics in world history. Two and a half years after the WHO declared a pandemic status for COVID-19, it is known that about 10-20% of Covid-19 patients fail to recover their initial health status and report persistent symptoms over time. This group of people suffer from what has been defined by the WHO as post-COVID-19 condition. Among this group of patients, the most common symptoms observed are fatigue, shortness of breath and cognitive dysfunction, as well as psychological sequelae. Among the latter, the group of Emotional Disorders ( EDs), a nomenclature that groups anxiety disorders, depressive and related disorders, are those most commonly reported by people with post-COVID-19 condition, with alarmingly high rates of persistent psychological distress (36%), anxiety disorders (22%), depression (21%), post-traumatic stress disorder (20%) and sleep disorders (35%). Therefore, it is necessary to apply intervention programs for the treatment of psychological sequelae derived from post-COVID-19 condition, as well as emotional demands and needs in this population highly affected by the COVID-19 pandemic.

The overall objective of this trial is to study the efficacy and acceptability of the "Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders" (UP) in the treatment of emotional symptomatology and/or ED in a sample of patients with post-COVID-19 condition. The investigators hypothesize that a structured psychological intervention focused on treating emotional dysregulation (the UP), a factor shared by the group of EDs, will generate an improvement in the emotional state of this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Belong to the autonomous community of Aragón
* Be at least 18 years of age
* Have a good understanding of Spanish
* SARS CoV 2 infection documented by PCR, Ag test or serology
* Persistence of symptoms beyond 12 weeks after acute SARS CoV 2 infection
* Emotional symptoms (score equal to or greater than 8 points in anxious symptomatology(OASIS) and/or equal to or greater than 7 points in depressive symptomatology (ODSIS)) and/or diagnosis of Emotional disorder (ED)
* Internet access available
* Signed informed consent.

Exclusion Criteria:

* Participating in the trial "Specialized nutritional intervention and rehabilitative treatment for improvement of quality of life in a cohort of patients with post covid-19 condition"
* That the symptom(s) already existed prior to acute SARS CoV 2 infection
* Receiving psychological and/or pharmacological treatment for a mental disorder at present
* Having a diagnosis of severe mental disorder
* Active suicidal ideation at the time of evaluation.
Effect of Erythropoietin on Preterm Brain Injury

EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of EPO.

Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants, which is related with the development of cerebral palsy. The current therapy is only supportive to maintain the live sign stable. There is no effective therapeutic strategy for preterm brain injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and clinical trials of neonatal hypoxic ischemic brain injury. Furthermore, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity during the past decade. It has been considered to be safe and well tolerated in preterm infants. However, there is no conclusion yet if the EPO has the effect to prevent preterm brain injury. The purpose of the study was whether the rhEpo (500 U/kg) given to very preterm infants (gestation age \< 32 weeks) within 24h after birth and subsequently each other day for2 week possesses neuroprotective properties. Very preterm infants with gestational age of \< 32 weeks and admit to our NICU are eligible for enrollment. After informed consent is obtained, infants will be randomly assigned to either EPO group or vehicle group. The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP. The long term outcomes are whether rhEpo in very preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants admitted to the NICU with gestational age \<32 weeks
* birth weight \<1500g and less than 72hours of age

Exclusion Criteria:

* 1. Infants with genetic metabolic diseases

  2. Congenital abnormalities

  3. Pneumothorax

  4. Grade III-IV intracranial hemorrhage
Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects

Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies, predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA). Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary to an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in the context of APS, APL can also be observed in various clinical situations and in healthy subjects. Published studies have reported a variable prevalence of APL in healthy subjects, essentially ACL and/or LA, and their clinical significance currently remains unclear.

Several studies have highlighted the link between APL and atherosclerosis. It therefore appears interesting to more specifically study the association between the presence of APL and the presence of cardiovascular risk factors in a population of healthy subjects. Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a complex interaction between atherogenic plasma factors and cells of the arterial wall. Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid peroxidation also plays a major role during the atherogenesis process. It will therefore also be important to correlate APL with markers of vascular inflammation and markers of oxidative stress.

A prospective case-control study will therefore be conducted on 1,500 healthy blood donors. Subjects screened APL-positive will be compared to APL-negative subjects in terms of cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular disease will not be studied). In the context of a blood donation, all subjects wishing to participate in this study will attend a medical interview and a clinical examination during which various data will be collected, mainly the presence of cardiovascular risk factors. A blood sample will also be taken to assay the various laboratory markers studied.

This study should provide a better understanding of the role of APL in healthy subjects and more clearly specify their possible link with atherosclerosis in this population.


Eligibility Criteria:
Inclusion Criteria:

* healthy blood donors

Exclusion Criteria:

* contraindication to blood donation
TRU-IMMUNO: Optimizing Liver Immunosuppression

This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of liver dysfunction to guide immunosuppression management.

This study will provide TruGraf Liver and TRAC liver tests to one group of transplant providers early after liver transplantation to clarify if the Trugraf Liver and TRAC Liver results can complement their immunosuppression minimization strategies to avoid complications and reduce the occurrence of acute rejection. The ability to decrease IS will be compared to the group that does not receive the test results.

Subjects will be randomized into 2 groups: one will receive Trugraf/TRAC Liver testing and the other will not. Subjects in the biomarker arm will have TruGraf Liver and TRAC Liver testing at study enrollment (1-2 months post-liver transplant) and thereafter every month for 6 months. Subjects will also have Trugraf Liver and TRAC Liver testing at months 9 and 12 following transplantation (7-8 and 10-11 months post baseline). The TruGraf and TRAC Liver results will be used in the biomarker arm in conjunction with all other clinical parameters available to guide decisions related to immunosuppression changes. There are no protocol mandated immunosuppression changes. Subjects in the standard of care arm will not have biomarkers available for decisions related to immunosuppression changes.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Recipient of a primary or subsequent deceased-donor or living donor liver transplantation.
* Normal liver function tests at the time of or within 2 weeks of the baseline visit, defined by Total Bilirubin (TB) ≤1.5 mg/dL and Direct Bilirubin (DB) \<0.5 mg/dL, Alkaline Phosphatase (AP) ≤200 U/L, and Alanine Transaminase (ALT) ≤60 U/L (males) ≤36 U/L (females).
* Between 1-2 months post-liver transplantation

Exclusion Criteria:

* Inability or unwillingness to provide informed consent.
* Recipients of previous hepatic or non-hepatic solid organ transplantation
* History of ≥2 mild or moderate rejections or 1 severe rejection prior to enrollment defined by BANFF 2016 criteria
* History of autoimmune liver disease
* Listed for repeat liver transplantation
* Infection with HIV
* Active HBV or HCV viremia (patients with undetectable virus can be included)
Cost-effectiveness of TPMT Pharmacogenetics

The purpose of this study is to determine whether thiopurine S-methyltransferase (TPMT) genotyping prior to thiopurine use is cost-effective in patients with inflammatory bowel disease (IBD) in need of immune suppression.

The study is designed to test the hypothesis that optimization of initial thiopurine dose based on pre-treatment TPMT genotyping will maximize treatment efficacy and minimize adverse drug reactions (ADRs) resulting in reduced costs.

Immunosuppressives, e.g. azathioprine (AZA) and 6-mercaptopurine (6-MP), are important in induction of remission and long term treatment of (ulcerative) colitis and Crohn's disease when treatment with 5-aminosalicylates and corticosteroids fails. ADRs to immunosuppressive treatment, including myelosuppression and hepatotoxicity, are frequently (15-30%) observed. Genetic variation in the TPMT gene results in 10-11% of the general population in reduced and in 0.3-0.6% to negligible TPMT enzyme activity. In IBD patients, this genetic variation predicts 25-40% of the haematological ADRs necessitating tempering of thiopurine dose or discontinuation of treatment.

Pharmacogenetics aims at providing optimized drug treatment to patients by maximizing efficacy and minimizing adverse drug reactions (ADRs) based on genetic testing. Despite the proven value of pharmacogenetics in clinical practice, its use in medical care is still limited.

The best-established example of a pharmacogenetic test is genotyping of thiopurine S-methyltransferase (TPMT) in the treatment of patients with immunosuppressive thiopurines. Nonetheless, it is not used on a large scale in clinical practice so far, which might be due to: insufficient information transfer from research to clinic; lack of cost-effectiveness analyses (CEAs); lack of availability of (or access to) fast and/or cheap genotyping; or lack of test reimbursement by health insurance.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of a form of IBD
* Indication for azathioprine/6-MP treatment
* Patient giving (written) informed consent

Exclusion Criteria:

* Previous treatment with azathioprine/6-MP
* Co-prescription of allopurinol (this treatment blocks xanthine oxidase, an enzyme important for thiopurine metabolism)
* Baseline leukocyte count less then 3x10\^9 per litre
* Reduced liver function at baseline
* Reduced renal function at baseline
* Known TPMT phenotype (enzyme activity / Therapeutic Drug Monitoring) or genotype
* Pregnancy or breastfeeding
Cell Biology of Steroid Resistant Asthma

The hypothesis is that patients who demonstrate steroid resistant asthma by showing little or no improvement in lung function after a course of oral steroids have different cellular responses to steroids than patients who are steroid sensitive. These altered responses are the reason they demonstrate steroid resistance.

Current NHLBI guidelines for persistent asthma management recommends the use of steroids for treatment of airway inflammation (1,2). However, some asthmatics do not respond to steroids (3-6). Unfortunately these patients are subjected to the unwanted side effects (osteoporosis, cataracts, etc) of high dose steroid therapy because non-immune tissues remain sensitive to steroids. Recent studies suggest that the costs of asthma are largely attributable to uncontrolled disease (7). Thus, it is important to understand the mechanism(s) of steroid resistance and introduce new forms of therapy for the treatment of these difficult to control asthmatics. As a prelude to pharmaceutical studies in steroid resistant asthma, it is imperative to develop biomarkers that can robustly identify individuals likely to be poor steroid responders so that alternative non-steroid anti-inflammatory therapies, such as Xolair®, can be introduced early in the course of asthma therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Will meet American Thoracic Society criteria for asthma
2. Pulmonary function tests consistent with asthma. This includes a baseline FEV1 \< 80% predicted as well as a 12% improvement in FEV1 following up to 4 puffs of albuterol.
3. Subjects must be 12 to 65 years old.

Exclusion Criteria:

1. Viral infection within four weeks of the starting date.
2. Abnormal hepatic function.
3. History of COPD
4. Pregnancy.
5. History of smoking.
6. Anemia (hemoglobin less than 12 gm %)
7. Concurrent therapy with anticonvulsants, erythromycin, rifampin and any systemic asthma medication including Singular®, Xolair® or oral prednisone.
8. Greater than 500 mcg per day of inhaled corticosteroids
9. Suspected non-compliance with medical care.
10. Abnormal prednisone pharmacokinetics (applies to phase 2 of trial)
11. Patients with severe medical conditions that in the view of the investigator prohibits participation in the study (specify as required)
12. Use of any investigational agent in the last 30 days
Healthcare Provider Attitudes Towards Patients With Substance Use Before and After Implementation of the SBIRT Model in the Emergency Room

The purpose of this quality improvement research project is to briefly survey attitudes among healthcare providers toward patients with substance use disorders before and after substance abuse counselors are placed in the Emergency Room.

The purpose of this quality improvement research project is to briefly survey attitudes among healthcare providers toward patients with substance use disorders before and after substance abuse counselors are placed in the Emergency Room. SBIRT stands for Screening Brief Intervention and Referral to Treatment. The pre-test survey contains 10 questions about attitudes toward patients with substance use disorders and the post-test survey consists of 13 questions about attitudes toward patients with substance use disorders and questions regarding the SBIRT model itself. Health care providers will be surveyed before the SBIRT Counselors begin and again at 6 months, after full SBIRT program with substance counselors on site has been in place, as a part of their regular staff education requirements. Part of the goal of the SBIRT counselors is to educate providers about treatment and analyze data collected by and comments of Emergency Room staff.

Eligibility Criteria:
Inclusion Criteria:

* UAB Emergency Department Staff (attending, resident, nurse, social worker, case manager, patient care technician) or Psychiatry Emergency Services staff (nurses, social workers and residents)

Exclusion Criteria:

* Not employed in UAB Emergency Department
Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA?

The purpose of this research is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee (ICD-9 Code of 715.16, 715.09 or 715.9)
* lives within interstate 95
* age 55 or older
* English speaking

Exclusion Criteria:

* Stroke or heart attack in last 3 months
* Treatment for cancer
* Severe systemic disease
* Medical condition that limits physical activity
* Inflammatory arthritis
* Plans for knee replacement
* Dementia or inability to follow exercise instructions and TLC system
COVID-19 Vaccine Response in Sickle Cell Disease

The purpose of this study is to assess the antibody response to COVID-19 vaccination in a cohort of patients with sickle cell disease (SCD) and to assess vaccine and SCD related complications around the time of vaccination.

Sickle cell disease (SCD) is a genetic disorder caused by a single base substitution of valine for a glutamine at the sixth amino acid of the gene encoding for the hemoglobin β chain. Patients with Hgb SS disease and other sickle hemoglobinopathies suffer from a variety of clinical complications related to this abnormal hemoglobin. These clinical manifestations include hemolytic anemia, painful vaso-occlusive crisis, and end organ damage. Persons with SCD generally auto-splenectomize in childhood secondary to infarctions from their hemoglobinopathy, thus increasing their risk of infection and rendering them immunosuppressed. Data suggest that general immune function in SCD patients may be impaired, and thus responses to vaccine may be suboptimal.

Patients with SCD are considered at increased risk of complications from infection from SARS-CoV-2 infection and are therefore an important group to receive vaccination against the virus. Understanding response to COVID-19 vaccination is this high-risk group of patients can provide a more targeted approach to vaccination in order to achieve adequate protection.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of sickle cell disease (HbSS, HbSC, HbSB0 thalassemia, HbSB+ thalassemia, HbS/Other)
2. Has not received any COVID-19 vaccination prior to enrollment
3. Scheduled for a COVID-19 vaccination (type does not matter) as part of routine clinical care
4. Willing and able to sign consent

Exclusion Criteria:

1. Unwilling to have labs drawn or complete study requirements.
2. Previous therapy curative of SCD (including bone marrow transplant and gene therapy)
3. Previous receipt of anti-COVID-19 antibody therapy
A Community Pharmacy-based Program to Improve Management of Diabetes

In this study the investigators aim to evaluate the impact of a community pharmacy-based program to educate type 2 diabetic patients about medications, life style and self-care.

Diabetes mellitus type 2 is a progressive metabolic disorder that leads to several morbidities and increased mortality and costs. Studies showed that strict control of blood glucose in diabetic patients reduces patients' risk of microvascular complications. Community pharmacies are a well-placed healthcare facility located at the heart of the community with convenient access to pharmacists as health care professionals. Some studies have shown effective interventions led by community and clinical pharmacist in developed countries. In developing countries, little evidence exists about feasibility of implementing community pharmacy-based services to promote medications adherence, self glucose monitoring and self-care in diabetic patients.

This study is a 2 arm randomized controlled trial. Eligible patients are referred to the community pharmacy from an endocrinologist's office. Of 135 type-2 diabetic patients who will be recruited in the study,68 will be randomly allocated to the intervention arm using telephone balanced blocked randomization method.

A community pharmacy-based program will provide training about medications, life style and self-care to the intervention arm. The control arm (67 patients) will receive usual care during the study period.

The primary outcome of this study is measured as change in hemoglobin A1C pre and post intervention. As the secondary outcome, medications adherence, diabetes self-care activity, body mass index and blood pressure are measured.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients using oral anti diabetic medications.
* Hemoglobin A1c \> 7 within the previous month before recruitment
* Adequate literacy and ability to use the glucometer.
* Signing the informed consent

Exclusion Criteria:

* Patients requiring adjunct insulin therapy.
* Patients with concurrent heart failure (stage 4).
* Patients who fast in Ramadan.
* Patients receiving diabetes education in other programs.