cyrilzakka/clinical-trials huggingface dataset:
Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer

This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.

A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. Recently initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
* No HER2 overexpression or gene amplification
* No previous therapy for metastatic breast cancer is allowed
* Age 18-75 years
* At least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines
* Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
* Performance status (WHO) 0-2
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the UNL in the presence of liver metastases)
* Adequate renal function (serum creatinine \<1.5 times the upper normal limit
* Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
* Written informed consent

Exclusion Criteria:

* Active infection
* Brain metastases
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* History of stroke
* Anticoagulation therapy (except of low dose aspirin \<325mg)
* Other invasive malignancy except nonmelanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for knee arthroscopy

Exclusion Criteria:

* Inadequate IV access.
* History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
* Less than 18 years of age.
* Use of analgesics less than 8 hours prior to surgery.
* Patients with active, clinically significant anemia.
* History or evidence of asthma or heart failure.
* Pregnant.
* Recent history of chronic opioid use.
* Concomitant use of probenecid.
* Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions and to return for the required assessments.
* Refusal to provide written authorization for use and disclosure of protected health information.
A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.

This is a Prospective Open label Single arm multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.

The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.

A total of 10 subjects will be enrolled from all breast cancer subtypes (HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2-.). No formal interim analysis is planned for this study.

Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.
* Tumor size ≤ 4 centimeters in the longest diameter.
* Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery
* De-novo or recurrent lesions.
* Single lesion per quadrant per subject.
* Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.
* Interstitial implant indication validated by multidisciplinary team.
* ECOG Performance Status ≤3.
* Life expectancy ≥12 months.
* Women Age ≥65 or younger if unfit for standard of care.
* Willing and have the ability to provide signed Informed Consent.
* Blood tests values:

  * Leucocytes ≥3000mm3,
  * Absolute neutrophil count ≥1500mm3,
  * Platelets ≥100,000 mm3,
  * Total bilirubin ≤ 1.5xULN,
  * AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.
  * Creatinine ≤ 2.0xULN.
  * INR or Prothrombin time ≤1.5xULN

Exclusion Criteria:

* T4 category with skin involvement.
* Ductal carcinoma in situ.
* Inflammatory breast carcinoma.
* Longest tumor diameter \>4 cm.
* Patients with prior radiation to the same area within the past 6 months.
* Has a known additional malignancy that is progressing or requires active treatment.
* Patients undergoing immunosuppressive and/or systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease
* Subjects not willing to sign an informed consent.
68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer

This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.

PRIMARY OBJECTIVES:

Evaluate the feasibility and biodistribution of 68Ga-PSMA.

OUTLINE:

Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later.

After completion of study, patients are followed up at 24 hours and 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent
* Known diagnosis of prostate cancer
* Patient has suspected recurrence based on biochemical data (prostate specific antigen \[PSA\] \> 2 ng/mL)
* Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

* Unable to provide informed consent
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Effects of a Probiotic in Hypertension

High blood pressure is a major risk factor for cardiovascular events, including stroke, heart and kidney failure. Typical anti-hypertensive drugs target vessels, the kidneys or the heart. Here we propose a randomized, placebo-controlled study to test the blood pressure-lowering effect of a probiotic in 110 patients with grade 1 hypertension. In addition, we will investigate glucose variability, fecal bacterial metabolome, peripheral blood effector T cell frequencies (%) and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women
* Treated or untreated hypertension (resting office blood pressure 130-159/80-99 mmHg)
* BMI 18.5 - 34.9 kg/m\^2

Exclusion Criteria:

* Secondary causes of hypertension
* Known target organ damage
* 10 years cardiovascular risk score of \>20%
* Diabetes
* Established cardiovascular or renal disease
* Other serious diseases
* Recent use of antibiotics
* Specialized diets, e.g. use of probiotics

Comments:

* Two inclusion criteria were changed in June 2021 to improve recruitment
* Age was changed from 50-75 to 50-80 years
* Resting blood pressure was changed from 140-159/90-99 to 130-159/80-99 mmHg
Virtual Diabetes Care for Low Socioeconomic Status Adults With Type 2 Diabetes on Insulin Therapy

This 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for low-socioeconomic status patients. It includes MyChart messing to give education, phone help on problem-solving with clinicians, and using a diabetes app to track data. The study aims to enhance self-management behaviors through health technology.

Guided by the Self- and Family Management Framework, which specifies facilitators and barriers to self- management behaviors, this project tests strategies for delivering virtual diabetes care to help low-socioeconomic status patients and clinicians use health information technology to support self-management behaviors. It is a 12-month pilot nurse-led, app-based behavioral intervention consisting of three evidence-based interventions: (1) education on A1C results and goal-setting via MyChart, the Epic electronic health record's patient portal; (2) a problem-solving action plan developed collaboratively by clinicians and patients; and (3) remote monitoring via mySugr, a top- rated diabetes app, to track blood glucose and identify the need for treatment adjustments.

Eligibility Criteria:
Inclusion Criteria:

* A1C\>8% within 12 months prior baseline
* A1C\>8% at baseline
* Low-SES (defined as a Medicaid recipient or dual Medicaid and Medicare recipient or self-reported low income based on National Poverty Guidelines)
* Age 18 or older
* Type 2 diabetes
* On insulin therapy
* Owning and using Android or iOS smartphone for at least 6 months
* English proficiency
* Adequate vision to read text messages on their current smartphone
* Smartphone use proficiency. Smartphone proficiency will be self-reported and determined by telephone as the ability to use a smartphone in ways other than emailing, texting, and making phone calls.

Exclusion Criteria:

* Pregnancy
* Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.
Atrial Fibrillation Characterization on Paroxysmal and Persistent Patients

Background and Hypothesis: Atrial Fibrillation (AF) treatment strategies have limitations. The efficacy of the procedure depends in several factors such as age, AF duration, atrial diameter and atrial electrophysiological behavior, determining what has been termed as atrial substrate. Therefore, the effectiveness of one specific treatment such as the ablation procedure, will be determined by the areas responsible for the maintenance of the fibrillation and its modification and/or elimination. The identification of these areas with a clear description of the arrhythmic substrate is one of the most important factors to determine new biomarkers that explain, at electrophysiological level, the properties of the substrate and therefore, increase the acute efficacy and long-term effectiveness of the treatment.

The main objective of this project is to develop and validate new biomarkers based on a pre-existing methodology for the non-invasive identification of the mechanisms that are responsible for the maintenance of AF. This will be achieved by using a body surface potential mapping recording and using the signal to develop a new algorithm that is able to, from the acquired signals acquired during sinus rhythm, extract relevant features for an accurate prediction of long-term ablation outcome for patients with AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal or persistent AF symptomatic and refractory to at least one antiarrhythmic medication arriving in sinus rhythm to the electrophysiology laboratory.
* Patients must be able and willing to provide written informed consent to participate in the study.
* Prior anticoagulation for\> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi.

Exclusion Criteria:

* Patients with inadequate anticoagulation levels, left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
* Patients with moderate-to-severe mitral regurgitation.
* Patients with contraindications to systemic anticoagulation with heparin or coumadin.
* Patients who are or may potentially be pregnant.
* Current enrollment in another investigational drug or device study.
STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)

This is a randomized study comparing the use of Anastrozole before and continuing during radiotherapy for breast cancer compared to the use of anastrozole after irradiation.

Adjuvant radiotherapy is well established as the primary modality to enhance local control in breast cancer. The use of adjuvant hormone therapy such as tamoxifen has shown to improve local control to a relatively minor amount on its own and does enhance local control of adjuvant radiotherapy. There is however, conflicting in vitro and clinical data regarding the effects of different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities.

Aromatase inhibitors such as anastrazole are establishing themselves as a class of drug superior to tamoxifen for the control of estrogen dependent breast cancers and overall are better tolerated with the exception of greater bone loss.

As the key question is whether the sequencing of the aromatase inhibitor anastrozole alters local control by acting as an enhancer of the radiation breast cancer cell kill, it is therefore the aim of this study to compare 3 months of anastrozole prior to radiotherapy versus 3 months of anastrozole after radiotherapy with a specific objective of reducing the baseline ratio of in- field radiotherapy failure from 6% to 3%.This pilot study is preliminary to a planned long term study to investigate local failure.

For the pilot a period of 6 months with all contributing centres open will provide a good test of recruitment matching estimates. 100 patients will provide a good sample to compare to the 270 tamoxifen treated women in the breast boost study for quality of life. It will also provide a 95% CI on the proportion of complying women in the order of ± 5% if 85 to 90 % of women comply.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more years. No upper limit.
* Post total mastectomy or lumpectomy. All planned surgery complete.
* Margins clear (no tumour contacting the inked margin)
* Tumour oestrogen or progesterone receptor positive
* Planned dose to irradiated volumes at least the biological equivalent of 45 Gy in 25 fractions or more.
* ECOG 0-2
* Patients post menopausal using same criteria as ATAC study.
* Written informed consent

Exclusion Criteria:

* Previous radiotherapy to the area to be treated.
* Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in-situ or skin cancer other than melanoma.
* Patients with clinical evidence of metastatic disease.
* Previous hormonal breast therapy.
* Ongoing hormone replacement therapy.
Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer

Evidence to justify the use of the pelvic field is lacking for men with high risk localized prostate cancer. An additional randomized study is needed in men with a potential risk of nodal involvement to test the hypothesis that the use of the pelvic field contributed to the benefit observed in those studies.

This trial aims to compare the outcomes with whole pelvis RT and Prostate alone RT in patients with High risk, non metastatic Prostate cancer with a Lymph nodal \>20% with Primary 5 year Biochemical failure free survival and Secondary Disease free survival, overall survival, Acute toxicity, Late toxicity and QOL Patients will be randomized to one of two arms Arm 1 Whole pelvis radiotherapy and Arm 2 Prostate only radiotherapy. The Dose prescription will be 66 Gy in 25 fractions will be prescribed for the prostate PTV in Arm 2 an additional 50 Gy in 25 fractions for nodal PTV in patients in Arm 1. An overlap volume at rectal-prostate interface will receive 64 Gy/25#.

All patients will receive hormone therapy starting at least 8 weeks prior to the beginning of radiotherapy. They will continue the hormone therapy and later for a total duration of 2-3 years.


Eligibility Criteria:
Inclusion

1. Any age according to the fitness estimated by the Physician
2. Physician estimated life expectancy \> 5 years
3. Biopsy proven Adenocarcinoma of prostate
4. High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases ≥ 20% as per the Roach formula (2/3 PSA) + \[(GS - 6) x 10\] If Gleason Score 8-10 - Any PSA, T1- T3a N0 M0 If Gleason Score 7 - PSA \> 15, T1-T3a N0 M0 If Gleason Score 6 - PSA \> 30, T1-T3a N0 M0 T3b-T4a N0 M0, Any Gleason Score, Any PSA
5. Ability to receive long term hormone therapy/ Orchidectomy
6. KPS ≥ 70 (see appendix)
7. Estimated life expectancy \> 5 years
8. No previous history of malignancy ≤5 years
9. No prior history of therapeutic irradiation to pelvis
10. Patient willing and reliable for follow-up and QOL
11. No major co morbidities preventing radical treatment
12. Signed study specific consent form

Exclusion

1. Any histopathology other than Adenocarcinoma
2. Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders
3. No prior history of pelvic surgery
4. Uncontrolled diabetes
5. Uncontrolled cardiac co morbidity
6. Presence of nodal or distant metastatic disease
Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.

Uveitic macular edema (UME) is one of the commonest and severest complications of chronic uveitis, and is also one of the important causes of permanent vision loss in uveitis. The pathophysiological mechanism of UME remains unclear, but was thought to be caused by damages of internal/external blood-retinal barrier mediated by inflammatory factors, including interleukin-2, interleukin-10, tumor necrosis factor α, prostaglandins and vascular endothelial growth factor (VEGF). Current treatments of UME include local or systemic glucocorticosteroids (GCS), immunosuppressants and biological agents. Although large dose of systemic GCS combined with immunosuppressants lead to quick resolution of ME in most of the cases, UME often relapse with tapering of GCS, and the side effects can be significant. Periocular or intraocular injection of GCS is effective in short term, but repetitive injections often lead to high intraocular pressure and cataract. Intravitreal injection of anti-VEGF agents is a huge advance of medical treatment in ophthalmology in recent years. Since 2007 till now, there have been a number of reports on the effectiveness of intraocular Bevacizumab and Ranibizumab injection in UME, but none about Conbercept. Besides, as the target of anti-VEGF agents, intraocular concentration of VEGF and its changes might be correlated to the sensitivity and responsiveness of UME to anti-VEGF agents, but has not been monitored. As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years old
* competent in signing the informed consent
* no severe systemic diseases unrelated to uveitis
* fulfill the criteria of refractory UME

Exclusion Criteria:

* pregnant or preparing pregnancy
* already in other clinical trials
* blood pressure \>= 180/110mmHg
* BCVA of the contralateral eye \<= 20/200
* cardiovascular events within 3 months
Effects of Vitamin D Dose and Genotype of the Binding Protein in Infants and Children

The purpose of this study is to determine if the vitamin D binding protein genotype influences circulating vitamin D levels and if it may have functional consequences on vitamin D activity.

Vitamin D has recently been the subject of much attention. Advantages to the prevention of vitamin D deficiency (VDD) in young children are obvious: acutely, hypocalcemic seizures may occur in VDD, and rickets can result in long-term skeletal deformities. Previous research has emphasized the importance of identifying optimal supplementation doses and appropriate target thresholds for circulating 25-hydroxyvitamin D (25-OHD), the best described marker of vitamin D status. The timely next step is to objectively establish effective doses for the prevention of VDD, without creating risk from overzealous supplementation, in a population representative of those most at risk for overt disease.

Although the primary role of vitamin D is considered to be its effect on intestinal calcium absorption, enormous variability of fractional calcium absorption in relation to 25-OHD levels exists. We provide evidence that a significant component of this variability is genetic in nature and in particular, relates to vitamin D binding protein (DBP) genotype.

The aggregate data suggest that the critical mechanism for the development of nutritional rickets is reduction in availability of calcium to the skeleton, which is largely determined by vitamin D status and intestinal calcium absorption. Our proposal focuses on the establishment of a workable definition of vitamin D deficiency in an underserved and highly vulnerable population and to assess the impact of genetic variance in VDR and DBP as factors to be considered in the recommendation of vitamin D status assessment, taking into account the outcome of 25-OHD level, and in additional studies, potential functional consequences of vitamin D related to both its classical and non-classical effects.

Eligibility Criteria:
Inclusion Criteria:

* 6 months to 6 years of age
* healthy or free from any diseases or conditions that may affect nutritional status or bone metabolism
* willingness of family to participate in a 6-month study of vitamin D supplementation

Exclusion Criteria:

* Chronic disease
* Prematurity \< 32 weeks gestational age
* Liver disease such as hepatitis or renal/urologic disease (e.g., recurrent urinary tract infection)
* Use of pharmacologic or prescription-level dosages of vitamin D or its metabolites. We will exclude users of any systemic glucocorticoid preparation and users of inhaled steroids that are considered greater than medium dose for age 4 yrs. Specifically, this would exclude users of over 1 mg/day of budesonide, and over 352 mcg/day of fluticasone.
* Current or recent (within 1 month) use of anticonvulsants or other medications known to affect bone and mineral homeostasis or alkaline phosphatase levels.