cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure

Prospective randomized, placebo controlled, clinical trial to evaluate the effect of human growth hormone supplementation compared with placebo to patients with severe heart failure for a duration of 6 months on exercise capacity, heart function and quality of life


Eligibility Criteria:
Inclusion Criteria:

Individuals with a diagnosis of CHF, NYHA functional class III or IV symptoms, an EF of \< 35 % estimated on radionuclide angiography (RNA) or 2D echo within the last 6 months, and a 6 minute walk distance of less than 400 meters. Patients must be stabilized on "CHF" therapy at the time of randomization.

Exclusion Criteria:

1. Exercise limited by claudication, angina, neurological, pulmonary (FEV1 \< 50%; FVC \< 50%), or musculoskeletal disease.
2. Active known malignancy; remission of \< 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.
3. Current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or Type I diabetes mellitus.
4. Any other non-cardiac condition that substantially decreases survival.
5. Significant valvular stenosis or hypertrophic cardiomyopathy.
6. Unable to comply with GH injection.
7. Pregnancy or women of child bearing age not using adequate contraceptive means.
8. Unstable angina, acute myocardial infarct, cardiac surgery, or PTCA within 3 months.
9. Cor pulmonale.
10. Acute myocarditis.
11. Known need for cardiac surgery (e.g., valvular intervention, or CABG, or PTCA) within the next 6 months.
12. Clinical hypothyroidism or hyperthyroidism with biochemical corroboration (TSH \> 7 or \< 0.2) at screening.
13. Patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible).
14. Sustained ventricular tachycardia (lasting \> 30 seconds) on screening Holter.
15. Significant liver disease (INR\>1.4 off anticoagulant therapy; or AST, or ALT, or GGT, or alkaline phosphatase \> 3X upper limit of normal; or bilirubin \> 2X the upper limit of normal) at baseline.
16. Failure to give informed consent
Chemotherapy in Treating Patients With Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.

OBJECTIVES: I. Determine the observed anti-tumor activity of annamycin liposomal in patients with anthracycline-resistant locally advanced or metastatic breast cancer. II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. III. Determine the clinical pharmacology of this regimen in these patients. IV. Determine the rationale for the dose and chosen schedule of this regimen in these patients.

OUTLINE: Patients receive annamycin liposomal IV over 60 minutes on day 1. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-30 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of locally advanced or metastatic breast cancer High likelihood of anthracycline resistance due to prior anthracycline exposure in the adjuvant or metastatic setting Prior anthraquinone (e.g., mitoxantrone) insufficient Prior cumulative anthracycline dose limited to doxorubicin-equivalent 350 mg/m2 by IV bolus or 450 mg/m2 by prolonged (at least 48 hours) infusion Measurable or evaluable disease Brain metastases treated by prior surgery and/or radiotherapy allowed if neurologic status stable 2 weeks after discontinuation of dexamethasone Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No history of heart failure Ejection fraction at least 55% by 2-dimensional echocardiogram Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Other prior malignancy allowed if curatively treated and there is clear diagnosis of metastatic breast cancer requiring treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics
Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue

This study is a prospective monocentric study aimed to evaluate the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue. Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited and 18F-PFPN PET/MR imaging will be performed. PET/CT imaging will be performed in patients with contraindications to MR. Additionally, to compare the diagnostic efficacy with the traditional imaging agent 18F-FDG, patients will also undergo 18F-FDG PET imaging, and the two imaging intervals will be completed two days apart. The general information, clinical data, 18F-PFPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the patients will be collected. The histopathology of the biopsy or surgical specimen, follow-up and other imaging examinations will be taken as evaluation references. This study plans to set the sample size as 10 cases.

Clear cell sarcoma of soft tissue is a rare malignancy derived from neural crest cells that contain melanin and/or melanin precursors. Melanin is an important target for the diagnosis of clear cell sarcoma of soft tissue. 18F-PFPN, a highly specific melanin-targeting positron probe, has been proven to have excellent pharmacokinetic properties and good biological safety, and can sensitively detect tiny melanin-containing lesions. Therefore, 18F-PFPN PET imaging is expected to be used in diagnosing and staging clear cell sarcoma of soft tissue.

This study was designed as a prospective study to explore the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue. In this study, patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited to undergo 18F-PFPN PET/MR imaging. PET/CT imaging will be performed in patients with contraindications to MR. The general information, clinical data, imaging data and histopathology results of patients will be collected. The efficiency of diagnosis and staging of 18F-PFPN was evaluated by comparing the gold standard pathological diagnosis and the general metabolic imaging agent 18F-FDG.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 years or above), regardless of gender;
* Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue (supporting evidence including visual examination, MRI, CT, ultrasound, and histopathological examination, etc.) ;
* Patients who agree to undergo both 18F-PFPN and 18F-FDG PET imaging.

Exclusion Criteria:

* Acute systemic diseases and electrolyte disturbances;
* Patients who plan to get pregnant within six months or are pregnant or breastfeeding;
* The patient or his/her legal representative is unable or unwilling to sign the informed consent.
Genentech Xenon MRI Idiopathic Pulmonary Fibrosis

The purpose of this study is being done to determine whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments.

Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyper-polarized 129 Xenon. The subjects will have this initial study prior to initiation of IPF therapies. Then the subjects will have repeat studies at 3, 6 and 12 months following the initiation of therapy. Additional studies including pulmonary function studies, serum for bio markers, 6 minute walk distance and a high-resolution computed tomography (HRCT) scan (only at the 6 month visit) will be performed to determine how 129 Xenon MRI performs relative to standard of care evaluations for IPF.

The MRI uses a magnet and radio waves to make diagnostic medical images of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. Risks of the xenon gas are slight numbness in legs, nausea, a feeling of well-being, and mild tingling in fingertips. You will have pulmonary function testing for the study, you may experience breathlessness or dizziness during or immediately following these tests.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients of either gender, age \> 18.
* Willing and able to give informed consent and adhere to visit/protocol schedules.

(Consent must be given before any study procedures are performed)

* Clinical diagnosis of IPF by confirmed by multidisciplinary diagnosis and naïve to treatment with an approved IPF therapy (either nintedanib or pirfenidone)

Exclusion Criteria:

* Subject is less than 18 years old
* Subjects who have been previously on either pirfenidone or nintedanib
* MRI is contraindicated based on responses to MRI screening questionnaire
* Subject is pregnant or lactating
* Resting oxygen saturation on room air \<90% on supplemental oxygen
* Respiratory illness of a bacterial or viral etiology within 30 days of MRI
* Subject with ventricular cardiac arrhythmia in the past 30 days.
* Subject has history of cardiac arrest within the last year
* Subject does not fit into 129 Xenon vest coil used for MRI
* Subject deemed unlikely to be able to comply with instructions during imaging
* Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
* Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
CD19/70 Bi-specific CAR-T Cell Therapy

The purpose of this study is to assess the feasibility, safety and efficacy of CD19/70 bi-specific CAR-T cell therapy in patients with CD19 and/or CD70 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/70 bi-specific CAR-T cells and their persistency in patients.

Patients with refractory and/or recurrent B cell malignancies have poor prognosis despite complex multimodal therapy. Despite impressive progress, more than 50% of patients treated with CD19-targeting chimeric antigen receptor T cells (CAR19) experience progressive disease. Further, more than 40% patients with progressive large B cell lymphoma (LBCL) experienced reduced or lost expression of CD19 on the tumor cells after CAR19 treatment; low surface CD19 density before treatment was associated with progressive disease. Therefore, novel curative approaches are needed. The investigation attempts to use genetically modified T cells to express a 4th generation lentiviral anti-CD19/70 bi-specific CAR (bi-4SCAR-CD19/70). The CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, CD19 or CD70, which is expressed at high levels on tumor cells but not at significant levels on normal tissues.

CD70 is highly expressed in many cancers, but limited in normal tissues, it is a potential CAR-T therapeutic target. Expression of CD70 was observed on multiple tumor types including solid tumor as well as B cell malignancies. In addition, it has been reported that anti-CD70 CAR T-cells can eliminate CD70-positive cells and exhibit strong anti-tumor effects in preclinical animal models. The CD70 targeted CAR-T cells with binding moiety of CD70 specific scFv exhibited a higher affinity and antitumor effect against CD70-positive tumor cells. A potential strategy to prevent relapse due to antigen escape is to infuse T-cells capable of recognizing multiple antigens.

To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy, a novel bi-specific CD19/70 CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory B cell cancer. The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in CD19 and/or CD70 positive cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. age older than 6 months.
2. malignant B cell surface expression of CD19 or CD70 molecules.
3. the KPS score over 80 points, and survival time is more than 1 month.
4. greater than Hgb 80 g/L.
5. no contraindications to blood cell collection.

Exclusion Criteria:

1. accompanied with other active diseases and difficult to assess patient response.
2. bacterial, fungal, or viral infection, unable to control.
3. living with HIV.
4. active HBV or HCV infection.
5. pregnant and nursing mothers.
6. under systemic steroid treatment within a week of the treatment.
7. prior failed CD19 and CD70 CAR-T treatment.
A Study of Galcanezumab in Healthy Participants

The purposes of this study are:

* To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)
* To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous \[SC\]) (Part B).

Information about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy participants
* Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive

Exclusion Criteria:

- Currently smoke in excess of 5 cigarettes/day
Quantitative EEG During PSG in Patients With and Without Fibromyalgia

The purpose of this study is to retrospectively analyze Clinical and Nocturnal Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.

Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha intrusions may be an objective marker for Fibromyalgia and may correlate with current clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.

This is a Retrospective Study of patients with and without Fibromyalgia seen in private practice from Aug 2007-July 2010 who underwent Overnight Sleep Studies (PSG)

The polysomnographic and clinical data from research subjects with a diagnosis of Fibromyalgia will be compared to other subjects' PSG and Clinical data who were also referred for Sleep Studies including those with Sleep Apnea, Narcolepsy, Periodic Limb Movement, Fatigue, and Insomnia which are standard indications for Overnight Sleep Studies.

Clinical Data: Clinical Data points will include the following: 1. Research Study Number, 2. Age, 3. Gender, 4. Body Mass Index, 5. Epworth Sleepiness Scale (self reported scale on Sleepiness), 6. Fatigue Severity Scale (self reported scale on Fatigue, 7. American College of Rheumatology (ACR) Criteria for Fibromyalgia, 8. Manual Tender Point Exam (# of anatomically specific tender points/18), 9. Medications: Benzodiazepines (Bnz, Bnz ), Tricyclic Antidepressants (TCA) and Serotonin Reuptake Inhibitors (SSRIs SNRIs).

Sleep Study Data Points: The following data points will be captured from Overnight Sleep Studies: 1. Total Sleep Time, 2. Sleep Efficiency, 3. Wake After Sleep Onset, 4.Apnea/Hypopnea Index, 5. Respiratory Distress Index, 6. Periodic Limb Movement Index, 7. Periodic Limb Movement Arousal Index, and 8. Quantitative EEG: Delta Event/Alpha Event Ratio.

Eligibility Criteria:
Inclusion Criteria:

* Completed a polysomnogram
* Complaints of disordered sleep
* Age 18 to 80 inclusive
* Men and women

Exclusion Criteria:

* History of seizure
* use of benzodiazepines
* use of AEDs
* any significant medical condition other than disorder sleep or fibromyalgia that would influence qEEG measures
Collection of Autologous Blood Products by Double Erythrocytapheresis

The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared.

The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery

Exclusion Criteria:

* Malignancies
* Severe arrhythmias
* Congestive heart failure
* Recent angina
* Epileptic seizures in the last 3 months before collection
Using Online Food Retail "Nudges" to Promote Healthier Beverage Intake Among Low-Income Children

The specific aims of this proposal are to 1) develop online food retail nudges to discourage sugary drink purchases and promote healthier substitutes; 2) examine the impact of online store nudges on purchases of sugary drinks in an online randomized controlled experiment with low-income parents, including Supplemental Nutrition Assistance Program (SNAP) and Women, Infants, and Children (WIC)-participating parents, of children age 1-5 years; and 3) disseminate findings to retailers, including those participating in the SNAP Online Purchasing Pilot.


Eligibility Criteria:
Inclusion Criteria:

For Aim 1, the inclusion criteria are as follows:

* parent (or caregiver) of children ages 1-5 years;
* the ability to read and write in English;
* aged 18 years or older;
* household income at or below 185% of the federal poverty level;
* previously purchased fruit drinks for their children;
* have ever shopped for groceries online in the last 12 months,
* live in the US, and
* have access to a personal computer, laptop, or tablet.

The inclusion criteria for Aim 2 are identical to the inclusion criteria for Aim 1, except the researchers will not aim to recruit exclusively parents who have previously purchased sugary drinks for their children or who have ever shopped for groceries online in the last 12 months.

Exclusion Criteria:

The exclusion criteria for Aim 1 include:

* not parent (or caregiver) of children ages 1-5 years;
* aged \<18 years or \>99 years;
* lack the ability to read and speak English;
* household income above 185% the federal poverty level;
* have never purchased fruit drinks for their children;
* have never shopped for groceries online in the last 12 months;
* do not live in the US, and;
* do not have access to a personal computer, laptop, or tablet. The exclusion criteria for Aim 2 are identical to the exclusion criteria for Aim 1, except participants who have never purchased sugary drinks for their children and have never shopped for groceries online in the last 12 months will not be excluded.
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.

This is a Phase 0 multi-center and longitudinal study of biomarkers and clinical parameters in patients with lupus erythematosus (LE). Approximately 80 participants (20 healthy participants and 60 patients with LE) will be enrolled. This will include 30 with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE), and 30 with DLE/SCLE with SLE. All patients with LE will continue to be managed by their personal physicians per their standard-of-care. Study participants will undergo interventional procedures that include collection of urine, blood samples and skin biopsy. There will be a single sample collection timepoint for healthy participants and two sample collection timepoints for LE patients, separated by approximately 12 weeks. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. The data obtained in this study will be used in the evaluation of new therapies for lupus and may help in developing new treatments. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examinations. The total duration of study participation will be approximately 11 days for healthy participants and 95 days for patients with LE.

Eligibility Criteria:
Inclusion Criteria:

* Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE)
* Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE)
* Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE)
* An active skin lesion that can be biopsied (for participants with lupus erythematosus)

Exclusion Criteria:

* Known or thought to have a diagnosis of drug-induced lupus
* An active skin disease that is not a manifestation of lupus erythematosus
* Has an acute cutaneous lupus erythematosus rash only
* If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1
* Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1
* Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus