cyrilzakka/clinical-trials huggingface dataset:
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma

This is a A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma

This clinical trial is for men and women ages 18 and older with follicular lymphoma with detectable BCL2-t or mantle cell lymphoma with presence of cyclin D1 overexpression (can be newly diagnosed or relapsed). The objective of this study is to assess the possibility of treating follicular lymphoma and mantle cell lymphoma patients with ribavirin and using cell free DNA (cfDNA) for BCL2-t and cyclin D1 extracted from peripheral blood to measure treatment effect.

Clinical trials of ribavirin have been conducted in relapsed and refractory acute myeloid leukemia (AML). Ribavirin, an antiviral agent with established doses, has resulted in the regression of the tumor.

* Ribavirin 1000 mg will be administered orally twice daily continuously for 28-day cycles.
* Patients will be followed for up to 7 months.
* Will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed follicular lymphoma with detectable BCL2-t or mantle cell lymphoma with presence of cyclin D1 overexpression (can be newly diagnosed or relapsed)
* Measurable disease (At least one tumor mass \> 1 cm in diameter)
* Low tumor burden:

  1. No individual masses larger than 6 cm in diameter
  2. No more than three masses larger than 3 cm in diameter
  3. No lymphoma-related symptoms
* The treating physician does not feel that treatment with chemotherapy is indicated
* ECOG performance status of 0-2
* Adequate bone marrow and end organ function:

  i. ANC≥1500/mm3, hemoglobin≥10 g/dL, platelet≥100/mm3 ii. CrCL≥50 mL/min by Cockcroff Gault calculation

Exclusion Criteria:

* Indication for treatment of lymphoma including large tumor burden or symptomatic disease
* Pregnancy or men whose female partners are pregnant
* Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
* Significant or unstable cardiac disease
* Hemoglobinopathy (thalassemia or sickle cell disease)
The Breast Program - Translational Cancer Resource

TRACR will provide a data/biospecimen repository for translational research to better diagnose, prognose, treat and cure breast cancer (and related diseases/treatment conditions). Patients at the Rowan Breast Center will be consented for donation of blood and if available tumor/healthy/archived tissue. Patients will be consented to give permission to use said specimens for future research and to be contacted in the future about other research participation and additional information.


Eligibility Criteria:
Inclusion Criteria:

* RBC patients with known invasive cancer pre-surgery (greater or equal to 1.5cm) are given priority in recruitment.
* RBC patients with known invasive cancer pre-surgery (less then 1.5cm). 3. RBC patients who are postsurgery for invasive breast cancer (performed at UPHS or non-UPHS entities).
* Patients that are of high risk for breast cancer (family history, known deleterious genetic mutation(s)) seeking a prophylactic mastectomy at the breast clinic.
* Only persons who can understand and give informed consent will be eligible to participate in this study. Furthermore, no persons belonging to vulnerable populations with as children (below 18 years of age), fetuses, neonates or prisoners will be recruited in this study. Pregnant women, who are pre-surgery and having surgery for clinical reasons, can still be recruited for tissue and blood collection.

Exclusion Criteria:

* Individual who cannot understand and give informed consent (cognitively impaired persons)
* Children (below 18 years of age), fetuses and neonates
* Prisoners
Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

Thrombocytopenia is a common biological disorder in critically ill patients. The main supportive treatment is platelet transfusion with the aim of preventing and treating bleeding and securing invasive procedures. Current guidelines suggest that prophylactic platelet transfusion should probably be administered in non-bleeding critically ill patients at platelet count triggers of 10 to 20 G/L, albeit with very low certainty since extrapolated from studies carried out in stable patients with hematological malignancies. Indications for prophylactic platelet transfusion have not been properly addressed in adult ICU patients with regard to their particular risk of bleeding and prognosis. We propose the TRAMPOLINE study in order to address two different platelet count thresholds of 10 G/L (low threshold) or 20 G/L (high threshold) for the prevention of ICU-acquired bleeding in critically ill patients with severe thrombocytopenia.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 y.o. AND
2. Hospitalisation in the ICU with at least one of the following life support during the current ICU stay (past or ongoing, regardless of indications)

   * circulatory support (inotropes/ vasopressors at any dose)
   * respiratory support (invasive mechanical ventilation, non-invasive ventilation, continuous positive airway pressure (CPAP), high-flow nasal oxygen, O2 supply ≥ 6 L/min)
   * renal replacement therapy for metabolic disturbances and/or acute and acute-on chronic kidney failure (if not previously under chronic hemodialysis) AND
3. Platelet count ≤ 20 G/L within the last 24h (first occurrence at any time during the ICU stay) AND
4. expected ICU stay for at least 48 hours from the time of enrollment AND
5. Signed consent by the patient or his/her relative, or under an emergency procedure (emergency enrollment notified in the medical file, with requirement for confirmation consent a posteriori)

Exclusion Criteria:

1. Major bleeding (WHO grade 3-4) or mild bleeding (WHO grade 2) within the present hospitalization
2. Major surgery within the recent 72 hours
3. Intracranial or retinal bleeding within the recent 7 days
4. Non- or contra-indication to prophylactic platelet transfusion (immune thrombocytopenia, thrombotic microangiopathy)
5. Indications for increased prophylactic platelet transfusion threshold \&gt; 20 G/L (conditions associated with increased risk of bleeding including, but not limited to extra-corporeal membrane oxygenation, therapeutic anticoagulant treatment, fibrinolysis...)
6. Known full refractory status to platelet transfusion (prophylactic transfusion not recommended)
7. Prophylactic platelet transfusion already applied at platelet count ≤ 20 G/L during the present ICU stay
8. Patient opposed to transfusion of blood products
9. Moribund patients (death expected within the next 24 hours)
10. Pregnancy/breastfeeding
11. Not covered by French Social Security (health insurance)
12. Patient under safeguarding of justice
Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.

The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.


Eligibility Criteria:
Inclusion Criteria:

proteinuria greater than 1 gram/day serum creatinine \< 2.6 for men, \< 2.0 for women

Exclusion Criteria:

blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months
Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise

This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.

A major subset of adults over the age of 65 is now classified as having sarcopenic obesity, a high-risk geriatric syndrome predominantly observed in an aging population that is at risk of synergistic complications from both sarcopenia and obesity.

Lifestyle interventions such as caloric restriction and exercise training are effective nonpharmacological strategies to mitigate some adverse effects related to this condition. Also, protein supplementation may boost the benefits of exercise, but this assumption is still to be tested. This trial aims to test whether protein supplementation is able to increase the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older;
* Body mass index (BMI) \> 30 kg/m2;
* Sarcopenia;
* not engage into exercise training programas.

Exclusion Criteria:

* cancer in the last 5 years;
* cognitive deficit or dementia that impossibility the patient to read and sign the informed consent form;
* any disease that limits participation in exercise training program.
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV

A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is between 18 and 60
2. Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline.
3. Patient is documented to be HBsAg positive for \> 6 months. Patient is HBeAg positive.
4. Patient has ALT levels which are in the range of ≥2 x ULN/L at least 2 consecutive visits, at least one month apart and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
5. Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
3. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient with clinical evidence of decompensated liver disease or HCC
6. ANA \> 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis
7. Patient is pregnant or breast-feeding.
8. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU

This is a quality improvement research project evaluating if a targeted feedback email to clinicians impacts their nutrition delivery in the ICU.

This prospective study looks to determine if a targeted email to clinicians taking care of critically ill patients will allow reduce malnutrition in the Intensive Care Units (ICU). Four ICUs will be included: medical ICU (MICU), coronary care unit (CCU) and two surgical ICUs. The investigators will rotate a 2 month period intervention amongst the aforementioned participating ICUs and follow simultaneous cohorts to evaluate the effect of our intervention (email feedback to treating clinicians) on nutrition delivery in the ICU. After the completion of the intervention, there will be a six-month follow-up of nutritional adequacy to assess the durability of changes in behavior.

Eligibility Criteria:
Inclusion Criteria:

* Clinicians taking care of patients admitted to the ICU within the past 48hrs
* Clinicians taking care of patients in whom enteral nutrition is prescribed

Exclusion Criteria:

* Clinicians taking care of patients in whom enteral nutrition is not prescribed.
Evaluation of Whole-body CZT Camera in Gated Tomographic Radionuclide Angiography

Tomographic radionuclide angiography (or blood pool) is a reproducible method to evaluate left ventricular ejection fraction that is needed during oncological treatments or to evaluate cardiopathies.

Cardiac-dedicated CZT systems allowed dose or time reduction. Multipurpose CZT cameras have not yet been evaluated in this indication. Moreover, the impact of attenuation correction is not known.

Tomographic radionuclide angiography is a simple, rapid and reproducible method of cardiac function measurement, including left (LVEF) and right (RVEF) ventricular ejection fractions.

In addition to cardiological indications, this examination is often performed as part of cardiac toxicity screening during the various oncological treatments. This indication is all the more true since the arrival of CZT gamma cameras dedicated to cardiological studies has made it possible to reduce injected activities, as well as examination times.

The multipurpose CZT camera allows tomoscintigraphic acquisitions to be carried out using CZT technology as well. Unlike the CZT gamma cameras dedicated to cardiological studies, this system can be used for the exploration of different organs, and also allows the realization of CT slices for attenuation correction.

Patients included in this study will be double scanned both on a dedicated cardiac CZT camera and on multipurpose CZT camera, with CT. LVEF and RVEF will be then compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to our Nuclear Medicine department for evaluation of cardiac function.

Exclusion Criteria:

* Patients treated with chemotherapy within 12 days.
* Under 18 years old patients.
* Pregnant women or at risk of pregnancy.
* Breast feeding.
* Painful patients.
* Patients under guardianship.
* Patients in whom a standard examination is not feasible (agitation).
* Patients who do not benefit from a social security system
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy
* Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment
* ECOG performance status of 0-1

Exclusion Criteria:

* Prior treatment with compounds with the same mode of action
* Patients with TP53 mutated tumors, if the molecular status is known
* Symptomatic central nervous system metastases
* Inadequate organ function
* Previous and concomitant therapy that precludes enrollment, as defined by protocol

Other protocol-defined inclusion/exclusion criteria may apply.
The Influence of Aerobic Exercise on Serum Brain Natriuretic Peptide and C- Reactive Protein in Cardiovascular Disease

The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with cardiovascular disease. Patients were divided randomly into two groups: control and experimental aerobic group. This study was done with two - stage blood sampling: at the beginning and at the end of the treatment phase. All subjects were requested to avoid any exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C - reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein. Blood samples for subsequent measurements were frozen immediately and transported to the Hormone Laboratory for serum separation. The experimental group did the aerobic exercise programs for 8 weeks for 3 sessions per week and the control group did not receive any training. After completion of training, the final blood samplings were performed. Exercise intensity according to the heart rate remained stable until the last week. Brain Natriuretic Peptide and C - reactive protein levels were measured by ELISA tests. All statistical analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05


Eligibility Criteria:
Inclusion Criteria:

* In this trial patients with coronary artery disease more than 70 percent at least in one coronary vessel with Ejection Fraction more than 40 percent in recent Echo cardiograph without acute evidence of ischemia or congestive heart failure symptoms were selected and are divide randomly into two groups.

Exclusion Criteria:

* Patients with acute evidence of ischemia or congestive heart failure symptoms are excluded.
A VR Intervention for Promoting Prosocial Behavior and Well-being in Youth

The objective of the present project is to develop a gamified prosocial VR intervention for youth transitioning from secondary to tertiary education, and to test the effectiveness of the gamified prosocial VR intervention for promoting prosocial behavior and well-being.

Targeting youth transitioning from secondary to tertiary education, the proposed project will adopt evidence-based intervention programs that use digital technologies to promote prosocial behavior and well-being, thereby supporting better intrapersonal and interpersonal development.

The investigators aim to develop a gamified prosocial VR intervention for youth transitioning from secondary to tertiary education and to test its effectiveness through a randomized controlled trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* Age 15-19
* Secondary 6 to college year 1
* Can read traditional Chinese and understand Cantonese

Exclusion Criteria:

* History of photosensitive epilepsy
* Impairment of stereoscopic vision
* Balance problems
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years or older
* Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
* Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
* Documented relapse or progression following last antineoplastic treatment
* At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)

Exclusion Criteria:

* Subjects with histological or clinical transformation to an aggressive lymphoma

  * prior treatment with VELCADE or fludarabine.
  * antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
  * nitrosoureas within 6 weeks before randomization
  * radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
  * major surgery within 3 weeks before randomization
  * chronic use of corticosteroids, such as dexamethasone
IONM During Radical Prostatectomy

At present, the preferred treatment for patients with prostate cancer is still radical prostatectomy. Postoperative patients often face some complications, the most common complications include urinary incontinence and erectile dysfunction. Urinary incontinence is caused by intraoperative injury of urinary control nerves or muscles. Erectile dysfunction is related to intraoperative injury of nerves that control erection. Therefore, intraoperative nerve preservation is a key measure to reduce postoperative complications, especially to prevent erectile dysfunction. This study intends to improve the nerve-sparing radical prostatectomy by monitoring the nerve during radical prostatectomy, locating the cavernous nerve and other related nerves, in order to reduce the incidence of postoperative complications such as erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

- 1: Prostate cancer patients undergoing surgical treatment in our Hospital 2: Understand the content of this study, actively provide complete and true medical history and examination data, and be willing to cooperate with postoperative interviewers.

3: Voluntarily participate in the study and sign the treatment document within the ethical framework.

Exclusion Criteria:

* 1: Histopathology showed that the patient did not have prostate cancer 2: Use a cardiac pacemaker or other electromechanical prosthesis device 3: Suffering from a serious neurological disease, mental illness or other illness that may be life-threatening within two years