cyrilzakka/clinical-trials huggingface dataset:
Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide

This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored

PRIMARY OBJECTIVES:

I. Ability to reach target collection of 5 x 10\^6 CD34+ cells/Kg with =\< 2 days of leukaphereses using one of two mobilization regimens.

SECONDARY OBJECTIVES:

I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =\< 5 days of leukaphereses.

II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.

III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8.

ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7.

After completion of study treatment, patients are followed up at 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MM by International Myeloma Working Group Criteria
* In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood \& Marrow Transplant Research
* Received at least 2 cycles of lenalidomide therapy
* Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT)
* At least 2 weeks since last exposure to lenalidomide
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Prior to the start of mobilization:

  * white blood cell count \>/= 2.5 x 10\^9/L
  * absolute neutrophil count \>/= 1.2 x 10\^9/L
  * platelet count \>/=100 x 10\^9/L
  * creatinine clearance \>/= 30mL/minute
* If childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy

Exclusion Criteria:

* Had prior autologous or allogeneic transplantation
* Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization
* Failed previous hematopoietic stem cell collections or collection attempts
* Received radiation therapy to the pelvic area
* Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization
* Had received experimental therapy within 4 weeks of enrolling in study
* Current or prior history of other malignancies, excluding basal cell carcinoma of the skin
Vehicle Automation Impact on Drivers

In the context of ever-increasing automation in surface vehicles, automation impact on drivers will be investigated through three complementary research axes undertaken under simulated driving:

Axe 1 (Cognitive ergonomics), how automation is impacting driving behaviors and visual explorations? Axe 2 (Experimental psychology), how automation is impacting drivers' mental representations of their own driving abilities? Axe 3 (Neuroimaging), how automation is modifying the car driving neural network? And what are drivers' mental representations neural bases? The project tackle both applied and basic research issues using an original experimental neuro ergonomics approach. AUTODRIVE will bring original data on human-machine cooperation, mental representations, cognitive control and brain processes depending on the characteristics of the automation used over a significant period of time (six weeks) on a large sample (N=120) of experienced and inexperienced drivers.


Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 22 and 45 years old
* Having given an informed consent for the study
* Being registered with the French Social Security System
* No driving license for 60 participants
* Driving license for 4 years or more for 60 participants

Exclusion Criteria:

* No signature on the consent form
* Inability to read or write French.
* Neurologic or psychiatric illness, known or revealed during the inclusion visit
* Substance intake ( taking psychoactive medications or recreational drugs) on the day of the experiment
* Noise intolerance
* Need of vision glasses to drive
* Persons under curators or deprived of civil rights or deprived of their freedom
* Unable to fill a questionnaire (severe cognitive troubles)
* Subjects must not have metallic or electronic implants in the body : pacemakers or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint o foreign metallic objects in the body (bullets, BBs, pellets, shrapnel, or metalwork fragments) or current or past employment as machinists, welders or metal workers, tattoos near the head or neck regions, permanent makeup
* Claustrophobia
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation

The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 years or older
* History of symptomatic atrial fibrillation (either paroxysmal or persistent)
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Permanent (chronic) atrial fibrillation
* Antiarrhythmic drug therapy which cannot be stopped
* Use of amiodarone with prior 6 months
* History of unsuccessful cardioversion
* History of certain cardiovascular conditions or cardiac surgery within prior 6 months
* History of stroke within prior 6 months
* Implanted cardio-defibrillator
* Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic conditions, or cancer (except non-melanoma skin cancer)
* Poorly controlled diabetes
Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser

Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin


Eligibility Criteria:
Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating
Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease

This study plans to learn more about pulmonary complications of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART) has dramatically decreased the number of opportunistic infections and deaths in HIV infected patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD) development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a major cause of morbidity and mortality in this population. The mechanisms underlying the increased risk of COPD and decreased lung function in HIV infected individuals is not well understand and needs to be studied.

The investigators hypothesize that the immunoregulatory consequences and immunosuppressive lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung infection and injury in HIV infected smokers, hastening the development of COPD. The mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from smokers and nonsmokers with and without HIV infection.

The first component of this study will be a longitudinal, prospective, 24 weeks study of the effects of HIV-1 infection on innate and acquired immunity in the lung (Cohort A). The second component of this study will be a cross-sectional, case-control study of lung function and immune dysregulation of HIV-1 infected persons on long-term ART (Cohort B).

Cohort A will consist of 120 subjects, stratified by HIV-1 and smoking status

Cohort B will consist of 90 subjects stratified by chronic obstructive pulmonary disease (COPD) and HIV-1 infection.

Eligibility Criteria:
Inclusion Criteria (Cohort A):

* Subjects with chronic HIV-1 infection (Cohorts A1 and A2)
* ART naïve or off all ART for \>6 months (Cohorts A1 and A2)
* HIV-1 RNA level \>1,000 copies/ml (Cohorts A1 and A2)
* HIV-1 seronegative with no high-risk exposure in the past 30 days (Cohorts A3 and A4)
* 18 years and older (All Cohort A)
* Active cigarette smoker (Cohorts A1 and A3)

Inclusion Criteria (Cohort B):

* Age from 30 to 70 years
* Subjects with chronic HIV-1 infection (Cohorts B1 and B2)
* Subjects on stable 3-drug ART regimen with plasma HIV-1 RNA \<50 copies/mL for past 6 months (Cohorts B1 and B2)
* HIV-1 seronegative with no high-risk exposure in the past 30 days (Cohort B3) COPD: forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) \<70% and forced expiratory volume (FEV), 45-100% of predicted (Cohort B1 and B3)
* Non-COPD: FEV/FVC \>70% and an FEV, \>80% of predicted (Cohort B2)

Exclusion Criteria (Cohort A and B):

* Pregnancy
* Weight less than 110 pounds (for venipuncture)
* Patient inability to participate in the study and undergo venipuncture and bronchoscopy procedures
* Use of systemic or inhaled corticosteroids in the past 3 months.
Multi-pronged Ethanol Ablation and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma

The purpose of this study is to compare the effectiveness of percutaneous ethanol ablation using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA) in the treatment of early-stage hepatocellular carcinoma (HCC).

Patients with early-stage (single tumor no more than 5 cm or up to 3 tumors each no more than 3 cm in size) primary hepatocellular carcinoma will be randomized into two percutaneous ablation treatment arms, including radiofrequency ablation and multi-pronged ethanol ablation. The local treatment responses, complications,and long-term disease-free survivals and overall survivals are analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Primary hepatocellular carcinoma, single tumor ≤5 cm or up to 3 tumors each ≤3 cm
* Ultrasound detectable tumor
* Liver function classified as Child-Pugh A or B
* Platelet count \> 50,000/mm3, or prothrombin activity \> 50%
* Not suitable for resection or patient refused surgery

Exclusion Criteria:

* Vascular invasion and extrahepatic spread
* Patients allergic to ethanol
CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast material, was studied as one method of evaluating children with suspected appendicitis. We felt that this technique could provide physicians with a faster and better-tolerated alternative to CT imaging which involves patients drinking oral contrast or needing rectal contrast administered.

SPECIFIC AIMS

1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in children in the setting of a pediatric emergency department (ED).
2. To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.

This was to be a prospective cohort study imaging pediatric patients (3-18 years old) in whom the diagnosis of appendicitis was suspected, but not clinically apparent. Patients that were to have a CT performed would be invited to participate and if enrolled, would be imaged using CT scan with IV contrast alone.

CT scans would be interpreted in real time by a resident radiologist and/or an attending radiologist. ED evaluation would remain unchanged and patient disposition would be based on the discretion of the ED provider using all information (patient exam, labs, surgical consultation as needed and the results of the CT scan).

CT scan performance would be determined by comparison of the CT interpretation with patient final outcomes as determined by either (1) pathology reports - in patients that went on to have surgery (appendectomy) or (2) clinical phone follow up at 24 hrs and then 1 week after ED discharge.

Performance of CT would be compared between the resident and the attending radiologists.

Further, we would compare the time to obtain a CT scan (defined as ED triage time - Time to CT) between our study cohort and a retrospective cohort of patients who had received CT scan in the ED for evaluation of appendicitis pre-study (CT using BOTH IV and oral contrast).

Eligibility Criteria:
Inclusion Criteria:

* Age 3- 18 years
* Signs/symptoms for \< 72 hours
* CT Scan requested for evaluation by attending or fellow

Exclusion Criteria:

* Clinically apparent appendicitis
* Pregnancy
* Sickle Cell Disease
* Known contrast allergy
* Previous enrollment
* Signs/symptoms for \> 72 hrs
* Known abdominal disease (e.g. Crohn's)
* Exam unreliable (neurologically impaired patient)
Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?

The study aims to investigate the effect of addition of an adsorber during cardio pulmonary bypassin patients with infective endocarditis undergoing valve surgery, and if it will decrease the use of vasoactive drugs postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Infected endocarditis patients undergoing heart valve surgery.
2. Age over 18 years.

Exclusion Criteria:

1 Declines participation
Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).


Eligibility Criteria:
Inclusion criteria:

* Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS Rating Scale.
* Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.

Exclusion criteria:

* Have secondary RLS.
* Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients

To evaluate the performance of volume responsiveness in predicting the outcome of mechanical ventilation weaning in critically ill patients.

82 patients, 61 succeed and 21 failed

Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation

Exclusion Criteria:

* pregnancy or breast-feeding
* tracheostomy at baseline
* myasthenia gravis or acute polyradiculoneuropathy
* end-stage chronic illness
Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery

The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery.

Postoperative pulmonary and musculoskeletal complications are the most frequent and significant contributor to morbidity, mortality with hospitalization. Pilates-based exercise has be applied to improve core control, movement efficiency and postural stability. High incidence of musculoskeletal problems have been concerned in relation to the patient's functional recovery after cardiac surgery. However, no literature is addressed how to manage this issue effectively till now. The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy for in-patients after cardiac surgery. This is a single-blinded, randomized control trial. Investigators will enroll pre-cardiac surgery and allocate subjects to modified Pilates-based training group or control group using block randomization.The training protocol will be based on pilates concepts. The control group is treated with a conventional protocol of physical therapy. The study will be carried on whole in-patient phase. During this period, patients received respiratory motion analysis, chest wall muscles mobility, lung function and endurance evaluation. Patients' changes in respiratory movement, cardiopulmonary endurance, and lung function will be evaluated by an assessor blinded to the intervention at admission and discharge from hospital. After 6 months after hospital discharge, patient's respiratory motion, lung function and disease specific health related quality of life will be evaluated. All outcomes will be described by mean (SD) or number (%). Independent t test or chi square test will be used to compare the basic data difference between training group and conventional group. Then, two-way analysis of variance or two-way analysis of covariance will be used to compare the outcomes difference between groups. Alpha level is set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* post open heart surgery
* FVC\> 80% of predicted and/or FEV1\>70% of predicted
* age \>/=20 years old
* approve inform consent

Exclusion Criteria:

* preoperative severe pulmonary hypertension
* moderate to severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease
* heart failure or s/p heart transplant
* emergent surgery
Sequential Coronary CT-angiography and Biomarkers

Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA.
* Age older than 18 years and competent to perform written informed consent.
* At least 2 coronary segments with plaques:
* 1 proximal lesion.
* At least one coronary plaque consisting of a non-calcified or mixed component.

Exclusion Criteria:

* Unstable angina.
* Renal insufficiency: calculated estimated glomerular filtration rate \<45mL/min.
* Iodine allergy.
* Pregnancy.
* Known history of atrial fibrillation.
* Inconclusive baseline computed coronary CT-angiography.
* Patients which are currently on oral vitamin K antagonists.
* Patients which are currently using selective anticoagulants.
* Previous PCI.
* Previous or planned coronary artery bypass grafting.
* Patients whereby the baseline CCTA was performed by a retrospective ECG-gated 'helical' protocol due to a high (\>90bpm) or irregular heart rate.
Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations

The purpose of this study is to investigate whether patients with diabetes due to Kir6.2 mutations can be treated with sulfonylurea medication rather than insulin, and if this is the case to investigate the mechanism for sulfonylurea response.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes due to KCNJ11 (Kir6.2) mutation

Exclusion Criteria:

* None
HIPEC After Radical Cystectomy for High Risk Bladder Cancer

This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk factors for tumor recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Primary urothelial cell carcinoma of the bladder
2. Patient's aged 45-85, both genders.
3. ECOG performance status \< 1
4. Hematology: ANC \> 1.5x109/L; Platelets \> 100x109/L
5. Women with child bearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
6. Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.

   Either any of the following preoperative factors for increased risk of recurrence:
7. Lymphovascular invasion
8. Variant histology in the background of primary urothelial (notably plasmacytoid)
9. Clinical T3 or greater
10. Clinical N+
11. No prior neoadjuvant chemotherapy (NAC) or lack of response to NAC

    Or any of the following perioperative factors for increased risk of recurrence:
12. Palpable concern for extravesical disease
13. Tumor spillage/bladder entry
14. Suspicious nodes or positive intraoperative frozen sections

Exclusion Criteria:

1. Subjects who have previously undergone intraperitoneal chemotherapy.
2. Subjects with tumor histology other than urothelial cell carcinoma.
3. Patients on concurrent anti-cancer therapy other than that allowed in the study.
4. Other prior malignancies, except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix or adequately treated malignancies for which there has been no evidence of activity for more than 3 years.
5. Subjects with renal insufficiency defined as creatinine \> 1.5x the upper limit of normal or a calculated creatinine clearance of \< 50 cc/min.
6. Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
7. Known HIV, Hepatitis B or Hepatitis C positive.
8. Subjects with uncontrolled concurrent illness including, but not limited to, ongoing or severe infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, acute gastrointestinal bleeding, psychiatric illness or other condition which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study.
9. Any condition that would preclude the ability to deliver appropriate IP therapy.