cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent could be acquired;
2. Diagnosed with relapse/refractory acute lymphoblastic leukemia;
3. Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;
4. Refractory was defined as failed to achieve complete remission after two courses of induction therapy;
5. CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;
6. Karnofsky score ≥70;
7. Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.
8. Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr \< 2.0mg/dL or \< 2 times upper limitation of normal; ALT and AST\<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 \> 45% of predict value;
9. At least 2 weeks intervals since the last chemotherapy;
10. At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;

Exclusion Criteria:

1. Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);
2. Women in pregnancy and lactation;
3. Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;
4. Long term use of systemic corticosteroids(5mg per day for 2 weeks);
5. Any other uncontrolled life-threaten diseases;
6. Patients with history of anaphylaxis to any drugs;
7. With central nervous system (CNS) involvement;
8. Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;
9. Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;
10. Other conditions that principle investigator considered may increase the risk of the patients or interference the results.
A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin

This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 19 and 50 years inclusive
* The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject)
* Body Mass Index (BMI) below 27 kg/m\^2
* Fasting blood glucose maximum 6 mmol/l

Exclusion Criteria:

* Participation in any other clinical trial involving other investigational products within the last 3 months
Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3

One of nicotine's effects on the body is at the level of the NMDA receptors in the brain. Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment of nicotine addiction. The purpose of this study is to evaluate the effectiveness of memantine using a laboratory model of smoking relapse in nicotine dependent volunteers. Investigators will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.

Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. Neurotransmission at NMDA receptors in the brain is associated with learning and memory and has been linked to many of nicotine's effects on humans. It is possible that altering NMDA neurotransmission may be helpful in treating nicotine addiction. The goal of this study is to evaluate the effects of memantine, an NMDA receptor antagonist, using the laboratory model of smoking relapse in nicotine dependent volunteers. The effects of memantine used in combination with bupropion, a medication currently used to facilitate smoking cessation, will be compared to a placebo.

This double-blind study will consist of three phases (placebo, bupropion, and memantine). Each phase will include 10 days of outpatient medication maintenance, followed by 5 days of inpatient testing. During the outpatient phase, study visits will occur every 2 to 3 days. During the first portion of inpatient stay, participants will not be permitted to smoke. During the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of nicotine dependence with psychological dependence
* Smokes at least 15 cigarettes per day for the three months prior to enrollment
* Currently not seeking treatment for nicotine dependence
* Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
* Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

* DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
* Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
* History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
* Currently seeking treatment for nicotine disorders
* On parole or probation
* History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
* History of significant recent violent behavior
* Blood pressure greater than 150/90
* History of eating disorders
* History of allergic reaction to any of the study medications
* Pregnant
Visual Performance With a Trifocal Intraocular Lens

The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity.

Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.

Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2).

Subjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near.

Defocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted.

Contrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart.

Near and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70yrs
* Bilateral implantation of a trifocal intraocular lens

Exclusion Criteria:

* existing ocular pathology
* surgical complications
* corneal astigmatism \> 1.50DC
Exercise Training in Individuals With Coronary Artery Disease

In this controlled trial, patients referred to post-myocardial infarction cardiac rehabilitation will be randomized to either interval or continuous training.

The trial would i) compare the acute effects of each exercise type on selected cardiovascular indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular indicators; iii) provide information on the association between acute and chronic effects of each exercise type; iv) provide insight into possible mechanisms of effectiveness of each exercise type; v) identify the most safe and effective exercise type for patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* myocardium infarction 120 days prior to cardiac rehabilitation

Exclusion Criteria:

* contraindications for exercise training,
* uncontrolled dysrhythmias,
* uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
* intellectual development disorder,
* pregnancy.
The Effects of Sedative on the Fluid Responsiveness in Critically Ill Patients

Hypotension and bradycardia are often observed following induction of dexmedetomidine or propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of main causes for this hypotension.The investigators hypothesized that hypotension after induction of sedation is caused by decrease of preload by sedative agents,and passive leg raising (PLR)test could predict this event.Dexmedetomidine or propofol infusion in patients with circulatory failure decrease cardiac preload and enhance preload-dependency and fluid responsiveness.

In this clinical trial,the investigators hypothesized dexmedetomidine or propofol infusion in patients with circulatory failure decrease cardiac preload and enhanced preload-dependency and fluid responsiveness,and PLR induced pulse pressure variation (PLR-ΔPP) could predict the hypotension during dexmedetomidine induction in critically ill patients.Before dexmedetomidine or propofol infusion, the investigators will conduct passive leg raising test. At first, the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak BP (usually within 30-90 s). Hemodynamic profiles planned to be measured are SBP, DBP, CVP and HR.Sedation was induced with a dexmedetomidine 0.5μg/kg over 10 min loading, followed by a maintenance infusion of 0.2-0.7 μg/kg/h for one hour. The dose of propofol was titrated targeting the Richmond agitation sedation scale (RASS) ranged from -2 to -1 (bispectral index: 60-75).Hypotension was defined as a SBP less than 80 mmHg or DBP was less than 50 mmHg, or greater than 30% decrease from baseline for longer than 60 s. Bradycardia was defined a HR 50 /min or greater than 30% change from baseline for longer than 60 s. Receiver operator characteristic curve analysis was performed to evaluate sensitivity and specificity of the value PLR-ΔPP to detect patients at high risk of hypotension.

Eligibility Criteria:
Inclusion Criteria:

* patients with at least one of the clinical manifestations of acute circulatory failure; patients undergoing dexmedetomidine or propofol infusion

Exclusion Criteria:

* deep venous thrombosis or elastic compression stocking
* an increase in the intra-abdominal pressure confirmed by clinical examination
* serious central nervous system pathology (head trauma, severe dementia, acute stroke, uncontrolled seizures)
* severe liver disease(Child-Pugh class C)
* unstable angina or acute myocardial infarction
* left ventricular ejection fraction less than 30%
* heart rate(HR) less than 50/min, heart block with second- or third degree
* systolic blood pressure (SBP) less than 90 mmHg despite 2 vasopressors infusion continuously before the begin of dexmedetomidine infusion
PEG-rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation

The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.

At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age between 18 and 65 years.
2. Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
3. The collected CD34+ cells≥1×10E6/kg.
4. ECOG score ≤2.
5. Heart and lung is normal.
6. Blood creatinine ≤1.5×ULN.
7. ALT, AST, TBIL ≤2 ×ULN
8. Not in pregnancy.
9. Written informed consent are acquired.

Exclusion Criteria:

1. Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
2. Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.
3. Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
4. LVEF \<55%.
5. Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
6. Refused to take contraceptive measures during the study period and the subsequent 1 years.
7. Severe mental or neurological disorders.
8. Serious heart, lung, central nervous system disorders.
9. Sickle cell anemia, hemolytic anemia and other hematologic diseases.
10. Participate in other drugs clinical trials 30 days before the screening.
11. Other situation that investigators consider as contra-indication for this study.

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Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum

The purpose of this study is to evaluate the use of personal genomic educational testing (PGET) on student knowledge and clinical skills surrounding pharmacogenomic testing to ensure it is of educational benefit to our student population. Students will be provided the opportunity to opt-in to test their own pharmacogenomic panel while participating in the standard curriculum. Students will have the option of using their own reports or dummy reports during classroom activities. Our hypothesis is that those students who have their own pharmacogenomics tested will show better overall performance.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to provide informed consent for participation in the study
* Enrolled in 3rd year Doctor of Pharmacy course

Exclusion Criteria:

* Unwilling or unable to provide consent for participation
The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic Patients

Second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood glucose after a subsequent meal. This phenomenon occurs in normal subjects while it is not clear whether it is also observed in type 2 diabetic patients. This study aims to define whether the second-meal phenomenon occurs in type 2 diabetic patients. We will also seek for the mechanism.


Eligibility Criteria:
Inclusion Criteria:

* age 35-70
* HbA1c 6-8%
* DM duration less than 5 yrs

Exclusion Criteria:

* type 1 DM, secondary DM, gestational DM
* patients using insulin, TZDs
* patients using corticosteroid, herb medication or other medications affecting glucose tolerance
* renal dysfunction (Cr \> 1.5mg/dL)
* hepatic dysfunction (LFT \> x 3UNL)
* anemia (Hg \< 10g/dL)
* ischemic heart disease, congestive heart failure
* severe diabetic complication (CRF, CVA, PDR, gastroparesis)
* infectious disease
* malignancy
* pregnant women
Feasibility of a Personalized SMS Intervention for Insomnia

The goal of this research is to establish a proof of concept for optimizing and evaluating a personalized SMS intervention based for individuals with chronic sleep problems.

Insomnia is a pervasive disorder affecting approximately 10-40% of the U.S. population in a given year. In addition, insomnia has been identified as a transdiagnostic symptom that cuts across numerous other psychological disorders. Interventions that target disordered sleep may attenuate symptomatic distress for a multitude of psychological disorders, making it a potentially potent intervention target with broad public health potential. Despite the ubiquity of the problem, only a fraction of individuals who could benefit actually receive the most effective intervention for insomnia, cognitive behavioral therapy for insomnia (CBT-I). Emerging research has pointed to the possibility of monitoring behavior and delivering personalized interventions to specific individuals via mobile devices. Personalized and adaptive interventions delivered via Short Message Service (SMS) provide a relatively simple solution to prompt individuals to engage in personalized interventions outside the context of opening or downloading a mobile mental health app. The content of text messages have the capacity to modulate behavior via prompts, motivational messages, and "nudges." By using brief, motivational messages based on evidence-based treatment for sleep (e.g. CBT-I), there is the potential to reduce dysfunctional sleep patterns at scale.

Eligibility Criteria:
Inclusion Criteria:

* clinical insomnia (defined by scoring ≥ 15 on the insomnia severity index)

Exclusion Criteria:

* under 18 y.o.
* unable to read or write in English
* do not own a Smart Phone
Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction

To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex


Eligibility Criteria:
Inclusion Criteria:

* Basic type intermittent exotropia

Exclusion Criteria:

* previous strabismus surgery restrictive strabismus
Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.

The purpose of this study is to examine the effectiveness of three common techniques for the treatment of lateral epicondylosis. Through objective and subjective assessments this study will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis. It is hypothesized that the more manual Astym technique and Graston technique will produce more significant results than the more frequently utilized ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Clients who are admitted to NYULMC Center for Musculoskeletal Care for outpatient occupational or physical therapy with a diagnosis of lateral epicondylosis will be included. To participate in the study participants must:
* Be able to follow a home exercise program
* Be able to consent to participation in the research study

Exclusion Criteria:

* Clients who are deemed unable to consent to participation in the research study and/or unable to following a home exercise program will not be included in this study
* Clients with additional acute orthopedic injuries and/or surgeries to the involved upper extremity will not be included in this study.
* Clients with open wounds of the involved upper extremity that will interfere with treatment techniques will not be involved in this study.
Blood Pressure and Cardiometabolic Risk (Diet-to-HTN)

Obesity is a significant health issue that increases the risk of serious cardiovascular problems. In recent years, two dietary methods, the Ketogenic Diet (KD) and Intermittent Fasting (IF), have become popular for their potential to treat obesity and its related issue, hypertension. While both diets are known for their effectiveness in weight loss, their specific impacts on blood pressure (BP) and overall heart health risks are less understood especially in menopausal women.

The main goal of this study was to investigate how the Ketogenic Diet and Intermittent Fasting compare to a regular, unrestricted diet (referred to as Free Diet or FD) in terms of their effects on clinic blood pressure levels in menopausal women.

Additionally, the study looked at changes in Body Mass Index (BMI), the percentage of total body weight loss, body fat percentage, waist and hip measurements, the ratio of waist-to-hip size, and the Phase Angle (PhA), which is a measure of the body's overall health status.

This research was conducted as a single-center, prospective, open-label clinical trial at Sant'Andrea Hospital in Rome, Italy. Participants included menopausal women with a BMI of 25 kg/m² or higher, who were already being treated for uncomplicated hypertension. These women were assessed at the hospital's Hypertension Unit and then placed into one of three diet groups: Ketogenic Diet, Intermittent Fasting, or Free Diet. Each participant received personalized dietary advice, underwent regular blood pressure checks aligned with European health guidelines, and completed standard health tests including electrocardiograms and blood tests for glucose, lipids, and liver and kidney functions. Measurements of all key health indicators were taken at the start of the study, then again after two months and six months.

This study is designed to offer clearer insights into how specific dietary choices can affect cardiovascular health and help manage hypertension in obese individuals.

Eligibility Criteria:
Inclusion Criteria:

* female individuals,
* aged between 50 and 65 years,
* BMI ≥25 kg/m2;
* diagnosis of essential uncomplicated arterial hypertension for at least 6 months;
* perimenopause or menopause confirmed,
* provision of informed consent.

Exclusion Criteria:

* previous history of major CVDs;
* severe heart or renal failure;
* poor adherence to prescribed pharmacological and non-pharmacological treatments;
* treated uncontrolled hypertension or diabetes;
* secondary forms of hypertension;
* uncontrolled thyroid diseases;
* previous bariatric surgery or endoscopic bariatric procedures;
* regular engagement in competitive sports activities;
* history of alcoholism and/or drug addiction;
* psychiatric and/or neurological conditions affecting the understanding and giving of informed consent;
* cancer or any other progressive severe disease;
* use of pharmacological treatments known to may interfere with the main purposes of the study protocol.
A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)

A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with OAB (with or without urgency incontinence) by the treating HCP, with symptoms for at least three months prior to study enrollment
* Initiating a new course of treatment with mirabegron or antimuscarinic medication (including patch formulation) for OAB, which may be first course of any treatment for OAB, restart or switch from one drug to another
* Willing and able to complete PRO questionnaires with minimal assistance

Exclusion Criteria:

* Current participation in clinical trials of OAB
* Use of more than one OAB medication at time of enrollment
* Patients whose OAB has been treated with onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (XRT), stents, surgery, or intermittent catheterization prior to or at time of enrollment
* Neurologic conditions associated with OAB symptoms
* Patients residing in a nursing home