cyrilzakka/clinical-trials huggingface dataset:
Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies

The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.

Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years
2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry
3. Refractory or relapsed B cell-acute lymphoblastic leukemia
4. No available curative treatment options (such as hematopoietic stem cell transplantation)
5. Stage III-IV disease
6. Creatinine \< 2.5 mg/dl
7. Aspartate transaminase-alanine transaminase ratio \< 3x normal
8. Bilirubin \< 2.0 mg/dl
9. Karnofsky performance status \>= 60
10. Expected survival time \> 3 months
11. Adequate venous access for apheresis
12. Ability to understand and provide informed consent

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients requiring T cell immunosuppressive therapy
3. Active central nervous system leukemia
4. Any concurrent active malignancies
5. Patients with a history of a seizure disorder or cardiac disorder
6. Previous treatment with any immunotherapy products
7. Patients with human immunodeficiency virus, hepatitis B or C infection
8. Uncontrolled active infection
Rheumatoid Arthritis Through Education and US Study (RAEUS)

Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on the ability of patients to assess for clinical synovitis swollen joints in RA.

Design: 6-month single centre randomized controlled trial. Patients: established RA. Intervention: education on self-assessment of joints that included initial brief patient training on tender (TJC) and swollen (SJC) joint counts, followed by US feedback every 3 months versus standard care without education. Patient and physician independently performed 28-joint counts at each visit. Outcome variables: (Primary) Percentage of patients with good agreement with physician derived swollen joints (prevalence-adjusted bias adjusted kappa, PABAK\>0.6). Other variables: Agreement in SJC (Bland and Altman 95% limits of agreement), feasibility/patient satisfaction survey and disease activity score (DAS28) at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* RA patients fulfilling ACR1987 criteria
* adults between age 21 and 80 years

Exclusion Criteria:

* pregnant
* no mental health illness
* fit to perform informed consent
Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography

The goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(CKD). The main questions it aims to answer are:

1. If first-phase ejection fraction（EF1）could early detect the left ventricular systolic dysfunction in patients with CKD.
2. Whether EF1 can detect left ventricular systolic dysfunction in patients with CKD more sensitively than speckle-tracking echocardiography and myocardial work.

Participants will need to cooperate to do an echocardiography. Researchers will compare healthy volunteers and patients with CKD to see if EF1 could early detect the left ventricular systolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.
* LVEF≥50%.

Exclusion Criteria:

* Patients with primary hypertension, diabetes and congenital heart disease.
* Patients who are pregnant or lactating.
* Patients with the blurry ultrasound images.
Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection

The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.

We carried a multicenter randomised controlled trial to assess the performance of this system in quality control of real-time colonoscopy, including the adenoma detection rate (ADR), withdraw time, adequate bowel preparation rate and other indicators.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.

Exclusion Criteria:

* Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
* Patients with a history of colorectal surgery.
* Patients with a contraindication for biopsy.
* Patients with prior failed colonoscopy.
* Patients with known stenosis or obstruction.
* Patients in pregnancy or lactation phase.
* Patients refused to participate in the trial.
Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive ANCA-associated Glomerulonephritis

Urinary CD4+ and CD8+ T lymphocytes may predict renal flares in patients with inactive ANCA-associated vasculitis and thus serve as early non-invasive biomarkers. Urine samples of patients with inactive renal ANCA-vasculitis will be analysed by flow cytometry and compared to clinical outcome after 6 months.

Data of previous studies have shown that counts of urinary T lymphocyte subsets correlate with disease activity in several immunological renal diseases, e.g. ANCA-associated glomerulonephritis. Thus, study authors hypothesise that CD4+, respectively CD8+, T effector memory lymphocytes found in urine samples of patients with inactive ANCA-vasculitis predict subsequent renal flares. Therefore, quantification of these cellular subsets might reliably predict relapse of ANCA associated glomerulonephritis at an early stage. In a prospective experimental study urine of patients with ANCA-vasculitis and no renal involvement or patients in renal remission will be analysed by flow cytometry. After 6 months of observation, clinical outcome and potential renal relapse will be determined and correlated to initial T lymphocyte count.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed ANCA-associated vasculitis (clinical diagnosis of granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions AND positive test for proteinase 3-ANCA or myeloperoxidase-ANCA)
* no currently active renal involvement (defined as BVAS = 0 with exception of hematuria or proteinuria as signs of renal scars)
* written and informed consent

Exclusion Criteria:

* urinary tract infection
* active menstrual bleeding
* active renal involvement
* other active renal disease (e.g. diabetic nephropathy)

Initially, we defined treatment with rituximab as exclusion criteria. However, upon closer examination, we recognized that this exclusion criterion was overly restrictive and may have inadvertently excluded eligible participants who met our other inclusion criteria. As a result of this reassessment, we have revised our exclusion criteria to no longer exclude individuals solely on the basis of receiving rituximab treatment.
A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

This study will consist of a randomized controlled trial in which the investigators test the feasibility and effectiveness of mandatory nap programs for physicians in training. One site will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The other will be the oncology service of the Hospital of the University of Pennsylvania. The primary outcome will be the amount slept while on call. The first year will test the efficacy of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour mandatory nap schedule.

Background: The release of the Institute of Medicine report on resident work hours and patient safety highlighted the risks to patient and resident safety of extended duty on-call shifts.

Objectives: The purpose of this study is to test the feasibility and effectiveness of mandatory naps during extended duty overnight shifts for residents.

Methods: For each site (PVAMC and HUP), every other month residents will be randomized to either work the standard schedule (which involves interns being on duty for 30 continuous hours) vs. the mandatory nap schedule, which involves interns signing out their beepers for 5 hours in the middle of the night to covering night floats and for 3 hours in Year 2. The primary outcome will be the amount slept as measured by actigraphs, with secondary outcomes of cognitive alertness measured by 3-minute psychomotor vigilance testing (PVT), Stanford sleepiness Scale, and other measures of resident and patient well-being.

Status: Recruitment complete, analyses phase only

Eligibility Criteria:
Inclusion Criteria:

* Residents in the University of Pennsylvania Internal Medicine Training Program who are rotating through either Philadelphia VA Medical Center Medical Service or Hospital of University of Pennsylvania Oncology Service

Exclusion Criteria:

* Refusal to consent to participate
Carbohydrates Under Target for Type 1 Diabetes Management

Recently there has been an increased interest in limiting intake of carbohydrates (CHO) for improving long term health. While healthcare professionals (HCPs) are sometimes reluctant to limit the CHO intake due to the lack of information related to safety issues, low CHO diets are increasing in popularity amongst both people with and without diabetes. One of these diets, the very low CHO high fat diet (VLCHF) raises concern on its impact on the lipid profile, liver, response to glucagon, and insulin dose adjustments when adopting it in the context of type 1 diabetes (T1D). The investigators recently conducted a series of interviews with people with diabetes following a VLCHF diet (Brazeau et al. Manuscript in preparation) to inquire on their reasons for adopting VLCHF as well as challenges they faced. The main reasons to initiate the diet were to limit blood glucose fluctuations and reduce medication. An issue that was frequently mentioned during the interviews was the lack of support from HCPs which often leads to not discussing it with said HCP. This is an important source of concern that can lead to additional safety issues. Our goal is to provide information regarding the safety of a VLCHF diet for T1D and the individualized insulin adjustments required.

The investigators aim to evaluate the changes in daily blood glucose fluctuations after 6 weeks of a VLCHF diet, to monitor the changes in the insulin dosing and to measure impact on lipid profiles, response to glucagon, and liver function.


Eligibility Criteria:
Inclusion Criteria:

* Duration of Type 1 Diabetes \> 12 months
* On intensive insulin therapy for \> 6 months
* Own a smartphone or tablet to use two mobile applications : Keenoa and Piezo: Achieve the Guidelines!

Exclusion Criteria:

* Known gastroparesis (clinical diagnosis)
* Advanced kidney disease (eGFR \< 50 mL/min)
* Known significant liver disease (e.g., cirrhosis, active hepatitis, liver transplantation)
* Recent (\< 6 months) major cardiovascular even (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.)
* Pregnancy (ongoing or planned in the next 6 months)
* Breastfeeding
* Severe hypoglycemia episodes or ketoacidosis in the 4 weeks prior to recruitment
* Claustrophobia or presence of metal devices/implants in the body
Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation

1. To evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience.
2. To evaluate the impact of treatment on emotional well-being and postinjury adjustment.
3. To evaluate the impact of the intervention on abilities including problem solving, communication, and stress management.
4. To examine the extent to which treatment benefits are sustained in the longer-term.

To design effective resilience interventions, a treatment modality which is effective for traumatic brain injury (TBI) survivors is needed. Virginia Commonwealth University (VCU) researchers have had considerable success in the past several decades developing and evaluating interventions for neurobehavioral, cognitive, and vocational challenges after TBI. Researchers have demonstrated the utility of the curriculum-based (C-B) treatment structure in various settings. Additionally, the efficacy of the C-B structure, independent of postinjury timeframe, allows the flexibility necessary to address the unique consequences of TBI.

The C-B treatment modality offers a promising strategy for the promotion of resilience postinjury. The primary purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote postinjury resilience and adjustment. Objectives include:

1. to evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience
2. to evaluate the impact of treatment on emotional well-being and postinjury adjustment
3. to evaluate the impact of the intervention on abilities including problem solving, communication, and stress management
4. to examine the extent to which treatment benefits are sustained in the longer-term

Eligibility Criteria:
Inclusion Criteria:

* mild, moderate, or severe TBI
* able to understand and provide consent

Exclusion Criteria:

* active substance abusers (e.g., intoxicated at arrival to intake)
* at imminent risk of psychiatric hospitalization
* in imminent danger of hurting themselves or others
Reducing Readmission Rates by Providing a Comprehensive Transition Plan From Hospital to Home for Cardiac Surgery Patients.

Patients who undergo cardiac surgery will be screened by a team member with the risk score once the patient has been admitted to the Cardiovascular Progressive Care Unit (CVPCU) after surgery. Participants will be randomized to the intervention or the control group. Both groups will receive standard discharge planning. In addition, the intervention group will have a nurse practitioner (NP) who will be responsible to verify that each essential step of the discharge process has been completed and will visit the patient in patient's home after discharge to complete a physical, review medications, titrate medications as needed, prescribe any necessary treatments, and perform education. The primary outcome variable will be a decrease in the 30 day readmission rate comparing high risk patients at pre and post intervention.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age or greater who have had cardiac surgery procedures including coronary artery bypass surgery (CABG), valve replacement, aortic aneurysm repair, and combined CABG and valve procedures.

Exclusion Criteria:

* Patients who have undergone orthotopic heart transplantation, orthotopic lung transplantation, or orthotopic heart-lung transplantation
* Patients who have undergone ventricular assist device placement
* Patients who do not reside in Maryland
* Non English speaking patients
* Patients discharged to a facility.
Acute Intestinal Necrosis- the Preoperative Diagnostic Approach

To investigate a number of blood based parameters in patients with intestinal ischaemia compared to patients with other acute abdominal diseases.

Intestinal ischemia is a life-threatening condition defined by interrupted blood supply to the intestinal tissue. Primary and secondary ischemia is obstruction of blood-supply due to vascular and extra-vascular pathology, respectively.

Early diagnosis and treatment are critical to save the ischemic bowel. Clinical findings of secondary intestinal ischaemia are related to the underlying cause e.g. vomiting and palpable hernia. Abdominal computed tomography (CT) can effectively visualize the causes. In contrast, the diagnosis of primary intestinal ischemia is often delayed due to the absence of specific clinical findings. Primary intestinal ischemia is visualized with CT ateriography, revealing mesentery arterial obstruction. However, in the acute setting a non-arterial phase CT is often performed but the findings are unspecific in the early stages and the pattern of findings which could indicate primary ischemia are not well understood. In primary and secondary ischemia, standard blood-based parameters are inconsistently elevated and highly unspecific. Newer blood-based parameters such as D-lactate has been proposed as ischaemic markers. D-lactate is produced by bacteria in the bowel lumen and translocation through a damaged bowel wall makes it a potential marker of intestinal ischemia.

A case-control-study of all acute admitted patients with abdominal pain in Aalborg, Denmark in the mentioned time range. The sensitivity and specificity of potiential biomarkers in a blood sample at time of admission as a marker of intestinal ischaemia will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Referred to The Department of Gastrointestinal Surgery, Aalborg University Hospital.

Exclusion Criteria:

* Children
Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage

The aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .

coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.Random allocation of the treatment sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.The parameters of the study are as following items: probing depth( PD), clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC) and the patients will be followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Having no systemic disease affecting the periodontium,
* No contraindication for elective surgery,
* Adequate oral hygiene ,
* No previous surgical attempts for root coverage at the studying sites,
* Vital teeth and signing a witness letter.

Exclusion Criteria:

* Smoking, presence of a restorations on tooth surface for test and control teeth,
* Pregnancy,
* Being under treatment with steroids,
* Peri-apical infection,
* Indication for antibiotic prophylaxis prior to dental treatments
Unilateral vs Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate Resistant Cases of Polycystic Ovarian Syndrome

The aim of the current study is to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in clomiphene citrate resistant cases of polycystic ovarian syndrome in terms of clinical response (regularity of the cycle), change in biochemical parameters, ovulation rate over six months, pregnancy rate within six months.

Polycystic ovary syndrome (PCOS), is considered the most common endocrine disorder in reproductive age in females. Polycystic ovary syndrome (PCOS) is characterized by reproductive and metabolic disturbances. Androgen excess is a hallmark of polycystic ovary syndrome (PCOS), driving many of the phenotypic features

The clinical response to laparoscopic ovarian drilling (LOD) seems to be thermal energy dose-dependent. Two punctures (300 J) per ovary are associated with poor results. Between three and five (450-750 J) punctures per ovary seem to represent the effective thermal dose. The application of six or more (C900 J) punctures per ovary may result in excessive destruction to the ovary and should therefore be discouraged.

Eligibility Criteria:
Inclusion Criteria:

* Age within 25-35 years.
* Polycystic ovarian syndrome as diagnosed according to modified Rotterdam criteria 2018: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; and transvaginal sonographic appearance of polycystic ovaries (≥ 20 follicles or an ovarian volume 10 cm3) .
* Infertile women who have clomiphene citrate -resistant polycystic ovary syndrome (150 mg/daily for 5 days for six cycles with no ovulation).
* Normal semen analysis in the husband.

Exclusion Criteria:

* Hyper-androgenic disorders like late onset congenital adrenal hyperplasia, hyperprolactinemia, thyroid diseases.
* Cushing's syndrome and androgen-secreting tumors.
* Body mass index \> 30 kg/m2.
* Other medical problems like diabetes, Hypertesion, patients on steroid hormone .... etc.
* Other causes of infertility as multiple uterine fibroids.
Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

To study the effective lens position concept in second eye refinement (SER) cataract surgery, by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pACD) measured in Pentacam and SER refractive outcomes.

A retrospective chart review was conducted, including demographics (age and gender) and several parameters for both the first and second eyes, including the intra-ocular lens power calculation using the HofferQ, SRK/T and Holladay 1 formulas. Pentacam HR was used for pseudophakic anterior chamber depth measurement, and manual measurement was performed by a single investigator tracing a line between the anterior surface of the intra-ocular lens and the central corneal epithelium apex. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 50% partial adjustment of the prediction error of the first eye. To relate refractive outcomes to pACD values, the investigators performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).

Eligibility Criteria:
Inclusion Criteria:

* patients admitted for bilateral age-related cataract surgery

Exclusion Criteria:

* Age \< 18 years old
* Previous or combined ocular surgery
* Manual extracapsular cataract extraction and not phacoemulsification
* Corneal sutures
* Implantation of any other IOL type
* IOL implanted in the sulcus
* Intra or postoperative complication
* Post-operative best-corrected visual acuity worse than 5/10
* Anterior corneal astigmatism\>3.00 D
* Inadequate cooperation for Pentacam HR examination