cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients

The purpose of this study is to determine maximum tolerated dose of Gleevec in combination with Chlorambucil in previously treated CLL patients.

A recent study by Aloyz et al demonstrated a synergistic effect of imatinib on chlorambucil-mediated cytotoxicity in CLL cells in vitro. Imatinib inhibits c-abl and sensitizes cells to chlorambucil. The Phase I component of the study will determine the maximum tolerated dose and recommended Phase II dose of Gleevec when used in combination with chlorambucil. Once the maximum tolerated dose has been determined, a total of 16 patients will be enrolled in the Phase II component of the study. This study will determine the dose limiting toxicities, pharmacokinetics and pharmacodynamics of Gleevec in combination with chlorambucil.

Eligibility Criteria:
Inclusion Criteria:

* B-cell chronic lymphocytic leukemia (a) Rai stage 0-II with indication for treatment by NCI Working Group Criteria: or (b) Rai stage III or IV.
* Received a minimum of one prior chemotherapy regimen. Prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.
* White blood cell count \> 25 x 10\^9/L
* ECOG 0, 1,or 2.
* Adequate renal and hepatic function
* Platelets \> 75 x 10\^9/L, transfusion independent.
* Neutrophils \> 1.0 x 10\^9/L, transfusion independent

Exclusion Criteria:

* Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood)
* Active cardiovascular disease as defined by NYHA class III-IV categorization.
* Intercurrent illness or medical condition precluding safe administration of ribavirin.
* Concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency
* Known infection with HIV, Hepatitis B or C.
* Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).
* Received any previous therapy for CLL within 28 days prior to study entry.
Techniques for Abdominoplasty After Massive Weight Loss

Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial issues.

The investigators will conduct a randomized, controlled trial where individuals with excess skin on the abdomen will be randomized to either standard abdominoplasty or abdominoplasty in combination with liposuction. The investigators will examine the rate of complications, and the functional and aesthetical outcomes of the two methods.


Eligibility Criteria:
This study is open only to individuals who are residents in Sweden and qualify for government-funded, inpatient, non-emergency health care within the Stockholm Region.

Inclusion Criteria:

* BMI \< 30
* Stable BMI for \>= 6 months
* \>= 24 months since bariatric surgery, if applicable
* Skin fold of \>= 5 cm
* Functional and/or psychosocial issues due to abdominal skin excess

Exclusion Criteria:

* Smoking
* Ongoing infection
Initial Parenteral Nutrition Education of Parent Assessment Plan

The department of gastroenterology, hepatology and pediatric nutrition at the Necker-Enfants Malades hospital has created an evaluation system for the initial therapeutic education program followed by parents of children requiring parenteral nutrition at the Necker-Enfants Malades hospital.

The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.

Due to the highly technical nature of the care to be provided at home by parents of children in need of parenteral nutrition, an assessment of the acquisition of both factual knowledge provided to parents in hospital, but also of the reasoning, decision-making, technical skills and parents attitudes seem necessary and essential before the child's return to his home in order to guarantee his safety.

The department of gastroenterology, hepatology and pediatric nutrition of Necker-Enfants Malades hospital has developed an educational assessment system based on previous studies in this field. Composed of 4 tools, this plan allows a complete assessment with relevant educational decision fields of the set of skills that parents must master to cope with their child's illness on a daily basis, following their participation in the initial program of therapeutic education offered by the Necker hospital team.

The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.

Eligibility Criteria:
Inclusion Criteria:

* Holders of parental authority for children with parenteral nutrition participating in the initial education program of pediatric home parenteral nutrition of Necker hospital.
* informed consent signed by the patient and the investigator.
* patient affiliated to a social security scheme (beneficiary or beneficiary).

Exclusion Criteria:

* Subject having difficulty understanding the French language.
* Illiterate subject.
The Prospect of Using Serum Taurine Level as a Potential Biomarker for Early Detection of Colorectal Carcinoma and Its Correlation With Other Prognostic Markers

Serum taurine results in this study showed that, besides CRC biomarkers; it is most attractive, more precious and more accurate early biomarker for early detecting of any malignant change which may led to CRC by other mean it is the most sensitive and more specific tumor marker for CRC. As a result, we can recommend measuring its level regularly with other prognostic tumor biomarkers and screening examination for all people with abdominal and gastrointestinal problems and for precancerous patients as a pre-early biomarker for colorectal carcinoma. So, it needs further studies to confirm that observations on large scale of population as it obvious the small sample size in early stage and lack data due to limited financial resources and it needs more efforts to collect first and precancerous stages patients.

Two-hundred and fifty Egyptian patients (males and females) who attended National Cancer Institute, Cairo university; most of them were referred from private clinics and non-specialized hospitals, complain with abdominal troubles and gastrointestinal problems and bleeding per rectum, after full investigation, clinical examination, biochemical analysis, screening examination according to their cases (Ultra sound, CT or endoscopy either rectal or colonoscopy) and histopathological examination, we choose 'after their approval' one-hundred patients and six which diagnosed as CRC patients aged (19-69 years old) and excluded the others from participated in these studies because they diagnosed as non-colonic diseases like; Irritable colon, Gastroenteritis, Pancreatitis, Liver flexure or Chronic cholecystitis. According to Histopathological architecture, we divided patients to:

1. Inflammatory group number=7.
2. Benign tumor group number=8 which was assessed preoperatively and postoperatively.
3. Malignant tumor group number=91 Lastly, ten health volunteers were enrolled as a frank control. For all included subjects, the measured biochemical analysis were CBC, ALT, AST, Albumin, Total Bilirubin, Creatinine, Blood urea, Sodium, Potassium, CEA, CA19.9 and Taurine.

Eligibility Criteria:
Inclusion Criteria:

Patients complain of abdominal troubles and gastrointestinal problems and bleeding per rectum

Exclusion Criteria:

Patients refusal,non-colonic diseases like; Irritable colon, Gastroenteritis, Pancreatitis, Chronic cholecystitis
Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

The purpose of this post-trial access (PTA) program is to provide nipocalimab for the treatment of participants with Warm Autoimmune Hemolytic Anemia (wAIHA) who are experiencing clinical benefit after completing 28-weeks open-label extension in MOM-M281-006 (NCT04119050) study.


Eligibility Criteria:
Inclusion Criteria:

* Participants demonstrate clinical benefit (improvement of hemoglobin from baseline) at the Week 28 assessment in the open-label extension of the MOM-M281-006 (NCT04119050) study
* Participants does not have co-morbidities that would alter the risk-benefit of nipocalimab administration (determined by treating physician)
* Participants completed treatment in the 28-week open-label extension of the MOM-M281-006 (NCT04119050) study without receiving rescue treatment or discontinuation of the study prior to Week 28 visit

Exclusion Criteria:

* Participants have a serious or clinically significant infection (example: pneumonia, biliary tract infection, diverticulitis, Clostridioides difficile infection) requiring parenteral anti-infectives and/or hospitalization
* Participants have a chronic infection (example: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or require chronic treatment with anti-infectives (example: antibiotics, antivirals)
Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue.


Eligibility Criteria:
Inclusion Criteria:

1. Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible)
2. In sinus rhythm (no pre-operative atrial fibrillation, no hx of AF)

Exclusion Criteria:

1. Age ≥ 80 years
2. Diagnosed pre-operative chronic or paroxysmal AF
3. Prior ablation procedure for AF
4. Previous cardiac surgery
5. Implanted pacemaker
6. Active smoker
7. Comorbidities such as congenital or cardiac re-operation
8. Use of antiarrhythmic agents
9. Active inflammatory or infectious disease or malignancy
10. Diagnosed autoimmune disease
11. Corticosteroid or other immunomodulatory or immunosuppressive medication
12. Known sensitivity to sorbitol
13. Known gastric sensitivity to acidic juices like orange juice
Treating Clozapine-induced Sinustachycardia With Bisoprolol

Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate variability, QTc and T-wave morphology.


Eligibility Criteria:
Inclusion Criteria:

* Treated with clozapine \> 3 months and minimum 100 mg/day
* Fixed dose 14 days before inclusion
* Heart rate \> 100 (ECG)
* Pregnancy test negative
* Clozapine-induced sinustachycardia documented by ECG or case record
* Sexual abstinence or contraception
* Informed consent

Exclusion Criteria:

* Substance abuse
* Physical diseases, contraindications for clozapine or bisoprolol
* Asthma or chronic obstructive lung disease
* Blood pressure \< 100/60 or recent history of syncopes
* QTc\>500 ms, SA-block, AV- block II or III
* Restrictions by Danish mental act
* Allergic to clozapine or bisoprolol
Brief Intervention to Create Smoke-Free Homes Policies in Low-Income Households: North Carolina Effectiveness Trial

The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S. over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited.

The proposed research will systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. During this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a North Carolina 2-1-1 call center. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services. The main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older.
* Must speak and understand English.
* Must smoke and live with at least one other non-smoking person OR be a non-smoker who lives with a smoker(s).
* Must not have a total smoking ban in their home.

Exclusion Criteria:

* All participants who are not in immediate crisis will be invited to participate in the study.
Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

Liver transplantation has been universally recognized to improve survival of patients suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the benefit of liver transplantation remains to be demonstrated. The aim of the present study was to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for immediate liver transplantation (group 1) or standard treatments (group 2).

120 patients (60 per group) were included. The therapeutic strategy defined by randomization was achieved in 68% of group 1 patients and 75% of group 2 patients (NS). All-causes death and cirrhosis-related death were not different in group 1 and group 2 patients: the five-year survival rate was 58% in group 1 and 69% in group 2 patients (NS). Through multivariate analysis, the independent predictors of long-term survival were absence of ongoing alcohol consumption (p\<0.001), recovery from Pugh C (p=0.046), and baseline Pugh score\<8 (p=0.029). Liver transplantation was associated with a higher rate of de novo malignancies (30.4% vs. 7.8%, OR=5.1, p=0.001).

Eligibility Criteria:
Inclusion Criteria:

* cirrhosis
* age 18-65yrs
* Pugh B
* written consent

Exclusion Criteria:

* HIV, HBV or HCV infection
* hepatocellular carcinoma
* Pugh A or Pugh C cirrhosis
* creatinin \>200µMol/L
* sepsis
* psychiatric disorders
* extrahepatic neoplasia
Real Time Remote Tele-Mentored Ultrasonography in the ED

The goal of this pilot study is to evaluate the use of real time remote tele-mentored ultrasound in the emergency department at hospitals with physician shortage designation. The main question the investigators aim to answer is:

• Will RTMUS be used in instances where it is available and indicated for abdominal pain or flank pain.

Point-of-care-ultrasound (POCUS) decreases time for clinical diagnosis and improves provider diagnostic accuracy. The use of the Focused Assessment with Sonography in Trauma (FAST) has decreased time to surgical intervention by over 50% for hypotensive trauma patients. POCUS also improves resource utilization, reducing the 6-month ionizing radiation exposure in patients with suspected renal colic in one study. Despite advances in deploying POCUS, the remaining gap is an adequate number of emergency department providers who feel confident in performing POCUS examinations, limiting the delivery of healthcare services to patients at the point of care. Real time remote tele-mentored ultrasound (RTMUS) can overcome this practice gap by enabling remote ultrasound experts to provide real-time assistance to bedside providers using a telemedicine platform. Preliminary studies at the investigator's institution have demonstrated the feasibility of deploying RTMUS to guide nurses in the intensive care setting to acquire accurate images suitable for complex clinical decision making. In this preliminary study, RTMUS had good concordance (90%-100%) between radiological transthoracic echocardiography or CT for evaluating cardiac findings such as left ventricular function, right ventricular dysfunction and pericardial effusion. The overall objective of this study is to examine the impact of RTMUS integration to emergency departments in hospitals with physician shortage designations. The investigators hypothesize the RTMUS system will be able to provide images sufficient for clinical diagnosis and that the local ED providers will accept RTMUS as a suitable option for ultrasound.

User's Acceptability of RTMUS: In this aim, the investigators will evaluate emergency department user's acceptability of RTMUS for abdominal pain and flank pain. The investigators hypothesize that in eligible patients, RTMUS will be used in at least 10% of the instances in which it is available and indicated. As a secondary data point, stakeholder surveys will be collected on the use and performance of RTMUS.

RTMUS is an innovative solution that can improve patient care. This project will engage emergency department providers at physician shortage designation hospitals to increase the use of POCUS in their clinical practice. In the future, RTMUS can be applied to various resource constrained settings to help providers use POCUS to care for their patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present to the emergency department with abdominal pain or flank pain.
* Age greater than or equal to 18 years

Exclusion Criteria:

* Patients who do not present to the emergency department with abdominal pain or flank pain.
* Age less than 18 years
* Unable to consent
Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study

This randomized controlled pharmacokinetic based study will be carried out on patients with both sexes and various ages, plasma triglycerides levels, clinical health disorders and using different agents for treatment of their hyperlipidemia in order to access the optimal drug therapy with best cost effectiveness in the elderly cases under investigation.


Eligibility Criteria:
Inclusion Criteria:

* Patients of dyslipidemia with high triglyceride level (200 to 499 mg/100 ml).
* Total cholesterol level more than 200 mg/100 ml
* Male and female
* Age 35 - 70 years

Exclusion Criteria:

* - Hypersensitivity of drugs
* Liver toxicity
* -Patients suffering from renal dysfunction
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin

To assess the occurrence of serum sickness after Diphtheria Antitoxin administration.

To assess local and systemic reactions within 24 hours to 10 days. To assess the occurrence of positive reactions after the sensitivity test (skin test). To assess the presence of SAE after Diphtheria Antitoxin administration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
* Subjects who received therapy with the intended DAT

Exclusion Criteria:

* Receiving a different brand of Diphtheria Antitoxin (DAT)
Neutrophil Oxidative Burst in Early and Late Onset Pediatric Inflammatory Bowel Disease

ABSTRACT Introduction Residual or absent oxidase function in peripheral neutrophils may point to an inborn defect of neutrophil function - chronic granulomatous disease (CGD) - whereas low to normal oxidative burst capacity has been linked to variants in various members of the NADPH-complex.

Aims To assess the clinical value of routinely measuring oxidative burst activity of granulocytes in pediatric patients diagnosed with very early onset IBD (VEO-IBD) and late onset IBD.

Objectives To investigate possible correlations between neutrophil function and IBD disease activity and to inquire the presence of genetic variants in those with low to absent oxidative burst. To identify the rate of monogenic VEO-IBD in our cohort.

Materials and Methods The proposal constitutes a collaborative effort among Romanian pediatric tertiary care centers to examine the value of assessing neutrophil function in all pediatric IBD patients. Children aged \<18 years diagnosed with Crohn's disease, ulcerative colitis or IBD-undetermined and age-matched healthy controls are recruited. A DHR flow cytometry assay is performed in included subjects and controls. Reduced or absent burst activity will lead to genetic testing in search of overt immunodeficiency or susceptibility variants. All VEO-IBD patients will have an immunological work-up in search of a primary immunodeficiency.

Expected Results We anticipate to include a number of 150 pediatric patients with IBD over 12 months from the three pediatric gastroenterology units in Bucharest, Romania. We expect to identify an overall diminished neutrophil function in IBD patients versus controls and possible variants in the NADPH-complex genes.


Eligibility Criteria:
Inclusion Criteria:

Subjects:

1. age under 18 years;
2. confirmed diagnosis of IBD fulfilling standard diagnosis criteria (clinical, radiological, endoscopical, histological features)
3. parental/guardian consent for study enrollment

Controls:

Healthy age-gender matched controls

Exclusion Criteria:

1. IBD associated to an already defined monogenic defect
2. Diagnosis of IBD uncertain
3. HIV/TB positive
Heart Failure Self-care Mobile Application to Reduce Readmissions Trial

This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient admission for acute decompensated heart failure
* Left ventricular systolic or diastolic heart failure
* Owns a smartphone with a data plan

Exclusion Criteria:

* Hospice or life expectancy less than 6 months
* Palliative inotrope use
* Heart transplant listed, or status post transplant
* Ventricular assist devise present, or awaiting placement
* Not being discharged to home
* Unable to provide consent or comply with the intervention
* Current enrollment in a remote monitoring/ telehealth program