cyrilzakka/clinical-trials huggingface dataset:
BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients

T-cell acute lymphoblastic leukemia (T-ALL), a hematological malignant neoplasm of immature T cells, accounting for a morbidity of 10-15% among pediatric and 20-25% among adult patients of ALL. Despite the application of improved intensive therapies, the overall survival (OS) of T-ALL patients is still unsatisfactory, with a 5-year OS rate of less than 60% in adults and 85% in children. Over the past few decades, allogeneic hematopoietic stem-cell transplantation (allo-HSCT) has emerged as a potential and the most likely curative treatment for patients with high-risk hematological malignant neoplasms, and it has been proven that allo-HSCT could hold the potential to improve the prognosis of T-ALL patients and may even cure T-ALL.

The two most common myeloablative conditioning regimens for T-ALL patients with allo-HSCT were total body irradiation (TBI) plus cyclophosphamide (TBI-Cy) and busulfan (Bu) plus cyclophosphamide (BuCy). The most common use conditioning regimen for ALL patients is the TBI-Cy conditioning regimen over other hematological malignancy patients because TBI possess potent and distinct anti-leukemic effects, particularly in organs not easily affected by systemic chemotherapy and intense immunosuppressive effects. However, TBI-based conditioning regimens may cause a high risk of cataracts, interstitial pneumonitis (IP), engraftment failure and even subsequent malignant neoplasms (SMNs). To avoid these disadvantages, intravenous Bu replaced TBI as a part of conditioning.

Extensive studies have shown that allo-HSCT with conditioning regimens based on TBI could benefit survival compared with conditioning regimens based on chemotheraphy in treating ALL. We retrospectively analyzed post-10-year data from T-ALL patients from two transplant centers, and all the databases were used to eliminate confounding factors via PSM. We demonstrated that the TBI-Cy conditioning regimen had inferior efficacy to the BuCy conditioning regimen, especially for T-ALL patients who were children, refractory, had extramedullary disease before transplantation, had active disease or an MRD-positive status at allo-HSCT, or who received haplo-HSCT.


Eligibility Criteria:
Inclusion Criteria:

1. T-ALL patients aged \> 2 years and ≤55 years;
2. For the first time accept allo-HSCT;
3. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; 4. Signing an informed consent form, having the ability to comply with study and follow-up procedures.

Exclusion Criteria:

1. With other malignancies;
2. With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy;
3. With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation;
4. With severe organ dysfunction;
5. In pregnancy or lactation period;
6. With any conditions not suitable for the trial (investigators' decision).
Hepatorenal Dysfunctions Among Workers Exposed To Petroleum Products

The aim of this study is to assess the liver and renal functions of individuals who are occupationally exposed to petroleum products.

Certain peoples have a greater risk of exposure to gasoline vapors; these include filling-station workers, service station attendants, drivers of gasoline trucks and refinery workers.Benzene is metabolized in the liver by cytochrome P450 (CYP) 2E1 to benzene oxide. The metabolites undergo further metabolism through oxidation, dehydrogenation or conjugation with sulfate or glucuronic acid . Activation of benzene and its reactive metabolites leads to continuous production of reactive oxygen species (ROS), which leads to lipid peroxidation and damages DNA, RNA, leading to genetic modification and alterations in the functions of important enzymes (i.e. liver) and proteins .

Volatile organic compounds such as gasoline and other fuels are associated with a wide variety of deleterious health effects including liver and kidney diseases. A comparative cross sectional study was conducted from January 2018 to April 2018 at Mekelle city, Tigray region, Northern Ethiopia among gasoline station workers and reporting that the mean level of ALT, AST, Urea, creatinine, and uric acid was significantly higher among gasoline stations workers when compared to control study participants and there was also a significant increase in ALT, AST, Urea, creatinine and uric acid among gasoline stations with increase duration of exposure .

Eligibility Criteria:
Inclusion Criteria:

for exposed group:

* Apparently health workers who exposed for petroleum products in The Petroleum Pipelines Company in assiut will be included in the study

Exclusion Criteria:

for exposed and Comparison groups

* history of hepatic and renal health problem
* history of taking medications affecting liver and renal function tests
Non-invasive Estimation of Pulmonary Artery Pressure in Healthy Subjects by Electrical Impedance Tomography

Pulmonary hypertension (PH) is a condition characterized by a sustained elevation in pulmonary artery pressure (PAP) above 25 mmHg assessed by right heart catheterization. PH is fatal in absence of adequate treatment or therapy, as the condition progressively increases the workload of the right heart and ultimately leads to its failure. With a minimal indicative prevalence of 1 case/300, PH affects at least 25'000 people in Switzerland alone. After initiation of PH therapy, the follow-up of the patient's health status is often limited to punctual PAP measurements at the clinic at intervals of several months. The lack of more frequent measurements of the patient's PAP strongly hinders the identification of short-term trends in pulmonary hemodynamics, and therefore the anticipation of worsening conditions or treatment inefficiency. As possible solutions, wireless implantable hemodynamic monitors such as the CardioMEMSTM HF System (CardioMEMS Inc., Atlanta, USA) have recently been introduced for the continuous monitoring of PAP in patients with PH. The benefits of frequent measurements over intermittent clinic visits have been demonstrated in several previous studies, notably in terms of prediction of therapy outcomes, anticipation of worsening heart failure, feedback rapidity during therapy, or decline in hospitalization rates. Nevertheless, despite the undeniable advantages that implantable monitors offer to the patient, they remain highly invasive solutions. In contrast, noninvasive alternatives for the measurement of PAP exist, such as transthoracic echocardiography, but are impractical for frequent PAP assessments due to their dependency on qualified personnel to perform the measurement. An optimal PAP monitoring modality for patients with PH should be non-invasive (free of any risks or complications associated with cardiac catheterization) and unsupervised (able to operate without supervision of a medical doctor). Such a modality does not currently exist. In the present study, the investigators propose and investigate the potential of a novel non-invasive, continuous and unsupervised PAP monitoring approach based on the pulse wave velocity (PWV) principle and the use of electrical impedance tomography (EIT).


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects ≥ 18 years old, BMI \< 30 kg/m2
* Good understanding of written and oral German
* Willing to provide a signed informed consent

Exclusion Criteria:

* Pace-maker/ ICD
* Chronic heart diseases
* Chronic pulmonary diseases
* Congenital heart/pulmonary diseases
* Instable angina pectoris
* Active alcohol or drug abuse
* Pregnancy or lactation (women of childbearing age will be asked to performed urinary pregnancy test before the screening phase)
Autonomic Nervous Activity in Women With Gestational Diabetes

Through complex hormonal pathways, insulin resistance can lead to the activation of the sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients, mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant and non-pregnant women. Studies assessing heart-rate variability and plasma noradrenalin concentrations also suggest increased sympathetic activity in PE. It has been hypothesized that sympathetic over-activity is a precursor of PE, normally compensated for by vasodilating mechanisms, but resulting in PE when the mechanisms fail. In addition to sympathetic activity, various markers of inflamma-tion are also associated with reduced insulin sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin resistance syndrome. The role of sympathetic over-activity and inflammatory markers in gestational diabetes has not been investigated


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gestational diabetes (OGTT) with or without BP \> 140/90.
* Pregnant control with normal OGTT-

Exclusion Criteria:

* Smoking
* Uncontrolled hypertension
* Diabetes
* Medication affecting sympathetic activity
Natural History Study of Patients With MPS IIIA

Evaluate the clinical progression in patients with MPS IIIA who are untreated with any investigational product and to obtain standardized assessments: neurocognitive, behavioral, sleep-wake habits and effect of MPS IIIA on the quality of life of patients and their families.

This is a multicenter, multinational, longitudinal, observational study in children aged up to and including 9 years, who have been diagnosed with MPS IIIA. The study will detail the natural course of MPS IIIA via standardized clinical, biochemical, neurocognitive, developmental, behavioral and imaging measures. This information is anticipated to inform the design and interpretation of future interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* Documented MPS IIIA diagnosis
* Children up to and including 9 years of age
* The patient is sufficiently able, in the opinion of the Investigator, to adhere to the study visit schedule and other protocol requirements
* The patient's parent(s) or legal guardian(s) has signed written informed consent, according to the local regulations and after all relevant aspects of the -study have been explained and discussed

Exclusion Criteria:

* The patient is participating in a clinical trial of any potential disease-modifying investigational medicinal product or taking high dose (\>100 mg/kg/day) synthetic genistein (patients on low dose or naturally derived genistein can be included in this study).
* The patient has received a hematopoietic stem cell or bone marrow transplant or gene therapy.
* The patient has received enzyme replacement therapy in the last 6 months.
* Homozygous or compound heterozygous for the S298P mutation or the investigator and/or trial steering committee considers the patient not to have the classical severe form of MPS IIIA.
* Individuals with rare and unrelated serious comorbidities e.g. Down syndrome, intraventricular hemorrhage in the new-born period, or extreme low birth weight (\<1500 grams).
* Visual or hearing impairment sufficient, in the clinical judgment of the investigator, to preclude cooperation with neurodevelopmental testing. Use of hearing aids is permitted.
The Genomic Medicine at VA Study

This trial will determine the clinical effectiveness of polygenic risk score testing among patients at high genetic risk for at least one of six diseases (coronary artery disease, atrial fibrillation, type 2 diabetes mellitus, colorectal cancer, breast cancer, or prostate cancer), measured by time-to-diagnosis of prevalent or incident disease over 24 months.

One of the most pressing controversies in genomics today is the clinical utility of polygenic risk scores (PRS). Broadening the scope of genomic risk testing beyond monogenic diseases, PRS combine information from hundreds or even millions of genetic loci, each with a very small effect size on the risk of common complex disease. The result is a continuous quantitative risk factor for susceptibility to conditions such as coronary artery disease (CAD), type 2 diabetes (T2D), and breast cancer. Compared to rarer monogenic disease variants, PRS have greater transformative potential for public health and healthcare in their ability to identify much larger proportions of the population at significantly elevated risk for disease, facilitating evidence-based prevention and management. Moreover, their prediction ability has vastly improved compared to earlier PRS that included only a limited number of genetic variants. However, while the associations between PRS and a wide range of common diseases are well established (clinical validity), the potential impact of this information on patient health outcomes (clinical utility) remains contested and understudied.

This study will examine the effectiveness and implementation outcomes from the use of PRS for 6 common diseases that are screened for by PCPs and have established prevention strategies: CAD, AFib, T2D, colorectal cancer, prostate cancer, and breast cancer. This trial has two aims:

Aim 1: Conduct a randomized controlled trial (RCT) to determine the clinical effectiveness of PRS among patients at high genetic risk for at least one disease, measured by changes in clinical management (process outcomes) and time to diagnosis of prevalent or incident disease (clinical outcome) over 24 months.

Aim 2: Measure high-priority genomic medicine implementation outcomes, including primary care provider (PCP) knowledge and beliefs about PRS, patient activation in healthcare, medication adherence, and costs.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-70 years at enrollment
* No known diagnosis of the following conditions, initially screened by the International Classification of Disease (ICD) codes or other electronic health record (EHR) data using validated methods and then confirmed with potential patient-participants during recruitment: coronary artery disease, atrial fibrillation, type 2 diabetes, colorectal cancer, breast cancer, prostate cancer

Exclusion Criteria:

* Patients will be ineligible if they:

  * Have a known diagnosis of at least one of the six diseases of interest
  * Are younger than age 50 or older than age 70
  * Are pregnant
  * Are incarcerated or institutionalized
First-in-Human Single Ascending and Multiple Dose of GLPG0259

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study

This study is a single-center, retrospective, cross-sectional study. It plan to investigate the predictors for asthma exacerbation in long term follow up real world management with analyzing big data of electronic medical records (EMR).

The long-term goals of asthma treatment are to achieve well control of symptoms and to minimize the future risk of asthma exacerbations (AEs). Asthma is a heterogeneous disease with various responses to treatment and clinical outcomes. AEs are a prominent feature of severe asthmatics; however, frequent AEs have also been reported in mild asthmatics.

This is a prospectively designed observational study to identify predictors for patients with frequent AEs among adult asthmatics by analyzing medical big data of electronic medical records (EMR), which will provide an insight in the long-term management of adult asthmatics in real-world practice.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥17 years
* Patients having bronchial asthma with J45-J46 code of International classification of Diseases (10th edition on EMR)
* Asthmatics who had been treated by allergy or respiratory specialists

Exclusion Criteria:

* Patients who has less than one year for asthma treatment
A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

The purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and 256mg daily) with placebo in long-term treatment of obesity.

Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study assesses long-term effectiveness and safety of topiramate in patients with obesity. After completing 6 weeks of run-in phase (a single-blind placebo-treatment phase during which patients begin non-pharmacological therapy), patients will be randomized to receive either topiramate or placebo. Topiramate group will receive 16mg of topiramate and the dose will be titrated over 8 weeks. Patients will then receive two years of treatment. Effectiveness will be evaluated by body weight, Body Mass Index (BMI), anthropometric measurements (waist circumference, hip circumference, waist/hip ratio), fasting lipid profile, fasting plasma glucose, HbA1c, fasting uric acid, fasting insulin, blood pressures, body fat compositions, mass of left ventricle of the heart (as measured by echocardiography), and Health Related Quality of Life scores. Safety evaluation (incidence of adverse events, laboratory tests, electrocardiogram, vital signs) will be performed throughout the study. The study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients. During the initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target dose (either 96mg, 192mg, or 256mg daily by mouth) and the doses will be maintained for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \>= 30 and \< 50
* BMI \>= 27 and \< 50 if patient has controlled hypertension or abnormal blood lipids
* Stable weight
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Known contraindication, or hypersensitivity to topiramate
* A diagnosis of diabetes (except those diagnosed during the enrollment if no medications are needed)
* History or evidence of clinically significant liver, disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels
* History of obesity with known cause
* History of weight loss surgery or liposuction
* History of malignancy within last 5 years
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas.

OBJECTIVES: I. Evaluate tumor response to a trimetrexate, fluorouracil and leucovorin regimen in patients with advanced pancreatic carcinoma. II. Evaluate the toxicities associated with this regimen in patients with metastatic carcinoma of the pancreas.

OUTLINE: The treatment plan consists of an IV infusion of trimetrexate, followed 24 hours later by IV infusions of leucovorin and fluorouracil. After another 24 hours oral leucovorin will be given every 6 hours for 7 doses. A treatment cycle consists of the regimen repeated weekly for 6 weeks followed by 2 weeks of rest. Treatment cycles will be repeated until disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 3 or more complete or partial responses are observed in the first 22 patients, an additional 11 patients may be accrued for a maximum of 33.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced pancreatic cancer with metastatic disease Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT, SGPT and alkaline phosphatase less than 3 times upper limit of normal Serum albumin at least 3.0 g/dL Renal: Serum creatinine no greater than 1.5 mg/dL Other: Not eligible for higher priority protocol No prior malignancy within 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective birth control No underlying medical condition precluding treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy No prior radiotherapy to only site(s) of measurable disease Fully recovered from therapy Surgery: Fully recovered from prior surgery
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, no gender and race limited;
2. Estimated life expectancy \> 12 weeks deemed by investigator；
3. CD19 were positive by histopathology and/or cytology diagnosis；
4. Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
5. Relevant indicators for disease or assessment within 4 weeks after the last treatment;
6. Quality of Life Score (KPS) \>50%；
7. Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST \<3 upper limit of normal (ULN); bilirubin\<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
8. No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
9. Unsuitable conditions for stem cell transplantation;
10. Signed informed consent form (ICF).

Exclusion Criteria:

1. Women in pregnancy or lactation;
2. In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
3. The absolute count of nonprimary neutrophil \< 0.75×10\^9/L or platelet count \< 50×10\^9/L;
4. Abnormal vital signs and failure to cooperate with examination;
5. Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
6. Highly allergic constitution or history of severe allergy;
7. Patients with systemic infection or severe local infection requiring anti-infection treatment;
8. Patients with severe autoimmune diseases;
9. Presence of any other conditions that are unsuitable for this study as judged by the investigator.