cyrilzakka/clinical-trials huggingface dataset:
New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

This study is to investigate the therapeutic efficacy and side effect of chidamide, azacitidine combined with priming HAG regimen for relapsed or refractroy acute myeloid leukemia


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 and ≤ 70 years
* Patients diagnosed with AML according to 2016 WHO myeloid malignant disease diagnosis standard (Non-APL)
* Patients with AML must meet one of the following criteria, A or B:

A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) \< 50% and \> 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.

* ECOG performance status score less than 3
* Expected survival time ˃ 3 months
* Patients without serious heart, lung, liver, or kidney disease
* Ability to understand and voluntarily provide informed consent

Exclusion Criteria:

* Patients who are allergic to the study drug or drugs with similar chemical structures
* Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
* Active infection
* Active bleeding
* Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
* Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met
* Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value)
* Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment
* Surgery on the main organs within the past six weeks
* Drug abuse or long-term alcohol abuse that would affect the evaluation results
* Patients who have received organ transplants (excepting bone marrow transplantation)
* Patients not suitable for the study according to the investigator's assessment
The Molecular Biology of Paroxysmal Nocturnal Hemoglobinuria (PNH)

This study is designed to better understand the molecular biology of paroxysmal nocturnal hemoglobinuria (PNH) and to determine if prion protein (PrP) functions in long term hematopoietic stem cell renewal.

Paroxysmal nocturnal hemoglobinuria (PNH) is characterized by hemolytic anemia, thrombosis, and variable cytopenia. It can be associated with significant morbidity including acute kidney failure, cerebral infarction, mesenteric infarction, Budd-Chiari syndrome, aplastic anemia, and leukemic transformation. The average survival time from diagnosis is 15 years.

PNH is an acquired clonal disorder of the hematopoietic stem cell. Two distinct populations of hematopoietic cells exist in each PNH patient: one non-clonal population of normal cells, and one clonal population of PNH cells. The clonal population of PNH cells is identified by a mutation in the PIG-A gene that results in absence of the glycophosphatidylinositol (GPI) anchor of several surface proteins. Consequently, these surface proteins are unable to perform their functions on the cell surface. Deficiency of two of these surface proteins, CD55 (decay accelerating factor) and CD59 (membrane inhibitor of reactive lysis) that prevent complement mediated destruction, have been shown to underlie the clinical presentation of PNH. Identifying the mutation causing the predominant clones may help us better understand the molecular biology of PNH. When this is accomplished, new therapies to control and eventually cure the disease can be designed.

In addition, we propose to determine the function of PrP in human hematopoietic stem cells. PrP is a glycoprotein attached to the cell membrane by a glycosylphosphatidylinositol (GPI) anchor. In PNH, a disorder whose pathogenesis lies in the absence of GPI anchors, PrP expression is reduced in monocytes and granulocytes from the PNH clone.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects suspected of or diagnosed with Paroxysmal Nocturnal Hemoglobinuria (PNH)
2. Age \> 7

Exclusion Criteria:

1. Those not meeting the inclusion criteria
Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer

Gastric cancer patients underwent total gastrectomy with curative intent between in a single center were included in this retrospective study. Patients divided to two groups as open and laparoscopic groups and compared in terms of demographic data, tumor characteristics, operative data and textbook outcome

Gastric cancer patients underwent total gastrectomy with curative intent between July 2018 and January 2024 in a single center were included in this retrospective observational study. Enrolled patients divided to two groups as open total gastrectomy (open group) and laparoscopic total gastrectomy (lap group).

Data of patients obtained via the hospital software system. Demographic data, body mass index(BMI), Charlson comorbidity index (CCI) score and baseline characteristics, operative and postoperative results, tumor characteristics and textbook outcome results were investigated. Postoperative complications were pancreatic fistula, pleural effusion, pneumonia, anastomotic leak, intraabdominal abscess, surgical site infection, postoperative ileus.

All patients were already curative surgery patients and underwent total gastrectomy and D2 lymphadenectomy. Apart from this, the list of criteria for a patient who had a textbook outcome was as follows: no intraoperative complication, achievement of tumor-negative margins, including ≥15 harvested lymph nodes in resected specimen, no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), no reintervention, no readmission to intensive care unit after once coming to the surgical ward, no prolonged hospital stay (≤21 days), no postoperative mortality (30 days) and no readmission after discharge from the hospital

Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer patients underwent total gastrectomy with curative intent

Exclusion Criteria:

* Emergency surgery,
* Recurrent disease
* Metastatic disease,
* Conversion to open surgery,
* Robotic gastrectomy.
Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder

The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for binge eating disorder.

This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) 18-week web-based intervention; and (4) a post-intervention assessment (18-weeks after baseline).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Meeting DSM-5 criteria for Binge Eating Disorder (BED)
* English-speaking

Exclusion Criteria:

* BMI \&lt; 18.5
* Requiring immediate treatment for medical complications
* Current anorexia or bulimia nervosa or purging behaviors within the past year
* Already receiving treatment for an ED or participating in a weight loss program or psychotherapy focused on weight (psychotherapy for other conditions was allowed)
* Currently pregnant or breast-feeding
* Experiencing other severe psychopathology or medical illness that would limit the participants' ability to comply with the demands of the current study (e.g. active psychotic disorder, cancer)
To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia

Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/- doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28 days for vivax malaria.

The study hypothesis was that current recommended antimalarial protocols were no longer effective.


Eligibility Criteria:
Inclusion Criteria:

-Male and female patients at least one 1year of age and weighing more than 10kg.

* -Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
* -Fever (axillary temperature \>37.5oC) or history of fever in the last 48 hours.
* -Able to participate in the trial and comply with the clinical trial protocol
* -Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent

Exclusion Criteria:

* Pregnancy or lactation

  * -Inability to tolerate oral treatment
  * -Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment
  * -Known hypersensitivity or allergy to artemisinin derivatives
  * -Serious underlying disease (cardiac, renal or hepatic)
  * -Parasitaemia \>4%
IMRT Lower Limb Soft Tissue Sarcoma

Intensity-modulated radiation therapy may make wound healing problems less likely by 1)precisely shaping the region of high radiation dose to the shape of the tissue which harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the shapes of the normal tissues which are more sensitive to radiation effects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven soft tissue sarcoma
* Lesion lies between the iliac crest (hipbone) and the ankle
* Lesion is newly diagnosed
* Assessed by radiation oncologist and surgical oncologist

Exclusion Criteria:

* Benign histologies
* Histologies generally treated with chemotherapy
* Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix
Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis

The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis

The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.

Eligibility Criteria:
1. Inclusion Criteria:

   1. Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks.
   2. Radiological findings:

      * Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation.
      * presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions.
   3. Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species.
2. The diagnosis of CCPA will be made if

   1. Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria.
   2. FNAC from the cavity wall will be considered in atypical cases
3. Exclusion Criteria:

   1. Invasive aspergillosis
   2. Allergic broncho-pulmonary aspergillosis (ABPA)
   3. Active tuberculosis or malignancy
   4. Pregnant females
Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)

Multiple center, open-label, PK study

Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in hospitalized infants with suspected systemic infection or receiving one of the study drugs per local standard of care. Number of participants are 16-32 evaluable per each study drug of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient intravascular access
* Suspected systemic infection or receiving 1 of the study drugs per standard of care
* informed consent from legal guardian

Exclusion Criteria:

* history of allergic reaction to study drugs
* urine output \<0.5 mL/hr/kg over the prior 24 hours
* serum creatinine \>1.7 mg/dl
* Any condition in investigator judgment precludes participation because it could affect participant safety
Optimizing the Diagnosis of Heparin Induced Thrombocytopenia

Multicentre (Ottawa and Halifax) prospective cohort study using a diagnostic approach in patients clinically suspected to have HIT that combines pretest probability assessment with quantitative interpretation of anti-PF4 assay.

The proposed is a prospective cohort study exploring a novel diagnostic approach to Heparin Induced Thrombocytopenia (HIT) using a combination of pretest probability assessment and quantitative interpretation of the anti-platelet factor 4 Immunological assay (anti-PF4). Patient with a clinical suspicion of HIT will follow the study diagnostic algorithm (Figure 1). The study algorithm will be considered a safe approach to move forward into a larger RCT if the upper limit of the 95% confidence interval for 'false negative management failures' is ≤ 4% based on a Serotonin Release Assay (SRA) gold standard. The main objective of the pilot study is to inform feasibility and recruitment barriers for a larger randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient with clinical suspicion of HIT by treating physician

Exclusion Criteria:

1. Less than 18 years of age;
2. Prior diagnosis of HIT ever;
3. Patient enrolled within preceding 100 days;
4. Functional/ confirmatory platelet activation results available at the time of enrollment;
5. Requiring cardio-pulmonary bypass or percutaneous cardiac angioplasty or any other cardiac or vascular surgery/procedure requiring intra-operative/procedural heparin administration planned within 30 days;
6. Unable to complete study follow up;
7. Unable to obtain consent (or proxy consent from substitute decision maker where applicable);
8. Life expectancy less than 30 days;
9. Greater than 72 hours from clinical suspicion of HIT and/or request for HIT anti-PF4 ELISA testing.
Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy

Assessing parental aesthetic acceptability of Silver Diamine Fluoride (SDF) staining is crucial for its potential implementation in paediatric dentistry. This study represents the third part of a wider project initially focused on evaluating SDF aesthetic acceptability in Italy, then comparing it between Spanish and Italian parents

The aim of the present study was to compare aesthetic perceptions and acceptance of SDF pigmentation between Spanish and Italian parents, and assess weather acceptability is influenced by location, child's cooperation, or demographic background. A cross-sectional comparative study was conducted among 267 Spanish parents and 234 Italian parents whose children were attending three university dental clinics. A validated Italian version of the questionnaire "Parental perceptions of Silver Diamine Fluoride Dental Color Changes" was implemented. The questionnaire included sets of colored photographs showing both anterior and posterior teeth before and after SD treatment. Respondents were requested to provide their assessments based on the presented visual stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Spanish and Italian parents, for each group respectively
* Parents of healthy children or children with mild systemic disease. American Society of Anesthesiologists (ASA) status 1-2
* Parents of children under the age of 12 years
* Parents of children with previous caries experience in primary teeth
* Parents who consented to participate

Exclusion Criteria:

* No Spanish and Italian parents, for each group respectively
* Parents of children with ASA status ≥ 3
* Parents of children over the age of 12 years
* Parents of children without previous caries experience in primary teeth
* Parents who no consented to participate
Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke

Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). SEMG and fMRI examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;
2. Age 35 to 75 years old;
3. Course of disease 0.5 to 3 months with stable vital signs;
4. No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;
5. Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point;
6. Agree to sign the informed consent;
7. Unilateral neglect.

Exclusion Criteria:

1. Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;
2. Contraindication to undergo a 3T MR imaging;
3. Claustrophobia;
4. Have severe heart, hepatic or renal failure;
5. Don' t cooperate with the treatment;
6. Have participated in other clinical trails recently.
Education Program for Caregivers of Children With Gross Motor Delays

The main objective of this project is to determine whether an educational intervention delivered via social media can improve parent understanding of child development and progression in child's developmental goals. A secondary objective is to determine whether this intervention can improve parent-related outcomes, such as well-being, parent-child bonding, attitudes toward parenting, satisfaction with the educational program.

Gross motor delays in childhood are common, though they vary in severity and outcome. Early detection and intervention are critical to promote best neurodevelopmental outcomes for these children; equally important is support for parents and/or caregivers of children with identified motor delays. Parent education programs for caregivers of children with gross motor delays have been shown to improve parent knowledge of motor development and decrease parental stress when offered in conjunction with physical therapy treatment, however, there is a lack of peer-reviewed evidence demonstrating the efficacy of educational interventions provided over a social media platform for the population targeted in this study.

Caregivers of children with gross motor delays will be randomized to receive an educational intervention delivered via social media over a 9 week period, or to receive the intervention after a 9 week waiting period.

Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian of child under 3 years with an identified motor delay
* Access to device with high-speed internet to access Facebook
* English speaking
* Resides in the continental United States

Exclusion Criteria:

* Non-English-speaking
FibroScan-Reproducibility and Repeatability Study

Chronic liver disease (CLD) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis. Early detection is crucial to help prevent these outcomes. Liver stiffness measurement (LSM) can detect fibrosis (scarring) in the liver, a common issue in CLD patients while traditional methods like liver biopsy are invasive and not ideal for regular screening and monitoring.

FibroScan, a non-invasive device, measures the liver stiffness and fat content in the liver. This study will assess how reliable and consistent FibroScan results are when used by different operators and across different days, focusing on patients with liver conditions like metabolic-related liver disease (MASLD), alcohol-related liver disease (ALD), and hepatitis B. This research also aims to test both the standard and Guided VCTE (Vibration Controlled Transient Elastography) FibroScan generations to evaluate their reproducibility and repeatability. As secondary objectives the Control Attenuation Parameter (CAP) results, and the FAST, Agile 3+, and Agile 4 scores will be evaluated to compare their reproducibility and repeatability.

Adult participants will attend two visits within three days. During these visits, they will undergo multiple FibroScan scans that include five scans on Day 1 (visit 1) and four scans on the follow up visit (visit 2), one blood sample for liver health assessment on each visit, and an AUDIT questionnaire on Day 1 (visit 1). Some participants may undergo only two scans on the follow-up visit since this will depend on operator availability. Each session will last 25-45 minutes including all examination types.

The study is funded by Echosens, the manufacturer of FibroScan, and will be conducted at UK healthcare facilities in England. By evaluating the variability of FibroScan results, this research could lead to a better understanding of the device's reproducibility and reliability in measuring liver stiffness across different operators and time points, potentially enhancing clinical confidence in its use for managing chronic liver diseases.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 y.o) with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD), Metabolic and Alcohol-related Liver Disease (MetALD), and Alcohol-related Liver Disease (ALD).
* Adult patients able to give written informed consent.

Exclusion Criteria:

* Vulnerable patients
* Patients with other chronic liver disease including but not limited to hepatitis B, hepatitis C, autoimmune hepatitis, cholestatic diseases
* Patients with ascites
* Patients with elevated conjugated bilirubin (\>1.5 ULN)
* Patients with heart failure