cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies

The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).

The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.
* Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.
* Patients with relapsed/refractory CMML.
* Estimated glomerular filtration rate (eGFR) \> 40 mL per 1.73 m\^2
* Patients must have adequate coagulation (international normalized ratio \[INR\] ≤ 1.5; activated partial thromboplastin time \[aPTT\] ≤1.5 X the upper limit of normal \[ULN\]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)
* Adequate liver function (total bilirubin ≤1.5 X ULN (or ≤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\] ≤3 X ULN (or ≤5 X ULN for patients with liver involvement of their myeloid disease)

Exclusion Criteria:

* Patients eligible for hematopoietic stem cell transplantation
* Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia
* Human immunodeficiency virus (HIV) infection
* Chronic or active hepatitis B or C if not controlled by antiviral therapy
* History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug
* Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted
* Left ventricular ejection fraction (LVEF) \<40%
Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.

Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm, representing 15% of all pediatric fractures. Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group. Treatment of pediatric fractures dramatically changed in 1982. The goals are to stabilize the fracture, control limb length, alignment, rotation, instability, promote bone healing, and minimize the morbidity and complications for the child and his/her family. Titanium elastic nails (TENs) fixation was originally meant as an ideal treatment method for femoral shaft fractures, but was gradually applied to other long bones diaphysial fractures in children, as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications.

Over the past 20 years, pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications. Each method has had its own complications: cast immobilization alone or following traction had resulted in limb-length discrepancy, angulations, rotational deformity, psychological and economic complications. External fixation had resulted in pin-tract infection, loss of knee range of motion, delayed union, non-union, and refracture after fixator removal. TENs work by balancing the forces between the two opposing flexible implants. To achieve this balance, the nail diameter should be 40% of the narrowest canal diameter or more. The nails should assume a double-C construct. They should have similar smooth curve and same level entry points.

Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively, especially for comminuted, spiral, and long oblique fractures.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria included children are patients presented with traumatic proximal shaft tibia fracture closed or open up to Gustillo grade II and patients between 4 and 12.

Exclusion Criteria:

* Exclusion criteria excluded children presented with Gustillo grade III A, B \& C open fractures and pathological fractures.
Hydroxychloroquine and Unexplained Recurrent Miscarriage

Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.


Eligibility Criteria:
Inclusion criteria

1. Women aged between 20- 40 years inclusive. 2. Body Mass Index (BMI) between 18.5 -35 Kg/m2 3. Had at least 2 previous miscarriage before 20 weeks 4. Women willing to conceive. 5. Regular Ovulatory cycles. 6. No anatomical or endocrine cause of recurrent pregnancy loss. 7. Women who have given their informed consent. 8. Negative antibody test for antiphospholipid syndrome (Lupus anticoagulant, Anticardiolipin IgM, IgG, B2glycoprotein) Exclusion criteria

1. Women who are already pregnant.
2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism .
3. Patient already using HCQ
4. Patient not get pregnant after 12 months of HCQ use.
Signature for Precise Chemosensitivity Prediction in PDAC

Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status score of 0-1 before resection
* complete clinicopathologic and follow-up data
* availability of formalin-fixed paraffin-embedded (FFPE) specimens of resected primary tumor and hematoxylin and eosin slides with invasive tumor components

Exclusion Criteria:

* any previous history of cancer
* any anticancer therapy prior to resection or adjuvant radiotherapy
* metastatic cases
* major postsurgical complications with Clavien-Dindo Grade ≥2
Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)

This is a prospective, multi-center study to capture information on sensitivity and specificity of CADence using coronary angiogram as the gold standard, on subjects who are already scheduled for coronary angiography.

CADence is an ECG and acoustic tool to assess coronary artery disease. This study's goal is to collect patient CADence information and compare it to the results of angiogram to determine performance: sensitivity and specificity. The CADence is not used to direct patient care. This is observational only.

Eligibility Criteria:
Inclusion Criteria:

* Age \>40 years
* Clinical indication for coronary angiogram
* Willing and able to give informed consent

Exclusion Criteria:

* Body Mass Index (BMI) \<18.5 or \>40
* Prior bypass surgery or coronary stenting
* Presence of pacemaker/defibrillator
* Presence of artificial valve
* Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta
* Presence of murmurs, including valve lesions, ventricular septal defects and arteriovenous fistulae
* Presence of moderate-severe valve disease
* Left Ventricular Assist Device (LVAD)
* Presence of scars on the site thorax areas
* Participation in trial within 30 days prior to collecting CADence data except participation in registry studies.
* Asthma or chronic obstructive pulmonary disease (COPD) with active wheezing
* Inability to lie in supine position
* Heart Transplant
Is a Single Daily Session Combining HS + Physio Sufficient to Obtain Long-term Clinical Benefits in Bronchiectasis?

The present study will aim to find out whether a home treatment in people with bronchiectasis consisting of a single daily session to facilitate expectoration (combining nebulization of hypertonic saline (HS) at 6% followed by airway clearance techniques) is at least as effective as performing two sessions per day following the same process in each of the sessions, during a period of 6 months.

A non-inferiority randomised clinical trial (single-blind) will be conducted. At least 50 participants will be recruited from the outpatient clinics of the Hospital Clinic in Barcelona and the Clinical University Hospital in Zaragoza. The experimental group will nebulize once/day the hypertonic saline (HS) solution followed by airway clearance exercises (15 min) for 6 months. The control group will follow the same procedure, but the frequency of the sessions will be twice a day (reference as usual clinical practice). The main study outcomes will be: (1) cough severity (primary endpoint), symptoms and quality of life; (2) functional exercise capacity; (3) time to first exacerbation and total number of exacerbations; (4) indirect measures of mucociliary transport (rheology and concentration of solids in sputum samples); (5) inflammatory parameters; (5) tolerance, safety and adherence to treatment. Measurements will be taken at baseline (prior to randomization), at 1 month, 3 months, and 6 months. Finally, hypothesis testing will be performed using a linear mixed model (2x3) of repeated measures, establishing a priori a margin of non-inferiority.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. a total score less than 16 on the Leicester Cough Questionnaire
3. chronic daily expectoration over at least 3 months
4. being in a period of clinical stability during the previous 4 weeks
5. presenting a forced expiratory volume in 1 second (FEV1) value greater than 40% of predicted or \>1 L
6. obtaining informed consent.

In addition, all participants will have had to satisfactorily pass the tolerability tests, which will be performed twice: i) on the first day; ii) and the following week.

Exclusion Criteria:

1. having received nebulised mucoactive treatment during the previous year
2. frequent haemoptysis (≥ 2 times/month)
3. diagnosis or suspicion of cystic fibrosis by genetic study or sweat test
4. being under active treatment for nontuberculous mycobacteria (NTM)
Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension

This study is to describe the long-term antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome in China.

This study is to describe the long-term (3 to 5 years after the acute coronary syndrome index event) antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome (i.e. ST-segment Elevation Myocardial Infarction, Non-ST-segment Elevation Myocardial Infarction, Unstable Angina) in China.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been provided.
2. Contact Order Form has been provided
3. Aged 18 years or older.
4. Enrolled in EPICOR Asia study and completed the 2 year follow-up.

Exclusion Criteria:

1. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances, alcohol or drug abuse).
2. Already included in the EPICOR Asia-China Extension observational study.
3. Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
4. Current participation in an interventional clinical trial.
5. Patients receiving ticagrelor beyond 12 months and other off label use.
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* English speaking
* female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion
* Gestational age \</= 70 days confirmed via ultrasound
* Access to a time keeping device
* Willingness to complete a telephone or in-clinic follow up

Exclusion Criteria:

* chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage
* Failed medical abortion resulting in surgical management
* Known intrauterine infection
* Known allergy to ondansetron or ibuprofen
* Subjects chronically receiving analgesic drugs
* Subjects unable to give consent
* Subjects taking medications that interact with ondansetron or ibuprofen
High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery Stenting

The purpose is to test whether a short-term, high-dose atorvastatin treatment (80mg once a daily (QD) from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS) is superior to conventional-dose atorvastatin treatment (20 mg QD from 3 days before to 30 days after CAS), in terms of efficacy for prevention of periprocedural ischemic brain damage in Chinese patients undergoing CAS.

Chinese patients with carotid stenosis scheduled for selective CAS will be randomized into two groups. The High-dose Atorvastatin group will receive Atorvastatin 80 mg QD from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS, while the Conventional-dose Atorvastatin group will receive Atorvastatin 20 mg QD from 3 days before to 30 days after CAS. All patients will receive cerebral diffusion-weighted (DW)-MRI within 7 days before CAS. Then, they will also receive repeated DW-MRI within 5 days after CAS. Efficacy for prevention of periprocedural ischemic brain damage of the two different Atorvastatin treatments will be compared, in terms of periprocedural incidence of transient ischemic attack (TIA)/ ischaemic stroke or new ischemic lesions on cerebral DW-MRI.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 50% stenosis of internal carotid artery in symptomatic patients; or ≥ 70% stenosis of internal carotid artery in asymptomatic patients
* received statin therapy for ≥ 2weeks before inclusion

Exclusion Criteria:

* nonatherosclerotic carotid disease (dissection, radiation-induced stenosis)
* received endovascular procedure within 30 days before inclusion
* CAS during the procedure of urgent endovascular therapy for acute ischaemic stroke
* need for oral anticoagulant therapy
* high risk of bleeding or contraindications to antiplatelet therapy (eg: platelet count \<70 X 109/L)
* active hepatic disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 upper normal limit
* myopathy or increased creatine kinase (CK) \> 2 upper normal limit
* renal failure with serum creatinine (Scr) \> 3 mg/dl or 264μmol/L
* unable to undergo MRI because of claustrophobia or pacemaker
* pregnancy, lactation, or child bearing potential women without any effective contraception
The SOLACE-AU Clinical Trial

The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial \[NCT01314313\].

Eligibility Criteria:
Inclusion Criteria:

* Age \> 70 years
* STS Score \> 4
* Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate

Exclusion Criteria:

* Age \<70 years
* Evidence of an acute myocardial infarction ≤ 30 days
* Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
* Stroke or transient ischemic attack (TIA) within 6 months of the procedure
Use of Pancreatic Enzymes in Short Bowel Syndrome

Patients with short bowel syndrome have a high mortality rate that is mainly attributed to complications from central lines and long-term intravenous (IV) nutrition. There are few medical therapies to date that improve gut absorption in patients with short bowel syndrome. The primary objective of this study is to evaluate if absorption from the GI tract improves in subjects with short bowel syndrome following therapy with pancreatic enzymes.

This is an interventional study of subjects with short bowel syndrome to determine if enteral absorption improves following therapy with pancreatic enzymes. The study will assess enteral absorption and nutritional status at baseline through a series of stool tests, blood tests, and anthropometric measurements. Following approximately ten days of therapy with pancreatic enzymes, the study will reassess enteral absorption.

Eligibility Criteria:
Inclusion Criteria:

* history of a small bowel resection with subsequent dependence on parenteral nutrition for at least three months
* age 4 years to 65 years
* usual state of health for the past two weeks with no medication changes
* able to participate in a study for about four weeks with four study visits
* able to take pancreatic enzyme medication orally

Exclusion Criteria:

* significant disease other than short bowel syndrome affecting the gastrointestinal tract that impacts absorption or digestions
* motility disorder
* medications that directly alter fat absorption
* cholestatic liver disease defined as a serum conjugated bilirubin greater than 1.0 mg/dL, chronic renal failure, gout, or hyperuricemia
* history of a pork allergy
* women who are pregnant or lactating
* history of fibrosing colonopathy

Those subjects who are eligible for the malabsorption blood test (MBT) test will be excluded if they have a history of a soy or safflower oil allergy.
A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study

The overall goal of this project is to determine the feasibility of conducting a cognitive intervention for children with sickle cell disease.

The primary aims of this clinical trial are:

1. Determine the effectiveness of targeted learning and memory strategy remediation in students with sickle cell disease and cognitive deficits.
2. Determine if there is improvement in academic achievement after targeted memory strategy remediation.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease that is confirmed by hemoglobin analysis
* Has a brain magnetic resonance imaging (MRI) document reading by a neuroradiologist
* Cognitive deficits, which are defined by one standard deviation lower than the normal ranges of an age-based standard score in cognitive tests that are evaluated by a psychologist
* Must be a student who will remain in school for at least 2 years
* Must provide informed consent with assent in accordance with the institutional policies (institutional review board approval)

Exclusion Criteria:

* Known developmental delays (these participants are ineligible because their learning potential may be biased from a prior insult)
* Intelligent quotient is less than 50 (may have impaired learning potential)
* Aphasic (i.e., unable to produce intelligible speech)
Smart Cupboard-based System for Memory Assessment in Alzheimer's Patients

The main objective of the research is to create a tool that can make a good diagnosis of cognitive abilities in Alzheimer's patients. As a secondary objective, the investigators intend to examine both the percentage of correct answers and the response times and see their relationship with age, gender, sex, months since the onset of the disease and years of training.


Eligibility Criteria:
Inclusion Criteria:

1. Being over 18 years.
2. Provide signed informed consent.
3. Have the ability to understand the study.

Exclusion Criteria:

Having any physical or medical problem that prevents or advises them not to stand upright, in a bipedal position.
Intentional Rounding in Internal Medicine

Each investigator will have to collect data for 50 hospitalized patients in the Internal Medicine wards. If the center is randomized to Intentional Rounding, the staff of nurses and OSS will have to implement the new care strategy.

The centers participating in the study are randomized to the Intentional Roundig group and the Control group, in a 1: 1 ratio. In the randomized centers for experimental intervention, a training intervention lasting about 4 hours was conducted by a nurse expert in Intentional Rounding.

At the end of the study, training is also scheduled for the Control Centers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signature of informed consent
* Patients who understand Italian

Exclusion Criteria:

* Patients who deny informed consent
Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer

This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Written informed consent and HIPAA authorization for release of personal health information.
3. Subjects with histologically and radiographically confirmed NSCLC.
4. Subjects must have stage IV disease or recurrent disease.
5. Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible.
6. Subjects who are eligible to receive single agent immunotherapy must have documentation of a PD-L1 Tumor Proportion Score (TPS) of at least 1%.
7. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria:

1. Subjects with curable or potentially curable NSCLC.
2. Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria.
3. Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy.
4. Subjects eligible for combination treatment with chemoimmunotherapy.