cyrilzakka/clinical-trials huggingface dataset:
Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) and / or Microvascular Invasion

Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. For hepatocellular carcinoma treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy, etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin \<1 cm and microvascular invasion is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin. To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant Radiotherapy for centrally located hepatocellular carcinoma after narrow margin (\<1 cm) hepatectomy on tumor recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Patients were pathologically diagnosed as BCLC-A stage hepatocellular carcinomas, liver function were Child-Pugh class A or liver function changed from class B to class A after short-term liver treatment, PS scored 0-1, and accepted hepatocellular carcinomas resection (R0 resection).
2. No recurrence was found within 3-4 weeks after surgery.
3. pathologically confirmed as narrow margin (the closest distance from margin to tumor capsule (\<1 cm) and microvascular invasion was found in tumor capsule and adjacent tissues junction (material selection and pathological diagnosis were based on "Standardization pathology Guide of primary liver cancer 2015 edition" ).
4. Postoperative radiotherapy was the only combination therapy within one month after surgery.
5. Radiation range was margin radiation along and/or joint portal vessels radiotherapy.
6. No lymph node and distant metastasis before surgery.

Exclusion Criteria:

1. Patients were pathologically diagnosed as BCLC-B, C, D stage hepatocellular carcinomas, liver function were Child-Pugh class C, PS scored ≥2. Or primary liver cancer patients were pathologically diagnosed as cholangiocarcinoma or mixed type liver cancer. Or patients did not accept hepatectomy.
2. Patients received transcatheter arterial chemoembolization, chemotherapy, targeted medicine or other anti-cancer therapy before surgery.
3. Recurrence was found within 3-4 weeks after surgery.
4. Postoperative adjuvant therapy included treatment other than radiotherapy within one month after surgery.
5. Radiation range involved lymph node other than portal vein area.
6. Lymph node and distant metastasis were diagnosed before surgery.
A Study of LY3305677 in Participants With Obesity Or Overweight

The main purpose of this study is to learn about the safety and tolerability of LY3305677 when given to participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin. For each participant, the study will last about approximately 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma
Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment

This was a retrospective observational study that relied on data extracted from patient chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). All data extracted from patient charts was entered into an electronic case report form (eCRF), specifically designed to capture all variables needed for the study data analysis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥18 years at index date.
* Patients with PsO diagnosed with PsA (concomitant or sequentially), either by a rheumatologist or dermatologist, at least 6 months prior to initiation of secukinumab treatment.
* Continuously treated with secukinumab for at least 24 weeks (6 months) after index date.
* Medical history available from at least the one-year study period (at least 6 months previous to the start of secukinumab treatment and at least 6 months after).

Exclusion Criteria:

* Patients who interrupted secukinumab treatment for 3 or more months during the 6-month period (post-period) for any cause.
* Patients known to be participating in an interventional study at any point of the one-year study period.
Continuous Glucose Monitoring in New Mothers With Type 1 Diabetes

With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and formula feeding new mothers with type 1 diabetes at the second after delivery diabetes control compared with the first after delivery diabetes control at Steno Diabetes Center.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years.
* Delivery of a single infant.
* Proficiency in Danish to read and understand the patient information sheet, questionnaires and to converse with the diabetes caregivers.

Exclusion Criteria:

* A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.

Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. In Cycle 1 (C1) only, to reduce the risk of CRS, each cohort will receive 4 priming doses of APVO436 respectively. APVO436 will be given in combination with venetoclax and azacitidine. For C1D15 and all doses in each subsequent cycle, cohorts will receive APVO436 at the determined cohort dose level.

APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated.

  3. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]). Confirmation at diagnosis is acceptable.

  4. Patient must be considered ineligible for induction therapy defined by at least one of the following:
  1. ≥75 years of age
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3
  3. Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
  4. Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)
  5. Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular
  6. Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks

Exclusion Criteria:

1. Patient has received treatment with the following:

   1. A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
   2. CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
   3. Experimental therapies for MDS or AML
2. Patient is currently participating in another interventional research study.
3. Patient has history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.
4. Patient has acute promyelocytic leukemia.
5. Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy \>10 mg methylprednisolone daily or its equivalent
6. Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose).
7. Patient has known active CNS involvement with AML. Patients who received intrathecal chemotherapy for prophylaxis of AML in the CNS prior to enrollment may enroll in this study.
8. Creatinine clearance \<30ml/min based on Cockcroft-Gault or MDRD formular.
9. Bilirubin of \>3xULN in the absence of Gilbert's Syndrome.
10. AST and/or ALT \>3 times the ULN.
BAX 826 Dose-Escalation Safety Study

1. To assess tolerability and safety of BAX 826 after a single infusion in previously treated patients (PTPs) with severe hemophilia A
2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE
3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)


Eligibility Criteria:
Inclusion Criteria:

1. Previously treated male participants aged 18 to 65 years (inclusive) at the time of screening
2. Diagnosis of severe hemophilia A (Factor VIII level \<1%)
3. Previously treated with FVIII concentrates for ≥150 documented Exposure Days (EDs)
4. Karnofsky performance score of ≥60
5. Human immunodeficiency virus negative (HIV-); or HIV+ with stable disease
6. Hepatitis C virus negative (HCV-); or HCV+ with chronic stable hepatitis as assessed by the investigator
7. Able to understand and have provided written informed consent including signature on an informed consent form (ICF) approved by an ethics committee (EC)
8. Have provided written authorization for use and disclosure of protected health information
9. Agree to abide by the study schedule and to return for the required assessments
10. Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

1. Detectable FVIII inhibitor at screening, with a titer ≥0.6 Bethesda Unit (BU)
2. Documented history of FVIII inhibitors with a titer ≥0.4 BU at any time prior to screening
3. Known clinical hypersensitivity towards mouse or hamster proteins or to polysialic acid (PSA)
4. Scheduled elective surgery during study participation
5. Severe chronic hepatic dysfunction
6. Severe renal impairment
7. Currently receiving, or has recently received (less than 3 months prior to study participation), or is scheduled to receive during the course of the study, other PSA-ylated drugs
8. Have received another investigational drug within 30 days prior to study entry and/or is scheduled to receive additional investigational drug during the course of the study in the context of another investigational drug study
9. Diagnosis of an inherited or acquired hemostatic defect other than hemophilia A
10. Currently receiving, or scheduled to receive during the course of the study, an immune-modulating drug other than antiretroviral chemotherapy
11. Has a clinically significant medical, psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect the safety or compliance of the participant during the study
12. Is a family member or employee of the investigator
Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.

The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.

A cross-sectional prospective study is taken place at Hospital General de Zona 1 in the city of Oaxaca, Mexico.

Participants are recruited from the maternity ward and emergency room and data collection is conducted by one experienced pediatrician and one paediatrics' resident. After informed consent is obtained, background data including time and date or birth, birth weight, gestational age, parent's skin type according to Fitzpatrick scale and newborn's skin color according to Neomar's scale is being collected. Visual assessment is performed by the researchers using Kramer's scale. To obtain the bilirubin measurements with the smartphone app Picterus Jaundice Pro (Picterus JP), the calibration card is placed on the newborn's chest and a set of six images, 3 with and 3 without flash, are captured. The smartphones used to capture the images are Samsung A23, iPhone 11 and iPhone 15 Pro.

Total serum bilirubin (TSB) levels are measured with a blood sample obtained within one hour of capturing the images and analyzed at the hospital laboratory facilities.

Demographic and clinical characteristics will be analyzed by descriptive statistic.

Bilirubin measurements correlation between Picterus JP using both models and TSB will be determined by Pearson's correlation coefficient. Systematic over or underestimation of bilirubin levels will be evaluated using Bland-Altman plots. Accuracy measurements will be determined using receiver operating characteristics (ROC) and area under the curve (AUC) analysis. To compare the correlations from both models, Fisher's r to z transformation approach will be applied

Eligibility Criteria:
Inclusion Criteria:

* gestational age of 37 weeks or more
* birth weight of 2500 g and above
* newborns in whom a blood test had been ordered for any reason, irrespective of the study

Exclusion Criteria:

* newborns with congenital diseases
* newborns transferred to pediatric wards for reasons unrelated to neonatal jaundice
* newborns who had undergone phototherapy
Reliability of the Angle Measurement of the Software for Photogrammetry Postural Assessment (SAPO)

The present study aims to verify the reliability of intra and inter-examiner of angular measures proposed by SAPO postural assessment software. Methods: 24 subjects were photographed and three experienced examiners analyzed the images.

The body posture in the orthostatic position has been widely utilized as in the clinical practice as in the research, for the diagnosis and physiotherapy treatment planning. The photogrammetry has been used as a valuable resource for the physiotherapist's diagnosis and verification of measuring postural changes, but the lack of standardization of anatomic references, the used angles between them and their meaning embarrasses comparison among studies.

Eligibility Criteria:
Inclusion Criteria:

* 20-35 years old
* diagnosis of temporomandibular disorder

Exclusion Criteria:

* neurological diseases
* systemic diseases
* lower limbs fracture
* balance disorder
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 20-25 years
* Somatically and mentally healthy
* Normal body weight (body mass index (BMI)18.5-25)

Exclusion Criteria:

* Smoking within the last 6 months
* Medication within last 6 months
* Current or former psychiatric illness
* Positive family history (first grade relatives) for metabolic diseases
* Alcohol abuse
* Current or former illicit drug abuse
* Current or former drug abuse
* Known intolerance to, or former prescription of study medication
* Participation in other clinical trials at the same time or participation in clinical trials associated with administration of a drug within the last 6 months
* Homelessness
* Shift work within last 12 months
* Known hypersensitivity to mirtazapine or other components of the drug given
* Known epilepsy; glaucoma; liver, kidney, or heart disease; urinary dysfunction; hypotonia; diabetes or any other metabolic disease
* Known hematologic disease, especially agranulocytosis or leukopenia
* Blood donation within last 6 months prior to the begin of the study
* Hemoglobin below 13.5 mg/dL
Accuracy of Glomerular Filtration Rate (GFR) Estimation Using Creatinine and Cystatin C and Albuminuria

The eGFR-C study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) chronic kidney disease (CKD).

The eGFR-C study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) CKD. Participants will be recruited from hospital clinics and General Practitioner (GP) practices at six major United Kingdom (UK) centres.

The best measure of kidney function is accepted to be the glomerular filtration rate (GFR), which measures the ability of the kidney to filter blood and is widely used in clinical practice. A low GFR suggests poor kidney function. An estimate of GFR can be obtained from a simple blood test.

Participants will undergo reference GFR testing at study entry with a second follow-up reference test three years later. The reference test involves injecting a small amount of iohexol into a vein and taking blood samples over the next 4 hours to see how quickly the iohexol disappears from the blood stream as a result of glomerular filtration. The rate at which iohexol disappears is equivalent to the level of kidney function. Blood tests for monitoring kidney function, including testing for creatinine and cystatin C, and measurement of urinary albumin will be done every six months during the study period.

Iohexol measured GFR will be accepted as the reference ('gold standard') measure of kidney function against which each GFR-estimating equations will be compared. The alternative estimated measures of GFR, derived from measuring substances (creatinine and cystatin C) in the blood, will be compared against the reference test. An important outcome is how much the reference test changes over the three years of the study, and how well the surrogate measures reflect this change.

The investigators will also collect accurate test cost data for subsequent cost-effectiveness analysis (e.g. do the relative costs of the tests justify any change in practice due to improved performance of one test compared to another?).

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 3 CKD (GFR 30-59 mL/min/1.73 m2) as defined internationally, diagnosed using MDRD/CKDEPI eGFR (at least two consecutive test results in this range at least 90 days apart, with the most recent test in the last 12 months)
* Aged 18 years or over
* Written informed consent

Exclusion Criteria:

* History of untoward reactions to iodinated contrast media or allergy to topical iodine
* Episode of acute kidney injury in previous 6 months (as defined by the Acute Kidney Injury Network criteria)
* Amputation of whole or part-limb
* Pregnant or breastfeeding
* Known current alcohol or drug abuse
* Kidney transplant recipient
* Any condition with an expected survival of less than study duration
* Inability to comply with study schedule and follow-up
* Inability to provide informed consent e.g. due to cognitive impairment
A Clinical Study to Assess the Effect of Clopidogrel on the Pharmacokinetics of Selexipag and Its Active Metabolite in Healthy Male Subjects

The purpose of this study is to evaluate the effect of clopidogrel on the pharmacokinetics of selexipag and its active metabolite (ACT-333679) in healthy male adults (by determining the blood concentrations of selexipag and its metabolite). Also, the safety of selexipag when administered alone or with clopidogrel will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in the local language prior to any study-mandated procedure.
* Healty male subjects aged between 18 and 45 years (inclusive) at screening.
* Body mass index from 18.0 to 28.0 kg/m2 (inclusive) at screening.
* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive).

Exclusion Criteria:

* Any contraindication included in the SmPC of selexipag or clopidogrel treatment.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatments.
* History or clinical evidence of any disorder of hemostasis, hemorrhagic diathesis, nose or gingival bleeding, hemophilia, thrombotic thrombocytopenic purpura, presence of any lesions with a propensity to bleed (particularly gastrointestinal and intraocular), history of bleeding complications after surgical procedures such as tooth extraction
* Previous history of stroke, fainting, collapse, syncope, orthostatic hypotension,vasovagal reactions, head injury.
* Excessive caffeine consumption
* Nicotine consumption within 3 months prior to screening, and inability to refrain from nicotine consumption during the course of the study
* Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first selexipag administration.
* Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children

The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged between 0 - 17 years 10 months.
* Subject admitted to a participating ward unit (Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Hematology-Oncology unit).
* Strongly suspected or confirmed systemic infection.
* Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is
* 40 hours for amoxicillin-clavulanic acid (based on elimination half-life)
* 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life) Subject planned to start on intravenous amoxicillin (without clavulanic acid) will not be included.
* Informed consent/assent signed by parents or legal representatives of the subject.
* Not previously enrolled in this trial.

Exclusion Criteria:

* Subject with serum creatinine level ≥ 2 mg/L at inclusion.
* Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique.
* Subject receiving (or planned to receive) body cooling.
* Subject death is deemed imminent and inevitable.
* Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours (\*) after start treatment.
* The subject is known or suspected to be pregnant.
* The subject has a known allergy to the specific beta-lactam antibiotic.

(\*) The first (a posteriori) dose calculation and dose adjustment if necessary, is performed within a maximum timeframe of 28 hours after start of treatment (i.e. maximum timeframe to first dose adjustment).