cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Duration of diabetes for longer than 12 months
* Body mass index (BMI) below 35.0 kg/m\^2
* HbA1c below 11.0 %
* Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion Criteria:

* Current treatment with agents affecting glucose metabolism
* History of drug or alcohol dependence
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Proliferative retinopathy
* Recurrent severe hypoglycaemia or advanced neuropathy
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
* Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
* History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
* Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
* History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients

The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC

Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment


Eligibility Criteria:
Inclusion Criteria:

* 18 - 75 years at screening
* Diagnosis of UC \>= 3 months prior to screening.
* Moderately to severely active UC as confirmed by Mayo Score ≥6
* Receiving conventional, non-biologic therapy for UC.
* Negative colon cancer screening
* Further inclusion criteria apply

Exclusion Criteria:

* Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs)
* Extensive colonic resection
* Evidence of infection with C. difficile or other intestinal pathogen \< 30 days prior to screening
* Active or latent tuberculosis
* Further exclusion criteria apply
A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)

A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is a non-smoker

Exclusion Criteria:

* Subject has irritable bowel disease
* Subject has a history of cancer
* Subject has a history of hypertension requiring treatment
* Subject is unable to refrain from the use of any prescription or non-prescription medication
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.


Eligibility Criteria:
Inclusion Criteria:

1. None previous chemotherapy, radiotherapy and other antitumor therapy;
2. Age:18 to 70 years old;
3. Man or female (except pregnant and lactating women);
4. Conﬁrmed to gastric adenocarcinoma and HER2-negative;
5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
6. Blood cell count has to meet the following certeria:

   WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
7. Liver/kidney function has to meet the following certeria:

   ALT and AST≤2.5×ULN TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN;
8. Left ventricular ejection fraction (LVEF) ≥50%;
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
10. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

1. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
2. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
3. Patients with other malignant tumors within 5 years;
4. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
5. Distant metastasis;
6. It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
7. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
8. Patients with severe or uncontrollable mental illness;
9. It have serious harm to the patient's safety or affect the patients who have completed the research.
10. The researchers think inappropriate.
Integrative Analysis of Large-cell Lung Cancer

Integrative analysis of LCLC

The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 75 years with histologically proven LCLC
* No severe major organ dysfunction
* World Health Organization (WHO) performance status of 0 or 1
* No prior cancer chemotherapy

Exclusion Criteria:

* Age ≥ 76
* Severe major organ dysfunction
* WHO performance status of \>1
* Prior cancer chemotherapy
Evaluation of the Nextdoor KIND Challenge

There is ample evidence showing that loneliness is a public health problem that influences social, mental and physical health. The current project is about evaluating the effectiveness of the Kindness Is NextDoor (KIND) Challenge, a social networking platform aimed at reducing loneliness and social isolation in specific Nextdoor communities within Australia. As the landscape through which people make social connections changes due to technology it is important to evaluate the effectiveness of platforms that are designed to reduce loneliness within communities. This is the first study of its kind in Australia and will help provide insight into how to target social isolation and loneliness within communities using social networking platforms.


Eligibility Criteria:
Inclusion Criteria:

* Community dwellers who use the Nextdoor platform.
* Aged 18 to 90 years old.

Exclusion Criteria:

- Individual's without proficient English reading comprehension skills will be excluded.
Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT

Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* liver tumor
* referred for stereotactic radiation therapy
* age \> 18 years

Exclusion Criteria:

* Impaired kidney function
* Pregnancy
Validation of a French Version of the Confusion Assessment Method (CAM)

To validate the French version of the CAM, a multicenter diagnostic study will be conducted. The principle of this study is identical to the study of Inouye which initially validated the CAM in 1990. This is to verify the diagnostic properties of the CAM (French version) compared to the gold standard represented by the confused state of psychiatric diagnosis using the DSM.

A representative sample of geriatric patients for whom a delirium is suspected, will be recruited in the various participating centers, patients will undergo two consecutive visits:

* A visit by a geriatrician, during which the confused state of the patient will be evaluated using the French version of the CAM.
* A visit by a psychiatrist during which the diagnosis of confusional state will be evaluated using the gold standard criteria of the DSM IV.

These two evaluations will be conducted on the same day and blinded from each other.

The order of these two procedures will be balanced within each center. This process will allow the calculation of diagnostic parameters of the CAM French version (validation competitive): sensitivity, specificity, positive and negative predictive values .


Eligibility Criteria:
Inclusion Criteria:

* A family member of the patient, or his/her "trusted person" must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Hospitalization in geriatric short stay OR patient consulting at a geriatric assessment center / memory clinic OR geriatric day hospitalization
* Patients for whom a state of confusion is suspected during the pre-inclusion visit run-in based on the following criteria:
* Presence of a cognitive function disorder as defined by a score greater than or equal to 3 on the Short Portable Mental Status Questionnaire (SPMSQ) (Pfeiffer E, 1975) AND / OR
* Presence of a mood disorder and / or behavior disorder (regardless of duration) according to the patient's family or caregivers
* Presence of a caregiver who can answer questionnaires concerning activities of everyday life

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient's family or "trusted-person" refuses to sign the consent
* The patient does not understand french
* Severe aphasia
* Stay is \< = 3 days
Neoantigen Vaccine Therapy Against H3.3-K27M Diffuse Intrinsic Pontine Glioma

Diffuse intrinsic pontine gliomas (DIPGs), which diffusely occupy the pons of brainstem, are the deadliest primary brain cancer in children. Biopsy for pathology plus radiotherapy remains the current standard-of-care treatment that is minimal effective. Thus, the median overall survival after diagnosis is just 10 months. Recent studies have identified a lysine 27-to-methionine (K27M) somatic mutation at histone H3 variant (H3.3), as a feature mutation in DIPGs. Several preclinical studies have already demonstrated H3.3-K27M as a promising target for immunotherapy. The researched vaccine is a cancer-treatment vaccine containing an H3.3-K27M targeted neoantigen peptide, that can be taken up by antigen-presenting cells (APCs). APCs can present the peptide with the major histocompatibility complex (MHC) molecules on cell surface, thereby activating neoantigen-specific T cells and triggering corresponding cytotoxic T cell immune responses to eliminate H3.3-K27M-expressing DIPG cells. The main goal of this study is investigating the safety and preliminary efficacy of the vaccine in treating newly-diagnosed DIPGs when the vaccine is administered in combination with the standard-of-care treatment.


Eligibility Criteria:
Inclusion Criteria:

A. First entry criteria

1. Age ≥ 5 years old;
2. Newly-diagnosed patients with DIPG appearance on MRI image;
3. HLA-A2 subtype;
4. The expected survival time exceeds 24 weeks;
5. The KPS score is greater than 50; B. Second entry criteria

1. The KPS score is greater than 50; 2. DIPG is diagnosed histologically on tumor tissue obtained by biopsy or surgical resection; 3. H3.3K27M mutation is detected on tumor tissue obtained by biopsy or surgical resection ; 4. Adequate organ functions that meet the following criteria: The absolute number of neutrophils: ≥1500/mm3 Platelet count: ≥75000/uL Hemoglobin: ≥80 g/L Creatinine≤1.5×ULN Bilirubin≤1.5×ULN ALT≤3×ULN AST≤3×ULN 5. Ability to comprehend and sign an informed consent form.

Exclusion Criteria:

1. With past medical history of malignant tumors (except being asymptomatic for more than 3 years);
2. History of allergy to chemotherapeutics or radiosensitizers for the treatment of cancer in central nervous system and head/neck;
3. History of allergy to the vaccine and its ingredients;
4. Comorbidity with HIV infection and/or acute phase of hepatitis B/C;
5. Any progressive diseases that hinder participation in the trial;
6. With unstable cardiovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia et.al.;
7. History of uncontrolled mental illnesses;
8. Inability to comprehend or sign informed consent form or abide by the research procedures;
9. Other conditions believed to hinder participation in this trial at investigator' discretion.
Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador

The goal of this observational study is to evaluate the epidemiological and clinical-pathological features of Philadelphia-negative myeloproliferative neoplasms through data from medical records

The investigators are proposing a study that provides descriptive understanding of patients with Philadelphia-negative myeloproliferative neoplasms in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry of Philadelphia-negative myeloproliferative neoplasms, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Patients with confirmed diagnosis of Philadelphia-negative Myeloproliferative Neoplasms

Exclusion Criteria:

* Patients with translocation t(9;22)(q34:q11.2) with subsequent formation of the BCR-ABL1 fusion gene determined by cytogenetics or fluorescence in situ hybridization (FISH)
* Absence of the histopathological report in the clinical history and the corresponding plaque, except in the case of Polycythemia Vera that does not require them for diagnosis, according to the 2022 WHO classification
Multimodality Prediction of Success of Atrial Fibrillation Rhythm Control Strategy

In this study the investigators aim to build a model to predict the maintenance of sinus rhythm (SR) after successful direct current cardioversion (DCC) incorporating standard predictors such as echocardiographic parameters, clinical parameter and 12-lead ECG parameters and new parameters, including 17-lead ECG, Oesophageal-ECG and single nucleotide polymorphisms (SNPs). Using this novel integrated prediction model will help in the identification of patients who will maintain SR after cardioversion. Another innovative aspect of our study is the use of daily rhythm monitoring using a versatile device (MyDiagnostick®). The clinical impact this study will have is that it helps the cardiologist to make a patient tailored strategy in the treatment of AF as advocated by the guidelines and to prevent exposing patients not likely to maintain SR to the potentially harmful side-effect of a rhythm-control strategy.

Primary objectives To show that a model incorporating the novel predictors 17-lead ECG, Oesophageal-ECG and SNPs is superior to existing models in predicting maintenance of sinus rhythm after successful DCC in patients with persistent AF.

Secondary objectives To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs) for maintenance of SR after successful DCC separately.

To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs) for time to recurrence of AF.

To assess the predictive value of predictors with respect to complete failure of cardioversion.

To assess the predictive value of predictors with respect to cardiovascular morbidity.

Hypothesis The investigators hypothesise that a model incorporating the novel predictors the 17-leads ECG, Oesophageal-ECG and SNPs performs significantly better than existing models using only clinical, echocardiographic and ECG parameters on a standard 12-lead ECG in predicting maintenance of SR after successful DCC. In addition the investigators hypothesise that Oesophageal-ECG is the best single predictor for maintenance of SR after successful DCC.


Eligibility Criteria:
Inclusion Criteria:

* Haemodynamic stable patients with persistent AF scheduled for DCC.
* Written informed consent.
* Patients \> 18 years old.

Exclusion Criteria:

* Atrial flutter at time of DCC.
* Patients with known oesophageal disease.
* Patients with previous operations on throat or oesophagus.
* Postoperative atrial fibrillation.
* Patients with previous ablation for AF.
* Previous inclusion in this study.
* Patients on anti-arrhythmic drugs (AAD).
* Patients with pacemakers unable to detect AF and with a regular paced rhythm during AF.
* Planned ablation for AF.
* Myocardial infarction within the last 4 weeks.
Biomarker Research for Personalized Medicine

The aim of this study :

1. Through the study of genes of protein, transporter, translator and epigenome investigating the effect of anti-cancer treatment or the key factor of the MDR (Multidrug resistance) on the blood cancer patients who are under the anti-cancer sork treatment
2. Giving a service of anticancer medicine therapeutic drug monitoring (TDM) and genotyping


Eligibility Criteria:
Inclusion Criteria:

* Korean
* Clinical diagnosis of Hematologic neoplasms
A Study of Minimally Invasive Surgical Strategies for Robot-assisted Supratentorial Large Hematoma

The AI robot is used to design precise coordinates and access routes for hypertensive cerebral hemorrhage patients with large supratentorial hematomas in conjunction with imaging data, to clarify the therapeutic efficacy of robotic-assisted endoscopic debridement of precise minimally invasive surgical system for perioperative and long-term functional recovery of supratentorial hematomas, and to ultimately achieve the improvement of prognosis for this group of patients, and to alleviate the economic burdens on the society and the families

In this randomized controlled study, we investigated the efficacy of robotic assistance for supratentorial large hematomas by comparing robotic-assisted minimally invasive removal of supratentorial large hematomas with conventional surgical hematoma removal. Our main comparisons were the 6-month mortality rate and good prognosis rate, and the main evaluation indexes included mRS score and GOS score.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were diagnosed by imaging (CT, CTA, etc.), measured by the ABC/2 method, and clearly recognized as having a supratentorial hypertensive cerebral hemorrhage.

   Patients with hematoma volume \>30mL and GCS score ≥5;
2. The patient's age is 18-70 years old; Patients aged 18-70 years;
3. Time from onset to surgery ≤72h;
4. Repeat CT scan at least 6 hours after the diagnostic CT scan showed that the hematoma was stable;
5. SBP \<180 mmHg was recorded near the time of random assignment;
6. mRS score ≤1 in the past medical history;
7. Patient/family informed and signed informed consent.

Exclusion Criteria:

1. The hematoma is not located on the curtain or the volume of the hematoma is less than 30 ml;
2. The onset of the disease is more than 3 days at the time of admission; Secondary cerebral hemorrhage (secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism).
3. secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism);
4. Presence of serious immune diseases (e.g., cirrhosis, malignant tumors, rheumatic immune diseases, etc.);
5. Poor compliance or inappropriate for enrollment as judged by the investigator.