cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn More About the Use of Aflibercept in Routine Medical Practice in Japanese Participants With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema

This is an observational study in which data already collected from participants with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.

The eye disorders, nAMD and DME, affect the macula, the central part of the retina at the back of the eye. This leads to blurry vision or blind spots, making everyday activities like reading or sewing difficult. While nAMD is linked to aging, DME is related to diabetes. Both conditions require similar treatment to help improve vision.

Aflibercept 8 milligrams (mg) is already approved in Japan for doctors to prescribe to people with nAMD or DME. It is a drug injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF), which causes abnormal growth and leakage of blood vessels at the back of the eye.

The participants in this study are already receiving treatment with aflibercept 8 mg as part of their regular care from their doctors.

There is limited data available on the use of aflibercept 8 mg in Japan. Data from routine medical practice will inform treatment in Japanese and other Asian populations.

The main purpose of this study is to learn more about the disease and patient characteristics of Japanese participants with nAMD and/or DME who receive aflibercept 8 mg during their routine healthcare, and how they use it.

To learn this, the study will use 2 methods:

Method 1: Researchers will study the health details of participants when they first started aflibercept 8 mg.

Method 2: Researchers will study the participants' data collected over 1 year to see how they used aflibercept 8 mg.

The data will come from a claims database called DeSC Healthcare Inc. The data will be collected from April 2023 to March 2025 for Method 1, and from April 2023 to March 2026 for Method 2.

Researchers will only look at the information from participants in Japan.

In this study, only available data from routine care are collected. No visits or tests are required as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are prescribed aflibercept 8 mg during the observable period from the collected data.

Exclusion Criteria:

* Patients in the nAMD cohort or nAMD and DME cohort who have the ICD-10 codes for nAMD who are aged \<40 years old.
* Patients in the DME cohort or others who are aged \<18 years old.
* Female patients who have any pregnancy-related records.
* Patients who do not have at least 365 days of continuous enrollment in the database.
Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics \& Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment.

The study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first):

1. Date of death - the date at which a patient was reported in the database as having died
2. Last month active - the last recorded mention of the patient in the dataset
3. End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.


Eligibility Criteria:
Inclusion criteria

* Diagnosis of any NET
* Evidence of re-treatment with lutetium-177 DOTATATE

  * Documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 DOTATATE, followed by evidence of progression, and then ≥1 subsequent dose of lutetium-177 DOTATATE
  * Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose

Exclusion criteria

• \<18 years of age
Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage (probably related to hypertension).

Cerebral Amyloid Angiopathy (CAA) and hypertension related hemorrhage are the main causes of non traumatic primary intracerebral hemorrhage. In vivo diagnosis of these two cerebral diseases may be difficult and is based on hematoma location and pattern of cerebral microbleeds (CMB) distribution. We aimed to evaluate a multimodal approach including brain MRI, Pet AV-45 Amyloid imaging and neuropsychological assessment to improve etiological diagnosis of primary intracerebral hemorrhage. 70 patients with acute primary non traumatic intracerebral hemorrhage will be prospectively included and two groups will be compared: lobar hemorrhage group and deep hemorrhage group. Brain MRI, Pet AV-45 Cerebral Amyloid imaging (during the first month) and neuropsychological assessment (Three months later) are performed. Differences between the two groups are evaluated for AV45 cortical binding, CMB distribution, White Matter Lesions and cognitive profile.

Eligibility Criteria:
Inclusion Criteria:

* Age : 40-90 years,
* Non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days from hemorrhage onset) confirmed on brain imaging (CT and/or MRI).
* Correct visual, hearing and language functions to perform neuropsychological tests.
* Written consent of patient

Exclusion Criteria:

* Secondary causes of intracerebral hemorrhage : vascular malformations (Arteriovenous malformation, intracranial aneurysm, Cavernous angioma, dural arteriovenous fistula), cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, Cocaine or alcohol use, Hemorrhagic ischemic stroke.
* Pregnancy
* Contraindication to MRI
* progressive neoplasm
* Cognitive impairment secondary to progressive neurological disease
* Depression,
* Drug addiction
A Non-interventional Retrospective Study on Overall Survival in Completely Resected Chinese NSCLC Patients With Adenocarcinoma Histology- ICAN Extension Study

ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. 2010 in 24 sites located in the mainland of China. The study had completed and major results showed that EGFR mutation rate was 55.1% and 3-year DFS rate was 61.7% in early stage Chinese NSCLC with adenocarcinoma histology after complete resection. Postoperative pathologic stage, gender, surgical and resection types had a statistically significant association with 3-year DFS.

This study is ICAN extension study with the purpose to collect the overall survival data from previous ICAN study. Approximately 571 patients who participated in ICAN study will be enrolled.

Primary objective

* To observe the overall survival of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study.

Secondary objectives

* To observe the updated DFS of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study;
* To observe the treatment pattern after tumor recurrence of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting;
* To explore the risk factors of OS for early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting, such as EGFR mutation status, gender, smoking history, treatment pattern after recurrence, etc.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years old.
2. Provision of informed consent prior to any study specific procedures
3. Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
4. Have completed lung cancer operation
5. The tumour EGFR gene mutation status test was performed as regular medical practice

Exclusion Criteria:

1. No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;
2. Patients withdrew consent for ICAN study;
3. Patients in whose medical record was objected to use the existing data for scientific research
A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of UC
* Moderately to severely active UC assessed by mMS
* Bodyweight \>= 40 kilogram (kg)
* Up to date with colorectal cancer (CRC) screening performed according to local standards
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation

Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Explorer systems during AF ablation procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 21 years of age or older who is:

   * indicated for AF ablation or
   * Who has received an AF-ablation with the past 24 months where VX1 was used or
2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
3. Patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

1. Patients not indicated or were not indicated for catheter ablation according to current guidelines
2. Patients with AF secondary to an obvious reversible cause
3. Patients who are or may potentially be pregnant
4. Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Synbiotics Interventions for Managing Cirrhosis and Its Complications

Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. However, the influences of the intestinal metagenomes and metabolic profiles of patients have not been fully elucidated.

Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the results.


Eligibility Criteria:
Inclusion Criteria:

* ① Hepatitis B cirrhosis was diagnosed by clinical biochemistry and imaging.

  * CTP rating is a-b.

    * There was a previous liver cirrhosis complication, including ascites, spontaneous peritonitis, massive gastrointestinal bleeding, liver coma, etc.

      * Over 18 years old. ⑤ Under 90 years old.

        * The patient or family member signs the informed consent form.

Exclusion Criteria:

* ① The CTP of liver cirrhosis was evaluated as grade C.

  * Other types of cirrhosis such as primary biliary cirrhosis.

    * Pregnancy status. ④ Have a history of diabetes, renal insufficiency, gastrointestinal surgery, etc.

      * Antibiotics, PPI preparations and microecological preparations (including yogurt) have been used in the past 8 weeks.

        * Have a history of narcotic drug abuse, drug abuse, or mental illness. ⑦ Patients and their families do not agree to sign the informed consent form. ⑧ Under 18 years old or over 90 years old.
A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18 when administered as a single agent or in combination with other anti-cancer drugs in patients with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years at time of signing informed consent form
* ECOG performance status of 0 or 1
* Patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable
* Patients with documented RAS alterations positive solid tumors
* Patients with measurable disease per RECIST v1.1

Exclusion Criteria:

* Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months
* Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
* Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection)
* Patients with a history or complication of interstitial lung disease (ILD)
30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease

The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.


Eligibility Criteria:
Inclusion Criteria

* Dyslipidemic participants with Chronic Kidney Disease Stage 3
* For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit\[s\]):

  * Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay).
  * Fasting lipid results following greater than or equal to 12-hour fasting period:
* Triglycerides level greater than or equal to 150 mg/dL,
* High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
* Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL Exclusion Criteria
* Participants with certain chronic or unstable medical conditions.
* Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications.
* Pregnant or lactating women, or women intending to become pregnant.
* Participants with diabetes mellitus that is poorly controlled.
* Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).
Burnout, Stress and Coping Strategies: Impact of the Covid-19 Epidemic

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel coronavirus detected in Wuhan, China on December 2019. This virus is responsible for the infectious respiratory disease called Covid-19.

The psychological effects of this epidemic are found among the general population, but also healthcare workers. Some studies have shown that psychological disorders such as stress, anxiety, depressive symptoms, insomnia, denial, anger and fear, post-traumatic stress disorder are emerging among healthcare workers. However, there is currently insufficient data to evaluate the burnout during the COVID-19 pandemic.

The purpose of this study is to understand the impact of the covid-19 epidemic on stress and burnout on healthcare workers and their coping strategies.

Burnout syndrome, a state of professional exhaustion, is prevalent among the medical and paramedical staff. The covid-19 pandemic may generate more stress and increase the risk for burnout.

The aim of this study is to evaluate burnout (prevalence and intensity) and stress of among healthcare workers in COVID-19 units and non COVID-19 units. We also explore the supportive coping strategies need to reduce their stress and burnout.

Eligibility Criteria:
Inclusion Criteria:

* Medical (physicians, interns) and paramedical (nursing managers, nurses, care assistants) staff in Reims University Hospital and EPSM Marne
* Person who have attained majority
* Person consenting to participate to the study

Exclusion Criteria:

* Healthcare workers outside of Reims University Hospital and EPSM Marne
* Person who is not a healthcare professional
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia

The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug trials.

Familial Hypercholesterolemia (FH) is an autosomal dominant metabolic disorder characterized by markedly elevated low density lipoprotein (LDL), premature onset of atherosclerosis, and development of xanthomata. There are two distinct subpopulations that have a high unmet medical need due to the lack of alternative therapy: homozygotes, who have two defective LDL receptor (LDL-R) genes, and heterozygotes with a history of cardiovascular disease (CVD) on maximally tolerated therapy. Treatment for FH is directed at lowering plasma levels of LDL-C.

Mipomersen is an antisense drug targeted to human apolipoprotein B (apoB), the principal apolipoprotein of atherogenic LDL-C and its metabolic precursor, very low density lipoprotein (VLDL). Mipomersen is complimentary to the coding region of the messenger ribonucleic acid (mRNA) for apo-B. Inhibition of apo-B would be expected to impair VLDL synthesis and result in lowered levels of LDL-C.

In early clinical trials, mipomersen has been shown to reduce levels of LDL-C to recommended target levels in some participants.

This was an open-label extension study, which consisted of a ≤2-week screening period, up to 3 years of treatment with mipomersen, and a 24-week post-treatment follow-up period. Patients who participated in Cohorts A, B, or C in study 301012-CS9 were randomized in a 1:1 ratio to mipomersen 200 mg once a week (QW) or 200 mg mipomersen every other week (QOW) for up to 3 years. Patients randomized to mipomersen 200 mg QOW were allowed to receive mipomersen 200 mg QW at the Investigator's discretion after the first 52 weeks of the treatment period. Patients who participated in study 301012-CS8 or Cohort D of study 301012-CS9 received 200 mg mipomersen QW for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

- Satisfactory completion of dosing and Week 7 or Week 15 assessments (depending on the treatment and dose received) in their initial study (Protocol 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008)).

Exclusion Criteria:

- Have a new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with patient's participation in or completion of the study.
Hepatocellular Carcinoma (HCC)_Torisel_

This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
* measurable disease
* Age \>=18 years.
* Life expectancy of greater than 12 weeks.
* ECOG performance status \<= 2
* Prior systemic therapy for HCC is allowed
* Adequate haematologic, renal and hepatic function
* Absence of cirrhosis or Child's A cirrhosis
* Fasting total cholesterol \<9.1 mmol/liter and fasting triglyceride level \<4.5 mmol/liter)

Exclusion Criteria:

* Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
* Patients receiving any other investigational agents concurrently.
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women.