cyrilzakka/clinical-trials huggingface dataset:
Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)

Clinical experience investigation (CEI) is to be conducted to confirm the following to characterise safety and efficacy of Tagrisso Tablets in actual clinical use.

1. Incidence of adverse drug reactions (ADRs) in actual clinical use
2. Factors which may affect safety and efficacy of the product (especially analysis of the incidence and risk factors of interstitial lung disease (ILD) events)
3. Information of ADRs not expected from "Precautions for Use" of the package insert in Japan


Eligibility Criteria:
Inclusion Criteria:

* patients treated with the product

Exclusion Criteria:

* No Account (NA)
Effect of Genetic Variation in the Transporter OCT2, MATE1 and MATE2-K on the PKPD of Metformin

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. The investigators will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), and the multidrug and toxin extrusion transporters, MATE1, MATE2-K to test the hypothesis that genetic variation in hOCT2, hMATEE1 and hMATE2-K are associated with variation in the pharmacokinetics and/or pharmacodynamics of the antidiabetic agent, metformin.

In the proposed study, a genotype to phenotype strategy is employed to study the role of the transporters, OCT2, MATE1, and MATE2-K and related variants in response and disposition to a known substrate, metformin. Recently, one polymorphic variant in MATE1 (PMT4302, g.-66T\>C) showed decreased promoter activity by 40-45% (p\<0.01), and one MATE2-K variant (PMT5597, g.-130G\>A) showed increased promoter activity by 30% (p\<0.05), compared to the reference. Both are the most common promoter variants in each gene (the frequencies of PMT4302: 32.1% and 23.1% in Caucasian and Asian; PMT5597: 26.2% and 48.5% in Caucasian and Asian) (unpublished data, Giacomini group). Specifically, the investigators will measure renal clearance of metformin, and plasma glucose and insulin levels, in healthy Caucasian and Asian subjects who carry either the reference or variant alleles in order to evaluate the effects of these variants on metformin disposition and response.

Eligibility Criteria:
Inclusion Criteria:

* Subjects self-identify racial background, identify themselves, parents and four grandparents as Caucasian and or Chinese.
* Subject status is healthy volunteer from the SOPHIE cohort
* Subjects over 18 years old
* Subjects who are healthy on the basis of medical history, physical examinations and laboratory tests if healthy volunteer from SOPHIE
* Subjects who agree with the written informed consent to participate in the study.

Exclusion Criteria:

* Under 18 years old
* Pregnant or lactating woman (female subjects will have a urine pregnancy test at the Day 1 visit)
* They report a prior history of any allergic reaction to metformin
* Has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
* Has a prior history of renal\* or hepatic dysfunction (renal and hepatic function will be evaluated based on screening blood tests conducted prior to study enrollment)
* Anemic (screening lab values, hemoglobin \<10 g)
* Taking a medication that could confound study results (such as known substrates or inhibitors of OCT2, MATE1 and MATE2-K such as cimetidine)
* Subjects are undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function
* They do not consent to participate in the study
Study to Evaluate Adverse Events and Movement of Intravenously (IV) Infused ABBV-787 in Adult Participants With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed.

ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide.

Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Laboratory Criteria matching those outlined in the protocol.
* QT interval corrected for heart rate (QTc) \<= 470 msec using Fridericia's correction, and no other clinically significant cardiac abnormalities.
* Documented diagnosis of non-promyelocytic acute myeloid leukemia (AML), per 2022 European Leukemia Net (ELN) criteria.
* Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) who have been treated with up to 3 prior lines of therapy and are refractory to or intolerant of all established AML therapies that are known to clearly provide clinical benefit at the judgement of the investigator.
* Must have a white blood cell (WBC) count \< 25 × 10\^9 /L prior to initiation of study drug (Note: Hydroxyurea or leukapheresis is permitted to meet this criterion and for use through Cycle 3 to control for hyperleukocytosis.).

Exclusion Criteria:

* Have received a CD33-targeting therapy within 3 months prior to the first dose of ABBV-787.
* Stem cell transplant within 3 months prior to first dose of study drug.
* Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-787.
* History of documented pneumonitis that required treatment with systemic steroids within the last 6 months, nor any evidence of active pneumonitis.
* Unresolved toxicity of Grade \>= 2 from prior anticancer therapy, or to levels dictated in the eligibility criteria, with the exception of alopecia.
* Known active severe or poorly controlled acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy

The purpose of this study is to find out more about differences of the quality of life in patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction. To find a better reconstruction for patients who received total gastrectomy.

Total gastrectomy has been indicated mainly for advanced gastric cancer located from the upper to middle third of the stomach or multiple gastric cancers.The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestines is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines ' lower down.

Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It often is associated with a limitation of postoperative quality of life (QOL). To improve postoperative nutritional status and QOL, surgeons have tried to establish ideal reconstruction after total gastrectomy and the optimum procedure for reconstruction has been discussed.

This study will compare the postoperative quality of life (QOL) of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes patients feel better.

Eligibility Criteria:
Inclusion Criteria:

* • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists.

  * Patients 20-75 years old
  * Normal organ function, able to tolerate surgery, no clear contraindication for surgery
  * No evidence of metastases of adjacent organs
  * be able to provide follow-up over 2 years
  * No specific treatment for gastric cancer before surgery
  * In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
  * The subjects were able to understand and comply with the trial protocol, and signed informed consent.

Exclusion Criteria:

* • Synchronous or metachronous (less than five years) and with other malignancies.

  * Cirrhosis and portal hypertension
  * Associated with blood diseases
  * Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
  * Suffering from a serious neurological diseases or psychological diseases affecting the life
CCTA-FFR Registry for Risk Prediction

The investigators sought to investigate the prognostic implication of qualitative and quantitative plaque analysis on coronary CT angiography (CCTA) according to fractional flow reserve (FFR). The main objective was to develop a comprehensive risk model by using clinical risk factors, FFR and CCTA parameters.

Coronary CT angiography (CCTA) is an evolving noninvasive modality in diagnosis of coronary artery disease (CAD). Its incremental prognostic value over traditional scheme of risk prediction has repeatedly been demonstrated. Beyond the assessment of CAD severity, the prognostic value of CCTA has increased with comprehensive plaque analysis. Certain plaque features on CCTA have a prognostic value in the prediction of future coronary events. The concept of fractional flow reserve (FFR) has been developed as an invasive index of the functional severity of stenosis. FFR represents maximal blood flow to the myocardium supplied by an artery with stenosis as a fraction of normal maximum flow. In moderate stenotic lesion, determining whether to perform PCI based on FFR is a current guideline, and has been proven to reduce unnecessary revascularization procedure and improve clinical prognosis. However, clinical events still occur in patients with FFR \>0.80. In a recent study, the prognosis in the vessel with FFR \> 0.8 was investigated. However, a comprehensive risk model according to FFR has never been investigated. Therefore, the investigators sought to investigate the prognostic implication of qualitative and quantitative plaque analysis on CCTA according to FFR. The main objective was to develop a comprehensive risk model by using clinical risk factors, FFR, and CCTA parameters.

Patients who underwent CCTA within 90 days before FFR measurement will be included. The study population will be from 2 different registries. The 3V-FFR-FRIENDS registry (NCT0620122050) enrolled a total of 1,136 patients (3,298 vessels). Among them, 299 patients who underwent CCTA within 90 days before FFR measurement will be included. The institutional registry of Tsuchiura Kyodo General Hospital included 448 patients who underwent FFR measurement and CCTA within 90 days. By retrospectively collecting clinical outcome data, coronary angiographic data, physiologic indices, and CCTA data from two registries, the CCTA-FFR Registry for Development of Comprehensive Risk Prediction Model will be created. For 3V FFR-FRIENDS registry (NCT0620122050), the collected clinical data for the previous study will be used, and 5-year outcome data will be collected from Seoul National University Hospital, Keimyung University Dongsan Medical Center, and Inje University Ilsan Paik Hospital. For the Institutional registry of Tsuchiura Kyodo General Hospital registry, the investigators will collect the baseline characteristics of participants, CCTA data, and clinical outcome data followed until Mar 2019.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent CCTA within 90 days before FFR measurement

Exclusion Criteria:

* Unanalyzable coronary CT angiography
* Inadequate fractional flow reserve measurement
An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus

A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be administered once daily. It is hypothesized that this supplement will lead to improvements in sleep, focus, and stress. Previous research supports that CBD supplementation provides support to the endocannabinoid system, allowing the brain to better control negative psychological outcomes like fear, stress, and negative mood states.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsules per day).
* Must be in general good health (e.g., no long term health issues that would impact your participation.
* Moderate self-reported issues with stress, mood, focus, and sleep.

Exclusion Criteria:

* Current use of selective serotonin reuptake inhibitors or prescription medication for the treatment of depression or anxiety and have not been on a stable dose for more than 60 days.
* Currently receiving other psychotherapeutic treatment for anxiety or depression.
* Diagnosed anxiety or depression
* BMI over 40
* Known allergic reactions that would require the use of an epi-pen
* Females who are pregnant or breastfeeding.
Time to Defibrillation Using Automated External Defibrillators by Pediatric Residents in Simulated Cardiac Arrests

Automated external defibrillators have improved survival for adult in hospital cardiac arrest. Automated external defibrillators are approved for children aged 1 year and older for out of hospital cardiac arrests. It is unknown whether automated external defibrillators have a role for in hospital pediatric cardiac arrests.

The purpose of study is to compare the management of cardiac rhythm disorders by pediatric residents using an automated external defibrillator versus a standard defibrillator in simulated pediatric cardiac arrests.

It is our hypothesis that residents using an automated external defibrillator will have a shorter time to defibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric resident at Baylor College of Medicine

Exclusion Criteria:

* Not a pediatric resident at Baylor College of Medicine
Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage

Randomized, placebo-controlled, double-blind, placebo-controlled clinical trial consisting of 15 triathletes in which it is intended to observe less inflammatory damage at the muscular level after performing eccentric exercises.


Eligibility Criteria:
Inclusion Criteria:

* Male sex.
* Age: between 18 and 45 years.
* BMI ≤ 35 Kg / m2.
* Volunteers capable of understanding the clinical study, competent to grant written informed consent and willing to comply with the study procedures and requirements.
* Subjects who do not suffer from chronic diseases.
* Non-smoking subjects or less than 10 cigarettes a day.
* Subjects who have not consumed any type of NSAID within 48 hours prior to the study or during its development.
* Subjects without a history of administration of corticosteroids the previous month or during the study.
* Subjects without allergy to any of the products under investigation.
* Patients who have not modified their habits in the performance of physical activity during the study (injuries, injuries ...).
* Patients who have not modified their dietary habits during the previous month or intend to do so during the study.

Exclusion Criteria:

* Subjects who do not consume medication or nutritional supplements with antioxidant and / or anti-inflammatory properties.
* Subjects who do not consume diets with abundant antioxidant and / or anti-inflammatory products.
Evaluation of VEGF Polymorphism as Predictive Factor in Metastatic Colorectal Cancer Treated With Folfiri Plus Bevacizumab

-1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of metastatic colorectal cancer patients. The present study aims to prospectively evaluate the predictive role of this polymorphism in metastatic colorectal patients receiving the same treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma;
* Measurable metastatic disease according to RECIST criteria;
* Patients receiving BV plus FOLFIRI as first-line treatment;
* Written informed consent;
* Availability of blood samples for genetic analysis.-

Exclusion Criteria:
rTMS in Elderly Depressed:Neuronavegated Study

This double-blind, controlled and randomized study intents to investigate the antidepressive response of rTMS on the elderly population.This is the first neuronavegated pulse intensity corrected study of rTMS in elderly depressed patients.

Most part of the studies uses samples of severe depressive patients with refractoriness and/or psychotic symptoms, which leave lacuna about the effects on depressive disorder with low or moderate scores. The literature is poor about the use of Repetitive Transcranial Magnetic Stimulation (rTMS) in the old age population.Therefore, we chose this group to research for the antidepressive effect of TMS; other interests are to identify modifications in the magnetic resonance imaging, evaluate cognitive functions and to verify the occurrence of collateral effects and safety use for this specific population.

Eligibility Criteria:
METHODS:Forty patients with the following criteria:

Inclusion Criteria

* Patients who meet criteria for Major Depressive Episode (MDE) (DSM-IV, 1994; SCID-P, 1994);
* Severity of the episode of mild to moderate
* Aged between 60 and 75 years;
* Both genders;
* In case of previous depressive episode, complete remission of the same for at least 6 weeks as measured by the clinical history;
* washed out of psychotropic drugs for one week, including antidepressants; except fluoxetine, which must have three week interval;
* Granting a written informed consent to participate in the study (Annex II)

Exclusion Criteria:

* metallic cerebral implants
* history of severe trauma or brain injury
* organic brain disease
* severe somatic disease
* history of other psychiatric diseases
* history of Epilepsy
* Non cooperating patients

Scales and Tests of clinical evaluation:

1. Hamilton Depression Rating Scale-17 items
2. Geriatric Depression Scale (GDS)
3. Mini Mental State Examination
4. Clock Drawing Test
5. Clinical Dementia Rating
6. Visual Analogue Scale
7. Clinical Global Impression.
Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System

Propeller Health is collaborating with Dignity Health (formerly Catholic Healthcare West (CHW)) to carry out a focused demonstration project to evaluate the effectiveness and potential cost savings of a deployment of the Propeller Health approach to asthma management. The Propeller Health goal is to bring together the best technology and asthma insight in order to provide Dignity Health with an engaging, data-driven chronic care program to improve asthma management and lower healthcare utilization costs, and to respond to prevention-focused reforms to health insurance laws.

This project has been designed to implement and evaluate a data-driven program to improve asthma management and control and lower direct costs through reductions in healthcare utilization. This program has been developed by Propeller Health and has gone through preliminary testing. Each subject participating in the study will receive an Propeller Health device, which captures the time and location of use of inhaled short-acting bronchodilators over a twelve-month period. This information is processed and delivered at regular intervals to the patient and his or her provider to support improved asthma management.

The purpose of the study is to evaluate the impact of the adoption of the Propeller Health system into a healthcare organization, and to provide sufficient information to inform decision making for potential future adopters. The researchers believe that the Propeller Health system has the potential to improve asthma control by providing rescue inhaler actuation data and tailored asthma management tips to patients with uncontrolled asthma, and rescue inhaler actuation data to their providers. Improvements in asthma control should be reflected in reductions in healthcare utilization for asthma, and potentially for general healthcare utilization. Reductions in utilization would result in lower healthcare costs. The study has been designed to capture data on individual subject asthma control, and changes in utilization and costs over a one-year introduction period.

Eligibility Criteria:
Inclusion Criteria:

* Provider diagnosis of asthma (ICD9 493.xx);
* At least one healthcare utilization event in CHW within last 12 months; and
* Prescription for Short Acting Beta Agonist (SABA) at study intake.

Exclusion Criteria:

* Subject is under the age of 5 at the beginning of the study;
* Subject does not speak either English or Spanish;
* Subject does not have access to the Internet or email to receive reports; and
* Subject has substantial co-morbidity (provider diagnosis of COPD
The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception

Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.

After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: \[1\] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; \[2\] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of retained products of conception
* Written consent obtained

Exclusion Criteria:

* Patients with severe complications of medicine and surgery
* Acute or chronic genital tract inflammation
* No understanding or approving the randomized controlled trial