cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.


Eligibility Criteria:
Key Inclusion Criteria:

* 18 to 75 years on the day of signing the informed consent form
* Histologically confirmed diagnosis of localized ESCC
* Measurable and/or non-measurable disease defined per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Adequate organ function

Key Exclusion Criteria:

* Indicators of severe malnutrition
* Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
* Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
* Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies
* Active autoimmune diseases or history of autoimmune diseases that may relapse

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Genome-wide Association Study of Pituitary Tumors

Pituitary adenomas is a very common disease, but the cause and genetics hasn't been identified. The investigators are going to use genome-wide association study to identify genes that may be related to pituitary adenomas.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with pituitary adenomas

Exclusion Criteria:

* patients with a family history of endocrine tumors
Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.

The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.

The follow up time-points are (as of standard of care and not different for this study):

* Baseline
* 6 weeks postop
* 6 months postop
* 12 months postop
* 24 months postop

Eligibility Criteria:
Inclusion Criteria:

* rotator-cuff arthropathy, osteoarthritis
* approving written informed consent

Exclusion Criteria:

* Female patients who are pregnant, nursing, or planning a pregnancy.
* All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
* not consenting in participating in this study
NovellusDx Cancer Early Detection Blood Test- Clinical Trial

NovellusDx early detection test is a simple to perform blood test, which identifies the deregulated signaling pathways within the patient tumor based on protein secretion to the blood, thus enabling early stage disease signature detection. The investigators' current clinical trial is focused on proving the main feature of NovellusDx's Early Detection Test- discriminating between cancer patients and healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* subjects ages 18 and above ICF obtain

Exclusion Criteria:

* none
A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence

An analysis of Low-Dose Cat Scan(LDCT) Screenings for Lung Cancer completed within the St. Elizabeth system from January 2015 until December 2019. The study investigator, or designee(s), will retrospectively review patient encounters, collecting data related to LDCT referrals and completions. Data analysis will focus on the subsequent imaging, procedures, reviews at The Nodule Review Board and Lung Cancers diagnosed as a result of the LDCT.

This study is a single center, minimal risk, physician initiated retrospective chart review. Potential subjects will be identified using records provided by the St. Elizabeth Healthcare Thoracic Oncology and Radiology Department. Potential subjects will be screened for eligibility. Study investigator and designees will review patient electronic medical records, extracting data related to the ordering/completion of a LDCT and interventions that occurs thereafter. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments. Please see Appendix A for a complete list of data points. All of the data that will be collected for study purposes will be kept confidential. This will be attained by the following: First, each enrolled subject will be assigned a study specific serial number for the database. All study documents and data collection tools will be maintained with the investigative site file in a locked cabinet in a secure location maintained by the investigator. The database will not include the patient's name or hospital medical record number. No one will have access to the database but the study principal investigator and study staff designated by the principal investigator. However, study data may be reviewed by the Institutional Review Board of record, an appointed study monitor, an internal auditor for St. Elizabeth Healthcare, and necessary regulatory authorities. The security of the database will be maintained under the direction of the principal investigator. Fourth, when the study is completed, the manuscript is published, and IRB storage document requirements have been met, the file will be permanently deleted and destroyed

Eligibility Criteria:
Inclusion Criteria:

* Patients within St Elizabeth Healthcare who are referred for and/or have completed a LDCT from January 2015-February 2018
* \>=18 years of age

Exclusion Criteria:

• Patient undergoes subsequent imaging, procedures and/or treatment at a facility outside of St. Elizabeth where records are not available through EPIC
Plasma Exchange vs Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis

To compare effectiveness in reducing triglycerides between daily plasma exchange and glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis with mildly elevated triglycerides


Eligibility Criteria:
Inclusion Criteria:

* mild acute hypertriglyceridemic pancreatitis
* triglycerides \>15 but \< 40 mmol/l

Exclusion Criteria:

* pregnancy
* severe course of pancreatitis
IPSC Repository of Pediatric Cardiovascular Disease

Obtain blood samples for generation and maintenance of induced pluripotent stem cells (iPSCs) and genomic/DNA sequencing for biomedical research that will improve the understanding and treatment of pediatric cardiovascular disease

Human induced pluripotent stem cells (iPSCs) are a type of pluripotent stem cell which can be generated from easily accessible patient cells, such as peripheral blood mononuclear cells and skin fibroblasts. As iPSCs are epigenetically reprogrammed from somatic cells, they retain all genetic information of the affected patients, thus providing an ideal model for studying the contribution of genetic variation to pediatric cardiovascular disease. In addition, human iPSCs can be differentiated into cardiomyocytes, endothelial cells, smooth muscle cells and cardiac fibroblasts, which are major affected cell types in the heart responsible for cardiovascular disease. Therefore, patient-specific iPSCs possess great promise in modeling pediatric cardiovascular disease, discovering novel drugs and prospective cell regeneration therapy.

The DNA from these patients will be analyzed for point mutations, rare sequence variations, single nucleotide polymorphisms in known cardiac development genes or for chromosomal copy number changes by using state of the art genetic approaches.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects must have the diagnosis of cardiovascular disease
2. The subject must have a syndrome associated with cardiovascular disease
3. The subject must be related to an individual in cohort 1 or 2
4. The subject is considered a control and does not fall into any of the other cohorts

Exclusion Criteria:

N/A
Blood Pressure Monitor Clinical Test (Cuff Range: 22 Cm-42cm)

The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 22 cm-42 cm.


Eligibility Criteria:
Inclusion Criteria:

* cuff circumference: 22cm-42cm
POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer

Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.

Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.

Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.

Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer and other neoplasms
* Age between 4 and 18 years at the time of inclusion in the study
* Patients diagnosed with cancer and other malignancies aged between 4 and 18 years who are experiencing relapse
* Paediatric patients requiring chemotherapy, radiotherapy, or oncological surgery
* Patients and parents or guardians who agree to participate in the study and sign the informed consent forms by current legislation depending on the patient's age.

Exclusion Criteria:

* Patients with cognitive deficits that prevent participation in and performance of physical exercise interventions.
* Patients with severe neurological pathology with a motor impairment that prevents or significantly hinders the performance of physical exercise
* Patients and families or guardians with language comprehension difficulties that make it difficult or impossible to carry out the physical exercise intervention.
* Patients \< 16 years with a functional status score according to Lanskyi scale \<60%
* Patients \> 16 years with Karnofsky scale \<60%.
* Any other criteria that the physician deems inappropriate for participation in the study
Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays

This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system.

This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \>18 years
* Subject is undergoing elective cardiac surgery with cardiopulmonary bypass
* Subject is willing to participate and has signed a consent form

Exclusion Criteria:

* Subject is younger than 18 years
* Subject has known congenital coagulopathy
* Subject is unable to provide written informed consent
A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age \>/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset \>/= 3 months prior to randomization and stable in the Investigator's judgment B. Age \>/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
* Patients with glucose abnormalities based on one of the following A-B criteria:

A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities

* Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Exclusion Criteria:

* Current treatment with a thiazolidinedione (TDZ) or fibrate
* Prior intolerance to a TDZ or fibrate
* Previous participation in a trial with aleglitazar
* Other types of diabetes
* Inadequate liver, hematologic or renal function
* Symptomatic heart failure classified as NYHA class II-IV
* Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
* Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
* History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
* Currently scheduled for arterial revascularization procedures
* Systemic corticosteroid therapy for \> 2 weeks within 3 months prior to screening
* Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
Extended Bolus for Meals in a Closed-loop System

This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.


Eligibility Criteria:
Inclusion Criteria

* Age between 13 and 19 years old, A1C \> 6% at screening
* Diagnosed with type 1 diabetes for at least one year
* Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day
* Currently using the Control IQ closed-loop system
* Willing to abide by meal recommendations and study procedures
* Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF
* Use an Android or Apple smartphone
* Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
* Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
* Parent/guardian proficient in reading and writing English
* Live in the United States, with no plans to move outside the United States during the study period

Exclusion Criteria

* A1C \>10%
* One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months
* Used non-insulin anti-diabetic medication within the last 30 days other than metformin
* Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease
* Pregnancy or lactation
* Untreated or unstable hypothyroidism
* Currently undergoing cancer treatment or systemic treatment with steroids
* Untreated or inadequately treated mental illness
* Current alcohol abuse
* Current illness that would interfere with participation in the study
* Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying
* Celiac Disease
Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions

A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions

Prospective, randomized, partly blinded, in part placebo-controlled, multicenter dose-finding trial with patients suffering from AK. Patients were observed for efficacy, local tolerability and safety. A total of 14 sites in Switzerland and Germany enrolled male and female patients over 18 years of age with clinically diagnosed AK lesions Patients were randomized to receive resiquimod gel (Treatment Arms 1, 2, 3, 4, or 5) or matching vehicle (Treatment Arms 1-Pla, 2-Pla, or 3-Pla):

Treatment Arms 1, 2 and 3: The patient was randomly assigned to one of three treatment groups and within each group there was one randomly assigned placebo patient for every two treatment patients (parallel-group randomization; 2:1 active vs placebo).

Treatment Arms 4 and 5: The patient was randomly assigned to one of two treatment groups (parallel-group randomization, 1:1).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or nonpregnant, nonlactating female, ≥18 years
* A minimum of 2 clinically diagnosed AK-lesions within a defined area (25 cm2 contiguous treatment area). One AK-lesion must have a diameter of at least 6 mm (indicator lesion)
* AK-lesions on balding scalp, forehead or face

Exclusion Criteria:

* Known allergy or hypersensitivity to any of the trial gel ingredients
* Dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments
* Evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer
Clinical and Biological Characterization of Patients and Collection of Samples

Objectives: Collect clinical and biological data about patients with SD/THE, collect samples of patients; create a secure on line database to collect worldwide data about SD/THE Partners : APHM, HCL, APHP

Currently10 patients (8 with TTC37 mutations and 2 with SKIV2l mutations) present a SD/THE and are managed in France in 5 different centers (Marseille, Paris Trousseau, Paris Necker, Paris Robert Debrés, and Lyon). Most of them are followed in hepato-gastro-enterology units for their intractable diarrhea. Three aspects of the disease: intractable diarrhea, immune defect and liver disease are responsible for the main part of the burden of the disease .For each aspect, the investigators will propose a close follow-up with collection of clinical, biochemical, functional and microbial data.

Collect of clinical date: during a programmed consultation clinical data about symptom will be collected twice a year. A detailed form will be used for better delineation of the symptoms. These data included growth, symptom (diarrhea, pain ...), and clinical signs. Most of these children have recurrent sample for follow up. During them some blood will be take for study the immune side but also the platelet function.


Eligibility Criteria:
Inclusion Criteria:

* patient \< 18 year-old
* patients with SD/THE

control group :

* patients with tufting enteropathy and short bowel syndrome.

Exclusion Criteria:

* child among whom the parents or the legal representatives refused that their child participates in this study
United Coronary Biobanks

The UNICORN consists of two collaborating biobanks, one in Utrecht and one in Singapore. From these two sites we include all patients who undergo a coronary catheterization for any reason.

At the moment of catheterization we draw blood, which will be stored in a biobank and we collect clinical characteristics. Patients are followed-up for 5 years for the occurrence of major cardiovascular events.

By including from two sites in the world we include 4 major ethnic groups: Caucasians, Chinese, Indians and Malays. We aim at including at least 2000 patients per ethnic group.

Our hypothesis is that there are differences in the risk factor burden, clinical presentation of CAD, and biochemical patterns in the blood among the ethnic groups.

Furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary angiography

Exclusion Criteria:

* \< 21 years of age
* Hemoglobin levels \<7 g/dL in women, or hemoglobin levels \<8 g/dL in men