cyrilzakka/clinical-trials huggingface dataset:
Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry

The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.

Vascutek Limited, a world leader in the development of vascular grafts, has combined their latest technological developments in polyester textile technology with unique endovascular design features to produce Anaconda™, the world's next generation of AAA stent graft systems. Intuitive and of a modular design, Anaconda™ is the only repositionable device which also features exceptional flexibility. The modular design comprises bifurcate bodies, iliac legs and aortic cuffs. Nitinol, an alloy of nickel and titanium, has self-expanding properties and forms the top "ring-stent" of the bifurcate body section. The "ring stent" is composed of multiple turns of Nitinol wire that provides significantly increased "hoop-strength" enabling a conformable and secure haemostatic seal against the vessel wall to be achieved. Nitinol hooks located adjacent to the "ring stent" anchor the graft in position thus preventing graft migration. The iliac limbs are fully supported with Nitinol and the bifurcate bodies feature a distal contra-lateral lumen Nitinol support, which in conjunction with a unique intrinsic magnet guidewire system facilitates cannulation of the bifurcate section.

The system is available in a wide range of sizes thus making it a flexible and adaptable stent graft system with the potential to repair diverse patient anatomy.

Eligibility Criteria:
Inclusion Criteria:

* Patient is implanted with Anaconda™ Stent Graft System

Exclusion Criteria:

* Ruptured or symptomatic aneurysm
* Juxta or Suprarenal extension of aneurysm
* Clinically serious concomitant medical disease or infection
* Need to sacrifice both Internal Iliac Arteries due to aneurysmal dilatation
* Connective Tissue Disease (Marfan's Syndrome)
* ASA Rating of Grade IV or V
* Known allergy to Nitinol, Polyester or contrast medium
* Excessive tortuosity of access vessels (femoral or iliac arteries)
* Patients with aneurysm neck lengths of less than 15mm
Restenosis in Coronary Stents And Cutaneous HEaLing

Case control study of patients with and without restenosis to demonstrate the link between in-stent restenosis and an excessive skin healing. Patients will undergo skin biopsy and blood sample tests to search for a relationship between both processes and for the identification of biomarkers and therapeutic targets.

Restenosis represents an excessive response to the coronary stent. On the other hand, skin healing with keloid formation is also an excessive repair response. There is evidence that both processes may be related because they share mechanisms mediated by inflammatory response. The purpose is to demonstrate the correlation between them for the identification of biomarkers and therapeutic targets.

The project is a case-control study with 2 groups of patients: a control group of 40 patients with ≥1 bare metal stent which in a posterior catheterization performed by clinical follow-up had no restenosis and a group of 20 patients with ≥1 bare metal stent and 20 patients with ≥1 drug eluting stent which had restenosis in a posterior catheterization also performed by clinical follow-up.

A skin biopsy will be performed at the baseline visit from which primary cell cultures of fibroblasts and keratinocytes will be obtained. Four to six weeks later a second biopsy on the scar will be performed and analyzed anatomically and pathologically. In addition, at the initial visit, blood samples will be drawn for analysis of inflammation markers, RNA and proteins. Studies can be performed at 3 levels:

1. The similarities and differences in cutaneous healing of patients with and without restenosis will be studied in the samples from the second biopsy.
2. With the cell culture from the first biopsy, the investigators will analyze the response of cutaneous cells to antiproliferative drugs and the potential advantage of vitamin D in inhibiting restenosis.
3. With the blood samples the investigators will analyze inflammatory factors, RNA and proteins that can predict these processes and that, in addition, can become potential therapeutic targets which might reduce the rate of restenosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previous coronary stent implantation and a posterior catheterization performed \> 8 months after the index procedure due to clinical follow-up (those ones with bare metal stents without restenosis will be included in the group of controls and those with restenosis will be included in the group of cases, 20 with bare metal and 20 with drug eluting stents).
* Age 18-75 years.

Exclusion Criteria:

* Patients on chronic anti-inflammatory treatment, including corticosteroids.
* Patients with previous or current history of malignancy or any other disease mediated by inflammation.
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
* Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
* Have postmenopausal status
* Have either measurable disease or nonmeasurable bone-only disease
* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have adequate organ function
* Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
* Are able to swallow capsules

Exclusion Criteria:

* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
* Have inflammatory breast cancer
* Have clinical evidence or a history of central nervous system (CNS) metastasis
* Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
* Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment
* Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
* Have received prior treatment with everolimus
* Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
* Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents \<7 days prior to randomization
* Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
* Have had major surgery within 14 days prior to randomization
Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A

We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)

Eligibility Criteria:
Inclusion Criteria:

* Patients with dislocated extraarticular distal radius fracture age 18-70 years

Exclusion Criteria:

* Cognitively impaired
* Drug abuse
* Congenital bone disease
* Earlier wrist injury
* Open fracture, Gustilo-Anderson type 3
* Pathological fractures( except osteoporotic fractures)
* Tourists
Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer

This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.

In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function

Exclusion Criteria:

1. Indicators of severe malnutrition;
2. A history of surgery for esophageal cancer;
3. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
4. Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
5. Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
6. Active autoimmune diseases or history of autoimmune diseases that may relapse
Hyperspectral Endoscopy Imaging for the Early Detection of Precancerous Lesions in Average Risk Patients

This trial studies whether hyperspectral endoscopy improves visualization of abnormal tissue in average risk patients during standard-of-care colonoscopies. Hyperspectral endoscopy is an emerging technique that has the potential to enable the signals from blood to be resolved from tissue-specific signals. Image-enhanced endoscopy may improve visualization of abnormal colonic tissue when compared to the standard-of-care high-definition white light endoscopy.

PRIMARY OBJECTIVE:

I. To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue.

SECONDARY OBJECTIVES:

I. To assess whether use of HySE could reduce the rate of missed flat polyps.

II. To assess whether use of HySE might in the future reduce the incomplete resection rate (IRR).

III. To examine accuracy of practitioners in predicting polyp histology.

OUTLINE:

Patients undergo standard of care white light endoscopy and hyperspectral endoscopy during routine colonoscopy procedure.

After completion of study, patients who experience a colonoscopy-related severe adverse event are followed up until resolution or stabilization of the event.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Patients scheduled for a standard of care screening or surveillance colonoscopy

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.

This UNITAID-funded study aims to assess feasibility and utility of birth testing, \[early infant diagnosis for HIV, (EID)\], using point-of-care (POC) HIV nucleic acid testing (NAT) at high volume maternity settings. Birth testing is defined as tests within 3 days of life. Outcome measures will include age at testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of anti-retroviral therapy (ART) initiation for HIV-positive infants. The study will document retention in care for those who tested positive at birth, and the percent of those who tested negative at birth who returned for six week testing. The study will also assess the feasibility and acceptability of POC birth testing using interviews with policymakers, health care workers and caregivers of HIV-exposed infants (HEI).

Eligibility Criteria:
Inclusion Criteria:

* HIV Exposed Infants

  * Must have been newly born at the study sites or presenting in study sites within 3 days after birth
  * Tested for HIV using POC EID platform (mother or caregiver agreed to have infant tested)
* Health Care Workers (HCWs)

  * HCWs who have used POC EID for at least three months, at project sites
  * HCWs that work directly with POC EID services at maternity providing clinical services or operating the platform
  * HCWs who consent to be interviewed
  * HCWs able to speak one of the study languages
* Laboratory Managers and program leads/focal persons:

  * National or regional level manager or head of department whose responsibilities include EID
  * Member of a national technical working group or advisory board member working on EID
  * National level representative from the MOH
  * Laboratory managers in the 3 study sites
  * Participants 18 years and above who consent to be interviewed
* Mothers/caregivers:

  * Mother/caregiver of an HEI who was offered POC EID at birth
  * Provides consent to participate in the study
  * Is 18 years or older, or is less than 18 years old but is legally married (and thus legally emancipated)
  * Speaks one of the study languages

Exclusion Criteria:

* HEIs:

  * HEI tested for HIV using conventional EID at projects sites
  * HEI whose caregivers refuse birth testing
  * HEI where the clinician deems there is a contra-indication for sample collection for birth testing (e.g. severe hemophilia)
* HCWs:

  * HCWs who work within project sites that do not make use of EID (i.e. HCWs who are not involved directly with EID)
  * HCWs working in non-project sites
  * HCWs who are unable to consent or do not speak a study language
* Laboratory Managers and program leads/focal persons:

  * Inability to give consent
  * Inability to speak study language
* Mothers/Caregivers:

  * Not eligible for POC birth testing services
  * Not able to consent
  * Does not speak English or SiSwati
Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure
2. 55.0 kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0
3. Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information
4. Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.

Exclusion Criteria:

1. Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder
2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug.
3. Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.)
4. Considered ineligible for the study by the investigator for reasons including laboratory test results
Cell Population Data in CLPD and Viral Disease

Hematological malignancies typically arise from two major blood cell lineages: lymphoid and myeloid cells . Hematological malignancies are the fourth most frequently diagnosed cancer around the world .

Chronic lymphoproliferative disorders (CLPD) comprise a heterogeneous group of diseases characterized by uncontrolled production of lymphocytes that cause monoclonal lymphocytosis, lymphadenopathy and bone marrow infiltration. These diseases often occur in immuno-compromised individuals. There are two subsets of lymphocytes: T and B cells that regenerate uncontrollably to produce immunoproliferative disorders, which are prone to immunodeficiency, a dysfunctional immune system, and lymphocyte dysregulation. Several gene mutations have been described as causes of CLPD that can be iatrogenic or acquired .

Viral infections induce lymphocyte activation, undifferentiated lymphocyte proliferation, and antibody or cytokine/lymphokine secretion. The immune defense against viral infection is more dependent on T cells and less dependent on antibodies. Cytotoxic T cells are important in killing virally infected cells. A number of cytokines, including interferon gamma and tumor necrosis factor (TNF), are secreted by the cytotoxic T cells.1It is conceivable that the activated lymphocytes may undergo not only morphologic changes, such as an increase in size, but also alterations in cytoplasmic composition as compared to their normal 'resting' counterparts .

Beyond the differential leukocyte count, modern hematological analyzers provide additional quantitative data known as "cell population data (CPD) which is regarded as the fingerprint of a blood cell at a given moment. CPD parameters harbor information associated with cell morphology and offer detailed information about the size, complexity, and fluorescence characteristics of different cell populations, potentially aiding in the diagnosis and management of various haematological conditions .

There has been no comprehensive study on the usefulness of cell population data (CPD) parameters as a screening tool in the discrimination of non-neoplastic(viral infection) and neoplastic haematological disorders such CLPD.

the aim of the study evalute clinical utility of CPD parameters generated by haematological analyser in diagnosis of both CLPD \&viral infection 2-to compare performance of CPD parameters with other established diagnostic \&prognostic markers in CLPD


Eligibility Criteria:
Inclusion Criteria:

* 1-Age \> 18 years old 2- Patient newly diagnosed CLPD according to the recent WHO classification; based on bone marrow examination, immunophenotyping \&/or LN biopsy 3- Patients are newly diagnosed with viral hepatitis infection based on viral serology

Exclusion Criteria:

* 1- patient on treatment 2- Patient has both chronic lymphoproliferative disorders and viral hepatitis infection 3- Patient has any other' hematological disease 4- Patient has any chronic disease affect hematological parameters. 5- patient with incomplete medical records
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure

The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM), the proposed investigational medicinal product (IMP; designated "Biological Ventricular Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. EHM are constructed from defined mixtures of induced pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. HFrEF (EF ≤ 35%) as assessed by high-resolution echocardiography or MRI
2. No realistic chance or not eligible for heart transplantation
3. At least one hypo- or dyskinetic segment to demark the implant target area
4. Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary bypass surgery, valve repair) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index \<16 mm (Rudski et al. 2010).
5. 18-80 years of age
6. Previous implantation of an ICD or CRT-D with event recorder
7. New York Heart Association (NYHA) Class III or IV under optimal medical therapy
8. Willingness and ability to give written informed consent
9. Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration.

Exclusion Criteria:

1. Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1)
2. Alloimmunisation against EHM implant cells
3. Hypertrophic cardiomyopathy (HCM)
4. Terminal kidney failure (stage 4; GFR \<30 ml/min)
5. Terminal liver failure
6. Autoimmune disease
7. History of stroke
8. Reduced life expectancy in the short term due to non-cardiac disease
9. Simultaneous participation in another interventional trial
10. Pregnant or breastfeeding females
11. Known or suspected alcohol and/or drug abuse
Volumetric Analysis in the Assessment of Therapy Response by CT

To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Registered and being treated on one of the following therapeutic protocols:

06-043, 07-052, 07-057, 07-112, 07-116, 08-093, and 08-054

* Have at least one measurable lesion\* as per RECIST criteria situated in lung, liver or lymph node meeting RECIST criteria noted on a baseline CT scan.
* Baseline\*\* and at least one follow-up CT scan to likely to be obtained at an MSKCC facility
* All patients must be \> or = to 18 years old

  * The measurable lesions are metastatic in the liver, lung and lymph nodes. The algorithms do not distinguish between primary and metastatic disease, therefore, in selected cases, a primary lesion such as in the liver or lung may also be assessed.

    * Baseline CT are prefer but if not able to obtain for volumetric reconstructions follow up studies will still be use for other objectives if the study.

Exclusion Criteria:

* Pregnant or lactating women