cyrilzakka/clinical-trials huggingface dataset:
To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic obstructive pulmonary disease.

A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients with COPD

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
* Provision of signed and dated, written informed consent prior to any study specific procedures
* Plasma myoglobin and CK not above the upper reference range of the analysing laboratory at Day -1
* Male and/or female patients with COPD aged above18 years with suitable veins for cannulation or repeated venipuncture.
* Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines

Exclusion Criteria:

* Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP
* Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment within at least 3 months of the first administration of the IP in this study
* Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator
* Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer

Retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis

Pancreatic cancer is the most malignant tumor of the digestive system and the seventh leading cause of cancer-related death worldwide.The rate of lymph node metastasis in pancreatic cancer is as high as 59%.Lymph node metastasis is an important prognostic factor, which is closely associated with poor prognosis of pancreatic cancer patients.Preoperative accurate prediction of lymph node status has important clinical value.At present, the preoperative LN status of pancreatic cancer patients is mainly evaluated by conventional imaging methods such as CT and MRI.The accuracy of evaluating LN state only from the perspective of morphology is poor.Ductal adenocarcinoma of the pancreas is highly malignant, has a median disease-free survival of only about 1 year, and most pancreatic cancer patients eventually relapse.At present, TNM staging system is mainly used for prognosis evaluation.However, even among patients with the same TNM stage, the prognosis is still significantly different, which reflects the lack of prognostic information provided by the TNM stage.Imaging omics extracts a large number of quantitative features from medical images in a high-throughput manner to enable non-invasive analysis of intra-tumor heterogeneity.In this study, we planned to construct a prediction study of preoperative lymph node metastasis and prognosis of pancreatic cancer based on multimodal imaging, so as to provide a basis for clinical treatment decision and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* radical resection was performed, and histopathologically confirmed pancreatic ductal adenocarcinoma and lymph node status;2) CT and/or MRI enhancement examinations were performed 2 weeks before surgery;3) Patients with complete clinical data

Exclusion Criteria:

* (1)Patients who received radiotherapy or chemotherapy before preoperative imaging examination;2) Poor image quality.
Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Recently, it was demonstrated that with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced.

Objective: To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells.

Study design: Randomized, controlled trial. Study population: Patients with nuclear cataract of a grade ≥ 5. Intervention: Microinterventional endocapsular nuclear fragmentation. Main study parameters: Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Informed consent.
* Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III).

Exclusion Criteria:

* Endothelial cell density (ECD) \< 1500 mm-2.
* Corneal opacification (any cause).
* Corneal surgery or trauma.
* Implant lens.
* Refraction surgery.
* Prior glaucoma surgery.
* Pseudoexfoliation.
Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area

Resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we used DTI-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional connections of the illustrated PT by direct electrical stimulation. We evaluated the reliability of DTI-based tractography for PT mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques.

Adverse effects caused by electrical stimulation during the operation were recorded. All subjects adopted early postoperative MRI examinations (within 3 days) to evaluate both the extent of tumor resection and the integrity of the PTs. Muscle strength was assessed preoperatively and postoperatively.The Karnofsky Performance Scale (KPS) was adopted for grading functional status at the 6-month evaluation. Further tumor progression interval and survival analysis was conducted for each subject with high-grade glioma (HGG)

Eligibility Criteria:
Inclusion Criteria:

* patients with an initial imaging diagnosis of single, unilateral, supratentorial primary glioma (or intrinsic neoplasm).
* The lesions were involved in PTs, comprising cortical regions in the motor or somatosensory areas, cortical regions adjacent to the central gyrus, subcortical regions with an infiltrative progression along the PTs, and temporal or insular regions in relation to the internal capsule.
* MRI enabled preoperative identification of patients in whom maximal tumor resection was likely to be achieved, and close PT approach within resection cavity at the time of surgery was possible.

Exclusion Criteria:

* patients with secondary or recurrent gliomas (or intrinsic neoplasm), patients with contraindications for MRI or direct electrical stimulation, and patients in whom initial muscle strength grades of the affected extremities was 2/5 or lower.
Food Order Intervention for Gestational Diabetes

This is a randomized controlled feasibility trial for women diagnosed with gestational diabetes mellitus (GDM). The current front-line treatment for GDM is medical nutrition therapy (MNT), i.e. personalized diets which may or may not include mild carbohydrate restriction. Use of carbohydrate restriction increases the risk of the mother developing ketosis, a harmful condition for both the mother and fetus. If MNT is not enough to stabilize blood sugar levels, then pharmaceuticals are prescribed. In patients with type-2 diabetes and prediabetes, the carbohydrate-last food order behavior has been shown to improve post-meal blood sugar control without the need of reduced carbohydrate intake. Given this data, the addition of this intervention to MNT in patients with GDM may be helpful in achieving controlled blood sugar levels without increasing the risk of ketosis. This study will include two randomized groups diagnosed with GDM. Patients in the control group will be prescribed standard MNT. Patients in the intervention group will have identical MNT but with additional food order instruction/therapy. All patients will be followed up with at 1-2 week intervals. At each follow-up the physician and dietician will analyze the patient's blood sugar measurements and, among additional factors, determine if pharmaceuticals should be added. Treatment will continue through delivery. The primary aim of this study is to assess the feasibility of the carbohydrate last food order in GDM and generate preliminary data on its effects on glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant subjects ≥18 years old
* Newly diagnosed with GDM between 24-32 weeks of gestation with at least 2 days of self-monitored glucose logs or diagnosed via a 50g glucose challenge test (GCT) greater than 200mg/dL

Exclusion Criteria:

* Pre-existing diabetes prior to conception
* Patients whom do not plan on consuming at least 3 meals daily throughout gestation (e.g. during Ramadan)
* Requirement of special medical diet (e.g. from phenylketonuria, celiac disease, etc.)
* History of bariatric surgery
Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project

Cancer Survivor Registry: The Breast Cancer M.A. P. (Mind Affects the Physical M.A.P.) Project to identify and help us understand the emotional and social needs of breast cancer survivors.

The Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project was the first registry of its kind to look at the emotional and social needs of individuals diagnosed with breast cancer and track how their needs changed throughout their cancer journey. Data will raise awareness and help develop programs to address the needs of breast cancer survivors. Findings from the Registry are disseminated online at www.CancerSupportCommunity.org/RegistryIndexReport2017

Eligibility Criteria:
Inclusion Criteria:

* Having received a cancer diagnosis

Exclusion Criteria:

* None
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged ≥ 18 to \< 65 years at the time of vaccination
* Non pregnant/ non lactating females

Exclusion Criteria:

* Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
* Vaccination against influenza in the previous 6 months
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
* Known history of Guillain-Barré Syndrome;
* Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
* History of neurological disorders or seizures
* Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
* Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
* Administration of immunoglobulins and/or any blood products;
* Participation in a clinical trial or use of an investigational compound;
* Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
* Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.
Proof-of-concept Trial of Apraglutide in GVHD

The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal acute graft versus host disease (aGVHD).

This is an international, multicenter, randomized proof-of-concept trial to evaluate safety, tolerability, efficacy, durability of response, and clinical outcomes of apraglutide administration to subjects with steroid-refractory (SR) aGVHD of the lower GI tract being treated with systemic steroids (SS) and ruxolitinib (RUX).

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent and agree to follow the details of participation as outlined in the protocol
* Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg. Only subjects aged 18 years and above will be included in Germany.
* Clinically confirmed steroid refractory lower GI-aGVHD (MAGIC stage 1-4) prior to randomization
* Have undergone alloSCT from any donor source, any conditioning regimen
* Treated with SS plus RUX (RUX starts concomitantly to apraglutide or a maximum of 72 hours before apraglutide initiation)
* Women of childbearing potential (WOCBP): highly effective method of contraception and refrain from donating eggs during the trial and for 4 weeks after the End of Trial (EOT) visit
* Male subjects with partner WOCBP: contraception and abstention from sperm donation during the trial and for 2 weeks after the EOT visit

Exclusion Criteria:

* Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate and mycophenolate mofetil at the time of randomization / Day 0
* Concomitant treatment with Janus kinase inhibitor other than RUX at the time of randomization
* Failed alloSCT due to relapse of underlying malignant disease
* Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence
* Any use of enteral glutamine or GLP analogs or known ADA, within 6 months prior to randomization / Day 0
* Significant organ system failures (respiratory renal hepatic and cardiac)
* Presence of relapsed primary malignancy or treatment for relapse after alloHSCT
* Presence or history of GI tumors (including the hepatobiliary system and pancreas) within the last five years before randomization
* Presence of colonic polyps not removed
* Active clinically uncontrolled infection or active tuberculosis
* Known chronic GVHD
* Known active GI inflammation not related to GI-aGVHD
* Major abdominal surgery in the last 6-months prior to randomization or history of clinically significant intestinal adhesions
* Abnormal liver function tests
QT Variability Pre and Post Cardioversion

The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.

Atrial Fibrillation variably activates the renin-angiotensin-aldosterone system (RAAS), stimulates the sympathetic nervous system, generates oxidant stress, produces natriuretic peptides, and increases ventricular rate. These are interrelated responses and the extent to which these or other pathophysiologic responses determine QT interval during and after Atrial Fibrillation (AF) is unknown. In this study, the QT variability is related to those potential markers in patients with AF undergoing elective DC-cardioversion.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Scheduled to undergo an elective DC-Cardioversion of atrial fibrillation or atrial flutter at Vanderbilt University Medical Center

Exclusion Criteria:

* Undergoing emergent DC-Cardioversion of atrial fibrillation for hemodynamic instability
* Undergoing DC-Cardioversion for post-cardiac surgery
* Dual chamber pacemakers
Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis

Evaluate the disease activity guided tapering and discontinuation strategies of etanercept (ETN) in patients with ankylosing spondylitis (AS) in 48 weeks.

Ankylosing spondylitis (AS), a subset of axial spondyloarthritis (axSpA), is a chronic inflammatory disorder characterized by inflammatory back pain and predominant involvement of sacroiliac joints and spine, leading to bony fusion of vertebrae and eventually disability in some patients. Nonsteroidal anti-inflammatory drugs (NSAIDs) are recognized as a first-line therapy for AS, but the overall response rates to NSAIDs are considerably unsatisfactory. With the advent of biologics, the outcomes of AS patients have been greatly improved. Biologics including tumor necrosis factor α (TNFα) inhibitors (TNFi) have been included in many recommendations for the treatment of AS. Etanercept, a recombinant human TNFα receptor, is capable of binding to TNFα and blocking its biological activities. It is effective in relieving symptoms, improving physical function, and reducing disease activity in patients with AS, and generally no severe adverse effects have been reported. However, the high expense of biologics restricts their long-term use, which urges a viable strategy to reduce the dosage of biologics while maintaining an optimal therapeutic efficacy. To investigate the stepwise tapering and discontinuation of TNFi based on disease activity in patients with AS, a 48-week, prospective, randomized, multicentric study was conducted. An etanercept biosimilar, rhTNFR:Fc (recombinant TNF receptor: Fc fusion protein, Yisaipu), which is one of the most widely used biosimilars in China, was used in this study.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 years old and 65 years old with AS, according to 1984-revised New York classification criteria.
* an active disease of ASDAS with C reactive protein (ASDAS-CRP) ≥2.1.
* a disease duration of 6 months to 30 years.
* no exposure to biologics in recent 6 months before recruitment. Concomitant medications with NSAIDs, conventional disease modifying anti-rheumatic drugs (cDMARDs), or prednisone or a prednisone equivalent (≤10mg/day), were allowed to continue if they were maintained at a stable dose for 4 weeks or more from baseline.

Exclusion Criteria:

* late-stage patients with spinal fusion.
* patients with severe cardiac, hepatic, renal, hematologic or endocrine diseases.
* patients with a history of multiple sclerosis, current or past malignancy.
* patients who were pregnant, or planning to become pregnant, or breastfeeding.
* patients with active or recurrent infections, or those who required oral antibiotics 2 weeks or intravenous antibiotics 4 weeks before screening.
* patients with current or past or potential tuberculosis.
Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (UIA).

Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. In the past years, the concept of benchmarking attaches greater importance in the field of healthcare, especially in surgery. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. The aim of our study is the establishment of robust and standardized outcome references after microsurgical clipping of unruptured intracranial aneurysms. After successful implementation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm
* High-volume centers with ≥40 cases per year during the study period

Exclusion Criteria:

* Treatment following subarachnoid haemorrhage
* Clipping following an incomplete occlusion after previous treatment
Early Prophylactic Donor Lymphocyte Infusion After Allo-HSCT for Patients With AML

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is a curative option for patients with acute myeloid leukemia (AML). However, transplantation related toxicity and mortality as well as the existence of HLA identical sibling donor represent major limitations. Over the 20 past years, the development of reduced intensity conditioning (RIC) regimen and the use of alternative donors allowed extending the possibility of Allo-HSCT for AML, with decreased toxicity and mortality. This invited to propose this strategy to more advanced patients, making that AML recurrence has become one of the main issues after Allo-HSCT. Thus, to develop prophylactic and preemptive strategies to minimize disease recurrence after Allo-HSCT is now the main challenge in the field. Among cellular and/or pharmacological treatments after Allo-HSCT, donor lymphocyte infusion (DLI) is probably one of the most commonly used treatments after Allo-HSCT. Indeed, DLI were reported as a potential efficient immunotherapy more than 20 years ago for the treatment of patients with leukemia relapsing after Allo-HSCT. However, most of experiences were reported in the setting of relapse after Allo-HSCT and no prospective evaluation of prophylactic DLI is available so far. Thus no strong recommendation for the use of DLI after Allo-HSCT can be made. Our study proposal would like to assess the question of prophylactic DLI efficacy, as a proof of concept of early immune intervention after Allo-HSCT. The investigators, therefore, designed a prospective multicenter randomized trial evaluating the impact of early DLI on outcome after Allo-HSCT for AML.


Eligibility Criteria:
Inclusion Criteria:

* AML in hematological complete remission at the time of inclusion
* Patient age from 18 to 70.
* Able to comply with the protocol.
* Written informed consent.
* Allogeneic stem cell transplantation from any donor except cord blood.
* Unmanipulated bone marrow or peripheral blood stem cells as graft source are allowed
* Ongoing GVHD prophylaxis using cyclosporin A at the time of inclusion.

Exclusion Criteria:

* Presence or history of grade 2 to 4 acute GVHD.
* No hematological CR of AML at the time of inclusion. CR patients positive with molecular or phenotypic minimal residual disease (MRD) can be included.
* Pregnancy/breast feeding.
* Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
* Concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure...).
* Primary or secondary graft failure.
* Previous solid organ allogeneic transplantation.