cyrilzakka/clinical-trials huggingface dataset:
Hyperoxia and Hypertonic Saline in Septic Shock

Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.

The study is designed as factorial 2x2. Patients will be stratified at the randomisation according the presence or absence of Acute Respiratory Distress Syndrome in order to perform a sub group analysis for all outcome criteria.

Eligibility Criteria:
Inclusion Criteria:

* patients with less than 6 hours septic shock according criteria of Bone
* minimal dose of catecholamines at least 0.1 µg/Kg/min
* patient with mechanical ventilation
* written informed consent

Exclusion Criteria:

* age \< 18 years
* pregnancy
* participation in other trial with the same endpoint
* moribund
* absence of registration in french health care system
* patient protected by law
* hypernatremia \< 130 mmol/l ou \> 145 mmol/l
* patient with P/F \< 100 mm Hg with PEEP \> 5 cms of water
* intracranial hypertension
* patient admitted for cardiac arrest
* overt cardiac failure
Prospective Evaluation of Asians With CRT for Heart Failure

Aim:To determine the baseline characteristics of heart failure patients in Singapore undergoing cardiac resynchronization therapy (CRT); the long term outcome and predictors of response to CRT.

Methodology:Among patients undergoing CRT for severe heart failure according to indications stipulated in international Cardiology guidelines, baseline demographic data is collected. Age, gender, NYHA functional class, co-morbidities, QRS width on ECG, presence of left bundle branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. In addition, during the CRT implant procedure, blood is drawn from the vascular access and analysed for NT-pro BNP levels and other biomarkers of heart failure.

The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and 12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of \>/= 15% and/or an increase in the LVEF of \>/= 10%.

Among patients undergoing CRT for severe heart failure according to indications stipulated in international Cardiology guidelines, baseline demographic data is collected. Age, gender, NYHA functional class, comorbidities, QRS width on ECG, presence of left bundle branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. In addition, during the CRT implant procedure, blood is drawn from the vascular access and analysed for NT-pro BNP levels and other biomarkers of heart failure. The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and 12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of \>/= 15% and/or an increase in the LVEF of \>/= 10%.

Eligibility Criteria:
Inclusion Criteria:

* Broad QRS (\>120 ms)
* EF \< 40%
* Symptomatic heart failure
* Not on optimal medical therapy

Exclusion Criteria:

* Pregnant
* \< 18 years of age
* Infection
* Unable to consent
Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

The purpose of this project is to determine if in a selected group of patients, at higher risk of wound dehiscence and other complications, treatment by local excision and management by a "watchful waiting" or an initial "non-operative management" approach, with an offer of radical resection only to those patients whose tumors demonstrate "regrowth" will maintain acceptable local control and overall survival rate for the whole cohort.

This is a prospective registration study of a very limited number of subjects (3-8/year) who have achieved full or near full clinical CR after neo-adjuvant FOLFOX chemotherapy prior to chemo-radiotherapy, but without subsequent surgery, to determine whether a "wait and see" approach will maintain local control while improving quality of life. Patients will undergo standard of care baseline work-up for their disease before being enrolled to the protocol followed by protocol treatment, all standard of care just in reverse order. Patients with less than 1/2 of the rectum being circumferentially involved at diagnosis will also receive additional brachytherapy which will be supported by hospital funded research dollars. Patients will undergo additional testing for study related purposes during the restaging processes such as MRI, endoscopic ultrasound, and will complete an assessment to determine impact on quality of life. Providers that will be conducting the MRI and endoscopic ultrasound have agreed to waive professional fees, as well as the hospital has agreed to waive facility fees that have been incurred while the patient is on study protocol. Patients will follow standard of care guidelines for follow up post-excision if they do not respond to treatment, and modified standard of care guidelines if their are identified as complete responders which will include additional imaging at specific milestones, again waived by providers and facility. Patients on watchful waiting, who recur locally will undergo total mesorectal excision. Patients will not be responsible for any fee incurred that is not considered standard of care.

Patients will be accrued as they present to the Van Elslander and Webber cancer center clinics. They will be enrolled in this arm of the study only if surgical evaluation indicates that surgical resection will extend to include the dentate line if said patients were candidates for local excision. We expect that about 3 patients/year will be eligible.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of rectal invasive adenocarcinoma
3. Tumor in the low rectum lying \< 4 cm from the anal verge
4. Clinical stage T3/N0-N1M0.
5. Patients with low T2 who will need abdominal perineal resection are also eligible.

Exclusion Criteria:

1. Age less than 18 years
2. Other forms of cancer
3. Tumors \>= 4 cm from the anal verge
4. Tumors of other clinical stages than listed above
A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.

This was a multinational, multicenter, randomized, double-blind, 2-arm, parallel-dosing designed study. The treatment period was 12 months. Eligible participants were randomized to 1 of 2 treatment groups: abatacept fixed dose approximating 10 mg/kg (based on participant's body weight; 500 mg for participants weighing \< 60kg; 750 mg for participants weighing 60 to 100 kg; and 1 gram for participants weighing \> 100 kg, monthly) or placebo intravenous (IV) infusion. All participants continued their background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period. Double-blind study medication (abatacept or placebo) was administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses.

All participants who completed the 12-month double-blind study period (Day 1 through Day 365), were eligible to continue into the open-label period. All eligible participants (active or placebo) were re-allocated to receive abatacept at a weight-tiered dose that approximated 10 mg/kg, based on their Day 365 body weight. Participants continued to receive infusions every 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology functional classes I, II III or IV
* Participants must be taking 1 or more DMARDs and/or biologic approved for rheumatoid arthritis (RA) for at least 3 months and be on a stable dose for 28 days prior to Day 1.

Exclusion:

* Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus \[SLE\], Scleroderma)
* Active tuberculosis (TB) requiring treatment within last 3 years
Perioperative Neuroprotection of Stellate Ganglion Block

To investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery

The vasospasm after cranial aneurysm surgery have a higher incidence, but not have an ideal treatment method. At present, the medical treatment is very limited effect to prevent the perioperative cerebral ischemia.Stellate ganglion block （SGB）is an effective and well-tolerated approach to the treatment of CVS in various clinical settings.Resent study indicated that SGB has a protective effect on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage.Therefore,we hypothesized that the preoperative SGB would be a effective treatment for improvement of vasospasm after cranial aneurysm surgery.

Eligibility Criteria:
Inclusion Criteria:

* aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery，
* ASA grade：Ⅱ-Ⅲ，
* Hunt～Hess grade :Ⅰ-Ⅲ,
* have a informed consent.

Exclusion Criteria:

* history of mental illness，
* local infection who can't do stellate ganglion block，
* pregnant or lactating，
* nausea cancer or diabetes，
* participated the study or other related research in the last 30 days，
* unruptured aneurysms patients
Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.

To evaluate the safety and efficacy of an implantable neural acquisitor \& stimulator system in patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders).

Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 80 years of age;
2. Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
3. After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
4. The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
5. The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.

Exclusion Criteria:

1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
2. Combined with progressive neurological disease；
3. Combined with surgical contraindications identified by surgeons and anesthesiologists;
4. Participating in other clinical trials;
5. Other conditions deemed inappropriate by investigators and medical staff.
K-RAS and EGFR in Lung Cancer

Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed NSCLC
* Signed and dated written informed consent
* Age 18 years
* Available cytological material

Exclusion Criteria: -
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
* Have moderately-to-severely active RA, at screening and baseline, defined by the presence of

  * ≥6 swollen joints based on 66 joint count, and
  * ≥6 tender joints based on 68 joint count.
* Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.

Exclusion Criteria:

* Have Class IV RA according to ACR revised criteria.
* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to

  * poorly controlled diabetes or hypertension
  * chronic kidney disease stage IIIb, IV, or V
  * symptomatic heart failure according to New York Heart Association Class II, III, or IV
  * myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
  * severe chronic pulmonary disease, for example, requiring oxygen therapy
  * major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,

    * systemic lupus erythematosus
    * psoriatic arthritis
    * axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
    * reactive arthritis
    * gout
    * scleroderma
    * polymyositis
    * dermatomyositis
    * active fibromyalgia, or
    * multiple sclerosis
Hepatitis E Virus Infection in Oncological Patients

The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany. Consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of HEV infection using two distinct anti-HEV IgG and IgM enzyme-linked immunosorbent assays (ELISAs). Serum was taken from each patient before treatment initiation and during treatment follow-up. Primary endpoint was determination of HEV seroprevalence. A healthy cohort was established alongside a cohort of patients who had been hospitalised due to a diagnosis of SARS-CoV-2 infection. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.


Eligibility Criteria:
Inclusion Criteria:

* different hemato-oncological entities without age restriction

Exclusion Criteria:

* patients already receiving antineoplastic therapies
* not given written consent
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects and their caregivers must provide informed consent prior to study entry.
* Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months.
* Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
* Female subjects of child-bearing potential must agree to abstinence or an approved form of birth control.
* Subjects must have adequate blood pressure and laboratory values.

Exclusion Criteria:

* Subjects with a diagnosis of possible, probable or definite vascular dementia may not participate.
* Subjects with known hypersensitivity to sunlight or a history of seizures, previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.
Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital

The Endocrinology Unit of the IRCCS San Raffaele Hospital is dedicated to establishing a prospective single-center registry with data from patients undergoing vitamin D supplementation, initiating their first visit to the outpatient unit until December 2029. 1000 patients will be enrolled, aligning with the unit's recent patient influx for hypovitaminosis D.

The registry's goal is to assess the epidemiological trend, identify risk factors, and evaluate the diagnostic and therapeutic clinical management strategies for hypovitaminosis D. It will involve collecting clinical, laboratory, and historical data during outpatient visits, adhering to the standard diagnostic and therapeutic protocols for endocrine-metabolic diseases. This data collection is expected to continue for a duration of ten years.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women (age ≥ 18 years) regardless of fertility status and pregnancy/breastfeeding conditions
* Vitamin D supplementation, with any formulation and dosage
* Signing of informed consent

Exclusion Criteria:

* Patients unable to understand and sign informed consent.
A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia

In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to which administration schedule of Neupogen is the best for patients, the investigators are performing a randomized study for which patients will receive either 5, 7 or 10 days of Neupogen. Neupogen can cost approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment, this can cost $16,000 compared to a 5 day treatment which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high cost. This study will use an oral consent model to compare 5, 7 and 10 days of Neupogen to evaluate rates of febrile neutropenia and hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary breast cancer
* Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy
* ≥19 years of age
* Able to provide verbal consent

Exclusion Criteria:

* Contraindication to Filgrastim
Imaging Control Study, 3D Echo, MR and RHC.

The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy.

The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.

It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.

Eligibility Criteria:
Inclusion Criteria:

* age \>17
* pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
* written informed consent
* Prostanoid naive
* no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study

Exclusion Criteria:

* pregnancy and lactation period
* Women of childbearing potential who do not use an effective and secure method for birth control
* severe chronic kidney insufficiency (glomerular filtration rate \<30), which will remain for more than 3 months
* liver insufficiency Child C
* life expectancy shorter than the course of the study (for example because of a malignant disease)
The Effect of Modified Valsalva Maneuver on Filling Degree of Internal Jugular Vein

To explore the effect of modified valsalva maneuver on the filling degree of right internal jugular vein.

Method: The anteroposterior diameter and left-right diameter of right internal jugular vein in thirty adult gynecology patients were recorded during normal respiration and modified valsalva maneuver respectively.

Investigators hypothesis that modified valsalva maneuver would enchance the filling degree of right internal jugular vein.


Eligibility Criteria:
Inclusion Criteria:

- female patients age 18-60 years

Exclusion Criteria:

* heart or lung disease mental illness communication barriers.