cyrilzakka/clinical-trials huggingface dataset:
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

For patients with advanced HCC not suitable for resection or liver transplantation but without extrahepatic manifestations, local therapy with TACE is regarded as standard treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A combination of TACE with a multitarget inhibitor like sorafenib may further improve the outcome of patients with HCC.


Eligibility Criteria:
Inclusion Criteria:

* with histologically confirmed HCC not suitable for resection or liver transplantation
* Patients with measurable disease according to RECIST
* Performance status ECOG 0-2
* Normal organ and bone marrow function (defined)
* Women of childbearing potential must have performed a negative serum pregnancy test
* male or female patients must use an approved contraceptive method during treatment and for 3 months after end of treatment after the end of treatment with study medication
* Written informed consent

Exclusion Criteria:

* Patient is eligible for liver resection or liver transplantation
* Extrahepatic tumor manifestation
* Thrombosis of the portal vein
* \> 8 points according to Child Pugh classification
* Prior TACE or RFTA or any other local ablative treatment
* Prior systemic anticancer chemotherapy or radiotherapy for HCC
* Total bilirubin \> 4.5 mg/dl
* Life expectancy of less than 12 weeks
* Esophageal varices grade III without prophylactic band ligation
* Cardiac diseases (defined)
* Uncontrolled hypertension
* Known or suspected hyperthyroid state
* Known brain metastasis
* Patients with seizure disorder requiring medication
* History of organ allograft
* Active clinically serious infections \> CTCAE grade 2
* Thrombotic or embolic events
* Hemorrhage/bleeding event (defined)
* Acute variceal bleeding
* Therapeutic anticoagulation with vitamin K antagonists (defined)
* Known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given in the course of this trial
* Contraindications to the use of sorafenib, doxorubicin or lipiodol
* Previous cancer distinct in primary site or histology from HCC (defined)
* substance abuse
* Participation in another clinical trial with any investigational study drug
* Lactating women
* Incapability to give valid informed consent
β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients

This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours
* IV access for administration of study drug
* Subject (or subject's legal representative) able to give written informed consent

Exclusion Criteria:

* History of hypersensitivity or intolerance to echinocandin antifungals
* Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
* Pregnant or lactating women
* Treatment with systemic antifungal therapy within the preceding 7 days
* Documented invasive fungal infection at baseline/screening
* Life expectancy less than 2 days or moribund
Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection

Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma/mucosa, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 6 months of receiving intervention will be analyzed.

Up to 25% of HIV-infected individuals receiving antiretroviral treatment demonstrate suboptimal blood cluster of differentiation 4（CD4） recovery despite effective viral suppression; this "immunologic non-responder" (INR) phenotype is associated with increased immune activation and with higher rates of AIDS and non-AIDS related conditions, and death. Poor gut integrity, increased microbial translocation, and reduced CD4 T-cell trafficking to the gut could be a source of ongoing inflammation in INR individuals. Researches have shown that the gut microbiota compositions are different in INRs and immunological responders (IRs). Probiotics, by modulation of gut microbiota, can help induce epithelial healing and prevent bacterial translocation. Probiotic supplementation, therefore, may be a nutritional target for INRs by boosting CD4 cell counts. We design a prospective, case-control, self-contrast study to explore the efficacy and safety of probiotic supplementation in INRs. Participants will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma/mucosa, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 6 months of receiving intervention will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* 18-65 years old
* On antiretroviral therapy (\>2 years)
* Ability to provide informed consent
* Undetectable plasma HIV-1 viral load for the past 2 years
* CD4 T-cell count \<350/mm3 for the last 2 years
* No history of gastrointestinal diseases

Exclusion Criteria:

* Administration of antibiotics, probiotics, or prebiotics or experience of diarrhea within the previous 3 months;
* Administration of anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, immunomodulator within the previous 3 months;
* Severe organ dysfunction
* Pregnancy or breastfeeding
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections

This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.

This was a Phase III, multi-center, randomized, double-masked, parallel group study with 2 masked arms in which participants were randomized 2:1 to receive brolucizumab or aflibercept. All participants had study visits every 4 weeks through week 104.

The study consisted of three study periods:

Screening Period: The screening period lasted up to 2 weeks prior to administration of the first dose of study treatment, dependent upon confirmation of the patient meeting eligibility criteria.

Double-Masked Treatment Period: Participants meeting eligibility criteria entered the treatment period and were randomized in a 2:1 ratio into one of the following 2 masked treatment arms at the Baseline visit: Brolucizumab 6 mg injected every 4 weeks or Aflibercept 2 mg injected every 4 weeks. Treatment period lasted up to week 100.

Safety Follow up Period: Participants were followed up for safety during 4 weeks after the last dose of study treatment. Including the Screening Period, the total study duration for a participant was up to 106 weeks.

Some participants were eligible to continue into an extension study in order to receive treatment with brolucizumab (a) after completing the 104 -week double-masked treatment period, (b) upon meeting all inclusion/exclusion criteria for the extension study, and (c) based on Investigator's judgment that the participant was expected to benefit from treatment with brolucizumab.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Diagnosis of wet age-related macular degeneration (AMD)
* Currently receiving anti-VEGF injections

Exclusion Criteria:

* Active infection or inflammation in either eye
* Significant fibrosis in the study eye
* Recent ocular surgery
* Uncontrolled glaucoma
* Use of medications as specified in the protocol
* Pregnant, nursing
* Of child-bearing potential unless using highly effective method of contraception
Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart

CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥18 years old.
* Subject must have been referred for an elective coronary angiography for one of several specified conditions.

Exclusion Criteria:

* The subject has impaired renal function with a serum creatinine level ≥1.7 mg/dL (150 μmol/L). If the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dL (150 μmol/L), the investigator should follow the practising guideline(s) of their institution.
* Subject has a known allergy to iodinated contrast agent
* Subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac CT images.
* The subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated.
* Use of nitroglycerin is contraindicated.
* Subject has had a prior CABG procedure.
* Subject has a metal cardiac stent in place or artificial heart valve(s).
* Subject has had a prior pacemaker or internal defibrillator lead implantation. Subject must agree to discontinue metformin day of and for 48 hours after the CTA procedure.
Modeling Outcome in Patients With Acquired Brain Injuries

Acquired brain injury (ABI) is the leading cause of death and disability worldwide. The degree of severity varies according to a combination of numerous demographics, etiological, clinical, cognitive, behavioral, psychosocial and environmental factors, which can interfere with the effectiveness of rehabilitation interventions and, therefore, with the final outcome.

The most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment, but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach.

In recent years, artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome. The classical approach of these algorithms provides only probabilistic values on the final outcome, without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period.

The objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period. The proposed approach combines a principal component analysis (PCA) for dimension reduction (capturing the maximum amount of information and reducing the dimensionality problem) and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions. By using this approach, we may determine the individual patient's temporal trajectories while examining particular clinical factors. The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index (ERBI), a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury.


Eligibility Criteria:
Inclusion Criteria:

* patients with clinical diagnosis of severe acquired brain injury of different etiology (traumatic, hemorrhagic vascular,ischemic vascular, anoxic, infectious, other etiology
* interval since the acute occurrence that led to the clinical condition of ≤3 months duration
* age of 18 years or older
* informed consent signed by family member/caregiver/supporting caregiver

Exclusion Criteria:

* Positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders
Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device

Survival of fully buried avalanche victims depends in major part on a triad of hypoxia, hypercapnia, and hypothermia and therefore decreases rapidly after complete burial. Besides optimizing companion rescue, which still today and even by trained people often takes more than 15 minutes to the extraction of an avalanche victim, prolonging the ability to breath after critical avalanche burial increases survival probability by giving rescuers more time to find and unbury avalanche victims. Based on previous research, the Norwegian company Safeback SE (Bergen, Norway) developed a new non-medical device using an innovative functional principle. The device, called the Safeback SBX (Safeback SE, Bergen, Norway), should make it possible to prevent asphyxia by delivering fresh air to the air pocket. Company claims to achieve a prolongation of survival up to over 60 minutes, giving companion rescuers as well as professional rescue teams more time to get access to the victim. Technical tests conducted by the developing company already provided some promising results regarding the general functioning. However, this study is needed to provide the scientific evidence of the effectiveness and influence on physiologic parameters buried in snow debris humans under realistic conditions.


Eligibility Criteria:
Inclusion Criteria:

- healthy ASA I subjects

Exclusion Criteria:

* ASA class II or higher
* chronic high degree cardiovascular or pulmonary disease
* claustrophobia
* psychiatric or neurological disease
* long-term medication
* pregnant woman
* no informed consent
* history of fever or serious cough in the past two weeks
* current Covid-19 symptoms or recently tested positive for Covid-19
* body temperature ≥ 37.5°on test days.
ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region

ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these.

The purpose of this study was to determine the impact of ICU delirium in terms of both patients and beds. The study was carried out prospectively, over a one-week period, at adult ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).

Previous delirium prevalence research has been carried out at single sites and yielded highly variable results (between 3-87%). Reliable multisite data can be obtained cost-effectively using a point-prevalence ("snapshot") approach.

Purpose: to obtain reliable data informing on prevalence of ICU delirium, in terms of both patients and beds, across the eastern UK region.

Design and Setting: this one-week observational prospective cohort study was carried out between June 25, 2012 (start of ICU day shift) to July 01, 2012 (end of night shift). Nine ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN) took part. Cambridgeshire 2 Research Ethics Committee approved the study (REC reference: 10/H0308/116) and waived the need for informed consent.

Patients and procedure: All adults treated over the study week at participating ICUs were considered eligible for inclusion. Delirium screening was carried out by patients' direct care clinicians using the Confusion Assessment Method for the ICU (CAM-ICU). All sites used this tool as part of their routine clinical practice and had delirium management guidelines in place at the time of the study. Patients who screened positive for delirium were treated according to local hospital practice.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK

Exclusion Criteria:

-
A Pilot Study Evaluating Heart and Lung Metabolism in Pulmonary Hypertension Associated With Left Heart Disease

Right ventricular (RV) failure is the leading cause of death in pulmonary arterial hypertension. (PAH) Right ventricular ejection fraction is one of the most important predictors of prognosis in heart failure patients regardless of cause. It is estimated that 30-50% of patients with heart failure and preserved ejection fraction (HFpEF) have right ventricular dysfunction and up to 70% of these patients will have significant pulmonary hypertension (PH), both of which are related to much worse prognosis. Right ventricular failure is becoming an increasingly prevalent and significant cause of morbidity in patients with left heart disease. Despite the significance of RV function to survival, there are no therapies available that directly or selectively improve RV function.

The overall theme of this research project is to evaluate the mechanisms that contribute to the cause of right heart failure. This small study is designed to look at the role of heart and lung metabolism and pulmonary hypertension as they relate to the development of right heart failure in cardiovascular disease.(PH-LHD)

The hemodynamic definition of PH-LHD involves a mean pulmonary artery pressure (mPAP) \>25mm Hg at rest and pulmonary capillary wedge pressure (PCWP) of ≥15.The coexistence of mitral insufficiency is also a characteristic of PH-LHD. HFpEF is a condition caused by impaired relaxation of a stiffened myocardium as a consequence of an increased load to the left ventricle due to elevated systemic pressures.

Pulmonary hemodynamics can be used to classify PH LHD as either passive or reactive, irrespective of LV function. It has been suggested that diastolic pressure gradient (DPG) may offer added prognostic value as a more accurate indicator of pulmonary vascular remodeling.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to provide their written informed consent to participate in the study after having received adequate previous information and prior to any study specific procedures.
* At least 18 years of age at the time of screening.
* Patients with PH secondary to left heart disease (known as group II PH) defined as a mean PAP\>25 mmHg and a PCWP of ≥15 mmHg.

Exclusion Criteria:

* All other types of pulmonary hypertension including Dana Point Classification Group 1, 3, 5.
* Type II Diabetes mellitus requiring medical therapy
* Previous myocardial infarction within the 3 months prior to screening.
* Renal insufficiency (glomerular filtration rate \< 30 ml/min.
* ALT or AST \> 3times ULN and/or severe hepatic insufficiency.
* Contraindication to MRI imaging.
Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy

This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six chemotherapy cycles.


Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females at least 18 years of age
2. Diagnosis of high-risk stage I, II or IIIa breast cancer suitable for adjuvant TAC chemotherapy as based on investigator judgment
3. Candidates for TAC chemotherapy, and no prior treatment with anthracyclines

Key Exclusion Criteria:

1. Received chemotherapy within last 3 month prior to screening, or expected to receive any chemotherapy other than TAC and / or immunotherapy between screening and 30 days after last planned study drug administration
2. Any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of TAC chemotherapy in the full dose, including abnormal liver function, inadequate cardiac function or clinically significant cardiac disease, neuropathy or other disease
3. Prior bone marrow or peripheral blood hematopoietic stem cell transplant
4. Any active cancer or history of prior malignancy within the last 5 years except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancy diagnosed 5 years or more before diagnosis of breast cancer
Attitudes Towards Receiving Mental Health Care Using Telehealth During the Coronavirus Disease 2019 (COVID-19) Pandemic

The purpose of this study is to collect patients' experiences and feedback to better understand and improve mental health care using telehealth services. This is critically important as telehealth appointments, including both phone and video calls, continue to be offered for regular appointments to reduce in-person interaction as a preventive measure to help control the spread of COVID-19.

Studying patients' perceived benefits and challenges of using telehealth services for mental health care will allow us to prioritize improvements to the telehealth experience and potentially, patient adoption of and comfort with remote appointments. This study's results would also inform policy makers and insurance companies about the potential utility of delivering mental health care through telehealth, even beyond the duration of the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and over who received mental health care through Northwestern prior to telehealth implementation from March 15th 2019 to March 14th 2020, and had at least one mental health care appointment through Northwestern between March 15th 2020 and September 30th 2020.

Exclusion Criteria:

* Adults unable to access study questionnaires via computer or mobile device