cyrilzakka/clinical-trials huggingface dataset:
Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

Part 1of the study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of increasing doses of a vaccine-based immunotherapy regimen (VBIR-2) for patients with advanced or metastatic non-small cell lung cancer and metastatic triple-negative breast cancer.

Part 2 will evaluate the safety, pharmacokinetics and pharmacodynamics, immunogenicity and preliminary evidence of efficacy of the Expansion dose of VBIR-2 in participants with advanced or metastatic non-small cell lung cancer.

The study is divided into two parts, Dose Escalation (Part 1) in participants with NSCLC and TNBC without acceptable alternative treatment options, followed by Dose Expansion (Part 2) in participants with NSCLC who have progressed on or after treatment with platinum-based chemotherapy and treatment with 1 immune checkpoint inhibitor, given concurrently or sequentially with chemotherapy.

Part 1 has been completed.

Eligibility Criteria:
Inclusion Criteria:

Part 1:Histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer. Adequate bone marrow, renal and liver function.

Part 2: Histological or cytological diagnosis of metastatic non-small cell lung cancer previously treated with 1 or 2 regimens in metastatic setting including a CPI and platinum-based chemotherapy. Adequate bone marrow, renal and liver function.

Exclusion Criteria:

* Known symptomatic brain metastases
* ECOG performance status greater than or equal to 2
* Concurrent immunotherapy
* History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
* History of inflammatory bowel disease.
* Current use of any implanted electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
* Presence of any surgical or traumatic metal implants at the site of administration
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.

The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute ischemic stroke
* Informed consent
* Age between 18 and 85 years
* Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
* NIHSS Score of 4-24
* Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries

Exclusion Criteria:

* Pre-stroke mRS \>1
* Previous exposure to desmoteplase
* Extensive early infarction on MRI or CT in any affected area
* Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
* Internal carotid artery occlusion on the side of the stroke lesion
* Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
* Treatment with oral anticoagulants and a prolonged prothrombin time
* Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
* Treatment with a thrombolytic agent within the past 72 hours
Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory

Frailty is common in patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the health ecology theory , to change some critical variable factors in the future, improving the overall prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastric cancer
* Age over 60 years old
* With clear surgical indication

Exclusion Criteria:

* Malignant tumors in other parts of the body
* Severe cardiopulmonary complications
* Receive palliative surgery
* Have received preoperative radiotherapy and chemotherapy
Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions with the defective visual field sectors of the visual field (primary outcome measure).

exploratory, randomized, controlled study

Eligibility Criteria:
Inclusion Criteria:

* residual vision
* patients with optic nerv lesion
* lesion age at least 6 months
* stable visual field defect

Exclusion Criteria:

* electric or electronic implants such as pace maker
* any metal artefacts in head and truncus
* epilepsia
* photosensitive epilepsy as determines by EEG
* autoimmune illnesses in acute stage
* mental diseases such e.g. schizophrenia etc.
* diabetes causing diabetic retinopathy
* addiction
* high blood pressure
* unstable or high level intraocular pressure (i.e. \> 27 mmHg)
* retinitis pigmentosa
* pathological nystagmus
* presence of an un-operated tumor or tumor recidive
Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents

Catheter occlusion and dysfunction are common complications of central venous access device (CVAD) use in children with cancer and hematologic disorders. These events can lead to interruption of therapy and may require device removal and replacement. Attempts to clear occlusion can cause device fracture.

There is a clear link between catheter occlusion and other serious complications including bloodstream infection and intravascular thrombosis.

There is evidence that catheter occlusion or dysfunction may be preceded by subclinical catheter narrowing, which could be detected by accurate measurement of catheter resistance.

This study aims to observe and describe the feasibility and results of catheter resistance monitoring (CRM) over time with the aim of prospectively identifying patients at high risk of catheter occlusion.

If CRM is feasible and proves to be sensitive and specific, it could provide an opportunity for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection or thrombosis.

Weekly measurement of catheter resistance will be determined using the Alaris® Syringe Module (Carefusion Inc., San Diego, USA), a commercially available, FDA-approved intravenous (IV) pump which is able to deliver accurate flow-rates and obtain accurate pressure measurements. The inline pressure will be measured at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve.

Primary Objective

* To describe the feasibility of weekly CRM in children and adolescents treated at St. Jude.

Secondary Objectives

* To describe patient and caregiver adherence with weekly CRM in children and adolescents treated at St. Jude.
* To explore the correlation between results of CRM and catheter occlusion or dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Receiving treatment for any disease at St. Jude Children's Research Hospital (SJCRH).
* Age ≥5 years to \<25 years.
* Participant is using either a single or double lumen tunneled CVAD (ports will not be eligible) as part of standard clinical care.
* Participant anticipates being present weekly at SJCRH for at least 12 weeks

Exclusion Criteria:

* Plan to remove CVAD within 12 weeks.
* Expected survival less than 12 weeks
* Past enrollment in the CaRMA study or past catheter resistance monitoring
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models. In this study, subjects will breathe gas mixtures of different densities and viscosities for brief periods of time in order to test those models.

Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models.

In this study, subjects will breathe gas mixtures of different densities (helium and sulfur-hexafluoride) or viscosity (neon) for brief periods of time during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP). The investigators will test some models of upper airway collapse by observing if flow while breathing different gas mixtures scales according to the differences in density and viscosity.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects or patients with OSA

Exclusion Criteria:

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Allergy to lidocaine or oxymetazoline hydrochloride
* For women: Pregnancy
Trauma-Focused Intervention With Women Experiencing Homelessness

Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.

Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. We have systematically adapted a trauma-focused intervention protocol (Narrative Exposure Therapy \[NET\]) to the self-identified needs and preferences of trauma-affected women experiencing homelessness. This adapted intervention, "NET+", incorporates strengths and preferences identified by women themselves, embedding principles of cognitive behavioral therapy (CBT) into conventional NET. NET+ aims to both employ core NET principles to re-process past trauma in parallel with building present-centered skills to address avoidant coping motives in PTSD+SUD. Via a pragmatic, waitlist randomized controlled trial, we will further assess the feasibility, acceptability, and preliminary effects of a 3-week NET+ intervention protocol with up to 100 women experiencing homelessness. We will determine pre- and post-NET+ intervention PTSD and trauma-related symptom scores (depression, anxiety, somatization, sleep), substance use behaviors, and effect sizes. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.

Eligibility Criteria:
Inclusion Criteria:

* self-identifies as a woman;
* greater than or equal to 18 years;
* positive screen on TAPS-1 (reflecting problematic substance use);
* recently (within 1 year) or currently homeless (HRSA definition);
* affected by a traumatic life event and trauma-related distress (+Life Events Checklist for DSM-5 Standard \[LEC-5\] response ≥1 and PTSD Checklist for DSM-5 \[PCL-5\] score ≥28).

Exclusion Criteria:

- impaired decisional capacity to consent to participation (University of California, San Diego Brief Assessment of Capacity to Consent \[UBACC\] score ≤14.5)
Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Prospective and randomized trial comparing internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm in a single center study at AC Camargo Cancer Center. Every surgery is assisted by ultrasound and radioscopic and the catheter is districath®, 8.5 French. Clinical assessment will be at 10 days and every 3 months after surgery. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Catheter due to chemotherapy.
* Cancer patients.
* ECOG (performance status) from 0 to 2.
* Signed informed consent form.

Exclusion Criteria:

* Non compliance.
* Anticoagulant therapy.
* Coagulopathy (platelet count below 50,000 and/or protrombin time above 18s).
* Death within 30 days after the procedure.
* Another catheter in superior vena cava.
* Previous long term catheter in superior vena cava.
* Obesity (IBM\>40 Kg/m2).
Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer.

II. Determine the toxicity and feasibility of this regimen in these patients. III. Determine potential antitumor activity of this regimen as assessed by objective response in these patients.

OUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).

Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed extensive stage small cell lungcancer
* No active CNS disease

  * CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 2 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* AST and ALT no greater than 2.5 times upper limit of normal (ULN)
* PT and PTT no greater than 1.5 times ULN
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reactions to compounds of similar chemical or biologic composition to study agents
* No other uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* See Disease Characteristics
* At least 1 week since prior CNS radiotherapy and recovered
* No prior radiotherapy to more than 25% of skeleton
* No other prior anticancer therapy
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent anticoagulation therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
Medication Regimen Complexity and Glycemic Control in Patients With Diabetes

Polypharmacy is an alarming health issue that is defined as prescription of multiple medications, of which some are redundant or unnecessary. Due to comorbidities, diabetic patients are often prescribed multiple medications. Over prescribing occurs either due to, prescribing medications that are not indicated, continuation of certain medications beyond the time of indication, or prescribing more than one medication with the same effect. Improving glycaemic control is the cornerstone for the prevention and treatment of the diabetic complications.

Hypothesis In addition to the side effects and cost of the unnecessary medications, the investigators hypothesis is that poly-pharmacy will adversely affect patients' compliance with the necessary medications.The investigators propose that elimination of unnecessary medications might improve patients' compliance and consequently improve glycemic control diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

All diabetic patients who are eligible by fulfilling all of the following criteria:

1. HGBA1c ≥7 mg/dl.
2. 2) Poly-pharmacy: defined as the use of five or more medications.
3. Non- compliance: patients were surveyed with both direct and indirect methods to identify non adherence.

Exclusion Criteria:

Exclusion after recruitment Any patient whose diabetic medications regimen changed after recruitment due to hospitalisation, illness, stress or patients preference, will be excluded.
Registry for Longitudinal Mortality and Therapy in Patients With Heart Failure

The purpose of this registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from hospitals across China.

Registry for Longitudinal mortality and therapy in patients with Heart Failure is a large, multicenter, prospective, open-label registry of the management of patients treated in the hospital for acute heart failure in China. The objective of this study is to investigate the clinical features and prognosis of patients with heart failure, and discover the characteristics of high-risk heart failure patients, and elucidate critical factors which predict the development and outcomes of symptomatic heart failure patients.

1. To elucidate the clinical characteristics and prognostic risks of patients with heart failure.
2. To study the characteristics of high-risk heart failure patients and predict the key factors for the development of symptomatic heart failure patients.
3. To elucidate the compliance of patients with heart failure and the incidence of adverse drug effects.
4. To investigate the effect of self-management on outcomes in patients with heart failure.
5. To elucidate critical factors associated with the development and outcomes of heart failure.
6. To investigate hospitalization expenses for heart failure.

Eligibility Criteria:
Inclusion Criteria:

- 1. 18 years and older. 2. Meet the diagnostic criteria of China 2018 or JACC/AHA 2017 or ESC 2016 heart failure guidelines.

3. Agree to be tested and sign an informed consent certificate.

Exclusion Criteria:

* 1. Age\<18 years old. 2. Patients who refused to participate. 3. Patients may have a life expectancy of less than 1 years due to non- heart failure clinical conditions.
Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis

Erbium:yttrium aluminum garnet (Er:YAG) ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional laser ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The formed MAZ depends on the laser parameters such as laser depth, laser density and laser passes, which affect the treatment outcome.

This study evaluated whether different laser densities influenced the efficacy, side effects, cosmetic outcomes, and protoporphyrin IX (PPIX) accumulation of AFL-PDT for facial AK in a randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions

Exclusion Criteria:

* photosensitivity disorder patients
* Lactating or pregnant women
* Patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
* Patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment