cyrilzakka/clinical-trials huggingface dataset:
Neuromodulation of Cognition in Older Adults

This study will investigate whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.

The current study will investigate methods for enhancing cognitive training effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Adults over the age of 65 represent the fastest growing group in the US population. As such, age-related cognitive decline represents a major concern for public health. Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. However, these effects are typically limited to the tasks trained, with little transfer to other cognitive abilities or everyday skills. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and CT combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age: 65 to 90 years
* English speaking
* Physically mobile
* working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.

Exclusion Criteria:

* Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
* Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
* Past opportunistic brain infection.
* Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality).
* Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
* MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
* Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
* Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
* Hearing or vision deficits that will not allow for standardized cognitive training.
* Left handedness
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)

The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.

Concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. In this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the World Health Organization (WHO) personal safety case report database (VigiBase) and FDA Adverse Event Reporting System (FAERS).

Eligibility Criteria:
Inclusion Criteria:

1. Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024.
2. Adverse events reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Sudden death (PT), Sudden cardiac death (PT), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT), Vascular disorders NEC(HLGT), Vascular inflammations(HLGT), Embolism and thrombosis(HLGT), Vascular hypertensive disorders(HLGT), Blood pressure disorders NEC(HLGT), Venous varices(HLGT), Arteriosclerosis, stenosis, vascular insufficiency and necrosis(HLGT), Aneurysms and artery dissections(HLGT).
3. Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
4. The number of reports corresponding to each drug or adverse event is at least three.
5. The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.

Exclusion Criteria:

1. Any of the information in the baseline information such as gender, age, region, date of report is empty.
2. The severity level of the reported adverse event is empty.
3. Adverse events were reported in patients whose drug indications included cardiovascular disease.
Mitochondrial Dysfunction Contributes to Sepsis Induced Cardiac Dysfunction

This proposal hypothesizes that mitochondrial bioenergetics in the patient will correspond to mtDNA DAMPs levels and markers of inflammation. We predict these will serve as a prognostic indicator of Sepsis induced cardiac dysfunction (SICD) outcomes. Successful completion of these studies will provide a clearer understanding of the etiology of SICD development and therefore will have a high impact on biomedical research by identifying a new mechanism for understanding sepsis induced organ failure. Importantly, they will also provide a means for more directed and focused therapies, based upon individual bioenergetic/mitochondrial-mediated inflammation profiles. The combined, complementary expertise of the Mentor/co-primary investigators (Drs. Mathru and Ballinger) provide an excellent combination in both basic and translational research. They also have experience conducting studies and publications that will strengthen this research project. Importantly, the methods for characterizing mitochondrial bioenergetics from platelets were developed here at UAB, and methods for quantitative assessment of mtDNA DAMPs have been recently developed.

Sepsis induced cardiac dysfunction (SICD) occurs in \~ 50% of the patients with severe sepsis and septic shock, with significant implications for patient's survival. Currently, the precise pathophysiological mechanisms leading to cardiac dysfunction are not fully understood, nor is there an effective therapy for SICD except antibiotics, source control and restoration of hemodynamics to improve organ perfusion.

SICD is characterized by minimal cell death, normal coronary perfusion, preserved tissue oxygen tension and reversibility in survivors. These characteristics point toward an oxygen utilization problem due to mitochondrial dysfunction; interestingly, sepsis mouse models demonstrated an improvement in cardiac function and decreased mortality when they were treated with mitochondrial targeted therapies, consistent with a growing body of evidence that suggests dysregulated mitochondrial metabolism plays a pivotal role in the pathogenesis of SICD. Ultrastructural and functional abnormalities of mitochondria have also been demonstrated in early sepsis, and reactive oxygen species (ROS) generated from mitochondria along with calcium overload trigger mitochondrial permeability transition pore (mPTP) opening which facilitates the externalization of mitochondrial DNA (mtDNA) fragments. These mtDNA fragments, or mtDNA Damage Associated Molecular Patterns (mtDNA DAMPs), activate innate immune response pathways - these pathways are well known to be significant components of intramyocardial inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years old
* With clinical symptoms suggestive of sepsis Control Group
* age matched
* gender matched
* cardiovascular risk factor matched

Exclusion Criteria:

* n/a
Outpatient Management of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease

Patients admitted to the hospital with chronic obstructive pulmonary disease are evaluated with regard to early follow-up by a specialized nurse in the home after discharge.

Patients admitted to Department of Internal Medicine M, Glostrup University hospital, with Chronic Obstructive Pulmonary Disease (COPD) are evaluated with regard to early follow-up by a specialized nurse in the home after discharge. Eligible patients receive education about disease management. The intervention is evaluated by comparing the number of readmissions for COPD and the duration of admissions during the study period to the the period prior to the implementation of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* Admission for chronic obstructive pulmonary disease

Exclusion Criteria:

* Other severe acute or chronic diseases
Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula

In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.

After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy infants born
* weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
* age between 5 - 7th month of life at study entry
* fully formula fed for at least 4 weeks before intervention start
* parents/caregivers understand the German language and are able to fill out questionnaires
* parents/caregivers agree to study participation and sign the informed consent form

Exclusion Criteria:

* acute or chronic illness of infant or mother
* drug and/or alcohol abuses of mother
* chronic medication
* participation of the infant in another intervention study
* gestational diabetes of the mother
Different Genetic Features Associated With Hepatic Carcinogenesis

The purpose of this study is to identify different genetic features in hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiological mechanisms of HCC.

Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in Taiwan. HCC normally develops as a consequence of underlying liver disease and is most often associated with cirrhosis. Surgical resection and liver transplantation are current best curative options to treat HCC. However, recurrence or metastasis is quite common in patients who have had a resection and survival rate is 30% to 40% at 5 years postoperatively.

MicroRNAs, small non-coding RNA, act as endogenous RNA interference by post-transcription regulation. Recent studies suggest that microRNAs may act as tumor suppressors or oncogenes and altered microRNA expression levels may play an important role in the cancer initiation and progression. Several studies, including ourselves, have shown that specific microRNAs are aberrantly expressed in malignant HCC tissues compared to normal counterpart. Although many microRNA profiling studies were done to diagnose hepatocarcinogenesis, data about prognostic significances for postsurgical survival are very limited. The main point of this study is to develop a predictive signature for postsurgical survival in HCC patients.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hepatocellular carcinoma

Exclusion Criteria:

-
Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax?

The purpose of this study is to determine if emergency room physicians can use bedside ultrasound to quickly determine the proper placement of a central venous catheter and to evaluate for complications such as a punctured lung.

Central venous catheterization (CVC) of the subclavian or internal jugular veins is a common procedure performed in the emergency department (ED). This procedure is followed by complications in 0.3 to 12% of cases. Pneumothorax (PTX) and catheter-tip misplacement can occur. The diagnosis of these complications requires a chest radiograph (CXR). In certain cases, CXR may be time-consuming, requiring more than 30 minutes. This could be harmful in the case of critically ill patients. Moreover, several investigators have questioned the need of routine post-procedural CXR in the absence of clinical complications.

Recent data has shown that ultrasound can accurately detect PTX in critically ill patients. Furthermore, bedside ultrasound is an easy technique to investigate the subclavian and internal jugular veins, and can improve the success rate of catheter insertion. Ultrasound also allows visualization of central venous catheters in vivo. Ultrasound has been reported as a tool to detect catheterization complications and misplacement when performed by ICU physicians, but has never been studied in the ED.

This method could be valuable in hemodynamically unstable patients, who quickly need a CVC for the measurement of central venous pressure, immediate fluid resuscitation, and infusion of vasoactive medications. Similarly, bedside ultrasound examination could quickly confirm PTX and allow immediate chest tube insertion in case of respiratory distress after catheter insertion.

We hypothesize that bedside ultrasound examination performed by ED physicians could accurately detect placement of the CVC and the presence or absence of a PTX after catheterization of the jugular and subclavian veins.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older
* Signed consent
* In need of subclavian or internal jugular central line placement

Exclusion Criteria:

* Any subject who refuses or whose family refuses to sign consent
* Any subject in whose immediate transfer from the care of the ED to another location is mandated by clinical presentation
* Any subject under the age of 18
* Any subject being evaluated for chest trauma.
Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity

The purpose of this research is to adapt and implement a pregnancy and postnatal smoking cessation intervention for couple that will begin early in pregnancy and have an additional postnatal component.

Pregnancy smoking and postnatal relapse are highly prevalent in Romania and Central and Eastern Europe, with lifetime negative health effects for the women and their children. There are higher odds of female smoking persistence during pregnancy, and of relapse once pregnant women quit, when the male partner also smokes.

Building on ongoing pilot work led by Dr. Meghea with Babes-Bolyai University (BBU) in Cluj-Napoca, Romania, the overall objective of the proposed research, conducted through BBU in the same target population as the ongoing pilot, is to adapt, enhance, and test the implementation feasibility and preliminary efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation that begins early in pregnancy and has a postnatal component.

The intervention will be based on the motivation and problem solving (MAPS) approach, successful in preventing smoking relapse postpartum in the US, which will be enhanced by targeting the couples' smoking behavior by focusing on dyadic efficacy for smoking cessation. The target population is primigravida pregnant women and their partners in Cluj-Napoca, Romania.

The specific aims are: (1) To develop an adapted and enhanced couple intervention to reduce pregnancy smoking and postpartum relapse in Romania based on the MAPS approach. (2) To conduct a pilot randomized controlled trial to test the fidelity of the culturally adapted MAPS intervention enhanced for couples smoking prevention during pregnancy and postpartum. (3) To examine in the pilot the implementation feasibility and initial efficacy in increasing maternal pregnancy smoking cessation and reducing postnatal relapse, with secondary hypotheses regarding maternal smoking reduction and spousal cessation, relapse, and reduction.

This study will form the basis for a larger, multicenter clinical trial that will be submitted by Dr. Meghea as an R01 application by the end of the 4th year of this award to evaluate the effectiveness of the proposed smoking prevention intervention. If proven effective in the subsequent R01 trial, the intervention has a high potential for broad spectrum population impact and sustainability. The long-term goal is the adoption in the national Romanian health system as a proactive extension of the existing STOP SMOKING national program which includes a quitline.

Eligibility Criteria:
Inclusion Criteria:

* the woman is pregnant,
* she is a smoker
* 18 years or older (legal age for consent and for consuming tobacco in Romania)
* married or in a stable relationship
* phone service in the home or mobile phone
* willing to have the partner contacted for participation, upon brief explanation of the study.
Visual Function and Ocular Pigmentation in Albinism

To study the relationship between visual function and ocular (iris, retina/choroidal) pigmentation in patients with albinism and other hypomelanotic disorders. To identify the carrier state in relatives of patients with ocular albinism.

Visual function and ocular pigmentation are being studied in patients with albinism and other disorders associated with hypopigmentation. The degree of ocular pigmentation is assessed clinically by estimating the melanin content of the iris, retinal pigment epithelium, and choroid. Visual function is measured in the conventional manner to study central vision, and electrophysiological methods to detect a misrouting of the visual pathways. The purpose of this study is to document the visual deficit and the pigmentary changes of patients with albinism, to observe their natural course, and to determine whether misrouting of the visual pathways is present and is correlated with pigmentation.

Eligibility Criteria:
Patients have been recruited into the study by referral from an ophthalmologist or pediatrician.

Entrance into the study was dependent upon clinical evidence of decreased or absent pigmentation in skin, hair, and/or eyes.

The definition was purposefully broad to include the broad range of phenotype variations and clinical heterogeneity.

The purpose of the study id to be able to document iris and retina/choroidal pigmentation and correlated these finding with visual function.
Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study

The investigators performed a retrospective review of all patients undergoing appendicectomy from March-November 2018 using the online theatre database and discharge letters. CA was defined as patients with perforated or gangrenous appendicitis on histology. Patients were divided into 2 groups; Group 1 (G1) included patients with CA who had a drain inserted; Group 2 (G2) included patients with CA and no drain.


Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 16 with complicated appendicitis (CA) were included

Exclusion Criteria:

* Patients with evidence of caecal/ appendicular malignancy were excluded.
Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer

Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. The purpose of this study is to determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.

Gastric cancer patients who diagnosed as Borrmann type 4 would be included in this study.They would receive 3 cycles of neoadjuvant chemotherapy with SEEOX regimen via combined intra-arterial and intravenous administration. The treatment schedule consisted of 3 courses (each, 2-week administration and 1-week withdrawal) of intra-arterial administration of oxaliplatin (150mg), etoposide (100mg) and epirubicin(30mg) by Seldinger method on day 1 and oral S-1(120mg) on days 1-14, followed by radical surgery.The efficacy and toxicity of SEEOX regimen would be examined.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed gastric adenocarcinoma;
* males or females, aged 30-70 years;
* gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (without definitive ulceration) that invaded more than half of the stomach;
* no peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
* eastern Cooperative Oncology Group performance status of 0 or 1;
* no serious concomitant diseases that make survival period \< 3 years;
* no prior anti-tumor therapy;
* have signed informed consent before the beginning of treatment.

Exclusion Criteria:

* patients can not bear surgical procedure;
* pregnant or lactating women;
* previous cytotoxic chemotherapy, radiotherapy or immunotherapy;
* with peritoneal metastasis or distant metastasis;
* history of another malignancy within the last five years;
* history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake;
* clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months;
* organ allografts requiring immunosuppressive therapy;
* serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease;
* moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN);
* hypersensitivity to any drug of the study regimen;
* unwilling or unable to comply with the protocol for the duration of the study.
Comparison of NICOM and Innocor for Non-Invasive Determination of Cardiac Output

Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The aim of the study at hand was to evaluate NICOM (bioreactance) as a new method for determinion of CO and to compare it to Innocor (inert gas rebreathing), which previously showed promising results.


Eligibility Criteria:
Inclusion Criteria:

* hemodynamic stability
* respiratory stability

Exclusion Criteria:

* patient unwilling to participate