cyrilzakka/clinical-trials huggingface dataset:
Advanced GC Multi-omic Characterization in EU and CELAC Populations

Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes.

Despite of multiple attempts to improve treatment in recent decades, none strategies has improved prognosis in locally advanced stage III and IV GC. A therapeutic approach to GC based on current histological and image criteria (Tumour Node Metastasis -TNM- stage) is insufficient. Although multiple targeted agents are currently under investigation, so far, only trastuzumab and ramucirumab have demonstrated efficacy in advanced GC and have a regulatory approval. For this reason, the identification of specific targets that could be susceptible for drug inhibition, is an urgent requirement. Moreover, most studies and current international databases on late-stage/advanced GC are largely based on Asian populations, in sharp contrast tumour biology and genome of EU or CELAC populations remain poorly known.

The primary objective of this study are to:

1. Characterize a multi-centric cohort including EU and CELAC populations diagnosed with advanced GC through a multi-omic approach including proteomics, genomics, transcriptomics, microbiome and exposome analysis due to study the determinants of GC.
2. Identify the regional differences in EU and CELAC populations recruiting patients for this study for each omic characterization due to identify the high-risk group populations.
3. Identify and select from the multi-omic approach those biomarkers useful for the development of an algorithm to guide the therapeutic approach for advanced GC.

Eligibility Criteria:
Cases:

* Inclusion criteria:

  * Subjects ≥18 years old.
  * GC diagnosis stages III and IV (including gastroesophageal junction cancer) and/or a gastroscopy indication due to the high diagnostic suspicion of GC as part of the study of his disease.
  * Has given and signed the IC to participate in this study.
* Exclusion criteria:

  • Patients diagnosed with GC early disease (stage I and II) suitable for resectable strategy.
* Withdrawal criteria:

  * Patients initially recruited with high suspicion of GC diagnosis but not confirmed by the pathological report.

Controls:

* Inclusion criteria (only for microbiome analysis):

  * Subjects ≥18 years old.
  * Subjects to whom a gastroscopy is indicated within clinical care and is confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case.
  * Has given and signed the IC to participate in this study.
* Exclusion criteria:

  * Subjects from a different geographic area from the cases.
  * Patients with high suspicion of GC.
  * Patients with previous histopathologic diagnosis of peptic (gastric or duodenal) ulcer disease and/or atrophy or intestinal metaplasia.
  * Patients that have received antimicrobials during the 4 weeks period prior to the endoscopy.
  * Patients that have received proton pump inhibitors or H2-receptor antagonists, at least 2 weeks prior to the endoscopy
Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire (BETY-BQ) in Patient with Temporomandibular Disorders

The aim of this study is to investigate the validity, reliability, and responsiveness of the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) in individuals with temporomandibular disorder. The following are alternative hypotheses of the study:

* BETY-BQ has significant convergence with the Patient Health Questionnaire-9 measuring depression.
* BETY-BQ has significant convergence with the Patient Health Questionnaire-15 measuring physical symptoms.
* BETY-BQ has significant convergence with the Generalized Anxiety Disorder-7 measuring anxiety.
* BETY-BQ has significant convergence with the Short Form-36 measuring quality of life.
* BETY-BQ has significant convergence with the Craniomandibular Pain and Disability Inventory measuring disability.
* BETY-BQ has significant convergence with the Mandibular Function Impairment Questionnaire measuring function.
* BETY-BQ has significant stability.
* BETY-BQ has significant internal consistency.

Patient Health Questionnaire-9 (Depression), Patient Health Questionnaire-15 (Physical Symptoms), Generalized Anxiety Disorder-7 (Anxiety), Short Form-36 (Quality of Life), Craniomandibular Pain and Disability Inventory (Disability), and Mandibular Function Impairment Questionnaire (Function) will be administered to participants. For reliability analysis, test-retest stability evaluations will be repeated with the same questionnaire on 30 individuals with a 2-week interval. To determine responsiveness, the same questionnaire will be reapplied to the same 30 individuals at 3-month intervals.

Eligibility Criteria:
Inclusion Criteria:

* Having received a diagnosis of temporomandibular disorder

Exclusion Criteria:

* Experiencing difficulty in cooperating to fill out the questionnaires
* Being unwilling to participate in the study
Effect of Auditory Distractions on Pediatric Postoperative Pain

The aim of the study was to determine the effect of different auditorial methods of attention distraction on postoperative pain and anxiety in children. Three group pre and post-test randomized clinical trial.The data were collected using the Socio-demographic Data Form for Child and Parent, Visual Analogue Scale, Wong-Baker Faces Pain Scale and State-Trait Anxiety Inventory for Children. The investigators found that listening to classical music, Turkish music and audiobook methods played an effective role in decreasing postoperative pain and anxiety state in children in the three groups in the study. As a result, investigators showed that different auditorial attention distraction methods had a decreasing effect on postoperative pain and anxiety in children.


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 7-14 years old,
* staying in a single room,
* those for whom a surgical procedure for inguinal or abdominal region had been planned,
* in the first hour of postoperative period,
* free of any problem that prevents expression of the post-operative pain,
* free of hearing problems,
* having undergone same analgesia protocol; were included in the study.

Exclusion Criteria:

-
Effects of Ulinastatin on Inflammatory Response During ECMO Support

This study is a multicenter, prospective, observational cohort study. The subjects were patients who received ECMO support. According to whether ulinastatin is used in the treatment regimen (determined by the competent doctor according to the patient's condition), the patients were divided into the ulinastatin and control groups. In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. Baseline data and inflammatory markers (CRP, IL-6, IL-10, TNF-α), capillary leakage markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3, and 5 days after the start of ECMO support, and patients were followed up on the 28th and 90th days.

This study is a multicenter, prospective, observational cohort study. The subjects were patients who received ECMO support. According to whether ulinastatin is used in the treatment regimen (determined by the competent doctor according to the patient's condition), the patients were divided into the ulinastatin and control groups. 144 subjects were enrolled, including 72 subjects in the ulinastatin group and 72 subjects in the control group. In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. The recommended clinical routine dosage of ulinastatin is 300,000 IU, q8h (continuous administration for more than 5 days). Baseline data and inflammatory markers (CRP, IL-6, IL-10, TNF-α), capillary leakage markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3, and 5 days after the start of ECMO support, and patients were followed up on the 28th and 90th days.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent;
* ≥18 years old;
* Patients have indications for ECMO support;

Exclusion Criteria:

* Pregnancy or lactation;
* Withdrawal of ECMO or death of the patient within 48 hours of the start of operation;
* Solid-organ or bone marrow transplant recipients;
* Previous history of allergy to ulinastatin or any ingredient or preservative;
* Patients with autoimmune diseases, tumors, or patients receiving high doses of glucocorticoids or immunosuppressant therapy within 2 months;
* Patients judged by the investigator to be unsuitable for participation in this study.
A Study to Evaluate Whether Correction of Anemia Using Recombinant Human Erythropoietin Reduces the Progression of Atherosclerosis and Cardiac Hypertrophy in Pre-dialysis Chronic Kidney Disease Patients

The primary aim of the study is to evaluate the effects of correction of anemia using erythropoietin on the progression of atherosclerosis and cardiac muscle thickening in patients with chronic kidney disease


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic renal failure with serum creatinine between 150umol/L and 800umol/L and at the same time Hb
* Patients with regression line of 1/serum creatinine versus time showing that they may not require dialysis within the coming 12 months
* Patients below the age of 75

Exclusion Criteria:

* Patients with valvular heart disease/congenital heart disease
* Patients with ischemic heart disease/history of myocardial infarction/coronary artery bypass surgery
* Patients with history of heart failure
* Patients with regression line of 1/serum creatinine versus time showing that the estimated date of end stage renal disease is within 12 months
* Patients with thalassemic trait or haemoglobinopathies
* Patients with underlying haematological malignancies
* Patients with active bleeding
* Patients with uncorrected iron or other vitamins deficiencies
* Patients with poor general condition
Problematic Use of the Internet in Child and Adolescent Psychiatry

Pathological internet use is a blanket term for problematic behavior types (e.g. uncontrolled gaming, cyber pornography, cyber mobbing and excessive use of social media): all perpetrated through the internet. There is little documentation or research on interdependencies/interplay between problematic internet and/or media use and child-adolescent disturbances. Very few clinical examples of syndromes like attention deficiency/hyperactivity (ADHS), anxiety disorder or affective disturbances associated with pathological media/internet use, or gaming, are found in literature.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients ages from 8 - 18 years
* All study participants or their legal representative have given written permission for their experiences to be documented in the study.

Exclusion Criteria:

* Inability to understand explanations and the questionnaire, whether linguistic or cognitative
Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity of Severe Acute Pancreatitis

In this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.In this prospective study, participants were divided into two groups based on serum SCD-1 concentration on admission and prospectively observe the disease severity and clinical outcomes of them.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission;
2. APACHEII score is more than 8 and Ranson score is greater than 3;
3. Age 18-75;
4. Obtaining informed consent.

Exclusion Criteria:

1. Pregnancy pancreatitis;
2. Patients with the following disease history: severe cardiac, pulmonary, renal, liver function insufficiency or immunodeficiency disease.
Dapagliflozin on Hypotensive Heart Failure Patients After Sacubitril/Valsartan Therapy

The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive heart failure patients receiving chronic sacubitril/valsartan treatment.

The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure (HF) events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive HFrEF patients receiving chronic sacubitril/valsartan (Sal/Val) treatment.

This is an investigator-initiated, interventional, prospective. open-label study. The inclusion criteria were (1) chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and LVEF less than 40%, (2) treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist (MRA), (3) 6-minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment, (4) systolic blood pressure ≤100 mmHg at enrollment. The exclusion criteria were (1) type 1 diabetes mellitus, (2) patients previously treated with any sodium glucose co-transporter 2 inhibitor (SGLT2i).

After applying the inclusion and exclusion criteria, if the participants had type 2 diabetes mellitus, the participants will receive dapagliflozin 10mg daily directly. If the participants did not have history of diabetes mellitus, the participants will be allocated to either receiving dapagliflozin 10mg daily or receiving standard heart failure treatment without dapagliflozin.

Vital signs and laboratory tests were examined at baseline, 2-week, 4-week and 12-week. Six-minute-walking-test, five-level EuroQol five dimensions (EQ-5D-5L) questionnaire and visual analogue scale (VAS) were collected at baseline and at 12-week.

Eligibility Criteria:
Inclusion Criteria:

* chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and left ventricular ejection fraction (LVEF) less than 40%
* treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist
* 6-minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment
* systolic blood pressure ≤100 mmHg at enrollment

Exclusion Criteria:

* hemodialysis
* severe co-morbidities with life expectancy less than 1 year
* type 1 diabetes mellitus
* ever treated with any type of sodium glucose cotransporter 2 inhibitor (SGLT2i)
Renal Denervation in Chronic Heart Failure

Renal denervation can be carried out for heart failure

There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety.

This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.

Eligibility Criteria:
Inclusion Criteria:

-Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone.

Exclusion Criteria:

* Clinically unstable patients or those with significant valvular disease
* An estimated glomerular filtration rate \<35 ml/min
* Unfavourable renal anatomy
* Tortuous femoral arteries were not eligible
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban

The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.


Eligibility Criteria:
Inclusion Criteria:

* Reasonably healthy men and women aged 50 to 75

Exclusion Criteria:

* History of abnormal bleeding, active bleeding or risk factors for bleeding
* History of thrombosis or risk factors for thrombosis
* History of adult asthma or use of inhaled medications
Intramuscular Ketamine for Suicidal Ideation

The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.


Eligibility Criteria:
Inclusion Criteria:

* Current clinically significant suicidal ideation, defined as a score of \> or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
* Inpatient status at the time of study initiation.
* 18 to 70 years of age
* Capacity to consent

Exclusion criteria:

* Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
* Diagnosis of pervasive developmental disorder
* Diagnosis of a major neurocognitive disorder
* A positive urine pregnancy test
* Currently breastfeeding
* Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.
* Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)
* Medical issues or laboratory abnormalities requiring acute intervention
* Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)
* Any lifetime history of ketamine or phencyclidine abuse
* A known hypersensitivity to or history of a serious adverse effect from to ketamine
Penicillin Allergy Risk-Stratification and Delabeling of Low-Risk Patients

Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic, however, recent studies have demonstrated that the majority of symptoms reported as an allergy by parents are often non-IgE-mediated adverse reactions or symptoms of a viral illness (e.g. rash, vomiting, diarrhea). Additionally, over 90% of patients with reported penicillin allergy have negative skin testing results. Several studies in children have found that an allergy questionnaire can accurately identify those who are at low risk for severe antibiotic allergy and the allergy label can be safely removed. Appropriately delabeling antibiotic allergies has been shown to improve patient care through changing prescribing behavior and lowering health care costs.

In this study, the investigators will perform a randomized trial comparing a provider-targeted clinical decision support tool to a pharmacist-led approach. The physician-targeted CDS tool will inform providers of their patient's allergy risk stratification result, protocol, electronic health record order and documentation support. The pharmacist-led approach consists of electronic health record dashboard that includes identical information to the provider arm. The primary outcome will be the frequency of penicillin allergy encounters with an allergy label removed at the time of discharge. Secondary outcomes will include the percentage of encounter with a penicillin allergy label in the electronic medical record 3 months after discharge, hospital length of stay and antibiotic utilization.


Eligibility Criteria:
Inclusion Criteria:

Pediatric Hospital Medicine service Existing penicillin allergy label in the EHR Screened as low-risk for true PCN allergy (based on usual-care nursing intake questions at time of admission)

Exclusion Criteria:

None, provider may opt out of CDS tool at any time
Effects of VR and Mural Curtain During Colonoscopy

Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as embarrassment, fear, and anxiety in the patient.

Purpose: To examine the effects of virtual reality glasses and video surveillance and picture screen application applied during colonoscopy on patients' satisfaction, tolerance, comfort and sense of shame.

Method: The population of the study consists of all patients who applied to Suleyman Demirel University Research and Practice Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 180 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 180 individuals for the three groups and at 60 individuals for each group. As a result, the sample of the research will consist of 180 people, 60 of whom are in the video with VR glasses, 60 people are in the mural curtain group and 60 people are in the control group. The study group of 180 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer-based Research Randomizer program. Data will be collected in the endoscopy unit on weekdays when the procedure is performed. The person who will collect the data is the endoscopy nurse working in the unit, one of the researchers. Colonoscopy procedure will be performed by the physician working in the unit, who is also one of the researchers. Before the colonoscopy procedure, the patients included in the study will be randomly divided into three groups: video group with VR, mural curtain group and control group. All participants in the study will first fill out a patient identification form containing patient demographic information. .


Eligibility Criteria:
Inclusion Criteria:

* 18 aged and over
* Written and verbal consent to participate in the study,
* Being conscious (person, place and time orientation),
* Undergoing colonoscopy for the first time

Exclusion Criteria:

* Having vision, hearing and communication problems
* Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
* Diagnosed with visual, auditory and / or balance disorders,