cyrilzakka/clinical-trials huggingface dataset:
Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression

The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.

Electroconvulsive therapy (ECT) is one of the most robust antidepressant treatments available. However, there is the potential for significant acute and longer term adverse cognitive effects with ECT and the antidepressant response requires multiple treatment sessions, increasing risk of adverse effects. Further, antidepressant response to ECT is often less than maximal and relapse is common. Growing preclinical and clinical evidence of the rapid-acting antidepressant properties of the anesthetic agent ketamine suggests the use of ketamine anesthesia as a strategy to increase rate of response and shorten treatment course in the administration of ECT. In addition, preclinical and clinical evidence suggests the potential of ketamine to decrease the adverse cognitive effects associated with ECT.

The investigators propose a pilot study to measure both acute therapeutic efficacy and cognitive side effects of ECT using ketamine compared to methohexital in depressed patients. The investigators will also explore other parameters of ECT such as seizure duration and morphology, as well as hemodynamic and behavioral changes.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients: 18 to 59 years
2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
3. DSM IV MINI diagnosis of major depressive episode (MDD), unipolar or bipolar
4. Pretreatment 24-item Hamilton Rating Scale for Depression score \> 21
5. ECT is clinically indicated
6. Patient has the capacity to provide informed consent.

Exclusion Criteria:

1. DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation
2. Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
3. Current diagnosis of delirium, dementia, or amnestic disorder
4. Baseline Mini Mental State Exam (MMSE) score \< 24 and a total score falling two standard deviations below the age- and education-adjusted mean
5. Any active general medical condition or CNS disease which can affect cognition or response to treatment
6. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
7. Lifetime history of ketamine or PCP abuse or dependence
8. ECT within three months
9. The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension arrhythmia severe coronary artery disease and porphyria
10. Pregnancy
Cancer Panel From Blood of Lung Cancer Patients

Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of patients is rapidly becoming established as a useful source of information to aid clinical decision-making. This study is aimed to to compare concordance rate between tissue based cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by NGS technique).

This study is comprised of two cohorts as below:

Cohort A: inoperable, untreated, non-small cell lung cancer patients

Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents including immune checkpoint inhibitors

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures, sampling, and analyses
* Pathologically confirmed non-small cell lung cancer
* Male or female, aged at least 20 years
* Matches one of two criteria :

  1. Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy
  2. Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent.

Exclusion Criteria:

* Any concurrent and/or other active malignancy that has required treatment within 3 years
* Patients with mixed small cell histology
* Life expectancy less than 3 months
* Insufficient tissue for NGS test
Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)
* Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)
* Subjects must be in good health
* Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception

Exclusion Criteria:

* Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper-or hypopigmentation, scars
* Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments
* Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
* Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression
1,5 Anhydroglucitol and 1,5 Anhydroglucitol / Glycated Hemoglobin Ratio as a Potential Biomarker for Islet β-cell Function and Insulin Resistance Among Patients With Type 2 Diabetes Mellitus

Hyperglycemia is a major risk factor for the micro- and macro-vascular complications of diabetes . Lowering blood glucose levels has been shown to reduce the incidence of diabetes complications.

Therefore, there is a need for a simple surrogate biochemical marker for glycemic variability. Glycated hemoglobin (HbA1c) is the standard clinical measurement used to monitor glycemic status and is recommended to assess control of diabetes over the preceding 2-3 months. However, being a measure of mean glucose, it does not reflect glucose variability.

It is well known that insulin secretion defects of islet β cells and/or tissue insensitivity to insulin are common pathophysiological mechanisms of diabetes mellitus (DM) .

The elevation in the blood glucose level usually represents the degree of glucose metabolism disorder, which is generally assessed by glycated hemoglobin A1c ( HbA1c) and indirectly reflects the extent of β-cell function damage .

In the recent years, 1,5-anhydroglucitol (1,5-AG) has received attention as a short-term blood glucose index that reflects the average blood glucose level 1,5 AG reflects the average maximum blood glucose level during the past 1-2 weeks and is reported to be a more sensitive marker of glucose variability and postprandial hyperglycemia than HbA1c, even for patients with prediabetes and for those with well or moderately controlled diabetes .

(1,5 AG ) is structurally similar to glucose . Due to this similarity, glucose inhibits renal reabsorption of 1,5 AG by competitive inhibition ,resulting in an inverse correlation of 1,5 AG with hyperglycemia .

1,5-AG levels are acting as an effective supplement to HbA1c. Additionally, previous study showed that 1,5-AG and HbA1c had opposite curves with increasing blood glucose levels; specifically, with the increase in HbA1c levels, 1,5-AG levels decreased significantly . Therefore, we speculate a ratio of 1,5- AG / HB A1C in relation to islet β-cell function and insulin resistance.

The aim of our study was to evaluate the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet β-cell function and insulin resistance among patients with type 2 diabetes .


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 20 to 70 years old with controlled and uncontrolled type 2 DM.

Exclusion Criteria:

* : type 1 DM,
* thyroid dysfunction,
* chronic kidney disease,
* chronic liver disease,
* cancer patients,
* cystic fibrosis,
* acute and chronic infection and
* pregnancy
Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia

The primary aim of this study is to evaluate the feasibility of virtual simulation-based diabetes foot care education on foot care knowledge and practice/behaviour.

Research Questions

The primary question for this study is:

• Is virtual simulation-based diabetes foot care education a practical and acceptable intervention among patients with diabetes in Ethiopia?

The secondary questions are:

* What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care knowledge among patients with diabetes mellitus?
* What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care behaviour among patients with diabetes mellitus?
* What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care efficacy among patients with diabetes mellitus?
* What is the impact of virtual simulation-based diabetes foot care education on diabetes foot health-belief among patients with diabetes mellitus?


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years of age or older).
* Type II diabetes mellitus patients who are on diabetes follow-up at University of Gondar tertiary referral hospital

Exclusion Criteria:

* Patients with type 1 diabetes or gestational diabetes
* Patients who previously attended any form of formal Diabetes Self Management Education (DSME) program /documented/ in the past three months.
* Individuals with documented severe cognitive impairment
* Individuals with documented visual impairment that diminished their ability to navigate the game
* Terminally ill individuals
* Individuals without the ability to read or understand the Amharic consent documentation
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic

Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.

In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.


Eligibility Criteria:
Inclusion Criteria:

* aged 6-18 years
* any sex
* port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic
* hematological or oncological diagnosis
* informed consent

Exclusion Criteria:

* epilepsy
* coronary artery disease
* history of severe vertigo
* obstacles to putting on and wearing VR glasses
* lack of informed consent for study participation.
Restoring Emotion Regulation Networks in Depression Vulnerability

Selective biases in attention can be modified by a simple computerized technique: The Attention Bias Modification Task (ABM) pioneered by MacLeod et al. Cognitive biases may be one reason depression recurs, and altering these biases should reduce risk of recurrence. Recently, evidence has supported this hypothesis . The mechanisms by which ABM works are not well understood. More research is needed to explore how altering an implicit attentional bias can lead to changes in subjective mood. One possible explanation is that positive attentional biases are an important component of explicit methods of emotion regulation. The ability to effectively regulate one's emotions is a fundamental component of mental health and this ability is impaired in depression. It has also been shown that recovered depressed people spontaneously show a more dysfunctional pattern of emotion regulation as compared to never depressed controls. Supporting this, growing evidence implicates dysregulation of a medial/orbitofrontal circuit in mood disorders. This circuit includes the orbitofrontal cortex and anterior cingulate cortex, the ventral striatum, the ventral pallidum and medial thalamus. Components of this circuit are reciprocally connected with the amygdala, which is implicated in emotional processing in the healthy brain and dysregulated in depression. Negative emotion processing biases depend on both enhanced "bottom-up" responses to emotionally salient stimuli and reduces "top-down" cognitive control mechanisms, required to suppress responses to emotionally salient but task irrelevant information. Cognitive reappraisal and distancing are common strategies to down- or upregulate emotional responses. Reappraisal is an emotion regulation strategy that involves reinterpretation and changing the way one thinks about an event or stimulus with the goal of changing its affective impact. Distancing is a type of reappraisal that involves creating mental space between oneself and the emotional event in order to see things from a different, less self-focused perspective. It has been shown that distancing is a strategy that people can improve at over time compared to reinterpretation. The neural systems which support the explicit regulation of emotion have previously been characterized and include both lateral- and prefrontal cortex. This frontal activity is predicted to downregulate limbic circuitry involving the amygdala during passive viewing of emotional salient stimuli.


Eligibility Criteria:
Inclusion Criteria:

* Currently no-depressed subjects with a history of major depression.

Exclusion Criteria:

* Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
A Retrospective Analysis of Outcomes in Patients with Hepatorenal Syndrome At Methodist Dallas Medical Center

Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in patients with liver disease \[1\]. Increased activity and presence of vasodilators such as nitric oxide in cirrhotic patients leads to vasodilation, especially in the splanchnic circulation, resulting in hemodynamic changes that precipitate renal injury \[1\]. Patients may present with elevated serum creatinine (Cr), benign urine sediment, and low urine sodium \[1\].

There are two main classifications of HRS: HRS-AKI (previously known as type 1 HRS) and diuretic-resistant ascites (previously known as type 2 HRS) \[1\].

The ultimate treatment for patients with HRS is to improve hepatic function via treatment of underlying etiology or liver transplantation; however, this is not always immediately possible due to the high demand for liver transplantation among other factors \[1\]. Continuous renal replacement therapy (CRRT) can also be considered, especially in patients with severe electrolyte derangements such as hypokalemia or pulmonary edema, that are not responding to medical therapy \[1\]. Often, CRRT is used as a bridging therapy to stabilize patients until they are optimized for receiving a liver transplant \[1, 2\]. CRRT, however, comes with its own risks and disadvantages such as hypotension and increased risk of cardiac adverse events \[2\]. In certain cases, transjugular intrahepatic portosystemic shunts (TIPS) can benefit patients with HRS by reducing portal pressure resulting in increase in renal perfusion \[1\].

Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years old that were hospitalized between April 1st 2019 and April 1st 2023 who either presented with HRS-AKI or developed a diagnosis of HRS during the hospital course. HRS-AKI will be defined based on the ICA criteria, described below:

  1. Presence of cirrhosis, acute liver failure, or acute-on-chronic liver failure
  2. An increase in serum Cr of ≥0.3 mg/dL within 48 hours or ≥50% from baseline value and/or urinary output ≤0.5 mL/kg of body weight for ≥6 hours (requires use of a urinary catheter)
  3. No full or partial response for ≥2 days of diuretic withdrawal and volume expansion with albumin (dosed at 1 g/kg of body weight/day)
  4. Absence of shock
  5. No current or recent treatment with nephrotoxic drugs
  6. Absence of parenchymal renal disease
  7. Suggestion of renal vasoconstriction based on FENa \<0.2%

Exclusion Criteria:

* 1. HRS-AKI patients \<18 years of age 2. All patients hospitalized between April 1st 2019 and April 1st 2023 without a diagnosis of HRS-AKI.
Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. Screening positive participants will be followed up annually.

All subjects will also be followed by record linkage to Cancer Register and Population Register.

Sample selection

- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.

Participants recruitment

* Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
* Face-to-face interviews are conducted by well-trained investigators.

Tests and follow up

* At initial screening, all participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in males, EBV-DNA will be tested. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or EBV DNA positive. The rest will be screening negative.
* During the initial screening and following up, people with high risk or P85-Ab positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
* Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
* EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
* The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
* All subjects will also be followed by record linkage to Cancer Register and Population Register.

Eligibility Criteria:
Inclusion Criteria:

* Subject residents in Zhongshan City or Wuzhou City
* Subject has no medical record of nasopharyngeal carcinoma
* ECOG 0-2
* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
* Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.

Exclusion Criteria:

* Subject has heavy cardiovascular, liver or kidney disease.
* Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
Laparoscopic Gas Pressure and Postoperative Pain Score

Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.

In this study investigator planned to randomize patients into three groups ; in the first group abdominal entrance pressure will be 15 mmhg and intraoperative pressure will be 15 mmhg too ; in the second group again entrance pressure will be 15 mmhg , intraoperative pressure will be 12 mmhg ; and in the thirth group both entrance and intraoperative pressures will be 12 mmhg. During operation intraoperative mean pressures will be recorded every 15 minutes , also end tidal CO2 pressures will also assesed by the anesthesiologist. Every participant will take , same standard analgesics ; 2 mg/kg contramal and 1 gr i.v. paracetamol at the end of the operation ; except the ones who has allergy to these analgesics. At postoperative 6 th and 24 th hours patients will be asked to execute the visual analogue score (VAS) form to assess the pain . Only patients with benign gynecologic pathologies will be included in to the study and informed consent forms will be taken from all participants.

Eligibility Criteria:
Inclusion Criteria:

* benign gynecologic pathologies which requires laparoscopic surgery

Exclusion Criteria:

* patients who has malign gynecologic pathologies
Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure

The purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF).

180 patients will be randomly assigned to either intervention (VExUS) arm or standard of care (SOC) arm. In the intervention arm, the treatment team will be informed by the study team about the results of the VExUS examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. Study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. Telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints.

The overall rationale of the the study is to investigate if venous organ congestion investigated by VExUS score, is a modifiable risk factor in patients hospitalized with ADHF. And secondary to assess if venous organ decongestion guided by VExUS score may safely be implemented in patients hospitalized with ADHF and result in:

* differences in length of hospitalization
* changes in biomarkers of cardiac strain
* changes in renal function and markers of renal injury
* achieved doses of heart failure treatment at discharge
* in-hospital complications

Safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or above
* Admitted the ward of Department of Cardiology OUH Ullevål with a clinical diagnosis of ADHFdefined by European Society of Cardiology
* Pro-BNP \> 800 ng/l at first day of admission
* Capable of giving signed informed consent

Exclusion Criteria:

- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation