cyrilzakka/clinical-trials huggingface dataset:
Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback

This study investigates whether the sense of agency is sensitive to self-regulation by means of EEG-based neurofeedback. During neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants. The participants can therefore use this information to adapt their performance on the motor task.


Eligibility Criteria:
Inclusion Criteria (all):

* Aged \> 18 years old
* Normal or corrected-to-normal visual acuity
* Willing to participate in the study (by signing the informed consent form)
* Neither caffein, nor alcohol intake 48 hours prior to the experiment
* Regular intake of drugs (except oral contraceptives in women)
* Employed by, or in a dependent relationship with, the sponsor and / or the investigator(s)
* Sufficient knowledge of German or English to understand study documents and instructions.

Inclusion Criteria (patients):

* A diagnosis of temporal epilepsy (TE), documented via video EEG. OR
* A diagnosis of psychogenic non-epileptic seizure (PNES), according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and documented via video EEG.

Exclusion Criteria (all):

* Past surgery in the brain
* History of alcohol or drug abuse
* Incompatibility with EEG recordings, e.g., inability to stay seated for 90 minutes.
Platelets to Lymphocytes Ratio in Sepsis

The aim of this study is to compare effectiveness of platelets to lymphocytes ratio (PLR) with procalcitonin as a predictor of sepsis outcome.

Sepsis is a rapidly progressive, life-threatening disease. Accurate and expeditious assessment of sepsis is important for early administration of antibiotics and removal of the source of infection.

In the 2016 version of the sepsis guidelines (Sepsis-3), the concept of the systemic inflammatory response syndrome has been deleted.

Although most patients with sepsis receive intensive management, such as early goal directed therapy (EGDT), in an emergency department (ED), the mortality rate of sepsis has been reported to be greater than 20% to 30%.

Many clinicians have studied the usefulness of blood biomarkers such as C-reactive protein, procalcitonin, and lactate for early assessment of sepsis and for prognostication, in order to initiate timeous treatment and to prevent rapid progression to multi-organ failure.

Several studies mentioned the advantages of the precursor molecule of calcitonin, namely procalcitonin as a biomarker for sepsis.

In recent years, studies have reported that platelets and lymphocytes play critical roles in the inflammatory process. Therefore, the platelet-to-lymphocyte ratio (PLR) a novel inflammatory factor has received research attention recently, as it may act as an indicator of inflammation, in a wide spectrum of diseases, such as myocardial infarction,acute kidney injury (AKI), Based on the findings of previous studies, it is reasonable to speculate the presence of a potential relationship between PLR and mortality for sepsis.

Platelet to lymphocytes ratio is defined as the ratio of the absolute platelet count and absolute lymphocyte count.

Eligibility Criteria:
Inclusion Criteria:

1. Septic patients according to Third International Consensus Definitions for Sepsis
2. with ICU stay more than 24 hours will be included.

Exclusion Criteria:

1. Pregnant and women in puerperium.
2. Patients with active hemorrhage
3. Patients with hematological diseases (including bone marrow diseases) and collagen diseases.
4. Patients on corticosteroid therapy or immunosuppressive drugs.
5. Patients who will need immediate surgical interventions.
6. Acute cerebrovascular or coronary syndrome.
7. Patients received blood or platelets transfusion before enrollment in the study.
Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine in Moderate-to-severe Dry Eye Disease

Aim of this pilot study is to evaluate the best treatment regime of Chitosan-N-Acetylcysteine (Lacrimera®) compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

The present pilot study seeks to investigate the best fitting treatment regime of moderate-to-severe DED with C-NAC compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine) by applying a randomized, prospective, adaptive, controlled design.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 22 years
* Corneal staining (marked to severe; NEI grading scale \>=10)

Exclusion Criteria:

* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
* Usage of systemic antibiotic therapy
* Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
* Ocular surgery within prior 3 months to screening
* Preceding refractive corneal surgery (e.g. LASIK)
* Ocular injury within prior 3 months
* Ocular herpes of eye or eyelid within prior 3 months
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Eyelid abnormalities that affect lid function
* Ocular surface abnormality that may compromise corneal integrity
* Pregnancy and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)
I.M. Sechenov First Moscow State Medical University (Sechenov University)

Single-institution uncontrolled open-label trial.

The single-institution uncontrolled open-label trial is to optimize the anticoagulant therapy in the out-patient practice.

The study embraces patients who are advised to take the anticoagulant therapy for some reasons. The study has two phases - a retrospective part and a concurrent part. At the first phase, researchers analyze the compliance with the anticoagulant therapy in the real clinical practice. At the concurrent phase, researchers conduct a single-institution uncontrolled open-label trial to evaluate the effectiveness, safety of the anticoagulant therapy and compliance with it at the antithrombotic therapy control ward, and estimate the glomerular filtration rate in patients taking the anticoagulant therapy.

Eligibility Criteria:
Inclusion Criteria:

* the age above 18
* indications for the anticoagulant therapy
* informed consent for inclusion into trials

Exclusion Criteria:

* denial to proceed in the trial

Non-inclusion criteria:

pregnancy and lactation

* Intracerebral hemorrhage within three preceding months
* severe mental disorders\* which could possibly affect the anticoagulant therapy dosage schedule
* anemia and a decrease in Hb by ˂100 GM/DL\*
* active gastroduodenal ulcer
* active bleeding during the preceding month
* other intensive bleeding instances as per the TIMI Score within three weeks before the inclusion
* severe hepatic impairment for over 10 points under the Child-Pugh Score
* oncology disease with the life expectancy less than one year
ciNPT in Autologous DIEP Flap Breast Reconstruction

In women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (DIEP) flap is a common surgical procedure that aims to restore both the appearance and texture of the breast(s).Specifically, this requires the transfer of skin, fat, and perforator vessels from the abdomen to a recipient artery and vein in the chest to create a viable breast mound. Post-operatively, the abdominal donor site is routinely monitored for wound dehiscence, which has a reported incidence of up to 39% in this patient population; however, this incidence typically varies from 3.5% to 14%.

At the investigators' academic institution, patients who undergo DIEP breast reconstruction typically have ciNPT or traditional tape dressings applied to the closed abdominal donor site. These dressings are selected according to surgeon preference and typically remain in-situ until hospital discharge. As there remains clinical equipoise regarding the ability of ciNPT to reduce abdominal wound dehiscence, further research in the form of a parallel, two-arm RCT is warranted.

The investigators propose a randomized controlled superiority trial with the primary objective of comparing the incidence of wound dehiscence at 1 month in patients undergoing autologous DIEP breast reconstruction with ciNPT versus standard tape dressings for the abdominal donor site incision. The design and conduct of the proposed study will mirror the methodology of the recently completed pilot trial (NCT04985552) including randomization, interventions, and clinical outcomes.

The secondary objective of this study is to evaluate other clinical outcomes comparing ciNPT to standard tape dressings applied to the abdominal donor site incision. Secondary clinical outcomes will include: 2) the incidence of seroma formation and surgical site infection at 1 month; 2) quality of life as measured by BREAST-Q physical well-being abdomen and EQ-5D-5L pre-operatively, 1-month, 3-months, and 6-months postoperatively; 3) Scar appearance as measured by the SCAR-Q at 1-month, 3-months, and 6-months postoperatively.

As an adjunct to the main study, another secondary clinical outcome will include the overall incidence of MINS as diagnosed by postoperative abnormally elevated troponin levels (as per site-specific laboratory assay thresholds) and electrocardiograms (ECG) at 6-12 hours and 1, 2, and 3 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* adult female patients (≥ 18 years old)
* consent to elective immediate (i.e. performed at the time of mastectomy) or delayed (i.e. performed following mastectomy) breast reconstruction using the DIEP flap

Exclusion Criteria:

* patients who are pregnant
* have a documented/reported allergy to adhesive dressings
* Body mass index (BMI) ≥ 40 kg/m2
The Effect of the Use of Gel Pillows on the Sleep Quality and General Comfort Levels

The study was conducted to evaluate the effect of using gel pillows on the sleep quality and general comfort levels of patients in the preoperative period.The main hypotheses are:

H1: 'The sleep quality of patients who use gel pillows in the preoperative period is higher than those who do not use gel pillows' H2: "The general comfort level of the patients who used gel pillows in the preoperative period is higher than those who did not use gel pillows".

Participants will be asked to use a gel pillow with a cooling surface the night before the day of surgery.

If there is a comparison group: Researchers will compare patients' control group to see if there is any difference in sleep quality and comfort levels.

Randomization method will be used to determine the groups. Randomization of the patients was done using the 'Random Allocation Software 2.0' program and they are allocated into 2 groups: 1) the control group and 2) the intervenion group.

1. The Control Group: The patients in this group will be visited by the researcher in their rooms on the morning before the surgery. Patients will be informed that they will be visited again in the evening of the day before the surgery and that they will be given a pillow to use while sleeping at night. They will receive no other interventions.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort levels.
2. The Intervenion Group: The patients in this group will be visited by the researcher in their rooms on the morning before the surgery. Patients will be informed that they will be visited again in the evening of the day before the surgery and that they will be given a pillow to use while sleeping at night. Patients who are visited in their rooms on the evening of the day before the surgery will be given a gel pillow with a cooling surface feature for night use. If patients stop using pillows at night, they will be asked to inform the investigator when they come to their room in the morning.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort levels.

Eligibility Criteria:
Inclusion Criteria:

To research;

* Planned elective surgery
* Those who will undergo cancer surgery related to the gastrointestinal system
* No diagnosis of sleep disorder
* No sensory, cognitive or mental disability
* Using pillows while sleeping
* Patients who volunteered to participate in the study were included.

Exclusion Criteria:

* Emergency surgical intervention will be performed
* In contact isolation
* The one who has given up using a gel pillow for sleep at night
* Diagnosis of diseases related to the endocrine system (such as diabetes, obesity)
* Using hormone replacement medication
* Patients using anti-depressant medication were excluded.
Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery

This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. Real-time PCR is used to detect copy number variations in the peripheral blood SMN gene on 1206 patients with heart surgery. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

Eligibility Criteria:
Inclusion Criteria:

* Age: Children (1 month -17 years old) and adults (18-80 years old);
* Sex: All;
* Those who will receive selective cardiac surgery with cardiopulmonary bypass;
* Those who signed the informed consent.

Exclusion Criteria:

* Those with glomerular filtration rate: eGFR\<15ml/min/1.73m2, and those who have received the renal replacement therapy before surgery;
* Those who have received nephrectomy and kidney transplantation;
* Those who have suffered from AKI before;
* Those with incomplete medical history or clinical data.
Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder

Family-focused therapy (FFT) is a comprehensive therapy approach applied to individuals and their families. In the present study, the researchers aimed to investigate the effects of family-focused therapy (FFT) in the early stages of psychotic disorder and bipolar disorder, regarding the psychiatric symptomatology, family communication skills, coping capacities, family burden and quality of life. A total of 34 young people diagnosed with bipolar disorder (BD) and 17 psychotic disorders (PD) will be included in the study.

In this study, the researcher's primary goal is to investigate the effects of family-focused therapy sessions on young people aged between 15 and 21. Subjects were referred to an early intervention center for psychotic and bipolar disorders. The target population of the study consists of the patients in remission after the episode of the illness.

Therapy sessions will be conducted in line with the manual for "Family Focused Therapy for High-Risk Adolescents and Young Adults for Bipolar Disorder or Psychosis" revised by Miklowitz et al. in 2018. FFT will be completed in nine sessions. The first module of the program consists of three sessions, which consists of group psychoeducation for the patients and families. The second and third modules also include three sessions in each to teach communication skills and problem-solving skills in individual therapy sessions including patients and their families. Sessions will be held once a week and completed in nine weeks.

Within the scope of this program, non-therapist clinicians will evaluate the participants' symptoms, psychosocial functioning, insight, and treatment compliance before and after the therapy sessions.

There are only a few previous studies investigating the effects of family therapy in early stages of bipolar disorder and psychotic disorder. According to the literature, no prior study compares the effects of FFT between BD and PD populations. This study is important in terms of developing effective strategies for management of psychosocial difficulties in early phases of BD and PDs.

Eligibility Criteria:
Inclusion Criteria:

* Not be in an active phase of the illness
* Able to comply with the interviews
* The total score of the Hamilton Depression Rating Scale ≤ 21 points.
* The total score of the Young Mania Rating Scale ≤ 14 points.
* At least one family member with the capacity to read and write in Turkish

Exclusion Criteria:

* Neurological disorders and serious physical disease that affect cognitive functions
* The symptoms due to substance use or a medical illness
* Autism Spectrum Disorder
* Comorbid alcohol and substance abuse (except nicotine)
* Co-morbid psychiatric disorders except disruptive behavior disorders and anxiety disorders
The Effect of Pistachio-Rich Breakfast Meals on Cognitive Function in Healthy Older Adults

This study aims to investigate the effect of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on cognitive function throughout the course of the day in healthy ageing adults aged 65-80.

This crossover RCT investigates the acute postprandial effect (over a 6-hour period) of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on the cognitive behaviour in healthy adults aged 65-80 years old. The study will also assess markers of inflammation and brain health by taking blood samples, and explore brain function (EEG) and blood flow (FMD) to understand how pistachio nuts may positively influence cognitive health. The study will involve a screening visit and four testing visits, with a week interval between each. During the four testing visits, cognitive and mood battery tests will be taken at baseline and then at 2-, 4- and 6-hour intervals following the consumption of the intervention meal. Blood draws are taken at the end of the day. For the subset of participants taking part in FMD, this will be measured at baseline, 2, 4 and 6 hours prior to cognitive testing. For those taking part in EEG, this data will be collected at 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* 65 - 80 years old
* Fruit \& veg intake less than or equal to 4 servings per day
* Not regularly consuming more than 3 servings of fish per week
* Adequate English language and visual \& auditory acuity to perform the cognitive tasks
* Normal BMI for age
* Normal MMSE performance between 26-30

Exclusion Criteria:

* Being diagnosed with psychological or psychiatric disorders
* ADHD or dyslexia
* Any food allergy or intolerance
* Use of medications and dietary supplements that may impact study results
* Antibiotic use within the last 3 months
* Adherence to vegan or vegetarian diets, or other specific diets that may impact study outcomes
* Being diagnosed with cardiometabolic disease (including type II diabetes and cardiovascular disease), or suffer from untreated hypertension or thrombosis related disorders
* Taking blood thinners
Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery

compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery .

* To Estimate End to start facial nerve MEP amplitude ratio
* To determine the effect of neuromuscular relaxant degrees on recovery and
* Assessment of propofol doses needed for enhancement of early recovery and ambulation.

40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients will be one of two groups: Both Induction will be accomplished with fentanyl, propofol , rocronium infusion will be given randomly to one of the groups.

Depth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological monitoring will be done.

Eligibility Criteria:
Inclusion Criteria:

* Patients age between \>18 and\<60.
* Patients scheduled for neurosurgical CPA surgeries
* Ability to sign the consent
* ASA classification I, II

Exclusion Criteria:

* ASA \> II
* Hemodynamically unstable
* Disease affecting neuromuscular transmission (myasthenia gravies ...etc.)
* GCS \< 15.
* Any cardiac patient (ischemic heart disease - cardiomyopathy...etc.)
Memory and Insulin in Early Alzheimer's Disease

To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.

Functional MRI study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early Alzheimer's disease and cognitively normal older adults. The role of the apoE-e4 allele in modulating brain insulin responses is also addressed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Early Alzheimer's disease

Exclusion Criteria:

* Patients with Late Alzheimer's disease
The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients

To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18; AND
* Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND
* Clinically indicated for central catheter insertion, which includes central venous catheters and dialysis catheters; AND
* Expected to have the central catheter in place for at least 5 days in their ICU stay.

Exclusion Criteria:

* Patients known to have active venous thromboembolism including deep venous thrombosis or pulmonary embolism;
* Patients known to have hypercoagulable states, e.g., hereditary thrombophilia, antiphospholipid syndrome; OR
* Patients with active solid organ or hematological malignancies; OR
* Patients already receiving therapeutic anticoagulation prior to study recruitment; OR
* Patients with thrombosis detected in the insertion site before central catheter insertion; OR
* Patients with a central venous catheter already in place prior to ICU admission; OR
* Patients admitted to the ICU for post-operative care; OR
* Patients admitted to the ICU for trauma care; OR
* Patients requiring extra-corporeal life support (ECLS); OR
* Patients with poor window or inaccessible for ultrasonographic examination; OR
* Pregnancy/post-partum within 6 weeks
Monitoring of Lung Sounds of Patients With Pneumonia

The aim of this study is to investigate if any correlation between lung sounds of pneumonia patients and the clinical development or therapy of the pneumonia exists.


Eligibility Criteria:
Inclusion Criteria:

* ambulant aquired pneumonia with typically radiological signs
* hospitalisation at medical clinic I, university hospital Aachen
* age at least \> 18 years
* CRB-65 score \> 1
* CRP\> 60mg/l
* fever
* lung sounds audible by stethoscope
* legal capacity and being able to understand and to follow the instructions of the study staff
* being able to consent and being able to understand the importance and the consequence of the study
* not being accomondated in an institution

Exclusion Criteria:

* pneumonia acquired in a hospital
* artificial respiration or other means for supporting respiration
* allergic reaction because of skin contact with polymers
* pregnancy or breast feeding