cyrilzakka/clinical-trials huggingface dataset:
Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome

The aim of the study is to collect information on feasibility and effect size of a confirmatory, prospective study with the question: Does a standardized checklist during intraoperative handover of anaesthesia care reduce the rate of postoperative complications?

During clinical routine, intraoperative handover of anaesthesia care occurs frequently. This handover between two anaesthesiologists requires the transmission of all relevant information concerning the patient and the ongoing procedure. Studies regarding the influence of such handovers on patient outcome are inconclusive and mostly of retrospective nature. Some studies report a negative effect of handovers on patients mortality and outcome, however studies exist reporting no effect. A positive effect of intraoperative handovers as a result of a "second man" effect ist also possible. To increase handover quality, the German Society of Anaesthesiology and Intensive Care Medicine (DGAI) recommends the application of the situation, background, assessment and recommendation (SBAR) concept. Information are arranged in those four groups with the goal of structuring the handover and incorporating all relevant information. Studies show increased accuracy of transferred information and improved comprehensibility when using the SBAR concept. Whether an intraoperative handover according to the SBAR concept reduces the rate of postoperative complications is not yet investigated. Due to lack of information regarding feasibility and effect size, the investigators plan a prospective pilot study to answer these questions. Initially, patients undergoing major surgery are recruited where handover is performed without a standardized handover. After the implementation of a checklist using the SBAR concept, this checklist will be used during intraoperative handover in recruited patients where a handover occurs. The primary endpoint is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications. Additionally, implementation rate and efficacy of the checklist will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Major surgeries with a duration of at least 2 h (requirement of postoperative admission to hospital for at least 1 night)
* American Society of Anesthesiologists (ASA) Classification 3-4
* Informed consent

Exclusion Criteria:

* Patients incapable of consent
* Previous surgery within the same surgical subgroup within the last 6 months
* Pregnancy, breastfeeding
* Patients participating in another interventional trial within the last 3 months with possible interference to the outcome of this study
* Persons with any kind of dependency on the investigator or employed by the investigator
Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious.

Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.

Forty-four children scheduled for hypospadias randomize into 2 groups. Group E (n=22) (0.2% ropivacaine 0.7 ml／kg and S-ketamine 0.5 mg/kg), group C(n=22)( 0.2%ropivacaine 0.7ml／kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. Postoperative pain is assessed using an established 6-item FLACC score at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. A score of more15μg/kg is administered.Investigators propose to compare the duration of caudal analgesia provided by plain ropivacaine and by a mixture of ropivacaine and S-ketamine.

Eligibility Criteria:
Inclusion Criteria:

* informed parent consent, ASA I or II children, between 3months and 18 years of age,and weighing \<28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited.

Exclusion Criteria:

* Patients who have congenital abnormalities of lower spine and meninges.
* Patients with hypersensitivity to any local anesthetics
* Children with coagulation disorders
* Presence of Infections at puncture sites
* Preexisting neurological disease
* Refusal to consent by parent/guardian
Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia

The aim of the study is to investigate whether intensive speech-language therapy (SLT) combined with anodal transcranial direct current stimulation (tDCS) leads to better communication performance than SLT combined with placebo stimulation (using sham-tDCS).

Intensive speech-language therapy (SLT) can promote recovery from chronic post-stroke aphasia, but effect sizes are moderate. This highlights the pressing need to explore adjunct strategies, such as transcranial direct current stimulation (tDCS), to enhance training effectiveness. Recently, the investigators provided evidence from a single-center randomized controlled trial (RCT) suggesting that anodal-tDCS of the left primary motor cortex (M1) improves naming and communication ability in chronic post-stroke aphasia, with medium-to-large effect sizes. However, prior to integration into clinical routine, a multi-center RCT with adequate power, duration, and outcomes relevant to everyday life is required, which is the goal of the present study. After trial completion, a workshop with relevant stakeholders will ensure transfer into best-practice guidelines.

Eligibility Criteria:
Inclusion Criteria:

* left-hemisphere cortical or subcortical stroke with first-ever aphasic symptoms
* at least 6 months post-onset of stroke;
* aphasia, as determined by the Aachen Aphasia Test (AAT);
* 13 moderate-to-severe word finding difficulties (maximum of 75% correct items on a computerized naming task at baseline);
* at least 1 correct reaction on the first part of the AAT subscale Token Test (ensuring basic comprehension skills);
* at least 1 point on the communicative task of the AAT subscale Spontaneous Speech (ensuring basic communication abilities);
* German as first language;
* intact left-hemisphere "hand knob" without right prefrontal lesions for placement of tDCS electrodes, as confirmed by magnetic resonance imaging or computer tomography scans.

Exclusion Criteria:

* contraindications for tDCS (e.g., cardiac pacemaker, history of seizures, implanted metal inside the head);
* more than one clinically apparent stroke with aphasic symptoms;
* other severe neurological diseases (e.g., brain tumor, and subdural hematoma);
* epilepsy with seizures during the last 12 months prior to study start and/or intake of sedating antiepileptic drugs (barbiturates and benzodiazepines),
* history of severe alcohol or drug abuse;
* current severe depression;
* current psychosis or other relevant psychiatric condition;
* very severe apraxia of speech, as revealed by Hierarchical Word Lists;
* severe non-verbal cognitive deficits, as indicated by the Corsi Block-Tapping Task;
* severe uncontrolled medical problems;
* severely impaired vision or hearing that prevents patients from engaging in intensive SLT;
* changes in centrally active drugs within 2 weeks prior to study inclusion.
Community Stroke Self-management Program

This pilot project aims develop a need-based community stroke self-management program that would improve the stroke self-management self-efficacy and competencies among African American stroke survivors living in rural Alabama. This study is a mixed-methods study to collect data related to the needs of these individuals and develop a need-based intervention based on the actual needs/ preferences of our target population. The specific aims are to assess the needs, access barriers, existing resources for a stroke self-management program; and develop a Community Stroke Self-management Program for improving stroke survivors' abilities to manage their medication adherence, diet, Physical Activity (PA) requirements, symptoms, and psychological distress to better meet their needs, expectations, and preferences. Another aim is to examine the feasibility and acceptability of delivering the CSSP after tailoring the proposed intervention in Aim 2a) among the AA chronic stroke survivors living in rural Alabama.

Stroke is a leading cause of mortality and morbidity. African American (AA) populations have a higher prevalence of stroke than whites do. The lack of resources leads to substantial physical, social, and psychological burdens and makes self-management more challenging, hence putting these individuals at high risk for secondary chronic conditions. This is especially prominent among underserved populations including AA living in the black belt of rural Alabama due to the additional factors related to their socio-demographic characteristics. This pilot project aims develop a need-based community stroke self-management program that would improve the stroke self-management self-efficacy and competencies among African American stroke survivors living in rural Alabama. This is a mixed-methods study to collect data related to the needs of these individuals and develop a need-based intervention based on the actual needs/ preferences of the target population. The specific aims are to assess the needs, access barriers, existing resources for a stroke self-management program; and develop a Community Stroke Self-management Program for improving stroke survivors' abilities to manage their medication adherence, diet, Physical Activity (PA) requirements, symptoms, and psychological distress to better meet their needs, expectations, and preferences. The study also aim to examine the feasibility and acceptability of delivering the CSSP after tailoring our proposed intervention in Aim 2a) among the AA chronic stroke survivors living in rural Alabama. Conducting this study would help to have a sustainable intervention with minimal need of healthcare workers for its online delivery, potentially it would have high scalability and a high economic impact in the long run. Therefore, this project is vital for meeting the unique needs of this underserved population.

Eligibility Criteria:
Inclusion Criteria:

* History of Stroke
* High blood pressure condition
* African American
* Age 50 and above

Exclusion Criteria:

-Low cognition
Population Study of the Prevalence of Celiac Disease and Other Gluten-dependent Disorders in Children and Adolescents

To study the prevalence and clinical features of celiac disease in children to develop new treatment approaches and rehabilitation strategies.

The purpose of this screening program is to identify people at high risk for developing celiac disease, which is due to the genetic intolerance of gluten - a protein found in wheat, rye and barley. When a person with celiac disease consumes gluten-containing foods, his immune system damages the mucous membrane of the small intestine. Inflammation develops and, as a result, the absorption of vitamins, minerals and other vital nutrients is disrupted. Studies have shown that timely diagnosis of celiac disease is important for the treatment or prevention of its complications. Left untreated, the disease can lead to impaired growth and development, diabetes, cancer, or other diseases. In Europe and the USA, celiac disease is a chronic disease that occurs in approximately one in 100 and one in 22 who have risk factors. There are frequent cases of an erased or low-symptom course of celiac disease. Unfortunately, ninety-seven percent of cases remain undiagnosed and, accordingly, do not receive proper treatment. A screening program will increase knowledge about the disease and contribute to the early detection of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren from various districts of Moscow selected as a result of questioning in the risk group for the development of celiac disease
* Availability of written informed consent of the child over 14 years of age to participate in the study;
* Availability of written informed consent of the parent of the child to participate in the study;
* Age from 7 to 18 years;
* Male and female gender;
* The number of points according to the results of the survey is more than 25.

Exclusion Criteria:

* Age up to 7 years and over 18 years.
* The lack of written informed consent of the child over 14 years of age to participate in the study;
* The lack of written informed consent of the parent / guardian of the child to participate in the study;
* The number of points on the results of the survey from 0 to 24
Colonoscope Insertion Trial Protocol

This research study is about determining how well a Technically Improved Colonoscope from Olympus works in helping the doctor in guiding the scope through the large bowel or colon. When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the appendix where the small bowel ends and the large bowel begins. There are points during this insertion where there are turns in the colon which can create a loop in the colonoscope. These loops can stretch the colon and create some discomfort and also require special maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the looping will make it more comfortable for the patient and more efficient for screening for polyps. The purpose of the study is to examine this colonoscope and compare it to the traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this colonoscope will function better with regard to insertion of the scope from the rectum to the cecum.

There will be two arms to the study, the CF-H180 adult colonoscope (Control Arm) and the Olympus Technically Improved Colonoscope (Olympus). (Control Arm). In this protocol the investigators will randomize patients to either the adult colonoscope or to the Olympus Technically Improved Colonoscope (Olympus) arm. The name of the arm (CF-H180 adult colonoscope or Technically Improved Colonoscope) will be in a sealed envelope and opened by the nurse. The endoscopist will be blinded to the scope that will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for outpatient colonoscopy between the ages of 35 and 75 years of age
* The patient population will be open. However, it is known that thin female patients (BMI \< 25) and/or past history of diverticular disease and/or gynecological surgery and men \& women who are tall (6'+) and patients with constipation are usually difficult candidates for a complete colonoscopy (retroflex in the cecum)
* Adequate bowel preparation
* The ability to provide informed consent

Exclusion Criteria:

* Women that are pregnant
* Patients with a past history of inflammatory bowel disease
* Patients with a past history of surgical resection (hemicolectomies, etc)
Feasibility of the Portable YouGrabber System

The aim of the study is to determine the feasibility of the portable version of the YouGrabber® system in children with central motor disorders.

In a feasibility trial with the portable version of the YouGrabber® system it will be determined if the technique and equipment are ready to be used in a home setting where children with central motor disorders train with assistance of caregivers but without a therapist. Furthermore, it will be examined if children and adolescents with central motor disorders accept this home-based system and if they are motivated for using it.

Eligibility Criteria:
Inclusion Criteria:

* Central motor disorders
* Ability to sit in an upright position for 45 minutes

Exclusion Criteria:

* Manual Ability Classification Scale (MACS) V
* Severe visual or auditory impairments
* Severe photosensitive epilepsy
Determining the Optimal Adenosine Provocation Test

Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial tree including the small airways (\<2mm). Since the introduction of the solution hydrofluoroalkane (HFA) technology it is possible to generate medication with small particles of approximately 1-2 μm, and therefore to reach the small airways. However, at this moment the investigators have no reliable instruments to identify the asthmatic subjects who particularly benefit from treatment with inhaled small particles. Recently the investigators research group investigated whether provocation with small and large particles AMP is able to identify responders and non-responders to treatment with small and large particles of inhaled corticosteroids. This provocation technique gave promising results but needs further optimization.

The aim of this study is to determine the optimal particle size of dry powder adenosine to assess small airway involvement in asthma. Secondary, to provide insight in the associations between the standard test, executed with nebulized AMP, and the new test, executed with dry powder Adenosine.

This is a cross-over study. The study population consists of 10 non-smoking asthma patients in the age of 18-65 years who have a PC20 metacholine value ≤4.9mg/ml.

Participating subjects perform 6 provocation tests in randomized order: one test with nebulized methacholine, one test with nebulized AMP, four times dry powder adenosine provocation test. (small particles with inhaled with a slow flow, small particles inhaled with a fast flow, large particles inhaled with a slow flow, large particles inhaled with a fast flow)

Eligibility Criteria:
Inclusion Criteria:

* A doctor's diagnosis of asthma
* Age: 18-65 years
* PC20 AMP \< 320 mg/ml
* Non-smoker
* Steroid naive or steroids have been stopped 4 weeks before entry into the baseline period

Exclusion Criteria:

* Recent exacerbation asthma (\<2 months) or upper respiration tract infection (\<2 weeks)
* Severe airway obstruction at baseline, FEV1pred\< 50% or \< 1.2L
* Diagnosis of COPD or any other pulmonary disease that could influence the study results as judged by the investigator
* Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).
Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray. The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in a dairy at defined time intervalls.


Eligibility Criteria:
Inclusion Criteria:

* Female or male individuals ≥ 18 years
* Patients with proven Allergic Rhinitis which are treated with Ectoin Nasal Spray or -Cromoglycic acid nasal Spray during the observational period

Exclusion Criteria:

* Contra indications according to the label
Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community

This study uses a multiple-baseline design and aims to replicate findings that a digital music-based mindfulness intervention can reduce elevated race-based state anxiety in Black Americans.


Eligibility Criteria:
Inclusion Criteria:

* Familiarity with meditation
* Turns to music for emotional support
* Elevated trait anxiety (\>=12 on the State Trait Anxiety Inventory - Trait \[STAIT\]-5)
* Majority of anxiety comes from racism or discrimination (\>=60 on a scale of 0 \[not at all\] to 100 \[entirely\] for the following question; "If you are a racial or ethnic minority, how much do you feel that racism and/or discrimination contribute to your elevated anxiety levels?")."

Exclusion Criteria:

-
Modelling Tau Distribution From DTI With Generative Adversarial Network for Alzheimer's Disease Diagnosis

The most significant impact of this project is to propose for the first time a novel generative adversarial network (GAN), as one kind of deep learning architecture, to automatically generate synthetic PET images reflecting tau deposition, from brain DTI images. If successful, this framework will become the most state-of-the-art approach to simulate the stereotypical pattern of intracerebral tau accumulation and distribution in vivo.

Synthetic tau-PET images via DTI, possessing overwhelming superiority in radiation-free, non-invasiveness and cost-effectiveness, will potentially serve as one of alternative modalities of PET in detecting tau-load and probably outperform PET on accessibility, generalizability, and availability in future, making it much more attractive in clinical application. A big conceptual shift may occur preferring a fire-new tau-PET simulated via DTI.

The DTI data-driven deep learning framework to be created in this project will constitute an accurate, robust, clinically applicable and explainable tool to efficiently categorize the subjects into tau-burden positive and tau-burden negative cases, which will undoubtedly contribute to both clinical and research activities.


Eligibility Criteria:
Inclusion Criteria:

* With the age of 55 years and above
* With brain MRI taken within ±6 months from the date of clinically confirmed diagnosis of AD, MCI or normal cognition.

Exclusion Criteria:

* AD with mixed dementia
* Non-AD dementia
* History of severe traumatic brain injury, severe depression, stroke, brain tumors, and incident major systemic illness