cyrilzakka/clinical-trials huggingface dataset:
DigiDiab Pilot: Impact Study Hospital

GlucoTab is an innovative workflow and decision support tool for standardised diabetes management by healthcare professionals which provides automated and personalised dosage recommendations for different insulin therapy regimens.

GlucoTab has already been tested in several clinical trials in Austria and has consecutively obtained the CE-mark that is valid throughout European countries.

The current study aims to further develop, implement and evaluate GlucoTab in different European pilot regions. For this reason, GlucoTab will be translated in different languages and tested in Sweden, Denmark, and Spain.

Eligibility Criteria:
Inclusion Criteria:

* informed consent obtained after being advised of the nature of the study
* a documented history of type 2 diabetes prior to inclusion or new-onset hyperglycaemia which requires s.c. insulin therapy during hospital stay
* admission to either surgical or internal medicine ward
* an expected length of hospital stay for at least 48 hours after enrolment

Exclusion Criteria:

* type 1 diabetes mellitus
* intravenous insulin therapy
* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
* continuous subcutaneous insulin infusion
* gestational diabetes or pregnancy
* known or suspected allergy to insulin
* total parenteral nutrition
* any mental condition rendering the patient incapable of giving his/her consent
* any disease or condition which according to the investigator or treating physician would interfere with the trial or the safety of the patient

Inclusion and exclusion criteria will be the same as above for the retrospective CG with the exception of:

* period of time will be from September 2022 to September 2023
* no informed consent will be obtained from the retrospective CG
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia

The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic multifocal, segmental or generalised dystonia
* duration of disease \> 5 years
* age between 14 and 75 years
* relevant disability in activities of daily living despite optimal drug treatment
* informed consent signed by the patient
* For adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary

Exclusion Criteria:

* Mattis-Score \< 120
* BDI \> 25
* previous stereotactic brain surgery
* severe brain atrophy
* increased bleeding risk
* immunosuppression and increased risk of infection
* relevant cerebrovascular disease
* psychiatric disorders, which might interfere with the cooperation in the study
* other contraindications for surgery
Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events

The purpose of this study is to evaluate optimal duration of antiplatelet therapy after Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic events.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women at least 19 years of age
2. Patients undergoing dual- or triple-antiplatelet therapy at least 12-14 months after PCI with BVS
3. Among the participants underwent PCI with BVS, event-free patients who survived the first 12 months without death, serious MI, stroke, repeat revascularization or major bleeding (except non-significant peri-procedural MI)
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Contraindication to antiplatelet therapy
2. If the physician believes that the patient need continuation of dual anti-platelet therapy because of comorbidities (ACS, peripheral vascular disease, significant carotid disease, etc.)
3. Continuous administration of clopidogrel is impossible due to comorbidities of the patient (major bleeding history, bleeding diathesis)
4. Cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
5. Pregnancy test positive (hCG test is performed before randomization in all fertile women)
BID WM Digital Intervention in Aging

The goal of this clinical trial is to learn if engaging with an digital intervention may improve cognitive function. The main questions it aims to answer are:

1. Does engagement in with a digital intervention improve working memory?
2. Does engagement in with a digital intervention improve inhibitory control?

Researchers will compare two different digital interventions to assess whether they may be helpful in improving cognitive function.

Participants will conduct study activities remotely (e.g., at-home):

1. Baseline Assessment. Complete a series of cognitive assessments and surveys.
2. Intervention. Engage in a digital intervention for up to 8 weeks.
3. Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment.
4. Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.

During the Baseline Assessment, participants will complete web-based cognitive assessments and surveys. The assessments will address various cognitive functions including working memory, long-term memory, inhibitory control, and sustained attention. Surveys will include a characterization of expectancy for the intervention, ratings of stress, and background health information. The Baseline Assessment will take up to 120 minutes and can be completed across more than one session.

During the Intervention, participants will be provided an iPad tablet to engage with the assigned intervention app. Participants will be randomly assigned to one of two intervention apps. Regardless of the assigned intervention, participants will engage with the app for 25-45 minutes of training per day, 5 days a week for up to 8 weeks for a total of 1000 minutes of training.

After the intervention, participants will complete a Post Intervention Assessment and 6 month later, a Follow-Up Assessment. Both of these assessment periods will consist of the same cognitive assessments and surveys as conducted during the Baseline Assessment.

Upon completion of all study activities, participants will be able to keep the iPad as a gift for their voluntary participation.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 12 years of education
* English fluency
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal vision
* Medically healthy older adults including those with below-average cognitive performance or mild cognitive impairment patients without dementia

Exclusion Criteria:

* Under the age of 60
* Clinical diagnosis of neurological or psychiatric disorder
* Visually or hearing impaired without correction to normal
* Clinical diagnosis of dementia or AD8 score of \>4
* Regularly (one or more times per week) practicing an instrument within the last year
The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

The purpose of this study was to determine the effect of different dietary fats (saturated or unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial endotoxemia.Participants were recruited via email and randomized to treatment meal in this single-blind, cross-over study. Each test session participants reported to the laboratory right away in the morning. An indwelling catheter was inserted into the participant non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant was then provided with one of four test meals (a porridge-type meal containing a different dietary fat), which they ate in entirety within 15 minutes. The participants remained in the laboratory for the next five and a half hours and were not allowed to consume any food or drink except water. During this time, further blood draws were taken at intervals of one hour for a total of five hours after the consumption of the test meal. Collected blood was processed on-site and the serum fraction collected and tested for endotoxin, inflammatory biomarkers, and metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 40 years old;
* Willingness to eat test meals;
* Body mass index ≥ 19.9 ±0.8 and ≤ 24.9 ±0.8;
* Weight stable (\< 2 kilogram weight change in the previous 3 months)

Exclusion Criteria:

* Presence of acute or chronic disease;
* Use of tobacco products;
* Consumes more than 21 units of alcohol per week;
* Use of anti-inflammatory medication;
* History suggestive of macronutrient malabsorption
Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids

The main purpose of this study is to update the pulmonary retention values of non-fibrous mineral particles in the general population.

This study will provide reference values for the interpretation and diagnosis of the cause of certain respiratory diseases potentially related to mineral particles.

Some non-fibrous mineral particles are responsible for respiratory or systemic diseases, most often of occupational origin. Their use concerns multiple professional sectors.

The bio metrology of these particles, namely their quantification in a biological medium requires reference values. These are essential for clinicians to interpret pulmonary retention in patients who may have been exposed professionally or environmentally to non-fibrous mineral particles.

A comparative study conducted in 2015 by lafp showed an increase in the particulate load of nonfibrous mineral particles, including titanium, in lung parenchyma samples over time.

Bronchoalveolar lavage fluid is typically considered to be representative of the lung for the analysis of nonfibrous mineral particles. The thresholds currently used for the bio metrology of nonfibrous mineral particles in bronchoalveolar lavage fluid samples are based on reference values established more than 20 years ago. It is therefore appropriate to update these reference values by establishing a new control population from the analysis of bronchoalveolar lavage fluid from subjects not exposed to the non-fibrous mineral particles in a professional or environmental manner.

Eligibility Criteria:
Inclusion Criteria:

* Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way.
* Smokers and non-smokers (or weaners who have been weaned for at least 5 years).
* Acceptance to participate in the protocol.
* Affiliated to a social security scheme.

Exclusion Criteria:

* Suspicion of fibrosing pulmonary pathologies.
* Suspicion of pulmonary sarcoidosis ≥ stage 2, pneumoconiosis.
* Subjects with cystic fibrosis.
* Subjects chronic obstructive pulmonary disease (COPD) stage ≥ 3.
* Presence of serious comorbidities that are life-threatening in the short term.
* Refusal to participate in the study.
Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)

The specific aims are to determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies across a heterogeneous sample of hospitals; identify organizational and practitioner factors associated with error rates, and evaluate the effectiveness of a multifaceted intervention in reducing prophylaxis error rates compared to written feedback alone in a sample of 44 hospitals enrolled in the study using a rigorous group-randomized design.

Numerous studies have shown that many surgical site infections (SSI) are preventable with appropriately timed antimicrobial prophylaxis. Patients receiving prophylaxis either well-before or well after surgery are up to 5 times more likely to develop an SSI than those receiving appropriate therapy (Classen et al, 1992). Unfortunately, errors in antimicrobial prophylaxis timing are extremely common with error rates typically reported to be between 35 and 40%. Given that errors in antimicrobial prophylaxis are common and the consequences of error so grave, identifying methods to assist hospitals in improving prophylaxis must be a high priority. TRAPE will evaluate a multifaceted, theory-based intervention to assist hospitals in progressing through stages of organizational change to improve the prophylaxis process. We will test the impact of the intervention using a rigorous group-randomized, nested, pretest-posttest design (Murray, 1998).

Our specific aims over the 4 year project period are:

1. determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies in 44 hospitals recruited to participate in the study;
2. identify organizational and system factors associated with error rates;
3. randomize the 44 hospitals to evaluate the effectiveness of a multifaceted intervention.

The interventions consist of: a) the promotion of specific process changes likely to reduce error rates, b) a site-visit, c) customized process feedback, d) facilitated benchmarking, and e) peer consultation. The 22 intervention hospitals will be compared to 22 hospitals that receive written feedback of their error rates only. The study has 80% power to detect a 12-15% improvement in the timing of prophylaxis in the full intervention group compared to the written feedback only group. Data collection will be done at each participating hospital, and the medical records of 100 surgical patients before and after the intervention will be abstracted at each hospital to establish performance rates. Changes in the processes of care, and the evolution through stages of organizational change will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Hospitals with a minimum number of surgeries per month
Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery

The aim of this study was to compare the effects of expiratory muscle training (EMT) and incentive spirometry (IS) in addition to conventional pulmonary rehabilitation after colorectal surgery. Twenty-four individuals (13 male) undergoing colorectal surgery were included. They were randomly divided into two groups. In addition to conventional chest physiotherapy, group 1 was performed EMT (n=12), group 2 was performed deep breathing exercises with incentive spirometry (IS) in postoperative period. Respiratory muscle strength, functional capacity, levels of movement and independence, and postoperative pulmonary complications (PPC) were evaluated. Length of stay in hospital (LOS) was recorded.

The aim of this study was to compare the effects of expiratory muscle training (EMT) and incentive spirometry (IS) in addition to conventional pulmonary rehabilitation after colorectal surgery. Twenty-four individuals (13 male) undergoing colorectal surgery were included. They were randomly divided into two groups. In addition to conventional chest physiotherapy, group 1 was performed EMT (n=12), group 2 was performed deep breathing exercises with incentive spirometry (IS) in postoperative period. Respiratory muscle strength, functional capacity, levels of movement and independence, and postoperative pulmonary complications (PPC) were evaluated. Length of stay in hospital (LOS) was recorded

Eligibility Criteria:
Inclusion Criteria:

* hemodynamically stable
* able to walk independently
* able to walk independently

Exclusion Criteria:

* any contraindication for chest physiotherapy (unstable cardiovascular disease, severe pulmonary hypertension, corrected severe hypoxemia, exercise desaturation, rib fractures, subcutaneous emphysema, advanced osteoporosis, thrombocytopenia, effort dyspnea and vertigo)
* any metastases
* severe chronic cardiovascular disease
* candidates for organ transplantation
* abdominal hernia repair
* history of surgery more than one year
* orthopaedic or neurological disease that would prevent independent walking
Peri-operative Slow-paced Breathing to Reduce Anxiety in Breast Cancer Surgery Patients

The purpose of this single-center trial is to examine the effects of a slow-breathing technique performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, state scale (STAI-S),13 compared to usual care.

Rationale: In the perioperative period anxiety for anesthesia and the surgical procedure is common. Breast cancer surgery patients have a higher level of anxiety compared to other patients undergoing (cancer) surgery. Relaxation techniques, like breath focus with deep belly breathing are easy to learn and can have a beneficial effect on postoperative anxiety, pain, and postoperative nausea and vomiting (PONV), but the quality of evidence is low. Slow paced breathing at a frequency of 6 breaths per minute can possibly increase vagal activation, decrease anxiety, reduce mean blood pressure, and postoperative pain.

The investigators aim to apply a pre-trained slow paced breathing technique at induction of anesthesia for surgery, to reduce perioperative anxiety and to explore effects on pre-operative blood pressure, per-operative need of hypnotics, postoperative pain and opioid use, PONV and patient satisfaction.

Objective: This study aims to examine the effects of guided slow paced breathing performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, State scale (STAI-S), compared to usual care.

Study design: Single center, two-group, prospective, randomized controlled trial Study population: patients scheduled for surgery for breast cancer in the Antoni van Leeuwenhoek Hospital.

Intervention: Performance of pre-trained guided slow paced breathing by the patient at induction of anesthesia for breast surgery.

Main study parameters: Anxiety scored by Spielberger's State Anxiety Inventory (STAI-S) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks related to the intervention. Participants randomized in the intervention group are trained in slow paced breathing after inclusion and asked to practice the technique daily until the day of surgery. All participants are asked to complete three questionnaires at baseline, and two short questionnaires on the day of surgery and at day 1.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Undergoing surgery for breast cancer in the Antoni van Leeuwenhoekziekenhuis

Exclusion Criteria:

* Age \< 18 years
* ASA ≥ 4
* History of severe pulmonary illness: severe asthma or severe chronic obstructive pulmonary disease (COPD) GOLD III or IV
* Known or suspected severe psychiatric disorder
* Unable to give written or oral informed consent
* Patient refusal
* Not able to understand Dutch
* No internet access
* Visual or hearing impairments interfering with reading and listening to the online material
The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children

The purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children. To determine the sensitivity/specificity and positive/negative predictive value of the APS in detecting sedation-related adverse acute respiratory events in propofol sedated nonintubated children.


Eligibility Criteria:
Inclusion Criteria:

* Patients 2 years to 18 years of age undergoing induction and maintenance of propofol sedation at the American Family Children's Hospital (AFCH) Pediatric Sedation Clinic
* American Society of Anesthesiology score (ASA) of 1-2

Exclusion Criteria:

* ASA scoring \> 3
* Oxygen requirement and cardiorespiratory instability
* Allergy to propofol or its components
* Patients requiring propofol sedation outside the AFCH Pediatric Sedation Clinic
The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial

Evaluation of the safety and effectiveness of disposable ultrasound soft tissue cutting and hemostasis equipment for coagulating 5-7mm blood vessels with ultrasound scalpel tips

Screening lung and esophageal surgery patients who must meet the inclusion/exclusion criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of 5-7mm blood vessel disconnection and occlusion

Eligibility Criteria:
Inclusion Criteria:

* 1) 18 years old ≤ age ≤ 75 years old, regardless of gender;

  2) Based on the preoperative CT examination results, it is determined that the patient has at least one blood vessel that needs to be coagulated during the surgery, with a diameter greater than 5mm but less than or equal to 7mm;

  3) Before the start of the study, the patient is willing and able to sign an informed consent form approved by the ethics committee;

  4) The patient understands the clinical study, cooperates with the research procedure, and is willing to conduct postoperative follow-up according to the protocol.

Exclusion Criteria:

* 1) Patient body mass index (BMI) ≥ 35.0 kg/m2;

  2) Prothrombin time greater than 5 seconds;

  3) Researchers have determined that the tumor may invade the target blood vessel, which may affect the operation or effectiveness of vascular occlusion and disconnection;

  4) Researchers have determined that there may be variations, deformities, or calcifications in the target vessel that may affect the evaluation of the primary endpoint, which may affect the operation or effectiveness of vascular occlusion and disconnection;

  5) Patients receive preoperative chemotherapy and radiation therapy;

  6) Patient's fasting blood glucose ≥ 11.1mmol/l;

  7) Hypertensive patients' blood pressure has not been effectively controlled, and their blood pressure is ≥ 140/90 millimeter of mercury （mmHg） in a stable state after medication;

  8) Pregnant or lactating women, or women with pregnancy plans during the trial period;

  9) Participated in other clinical studies within 3 months;

  10) Individuals with mental disorders and lack of autonomous behavioral ability;

  11) Other researchers believe that it is not suitable to participate in the experiment.
The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors

To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean Hemophilia A patients with/without FVIII Inhibitors.

Target subject :

1. Patients with Hemophilia A with FVIII inhibitors
2. Patients with severe Hemophilia A without FVIII inhibitors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator
2. Signed informed consent form

Exclusion Criteria:

1. Subjects who are hypersensitive to Emicizumab
2. Subjects who are hypersensitive to mouse or hamster protein
3. Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug
4. Subjects who participated in other clinical trials within a month before enrollment (or the first administration of Hemlibra SC inj.) (Unable to participate in other clinical trials related to Hemophilia A treatment even after enrollment)
5. Subjects who the investigator deems inappropriate for the study.
6. Moderate/Mild for Hemophilia A patients without FVIII inhibitors