cyrilzakka/clinical-trials huggingface dataset:
Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures

Patients with cirrhosis are frequently hospitalized and often undergo procedures. Knowledge surrounding bleeding risk is sparse and practice patterns vary across centers in regards to bleeding prophylaxis. The goal of this study to is to obtain more knowledge regarding risk factors for procedural related bleeding in patients with cirrhosis and to develop a predictive model to risk stratify patients before undergoing procedures. Through collaboration from centers across the world this study should provide information on prevalence of bleeding and variation in practice patterns for prophylaxis.

Hospitalized patients with cirrhosis who undergo 1 or more non-surgical procedure will be enrolled. The investigators will collect multiple clinical characteristics from the medical record and follow the patients prospectively over the hospitalization and/or until 28 days to determine if clinical events have occurred including bleeding, thrombosis, re-hospitalization and death. Characteristics of the hospitalization will be recorded including presence of acute decompensation and acute on chronic liver failure (ACLF). Procedure type will be recorded including coagulation laboratory data before and after each procedure. All bleeding events will be recorded and characteristics surrounding each bleed will be recorded. Bleeding will be defined according to International Thrombosis and Haemostasis (ISTH) definitions of major bleed and clinically relevant non-major bleed. REDCap (https://www.project-redcap.org) will be used to collect and centralize data maintained at the University of Virginia. Characteristics of each hospitalization will be recorded accordingly and patients will be followed for 28 days for outcome and mortality information. Each participating center will obtain local Institutional Review Board (IRB) approval to participate and enter data directly into REDCap. After center IRB approval is obtained, centers will consecutively enrolling patients on a rolling basis. Data will be collected from enrollment until death, transplant, discharge and/or 28 days on each individual enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with cirrhosis admitted to a hospital ward or ICU for greater than 24 hours.
* Patient must undergo 1 or more invasive non-surgical procedures at admission or during the hospitalization.

Exclusion Criteria:

* Age \< 18 years old
* Prisoner
* Pregnant
* Unable to provide consent
* Previously enrolled in this study
Effect of Diluent Volume on Colistin Inhalation Therapy

The aim of this study is to investigate the impact of different diluent volumes for the same dosage of colistin in mechanically ventilated respiratory patients receiving colistin inhalation therapy. The study aims to determine whether the diluent volume has an effect on clinical outcomes, including ICU length of stay, total hospitalization duration, duration of respiratory support within 28 days, mortality rates within 28 days and 90 days, as well as analyze the pharmacokinetic profile of colistin in blood and bronchoalveolar lavage fluid. Additionally, the study will evaluate the incidence of nebulizer malfunctions and blockages. The findings of this research will help identify the optimal diluent volume for colistin inhalation therapy in clinical practice.

Background： Colistin is an antibiotic used to treat infections caused by multidrug-resistant Gram-negative bacteria. In recent years, it has been widely utilized as an inhaled antibiotic for the treatment of respiratory infections in critically ill patients on mechanical ventilation. Despite the increasing use of colistin inhalation therapy for ventilator-associated pneumonia, the clinical impact of diluent volume on nebulization efficiency remains unclear.

Study Design： A single-center, prospective, randomized controlled trial.

Methods： The study plans to enroll 60 participants. Colistin inhalation therapy will be administered using a blocked stratified random allocation. The control group will receive colistin 6 MU diluted in 6 ml of normal saline (1 MU per 1 ml), while the experimental group will receive colistin 6 MU diluted in 12 ml of normal saline (1 MU per 2 ml). The dosage, frequency, and administration method of colistin inhalation will follow the clinical standard of 6 MU, administered every 8 hours, continuously for 7 days.

Effect： The investigators anticipate that the clinical outcomes and pharmacokinetics of colistin inhalation therapy will not differ significantly between different diluent volumes. Based on comprehensive evaluation, a diluent volume of 12 ml is considered more suitable than 6 ml for the dilution of colistin.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Intensive Care Unit.
* Age greater than 18 years and using a ventilator due to acute respiratory failure.
* Requires inhalation colistin treatment as determined by the disease.
* Sign the written informed consent form.

Exclusion Criteria:

* Renal failure requiring renal dialysis.
* Receiving both inhaled colistin and intravenous colistin treatments.
Vascular Dysfunction During Physical Inactivity

Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to a sedentary lifestyle or acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is the goal of this study to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have recently undergone surgery or injury requiring inactivity

Exclusion Criteria:

* Cardiac abnormalities considered exclusionary by the study physician (congestive heart failure, coronary artery disease, right-to-left shunt)
* Uncontrolled endocrine or metabolic disease
* Glomerular filtration rate \< 45 mL/min/1.73 m\^2 or evidence of kidney disease or failure
* Vascular disease or risk factors of peripheral atherosclerosis
* Risk of deep vein thrombosis including family history of thrombophilia, pulmonary emboli, deep vein thrombosis
* Use of anticoagulant therapy
* Elevated systolic pressure \> 180 or a diastolic blood pressure \> 110
* Implanted electronic devices such as pacemakers, infusion pumps, stimulators
* Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
* Currently on a weight-loss diet or body mass index \> 35 kg/m\^2
* Inability to abstain from smoking for duration of study
* History of \> 20 pack per year smoking
* Positive for human immunodeficiency virus, hepatitis B or hepatitis C
* Recent anabolic or corticosteroids use (within 3 months)
* Subjects with hemoglobin or hematocrit lower than accepted lab values
* Agitation/aggression disorder
* History of stroke with motor disability
* Recent history (\< 12 months) of gastrointestinal bleed
* Depression diagnosis
* Alcohol or drug abuse
* Liver disease (AST/ALT 2 times above the normal limit, hyperbilirubinemia)
* Respiratory disease (acute upper respiratory infection, history of chronic lung disease with resting oxygen saturation \< 97% on room air)
* Pregnancy
Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection

Safety and effectiveness of a new hemostatic system to prevent delayed bleeding after endoscopic resection in a selected high-risk population (NEXPOWDER- ENDOHS).

Indication:

Patients with indication of endoscopy resection by endoscopic mucal resection (EMR) or endoscopic submucosal dissection (ESD) with high risk of delayed bleeding (≥5%).

Hypotheses:

The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.

Hypotheses:

The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.

Study design:

This is an investigator-initiated, multicentric, international, open-label, non-controlled, prospective study:

* All subjects with indications undergo screening and baseline visit,
* Informed consent is obtained when scheduling the ESD or EMR procedure,
* ESD or EMR is performed, at the end of resection, NexpowderTM is applied on the resected field,
* A follow up visit is scheduled at 4 weeks.

Endpoints:

* Primary:
* Assess the delayed bleeding rate after ESD or EMR of ≥20mm in a selected high-risk population when using NexpowderTM at the end of the procedure.

This hypothesis is that the use of NexpowderTM will reduce the rate of DB from 16% (reported rate in the literature) to less than 5% (excepted observed rate during the study).

* Secondary:
* Safety of NexpowderTM endoscopic hemostasis system,
* Procedure duration and NexpowderTM spaying duration,
* Length of stay in hospital,
* Post intervention pain,
* Adverse events related to the use of NexpowderTM:
* Per procedural
* Early (up to controlled endoscopy or at 24hours post procedure)
* Late (up to 4 weeks follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 year of age at the time of informed consent,
* Patients must have given written informed consent,
* Subjects with documented lesions with indication of upper or lower endoscopic removal by ESD or EMR with high risk of delayed bleeding (+/-16%), namely:
* All patients under anticoagulation (vitamin K antagonist, direct anticoagulant, non-fractionated heparin or low molecular weight heparin) or anti-aggregating (P2Y12 receptor antagonists),
* Patients without anticoagulation or anti-aggregating with indication of duodenal EMR or ESD (if duodenal cold snare EMR: only under anticoagulant or P2Y12 receptor antagonist),
* Resection field of ESD or EMR is ≥ 20mm (same size restriction in case of endoscopic papillectomy).

Exclusion Criteria:

* Resection bed \<20mm,
* Subject currently enrolled in another interventional confounding research (no contra-indication for image or blood collection in another protocol),
* Incapacitated subjects, pregnant or lactating women.
Adult Arm of DZL All Age Asthma Cohort (ALLIANCE)

Deep Phenotyping of adult asthma patients:

* severity from mild to severe
* both atopic and non-atopic
* both childhood and adult onset
* both smokers and non-smokers
* corresponding pediatric cohort (Pediatric Arm of DZL All Age Asthma Cohort) with equivalent SOPs regarding collection of biomaterial and clinical data incl. lung function, further processing of biomaterial and further analyses

The clinical heterogeneity of asthma patients has been increasingly recognised within the last years. Recent studies and articles highlighted the idea of asthma not beeing a single disease but rather a unifying term for multiple phenotypes. Phenotype in this sense is defined as the combination of observable properties of an organism, that are produced by the interactions of a genotype and the environment. In contrast, endotype describes a specific underlying pathophysiological pathway. Linking asthma phenotypes and endotypes in a system biological approach is an important research goal in order to develop targeted therapy, especially for severe asthma.

The advantage the investigators' cohort provides is the collaboration with an equivalent pediatric cohort. In this setting questions regarding disease onset, exacerbation and chronicity can be posed and worked with in a comprehensive manner.

Eligibility Criteria:
Inclusion Criteria:

* Proven Diagnosis according to current GINA Guideline (2014)
* Ability to read and understand German
* Ability to understand and agree to informed consent

Exclusion Criteria:

* History of respiratory tract infection within the last 4 weeks before inclusion
PACED-digitized Support During Adjuvant Endocrine Therapy

The research team want to investigate whether digital support, an app under preventive hormonal breast cancer treatment can lead to less late side effects, better quality of life and increased adherence to treatment.

Patients with hormon receptor positive breast cancer and adjuvant endocrine treatment will be invited to participate in the study after adjuvant radiotherapy is completed. Participants will be randomised to 12 months of access to a digital support-an app-in addition to standard follow-up or standard follow-up. Research team want to investigate whether digital support under hormonal breast cancer treatment can lead to less late side effects, better quality of life and increased adherence to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Hormone receptor positive breast cancer
* On adjuvant endocrine treatment 0-16 weeks ago

Exclusion Criteria:

* Cognitively impaired
* No access to a mobile phone or internet
* Not understanding Swedish
Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents

Mental health literacy (MHL) is necessary for the prevention, detection, and treatment of eating disorders, whereas the MHL about eating disorders is inadequate in China. Thus, the current study aimed to improve the MHL for eating disorders among Chinese adolescents via a brief online intervention.


Eligibility Criteria:
Inclusion Criteria:

* Middle school students

Exclusion Criteria:

-
FRailty Among Elderly Emergency Department Patients With Outcome Measures

Our study aims to compare 4 clinical frailty scores, namely Clinical Frailty Scale (CFS), Edmonton Frail Scale (EFS), FRAIL 5-item scale (FRAIL) and SARC-F Sarcopenia Score (SARC-F), which can potentially be adopted for daily practice in the busy ED. It is timely as we projected that we will be seeing more elderly patients attending the ED for various medical and surgical conditions. Their attendance at the ED would be a good opportunity to screen for frailty among them, and to intervene to prevent adverse outcomes such as ED re-attendance or subsequent hospitalisation that might lead to poor functional outcomes and higher dependence on step-down care facilities.


Eligibility Criteria:
Inclusion Criteria:

- Elderly patients aged 65 years and above attending ED irrespective of reason for attendance.

Exclusion Criteria:

* Haemodynamically unstable patients
* Inability to obtain informed consent
* Inability to obtain reliable information from patient or caregiver (e.g. deafness, blindness, language barriers)
* Vulnerable populations (e.g. prisoners)
* Patients who are planned for hospital admission from the ED
Asthma and Intimate Partner Violence

This is a cross-sectional observational study on adult asthmatics evaluating the relationship between asthma control and psychosocial factors to include intimate partner violence, stress, anxiety, depression, post-traumatic stress disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma as defined as postbronchodilator response of at least 12% and 200 milliliters improvement in forced expiratory volume in 1 second (FEV1) or forced vital capacity and/or evidence of positive airway hyperresponsiveness.

Exclusion Criteria:

* Medical factors that would preclude participation as determined by the investigators. Examples include blindness, mental illness that grossly impairs judgment, or active injury requiring treatment.
Mindfulness App Versus Mindfulness-based Intervention for Healthcare Students

The main purpose of this study is to compare the efficacy of a mindfulness-based training app ('REM Volver a Casa') versus a regular, presence-based program (MBSR) on the reduction of anxiety and other factors related to the physician-patient relationship, in healthcare grade students.

Healthcare students suffer from higher levels of anxiety and depression than the general population. It compromises not only their mental health, but also the quality of care provided. Aptitudes such as empathy and self-compassion are essential to improve this deficit and overcome the well-known burnout syndrome.

Mindfulness-Based Stress Reduction (MBSR) program has proven to be an effective intervention for lowering stress in numerous studies. However, this intervention asks for a significant degree of personal involvement, thus the number of dropouts is often reported as a problem. New technologies might allow users to adapt training to their personal schedules.

The present randomized trial aims to compare the efficacy of a mindfulness-based training delivered through a mobile application ('REM Volver a Casa'), a presence-based program (MBSR), and a control group in healthcare grade students.

Eligibility Criteria:
Inclusion Criteria:

* Student of Medicine, Nutrition, Psychology or Nursing.
* Ability to read and understand Spanish language.
* Signature of Informed Consent.

Exclusion Criteria:

* Previous MBSR or anorther standardized Mindfulness training.
* Inability to read or understand Spanish language.
prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia

Retrospective multicentre study on management of supraventricular tachycardia in prehospital setting.

Supraventricular tachycardia in prehospital setting may be managed with adenosine administration or with synchronised electrical cardioversion and there's no clear advantage between the two, even if international guidelines suggests to practice drug-first method.This study aims to evaluate any difference in outcomes and efficacy of the two methods and possible adverse effects of both.

Eligibility Criteria:
Inclusion Criteria:

* patients accepting to participate
* patients affected by supraventricular tachycardia that are managed prehospitally by the emergency medical service

Exclusion Criteria:

* not willing to participate, not able to give consent
Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome

No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS. The outcome measures included the validated CTS symptom severity and functional status scales completed at baseline and 1 year postoperatively. The trial showed that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and function were equivalent. This extended follow-up of the randomized trial will primarily measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by mail to the patients. The questionnaire will consist of the CTS symptom severity and functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog scale about treatment satisfaction. The patients will also be asked about whether they had undergone further surgery for CTS in the same or contralateral hand after their operation in the randomized trial. The completed questionnaires will be scanned into a database. The scores for the different scales will be calculated. Analysis will include comparison between the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15 years.


Eligibility Criteria:
Inclusion Criteria (original trial):

* Primary idiopathic carpal tunnel syndrome
* age 25-60 years
* currently employed
* duration of symptoms of at least three months
* inadequate response to six weeks' treatment with wrist splint
* symptoms of classic or probable carpal tunnel syndrome according to the diagnostic criteria in the Katz hand diagram, and nerve conduction test showing median neuropathy at the wrist (distal motor latency ≥4.5 milliseconds, wrist-digit sensory latency ≥3.5 milliseconds, or sensory conduction velocity at the carpal tunnel segment \<40 metres/second but no other abnormalities.

Exclusion Criteria (original trial):

Inflammatory joint disease

* diabetes mellitus, thyroid disorder, pregnancy, trauma to the affected hand during the preceding year
* previous carpal tunnel release surgery in the affected hand
* carpal tunnel release surgery in the contralateral hand during the preceding year
* symptoms of carpal tunnel syndrome in the contralateral hand not adequately relieved by splint at the time of enrollment
* current sick leave because of disorders other than carpal tunnel syndrome
* inability to complete questionnaires because of language problem or cognitive disorder.
The Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.

The aim of the present investigation was to evaluate the effect of stevioside and rebaudioside on several variables related to caries development. Two approaches were performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in vivo randomized study on the effect of a single rinse containing stevioside and rebaudioside on plaque-pH.


Eligibility Criteria:
Inclusion Criteria:

good general health, normal salivary secretion rate, normal buffer capacity

Exclusion Criteria:

systemic diseases, salivary secretion reduction, reduced buffer capacity
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research

The China Alliance for Type 1 Diabetes (CAT1D) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center prospective clinical research on type 1 diabetes.

1. Through the CAT1D, expand the cohort construction of type 1 diabetes patients and first-level relatives in China, establish the electronic information database of type 1 diabetes, and lay a foundation for obtaining the research data of type 1 diabetes in China.
2. observe and study the occurrence and development rules of acute and chronic complications of type 1 diabetes in China, analyze the influencing factors, and provide intervention means for reducing acute complications and preventing chronic complications.
3. Through the established management platform and structured education system, verify and promote the comprehensive management mode based on structured education, and build a standard treatment plan and process based on evidence-based science and suitable for Chinese people and medical background.
4. By using mobile health (mHealth) and Artificial Intelligence (AI) technologies, a new mode of intelligent structured education is established, which provides a new way to explore the individualized education management mode and improve the outcome of chronic diseases through modern technology.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
* Written informed consent from the patient or family representative;
* Individuals who own smartphone and are capable of using wechat or apps

Exclusion Criteria:

* Non-t1dm patients with autoimmune polyendocrine adenopathy syndrome (APS) are the first disease
* With mental disorders
* Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial