cyrilzakka/clinical-trials huggingface dataset:
Factorial Optimization Trial to Test Effects of Coping Intervention Components

This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to fewer mental health problems among children, making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention. The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components (reappraisal, distraction, relaxation) on children's coping efficacy, emotional security, and internalizing and externalizing problems. Secondary aims are to assess indirect effects of the intervention components on children's coping efficacy, emotional security, and internalizing and externalizing problems through their cognitive, emotional, and behavioral reactions to post-separation/divorce interparental conflict events.

A randomized and counterbalanced 2x2x2 factorial trial (N = 144 children, ages 9-12) will be conducted to assess the individual effects of the three digital coping intervention components. The three components to be tested will be: (1) Reappraisal (No vs. Yes), (2) Distraction (No vs. Yes), (3) Relaxation (No vs. Yes). Components that meet a priori thresholds for meaningful change will be combined to form an intervention package that will be evaluated in a subsequent randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* child between ages 9-12 whose parents are separated or divorced
* child and one parent are fluent in English
* a parent with sufficient contact (i.e., at least 4 overnights and/or 12 daytime visits per month) with child who is willing to complete study assessments and has legal right to give permission for the child to participate in research
* child-report of high exposure to IPC (mean Z score ≥ 40th percentile on the two child report measures of IPC; score standardization based on data from 559 youth whose parents participated in an experimental parenting program)
* elevated internalizing or externalizing problems (T score in the borderline clinical range according to either child or parent report on the BPM).

Exclusion Criteria:

* in active therapy
* score ≥ 99th percentile on either internalizing and externalizing problems subscale
* endorse suicidality (will be ineligible for the study and referred for treatment)
Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?

Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little data to support the practice, purported benefits include reduced pelvic fluid accumulation or blood loss. Patients often complain of discomfort associated with the packing or its removal.

This randomized controlled trial seeks to document differences in subjective impressions of pain in women undergoing vaginal repairs treated with and without packing. The investigators also aim to assess differences in postoperative fluid collection in those with and without packing.


Eligibility Criteria:
Inclusion Criteria:

* Any female aged 18-85 planning to undergo a vaginal hysterectomy with vaginal reconstructive surgery for pelvic organ prolapse, with or without a suburethral sling. Must be able to speak and read English and be able to understand the informed consent.

Exclusion Criteria:

* Undergoing abdominal prolapse repair or repairs not involving hysterectomy, use of mesh, obliterative procedures, concurrent removal of mesh kit, performance of vaginal relaxing incisions, presence of vaginal, uterine, cervical or ovarian malignancy, having a clotting disorder, taking anticoagulation, needing heparin prior to surgery, having intraoperative blood loss greater than 500 cc, or use of regional anesthesia for surgery.
Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population

The COVID-19 pandemic has disrupted routine hospital services globally. The hospital services include surgeries for benign diseases, cancer surgery and obstetric surgery. A study conducted by CovidSurg Collaborative estimated that 28,404,603 operations would be cancelled or postponed during the peak 12 weeks of disruption due to COVID-19. Globally, 81.7% of benign surgery, 37.7% of cancer surgery and 25.4% of elective Caesarean sections would be cancelled or postponed. If countries increase their normal surgical volume by 20% post-pandemic, it would take a median 45 weeks to clear the backlog of operations resulting from COVID-19 disruption. This study aims to estimate total number of elective operations postponed during COVID-19 in geriatric population.

An audit study will be conducted among geriatric patients that are admitted for elective surgeries in University Malaya Medical center (UMMC). Patients who fulfil inclusion/ exclusion criteria will be recruited with consent and will have a face-to-face interview in the surgical ward prior to their elective surgeries.

Data collection in the form of a questionnaire designed in English and filled up by the research interviewer is created to document patient demography, surgical details and level of depression/ anxiety prior to surgery.

The primary objective of this study is to find incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population. This overarching aim raises two secondary objectives of the research:

1. To find the incidents of cancer surgeries postponed during COVID-19 pandemic in geriatric population.
2. To find the physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic.

Random convenience sampling will be conducted. Data will be collected using REDCap (Research Electronic Data Capture) system and analyzed using SPSS software. Results will be presented as mean ± standard deviation, median or frequency (percentages) as appropriate. Mann-Whitney U test will be used for non-normally distributed data while t test will be used for normally distributed data. The qualitative data analysis will be performed using chi-square test or Fisher's exact test if insufficient numbers are present. A p value \< 0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric patients (aged 65 and above)
* All elective surgeries under general anesthesia, regional anesthesia and ALA

Exclusion Criteria:

* Refuse to participate in the study
* Patients with cognitive disorders such as dementia and Alzheimer's disease
Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a well-recognized complication with significant morbidity and even mortality. A variety of possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema caused by manipulations during cannulation or endoscopic treatment has received the most attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical application of epinephrine on the papilla may reduce papillary edema. Moreover, it is reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after endoscopic retrograde cholangiopancreatography. We therefore designed a prospective randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after ERCP.

Between July 2016 and December 2017, 670 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to undergo a spray of epinephrine (epinephrine group) or saline (control group) on the major papilla. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, age \> 18 years.
2. Normal amylase level before undergoing ERCP.
3. Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

1. Pregnancy or history of allergy to epinephrine.
2. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
3. Patients involved in other study within 60 days.
4. Billroth II or Roux-en-Y anatomy
5. Acute pancreatitis.
6. All contraindications to epinephrine.
Psycho-social Consequences of Systemic Lupus Erythematosus

this project will allow us to evaluate and understand the impact of SLE on the couple's life and its relational and affective components. In addition, the Psy-LUP study will describe the representations that sick people and their relatives have of lupus disease. All the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with SLE, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.

Systemic lupus erythematosus (SLE) is a rare chronic autoimmune disease (1/2000 inhabitants) that evolves in periods of recurrent remissions. Sufferers are most often young women of childbearing age. SLE affects the life of a couple like family life (financial, emotional, relational or sexual conditions of the couple). In addition, the disease and its treatments can hinder the possibility of building a family project (pregnancy).

The purpose of the Psy-LUP study is to study the impact of SLE on the social participation of patients, that is to say on their ability to get involved in different areas of daily life. These repercussions could be all the more important as lupus disease is active and complicated by severe diseases such as kidney disease. We want to study how sick people and their loved ones (spouse in particular) think about lupus disease, how it fits into their life history, how people have adapted to this disease, and how it affects their lives. could have on their social participation, their social support, their life of couple. The Psy-LUP study will be carried out in different care services, and by telephone interviews at home, with two main axes: (1) a study by questionnaire with patients (n = 100); (2) a qualitative study through research interviews with patients (n = 40) and their spouses (n = 20). The realization of this project will allow us to evaluate and understand the impact of SLE on the life of the couple and its relational and affective components. In addition, the Psy-LUP study will describe the representations that sick people and their relatives have of lupus disease. All the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with SLE, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Presenting an LES according to ACR or SLICC criteria
* Being followed in Marseille in Nephrology or Internal Medicine as part of the Competence Center Lupus PACA
* Having agreed to participate in the study after information

Exclusion Criteria:

* Minor person
* Person deprived of liberty
* Person not affiliated to a social security scheme
Quercetin as Possible Supportive Therapy for Mild to Moderate Hyperuricemia

Uric acid, a metabolic byproduct of purine degradation in humans, is a known risk factor for conditions such as gout and type 2 diabetes. Research has shown that supplementation with quercetin can significantly reduce plasma uric acid levels in individuals with mild hyperuricemia, potentially mitigating these associated risks.

Uric acid, a metabolic byproduct of purine degradation in humans, is a significant risk factor for the development of gout and type 2 diabetes. Supplementation with quercetin, a flavonol not naturally produced by the human body, has been shown to significantly reduce plasma uric acid levels in individuals with mild hyperuricemia. This effect is primarily achieved through the inhibition of xanthine oxidoreductase, an enzyme crucial to uric acid production.

Quercetin is the most abundant polyphenol found in fruits and vegetables and is widely used as a dietary supplement to boost the immune system and promote overall health. It is characterized by three key properties: antioxidant, anti-inflammatory, and immunomodulatory. These combined actions make quercetin a promising candidate for supporting various health conditions where oxidative stress, inflammation, and immune function play a role, including cardiovascular health, healthy aging, bone and joint health, sports and physical activity, gut health, and respiratory well-being.

The above-described properties of quercetin prompted investigators to explore its potential uricosuric therapeutic effect in two clinical studies. The first study will assess this effect in a retrospective cohort of COVID-19 patients who received quercetin as a supplemental therapy. In the second study, its potential uricosuric therapeutic effect will be assessed in a randomized controlled prospective clinical trial involving patients with mild to moderate hyperuricemia.

Eligibility Criteria:
Inclusion criteria:

* Aged between 18 and 75 years.
* Diagnosed with obesity.
* Diagnosed with hypercholesterolemia.
* With or without moderate hyperuricemia (serum uric acid ≥ 8 mg/dL).
* No restrictions on BMI, alcohol consumption, or smoking habits.

Exclusion criteria:

* Current use of uric acid-lowering medications (e.g., allopurinol, febuxostat).
* Diagnosed with oncological diseases.
* Diagnosed with neurological diseases.
* Diagnosed with inflammatory bowel diseases.
High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19

COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc.

One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc.

In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COVID-19 Pneumonia treated in the Intensive Care Unit
* Clinical deterioration during intensive care follow-up
* First 14 days from the COVID-19 diagnosis

Exclusion Criteria:

* More than 14 days passed from the COVID-19 diagnosis
* Clinical and laboratory signs of secondary bacterial infection
Atropine Weight and Risk of Postoperative Confusion in the Elderly

The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits:

* Pharmacoepidemiological: identify factors associated with postoperative confusion
* Clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take.
* Socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...).

In total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the orthopedic department for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis
* Patient able to understand and respond to the protocol
* No opposition to the collection of data of the patient or his / her designee

Exclusion Criteria:

* Pre-existing confusion to surgery, detected by the CAM scale
* Serious or moderate head trauma less than three months old
* Removing / installing prosthesis.
Work-related Challenges in Psychiatric-psychosomatic Clinics

The aim of this project is to evaluate the work-related challenges faced by healthcare professionals (nurses, psychologists, and doctors) in German psychiatric-psychosomatic clinics. By applying the Job Demands-Resources (JD-R) model, this study investigates how job demands and resources influence job satisfaction, turnover intention, and subjective service quality. Special focus is given to the roles of burnout, engagement, and psychological safety as mediators and moderators in these relationships. Through a cross-sectional online survey targeting 600 healthcare professionals, this study aims to identify key factors affecting well-being and performance in mental health settings. The findings will contribute to the development of interventions to improve the working conditions and service quality in psychiatric-psychosomatic care.

This study uses an online questionnaire to collect data from healthcare professionals (nurses, psychologists, and doctors) working in psychiatric-psychosomatic clinics in Germany. The survey aims to assess their experiences and perceptions regarding work-related challenges, job demands, and resources, as well as their impact on job satisfaction, turnover intention, and subjective service quality. The study applies the Job Demands-Resources (JD-R) model to explore the relationships between these factors, with a particular focus on the mediating roles of burnout and engagement and the moderating role of psychological safety.

The survey will be conducted at a single time point, targeting 600 healthcare professionals (200 nurses, 200 psychologists, and 200 doctors) across various psychiatric-psychosomatic clinics in Germany. Data will be collected using standardized scales to ensure reliability and validity. Participants will be recruited via email invitations sent to clinics, with the survey distributed through the SoSci Survey platform. Participation is voluntary, and all data will be anonymized and handled in compliance with ethical and data protection regulations.

Main Research Questions are:

I. How do the surveyed resources and demands of healthcare professionals impact job satisfaction, turnover intention and subjective service quality? II. What roles do burnout, engagement, and psychological safety play as mediators and moderators in these relationships? III. What are the key challenges and resources identified by healthcare professionals in their daily work within psychiatric-psychosomatic settings?

Eligibility Criteria:
Inclusion Criteria:

* Healthcare professionals (nurses, psychologists, or doctors) working in psychiatric-psychosomatic clinics in Germany
* Age 18 years or older
* Sufficient German language proficiency to complete the questionnaire
* Willingness to provide informed consent

Exclusion Criteria:

* Individuals not working as nurses, psychologists, or doctors in psychiatric-psychosomatic clinics
* Age under 18 years
* Insufficient German language proficiency to complete the questionnaire
* Massively limited cognitive abilities
EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage and pregnancy complications. Thrombophilia could favor the development of thrombosis of the maternal vasculature and obstacle placentation. Some studies have suggested a role of thrombophilia in the failure of assisted reproductive techniques although this association has been recently questioned. The scope of this study is to evaluate the effect of thrombophilia on the implantation rate and live birth rate in women undergoing ART.

Design: prospective, observational study Primary end-point: live birth rate. Secondary end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks post-partum


Eligibility Criteria:
Inclusion Criteria:

* women undergoing ART
* age 18 years or older

Exclusion Criteria:

* ongoing anticoagulant therapy
* previous venous thromboembolism
* no informed consent
The Impact of Air Travel on Passenger Cognitive Functions

In the period from June 2021 to June 2022, a prospective clinical study will be conducted in the Republic of Kazakhstan with economy class passengers traveling by plane with a minimum flight period of 5-7 flight hours in the territory of the Republic of Kazakhstan.


Eligibility Criteria:
Study participants (Volunteers) will be recruited through media, advertisements and announcements. Prior to the study, study participants will receive written and oral explanations of the study protocols, and written informed consent will be obtained from each study participant. All potential research participants will undergo medical and psychological selection. The components, stages of selection are almost the same as those of general professional selection: the first stage is professiography / psychogram, the second stage is psychodiagnostics, the third stage is assessment and forecasting, and the fourth stage is decision making. Selection will assess the ability of participants to perform complex sequential actions.

Inclusion criterion:

* Age from 22 to 30 years old;
* at least 15 years of education, including secondary education;
* understand and speak Russian (Due to the valid Russian-language questionnaire and methodology).

In addition, study participants will be asked not to limit their caffeine intake from their daily intake, but only water is allowed 4 hours before the neuropsychological testing. Participants in the study should not hmedical/medicallane in the last two weeks prior to the start of the study, nor should they consume alcohol during the study.

Exclusion criterion:

* A member taking melatonin (affects circadian rhythm);
* Participant with comorbidities that affect cognitive function and sleep (eg, stroke, TIA, concussion with loss of consciousness, hearing problems, chronic fatigue syndrome, depression, seasonal affective disorder, anorexia);
* A participant with another ongoing sleep disorder.

All participants must be free of a history of venous thrombosis, antithrombotic or anticoagulant medications and oral contraceptives and / or any other drugs that interfere with blood coagulation (i.e. warfarin, coumadin) for at least 2 months prior to study initiation, and sign a consent to refrain from taking medications that may affect coagulation, such as aspirin or non-steroidal anti-inflammatory drugs, within 3 days after the flight, unless there is a medical / medical need.

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