cyrilzakka/clinical-trials huggingface dataset:
Cognitive Training for Emotion Regulation in Psychotic Disorders

The current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.

Psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and present major challenges to our health care system. Difficulties with emotion regulation (i.e., the ability to control the emotion response using strategies) significantly predict the development and maintenance of psychotic symptoms and poor community-based functional outcomes. Recent neuroimaging research indicates that hypofrontality may underlie these deficits. Unfortunately, there is no accepted technique for remediating these emotion regulation abnormalities in psychotic disorders. Recent advances from the field of cognitive neuroscience provide hope for a resolution to this critical unmet need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive training interventions are capable of improving emotion regulation ability by targeting neural activation in the prefrontal cortex. The goal of the proposed project is to determine whether an emotional working memory cognitive training program is effective for remediating emotion regulation abnormalities and associated clinical outcomes in people with psychotic disorders. Outpatients with psychotic disorders will be randomly assigned to either an emotional working memory training (n = 35) or placebo (P: n = 35) cognitive training control intervention delivered via an app on a smart phone for 30 days. The primary aim is to determine whether the emotional working memory intervention successfully engages the target mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer task beyond a pre-specified effect size criterion. Results will also be used to determine the treatment duration (15 vs. 30 days) that most effectively and efficiently improves the target.

Eligibility Criteria:
Inclusion Criteria:

* diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder
* 18-60 years old
* speaks English
* premorbid intelligence quotient \> 70
* clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.

Exclusion Criteria:

* history of intellectual disability or neurological disorder
* history of traumatic brain injury with loss of consciousness \> 10 minutes or behavioral sequelae
* substance use disorder within the last 6 months (other than nicotine)
* 4) endorsement of MRI exclusion factors
Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge

The purpose of this research study is to evaluate the knowledge of parents and children with respect to dementia symptoms, risk factors, and response before and after an interactive dementia education program that uses music and dance to enhance a health education curriculum at 1-week and 3-months after the intervention.

Public awareness of Cardinal Alzheimer's disease (AD) symptoms remains low. Adults often underestimate personal dementia risk; minority populations are more likely to have low dementia literacy and be unaware of it. Cultural dementia belief in minority groups are complex and pose barriers to diagnosis, with dementia symptoms being considered a part of normal aging, or that discussion may be taboo even when recognized. A key barrier to timely AD diagnosis in African Americans is delayed physician contact, often years-long, following the onset of first symptoms. Despite studies demonstrating that dementia concepts first develop in elementary school periods, apart from our work, no dementia awareness programs focus on children. This intervention therefore addresses a major gap regarding optimal approaches for shifting cultural perceptions of dementia in low-income minority populations and reducing barriers to its timely diagnosis.

All R01 aims have been completed in this study.

Eligibility Criteria:
Inclusion Criteria:

* 4th and 5th-grade children (ages 9-11y) and their parents (age \> 20 years).
* Selected New York City public schools with similar socio-demographic composition.

Exclusion Criteria:

* Schools have already received pilot OSHH and the U.S. Department of Health and Human Services (HHS) programming.
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome

Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"
* Symptoms have been present at a similar level for at least 3 months
* Stable medication for at least 2 months
* visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)
* The patient does not have a disorder that would otherwise explain the pain

Exclusion Criteria:

* Alcohol/substance abuse
* Pregnancy
* Neuropsychiatric disorders
* Metal implants near stimulation area
* Cardiac pace maker
* Local injuries
* Inflammatory rheumatic disease
* Acute tumor
* Acute fracture
* Well-defined neuropathic induced pain
Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting

Laparoscopic sleeve gastrectomy (LSG) is an emerging treatment modality among the various types of surgical approach to obesity (1). The incidence of PONV in obese patients undergoing bariatric surgery, who did not receive antiemetic prophylaxis, is high at nearly 70-80 % (2,3). Postoperatively, bariatric patients appear to suffer from nausea and vomiting more frequently than normal weight or obese patients.

Currently, available interventions for PONV prophylaxis, especially as monotherapy, lack universal efficacy. Use of combination therapies with different pharmacological basis is likely to bring down rates of PONV. (6) Intravenous dexamethasone (8-10mg) reduces the incidence of PONV, minimizing activity of phospholipase A2 and blocking the expression of cyclooxygenase (COX)2 mRNA that reduce production of prostaglandin and control the release of endorphins.

Aprepitant has demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV), and in the prevention of postoperative nausea and vomiting (PONV) The use of mirtazapine in the management of nausea and vomiting has been reported for both treatment and premedication

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* Body mass index (BMI) ≥ 35 kg/cm-2

Exclusion Criteria:

* Patients with gastrointestinal disorders,
* Patients with significant major organ disease,
* Patients received antidepressant drugs,
* Patients received an anti-emetic drug within 48 h before surgery,
* Patients on treatment with systemic glucocorticoids within 4 weeks before surgery.
Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)

Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options have had limited symptomatic effect and are associated with significant side effects. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have, besides its antidepressant properties, a centrally acting analgesic effect.

The aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA.

288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary knee OA attending the outpatient clinic of our institution were enrolled in this study. All patients underwent a physical examination and where questioned about the number of flares. Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included improvements in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline and at monthly intervals for 4 months. All staff involved in data collection was blinded to the treatment assignment groups.


Eligibility Criteria:
Inclusion Criteria:

* primary knee osteoarthritis

Exclusion Criteria:

* inflammatory conditions
* autoimmune disorders
* psychiatric illness
* morbid obesity
Esketamine Combined With Pregabalin on CPSP in Spinal Patients.

Chronic postsurgical pain has become one of the most common complications of surgery. The quality of life will be impacted once the postsurgical patients are combined with persistent pain. What's more, the postsurgical pain may increase other adverse outcomes. It's important to find a better way to keep the postsurgical patients away from postoperative pain. Esketamine and pregabalin have become potentially effective drugs on CPSP.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective primary spinal tumor surgery;
* Ages between 18 and 65 years old;
* American Society of Anaesthesiology (ASA) status I-III;
* Signed informed consent.

Exclusion Criteria:

* Previous adverse reaction to ketamine, s-ketamine or pregabalin;
* Patients with a diagnosed history of severe chronic pain;
* Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
* Patients with aphasia or inability to cooperate with the pain assessments;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with a diagnosed history of psychiatric disorder;
* Patients treated with gabapentin/pregabalin in the last three months;
* Drug abuse;
* Body mass index (BMI) \> 35 kg/m2 ;
* Pregnancy or lactation.
Exercise and Sauna on Blood Pressure and Cardiovascular Health

The study aims to investigate the effects of including regular heat therapy when included to exercise. Specifically, participants in the sauna intervention group will undergo 15 minutes of sauna exposure immediately after a 50-minute session of exercise, 3 times a week, while participants in the exercise intervention group will follow only the same exercise protocol.

The 50-minute exercise session consists of 20 minutes of moderate intensity strength exercise, followed by 30 minutes of moderate-vigorous aerobic exercise on stationary bikes. This exercise intervention protocol was selected in order to meet and adhere to the recommended physical activity guidelines.

The main purpose of the experiment is to investigate the cardiovascular modulations of sauna use with respect to vascular compliance and hemodynamics. The investigators seek to understand the long-term adaptations of regular sauna bathing in conjunction with exercise, particularly in sedentary populations with cardiovascular risk factors.

Of particular interests are the cardiovascular adaptations of regular sauna bathing when used in conjunction with exercise training; which meets the recommended minimum of current physical activity guidelines. Recent studies have shown that long-term sauna use with exercise is more effective than sauna use alone in patients with chronic heart failure. However several questions pertaining to regular exercise in combination with sauna use remain to be answered, as experimental data in the general population is still lacking.

This research project aims to find out the differences (if any) in cardiovascular and hemodynamic-related outcome parameters, between regular exercise according to the minimum recommended guidelines, and the same exercise program with an additional regular 15 minute sauna session post exercise.

The training intervention will last for 8 weeks, with each session consisting of 20 minutes of moderate intensity resistance training, followed by 30 minutes of aerobic training. Participants in the exercise only group rested in the training area for 15 minutes while the exercise and sauna participants went to the sauna for 15 minutes.

Temperature of the sauna room was increased by 5 degrees celsius every fortnight starting from 65 degrees celsius; during the final 2 weeks of the intervention the sauna temperature was at 80 degrees celsius. (65, 70, 75, 80). Participants were told that they could leave the sauna room anytime they felt uncomfortable or if they wish to.

Eligibility Criteria:
Inclusion Criteria:

* At least one conventional cardiovascular risk factor but asymptomatic for coronary heart disease or diabetes

Exclusion Criteria:

* Use of sauna more than once a week,
* Exercise more than 30 minutes a week,
* low blood pressure,
* any diagnosed and/or symptomatic cardiovascular disease,
* musculoskeletal injury,
* any other physical or mental condition that will prohibit the participation in the experiment,
* participation to any other study at the same time.
Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 on Transcriptomic Changes of Low Vitamin D Responders

The purpose of the study is to investigate in vivo whether a high-dose vitamin D3 oral bolus (2000 micrograms) produces marked vitamin D receptor target gene expression response and whether there is large inter-individual variation. These effects are compared to in vitro treatment of peripheral blood mononuclear cells from these subjects with 25(OH)D.

Serum 25-hydroxyvitamin D3 \[25(OH)D3\] is a well-established marker for vitamin D status of the human body. In addition to the general importance of vitamin D for bone health, low serum 25(OH)D3 concentrations have been associated with increased risk of several health outcomes, such as autoimmune diseases, type 2 diabetes and cardiovascular complications. However, there is significant inter-individual variation in the average serum 25(OH)D3 concentrations and also in the response to supplementation with vitamin D. Genetic and epigenetic factors have been suggested to be responsible for a large part of the variation, but currently there is little information about the health effects of the variation.

In our previous studies VitDmet (Clinicaltrials.gov NCT01479933) and VitDbol (Clinicaltrials.gov NCT02063334) we showed that the participants can be classified into high, mid and low responders to vitamin D and defined the new biomarker "vitamin D response index". Some 25% of the population seem to be low responders and are under higher risk to suffer from insufficient supplementation with vitamin D. The current study will focus on low vitamin D responders (among the 40 healthy individuals recruited in the study, 20-60 years old), i.e. it will use the same oral vitamin D3 bolus (2,000 µg, i.e. 80,000 IU in one day) as in our VitDbol study, in order to identify low vitamin D responders.

By in vitro treatment of peripheral blood mononuclear cells (PBMCs) of low responders with 25(OH)D3 for 24 h (in comparison to in vitro stimulations with 1,25-dihydroxyvitamin D3 \[1,25(OH)2D3\] and in vivo vitamin D3 supplementation of the same subjects) we will obtain samples that allow the transcriptome-wide investigation of changes in gene expression. The underlying hypothesis of this study is that a stimulation with 25(OH)D3 is more efficient than a treatment with vitamin D3, so that in future low vitamin D responders may be supplemented with 25(OH)D3 rather than with vitamin D3.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* BMI 20-25 kg/m2.

Exclusion Criteria:

* History of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or Wegener's granulomatosis.
* Continuous use of anti-inflammatory medicines.
* Regular use of supplements containing over 20 micrograms of vitamin D.
Validation of a Food Frequency Questionnaire for the Assessment of Omega-3 Fatty Acid Intake

As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due to eating habits varying in different countries the questionnaire documenting dietary habits needs to be adapted to the situation in question. Based on a US version the investigators developed a questionnaire suitable for Switzerland and now wish to validate it by measuring the fatty acid composition of red blood cells, which will provide information on the intake of the various fatty acids.


Eligibility Criteria:
Inclusion Criteria:

* healthy males and females aged 18 to 60

Exclusion Criteria:

* known disorders of the gastrointestinal tract which can lead to malabsorption
* intake of medication which could affect the absorption of any nutrients
* Pregnant or breast-feeding women
Treatment of Dysphagia Using the Mendelsohn Maneuver

The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia.

The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver (voluntary prolongation of laryngeal excursion at the midpoint of the swallow) on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia (specifically, reduced duration of hyoid maximum elevation, reduced extent of hyoid maximum elevation, reduced duration of hyoid maximum anterior excursion, reduced extent of hyoid maximum anterior excursion, and reduced duration of upper esophageal sphincter (UES) opening with subsequent residue in the pyriform sinuses and, potentially, aspiration). Participants are assessed with videofluoroscopy at the initiation of the study and after each week of the study. After the 4 weeks of participation are complete, all participants will be discharged from treatment and will be brought back to the clinic for a final Videofluoroscopic Swallow Study (VFSS) evaluation after 2 weeks. This means that individuals in Group 1 will be re-analyzed after 1 month of additional no-treatment, and Group 2 will be re-analyzed after 2 additional weeks of no-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Stroke (1-18 months post)
* Pharyngeal Dysphagia

Exclusion Criteria:

* Other neurologic or structural abnormality to oropharynx
* History of dysphagia prior to latest stroke
Implementation Strategy and Systemic Effects of Routine Telemedical Care in Prehospital Emergency Medicine

In two research projects a comprehensive prehospital telemedicine system was developed and general feasibility as well as impact on guideline adherence were evaluated. These results allowed stepwise implementation into medical routine care.

All steps and milestones from the research idea to implementation were analyzed and evaluated descriptively in this study. Using a pre-post intervention analysis the systemic effects of the implementation on change in emergency medical resource utilization were analyzed.

In two interdisciplinary research projects a comprehensive prehospital telemedicine system was developed and general feasibility as well as impact on guideline adherence were evaluated. Feasibility and general safety were demonstrated. These results allowed stepwise implementation into medical routine care during a one year phase. During implementation positive effects on guideline adherence were found. Despite positive results there are many barriers that prevent implementation of research projects into routine medical care. Therefore, the current study evaluated and interpreted all steps and milestones from the research idea to implementation and evaluated them descriptively. Using a pre-post intervention analysis the systemic effects of the implementation on change in emergency medical resource utilization were analyzed. Resource utilization of physician staffed emergency medical service units was compared between a pre-implementation period (12 months, April 2013 - March 2014) and a post-implementation period (12 months, April 2015 - March 2016). During the pre-implementation period only standard care was available.

Inclusion criteria: All emergency medical service (EMS) missions in both periods.

Data sources: Electronic health records of the EMS missions (data pseudonymity) and database of the regional EMS dispatch center.

Eligibility Criteria:
Inclusion Criteria:

All patients treated by emergency medical service during the pre- and post-implementation period.

Post-implementation period: Patients had to give verbal consent prior to teleconsultation.

Exclusion Criteria:

Pre-implementation period: none Post-implementation period: Patients who refused teleconsultation.
Vaginal Transluminal Endoscopic Sacrocolpopexy

This study aims to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results. The impact of V-NOTES sacrocolpopexy on patients' quality of life is investigated using validated assessment tools. Additionally, operative time, complications, pain scores were assessed.

Patients who presented to the obstetrics and gynecology outpatient clinic with complaints related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q classification, were between 45 and 79 years old, had no contraindications for pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES and gave written informed consent were included in the study. Demographic data, age, medical and surgical history, body mass index (BMI), operation time, preoperative and postoperative haemoglobin levels, perioperative complications and length of hospital stay were collected. Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after surgery. Quality of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20).

Eligibility Criteria:
Inclusion Criteria:

* Patients who presented to the obstetrics and gynecology outpatient clinic with complaints related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q classification, were between 45 and 79 years old, had no contraindications for pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES were included in the study.

Exclusion Criteria:

* Patients with previous pelvic inflammatory disease, deep endometriosis, severe pelvic adhesions, and patients who are at risk of gynecological malignancy and are not suitable for transvaginal surgery were not included in the study.