cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women

Female sexual dysfunction (FSD) includes impairments in sexual desire, arousal, orgasm, and genital pain resulting in significant subjective distress. This study is aimed to assess a mindfulness-based intervention for improving sexual functioning among women with epilepsy


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Female sexual dysfunctions are categorized by the DSM-5 as sexual interest/arousal disorder, genitopelvic pain/penetration disorder, and female orgasmic disorder. The diagnoses require symptoms to be present for six months or more,
* Currently in a relationship that has lasted longer than 1 year
* Both members of the couple are able to speak and read Persian
* Both members of the couple provide signed and dated informed consent form

Exclusion Criteria:

* Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program
* Major psychiatric disorder (e.g., psychosis, personality disorder)
* Current suicidal ideation or suicide attempt within past 3 months
* Past participation in an MBCT program
Crural Dissection in Sleeve Gastrectomy

The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.


Eligibility Criteria:
Inclusion criteria:

1. All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
2. Age between 18-69 years
3. Able to provide consent

Exclusion criteria:

1. History of anti-reflux procedure
2. History of foregut surgery
3. Narcotic dependence
4. History of gastroparesis
5. Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study
Comparison of Breathing Exercise for Hypertensive Patients

To determine the Effectiveness of diaphragmatic breathing vs. slow breathing techniques on blood pressure and Quality of life in adults with stage 1 hypertension. In accessible literature limited data was found on the comparison of different breathing techniques. The current study will compare the effect of slow vs. diaphragmatic breathing exercises and will demonstrate which one is more effective.

Literature reports that inspiratory muscle training is more effective in reducing Blood Pressure and voluntary diaphragmatic breathing at 10 or 6 breaths per minute for 10 min twice a day for 4 weeks is effective in producing positive outcomes in hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient having stage 1 hypertension, Diagnosed after 1 week BP charting

Exclusion Criteria:

* Patients taking antihypertensive medication Patient having comorbidities Smokers and women taking oral contraceptives
Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)

The purpose of this study is

* to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.
* to observe the impact of adjusting the expiratory trigger setting on asynchronies during pressure support
* and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).

Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.

Criteria for initiating non-invasive ventilation will follow the usual practice guidelines of the unit.

Ventilation parameters in Non-invasive-Pressure Support will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant \< 5 years), according to commonly applied guidelines in this unit.

One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)above the initial set value, and will be recorded the following 5 minutes after stabilization.

NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava non-invasive-ventilation will be recorded during 20 minutes.

The 2 sessions, Pressure support and Nava, will be recorded consecutively.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation

Exclusion Criteria:

* Non treated pneumothorax
* Hemodynamic instability
* FiO2 \> 0.6
* Poor short term prognosis (defined as a high risk of death in the next seven days)
* contraindication for gastric tube or obtention of a reliable EMGdi signal
* Known esophageal problem (hiatal hernia, esophageal varicosities)
* Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
* Neuromuscular disease
Investigation of TWK10 Administration on the Effects of Amino Acid Absorption

The most common problem among sports people is that no matter how much protein food or products they eat, their sports performance cannot be improved, resulting in failure to achieve breakthroughs in sports performance. The cause of the trouble is digestion and absorption problems. The key is intestinal problems. If gastrointestinal function is maintained in a healthy state, then exercise performance must be maintained at a considerable level. Therefore, how to choose the source of protein in the diet is one of the most concerned issues of the sports crowd. Although past studies have confirmed that the essential amino acids in animal protein can be absorbed and utilized better than plant protein, plant protein can be broken down into easily digestible peptides and amino acids by pepsin. Promote the metabolite pool in the large intestine and the amino acid balance of the host in the small intestine. Recent studies have pointed out that the proteases and peptidases in lactic acid bacteria can provide free amino acids for the best growth of bacteria, and can increase the distribution of amino acids in the blood, the speed of muscle synthesis and the content of branched chain amino acids. However, the mechanism of action of Lactobacillus plantarum on protein digestion and amino acid absorption in the host is still unclear. Therefore, the purpose of this study is to explore the effect of supplementing sports lactic acid bacteria TWK10 in human experiments to effectively improve the amino acid bioabsorption rate of plant protein supplements. 40 subjects were randomly divided into 2 groups, each with 20 people (male and female): (1) pea protein without TWK10 (placebo), (2) TWK10 group (TWK10). The two groups of subjects were supplemented with test samples for 28 consecutive days and performed paired sports training 3 times a week. Before and after the intervention, the samples were subjected to exercise testing, blood and fecal sample collection, body composition analysis, and muscle mass analysis.


Eligibility Criteria:
Inclusion Criteria:

* Have exercise habits (exercise at least 3 times a week for at least 30 minutes each time),
* Healthy body

Exclusion Criteria:

* Smoking
* Alcohol consumption
* Cardiovascular disease
* Neuromuscular disease
* Metabolic disease
* Asthma, pregnant or breastfeeding
* BMI\>27
* Allergic to peanuts .
Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women

Iron deficiency is common in Switzerland and the main reason for anaemia. Nearly one in five premenopausal women suffers from iron deficiency. Low iron intake, reduced iron resorption or loss of blood are the main cause for iron deficiency. Symptoms of iron deficiency, for example fatigue, weakness, headache or exercise intolerance are primarily due to anaemia, but the same symptoms may also be present in non-anaemic patients with low serum ferritin. Consequently it is important to detect and treat non-anaemic iron deficiency. Common side effects of oral iron supplementation are primarily gastrointestinal symptoms like nausea, vomiting, diarrhea or abdominal pain. There is a positive correlation between appearance of gastrointestinal symptoms and administered iron dose. To date, only few studies have investigated effectiveness of low-dose iron supplementation in different target groups. The aim of this study is to investigate if low dose iron supplementation with 12mg iron per day for 8 weeks is sufficient to increase serum ferritin levels into a normal range in healthy premenopausal women suffering from non-anaemic iron deficiency


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Female gender
* Premenopausal
* Age \> 18 years
* Regular menstrual cycle
* BMI in normal range (18-25 kg/m²)
* Serum-ferritin \<30ng/ml
* No anaemia
* symptomatic iron deficiency in the past
* No intake of dietary supplements

Exclusion Criteria

* Intake of dietary supplements
* Pregnancy
* Hypermenorrhea
* Anaemia
* Serum-ferritin \>30ng/ml
* BMI \<18 kg/m² or \>25 kg/m²
* chronic inflammatory diseases (e.g. colitis)
* Hypersensitivity to iron-supplements
* psychiatric disorder
A Registry Study on Biomarkers of Takayasu's Arteritis (ARSBTA)

Takayasu arteritis is a chronic vasculitis mainly involving the aorta and its main branches such as the brachiocephalic, carotid, subclavian, vertebral, and renal arteries, as well as the coronary and pulmonary arteries. Inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very rare but most commonly occurs in young Asian women. However, there is a considerable lack of understanding of the disease mechanism of Takayasu arteritis. Initially, the disease remains clinically silent (or remains undetected) until the patients present with vascular occlusion. Additionally, many individuals with Takayasu arteritis, however, have no apparent symptoms despite disease activity. Therefore, biomarkers for diagnosis and monitor disease activity in individuals with Takayasu arteritis are needed. In this study, the investigators therefore to use different methods to identify new biomarkers for diagnosing or monitoring the disease activity in individuals with Takayasu arteritis. These biomarkers may provide valuable insights into the underlying biochemical processes and aid the understanding of the pathophysiology of this disease.


Eligibility Criteria:
Retrospective

Inclusion Criteria:

Subjects who met the American College of Rheumatology 1990 classification criteria for Takayasu arteritis:

1. Age of onset ≤40 years,
2. Claudication of upper or lower extremities,
3. Decreased pulsation of 1 or both brachial arteries,
4. Difference of ≥ 10 mmHg in systolic blood pressure between arms,
5. Bruit over subclavian arteries or aorta,
6. \*Arteriographic evidence showing a branch of the aorta stenosis or occlusion.

Meeting more than 3 of 6 criteria suggests the diagnosis of Takayasu arteritis.

\*Angiography in this study was replaced by vascular magnetic resonance angiography(MRA)or computed tomography angiography(CTA).

Exclusion Criteria:

1. Arteriographic lesions that could be entirely due to atherosclerosis,
2. Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.) besides Takayasu arteritis,
3. Cogan's syndrome,
4. Behcet's disease,
5. Subjects with any serious acute or chronic infection,
6. Giant cell arteritis (large vessel vasculitis and at least 50 years old) or other infectious forms of large vessel vasculitis.

Prospective

Inclusion Criteria:

Subjects with initial suspicion of having Takayasu arteritis or patients with Takayasu arteritis need assessment of disease activity were prospectively enrolled.

Exclusion Criteria:

1. Patients without image studies.
2. Patients with confirmed other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.)
Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.

The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:

1. Does obstruction of the olfactory cleft predict return of the sense of smell?
2. Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?

Participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.


Eligibility Criteria:
* Well documented history of CRSwNP
* BSIT age/sex classified as "abnormal" score
* Self-reported stable olfactory deficit of moderate to severe quality \> 3 months
* Prior endoscopic sinus surgery \>3 months, \<10 years prior
Mucosal Versus Fecal Microbiota in FMT

Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea. Treatment of this infection usually occurs using other antibiotics, but many individuals have persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal Microbiota Transplantation, (IMT) has been shown to be efficacious when administered after treatment for C. difficile. This study will involve taking biopsies from patients during their FMT/IMT via colonoscopy, and determine if there are differences in the mucosal flora as compared to the stool flora. The investigators hope to discover the critical parts of a healthy microbiota.

A total of 20 subjects with at least one relapse of Clostridium difficile infection undergoing Intestinal Microbiota Transplantation via colonoscopy will be recruited in this study. The patients will produce a stool specimen at the time of colonoscopy and a biopsy will be obtained during the colonoscopy. At 2 weeks and 10 weeks, stool specimens and anoscopy will be collected to be tested for C. difficile polymerase chain reaction (PCR) and the fecal microbiota. Subjects will be referred from all locations of Emory Healthcare.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient or outpatient adults, age ≥18
* Have had at least 1 relapse of C. difficile
* Patients who have had previous FMT

Exclusion Criteria:

* Pregnant or breastfeeding
* Critically or acutely ill (Fever will be defined as a documented temperature \>37.8°C)
* Ileus or toxic megacolon
* Unable to give consent
A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.

This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients \>=18 years with locoregional advanced unresectable non-squamous NSCLC;
* ECOG performance status of 0 or 1;
* no prior thoracic head and neck irradiation or surgical resection for current lung cancer.

Exclusion Criteria:

* mixed, non-small cell and small cell tumors;
* mixed adeno-squamous carcinomas with a predominant squamous component;
* evidence of tumor invasion or encasement of major vessels;
* history of grade \>=2 hemoptysis;
* presence of cavitations in lung lesions at baseline.
Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients

The purpose of this study is to compare between two surgical techniques for anterior abdominal wall blocks in obese patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane \[TAP\] block versus Rectus Sheath block as regards the efficacy and adverse effects


Eligibility Criteria:
Inclusion Criteria:

* female patients
* undergoing major gynecological surgery with supraumbilical midline incision the first time
* Body mass index (BMI) more than 40.

Exclusion Criteria:

* patient refusal to participate in the study,
* reoperation,
* addiction
* alcohol abuse
* hypersensitivity or allergy to the study drugs
UHW Angiogram Video Project

This study is a randomised control trial which aims to assess whether the use of an immersive virtual reality angiogram experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation.

Patients undergoing cardiac catheterisation are understandably anxious. This is due to a lack of familiarity with both the hospital environment and the planned procedure. Anxiety may negatively affect their patient experience. Appropriate patient information can help improve understanding and reduce anxiety. In particular, video-based patient information prior to cardiac catheterisation has been shown to improve patient's knowledge and reduce peri-procedural anxiety. Generic video-based patient information about the cardiac catheterisation procedure is widely available. Ideally any patient information delivered pre-cardiac catheterization would be specific to the hospital delivering care. The use of virtual reality (VR) in healthcare is novel, but expanding rapidly. The immersive nature of VR allows patients a unique opportunity to prepare for the procedure and environment within which they will be treated. To date, the use of VR to prepare patients for invasive cardiac procedures has not been studied.

The aim of this study is to assess whether the use of an immersive VR experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation. The investigators will also assess whether the VR experience improves overall patient satisfaction.

With the help of a local media company, a VR cardiac catheterisation video was produced (Figure 1 depicts a screenshot from the VR video). The video is watched with a VR headset to create a 360 immersive experience. The investigators are undertaking a single-centre randomised control trial comparing the use of an immersive VR experience 1 week prior to catheterisation with standard pre-procedural care. Pre procedural anxiety levels and procedural knowledge are assessed by questionnaire, using the validated six-item short-form of the Strait Trait Anxiety Inventory (STAI). A satisfaction questionnaire is also completed before the patient is discharged.

Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing their first cardiac catheterisation

Exclusion Criteria:

* Patients who cannot comprehend English or Welsh
* Those who have significant visual or auditory impairment meaning they would be unable to fully appreciate the video material
A Novel Serious Game As an Alternative for Teaching Basic Point-of-Care Transthoracic Echocardiography Skills

The goal of this clinical trial is to compare different digital learning methods for teaching basic skills in point-of-care transthoracic echocardiography to medical students.

The main question it aims to answer is:

• Is a novel digital learning tool, such as a serious video game, non-inferior to traditional ultrasound simulator teaching methods in the context of basic point-of-care transthoracic echocardiography skills training?

Participants will train basic point-of-care ultrasound skills using either a traditional basic ultrasound simulator course or the serious video game "Underwater". Both methods focus on training hand-eye coordination, which is particularly important in transthoracic echocardiography. To compare the performance of the participants, a baseline assessment will be performed before and a final assessment after the two-week training period.

Point-of-care ultrasound education follows non-standardized teaching and learning methods. In many cases, ultrasound is practiced directly on patients without proper training, or ultrasound simulators are used. However, these simulators are expensive to purchase and are not always readily available to students. In addition, there are a growing number of new digital tools, such as serious video games, that aim to deliver the same content in a more accessible and cost-effective manner. However, in the field of point-of-care echocardiography, there is still little scientific evidence to support their use.

This single-blind, prospective, randomized, controlled, non-inferiority trial aims to demonstrate the non-inferiority of a serious video game compared to conventional simulator-based training of basic echocardiography skills to make ultrasound training more accessible to every trainee.

Only medical students who already have the necessary anatomical knowledge but no experience with ultrasound diagnostics will be recruited to participate in this study. Participants will attend a 90-minute workshop to learn the basics of point-of-care echocardiography. They will then be required to perform standardized transthoracic echocardiography before and after a two-week training period, which will be scored by blinded experts. During the training phase, one group will practice the hand-eye coordination required for echocardiography using an ultrasound simulator, while the second group will practice the same content using a serious video game. In addition, questionnaires will be used to collect additional data from the participants.

Eligibility Criteria:
Inclusion Criteria:

* Medical student at the Medical University of Vienna (Medicine Degree Program)
* ≥18 years
* Basic knowledge of anatomy (completed Block 2 of the MUV curriculum)

Exclusion Criteria:

* Previous experience using an ultrasound device