cyrilzakka/clinical-trials huggingface dataset:
Diaphragmatic Breathing Exercise Improves Non-alcoholic Fatty Liver Disease

The non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and hyperlipidemia in recent years. Aerobic exercise indeed reduces adipose, hepatic insulin resistance and hepatic fat. However, diaphragmatic breathing improves cardiopulmonary function, the oxygen content of the body and therefore reduces inflammation of cells. The aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing exercises instead of aerobic exercise to reduce the fat in liver inflammation.

The non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and hyperlipidemia in recent years. Aerobic exercise indeed reduces adipose, hepatic insulin resistance and hepatic fat. However, diaphragmatic breathing improves cardiopulmonary function, the oxygen content of the body and therefore reduces inflammation of cells. The aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing exercises instead of aerobic exercise to reduce the fat in liver inflammation. The project intends to be accomplished within three years because of the ideal exercise leaves an uncertain question for curing non-alcoholic fatty liver disease. Hence, with the literature and empirical data analysis to review and identify the strength of patients' motion and duration, carry out a pilot observational study by including 20 patients, then teach diaphragmatic breathing exercises in the first year of the project. Observe the initial correlation measurement, the variables of the following one month and three months. For the second year, develop the training of diaphragmatic breathing process with assisting device (Diaphragmatic breathing-facilitated exercise device). Use diaphragmatic breathing exercise assisting device in a 12-week program of diaphragmatic breathing on randomized clinical trial, verifying the impact of this item interventions on patients' metabolism indicators in the final year.The project includes people who are over 20 years old without the non-alcoholic fatty liver disease. Taking liver function, body mass index, the thickness of subcutaneous fat, heart rate variability, metabolism indicators are mainly study measured variables. Regression Analysis helps understand the correlation between breathing exercise and indicators related to the disease. With the intervention of diaphragmatic breathing assist device, the program extensions to the two-factor analysis of variance (two-way ANOVA) as the results of verification. The study results can provide a reference for clinicians, thereby improving the prognosis of non-alcoholic fatty liver disease people.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are confirmed by echo without non-alcoholic fatty liver disease and over 20 year-old, and willing to learn the exercise.

Exclusion Criteria:

* Patients who could drop out the trial if he or she doesn't want to continue the exercise.
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.

The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:

  1. have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or
  2. have intolerable side effects to one or more components of their current opioid-containing analgesic regimen.
* Currently receive a stable (at least 2 weeks duration) analgesic regimen
* If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method).
* Understand written and spoken English
* Have been informed of the nature of the study and provided written informed consent

Additional Inclusion Criteria for Cancer Patients Only:

* Have a life expectancy of at least 12 months

Additional Inclusion Criteria for Neuropathic Patients Only:

* Have a diagnosis of:

  * post-herpetic neuralgia (PHN)
  * diabetic neuropathy (DN)
  * complex regional pain syndrome (CRPS)
  * HIV neuropathy
  * idiopathic sensory neuropathy
  * traumatic peripheral neuropathy
  * central neuropathic pain condition (spinal cord injury, post-stroke pain), OR
  * other peripheral neuropathy (upon mutual agreement of the sponsor and investigator).

Exclusion Criteria:

* Have a positive pregnancy test (females only)
* Have a history of or active asthma or emphysema
* Have clinically significant hepatic impairment
* Have a history of alcohol or substance abuse within the last 3 years
* Have a history of opioid abuse within 6 months prior to study entry
* Have a known allergy or significant reaction to opioids, including codeine
* Have a known oxymorphone sensitivity or allergy
* Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
Scaling Up Science-based Mental Health Interventions in Latin America

Conduct systematic, multi-site mental health implementation research in both rural and urban primary care settings with a broad group of stakeholders in the US and Latin America.

The investigators plan to launch and evaluate a new mental health service delivery model in Latin America. Specifically, in this new multi-component, mental health service delivery intervention, the investigators propose to: (1) harness mobile behavioral health technology for mental health (with a primary focus on depression and a secondary focus on problematic alcohol and other substance abuse), (2) launch new workforce training and service delivery models (including the integration of technology into service delivery), (3) launch and evolve an integrated data management system for systematic data tracking and outcomes assessment, and (4) launch and grow a learning collaborative of organizations integrating mental health into primary care. The investigators will launch this project at multiple primary care sites in various parts of Colombia, with a plan to inform subsequent adoption in several other Latin American countries, including Chile and Peru.

Eligibility Criteria:
Inclusion Criteria:

* Provider and administrative staff Inclusion Criteria:

  * Aged \> 18 years
  * Have worked for the study site for at least 3 months.
* Participant Inclusion Criteria:

  * Aged \> 18 years
  * Patients at one of our collaborating primary care sites
  * Screen positive for minor (score of 5-9), moderate (score of 10-14), moderately severe (score of 15-19) or severe (score of 20-27) depression on Patient Health Questionnaire (PHQ-9)62 and/or screen positive for problematic alcohol use on Alcohol Use Disorder Identification Test (AUDIT) developed by the World Health Organization (a score of 8 or more on 10-item AUDIT)63 and have a confirmed diagnosis of depression and/or alcohol use disorder based on clinical consultation at the primary care site
  * Willing to provide informed consent to use mobile intervention and complete study assessments

Exclusion Criteria:

-Participant Exclusion Criteria

* Diagnosis with co-occurring severe mental illness (e.g., schizophrenia, bipolar disorder, depression with psychotic features)
* Alcohol withdrawal symptoms that require higher level of care (e.g., emergency medical or inpatient treatment)
* Express suicidal intention. This assessment will be based on a combination of a patient's response on the PHQ-9 assessment followed by further assessment by a primary care clinician. The PHQ-9 measure will not be used solely to determine eligibility on this criterion. Persons who express suicidal intention will immediately be provided immediate crisis management in accordance with the crisis management protocol at the collaborating primary care site.
* Intoxicated or otherwise impaired at the time of assessment (rendering the individual incapable of informed consent)
Diet and Prevention of Ischemic Heart Disease: a Translational Approach

The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.

225 participants will be included in the intervention. The intervention is planned to run for six months in a real life setting.

The study is a randomized, parallel dietary intervention study. Dietary intake, selected IHD biomarkers and anthropometric measurements will be measured at two visits during the intervention period as well as 6 months after the end of the intervention. The study includes a baseline visit followed by a visit where web based dietary records will be completed by the subjects and blood samples and anthropometrics will be measured.

The intervention will consist of information on dietary advice due to the specific IHD dietary guideline or the current national dietary guidelines. The information will be provided to the participants via leaflets and recipes.

After the baseline visit the subjects will be randomized to group A, B or C: In group A the subjects will receive dietary advice, according to the specific IHD dietary guideline, in group B the subjects will receive dietary advice according to the current national dietary guidelines and in group C the subjects will be instructed to follow their normal dietary habits.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women aged 30 to 65 years who has one or more self-assessed ischemic heart disease risk factors at screening: physical inactivity, overweight or obese (BMI ≥ 25/m2 ), waist circumference (≥ 80 cm for women, ≥ 94 cm for men). In addition, the participants should have the motivation and willingness to be randomized to any of the three groups, and to do their best to follow the given protocol .

Exclusion Criteria:

* no internet access or no access to a computer, smoking, pregnancy, or breast-feeding or planning to become pregnant within the next 12 months, a history of cardiovascular disease, type 2 diabetes, chronic disease / disorders that may affect the results of the study, substance abuse within the past 12 months, regular alcohol consumption \> 21 units / week for men or \> 14 units/ week for women, allergy or intolerance to food groups in the dietary guidelines, supplements with mega doses of nutrients that can have potential impact on ischemic heart disease risk markers (eg . fish oils).
Music Therapy During Botulinum Injections

The primary objectives for this study are:

1. To demonstrate that music therapy can be an effective means of procedural support for children undergoing botox injections.
2. To explore patient, parent and healthcare personnel satisfaction with music therapy as procedural support.
3. To assess the influence of music therapy on physiologic (blood pressure, oxygen saturation, heart rate) and emotional (crying time) responses of patients.

Many children with spastic Cerebral Palsy and other types of muscle dystonia are injected with Botulinum toxin A (Botox) to reduce pathological reflexes and improve muscle function. Such treatment requires injections to each affected muscle group, which can be both painful and distressing. Music therapy has been shown to reduce pain and decrease stress and anxiety for pediatric patients undergoing other types of medical procedures.

The goal of this study is to determine whether music therapy can be effectively integrated as a means of procedural support during Botox injections. This study investigates the efficacy of music therapy in reducing manifestations of pain during Botox injections. Secondary benefits may include increased satisfaction among medical personnel and parents.

Patients between the ages of 2-17 being treated with Botox were eligible for enrollment. Prior to the start of this study, patients had the option of receiving music therapy support during their Botox injections; these subjects continued to receive music therapy upon enrolling in the study. Subjects who had not previously received music therapy were videotaped for two Botox sessions before having a music therapy intervention. The percentage of crying time during the procedure was calculated from videotapes taken during the sessions. Surveys were given to parent/guardians and the healthcare provider performing the procedure to provide feedback on the effectiveness of the music intervention for the child and themselves.

Comparing average crying times for 44 children's first study visit with or without music therapy shows that children who receive music therapy cry less than children who do not, although the difference is not statistically significant. Both parent and healthcare provider surveys indicate a high level of satisfaction with the music therapy intervention.

The current data indicate that music therapy may be a highly effective means of procedural support, but strong conclusions cannot be drawn without more data.

Eligibility Criteria:
Inclusion Criteria:

* Treatment for diplegic or hemiplegic cerebral palsy or muscle spasticity resulting from brain injury, with Botulinum toxin injections.

Exclusion Criteria:

* None
Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia

GECKO is a prospective, international, multicentre, observational cohort study delivered by GlobalSurg Collaborative. This will be on consecutive patients undergoing cholecystectomy, between 31st July 2023 to 19th November 2023, with follow-up at 30-day and one-year postoperatively. Mini-teams of up to five collaborators per 14-day data collection period will prospectively collect data at each participating centre.

The primary aim is to define the global variation in compliance to pre-, intra-, and post-operative audit standards. The subjects will be observed and interviewed during pre-surgery hospitalization up to one-year post-surgery.

Audit Standards include:

1. Pre-operative

   * Interventional radiology service
   * Risk Stratification (Tokyo Guidelines).
   * Timing of surgery
2. Intraoperative

   * Critical Safety View (CVS)
   * Intraoperative imaging
   * Bailout Procedures
   * Antibiotic use
   * Use of drains
   * Bile Duct Injury (BDI)
3. Postoperative

   * 30-day readmission
   * Critical Care

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (greater than or including 18 years of age)
* Undergo primary cholecystectomy (as the main procedure)
* Any open, laparoscopic, robotic approaches are eligible
* Elective, delayed and emergency cholecystectomy

Exclusion Criteria:

* Cholecystectomy as a part of another surgical procedure (Whipple's, bariatric, transplant)
* Patients with Mirizzi syndrome
* Patients returning to theatre and requiring a cholecystectomy for whatever indication
* Known gallbladder malignancy: Gallbladder cancer diagnosed preoperatively
Effect of Personalized Robotic Therapy

The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed at Wearable Robotics srl, for the force assistance of stroke patients during robotic-rehabilitation.

The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient.

Finally, the study also aims to define the "neuro-biomechanical state" of the patient and its evolution during the therapy by studying cortical signals and muscular synergies. This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient.

The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment. Moreover, in order to estimate the long-term clinical effectiveness of the treatment, the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* stroke patients
* right and left hand dominant
* cerebral lesion onset between 2-8 weeks
* able to participate in a session of about 30-60 minutes
* right-hemiplegic with at least 10° of motion in the treated joints (shoulder and elbow)
* age: more than 18 years old

Exclusion Criteria:

* subjects with an active implantable device or wearing an active device (e.g., pacemakers, metallic objects in the brain, infusion pumps, etc.)
* persistent delirium or disturbed vigilance
* moderate or severe language comprehension deficits
* skull breach
* new stroke lesions during rehabilitation
* patients incapable of discernment
* subjects with reduced mobility due to previous injuries or abnormalities unrelated with the cerebral accident
Follow up of Radiofrequency Maze in Mitral Patients

The present study aimed at evaluating mid-term results of radiofrequency modified maze procedure in mitral patients in terms of sinus rhythm and atrial contractility restoration

Atrial fibrillation presents with different frequencies in patients affected by structural heart diseases requiring surgery, showing a peak incidence of up to 60-80% in mitral subjects. It causes an increased risk of systemic embolism, cardiac failure development and higher limitations due to dyspnoea and fatigue on exercise. Cox-Maze technique for surgical atrial fibrillation treatment was first used in 1987 and suffered lots of modifications since then. Nowadays, most centers have replaced the "cut and sew" technique by other methods using several power sources to achieve the same target in a much easier way. One of the alternative energy source currently used is radiofrequency ablation which has been demonstrated to be a simple, safe and reproducible procedure with an acceptable success rate in terms of sinus rhythm restoration. However, organized atrial activity (sinus rhythm on surface electrocardiogram) is not always accompanied by an effective mechanical atrial contraction, whose restoration represents one of the original Maze objective. Atrial contraction is effective when A waves are found in tricuspid and/or mitral transvalvular flow using Doppler echocardiography, allowing the patient to fully profit from hemodynamic and clinical advantages of an organized atrial contraction. Predictive factors of atrial contractility recovery and, more widely, of sinus rhythm achievement after modified Maze procedures have been investigated, but, at our knowledge, a parallel deep analysis and comparison of possible determinants of both surgical ablation goals is still lacking. In the present study, the investigators describe mid-term results of concomitant modified radiofrequency Maze in a large homogeneous population of mitral patients, focusing onto common predictors of sinus rhythm and atrial contractility restoring, their time course appearance and interrelation.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by atrial fibrillation undergoing mitral valve surgery

Exclusion Criteria:

* Other cardiac procedures in addition to mitral valve surgery
Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia

The purpose of this study is to compare the effects of aerobic exercise versus digital CBT-I in university students with insomnia complaints. This is a clinical trial. Participants will be randomized into two groups: aerobic exercise (n=25) and digital CBT-I (n=25). The severity of insomnia, sleep quality, pre-sleep cognitive and somatic arousal, and participants' complaints of depression, anxiety, and stress will be assessed using self-administered questionnaires. Based on previous studies describing the effects of physical exercise on chronic insomnia, the hypothesis of this study is that aerobic exercise promotes similar results compared to digital CBT-I in insomnia severity and sleep quality, in addition to improving the complaints of depression, anxiety and stress of the participants.


Eligibility Criteria:
Inclusion Criteria:

* ages ≥ 18 years old
* insomnia severity index score \>8
* be physically inactive according to the IPAQ questionnaire

Exclusion criteria:

* non-adherence to intervention protocols
* absence or incomplete answers in the questionnaires/evaluation methods of the study
* shift workers
Monitoring Allergen Immunotherapy in Allergic Rhinitis

Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment.

This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood.

Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. Biomarkers, like Basophil Activation Test (BAT) and IgE-facilitated allergen binding (FAB), using nasal fluid instead of blood, probably better reflect therapy effect (inhibition of an IgE-mediated allergic reaction) as the nose is the main target organ for AIT in allergic rhinitis.

This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood. Nasal fluid and blood samples are collected at baseline and after 8 and 16 weeks of treatment. A nasal fluid inhibition BAT is developed and validated by comparison with a BAT using serum and an IgE-FAB assay.

15 adults with birch pollen allergy, who are treated with AIT (Itulazax birch pollen tablet) and 10 adults with birch pollen allergy, who are treated with immunosuppressive medication (control group) will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* IgE-sensitized birch pollen allergy
* Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops)
* Signed informed consent

Exclusion Criteria:

* Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological)
* Unstable uncontrolled asthma
* Smoking