cyrilzakka/clinical-trials huggingface dataset:
NASH AMPK Exercise Dosing (AMPED) Trial

There is no known cure or regulatory agency approved drug therapy for nonalcoholic fatty liver disease (NAFLD), the leading cause of liver disease worldwide, and its progressive type, NASH. This places increased importance on using exercise to treat NAFLD.

While physical activity is recommended for all with NAFLD, how to best prescribe exercise as a specific treatment remains unknown, including what dose of exercise is most effective.

The mechanism explaining how exercise training benefits patients with NAFLD and NASH is unclear. The AMPK pathway may be responsible for the benefits seen with exercise training because: 1) AMPK has a liver-specific role in hepatic de novo lipogenesis and fatty acid oxidation, 2) AMPK activity is abnormally low in NAFLD and 3) NAFLD animal models demonstrate exercise changes the liver-specific AMPK pathway, leading to less liver fat accumulation by reducing lipogenesis and increasing fatty acid oxidation (This has not been studied in patients). Importantly, exercise-induced AMPK activation appears to be dose dependent.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-69 years
* Sedentary \[\<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ)
* BMI \>25kg/m2
* Liver biopsy within six months prior to enrollment showing:

  * NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) \>4 and MRI-PDFF \>5% and;
  * Liver fibrosis stage 1-3

Exclusion Criteria:

* Active cardiac symptoms
* Body mass index (BMI) \>45kg/m2
* Cancer that is active
* Inability to walk \>2 blocks
* Institutionalized/prisoner
* Other liver disease
* Pregnancy
* Secondary hepatic steatosis
* Severe comorbidities
* AUDIT-C questionnaire identified significant alcohol use
* Substance abuse/active smoking
* Uncontrolled diabetes (changes in drug dosing over previous three months or A1c \>9%)
* GAQ response indicates exercise may be unsafe.
Combined Effects of Whole Body Vibration and Abdominal Binders on Outcome Measures of Constipation in Postnatal Women

Constipation is a prevalent issue among postnatal women, often resulting in significant discomfort and reduced quality of life. Traditional treatments like dietary adjustments and laxatives frequently provide only temporary relief and may lead to dependency. Whole-body vibration therapy and abdominal binders have emerged as promising non-invasive interventions for improving bowel function and relieving constipation.

Constipation is a complex condition arising due to many interrelated causes. Dietary inadequacies, most notably for fiber or fluid, often constitute a centerpiece of constipation. But other lifestyle factors including lack of movement and irregular bowel movements are also to blame. Known conditions affecting the gut motility, from medical perspective, include irritable bowel syndrome (IBS), diabetes, hypothyroidism, and neurological disorders including Parkinson's disease. Often listed as a side effect in medications such as opiates, antacids and antidepressants for example. Additionally, gut brain axis demonstrates that psychological aspects play a substantial part in the well being of the gut, since stress and anxiety frequently make matters worse. It is important to understand the causes of constipation to develop treatments.It is usually described as occurring less than three times per week, difficult to pass stools or passage of stools that does not feel satisfactory. Whereas, acute constipation can be often attributed to alteration in diet and water intake or stress, the chronic constipation is a long-standing pathological entity which can negatively affect the quality of life. Whole body vibration therapy (WBV) is a therapeutic modality that utilizes mechanical vibrations to excite muscle, nerve and tissue structures in the body. WBV is typically administered on a vibrating platform where the device is either controlled to deliver vibrations at specified frequencies and amplitudes as the individual performs a standing, sitting, or lying position. The vibrations produce rapid, involuntary muscle contractions- and result in a similar exercising effect without the impact to your body. Abdominal binders are conventionally used for physical support but recent evidence supports their use in improving bowel function as increased abdominal muscle recruitment and intra-abdominal pressure, both integral to a healthy peristaltic push.

Eligibility Criteria:
Inclusion Criteria:

* Females age 22-35 years
* Females underwent C-section were included in the study
* Participants who had severe constipation
* Primary gravida
* Women who had 6 months of Postpartum period
* Single fetus pregnancy

Exclusion Criteria:

* Females who had normal delivery were excluded
* History of episiotomy
* Participants taking laxative were excluded
* History of post cesarean abdominal suture infections
Effect of Diet Orange Soda on Urinary Lithogenicity

Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.

The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* able to sign consent
* ability to reliably urinate into a vessel and measure urine volume

Exclusion Criteria:

* prior history of nephrolithiasis
* a known history of metabolic bone disease
* hyperthyroidism
* hyperparathyroidism or chronic kidney disease
* current use of diuretics
* current use of potassium citrate or other oral alkali supplementation and
* use of calcium supplementation that could not be stopped
Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)

The purpose of this study is to describe patterns of care in CRPC patients, as well as health-related quality of life (HRQoL) outcomes associated with CRPC and its management.

This study will also describe factors influencing treatment decisions including reason(s) for treatment choices and triggers for treatment changes for CRPC as well as describe clinical outcomes based on patient characteristics.


Eligibility Criteria:
Inclusion Criteria:

Patient Inclusion:

* Patient may have M0 or M1 disease
* Confirmed diagnosis of CRPC defined by both Testosterone at castrate levels, as evidenced by a serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) and Clear progressive disease, as evidenced by a minimum of two rising PSA levels measured at least 7 days apart or new clinical or imaging evidence of progressive metastatic disease
* Initiating the first or second line treatment for CRPC: including anti- androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. Previous first line CRPC treatments are limited to: First generation anti-androgens (bicalutamide, flutamide, or nilutamide) or Sipuleucel-T
* Patients may be enrolled within 90 days from the time of decision to treat or within 90 days of treatment initiation.
* Willing and able to complete periodic patient-reported outcome (PRO) questionnaires, with or without assistance
* Estimated life expectancy of ≥ 6 months

Caregiver Inclusion:

* Meets the definition of an unpaid relative or friend who helps the patient with his or her activities of daily living
* Willing and able to complete caregiver-reported outcome questionnaires over the course of the patient's participation in the study

Exclusion Criteria:

Patient Exclusion:

* Receiving concomitant treatment for other cancer (excluding basal cell carcinoma, squamous cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment.
Evaluation of CRB in PROM Patients

The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).


Eligibility Criteria:
Inclusion Criteria:

* PROM not in labor

Exclusion Criteria:

* Contraindication to vaginal delivery
* Contraindication to labor induction
* Abnormal fetal heart-rate patterns
* Maternal heart disease
* Severe maternal hypertension
* Pelvic structural abnormality
Behçet's Disease and Eosinophil Cationic Protein

Eosinophil cationic protein (ECP) is a matrix protein of eosinophils and has been reported to reflect eosinophil activity. Few studies have examined the role of eosinophils in the pathogenesis of Behçet's disease. The purpose of the present study is to investigate the serum ECP levels in BD and its relation to clinical activity.

Behçet's disease (BD) is a systemic vasculitis, characterized by recurrent oral aphthae, genital ulcers, uveitis, skin lesions, arthritis, gastrointestinal and neurologic manifestations. There has been a growing interest in research on the pathogenesis of the disease. Eosinophils has been implicated in the vascular injury associated with several vasculitis syndromes like Churg Strauss syndrome, temporal arteritis and Henoch-Schonlein purpura. In Behçet patients, serum IgE and eosinophils have been reported to be comparable with the controls but eosinophil activity has not been studied extensively. Eosinophil cationic protein (ECP) is a matrix protein of specific granules of eosinophils with considerable capacity to damage tissue and cells and has been reported to reflect eosinophil activity. Increased serum levels of ECP has been reported in patients with seasonal allergic rhinitis. Several immunomodulatory features of ECP has been reported, such as inhibition of the proliferative T-lymphocyte response to antigen, immunoglobulin production, proliferation of plasma cell lines and upregulation of ICAM-1. Procoagulant effects of ECP has also been reported. The present study was conducted in patients without usage of any confounding drugs that can effect serum ECP levels. The purpose of this study was to investigate the serum ECP levels in BD and its relation to the clinical activity.

Forty-seven consecutive patients with BD (22 active, 25 inactive) meeting International Study Group Criteria , 21 age and sex matched patients with allergic rhinitis and 21 apparently healthy controls were evaluated prospectively in Rheumatology-Immunology Outpatient Clinic. Clinical activity was defined according to the criteria proposed by "Behcet's Disease Research Committee of Japan" . Activity scoring was made according to the "Behçet's Disease Research Committee of Japan" which was proposed in 1994. Organ involvements of the patients were summarized.

Patients on corticosteroids or immunosuppressives were excluded. Colchicine was stopped 10 days prior to the blood collection in inactive patients. Blood was drawn from the active patients before starting treatment. Cases with any allergy history or parasitosis were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive Behçet patients who gave the written informed consent were included.

Exclusion Criteria:

* Patients on corticosteroids or immunosuppressives were excluded.Cases with any allergy history or parasitosis were excluded.
Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias

The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.

Sudden cardiac death (SCD) accounts for half of all deaths from cardiovascular causes, with an annual incidence of 1 to 2 deaths per 1000 population. In the United States this translates to between 300,000 to more than 400,000 deaths annually. Results from numerous large, well designed clinical trials have demonstrated the efficacy of the implantable cardioverter-defibrillator (ICD) for improving survival in patients with ischemic heart disease. However, measures used to risk stratify patients, such as left ventricular ejection fraction do not adequately identify those patients who can most benefit from ICD therapy. As a result, many patients who currently receive an ICD do not use the device. In addition, many more patients who could benefit from ICD therapy are outside of current guidelines and do not have access to this life-saving therapy.

This prospective study was intended to determine how well the Harbinger Wedensky Modulation Index (WMI) technique risk stratifies patients into two groups: those needing antiarrhythmic therapy and those who do not need antiarrhythmic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria:

* Patients unable to give consent
* Pacemaker dependant patients
* Pregnant women
Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content

This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in patient position on the measurement of respiratory heat loss (enthalpy). This study would be carried out on patients whose operation requires the use of the steep Trendelenburg position independent of this study.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* scheduled for an elective surgical procedure requiring general anesthesia, positive pressure ventilation using an endotracheal tube and the steep Trendelenburg position

Exclusion Criteria:

* Adults unable to give primary consent
* age less than 18 years
* pregnancy
* prisoners
* infusion of inotropic drugs
* positive end expiratory pressure (PEEP) requirements \>8 cm H2O Women, minorities or non-English speaking subjects will not be excluded.
EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY

this study evaluates the effect of cold application after impacted third molar extractions. Patients have bilateral impacted third molar tooth included in this study. Patients do not applied cold after extraction of third molar on one side and applied cold cold after extraction of third molar on the other side.

Extraction of impacted teeth causes a trauma which results in an inflammatory response. Some postoperative symptoms may occur such as edema, pain, limitations in mouth opening and dysfunction as a consequence of the wisdom tooth extraction surgery.

Local cold application reduces the magnitude of postoperative symptoms. The physiological effects of cold application are as follows: vasoconstriction of blood vessels, blood flow to the region decreases, edema and inflammation decreases, slowdown in cell metabolism and a decrease in local oxygen demand due to the vasoconstriction effect of the cold. Cold therapy also induces muscle constriction which reduces muscle stress, pain and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral bony mandibular third molar impactions
* Has no systemic disease

Exclusion Criteria:

* Different Pell-Gregory classification of impacted teeth
* Previous or current gastric ulcer
* Allergies or hypersensitivities to any common medications
* pregnant or breastfeeding patients
Coronary Angiography THerapeutic Virtual Reality

The CATH-VR study will investigate the effect of virtual reality (VR) on patient pain, anxiety, and radial artery vasospasm during coronary angiography. Our hypothesis is that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery. In addition, we hypothesize that the amount of opioid and benzodiazepine medications utilized for procedural sedation will be lower in the intervention arm. VR has gained recent attraction as an alternative or adjunctive treatment option for pain, but its effect on reducing procedural sedation has not been studied. We propose a single center, randomized control pilot study to further investigate. The patient population will include adults older than 18 years who present for outpatient diagnostic coronary angiography.

We plan to conduct a prospective, unblinded, randomized control pilot study to test our hypothesis that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery.

Patients will be eligible if they are greater than 18 years of age and undergoing an elective outpatient coronary angiogram with or without percutaneous intervention. Exclusion criteria will include patients with claustrophobia, seizure disorder, motion sickness, stroke within the past year, dementia, nausea, isolation status for infection control or those who do not wish to participate.

Outpatients undergoing routine coronary angiography with or without possible percutaneous intervention will be screened for enrollment criteria. Those who agree to participate will be randomized to either the intervention or control arm. Those randomized to the intervention arm and agree to participate in the study will wear a VR Headset and headphones; those who are randomized to the control will receive the standard of care, which is moderate sedation for patient anxiolysis and pain control during the case. In both arms, the patient and operator will still be able to communicate verbally if needed to assess for pain, to ask questions, or to ask for anxiolytic or analgesic medications as needed. The procedure will be completed when vascular sheaths are just about to be removed.

Eligibility Criteria:
Inclusion Criteria:

- Age greater than or equal to 18 years undergoing diagnostic coronary angiogram

Exclusion Criteria:

* Claustrophobia
* Seizure disorder
* Motion sickness
* Stroke within the past year
* Dementia
* Nausea
* Isolation status for infection control
* Do not wish to participate.
Comparison of the Effects of Hydromorphone and Nalbuphine Patient Controlled Analgesia in Postoperative Pain After Cesarean Section

Cesarean section is an essential surgical procedure in obstetrics, which not only addresses dystocia and certain obstetric syndromes, ensuring the safety of the maternal participants, but also increases perinatal survival rates and can save the mother's life. However, the surgical trauma and uterine contractions resulting from cesarean delivery lead to severe pain, which can hinder the mother's postoperative recovery and negatively affect her mental health. Therefore, improving postoperative pain management and addressing issues such as depression and anxiety are crucial challenges in clinical practice today.

Patient-controlled intravenous analgesia (PCA) is widely used in postoperative pain management after cesarean section due to its ability to maintain the minimum effective drug concentration, minimal fluctuation in drug levels, ease of management, and no restriction on activity. However, research on the effects and adverse reactions of hydromorphone and nalbuphine for postoperative pain relief in cesarean section is limited.

In this study, the investigators aim to compare the effects of hydromorphone hydrochloride and nalbuphine in obstetric PCA and examine how various clinical factors influence pain outcomes and adverse reactions. Based on multivariate analysis, the investigators further aim to construct and validate a predictive model for poor analgesic outcomes. To develop more personalized strategies for postoperative pain management following cesarean section, more personalized guidance strategies for postoperative pain management following cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 20 to 50 years old;
* ASA grades I to III;
* Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;
* Pregnant women who are willing to participate in this study and sign informed consent forms.

Exclusion Criteria:

* Have a history of dementia, mental illness, or any central nervous system disorder;
* Pregnant women who are addicted to alcohol and drugs;
* Difficulty in follow-up or poor patient compliance;
* Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;
* Serious complications occur during delivery;
* Unable to cooperate with the research for any reason.
A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.

The goal of this clinical trial is to test a novel medical device (ISO-101) in patients diagnosied with orthostatic hypotension. The main question\[s\] it aims to answer are:

* to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation.
* Assess the safety and performance of the ISO-101 device in patients with orthostatic hypotension.

Participants will use the device under controlled conditions and have the following parameters measured before and after standing up:

* blood pressure
* markers of peripheal vascular resistence
* sympathetic nervous system activity measure before and after standing up

This is a proof of principle study aimed at evaluating if there is a signal of efficacy from use of the ISO-101 device in people with orthostatic hypotension. The study is a single centre, unblinded, pre-post study. All participants will act as their own control, and all will receive the intervention.The primary objective is to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Adults aged over 18 years with a clinical diagnosis of orthostatic hypotension
* A drop in systolic BP of ≥20 mmHg (with or without a drop in diastolic BP ≥10 mmHg) within 3 minutes of standing up from a supine position
* Able to stand up from a supine position (with assistance if required)

Exclusion Criteria:

* Cognitively unable to follow research procedures
* Physically unable to use the ISO-101 device (e.g., unilateral arm weakness due to stroke)
* Acute or reversible cause of OH (e.g., haemorrhage or sepsis)
* Current pregnancy
* Participants on insulin (participants will be asked to refrain from breakfast on the morning of their assessment)
* Resting supine systolic BP ≥180 or diastolic ≥110 mmHg
Postoperative Delirium - European Society of Anaesthesiology Survey

The ESA is currently preparing a guideline on the management of postoperative delirium (POD), which attempts to reduce the impact of postoperative delirium and provide recommendations for prevention, diagnostics and treatment of delirium outside the intensive care unit. The guidelines are going to be published during 2015.

While the guideline provides recommendations for daily practice, assessment of current practice and knowledge is of utmost importance, because the implementation and the measurement of a change in clinical practice will be dependent on these measurements.

This Survey has been approved by the Scientific and Research Committees of the European Society of Anaesthesiology (ESA), the Media Committee of the ESA, as well as the institutional ethical committee of Charité - Universitätsmedizin Berlin.


Eligibility Criteria:
Inclusion Criteria:

* Anaesthesists, nursing staff, which are invited to the online - Survey of the European Society of Anaesthesiology