cyrilzakka/clinical-trials huggingface dataset:
Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

This study consists of 2 parts:

Part 1: a cross-sectional study, looking at the prevalence of metabolic dysfunction-associated fatty liver disease (MAFLD) among nurses in Hospital Canselor Tuanku Muhriz (HCTM).

Part 2: a randomized controlled trial of intermittent fasting with MAFLD subjects.

The investigators aim to screen at least 350 participants for fibroscan-detected fatty liver. Baseline anthropometric data will be taken. Questionnaires on dietary habits - Foof Frequency Questionnaire (FFQ) and exercise habits - International Physical Activity Questionnaire (IPAQ) will be done.

Approximately 100 participants who have fatty liver from Part 1 study, will be enrolled and randomized into Part 2. The intervention group will undergo intermittent fasting (3 fasting day:4 non-fasting days) while the control group will continue the usual standard care, for 8 weeks.

Measurements pre- and post-intervention include Fibroscan measurement, blood LiverFASt, anthropometric data, and exercise habit (IPAQ).

Eligibility Criteria:
Inclusion Criteria:

* nurses at HCTM, 18 years and above

Exclusion Criteria:

* pregnancy
* previous bariatric surgery
* liver cirrhosis
* liver cancer
* steatogenic drugs
An E-health Letter Intervention for Caregivers

The purpose of the present study is to conduct a two-arm Randomized Control Trial (RCT) comparing individuals receiving the 90Second Caregiver health letter, with a usual care (routine care received by caregivers) control group.

The goals of the present study are:

* To evaluate the effectiveness of the 90Second Caregiver health letter in improving caregiver's self-efficacy (primary outcome), savouring, and quality of life (secondary outcomes).
* To evaluate the effectiveness of the 90Second Caregiver health letter in reducing caregiver's psychological strain and caregiver burden (secondary outcomes).
* To examine the impact of levels of engagement with the 90Second Caregiver health letter on primary and secondary outcomes.
* To assess the usability of the 90Second Caregiver health letter, as it relates to the relevance of topic, user friendliness, and appropriateness of the readability levels.
* To evaluate psychometric properties of self-constructed measures in 90Second newsletter.

The present study will examine the effectiveness of the 90Second Caregiver health letter in increasing self-efficacy in a sample of informal caregivers of ABI survivors in Nova Scotia. Participants in this study will be recruited from the Caring Forward Trials within Cohort Study (REB#1025253). The study is funded by the Nova Scotia Department of Health and Wellness.

Eligibility Criteria:
Inclusion Criteria:

* Participant is currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
* Participant has agreed to be contacted for future studies by Dr. McGrath's staff
* Participant has agreed for their data to be used for future studies
* Participant has mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF

Exclusion Criteria:

* Participant is NOT currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
* Participant has NOT agreed to be contacted for future studies by Dr. McGrath's staff
* Participant has NOT agreed for their data to be used in future studies
* Participant does NOT report mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists

The main purpose of this study is to investigate if improvements in patient self-reported pain, symptoms, function and quality of life 12 months after Lumbar spinal fusion among patients that have good projected prognosis differ from those among patients with a poor projected prognosis.

The secondary purpose is to explore the underlying factors of the physiotherapists projected prognosis to identify objective and possible modifiable candidate prognostic factors for recovery.

Background:

Over recent decades, an increasing number of patients with Chronic Low Back Pain (CLBP) undergo surgical lumbar spinal fusion (LSF). For many of the patients LSF is their last resort in the hope of a better life with less pain, disability and use of medication. Unfortunately, several reports show, that the pain level remains the same after LSF for many patients, and that consumption of medication remains unchanged in almost 50 % of the patients.

Knowing that characteristics such as maladaptive coping strategies, fear avoidance beliefs and pain catastrophizing seem to be predictive of worse outcome in pain, function and quality of life after surgery. It is important to assess how these individual factors in the postsurgical rehabilitation can be addressed.

The single physiotherapists have an essential role in mobilizing the LSF patient post-operatively. In clinical practice it is not enough for the physiotherapists to use their biomechanical understanding of LSF material and heeling processes, it is also essential to use a so-called "silent knowledge" of experience and personal interaction with the patient.

It remains unknown if this "silent knowledge" is a reliable predictor of the outcome of LSF surgery. If the physiotherapist can predict the outcome, it is important to explore which factors the physiotherapist rely their prognosis upon in order to identify objective and possible modifiable candidate prognostic factors for recovery.

The aim of this study is to assess if physiotherapists attending inpatients at public back surgery hospitals can predict the future course (post hospitalisation) of recovery of patients undergoing LSF. The study will also break down the physiotherapists' "silent knowledge" in an attempt to identify objective (and hopefully modifiable) candidate prognostic markers of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Received primary LSF surgery for treatment of CLBP
* Degenerative lumbar disease with or without lumbar spondylolisthesis grades 1 to 2
* Fusion of a maximum of 3 adjacent vertebrae
* Above 18 years of age
* Competence in the Danish language
* Has an email address

Exclusion Criteria:

* Prior LSF surgery
* Cognitive impairments that preclude reliable answers to patient reported outcome questionnaire
The Effect of Time-Slot Scheduling on Flu Vaccination Rates

The goal of this project is to see if encouraging an individual to privately choose in advance a narrow time window in which to obtain a flu vaccination shot affects the likelihood that he or she will become vaccinated.

Influenza causes 36,000 U.S. deaths per year, but influenza immunization rates average just 28%. Behavioral "nudges" may increase the effectiveness of immunization reminder mailers at little or no added cost. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. We study whether adding a planning prompt to a vaccination reminder mailer increases immunization rates.

Eligibility Criteria:
Inclusion Criteria:

* seasonal influenza vaccine indications according to the CDC
* employees of partner corporations executing study

Exclusion Criteria:

* none
Protocol for the Treatment of Metastatic Ewing Sarcoma

Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.

Study for the treatment of Ewing metastatic sarcoma with and induction phase with Vincristine (VIN), Adriamycin (ADM), Ciclofosfamide(CYC), Ifosfamide(IFO), Etoposide(ETO) and radiotherapy (RT)followed by a consolidation phase with Busulfan and Melfalan (BUMEL) and Peripheral Blood Stem Cells Transplantation (PBSCT) and a subsequent maintenance phase with Ciclofosfamide and Celecoxib for High Risk (HR) patients.

Very High Risk (VHR) patients will receive a prior frontline therapy with Temozolomide and Irinotecan (TEMIRI), while patient with lung metastasis only will undergo to total lung irradiation after PBSCT

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven Ewing's sarcoma
* Age ≤ 40 years
* No previous treatment
* Multiple skeletal metastasis or bone marrow infiltration , with/without lung/pleural metastasis
* Signed Informed Consent

Exclusion Criteria:

* Localized Ewing's sarcoma
* Any contraindications to the study treatment
* Female patients who not accept to use an effective birth control method.
* Pregnant or breast-feeding patients
Characterization of Pseudoxanthoma Elasticum

Pseudoxanthoma elasticum (PXE) is a rare multisystem disorder of autosomal recessive inheritance (OMIM# 264800) and an estimated prevalence between 1:25.000 and 1:100.000. PXE is characterized by calcification and fragmentation of connective tissue rich in elastic fibers. Due to its high content of elastic fibers, Bruch Membrane in eyes of patients affected by PXE becomes thickened and calcified. The ocular phenotype is characterized by angioid streaks and peau d'orange but also choroidal neovascularizations and chorioretinal atrophy thereby in part mimicking the phenotype of age-related macular degeneration. The disease is due to mutations of the ABCC6-gene coding for a transmembrane protein which is mainly expressed in the liver and kidney. It is hypothesized that ABCC6 is involved in the excretion of a yet unknown factor from the liver which inhibits systemic calcification. In animal models several candidates for this factor have been identified but direct evidence for such a factor in patients with PXE is still missing. The primary purpose of this study is to further investigate the ocular phenotype of patients with PXE using multimodal imaging and functional testing to delineate the impact of Bruch membrane pathology on the eye. Furthermore, possible systemic anti-calcification factors, as well as associations with the vascular alterations are investigated to gain more insights into the pathogenesis of PXE..


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing
Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer

The purpose of this study is to determine whether MRI is more accurate than CT in determining the T stage, N stage, depth of tumour invasion and extra mural venous invasion (EMVI) preoperatively in colon cancer.

The patient will proceed with their usual colon cancer assessment and treatment, including colonoscopy with biopsy and histology and preoperative CT chest abdomen and pelvis. In addition, patients who enroll in the study will have 2 preoperative MRIs of their abdomen and pelvis performed. One of these will be performed on a 1.5T and the other will be performed on a 3.0T MRI scanner. We will use 20mg of IM buscopan to reduce bowel mobility for each scan. A coronal scout scan will be taken to identify the tumour and select the target volume. IV gadolinium (a contrast agent routinely used in MRI scans to help identify different tissues) will be administered, and a 3D VIBE scan (T1 weighted) will be performed of the target volume. The liver will also be imaged at this time to look for liver metastases. A T2 weighted 3D volume acquisition will then be obtained of the target volume containing the tumour (and its lymphatic drainage).

The MRI will be independently reported by an expert without knowledge of the results of any other investigations. The results of the MRI scan will then be made available to the clinical team. The patient will then proceed as normal with any other investigation which the clinical team feel is necessary, and be treated as normal for their colon cancer. The patient will proceed with their surgery as normal, and the specimen removed at the time of the operation will be examined in the pathology laboratory to determine the exact stage of the cancer.

The accuracy of CT and MRI in staging colon cancer will then be determined against the reference standard provided by the histology examination.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing treatment for colon cancer
* patients undergoing primary surgery for colon cancer and who do not require neo-adjuvant therapy on the basis of their pre-operative CT

Exclusion Criteria:

* age \<18
* unable to consent
* consent withheld or withdrawn
* Unable to have an MRI (e.g pacemaker, metal implant)
* Allergy or contraindications to busocopam, gadolinium, small bowel contrast agent
Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

During conjunctival flap surgery the corneal epithelium is removed and a conjunctival flap is placed on the cornea and after a few weeks the conjunctiva covers the surface of the eye.

Complications of this operation are flap retraction, conjunctival inclusion cysts, bleeding, infection and pain. Pain is one of the main complications of conjunctival flap surgery. Two sources are conceivable for pain: 1) conjunctival pain 2) corneal pain, the second of which is the main part of the pain.

Numerous methods for controlling corneal pain have been reported in various articles. Eye patches are often recommended for the treatment of corneal abrasions despite the lack of evidence. Recommended analgesics to control corneal scratch pain include nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetics, and topical cycloplegias.

In this article, we are going to review and evaluate a new method called corneal neuorotomy, i.e., corneal nerve endings that inserted radially can be cut to reduce postoperative pain.

The main idea of this randomized clinical trial is to test the extent of pain relief after incision of radial corneal nerve endings.

Patients are divided into two groups. In the first group, the same classic method of conjunctival flap surgery was used and in the second group, conjunctival flap surgery was performed adjuncted by cutting the radial superficial nerves of the cornea. The postoperative pain scores of these two groups will be measured using visual analogue scale, after 6 hours, 24 hours and 48 hours, and finally the average pain of the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* VLE (vision loss eye)Patients who are candidates for prosthesis implantation

Exclusion Criteria:

* 1 painful vision loss eye
* 2 Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.)
Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults

This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.


Eligibility Criteria:
Inclusion Criteria:

1. This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period.

Exclusion Criteria:

1. Subjects who received daclatasvir as part of a clinical trial.
2. Subjects who received daclatasvir for any indication other than local approved.
3. Contraindications included in the approved Mexican prescribing information.
Buckberg vs Del Nido in Isolated Aortic Valve Replacement

The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures. Half the patients will receive the Del Nido solutions while the other half will receive the Buckberg solution.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Patients listed for elective aortic valve replacement
* Patients that have signed informed consent

Exclusion Criteria:

* Emergent surgery
* Patients that do not accept blood transfusion
Piloting Use of Multi-Level Pregnancy Tests in Remote Abortion Services

Serial use of urine multi-level pregnancy tests (MLPTs) has been shown to be a reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at ≤ 63 days of gestation. This pilot project will assess whether MLPTs can enhance the quality of remote medical abortion services through enabling women to reliably ascertain their abortion outcomes at home sooner than would otherwise have been the case.

safe2choose provides remote medical abortion services through the Internet (information, counselling and access to abortion pills) in a growing number of countries worldwide. safe2choose will collaborate with Gynuity Health Projects to pilot the utility of MLPTs for home follow-up as part of its remote medical abortion services.

As safe2choose does not have a physical office, the location of the sponsor's office is listed in this entry as the study location. Women from the United States are NOT eligible to enroll.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of safe2choose medical abortion services
* Able to read English or Spanish
* ≤ 56 days LMP
* Willing and able to read and sign consent form
* Agree to comply with the study procedures, including completing the follow-up survey

Exclusion Criteria:

* Does not meet inclusion criteria
Optimal End-Tidal (ET) Sevoflurane and Desflurane Concentration for Extubation of Supreme Laryngeal Mask Airway (LMA) in Adults

The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.

Null hypothesis: there is no significant difference between the optimal end tidal concentration of sevoflurane and desflurane for Supreme LMA removal.

The manufactures' instructions for removal of the LMA recommend waiting until protective reflexes have returned. However, the appropriate timing for removal remains controversial. A more frequent incidence of airway hyperreactivity and complications has been reported by some studies when the LMA was removed in the awake state versus the anesthetized state. Techniques that reduce the time from LMA removal to the return of protective airway reflexes would minimize the risk of aspiration, contamination, or airway obstruction.

With increasingly common use of Supreme LMA in anaesthetic practice, a safe and suitable depth for removal of the Supreme LMA requires research.

Thus the determination of the optimal end-tidal concentration of commonly used volatile agents ie. Sevoflurane and Desflurane for Supreme LMA removal requires research, both for patient safety and minimising anaesthetic costs in dealing with airway complications.

Eligibility Criteria:
Inclusion Criteria:

1. ASA 1-2 patients
2. Age 18 - 49 years old
3. Elective surgery of short duration ( \< 2 hours ) which require local anaesthetic infiltration

Exclusion Criteria:

1. Upper respiratory tract symptoms in the previous 10 days
2. Risk of gastric oesophageal reflux or regurgitation
3. Known or predicted difficult airway
4. Poor dentition with high risk of damage
5. BMI \> 30 kg/m2
6. Refusing to participate
Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls

The goal of this study was to evaluate the effects of reactive balance training (RBT) targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build upon prior work, the present study included: 1) a control group receiving an alternative balance training intervention; 2) separate training and assessment sessions; 3) alternative RBT methods that may be more amenable to work outside the lab compared to prior methods, and 4) older adult participants receiving individualized training to reduce drop-out. The investigators hypothesized that slips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial slips before any intervention or after a control intervention. The investigators also hypothesized that trips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial trips before any intervention or after a control intervention. Results were intended to contribute to knowledge regarding the efficacy of alternative methods for RBT, and provide additional evidence regarding its efficacy.


Eligibility Criteria:
Inclusion Criteria:

1) pass a medical history and screening administered by a physician that excluded participants with osteoporosis of the lumbar spine or proximal femur as assessed by Dual Energy X-ray Absorptiometry (Lunar iDXA, GE Healthcare, Chicago, IL), or any unstable or progressive medical conditions that could contribute to imbalance or falls

Exclusion Criteria:

1. smoked
2. were in physical therapy
3. had a self-reported fragility fracture within the last 10 years
4. had an acute lower extremity injury within the last 3 months
5. had lower extremity surgery within the last six months
6. had an ankle arthroplasty
7. had a knee or hip arthroplasty within the last 12 months
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients.

This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks.

SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subject age ≥ 18 and ≤75 years of age at randomization.
* Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization).
* Subject should have at least three-month history of Ulcerative Colitis diagnosis at randomization.

Exclusion Criteria:

* Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
* Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
* Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).