cyrilzakka/clinical-trials huggingface dataset:
Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer

This trial studies information from a home sleep apnea machine to evaluate obstructive sleep apnea in patients with stage III-IV head and neck cancer. Sleep apnea (trouble breathing during sleep) can occur in head and neck cancer patients who have swelling in their neck. Wearing a sleep apnea machine overnight may help doctors evaluate obstructive sleep apnea in patients with head and neck cancer.

This is a single center study in HNSCC subjects to assess the effects of CRT on OSA.. Patients will be screened with a physical exam and questionnaire (The Berlin questionnaire, STOP-BANG, PSQI) and when eligible, will have the home sleep study (Specific aim 1). The low risk group (based on the physical exam and questionnaire) with stage IVc will not be eligible for the home sleep study and will concentrate on palliation of their symptoms. For locally advanced HNSCC patients undergoing definitive CRT, post CRT home sleep study results will also be assessed (Specific aim 2). When the patient is diagnosed with OSA based on the home sleep study, or if the home sleep study is negative but if the patient had high risks based on the screening process, the patient will be referred to the sleep medicine clinic. If life-threatening obstructive sleep apnea is found, the patient will be referred to sleep medicine clinic right away and will be taken off study. Otherwise, the patients will prioritize their definitive CRT for HNSCC, and will be referred to sleep medicine clinic once CRT has been completed.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced (stage III-IVb) and metastatic (stage IVc) HNSCC who are referred to medical oncology. Patients may not have received upfront definitive surgical resection of the primary tumor or upfront neck dissection.
* Patients must be able to operate the home sleep study device.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

* Patients should not have received any prior systemic chemotherapy or radiation therapy for locally advanced or metastatic HNSCC.
* Patients with tracheostomy or those requiring the assistance of a ventilator will be ineligible for the study.
Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients

Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. However, few studies have explored the use of both in-person and virtual escape-room as an educational methodology in nursing. Objective: To assess the effectiveness of the gamification strategy through the in-person escape-room model compared to the virtual model in enhancing cognitive and affective competencies for recognizing cardiac arrhythmias in critical care patients within the nursing field. Method: A randomized clinical trial to be conducted with nursing students from higher education institutions in the Federal District, Brazil. Students will undergo a theoretical class on cardiac arrhythmias in critical patients and will then be randomized to experience either the in-person or virtual escape-room scenario. Knowledge tests, the Depression, Anxiety, and Stress Scale, Satisfaction and Self-confidence Scale in nursing management learning, and perceived gains will be administered pre and post-intervention. Results with p≤0.05 will be considered significant. Expected Results: It is anticipated that this study will contribute to the enhancement and broadening of cognitive and affective competencies in nursing students, improving the quality of care through an active educational strategy like the escape-room, and consequently reducing costs for the Unified Health System by minimizing errors in recognizing clinical changes in critical patients. Additionally, the study aims to address gaps in understanding the use of educational escape-rooms in the field of nursing.


Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in the undergraduate nursing program who have successfully completed the course related to adult and elderly health.

Exclusion Criteria:

* Healthcare professionals, including those participants who, at any point during the research stages, choose to withdraw or who have not completed/participated in one of the study phases.
A Study to Investigate Quality of Recovery up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis

SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided Apfel-score based PONV care and prophylaxis.

Study period: September 2018- September 2019

Hypothesis: When a high risk patient, Apfel-score 3 or 4, is given Apfel-score based PONV care with strict adherence to PONV guidelines there should be no difference in Quality of Recovery between a high-risk patient and a low-risk patient.

Aim: The aim of the study is to investigate if it is possible to reach no difference in Quality of Recovery (QoR) between a high-risk patient and a low risk patient using Apfel-score based PONV care.

Primary objective: Assessing Quality of Recovery, using QoR15 at 24h, 48h, 72h and after 7 days.

Secondary objectives: Assessing the incidence and severity of PONV and PDNV in females undergoing laparoscopic surgery up to 72h. Assessing PONV and PDNV severity and duration. Nicotine habits and impact on PONV.

Study outline: Females scheduled for elective abdominal laparoscopic surgery will be provided PONV care based on Apfel risk-score. All patients will fill in the QoR15 form before surgery (base line). PONV and PDNV will be assessed in the PACU postoperatively, after 24h, 48h and 72h. Quality of Recovery will be assessed up to 7 days after surgery.

Treatment: The females will be given ordinary care after local routines, with strict adherence to PONV guidelines.

Study population: 100 females aged 18-65, ASA 1-2, undergoing laparoscopic abdominal surgery in Danderyds Hospital.

Primary outcome variables and examinations: When the QoR 15 reaches base line or better after surgery. Number of times the females experience nausea, retching or vomiting and the impact of emetic symptoms on the QoR.


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1-2

Exclusion Criteria:

* ASA 4, obese
The Effects of Unstable Shoes on Chronic Low Back Pain

Some physicians, physiotherapists and nurses use or even suggest unstable shoes in cases of low back pain. No studies on the real effects of these shoes on low back pain in health care professions have been carried out and therefore as yet there is no real evidence of their effectiveness. Thus the investigators assume that wearing unstable shoes over a period of six weeks could reduce low back pain and functional disability due to the changes of the gait and posture and may increase the quality of life.

The purposes of this study are:

1. To evaluate the modifications of pain level, functional capacity and quality of life among individuals with moderate level of non-specific chronic low back pain after wearing unstable shoes.
2. To quantify biomechanical modifications of gait and posture.


Eligibility Criteria:
Inclusion criteria:

* employees of Geneva University Hospital
* working in a standing position for at least 50% of their working day
* aged between 30 and 65
* having chronic low back pain that has been defined at least 3 out of 10 on a visual analogue scale during the last 3 months or the need to take regular pain medication for this reason

Exclusion criteria:

* having severe pain in other body parts
* undergone back surgery, neurological or balance problems
* inability to walk a distance of 100 meters
* already worn unstable shoes and being off of work because of low back pain
Epigenetic Changes in Hepatocellular Carcinoma Developed After Direct Acting Antiviral Therapy for Chronic Hepatitis C

Hepatocellular carcinoma (HCC) is the most common type of liver cancer, its survival rate ranks only second to lung cancer and it is a severe threat to human health.

In Egypt, HCC constitutes a significant public health problem. Where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively. It has a poor prognosis after discovery, which is usually at a late stage of disease. This had been strongly linked to the hepatitis C virus epidemic that affected around 10-15% of the Egyptian population during the last 3 decades, and was reported as the highest prevalence of HCV in the world. However, the pathophysiological mechanisms involved remain unclear. The occurrence of HCC is a complicated process involving multiple genes and steps. Imbalances in cellular signal transduction pathways, deficiencies in DNA repair regulating genes, activation of protooncogenes, inactivation of tumor suppressor genes and epigenetic modifications all promote the occurrence of liver cancer.

HCC is the fourth leading cause of cancer mortality in 2018. The alarming incidence of HCC is explained by genetic and epigenetic alterations, as well as by the presence of risk factors: hepatitis C virus (HCV), hepatitis B virus (HBV) infection, alcohol consumption, smoking, diabetes, dietary exposure to aflatoxins, and obesity.

The development of direct-acting antivirals (DAAs) with cure rates of higher than 90% has been a major breakthrough in the management of patients with chronic HCV infection. However, although viral cure decreases the overall HCC risk in HCV-infected patients, it does not eliminate virus-induced HCC risk, especially in patients with advanced fibrosis. Furthermore, convenient biomarkers to robustly predict HCC risk after viral cure and strategies for HCC prevention are absent. These unexpected findings pose new challenges for patient management. Meanwhile, recent studies in patients treated with interferone-free therapy have also identified several risk factors for developing HCC after achieving sustained virological response (SVR), namely advanced hepatic fibrosis and higher levels of alpha feto protein and agglutinin-positive Mac-2 binding protein.

Epigenetics refers to inherited altered gene expression without an alteration of the DNA sequence itself. Epigenetic alterations, such as DNA hypomethylation or hypermethylation and aberrant expression of micro-RNAs have been studied and associated with HCC. Epigenetic changes may represent diagnostic and prognostic biomarkers of HCC.

Eligibility Criteria:
Inclusion Criteria:

* HCC treated with DAAs drugs for chronic hepatitis C in Assiut University Hospital.

Exclusion Criteria:

* Cases who started treatment for HCC like alcohol ablation or chemoembolization
* Hepatitis B infection
* Non-responder patients to DAAs
Effect of Video-Module Based Mindfulness Training on Physician Stress and Well Being

An eight week mindfulness training for physicians in a community hospital setting, largely administered through web-casts, will decrease stress and burnout, increase job satisfaction, and develop lasting mindfulness skills in the participants.

The purpose of this study was to evaluate the impact of a video-module based mindfulness pilot program on the stress, well-being, and mindfulness skills of physicians in a community hospital setting. We administered an eight-week mindfulness training in October/November of 2013, offered as part of a wellness initiative for medical staff in a suburban community hospital in Puyallup, Washington. Participants enrolled on a first-come, first-serve basis, engaging in three 90-minute in person trainings, weekly online video-module trainings, and weekly teleconference coaching calls. Video-module trainings were available at all times, to be accessed at the participants' convenience. Journals and a guided meditation audio library were also provided. Physician stress, well-being (emotional exhaustion, depersonalization of patients, sense of personal accomplishment), and mindfulness skills (observing, describing, acting with awareness, accepting without judgment) were evaluated at baseline, end-of-program, and eight weeks post-intervention using well-validated instruments. Risks to participants were minimal, including only the possibility of a strong emotional response to personal work undertaken by participants during the course of the study. The project was funded by MultiCare Health System.

Eligibility Criteria:
Inclusion Criteria:

* GSH medical staff member

Exclusion Criteria:

* Other MultiCare employees
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis

To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson \& Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis

In this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by Johnson \& Johnson.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects are 18 \~ 75 years old, regardless of gender:
2. Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis:
3. The subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol And sign informed consent.

Exclusion Criteria:

1. The subject plans to perform emergency gastrointestinal surgery:
2. Subjects with moderate malnutrition (BML \< 17kg / m2) and severe anemia (HB \< 60g / L):
3. Subject BMI 228kg / m2;
4. Subject platelet (PLT) \< 60x 109 / L or international normalized ratio (INR) \> 1.5;
5. Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) \< 60%;
6. Subject's cardiac ejection fraction ≤ 50%;
7. Have important organ failure or other serious diseases (e.g. preoperative subject aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum creatinine (SER) exceeds normal values

   Upper limit 3 times and above: subjects with fasting blood glucose value \> 10.0mmol/l before operation:
8. The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and components for disposable electric endoscopy for cutting and anastomosis of gastrointestinal tissue
9. Subjects participated in clinical trials of other drugs or devices within 3 months before the trial;
10. Other conditions that the researchers judged not suitable for inclusion.
Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of \[14C\]PF-05221304 in Healthy Adult Male Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Ages of 18 and 45 years, inclusive.
2. Body mass index (BMI) of \>= 17.5 and \<= 30.4 kg/m2
3. Total body weight \> 50 kg (110 lb).

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.
Isokinetic Strength and Balance Assessment in Diabetic Patients

Diabetic polyneuropathy (DPN) is a type of nerve damage that can occur in diabetics. It can cause weakness and a loss of sensation, particularly in the legs and feet. This can have an impact on muscle strength and balance, making walking more difficult and increasing the risk of falling. Evaluating ankle muscular strength and balance using quantitative and standardised tools is critical for patients with and without DPN as well as determining how much DPN affects ankle muscle strength and balance.

Diabetic Peripheral Neuropathy (DPN) can affect ankle muscle strength and increase the risk of falling. This occurs due to nerve damage that impairs muscle function and reduces sensitivity in the feet, leading to difficulty maintaining balance and coordination. Risk factors for DPN-related falls include poor glycemic control, the duration of diabetes, age, and other comorbidities such as peripheral vascular disease. It is important for individuals with diabetes to regularly monitor and manage their DPN to prevent falls and maintain overall health. So, conducting this study to measure ankle muscle strength through isokinetic testing and dynamic balance through the Biodex balance system will help researchers quantify the extent of DPN's impact on these aspects. This study can provide a valuable predictor and assessment tool for determining the severity of neuropathy in diabetic patients. The results of this study could also help identify those at a higher risk for falls and diabetic foot complications. This information can aid healthcare providers in developing tailored interventions to improve muscle strength and balance and reduce the risk of falls in individuals with diabetes and DPN.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 40 to 55 years for both gender.
2. Patients with diabetes for more than 5 years.
3. Diabetic polyneuropathy was diagnosed by a neurologist.
4. Their BMI from 18 to 24.9 kg/m2.
5. The study population must be willing to participate in the study.

Exclusion Criteria:

1. Patients with marked deformities of the lower limbs, foot ulcers and Charcot foot.
2. .Patients with any other neurological or orthopedic diseases that may affect balance.
3. Patients with marked weakness or drop foot.
4. Patients with amputation, mental deficits, liver or renal diseases.
5. patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment
Prevalence of Musculoskeletal Symptoms in the Cambridge NIHR BioResource

Musculoskeletal diseases, such as osteoarthritis, represent a large proportion of the global burden of disease with hip and knee osteoarthritis alone being the 11th greatest cause of disease burden.

The purpose of this study is to determine the level of musculoskeletal symptoms in members of the Cambridge National Institute for Health Research (NIHR) BioResource and see if this is associated with their possession of genetic markers that have been identified as being associated with osteoarthritis.

This will allow us to determine the real level of musculoskeletal symptoms in this large cohort of volunteers and provide basic information that could be used to facilitate further musculoskeletal research in the NIHR BioResource population.

All active members of the Cambridge NIHR BioResource will be approached.

They will be sent an email outlining the purpose of the study and asking that if they would like to take part to please complete the online questionnaire which will be linked to in the email.

For those individuals who agree to participate and complete the questionnaire, the Cambridge NIHR BioResource will provide the genetic marker information it already holds for specific markers that are known to be associated with osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Member of the NIHR BioResource
* Willing to consent to participate

Exclusion Criteria:

* Previous self-report of osteoarthritis on joining BioResource
Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia

CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.

Patients will receive standard dose CLAG-M (cladribine, cytarabine, mitoxantrone, filgrastim). Standard support care will be given. Efficacy will be assessed through bone marrow examinations and blood tests.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory acute lymphoblastic leukemia,
* Burkitts leukemia/lymphoma,
* Lymphoid blastic CML,
* Lymphoblastic lymphoma.
Probiotics for Diaper Dermatitis

The goal of this randomized controlled clinical trial is to determine the effect of the probiotic OMNiBiOTiC® Panda in treating diaper dermatitis in children under the age of two years. The main question it aims to answer is:

Is the probiotic OMNiBiOTiC® Panda effective in reducing the duration of diaper dermatitis in children under the age of two years?

Researchers will compare the probiotic and placebo group to see if the duration of diaper dermatitis is significant among the two groups.

Participants will:

* receive 6 droplets daily of probiotic or placebo for 3 weeks and
* observe and record improvement of diaper rash symptoms each day using a diary.


Eligibility Criteria:
Inclusion Criteria:

* presence of diaper dermatitis
* age less than two years

Exclusion Criteria:

* previous use of probiotics
* age more than two years
* an acute bacterial infection
* chronic disease
* local use of antibiotics in the anogenital region