cyrilzakka/clinical-trials huggingface dataset:
Effect of Combined Neck Strength Exerciser Plus Physiotherapy to Treatment Chronic Neck Pain

1. Chronic neck pain is common in general population.

   * High health care source expenditure
   * Multiple therapeutic approaches available with limited evidence
   * Previous studies showed active strengthening exercise improved pain (VAS) and functional performance (NDI)
   * Muscle strengthening exercise with biofeedback technique showed more long-lasting effect in patients with chronic neck pain
2. The investigators hypothesize that daily use of the neck strength exerciser (NSE), combined biofeedback technique with muscle strengthening exercise posture adjustment, in addition to traditional physiotherapy, could have more long-lasting and prominent effect on pain and functional improvement in patients with chronic neck pain.

1. A randomized single-blinded trial to compare the effect of combined home-based NSE with physiotherapy could be more effective to treat people with chronic neck pain

* The NSE is a simple equipment that is easy to learn and safe to apply as home-based program
* The NSE will apply to the patients in the NSE group for 6 weeks, and we will compare the target variables to see if it brings better improvement by correction of maladaptive habitual posture and daily postural muscle exercise

Eligibility Criteria:
Inclusion Criteria:

* Adult, ≧20 yr.
* Constantly or frequently occurring neck pain for more than 3 months in the last 1 year.
* Motivated and willing to participate in rehabilitation therapy
* Sign written informed consent.

Exclusion Criteria:

* Neck or shoulder surgery.
* Clinical evidence of cervical radiculopathy or myelopathy.
* History of disk disease, degenerative joint disease, fracture, or dislocation in the cervical vertebrae.
* Severe pathological change in the cervical vertebrae, including inflammatory rheumatic disease and tumor.
* History of poor diet, hypothyroidism, or other severe systemic disorders.
* Cognitive deficit and severe psychiatric illness.
Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring

To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.

Patients with metastatic colorectal or breast cancer will be recruited.

* Metastatic Colorectal Cancer: capecitabine alone or capecitabine + oxaliplatin for 8 3-week cycles
* Metastatic Breast Cancer: capecitabine alone or capecitabine + docetaxel for 8 3-week cycles.

All patients will be given a mobile phone onto which they will enter any side-effects experienced prior to taking capecitabine in the morning and evening. Any grade 3 or 4 symptoms will trigger an alert to a pager held by the ward-staff for immediate attention. Thus, patients' severe side-effects will be monitored in real time and the trial will allow real-time dose reductions during cycles and dose-increases at clinics. Patient experience in the trial will also be evaluated during their participation in the trial.

Patients will already be receiving the drug prior to this study and will not be administered to patients as part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens

For metastatic colorectal cancer:

* capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)
* capecitabine 2500mg/m2 d 1-14, q 3 weekly

For metastatic breast cancer:

* capecitabine 2000mg/m2d 1-14, q 3 weekly
* capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
* Age \> 18 years
* Fit to start at full (100%) starting dose of all drugs
* Able and willing to use mobile phone
* Reasonable renal, liver and bone marrow function
* Absolute neutrophil count (ANC) \>1.5 x 109/L
* Platelet count \> 100 x 109/L
* Total bilirubin \<1.5 ULN
* ALT, AST \< 2.5 x ULN
* Alkaline phosphatase \< 2.5 x ULN
* No obvious contra indications to capecitabine or oxaliplatin or docetaxel
* Patients must also be able to read, write and understand English.

Exclusion Criteria:

* Patients who live in an area of no Vodafone or Orange mobile phone network - - Patients participating in other cancer treatment trials
* Moderate or severe renal impairment \[creatinine clearance \<30ml/min (calculated according to Cockroft-Gault formula)\]
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

A randomized, double-blind, placebo-controlled intervention trial involving 100 treated subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in the standard post-operative medication arm.

Post-operative pain control is a common concern patients have when they consider undergoing a surgical procedure. Although effective for treating acute pain, opioid analgesics are also associated with dose-dependent adverse effects, including constipation, nausea and vomiting, altered mental status, and respiratory depression, all of which have been shown to increase patient length of stay. The use of non-opioid analgesics with different mechanisms of actions for acute pain control via a multi-modal approach is efficacious in reducing opioid consumption, decreasing the incidence of adverse effects, improving patient satisfaction and recovery time, and decreasing hospital costs.Certain minimally invasive procedures may afford many patients the opportunity to achieve adequate post-operative pain control with minimal to no requirement of opioid analgesics, thereby sparing the patient known adverse effects that can increase length of stay and costs. The ENTS approach for resection of pituitary tumors is the standard surgical procedure for these lesions, and is associated with pain that is more easily managed post-operatively, making it an ideal procedure for an opioid-sparing post-operative pain regimen. Anecdotally, the investigators note that in the investigator's post-operative pituitary patient population that post-operative pain can frequently be adequately managed with scheduled non-opioid analgesics, often without requiring breakthrough opioid doses. Another safe and effective non-opioid analgesic that is widely used in multi-modal pain management for moderate pain is IV Caldolor (ibuprofen). After literature review, the investigators were unable to find a study that had attempted to use an opioid-sparing analgesic regimen for post-operative pain control following ENTS approach for resection of pituitary tumors.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient undergoing ENTS surgery for resection of pituitary tumor.
* Adults \>18 years and \<80 years of age.
* English speaking and literate or able to understand the use of a pain scale.
* Body Mass Index \>19 and \<40 kg/m2

Exclusion Criteria:

* Renal failure (acute or chronic) or creatinine \>2.0
* Allergy or intolerance to acetaminophen, ibuprofen, or opioids
* Pre-operative opioid tolerance, dependence, or abuse
* Anaphylaxis to opioids
* History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery
* Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range, defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin\> 3x upper limit of normal range
* Subject unwilling or unable to sign informed consent for the study
* Pregnancy
* Incarcerated patients
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.

Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners.

Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units of Brest University Hospital with systematic testing for Rotavirus.

Evaluation of the impact of the vaccination program on rotaviral gastroenteritis hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from 2002-2007 in the absence of vaccination.

The principal judgement criterion is the number of pediatric hospitalizations for rotaviral GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the suburbs of Brest.


Eligibility Criteria:
Inclusion Criteria:

* infants aged 6 to 12 weeks
* born in Brest District, France
* born between Feb 01, 2007 and Nov 19, 2009

Exclusion Criteria:

* contraindication to rotavirus vaccine
A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of overactive bladder
* Must be able to complete the micturition diary

Exclusion Criteria:

* Pregnant or lactating
* Clinically significant outflow obstruction
* Significant post void residual urine
* Significant stress incontinence
* Urinary tract infection
* Chronic inflammation
* Bladder stones
* Previous pelvic radiation therapy
* Previous or current malignant disease of the pelvic organs
* Uncontrolled narrow angle glaucoma
* Urinary or gastric retention
* Electrostimulation therapy
* Bladder training
* Diabetic neuropathy
Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children

School-based programs are an essential strategy for preventing obesity, yet the most effective way to implement them remains unclear. This study aims to evaluate the effectiveness of a school-based obesity prevention program, delivered by different implementers, in comparison to a control group, focusing on body fat reduction in Mexican children. This is a cluster randomized controlled trial. Approximately six public elementary schools (240 children) in Hermosillo, Mexico, will be invited to participate. Schools will be randomly assigned to one of three groups: a program implemented by advanced undergraduate students in Nutrition and Physical Activity (NUT-PA), a program implemented by Physical Education teachers and Physical Activity students (PEST-PA), or a control group. The intervention will consist of a 6-month obesity prevention program that includes nutrition education, physical activity sessions, and parent participation. The control group will continue with their regular school activities. The primary outcome will be the difference in body fat percentage at 6 months between the NUT-PA group and the control group, as well as between the PEST-PA group and the control group. Secondary outcomes will include BMI Z-score, waist circumference, and various lifestyle parameters. A mixed-effects linear analysis will be conducted using an intention-to-treat approach.

This is a cluster randomized controlled trial with three parallel groups and a 1:1:1 allocation ratio. The current protocol represents the definitive phase of the study, which was previously registered and approved in clinical trials (NCT05461703). The project has been approved by the Research Ethics Committee of the Nursing Department at the Universidad de Sonora (EPD-007-2022).

Eligibility Criteria:
Schools

Inclusion Criteria:

* School principals, 4th- and 5th- grade teachers willing to participate, availability of space for physical activity classes, and groups with a minimum of 20 students.

Exclusion Criteria:

* Participating in a similar study.

Children

Inclusion Criteria:

* To be a 4th or 5th grade student (9 to 12 years) in one of the participating schools. To be eligible for this study, parents and children will be required to sign an informed consent and assent form, respectively, and had to complete anthropometric measurements (children) and lifestyle questionnaires (parents).

Exclusion Criteria:

* A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.

Implementers

Inclusion Criteria:

-Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.
Improving Personal Recovery After Depression with a Blended Module (STAIRS)

Almost all mental healthcare treatments of depression focus on symptomatic recovery. However, such recovery does not inherently mean that personal recovery is reached. In fact, many persons still experience functional impairments after symptomatic recovery. As this has a negative influence on daily life, a new blended module (STAIRS) was developed to promote personal recovery in persons that are in the final stage of symptomatic recovery from depression. The current study will investigate the efficacy of STAIRS, by adding STAIRS to care as usual and comparing it with care as usual. It is hypothesized that STAIRS will have a positive effect on personal recovery and that this effect is larger than in the control group.

The study uses a mixed methods design to determine efficacy and underlying mechanisms contributing to the effect of the STAIRS-training. One hundred forty adults, who are in the last phase of their depression treatment, will be enrolled and randomized (1:1) to (1) a group receiving the STAIRS-training next to Care as Usual (CAU) or (2) a group receiving CAU added with three information letters. Level of personal recovery, symptom severity, empowerment and control will be determined at baseline, at the end of the program (8 weeks) and at 6 months follow up. Approximately fifteen participants from the STAIRS group will be asked about their experiences with the different elements of the program and the perceived effects, in a semi-structured interview at the end of the program.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old
* Being in the last phase (recovery phase) of treatment for a diagnosed Major Depressive Disorder; psychological treatment is expected to end within three months or treatment is finished within the past 3 months and patient receives an aftercare and/or maintenance antidepressant treatment.
* No more than moderate depression severity: Score of \<38 on the Inventory of Depressive Symptomatology - Self Rated (IDS-SR).
* The willingness to participate: an affirmative response to the question 'after being explained what participation means for you, are you willing to participate?'.

Exclusion Criteria:

* Bipolar depression or depression with psychotic features.
* Comorbid schizophrenia spectrum or other psychotic disorder.
* Comorbid moderate or severe dependence of alcohol or drugs.
* Neurological disorder (e.g., dementia).
* Insufficient command of the Dutch language.
* Cognitive problems or indication of low IQ (i.e.\< 80).
* Not in possession of a pc or smartphone.
* Having been referred to a different mental health service for other mental problems
Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.

The objective of the present study was to analyze the differences between the formulas used to estimate fat mass and to establish the existing relationship with the skinfold sum in anthropometry. A total of 2,458 active subjects participated in the study (mean age: 27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass. Significative differences were found between all the formulas for the percentage of fat mass and the fat mass in kilograms. The correlations among the skinfolds sums and the different equations were high and significative in all the cases. There were differences between all the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat mass in physically active adults.


Eligibility Criteria:
Inclusion Criteria:

* To be between 18 and 50 years old and to practice any sport in a regular basis

Exclusion Criteria:

* To have overweight or obesity
Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study

To study the etiologies of patients diagnosed as non-B, non-C liver cirrhosis (NBNC-LC).

To describe the different patient's outcomes.

Liver cirrhosis is the ultimate fate of many hepatic insults that may be viral, immunologic, and metabolic or even cryptogenic. (Tsochatzis EA et al., 2014)

Recently, Non-Alcoholic Fatty Liver Disease (NAFLD) present a serious health burden worldwide that affects around 25% of the global adult population with a prevalence of around 31.8% in the Middle East. (Younossi ZM, et al., 2019)

Most of Egyptian patients presented with end-stage liver disease are secondary to post-hepatitic cirrhosis is estimated to be more than 80% of cases. (Guerra J et al., 2012)

The real profile of non-B, non-C etiologies of liver cirrhosis, in Egyptian patients, is still not fully evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023

Exclusion Criteria:

* We will exclude the pateints that will be diagnosed as HBV-HCV induced Liver Cirrosis
A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential
* Pain present for more than 3 months after healing of herpes zoster skin rash
* VAS score of \>=40mm at screening and baseline visits

Exclusion Criteria:

* Patients with pain conditions which might impair the assessment of postherpetic neuralgia
* Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
* History or diagnosis of DSM IV major depressive disorder
Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields

This purpose of this study is to describe the effect of Tumor Treating Fields (NovoTTF) on quality of life (QOL), including exercise, sleep quality, and mood, in patients with World Health Organization (WHO) Grade IV malignant glioma who have been prescribed and approved to receive Optune™. This is an observational, longitudinal study, meaning that information about QOL will be collected over time while the patient is using the NovoTTF device (for example, Optune™).

Patients will be provided with a Fitbit Charge HR™, which they will begin wearing immediately to collect baseline information. The study team will teach the patients how to use the Fitbit and the associated smart phone application. Patients will also set an account with a platform that will provide information from the Fitbit (number of steps, sleep behaviors, and exercise log) to the study team. Patients will also have blood drawn, do a 6-minute walk test, and complete questionnaires at clinic visits 1, 8, 16, and 24 weeks after receiving the Fitbit. At the end of the study, patients will return the Fitbit to the study team.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to beginning specific protocol procedures
* Histologically proven World Health Organization (WHO) grade IV malignant glioma
* Completed standard-of-care treatment for newly diagnosed WHO grade IV malignant glioma, consisting of temozolomide (TMZ) and radiation therapy (RT)
* Signed Optune™ Prescription Form indicating intention of initiating NovoTTF therapy
* Stable disease status
* Patients ≥ 18 years of age
* Karnofsky Performance Status (KPS) ≥ 70
* Patient must be able to ambulate and complete the 6-minute walk test without use of a walker, cane, or any assist device
* Technology requirement:

  * Patients need to own a smart phone that can interface with the Fitbit Charge HR™.
  * Patients must be willing to provide their own internet access for this study. This will include either a data plan or Wi-Fi access on the patient's smart phone for use of the Fitbit Charge HR™ App. They will also need internet access (through their smart phone or home computer) for setting up a SGHIx account. Patients are welcome to use the free guest Wi-Fi access within the Duke Outpatient clinic area for the purpose of this study.
  * Patients will need a home computer or adaptor with USB port to charge the Fitbit Charge HR™.

Exclusion Criteria:

* Non-English speaking or inability to read and understand English.
* Presence of cardiovascular disease that would make physical activity risky, at the discretion of the provider.
* Any patient who is unable to comprehend and operate the activity tracker, at the discretion of the enrolling provider.
Collaborative Consultation for Participation Among Students With IDD

Objective: Developing and corroborating the Collaborative Consultation for Participation of Students with Intellectual Disability (Co-PID) program, for enhancing classroom participation among students with moderate Intellectual and Developmental Disability (IDD).

Method: study took place in two special education schools and included students with moderate IDD (n=60) and their teachers (n=11). The settings were randomly assigned to intervention or control group. In the intervention group, Co-PID program was employed; in the control group an In-Service (IS) was employed. Participation was evaluated at pre-test and post-test.

The study was conducted in three phases: (a) pre-test; (b) intervention; and (c) post-test

Pre-test. Using the 'Structured Observation of Students' Participation in Class', each student in both groups was observed four times during different lessons (with a 1-week interval between observations) to establish a baseline for level of participation. All pre-test observations were conducted between the 2nd and 3rd months of the school year, by an occupational therapist with 8 years of experience working with children with developmental delays. The observer was trained in using the 'Structured Observation of Students' Participation in Class' and was not blinded to the schools' assignment (Co-PID or IS). During this period the teachers, who were blinded to the school assignment, were asked to teach in a regular manner without changing the content or design of their lessons. Next, the teachers filled out the School Function Assessment questionnaire for each student. Finally, based on the 'Structured Observation of Students' Participation in Class' scores and teachers' familiarity with the students' function, the occupational therapist and each of the participating teachers jointly filled-out the 'Goal Attainment Scaling' form. Each student had three goals, one for each of the participation skills: Communicating, Choosing and Initiating. Post-test. This phase was conducted during the 9th and 10th months of the school year, and was identical to the pre-testing phase in terms of both process and measures used

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of moderate IDD
2. Mobility independence
3. No secondary diagnosis of autism, nor sensory disabilities such as blindness or deafness
4. Students had been studying at the school for at least one year prior to data collection.

Exclusion Criteria:

-