cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effects of Music and White Noise in Children Performed Endoscopy

The study was planned as a randomized controlled experimental study to compare the effects of music and white noise on fear, anxiety and pain levels before, during and after the procedure in school-age children (6-12 years old) who will undergo endoscopy.

Hypothesis 0 (H0): There is no difference in fear, anxiety, pain, parental anxiety and pulse, respiration and oxygen saturation values between children exposed to music and white noise.

Hypothesis 1 (H1): Children who were exposed to music and white noise had lower fear scores than children who were not exposed to any application.

Hypothesis 2 (H2): Children who were exposed to music and white noise had lower anxiety scores than children who were not exposed to any application.

Hypothesis 3 (H3): Children who were exposed to music and white noise had lower pain scores than children who were not exposed to any application.

Hypothesis 4 (H4): Children who were exposed to music and white noise had lower pulse value scores than children who were not exposed to any application.

Hypothesis 5 (H5): Children who were exposed to music and white noise had lower respiratory rate scores than children who were not exposed to any application.

Hypothesis 6 (H6): Children who were exposed to music and white noise had higher oxygen saturation value scores than children who were not exposed to any application.

Hypothesis 7 (H7): Parents of children who were exposed to music and white noise had lower parental anxiety than parents of children who were not exposed to any treatment.

There are music group, white noise and control group in the study.

The independent variables of the study are age, gender, music and white noise application.

The dependent variables are; Children's Fear Scale (CFS) scores used to measure children's fear, Children's Anxiety Scale-State (CAS-D) scores used to measure anxiety, The Faces Pain Scale Revised (FPS-R) scores used to measure pain status, pulse, respiratory rate and oxygen saturation values and Beck Anxiety Inventory scores obtained from parents.

Eligibility Criteria:
Inclusion Criteria:

* School age (6-12 years old) child,
* Have not had an endoscopy procedure before,
* Have not had a surgical procedure before,
* Have been requested to have an endoscopy by a physician,
* Be able to communicate,
* Have no hearing or speech problems,
* Agree to participate in the study,
* Have not used analgesics for 6 hours before the procedure,
* The child can count from 1 to 10,
* Have the ability to order numbers (knowing that numbers are big or small (e.g. 6 is less than 7, 4 is greater than 2, etc.).

Exclusion Criteria:

* Not being of school age (under 6 years old, over 12 years old),
* Having had an endoscopy procedure before,
* Having had a surgical procedure before,
* Not being able to communicate,
* Having hearing and speech problems,
* Not agreeing to participate in the study,
* Having used analgesics up to 6 hours before the procedure,
* The child not having the ability to sort and count numbers.
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:

* To determine oncologic outcomes, specifically 2-year recurrence-free survival
* To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
* To determine time to recurrence and recurrence patterns
* To determine use of adjuvant therapies
* To determine perioperative complications

Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.

Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade)
* Planned for nephroureterectomy by their urologic surgeon
* Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis.
* No concomitant muscle-invasive bladder cancer
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (\>cN0)
* Presence of distant metastases
* Concomitant muscle invasive bladder cancer
* The participant is in a reduced general condition or has a life-threatening disease.
* The participant has a psychiatric disorder that precludes them from understanding the consent process.
MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing

The aims of this study were to evaluate the diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques and to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible.

Exclusion Criteria:

* Patients included in other prospective studies
Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias

The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.

This is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (ICD). In addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events.

The data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. The final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. The investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Current treatment with an ICD
* Signed written informed consent before study commencement

Exclusion Criteria:

* Participation in other interventional clinical trial or previously included in the current study
* Patients not able to provide written informed consent
* Known or suspected, non-curable cancer,
* Neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis (ALS)
* Patients unwilling or unable to comply with the protocol
* History of non-compliance to medical management and patients who are considered potentially unreliable by the Investigator
* History or evidence of alcohol or drug abuse with the last 12 months that may influence the participation of the patient in the study, as assessed by the Investigator during the screening phase
* Any surgical or medical condition, which in the option of the Investigator, will impair the ability of the patient to participate in the study
Long-term Follow up of Patients With Longstanding Hip and Groin Pain

In this longitudinal cohort study including young to middle aged people with longstanding hip and groin pain (LHGP) referred to tertiary care, we will collect data of patient reported symptoms, function and quality of life three and seven years after the initial contact with orthopedic surgeon.

81 physically active patients (18-55 years) with (LHGP) who were enrolled in a cross-sectional study (Diagnosis and functional limitations in the young to middle-aged physically active population with long-standing hip/groin pain: A cross-sectional study) during the period October 2014 to January 2017 will be recruited to this longitudinal cohort study.

A research coordinator will contact the patients and provide them with written and oral information about the study. Patients who accept to participate will electronically complete the following questionnaires. The same questionnaires were included at baseline, i.e., in the cross-sectional study.

* Copenhagen Hip and Groin Outcome Score (HAGOS)
* HSAS - Hip Sports Activity Scale (HSAS)
* Patient Specific Functional Scale
* Medical Outcomes Study short form 36 (SF-36)
* K-10 questionnaire
* Self-Presentation in Exercise Questionnaire (SPEQ)
* Multidimensional Scale of Perceived Social Support (MSPSS)

Additional questions about treatment, medication, patient satisfaction and perceived change in hip function will be included.

For descriptive purposes, the mean difference (95% CI), or median (quartiles), between baseline and follow-up assessments will be used as appropriate. Separate linear regression models will be used to evaluate the change in each variable compared to baseline values.

Eligibility Criteria:
At baseline, the following inclusion and exclusion criteria were used:

Inclusion criteria:

* Unilateral or bilateral hip/groin pain \>3 months
* Age 18-55 years
* No previous hip surgery

Exclusion criteria:

* Hip pathology (i.e., Perthes' disease)
* Verified moderate or severe osteoarthritis (OA) (Tönnis grade \>1)
* Palpable hernia
* Low-back pain with a positive Lasègue test
* MRI-verified lower back/spine pathology (i.e., spinal stenosis, disc herniation)
* Other musculoskeletal co-morbidities overriding the hip-related symptoms and dysfunction
* Co-morbidities excluding physical activity and training
* Psycho-social disorders
* Drug abuse
* Not understanding the language of interest.
Assessment of Knowledge on Pneumococcal Vaccination Among Diabetologists in India

Asia has the highest burden with the largest contribution of pneumonia burden from India. Pneumonia is also observed as 5th leading cause of deaths in India. People with diabetes with uncontrolled glucose are significantly at higher risk of development of pneumonia. Even though, pneumonia is a vaccine-preventable disease, hospitalization for pneumonia of patients with diabetes are rising. Very limited literature is available on the knowledge and practice of pneumonia vaccination among diabetologists and the rate of pneumonia vaccination received by the patients with diabetes. Hence this study aims to assess their knowledge on the same. In addition, this study also aims to identify the real barriers and facilitators of pneumococcal vaccination among diabetologists in India. A cross-sectional study will be conducted among 25diabetologists in each of the four zones in India representing all directions - North, East, West and South. Diabetologists will be selected through purposive sampling. A semi-structured questionnaire (study tool) is designed based on the existing literature that addresses our objectives. An education session on Pneumococcal vaccination will be conducted for the diabetologists through webinar after completing the survey. A post assessment will be done using the same questionnaire among the study participants after the education session in order to see an increase in the knowledge of pneumococcal vaccination.


Eligibility Criteria:
Inclusion Criteria:

Diabetologists willing to participate in the study

Exclusion Criteria:

Unwillingness to give consent for participation
Survivor Choices for Eating and Drinking - Colorectal Cancer

Epidemiologic data suggest that a Western dietary pattern after diagnosis of colorectal cancer increases risk of disease recurrence and death. High intake of red and processed meat, dairy, refined grains, and sweets/desserts characterize a 'Western dietary pattern'. This study aims to translate the epidemiologic findings into a patient-centered, web-based dietary intervention with text messaging to inform and modify users' dietary choices. The investigators' specific aims are to: 1) Develop a web-based dietary intervention with text messaging for colorectal cancer survivors; and 2) Conduct a 12-week pilot randomized controlled trial to determine the acceptability and feasibility of the dietary intervention among 50 colorectal cancer survivors. All participants will receive standard of care print materials regarding diet following a colorectal cancer diagnosis. Participants in the intervention group will also receive access to a web-based dietary intervention with text messaging for 12 weeks. This study will generate preliminary data on the effect of the intervention on dietary choices among colorectal cancer survivors for future studies.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with colon or rectal adenocarcinoma
* completed standard cytotoxic chemotherapy prior to enrollment, if medically indicated
* considered disease-free or have stable disease at baseline
* able to speak and read English
* access to a mobile phone with Internet and text messaging capabilities
* able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the Internet

Exclusion Criteria:

Individuals who are already meeting four or more of the six target dietary behaviors will be excluded:

* ≥5 servings/day of fruits \& vegetables
* ≥3 servings/day of whole grains
* ≥2 servings/week of fish
* no processed meat
* no sugar-sweetened beverages
* ≤1 alcoholic drink/d for women and ≤2 alcoholic drinks/d for men.
Head and Neck Cancer Screening and Serum Repository

Head and Neck Squaumous Cell Cancer(HNSCC) is the 6th most common cancer in the United States and the 3rd most common worldwide. Risk factors include abuse to tobacco and alcohol. Survival is related to stage of HNSCC when treatment is sought. Most HNSCC patients present with advanced staged disease. This screening activity will educate patients with HNSCC rick factors and screen for pre malignant and/or early staged lesions.

Otolaryngology staff memebers and residents will perform head and neck examinations upon participants after the participant has completed their questionnaire and had the opportunity to partcipate in the research portion by having blood drawn. A suspicious head and neck examination will be considered abnormal, and further recommendations for follow-up will be made. Participants will be provided with a list of practicing head and neck surgeons within the state of Arkansas.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Under the age of 18 years of age
A Study With SAGE-547 for Super-Refractory Status Epilepticus

This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).


Eligibility Criteria:
Inclusion Criteria:

* Subjects two (2) years of age and older
* Subjects who have:

  * Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial anti-epileptic drug \[AED\] treatment), according to institution standard of care, and;
  * Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED), according to institution standard of care, and;
  * Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agent and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent but not in an EEG burst or seizure suppression pattern

Exclusion Criteria:

* Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
* Children (subjects aged less than 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder
* Subjects who have any of the following:

  1. a glomerular filtration rate (GFR) low enough to warrant dialysis but for whatever reason, dialysis is not planned or non-continuous dialysis planned (that would not adequately remove Captisol®);
  2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
  3. fulminant hepatic failure;
  4. no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is less than 30 days.
* Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol
Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection

This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.

Self-collected vaginal samples for high-risk human papillomavirus (hrHPV) DNA testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. Transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. Dry transport of samples has the advantage of lower cost and ease of handling. Evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (LMICs). The effect of using dry swabs on HPV-DNA detection in LMICs needs to be determined.

This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA using LBC and as reference standard.

Eligibility Criteria:
Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site:

* Sexually active adult females ≥30 years of age (≥25 years of age if HIV+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy)
* Able to understand scope of study
* Able to provide written informed consent
* Willing to provide all necessary samples

Exclusion Criteria:

* Vaccinated for HPV
* Pregnancy
* Patient not willing or unable to provide the all three swab samples (self-collected dry and wet and HCW collected cervical swabs)
Effect of Pelvic Floor Muscle Training in Stroke

Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.


Eligibility Criteria:
Inclusion Criteria:

* Female stroke patients
* one month since stroke
* UI in close relation to the stroke
* normal cognitive level
* independent walking indoor ability \> 100 m
* independence in toilet visit

Exclusion Criteria:

* urinary ineffections
* vaginal prolabs
* qronical lung disease
* psychiatric diseases
* other neurological diseases
* do not speak Danish
Investigation of Efficacy of Use of a Bandage

This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.

Patients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage.

This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.

Patients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage. Patients in the intervention group will use the bandage for 12 weeks and patients in the control group will receive the normal treatment which is information by a physiotherapist on movement restrictions.

50 patients will be allocated in the intervention group and 50 patients will be allocated to the control group.

We will investigate:

1. Whether there is a difference in number of dislocations between the two groups in the project period (12 weeks).
2. Patients' hip function, quality of life and satisfaction with the treatment in the two groups
3. The safety, wear and durability of the bandage after 12 weeks of use

Eligibility Criteria:
Inclusion Criteria:

* Has had at least one previous hip dislocation after total hip arthroplasty

Exclusion Criteria:

* Dislocation in other directions than posterior/superior
* Loose prosthesis
* wounds in the area of skin that is in contact with the bandage
Effects of ONO-2506PO in Patients With Alzheimer's Disease

The purpose of this study is to establish the presence of an effect of treatment with ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's Disease using NINCDS/ADRDA criteria
* Standardized MMSE Score of 13 to 24 points (inclusive)
* Modified Hachinski score equal or less than 4

Exclusion Criteria:

* Serious systemic disease that may preclude survival to study completion
* Other illnesses that may include dementive features