cyrilzakka/clinical-trials huggingface dataset:
Management of Post-Tonsillectomy Pain in Pediatric Patients

Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.


Eligibility Criteria:
Inclusion Criteria:

* 4 to 17 years of age at time of enrollment
* Undergoing tonsillectomy with or without adenoidectomy
* Able to provide informed consent from parent or legal guardian
* Able to provide assent if subject is a minor of appropriate age

Exclusion Criteria:

* Allergy to acetaminophen or ibuprofen
* Inability for study participant to cooperate with pain assessments
* Known pregnancy
* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health

Aim of the study:

This study aims to evaluate the antioxidant and beneficial effects of matcha tea daily intake on periodontal health.

Objectives:

* To evaluate the salivary level of antioxidants (catalase, total antioxidant capacity) after matcha tea intake compared to green tea over a period of one month.
* To evaluate the clinical periodontal parameters including bleeding on probing (BOP), probing pocket depth (PPD) and plaque index (PI) after matcha tea intake compared to green tea over a period of one month.
* To evaluate the salivary levels of IL-1B after matcha tea intake compared to green tea over a period of one month.


Eligibility Criteria:
Inclusion Criteria:

* • having at least 20 teeth,

  * underwent no medical treatment during the last 3 months before examination and sampling,
  * non-smoker,
  * no history of systemic disease,
  * gingivitis patient (having \>10% bleeding sites with no PPD \>3 mm).

Exclusion Criteria:

* • wore orthodontic appliances,

  * pregnant or currently in the breast-feeding period,
  * periodontitis patient,
  * smoker,
  * has a history of systemic disease.
PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial

The aim of the study is to compare programmed intermittent bolus application and continuous epidural infusion with regard to additionally applied patient-controlled volume of local anesthesia and quality of analgesia.

Usually, patient controlled epidural analgesia (PCEA) is performed with a constant background infusion and patient-controlled bolus applications. An alternative approach is to give boluses at a regular rate for basic medication, instead of the continuous background infusion, maintaining the same amount of medication delivered per hour, (Programmed Intermittent Epidural Bolus injection; PIEB). In both cases, the patient has the option to trigger additional boluses. PIEB has been applied successfully in pain relief for lumbar epidural anesthesia in obstetrics, with better quality of analgesia and less total volume of local anesthetic required. It is assumed that the higher pressure in the epidural space with bolus injection results in a better and more uniform spread of the local anesthetic. In this study the PIEB-mode will be applied in major gynecological and abdominal surgery. In order to address the possibility that the different types of surgery result in different degrees of postoperative pain, the patients are stratified in three groups and randomized within these groups (Wertheim, Whipple, major colon surgery).

Eligibility Criteria:
Inclusion Criteria:

* Abdominal tumors in gynecology and general surgery
* Enlightenment and written consent to the investigation

Exclusion Criteria:

* refusal to participate
* pregnancy and breast feeding period
* general contraindications for thoracic epidural anesthesia (e.g. coagulation disorders, --anticoagulation according to the guidelines of DGAI)
* Impossibility to place the epidural catheter correctly
* Known allergy to the drugs used in the study
* Lack of understanding how to use the patient-controlled system
* postoperative follow-up respiratory assistance
Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys

SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.

SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle. Harnessing the power of technology, young people will be recruited online and largely enrolled digitally. The main outcome of interest is HIV incidence. The impact of the intervention on STI testing and pre-exposure prophylaxis (PrEP) will also be examined.

Eligibility Criteria:
Inclusion Criteria:

1. have been assigned male sex at birth and currently have a cisgender identity;
2. be aged 13-22 years old;
3. have had anal sex in the past 12 months;
4. be English-speaking;
5. exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;
6. have Internet access to complete online surveys;
7. provide informed assent for those under 18, and consent for those 18 years of age and older, including a capacity to consent and a positive self-safety assessment;
8. Willing to take an OraQuick home test to confirm HIV negativity for youth who are 19-20 years of age or 18 years old and graduated high school. If they agree to do the test but do not upload a photo of their result, they will be eligible if they self-report a negative sero-status. Youth 18 years old who have not graduated high school, and 13-17 years of age will be asked to take a home test. If they determine that they cannot do so safely, they will be allowed to self-report their sero-status; and
9. not currently enrolled in another HIV prevention program; or
10. know anyone already enrolled in the RCT.

Exclusion Criteria:

* Being HIV positive
Identification of PAthways of Kinase Inhibitors TOxicity

The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.


Eligibility Criteria:
Inclusion Criteria:

* Patient treated with a kinase inhibitor
* Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase

Exclusion Criteria:

-
Renal Arterial Resistive Index for Differential Diagnosis of Acute Kidney Injury

early differential diagnosis of anticipated acute kidney injury via ultrasound renal resistive index calculation

acute kidney injury is a common clinical syndrome introducing to emergency services with varying symptoms. acute kidney injury is divided into 3 subgroups: prerenal, renal and postrenal. there is not any certain laboratory or imaging modality for early detection of injury's type. calculation of renal resistive index with doppler ultrasound at emergency setting can be helpful for early detection of etiology of acute kidney injury subgroup.patient will be selected according to clinical status and detailed history and laboratory parameters.renal resistive index will we calculated with doppler ultrasound of arcuate and interlober arteries of kidneys. resistive index values of acute kidney injury patients will be compared depending on further tests and resistive indexes of suggestive etiologies will be compared according to final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. age over 18
2. patient with acute kidney injury diagnosed according to KDIGO, AKIN or RIFLE criteria

Exclusion Criteria:

1. end stage kidney disease
2. patients receiving renal replacement treatment
Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity

This study aims to evaluate the effects of oral glycine supplementation on plasma glycine concentration, intracellular glutathione (GSH) concentration, plasma acylglycine concentration, urine acylglycine concentration, and insulin resistance in subjects with morbid obesity.

This is an open-labelled trial. 20 adults with morbid obesity will be recruited. Following screening and baseline metabolic evaluations, eligible subjects will be given oral glycine supplements for 14 ± 5 days. Upon completing glycine supplementation, subjects will return for their post-supplement metabolic assessment.

The investigators hypothesize that oral glycine supplementation in morbidly obese patients normalizes plasma glycine concentration, increases intracellular GSH concentration, increases plasma and urinary acylglycine concentration, and improves insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 21-65 years
2. BMI ≥ 32.5 kg/m2
3. Able to provide informed consent
4. Able to maintain present diet throughout the study duration

Exclusion Criteria:

1. Weight \> 150 kg
2. Type 2 Diabetes Mellitus
3. Allergy to soy
4. Ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide)
5. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
6. Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation \< 60 ml/min)
7. Haemoglobin concentration \< 10 g/L
8. Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
9. Uncontrolled hypertension (BP \> 180/110 mmHg)
10. Pregnancy
11. Nursing mothers
12. Uncontrolled thyroid disease
13. Surgery requiring general anaesthesia within 4-weeks before enrolment
14. Psychiatric disorders requiring medication
15. Significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men)
16. Cancer within the last 3-years (except squamous cell and basal cell cancer of the skin)
17. Any factors likely to limit adherence to study protocol
Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

Cryoglobulinemia are responsible for systemic vasculitis, and the most frequently targeted organs are the skin, joints, kidney and peripheral nervous system. Cryoglobulinemia vasculitides are associated with significant morbidity and mortality, and require therapeutic intervention. With the discovery of hepatitis C virus (HCV) as the etiologic agent for most cases of mixed cryoglobulinemia new opportunities and problems for crafting therapy of HCV mixed cryoglobulinemia (MC) have emerged. A new and major concern was the potential adverse effects that immunosuppressive therapy with glucocorticoids and cytotoxic drugs could have on an underlying chronic viral infection. Alternatively the discovery of HCV provided the opportunity to control HCV-MC with antiviral therapy based on the belief that the underlying infection was driving immune complex formation and resultant vasculitis. Inducing a sustained virologic and clinical response and minimizing the use of immunosuppressive drugs are the main goals in the treatment of patients with HCV-MC vasculitis. Aggressive antiviral therapy has been shown to induce a complete remission of HCV-MC in up to 70% of patients. New antiviral combination, Interferon (IFN)-free regimens have recently proved very high virological response rate and with a very good safety profile and now need to be evaluated in severe and/or refractory HCV-MC patient's population.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age or older
* present an active HCV vasculitis defined by a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and/or cardiac involvement (no histological evidence needed if patient had purpura)
* chronic active HCV infection (positive HCV RNA)
* informed consent

Exclusion Criteria:

* non-active cryoglobulinaemia vasculitis
* HIV
* active hepatitis B virus (HBV) infection
* current decompensated cirrhosis.
Investigation of the Effect of Virtual Reality Environment on Developing Clinical Skills in Nursing Students

To reduce the negative consequences of these problems in clinical practice on the quality of education in the nursing profession, laboratory applications of vocational courses in undergraduate education have become more important. In this context, the research aimed to determine the use of a virtual reality application, an innovative training method to increase the quality of nurses' clinical practice training, in the Obstetrics-Gynecology and Diseases Nursing (DKSH) course and its effect on students' course success. I

When considering the duties and responsibilities of nurses in the health system, it is necessary to train well-educated, professional nurses to ensure patient safety and quality of care. However, nurses' many problems with their clinical practice are important obstacles to getting a good education. To reduce the negative consequences of these problems in clinical practice on the quality of education in the nursing profession, laboratory applications of vocational courses in undergraduate education have become more important. In this context, the research aimed to determine the use of a virtual reality application, an innovative training method to increase the quality of nurses' clinical practice training, in the Obstetrics-Gynecology and Diseases Nursing (DKSH) course and its effect on students' course success. In the study, the virtual reality application was prepared for preeclampsia, postpartum care and condom counseling, which are the most frequently encountered by students in professional practice and are of great medical importance. In addition, the effect of simulation training in the virtual reality environment on the student's decision-making self-confidence and anxiety in real clinical practice was also evaluated. In this context, the research aims to determine the effect of a virtual reality environment on improving clinical skills in nursing students.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older, taking the Obstetrics, Gynecology and Obstetrics Nursing course for the first time, attending the course and taking the information technology course.

Exclusion Criteria:

* Being visually or hearing impaired, graduating from a health vocational high school, arriving late or leaving early for case discussions or role-play scenarios, and staying in the virtual environment for less than 5 minutes.
Ready for Change: Enhancing Motivational Engagement Prior to IIPT

This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.

Readiness to change, or willingness to engage in a self-management approach to chronic pain and disability, is the most powerful predictor of children's success in intensive pediatric pain rehabilitation. Motivational Enhancement Therapy (MET) is an approach that has been effective in increasing readiness to change and treatment engagement for other behaviorally-oriented health interventions. However, MET has never been systemically employed in the context of treating pediatric chronic pain and disability.

This demonstration project seeks to test the effects of a novel telehealth intervention using motivation enhancement therapy to improve patient and parent engagement in, and outcomes of, an intensive interdisciplinary day hospital program for children with complex chronic pain conditions and associated disability, the Pediatric Pain Rehabilitation Center (PPRC). The intervention, PPRC-Prep, is a 4 week MET-based telehealth intervention that will be offered to families of children with refractory chronic pain conditions awaiting admission to the PPRC at Boston Children's Hospital at Waltham. Families approved for and awaiting PPRC admission will be randomized to receive PPRC-Prep along with usual care or to a comparison group receiving treatment as usual. Study aims include assessing the feasibility and acceptability of the intervention along with measuring its potential to increase readiness to engage in a self-management approach assessed at time of admission to the PPRC using established measures of readiness to change, pain acceptance, and committed action. Investigators will also evaluate the effects of PPRC-Prep on program length of stay and on reductions of disability and pain at PPRC discharge and short-term (8-week) follow up through comparison of families who undergo PPRC-prep with families who do not undergo PPRC-prep. Demonstrating the feasibility and preliminary effectiveness of PPRC-Prep will enable the study team to establish this as a routine component of our approach to care for children with complex, refractory chronic pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 8-18 at enrollment
* Presence of chronic pain condition for \> 3 months with moderate or severe disability
* Accepts referral to PPRC and awaiting admission

Exclusion Criteria:

* Non-English speaking
* No access to device with telehealth capability
Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases

The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases.

Dyspnea is a cardinal Respiratory symptom.

According to the ATS dyspnea is the term used to characterize a subjective experience of breathing discomfort, covering qualitatively distinct sensations of varying intensity.

The subjective nature of dyspnea and the high complexity of its determinants explain the often moderate correlations obtained with physiological data. Dyspnea must therefore be measured specifically.

The aim of this study is the cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities restriction), usable in clinical practice in order to assess dyspnea and its alterations in adult patients with chronic respiratory diseases.

(COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)

Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally satisfy all the following required features: evaluative, discriminant, good reproducibility, and high sensitivity to change.

The desired features apart from content validity are reproducibility and especially a high sensitivity to change, particularly following pulmonary rehabilitation.

Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and it's sustainment in maintenance phase.

Eligibility Criteria:
Inclusion Criteria:

* 1) Sample1: COPD GOLD / ATS \> 2 without major co-morbidity

  * Sample 1A: n = 50: group of patients with no change in usual care and no acute event (evaluation of reproducibility)
  * Sample1B: n = 60: patients assessed before and after a qualifying period of pulmonary rehabilitation
* 2) Sample 2 (n = 30): diffuse interstitial lung diseases Criteria: Pulmonary Fibrosis: Idiopathic or nonspecific interstitial lung diseases (NILD) according to international criteria (ATS), sarcoidosis with parenchymal lesions (old classification stage II and III), and exceptionally alveolar proteinosis.
* 3) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
* 4) Sample4 (n = 30): Adult with Cystic fibrosis.
* 5) patient with stable Status (no exacerbation for at least one month)

Exclusion Criteria:

* 1) Patient under 18 years
* 2) Inability to fill in questionnaires
* 3) Other respiratory disease
* 4) left symptomatic heart failure
* 5) Obesity with a BMI\> 35 kg/m2
* 6) Inability to perform PFT (Pulmonary Function Testing)
* 7) Pregnant or breastfeeding woman
* 8) Patient unable to consent
* 9) Lack of social insurance coverage
* 10) Patient in exclusion period because of another protocol
Family Focused Nursing for Elderly Medical Patients

The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of elderly medical patients with respect to prevalence of depression

Psychosocial issues such as lack of social support and symptoms of depression, are risk factors associated to readmission for elderly medical patients. Families with elderly members in general want to be involved in the caring and want to maintain a close relation to their elderly family member. However, disease in a single family can have a negative effect on all members and may result in dysfunction of the family. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to decline depression and readmissions, besides enhanced quality of life and family function among elderly medical patients and their next of kin.

Eligibility Criteria:
Inclusion Criteria:

* acute hospitalized
* an expected hospitalization of minimum two days
* speak and understand Danish
* signed informed consent

Exclusion Criteria:

* dementia (evaluated by the Mini Mental State Examination \[MMSE\] \< 24)
* terminally ill patients whose survival rate is assessed to be less than a month
Decremental Exercise: a New Training Approach?

Different types of high-intensity interval training (HIIT) sessions are used by athletes in order to improve their physical performance, but innovative approaches to training are lacking. Therefore, in Part A of this study the physiological response to a standard HIIT and a new decremental exercise training (DECT) will be compared in runners and cyclists. Next, in Part B the training effects of a 4-week block of the HIIT and DECT will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 years
* Healthy, i.e. normal physical and mental status (not taking any medication on a regular basis for more than a month, except contraceptive medication)
* Normal Body-Mass-Index (BMI): 18.5-24.9 kg·m-2
* Well-trained athletes: V̇O2max \> 55.1 ml·min-1·kg-1 for men and \> 50.1 ml·min-1·kg-1 for women
* Normal lung function
* Non-smoking
* Willing to adhere to the general study rules

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the same part (A or B) of the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Acute or chronic illness
* Intake of medications affecting performance or the respiratory, cardiovascular or neuromuscular system
* Insufficient training history (\<3 yrs of participation in competitive cycling/running) or training volume (\<40 km running/week or 150 km cycling/week) in the previous 6 months
* Recent (\<3 months) history of orthopaedic injury or participation in structured high-intensity training blocks