cyrilzakka/clinical-trials huggingface dataset:
Effect of a 4-week Fun Fast Interval Training (FFIT) Activity Programme on Physical Fitness and Quality of Life in Adolescent School Pupils

Low-volume high-intensity interval exercise training may improve aspects of health and fitness in young people, but the effect of this type of exercise on quality of life has yet to be assessed. The investigators aim to examine the effect of a 4-week school-based low-volume high-intensity interval training programme (called the Fun Fast Interval Training \[FFIT\] activity project) on physical fitness and quality of life in adolescent school pupils. Approximately 145 English adolescents aged 11-12 years will be approached and invited to take part in the study. Participants will be healthy female volunteers, recruited from one school in Northeast England. Using a non-randomised design, one school year group will be assigned to take part in the intervention, and a second year group assigned to the control condition.Those in the intervention group will complete a 4-week school-based high-intensity interval exercise training programme. The intervention will take place twice per week, and comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and basketball drills), each interspersed with 90-s rest. Participants will be encouraged to work maximally during the 45-s repetitions. Control participants will be instructed not to change their lifestyle, dietary or physical activity habits during the intervention period, and maintain their normal school physical education routine. Study outcomes will be 20 m shuttle run test performance, health-related quality of life, standing broad jump performance, hand dynamometer performance, waist circumference and 10 m and 20 m sprint performance.


Eligibility Criteria:
Inclusion Criteria:

1. Must be in school Year 7 or 8 at the school where the study will take place
2. Must provide parental consent and participant assent
3. Must be free from exclusion criteria

Exclusion Criteria:

1. Symptoms of or known presence of heart disease or major atherosclerotic cardiovascular disease.
2. Condition or injury or co-morbidity affecting the ability to undertake exercise.
3. Diabetes mellitus
4. Early family history of sudden death
5. Pregnancy or likelihood of pregnancy
Prevention of Delirium Among Elderly Patients With Hip Fractures

Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures.

Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years
* with hip fractures
* treated surgically

Exclusion Criteria:

* \<65 years
* psychiatric history
* ICU post-operation
* refuse to join this study
* have delirium pre-operation
Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion

The objective of this trial is to examine if regional anesthetic blockade of the anterior abdominal wall via the transversus abdominis plane is a safe and feasible method of providing analgesia for children undergoing gastric tube insertion.

Regional abdominal field blockade has been demonstrated to deliver effective analgesia for procedures involving the anterior abdominal wall and may represent a feasible, minimally invasive alternative to central neuraxial blockade for some procedures and surgery of the abdomen.

Regional anesthesia and analgesia techniques are commonly advocated for post-operative pain control in pediatric surgical practice. Regional techniques decrease morphine requirements and improve the quality of post-operative pain control and patient-parent satisfaction. The most commonly used technique is caudal anesthesia, which is generally indicated for urologic surgery, inguinal hernia repair and lower extremity surgery. Complications are rare and usually minor, however, the caudal technique is limited in its ability to provide reliable analgesia to the abdominal wall and for surgical procedures involving the mid and upper abdomen. A reasonable alternative for these surgical procedures is to perform a formal lumbar epidural. This provides excellent post-operative analgesia and complications are rare. However, when complications do occur they are not minor. Because of the risks and potential complications of epidural catheter insertion, current clinical experience reveals an unwillingness for parents to consent to this technique.

On average, two hundred gastric tube insertions are performed in Image Guided Therapy (IGT) per annum (year) in this institution. Current standard practice for post-procedure pain control is local infiltration of the insertion site with local anesthetic during the procedure and intravenous morphine supplemented by rectal acetaminophen post-operatively. A retrospective review of this patient group demonstrates that approximately 80% of patients require one to three doses of morphine in the first 12 - 16 hours after the procedure. Even a single dose of intravenous morphine can increase the incidence of vomiting in children undergoing day surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - III
* One to ten years of age
* Scheduled to undergo gastric tube insertion in IGT
* Signed informed consent

Exclusion Criteria:

* Patients requiring emergency procedures
* Refusal of regional block
* History of seizure disorder
* Allergy or sensitivity to bupivacaine, morphine, or radiological contrast
* Hepatic disease
* Bleeding disorder
* Use of pre-operative sedation
* Skin lesions or wounds at site of proposed needle insertion
* Evidence of peritonitis or septicemia
* Patients with ventriculo-peritoneal shunts in situ
* Patients taking any of the following drugs: procainamide, disopyramide, flecainide, mexiletine, cimetidine and ranitidine
Transcranial Direct Current Stimulation in Autistic Spectrum Disorder

To understand the changes in the resting electroencephalogram (EEG) brain networks of children and adolescents with autistic spectrum disorder (ASD) induced by transcranial direct current stimulation (tDCS), we asked two questions. First: how can tDCS modulate the expression of neural network dynamics? Second: how can tDCS modulate functional connections at specific frequencies? We hypothesized that the tDCS mechanism results in increased cortical frequencies in the areas under the anode, which may reflect an increase in synaptic connectivity, and that this tDCS-related increase changes connection profiles at specific frequencies important for ASD, indicating improvement in symptoms. To verify this improvement, the researchers used the Autism Treatment Evaluation Checklist (ATEC) after an intervention, comparing baseline scores with post-treatment scores.


Eligibility Criteria:
Inclusion Criteria:

Patients with ASD reported by a Neuropediatrician; Age group between 5 and 18 years; Mild and moderate clinical symptoms

Exclusion Criteria:

Patients with severe mental illness; Use of a pacemaker or other metal device on the body; Brain tumor or intracranial infection; Uncooperative parents or caregivers; Epilepsy; structural change in the skull
A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer

This study aims to provide preliminary data on the feasibility and outcomes of a 12 week exercise program on the quality of life of men with hormone refractory prostate cancer receiving docetaxel-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of prostate cancer
* receiving docetaxel-based chemotherapy at the CCI
* age 18 years or over
* approval of oncologist
* informed written consent

Exclusion Criteria:

* life expectancy less than 6 months
* Karnofsky performance score less than 70
* contraindications for exercise (e.g. uncontrolled cardiac, respiratory, hypertensive or psychiatric disorder)
* unable to understand, read, write and speak English
* unable or unwilling to attend supervised exercise sessions 3 times weekly
* unable or unwilling to complete outcome assessments
Effectiveness of Office Bleaching Agents in Patients of Different Age Group

To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute risk and intensity of dentin sensitivity due to dental bleaching in the office with 35% hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent, South Jordan, UT, USA) in the same arch in patients of different age groups: 18 to 25 years and 40 to 65 years. Data will be collected, tabulated and submitted to statistical analysis

Throughout life, the aging of the human being as a whole is inevitable. The dental structure such as cementum and dentin undergo some changes over time, such as secondary deposition of dentin, which results in the reduction of root canal length. In addition, with aging the teeth undergo color changes, presenting a more yellowish or grayish coloration (Ravindra SV et al., 2015). The fact is that most of the studies that involve the technique of dental bleaching have as inclusion factor only young adult patients, excluding patients of more advanced age groups. Therefore, it is fundamental to evaluate the whitening technique in these older patients, since it is a treatment that does not cause harm to the individuals To assess the effect of dental bleaching in the office with Whiteness HP Automixx, FGM at 35% and Opalescence Boost at 38% in the same arch, in different age groups (18 to 25 years and 40 to 65 years) in absolute risk and intensity Of the postoperative dental sensitivity through the visual analog (VAS 0-10) and analogue (NRS 0-4) scales.

* Evaluate the efficacy of Whitening HP Automixx, FGM 35% and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years) using Color Vita Classical and Vita Bleachedguide, and the Vita Easyshade spectrophotometer.
* Evaluate the satisfaction of patients after Whitening HP Automixx at 35, FGM and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age up to 25 years
* Patients aged 40 years up to 65 years
* Good oral and general health
* Teeth free of restorations or with small restorations
* Free from carious injury,
* Patients with tooth color A2 or darker according to the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany)
* Agree to the informed consent form

Exclusion Criteria:

* extensive restoration
* Patients who have already undergone dental whitening
* Pregnant or lactating women
* That report dental sensitivity
* With non-carious cervical lesion
* Parafunctional habits
* Orthodontic appliances
* Any other type of oral pathology
* Smokers, patients who are using analgesic or anti-inflammatory drugs, present systemic alterations such as gastric, cardiac, renal and hepatic problems, diabetics, hypertensives or pre-existing neoplasias.
Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

The purpose of the study is to compare quality of life, adherence, insulin resistance, body composition and efficacy of long-acting growth hormone (LAGH) to daily growth hormone (DGH) in children with growth hormone deficiency (GHD). These objectives will be evaluated every 6 months for subjects prior to switch from DGH to LAGH, and 6 months after.

Daily subcutaneous injections of recombinant human growth hormone (GH) is the standard of care therapy for children with GH deficiency (GHD). A potential impediment to long-term efficacy of daily GH (DGH) is a lack of adherence and persistence. Multiple Long-Acting Growth Hormone (LAGH) molecules are being developed with the expectation that reduced frequency of injections will improve the patient and caregiver experience leading to improved adherence and, ultimately, improve efficacy. However, the connection between reduced injection frequency, improved adherence and improved efficacy have not yet been demonstrated. GH has metabolic effects that impact insulin resistance, body composition and lipid levels. There is concern that persistently elevated levels of GH provided by LAGH may have a negative effect on metabolism. There is also concern that the larger size of the LAGH molecules in development may limit their access to the target tissues leading to an imbalance of the linear growth and metabolic effects. The purpose of the study is to compare quality of life, adherence, insulin resistance, body composition and efficacy of long-acting growth hormone (LAGH) to daily growth hormone (DGH) in children with growth hormone deficiency (GHD). These objectives will be evaluated every 6 months for subjects prior to switch from DGH to LAGH, and 6 months after.

Eligibility Criteria:
Inclusion Criteria:

* Girls must be between the ages of 2 and 11 years, and boys must be between the ages of 2 and 13 years
* Have established diagnosis of pediatric growth hormone deficiency (GHD). For the purposes of the study, GHD is defined as peak growth hormone response to clonidine/arginine stimulation testing of \<10 ng/mL
* Either treatment-naive or currently treated with a daily growth hormone as approved by health insurance

Exclusion Criteria:

* Any medical condition which, in the opinion of the Investigator, can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment
* Current treatment with long-acting growth hormone
* Currently pregnant or breastfeeding
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients

We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.

Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.

Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study

This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study.

It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin.

Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-80
* Diagnosed with type 2 diabetes mellitus (DM)
* Uncontrolled type 2 DM: HbA1c 7.0-10.0%
* Signed informed consent

Exclusion Criteria:

* Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
* Use of prandial insulin
* Change in diabetes medication in the preceding 3 months
* Pregnant/lactating women
* Addiction to drugs and alcohol
* Use of medications that result in drug-induced hyperglycemia (i.e. steroid)
* Severe liver disease
* End-stage renal disease (i.e. on dialysis)
* Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.)
* Conditions that impact the stability of HbA1c measurement
Risk Factors for Aortic Dissection in the Chinese Patients

To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese patients.

Aortic dissection (AD) is a life-threatening cardiovascular disease with high mortality. Without optimal treatment, approximately 50% of patients die within one week of the onset of symptoms, and 80% die within 2 weeks. With the change of life-style and the development of diagnostic technology, the incidence and detection rate of AD were increasing in China recently. However, the cause remains unclear. Studies showed that AD were associated with some risk factors, such as hypertension, connective tissue disease, iatrogenic injury, drug, pregnancy, etc. It is reported that two thirds patients with AD had a history of hypertension; 50% patients aged \<40 years were accompanied with hereditary Marfan syndrome; 13～19% had a familial history of aortic aneurysm or dissection. These epidemiological data were obtained from Caucasian population, however, such information was not available for the Chinese population. Moreover, epidemiological investigation was absent in China, and the assessment of risk factors for AD was mainly referred to the studies from developed countries. Therefore, the aim of our study was to evaluate epidemiological features of risk factors for AD in Chinese patients using 3045 individuals from the 15 major centers in China. We anticipated that this analysis would provide helpful information preventing and controlling AD in China.

Eligibility Criteria:
Inclusion Criteria:

* Aortic dissection
* Acute stage

Exclusion Criteria:

-Simple aortic aneurysm and pseudoaneurysm were excluded.
Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy volunteers to compare the effect on MAL penetration into the skin following various mechanical penetration enhancement techniques.

At baseline, each mini-zone was selected and randomly assigned to a pretreatment: 3 zones with microneedling Dermaroller®, 3 zones with ablative fractional CO2 Laser, and 3 zones with no pretreatment. After performing pretreatment, MAL cream was applied on the 6 assigned mini-zones for 3 hours incubation. Each condition was tested with and without occlusion. The three mini-zones with no product applied were used to perform biophysics measures.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of non childbearing potential, who is at least 18 years of age or older at screening visit.
* The subject has a skin phototype of I to III on Fitzpatrick's scale (Fitzpatrick et al., 1993) at screening visit.
* Subject should have 9 mini zone areas on the back that will be able to receive pre-treatments according to protocol. (checked at Screening visit, and assigned at Baseline visit)
* Female of non childbearing potential (postmenopausal \[absence of menstrual bleeding for 1 year prior to screening visit, without any other medical reason\], hysterectomy or bilateral oophorectomy).

Exclusion Criteria:

* Subject with porphyria,
* Subject with past history of skin cancer, or current clinical diagnosis of other skin disease (including non-melanoma skin cancer), or tattoos, or cheloid and hypertrophic scars on the test zones, which, in the opinion of the investigator, might interfere with the interpretation of the clinical results,
* Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
* Known or suspected allergies or sensitivities to any components of any of the study drugs (see Product label).
* The subject has received, applied or taken some specific treatments within specified time frame prior to the baseline visit
Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)

This is an observational study of pain and outcomes from patients undergoing transgastric NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:

* Subjects will complete a 7 day pain/temperature log after surgery
* Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction

Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.


Eligibility Criteria:
Inclusion criteria for the Group #1 transgastric appendectomy:

1. Males and Females between the ages of 18-75
2. Clinical diagnosis of appendicitis Emergency room evaluation within 36 hours of the onset of pain
3. ASA classification I
4. Mentally competent to give informed consent.
5. Scheduled to undergo a transgastric NOTES appendectomy.

Exclusion criteria for group #1 transgastric appendectomy:

1. Pregnant women
2. Morbidly obese patients (Body mass index \> 35)
3. Patients who are taking immunosuppressive medications or are immunocompromised
4. Patients who are on Proton Pump Inhibitors (PPI)
5. Patients with evidence of an abdominal abscess or mass on CT scan
6. Patients who present with a clinical diagnosis of sepsis
7. Patients who have a history of open abdominal surgery
8. Patients with diffuse peritonitis
9. Patients on blood thinners or aspirin

Inclusion criteria for Group #2 transgastric cholecystectomy:

1. Males and Females between the ages of 18 -75
2. Diagnosis of gallstone disease that require cholecystectomy
3. ASA classification I
4. Mentally competent to give informed consent.
5. Scheduled to undergo a transgastric NOTES cholecystectomy.

Exclusion criteria for Group #2 transgastric cholecystectomy:

1. Pregnant women
2. Patients with a Body mass index \> 35
3. Patients who are taking immunosuppressive medications or are immunocompromised
4. Patients who are on Proton Pump Inhibitors (PPI)
5. Patients with suspicion of gallbladder cancer
6. Patients with a history of open abdominal surgery
7. Patients with known common bile duct stones (gallstones are not limited to the gallbladder)
8. Patients on blood thinners or aspirin
Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis

In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.

Patients are treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen

Exclusion Criteria:

* contraindications according to instructions for use