cyrilzakka/clinical-trials huggingface dataset:
Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only

The purpose of this study is to determine if dry needling both low back and extremity areas is more effective for reducing pain and improving strength, balance and functional performance among patients with chronic musculoskeletal conditions compared to dry needling of extremity areas only.

This study will determine if spinal and peripheral dry needling sites results in decreased pain, increased muscle strength, increased proprioception and increased functional performance among individuals with chronic musculoskeletal conditions of the lower extremities, such as plantar fasciitis, Achilles tendinopathy, and patellofemoral pain syndrome. Specific aims are to determine if individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to both spinal and peripheral sites exhibit differences in pain, muscle strength, proprioception, and unilateral hop test scores compared to individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to peripheral sites only.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral chronic lower extremity musculoskeletal condition
* Ability to perform a unilateral one-quarter squat on involved side without pain
* Asymptomatic during walking

Exclusion Criteria:

* History of systemic neurological or arthritic condition
* History of bony or peripheral nerve trauma or surgery lower extremities
* No contraindications to dry needling
* Not currently receiving treatment for the chronic lower extremity musculoskeletal condition
Body Composition, Growth, and Maturation of Triathletes

The goal of this observational study is to determine if physical activity and the adherence to a Mediterranean diet have a relationship with body composition, growth, and maturation status in youth triathletes. The main question it aims to answer is:

• Is body composition (fat and muscle) determined primarily by growth and biological maturation or by physical activity and the Mediterranean diet in youth triathletes? Participants already have been evaluated in body composition, mediterranean diet adherence and practical of physical activity during 3 years.

Triathlon is an individual, multidisciplinary and resistance sport with three stages: swimming, cycling and running, linked by two transitions. The importance of knowing body composition, eating patterns, level of physical activity and maturational state, will allow influence on training, increasing sports performance.

Regarding body composition and its relationship with performance, it has been observed that the greater the body fat, the lower the physical performance of triathletes. In each sport, athletes have different composition somatotypes. For triathlon, it is difficult to establish a specific somatotype, since it is a modality that encompasses three sports, among which the anthropometric characteristics of the athletes who practice them are not similar. In addition, since it is a relatively new category, there are not enough bibliographical references regarding anthropometry and body composition.

During biological maturation, there is an increase in the basal metabolic rate, so an optimal diet helps the growth process and improves the performance and recovery of athletes. Therefore, in the early stages of childhood and adolescence, adherence to the diet plays an important role in the acquisition of healthy lifestyles to determine an optimal state of health. The Mediterranean Diet model is associated with healthy eating habits, high levels of quality of life and physical benefits.

Eligibility Criteria:
Inclusion Criteria:

* Acceptation of informed consent by parents

Exclusion Criteria:

* No attendance to body composition evaluation
* Reporting less than 80% of assistance to physical activity sessions reported by trainer
User Evaluation of a Home-collection Kit for People With Diabetes

Type 1 and Type 2 are the most common types of diabetes mellitus. Although the cause of Type 1 is different to Type 2, they can both lead to high blood glucose levels as the patient is unable to store and use sugar. The disease is an epidemic of the 21st century which is increasing, having a current prevalence of approximately 8%.

Poor disease control is associated with a range of long-term health conditions which have a severe impact upon quality of life and are responsible for the increased morbidity and mortality associated with the disease.

Healthcare professionals use HbA1c as the main marker to monitor diabetic control. Patients with diabetes have regular review appointments to monitor their overall health and discuss their HbA1c target and results. The purpose of monitoring patients with diabetes is to improve patient outcomes. It is known that poor control is associated with poor clinical outcomes and also that reduced monitoring is linked to suboptimal diabetic control. Therefore, aiming for the correct monitoring frequency helps towards achieving the best control which can lead to the most favourable clinical outcomes. The inconvenience of attending for a blood test and follow-up appointment is a major factor affecting patient adherence to monitoring, locally approximately 50% of patients with diabetes have their HbA1c level measured either too soon or too late.

To address this issue and improve access to monitoring at the correct time interval we aim to produce a HbA1c home testing kit which can be posted back to the laboratory at the convenience of the patient. The kit will be developed based on feedback from patients with diabetes and will use a dried blood spot sample to produce HbA1c results comparable to the whole blood standard method.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type I or Type II diabetes
* Aged 18 years or over
* Venous blood sample for HbA1c collected within the two weeks prior to the clinic appointment
* Ability to provide fully informed consent

Exclusion Criteria:

* Non-English speaking where translation of the study documents and procedures could limit fully informed consent
* Severe visual impairment which would leave the participant unable to complete the study procedures.
Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate

Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium laser enucleation of the prostate


Eligibility Criteria:
Inclusion Criteria:

* Male patient scheduled to undergo prostatectomy using holmium laser

Exclusion Criteria:

* Urethral stricture, large bladder diverticulum, bladder neck contracture
Withings Pulse Wave Velocity and Blood Pressure Study

Measure pulse wave velocity stability in relation to time of day, day of the week, physical activity, sleep quality, stress levels and blood pressure.

The study population will be an estimated 300 healthy adult subjects from the United States. This population will be approximately 150 men and 150 women. In order to obtain a relatively diverse age range of users (with varying levels of arterial stiffness), we hope to enroll participants across three age ranges entered in the Withings application by the user: 18-40 years, 41-60 years, and \> 60 years. These spots will be filled by those that satisfy the inclusion/exclusion criteria on a first come, first served basis.

Eligibility Criteria:
Inclusion Criteria:

* User of a (1) Withings blood pressure cuff (2) Withings activity tracker and (3) Withings Body Cardio scale
* User has measured their blood pressure at least once per week for the majority of weeks over the last three months.

Exclusion Criteria:

* Aortic artery disease
* Peripheral vascular disease
* Atrial fibrillation
* Weight \> 396 lbs.
* Pregnant women
Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety

This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Intravenous (IV) cannula had been set and The Amsterdam Preoperative Anxiety and Information (APAIS) score questionnaire was filled by the subject. Blood pressure, pulse rate, and mean arterial pressure were recorded. Subjects were then randomized into two groups (music therapy and midazolam). In music therapy group, subjects listened to music using headphone attached to music player for 30 minutes. Music player has been filled with variety of slow beat songs (60 - 80 BPM), including instrumental, pop, jazz, classical, and so forth. In midazolam group, subjects was given intravenous midazolam 0,02 mg/kgBW injection without listening to music. After injection, subjects are allowed to rest or sleep for 30 minutes. After intervention, APAIS score was filled by subjects with blood pressure, pulse rate, and mean arterial pressure recorded again. Subjects then were moved to brachytherapy room.

Eligibility Criteria:
Inclusion Criteria:

* Woman aged 18-65 years old
* Undergoing one day care brachtherapy with spinal anesthesia
* American Society of Anesthesiologist (ASA) physical status of I-III
* Agreed to participate in this study and signed informed consent
* Able to read, write, and speak in Indonesian language.

Exclusion Criteria:

* Subjects with severe hearing impairment
* Subjects with cognitive/mental impairment based on medical record
* Subjects with previous routine use of antipsychotic and benzodiazepine drug
* Subjects with prior heart disease or uncontrolled hypertension.
Influence of Percutaneous Electrolysis on Endogenous Pain Modulation

Percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. Although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. The aim of this study is to investigate the influence of percutaneous electrolysis on the endogenous pain modulation. Four groups of intervention will be involved: no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and high intensity percutaneous electrolysis. The effects on the pain modulation system will be evaluated before and immediately after the intervention, through pressure pain thresholds, conditioned pain modulation and temporal summation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy asymptomatic subjects
* Aged 18 to 40 years
* Both genders

Exclusion Criteria:

* Belonephobia or fear of needles
* Neurological, cardiovascular or metabolic diseases
* Any pathology or process that causes pain
* Cutaneous alterations
* Pregnancy
* Cognitive and sensitivity disorders
* Fibromyalgia
* Frequent or recent (24 hours before) intake of alcohol and other drugs
* Have received pharmacological, physiotherapeutic or other treatment in the last week
* Intake of caffeine in the two hours prior to measurement
* Vigorous physical activity on the day of testing
Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery

This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient population due to the effects on hepatic glucose production (a major feature of SH), safety (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and tolerability. The secondary objective of this study is to determine whether the management of patients with persistent insulin requirements following cardiac surgery differs among patients with stress hyperglycemia or mild diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia
* AND:
* Cardiac Surgery
* Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose \>150 mg/dL at least twice in a 24 hour period (\>4 hours apart) and otherwise not requiring basal insulin

Exclusion Criteria:

* use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours
* glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours
* left ventricular assist device
* percutaneous or laparoscopic surgery
* end stage renal disease
* end stage liver disease
* history of pancreatitis
* type 1 diabetes
* pregnancy
* unable to give consent in english
* no phone
* prisoners
* less than 18 years of age
Respiratory Physiology Under High Flow Therapy

The aim of this study is to gain knowledge about effects of high flow transnasal insufflation on various breathing parameters like intratracheal pressure conditions, CO2 elimination, breathing frequency and tidal volume.

Ten patients, who are supplied with a tracheostomy stent (placeholder) for reinsertions after long term ventilation will be treated for a short time during the day with the nasal high flow system AIRVO at different flow rates (15, 30, 45L/min) to estimate possible long term implications of high flow treatment.

Respiration is measured by impedance plethysmography with a calibrated belt system (Respitrace, VIASYS). Pressure and end tidal CO2 concentration is measured inside of the placeholder.

The order of the high flow rates (15, 30, 45L/min) is randomized; each flow rate is measured for 15 minutes. A wash out time of ten minutes is planned after each phase. In this time the patient breathes his individual oxygen flow rate with attention to the oxygen saturation, which should not exceed 96%. Transcutaneous PCO2 and SpO2 is monitored with TOSCA during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients in a stable weaning phase after long term ventilation
* Patients supplied with tracheostomy stent (placeholder)
* Patients in stable respiratory situation

Exclusion Criteria:

* Incapable of giving consent
* Any other severe or acute physical illness which requires intensive medical care
Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study

The investigators hypothesize that high definition colonoscopy with close focus narrow band imaging features has a high diagnostic accuracy for colorectal polyp histology, and can replace formal pathologic assessment in cases of high diagnostic confidence.

A recent single arm prospective cohort study suggested that high definition colonoscopy with narrow band imaging is an acceptable strategy to diagnose polyp histology and determine future surveillance intervals. Endoscopic proficiency in macroscopic features to differentiate polyp histology can be attained in a relatively short time period. A new high definition colonoscope with close focus narrow band imaging features may further improve diagnostic accuracy for polyp differentiation, and can replace formal pathologic assessment in cases of high diagnostic confidence.

Primary Aim: Compare the diagnostic accuracy of high definition narrow band imaging colonoscopy with and without close focus features for the macroscopic differentiation of neoplastic and non-neoplastic colorectal lesions using histopathologic diagnosis as the reference standard.

Secondary Aims: Compare diagnostic characteristics of the colonoscopes, measure concordance of high confidence and accuracy, compare accuracy of predicted versus actual surveillance interval recommendations, perform a cost-effective analysis of endoscopic versus pathologic diagnoses, and measure complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients referred for routine colonoscopy

Exclusion Criteria:

* Known inflammatory bowel disease
* Personal or family history of polyposis or non-polyposis syndrome
* Presentation for emergency endoscopy
* Inability to remove polyp due to coagulopathy or thrombocytopenia
* Inability to provide informed consent
Evaluation of Biomarkers of Traumatic Brain Injury

The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT scan of the head.


Eligibility Criteria:
Inclusion Criteria:

* subject is at least 18 years of age at screening
* suspected traumatically induced head injury as a result of insult to the head from external force
* GCS 9-15 at time of informed consent
* workup includes head CT scan as part of clinical emergency care within 3 hours of presenting and within 12 hours of injury
* blood sample collected within 3 hours of presenting and within 12 hours of injury
* subject or legal representative is willing to undergo informed consent

Exclusion Criteria:

* participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study acceptable)
* time of injury cannot be determined
* primary diagnosis of ischemic or hemorrhagic stroke
* venipuncture not feasible
* a condition precluding entry into the CT scanner
* subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, and history of neurosurgery, stroke or TIA within the last 30 days
* administration of blood transfusion after head injury and prior to study blood draw
* subject is otherwise determined by the Investigator to be unsuitable for participation
Amyloidosis Incidence in High-Risk Cardiac Device Patients

This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. By analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. The study, running from December 2023 to December 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.

The study targets a key gap in cardiac amyloidosis diagnosis by systematically evaluating the histopathological incidence of the disease using chest wall fat pad biopsies-tissue that is typically discarded during the implantation of cardiac devices like pacemakers, ICDs, and CRT-D/Ps. Standard surgical procedures are adhered to, ensuring minimal additional risk to patients. The collected tissue samples are analyzed by the HCA pathology laboratory to detect amyloid deposits, thereby potentially identifying amyloidosis in a non-invasive manner. In addition to the primary endpoint of histopathological diagnosis, the study retrospectively aims to validate a predictive model that incorporates a wide range of data to streamline the identification of patients at high risk for cardiac amyloidosis. Strict measures are in place to protect patient confidentiality and data security. By potentially improving diagnostic efficiency, this research could contribute to earlier detection and treatment strategies, thus improving patient outcomes for those at high risk of this life-threatening condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 40 years of age or older
* Patients who are able and willing to provide informed consent
* Patients who are scheduled for CIED implantation within the study period and with clinical lab and imaging features suggestive of cardiac amyloidosis

Exclusion Criteria:

* Individuals below the age of 40.
* Persons who are unable to consent or who do not consent to participate.
* Patients who have already been diagnosed with cardiac amyloidosis prior to the study
Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries

To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children

Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.

Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.

Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.

Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Eligibility Criteria:
Inclusion Criteria:

1. 3-5 year old children attending the first to the third year of kindergarten;
2. free from any systemic conditions and generally healthy;
3. parents sign informed consent;
4. having at least 1 tooth with cavitated dentine carious lesion

Exclusion Criteria:

1. are uncooperative to accept oral examination or treatment;
2. have a significant systematic disease or long-term medications;
3. have abnormal dentition.
4. Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.
Long-term Follow-up Gene Therapy Study for RPGR- XLRP

This is a long-term follow-up study assessing safety of patients for up to 60 months following advanced therapy investigational medicinal product (ATIMP) AAV5-hRKp.RPGR vector in participants with XLRP caused by mutations in RPGR.


Eligibility Criteria:
Inclusion Criteria:

* Received AAV5-hRKp.RPGR in the MGT009 Study

Exclusion Criteria:

* Unwilling or unable to meet with the requirements of the study