cyrilzakka/clinical-trials huggingface dataset:
Neurological Influences on Drug Prevention Intervention

In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster parenting skills followed by brief family therapy to foster adaptive family communication and age-appropriate roles. The Teen Achievement Intervention is comprised of a clinician-delivered learning strategy curriculum to foster academic achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and prosocial peer networks. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of the Family Management and Teen Achievement components on post intervention drug use, problem behavior, psychological distress, and academic achievement of indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated pathways by which the interventions might reduce drug involvement and problem behavior by promoting changes in targeted skills and behavior change processes. The possibility of effect-modification also is considered, with a focus on neurocognitive, internalizing/externalizing, and demographic factors, in an effort to discern why interventions work for some youth but not others. This application revision has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. In response to a key limitation, this revision includes further specification of anticipated relationships between neurocognitive variables, skill acquisition levels, and prevention intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive effects are informed by empirical findings and the clinical experience of investigative team members specializing in neuropsychology. If successful, this project should improve prevention practices by identifying malleable behavior change processes fostered by effective interventions. Improving our understanding of how individual characteristics of indicated youth, such as neurocognitive deficits or externalizing problems, influence the development of skills during interventions and subsequent outcomes may also help to improve existing prevention interventions. The significance of the proposed study is underscored further by the substantial size of the targeted population of indicated youth, and the range of morbidities and mortality that often result when early warning signs of drug abuse are not addressed.


Eligibility Criteria:
Inclusion Criteria:

* 11 to 15 year old middle school students

Exclusion Criteria:

* Acute suicidal, homicidal, psychotic ideation
* Problem severity indicating outpatient or residential treatment
Impact of Strength and Power Training on Golf Performance and Swing Biomechanics

Assess the impact of 10 weeks of strength and power training on Golf performance and swing biomechanics as measured by Trackman radar device and 16-camera monitoring system.

Golf-specific exercise programs have been shown to improve strength, flexibility, and balance in golfers (1) and golf-specific plyometric training programs have been shown to significantly improve club head speed and ball carry distance in skilled adolescent golfers (2). Further, leg power, upper body strength, and arm strength have positively correlated with golf performance measures; most notably measures of distance and total score (3). The purpose of this study is to assess the effect of a 10-week strength and power training program on the biomechanics of the golf swing and golf performance.

Participants will have anthropometric data taken, including height, weight, and body composition.

Golf swing biomechanics will be assessed utilizing high-speed motion analysis cameras and software available in the Motion Analysis Laboratory in the McLean Health Sciences Building. The participant will don garments that fit snug to the skin and light-sensitive reflective markers will be placed on the subject. The motion of the swing will be captured utilizing the 14 camera Vicon Bonita 10 system with the Motion Monitor real-time Vicon plug-in. Club head speed will be assessed utilizing a Tracman 4 dual radar tracking system.

Power output for participants will be measured by performing a countermovement vertical jump and a static vertical jump on the 4 Bertec non-conductive forceplate system.

Strength assessments will be performed in the Nimocks Fitness Center by the Lead Investigator. Maximal strength will be assessed in the following lifts utilizing the parameters described by the National Strength and Conditioning Association (4): Back Squat; Flat Bench Press. Other maximal strength numbers for primary lifts involved in the program (Front Squat; Incline Bench; Power Cleans) will be prescribed as percentages of the tested lifts as follows: Maximal Front Squat = 80% of Maximal Back Squat; Maximal Incline Bench = 80% of Maximal Flat Bench; Maximal Power Clean = 70% of Maximal Back Squat.

Eligibility Criteria:
Inclusion Criteria: college aged golfers with no contraindications to exercise as measured by PAR-Q+

* No history of Heart condition or uncontrolled hypertension
* No history of chest pain at rest or with exertion
* No history of loss of balance or dizziness at rest or with exercise in previous 12 months
* No medications for chronic medical conditions
* No bone, joint, or soft tissue issue that could be made worse by becoming more physically active

Exclusion Criteria: As indicated by PAR-Q+

* History of arthritis, osteoporosis, or chronic back issues
* Current, or recent history of, cancer
* Diagnosed cardiovascular disease: CAD, heart failure, diagnosed abnormality of heart rhythm
* Uncontrolled high blood pressure (resting blood pressure of 160/90 or greater)
* Diagnosed Metabolic Condition: Type 1 diabetes, Type 2 diabetes, Pre-diabetic
The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis

The improvement in uroflow and postvoid residual urine in children after urethral meatotomy for meatal stenosis. The hypothesis is that there is an improvement in both parameters, thus justifying the procedure.

Urethral meatal stenosis is a known complication of circumcision occuring in up to 3% of newborns undergoing circumcision. It is customary to perform a meatotomy in order to prevent bladder outlet obstruction, although bladder outlet obstruction has never been proven and improvement has only been proved in a single, small, retrospective study. Our intention is to evaluate the improvement in objective parameters (uroflow and postvoid residual urine) after urethral meatotomy by measuring these parameter before the procedure, one month after the procedure and one year after the procedure. Symptoms assessment will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Toilet trained children
* Before puberty
* No other urologic disease that might affect the measurements
* Primary (first) repair

Exclusion Criteria:

* Children unable to urinate on command
* Children that have started their sexual puberty
* Children with other urologic disease that might affect the study measurements
* Recurrent stenosis after previous repair
A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)

The objective of the ASCEND Study is to assess the safety, performance, and efficacy of the Intersect ENT UP Drug-Coated Device when used in chronic rhinosinusitis (CRS) patients undergoing balloon dilation of frontal sinus ostia (FSO)

This is a prospective, multicenter study enrolling two consecutive cohorts:

PK cohort (N=5): A non-randomized cohort to assess the systemic safety and performance of the UP Drug-Coated Device for in-office bilateral dilation of the FSO (2 inflations in each FSO for a total of 4 inflations per device). Subsequently, the UP Drug-Coated Device may be used to dilate any sphenoid or maxillary sinuses.

Randomized cohort (N=70): A randomized, intra-patient controlled, double-blind cohort of 70 subjects to assess the safety and efficacy of the UP Drug-Coated Device used for in-office dilation of the FSO. The FSO randomized to the treatment (Treatment) will undergo dilation using the UP Drug-Coated Device (2 inflations per device) while the contralateral FSO (Control) will be dilated with a UP Control Device (2 inflations per device).

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of CRS per the 2016, "International Consensus Statement on Allergy and Rhinology" definition.
2. Bilateral disease in the frontal sinuses (Lund-Mackay score ≥ 1 on each side) on CT scan within 30 days prior to enrollment in the PK cohort and prior to randomization in the randomized cohort.
3. Patient has bilateral obstruction of the frontal recess/FSO due to scarring and/or polypoid edema confirmed on endoscopy (patency grade of 0 or 1 for each FSO).
4. Balloon dilation of the FSO judged to be feasible and medically appropriate.
5. Patient has had prior ESS (\> 30 days with a healed mucosa) including bilateral ethmoidectomy (anterior or total) and uncinectomy for better visualization of the FSO.
6. Balloon dilation of the FSO with a 6 mm balloon is judged to be feasible (use light-assisted or image-guided instrument such as a frontal sinus seeker tip to confirm access of each FSO) and medically appropriate.

Exclusion Criteria:

1. Expanded amount of ethmoid polyposis (grade \> 2 PK cohort, grade ≥ 2 randomized cohort).
2. Complications from prior ESS or balloon dilation procedure (e.g., cerebrospinal fluid leak or injury to the skull base).
3. History of aspirin exacerbated respiratory disease (AERD).
4. Current smokers.
5. History of allergy or intolerance to mometasone furoate.
6. Oral-steroid dependent condition.
7. Evidence of acute rhinosinusitis, invasive fungal sinusitis or another disease or condition expected to compromise survival or ability to complete assessments during the 30-day follow-up period in the PK cohort and druing the 60-day follow-up period in the randomized cohort.
8. Use of parenteral and injected steroids (e.g., Kenalog) 30 days prior to the baseline procedure.
9. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to screening in the PK cohort and prior to baseline in the randomized cohort.
10. Glaucoma or posterior subcapsular cataract.
Smart Monitoring Assessing Spasticity-related Health

This observational study seeks to investigate the underlying of spasticity in patients with multiple sclerosis (MS) by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, the investigators aim to evaluate whether digital measurements are suitable for monitoring spasticity-related everyday limitations and to compare them with established clinical scores, blood analyses and questionnaires including sores on quality of life, sleep quality or activities of daily living.

The symptomatic treatment of spasticity in patients with multiple sclerosis (MS) is a major challenge for both patients and healthcare providers. However, monitoring and measuring the success or failure of treatments in clinical practice remains difficult. This is mainly due to the lack of clinical scores and biomarkers that can be easily and longitudinally collected. Existing scores (such as questionnaires and the Modified Ashworth scale) are rarely used in practice. In addition, the monitoring of side effects (such as dizziness, nausea and fatigue) is difficult in routine clinical practice and often leads to premature discontinuation or switching of treatment. As a result, therapeutic options are often exhausted prematurely. Continuous monitoring with sensitive assessments could enable a better understanding of spasticity treatment.

Approximately 50 patients with moderate and severe spasticity due to MS are to be included in the study. After inclusion, follow-up examinations are carried out every 12 weeks; a total of 3 visits are planned, including the baseline examination.

The study aims to improve the understanding of spasticity symptoms and assess them in patients through multimodal clinical and longitudinal digital measurements.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all the following criteria to be eligible to participate in the study:

* ≥ 18 years of age
* Diagnosis of multiple sclerosis according to the McDonald criteria of 2017
* Presence of spasticity that requires medical treatment from a medical point of view
* own and use a smartphone with Android 8.1 (or higher version) or iOS 12.3 (or higher version)
* Able to operate a smartphone

Exclusion Criteria:

* Missing informed consent
* Lack of declaration of consent
* Unwillingness or inability to use the smartphone app
* Any comorbidity that leads to impaired understanding or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be made at the discretion of the investigators.
Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries

The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.

Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.

In several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.

Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age from 4 to 15 years.
* American Society of Anesthesiology (ASA) physical status I, II.
* Pediatric patients undergoing squint surgeries.

Exclusion Criteria:

* Patients who had received any medication with antiemetic properties within 24 h before surgery.
* Post-operative period (for reasons other than rescue antiemetic therapy).
* Patients with known liver or renal disease.
* Patients with a history of vomiting or retching within 24 h before surgery.
Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.

The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing general anesthesia requiring tracheal intubation
* Weight 5-20 kg
* Age one month-six years

Exclusion Criteria:

* ASA class IV, V Emergency procedures
* History of a difficult airway
* Active upper respiratory tract infection
* Children receiving emergent surgery
ParisK: Validation of Imaging Techniques

The possibility of the identification of the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. Firstly, in symptomatic patients with a 30-69% stenosis, who are currently not operated upon according to the current guidelines, identification of the risk of rupture plaque could identify patients who have a high risk of recurrent stroke, and would benefit of carotid intervention, such as endarterectomy or stent placement. This could potentially prevent a substantial number of strokes. Secondly, in all symptomatic patients with a 70-99% stenosis carotid intervention should be considered, according to the guidelines. However, only one out of six patients with a 70-99% stenosis benefits from a carotid intervention. Identification of patients with a high risk of a recurrent stroke would reduce the number of unnecessary interventions substantially.

The main objective is to show whether imaging characteristics assessed at baseline can predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.


Eligibility Criteria:
Inclusion Criteria:

* neurological symptoms due to ischemia in the carotid artery territory as diagnosed by their neurologist based on anamneses, physical examination and brain imaging (CT or MRI)
* carotid artery stenosis \< 70% (upper cut-off value is based on the NASCET criteria, the lower cut-off value is an atherosclerotic plaque with a thickness of at least 2-3 mm, which corresponds to an ECST stenosis of 30%
* written informed consent

Exclusion Criteria:

* patients with probable cardiac source of embolism (rhythm disorders, mitral valve stenosis, prolapse or calcification, mechanical cardiac valves, recent myocardial infarction, left ventricular thrombus, atrial myxoma, endocarditis, dilated cardiomyopathy, patent foramen ovale) or a clotting disorder
* patients with evident other cause of neurological symptoms than carotid stenosis due to atherosclerotic disease (like demyelinating diseases, epilepsy, congenital brain disorders, aneurysms, fibromuscular dysplasia etc)
* patients already scheduled for carotid endarterectomy or stenting.
* severe co-morbidity, dementia or pregnancy
* standard contra-indications for MRI
* patients who have a documented allergy to MRI or CT contrast media
* patients with renal clearance \< 30 ml/minute are not eligible to undergo contrast-enhanced MRI
* patients with renal clearance \< 60 ml/minute are not eligible to undergo MDCT
* patients who had a TIA or minor stroke more than 3 months before inclusion
Metabolic Changes as a Diagnostic Indicator for Cancer

This study aims to determine whether metabolic changes occur in blood plasma of cancer patients, and whether these changes can be used as a biomarker to detect cancer. These analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast or lung cancer (new lesion)

Exclusion Criteria:

* Not fasted for at least 6 hours
* Plasma glucose concentration ≥ 200 mg/dl
* Intake of medication at the day of investigation
* History/treatment of cancer in the previous 5 years
Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors.

To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group.

To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.

Since joint replacement procedures have been successful in recent decades, every year the number of implanted prostheses is increasing, however, at the same time, orthopaedic surgeons also find complications inherent to this surgery, where peri-prosthetic infection results to be the most devastating. In order to find a solution to this terrible complication, prophylactic and therapeutic measures have been implemented, emerging techniques where the application of local antibiotics in the surgical site has turned out to be a promising concept. It has been shown that the non-modifiable risk factors of patients undergoing joint replacement surgery increase the risk of infection rate. Therefore, the identification of risk factors, decolonization and the prophylactic administration of antibiotics allow an effective reduction of periprosthetic infection. In order to reduce and, as far as posible, avoid periprosthetic infections in participants undergo knee or hip joint replacement with non-modifiable risk factors, the prophylactic use of calcium sulphate loaded with antibiotic for local application is proposed.

Eligibility Criteria:
Inclusion Criteria:

* patients with fracture or osteoarthrosis of the hip or knee that require treatment by joint replacement.
* patients who have any of the Non-Modifiable Risk Factors prior to surgery or during transoperative period.
* Patients entitled to the ISSEMyM (Instituto de Seguridad Social del Estado de Mexico y Municipios)

Exclusion Criteria:

* Patients that lose their validity of institutional rights and do not follow up
* Patients who die during the study due to other causes not related to the orthopedic procedure.
* Patients who do not have any of the risk factors for periprosthetic infection
* Patients allergic to vancomycin or ceftriaxone.
Adaptation to Living With a BRCA1/2 Mutation

Background:

- Women who have a BRCA1/2 gene mutation have a very high risk of developing breast or ovarian cancer. They are also at increased risk of other developing other cancers. Male carriers are at increased risk for breast, prostate and other cancers. Testing for this mutation and living with this increased risk can be a source of stress for both people with the mutation and their partners. Researchers want to look at how well people adapt to living with this type of cancer risk over time.

Objectives:

- To see how women with the BRCA1/2 gene mutation and their partners adapt to the stress of long-term cancer risk.

Eligibility:

- Women at least 18 years of age who have a BRCA1/2 mutation, and their male or female partners.

Design:

* This study involves a one-time self-administered questionnaire. Participants will be recruited from local and national hereditary cancer support groups and cancer centers.
* There are two versions of the survey. One is for the woman with the BRCA1/2 gene mutation. The other is for her partner.
* The survey will ask about risk perception, cancer worry, risk-related stress, and coping and adaptation methods.
* Treatment will not be provided as part of this study.

The proposed study aims to describe adaptation and dyadic adjustment in unaffected BRCA1/2 carriers and their partners. It is not fully understood how women and their partners adapt to highrisk status over time, nor how different aspects of living at risk relate to this process. Neither psychological adaptation nor dyadic adjustment has been systematically measured in this population. This study is informed by Lazarus \& Folkman s Transactional Model of Stress and Coping and modifications made to this model for use in studying dyadic relationships. A crosssectional research design will quantitatively explore the relationships between the appraisals and timing of risk-related stressors, dyadic coping, and the outcomes of adaptation and dyadic adjustment. Participants will be recruited from hereditary breast and ovarian cancer (HBOC) support groups, website postings, listservs, and clinic patient lists. They will have the option of completing either a paper or online version of the survey.

Eligibility Criteria:
* INCLUSION AND EXCLUSION CRITERIA:

Participants will be women aged 18 or older who have a BRCA1/2 mutation and their (male or female) partners. Carriers must have no personal history of cancer, but partners will not be excluded based on cancer history. Participants will be asked to disclose their mutation status (BRCA1 or BRCA2), but no screening evaluation will be required. If only one member of a couple completes the survey, their data will be included in the individual level analysis, but excluded from the dyadic level analysis.