cyrilzakka/clinical-trials huggingface dataset:
Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions

The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been FDA approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. We hypothesize that the administration of liposomal bupivacaine (Exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.

In this study, we will prospectively collect data from all patients receiving bilateral third molar extractions with Exparel versus 0.5% bupivacaine 1:200,000 epinephrine (standard bupivacaine) injections to determine the efficacy of Exparel in reducing postoperative pain. Outcomes measured will be pain intensity based on a numeric scale, date and time when pain completely subsides for each side, adverse events, use of NSAID or acetaminophen outside of prescribed pain regimen, and use of narcotics. The purpose of this research project is to evaluate the use and efficacy of Exparel in postoperative pain management in third molar extractions.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving bilateral mandibular third molar extractions at the Herman Ostrow School of Dentistry by an oral \& maxillofacial surgery resident.

Exclusion Criteria:

* Patient unable to complete form for four days postoperatively.
* Patient with severe hepatic disease
* Patient with a history of allergy or contraindication to amide-type LA or opioids
* Patient with recent history of antibiotic use within the past thirty days
* Patients with use of long-acting opioids, NSAIDs, aspirin, acetaminophen within 3 days prior to screening.
* Patients who are pregnant.
* Patients receiving additional mandibular teeth extractions.
Comparing the Effect of TAP-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery

This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. The hypothesis is that the effect of the two modes of pain treatment are equal.

Patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:TAP) catheters. After randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the TAP-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the TAP-catheters and bupivacain-infusion in the epidural catheters.

The investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12.

The investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for open gynecologic surgery
* acceptance to participate

Exclusion Criteria:

* allergies to local analgetics
* daily use of strong opioids
Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults

The purpose of the study is to determine the effects of 8 weeks Vitality Product supplementation on physical and mental function in middle-aged adults


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 40-70 years
* Signed Informed Consent
* BMI between 19 and 30 kg/m2
* Normotensive, defined as systolic blood pressure 90-140 mmHg and diastolic blood pressure 50-90 mmHg

Exclusion Criteria:

* Regular dietary supplement use and unwilling to discontinue use at least 1 month prior to enrollment in the study
* Self-reported chronic condition that may affect subject safety (e.g. diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g. chronic fatigue)
* Pregnancy/suspected pregnancy, breastfeeding
* Antihypertensive medication use
* Allergies to any supplement ingredients
* Consumption of more than 600mg caffeine from any source per day
* Consumption of "energy drinks" (e.g. Red Bull, Monster) or any herbal supplement known to affect energy levels
* Known iron anemia
* Medically treated for insomnia
* Medically treated for depression
* Taking medications known to affect energy, e.g. thyroid medication
* Tobacco user
* Planned surgical procedure in next 2 months
* Participating in another clinical (medical or nutritional) study or likely to enroll in another medical or nutritional study
NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)

The aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (NBS) can be done at scale, and that the glucose test has a carefully established cut-off to define what level glucose is abnormal at day 5 of life.

The investigators aim to run this feasibility study for a period of 6 to 12 months to fully embed and test the process. This will equate to assessing glucose levels in approximately 10,000 NBS samples. The results from this study will inform a future large scale prospective screening study.


Eligibility Criteria:
Inclusion Criteria:

* Babies having a routine NBS screening test.
* Routine maternity care team within the area served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset \& parts of Wiltshire)

Exclusion Criteria:

* Parent decides to opt-out of the blood glucose test feasibility study.
Solution Focused Coaching Strategy Within a Paediatric Multidisciplinary Neuromuscular Clinic

The purpose of this study is to implement Solution Focused Coaching in pediatric rehabilitation (SFC-peds) within the multidisciplinary neuromuscular clinic at Holland Bloorview Kids Rehabilitation Hospital and evaluate its effect on children's ability to set and attain personally meaningful goals. A secondary goal is to determine the impact of SFC-peds on self-determination in children with neuromuscular conditions. This study aims to compare two methods of SCF-peds delivery, a single coaching session vs. intensive coaching (5 sessions) on goal attainment. This study will also help researchers and clinicians understand the types of goals that are set by children with neuromuscular conditions. Lastly, this study is going to explore with the participants their perception of the feasibility of using this methodology within a clinical context.

Nationally, standards of care have been published for paediatric neuromuscular (NM) conditions to optimize care, improve quality of life and increase life span. Children with NM conditions are followed in regional multidisciplinary clinics in Ontario and across Canada. At each visit they can be seen by 8 health care providers each focusing on and making recommendations for the different aspects of their care. Currently, there are no evidenced based interventions for children with NM conditions evaluating the ability of children to set and attain their care goals and/or other personally meaningful goals.

Self-determination is defined as the ability to "use skills, knowledge and beliefs that enable a person to engage in goal directed, self-regulated, autonomous behavior." The development of self-determination is a process that begins in childhood. Solution Focused Coaching (SFC) is a strengths- based, client-centered approach to service delivery that supports clients to build on their existing capacity to move closer to meaningful goals. This study will evaluate the impact of SFC on goal setting, achievement and self determination in children with NM conditions.

Eligibility Criteria:
Inclusion Criteria:

* child has a primary NM diagnosis
* child ages 10-18 years
* child able to converse orally in English
* child has a willingness to engage in the coaching intervention
* child is aware that they have a neuromuscular condition
* child is followed clinically in the Neuromuscular Clinic at Holland Bloorview Kids Rehabilitation Hospital at 4-6 month intervals
* child has internet access at home and a device to connect to the internet with a camera
* child is able to demonstrate capacity to consent
* parent is able to read and write in English

Exclusion Criteria:

-child has a moderate to severe intellectual disability
Phase III/Seroquel SR Bipolar Depression Monotherapy - US

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
* Outpatient status at enrollment

Exclusion Criteria:

* Patients with \>8 mood episodes during the past 12 years
* Use of prohibited medications
* Substance or alcohol abuse or dependence
* Current suicide risk or suicide attempt within last 6 months.
Leading Healthy Eating and Activity Promotion Program

The goal of the LEAP project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. This will be done by engaging the community in adapting beneficial approaches for promoting healthy diet and regular physical activity into a program for cancer survivors and co-survivors that is appropriate for the persistent poverty context and social determinants of health.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 89
* English speaking
* Resident of Birmingham area or surrounding community
* History of any type of cancer or the friend or family with of a cancer survivor

Exclusion Criteria:

* Serious difficulty hearing
* History of dementia or organic brain syndrome
* On primary treatment for cancer
* No other other medical, psychological, or social characteristic that would interfere with participation in evaluation
Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer

The present study evaluates the clinical outcomes following definitive ultra-high dose per fraction external beam radiation therapy delivered in patients with organ-confined adenocarcinoma of the prostate.

Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.

Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. Acute and late toxicity evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and will be assessed through validated Expanded Prostate Cancer Index Composite (EPIC), International prostate symptom score (IPSS) and International index of erectile function (IIEF) questionnaires. Serum Prostate Specific Antigen (PSA) values will be drawn on the same schedule as clinical follow-up. Patients will be continuously monitored for a minimum of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Signed study specific informed consent form;
* Histologic confirmation of adenocarcinoma of the prostate by biopsy;
* Previous hormonal therapy is allowed (but not required);
* No direct evidence of regional or distant metastases after appropriate staging studies;
* Age ≥ 40;
* Performance Status 0-2;
* American Urological Association (AUA) score must be ≤ 20 (alpha blockers allowed);
* Computerized Tomography (CT) or Ultrasound-based volume estimation of prostate gland ≤ 150 grams.

Exclusion Criteria:

* Metastatic disease from prostate cancer on imaging studies MRI evidence of radiographic T3, T4;
* Previous pelvic radiotherapy;
* Previous surgery for prostate cancer;
* Previous hormonal therapy given for more than 6 months prior to therapy;
* History of Crohn's Disease or Ulcerative Colitis;
* Previous significant obstructive symptoms;
* Significant psychiatric illness;
* Severe, active co-morbidity as defined in section 3.
Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause

The aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer diagnosis and treatment.

It was recognized that GSM is likely to be underdiagnosed and undertreated9. The North American Menopause Society (NAMS) issued the treatment guideline of GSM in 2014 and encouraged the physicians and nurses to pursue menopausal women to check if they have genitourinary syndrome. GSM is considered a progressive condition in menopausal women, and the primary goal of treatment strategy is symptom relief. Options include lifestyle changes, non-hormonal, and hormonal treatments. Hormonal therapies include both topical and systemic approaches. However, many women reported that substantial concerns about the long-term safety of hormonal products.The patients are aware of the possible relationship between cancer, heart disease, stroke, and estrogen-based treatments10. For considering long-term treatment strategy, estrogen free products of vaginal lubricant or vaginal moisturizer are recommended as first line treatment for those with mild to moderate syndrome.

Eligibility Criteria:
1. Subjects who have the relevant syndromes of vulvovaginal atrophy, and who are

   1. In the status of menopause (≥12 months after the last menstrual cycle); or
   2. FSH \> 40 mIU/ml and estradiol level \< 20 pg/ml; or
   3. bilateral ovary resection; or
   4. the patients, i.e. breast cancer patients, who completed cancer therapy
2. Subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her.

   1. Vaginal dryness
   2. Vaginal and/or vulvar irritation/itching
   3. Dysuria
   4. Vaginal pain associated with sexual activity
   5. Vaginal bleeding associated with sexual activity
3. Subjects are willing to comply with all aspects of the study and have signed informed consent form.

Exclusion Criteria:

1. Subjects have been diagnosed with cervical or vaginal malignant neoplasms
2. Subjects with abnormal undiagnostic genital bleeding
3. Subject with active vaginal infection
4. Subjects with vaginal pH value \< 4.5
5. Subjects are under hormone replacement therapy within three months
6. Subjects are under phytoestrogen treatment within two month
7. Subjects use of vaginal douche, lubricant or moisturizer in one week
8. Subjects are hypersensitive to sodium hyaluronate, carrageenan
Psychometric Study of Outcomes Instruments

The purpose of this study is to develop a standardized, practical self-administered questionnaire to monitor young adult burn patients and to evaluate the effectiveness of burn management treatments with regard to improved function, physical appearance and other relevant outcomes.

Identifying young adult burned patients at risk for poor outcomes remains an underpublished field of study. The first step to identifying these patients is to review their responses to this burn specific young adult measure, that attempts to quantify aspects of quality of life. We are validating this questionnaire by now collecting information from non burned community based subjects and by having burned patients complete the questionnaire at 4 timepoints. Once we have recruited sufficient subjects we will finalize our testing of this questionnaire and publish the validity and reliability of the instrument. Our questionnaires will help us answer the question of how burn people differ from non burned person's reported quality of life. This will complete our array of burn specific outcomes questionnaires from infancy through young adulthood.

Eligibility Criteria:
Inclusion Criteria:

* All burn injured young adults with or without grafting
* All burned on or after their 17th birthday
* Between the ages of 19-30
* English speaking
* Present for inpatient or outpatient treatment

Exclusion Criteria:

Non-burned skin conditions

* Non-English speaking
* Patients less than 19 years of age
* Patients over 30 years of age
Complementary Medicine Practices in Chronic Low Back Pain: Randomized Controlled Trial

To compare the effectiveness of classical physiotherapy and leech therapy in patients with chronic low back pain.

investigators research will last 6 weeks in total. There will be a total of 60 participants in three groups, 20 people in each group. Participation will be on a voluntary basis. There will be no control group in our study. Physiotherapy treatments will be applied two days a week for a total of 6 weeks. In the group where leeches will be applied together with classical physiotherapy, leech application will be done every two weeks. However, in the group where leeches will be applied, the classical physiotherapy method will continue to be applied two days a week for a total of 6 weeks. Roland Morris Disability Questionnaire, Oswestry Disability Index, Short Form McGill Pain Questionnaire, Pittsburgh Sleep Quality Inventory (PSQI) will be administered before and after our study.

Eligibility Criteria:
Inclusion Criteria:

* By a specialist physician (orthopedics, neurology, algology) for more than three months
* low back pain confirmed throughout
* Complaint of lower back pain at least three days a week in the three months before treatment
* Those who do not have any blood disease
* Those who do not use blood thinners

Exclusion Criteria:

* Regular intake of opioid analgesics
* Presence of hemophilia
* Presence of anemia or known erythropoietic disorder
* Presence of erosive gastritis, gastrointestinal bleeding or stomach ulcer in the last three months
* Immunosuppressive drugs
* Wound healing disorder
* Pregnancy, breastfeeding status
* Presence of rheumatoid arthritis, spondyloarthropathy or other inflammatory joint disease
NeuroCytotron in the Treatment of Autism Spectrum Disorder

Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder

Experimental, pilot, one-arm, open-label, single-center, 13-month, single-center study to evaluate the effect of NCX neuronal regeneration treatment in subjects with Autism Spectrum Disorder (ASD) to explore the therapeutic effects of NeuroCytonix neuronal regeneration technology on ASD symptoms. Specific objectives include collecting preliminary safety and efficacy data, assessing appropriate dosing, and measuring the impact on participants' quality of life after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with a confirmed diagnosis of ASD according to DSM-5 criteria.
2. Subjects ≥ 3 and ≤ 50 years.
3. Subjects with ASD severity grade 1 to 3 according to DSM-5 criteria.
4. To have the informed consent of the parents or legal representatives for the subject's participation in the study.
5. Subjects must be physically able and willing to undergo the treatment sessions.
6. Subjects must be medically and psychologically stable to participate in the study.

Exclusion Criteria:

1. Presence of medical conditions that could contraindicate the use of NeuroCytotron DM, such as severe neurological disorders and difficult-to-control epilepsy.

   1. uncontrolled epilepsy is defined as: more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit, or
   2. history of any of the following within 9 months prior to the day 1 visit: prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc.) more than once a month, seizures lasting more than 10 minutes, status epilepticus or epilepsy with autonomic involvement.
2. Concurrent participation in other therapies or interventions for autism during the study period.
3. Logistical or situational limitations that prevent regular attendance at treatment sessions.
4. History of significant adverse reactions to similar treatments or involving the use of anesthesia.
5. Presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions.
6. Current or recent (previous 14 days) history of clinically significant bacterial, fungal, viral or mycobacterial infection.
7. Subjects with magnetic implants, pacemakers, claustrophobia or any other condition that prevents them from entering or remaining in the DM NeuroCytotron.
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing and capable of providing informed consent
2. Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator
3. Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
4. Willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
5. Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Known or suspected sensitivity to dexamethasone acetate (DXA)
2. Has a mechanical tricuspid heart valve
3. Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion)
4. Currently requiring hemo- or peritoneal dialysis
5. Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
6. Intended to receive a single chamber device
7. Documented history of permanent or persistent AF
8. Currently on an active organ transplant list
9. Documented life expectancy of less than 12 months
10. Enrolled in any other concurrent study unless prior approval is received from the Sponsor