cyrilzakka/clinical-trials huggingface dataset:
Patient Education Using 3D Printed Model

Complex high energy fractures of the lower extremity are life changing injuries and are known to be associated with poor functional outcome post operatively. The list of potential post-operative complications associated with these injuries is long, and the worst of these fractures can even be limb threatening. One of the most difficult and prevalent post-operative issues this patient population faces is chronic pain and its association to opioid addiction, which is currently an epidemic across North America. These individuals not only present with physical insult but psychological trauma as well, which also greatly affects these patients post-operatively. Properly educating the patient about their injury and the process that they will embark on can greatly empower the patient as they begin their journey of rehabilitation. This process can hopefully mute or silence some of these modifiable risk factors predisposing patients to poor functional outcomes and chronic pain. The investigators also hope to help them initiate/develop coping strategies to better overcome the many obstacles these patients face and to do so using 3D printing. 3D printed models have not only been demonstrated to be valuable in orthopaedics, when it comes to educating patients about their disease and associated interventions, but many other specialties as well; such as: cardiac surgery, urology, and general surgery. Literature suggest that often little is understood or retained by the patient following a patient consent with regards to their injury, potential complications, interventions to be undertaken, as well as the rehabilitation process to follow. By providing the patient with a 3D printed model of their fracture while educating them pre-/post-operatively, the investigators hope they will better understand the aforementioned, often forgotten points, indirectly yielding better overall patient satisfaction, patient outcomes and pain scores.


Eligibility Criteria:
Inclusion Criteria:

* periarticular injury involving the plafond, calcaneus or talus that requires open reduction and internal fixation
* Patient must have a completed CT scan as part of their pre-operative planning protocol

Exclusion Criteria:

* open fracture
* patient with known psychiatric history (depression, borderline personality disorder, bipolar etc)
* prior fracture fixation of the same ankle or foot
* diabetic neuropathy/Charcot foot
* dementia or other cognitive comorbidities (ie stroke etc)
* no primary address
* patient who were not independent mobilizers prior to injury
Tranexamic Acid and Head and Neck Surgery Patients

Tranexamic acid belongs to fibrinolytic inhibitors. Several prospective randomized clinical trials have proved its effectiveness in reducing intra-operative and post-operative bleeding in orthopedic and cardiovascular surgeries. However, there is little study about tranexamic acid in reducing post-operative bleeding in head and neck surgery. So the aim of this study is to investigate if tranexamic acid could reduce post-operative bleeding via prospective double-blinded randomized clinic trial.

Otolaryngologists often use drainage tube after head and neck surgery to reduce hematoma or seroma formation. In addition, the duration of drainage tube placement is closely related to the length of hospital stay. So early removal of drainage tube could eventually shorten the admission period. The factors related to the duration of drainage tube placement include: type of surgery, intra-operative bleeding, underlying disease of coagulation disorders, etc. According to the literatures, the average duration of drainage in head and neck surgery is 4 days. Another study showed that one of the risk factors associated with surgical site infection is the longer drainage duration. Therefore, how to remove drainage tube as soon as possible is crucial to head and neck surgeon.Tranexamic acid belongs to fibrinolytic inhibitors. Several prospective randomized clinical trials have proved its effectiveness in reducing intra-operative and post-operative bleeding in orthopedic and cardiovascular surgeries. However, there is little study about tranexamic acid in reducing post-operative bleeding in head and neck surgery. So the aim of this study is to investigate if tranexamic acid could reduce post-operative bleeding via prospective double-blinded randomized clinic trial.This study includes 60 consecutive patients who will undergo head and neck surgery. Those who are allergy to tranexamic acid, history of coagulation disorders, under anti-coagulation therapy will be excluded. Basic data will be recorded along with detail physical examination and operation type. Then they will be divided randomly into study group and control group. Study group will receive tranexamic acid before and after operation while control group not. PT, APTT, level of prothrombin fragments 1+2, D-dimers, plasminogen, α2-antiplasmin, tissue plasminogen activator (tPA), and plasminogen activator inhibitor (PAI-1) will be obtained before and after operation. The drainage amount, duration of drainage tube placement will also be recorded. Relevant variables will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* head and neck neoplasm scheduled for operation

Exclusion Criteria:

* allergy to tranexamic acid
* history of coagulation disorders
* under anti-coagulation therapy
Detection Rate of Prostate Cancer in Men Undergoing MRI

To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy.

Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.

The trial is a retrospective observational study, with the aim to compare two cohorts of patients with suspicion of PCa who will undergo MRI. Group A is composed by patients with previous negative biopsy, while group B is composed by men with no previous negative prostate biopsy.

To reach primary aim, men with positive MRI (clinically significant lesions with PI-RADS score \>= 3) and biopsy data will be considered.

In men with negative MRI (clinically insignificant lesions or regions classified as PI-RADS 2 at MRI), follow-up with PSA data and repeated MRI and/or biopsy will be considered.

Eligibility Criteria:
Inclusion Criteria:

* age 50 and life expectancy greater than 10 years
* PSA values persistently greater than 4 ng/ml
* multiparametric MRI of the prostate between nov-2014 and nov-2016
* MRI with endorectal coil

Exclusion Criteria:

* previous history of PCa
Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients

This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).

Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.


Eligibility Criteria:
Inclusion Criteria:

* One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
* One or more outpatient pharmacy claims during the study for one or more of the following "study medications":
* Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations
* Fluticasone propionate 110 mcg or 220 mcg
* One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date ("pre-index period") or
* Five or more prescriptions for a short-acting beta agonist during the pre-index period.

Exclusion Criteria:

* Patients with more than one of the study medications during the 3-month period beginning with the index date;
* One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
* One or more prescriptions within three months of post index date for:
* Any asthma maintenance medication
* Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)
pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress

Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a 1-hour brain scan for both patients and controls. In the first 6 months of the study, investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI, pH-weighted imaging will be validated for its robustness and reproducibility.

The contrast agent (Gd-DTPA, Gadavist) will be injected intravenously (IV) in the arm (patients only). The IV will be inserted by qualified medical professional at CBI. This contrast agent will be standard dose in accordance with its FDA approved labeling and dosing. Controls will NOT be administered the contrast agent.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female non-MS control volunteers

Exclusion Criteria:

* Medically unstable or with cardiac, pulmonary, hematological, renal, or hepatic dysfunction.
* Current or past DSM-IV diagnosis of major depression, bipolar and psychotic disorders.
* Contraindications for MRI, including
* Intracranial clips
* Metal implants
* External metallic devices/objects/clips within 10mm of the head
* Suspected or confirmed metal in the eyes (history of welding or similar activity)
* Claustrophobia
* Cardiac pacemaker or pacing wires
* Pregnancy - Pregnancy tests will be offered to women of childbearing age at no cost to the subject
* History of moderate to severe head injury, stroke, and seizures.
* Alcoholism or drug dependency.
* Renal or liver disease as this may cause concerns related to Gd-DTPA contrast agent.

  * Allergy to the contrast agent Gadolinium
  * Relapses or steroid therapy in patient at or in the month preceding the study
  * Patients only
Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain

this research will evaluate the effect of PRF with different bioactive materials in dentistry

PRF will be used with MTA and Theracal to evaluate its effect upon these materials in reliving pain and maintains the teeth vitality in permanent teeth with closed apices, in order to improve the materials outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Symptomatic pulpitis.
* Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
* Patients who will agree to the consent and will commit to follow-up period.
* Patients with mature root.
* Patients with no periapical lesion.
* Patients with localized pain.
* Posterior teeth only will be involved

Exclusion Criteria:

* Patients with immature roots.
* Patients with any systemic disease that may affect normal healing.
* Patients with periapical lesions or infections.
* Pregnant females.
* Patients who could/would not participate in a 1-year follow-up.
* Patients with fistula.
* Patients with necrotic pulp.
* Patients with old age.
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age

This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to \< 72 Months of Age.


Eligibility Criteria:
Inclusion Criteria:

1.Children 6 months to 72 months of age.

Exclusion Criteria:Children

1. Who had been hospitalized at the time of enrollment
2. Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein
3. Who had known impairment of the immune function
4. Who had fever interfering with normal daily activities at the time of enrollment
5. Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study
6. Concomitant participation in another clinical study
7. Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.
Monitoring Trends in Venous Thromboembolism

To describe time trends in the epidemiology of venous thromboembolism.

BACKGROUND:

Venous thromboembolism (VTE) has been estimated to be the third most common cardiovascular disorder. Frequently cited estimates of the incidence of VTE, and its associated outcomes, are based on studies conducted more than a decade ago and only in hospitalized patients. Contemporary data on the magnitude of this disorder, clinical profile of patients affected, acute and long-term outcomes, and use of different treatment strategies are needed given recent advances in diagnostic and therapeutic modalities.

DESIGN NARRATIVE:

The goals of the study are to collect population based data describing trends over time in the epidemiology of VTE including its incidence, management, short and long-term recurrence rates, and mortality. The study will take place in residents of the Worcester, Massachusetts, metropolitan area, (2000 census = 477,800) and will examine changes over time in these and additional endpoints for patients with validated VTE in 1998, 2000 and 2002 with a minimum follow-up of three years. Complementing the community based surveillance of VTE, newly diagnosed cases of VTE occurring in members of the largest Health Maintenance Organization (HMO) in Central Massachusetts between 1998 and 2002 will be identified. This cohort is tracked by an outpatient computer database allowing for the systematic collection of additional data on treatment practices and outcomes occurring outside of the hospital setting. The project will build on the investigators' clinical and epidemiological experience and on data collection methodologies used in the Worcester Deep Vein Thrombosis (DVT) study (1985-1989) and the ongoing Worcester Heart Attack Study. The medical records of Worcester area residents diagnosed with VTE and related diagnostic rubrics will be reviewed and validated according to pre-established diagnostic criteria. Records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term recurrence and survival rates through 2005. The results of this study will provide much needed current reformation about the epidemiology of VTE and provide important data on current diagnostic and therapeutic strategies used in these patients. Implementation of this registry will set the stage for systematic long-term surveillance of this medically important problem.

Eligibility Criteria:
No eligibility criteria
Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

This study is being conducted to address the need for effective and well-tolerated interventions in preventing chronic migraine attacks. Chronic migraines significantly impact the quality of life for individuals suffering from them, often leading to substantial discomfort and impairment. By evaluating the feasibility, safety, and acceptance of noninvasive vagus nerve stimulation (nVNS), researchers aim to determine if this approach can offer a viable solution for alleviating the frequency and severity of chronic migraine episodes. If successful, this study could potentially introduce a promising new treatment option that enhances the well-being and daily functioning of those affected by chronic migraines.

Neuromodulation is a growing field in headache management. Technology ranges from invasive deep brain stimulation (DBS) of the posterior hypothalamus, to minimally invasive percutaneous electrode implantation for occipital nerve stimulation, and noninvasive transcranial magnetic stimulation and transcranial direct current stimulation. Neurostimulation can be particularly useful to those who failed triptans or other prophylactic treatments. The European Headache Federation positioned that a neurostimulation device should only be used in medically intractable headache patient who has been evaluated at a tertiary headache center. Vagus nerve stimulation (VNS), which has demonstrated its antinociceptive potential, may also provide a relief of pain associated with headache

Eligibility Criteria:
Inclusion Criteria:

* Chronic migraine (headache for 15 or more days/month for more than three months), Migraine with/without aura

Exclusion Criteria:

* Mental illness, Photophobic individual, Presence of shunt and/or implant at the cranial region
VANOS Cream and Skin Barrier Function

The purpose of this study is to determine the effect of short-term therapy using "VANOS Cream," a super-potent topical steroid cream on skin barrier function in patients with atopic dermatitis. This cream is already approved for this indication, but the investigators will further examine its effects on the skin barrier. This cream is a novel formulation of fluocinonide designed to enhance compliance with a cream base, but have the skin barrier repair properties of an ointment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD according to Hanifin-Rajka criteria (see Appendix B)
* Age 12 years or older
* Must have an Investigator's Global Assessment (IGA) Score of Moderate, Severe, or Very Severe (See Appendix C)
* Must have failed to achieve adequate disease despite adequate topical or systemic therapy
* Must be a candidate, according to the principal investigator and standard of care, for a super-potent topical steroid course. Subjects that are candidates for super-potent topical steroids are defined as subjects whose disease is not adequately controlled with medium-potency topical steroids or systemic therapy, including phototherapy.

Exclusion Criteria:

* Active skin infection
* Hypersensitivity to any ingredients in Vanos cream
* Previous use of super-potent topical steroids within 2 weeks of starting study (Class I steroid).
3D Printed Assistive Devices for Individuals With Physical Disabilities

Our research aims to examine 3D printed device satisfaction when using mobile devices for individuals with physical disabilities in long-term care facilities, and the impact of the 3D printed device integration on overall occupational performance and satisfaction.

This feasibility study will be conducted at Good Shepherd Rehabilitation Network (GSRN) in the collection of data examining 3D printing outcomes. The 3D printed devices are within the current normal and customary care of GSRN services, with the focus on the created 3D printed adaptations for mobile device usage (i.e. smartphone adaptations). The feasibility data will assist in understanding the satisfaction and performance of 3D printed devices for persons with a physical disability.

Eligibility Criteria:
Inclusion Criteria:

1. Being over the age of 18
2. Self-identified accessibility needs of the mobile device to address secondary to a physical accessibility limitation(s)
3. Accessibility requests of a device that has not already been addressed by 3D printing
4. Ownership or borrowing of a mobile device for personal use Operational definition of mobile devices: Mobile devices are a maximum length and width of 9.4" by 6.8" and must weigh less than 1.03 lb (e.g. dimensions of a standard iPad mini) and should be a one-handed use device with touch-screen capabilities

Exclusion Criteria:

1. Individuals with severe cognitive impairment (BIMS score of 7 or less)
2. Individuals who were unwilling to use a 3D printed device
Bilateral and Unilateral Horizontal Strabismus Surgery

This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery


Eligibility Criteria:
Inclusion Criteria:

* more than 3 years old.
* alternating esotropia or exotropia

Exclusion Criteria:

* unilateral strabismus
* paralytic or restrictive strabismus
Comprehensive Program for Youth Mental Health

The majority of addiction and mental health problems seen in adults present first in youth. There is strong evidence that prevention and early identification during childhood can mitigate some of these risks. Students who screen at risk for the development of mental illness will be offered online intervention programs with personal guidance from a trained coach. In addition, lessons revolving around resiliency will be provided to all students.

The objectives of this study are:

* Decreased rates of depression and suicide (as well as rates of suicide attempts)
* Decreased use of alcohol, tobacco, and other drugs, with additional downstream benefits such as reduced rates of fetal alcohol spectrum disorder (FASD) and cancer
* Decreased school drop-out rates Decreased rates of interactions with the justice system
* Decreased costs across a range of ministries (health, education, justice, human services), both for youth as well as their families who have been involved in this program


Eligibility Criteria:
Inclusion Criteria:

* The intervention group will be the top 10% of all students participating in the school screening.

Exclusion Criteria:

* Lack of consent, lack of assent, lack of the ability to read and understand the screening tools or intervention tools