cyrilzakka/clinical-trials huggingface dataset:
Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes

The surgical results of thoracolumbar and lumbar burst fracture have been reported to be comparable between patients with and without fusion in a midterm follow-up. There is, however, no report comparing the results of fusion and non-fusion with a long-term follow-up. Therefore, a long term comparative study is still needed to focus on the issues of functional and radiographic outcomes, especially preservation of the motion segment in the long run, to determine whether fusion should be a routine procedure for surgically treated burst fractures of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative study of fusion and non-fusion based on our previous work, with an average 134 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* neurologically intact spine with a kyphotic angle more than 20o, decreased vertebral body height more than 50% or a canal compromise more than 50%;
* incomplete neurological deficit with a canal compromise less than 50%;
* complete neurological deficit;
* multilevel spinal injury or multiple trauma.

Exclusion Criteria:

* progression of the neurological deficit;
* a canal compromise still more than 50% in those who showed no improvement of the neurological deficit.
Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).

Patients undergoing descending aortic repair often experience post-operative pain, and have high post operative opioid requirements. That pain is partially due to the use of naloxone continuous infusion (NCI). NCI is part of a bundled approach used in the first 48 hours post-operatively to prevent spinal cord ischemia, a devastating complication associated with surgical repair of the descending aortic. Data indicate that patients receiving NCI experience elevated post-operative pain scores and increased opioid requirements during the 48-hr post-operative NCI administration, compared to patients not receiving NCI.

Ketamine is an FDA-approved N-methyl D-aspartate (NMDA) antagonist that has been shown to provide adjunctive analgesia and opioid-sparing effects in post-operative surgical patients. At low doses, ketamine provides analgesic benefit without the anesthetic effects seen at higher doses. These doses are commonly referred to sub-dissociative. This study will evaluate whether use of sub dissociative ketamine (SDK) in patients undergoing aortic procedures with the use of NCI will lead to decreased post-operative opioid consumption, and produce improved pain scores in the first 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* willing to give informed consent
* scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
* requires naloxone continuous infusion for spinal prophylaxis

Exclusion Criteria:

* allergy to ketamine, acetaminophen, or fentanyl
* diagnosis of schizophrenia
* history of hydrocephalus or central nervous system mass
* incarcerated individuals
* pregnant or lactating individuals
Frequency of Oral Care Intervention Study

Tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse as part of clinical care. The purpose of this study is to determine how often tooth brushing should occur for adult patients with breathing tubes (mechanical ventilation), balanced with equivalence and safety.

A total of 345 adult subjects who are intubated and require mechanical ventilation will be randomly assigned to one of the three different tooth brushing frequency groups: once a day, twice a day or three times a day, up to a maximum of seven days. Teeth will be brushed with a soft child size toothbrush will take approximately 2 minutes. Following tooth brushing, the mouth will be rinsed with alcohol-free mouthwash and oral fluids will be removed with an oral suction tip. Moisturizing gel will be gently applied. The complete intervention requires approximately 15 minutes.

Information will be collected will include clinical condition, medications, age, gender, and smoking status. Once every day, digital pictures will be taken of each tooth (takes approximately five minutes) using a small intraoral camera to be evaluated for plaque by a dental hygienist that is blinded to frequency group assignment. Once every day, gingival crevicular fluid samples (takes 30 seconds) to look for factors that predict infection.

Gingival crevicular fluid samples and digital pictures of the teeth will also be collected on day 1, day 3 and day 5 after extubation.

Eligibility Criteria:
Inclusion Criteria:

* within 36 hours of initial intubation,
* have at least one tooth, and
* they or their legally authorized representative are able to provide informed consent in English or Spanish.

Exclusion Criteria:

* anticipation by the clinical provider of imminent patient death, or
* medical contraindication to tooth brushing.
Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

This pilot trial studies how well serial liquid biopsies work in detecting microsatellite instability in participants with stage IV colorectal cancer. Serial liquid biopsies may help doctors learn better methods to track cancer in the bloodstream and how to use these to improve cancer treatments.

PRIMARY OBJECTIVES:

I. To test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfDNA) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability.

II. To test the hypothesis that changes in the electrophoretic mobility profile of microsatellite biomarkers in liquid biopsies from patients with colorectal carcinoma correlate with therapeutic responsiveness measured based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

III. To determine whether microsatellite alleles generated as a result of microsatellite instability detectable in liquid biopsy specimens from patients with colorectal carcinoma represent the entire cancer cell population or only a subset of cancer cells differentially affected by genomic instability.

OUTLINE:

Participants undergo collection of blood samples to evaluate microsatellite instability via serial liquid biopsies at baseline, then every 6 weeks and at progression or 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy.
* Trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy.
* Zubrod performance status of 0 or 1.
* Patients have measurable disease according to RECIST version (v)1.1.
* Ability to understand and willing to sign a written informed consent.

Exclusion Criteria:

* Severe anemia (hemoglobin \[Hb\] \< 8 g/dL).
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.

This is a Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with ampreloxetine.
* The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
* The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of \>4 in OHSA#1.

Exclusion Criteria:

* Subjects may not be enrolled in another clinical trial.
* Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
* Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
* Hypersensitivity to ampreloxetine or the formulation excipients.
Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor

The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.

A single-centre, prospective, randomized controlled trial was conducted. Eligibility and informed consent to participate were checked once the woman was in established labor. Eligible participants were randomized at the second stage of labor. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on).

Eligibility Criteria:
Inclusion Criteria:

* Women with 18 years or older
* Between 37 and 41 weeks of pregnancy
* Expected spontaneous vaginal birth
* Fetus in the cephalic presentation
* Able to provide informed written consent

Exclusion Criteria:

* Multiple pregnancy
* Meconial amniotic fluid
* Fetal distress
* Suspicion of fetal growth restriction
* Gestational hypertensive disorders
Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.

Children with ASD share common symptoms in the core domains of social reciprocity, communication, and repetitive behaviors. In addition to the core symptoms, 50 to 70 percent of children with ASD often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, aggression and self-injury.

In this open pilot study expands clinical research on CBT for irritability to children with autism and mild cognitive impairment. CBT consists of individual weekly sessions dedicated to teaching children to recognize situations that may lead to frustration and to build coping skills for dealing with frustration in socially appropriate ways. Recent research as well as clinical reports suggest that children with mild intellectual disabilities (IQ between 55 and 85) can also benefit from CBT. The intervention is modified to reduce complexity of activities during therapy sessions but retains key elements and principles of CBT. Thus, the modified version of CBT is referred to as "Principles-Based Cognitive Behavior Therapy for Irritability in Autism" or PB-CBT for short. Subjects in this study will receive a comprehensive evaluation of ASD and associated psychopathology. Irritability and related disruptive behaviors will be rated on weekly basis to utilize a single-subject approach to data analysis. Children will be asked to participate in functional magnetic resonance imaging (fMRI) with tasks of social perception and emotion regulation before and after CBT. The purpose of the fMRI portion of the study is to evaluate feasibility of fMRI as an outcome measure in studies of behavioral interventions for children with ASD and intellectual disability.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnosis of Autism Spectrum Disorder
* Presence of disruptive behaviors such as irritability and anger outbursts
* IQ between 55 and 85
* ABC Irritability Scale score greater than or equal to 15
* Un-medicated or on stable medication regimen
* Able to complete all study assessment and fMRI procedures

Exclusion Criteria:

* Medical or psychiatric condition that would require alternative treatment
High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove

This study aims to define the intermuscular bridges between the scalene muscles at the interscalene groove (around neck area) using high definition US imaging in a cohort of volunteers.

The Interscalene brachial plexus block (ISBPB), with recent techniques like phrenic nerve sparing interscalene approach, has better safety profile than before and because of this, it is often the technique of choice for anaesthesia and/or analgesia during shoulder and proximal arm surgery. Anatomical variations at the interscalene groove are not uncommon and few have been described in the literature. Understanding the anatomy of the brachial plexus and its sheath at the interscalene groove is vital for the success of the block and to reduce the risk of complications during ultrasound (US) guided ISBPB. Recently, with the use of high definition ultrasound, using high frequency linear transducer, the principal investigator have identified intermuscular bridges appearing between the ventral rami of the brachial plexus at the interscalene groove. These intermuscular bridges may affect the spread of local anesthetic dispersion within the brachial plexus sheath thereby affecting the block dynamics of ISBPB. Therefore, this prospective observational study aim to define the intermuscular bridges at the interscalene groove using high definition ultrasound imaging in a group of healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* volunteers consented for the scanning

Exclusion Criteria:

* prior surgery on either side of the neck
* presence of obvious deformity
Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Able to give informed consent
2. Male - age \> 18
3. mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa)
4. Scheduled for TRUS biopsy for prostate lesion or mass

Exclusion Criteria:

1. Age under 18 years of age.
2. Female
3. Pre-existing blood dyscrasias
4. Inability to perform TRUS due to anal sphincter closure/surgery
5. Patients needing general anesthesia
6. Patients allergic to lidocaine
7. Patients allergic or unable to take antibiotics
Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon

The investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

Hand lacerations are divided to "complicated" which involves tendons, nerves, bones, and joints, and "simple" which involves only cutaneous and subcutaneous tissue.

prophylactic antibiotic should not be given in a clean simple lacerations, and should be given when a bone is involve (open fracture). But there is not enough data, weather prophylactic antibiotic treatment should be given when only tendons are involved. The investigators will examine 2 groups of 30 patients each with clean hand lacerations involving tendons. One group will be treated with prophylactic antibiotic and the other wont be treated, randomly. The investigators assume that the rate of wound infection wont be different between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Hand laceration
* Tendon involeved
* Clean laceration
* No bone involved

Exclusion Criteria:

* Pregnant
* Children
* Immunocompremised patients
* "Dirty" lacerations
Upper Extremity Lymphatic Mapping for Breast Cancer Patients

This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.


Eligibility Criteria:
Inclusion Criteria:

* Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.
* Females \> 21 years of age

Exclusion Criteria:

* Prior ipsilateral axillary surgery
* Prior ipsilateral axillary radiation
* Prior ipsilateral breast cancer
* Prior ipsilateral breast radiation
* Allergy to isosulfan blue dye
* History of ipsilateral upper extremity lymphedema
* Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast
* Prior history of neoadjuvant chemotherapy for current breast cancer
* Bulky axillary disease at presentation (N2)
Lycopene In Preventing of Prostate Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.

OBJECTIVES:

* Determine any dose limiting toxicities and the maximum tolerated dose of lycopene administered orally as a food based delivery system in healthy male subjects 18-45 years of age for the chemoprevention of prostate cancer.
* Determine the pharmacokinetics of this regimen in this population.
* Determine the dose range of this regimen to be used in the 3 month multiple dose study, based on the toxicity, pharmacokinetics and feasibility resulting from the present study in this population.

OUTLINE: This is a dose-escalation study.

Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains negligible carotinoid for 28 days.

Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicities.

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions
* Baseline serum lycopene less than 600 nM

PATIENT CHARACTERISTICS:

Age:

* 18 to 45

Performance status:

* Karnofsky 100%

Life expectancy:

* Not specified

Hematopoietic:

* Hematologic function normal

Hepatic:

* Liver function normal
* No hepatic disease

Renal:

* Kidney function normal
* No renal disease

Cardiovascular:

* No hypertension requiring medication
* No cardiovascular disease
* Normal EKG

Other:

* No evidence of a psychiatric disorder
* Must be within 15% of ideal body weight based on standard weight tables
* No history of smoking within the past 3 months
* At least 72 hours since prior alcohol consumption and no history of alcohol abuse
* No history of gastrointestinal malabsorption or any other condition that could affect drug absorption
* No allergy to tomato based products
* No active malignancy at any site
* No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* At least 14 days since prior prescription drugs
* No concurrent regular prescription medications
* At least 30 days since other prior experimental drugs
* No concurrent participation in any other experimental trial
Biomarker Development for Muscular Dystrophies

Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample, and some muscles in the arms and legs using tests called ultrasound and electrical impedance myography; both tests are painless and non-invasive. The information that is gathered from this study may help to evaluate, prevent, diagnose, treat, and improve the understanding of human muscle diseases.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with DM1 or DM2 based on genetic testing and/or clinical criteria (some subjects who have positive genetic testing may be asymptomatic, while other subjects who show characteristic clinical features may have declined to have genetic testing done). Control non-DM subjects are unknown to have DM or any other muscular dystrophy by history and may have had no genetic testing.
* Able to provide informed consent or assent for participation in the study.
* Demographic characteristics for single biofluid collection: Males and females age 5 years and older.
* Demographic characteristics for serial biofluid and muscle function testing: Males and females age 14 years and older with DM1.
* Demographic characteristics for biofluid and muscle biopsy: Males and females, ages 18-65 years.

Demographic characteristics for single biofluid collection, ultrasound, and myography: Males and females age 14 years and older.

Exclusion Criteria:

* Medical history of any of the following. State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and/or C positive.
* Medications and other drugs. Use of anti-platelet drugs within 7 days prior to blood draw or biopsy; use of anticoagulants within 60 days prior to blood draw or biopsy; active drug or alcohol use or dependence that, in the opinion of the biopsy surgeon, would interfere with post-procedure wound care.
* Other. Inability or unwillingness of the subject to give written informed consent.