cyrilzakka/clinical-trials huggingface dataset:
A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture

In this study, a new method was proposed to calculate the length of sideburns mini incision for zygomatic arch fracture. The purpose of this study was to compare the sideburns mini incision calculated by this method with the coronal scalp incision, so as to determine the therapeutic effect and advantages of sideburns mini incision calculated by this method.

Eighty patients with zygomatic arch fracture were treated with surgical intervention. Forty patients were treated with sideburns mini incision, and the other forty patients were treated with coronal scalp incision. Data such as incision length, operation time and postoperative complications were recorded. The follow-up periods were 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical and imaging diagnosis of zygomatic arch fracture or zygomatic maxillary complex fracture.
2. Fracture fragments are obviously displaced, which affects the appearance and function of the patient. Simple prying is instable and requires open reduction and internal fixation.
3. No previous surgical treatment.

Exclusion Criteria:

1. Accompanied by multiple fractures of mandible, nasal bone and so on.
2. There are traumatic scars in the operation area, which can be accessed through the original wound.
3. History of bone disease and / or wound healing disorders.
4. Mental and intellectual disorders.
Behavior Addictions Improvement in Parkinson Disease's Patients Treated by Subthalamic Stimulation : Long Term Follow-up

Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up

Whereas subthalamic nucleus (STN) stimulation is considered an established treatment for motor symptoms in advanced Parkinson's disease (PD), its behavioral and psychiatric effects are strongly debated, with some studies showing a worsening or new onset of behavioral and psychiatric issues after STN stimulation and other showing an improvement. However, these data are based mainly on case reports and retrospective series.

Recently, the investigators group has conducted a prospective study assessing behavior and psychiatric symptoms in patients undergoing STN stimulation up to one year after surgery. After subthalamic stimulation non-motor fluctuations improved and pathologic hyperdopaminergic syndrome, i.e. behavioral addictions (including pathological gambling, hypersexuality, binge eating, compulsive shopping, ...), compulsive use of dopaminergic treatment and dopaminergic dysregulation syndrome (defined as the association of one or more behavioral addictions to compulsive use of dopaminergic treatment), disappeared. These findings represent a milestone because, if confirmed, the indications of STN stimulation might be extended beyond motor complications. To date, there are several long-term studies on motor and cognitive effects of STN stimulation, whereas no long-term longitudinal data on neuropsychiatric effects do exist. Therefore, the investigators designed a long-term prospective study, assessing over 3-8 years behavioral and psychiatric effect in the same cohort of patients included in the one-year study. This study will allow to better evaluate the change in non-motor fluctuations and of behavioral issues in the long-term with a standard management.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the protocol 'Apathy'

Exclusion Criteria:

* NA
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures

The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).


Eligibility Criteria:
Inclusion Criteria:

1. Primary laparoscopic or open procedure (thoracic, urologic or ear, nose, and throat \[ENT\]) where at least one vessel is planned to be transected by the ENSEAL X1 curved jaw tissue sealer (ENSEAL X1) device per the Instructions for use (IFU)
2. Willingness to give consent and comply with all study-related evaluations and treatment schedule
3. At least 18 years of age

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation
2. Enrollment in a concurrent interventional clinical study that could impact the study endpoints
Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.
* Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.

Exclusion Criteria:

* Diagnosed with atypical parkinsonism
* Prior surgical interventions for Parkinson's disease
* Glaucoma
* Undiagnosed skin lesion or history of melanoma
* Epilepsy or history of seizures
Efficacy and Safety of L Arginine to Prevent Preeclampsia

Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia.

applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes

Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo.

Each three weeks were evaluated in search of high blood pressure and proteinuria.

The follow-up was until the end of pregnancy and two weeks after this

Eligibility Criteria:
Inclusion Criteria:

* one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)

Exclusion Criteria:

* pregnant women carriers of chronic renal failure
* pre gestational diabetes
* multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)
Effectiveness of Immersive Virtual Reality in Nursing Students' Learning

Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.


Eligibility Criteria:
Inclusion Criteria:

- having completed the scheduled in-person simulation in previous years of the degree .

Exclusion Criteria:

-the student does not sign the informed consent to participate in the study.
Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites

Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.

The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve randomizing subjects to treatment with the AWBAT-D dressing or Tegaderm and monitoring outcomes. The AWBAT-D device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. The purpose of this study is to evaluate if there are differences in outcomes between AWBAT-D and Tegaderm in healing split thickness skin graft donor sites.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age or older
2. Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um.
3. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Subjects \< 18 years of age
2. Subjects with an allergy to porcine products.
3. Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2.
4. Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
5. Subjects undergoing repeat skin graft harvesting at the same donor site.
6. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
7. Subjects participating in any other trials involving the split-thickness skin graft donor site.
Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education

The study is designed to evaluate the efficacy of a novel couple-based treatment for PTSD, called Structured Approach Therapy, to decrease PTSD and improve the marital and social functioning of Iraqi war Veterans and their partners. The effectiveness of couples therapy will be compared with the effectiveness of a couple-based educational intervention.

The goal of the proposed study is to test the efficacy of a novel couple-based PTSD treatment, called Structured Approach Therapy, by randomly assigning 57 Iraqi war Veterans and their partners to either a 12-15 session Structured Approach Therapy program, or to a 12-15 session PTSD Family Education comparison condition. The efficacy of the two experimental conditions will be ascertained by obtaining measures of PTSD severity from Veterans and measures of relationship functioning and emotion regulation from Veterans and their partners prior to treatment, immediately after treatment, and three months after the last treatment session. The investigators will test the hypothesis that couples participating in Structured Approach Therapy will show significantly greater improvements on all three clinical outcome measures than couples participating in PTSD Family Education. These hypotheses will be tested with an intent-to-treat analysis using general linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcome, separately for the Veterans and their partners. The objectives of the Structured Approach Therapy intervention are to decrease PTSD severity, improve relationship and family functioning, and decrease problems in emotion regulation in a group of young Veterans at risk for developing chronic PTSD, and to reduce emotional distress and relationship and family problems in their partners.

Eligibility Criteria:
Inclusion Criteria:

* Exposure to at least one combat-related stressful event during combat deployment,
* Current diagnostic criteria for PTSD for that event, and
* Veteran is in a committed relationship and living with an opposite sex partner for at least six months.

Exclusion Criteria:

* Current psychotic symptoms in either partner,
* Current diagnosis of alcohol or drug dependence in either partner,
* History of recent physical assault/abuse,
* Currently receiving an evidence-based PTSD treatment (exposure-based or cognitive processing therapy)
* Currently receiving couples therapy or family therapy
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage

Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. The current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per procedure. Computed tomographic perfusion imaging (CTP) and computed tomographic angiography (CTA) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of embolic and thrombotic cerebral infarct. The investigators hypothesize that CTP and CTA may be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid hemorrhage requiring treatment and provide prognostic information.


Eligibility Criteria:
Inclusion Criteria:

* subarachnoid hemorrhage after aneurysm rupture

Exclusion Criteria:

* renal insufficiency
* pregnancy
* contrast reaction
ADINA vs. High Flow Nasal Cannula Comparison Study

This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.

NCPAP has been used increasingly to manage respiratory distress in newborns as well as apnea of prematurity. Humidified high flow nasal cannula devices (flows 1-8 lpm) have also been used in neonatal intensive care units.

This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.

Eligibility Criteria:
Inclusion Criteria:

* Neonates admitted to NICU
* Weights of 400-500 grams
* Requiring oxygen greater than 30%
* No evidence of focal lobar consolidation in lung fields

Exclusion Criteria:

* Intolerance to procedure
* gelatinous skin
* known allergy to adhesive material
* interference with therapy
* profound sepsis
* pneumonia
* unmanaged apnea/bradycardia
* known or suspect complex congenital heart disease
* severe cleft lip or palate
* suspect or proven lethal congenital anomaly
* intolerance to the interface used in the devices
* inability to secure an appropriate fit of the patient nasal interface
* considered non-viable or of uncertain viability
* parental refusal.
Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)

The purpose of this study is to investigate over a 6 month period the effect of octreotide therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning calories, biomarkers of weight regulation and growth hormone markers in children and young Adults with Prader-Willi Syndrome(PWS).

Obesity continues to be a prevalent health concern affecting every race of the American population. According to data from the World Health Organization, 54% of U.S. adults are overweight (body mass index (BMI) \>25 kg/m2 ) and 22% are obese (BMI \>30 kg/m2) (1). In addition, 25% of U.S. children are overweight or obese (1). Studies show that obese children are likely to become obese adults (2-5). Also, recent studies report significant years of life lost due to the impact of being an obese adult (6, 7). Thus, insights into the pathogenesis of childhood obesity and preventative measures are needed to combat the inevitable increase in worldwide incidence of obesity and its associated co-morbidities. Recent studies have identified a new gastroenteric hormone, ghrelin, as a long-term regulator of energy balance in humans (12). Ghrelin is a 28 amino acid acylated peptide which is an endogenous ligand of the growth hormone secretagogue receptor (GHS-R), a hypothalamic G-protein-coupled receptor (13). Enteroendocrine cells (X/A-like cells) of the stomach are the major site of ghrelin synthesis, although a minor proportion of ghrelin synthesis occurs in other sites such as the hypothalamus, pituitary, duodenum, jejunum and lung (14) (15, 16).

The hypothesis that hyperghrelinemia causes some of the features of PWS predicts that this disorder will be ameliorated (partially or completely) by lowering ghrelin levels. We have recently shown that the somatostatin agonist, octreotide, suppresses ghrelin levels in humans. If octreotide remains effective in longer term studies, the drug may become an adjuvant therapy, in addition to growth hormone, to control the insatiable appetite and morbid obesity seen in this condition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PWS confirmed by chromosome analysis
* Ages 5 years to 21 years
* BMI for age ≥ (greater-than or equal to)85th percentile
* Written informed consent and assent obtained and willingness to comply with the study schedule and procedures
* Free T4, Thyroid stimulating hormone (TSH) values in the normal range (either endogenous or with thyroxine replacement)

Exclusion Criteria:

* Patients with any other clinically significant disease that would have an impact on body composition, including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
* Concomitant use of an investigational drug or Octreotide in the past year
* Use of steroids for longer than 7 days within the past 30 days
Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
* Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

Exclusion Criteria:

* Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
* Prior stent implantations (study eye)
Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network

The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC).


Eligibility Criteria:
Inclusion Criteria:

* 12-18 year olds
* Coming for non-emergent care
* Access to a private computer
* Have email address

Exclusion Criteria:

* Not available for follow-up questionnaires
* Unable to read or understand English at a 6th grade reading level
* Medically or emotionally unstable on the day of the visit
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

This observational study will assess the median time of treatment duration and the safety of Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data will be collected for approximately 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic breast cancer in first line treatment who have completed treatment with Avastin

Exclusion Criteria:

* Patients not willing or unable to signed written consent form
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

This phase 2, multicenter, two-part, open-label, single-arm study will be conducted in Japan and will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of pexidartinib in adult participants with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitation and not amenable to improvement with surgery.

This study will consist of 2 parts. In Part 1, pexidartinib 800 mg/day (400 mg twice a day \[BID\]) will be administered on an empty stomach and tolerability and PK of pexidartinib will be evaluated to determine the initiation of Part 2. In Part 2, pexidartinib 800 mg/day (400 mg BID) will be administered on an empty stomach and efficacy, safety, and PK of pexidartinib will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years
* A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board).
* Measurable disease as defined by RECIST version 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.

Exclusion Criteria:

* Known metastatic TGCT.
* Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (\>upper limit of normal); or active liver or biliary tract disease, including increased alkaline phosphatase.
* Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with a participant's study participation or the interpretation of his or her results.
* Use of strong cytochrome P450 3A inducers, including St John's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.
Simplified Monitoring Myanmar SM2 Study

The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.

A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling.

In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing.

They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine.

Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated.

The proportion of patients reaching SVR will be calculated.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in this study.

1. Have voluntarily signed the consent form.
2. 18 years of age or older.
3. HCV antibody positive.
4. HIV antibody positive.

Exclusion Criteria:

Subjects who meet any of the exclusion criteria are not to be enrolled in this study.

1. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol.
2. Creatinine clearance (CLcr) \< 30mL/min at screening.
3. Pregnant or nursing female.
4. Use of prohibited concomitant medications.
5. Inability or unwillingness to provide informed consent or abide by the study requirements.