cyrilzakka/clinical-trials huggingface dataset:
The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars

The purpose of this study to evaluate the SmartLipo Triplex laser system along with the SideLaze800 hand piece in the treatment of Acne Scars.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female between 18 and 65 years old
* Has unwanted facial acne scars and wishes to undergo laser treatments.
* Is willing to consent to participate in the study.
* Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending follow up visits.

Exclusion Criteria:

* The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
* The subject is hypersensitive to light exposure OR takes photo sensitized medication.
* The subject has active or localized systemic infections.
* The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin) {greater than 81 mg per day}).
* The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the planned treatment area 3 months prior to entering this study.
* The subject has used Accutane within 6 months prior to enrollment.
* The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
* The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
* The subject has a history of keloids.
* The subject has evidence of compromised wound healing.
* The subject has a history of squamous cell carcinoma or melanoma.
* The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
* The subject has an allergy to lidocaine and epinephrine.
* The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Intervention for the Promotion of Gratitude

This study aims to analyze the effects of a psychological intervention to promote wellbeing. To do so, a brief intervention is developed to enhance a sense of gratitude through a multiple baseline across components design. Traditional measures will be used together with the incorporation of a novel evaluation methodology such as the EMA, which allows the collection of data in the context of people's daily lives and at different specific times, that is, in real time.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* A score of, at least, 1 standard deviation below the mean for the PANAS positive subscale, based on the norms of the general population

Exclusion Criteria:

* Suicide risk
* Bipolar disorder
* Psychosis
* Any medical or psychiatric condition that hinders participation in the study
HF10 Treatment of Chronic Knee Pain

This is a multi-center study where patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery. The primary endpoint will be assessed at 3 months, but observational assessments will continue until study completion at 12 months following implant.


Eligibility Criteria:
Key Inclusion Criteria:

1. Have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s).
2. Average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment.
3. Have a score of at least 4 out of 10 in Douleur Neuropathique 4 (DN4) questionnaire at the time of enrollment or eligibility verification.
4. Deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee.
5. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
6. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion #2, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.

Key Exclusion Criteria:

1. Have radiculopathy or radicular leg pain resulting from failed back surgery.
2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia).
3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, acute herniating disc, severe spinal stenosis and brachial plexus avulsion as determined by the Investigator.
4. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the Investigator.
5. Have any prior experience with SCS.
6. Have objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator.
7. Be benefitting from an interventional procedure to treat their trunk or limb pain (Subjects should be enrolled at least 30 days from last benefit).
8. Have an existing drug pump and/or another active implantable device such as a pacemaker.
9. Be involved in an injury claim under current litigation.
10. Have an active or unsettled worker's compensation claim.
Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis

This study aims to evaluate whether placing nasogastric tubes for gastric decompression improves respiratory distress for patients with bronchiolitis who are receiving oxygen via high-flow nasal cannula.

All patients will be consented per IRB procedure. The study will be a prospective study. Study participants will be enrolled after placement on high flow nasal cannula. The respiratory therapist or study staff will use a bronchiolitis scoring tool, the Marlais Risk of Admission Score, to assess the respiratory status of patients after placement on high flow nasal cannula, and prior to placement of NG tube to establish a baseline measurement. This tool includes the following components: respiratory rate, oxygen saturation, heart rate, age, and length of illness. An NG tube will then be placed. Thirty minutes and sixty minutes after placement of the NG tube, the respiratory therapist or study team will again use this scoring tool to assess the respiratory status of the patient. After 60 minutes the study will be concluded. As subject will be requiring oxygen use, admission to an inpatient unit is required. The NG tube will be removed at the discretion of the provider or the admitting physician, who may choose to keep it in at their discretion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bronchiolitis by the attending physician
* On high flow nasal cannula (4 liters or greater)
* Ages 0 months to 23 months

Exclusion Criteria:

* Diagnosis of bacterial pneumonia
* History of cranio-facial anomalies
* History of congenital heart disease
* History of G-tube dependence
* History of short gut syndrome
* History of tracheostomy or current tracheostomy
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.

To conduct a prospective, randomized, controlled trial of all virgin penile prosthesis implantations with the goal of assessing Irrisept's candidacy as an alternative to traditional antibiotic irrigation (Rifampin, Gentamicin for all patients, with the addition of Amphotericin B if patient has a history of diabetics) during penile prosthesis surgery. The investigators believe that Irrisept provides adequate antibacterial and antifungal coverage to serve as an alternative to traditional antibiotic therapy. Additionally, the investigators believe a cost analysis would support the use of Irrisept in the event that non-inferiority is demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)

Exclusion Criteria:

* Exclusion criteria include men who are having revision implant surgeries, men who may require intraoperative complex reconstruction including graft for Peyronie's Disease, and transgender males
Comparison of the Epifaith® Syringe With the Plastic Syringe

The goal of this clinical trial is to compare the efficiency of identifying epidural space with either the Epifaith® syringe or the plastic syringe in parturients. The main questions it aims to answer are:

* Whether it consume less time identifying epidural space with the Epifaith® syringe
* Whether the usage of the Epifaith® syringe decrease the complication rate and failure of labor analgesia Participants will receive labor analgesia either with the Epifaith® syringe or the plastic syringe conducted by experienced resident doctors.


Eligibility Criteria:
Inclusion Criteria:

* ASA II to III
* Require labor analgesia
* Has submitted inform consent

Exclusion Criteria:

* ASA IV or above
* Coagulopathy
* Spinal deformity
* Neurological, psychological, cardiopulmonary disorder
* Active liver or kidney injury
SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET

The investigators propose to compare the effectiveness of 3 strategies (low, medium, high intensity) at supporting CHCs' implementation of the ALL Initiative (an intervention shown to reduce patients' cardiovascular disease (CVD) event risk), through a cluster-randomized trial.

The investigators propose to compare the effectiveness of 3 support strategies for optimizing the sustainable implementation of the evidence-based ALL intervention. To do so, the investigators will randomize 30 community health centers (CHCs) to receive 1 of 3 implementation support strategies: Low support (toolkit only), Medium (toolkit, staff training), High (toolkit, training, on-site facilitation). The study aims are as follows:

Aim 1: Compare the effectiveness of the 3 strategies (low, medium, high intensity) at supporting CHCs' implementation of the ALL intervention, through a cluster-randomized trial.

Hypothesis: Clinics randomized to receive more implementation support will be more likely than those randomized to receive less support (high\>medium\>low) to significantly improve the percent of their patients with (i) guideline-appropriate prescriptions for ACE/ARBs and statins, and (ii) last blood pressure (BP) and low-density lipoprotein (LDL) under control).

Aim 2: Assess how effectively the 3 strategies support intervention sustainability at 12, 24 and 36 months post-implementation, measured as maintenance of change over time (outcomes as in Aim 1).

Hypothesis: Clinics randomized to receive more implementation support will be more likely to maintain changes in the outcomes of interest.

Aim 3: Identify clinic characteristics associated with the support strategies' effectiveness (e.g. decision-making structures, leadership support, team processes / characteristics, readiness and capacity for change).

Research questions: What are the characteristics of clinics that achieve sustained change even with less implementation support, and of those that do not achieve change even with more support?

Eligibility Criteria:
Inclusion Criteria:

* Convenience sample, all patients with Diabetes Mellitus from 30 community health clinics (CHCs) that are members of OCHIN, Inc.

Exclusion Criteria:

* Patients without diagnosed DM
The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial

This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial.

The aim of this trial is to provide additional data on the factors influencing interferon (IFN) beta response.

This is a Phase 4 trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Was randomized in the REGARD 24735 study
* Is willing and able to comply with the protocol
* Has given written informed consent before performing any trial-related activities

Exclusion Criteria:

* Is unwilling or unable to participate in the study
* Is already included in the initial REGARD 24735 PGx sub-study
Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn

The Jebsen-Taylor Hand Function Test and Canadian Occupational Performance Measure (COPM) were considered as primary outcome measurements. Secondary outcomes included total active range of motion (ROM) of the digits, hand grip strength and pinch strengths (tip, palmer and lateral pinch). All measurement was conducted at two occasions: at the baseline and after intervention.

The included participant were children with a deep partial thickness or a full thickness burn induced by either a scaled or a flame thermal burn with involvement of more than 50% of the hand and wrist, total body surface area (TBSA) less than 30% , age ranged from 7 to 14 years, recent discharge of inpatient acute care, spontaneous healing (within 34 weeks) or grafting with split thickness or full-thickness skin grafts (at least before 2 weeks). Children were excluded from this study if they had infection, juvenile arthritis, fracture, tendon injuries, muscle injury, degenerative joint diseases, peripheral nerve diseases, Pre - established psychologically and physically disorders (extreme aphasia, cognitive and developmental deficits that can influence the rehabilitation).

Eligibility Criteria:
Inclusion Criteria:

* children with deep partial thickness or a full thickness burn
* burn induced by either a scaled or a flame thermal burn
* involvement of more than 50% of the hand and wrist
* total body surface area (TBSA) less than 30%
* age ranged from 7 to 14 years
* recent discharge of inpatient acute care
* spontaneous healing (within 34 weeks)
* grafting with split thickness or full-thickness skin grafts (at least before 2 weeks).

Exclusion Criteria:

* children with infection
* juvenile arthritis
* fracture
* tendon injuries
* muscle injury
* degenerative joint diseases
* peripheral nerve diseases
* Pre - established psychologically and physically disorders
* extreme aphasia
* cognitive and developmental deficits that can influence the rehabilitation
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo


Eligibility Criteria:
INCLUSION CRITERIA

1. Age greater than or equal to 18 years at the time of signing of the ICF.
2. The patient agrees to comply with the contraception and reproduction restrictions of the study
3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
4. At least 2 ferritin values during Screening \> 300 ng/mL
5. At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)

EXCLUSION CRITERIA:

1. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
2. Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
3. Actively treated or active malignancy
4. Known or suspected occult or active bleeding
5. Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry

Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device

The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System.

The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.

The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device.

The secondary objective is to evaluate adverse events and device performance of the newly marketed device.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use
2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry
3. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma

The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:

1. rate of abdominal CT scanning
2. time to emergency department disposition
3. the rate of missed/delayed diagnosis of intra-abdominal injury
4. the costs.


Eligibility Criteria:
Inclusion Criteria:

* Blunt torso trauma resulting from a significant mechanism of injury

  * Motor vehicle collision: greater than 60 mph, ejection, or rollover
  * Automobile versus pedestrian/bicycle: automobile speed \> 25 mph
  * Falls greater than 20 feet in height
  * Crush injury to the torso
  * Physical assault involving the abdomen
  * Decreased level of consciousness (Glasgow Coma Scale score \< 15 or below age-appropriate behavior) in association with blunt torso trauma
* Blunt traumatic event with any of the following (regardless of the mechanism):

  * Extremity paralysis
  * Multiple long bone fractures (e.g., tibia and humerus fracture)
* History and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)

Exclusion Criteria:

* No concern for inter-abdominal injury or no planned evaluation for possible IAI
* Prehospital or ED age adjusted Hypotension
* Prehospital or initial ED GCS score ≤ 8
* Presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt
* Penetrating trauma: stab or gunshot wounds
* Traumatic injury occurring \> 24 hours prior to the time of presentation to the ED
* Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
* Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
Female Muscle Enhancement

Participating in regular physical activity has been shown to reduce the risk of developing some diseases and disabilities that can occur with ageing. Muscles naturally decline with age, and in females this appears to occur more so around the time of menopause. Time, work, family commitments and the availability of facilities have all been identified as barriers to exercise in middle age.

Increasing activity levels in middle age appears to improve muscle function and bone health. However, there is a lack of evidence in how muscle function responds to low impact resistance exercise in middle aged females.

This study aims to assess the effectiveness and the mechanisms associated with building muscle as well as the effect on quality of life in middle aged (40-60 years) females using a low impact resistance training programme.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 40-60 years of age at time of screening.
* Body mass index \<30kg/m2 and \>18.5kg/m2
* Considered moderately active according to the 7 day International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)
* Self-reported as healthy (absence of injury or disease).
* Availability and willingness to attended 12 weeks of exercises classes 4-5 times per week at St Luke's Campus Exeter and participate in the study lasting a total of 26 weeks.

Exclusion Criteria:

* Pregnant, lactating or planning a pregnancy.
* Current diagnosis of a chronic disease such as diabetes, autoimmune disease, cardiovascular disease, kidney disease.
* Hysterectomy and/or ovariectomy.
* Currently prescribed hormone replacement therapy.
* Hypertension (BP ≥149/90 mm/Hg)
* Either current smoker, or history of smoking in the past 6 months.
* Currently taking supplements that have been shown to impact muscle function and muscle mass, such as creatine, in the last 6 months.
* Prescribed medications that have been shown to impact muscle function and muscle mass, such as steroids, in the last 6 months.
* History of epilepsy.
* Current or recent injury within the last 6 months that may affect their ability to carry out the resistance training program.
* Advised not to exercise by their General Practitioner or medical professional.
* Resistance training consistently for 3 or more times per week for the last 2 months