cyrilzakka/clinical-trials huggingface dataset:
Eon™ FR Clinical Study Protocol 1064

This study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue.

This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 30 kg/m2 or less.
* Healthy male or female between the ages of 21 and 60.
* Had, at least 25 mm thickness adipose tissue on abdomen.
* Able to read, understand and sign the Informed Consent Form (ICF).
* Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
* Willing to have limited sun exposure for the duration of the study, including the follow-up period.
* Willing to have photographs and ultrasound measurements taken of the treated area, which could be used de-identified in evaluations and could be used de-identified in presentations and/or publications.
* Female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study.
* Female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative.
* Agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight.

Exclusion Criteria:

* Aesthetic fat reduction procedure in the treatment area within the previous year.
* Age less than 21 or greater than 60 years old.
* Female subject pregnant or planning to become pregnant during the study duration,
* Had an infection, dermatitis or a rash in the treatment area.
* Had tattoos or jewelry in the treatment area.
* Had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
* Had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
* Had a history of a known bleeding disorder.
* Had a known photosensitivity to the study laser wavelength, history of ingesting. medications known to induce photosensitivity, or history of seizure disorders due to light.
* Had known collagen, vascular disease or scleroderma.
* Underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
* Had underwent a fat reduction procedure in the treatment area within the past 12 months.
* Had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
* Underwent systemic chemotherapy for the treatment of cancer.
* Used gold therapy for disorders such as rheumatologic disease or lupus.
* Participated in a study of another device or drug within three months prior to enrollment or during the study.
* As per the investigator's discretion, the subject had any physical or mental condition which might make it unsafe for the subject to participate in this study.
* Concurrent use of steroids or secondary rheumatoid drugs.
* Prior liposuction or a tummy tuck in the study area.
Asymptomatic COVID-19 Trial

The coronavirus disease-2019 (COVID-19) is spreading throughout the United States. While there are no known therapies to treat those who have become sick, there have been some reports that a medication currently used to treat rheumatoid arthritis, lupus, and malaria (Hydroxychloroquine sulfate, also known as Plaquenil) may help to lessen the chance or severity of illness, especially if combined with a medicine that treats other kinds of infections (Azithromycin, also known as Zithromax or Zmax or Zpak).

There are some people who test positive for the virus but who are otherwise not ill. Current standard of care is to advise these people to self-monitor but no treatment is offered. It is not known how many of these individuals will remain symptom free, and how many will become sick or how severe those symptoms will be. This study will randomize those people who do not have symptoms into one of three treatment plans 1) Hydroxycholoquine and Azithromycin, or 2) no active medication (placebo). All participants will be followed for 2 months.

The study will determine if there is any benefit to those who are asymptomatic to taking taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit from taking these medications.

Participants will be randomized into one of two treatment plans

1. Hydroxycholoquine sulfate in combination with Azithromycin Hydroxycholorquine as above, plus Azithromycine: 500 mg po for day 1and then 250 mg QD for 4 days
2. no active medication (placebo)

All participants will be followed for 2 months. The primary aim is to determine if there is any benefit (reduced likelihood for development of fever and other symptoms of COVID-19 ) to taking only Hydroxychloroquine sulfate, or to taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit to taking these medications for this population.

Eligibility Criteria:
Inclusion Criteria:

1. Documented SARS-CoV-2 infection by qPCR assay without symptoms consistent with COVID-19 within 1 week of enrollment
2. Age ≥20

Exclusion Criteria:

1. Retinal eye disease
2. Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
3. Known chronic kidney disease, stage 4 or 5 or receiving dialysis
4. Current use of:

   * Class 3 AAD - amiodarone, dronaderone, dofetilide, sotalol)
   * Class 1A AAD (procainamide, quinidine, disopyramide)
   * Flecainide
   * chlorpromazine
   * Cilostazol (Pletal)
   * Donepezil (Aricept)
   * Droperidol
   * Fluconazole
   * Methadone
   * Ondansetron(Zofran)
   * Thioridazine
   * Macrolides (clarithromycin, erythromycin)
   * Fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin)
5. Pregnancy or women who are breast feeding
6. Inability to tolerate oral medications
7. Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate
8. Allergy to adhesives
9. QTc interval \> 450 mSEC for men and women
10. History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval
11. Non-English-speaking
Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.

Current management of hypertension in PD motor fluctuators is flawed. The current practice often is to treat transient hypertensive spikes reported by patients or measured in clinics with anti-hypertensive medications. This may contribute to morbidity by worsening orthostatic hypotension and increasing fall risk. There is a scarcity of literature on this subject and there is no documentation of severe hypertension with rises in systolic blood pressure exceeding 50% of baseline occurring during motor "OFF". There are two studies that have demonstrated that blood pressure fluctuation can occur in motor fluctuators during the "OFF" state1,2. The study by Baratti et al measured blood pressure in 13 Parkinson's disease patients, 7 with motor fluctuations and 6 without fluctuations. In the fluctuators, the mean systolic/diastolic blood pressures were significantly higher than the non-fluctuators during the "OFF" state but not the "ON" state.

This is an observational study. This study will only recruit Parkinson's subjects with rises in systolic blood pressure exceeding 50% of baseline during motor off periods to select for subjects with severe blood pressure fluctuations. The clinical characteristics, including but not limited to, the degree of change of the motor tapping score, during an "off" period of this group of subjects with severe hypertension. There is a screening visit, a at home monitoring period, and a one-time 4-8 hour study visit for subjects that satisfy the inclusion criteria. The screening visit will assess Parkinson's motor state and review the inclusion/exclusion criteria. The at home monitoring period will measure blood pressure twice a levodopa cycle for 5 cycles (for most subjects, this will be for two days and is dependent on the subject's clinical levodopa cycle). Measurements will occur pre-levodopa dose (the maximal "OFF" time), and half-way through the cycle (maximal "ON" time). The percentage of change will be calculated and those that have a systolic change of greater than or equal to 50% will proceed to the outpatient visit. The outpatient visit will measure blood pressure, pulse, Parkinson's motor symptoms, and plasma levodopa levels.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease fulfilling UK Brain Bank clinical criteria.
* Treatment with chronic levodopa (levodopa treatment for ≥ 3 years).
* Rise in "OFF" systolic blood pressure exceeding 50% of baseline "ON" systolic blood pressure as shown by at home monitoring.
* History of "wearing off" prior to 4 hours after the previous levodopa dose per patient report or chart documentation.

Exclusion Criteria:

* Daily beta-blocker therapy.
* Diabetes mellitus, autonomic neuropathy, or other condition known to alter autonomic functions.
* Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of \< 16
GDM Post Partum Screening

Immediate postpartum screening for diabetes mellitus in women with gestational diabetes

The objective of this study is to determine if screening for type 2 diabetes can be done 24 hours after delivery, versus 6-12 weeks postpartum, in recently delivered women having been diagnosed with gestational diabetes requiring medication therapy in the antecedent pregnancy.

1 Overview The purpose of the project is to determine if screening for diabetes mellitus, in women with gestational diabetes, can be done 24 hours postpartum versus 6-12 weeks postpartum.

Primary Objective: To compare the results from screening for type 2 diabetes 24 hours postpartum versus 6-12 weeks postpartum.

Design and Project Type Prospective cohort study. Women diagnosed with gestational diabetes and receiving anti-hyperglycemic medication therapy will have testing for type 2 DM done 24 hours after delivery. They will also have routine screening for type 2 DM done at 6-12 weeks postpartum.

Description of Intervention The intervention is early screening for type 2 DM which involves oral intake of a 75-- gram (g) glucose drink and subsequent measurement of fasting, 1- hour, and 2- hour postprandial point of care fingerstick s for blood glucose measurement.

Instruments Fingerstick testing will be done with StatStrip Glucose Hospital Meter (Nova Biomedical). This device is used routinely throughout the hospital and has been validated for use in all patients, including the critically ill. Using point of care testing will allow for accurate results with less pain for the patient, as compared to (fingerstick versus venipuncture).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, or recently postpartum, women with the diagnosis of GDM requiring medication therapy after 20 weeks,
* \>18 years-old (yo)yo,
* English speaking.

Exclusion Criteria:

* have pre-existing type 2 DM,
* did not require anti-hyperglycemic medication therapy (GDMA1),
* early onset GDM (\<20 weeks).
* do not speak English .
Multimodal, Task-Aware Movement Assessment and Control: Clinic to the Home

The investigators seek to construct a novel, multimodal, distributed system that facilitates a new paradigm of home-based medical surveillance and treatment for frail older adults centered on timely diagnosis of movement system impairments and personalized intervention. Measurements from a heterogeneous set of complementary sensors will be combined with clinically-informed and data-learned dynamic models of human motion to enable real-time activity recognition (e.g., sitting, standing, walking) and movement assessments (e.g., speed, repetition, quality). As the study progresses, the system will be integrated with wearable assistive technology to provide "smart", activity-specific assistance of movement deficits or the activation of caregivers if a decline in function is detected. Finally, the investigators will test the combined assessment and intervention system in the clinic and the home, identifying challenges and solutions for the scaling up to unconstrained real-world settings.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Capacity to consent
* Community dwelling
* Ability to follow 3-step commands
* Lives within 15 miles of Boston

Exclusion Criteria:

* Undomiciled
* Active substance use disorder
* Active psychosis
* Domestic violence or neglect
* Inability to communicate with investigators
* Other comorbidities that prevent full participation in the research
Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia (PCA)

The best way to provide analgesia after total hip arthroplasty is hotly debated. There are two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their proponents, but there are limited data for making an informed choice of protocols. For total hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with physical therapy. However, epidural analgesia can be associated with nausea, pruritis, dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided to use a different analgesic protocol, based on a peri-articular injection. This protocol avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as part of a multimodal pain therapy. The investigators propose to compare peri-articular injection to epidural patient controlled analgesia (Epidural PCA). The investigators will enroll 90 total patients (45 per study arm). The enrollment period will be approximately one year and the duration of the follow-up with study patients will be three months following their procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
* Age 50 to 80 years old
* Planned use of regional anesthesia
* Ability to follow study protocol

Exclusion Criteria:

* Patients younger than 50 years old and older than 80
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Patients with insulin-dependent diabetes
* Patients with hepatic (liver) failure
* Patients with chronic renal (kidney) failure
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with any prior major ipsilateral hip surgery
* Allergy to any of the medications (or adhesives) involved in the protocol
In Vivo Assessment of Endodontics Procedures

In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would be that the choose of this system based on the anatomical characteristics of the canal and the biological precepts. In teeth with lesions, contaminated dentin should be removed. However, in many systems, the manufacturer's approach disregards the fact that in wider root canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch the walls at the final apical. Therefore, the establishment of the initial apical file (LAI), the first instrument that measures the resistance of the walls in working length, could be a criterion in the choice of which system to use, and how many files work within the root canals after LAI determination. However, there is a lack of studies that demonstrate that LAI determination affects the degree of cleaning achieved, as well as the impact that LAI-based instrumentation may have on microcracks formation, canal transportation, postoperative pain and quality of obturation.In this way, the investigators propose a study in vivo performed, in patients from 8 to 18 years of age, therefore in large root canals. The protocol recommended by the manufacturer will be compared by means of a prospective randomized clinical trial, with the addition of the XP Endo finisher and with the protocol based on the initial apical file evaluating postoperative pain, exacerbation between the sessions, the quality of the obturation and periapical radiolucency repair. Considering that currently performing endodontic treatments using mechanized instruments is taught in undergraduate courses throughout the country, studies of this nature help the execution of a endodontics more critical and effective.

Infected root canal treatments will be performed in two sessions with a TF Adaptive system (Protocol recommended by manufacturer (Group Control) vs. Protocol based on the initial apical file). The root canals will be completed after 14 days. Patients will record postoperative pain during the follow-up period (7 days) using a Visual analogue scale (VAS) and the change in periapical radiolucency will be assessed by periapical index (PAI) scores.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have in their mandibular or maxillary molar teeth apical periodontitis symptomatic or asymptomatic with apical radiolucence.

Exclusion Criteria:

* Patients with medical history compromises outcomes
* Atresic and root canals
* Root canals with curvature greater than 30 degrees
* Previously performed endodontics treatment.
Femoral Neck Locking Plate Vs Multiple Cannulated Cancellous Screws in Treatment of Femoral Neck Fractures in Young Adults: Randomized Controlled Clinical Trial Study

Fracture neck femur are common injuries, especially seen in the elderly in the emergency setting. It is also seen in young patients with high-energy trauma. Immediate diagnosis and management are required to prevent threatening joint complications. Fracture neck femur in young adults is unsolved problem. The preservation of the native hip anatomy and biomechanics is essential in active young adults. Because of the vulnerable blood supply to the femoral part of the hip joint following these fractures, there is a high risk of developing avascular necrosis (AVN) and non-union. Any sort of surgical fixation should aim at preservation the blood supply while securing enough mechanical stability until the fracture unites. Open reduction is indicated in fractures which cannot be anatomically reduced by gentle manipulation. This should be carried out without any delay since this potentially can reduce the incidence of AVN. Treatment of fracture neck femur still controversial. There are several methods for treatment of fracture neck femur as multipe cannulated cancellous screws, locking plate, dynamic hip screw (DHS) with anti-rotational screw, and arthroplasty. There is no internal fixation method superior to another. In this study, we will compare the clinical and radiographic results of femoral neck locking plate vs multiple cannulated cancellous screw in treating femoral neck fractures in young adults.


Eligibility Criteria:
Inclusion Criteria:

* patients (20-55) years
* having unilateral traumatic femoral neck fracture
* idependent walker before trauma without any aids

Exclusion Criteria:

* open fracture
* pathological fracture
* preexisting deformity
* other pelvic or ipsilateral femoral injuries
* renal impairment or were on high dose steroids
Haptoglobin and Iron in Parkinson's Disease

This is a case/control epidemiology study to identify what are the iron-metabolism abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD predisposition.

A total of 342 participants, 100 PD patients and 242 age- and gender matched controls, were included in the study. All study participants were seen for one study visit in the morning at one of two Bastyr University Clinics in the Seattle area. Study participants were fasting at the time of the visit. During the study visit, participants donated a blood sample for the blood tests and complete an epidemiology questionnaire.

A subset of 51 of the study participant who were seen for the visit at Bastyr University, underwent brain scan and Magnetic Resonance Imaging (MRI), at the University of Washington Department of Radiology. The MRI part of the study aims at estimating brain iron levels.

Eligibility Criteria:
Inclusion Criteria for the Controls, for the blood draw and epidemiology visit:

* Volunteers should be of age between 52 and 82 years of age, males of females.

Exclusion Criteria for the Controls:

* presence of a neurodegenerative disease,
* presence of active cancer under treatment,
* HIV sero-positivity, Hepatitis B, C, of A sero-positivity
* rheumatoid arthritis
* recent blood donation (less than three months before the visit).
* fever at the time of the visit

Inclusion Criteria for the Parkinson's disease patients:

Diagnosis of Parkinson's disease (UKBB clinical criteria).

Exclusion criteria for the Parkinson's disease patients, for the blood draw and epidemiology visit:

* Presence of other neurodegenerative diseases, apart for Parkinson's disease
* two or more family members with Parkinson's disease
* presence of active cancer under treatment
* HIV sero-positivity, Hepatitis B, C, of A sero-positivity
* rheumatoid arthritis
* recent blood donation (less than three months before the visit).
* fever at the time of the visit

Exclusion criteria for the Magnetic Resonance Imaging:

* presence in the body of a ferro-magnetic metallic foreign object such as, but not limited to:
* a cardiac pacemaker
* aneurism clip
* neuro-stimulator
* surgical clip
* artificial limb or joint
* orthopedic items, such as screws, nails, pins, rods,
* any metallic foreign body from a previous injury, bullets, shrapnels, metal slivers.
* exclusion criteria for MRI is also the presence of claustrophobia
Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma

The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be greater than or equal to 18 years of age at Screening.
* Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
* Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
* Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.

Exclusion Criteria:

* Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
* Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
* Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of \>34 mm Hg.