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221. A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice

, ability and sufficient cognitive awareness to comply with the study protocol including: randomization; examination procedures; completion of planned bilateral cataract surgeries; compliance with no use of other MGD or dry eye treatments. Ability to understand, read and write English to consent to study participation and complete study questionnaires. Willingness to sign informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining

2018 Clinical Trials

222. Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.

speaking Signed HIPAA authorization Exclusion Criteria: Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (assessed via urine test). Current serious medical illness (assessed via self report). History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial

2018 Clinical Trials

223. Detection of Breast Cancer with Mammography: Effect of an Artificial Intelligence Support System. Full Text available with Trip Pro

Detection of Breast Cancer with Mammography: Effect of an Artificial Intelligence Support System. Purpose To compare breast cancer detection performance of radiologists reading mammographic examinations unaided versus supported by an artificial intelligence (AI) system. Materials and Methods An enriched retrospective, fully crossed, multireader, multicase, HIPAA-compliant study was performed. Screening digital mammographic examinations from 240 women (median age, 62 years; range, 39-89 years

2018 Radiology

224. Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)

Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: ≥ 18 years and ≤ 70 years old at the time of informed consent Ability to provide written informed consent and HIPAA authorization Eastern cooperative group (ECOG) performance status of 0 or 1 at time of informed consent (see Appendix 2) Histologically confirmed Lung Adenocarcinoma for which combined chemoimmunotherapy in the form of carboplatin/pemetrexed and pembrolizumab is being utilized. Subjects must have untreated

2018 Clinical Trials

225. Daily Liraglutide for Nicotine Dependence

device (IUD), tubal ligation) or agree to abstain from sexual intercourse during the time they are in the study. Able to communicate (speak, read, and write) fluently in English. Capable of giving written informed consent before any study-related activities, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form. Exclusion Criteria: Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study

2018 Clinical Trials

226. Evaluate Ease of Use and Surgeons Opinions of Presygenâ„¢/Si-1

for eligibility information Ages Eligible for Study: 22 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Sampling Method: Non-Probability Sample Study Population Patients undergoing breast reconstruction surgery and meet the inclusion and exclusion criteria. Criteria Inclusion Criteria: Candidate for surgical intervention with breast reconstruction as part of the surgical plan 22 years of age or older; Able to understand and provide informed consent with HIPAA

2018 Clinical Trials

227. Initiative for Early Lung Cancer Research on Treatment: Development of Study Design and Pilot Implementation. Full Text available with Trip Pro

Research for Treatment, to compare treatments for stage I NSCLC. HIPAA compliant institutional review board approval was obtained and we performed a feasibility study of the first 206 surgical patients.Lobectomy was performed in 89 (43.2%) patients, and sublobar resection was performed in 117 (56.7%) patients. Mediastinal lymph node resection was performed in 173 (84.0%) patients, 8 had N1 and 3 N2 lymph node metastases. Patients stated that both the surgeon's opinion (93%) and the patient's own

2018 Journal of Thoracic Oncology

228. Evaluation of Two Regimens, With Healthy Male and Female Babies, Ages 3-6 Months Old, Using Various Assessments.

. Parent/LAR Is 18 years of age or older and willing/able to present proof of guardianship for the infant subject (i.e., birth certificate, hospital records, adoption record, insurance card, other ID along with valid ID of parent/LAR). Parent/LAR has signed the ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure in English, for the infant to participate in the study. Parent/LAR agrees not to introduce any new products or fragrances on his/her person, on his/her infant

2018 Clinical Trials

229. Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

have no known allergy to riluzole or inactive ingredients* in ROSF. Subjects or subject's legally authorized representative must be willing and able to complete informed consent/assent and HIPAA authorization. Ability to comprehend and be informed of the nature of the study, as assessed by the Primary or Sub-Investigator. Subjects prescribed to take riluzole at or before the time of first dose. (The study is open to subjects currently taking riluzole at screening, subjects who are not currently

2018 Clinical Trials

230. The Use of Oracea and Epiduo Forte in Severe Acne Patients

will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.] ii. Facial acne IGA score of 4 iii. Minimum of 20 or more inflammatory lesions and 20 or more non-inflammatory lesions and not more than 4 nodules iv. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization

2018 Clinical Trials

231. LaseMD System for the Treatment of Melasma

to enrollment and during the entire course of the study. Absence of physical or psychological conditions unacceptable to the investigator. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup). Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. Exclusion Criteria: Inability to understand the protocol or to give

2018 Clinical Trials

232. Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age ≥ 18 years at the time of consent (no upper age limit) Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 (see Section 10.1 Appendix A) Tumor Eligibility: Dose escalation cohorts: Histologically confirmed advanced solid tumor

2018 Clinical Trials

233. Topical Collagen Powder for Healing of Acute Full-thickness Wounds

, Layout table for eligibility information Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Outpatient, male or female subjects of any race, 18-75 years of age Able to understand the requirements of the study and understand and sign Informed Consent/HIPAA Authorization forms Patients willing to refrain from using topical medications to punch biopsy sites Patients who are willing to follow

2018 Clinical Trials

234. Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma

personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Written informed consent and HIPAA authorization for release (...) of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age ≥ 18 years at the time of consent. ECOG Performance Status of 0-1 within 28 days prior to registration (Appendix 1). Life expectancy of 6 months or greater as determined by the site investigator. Histologically-confirmed diagnosis of unresectable stage IV or metastatic melanoma not amenable to local therapy. Measurable disease, defined as at least 1 tumor

2018 Clinical Trials

235. Evaluation of Skin Attributes Following Dietary Supplement Consumption

images for use in relation to this clinical study; Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; Subject understands and is willing to sign an Informed Consent in conformance with 21 CFR Part 50: "Protection of Human Subjects." Exclusion Criteria: Subject is pregnant, planning to become pregnant, or nursing; Subject is known to have, or at risk for, photosensitivity reactions (e.g. very sensitive to ultraviolet light); Subject has scars, tattoos, moles

2018 Clinical Trials

236. A Randomized Control Trial: Returning to Run After Injury

will be kept in a secure location and access limited to authorized research study personnel. This research study meets the confidentiality requirements of the Health Insurance Portability and Accountability Act (HIPAA). Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Wounds and Injuries Knee Injuries Leg Injuries

2018 Clinical Trials

237. Effect of CT1812 Treatment on Brain Synaptic Density

consent or oral assent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable]. If the Participant can provide only assent, their legally authorized representative also must provide written informed consent. Written informed consent also shall be obtained from the responsible caregiver. All consent processes must be undertaken in the presence of a witness and prior to any study procedures. Must

2018 Clinical Trials

238. Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers

from participation with urine dipstick tests used to rule out pregnancy (pregnancy test performed before each treatment session, days one, five) All non-English speaking/writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study. If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well. Allergy to any

2018 Clinical Trials

239. Autologous, Culture-Expanded Mesenchymal Stromal Cells for Degenerative Disc Disease

, diagnostic imaging, and follow-up visits and assessments. Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure. Exclusion Criteria: Subjects who are pregnant or nursing, or subjects planning to become pregnant in the first 24 months post-treatment. If a subject becomes pregnant during the study, the subject will remain in the study and only the requirement for radiation (x-ray or MRI

2018 Clinical Trials

240. Activated Carbon Interphase Effect on Biofilm and Total Bacterial Load

products. Patients with full-thickness wounds that are not yet extending to the bone or tendon. Patients with wounds present for at least 4 weeks, but no longer than one year. Patients with initial bacterial load greater than or equal to 104 colony forming units (CFUs), but less than or equal to 106 CFUs. Patients who have voluntarily signed the informed consent form, including HIPAA Authorization. Exclusion Criteria: Patients who are younger than 18 years of age. Patients with autoimmune conditions

2018 Clinical Trials

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