cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.

When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* 18 years of age or older
* Capable of giving informed consent
* Pigmented lesions (such as moles) present on the forearm

Exclusion Criteria:

* Unable to provide consent
* Open cuts/sores on the skin, skin infection, or any contagious skin condition
* Pregnant women (according to subject)
* Employees under the direct supervision of the investigator
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

The best reperfusion strategy for medium-sized vessel occlusion (MeVO) is not well established. Given the proven treatment effect of intra-arterial thrombolysis in patients with large vessel occlusion (LVO), the investigators hypothesized that intra-arterial tenecteplase (TNK) could increase the recanalization rate of MeVO and thus improve clinical outcome. The current study aimed to explore the safety and efficacy of intra-arterial TNK in patients with MeVO.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Medium vessel occlusion (MeVO), referring to M2-3 of MCA; A1-3 of ACA; P1-3 of PCA; PICA, AICA or SCA (including primary, distal embolism in the same region after thrombectomy or concurrent embolism in other regions).

   * Primary MeVO as detected by the first DSA examination or secondary MeVO after mechanical thrombectomy for large vessel occlusion;
   * MeVO causes neurological deficits in motor strength, language, vision etc;
   * Endovascular mechanical thrombectomy cannot be performed as assessed by the investigator;
   * Absence of parenchymal hematoma on CT images performed in the angio suite.
3. Within 24 hours from symptom onset;
4. Signed informed consent by patient or patient's legally authorized representative.

Exclusion Criteria:

1. Patients with completed infarction in the territory of the MeVO on non-contrast CT;
2. Patients with intracranial hemorrhage;
3. Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (\<100,000/mm3);
4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
5. After mechanical thrombectomy, severe and sustained (\> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg);
6. Patients with contraindication or allergy to any ingredient of study medication;
7. Pregnancy, plan to get pregnant or active lactation;
8. The estimated life expectancy is less than 6 months due to other serious diseases;
9. Other conditions unsuitable for this clinical study as assessed by researcher.
Association Among Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Caregivers of Stroke Individuals

This study aims to examine pain perception, temporomandibular disorder severity and spine health in caregivers of stroke patients.

The sample of the study will consist of caregivers who reside in Tokat and Kırıkkale, are over 18 years old, care for an individual who has had a stroke and volunteer to participate in the study. Individuals will be contacted via social media, and squestionnaires will be administered face-to-face to those who agree to participate in the study. According to the G\*Power analysis, if the sample size is α= 0.05, β= 0.80, acceptable correlation coefficient r= 0.70, and negligible correlation coefficient r= 0.20, 16 individuals are sufficient to measure the relationship between two parameters. Since the relationship between four parameters will be evaluated, a total of 64 individuals are required.

Data for the study will be collected face-to-face by individual researchers using data tools that individuals can fill in themselves. Data will be collected from individuals with The Centrality of Pain Scale, Discomfort Intolerance Scale, Spine Functional Index, and Fonseca Anamnestic Index instruments.

Statistical Package for Social Sciences (SPSS), version 22.0 computer package program for Windows, will be used for statistical analysis. Statistical data will be expressed as mean ± standard deviation (X±SD), median or percentage (%). One Sample Kolmogorov Smirnov test will be performed to show parametric or nonparametric distribution of the data. When parametric test assumptions are met, the relationship between parameters is determined by Spearman correlation test; When parametric test assumptions are not met, the relationship between the parameters will be examined with the Pearson correlation test. Statistical significance value will be accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* To be volunteer

Exclusion Criteria:

* Those who cannot speak, read or write Turkish.
Shared Decision-Making for Colorectal Cancer Screening

The overall objective of this study is to conduct a three-arm randomized controlled trial to evaluate the impact of an interactive, web-based decision aid on shared decision-making and patient adherence to colorectal cancer (CRC) screening recommendations.

Colorectal cancer (CRC) is the second leading cause of cancer-related death and third most commonly diagnosed cancer among men and women in the United States. Screening has been shown to be a cost-effective strategy for reducing both CRC mortality through early detection and incidence through the detection and removal of precancerous adenomatous polyps (adenomas). Despite a compelling rationale and widespread endorsement by authoritative groups, screening rates remain far below those necessary to achieve significant reductions in CRC mortality or incidence. Poor patient acceptance and non-adherence to screening recommendations are partly responsible for low screening rates. Shared decision-making has been advocated as a potentially effective yet unproven strategy for addressing this problem. Implicit in this approach is the need for an unbiased decision aid that not only educates patients about the pros and cons of the different strategies so as to enable them to identify a preferred strategy but also empowers patients to take a proactive role in the decision-making process, thereby increasing satisfaction and promoting adherence. From a logistical standpoint, the decision aid must also be easy to implement in the ambulatory setting so as to maximize use but minimize demands on physician time and office resources. To address this need, we have developed an interactive, web-based decision aid and implementation strategy for use in routine clinical practice.

Comparison(s): Average risk subjects assigned to one of two intervention arms (decision aid alone versus decision aid plus personalized risk assessment with feedback) compared to a control arm(generic website that discusses lifestyle changes that can reduce overall cancer risk).

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic average-risk subjects
* Under the direct care of one of participating site's staff (attending) physicians or physician extenders;
* No prior screening other than fecal occult blood testing (FOBT);
* No major co-morbidities that preclude CRC screening by any method

Exclusion Criteria:

* Prior CRC screening by any method other than FOBT occult blood testing
* High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives, chronic inflammatory bowel disease)
* Lack of fluency in written and spoken English (since decision aid and personalized risk assessment tool will be in English only due to funding issues);
* Comorbidities that preclude CRC screening by any method
Ischemic Preconditioning in Total Knee Arthroplasty

The application of a tourniquet for 5 minutes and subsequent reperfusion before actual inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases the level of local inflammation and therefore postoperative pain in response to reperfusion of the ischemic extremity.

During knee surgery your surgeon routinely uses a device called a tourniquet that allows us to temporarily cut of blood supply to the site of surgery. This helps to reduce blood loss and improves operating conditions. When allowing blood back into your leg at the end of the procedure, debris (bone, fat, tissue breakdown products and cement from the surgery) gets washed out and gains access to the rest of your body. In the vast majority of cases this event bares no major clinical consequences, but can rarely result in signs of inflammation of various body systems. Patients with evidence of impaired organ system function such as pre-existing lung and heart disease may be more vulnerable. Previous studies suggest that cutting off the blood supply for a short period of time just before a prolonged episode, could lead to a decrease in the extent of tissue breakdown products in this extremity and may thus be associated with a decrease in the inflammation of other organ systems. We propose to study this theory in knee surgery patients by looking at levels of markers of inflammation present in the blood before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing primary total knee arthroplasty

Exclusion Criteria:

* Patients who chronically use narcotics (\<1 month).
* Patients with contraindications (severe peripheral vascular disease, presence of femoral-popliteal bypass grafts, etc.) or no plan for tourniquet use as determined by the clinical care team.
* Patients who are on corticosteroids prior to their surgery
Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy

This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing Cholecystectomy.

see above

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* referral for cholecystectomy
* preoperative anxiety at least 4/10 points on a numeric rating scale
* physical and mental capability to participant
* written informed consent

Exclusion Criteria:

* Emergency surgery
* malignoma
* severe comorbidity
* severe psychological disorders
* immunosuppression
* coagulation disorders
Continuous Versus Intermittent Sciatic Block for Total Knee Arthroplasty

The role of a sciatic block in addition to a femoral block remains controversial. The study addresses this topic by comparing a continuous block versus an injection on demand.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total knee arthroplasty

Exclusion Criteria:

* failure to establish femoral and sciatic block
* insufficient analgesic effect of the block
* patient declines to participate
The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study

The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of this multi-center definitive study is to assess the safety and efficacy of the EarLens System for subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully activated system in their daily lives for a 4 month period of time. This study is designed to support US and International marketing applications to commercialize the EarLens System. The main efficacy hypothesis is that the EarLens System will be shown to improve speech understanding in quiet.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85 years
* Mild to severe hearing impairment between 125 to 4000 Hz
* No significant conductive hearing impairment
* Able and willing to commit to travel and time demands of the study

Exclusion Criteria:

* Must not have known or active medical issues that would preclude having a device including:

  1. an abnormal tympanic membrane
  2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes
  3. an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane
* Must not have other known or active medical issues including:

  1. history of chronic and recurrent ear infections in the past 24 mouths
  2. history of dizziness and/or vertigo in the past 24 months
  3. taking medications/treatments with known ototoxic effects
  4. a rapidly progressive or fluctuating hearing impairment
  5. having been diagnosed with having a compromised immune system
* Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
* Must not have an ear canal anatomy that preclude manufacture of the device as determined by EarLens manufacturing personnel
Bleeding, Cardio- and Cerebrovascular Complications in Head and Neck Surgery

In this retrospective registry trial, the investigators sought to assess the incidence and predictors of cardiovascular and cerebrovascular complications as well as their derivatives (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism) in cohort of patients undergoing head and neck surgery.

Inclusion criteria consisted of all the consecutive patients (n=456) diagnosed with head and neck cancer at Turku University Hospital between 1999 and 2008. Patients receiving palliative procedures were also included. Patients whose treatment had started in other institute or whose treatment was not finished in the investigators institute and patients with primary diagnosis of skin cancer were excluded from this study. All head and neck surgery operations (n=591) were assessed. Information was collected by the first author of this article from referral letters, patient files, anesthesiology reports, intensive care unit reports, laboratory database, radiology database, electrocardiograms and pathology reports. Death was certificated from national authority for collecting and compiling statistics on various fields of society and economy.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with head and neck cancer in Turku University hospital between 1999-2008

Exclusion Criteria:

* skin cancer, treatment started in other institute or not finished in our institute
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* FIGO stage: ⅠA, endometrial carcinoma;
* Female, Chinese women;
* premenopausal women；
* ≤ 50 years old;
* Pathological diagnosis by curettage/hysteroscopy : G1
* No prior treatment;
* Provide written informed consent.

Exclusion Criteria:

* The suspicious metastasis of ovarian;
* Family history of ovarian cancer;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials;
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy.

The objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for routinely accepted indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).
* 18 years of age or older.
* Otherwise in good health, as determined by physical exam and medical history.
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, or vasectomized spouse).
* Subjects with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia must have them corrected prior to study participation.
* Subject has read and signed the written informed consent document prior to study participation.

Exclusion Criteria:

* Subjects with known or suspected bowel perforation or obstruction, severe inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon, or massive and/or abnormal rectal bleeding.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects with uncontrolled cardiovascular disease.
* Subjects with congestive heart failure.
* Subjects with unstable angina pectoris.
* Subjects with ascites.
* Subjects with renal insufficiency.
* Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
* Subjects who are pregnant or lactating.
* Subjects who are allergic to polyethyleneglycol.
* Subjects who are allergic to sodium phosphate salts.
* Subjects who are currently taking, or plan to take, other sodium phosphate- containing products, such as enemas or non-prescription liquid purgatives.
* Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics.
* Subjects who are taking drugs that may affect electrolyte levels.
* Subjects receiving non-study laxatives, antacids and prokinetic agents during the study.
Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus

This study aims to investigate the feasibility and effectiveness of a remotely delivered psychological intervention for youth with cSLE. This intervention aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.

This project is investigating whether a remotely delivered psychological intervention is acceptable and beneficial to teens and young adults coping with cSLE. This study uses a cognitive behavioral therapy (CBT) intervention called the Treatment and Education Approach for Childhood-onset Lupus (TEACH) to address symptoms of fatigue, depression, and pain that commonly occur in individuals with cSLE. The TEACH program includes six-weekly, one hour sessions, conducted over HIPAA-compliant video conferencing.

Participation in this study will take approximately 8-15 weeks, with a follow-up survey occurring 3-months after post-assessment, and a long-term follow-up survey occurring between 12-27 months after post-assessment. After qualifying for the study, participants will be randomly selected, like flipping a coin, to the TEACH program plus medical treatment as usual (TAU) OR medical TAU alone for six weeks. After this six-week time period, a post-assessment will be completed. Participants that only continued medical TAU will then be eligible to receive TEACH after completing the post-assessment. If these participants choose to undergo the TEACH treatment, they will be asked to complete a short interview about the program and answer questions about how their mood, pain, and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years
* Participants must have at least one elevation (based off of screening measures) in fatigue, or depressive symptoms, or pain
* Patient participants must have English language proficiency
* For participants under age 18, must have a primary caregiver willing to participate.

Exclusion Criteria:

* Patients with other chronic medical conditions (e.g., juvenile arthritis),
* Patients with a documented developmental delay, severe cognitive impairment, or thought disorder
* Patients with an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression, or active suicidal ideation)
* Patients currently receiving psychological treatment for depression, fatigue or pain will be excluded to prevent overlapping treatments that may confound outcomes.
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

The study aims at the identification and the quantification of urinary branched-chain amino acids (BCAAs) by mass spectometry in healthy subjects and patients with insulin resistance and correlating urinary BCAAs with HOMA index.

Blood and urine levels of BCAAs will be correlated with HOMA index to assess and quantify insulin resistance.

Identification and quantification of urine BCAAs by an innovative method based on synthetic biology will also be performed.

Correlations between mass spectometry and the innovative detection method of BCAAs will be searched.

Blood and urine samples will be collected in 330 persons to assess BCAAs levels and correlate them with HOMA index.

Persons included will be:

110 persons with BMI\>27 and HOMA \>4 with no diabetes 110 persons with BMI\>27 and HOMA \< 4 with no diabetes 110 persons with BMI \< 27 and HOMA \<4 with no diabetes, including at least 50 men and 50 women, 30 aged 18-35, 30 aged 36-55, 30 aged 56-75.

Urine BCAAs will be measured by both mass spectrometry and the innovative method based on synthetic biology.

Eligibility Criteria:
Inclusion Criteria:

* no diabetes
* according to studied subpopulations: BMI\<27 and HOMA \<4, BMI\>27 and HOMA\>4, BMI\>27 and HOMA\<4

Exclusion Criteria:

* pregnancy or lactation
* active or suspected chronic infection
* treatment affecting insulin sensitivity
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17


Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.

Exclusion Criteria:

* Serum creatinine \>2 mg/dL
* Positive pregnancy test in females of childbearing potential
* History of intolerance or hypersensitivity to macrolide antibiotics