cyrilzakka/clinical-trials huggingface dataset:
nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy

Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis. (Wijmans, et al., 2019). The effectiveness of nCLE with intravenous fluorescein has been demonstrated in central lung cancers using esophageal ultrasound guided needle placement (Wijmans, et al., 2019). In this study, the proposed nCLE lung cancer criteria had high accuracy for lung cancer detection and were consistently recognized by multiple raters. Probe based confocal microscopy (pCLE) has also been used in conjunction with a radial probe EBUS in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (Hassan, et al., 2017) Needle based confocal laser endomicroscopy (nCLE) has not previously been used in conjunction with robotic navigational bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.
* Patients undergoing robotic navigational bronchoscopy for evaluation of indeterminate lung nodules with largest dimension size of 8-30 mm
* Age \> 18 years.
* Patients must have normal organ and marrow functions as defined below:

Leukocytes \> 3,000/mcL Absolute neutrophil count \> 1,500/mcL Total bilirubin within normal institutional limits Hemoglobin ≥7.0 AST/ALT (SGOT/SGPT) \< 2 times institutional normal limits Creatinine OR Creatinine Clearance within normal institutional limits OR \> 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal

* Ability to understand and willingness to sign a written informed consent and HIPAA consent document
* WOCBP must agree not to get pregnant until after the day of the procedure

Exclusion Criteria:

* Patients with uncorrectable coagulopathy will be excluded.
* Known allergy to fluorescein or other contrast media
* Patients with hemodynamic instability will be excluded
* Patients with refractory hypoxemia will be excluded
* Patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure
* Patients who are unable to tolerate general anesthesia according to the anesthesiologist
* Patient requires chemotherapy
* Pregnant or breast feeding. Refer to section 4.5 for further detail.
* Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
* Pregnancy:

Women of child-bearing potential (WOCBP) who are pregnant on the day of the procedure will be excluded from the study.
Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders

Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to evaluate the efficacy of CROCUVIS® in computer vision syndrome, sleep and mood disorders in a sample of university students who use digital devices.


Eligibility Criteria:
Inclusion Criteria:

* CVS-Q© score ≥6.
* Age between 18 and 40 years (both inclusive).
* Exposure to digital devices 4 hours a day, at least five days a week or more and maintain the same level of exposure throughout the study period.

Exclusion Criteria:

* Monocular corrected distance visual acuity \>0.0 LogMAR.
* Ocular pathology under treatment at the time of the study.
* Previous ocular surgery that could affect the tear film or the ocular surface.
* Ocular Surface Disease Index (OSDI) questionnaire score ≥13.
* Previous diagnosis or history of dry eye syndrome and/or blepharitis.
* Regular (daily) use of rigid or soft contact lenses ≥3 days a week.
* Regular use of any ocular lubricant.
* History of oral intake of dietary supplements, with or without herbal ingredients, intended to contribute, maintain or reduce the risk of suffering diseases related to visual function, mood or sleep within the four weeks before the study enrollment.
* Systemic disease:

  1. Uncontrolled hypertension (systolic/diastolic blood pressure \>140/90 mmHg).
  2. Uncontrolled diabetes mellitus (fasting blood glucose level \>180 mg/dL).
  3. Rheumatoid arthritis.
  4. Tumor disease.
  5. Active hepatitis (type B and C).
  6. Active infectious disease.
  7. Kidney disease that compromises diuresis.
* Current systemic treatment or in the last 3 months with drugs that may interfere with the results, for example:

  1. Opioids.
  2. Antipsychotics.
  3. Antibiotics (tetracyclines, sulfonamides)
  4. Antiarthritic drugs (hydroxychloroquine)
  5. Hypotensive drugs (beta-blockers)
  6. Anticoagulants (heparin, warfarin, or clopidogrel)
  7. Antidepressants (such as fluoxetine, among others)
  8. Hypnotics (eg, benzodiazepines)
* Habitual smoker and/or alcohol drinker. More than 3 cigarettes per day and/or more than 3 Standard Drink Units (SDU) per week, including weekends. SDU is defined as the consumption of 10 ml of alcohol.
* Regular job with rotating shifts including night shift in the last month (including weekends).
* Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.
* Participation in another clinical trial in the last 3 months.
* Take any type of dietary supplements with botanical components in the last month.
A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine

The purpose of the study is to collect information on how the medicine Victoza® (liraglutide) works in people with Type 2 diabetes in Iran. Patients will get Victoza® as prescribed to them by their study doctor. The study will last for about 5 to 8 months. Patients will be asked to complete some questionnaires about their health and diabetes treatment. Patients will complete these during their normally scheduled visits with study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* The decision to initiate treatment with commercially available Victoza® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
* Patients diagnosed with type 2 diabetes mellitus (T2DM), with treatment planned according to the Iranian label for Victoza® at treatment initiation
* Available glycated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of treatment with Victoza®

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Known or suspected hypersensitivity to Victoza® or related products
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Photocil (Topical) for the Treatment of Psoriasis Vulgaris

Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of psoriasis

NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Psoriasis Area Severity Index (PASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.

Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.

In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with psoriasis vulgaris confirmed by a dermatologist
* Psoriasis lesions affecting at a minimum 5% of the facial, legs, or arms surface area
* ￼Age: 18 to 65
* Participants able to give informed consent

Exclusion Criteria:

* Subject did not respond to prior phototherapy treatment
* Subject completed phototherapy for same lesion(s) in last 6 months
* Subject has previous history of skin cancer
* Subject has previous history of photosensitivity
* Subject has a history of herpes (HSV I or II) outbreaks
* Subject has previous history of autoimmune disease may be excluded at investigator's discretion
* Subject is currently taking of immunosuppressive or photosensitizing drugs
* Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigator's discretion
* Subject is pregnant or lactating women
Implementation and Evaluation of Measurement-Based Care (MBC) Training

The purpose of this study is to get feedback on a new standardized Measurement-Based Care (MBC) provider training program.

Measurement-Based Care (MBC) is the systematic ongoing collaborative evaluation of patient symptoms and well-being to inform clinical decision-making and behavioral health treatment. In this study, the goal is to receive feedback through surveys with experienced clinicians/practitioners to improve the training program design. Patient Satisfaction Surveys (PSS) were completed prior to and after clinician training. PSS assessed how Patient-Rated Outcome Measures (PROMs) are utilized by their clinicians, communicated during sessions and the ease to which completion is attainable as well as the patients' opinion regarding the use of such measures in treatment.

Eligibility Criteria:
Inclusion Criteria:

* Mental health providers in Carilion Clinic

Exclusion Criteria:

* None
Non Invasive Ventilation After Cardiac Surgery

Patients with respiratory failure following cardiac surgery are randomized to receive standard therapy versus non invasive ventilation. The hypothesis is that patients receiving non invasive ventilation will perform better than those who received standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* hypoxia

Exclusion Criteria:

* pneumothorax
* cardiocirculatory instability
* no written consent
MoVE Trial: Motivational Strategies to Empower African Americans to Improve Dialysis Adherence

MoVE Trial is a randomized clinical trial designed to rigorously test the impact of a behavioral intervention (culturally tailored motivational interviewing - (MOVE)) delivered by trained health coaches, on hemodialysis treatment non-adherence. It is a a two-arm, parallel group randomized clinical trial with 24-week follow-up. It involves completion of surveys by patients enrolled in the study. It also involves participation in motivational interviewing sessions by patients who are randomized to the intervention (MI).


Eligibility Criteria:
Inclusion Criteria:

* African American
* Receiving hemodialysis treatments
* Been on hemodialysis for more than 30 days
* 18 years of age and older
* Within a 2-month look back at the time of screening, patients who have missed at least one dialysis session or shortened at least one dialysis session by 15 minutes.

Exclusion Criteria:

* Not self-identified as African American
* Impaired with mental status or severe illness
* Non-English speaking
* No documented evidence of dialysis treatment non-adherence
* Missed or shortened treatments due to hospitalizations or excused travel
* Terminal condition
* Living in a nursing home/rehab
* Planned transplant within the next 6 months
* Planned conversion to peritoneal dialysis within the next 6 months
Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer

Altered quality of life in patients with stage III or IV colon cancer is well known. At their sides, their spouse/partner must also cope with the suffering caused by the disease and the upheavals that it engenders, with the treatments, in the organization of their everyday life. The physical, emotional, social and financial impact of cancer in general and its treatment on care-givers has already been studied. However, there are no data concerning the "objective burden", that is to say the nature and the magnitude of the care weighing on the spouse of persons with colon cancer. Objective is to develop and validate a questionnaire that can be completed by the spouse/partner of patients with stage III or IV colon cancer so as to evaluate the burden of the disease in everyday life. It will allow medico-social professionals to identify spouses/partners in difficulty and the needs of patients so as to offer the best support.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients:

Men or women :

* able to understand written and spoken French ;
* Who have been informed about the study;
* with stage III or IV cancer of the colon or recto-sigmoid junction (Code C18 and C19 of the ICD 10), operated or not with curative intent; treated with chemotherapy in one of the study centres (adjuvant or 1st-line chemotherapy or palliative chemotherapy);
* Currently living with a spouse or partner;
* Who has consented to his/her spouse/partner taking part in the study.

Inclusion criteria for the spouse/partner:

Men or women:

* able to understand written and spoken French ;
* Who have been informed about the study; living at the home of the spouse/partner;
* Able to take part in an interview of approximately one hour;
* Who has provided consent to take part in the study.

Exclusion Criteria:

Exclusion criteria for patients:

Men or women :

* Under guardianship;
* With a severe disease resulting in a major handicap;
* With severe mental retardation affecting ability to understand;
* With rectal cancer;
* with stage I or II cancer of the colon or recto-sigmoid junction;
* with a history of treated cancer (colorectal or other);
* with another cancer under treatment

Exclusion criteria for the spouse:

Men or women:

* Under guardianship;
* With a severe disease resulting in a major handicap;
* With severe mental retardation affecting ability to understand
Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

The purpose of this study is to determine if a handheld ultrasound device helps in the placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound device compared to a standard ultrasound machine.

Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Ultrasound evaluations will be conducted in a cohort of 50 parturients who decide they want epidural analgesia in labor. Prior to epidural placement, a hand held ultrasound device will be utilized to identify L2/3, L3/4 and L4/5 interspace. A mark will be made on the patient's back at these levels. The handheld ultrasound device will also estimate the depth to epidural space at each level using its programmed algorithm. A standard ultrasound will then be used to locate the same interspaces, identify midline, and estimate depth to epidural space with caliper calculation. Upon patient request, an epidural will be placed at L3/4 with a loss of resistance to saline technique. The actual depth to loss of resistance during epidural insertion will be determined by measuring the Tuohy with a sterile measuring tape while it is in the skin.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status class I, II, or III
* age between 18 and 50
* singleton term pregnancy
* requesting epidural analgesia for anticipated vaginal delivery
* all ethnicities

Exclusion Criteria:

* contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
* inability to adequately understand the consent form
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women

The primary objective of this study is to compare blood loss resulting from surgical termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to therapeutic levels and those who are not anticoagulated. This study is based on the hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women receiving surgical abortions up to 12 weeks gestation.

We intend to conduct a prospective cohort study at Oregon Health and Science University and the University of Hawaii. This study will not be blinded and subjects will not be randomized. Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. For patients who are receiving anticoagulant medications, the decision to continue anticoagulant therapy or interrupt it will be made by the patient's physician, independently of this study.

We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment. This is a matched study and our control group will be matched for gestational age, parity, and cesarean section history.

Eligibility Criteria:
Inclusion Criteria:

* Female seeking abortion services
* Less than or equal to 12 weeks gestation
* Age 18-50
* Willing and able to sign informed consent
* Use of Coumadin or LMW heparin (treatment group only)

Exclusion Criteria:

* Unwilling or unable to sign informed consent
* Women taking daily aspirin or herbal therapies containing gingko biloba
* Women with a known history of a bleeding disorder such as von willebrand's disease
The Effect of Intravenous Lidocaine on Allodynia

The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Regional Pain Syndrome diagnostic criteria by the Work Safe BC. vi

Exclusion Criteria:

* History of Substance abuse
* Other Medications: CRPS patients are expected to be treated for chronic pain, whether the current treatment regimen interferes with sensory motor testing will be determined on a case by case basis.
* Coronary Artery Disease (CAD): unstable
* Congestive Heart Failure (CHF): unstable
* Heart Arrhythmia: symptomatic
* Chronic Obstructive Pulmonary Disease (COPD)
* Lidocaine Allergy
* Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders, bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
* Presence of Contraindications for MRI
* Presence of electronically, magnetically, and mechanically activated implants
* Electronically, magnetically, and mechanically activated implants
* Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
* Cardiac pacemakers
* Metallic splinters in the eye
* Ferromagnetic haemostatic clips in the central nervous system (CNS)
* Claustrophobia
* Pregnancy
Syndesmosis Ankle Study

A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work.

Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation).

Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT).

Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
3. Ability to ambulate preoperatively

Exclusion Criteria:

1. Younger than 18
2. Length unstable syndesmotic injury (i.e. Maisonneuve)
3. Neuropathic diabetics
4. 325 pounds or more
5. Prisoner
6. Pregnant or lactating
7. End stage renal disease
8. Inability to follow commands (dementia, TBI, etc.)
9. Polytrauma patients