cyrilzakka/clinical-trials huggingface dataset:
CaveoVasc System - a New Femoral Vascular Access and Closure Device

The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients eligible for a non-emergent diagnostic or interventional catheterization via a femoral sheath of less or equal 6Fr
* In the investigator's opinion, the patient is suitable for the CaveoVasc® System , conventional hemostasis techniques and participation in an investigational trial.
* Understand and sign the study specific written informed consent form.

Exclusion Criteria:

* Patients with significant anemia (hemoglobin \<10g/DL, Hct\<30).
* Patients with a baseline INR \> 1.5
* Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance \< 30 mL/min, platelets count \< 100,000 mm3), patients with chronic use of vitamin K antagonists, direct thrombin inhibitors or oral factor Xa antagonists
* Severe concomitant disease with life expectancy below 12 months
* Uncontrolled systemic hypertension
* Patients who are immunocompromised.
* Patients who need a puncture needle longer than 8 cm due to morbidity obesity
* Active systemic or cutaneous infection or inflammation
* Prior arterial surgery in abdomen and/or lower extremities
* Cardiogenic shock
* Patients who are known to be pregnant or lactating.
* Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula.
* Prior femoral vascular surgery or vascular graft in region of access site.
* Documented chronic peripheral arterial insufficiency preventing the use of the femoral technique
* Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period.
* Patients with known allergy to components of the device.
* Patients who cannot adhere to or complete the investigational protocol for any reason
Clinical Characterization of Symptomatic Populations

This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Between 18 and 55 (inclusive) years of age at the time of screening.
  4. Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week wear time over the last 1 month by self-report.
  5. Have a baseline CLDEQ-8 score of either:

     1. 7 or lower
     2. 15 or greater
  6. Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
  7. Subjects must pass a pre-screening questionnaire.
  8. Subjects must be willing to discontinue all contact lens wear for approximately 1 week/
  9. Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating, by self-report.
  2. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
  3. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
  4. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  6. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
  7. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
  8. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  10. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
  11. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
Health-related QoL Following TAVI TAo, TAVI TF and AVR

The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and surgical aortic valve replacement (SAVR).


Eligibility Criteria:
Inclusion Criteria:

* aortic valve stenosis

Exclusion Criteria:

-
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI

The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer.

The purpose of this study is to determine the ability of functional MRI techniques \[High Resolution Dynamic Contrast Enhanced MRI (HR-DCE-MRI), diffusion weighted MRI (DWI) and BOLD MRI\] to detect, measure and locate intra-prostatic cancer. 70 patients undergoing MRI for staging of prostate cancer prior to radical prostatectomy will be studied. Results of MRI obtained prior to surgery will be correlated with pathologic specimens to determine MRI accuracy.

Eligibility Criteria:
Patients will be recruited from the University Health Network (UHN). Eligible patients will be undergoing radical prostatectomy for prostate cancer at UHN. Patients with a contraindication to MRI or MRI contrast agents, claustrophobia, renal failure, allergy to MRI contrast agents, or prior hormonal therapy or radiation therapy for prostate cancer, a biopsy within 3 weeks of the surgical date or active prostatitis will be excluded.
Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.

The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection. The main questions it aims to answer are:

* Is there an increased risk of infection/complications with showering 48 hours after drain tubes are in place
* Does showering after 48 hours with drain tubes in place affect quality of life.

SSI (soft tissue infection) is an aggravating risk specifically associated with implants. Breast reconstruction quotes infection rates anywhere from 1-35% while cosmetic augmentations quote rates around 1.5%. Usually, the causative organisms are skin flora like Staph aureus and Staph epidermidis. Occasionally mycobacterium and other atypical bacterium are isolated more commonly in the immunocompromised. Despite perioperative antibiotics, SSI is still a prevalent complication increasing total expenditure of patients and hospital systems upwards of $4000/patient in reoperation fees and hospital stay costs. Skin prep and antibiotics in the preoperative phase is very important to the sterile technique and decreasing risk of infection by decreasing bacterial load at the time of incision and surgery. However, postoperative care and interventions are less strictly evaluated and defined. Currently, there is no standard of care in regards to showering post operatively with JP (Jackson-Pratt) drains in place. Timing of showering is ultimately based on surgeon preference. In practice, the investigators routinely have had patients wait to shower until the JP drains are removed. The investigators hypothesize that showering daily, even with drains in place, will not increase rates of infection in breast reconstruction and perhaps improve quality of life during first stage. This study is prospective with participants randomized to either shower daily after 48hrs or standard of care and shower after drains removed. The participants will be asked to fill out a quality of life survey 90 days after enrollment. The patients will also be monitored for signs of infection for 90 days.

Eligibility Criteria:
Inclusion Criteria:

* undergoing breast surgery with placement of tissue expander and drains, acceptance of protocol and procedures, age \> 18

Exclusion Criteria:

* no existing wounds, previous infections related to implant device if delayed, refusal by patient
Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Cardiac arrest is the most common cause of death in the United States and as many as 590,000 Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to 89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury is the most common cause of death and disability after cardiac arrest. The investigators use advanced brain monitoring in patients who are at high risk of death after cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem the investigators have observed is low oxygen levels in the brain, which is often very difficult to treat.

In this study, the investigators plan to use two additional brain monitors in the care of these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in the brain. The investigators will use these to detect and treat potential causes of low brain oxygen levels. The main hypotheses are that electrical events in the brain such as seizures and "spreading depolarizations" will occur during times of low brain tissue oxygen level, and that treating these events and low blood flow will reduce the rate of low brain oxygen levels.


Eligibility Criteria:
Inclusion Criteria:

* High risk survivors of cardiac arrest
* Decision by potential subject's clinical team to use our institutional standard invasive, multimodal neurologic monitoring for post-arrest care

Exclusion Criteria:

* None
Inspiratory Resistive Loading and Proprioceptive Postural Control

Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. Deficits in proprioception are found in a subgroup of patients with low back pain. In addition, disorders of respiration have been identified as strongly related to low back pain.

The aim of the study is to clarify whether loading of the inspiratory muscles has a negative effect upon proprioceptive postural control in healthy individuals and individuals with recurrent low back pain.


Eligibility Criteria:
Inclusion Criteria individuals with low back pain:

* Age: 18-45 years old
* At least 1 year of low back pain with/without referred pain in buttock/thigh
* At least 3 episodes of disabling low back pain
* At least a score of 20% on the Oswestry Disability Index
* Willingness to sign the informed consent

Inclusion Criteria healthy individuals:

* Age: 18-45 years old
* No history of low back pain
* A score of 0% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Smoking history
Physician Attire and Appreciation of Physician Communication in Postpartum Women

Wearing white coat during hospital rounds has been associated with increased risk of colonization and transmission of resistant pathogens. On the other hand, studies have shown that physicians' attire affects patients' confidence in their physician and the patient-physician relationship. The results of these studies were highly dependent on the practice setting, with no data in postpartum patients.

The objective is to test the hypothesis that not wearing a white coat during physician postpartum rounds impact patient-physician communication scores.

Patient satisfaction is an important measure of quality of care. One of the most important variables in patients satisfaction scores is the physician communication skills. There have been several studies evaluating different strategies to improve the patient perceptions of patient - physician communication including delayed physician rounds, improvement of handoff strategies, and family centered rounds. Additionally, research has shown that patients develop a first impression of their physician based on the physician's verbal and nonverbal communication, including the clothing and cleanliness. Patient - physician communication scores not only have an impact on patient care, but are also now linked to Medicare reimbursements.

White coats have been widely used in the medical profession, however some physicians believe that this can be a nonverbal barrier to patient's interaction. Prior studies on the impact of physician attire have reported conflicting results. In a survey published by Cha et al, obstetric and gynecologic patients seen in the outpatient clinic preferred that the resident use white coats. Another study showed that patients favor the use of white coat in the Internal Medicine outpatient clinic which may favorably influence trust and confidence in the medical encounter.

No randomized controlled trial has been published on the impact of the use of white coat on patient - physician communication scores in the postpartum patients. This trial's primary outcome is to evaluate the impact of physician attire (specifically wearing white coat) during postpartum rounds on "patient - physician communication" scores.

This study is a randomized controlled trial performed in postpartum patients to evaluate the impact of not wearing white coat during rounds on "patient - physician communication" scores.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age ≥ 18 years and \<50 years
* Patient admitted to postpartum floor at University of Texas Medical Branch (UTMB)
* Patient care managed by obstetric physicians during the postpartum period.

Exclusion Criteria:

* Patient admitted to ICU
* Delivery resulting in stillbirth Patient not fluent in Spanish and/or English
Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate

The purpose of this study is to evaluate whether anecortave acetate can slow or stop the progression of age-related macular degeneration in patients who do not qualify for other studies and have no other treatment options.

Choroidal neovascularization (CNV), a complication of age-related macular degeneration (AMD), is the most common cause of profound visual loss in the United States. Laser photocoagulation has been shown to retard visual loss, however only about 20% of patients with CNV are eligible for laser treatment.

Conventional laser photocoagulation of CNV requires laser intensities adequate to coagulate proteins in the target tissue. Due to the proximity of CNV to the center of vision (fovea), the intensity of laser irradiation necessary, and the heat conduction in the ocular tissues, collateral tissue damage often results which further compromises vision. Recently, a new class of compounds (angiostatic steroids) have been found to inhibit the formation of new blood vessels (i.e. neovascularization) in the eye. One new angiostatic steroid, anecortave acetate (AL-3789), may represent a breakthrough in the therapy of ocular neovascular diseases such as AMD and diabetic retinopathy. Anecortave acetate suppresses the formation of new blood vessels in a variety of models of neovascularization. Unlike some of the angiostatic steroids, anecortave acetate appears to be lacking in the pharmacological activities typical of the steroid family (i.e. glucocorticoid, anti-inflammatory, cardiovascular, neurologic, diuretic, etc.) Additionally, anecortave acetate has been shown to arrest lipopolysaccharide (LPS) and basic fibroblast growth factors (bFGH) induced corneal neovascularization, to attenuate oxygen-induced retinopathy and to inhibit the growth of a highly vascularized intraocular tumor.

The purpose of this study is to treat a small number of patients who would not normally qualify for the other anecortave acetate studies. These patients who are not eligible for the other anecortave acetate studies have no other treatment options and will likely experience a poor visual outcome as a result of their AMD. These patients are excluded from other studies because of "occult" neovascularization and visual acuity worse than 20/40. Sub-Tenon's injection of either 15 mg or 30 mg of anecortave acetate will be administered at the University of Iowa. The patients will be followed for a minimum of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Choroidal neovascularization, mostly occult
* Visual acuity \> 20/40 in study eye

Exclusion Criteria:

* Allergy to fluorescein dye
* Inability to stop warfarin prior to treatment
* Pregnancy
* Other serious ocular diseases or conditions
Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder

This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Female patients \> 18 years of age
* OAB symptoms for \> 3 months
* Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
* May or may not be accompanied by urinary frequency
* May be accompanied by stress urinary incontinence where stress incontinence does not predominate

Exclusion Criteria:

* Male Patients
* Underlying cortical or spinal cord pathology including SCI, MS, or
* Parkinson's Disease
* Urinary retention with post-void residual \> 150cc
* Current treatment or treatment within the last 3 months with anticholinergic medications
* Patients not able to complete the questionaires or voiding diaries in English
* Pregnancy
* Active urinary tract infections
* Bladder Cancer or unevaluated hematuria
* Known diagnosis of narrow angle glaucoma
* Severe constipation
* History of reduced renal function (CrCl\<30ml/min)
* History of liver disease
* Current treatment with cytochrome P450 inhibitor medications
A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.


Eligibility Criteria:
Inclusion Criteria:

* give written informed consent prior to their participation;
* be 18 to 65 years of age at the time of enrollment;
* agree not to participate in any other oral/dental product studies;
* agree to delay any elective dentistry (including a dental prophylaxis);
* agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
* agree to return for the scheduled visits and follow study procedures;
* be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;
* have more than 10 bleeding sites at visits 1-3
* Consistency of bleeding site number at baseline may be considered;
* have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and
* refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.

Exclusion Criteria:

* teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
* antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
* medical conditions that the investigator considers significant and that may compromise the evaluation of study results
* currently participating in any other clinical trial
* participated in a clinical trial for plaque/gingivitis within the previous 30 days
* pregnant or lactating
* orthodontic appliances or removable partial dentures
* soft or hard tissue tumor of the oral cavity
* advanced periodontal disease
* history of hepatitis, diabetes, or other communicable diseases
* history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* history of significant adverse effects following the use of oral hygiene products such as toothpaste
* oral pathoses that could interfere with compliance and/or examinations or that need treatment.