cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy

The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.

The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.

Eligibility Criteria:
Inclusion Criteria

1. Male or Female subjects must be ≥ 18 years of age
2. Subject is willing and able to provide written informed consent and comply with protocol required procedures
3. Subject has a calcaneal, dorsal or plantar diabetic foot ulcer no greater than a Grade 2 on the Wagner Grading System for which ActiV.A.C.® Therapy has been prescribed and requires off loading of the SensaT.R.A.C. PadTM
4. Subject has a foot ulcer that is ≥ 1.5cm2 but no greater than 84 cm2
5. Female subject that is willing to use an effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. Acceptable means of contraception is defined as use of Birth control pills, Depo Provera® , Norplant® , IUD (intrauterine device), Diaphragm with spermicide, Condom with spermicide

Exclusion Criteria

1. Subject's wound measures \> 84 cm2
2. Presence of untreated cellulitis
3. Presence of untreated or refractory osteomyelitis (including untreated necrotic bone, non-viable tissue and infected bone)
4. History of radiation to the wound area
5. History of thermal injury in the wound area
6. Known hypersensitivity to any disposable component of the V.A.C.® Therapy system
7. Necrotic tissue with eschar present that cannot be debrided prior to subject enrollment in the study
8. Subject is exhibiting active signs and symptoms of infection of the wound(i.e. increased redness or erythema, increased pain, warmth, purulent drainage)
9. Past or current enrollment in this clinical study or any other clinical study within 30 days
10. Female Subject who is pregnant or is unwilling to use acceptable means of contraception during the duration of her participation in the study
11. Subject exhibits significant peri-wound issues that in the opinion of the investigator can interfere with the study assessments
12. Subject is unable to co-operate with study assessments or has a history of non-compliance with off-loading modalities or has a foot deformity that in the opinion of the investigator does not allow for appropriate dressing application or off loading placement.
Latent Tuberculosis Infection in Korean Health Care Workers

The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.

Further study details as provided by Hanyang University Hospital

Eligibility Criteria:
Inclusion Criteria:

* Health care workers in University affiliated hospital
* Adult aged 20-65

Exclusion Criteria:

* Active tuberculosis
* Subjects diagnosed with HIV infection, malignancy
* Subjects having immunosuppressive drug therapy
Prehospital Transfusion Strategy in Bleeding Patients

The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion.

A) Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell transfusion (RBC) only C) Plasma transfusion only

Hypothesis:

1. Transfusion strategy including a mixture of RBC and plasma is superior as compared with only plasma or only RBC strategy in terms of initial treatment of circulatory shock (expressed as base deficit).
2. Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.

Rationale for the study:

The warranted clinical question to be unsolved is whether initial pre-hospital transfusion in bleeding patients should base on a strategy including plasma, RBC or combination of both.

Despite possible benefits, allogenic blood product are associated with side effects and pose significant logistic challenges in the prehospital environment. So far, a majority of the present knowledge is based on retrospective evaluations or clinical trials without relevant control groups.

Eligibility Criteria:
Inclusion Criteria:

* Major bleeding requiring prehospital transfusion

Exclusion Criteria:

* Transfusion with blood products already initiated
Initial Evaluation of Telehealth Blood Pressure Stations in Nutrition Centers

The purpose of TEAhM is to determine if telehealth blood pressure stations can be installed and used in senior nutrition centers and to do a preliminary comparison of blood pressure outcomes among nutrition center clients who use the telehealth blood pressure stations compared to participants who do not use the stations. Specifically, the goals of the project are to determine if these monitors can be successfully implemented in this community-based setting, the degree to which older adults with hypertension are comfortable using the technology, and whether remote nurse monitoring of blood pressure using this technology is a feasible supplement to office-based care.

TEAhM will be conducted in four senior nutrition centers in the state of Ohio. Using these facilities as field centers, we will recruit 144 older, hypertensive adults who receive nutrition assistance at these centers. Wright State staff will obtain permission from enrolled participants in the intervention centers to contact primary care physicians for the purpose of obtaining recommended intervention protocols and defining referral criteria for changes in blood pressure treatment. We will install telehealth kiosks at two of the four nutrition centers. Participants who enroll at the two centers with kiosks will be considered "intervention participants" and those who enroll at the two centers without the kiosks will be considered "control participants." The kiosks will enable participants to conduct self-monitoring of their blood pressure at the nutrition facility. Blood pressure data from intervention participants will be sent to a central server managed by Healthanywhere, the telehealth partner in this project. Nurse-researchers from WSU will receive email alerts about out of range blood pressure measures, monitor blood pressure readings once a week, and make referrals for medical care according to criteria defined by participants' primary care physicians at the time of enrollment. Control and intervention participants will receive educational materials on general wellness that are publicly available.

Demographic information, background health, comfort with technology, and baseline blood pressure measures will be collected at baseline in on paper forms by WSU nurse researchers. Follow up blood pressure measures and other health utilization measures and reported health events will be collected from both intervention and control facilities during follow-up phone contacts with study personnel every two months. Blood pressure will be measured for all participants at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥55 years
* Current use of nutrition center resources ≥1 time/week
* Physician-diagnosed hypertension
* Clinically stable if on oral therapy
* Physician willingness to interact with nurse reviewers (intervention arm only)

Exclusion Criteria:

* Age \< 55 years
* Self-reported dialysis or renal failure
* Cognitive impairment as evaluated by study staff
* Failure to provide consent
* Failure to meet all inclusion criteria
POSTERIOR SUB-TENON'S Avastin

Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema


Eligibility Criteria:
Inclusion Criteria:

Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment
Telehealth Psychotherapy for Depression in Parkinson's Disease

Depression is a prevalent non-motor symptom of Parkinson's disease (PD). Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for depression in PD. CBT is usually administered in-person in weekly sessions, but PD motor disability, stigma, and transportation issues may prevent attending such therapy sessions. CBT administered via live videoconference technology may allow the treatment of depression, while circumventing the barriers that deter those with PD from seeking psychological services. The investigators propose that videoconference CBT will improve mood in individuals with PD who have depression.

The investigators plan to conduct a randomized control trial with 12 participants. Six (PD-early) will receive three assessments: baseline, immediately post-treatment (post1), and 6 weeks after treatment (post2). The other six (PD-waitlist) will have an additional assessment (Baseline 2; 12 weeks after Baseline 1) to examine practice effects before beginning treatment, and then will have the post1 and post2 assessments (four assessments).

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease (PD), any subtype
* Depression
* Internet access and a webcam
* For psychotropic and dopaminergic medications, participants may enroll only if they are stable for at least 6 weeks and 2 weeks, respectively, before beginning the study
* The investigators will enroll only depressed individuals with PD who are not already receiving or are willing to stop other ongoing psychotherapy before beginning this treatment study

Exclusion Criteria:

* Serious chronic medical or neurological illness, other than PD
* History of traumatic brain injury
* Mental retardation
* Current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine
* Active suicidal or homicidal ideation or intent
* Dementia
* Current DSM-5 diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or substance/medication-induced disorder
* Previous experience with an adequate trial of cognitive-behavioral therapy (8 sessions within the past 5 years
* Concurrent psychosocial treatment (i.e., therapy) focused on depression, anxiety, or other related disorders, or are not willing to refrain from initiating additional therapy during the study
* Concurrent psychotropic medications if not stabilized or not willing to maintain a stable dosage of psychotropic medications, such as medications for depression or anxiety, during study participation
Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

The primary objective of this study was to determine the ability of cardiac magnetic resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were to undergo CMR in addition to routine clinical evaluation.

In patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. Cardiovascular magnetic resonance (CMR) can detect cardiac involvement including minute amounts of myocardial damage. Therefore, the objective of this study was to determine the usefulness of CMR and compare it with standard clinical evaluation for cardiac involvement. Patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven sarcoidosis
* Suspected cardiac sarcoidosis

Exclusion Criteria:

* Contraindication to MRI
Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade 0 with an estimated duration of at least 3 months. The interest in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to 20%, leading to important developments in dedicated equipment and techniques.

In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was recommended to guide stent implantation in selected patients, and this recommendation was a class IIa/level of evidence B.

In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel increase procedural difficulty


Eligibility Criteria:
Inclusion Criteria:

* patients with coronary angiography showing chronic coronary total

Exclusion Criteria:

1. Acute coronary syndrome within 3 months.
2. Patients with previous coronary artery bypass graft (CABG).
3. Patients with known renal insufficiency (eGFR \< 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice

Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance.

The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 6 months of age or older.
2. Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005.
3. Agree not to use any other pediculicides or medicated hair grooming products during the duration of the study.
4. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
5. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
6. Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
7. Subject is willing to participate in the study, and abide by the protocol requirements.

   -

Exclusion Criteria:

1. Participation in any clinical study, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days.
2. Known hypersensitivity to any ingredient in the product formulation.
Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV

This prospective observational study aims to evaluate the influence of somatic symptom load and anxiety sensitivity as risk factors for the occurrence of postoperative nausea and vomiting (PONV). Physiological and psychological variables are assessed in female patients with an increased risk for PONV prior to a planned surgical intervention with a 33-item questionnaire composed of the ASI-3 and the PHQ-15. Postoperative evaluation includes the occurrence of nausea and vomiting in the first 24 hours after surgery. It is hypothesized that patients with high sum scores for somatic symptom load (measured with the Patient Health Questionnaire, PHQ-15) and with increased levels for anxiety sensitivity (measured with the Anxiety Sensitivity Index, ASI-3) experience more frequently postoperative nausea and vomiting (PONV) than patients with low scores in both self-rating instruments.


Eligibility Criteria:
Inclusion Criteria:

* female patients 18-75 years
* non-smokers
* must be able to give written informed consent
* planned surgical intervention requiring hospitalisation
* not included in another clinical trial

Exclusion Criteria:

* emergency intervention
* total intravenous anesthesia (TIVA) with propofol
* disability to give written informed consent
* physical or psychic disorders requiring permanent psycho-social care
* no German language skills
Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery

The primary objective of this study is to determine if the addition of PECS2 block provides superior post-operative analgesia for cardiac surgery patients after midline sternotomy compared to only standard-of-care post-operative pain medication.

The current study is a prospective, double-blind study investigating the use of pectoral nerves (PECS) block 2 to alleviate post-operative pain in cardiac surgery patients. The investigators anticipate enrolling a total of 220 participants in one of two groups, an interventional PECS block group and a control group not receiving the block. The intervention will occur in the operating room after the completion of the cardiac procedure and prior to the transfer of the participants to the cardiothoracic intensive care unit (CTICU). Both groups will receive the standard-of-care (SOC) pain regimen; the intervention with receive the PECS block in addition to SOC pain regimen. The procedure takes approximately five to ten minutes and will be conducted by the attending cardiac anesthesiologist. Pain will then be monitored hourly in the post-operative period in the CTICU. Additional measures will be investigated that are regularly logged in the electronic medical record.

Eligibility Criteria:
Inclusion Criteria:

1. Obtaining one or more of the following elective surgical procedures at NYU Winthrop Hospital with midline sternotomy:

   * Coronary artery bypass graft (any number of vessels)
   * Aortic Valve Replacement (AVR)
   * Aortic Valve Repair
   * Mitral Valve Replacement (MVR)
   * Mitral Valve Repair
   * Tricuspid Valve Replacement
   * Tricuspid Valve Repair
   * Pulmonic Valve replacement
   * Pulmonic Valve Repair
   * Congenital Heart Defect Repair
   * Ascending Thoracic Aortic Aneurism Repair
   * Patient Age \> 18 years.
2. Willingness and ability to participate in the study procedures
3. Sufficiently hemodynamically stable to give consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Hemodynamic instability
* Preexisting infection at site of block
* Allergy to block agents
* Severe psychiatric illness
* Intubated emergently prior to reception by the perioperative team
* Patient is preoperatively on extracorporeal membrane oxygenation (ECMO) treatment.
* Pregnant patient
* Recent surgery
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain

The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.

Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are much more common than is perhaps generally recognized. Approximately 1% of the population in western countries suffers from neuropathic pain. Some clinical conditions are associated with a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic neuropathy have persistent neuropathic pain in the feet, legs and hands.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18-75 years of age
* Diabetes mellitus (type I or type II)
* No change in medications for reducing blood sugar within 4 weeks before screening
* Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years
* Neuropathic pain must begin in the feet, with relatively symmetrical onset.
* Willing to perform self-monitoring of blood glucose
* Able to communicate intelligibly with the investigator and study coordinator
* Keeping all appointments for clinic visits, tests, and procedures

Exclusion Criteria:

* Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
* Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
* Prior renal transplant or current renal dialysis
* Pernicious anemia
* Untreated hypothyroidism
* Amputations due to diabetes mellitus (with the exception of toes)
* Any clinically significant abnormal electrocardiogram (ECG)
* Any history of cardiac arrhythmia
* History of myocardial infarction
* Active angina
* Uncontrolled hypertension (i.e., \> 140/90 mm Hg)
* Known or at high risk of hepatitis B or C infection
* Known or at high risk of human immunodeficiency virus (HIV) infection
* Any anticipated need for surgery during the study
* Glycosylated hemoglobin (HbA1c) \> 9%
* Known seizure disorder
* Any malignancy in the past 2 years (with the exception of basal cell carcinoma)
* Pain that cannot be clearly differentiated from, or conditions that interfere with the assessment of diabetic neuropathic pain.
* Use of anticonvulsants, antidepressants, or prescription membrane-stabilizing agents
* History of substance abuse or dependence within the past year, excluding nicotine and caffeine
* Frequent and/or severe allergic reactions with multiple medications
* Participation in any clinical trial within 30 days before screening