cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Different Videolaryngoscopes Regarding Hemodynamic Parameters in Open Heart Surgey

Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.

Aim: Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.

Material and methods: 50 patients undergoing coronary bypass surgery enrolled in this prospective.randomized study. Demogaphic variables and airway characteristics of patients were recorded. Glottic visulisation and intubation time were recorded. Systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate were recorded 2 minutes intervals before intubation, after intubation during 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing open heart surgery
* \< 18 years of age

Exclusion Criteria:

* emergency
Premixed vs Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation

This study aims to compare premixed and sequential injections of lidocaine and bupivacaine for supraclavicular brachial plexus block in patients undergoing arteriovenous fistula creation.

Hemodialysis is the common treatment for end-stage renal disease (ESRD) condition which improves quality of life and survival rate for this group of patients. Arteriovenous fistula (AVF) creation is the vascular access technique that provides long-term vascular access for hemodialysis patients.

Ultrasound-guided supraclavicular brachial plexus block (SCBPB) is a widely accepted and effective technique for AVF creation procedures. It provides analgesia, sympathetic blockade, optimal surgical conditions, and adequate duration of postoperative block that prevents arterial spasm and graft thrombosis. It offers higher blood flow in the radial artery and arteriovenous fistula than is achieved with infiltration anesthesia.

Lipid-soluble local anesthetics (LA) such as ropivacaine and bupivacaine are generally more potent and have a significantly longer duration of action as well as a more prolonged onset of action compared to intermediate-potency drugs such as lignocaine, mepivacaine, and prilocaine. A combination of two LAs is often used in regional blocks to utilize the different clinical properties of the drugs to achieve a faster onset and longer block duration.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status III.
* Undergoing arteriovenous Fistula creation.

Exclusion Criteria:

* Allergy to local anesthetics.
* Body mass index (BMI) ≥ 35 kg/m2.
* Preoperative neurological deficit.
* Neuromuscular disorder.
* Psychiatric disorder.
* Coagulation disorder.
* Congestive heart failure.
* Pregnancy.
* Infection at the site of block.
Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation

Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for Parkinson's disease

Parkinson's disease (PD), the second most prevalent neurodegenerative disease (after Alzheimer's disease), affects more than a million Americans and is a common condition in the Veteran population. Although there is currently no cure for the disease, many of the symptoms of the disease can be effectively managed with medications and with deep brain stimulation (DBS). This study seeks to build upon the original CSP#468 protocol by providing an efficient long-term follow-up study. The objectives of this study are to:

determine whether the motor benefits of deep brain stimulation persist beyond two years of follow-up in patients with Parkinson's disease; determine whether the target of stimulation (GPi vs. STN) affects the durability of long-term motor improvement; define the impact of DBS on long-term function and quality of life in patients with Parkinson's disease; identify clinical features that predict favorable or unfavorable long-term outcome; and describe the long-term performance of the DBS devices, including device durability, device explanation rate, neurostimulator replacement frequency, and changes in stimulation parameters to achieve optimum symptom control.

Eligibility Criteria:
Inclusion Criteria:

* Participant in CSP#468
* Available and willing to be followed-up according to study protocol

Exclusion Criteria:

* DBS device explanted or permanently turned off without anticipated resumption of DBS therapy.
A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC

To determine the safety of intravenous infusion of ampligen in symptomatic HIV-infected patients at several dose levels, to determine the maximum dose that can be tolerated, and to measure the effects of ampligen on the HIV virus infection, immune function, and clinical condition. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that can be achieved without noticeable harmful side effects.

Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that can be achieved without noticeable harmful side effects.

Patients entered in the study are given ampligen by intravenous infusion at hemophilia treatment centers once during the first week of the trial and twice a week during the following 12 weeks. The dose each patient receives is determined by the responses of earlier patients. If the status of the HIV infection does not improve after the first 13 weeks, ampligen will be stopped. Each patient maintains a daily diary listing any symptoms or problems that occur such as headache, nausea, or change in appetite. Other anti-HIV drugs cannot be taken during the trial, and aspirin or acetaminophen should not be taken for more than 72 hours at any time during the trial without consulting the research staff. Blood will be drawn at intervals during the 13-week trial and 8-week follow-up and used to determine the effect of ampligen on HIV and the immune system as well as to monitor toxicity and side effects.

Eligibility Criteria:
Inclusion Criteria

Hemophiliacs are included. Patients must have:

* Consistently positive serum HIV p24 antigen (= or \> 70 pg/ml) defined by the Abbott HIV antigen test. This demonstration must be seen on two occasions, each separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy.
* Positive HIV antibody test.

Prior Medication:

Allowed:

* Acyclovir for short course (7 days).
* Ketoconazole for short course (7 days).
* Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
* Trimethoprim / sulfamethoxazole for PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with AIDS encephalopathy as a sole indicator are excluded.

Patients with AIDS encephalopathy as a sole indicator are excluded.

Prior Medication:

Excluded:

* Other experimental medication.
* Antineoplastic therapy.
* Amphotericin B.
* Ganciclovir.
* Excluded within 14 days of study entry:
* Biologic modifiers.
* Corticosteroids.
* Excluded within 30 days of study entry:
* Other antiretroviral agents.
* Excluded within 60 days of study entry:
* Ribavirin.

Active drug or alcohol abuse.
Effects of Plant Stanol Esters on Blood Flow

Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to 10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s complications (e.g., acute myocardial infarction) in adult human subjects.

The purpose of the present study is to evaluate among healthy human subjects (N=100) effects of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries, arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat® and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary habits are fulfilled. Dietary records (twice for a 3-day-period) are done.

Hypothesis of the study is that a dietary serum cholesterol lowering intervention has beneficial influence on the early prognostic markers of premature atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* healthy human subjects

Exclusion Criteria:

* abnormal liver, kidney and thyroid function
* unstable myocardial disease
* inflammatory bowel disease
* alcohol abuse
* pregnancy
* any lipid-lowering medication
Evaluation of Accelerated Sampling Techniques for Vessel Wall Imaging

The purpose of this study is to compare and evaluate a faster MR image that has been optimized to look at participants blood vessel walls.

The purpose of this study is to compare and evaluate a faster MR image that has been optimized to look at participants blood vessel walls. This faster MR image technique will image participants blood vessel walls in a shorter period of time and will be compared to the routine MR images that is typically used to image participants blood vessel walls.

The purpose of testing these faster images is to compare the image quality with longer conventional images. The goal is to ensure the investigators maintain high image quality over a shorter period of time. These faster images over a shorter period of time have the advantage of fewer motion-related artifacts.

The hypothesis of this research study is that the compressed sensing (fast acquisition technique) based acquisitions will considerably reduce the scan time and will maintain the diagnostic image quality necessary for the assessment of participants blood vessel walls. Thus, the information gained from this study will help us to determine the efficacy of the accelerated protocols for vessel wall imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age and scheduled to undergo clinical vessel wall MR imaging exams as part of their standard of care.

Exclusion Criteria:

1. Any person under the age of 18
2. Presence of artifact-producing intracranial devices (aneurysm clips/coils, ventricular drains, craniectomy mesh, etc.)
3. Any person with contraindications to MRI (medical instability, non-MRI compatible implanted devices, retained metallic foreign bodies, claustrophobia)
4. Large space-occupying lesions (50 mL) or substantial mass effect (herniation, 5mm midline shift) on preceding brain imaging,
5. Imminently life-threatening co-morbid conditions
6. A history of premorbid disabling neurological or psychiatric disease, current substance abuse or remote substance abuse with permanent organic sequelae
7. Pregnancy or lactation
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the "instruction" molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at \</= 30 mg per day.


Eligibility Criteria:
Inclusion Criteria

1. Age \>/= 12 years
2. Weight \>/= 36 kg
3. CDAI score of 220 - 400
4. Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years
5. No TNF-α inhibitor treatment for three months prior to first study drug infusion

Exclusion Criteria

1. Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
2. Extensive external fistulization (\> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
3. Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
4. Malignancy within 3 years or poorly controlled medical illness
5. Requires intravenous heparin therapy or with a history of a bleeding problem
Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

The investigators will conduct a 2x2 factorial randomized controlled trial to test the separate and synergistic effects of an in-person hands-on dietary and physical activity change curriculum (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed newsletters and an interactive website) on changing dietary and physical activity behaviors among a diverse population of Latina breast cancer survivors who have completed breast cancer treatment. Participants will be evenly randomized to 4 arms: in-person education alone, e-communication alone, in-person education plus e-communication, or control.

There are clear diet and physical activity guidelines for cancer survivors: eat a diet high in fruits/vegetables and low in energy-dense foods and engage in 150 minutes of moderate-to-vigorous physical activity each week. However, cancer survivors are provided with few, if any, resources to meet these guidelines and there are limited data supporting how cancer survivors can achieve sustained dietary change. There are even fewer behavioral change resources available to minority cancer survivors. Few studies have examined the separate and synergistic effects of in-person education and electronic or "e-"communication strategies in changing and maintaining health behaviors.

Eligibility Criteria:
Inclusion Criteria:

1. Female.
2. 21 years of age or older.
3. Self-identify as Hispanic/Latina.
4. Speak Spanish or English.

   Disease Related Criteria
5. Medical history of histologically confirmed stage 0, I, II, III breast cancer, with no evidence of metastatic disease.

   Prior/ Current Therapy Criteria
6. At least 90 days post chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery. Current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors).

   Accessibility Criteria
7. Have access to computer or smartphone.

   Clinical/ Laboratory Criteria
8. No history of smoking within the past 30 days.
9. No uncontrolled diabetes mellitus defined as Hgb A1C \>7%
10. Consume \<5 servings of fruits and vegetables per day and/or engages in \<150 weekly minutes of moderate to vigorous physical activity.

Exclusion Criteria:

Any criterion not met under inclusion.
Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Percutaneous microwave ablation(MWA) was reported as an effective modality for the management of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one group to treat with MWA and the other group to receive regular ultrasonic follow-up without any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical symptoms.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* benign thyroid nodules(TYP 2)
* solid or predominantly solid(colloid component\<30%)large (\>3.0ml) thyroid nodules
* refusal and/or inefficacy of surgery

Exclusion Criteria:

* pregnancy
* malignant or suspicious thyroid nodules
De-prescribing Program to Evaluate Falls in Older Adults

Purpose: The proposed study will implement and evaluate the effect of an opioid and benzodiazepine (BZD) de-prescribing intervention on falls risk in older adults.

Participants: Outpatient clinics with older adult patients, healthcare providers, older adult patients

Procedures (methods): In this proposed study, there will be 10 primary care clinics randomly assigned to the intervention arm and 10 primary care clinics randomly assigned to the control arm. In the first phase of this study, patient and provider focus groups will be used to inform the development of the intervention which will be tested during the active trial phase. The intervention has the following components: 1) alerts given to providers to identify patients taking opioids or benzodiazepines (BZD) and therefore at risk for falls; 2) educational materials to inform providers on best practices for de-prescribing opioids and BZDs in patients at risk; and 3) recommendations on de-prescribing provided by a consultant pharmacist. Impact of the intervention will be evaluated using pre-post surveys evaluating changes in providers' knowledge, confidence, and skills as well as information from the electronic health record (EHR) to evaluate impact of the intervention on de-prescribing opioids and BZDs.

Falls among older adults is costly and dangerous. Observational studies show consistent associations between falls and certain medications. It is widely accepted that falls-related morbidity and mortality could be reduced if systems were in place to identify falls risks and intervene to reduce the risks identified. In this study, health care professionals (HCPs) within UNC outpatient clinics will be alerted to patients on high-risk medications and provide team-based interventions to maximize the success of falls education and medication deprescribing.

This deprescribing intervention will focus specifically on opioids and benzodiazepines (BZDs) in patients 65 years of age and older since these medications have high susceptibility to negative cognitive effects in older adults and contribute to a higher risk of falls. This study will identify factors affecting the adoption, effective implementation, and maintenance of a deprescribing program focused on opioids and BZDs with the intent of reducing falls.

Eligibility Criteria:
Inclusion Criteria:

* UNC HealthCare clinic providing primary care services
* age at least 65 years old
* taking at least one chronic opioid or one chronic benzodiazepine medication

Exclusion Criteria:

* Clinics that do not provided primary care services
* Patients who exhibit signs of cognitive impairment or speech/hearing deficits that make obtaining informed consent and completing data collection activities difficult
* Patients undergoing active cancer treatment, receiving hospice care, or living in a skilled nursing facility
* Non-English speaking patients will be excluded from participating in the patient focus group.
* Participants who do not wish to be audio-recorded during focus group
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.

• A prospective randomized controlled study will be performed on preterm infants 34 weeks gestational age or less with placental insufficiency, and those without placental insufficiency where DCC will be performed in both groups. A third group of preterm with placental insufficiency and immediate cord clamping will be performed as a control.

Eligibility Criteria:
Inclusion Criteria:

* preterm neonates \< 34 weeks gestational age

Exclusion Criteria:

* Vaginal bleeding due to placental abruption or tears Multiple pregnancies Suspected major fetal anomalies Suspected chromosomal aberration Maternal drug abuse Hydrops fetalis preterm who needed major resuscitative measures
Thoracic Paravertebral Block, Erector Spinae Plane Block, and in Combined Paravertebral-erector Spinae Block

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated. However, no research could be found in the literature combining ESPB and TPVB. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of TPVB and ESPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB, ESPB and combined TPVB-ESPB pain after VATS.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective video assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use