cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study

The Realist Women Study wants to see if a special program using virtual reality can help Black women deal with stress and improve Black women's heart health. The study team wants to see if using virtual reality (VR) can help with stress of Black women. The investigator will look at things like sleep, stress, and how well the VR works. The investigator also wants to know about any problems Black women might have using virtual reality.


Eligibility Criteria:
Inclusion Criteria:

* self-identified as a Black woman
* at least 21 years of age
* fluency in English
* International Classification of Diseases (ICD)10 diagnosis of hypertension
* being a South Florida resident
* willing to be audio-recorded

Exclusion Criteria:

* History of psychosis disorders
* absence of vision and cognitive impairment
* absence of epilepsy disorders
* absence of motion sickness.
Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation

The main purpose of this study is to define at the bedside the "Titrated-PEEP" level for obese patients that increases the likelihood of extubation and ventilator liberation.

The investigators hypothesized that a titrated level of PEEP ("Titrated-PEEP") during SBT will keep the lung recruited, maintain oxygenation, and decrease the work of breathing resulting in successful ventilator liberation. In addition, post-extubation the investigators hypothesize that these patients will require noninvasive ventilatory support in the form of CPAP at the level of "titrated-PEEP" used during the SBT.

The high WOB of morbidly obese patients is associated with respiratory muscle fatigue and failure in extubation. The investigators hypothesized that the use of a titrated PEEP level prior to and after extubation might improve successful extubation rates and avoid re-intubation.

In this study, patients will be awake and ventilated in the pressure support ventilation (PSV) mode. The investigators will apply different PEEP levels to measure WOB, transpulmonary pressure and characterize the response of the respiratory system to increasing or decreasing PEEP. The "Titrated-PEEP" will be identified as the PEEP level associated with the lowest value of respiratory system elastance and an end expiratory transpulmonary pressure of 2 cmH2O. Then the participants will have two spontaneous breathing trials; one at PEEP 0-5 cmH2O, and the other at the "Titrated-PEEP" level, with PSV=0 and FiO2 unchanged. After extubation, the participants will first receive CPAP set at "Titrated-PEEP", then spontaneous breathing. Electrical impedance tomography (EIT), respiratory system mechanics and gas exchange will be recorded during the study.

The investigators believe that the real-time determination of "Titrated-PEEP" can guide the treatment of mechanical ventilation and give us a better understanding of the physiology and pathophysiology of morbidly obese patients. As a result, this study will improve patient safety; reduce the duration of mechanical ventilation, complications and healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* Intubated and mechanically ventilated;
* Weaning from mechanical ventilation;
* BMI ≥ 35 kg/m2 with waist circumference \> 88 cm for women; waist circumference \> 102 cm for men.
* A well functioning arterial line.

Exclusion Criteria:

* Known presence of esophageal varices
* Recent esophageal trauma or surgery
* Severe thrombocytopenia (PTL ≤ 5,000/mm3)
* Severe coagulopathy (INR ≥ 4)
* Presence of pneumothorax
* Pregnancy
* Pacemaker and/or internal cardiac defibrillator
Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops

To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients


Eligibility Criteria:
Inclusion Criteria:

* documented diagnosis of dry eye

Exclusion Criteria:

* use of topical ocular drops within 2 hours preceding enrollment
Ultrasound-guided L5 Dorsal Ramus Block

This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.

The lumbar facet joints have been implicated as a causal factor in 15 to 40% of patients suffering from chronic low back pain. Because physical examination and medical imaging have limited value in determining the source of pain, diagnostic blocks play an important role in the management of this common condition. Blocks of the L5 dorsal ramus (DR) are used to diagnosed pain originating from the L5-S1 facet joint, which is one of the most commonly implicated levels in patients with low back pain. Fluoroscopic guidance, which uses x-rays, is currently the standard imaging modality used to perform this block. Recently, ultrasound guidance has seen increasing use because of its greater accessibility and lack of ionizing radiation. Although USG has been shown to provide a high level of accuracy at other levels, the greater anatomical complexity found at the L5-S1 has hindered the development of a satisfactory L5 DR block technique. In this study the investigators will use fluoroscopic control to examine the accuracy of a novel ultrasound-guided approach to this block.

Eligibility Criteria:
Inclusion Criteria:

-Any consenting patient over 18 years of age with axial low back pain who requires a diagnostic L5 dorsal ramus block.

Exclusion Criteria:

* Inability to consent
* Iodine or lidocaine allergy,
* Pregnancy,
* Coagulopathy (as defined by an INR over 1.4, platelets under 100,000, or a documented bleeding disorder)
* Inability to visualize lumbosacral anatomy during an ultrasound pre- scan
Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects

This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.

Vitamin E tocotrienols have been shown to exhibit cancer-preventive activities in preclinical studies. Vitamin E tocotrienols are composed of α-, β-, δ-, and γ-tocotrienols. The investigators preclinical studies indicate that δ-tocotrienol possesses the most potent antitumor activity against pancreatic cancer. It is believed that this micronutrient may have a role in the prevention of pancreatic cancer in healthy participants who are at increased risk of developing the disease.

Eligibility Criteria:
Inclusion Criteria:

* The participant is ≥ 18 years old
* The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* The participant has adequate organ function as follows:

  * Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min.
  * Bilirubin ≤ the institutional upper limits of normal (ULN)
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within institutional normal range.
  * Absolute neutrophil count (ANC) ≥ 1000mm³
  * Platelet count ≥ 100,000/mm³
* The participant has the capability of understanding the informed consent document and has signed the informed consent document.
* Sexually active participants (male and female) must use medically acceptable methods of contraception during the course of the study.
* Female participants of childbearing potential must have a negative pregnancy test at screening.
* Able to understand and comply with the requirements of the protocol.

Exclusion Criteria:

* The participant is receiving investigational therapy (other than the investigational therapy under study).
* The participant has received investigational therapy within 30 days prior to first dose of study drug.
* Patients who are unable to swallow capsules.
* Patients with prior malignancies, other than squamous or basal cell carcinomas, unless disease free for ≥ 5 years.
* The participant has had prior major surgery within 30 days prior to first dose of study drug.
* The participant has active infection or fever \>38.5C within 3 days prior to first dose of study drug.
* The participant has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* The participant is unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription medications.
* The participant is pregnant or breastfeeding.
* The participant is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will examine the long-term safety of Nasalfent in the treatment of breakthrough cancer pain.

Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.

This study will examine the long-term safety of Nasalfent treatment for breakthrough cancer pain.

After the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. Safety information will continue to be collected during this period. Treatment may continue on study for as long as the patient requires treatment or until Nasalfent becomes commercially available.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give consent
* Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception
* Diagnosis of cancer
* Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain
* Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication
* Able (or via caregiver) to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary
* Able to be up and about for 50% of the day or greater

Exclusion Criteria:

* Intolerance to opioids or fentanyl
* rapidly increasing/uncontrolled pain
* pain that is not cancer related
Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy

This retrospective cohort study was conducted by reviewing the records of consecutive patients referred to Bu Ali Sina Hospital from 2016 to 2023, who were hospitalized with a diagnosis of ischemic stroke. The records of all patients treated with intravenous alteplase during the above period were extracted, and the relevant characteristics were recorded in a questionnaire. In each year, patients with ischemic stroke who were not treated with alteplase but were hospitalized at the Bu Ali Center were selected in a similar number to patients who received alteplase in the same year, and the relevant information was extracted from their records and recorded in a questionnaire. The incidence of post-stroke seizures and epilepsy was determined in both groups, and the factors associated with their incidence were studied and compared.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic stroke
* Treatment with IV alteplase

Exclusion Criteria:

* History of epilepsy
* Taking antiseizure medications
* Unavailable patients
* Unreliability of recorded patients' files
Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic Agents

The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i) versus new use of various other antihyperglycemic agents (AHAs), combined as one group.

This study will be an overall retrospective, observational, new-user cohort study using 4 large administrative claims databases in the US. Participants diagnosed with T2DM and initiated on SGLT2i or other AHAs (metformin, sulfonylureas (SU), thiazolidinediones (TZDs), DPP-4 inhibitors (DPP4i), GLP-1 agonists, insulin, and other AHAs) between April 1, 2013 and the end of claims data availability will be included in the study and will be estimated for incidence rates of DKA in the different AHA new-user groups.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 antihyperglycemic agents (AHA) prescription (Rx) during the study period, between 4/1/2013 and 9/30/2014.
* Diagnosed of type 2 diabetes mellitus
* Enrollment history of at least 12 months
* Having prescription drug coverage
* Having no prescription of the index drug during the 6 months prior

Exclusion Criteria:

- Participants who receive diagnosis of type1 diabetes mellitus (T1DM) and/or secondary diabetes mellitus (SDM) any time after index date.
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Primary objective:

* To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)

Secondary objectives:

* To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine
* To compare the risk of vascular events of clopidogrel with ticlopidine
* To document the long-term safety of clopidogrel for a total of 52 weeks
* To document the vascular events of clopidogrel for a total of 52 weeks


Eligibility Criteria:
Inclusion Criteria:

Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):

* Current intermittent claudication with Ankle Brachial Index (ABI) \< 0.90
* A history of intermittent claudication together with previous related intervention in a leg

Exclusion Criteria:

* Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization
* Bleeding diathesis, coagulopathy and present bleeding disease
* Previous intracranial bleeding or hemorrhagic stroke
* Uncontrolled hypertension

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Low-Dose Enoxaparin in Psoriasis

Rationale:

* Psoriasis is a chronic immune-mediated inflammatory skin disorder where T cells play a fundamental role in its pathogenesis.
* Low molecular weight heparin has been reported to exert immunomodulatory effect at small doses through inhibition of T cells heparinase enzyme.
* Low molecular weight heparin may have promising results for treatment of psoriasis.

Research question:

* Can low molecular weight heparin be used safely for treatment of psoriasis with good outcome?
* Is enoxaparin inhibitory effect on T cell heparinase enzyme responsible for its beneficial effect?

Hypothesis:

* Low molecular weight heparin can achieve good results when used at small doses for treatment of psoriasis.
* Heparin can exert immunomodulatory effect in psoriasis through inhibition of T cell heparinase enzyme.

AIM OF WORK

-The aim of this work is to assess the possible clinical efficacy and safety of low-dose enoxaparin in the treatment of psoriasis and to detect if inhibition of heparinase enzyme might account for its beneficial therapeutic effect.

Objectives:

* To evaluate safety and efficacy of low molecular weight heparin at small dose for treatment of psoriasis.
* Contribute to the ongoing efforts to optimize psoriasis management and improve the lives of individuals affected by this chronic condition.


Eligibility Criteria:
Inclusion Criteria:

* Patients with plaque psoriasis, who met the following criteria will be enrolled.

  1. Age 18 and above.
  2. No systemic (oral, parenteral, photobiological) treatment for psoriasis within the last 2 months.
  3. No topical treatment for psoriasis within the last 2 weeks.

Exclusion Criteria:

* 1. Pregnancy or lactation. 2. Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia.

  3. History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer, liver disease and/or abnormal liver function tests or abnormal kidney function tests.

  4. History of major surgery within the last 3 months. 5. A family history of bleeding diathesis, or cerebrovascular accident. 6. Concomitant use of oral anticoagulants, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs.
Evaluation of N6 Sound Processor in Group of Freedom Users

Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with sensorineural hearing loss
* 12 years of age and older
* Currently using Freedom Sound Processor
* Recipient of a Ci22M or CI24 series implant
* Minimum of 3 months experience with Freedom Sound Processor
* Prior documentation of sentence recognition in noise at a +10 SNR or better
* Native English speaker
* Willingness to participate and comply with requirements of protocol

Exclusion Criteria:

* Unable to complete test metrics
* Unrealistic expectations regarding possible benefits
* Additional handicaps that would prevent or restrict participation in audiological evaluations
* ABI cochlear implant recipient
Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

The outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).


Eligibility Criteria:
Inclusion Criteria:

* all patients treated for Covid-19

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery

Negative pressure wound therapy (NPWT) could improve surgical outcomes and reduce complications like SSI, wound dehiscence and seroma in closed surgical wounds. To date, NPWT was not evaluated in patients undergoing breast conserving surgery without direct reconstruction.Therefore, the aim of this trial is to evaluate the feasibility of NPWT after surgery and its effects on postoperative complications.

Rationale:

Negative pressure wound therapy (NPWT) could improve surgical outcomes and reduce complications like SSI, wound dehiscence and seroma in closed surgical wounds. Complication rate after breast conserving surgery for breast cancer is 2-17%, surgical site infections (SSI) being the most common. To date, NPWT was not evaluated in patients undergoing breast conserving surgery without direct reconstruction. Therefore, in this trial, the aim is to evaluate the feasibility of NPWT after breast conserving surgery and its effects on postoperative complications.

Objective and study parameters:

Primary objective is to compare surgical site complications in patients with and without NPWT. Secondary objective is to assess the number of re-interventions, unplanned visits and pain scores.

Study design:

A prospective cohort of 150 patients will be compared to a retrospective cohort of 150 patients.

Study population:

Breast cancer patients undergoing breast conserving surgery with or without sentinel lymph node biopsy.

Intervention (if applicable):

Negative pressure wound therapy.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

When participating in this study, patients will need to pay at least one extra visit to the hospital, possibly two if this cannot be combined with the standard postoperative visits. In addition, patients will need to have a device with them for 14 days after surgery. This device is connected to the wound dressing. All wound dressings may cause irritation or an allergic reaction. This risk is not higher than when receiving standard wound dressing, but it is something to take into consideration.

Patients participating in this study may benefit from NPWT regarding the postoperative complication rate.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years or older.
* Female sex.
* Indication for breast conserving surgery, with or without sentinel lymph node biopsy.

Exclusion Criteria:

* Undergoing mastectomy or modified radical mastectomy.
* Undergoing direct breast reconstruction.
* Patients with a pacemaker, intra cardiac defibrillator (ICD) or other medical device in the proximity of the wound area, due to the magnet in the PICO® device.
* Unable to comprehend implications and extent of the study and/or unable to sign for informed consent.
* Participation in another breast cancer surgery related clinical trial.
How Should Surgical Residents Be Educated About Patient Safety

The purpose of this study is to compare the effectiveness of two methods, safety curriculum in addition to online training alone, for teaching patient safety to surgery residents. Despite multiple studies evaluating educational safety curricula, the best methods for teaching residents about patient safety is unknown. It is hypothesized that empowering surgery residents to actively engage in behaviors to increase patient safety may lead to a higher quality perioperative care and communication.


Eligibility Criteria:
Inclusion Criteria:

* All surgery residents at the University of Texas Health Science Center at Houston, from post-graduate year (PGY)-1 to PGY-5.

Exclusion Criteria:

* Non-surgery residents at the University of Texas Health Science Center at Houston.
Angelman & Rett Syndrome: Interaction and Communication

We aim to describe the communicative and sensory profile of children with Angelman syndrome or Rett syndrome and their use of augmentative and alternative communication. In addition, parents are surveyed regarding parent-child interaction and access to communication support.


Eligibility Criteria:
Inclusion Criteria:

* Angelman or Rett syndrome

Exclusion Criteria:

* none