cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Simplified Permanent Left Bundle Branch Pacing Without Electrophysiological Recording System

This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system).

Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, the implanter was blinded to EP system, only refer to ECG monitoring. The transition of QRS morphology from S-LBBP (or LVSP) to NS-LBBP, abrupt shortening of Stim-LVAT in lead V5, combined with LV septal-derived PVCs and obvious LBB potential in pacing system analyzer were recorded to help the implanter confirm LBB capture. Meanwhile, the technician recorded the data by EP system and evaluated the consistency of the judgment. The primary endpoints included the success rate, procedure-related information, parameters and complications during 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* (1) requiring ventricular pacing; (2) older than 18 years; (3) signed informed consent.

Exclusion Criteria:

* (1) acute anterior myocardial infarction; (2) intraventricular conduction delay (IVCD); (3) ventricular septal hypertrophy (end-diastolic thickness over 15 mm).
Bronchoscopy and Electric Impedance Tomography (EIT) Pilot Study

Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a radiation free, non-invasive and portable lung imaging technique. Impedance changes in lung ventilation are investigated in mechanically ventilated patients who routinely undergo bronchoscopy in intensive care medicine. Bronchoscopy is performed to suction secretions as well as to analyze the secretions to recognize inflammations and diseases. It is an essential intervention which causes changes in ventilation which remain for 1-2 hours. It is not completely investigated why these changes in ventilation remain for so long time and how they are distributed regionally. Therefore the purpose of this study is to investigate the change in pulmonary regional ventilation in patients who routinely undergo bronchoscopy to possibly generate ideas how to optimize the ventilation after bronchoscopy to optimize the patient´s treatment.

In 20 mechanically ventilated patients who routinely undergo bronchoscopy Electrical Impedance Tomography (EIT) measurements whereby, evaluable data of 10 patients are needed, of about 1-2 minutes are performed directly before, directly after and 10, 30, and 60 minutes after bronchoscopy parallel to the following routine measurements: tidal volume, resistance, compliance, heart rate, blood pressure, SpO2 and blood gas values. Prior to the examination a rubber belt with 16 integrated electrocardiographic electrodes is placed around the thorax connected with an EIT- device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. The EIT provides a mapping of the distribution of the lung´s electrical impedance and exhibits a far temporal resolution of up to 40 tomograms per second. Because of electrical impedance of the pulmonal tissue is dependant to the air content, the air distribution within the lung over a certain period can be monitored. Analyzing the EIT- data it might be possible to explain the distribution in regional ventilation and how the ventilation could be optimized right after the bronchoscopy to optimize the patient´s treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients \> 18 years old
* Mechanically ventilated patients who routinely undergo bronchoscopy

Exclusion Criteria:

* Pregnancy and Breastfeeding
* Active implants, heart pace makers and implanted converter defibrillator
* Foreign metallic objects in the thorax
* Cardiac valves
Strength at Home - Parents RCT

The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. The participant population will have elevated PTSD symptoms and parent-child functioning difficulties with an index child between the ages of 3-12. The main question\[s\]it aims to answer are: • Does Strength at Home Parents improve parenting stress and parenting behaviors in comparison to a no-treatment control condition? • Are gains maintained over time and is there a gender difference in efficacy? Participants will complete 4 online assessments, and if randomized to the intervention group they will complete an 8 week tele-health group program. If randomized to the control group participants will receive a link to the VA parenting resources website and any referrals they would like to have. Researchers will compare Strength at Home Parents to VA treatment as usual see if the group intervention improves parenting stress and behaviors above and beyond the existing resources.


Eligibility Criteria:
Inclusion Criteria:

Eligible participants are veterans enrolled in any VA VISN 17 facility who meet the following inclusion criteria: Current parent to a child between the ages of 3 and 12 (the index child), who resides with the participant or spends at least two days per week with the participant, elevated PTSD symptoms and Parent-child functioning problems.

Exclusion Criteria:

Major neurocognitive disorder likely to impact comprehension of material, including severe TBI .
Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -

A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed informed consent prior to any study specific procedures.
2. Female and male patients ≥18 years of age.
3. COVID-19 positive or typical CT image of COVID-19 infection.
4. Clinical status requiring hospitalization.

Exclusion Criteria:

1. According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).
2. Known hypersensitivity to Omegaven® or any of the ingredients.
3. Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.
4. Pregnancy and breastfeeding.
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins

Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis).

Patients participating in this study will receive injections of lipoproteins or apolipoproteins (the protein component of lipoproteins) that have been isolated and purified. These lipoproteins will be labeled with small amounts of radioactive material and sterilized before they are injected into the patient.

Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.

We propose to investigate human in vivo lipoprotein metabolism using radiolabeled apolipoproteins on plasma lipoproteins. Paired kinetic studies using dual-labeled iodinated lipoproteins and apolipoproteins are performed in healthy volunteer controls with normal lipids and subjects with dyslipidemia under controlled metabolic conditions. Studies are designed to formulate metabolic pathways in patients with undefined genetic disorders of lipid metabolism as well as in healthy volunteers to provide original insights into normal and pathologic metabolic pathways. All kinetic data is computer analyzed to provide quantitative data and facilitate direct comparison of multiple studies.

Eligibility Criteria:
* INCLUSION CRITERIA:

Subjects with new and undefined dyslipidemia-particularly familial disorders with extreme phenotypes.

Healthy normal volunteers - (18 years old or older) controls to investigate the formation of HDL for prebeta HDL.

Euthyroid.

EXCLUSION CRITERIA:

Healthy control volunteers are initially screened for secondary causes of hyperlipidemia and are excluded if they have any clinically significant laboratory abnormality (i.e., liver disease, disease, kidney disease, endocrine disease,), chronic medical problems (i.e., hypertension, migraines, inflammatory bowel, hepatitis, HIV) or require any chronic medications (i.e., acne, asthma).

The healthy control volunteers weight must fall within the current guidelines for ideal body weight.

Pregnant women.

Unwilling to follow metabolic diet.

Allergic to iodine.

Unable to sign consent form.
Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets


Eligibility Criteria:
Inclusion Criteria:

Menopausal women between the ages of 30 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent and HIPAA document read, signed, and dated.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

Exclusion Criteria:

* History of hypersensitivity
* Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
* One functional eye or a monofit eye
* Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
* Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
* Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
* Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
* Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
* Abnormal lenticular opacity in the visual axis of the lens in either eye
* Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
* Pregnant or lactating females
Validation of Ultra Sound (US) Elastography

This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

The investigators propose UltraSound Elastography as an imaging method which allows for a better evaluation of soft tissue and organ lesions compared to the conventional US modalities used nowadays in the dayly clinical routine.

This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for clinically indicated conventional Ultrasound examination

Exclusion Criteria:

* Age \< 18 years
Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints

To evaluate the efficacy of choline alphoscerate on improving symptoms related to depression, anxiety, and subjective memory complaints compared to placebo in patients with Major Depressive Disorder(MDD) accompanied with subjective cognitive decline, who are over the age of 60.

This clinical trial will include the participants over age 60, diagnosed as MDD under treatment of antidepressant longer than 1 month's period, assessed as Hamilton Rating Scale for Depression(HAM-D) ≥ 14, and Mini-Mental State Examination(MMSE) ≥ 20, and those who are accompanied with subjective memory complaints. The investigators will evaluate the clinical efficacy of symptomatic improvement in depression, anxiety, and subjective memory complaints. The investigators will assess these outcomes including memory function, depression, anxiety, and satisfaction on medication with scales comparing control group with treatment group under 8 weeks of medication.

This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV trial to evaluate the efficacy.

Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants. Participants in the control group will take the placebo, which would not affect their medical condition, for the adjunctive therapy is the choice of agreement between clinician and participants. If there is the necessity of change in antidepressant or of adjustment of their dosage, investigator can stop the clinical trial and proceed to another treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years
2. Diagnosed as MDD under the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed with MINI-Depression
3. HAM-D ≥ 14
4. MMSE ≥ 20
5. Who had continuous subjective memory complaints more than 6 months before the period of screening
6. Who had taking antidepressants longer than 1 month in the period of screening

Exclusion Criteria:

1. Diagnosed as schizophrenia, bipolar disorder, PTSD, OCD or other significant mental disorder under the criteria of DSM-5 (only the participants who had depressive disorder, sleep disorder, and the anxiety disorder are allowed to be included)
2. Who have medically unstable disease (only the participants, who have diabetes mellitus or hypertension under control with stable medication for 3 months could be included)
3. Diagnosed as dementia or mild cognitive impairment
4. Participants who are already taking choline alfoscerate within 6 months of period
5. Participants who have been taking medication of antipsychotics (including quetiapine), mood stabilizer, cognitive enhancer including donepezil, rivastigamine, galantamine, and memantine within 1months.
6. Participants who had previous history of liver disease or renal disease
7. Participants who had allergic reaction to choline alfoscerate
8. Other specific condition, which could be inappropriate for the trial inclusion, under the judgement of the principal investigator
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair

This prospective randomized controlled study will determine the efficacy of continuous local anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament fixation.

Direct post-operative analgesia can be administered via a direct continuous analgesia pumps providing local anesthetic into a dissected area. To date, no studies have been conducted to evaluate pain control or infection with vaginal placement of catheters for pelvic organ prolapse surgery. To help pelvic surgeons assess the relative benefit of continuous local infusion of topical anesthetic following sacrospinous ligament fixation versus PCA pump, we compared pain scores, narcotic, anti-pruritic and anti-emetic drug usage, and wound complications.

Eligibility Criteria:
Inclusion Criteria:

* Female patients greater than 18 years of age
* Undergoing posterior colporrhaphy at Saint Lukes Hospital, Kansas City, MO.

Exclusion Criteria:

* Patients with chronic pain conditions requiring daily narcotics were excluded
Rutgers Pilot for PREDICT- Patient POC Test

A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test.

14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures.

Institutional Clinical Laboratory Improvement Amendments (CLIA) certification of waiver was obtained prior to conducting the study. Communicable Diseases Reporting and Surveillance System (CDRSS) registration and training were completed to enable reporting results of the POC test.

A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test.

14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures on their appointments, the remaining 4 patients did not present for their appointment.

Following initial interest in participation over the phone, the subjects completed a pre-visit survey prior to their upcoming appointment. The day prior to their visit, a phone triage was completed and repeated as they checked in for their appointment. A nasal sample was collected and processed using the FDA EUA authorized Rapid Antigen Test BD Veritor Plus Analyzer, BD Sciences. An end-of-study survey was collected to assess patients' feedback about their experience and their perception of safety.

Eligibility Criteria:
Inclusion Criteria:

* Dental Patients with upcoming appointment at the Oral Medicine Clinic at Rutgers School of Dental Medicine

Exclusion Criteria:

* Patients previously participating in the study
* Patients unwilling to have their de-identified data made available to researchers
A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult Participants

The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects, not of child bearing potential.
* Age 18-55 inclusive
* Total body weight \>50 kg.

Exclusion Criteria:

* Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
* History of orthostatic blood pressure changes or orthostatic symptoms
* Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
* Smoking more than 5 cigarettes per day
SPRINT - Randomized Trial of Tibial Fracture Fixation

The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.

Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.

Eligibility Criteria:
Inclusion Criteria:

* Fractured tibia requiring fixation using an intramedullary nail