cyrilzakka/clinical-trials huggingface dataset:
Care After Resuscitation

The purpose of this study is to investigate whether simple psychological interventions can be implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.

At the Essex Cardiothoracic Centre (CTC) the follow up of patients surviving cardiac arrest demonstrated that standard psychological support arrangements for patients and their families/relatives were inadequate.

The purpose of this study is to investigate simple psychological interventions can be implemented here at the Essex CTC with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.

The investigators propose to recruit 2 groups of patients. The first group will be chosen from patients who have already survived a cardiac arrest \> 3 months prior to the start of the study. Participants in this group (patient and a relative/friend) will be invited to attend an outpatient clinic at the Essex CTC with members of the research team. The investigators will record general physical health condition and psychological wellbeing, using recommended questionnaires. A referral to onsite consultant psychiatrist will be offered to anyone expressing signs of severe depression.

The second group will be recruited from patients who survive cardiac arrest from the start of study date. Participants in this group (patient and a relative/friend) will be approached by a member of the research team whilst in hospital and an informed consent will be obtained. Baseline data will be acquired using the recommended questionnaires and a supportive psychological intervention will be offered in the form of a dedicated telephone helpline, attendance at a cardiac arrest clinic and early referral to clinical psychiatrist if appropriate for psychological help. At around 6 months from the date of cardiac arrest, participants will be invited to attend a clinic to reevaluate post cardiac arrest care using the same recommended questionnaires. At the end of the study, the data between the 2 groups will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Anyone surviving cardiac arrest
* Age greater than or equal to 18 yrs
* Cerebral Performance Category (CPC) 1-2 at the time of discharge from hospital
* English speaking
* Able to give informed consent

Exclusion Criteria:

* Age less than 18yrs
* CPC 3-5 at the time of discharge from hospital
* Non-English speaking
* Unable to give informed consent
NEtwork to Control ATherothrombosis (NEAT Registry)

NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting.

National multicenter registry in Brazil with initial plan of 25 sites from the 5 Brazilian regions. It will be coordinated by HCOR Research Institute which will perform regulatory, data and site management beyond academic leadership.NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting with 12 months of follow-up with collection of data at baseline, 6 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

Patients ≥45 years followed in ambulatory setting with ≥1 of the following 3 criteria:

1. Documented coronary disease (≥1 criteria must apply):

   * Stable angina
   * History of Unstable Angina
   * History of coronary angioplasty/stenting
   * History of coronary artery bypass graft
   * Myocardial infarction within the last 20 years
2. Documented symptomatic Peripheral Arterial Disease (≥1 criteria must apply):

   * Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infra-inguinal arteries, or
   * Previous limb or foot amputation for arterial vascular disease, or
   * History of intermittent claudication and one or more of the following: 1) An ankle/arm blood pressure (BP) ratio \< 0.90, or 2) Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound.

Exclusion Criteria:

* Patients from institutions that don't provide the Institutional Authorization Term,
* Incapacity of follow-up in one year according to investigator judgment (severe neuropsychiatric condition, life expectancy \< 12 months)
Efficient, Holistic, Heuristic and Semi-structured Suicide Assessment Tool (EHSSA) - Very Accurate Prediction of Risk.

Many studies have found that insights regarding suicide risk-factors for cohorts does not translate to practical value in the identification of such risk in specific individuals.

E.H.S.S.A. - a suicide assessment tool that was empirically designed by an emergency psychiatry department (P.E.S.P. of Bergen County) in its effort to accurately predict, in specific patients, the risk of suicide attempts in the reasonably foreseeable future. It is of a unique paradigm that combines critical elements of holism, heuristics and semi-structured design.

Objective:

Many studies have found that insight regarding suicide risk-factors for cohorts does not translate to practical value in the identification of such risk in specific individuals.

This performance improvement study formally examined the effectiveness of "EHSSA" (efficient, holistic/heuristic semi-structured suicide-risk assessment) - an empirically derived tool designed by this emergency psychiatry department. It is a suicide assessment tool for predicting in a specific patient (as opposed to a cohort), the risk of serious suicide attempts in the reasonably foreseeable future.

Methods:

At P.E.S.P. (Psychiatric Emergency Screening Program) of Bergen County of New Jersey, a prospective performance improvement study was done on all patients (N = 1,505) that had presented with psychiatric crisis to the department over the course of a 6 month period, (of which approximately 50% had significant suicidal ideations). The only exclusionary criteria was active delirium.

Each patient was evaluated using "EHSSA" by departmentally trained mental health professionals. Patients were deemed to either require hospitalization or be safe to be discharged to the community (with appropriate outpatient referrals). Those that were discharged (N = 137) were followed up with phone calls approximately 15 days post discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age/gender/economic class with or without dementia and/or substance use disorders
* All patients presenting to P.E.S.P.(Psychiatric Emergency Screening Program of Bergen County) in psychiatric distress/crisis.

Exclusion Criteria:

- Active Delirium.
Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients

Steep Trendelenburg positioning and insufflation of the abdominal cavity have shown to increase intra ocular pressure. Different anesthetic techniques can alter intra ocular pressure and a small pilot study showed decrease in Intraocular Pressure (IOP) in robotic case in steep Trendelenburg with IV anesthetics (TIVA).

We want to quantify the degree of change in Intraocular Pressure (IOP) in female patients undergoing robotic procedures for cancer. We want to detect the difference in increase of pressure with total IV anesthesia versus conventional balanced anesthesia

During the day of surgery, the anesthesiologist trained by an ophthalmologist, will measure each eye's Intraocular Pressure (IOP) using a tonometer for both the Trendelenburg with IV anesthetics (TIVA) and propofol/fentanyl/rocuronium arms of the study. (The Tono-Pen XL Medtronic Solan, Jacksonville, FL) The Intraocular Pressure (IOP) for both eyes will be measured at seven time points:

Time 1 induction after administration of sedative and local anesthesia in the eye. Both eyes of the patient will anesthetized using topical proparacaine hydrochloride ophthalmic solution 0.5%.

Time 2 Post induction table 0 degrees Time 3 Supine after pneumoperitoneum with 14 mmHg pressure Time 4 After docking robot at correct Trendelenburg positioned measured by a level Time 5 After undocking and before moving supine Time 6 Supine and before extubation. If the intraocular pressure remains elevated above 19 mmHg will require a 7th measurement in PACU with HOB at 30 degrees and if the pressure still at or above 19 ophthalmology consult initiated.

Time 7 if needed, see above

If the patient has any increased reading at the end of the procedure, the same attending anesthesiologist in the post-operative recovery area prior to discharge will do a post op measurement. Any abnormal readings will prompt an ophthalmology consult and follow up with ophthalmology department.

Eligibility Criteria:
Inclusion Criteria:

* Females ≥ eighteen years of age
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
* Subjects must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer)
* Subjects must be cleared for surgery by the pre-anesthesia clinic
* All robotic GYN cancer patients 18 years of age and older with any preexisting medical conditions that are deemed ready for surgery by the pre anesthesia clinic

Exclusion Criteria:

* Known increased intraocular pressure, prior eye surgery within a month, eye conditions where the ophthalmologist would not allow an intra ocular pressure measurement
* Subjects with a previous treatment of diagnosis of increased intraocular pressure
* Subjects who have undergone eye surgery in the 30 days prior to consent
* Subjects for whom an ophthalmologist has determined cannot undergo intraocular pressure measurement
Surveillance Monitoring as an Alternative to Telemetry

The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.

This will be single-center, prospective, pilot, pre/post implementation study to collect post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent by subject
2. Male or female 18 years of age or older
3. Expected hospitalized admission on the general care floor or medical surgical unit for at least one overnight stay and/or \> 12 hours
4. Scheduled for telemetry monitoring
5. Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and therefore not indicated for telemetry monitoring
6. For surveillance monitoring group subjects, treating provider who scheduled subject for telemetry agrees to alternative monitoring plan of surveillance monitoring
7. Willingness to have study devices attached and hair shaved at sensor location as needed during study participation
8. Willingness to participate in all aspects of the study

Exclusion Criteria:

1. Implanted pacemaker or atrial defibrillator
2. Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads
3. Current AHA Class I or II indication/prescription for telemetry monitoring
4. Prescription for other continuous condition monitoring such as capnography or pulse oximetry
5. Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or intrathecal infusions or by intravenous analgesia, per Investigator discretion
6. Ventilated or intubated patients at the time of enrollment
7. Female subject is pregnant, lactating, trying to get pregnant, or has a positive pregnancy test for women with childbearing potential
8. Condition that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
9. Subject is considered as being morbidly obese (defined as BMI \>50.0)
Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets

This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject who voluntarily participate and sign the informed consent form;
2. Healthy male/female volunteers aged 18 to 45 years;
3. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 \~ 26.0 kg/m2, inclusive;
4. Able to comply with the lifestyle restrictions.

Exclusion Criteria:

1. Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
2. Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
3. Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
4. Subject has a history of self-mutilation; or at risk of suicide;
5. Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
6. Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
7. Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
8. Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
9. Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
10. Subject has a history of substance abuse within 1 year or a positive urine drug screen;
11. Subject who has daily smoking of ≥ 5 cigarettes within 3 months;
12. Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia
13. Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
14. Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
15. Subject who has participated in other clinical trials and were enrolled/randomized within 3 months before administration;
16. Subject has used blood products or being blood donor or blood loss within 3 months;
17. Pregnant, lactating women, or positive pregnancy test;
18. Subject who refusal to contraception, or plan to donate sperm or ovums;
19. Other conditions which would make participation in the study unsuitable
Remote Methadone Ingestion Surveillance Trial (RMIST)

The Remote Methadone Ingestion Surveillance Trial (RMIST) will explore a potential method of methadone ingestion surveillance that may mitigate patient safety risks of take-home methadone treatment regimens while minimizing the risk of diversion and evaluating the acceptability and feasibility of these monitoring methods. The method utilizes an innovative existing technology.

The Remote Methadone Ingestion Surveillance Trial (RMIST) aims to evaluate the performance and acceptability of a remote methadone ingestion surveillance that may mitigate the patient safety risks of take-home methadone treatment regimens for opioid use disorder (OUD) while minimizing the risk of diversion. Data describing the monitoring performance and patient acceptability of the method will inform investigators of the feasibility of using remote surveillance technology to monitor medication for OUD and mitigate treatment barriers. This study will lay the groundwork for a safe and robust remotely monitored methadone treatment platform that addresses long-standing accessibility and acceptability barriers to treatment for OUD.

Eligibility Criteria:
Inclusion Criteria:

* Be male or female, 18-65 years of age
* Currently receiving methadone maintenance treatment (MMT) for the treatment of opioid use disorder (OUD)
* Currently receiving a take-home methadone regimen of no more than three days per week (with or without COVID-19 exceptions)
* Possess an internet-connected computer or smartphone with a front facing camera.

Exclusion Criteria:

* Drug overdose requiring hospitalization within the last 12 months
* Currently or soon to be in jail or prison; currently on probation; currently in any inpatient overnight facility as required by court of law or have pending legal action or other situation that could prevent participation in the study or in any study activities
* Pregnant women
* Serious psychiatric disorders that would interfere with study participation as determined by the study site Medical Clinician
* Any participant that, according to the study team, may find it difficult to adhere to study procedures (e.g., no internet access, etc.) or are unable to operate the web-based platform for remote methadone ingestion
Keratized Mucosa in CG Implant Placement: CTG vs Flapless

The present study will evaluate the difference in terms of keratinazed mucosa (KM) in computer guided implant placement with immediate loading, comparing a flapless approach to flap surgery with connective tissue graft.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Patients with partial edentulism in the posterior region (4-7) upper or lower for at least 3 months
* Patient whose tomographic examination shows adequate bone volumes for computer guided placement of a standard diameter implant (\> 3.5 mm) without the need for bone regeneration procedures
* Patients who have accepted informed consent and participation in the study
* Patients who do not have exclusion criteria

Eclusion Criteria

* Patients who refuse to co-operate
* Systemic conditions of exclusion:

  * Medical conditions requiring prolonged use of steroids
  * Severe hemophilia
  * In therapy with intravenous bisphosphonates
  * History of white blood cell dysfunction or deficiency
  * History of head and neck radiotherapy or chemotherapy
  * History of kidney failure
  * Pregnant or breastfeeding patient
  * History of uncontrolled endocrine disorders
  * Physical handicaps that hinder proper oral hygiene
  * Use of experimental devices or drugs within 30 days prior to implant placement surgery
  * Alcoholism or drug abuse
  * Smokers of\> 10 cigarettes per day or the equivalent cigar or\> 10 tobacco-based chewings per day
  * Conditions or circumstances that prevent the completion of participation in the study or interfere with the analysis of the study results

Local exclusion conditions:

* Local inflammation, including untreated periodontitis
* Patients with erosive lichen planus
* History of local radiation therapy
* Presence of bone lesions
* Unhealed extraction sites
* History of bone reconstruction and bone grafting techniques in the sites where the implants are to be inserted
* Bruxism
* Bleeding index\> 30% and number of pockets\> 5mm greater than 10
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.


Eligibility Criteria:
Inclusion Criteria:

* at least 12 years of age
* use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months
* provide written informed consent (subjects 12-\<18 years of age provide a written assent and parent/guardian will provide written informed consent)
* capable of and willing to swallow the study medication

Exclusion Criteria:

* participated in other research studies in the last 6 months
* they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study
* have a history of known allergies to ibuprofen, aspirin, or other NSAIDs
* have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days
* female subjects are pregnant or breast feeding
Flourish Vaginal Care System to Establish Neovaginal Microbiome

This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.

Very little is known about the neovaginal microbiome, but it has been described as being a polymicrobial state similar to bacterial vaginosis (BV) in cis women. The Flourish Vaginal Care System is a commercially-available over-the-counter vaginal wellness kit that helps relieve symptoms of BV. This study is intended to determine whether that kit could also help transgender women who have recently undergone gender-confirming surgery to establish a neovaginal microbiome that is dominated by lactobacilli, as observed in healthy cis women. This could increase health and subjective satisfaction of the neovagina. This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.

Eligibility Criteria:
Inclusion Criteria:

1. Transgender women over age 18 who are preparing to undergo gender-confirmation surgery.
2. Healthy cisgender women ages 18-52

Exclusion Criteria:

1. Immunosuppressed
2. Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh®
3. Known (neo)vaginal infection that is not yeast or BV at start of protocol
4. Inability to tolerate Restore gel by day 13 after surgery.