cyrilzakka/clinical-trials huggingface dataset:
COVID-19 SAFE Enrollment

In order to safely and effectively reopen businesses and universities across the US, institutions will need to develop approaches to rapidly identify COVID-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability.

The investigators will evaluate the implementation of a COVID-19 screening program that coordinates several existing systems at the University of Pennsylvania including saliva-based viral testing and test different outreach strategies (opt-in vs opt-out) to improve program enrollment.

The coronavirus disease 2019 (COVID-19) pandemic has resulted in close to 10,000,000 reported cases worldwide, including more than 2,000,000 aggregated reported cases and 120,000 deaths in the United States. Initial efforts to address the COVID-19 pandemic were aimed at testing symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity to meet surge demands. While the US continues to confront the current crisis, we must plan for the future by putting in place tools to enhance our ability to conduct effective screening, containment, and case management.

Widespread COVID-19 testing is needed to safely and effectively reopen schools and businesses across the US. However, currently approved testing options require reagents that are limited in supply, severely hindering scalability. Emerging evidence indicates that saliva testing with the option of at-home sample collection can accurately identify COVID-19 viral infection. Additional diagnostic testing options will continue to increase patient access. Moreover, this approach provides an option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital, or testing site. Collection by the patient also reduces exposure of health care workers to the virus and preserves limited personal protective equipment.

With access to expanded testing, health systems and universities will need to test alternative methods to manage COVID-19 spread while balancing program effectiveness, feasibility, costs, and scalability. Insights from the field of behavioral economics offer promise for designing and sustaining these kinds of policies. Specifically, research has demonstrated that an opt-out framed recruitment strategy compared to a conventional opt-in strategy can improve enrollment and adherence to behavioral interventions.

For these reasons, the investigators propose to evaluate the implementation of a COVID-19 screening program that uses saliva-based testing and to test approaches to improve program enrollment.

Eligibility Criteria:
Inclusion Criteria:

•University of Pennsylvania staff, faculty, and trainees that have returned to work on campus who have been identified by leadership at the University of Pennsylvania Perelman School of Medicine.

Exclusion Criteria:

•Participants will not be eligible for the study if they identify any reason they are unable to participate in the study.
Collision Warning Device for Blind and Visually Impaired

This study evaluates a novel collision warning device to help people with severe vision impairment or blindness avoid collisions with obstacles. The main hypothesis to be tested is that the device reduces the number of collisions with obstacles in everyday activities.

Participants with blindness or severe visual field loss (hemianopia or tunnel vision) will be trained to use a collision warning device that alerts them to impending collisions. Participants will use the device at home during everyday mobility for about 1 month. The device is designed to supplement existing mobility devices, such as a long cane or dog guide. The device will provide warnings about potential collisions with mid- or high-level obstacles (which are typically not detected by a long cane).

Eligibility Criteria:
Inclusion Criteria:

* Blindness (or very limited vision with visual acuity no better than "counting fingers"),
* Or severe peripheral field loss / tunnel vision (≤ 40° remaining visual field) with visual acuity of at least 20/200,
* Or homonymous hemianopia with visual acuity of at least 20/200;
* Able to walk independently either with or without mobility aids such as a long cane or guide dog (but without the aid of a sighted guide);
* Reports at least minor bumps or collisions within the last 3 months;

Exclusion Criteria:

* Currently participating in a mobility training program
* Diagnosed dementia
* Significant cognitive decline
* Participants with hemianopia will be excluded if they have hemianopia for less than 3 months and/or have spatial neglect
Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome With Orthostatic Hyperpnea and Hypocapnia

Postural tachycardia syndrome (POTS) is the most common chronic cause of postural lightheadedness, and upright confusion afflicting many Americans, mostly young women. Many POTS patients hyperventilate by increasing their depth of breathing that produces tachycardia, alters blood flow and blood pooling in the body and importantly reduces brain blood flow causing "brain fog". In this proposal the investigators will demonstrate in young women that abnormal repeated brief impairment of blood pressure and brain flow just after standing sensitizes the body's oxygen sensor in POTS to respond as if it were in a low oxygen environment causing hyperventilation and its consequences. In this project the investigators will use various drugs that will help to understand the mechanisms that cause POTS in this unique subset of POTS patients who hyperventilate.

The Investigators will compare results from female POTS patients, free of known pulmonary or sleep disorders aged 15 to 39 years with, and without orthostatic hyperpneic hypocapnia, to healthy female volunteers with the following two (2) specific aims:

1. To test poikilocapnic (allowing carbon dioxide (CO2) to vary) orthostatic cardiorespiratory responses to determine whether prolonged initial orthostatic hypotension (IOH) precedes upright hypocapnia in hyperpneic POTS but not in controls or non-hyperpneic POTS. Subjects are instrumented for cerebral blood flow, respiratory and hemodynamic measurements, investigating splanchnic blood flow by indocyanine green infusion, and measuring changes of CBV, regional blood volumes, and cardiac output (CO) by impedance plethysmography during a 10 min stand to quantify IOH, and a 10 min tilt test to 70⁰ to quantitate cardiorespiratory changes. These changes during tilt stratify hyperpneic and non-hyperpneic POTS.
2. To test if chemoreflex sensitization of ventilation and sympathetic activity (by microneurography) are abnormal when supine and tilted upright at 45o and how that interacts with Oxford measured cardiovagal and sympathetic baroreflexes under controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. Hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses.

Eligibility Criteria:
Inclusion Criteria:

* The investigators will recruit female POTS cases (N=80) and healthy female control subjects (N=40) aged 15-39 years, matched for BMI. POTS is a disease in which 80-90% are females. Therefore, the investigators will only recruit female POTS patients and controls.

Exclusion Criteria:

* Any subjects with systemic disease or who cannot stop taking prescribed medications for at least 2 weeks prior to study.
Reliability and Validity of Urdu Version of Mini-BESTest in Persons With Parkinson's Disease

Various clinical scales are available to investigate balance impairment, Mini-BESTest is one of them. Thus, this study aims to translate the Mini-BESTest into Urdu and investigate its psychometric properties in the Pakistani Parkinson's population with dynamic balance impairment.

The aim of study is to translate and culturally adapt Mini-BESTest into Urdu language and secondly to investigate the reliability and validity of Urdu Version of Mini-BEStest in Parkinson's Pakistani population. This study will be cross sectional survey study in which convenience sampling technique will be used.

The results of study will help to know the validity and reliability of Mini-BESTest in Urdu version with dynamic balance impairments in Parkinson's population. The reliability of the scale will be checked through internal consistency and test-retest methods. Internal consistency will be analyzed with Cronbach's alpha value. Test-retest reliability will be assessed using an intraclass correlation coefficient with 80 patients.

Eligibility Criteria:
Inclusion Criteria:

1. All persons with Parkinson disease and ability to follow commands were included in the study.
2. living independently in the community
3. able to walk 6 m independently
4. willing to participate in the study.

Exclusion Criteria:

1. History of other neurological disorders
2. Musculoskeletal damage which affects walking ability
3. Presence of serious medical condition
4. History of surgical treatments for Parkinson disease
5. Not willing to participate in the study
6. history of faint, vertigo, dizziness,or taking medications which can cause dizziness
7. history of any medical condition which can affect balance.
Telephone Calls for Health for Homebound Older Adults

A randomized controlled trial of the effect of 4 weeks of regular check-in calls, up to 5 per week based on participant's choice and 2 survey collection calls and possible referral of other services, versus no daily check-in calls, on self-reported loneliness measures for current Meals on Wheels participants (MOW).

The intervention arm will include 125 MOW clients to receive a call of between 5 - 10 minutes in length each by a consistent caller, five times a week, Monday through Friday for 4 consecutive weeks to check in on them. After the first week of calls, subjects in the intervention arm will be asked if the frequency of calls is acceptable or if they would like to reduce the call frequency, potentially to a minimum of twice per week.

Brief guidance and training will be provided for the daily conversation to maximize time spent speaking by the recipient but otherwise, the calls are unscripted other than specific prompts to ask about the recipient's general sense of well-being. "How are you doing today?"

The control Arm will include 125 MOW clients who will be randomized to a control group that will not receive the intervention calls. The control group will receive calls from a member of the research team at the beginning of the study to collect baseline survey data and at the post-4-week period to collect post-study survey data.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+) clients of Meals on Wheels of Central Texas

Exclusion Criteria:

* Cognitive impairment or in a hospice program.
Ultrasound Assessment of Gastric Content in Fasted Pregnant Women

Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode.

The main objective is evaluating prevalency of "full stomach" in differents stages of pregnancy in fasted pregnant women.

Subjects will be recruited at Montpellier University Hospital, from fasted pregnant women before surgery or from ultrasound exam performed during pregnancy.

Eligibility Criteria:
Inclusion criteria

An subject must fulfill all of the following criteria in order to be eligible for study enrollment:

* Aged at least 18 years old
* Pregnant women
* Fasted ( at least 6h for solid , 2h for clear fluid )

Exclusion criteria

* Previous Bariatric surgery / upper gastro-intestinal surgery
* Adult under protection
Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

The primary objective of this study is to determine if there is a time savings in the operating room by using a septal stapler instead of suture in closure of primary septoplasty.

The secondary objectives are to determine the subjective outcome of patients undergoing closure with the septal stapler instead of suture via questionnaire, and to determine if there is a difference in postoperative complications between groups.

Nasal Septoplasty is the third most common surgical procedure performed by otolaryngologists. The surgery is done to relieve nasal obstruction, which is often caused by a bend in the tissues in the middle of the nose. The current technique for completing a septoplasty involves elevating subperichondrial flaps bilaterally and resecting the deviated portion of cartilage and/or bone. The technique to prevent a septal hematoma by removing the potential dead space after cartilage resection has evolved over time. Traditionally, the nose was packed with petroleum gauze, but using sutures to coapt the mucosa back together has become the preferred method of choice.

Placing sutures to reapproximate the mucosa is very effective, but can be challenging, particularly in a narrow nose. The amount of time required varies from 4 to 20 minutes for this part of the surgery, and is potentially associated with its own set of complications. The needle or suture can break, and the lateral nasal wall can be traumatized, leading to formation of scar bands to the septum.

Recently, a septal stapler has been developed that uses bioabsorbable staples. The staples are made of polylactide-co-glycolide (PLG), the same copolymer found in Vicryl sutures. It can provide a more uniform closure, is able to reach the posterior septum and could lead to a significant time savings in the operating room. The stapler has been demonstrated to be safe and effective, and required less than a minute to apply in most studied cases. The amount of time saved in the operating room has not yet been studied.

Eligibility Criteria:
Inclusion Criteria:

* primary septoplasty
* age\>18
* septal deviation
* ability to read and communicate in English
* absence of allergic rhinitis
* non-smoker

Exclusion Criteria:

* revision septoplasty
* age \<18
* concurrent sinusitis or endoscopic sinus surgery
* existing nasal septal perforation
* smoker
* diabetes mellitus
* allergy to polylactide-co-glycolide (PLG)
* non-English speaker
Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt

More than two billion individuals have serological evidence of hepatitis B virus (HBV) infection worldwide. Of these, 240 million are chronic carriers and approximately 786,000 hepatitis B related deaths occur annually.

Currently available hepatitis B vaccines are extremely safe and have an efficacy of \>90 percent against all HBV serotypes and genotypes. Thus, HBV infection can potentially be eradicated through global vaccination. A positive immune response to the vaccine is defined as the development of hepatitis B surface antibody (anti-HBs) at a titer of \>10 mIU/mL.

Although anti-HBs titers decrease with time, the duration of protection is long. Protection has been estimated to persist for up to 22 years after the primary vaccination schedule. Protection from clinical disease, despite declining or even undetectable anti-HBs levels, is probably due to the priming of memory cells, which are capable of eliciting an anamnestic response when challenged. This is supported by the rapid increases in anti-HBs titers in previously vaccinated individuals who administered booster injections.

A significant proportion of the vaccinated population loses both the protective levels of anti-HBs and an anamnestic response. Recommendations for booster vaccination have been proposed in a European consensus statement. Countries like the Netherlands, Germany, Spain, France and Belgium recommend a booster dose depending on the post-vaccination anti-HBs titer. In the UK, a single booster dose is recommended five years after primary vaccination.

In Egypt, the routine infant immunization for hepatitis B virus started in 1992, and was given at 2nd, 4th and 6th months of age. In the present study the investigators will investigate the long term efficacy of hepatitis B vaccination in young adults 20 to 22 years after the primary vaccination in Nile Delta of Egypt.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-22 years
* Administration of HBV vaccine during routine infant immunization (2nd, 4th, 6th months after birth)

Exclusion Criteria:

* Overt co-morbid condition
* Treatment with immune-modulatory or immune-suppressive drugs
Epidemiological Study on Asymptomatic Infections and Mild Illness With Covid-19 in Shanghai

this study is to clarify the epidemiological characteristics of Omicron variant infected persons in Shanghai, such as distribution characteristics, host and clinical characteristics, disease outcome and risk factors. especially asymptomatic infections.


Eligibility Criteria:
Inclusion Criteria:

* SARS-Cov-2 RNA positive.
* asymptomatic or mild clinical manifestation.
* informed consent signed.

Exclusion Criteria:

* informed consent rejected.
Use of Alexa as a Cognitive Aid for Emergency Front Of Neck Access (FONA)

The aim of the study is to investigate whether a voice activated cognitive aid can improve performance in a simulated emergency front-of-neck access scenario. This skill is ideally practiced on an annual basis by anaesthetists in training, with a variety of usually low-fidelity simulation used.

The addition of the Alexa cognitive aid is a novel step with the aim of improving adherence to the recommended steps required to successfully complete the procedure. One arm of this study will be introduced to the Alexa checklist in advance of performing the procedure prior to crossover, whereas the second arm will not (subject to standard anaesthetic training).


Eligibility Criteria:
Inclusion Criteria:

* CT1 to Consultant level Anaesthetists, who have completed the Initial Assessment of Competencies (IAC)

Exclusion Criteria:

* Anaesthetists without the above criteria, refusal
Effect and Tolerance of a Probiotic-based Medical Device Administered to Patients With Irritable Bowel Syndrome

This is an observational, open, longitudinal, multicentre study conducted in France.

The study plans to enrol 119 patients with irritable bowel syndrome who will be included by about 50 general practitioners or gastroenterologists consulting in private offices. The treatment, Lactiplus® is a medical device, in the form of capsules containing L. gasseri LA806. The main objective of the study is to assess the effect of a 4-week treatment with the medical device on abdominal pain.

The study is designed as an observational post-market follow-up study, to confirm the performance of the medical device in real life conditions and document its safety profile.

The eligible population corresponds to the population that could benefit from the treatment, according to the MD's instructions for use. Non-inclusion criteria prevent from including patients with other pathologies associated with gastro-intestinal troubles, who may beneficiate from more adequate treatments.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥ 18 years)
* Suffering from IBS (Rome IV criteria), whatever the predominant stool pattern, i.e recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: Related to defecation; Associated with a change in frequency of stool; Associated with a change in form (appearance) of stool; with symptom onset at least 6 months before diagnosis;
* Having access to electronic tools (computer, tablet...) and an internet connection, allowing him to complete the online self-questionnaire.

Exclusion Criteria:

* Presence of clinical signs of alarm such as rectorrhagia, fever or recent unexpected weight loss or patient with suspicion or evidence of diseases that exclude IBS diagnosis: including but not limited to inflammatory gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis), colorectal cancer, celiac disease, hyperthyroidism, intestinal infection, lactose intolerance, other malabsorption syndromes (e.g.: fructose), bile acid malabsorption;
* History of abdominal surgery except appendectomy;
* Allergy or hypersensitivity to one of the ingredients of the medical device;
* Inability to fill self-questionnaires or to understand the information notice (cognitive or linguistic issues);
* Participation to another clinical study or in the exclusion phase of a previous clinical study;
* Refusal to participate.
Criminal Justice Coordinated Transitional Care

This project aims to enroll 220 incarcerated individuals living with HIV, Hepatitis C (HCV), or history of substance misuse preparing for release into a pilot implementation study to test the feasibility and acceptability of an adapted Coordinated Transitional Care intervention in a Criminal Justice setting (CJC-TraC). Participants can expect to be on study for up to 6 months.

This protocol describes the second, implementation phase of a 5-year NIH-funded research project designed to evaluate post-incarceration health care utilization and outcomes for underserved people living with HIV, HCV and substance use disorder.

In the first study phase, conducted from 2020-21, the investigators analyzed Wisconsin Medicaid data to characterize the baseline level of outpatient care utilization for adults during their first 6 months after release from prison, and conducted formative research necessary to adapt an existing transitional care intervention, called C-TraC, to support individuals leaving prison.

The current project aims to enroll participants in a pilot implementation study to test the feasibility and acceptability of the adapted intervention in a criminal justice setting, which has been given the name "CJC-TraC."

Participants will be enrolled from one of two institutions:

* men from Oakhill Correctional Institute (OCI)
* women from the Wisconsin Women's Correctional System (WWCS)

Primary Objectives: To evaluate the feasibility and acceptability of CJC-TraC when implemented in a state prison system.

Secondary Objectives: To gather preliminary evidence describing the effectiveness of CJC-TraC for improving the rate of outpatient care utilization.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and speak in English
* Plans to reside in Wisconsin after release
* Eligible for Wisconsin Medicaid and willing to enroll prior to release
* Has a history of one or more of the following: current HIV infection, current or past HCV infection, identified need for substance use related services based on Correctional Offender Management Profiling for Alternative Sanctions (COMPAS) assessment
* Anticipated release date (must be within 6 months of review)

Exclusion Criteria:

* Unable to provide informed consent form or impaired ability to make decisions
* Planned discharge to another correctional facility or other carceral setting (e.g. release to jail or immigration detention center)