cyrilzakka/clinical-trials huggingface dataset:
COVID SAFE: COVID-19 Screening Assessment for Exposure

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.

This study 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.

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 nations continue to confront the current crisis, plans for the future must be put 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. For these reasons, the investigators propose to evaluate the implementation of a COVID-19 screening program that uses saliva-based testing.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older
* University of Pennsylvania faculty, staff, or trainee
* Have a phone or device capable of receiving text messages
* Willing to participate in the study for 6 months

Exclusion Criteria:

* Participants will not be eligible if they identify any reason they are unable to participate in the study.
A Study of LY3502970 in Participants With Normal and Impaired Renal Function

The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive.
* Men and women who agree to use highly effective or effective methods of contraception may participate in this trial.

Participants with Normal Renal Function:

* Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min)

Participants with Renal Impairment:

* Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis.
* ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.

Exclusion Criteria:

* Have a current, functioning organ transplant. Non-functional renal allografts may be allowed.
* Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications.
* Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy.
* Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study.
* Have a history or presence of chronic or acute pancreatitis

Participants with Renal Impairment:

* Have hemoglobin \<8.5 g/dL.
* Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension


Eligibility Criteria:
Inclusion Criteria:

* Provided signed, written informed consent.
* Diagnosed with primary open-angle glaucoma or ocular hypertension.
* 18 years of age and older.
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
Brain Imaging in Cerebral Venous Outflow Disturbance

Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. These changes are associated with numerous neurological signs and symptoms. Therefore, understanding the brain structural and functional changes in patients with cerebral venous outflow disturbance is essential to provide specific imaging evaluation indicators and new diagnosis and treatment methods for patients with cerebral venous return disorders.

Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. These changes are associated with numerous neurological signs and symptoms. A number of central nervous system disorders such as transient global amnesia, transient monocular blindness, primary labor headaches, and even Parkinson's have been reported to be closely associated with internal jugular vein stenosis. Other common clinical manifestations include sleep disturbances, tinnitus, tinnitus, headache, visual impairment, optic papilledema, hearing loss, cognitive decline and neck discomfort and even autonomic dysfunction. The main objective of this study is to investigate the structural and functional network changes in patients with cerebral venous outflow disturbance using different brain imaging techniques, to clarify the correlation between symptoms of cerebral venous outflow disturbance and brain structure and function; to identify areas with corresponding structural and functional changes in patients with cerebral venous outflow disturbance and or comorbid symptoms, and to provide specific imaging assessment indicators and new diagnostic and treatment tools for patients with cerebral venous outflow disturbance and comorbid symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral venous outflow disturbance( moderate to severe stenosis in cerebral venous sinus or intracranial jugular veins ) is confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA)
* Accompanying symptoms such as tinnitus cerebri, cognitive decline, anxiety depression, sleep disorders, etc. for more than 6 months

Exclusion Criteria:

* ear primary disease medicine related intracranial hypertension; Systemic disease of abnormal metabolism or inflammation; moderate to severe stenosis in intracranial, carotid or vertebral arteries; intracranial lesions.
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).

ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have become more common. There is an urgent need for additional antibacterial drugs with modes of action different from those currently available. CEM-102 is one such agent with excellent activity against S. aureus, including MRSA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen.
* Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections
* Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy.
* Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature \>=100.4 degree F, increased white blood cell count, or bandemia.
* Must not have received treatment with another systemic antibiotic for the current ABSSI.

Exclusion Criteria:

* Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis.
* Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.
* Suspected polymicrobial infection involving Pseudomonas aeruginosa
* Anticipated need for \>14 days of antibiotic therapy.
* Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis.
* Known significant renal, hepatic, or hematologic impairment.
* Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.
Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study

The study aims to observe the ocular development and refractive error changes among school children and adolescents

This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

Eligibility Criteria:
Inclusion Criteria:

* School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).
* No allergy to tropicamide or topical anesthetics
* written informed consent is obtained from guardian
* Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria:

* No history of eye diseases
* Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses
* A history of allergy to topic amide or topical anesthetics
* Have severe systemic disease
* Missing ability to give informed consent
Long-term Active Surveillance Study for Oral Contraceptives (LASS)

The objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.

The LASS Study is a large, multinational, prospective, controlled, non-interventional, long-term cohort study that follows a series of cohorts. The cohorts consist of new users (first-ever users, switchers and restarters) of three different groups of oral contraceptives (OCs): OCs containing drospirenone (DRSP), OCs containing levonorgestrel (LNG) and OCs containing other progestogens. A "non-interference" approach is used to provide standardized, comprehensive, reliable information on these groups of OCs under routine medical conditions.

The main clinical outcomes of interest for the long-term follow-up are arterial and venous thromboembolism as well as breast cancer. Regular, active contacts with the cohort members (=active surveillance) provide all necessary information on health-related events or changes in health status.

The study is based on the existing long-term EURAS cohorts who are still in follow-up. LASS succeeds EURAS and prolongs the follow-up period for another five years. Total follow-up time of members of the long-term cohorts will be between 6 and 10 years. By means of annual contacts almost all relevant clinical outcomes will be captured. This will be accomplished by contacting the relevant physicians and by reviewing relevant source documents in the case of relevant clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation

Exclusion Criteria:

* Women who do not consent to participate in the study
Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.

Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \>= 25 years
* Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
* BVCA using ETDRS of 20/32 to 20/400

Exclusion Criteria:

* Any history of prior vitrectomy
* Any prior treatment with verteporfin PDT in the study eye
* Previous cataract surgery within the preceding 2 months of D0
* Active intraocular inflammation in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* A condition, that in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease)
* Participation in another investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
* Prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study
* Known allergy to any component in the study drug
* Uncontrolled hypertension: \>180/110
* major surgery within 28 days prior to randomization
* Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization
* Systemic anti-VEGF or pro-VEGF within 3 months of randomization
* Pregnancy or lactation
* History of recurrent significant infections or bacterial infections
Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women

The primary objective of this trial is to determine whether two doses of an extract from bran demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial populations, particularly bifidobacteria). The secondary objective is to measure the potential beneficial effects of consuming an extract from bran on the following physiological parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers of oxidative stress and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-75 years of age
* Body mass index ≥18.5 and \<35.0 kg/m2
* Fasting LDL-C level ≥100 mg/dL and \<200 mg/dL
* Otherwise judged to be in good health, willing to maintain habitual food and beverage intake and physical activity patterns throughout the trial

Exclusion Criteria:

* Significant gastrointestinal condition
* Use of pre/probiotic foods or supplements
* Use of antibiotics
* Pregnancy
* Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
* Poorly controlled hypertension
* Cancer treated within prior 2 years
Reactor Thoracostomy

Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.

Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects age ≥ 18 years old
2. Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
3. Hemodynamically stable

Exclusion Criteria:

1. Pregnant patients
2. Prisoners
3. Need for emergency thoracostomy
4. Hemodynamic instability
5. Respiratory distress
Multi-center Study of Deep Learning AI in Breast Mass

This multi-center study intends to evaluate the value of the detection and differential diagnosis of breast mass using deep learning AI-based real-time ultrasound examination.

As the most common cancer expected to occur all over the world, extensive population screening plays a very important role in the early diagnosis and prognosis of the breast cancer. X-ray and ultrasound are the most commonly used screening methods, and ultrasound is especially important for Asian women with dense breasts. However, ultrasound is greatly affected by the operator's skill and experience, and the diagnostic accuracy varies greatly.

Artificial intelligence (AI) is a new method emerging in recent years, active in many medical fields and can effectively improve the diagnostic efficiency. However, previous researches on the application of AI in ultrasound are focused on single or multi-modality static ultrasound images. This multi-center study intends to evaluate the value of the detection and differential diagnosis of breast mass using deep learning AI-based real-time ultrasound examination.

Eligibility Criteria:
Inclusion Criteria:

1. Females who undergo ultrasound examination for a complaint of breast lesion;
2. The breast lesion that will obtain definite pathological diagnosis or follow-up at least two years.

Exclusion Criteria:

1. The breast lesion that has received CNB or FNA;
2. The breast cancer patient who has received neoadjuvant chemotherapy.
Tissue Quality of Integra vs. BTM Treated Burns

An observational analysis of Integra-treated burns and Novosorb Biodegradable Temporizing Matrix (BTM)-treated burns will be undertaken 12-36 months post final skin graft application by retrospectively analyzing the patient's electronic medical record, and prospectively using a non-invasive measures of tissue quality and patient-reported outcomes. Patients will be offered the option to consent for a tissue biopsy for pathological evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has reviewed the IRB-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form.
2. Patient had a deep dermal or full-thickness burn that required skin grafting that was first treated with Integra\* or BTM, and at least 70% 'take' followed by an autograft
3. Patient had final skin graft between 12-36 months prior enrollment in the study.
4. Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA.
5. Patient is ≥ 21 years of age at the time of treatment.

Exclusion Criteria:

1. Patient had a radiation burn.
2. Patient was treated with Integra or BTM and closed via secondary intention.
3. Severe cognitive dysfunction or psychiatric disorders.
4. Immunocompromised patients.
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study

To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use

To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) (hereinafter referred to as "CALQUENCE") used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use.

This investigation will be conducted as the additional pharmacovigilance activity specified in the Japan Risk Management Plan (J-RMP) of CALQUENCE, in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices (PMD Act).

Eligibility Criteria:
Inclusion Criteria:

Patients with previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma) who are treated with Calquence for the first time will be enrolled in the study after the approval date of the sJNDA for the additional indication.

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Exclusion Criteria:

None

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