cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)

This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic criteria with a disease history of at least one year
2. Male or female greater than or equal to (\>=)18-years of age at time of informed consent
3. Active RA as defined by:

   * \>=8 swollen joints (66-joint count),
   * \>=8 tender joints (68-joint count), and
   * C-reactive protein (CRP) \>=10 milligram per liter (mg/L) (central laboratory) and/or erythrocyte sedimentation rate (ESR) \>= to 28 millimeter per hour (mm/h)
4. Failure of at least one TNFa antagonist therapy (previously or at the time of screening) as specified in the protocol
5. Other protocol defined inclusion criteria could apply

Exclusion Criteria:

1. Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
2. Treatment with biologics aiming at B cell modulation such as rituximab or belimumab within 2 years before study Day 1
3. Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab within 3 months before study Day 1
4. Use of etanercept (Enbrel) within 28 days before study Day 1, or of infliximab (Remicade) or adalimumab (Humira) within 60 days before study Day 1
5. Participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study Day 1, whichever is longer)
6. Other protocol defined exclusion criteria could apply
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers.

This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women (of nonchildbearing potential) between 20 and 60 years of age, inclusive.
2. Body mass index between 20.0 and 32.0 kg/m2, inclusive.
3. No clinically meaningful findings on physical examination, electrocardiogram, laboratory tests or vital signs
4. Subject has been given signed informed consent

Exclusion Criteria:

1. History of any significant illness or disorder
2. Acute illness within 30 days of administration of first dose of study drug
3. Positive screening result for HIV, hepatitis B or hepatitis C
4. History of or current substance abuse (drug or alcohol) within past 1 year or positive test for drugs of abuse during screening
5. Use of nicotine-containing or vaping products within 3 months prior to screening or check-in
6. Use of cannabis within 45 days prior to check-in
7. Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening or platelets within 6 weeks prior to screening
8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within past 30 days
Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks

Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by thrombosis and pregnancy morbidity in patients with persistently positive antiphospholipid antibodies (aPLs). However, large-scale research on general population with persistent aPLs has been lacking. This project proposes to establish the first multicenter cohort of patients with persistently positive aPLs in China and conduct a comprehensive clinical phenotyping study. Based on traditional phenotypes of thrombotic and pregnancy events, the focus will be on extra-standard clinical phenotypes and prospective assessment of event risk and prognosis in aPL-positive population. A prospective analysis of extra-standard antibodies will also be conducted to recommend detection criteria for extra-standard antibody application in China and to assess their clinical significance.

Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks (CAPSTONE) is a national research network created to register patients with persistent aPLs. We aim at enrolling 2000 patients from a total of six centers, lead by the Peking Union Medical College Hospital (PUMCH). The aPLs assay will be validated in the central lab in PUMCH. All patients will be followed every six months, and up to three years. Thrombotic and pregnancy events related to aPLs will be recorded, as well as extra-criteria clinical phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* The presence of one or more of the antiphospholipid antibodies (aPL) tested according to the 2006 Sapporo APS clasification criteria, on two or more occasions at least 12 weeks apart:

Exclusion Criteria:

* Patients refuse to participate;
* Unable to be followed.
Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC.


Eligibility Criteria:
Inclusion Criteria:

* For Cohort 1, 3 and 4 patients must have failed treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for metastatic MCC
* For Cohort 2, patients must not have received any anti-PD-1 or anti-PD-L1 therapy
* For Cohort 3, patients must not have received any prior chemotherapy
* For Cohort 4, patients must have received at least one prior line of chemotherapy
* ECOG performance status of 0 to 1
* Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST 1.1
* MCC expressing p53WT based on any CLIA or test approved by local health authority or a validated test (Cohort 1 and 2)
* MCC expressing p53WT based Central Lab test (Cohort 3 and 4)
* Adequate hematological, hepatic, and renal functions

Exclusion Criteria:

* For Cohort 2, subjects must not have autoimmune disease, medical conditions requiring systemic immunosuppression, prior stem cell transplant, or active infection with HBV or HCV.
* Patients previously treated with MDM2 antagonist therapies or p53-directed therapies
* History of major organ transplant
* Patients with known central nervous system (CNS) metastases that are previously untreated
* Grade 2 or higher QTc prolongation (\>480 milli-seconds per NCI-CTCAE criteria, version 5.0)
Non Attendance at Scheduled Appointments as a Marker of Mortality and Hospital Admission

To evaluate the association of non attendance at scheduled appointments with visits in the emergency department, hospitalizations and mortality during one year follow up.

Nonattendance at scheduled appointments at outpatient clinics is a common problem in general medical practice, representing a significant cost to the health care system, and resulting in disruption of daily work planning.Nonattendance at medical appointments has consequences not only for doctors (as it requires a greater use of resources and time), but also for patients, because there may be deterioration in the quality of care, and dissatisfaction associated with delays in obtaining a new appointment

Eligibility Criteria:
Inclusion Criteria:

* Over 17 years.
* Adults who attended, did not attend a scheduled appointment at the Outpatient care system at the Italian Hospital of Buenos Aires (HIBA)

Exclusion Criteria:

- The refusal to register or to the informed consent process.
Nature-Oriented Chatbots on Older Adults' Mental Health

This study aims to explore the influence of nature-oriented chatbots on the mental health of older adults residing alone. Leveraging the therapeutic potential of nature exposure and the interactive capabilities of chatbot technology, our research seeks to investigate whether engaging with nature-oriented chatbots can mitigate feelings of depression, and loneliness while enhancing overall psychological well-being and quality of life. Through a combination of experimental interventions and psychological assessments, the investigators will assess the impact of nature-oriented chatbots on participants' mental health outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 60 years and above who live alone.
2. Regular users of smartphones, with internet access, and proficient in using LINE.
3. Individuals who consent to participate in the study and sign the consent form.
4. Capable of understanding interactive messages and the content of pre- and post-test questionnaires.

Exclusion Criteria:

1. Individuals without smartphones, internet access, or not using LINE.
2. Diagnosed with sensory impairments.
3. Diagnosed with mental illnesses requiring continuous treatment.
Safety and Immunogenicity Study of Rift Valley Fever Vaccine

This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine

Study Objectives:

The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.

Eligibility Criteria:
Inclusion Criteria:

Parts A \& B:

* At least 18 years old, or if active military duty, 17 years old,
* Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding,
* Subject must be actively enrolled in the SIP to be vaccinated at USAMRIID or be otherwise authorized (with documentation) by the DOD
* Subjects must be at risk for exposure to RVF virus,
* Subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. Examinations or tests may be repeated within 1 year at the discretion of the enrolling physician.
* Volunteer must have signed and dated the approved informed consent (Volunteer Agreement Explanation and Affidavit).

Additional Inclusion Criteria for Part B:

• Completion of primary series and any follow-up titer (PRNT80) \< 1:40 from the current or a previous RVF IND 365 protocol.

Exclusion Criteria

Parts A \& B:

* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests.
* Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician.
* Confirmed HIV infection.
* Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer.
* Any serious or life-threatening allergies to any component of the vaccine: formalin, human serum albumin, neomycin, streptomycin
* Administration of any other vaccine within 28 days of any dose of RVF vaccine.
* Any unresolved adverse event resulting from a previous immunization.

Additional Exclusion Criteria for Part B:

• An adequate PRNT80 (≥ 1:40) after completion of primary series.
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year


Eligibility Criteria:
Main Inclusion Criteria:

1. Postmenopausal women
2. Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year

Main Exclusion Criteria:

1. Any contraindication to risedronate
2. Those evaluated as inappropriate at the discretion of the investigator
Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.

A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.

Eligibility Criteria:
Inclusion Criteria:

* currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
* correct visual acuity of 20/30 or better each eye

Exclusion Criteria:

* history of hypersensitivity to any components of solution being tested
* any ocular condition prohibiting contact lens wear
* excessive baseline staining as defined in protocol
* use of topical or OTC ocular medications during the study
* seasonal allergies with significant effect on contact lens wear
Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.

One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women with osteoporotic fracture at spine or wrist
* postmenopausal women no history of fracture at spine or wrist

Exclusion Criteria:

* women with a history of metabolic disease
* stroke
* tibia fracture or surgery
* BMI ≥ 35 kg/m2
* Teriparatide use currently or within the past 6 months,
* Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.
Cost Effectiveness and Utility of Computed Tomography Angiography (CTA) and Cardiac Cath

This is a research study to determine patient preferences between two different diagnostic tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the University to screen for and detect heart disease.

This is a single site study that will retrospectively and prospectively identify and enroll 100 subjects, both male and female, 18 years of age and older who undergo both coronary angiography and coronary artery computed tomography (CT), using the electronic radiology and cardiology databases. The purpose is to conduct a survey to assess their preference for either test to diagnose coronary artery disease. Subjects should be within six months of having the tests to avoid memory and recall problems.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have had both CTA and Coronary angiogram.
* 18 years old and older.

Exclusion Criteria:

* Under 18 years of age
* Memory Impairment:

  * Stroke
  * Traumatic brain Injury
  * Dementia
Global, Regional, and National Burdens and Trends of Tracheal, Bronchial, and Lung Cancer in Individuals Aged 70 Years and Older from 1990 to 2021

Despite the increasing health burden of tracheal, bronchial, and lung (TBL) cancer patients aged ≥ 70 years worldwide, data on its burden and trends are limited. This study aimed to analyze the global, regional, and national burdens and trends of TBL cancer from 1990 to 2021.

The latest cancer report indicates that tracheal, bronchial, and lung (TBL) cancer, the most widespread cancer globally, accounts for 12.4% of new diagnoses and 18.7% of cancer-related deaths, thereby presenting significant societal, public health, and economic challenges.Despite the increasing health burden of tracheal, bronchial, and lung (TBL) cancer patients aged ≥ 70 years worldwide, data on its burden and trends are limited. This study aimed to analyze the global, regional, and national burdens and trends of TBL cancer from 1990 to 2021.

Eligibility Criteria:
Inclusion Criteria:

Pathologic Diagnosis of lung cancer

Exclusion Criteria:

breast cancer Age less than 70 years
Self Fitting Hearing Aid Clinical Investigation

Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids

The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.

Eligibility Criteria:
Inclusion Criteria:

1. Native English speakers
2. Ability to complete questionnaires and laboratory assessments
3. Symmetric, mild to moderate sensorineural hearing loss
4. Informed consent completed with signature
5. Healthy outer ear/middle ear status
6. Limited hearing aid use (non-owners of hearing aids)

Exclusion criteria:

1. Inability to visit the Starkey Headquarters building for testing
2. Central or middle ear hearing pathology
3. Medical contraindications to wearing hearing aids
4. Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
5. Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural hearing loss)
Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy

The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.


Eligibility Criteria:
Inclusion Criteria:

* All adults patients (age 18 or older) with reflux symptoms willing to participate

Exclusion Criteria:

* Pregnancy
* Prior esophageal or gastric surgery
* Achalasia
* Scleroderma
* Gastroparesis.
Web-based Education Module for Pain Management

This study's objectives are as follows:

1. To evaluate the utility of a website to provide information and guidance about pain management in children 2. To educate parents about the pathophysiology of pain, proper use of analgesic medications and signs of pain in children 3. To reduce the functional impact of pain in children following treatment for fracture 4. To endow parents with confidence to manage their child's pain at home 5. To dispel misconceptions about the use and safety of analgesics in children 6. To increase awareness of complications of fractures such as compartment syndrome

This study will compare the effectiveness of three mediums of parental education among parents of children treated for non-operative fractures in the emergency department (ED): 1) A novel website entitled, "Online User-Centered Home Pain Management for Fractures" (OUCH PMF) 2) An online educational video (OV) and 3) standard discharge instructions (SOC). The investigators primary goal is to see which modality results in a greater improvement in scores on a on a knowledge questionnaire. The investigators secondary goals are to see which modality results in better parental satisfaction, confidence in managing pain, and lower impact of injury on the child and family. As participants will receive the standard-of-care that includes a pamphlet on how to take care of the cast. During their stay in the ED, participants will be randomly assigned to one of the three aforementioned groups. Participants will then be given the pre-intervention knowledge questionnaire, followed by the intervention and then the post-intervention knowledge questionnaire, prior to being discharged. At 120 hours post-discharge, participants will be asked to access an online survey to obtain information about the functional impact of the injury on their child. The investigators goal is to compare online and video education tools in their ability to improve parental knowledge, confidence, and satisfaction regarding the treatment of fracture pain.

Eligibility Criteria:
Inclusion Criteria:

* All caregivers who are in attendance with their child (any age) for a primary complaint of a non-operative fracture managed by the paediatric emergency physician AND will be the primary caregiver for the child at home.

Exclusion Criteria:

* Poor parental English fluency
* Lack of a home computer with Internet access
* Child with a history of renal disease, liver disease, bleeding diathesis, chronic pain issues, or pregnancy.