cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis

The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).

This is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Participants

  * Are overtly healthy males or females, as determined by medical history and physical examination
  * Females must be of non-childbearing potential
  * Are between 18 and 64 years of age, inclusive, at screening
  * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
  * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Psoriasis Participants:

  * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline
  * Meet psoriasis disease activity criteria
  * Are at least 18 years of age
  * Have a minimum body weight of 50 kilograms (kg)

Exclusion Criteria:

* Healthy and Psoriasis Participants

  * Have known or ongoing neuropsychiatric disorders
  * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study
  * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline
  * Show evidence of active or latent tuberculosis (TB)
  * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data
* Psoriasis Participants Only:

  * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)
  * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval
  * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline
  * Have received topical psoriasis treatment within 14 days of baseline
Psychological Impact of Pregnancy of Unknown Location

To assess the psychological impact of pregnancy of unknown location (PUL) classification pending a final diagnosis.

PUL is a syndrome of early pregnancy composed of a positive urine pregnancy test without the visualisation of a pregnancy on trans-vaginal ultrasound (TVUS). The current method for risk stratifying a PUL is via serum BhCG levels at the time of identification of PUL and after 48 hours, in order to ascertain the viability of the pregnancy. Patients and their partners need to wait for this result before a management plan can be adopted, taking at least 2-3 hours. There is a clear need for the patient care pathway to evolve in order to aid and improve the management of women classified with a PUL. By using point-of-care BhCG testing, the investigators hope to shorten the time to management. The investigators therefore propose that shortening the time interval would reduce psychological morbidity. This is a prospective cohort observational study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending the Early Pregnancy Unit in the first trimester (up to 14 weeks gestation) with a pregnancy of unknown who are over 18 years old and are able to give consent.

Exclusion Criteria:

* Presence diagnosed with cancer
* The presence of an acute medical condition
* Patients/partners aged less than 18 years
* Patients or partners who cannot give fully informed study consent (language or learning impairment)
* Presence of a viable intrauterine pregnancy, ectopic pregnancy and miscarriage.
Doctor-Patient Communication About Colorectal Cancer Screening

The purpose of this study is to learn more about doctor-patient communication about colon cancer screening. This study will also look to see if there are differences in those who get colon cancer screening based on the discussion the doctor had with the patient.


Eligibility Criteria:
Inclusion Criteria:

Physicians

* Attending physicians or third year residents specializing in internal medicine or family medicine, as per the medical director from the clinic.
* Clinic is based at a NYC RING-affiliated practice.
* English speaking; Due to limited resources, we cannot have each audio recorded consultation translated therefore, the consultation needs to be in English.

Patients

* Ages 50-75 years old, per the United States Preventive Services Task Force recommendations for screening. This will be determined by a pre-screening of medical records by the RSA.
* Due for colorectal cancer screening at the time of the visit, ascertained through patient self-report (e.g., no colonoscopy within the past 10 years, no flexible sigmoidoscopy or barium enema within the past five years, and no FOBT within the past year).
* Coming for either an annual physical exam or chronic care follow up visit, per patient self-report.
* Planning to consult with the physician in English, per patient self-report. Due to limited resources, we cannot have each audio recorded consultation translated therefore, the consultation needs to be in English.

Exclusion Criteria:

* History of colorectal cancer, per patient self-report or per EMR..
* History of polyps being removed, per patient self-report.
* Colonoscopy scheduled in EMR at time of screening.
Effects of Home-based CIMT and Clinic-based CIM on Stroke

Constraint induced movement therapy (CIMT) is based on the theoretical basis that constraining the unaffected limb following injury of the brain such as stroke can help overcome learned non-use. It comprises of constraint of the unaffected limb, massed tasks practice with the affected limb and a behavioral contract known as the transfer package whereby use of the affected limb is extended to the real-world situations. home-based rehabilitation is likely to be cost-effective, and it may reduce cost for patients in terms of hospital charges and transport fares. However, one of the major problems with the existing home-based CIMT protocols is that, they used number of hours spent carrying out tasks practice as the measure of intensity of practice, and it has been argued that, such method is not clear and it does not reflect the correct intensity of practice.

The aim of this study is to determine the effects of home-based CIMT compared with clinic-based CIMT that use number of repetition of tasks practice on motor impairment, motor function, quantity and quality of use of the limb in everyday life, community integration, stroke self-efficacy and quality of life. Constraint induced movement therapy (CIMT) can be administered either at home or in the clinic. The home-based CIMT is used to make CIMT easier for the patients

Eligibility Criteria:
Inclusion Criteria:

* have stroke 1-2 years before
* moderate disability
* a score of 1 to 3 on the motor arm item of the National Institutes of Health Stroke Scale (NIHSS)
* a score of 3 or more on the upper arm item of the Motor Assessment Scale (MAS)
* no significant cognitive impairment (a score of ≥24 points on Minimental state examination)

Exclusion Criteria:

* patients with re-stroke
* serious orthopaedic conditions such joint contracture, osteoarthritis and burns that will interfere with carrying out CIMT
* who are receiving rehabilitation at the time of the study
A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)

The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.

The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:

re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.

or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.

Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.

After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.


Eligibility Criteria:
Inclusion Criteria:

* Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile).
* Symptoms of acute MI of more than 30 min but less than 6 hours
* New persistent ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram (ECG) leads.

Exclusion Criteria:

* Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes
* Contraindication to ticagrelor (refer to SmPC)
* Concomitant medication that may increase the risk of bleeding \[e.g non steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned or administered 24 hours before randomization\]
* Any of the following conditions in the absence of a functioning implanted pacemaker: known SSS, second or third degree AVB, or documented syncope of suspected bradycardic origin.
Study of Various Insoles in Patients With Knee Osteoarthritis

It is critical to improve our understanding of knee osteoarthritis and to design better therapeutic options for this disease. The function of the knee during walking is an important factor in the development and progression of the disease. Many models of insoles that can be inserted in regular shoes with the objectives of improving the function of the knee are available on the market without prescription. Prior studies on these insoles failed to report clear benefits for the patients, mainly because the results varied strongly between persons. Walking is a complex tasks and it is well known that everybody develops his/her individual way of walking (ie., there are subtle but very important differences in the function of the knee). This observation and the fact that patient responses could vary between individuals suggest that using the same standard insoles with all patients might not be appropriated. This further suggests that care could be greatly improved if it was possible to identify patients that would respond positively to a model of insoles. Unfortunately, while several randomized controlled trials were conducted on these insoles for knee osteoarthritis, there is a paucity of data regarding their effects on the ambulatory function of the knee. Therefore, this study aims to improve the understanding regarding the effects of insoles freely available on the market in terms of knee mechanics during walking and its relation with quality of life. This study will test the hypotheses that (i) insoles have an effect on the static and dynamic lower-limb function and (ii) that benefits perceived by the patients are related to the mechanical effects produced by the insoles.


Eligibility Criteria:
PATIENTS WITH KNEE OSTEOARTHRITIS

Inclusion Criteria:

* Knee x-ray with less than a year
* Medial compartment knee osteoarthritis
* Varus knee between 0 and 10 degrees

Exclusion Criteria:

* Neurological impairments
* Prior lower-limbs surgery
* Joint injection during the last six months
* Convergent patella

CONTROL SUBJECTS

Inclusion Criteria:

* No lower-limbs or spine osteoarthritis
* No pain during ambulation

Exclusion Criteria:

* Neurological impairments
* Prior lower-limbs surgery or current treatments
Detecting Delayed Discharge in Acute Geriatric Unit Using Natural Language Processing

Delayed discharge in geriatric units is a health and economic issue. There is no algorithm to automatically measure the appropriateness of admissions or hospital days. 30% of the days of hospitalization in acute geriatric units (AGU) are not appropriate. Waiting for a transfer to a follow-up care and rehabilitation unit (SSR) is the main risk factor for inappropriate days. The purpose of this project is to develop an algorithm using natural language processing to predict the appropriateness of an admission to UGA, or a day at UGA.


Eligibility Criteria:
Inclusion Criteria:

* age : \>75 years
* patient hospitalized in an AGU

Exclusion Criteria:

* refusal to participate
Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter

The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.
* Patient must have a patent internal jugular vein.
* Patient has given informed consent.

Exclusion Criteria:

* Patient is less than 18 years.
* Patient has a pre-existing filter
* Patient had indications for a permanent filter at the time of the initial evaluation.
* Patient has uncontrollable coagulopathy.
* Patient has a short life expectancy \< 6 months.
* Patient has metastatic malignancy.
* Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
* Patient has a contrast allergy that cannot be adequately pre-medicated.
* Patient is at risk of septic embolism.
* Patient has sepsis.
* Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.
* Patient has impaired renal function (creatinine \> 2.0).
* Patient is pregnant or planning to become pregnant within the next 6 months
Time to Peak Effect of Propofol in Children

In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will enable investigators to quantify the difference with age in the hypnotic effect of propofol.


Eligibility Criteria:
Inclusion Criteria:

* The study population will be healthy children in the ranges of 1-6 and 8-13 years of age having surgery with American Society of Anaesthesia (ASA) grades I-II (ie. no prior functional limitation due to comorbidities) that fulfil the following points:
* parental written consent obtained at least a day prior to begin of the subject's study episode; and
* the child is appropriate for induction and maintenance of anaesthesia with propofol.

Exclusion Criteria:

* Any significant subject co-morbidity (ASA III or IV);
* Withdrawal of consent/assent at any point in the study;
* Failure to cannulate a peripheral vein prior to induction after two attempts;
* Any other reason making IV induction with propofol impossible;
* Allergy to propofol (or its emulsion carrier), Eutectic Mixture of Local Anesthetics (EMLA) cream or Nitrous Oxide (N2O);
* previous enrolment in the study;
* Any anaesthetic problem that would take precedence over completion of the study protocol.
Clinical Evaluation of a New Aspheric Intraocular Lens.

This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
* Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.

Exclusion Criteria:

* Patients with corneal damage.
* Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Patients with any ocular pathology, other than the cataract, having repercussions on visual function:
Non Invasive Extra-corporeal ECG Signal Analysis Algorithm( NID Algorithm) for Myocardial Ischemia

The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly.

In this project, the investigators hope to compare the data collected under this new technology of NIA algorithm with results from final diagnoses of cardiac catheterization. As the NIA algorithm is a fast and less costly, if it provides more sensitivity and specificity than does exercise ECG, nuclear myocardial perfusion test, and high-resolution coronary CT angiogram, it will expedite diagnosis for patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* patient with acute coronary syndrome who accepted percutaneous coronary intervention

Exclusion Criteria:

* no percutaneous coronary intervention
Relationship Between Musculoskeletal, Sensorimotor and Functional Factors and Nonspecific Chronic Neck Pain

Several factors have been associated with neck pain. Controversy exists regarding the degree of association between some of these factors and neck pain. Information regarding the degree of association of each factor to neck pain is needed for effective prevention and appropriate treatment strategies. The aim of this study is to investigate the association among musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic nonspecific neck pain.


Eligibility Criteria:
Inclusion Criteria:

* for subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
* for healthy subjects: no history of neck pain

Exclusion Criteria:

* history of cervical discopathy
* any surgery on neck
* traumatic neck injury
* any congenital disorders
Deep Clinical Trajectory Modeling to Optimize Accrual to Cancer Clinical Trials

This study aims to evaluate the effectiveness of proactive notifications to treating oncologist to optimize participant accrual to clinical trials by utilizing the MatchMiner AI platform. This study compares the standard MatchMinder AI access method to two enhanced recruitment methods.

The goal of this medical record data analysis and health system implementation study is to evaluate the effectiveness of proactive notifications to treating oncologist to optimize participant accrual to clinical trials by utilizing the MatchMiner platform. This study compares the standard MatchMinder access method to two enhanced recruitment methods.

In the first phase, investigators will provide qualitative feedback to improve AI algorithm impact on clinical trial accrual and the delivery of information from the MatchMiner platform that is utilized by treating oncologists and investigators.

In the second phase, medical records identified by the MatchMiner platform as available or a "match" for clinical trial enrollment will be randomized into three cohorts with the randomization occurring at the participant level. In Group 1, treating oncologists can use MatchMiner in its traditional form to identify potential clinical trial candidates based on structured genomic data and cancer type. In Group 2, treating oncologists will automatically receive emails with lists of potential genomically matched clinical trials identified by MarchMiner for patients in whom our AI algorithm detects an elevated probability of changing treatment based on imaging reports; oncologists can also still use traditional MatchMiner workflows. In Group 3, treating oncologists will receive email lists of genomically matched clinical trials identified by Matchminer for patients with AI-detected elevated probability of treatment change, after additional manual review to confirm that patients had progressive diseased based on their imaging reports and did not meet one of the common exclusion criteria for most cancer trials (including uncontrolled brain metastases, multiple primary cancers, poor performance status, lack of measurable disease, already having changed treatment, and hospice enrollment).

Of note, this study was not itself considered a clinical trial during the initial NCI grant application process or on subsequent discussion with NIH staff, since the outcomes were research processes (whether patients enrolled in other therapeutic clinical trials), not health-related patient outcomes as per the NIH definition of a clinical trial. However, for publication, a medical journal determined that the study met ICMJE criteria for a clinical trial and requested that it be registered.

Eligibility Criteria:
Inclusion Criteria:

-≥ 18 years of age

-adults with any type of cancer whose tumors underwent OncoPanel genomic sequencing from 2013-2022

Exclusion Criteria:

-≤ 18 years of age.
Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes

The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes


Eligibility Criteria:
Inclusion Criteria:

* Self identify as African American
* smoke primarily menthol cigarettes
* be between the ages of 18 and 64
* smoke a minimum number of cigarettes per day
* agree to abstain from menthol cigarettes for an 8 week period

Exclusion Criteria:

* current unstable medical / psychiatric condition
* regular use any form of nicotine or tobacco other than cigarettes
* are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not be eligible to participate