cyrilzakka/clinical-trials huggingface dataset:
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction

This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
* Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
* Body weight \>50 kg (110 lbs).
* Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
* Additional criteria exist.

Key Exclusion Criteria:

* Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).
* Positive urine drug screen within 28 days prior to first dose of study drug.
* Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
* Additional criteria exist.
A Multiple-dose Study of LY3031207 in Healthy Participants

The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to healthy Japanese and non-Japanese participants as multiple doses. In addition, effects of 28-day oral dosing of LY3031207 on the amount of a cholesterol-lowering drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of it will be determined. The effects of LY3031207 after single and 28-day dosing on blood pressure will also be studied. Information about any side effects that may occur will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy individuals based on the history and physical examinations as determined by the investigator, including first generation Japanese
* Body mass index between 17.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive

Exclusion Criteria:

* Have known allergies to LY3031207 or any components of the formulation, simvastatin or related compounds (other 3-Hydroxy-3-Methyl-Glutaryl-CoA \[HMG CoA\] reductase inhibitors), celecoxib, or sulfonamides. Participants with known aspirin allergy or allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded
Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects btween the ages of 18-55 years
* Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
* Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
* Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
The Changes Under Different Accommodation of Anterior Eye and 3D Crystal Reconstruction.

Accommodation is defined as a dynamic change in the overall refractive power of the eye during near fixation. Despite extensive investigations, the exact nature of human accommodation remains controversial. And recent alternative theories question the original concept of accommodation.Different experts have put forward different hypotheses. The age-related changes that underlie presbyopia are also not fully understood.Because of these unanswered questions, the topic of regulation and presbyopia remains a focus of research.

Accommodation is the process by which the eye changes the shape and diopter of the lens to obtain a clear image of an object at different distances. Despite extensive research on regulation, the exact nature of human regulation remains controversial. Age-related changes in presbyopia are also not fully understood. Some studies have shown that a hardening of the lens and an increase in the thickness and diameter of the lens with age can lead to presbyopia. Others believe that the main cause is external lens factors, such as age-related changes in the Angle of lens suspension ligament attachment, reduced ciliary body movement, etc. Due to these unanswered questions, the topic of regulation and presbyopia remains the focus of research. In living humans, modulation studies utilize different imaging modes, and ultrasound biomicroscopy (UBM) and Optical Coherence Tomography(OCT) are particularly important in studying anterior segments and modulation. However, UBM is a contact inspection and requires highly skilled technicians. And UBM cannot image the entire anterior segment in a single capture. Anterior segment OCT (AS-OCT), on the other hand, is non-invasive and provides higher resolution imaging, allowing us to capture the morphology of the anterior segment structures in different populations and the changes of the anterior segment structures in response to regulatory stimuli. Studies have shown that with age, reduced anterior chamber depth, pupil contraction, increased lens thickness, increased lens arch height, and loss of posterior ciliary muscle contraction may be biomarkers of early presbyopia. In this study, anterior segment OCT was used to explore whether there were differences in the structural morphology of the anterior segment in people of different ages, and what changes occurred in the structure of the anterior segment after initiation of regulation.

Eligibility Criteria:
Inclusion Criteria:

· Patients with astigmatism ≤-1.50D and best corrected visual acuity ≥4.9

Exclusion Criteria:

* Patients with other systemic diseases
* Patients with a history of eye surgery
* Patients with intraocular lens or aphakia
* Patients with strabismus and amblyopia
* Pregnant or lactating women
* People with mental disorders or neurological diseases who cannot cooperate with the examination
JX09 SAD/MAD in Healthy Participants

This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 55 years (inclusive)
* In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests
* Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening

Exclusion Criteria:

* Clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal, psychiatric, or other condition that in the opinion of the Investigator or Medical Monitor would make is unsafe for the participant to join the study or fulfill its requirements.
* A clinical abnormality or abnormal laboratory parameter(s) in the opinion of the Investigator or Medical Monitor is likely to introduce additional risk or will affect data interpretation.
* Postural tachycardia or hypotension.
* Female of childbearing potential who is pregnant, lactating, or planning to become pregnant.
Effects of Psilocybin in Anorexia Nervosa

This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely produced in people with AN when psilocybin is administered in a supportive setting with close follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in people with AN, that it will reduce measures of anxiety and depression, and that it will lead to increased quality of life. The investigators will also assess a number of exploratory measures related to eating disorder pathophysiology.


Eligibility Criteria:
General Inclusion Criteria:

* Currently meet criteria for AN restricting subtype by Diagnostic and Statistical Manual 5th edition (DSM-5) criteria, and have a history of AN for at least 3 years prior to screening
* Have at least one prior attempt at treatment
* Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (complete blood count, comprehensive metabolic panel, urine pregnancy test, urine toxicology screen).
* Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.

General Exclusion Criteria:

* Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of childbearing potential and sexually active who are not practicing an effective means of birth control.
* Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, heart valve, or transient ischemic attack in the past year. Resting heart rate may be no less than 50 beats per minute unless cleared by a cardiologist.
* Epilepsy with history of seizures
* Type 1 diabetes
* First degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder
* Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
Titanium Zirconium (TiZr) Mini Implants

H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient-reported outcome measures (PROMS) compared to two interforaminally placed, early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular overdenture."The specific aim is to compare both treatment alternatives to evaluate which one may be recommended for elderly edentulous patients.


Eligibility Criteria:
Inclusion Criteria:

* At patient level:

  * Written informed consent
  * Age ≥ 18 years
  * Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year
  * Patient is unsatisfied with mandibular denture to the degree that he/she seeks treatment
* At site level:

  * Healed edentulous mandible (minimum 8 weeks since last extraction)
  * Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10 mm (length) implants
  * Opposing dentition: complete denture on a edentulous maxilla
  * Physical status (PS) 1 and 2 (American Society of Anesthesiologists)

Exclusion Criteria:

* At patient level

  * Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
  * Any disorder that would interfere with wound healing or represent a contraindication for oral surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
  * Pregnancy or lactation
  * Heavy smoking habit with \> 20 cig/d
  * Severe bruxism or clenching habits, present oro-facial pain
* At site level:

  * Ridge defects requiring staged bone augmentation procedures (simultaneous Guided Bone Regeneration (GBR) within the ridge contour allowed)
Study to Evaluate an Influenza Vaccine Candidate

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
* A male or female between, and including, 18 - 64 years of age at the time of vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
* Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Confirmed influenza infection within a year preceding the study start.
* Administration of an influenza vaccine within a year preceding the study start.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female.
* Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
* Acute disease at the time of enrolment.
* History of chronic alcohol consumption and/or drug abuse.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
* History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
Brilinta Clinical Experience Investigation

To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as "BRILINTA") in clinical practice in the post-marketing phase.

1. Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc.
2. Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
3. Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke)
4. Factors which may affect safety or efficacy of ticagrelor


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Exclusion Criteria:

-
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older
2. After allogeneic transplantation
3. Grade III or IV acute GVHD
4. No psychiatric contra-indication
5. Informed consent

Exclusion Criteria:

1. History of psychosis
2. Asthma
3. Known allergy to cannabis constituents
Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo

To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.


Eligibility Criteria:
Inclusion Criteria:

* Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
* Has a Modified Hachinski Ischemia Scale score of less than or equal to 4
* Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit
* Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form)
* Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD
* Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening

Exclusion Criteria:

* Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
* Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of \<2 years
* Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness
* Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment
* Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments
* Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks
* Has a history of chronic alcohol or drug abuse/dependence within the past 5 years
* Has a Visit 1 MRI with results showing \>4 Amyloid-related Imaging Abnormality (ARIA), -hemorrhage /hemosiderin deposition (ARIA-H) or presence of ARIA-E (edema/effusions)
Routine Activity and Preterm Delivery Risk in Women With a Short Cervix

The goal of this clinical trial is to evaluate the effect of routine activity versus rest on the risk of preterm delivery in pregnant women with a short cervix diagnosed between 24 and 34 weeks of gestation. The main questions it aims to answer are:

Does routine activity influence the gestational age at delivery? How does routine activity affect secondary outcomes such as preterm labor, premature rupture of membranes, delivery mode, maternal anxiety, and satisfaction?

Researchers will compare women instructed to maintain routine activity (control group) to women advised to practice maximal rest (intervention group) to see if physical activity impacts preterm birth outcomes.

Participants will:

Wear a smart band to monitor step counts over a two-week period. Be randomized into two groups: one encouraged to maintain routine activity and the other advised to follow strict rest protocols.

Undergo regular follow-ups at a high-risk pregnancy clinic and have their data collected through hospital records and smart band tracking.

This randomized controlled trial will assess gestational age at delivery as the primary outcome, along with secondary maternal and neonatal outcomes, providing insight into the role of physical activity in managing pregnancies complicated by a short cervix.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies between 24+0 and 34+6 weeks.
* Short cervical length (\<25 mm) confirmed via transvaginal ultrasound.
* No medical contraindications to physical activity.

Exclusion Criteria:

* Twin pregnancies or higher-order multiples.
* Medical indications for reduced mobility (e.g., symphysiolysis, fall risk).
* Maternal comorbidities, fetal distress, vaginal bleeding, PPROM, or need for immediate delivery.