cyrilzakka/clinical-trials huggingface dataset:
Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects

This study was a single-center, single-dose, open-label study in healthy male subjects to investigate the absorption, metabolism and excretion of HRS9531 after a single subcutaneous injection of \[14C\]HRS9531.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
2. Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
3. Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
4. From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.

Exclusion Criteria:

1. History of any clinically important disease or disorder.
2. History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug.
3. Physical examination, vital signs or other laboratory measurements, other electrocardiographic parameters, abdominal ultrasound (except mild fatty liver), and abnormalities on chest radiography as judged by the investigator to be clinically significant.
4. The subject was considered by the investigator to have any other factors that would preclude him from participating in the study or the subject withdrew from the study due to his own reasons.
Effect of Animated Video on Comprehension and Implementation Feasibility

The aim of this study is to evaluate the effects of a brief web-based educational intervention on improving Anterior Cruciate Ligament (ACL) injury prevention comprehension and implementation feasibility among coaches of athletes participating in landing and cutting sports (e.g., soccer, basketball, football, etc.). The two main hypotheses are that, compared to both an active and placebo control group, the brief animated video will produce greater improvements in:

1. Overall comprehension of ACL injury risk and mitigation: placebo control group \< active control group \< intervention group.
2. Feasibility of utilizing ACL injury prevention strategies: placebo control group \< active control group \< intervention group.

Exploratory hypothesis: The brief animated video will produce greater improvements in various subcomponents of comprehension-specifically: basic ACL knowledge, risk knowledge, prevention knowledge and severity knowledge compared to both active and placebo control group conditions.

This study is a computer-based, three-arm pre-post randomized control design trial. Participants were randomized into an intervention group, active control group or passive control group on a 1:1:1 ratio by a computer-generated algorithm embedded within the Qualtrics software (Qualtrics, Provo, UT). Sports coaches of youth and adolescent athletes in various landing and cutting sports (e.g., soccer, basketball, volleyball, etc.) in the United States were recruited and invited through Qualtrics' panelists. The intervention group was shown a three-minute animated video consisting of various information components aimed at improving capability, motivation and opportunity to implement ACL injury prevention strategies. The active control group received commonly accessed information from a WebMD web-based article on ACL injury prevention. The placebo control group intervention received an educational video from the CDC about concussions that is comparable in duration to that of the ACL video. Overall ACL comprehension-composed of basic ACL knowledge, risk knowledge, prevention knowledge, and severity knowledge-as well as implementation feasibility were all measured prior to and immediately following the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Sports coaches of youth and adolescent athletes in various landing and cutting sports (e.g., soccer, basketball, volleyball, etc.) in the United States.

Exclusion Criteria:

* Non sport coach or coach of non-landing and cutting sport (e.g., golf, swimming).
Work Injury Prevention in Law Enforcement Officials

Law enforcement officials (LEOs) demonstrate an elevated risk for occupational injury. The effectiveness of exercise-based work injury prevention programs (WIPPs) to reduce the risk and costs associated with occupational injury has yet to be tested rigorously in LEOs. The accuracy of existing field tests of physical functioning to predict occupational injuries and related expenses remains unclear. The objectives of this study are to: (i) determine the effect of an exercise-based WIPP on occupational wellness and productivity in a cohort of LEOs, and (ii) to determine the accuracy of 2 common field assessments of physical function to predict lost work productivity and related expenses in a cohort of LEOs.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* Working full duty as a law enforcement official

Exclusion Criteria:

* Current history of pathology or symptoms that preclude exercise
* Medical or rehabilitative treatment for a work-related injury within the past year prior to enrollment in this study
Studying Blood Samples From Patients With Multiple Myeloma Who Were Treated With Thalidomide or Lenalidomide

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood samples from patients with multiple myeloma who were treated with thalidomide or lenalidomide.

OBJECTIVES:

Primary

* To analyze the mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE) in patients with multiple myeloma treated on clinical trial ECOG-E4A03 or E-E1A00.
* To determine the intensity, dynamics, and specificity of cathepsin G (CG) upregulation in response to thalidomide and lenalidomide treatment.
* To determine the specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development.

OUTLINE: Blood samples obtained before, during, and after treatment with thalidomide or lenalidomide from patients previously enrolled on clinical trial ECOG-E4A03 or E-E1A00 are analyzed to determine the total content of cathepsin G (CG) via ELISA; to determine mRNA levels of CG via RT-PCR; and for platelet aggregation studies. Blood samples are collected from healthy volunteers for platelet preparation.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosed with multiple myeloma and treated with thalidomide or lenalidomide on clinical trial ECOG-E4A03 or E-E1A00
  * Healthy volunteer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Diagnostic Performance of "Emergency Department Assessment of Chest Pain Score"

This study aims to evaluate whether EDACS performed during triage to assess patients with chest pain could improve the predictive validity of triage for an acute cardiovascular event.

Chest pain is common reasons for presentation to the emergency department (ED).Up to 6.3% of emergency department (ED) visits are related to chest pain. Causes of chest pain range from musculoskeletal chest pain to potentially life-threatening emergencies as acute coronary syndrome(ACS), aortic dissection or pulmonary embolism. Therefore, accurate and fast risk stratification is paramount in the acute management, mainly to identify those patients with immediate risk of complications, as those with an ACS. Those patients are challenging to discriminate, as there is a variety of clinical manifestations.

Chest pain is considered to be an acute chest pain, described as pain, pressure, tightness, or burning as outlined in the guidelines Chest pain equivalent symptoms may include dyspnea, left arm, and epigastric pain.

Triage helps recognize the urgency among patients. An accurate triage decision helps patients receive the emergency service in the most appropriate time. Various triage systems have been developed and verified to assist healthcare providers to make accurate triage decisions. Despite good levels of specificity, the available triage systems appear to have suboptimal sensitivities that cannot adequately prioritize patients with acute cardiovascular diseases. The Emergency Department Assessment of Chest Pain Score (EDACS), through a standardized assessment of the patient's history and presenting symptoms only, provides good levels of sensitivity in stratifying time dependent acute cardiovascular diseases. The good discriminatory ability of EDACS, combined with its easy clinical applicability, could be used to overcome some of the limitations of triage systems in assessing chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old who admitted to ED complaining of chest pain.
* Chest pain is considered to be an acute chest pain, described as pain, pressure, tightness, or burning as outlined in the guidelines.
* Chest pain equivalent symptoms may include dyspnea, epigastric pain, and pain in the left arm.

Exclusion Criteria:

* Patients unable to complete the EDACS
* Posttraumatic chest pain
* Patients who did not give consent to participate
Probiotics in Radiation-treated Gynecologic Cancer

The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with cancer in the small pelvis and waiting to receive radiotherapy either as a primary or as a secondary treatment following surgery. Chemotherapy may or may not be part of the treatment regimen.
* Age, older than 18 years old.
* Agreement for participation in the study by signed written informed consent.

Exclusion Criteria:

* Previously treated with irradiation of the pelvic area.
* Reluctance to refrain from using other probiotic products during the participation in the study.
Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.

Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX \< 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "Short-term therapy")\*.

\* Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with moderate to severe hemophilia B ( \< 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
2. HIV seropositive ( asymptomatic) or seronegative subjects.
3. No history or detectable inhibitors.
Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries

sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal according to the capping material (A),where (A1)represents calcium silicate group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group (A1) in deep occlusal caries and taking the base line image after restoring the cavity with composite restoration and apply light activated calcium hydroxide for(A2)group in deep occlusal caries and taking the base line image after restoring with composite restoration.Take follow up image after one year to measure the calcific bridge formation for both groups.

Management of deep carious lesion may constitute a real challenge for the operator.The basic idea for treating deep caries is to enhance calcific reparative capacity.Calcium hydroxide has been the gold standard as a capping material but there are some drawbacks like solubility,gaps formation and mechanical instability so a need for a capping material such as calcium silicate has shown several advantages.

Sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal.The first group(A1) will be treated by light activated calcium silicate and the second group(A2) will be treated by light activated calcium hydroxide after partial caries removal of deep occlusal caries then restore by composite restoration.Paralleling technique using film holders and custom made bite blocks will be used to standardize the serial radiographs and to prevent the distortion of the radiographic image.An increase in dentin thickness will be measured through sequential imaging by soft ware named Digora (Digora Optime,Soredex,Helsinki,Finland) will be used for measurements by digitalizing the scanned image.All images will be studied carefully for an increase in dentin thickness keeping the reference point constant from the furcation area.

Eligibility Criteria:
Inclusion Criteria:

* Normal adults will be recruited in this study ,all the volunteers participated in this experiment will be healthy looking free medical history.
* Patients have simple deep carious lesions in his /her mouth with no pain or history of sensitivity to cold which disappear immediately after removal of the stimulus.

Exclusion Criteria:

* Medically compromised patients and teeth with history of spontaneous pain or tenderness to percussion were excluded from the study.
* Pregnant females will be excluded from the study.
Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

The primary objective of this study is to determine any changes in cardiovascular risk among individuals receiving a statin by assessing their multi-analyte profile.

Over the past decade there has been a growing debate about the clinical value content of a single individual diagnostic indicator of disease onset, progression or therapeutic intervention. In particular there has been a discussion about the comparative value of a single biomarker versus a panel (3-6 different analytes) versus a multi-analyte profile (\>10 different analytes) of biomarkers to provide high content clinical information about a specific disease onset, progression, remediation or treatment efficacy.

With the advent of personalized medicine, and recognition of the high degree of biological variability in human pathobiology, it is important to understand the comparative value of a single biomarker/diagnostic versus a panel versus a profile. In addition, the growth of Preventive Medicine has spurred the development of "Wellness" in individual patients, and the necessity for understanding and measuring the transition from a state of health (wellness) to ultimately a state of full blown disease onset. This complex process occurs via a multitude of biological pathways and networks and manifests at a biochemical and clinical systems level.

In a previous study currently being analyzed, MaiHealth measured a Multi-Analyte Profile of approximately 800 patients consisting of 400 cardiovascular compromised individuals and 400 control patients. This preliminary study was a single time point only, in which 25 individual analytes were measured as well as 3 calculated ratios or values for the 800 individuals.

The current study is a small cohort time course study over 6 months involving therapeutic intervention with an FDA-approved statin.

The overall goal of the study is to determine the predictive capability of a single versus panel versus multi-analyte profile set of biomarkers in cardiovascular compromised patients with therapeutic intervention. The ultimate application of this research is information delivery and behavioral intervention.

Eligibility Criteria:
Inclusion Criteria:

* Sign and Date IRB approved consent form
* Be between 30-65 years of age as of date of consent
* Have a total cholesterol value of 200-300 (units)
* Have an LDL cholesterol value of \> 100 (units)
* Able to speak and understand English
* Willing and able to participate for the 6 months required by the study
* Willing and able to provide fasting blood specimens
* Women of child-bearing potential must have a negative pregnancy test at screening
* Medically (appropriate) eligible to take the statin as determined by PI

Exclusion Criteria:

* Have a body Mass Index (BMI) \> or = 35
* Pregnant (or planning to become pregnant during the course of the study)
* Currently taking a statin or discontinued taking a statin within 9 months of the date of screening
Safety and Efficacy of Different Onset Times of Treatment With Pulsed Dye Laser on Improvement of Surgical Scars

The appearance of skin after surgery plays an important role in patient's self confidence and life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. Among different kind of lasers, used to improve the appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture, and elasticity of scars. Also, treatment with this technique is noninvasive, minimally uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of different onset times of treatment with pulsed dye laser on improvement of surgical scars.


Eligibility Criteria:
Inclusion Criteria:

* Surgical scar with minimum length of 6 cm

Exclusion Criteria:

* History of light sensitivity or photodermatoses
* History of adverse reactions to laser treatment
Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

The purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. The ultimate purpose of the study is to test an intervention to improve financial conditions and reduce HIV risk behaviors in transgender women.

The study includes a microeconomic intervention which will provide education on a variety of economic and behavioral topics. Participants will complete questionnaires on multiple occasions during the study.

Eligibility Criteria:
Inclusion Criteria:

* Transgender woman
* 18-45 years of age

At least one of the following economic vulnerability factors:

unemployment or underemployment \[less than 20 hours/week\], low income \[less than the Medicaid poverty threshold\], housing insecurity in the past year or food insecurity in the past year

• Behavioral vulnerability to HIV transmission (reported at least one episode of unprotected sex in prior 6 months or at least one other behavioral HIV transmission risk factor in the past 6 months: \[transactional sex, multiple sexual partners, 1-time sexual partner, sex under the influence of drugs or alcohol, sex with partner of unknown HIV status).

Exclusion Criteria:

* obvious signs of intoxication or cognitive impairment
* cannot speak English.
Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea

Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces the risk of cardiovascular morbidity and mortality.

1. Primary outcome:

   Incidence of cardiometabolic diseases in subjects with OSA over 9 years.
2. Secondary outcomes:

Effects of CPAP treatment on cardiometabolic conditions

Eligibility Criteria:
Inclusion Criteria:

* From previous cohort for reassessment.

Exclusion Criteria:

* Unstable medical conditions
Dorothy P. and Richard P. Simmons Center for ILD Research Registry

The purpose of this study is to place past, current, and future medical record information into the UPMC Simmons Center for Interstitial Lung Disease Research Registry.

This study gives participant's permission to allow the staff at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease to to place past, current, and future medical record information into a UPMC Simmons Center for Interstitial Lung Disease Research Registry. By placing the medical record information of many patients into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about interstitial lung disease. It is anticipated that the research registry will assist out investigators by allowing researchers to review and study the medical records of many individuals to answer questions about interstitial lung disease and its treatment. In addition, it will help researchers identify and recruit patients for participation in future research studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are seeking treatment at the UPMC Simmons Center for Interstitial Lung Disease
* 18 years of age or older

Exclusion Criteria:

* N/A
Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care (LUS-COVID19)

It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease.

The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training.

In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient.

Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic.

In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient.

In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause.

Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality.

And a new applicability in the pulmonary recruitment by PEEP titration has been presented.

The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Sars-Cov2 patient, with PCR method qualitative or quantitative as usual.
* Intensive or critical care admission
* ARDS with PaO2/FiO2 \<300 at the admission
* Ventilatory support or oxygen-therapy

Exclusion Criteria:

* Age \< 18 years-old
* Pregnancy
* Patient with tutor- or curatorship or in prison