cyrilzakka/clinical-trials huggingface dataset:
Interactive Roles of Cardiorespiratory Fitness and Adiposity on Glucose and Vascular Control After Physical Inactivity

The far-reaching negative health effects of the reduced physical activity (RPA) epidemic are often overlooked by the general population and health professionals. Short-term RPA induces cardiometabolic dysfunction, including impaired glucose control and vascular function, that may precede disease development. The impact of existing health status on RPA-induced cardiometabolic dysfunction and recovery of impaired glucose control following RPA is unexplored. Thus, the investigators' objectives are 1) to investigate the effect of existing health status (cardiorespiratory fitness and adiposity) on the recovery of impaired glucose control following a period of RPA and 2) to determine the role of vascular function as a mechanism of impaired glucose control. The investigators' final objective is to 3) expose undergraduate students to meritorious biomedical clinical research methods. The investigators have piloted the clinical research methods and analysis with undergraduate researcher associates and are well-prepared to complete this proposal. Preliminary data show that low cardiorespiratory fitness and/or high adiposity impair the recovery of glucose control following short-term RPA. Thus, the investigators aim to examine the interactive role of health status (cardiorespiratory fitness and adiposity) on the ability to recover impaired glucose control following short-term RPA. The investigators also seek to examine changes in vascular function as a mechanism of recovery of impaired glucose control following a return to normal PA. The investigators will recruit men and women with divergent health status (cardiorespiratory fitness and adiposity) to examine glucose control and vascular function during 7-d of normal PA, 7-d of RPA, and 7-d of resumption of normal RA. Continuous glucose monitoring and oral glucose tolerance tests will be performed to assess glucose control. Increases in vascular shear stress induced by passive leg movement and central arterial stiffness will be measured to assess vascular function.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 40 years of age.
* Ability to safely ride an electric scooter (e-scooter) for at least 10 minutes.
* Active (\>7000 steps per day, walking \> 1 mile a day outside)
* Stable body weight for at least 1 year
* aerobic fitness level, CRF is \< 9 and \>14 METS
* Visceral adipose tissue \<130 cm2 or ≥130 cm2 for men and \<100 cm2 or ≥100 cm for women

Exclusion Criteria:

* Any injury preventing them from exercising regularly at the time of the screening.
* Implantable defibrillator or pacemaker
* Active cancer
* Alcohol or drug abuse
* Use of an assistive walking device
* Presence of significant signs/symptoms of cardiovascular, metabolic, or pulmonary disease (determined from the American College of Sports Medicine (ACSM) Health History Questionnaire)
* Daily vitamin consumption of \> 500mg per day during the study
* Acetaminophen or aspirin use during the study
WATS3D for the Detection of Esophageal Dysplasia

Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients age: ≥ 18 years
* Patients should have a history of Barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
* Willingness to undergo both WATS and forceps biopsies while undergoing conventional EGD with sedation
* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
* Only patients who undergo both forceps biopsies and WATS of the esophagus will be included in this study

Exclusion criteria:

* Coagulopathy with an international normalized ratio above 2.0;
* Thrombocytopenia with platelet counts below 50,000
* History of prior esophageal ablation therapies, esophageal or gastric surgery
* Unresolved drug or alcohol dependency
* Pregnancy or planned pregnancy during the study period
* Patients found to have a BE length less than 1 cm or greater than 10 cm
* Patients with any visible lesions greater than 10 mm
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.


Eligibility Criteria:
Inclusion Criteria:

* At least 1 of the following:

  1. Untreated male with urethral gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
  2. Untreated female with cervical gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
  3. Urethral (male) or cervical (female) Gram stain demonstrating Gram-negative intracellular diplococci and leukocytes.
* The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all of these until study completion.
* Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

* Confirmed or suspected complicated or systemic gonococcal infections such as pelvic inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated gonococcal infection.
* Individuals who have already received antibiotic treatment for their gonorrhea.
* Use of systemic or intravaginal antibiotics within 7 days prior to study drug administration.
* Women who are pregnant or nursing.
* Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.
* History of significant intolerance or allergy to macrolide or cephalosporin antibiotics.
Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography

\[18F\]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.

Diagnostic validity of \[18F\]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Subject is over 19 years old and male or female of any race/ethnicity
* Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist
* Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected
* Subject has voluntarily agreed to participate in the study

Exclusion Criteria:

* Subject or subject's legally acceptable representative does not provide written informed consent.
* Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of \[18F\]Florbetaben has to be negative and the women is advised to apply contraceptive measures during her participation in this study.
* Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator.
* Subject has received any investigational drugs or devices within four weeks prior to the study enrollment.
* Subject has been previously included in this study.
* Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
* Subject is allergic to Florbetaben or any of ingredients of Florbetaben
The Medacta Quadra-P Anteverted Study

This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.

The primary objective of this study is to evaluate the 10-year survival of the anteverted Quadra-P stem in patients operated for primary total hip arthroplasty, according to the inclusion criteria.

Secondary objectives:

* To assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
* Assess radiological performance by standard radiographic examination performed preoperatively, postoperatively before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
* Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
* Assessment of functional recovery by gait analysis study
* Collect the rate of complications throughout the course of the study

Eligibility Criteria:
Inclusion Criteria:

* Subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis
* Adult subjects between 18 and 75 years of age on the date of surgery
* Subjects eligible for primary total hip arthroplasty surgery for whom the anterior Quadra-P femoral component will be implanted according to the indications for use of the implant
* Subjects who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to surgery.

For the anatomical-functional subgroup:

- Adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study.

Exclusion Criteria:

* Subjects with acute or chronic infection
* Subjects with a femoral neck fracture
* Subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits
* Subjects with severe deformities, at the discretion of the surgeon
* Subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated
* Subjects with muscular atrophy or neuromuscular diseases
* Subjects allergic to the materials used during surgery
* Subjects unable or unwilling to provide consent for participation in the study
* Any other condition not mentioned in the inclusion criteria
Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

RATIONALE: To improve strategies for detection and prevention of early-stage disease.

PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.

OBJECTIVES:

* To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies.
* To identify new prevention approaches and therapies.
* To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer.

OUTLINE: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer.

The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified.

Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Considered to be at increased risk for developing ovarian cancer, as defined by one of the following:

    * Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer
    * Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor
    * A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer
    * Increased risk as deemed by a certified genetic counselor
  * Undergoing surgery for a gynecologic condition, including any of the following:

    * Diagnosis of a reproductive cancer
    * Benign gynecological condition (e.g., uterine leiomyomata, endometriosis, pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts)
    * Highly suspicious adnexal mass
    * Risk-reducing prophylactic oophorectomy

PATIENT CHARACTERISTICS:

Age

* Between the ages of 18 and 80
Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations

Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.

The objective of the project is to test an intelligent platform for monitoring at home, using non-intrusive sensors, patients with heart failure, particularly those with stage II and III NYHA. It will assist the medical automating the processing of information from these sensors to detect and report an early stage risk situations.

Patient monitoring, by a system of telemedicine tools associated with motivation and education helps significantly reduce the number of days of hospitalization becomes important when the patient is hospitalized for acute HF.


Eligibility Criteria:
Inclusion Criteria:

* Population with heart failure stage II and III

Exclusion Criteria:

* Population whose age is less than 18 years
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.

Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.

Eligibility Criteria:
Inclusion criteria:

1. Transplant patients
2. BMI \>30
3. Type I (insulin-dependent) diabetics
4. Severe chronic obstructive pulmonary disease (COPD)
5. Steroid-dependent patients
6. Previous Tracheostomy

Exclusion criteria:

1. BMI\<30
2. Thoracotomy
NuVent™ Revision Study

This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery.
3. Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia.
4. Subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the Investigator.
5. Subject is willing and able to comply with protocol requirements.

Exclusion Criteria:

1. Subject is pregnant or breastfeeding.
2. Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator.
3. Subject has sinonasal tumors.
4. Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
5. Subject lacks capacity to consent to participation in this research himself/herself.
ENgaging in Advance Care Planning Talks Group Visit Intervention

The main goal of the ENACT (ENgaging in Advance Care planning Talks) Group Visit intervention is to integrate a patient-centered advance care planning process into primary care, ultimately helping patients to receive medical care that is aligned with their values. The ENACT Group Visit intervention involves two group discussions about advance care planning with 8-10 patients who meet for 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. This study will compare the ENACT Group Visit intervention to mailed advance care planning materials.

This pilot feasibility randomized controlled study will determine the feasibility, acceptability and preliminary efficacy of the ENACT Group Visit intervention compared to a comparison arm.

The ENACT Group Visit intervention aims to engage patients in an interactive discussion of key ACP concepts and support patient-initiated ACP actions (i.e. choosing decision-maker(s), deciding on preferences during serious illness, discussing preferences with decision-makers and healthcare providers, and documenting advance directives). The group visits involve two 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. The ENACT Group Visit is based on an intervention manual that guides the structure, facilitator considerations, session format, and documentation and billing details. The discussions include sharing experiences related to ACP, considering values related to serious illness, choosing a surrogate decision-maker(s), flexibility in decision making, and having conversations with decision-makers and healthcare providers. The facilitators support an interactive discussion that promotes opportunities for patients to learn from others' experiences.

Eligibility Criteria:
Inclusion Criteria:

* 50 or older
* Receive primary care through UCHealth, Colorado, USA.

Exclusion Criteria:

* Severe cognitive impairment, known diagnoses of dementia
* Severe hearing loss or deafness
Impact of Gut Microbiota and Tryptophan Metabolites on Acute Pain in Lumbar Disc Herniation Surgery Patients

It is well-established that the gut microbiota plays a crucial role in various pain mechanisms, including visceral pain, inflammatory pain, headache, neuropathic pain, and opioid tolerance. Changes in the gut microbiome can alter pain perception. In our study, The investigator investigated the effects of microbiota alterations and the associated tryptophan metabolites on acute pain using the Visual Analog Scale (VAS).

The study included patients aged 18 and above undergoing lumbar disc herniation surgery. Blood samples were collected preoperatively, at 8 hours, and at 24 hours postoperatively to analyze tryptophan metabolites (picolinic acid, 3- Hydroxykynurenine, anthranilic acid, kynurenine, quinolinic acid, kynurenic acid, xanthurenic acid). Concurrent VAS pain assessments were conducted, and correlations between tryptophan metabolites and VAS were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar disc herniation surgery at Dokuz Eylül University Hospital.
* Patients who have read and consented to the informed consent form for the study.
* Age 18 years or older.
* Surgery duration exceeding 2 hours.

Exclusion Criteria:

* Patients are unwilling to participate in the study.
* Surgery duration less than 2 hours.
* Patients under the age of 18.
* Patients with a history of abdominal surgery.
* Patients who received antibiotic therapy for intestinal pathology within the last 3 weeks.
* Patients with known abdominal pathologies suspected to alter the microbial flora (e.g., Crohn's disease, ulcerative colitis, celiac disease).
NAC for Attenuation of COVID-19 Symptomatology

The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.

STUDY DESIGN: Randomized double-blinded placebo-controlled trial

ELIGIBILITY

Inclusion criteria:

* age 18 years and older
* participants will need daily access to use of a smartphone for at least six weeks from time of enrollment
* Positive COVID-19 test within 10 days of date of enrollment
* not already hospitalized for treatment of COVID

Exclusion criteria:

* pregnant
* already hospitalized for treatment of COVID

PROTOCOL

* 50:50 randomization: half of participants will take NAC, half will take placebo
* Participants will take NAC/placebo following this outpatient protocol:
* 2400 mg x 1 PO then
* 1200 mg PO BID x 14 days
* Participants will complete an online symptom-tracker for six weeks (daily for three weeks, weekly for three weeks)

Eligibility Criteria:
Inclusion Criteria:

* positive COVID test \<= 7 days of enrollment

Exclusion Criteria:

* pregnant
* already hospitalized due to COVID