cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer

The primary objective of this study is to evaluate the efficacy and safety of cyclophosphamide and bevacizumab in combination with Envafolimab in the treatment of recurrent epithelial ovarian cancer (EOC), fallopian tube cancer, and primary peritoneal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer Patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer following platinum-based chemotherapy measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions CT scan long diameter ≥ 10 mm, lymph node lesions CT scan short diameter ≥ 15 mm) ECOG PS score: 0 - 1;

Exclusion Criteria:

* Subject has prior or concurrent other malignancy Prior treatment with other PD-L1/PD-L1 inhibitors cannot be enrolled; Subject has known previous hypersensitivity to macromolecular protein preparations or applied drug components
Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency Department (ED) to promote self-disclosure.

To develop and refine the interactive VOICES tool, which will promote self-identification and self-disclosure to increase reporting of EM at point-of-care in the Emergency Department (ED) setting. Prior to conducting a feasibility study, focus groups will be conducted to inform the process and to develop a tool to evaluate the use of VOICES.

Feasibility Study: To conduct a feasibility study (N= 800) examining the use of VOICES in a busy ED.

Exploratory Aim: To perform a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were referred to Adult Protective Services (APS).

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Non-full trauma track
* Alert and oriented to person and place
* AMT-4 score of 4
* Able to consent and communicate in English
* Agrees and able to use the iPad
* Not in police custody

Exclusion Criteria:

* subjects who live in nursing homes or other long-term care sitting and do not reside in community setting
* patients will be excluded if they cannot safely undergo the studies required for participation
* subjects with clear signs of EM
* Patient or clinician refusal to participate
* severe hearing and vision impairment
* presenting with active psychotic symptoms
* presenting with acute intoxication
* COVID-19 positive
Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.

This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.

Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
* eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria:

* Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
* Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.
A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase

This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects.

The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers of either sex, age 18 to 65 years, inclusive.
2. Intact normal skin on both upper extremities without tattoos or potentially obscuring pigmentation or lesions.
3. Vital signs (BP, HR, temperature, respiratory rate) within normal range.
4. Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of injection.
5. A negative serum or urine pregnancy test (if female of child-bearing potential) within 7 days of injection.
6. Female subjects of child-bearing potential must be practicing effective birth control or abstinence currently and plan to continue to do so for the duration of the study.
7. Decision-making capacity and willingness and ability to comply with the requirements for full completion of the trial.
8. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

1. Upper extremity edema.
2. Upper extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.).
3. Contraindication to an antibody, such as known history of anaphylactic or severe systemic reactions.
4. Known predisposition to renal insufficiency or renal failure, including diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs.
5. Known allergy to hyaluronidase or any other ingredient in the formulation of Hylenex.
6. Known allergy to bee or vespid venom.
7. Known coagulopathy.
8. Pregnancy or breast-feeding woman.
9. Known clinically significant cardiovascular, gastrointestinal, hepatic, neurological, psychiatric, endocrine, cancer, HIV infection, diabetes mellitus, intercurrent illness such as influenza, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results.
10. Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults

The purpose of this study is to evaluate the effects of a common over-the-counter medication, omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.

This study aims to enroll 25 healthy subjects from San Antonio, Texas and the surrounding area. Study participants will be asked to provide a blood and stool sample at baseline, complete a 14-day course of omeprazole (Prilosec®), and then complete a follow-up blood and stool sample.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older

Exclusion Criteria:

* No prior major gastrointestinal surgery
* No chronic daily use or any use within the past two months of the following medications: antibiotics, proton pump inhibitors, other acid reflux medications, probiotics, anti-inflammatory medications, anti-diarrhea medications, laxatives, anti-depressants, anti-anxiety medications, steroids, metformin, or biologic/immune modulating drugs
Registry On Efficacy and Safety Of Rosuvastatin, and Atorvastatin and Simvastatin In Hypercholesterolaemia

The objective of this follow-up retrospective study is to evaluate the long term efficacy and safety of rosuvastatin in reducing lipid parameters in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Primary hypercholesterolemia
* Subjects from first rosuvastatin Registry study
Effect of Exercise on Chocolate Addiction

The study will use stress inducing tasks to determine if there are significant improvements in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate abusers following rest and a bout of high intensity interval exercise.

The purpose of this research study is to investigate whether a single high intensity interval exercise (HIIE) bout, following two stress-inducing tasks, reduces addictive behavior to chocolate. Volunteers must complete the consent form before being able to participate in two days of testing (exercise day and control day) which will be presented in randomized order. The two days will be separated by a one to 7 day washout period. Subjects will be required to submit a three day chocolate diary then abstain from chocolate on the 4th day. They will also be asked to record everything they eat and drink on the day before and the morning of the study and list three types of chocolate they crave most. Two stress-inducing tasks will be performed on both days followed by completion of either 26 minutes of HIIE or seated resting condition followed by the completion of two mood and craving questionnaires. They will finally be asked to complete a task that measures the amount of attention they pay to chocolate. Statistical analyses will be conducted to determine the effect of either exercising or not on addictive behaviors to chocolate.

Eligibility Criteria:
Inclusion Criteria:

* BMI equal or greater than 25
* Eat at least 3.5 oz of chocolate per day
* Scorer at least 33 out of a possible 36 on the Handedness Questionnaire
* Ability to provide informed consent
* No medical contraindications to exercise
* Premenopausal

Exclusion Criteria:

* PMS
* Pregnancy
* Prisoners
* Risk factors for heart disease as determined by physician
* Medication that interferes with capacity to exercise
* Answer "Yes" to PAR-Q
To Compare the Effect of Concomitant Administration of Probucol and Cilostazol with Probucol Single Treatment on the Atherosclerosis Related Markers (including the Thickness of the Achilles Tendon) and Evaluate Safety (based on Atorvastatin Treatment) in Severe Hypercholesterolemia Subject

To evaluate the effect of concomitant administration of Probucol and Cilostazol (based on Atorvastatin treatment) on the atherosclerosis related markers (including the thickness of the Achilles tendon) in severe hypercholesterolemia subject, through the observation of the thickness of the Achilles tendon, the thickness of mean carotid intima-media, anti-oxidation biomarkers and serum lipid profile.

Multicenter, randomized, controlled, single-blinded, three parallel arms study. Group A: Atorvastatin + Probucol-placebo + Cilostazol-placebo Group B: Atorvastatin + Probucol + Cilostazol-placebo Group C: Atorvastatin + Probucol + Cilostazol

Eligibility Criteria:
Inclusion Criteria:

1. The subject whose voluntary written informed consent is obtained for participation in this study;
2. 18≤age≤70；
3. The subject with low-density lipoprotein cholesterol (LDL-C) ≥ 4.66 mmol/L (180 mg/dL) (the highest level either pre-treatment or on treatment);
4. The subject with ATT≥9mm.

Exclusion Criteria:

1. The subject with homozygous familial hyperlipidemia;
2. The subject who took Probucol within 6 months before the screening test;
3. The subject who took Cilostazol within 1 month before the screening test;
4. The subject who took Ezetimibe within 1 month before the screening test;
5. The subject who hoped to treat with Ezetimibe within this study period;
6. The subject being treated with Cyclosporine;
7. The subject with a history of hypersensitivity to Probucol and Cilostazol;
8. The subject with a triglyceride (TG) level greater than 4.52 mmol/L (400 mg/dL);
9. The subject with diabetes: HbA1c level greater than 8.4% (NGSP);
10. The subject with New York Heart Association (NYHA) classification: Class III and IV;
11. The subject with a QTc interval greater than 450 msec (male) or 470 msec (female);
12. The subject with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole);
13. The subject with atrial fibrillation (including paroxysmal atrial fibrillation);
14. The subject with congestive cardiac failure or unstable angina;
15. The subject with liver and renal functions that satisfy the following criteria within 28 days prior to start of the investigational medicinal product (IMP) administration.

    * AST ≥100 IU/L, ALT≥100 IU/L
    * Serum creatinine ≥1.5 mg/dL (133 µmol/L)
16. The subject who are participating in another clinical trial;
17. Woman during pregnancy or potential pregnancy, and breastfeeding;
18. Women of childbearing potential who are not agree to use an appropriate method of contraception;
19. The subject who are not considered by the Investigators to be appropriate to participate in this study for any other reasons.
Stay Active Physical Activity Program

The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic.

This study will compare the impact of two physical activity interventions on student's physical activity.

Eligibility Criteria:
Inclusion Criteria:

Classrooms

* Teacher of a 4th or 5th grade class in the Kansas City area.
* English speaking only

Students

* Any student in the selected classrooms
* A parent or guardian of the student
* English speaking only

Exclusion Criteria:

* Does not meet the required criteria above.
Beef Burger Versus a Vegetarian Burger

The purpose of this graduate student research study is to compare the rise of serum lipids, glucose, and hs-CRP levels after consumption of a beef burger versus a vegetarian burger in healthy adults between the ages of 21 and 55

Visit 1

* Sign an informed consent.
* Complete a brief questionnaire about demographics (age, gender, and race), eating habits, physical activity level, and medical history (known allergies, and history of dyslipidemia, diabetes mellitus, or arthritis)
* Will be directed to fast for 8 hours prior to Visit 2. Visit 2
* Be randomized into either Group 1 or Group 2. One group will eat the beef burger first and the other group will eat the vegetarian burger first.
* Fill out a questionnaire on number of hours slept and current stress level.
* Take a finger prick test (tiny drop of blood) to determine baseline measurements for serum lipids, glucose, and hs-CRP levels.
* Consume either a beef burger or vegetarian burger.
* Afterwards, remain in Nichol Hall, Room A112, for 2 hours (may study, watch a movie, etc.).
* May not consume anything except for water.
* After 30 min, 60 min, 120 min, finger prick tests will be used to measure post-consumption serum lipids, glucose, and hs-CRP levels.
* Will be asked to try and identify burger consumed and rate the taste of the burger.
* Will be directed to fast for 8 hours prior to Visit 3. Visit 3
* Repeat the same procedure as Visit 2. However, this time the burgers will be switched.

Eligibility Criteria:
Inclusion criteria:

* Healthy adults between 21 and 55 years of age
* Consume both beef and vegetarian products
* No distaste for whole wheat buns, lettuce, soy, tomatoes, or vegan mayonnaise
* Willing to abstain from caffeine and exercise the morning of visits (2 days)

Exclusion criteria:

* Those allergic to the following food items:

  * Gluten
  * Lettuce
  * Soy
  * Tomatoes
  * Vegan Mayonnaise
* Have a known history of dyslipidemia, diabetes mellitus, or arthritis
Impact of Blueberries on Uric Acid and Quality of Life

The purpose of this study is to determine the impact of blueberries on uric acid in patients with hyperuricemia that are not receiving uric acid pharmacotherapy. The central hypothesis the investigators propose is that daily blueberries added to a pre-existing diet will promote uric acid lowering and improve quality of life without detriment to vital signs.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Uric acid \> 6.0 mg/dL

Exclusion Criteria:

* Current moderate-to-severe symptomatic gout
* Currently receiving gout pharmacotherapy
* Current participation in another clinical trial
* Documented non-compliance or consistent missed appointments
* Women who are pregnant or nursing
Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression

The goal of this observational study is to determine the urinary proteomic characteristics in women with and without ovarian cancer. The main questions it aims to answer are:

1. What is the difference in urinary protein composition between patients with ovarian cancer and those without it?
2. Can these differences in urinary protein composition aid in the diagnosis of ovarian cancer?
3. Are urinary protein markers associated with tumor burden in urine samples from patients with ovarian cancer?
4. Can urinary protein markers be used for disease surveillance in ovarian cancer patients?


Eligibility Criteria:
Inclusion Criteria:

* Female patients in the gynecological ward for surgical treatment.
* Initial diagnosis of "pelvic mass" or "malignant ascites" may be considered as ovarian cancer; Or the initial diagnosis of "ovarian cyst", "hydrosalpinx", "uterine fibroids" or "uterine adenomyosis" are considered as gynecological non-malignant diseases.
* Over 18 years of age.
* Voluntary participation and signing of informed consent.

Exclusion Criteria:

* Study participants with a prior history of malignant tumors.
* Study participants with prior chronic kidney disease or renal insufficiency.
* Study participants who have received or are receiving treatment for primary disease.
* Study participants whose pathological diagnosis was not clear.

Any patient should be excluded from the study if:

* Study participants withdraw informed consent and request withdrawal.
* Study participants were unable to provide a qualified urine sample.
* There are situations in which the researcher considers it necessary to withdraw from the study.
NOL Index in Response to Pacemaker Stimulation

The Nociception Level Index (NOL Index) utilizes various signals to assess the balance of nociception and antinociception during anesthesia. Its correlation with nociceptive stimuli and opioids is known, but its response to isolated heart rate changes remains uncertain. The aim is to investigate how cardiac pacing affects the NOL Index.

The Nociception Level Index (NOL Index) represents an innovative approach to monitoring nociception during general anesthesia, utilizing a combination of signals from photoplethysmography, accelerometry, thermometry, and skin conductance to assess the balance between nociceptive and antinociceptive states. Research has already established how the NOL Index correlates with both nociceptive stimuli and opioid levels, providing valuable insights into patient responses. However, the impact of changes in heart rate, specifically through isolated cardiac pacing, on the NOL Index is not yet clear. The primary goal of this study is to explore and understand how cardiac pacing might influence the readings of the NOL Index, potentially offering a new dimension to managing anesthesia effectively.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Preoperative and postoperative sinus rhythm (50-80 bpm)
* Norepinephrine support \< 100 ng/kg/min

Exclusion Criteria:

* Redo or emergent surgery
* History of any cardiac arrhythmia
* Any cardiocirculatory support other than norepinephrine
* Perioperative treatment with beta-blockers, calcium-channel blockers or ivabradine
Mobile App Logging for Diabetes in Pregnancy

To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.

Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is often the first time they've had to keep such strict logs. Patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. Subjects will be recruited from the Augusta University downtown location obstetric clinics.

Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (GTT) \> 200mg/dL or 3h GTT with 2 or more abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application to track blood sugar readings, and type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Verified intrauterine pregnancy
* At least 12 weeks gestation
* Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus.

Exclusion Criteria:

* Patients with less than 4 weeks anticipated to be remaining in pregnancy
* Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking
* Type 1 diabetes mellitus
* Non-English speaking patients
Is Ibrutinib-related Atrial Fibrillation Dose Dependent

Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has recently revolutionized the treatment of various chronic B-cell malignancies and particularly chronic lymphocytic leukemia (CLL). Atrial fibrillation (AF) has early emerged as a cardiovascular adverse effect (CVAE) of ibrutinib but underlying mechanisms of IRAF are not fully understood.

While a dose-reduction or an interruption of ibrutinib is mentioned in the summary of product characteristics of ibrutinib, any beneficial effect on IRAF management of such a management is unclear.

The main aim of this study is to determine if IRAF is a dose-dependent CVAE in chronic B-cell malignancies patients by studying the association between ibrutinib dose and IRAF reporting in Vigibase®, the World Health Organization (WHO) pharmacovigilance database.

Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has recently revolutionized the treatment of various chronic B-cell malignancies and particularly chronic lymphocytic leukemia (CLL). Atrial fibrillation (AF) has early emerged as a cardiovascular adverse effect (CVAE) of ibrutinib. In phase 3 randomized clinical trials (RCT), ibrutinib exhibits a ≈4-fold increase-risk of AF compared with controls (pooled relative-risk (RR) 3.9; 95% confidence interval (CI): (2.0-7.5); p\<0.0001). The annualized incidence rate of ibrutinib-related AF (IRAF) reporting in clinical trials is estimated to 4.9 (95% CI: 2.9-8.3) per 100 person-years. IRAF risk persists throughout ibrutinib exposition and seems to be cumulative with the extension of follow-up and cardiac monitoring.

Underlying mechanisms of IRAF are not fully understood. Ibrutinib potently inhibits multiple off-target kinases at therapeutic concentrations.

While a dose-reduction or an interruption of ibrutinib is mentioned in the summary of product characteristics of ibrutinib, any beneficial effect on IRAF management of such a management is unclear.

The main aim of this study is to determine if IRAF is a dose-dependent CVAE in chronic B-cell malignancies patients by studying the association between ibrutinib dose and IRAF reporting in Vigibase®, the World Health Organization (WHO) pharmacovigilance database.

Eligibility Criteria:
Inclusion Criteria:

* ibrutinib-related atrial fibrillation reports in Vigibase at the time of data extraction
* involving adult patients
* with an available ibrutinib daily dose

Exclusion Criteria:

* minors
* no ibrutinib dose available