cyrilzakka/clinical-trials huggingface dataset:
Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer

To explore the efficacy and safety of Penpulimab combined with SOX in the perioperative treatment of gastric cancer

Gastric cancer is one of the malignant tumors that seriously threaten human health. It is the sixth most common malignant tumor in the world. According to Global Cancer Statistics 2020, there were about 1.089 million new cases of gastric cancer and 768,000 deaths of gastric cancer worldwide in 2020. Multidisciplinary treatment with radical surgical resection as the core is the mainstream mode of comprehensive treatment of gastric cancer at present, and radical gastrectomy is recognized as the best treatment. However, for patients with advanced gastric cancer, the effect of surgery alone is not good, and the postoperative tumor recurrence rate is high. In order to improve the disease-free survival rate and overall Surv Ival (OS) rate of gastric cancer patients after surgery, perioperative comprehensive therapy has been gradually adopted by the majority of scholars, and has achieved encouraging efficacy in clinical application.

Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent;
* At least 18 years of age;
* ECOG PS: 0-1;
* Patients with gastric cancer diagnosed as T3-4NXMX by imaging;
* Patients with gastric adenocarcinoma diagnosed by cytology;
* Patients with gastric cancer assessed by the surgeon as suitable for neoadjuvant therapy or conversion therapy followed by radical resection;
* Laboratory tests should meet the following requirements (28 days before enrollment in baseline period) :
* Women should agree that they must use contraception during and for 6 months after the study; Had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating; Men should agree that they must use contraception during the study and for 6 months after the end of the study period.

Exclusion Criteria:

* Co-existing with other malignant tumors (except cured basal cell carcinoma of the skin);
* Gastric cancer patients with T1-2N0M0;
* Previous treatment including anti-PD-1 /PD-L1/CTLA-4 antibody therapy or other immunotherapy directed against PD-1/PD-L1/CTLA-4;
* Weight loss greater than or equal to 20% within 4 weeks before the first dose;
* Severe hypersensitivity after administration of other monoclonal antibodies;
* The presence or history of any active autoimmune disease
* Immunosuppressive therapy, systemic or absorbable local hormone therapy (dose \> 10mg/ day prednisone or other effective hormone) is required to achieve immunosuppression and continues to be used within 2 weeks of the first administration;
* Patients with multiple factors affecting oral medication
* Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
* Had received a prophylactic or attenuated vaccine within 4 weeks before the first dose;
Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders

To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult smoker of combustible cigarettes.
* Age 22 to 65 years at time of screening (verified by government issued ID).
* Smoke cigarettes for ≥12 months prior to screening.
* Currently smokes at least 10 tobacco cigarettes per day.
* Screening eCO ≥ 10 ppm.
* Voluntarily provides consent for participation by signing the informed consent form (ICF).
* Willing and able to comply with study requirements.

Exclusion Criteria:

* Unable to read, speak or understand English
* Has a history or presence of clinically significant medical or psychiatric disease, or any other condition that would in the PI's judgement jeopardize the safety of the participant, impair the participant's ability to comply with study procedures, or impact the validity of the study results.
* Has used nicotine-containing e-cigarettes (or vapes) or any nicotine replacement therapy (nicotine patch, nicotine gum, nicotine spray, nicotine inhaler, nicotine lozenge) or prescription smoking cessation medications, including, but not limited to, varenicline (Chantix\*) or bupropion (Zyban®) within the past 30 days.

If female, participant is pregnant, nursing, or intends to become pregnant during the time period from screening through the end of study.

* Has participated in a research study about tobacco products or ENDS within the past 30 days.
* Has participated in a smoking cessation or nicotine switching research study in the past year.
* Smokes or vapes cannabis more than once a week.
* Cannabis Use Disorder Identification Test-Revised (CUDIT-R) score of 8 or greater.
* Heterosexually active participants of Childbearing Potential (not sterilized by tubal ligation, oophorectomy, hysterectomy, or other surgical methods, or post-menopausal) that do not agree to practice medically appropriate methods of birth control (or remain abstinent) during the course of the trial. Medically acceptable methods of birth control include: vasectomy, vaginal diaphragm with spermicide, intrauterine device, hormonal birth control (oral, injected, or implanted), condom with spermicide, or sponge with spermicide.
* Subgroup enrollment is complete.
Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence

Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women

Subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the Leva pelvic digital health system.

Subjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training.

Adherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence.

Subjects are expected to participate in at least 80% of the weekly exercises (11 weekly).

Subjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. At 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training.

Following 10 weeks of training, subjects will be free to pursue any additional therapies, but will also retain the leva device and may continue its use if desired. Adherence will be monitored for one additional year, with follow up surveys to be completed by mail or digitally at 6- and 12-months

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
3. Ambulatory

Exclusion Criteria:

1. Absence of a vagina
2. Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
3. Current or past diagnosis of colorectal or anal malignancy
4. Diagnosis of inflammatory bowel disease
5. Current or history of rectovaginal fistula or cloacal defect
6. Rectal prolapse (mucosal or full thickness)
7. Prior removal or diversion of any portion of colon or rectum
8. Prior pelvic floor or abdominal radiation
9. Refusal or inability to provide written consent
10. Inability to utilize smart phone technology ("app" use)
11. Fecal impaction by exam
12. Stage 3 or 4 pelvic organ prolapse
13. Incontinence only to flatus
14. Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.
15. Childbirth within the last 6 months
16. Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
17. Chronic abdominal pain in the absence of diarrhea
18. Presence of an active (turned on) sacral neuromodulator within the last 6 months
19. Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.
Mayo Clinic Family Medicine Resident Wellness Study

The objectives of this study are to better understand the association between sleep characteristics (sleep disruptions and deprivations) during overnight shifts and mental fatigue among medical residents, and to explore the feasibility of a virtual, tailored exercise program on sleep characteristics, subjective mental fatigue, and burnout level among residents in family medicine.

The purpose of the proposed study is two-fold: 1) to better understand the association between sleep characteristics (sleep disruptions and deprivations) during overnight shifts and mental fatigue among medical residents; and 2) to explore the feasibility of a three-week tailored, virtual exercise program on sleep characteristics, subjective mental fatigue, and burnout level among residents in family medicine. It is hypothesized that: 1) the greater the number of average sleep disruptions, and the greater the sleep deprivation, the greater the acute mental fatigue during overnight shifts reported by the family medicine residents; 2) the number of average sleep disruptions and the magnitude of sleep deprivation are greater during overnight shifts than non-overnight shifts among family medicine residents; and 3) a three-week tailored virtual exercise program will significantly increase the amount of physical activity throughout the day and reduce the levels of mental fatigue and perceived burnout during overnight shifts.

Eligibility Criteria:
Inclusion Criteria:

• A Family Medicine Resident at the Mayo Clinic Health System of Eau Claire in either the PGY-1 Year, PGY-2 Year, or PGY-2 Year (5 residents from each year).

Exclusion Criteria:

* Participant is not able to wear the devices for the assigned timeframe.
* Any condition the investigator considers will prevent compliance with study instructions.
Efficiency of the Hepatitis B Sci-B-Vac Vaccine in HIV Positive Patients

HBV vaccination is of paramount importance among HIV positive persons due to an increased risk of infection and disease progression. The most widely used ENGERIX B vaccine reaches a lower rate of vaccination (20-70%) among HIV positive vaccinees (compared to over 90% in the normal population). Sci-B-Vac is novel vaccine containing 3 antigens and is therefore more immunogenic (as opposed to one in ENGERIX B). Its use has been associated with higher and more rapid vaccination rates. Therefore, it has a theoretical advantage in HIV positive individuals.

A cohort of 100 HIV positive, HBV negative individuals who have not been vaccinated against HBV before will be prospectively given 3 doses of Sci-B-Vac at 0, 1 and 6 months. HBV antibodies will be checked one month after every dose given.

Eligibility Criteria:
Inclusion Criteria:

* HBV negative
* HIV positive individuals
* Above the age of 18
* Treated at the TASMC Aids clinic, who have signed and informed consent and have never been vaccinated against HBV before

Exclusion Criteria:

* Pregnant women
* HBV positivity
* Previous HBV vaccination
Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.

OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone.

OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and regional lymphadenectomy alone. All patients are followed for survival.

PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.

This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI).

Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.

Improvement in SUI symptoms as measured by the following parameters:

Objective parameters:

* Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:

  * Number of incontinence episodes per day
  * Number of pads used per day
* Change from baseline in 1 hour pad test 1, 2, 6 and 12 months
* Change from baseline as assessed with Vaginal Biopsy

Subjective parameters:

* Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1, 2, 6 and 12 months
* Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2, 6 and 12 months
* Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) - at 1, 2, 6 and 12 months
* Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Females between 30 and 75 years of age
* Provided written Informed Consent
* Patients with mild to moderate stress urinary incontinence (SUI) \[according to the severity index developed by Sandvik\]
* Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled
* Normal Papanicolaou smear (up to 1 year prior to screening)
* Negative urine culture
* Vaginal canal, introitus and vestibule free of injuries and bleeding
* Positive urinary stress test (Urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs).

Exclusion Criteria:

* Positive pregnancy test
* Planned pregnancy within the next year
* Severe prolapse (POP\>= grade 3)
* Use of photosensitive drugs
* Injury or/and active infection in the treatment area
* Active vaginal infection
* human papillomavirus/herpes simplex virus
* Undiagnosed vaginal bleeding
* Urge or overflow incontinence
* Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
* Patients with immune system diseases.
* Patients with allergic reaction to laser.
* Patient under treatment with photosensitivity side effects medication.
* Obese women (BMI \>30)
* Patient unable to follow post treatment instructions.
Reducing Cardiovascular Risk in Adults With Serious Mental Illness

This purpose of this study is to adapt, implement and test the ability of a sophisticated point-of-care electronic health record-based clinical decision support that identifies and prioritizes all available evidence-based treatment options to reduce cardiovascular risk in patients with serious mental illness.

This study adapted a point-of-care electronic health record-based clinical decision support system (The Cardiovascular Wizard) to help primary care providers identify, provide appropriate care for, and control cardiovascular risk factors for patients with serious mental illness (bipolar disorder, schizophrenia, schizo-affective disorder). The Cardiovascular Wizard is designed to educate primary care providers about the increased risk of cardiovascular disease and mortality in people with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, prioritize these cardiovascular risk based on how much improvement in cardiovascular risk a patient would experience if the cardiovascular risk factor was adequately addressed, recommend specific medications and other interventions to decrease each elevated cardiovascular risk factor, and provide this information in an easy-to-understand format for both patients with serious mental illness and their primary care providers.

The Cardiovascular Wizard was printed in intervention clinics and (i) compiled lab data (most recent glycated hemoglobin, systolic blood pressure and low-density lipoprotein levels), body mass index, smoking status, and aspirin use, (ii) calculated a modifiable 10 year cardiovascular risk for stroke or heart attack using the American College of Cardiology/American Heart Association 10-year atherosclerotic cardiovascular disease risk equation, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to liver and renal function, creatinine kinase level, and previous diagnoses (Congestive Heart Failure, Cardiovascular Disease, Diabetes Mellitus, and (v) provided recommendations for intensification of therapy for glycated hemoglobin, systolic blood pressure, and/or low-density lipoproteins if not at goal. Recommendations were based on evidence-based protocols including Joint National Committee, American Diabetes Association, and the Institute for Clinical Systems Improvement.

Eligibility Criteria:
Inclusion Criteria:

* Serious Mental Illness diagnosis
* Age 18-75
* Index visit during the enrollment period
* First primary care visit where patient was not at goal for at least one of the six cardiovascular risk factor areas, and patient was not pregnant
* One or more post-index visits during the intervention period

Exclusion Criteria:

* No Serious Mental Illness diagnosis
* Under age 18 or over age 75
* In hospice or nursing home
* At goal for all cardiovascular risk 6 areas
* On research exclusion list
A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During Endoscopic Ultrasound (EUS)

Objective: The purpose of this study was to compare the performance of the monolayer preparation (Cyto Lyt or Thin prep) to the routine use of Papanicolau methods on the analysis of specimens obtained using EUS-FNA.

Introduction: The presence of a pathologist during an endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is often a luxury. In addition, preparation of multiple slides for a fine needle aspiration can be time-consuming for the gastroenterologist who waits for verbal feedback on the adequacy of the specimen. Often, a timely diagnosis is needed to direct patient management. Currently, there is no established standard of care for EUS-FNA preparation. A liquid based cytologic fixative preparation (Thin-prep or CytoLyt), is a well-established process used by pathologists for evaluating cervical smears. It has not yet been adopted or accepted for EUS-FNA. This method combines multiple aspirates on a single slide, thereby decreasing the number of slides that need to be processed and interpreted by the pathologist

Eligibility Criteria:
Inclusion Criteria:

* Subjects with known or suspected malignancy (solid mass or lymph node) that are undergoing EUS will be eligible to participate in this study.
* Target lesions such as ascites and cystic lesions will not be considered for this study. However, if a patient has an abnormal solid lesion and abnormal lymph node in addition to the ascites or cystic lesion, they may still be considered for the study. That is, the solid lesions and abnormal lymph nodes are appropriate target lesions for this study.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
* Subject must provide signed written informed consent.

Exclusion Criteria:

* Subjects that have had a previous EUS-FNA are eligible for this study
* Target lesions such as ascites and cystic lesions will not be considered for this study.
Frozen Blastocyst Transfer in Natural Cycle

The rational of the study is to assess the pregnancy rate after the transfer of frozen blastocyst in natural cycle controlled by external administration of hCG.


Eligibility Criteria:
Inclusion Criteria:

* age \< 40
* BMI:18-29 kg/m2
* day 5 frozen embryo
* previously IVF/ICSI

Exclusion Criteria:

* OOCYTE DONATION CYCLES
Calcium Phosphate Cement As Bone Void Filler

This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.
* Give written informed consent to participate in the study and be willing to comply with the protocol requirements.
* Able to verbalize and differentiate regarding the location and intensity of pain.
* Physical and mental availability to meet the clinical and radiographic follow-up schedule.

Exclusion Criteria:

* Serious infection within two months before surgery.
* Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases.
* Primary bone tumors and contraindications in performing an X-ray or CTscan.
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
* The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.