cyrilzakka/clinical-trials huggingface dataset:
Attitudes and Believes About Vaccinations in a Supportive Care Patient Population

To learn about the attitudes and beliefs towards vaccination both before and after the COVID-19 pandemic in patients who have received supportive care.

Primary Objective:

Our primary objective is to assess patient perception of efficacy and safety of vaccinations.

Secondary Objectives:

To assess demographic predictors of those who would be considered as vaccine hesitant.

To assess patient preferred source of recommendations for or against vaccination.

To assess the role past side effects or allergic reactions play on patient perception of future vaccines.

To assess patient perception of vaccination prior to COVID-19.

To assess patient willingness to get the COVID-19 vaccine.

To assess patient willingness to get the influenza vaccine.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are seen as part of a clinic visit with the Supportive Care Clinic at M.D.

   Anderson Cancer Center, also patients who are being seen by the inpatient Supportive Medicine Consultation Service.
2. Patients who are 18 years of age or older
3. Patients who are able to speak English.

Exclusion Criteria:

1. Patients who are unable to sign written consent
2. Patients who are considered delirious at the time of the clinic encounter as defined by a Memorial Delirium Assessment Scale score of 7 or greater. The nursing staff, as a part of the patient intake process and routine care, performs the delirium assessment for clinic patients.
Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases

Previous studies should that patients with chronic liver diseases, cirrhosis, hepatocellular carcinoma and post-liver-trasplant status had lower immunological response to SARS-CoV-2 vaccines than healthy population. Along with the waning of antibody and emerging SARS-CoV-2 variants, a third dose SARS-CoV-2 booster vaccination is now considered as an effective strategy. Previous studies showed good safety and immunogenicity of the SARS-CoV-2 booster vaccination in healthy population. However, the relevant information in patients with liver diseases need further research. This study (NMCID-CHESS 2201) aimed to investigate the safety and immunogenicity of the SARS-CoV-2 booster vaccination in population with chronic liver diseases


Eligibility Criteria:
Inclusion Criteria:

* Previously vaccinated with two doses of SARS-CoV-2 vaccines and planning to get booster vaccination.
* Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver diseases, cirrhosis, liver cancer, liver transplant subjects, etc.
* Understanding and willing to comply with the study procedures and provides written informed consent.

Exclusion Criteria:

* Pregnancy or lactation.
* Active or known history of SARS-CoV-2 infection.
* Diseases causing immunosuppressive or immunodeficient status or autoimmune diseases.
* A history of discontinuing anti-HBV agents in recent three months.
Bone Quality and Quantity Following Guided Bone Regeneration

Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance.

Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area.

The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women over 18 years of age, eligible for signing
2. Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been inserted yet
3. Patients who understand the meaning of the treatment (routine dental implant insertion) and the follow up study, and approves participation in booth of them

Exclusion Criteria:

1. Pregnant or nursing women. children or non judgemental patients
2. Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
3. Patients with a pathology present near the site of dental implantation
Membrane Stripping for Cervical Ripening

The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction.

The study population consists of women undergoing labor induction.

The main questions it aims to answer are:

1. Is membrane stripping as effective as double balloon catheter induction in cervical ripening?
2. What is the influence of membrane stripping on the time required for cervical ripening, delivery duration, and maternal and fetal outcomes compared to balloon induction.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and above
* Patients with a cervical dilation of at least 1 cm
* Full-term pregnancy
* Cephalic presentation
* No contraindication to vaginal delivery

Exclusion Criteria:

* Patients with rupture of membranes
* Patients who do not require cervical ripening and proceed directly to the delivery room for induction with oxytocin
* Patients for whom the use of a double-balloon catheter is contraindicated
* Twin pregnancies
* Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated
* Vaginal deliveries after a cesarean section
* Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress
Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.

Primary Objective:

1. The primary end points:

   To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α).
2. Secondary Objectives:

(1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count.

(2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.

Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each.

Plan of the Study:

1. This is a randomized, comparative, double blinded study in 2 arms.
2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
3. Duration of Treatment: Treatment was administered before curative surgery for gastric adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-85 years old
* Histologically proven primary gastric cancer or GIST.
* Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc.
* Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.

Exclusion Criteria:

* They were less than 20 years or over 85 years old
* Hepatic dysfunction or bile stasis (serum total bilirubin \>2.5 mg/dL)
* Renal dysfunction (serum creatinine \>1.5 mg/dL), or required hemodialysis
* Cardiac dysfunction (NYHA functional class \>III, or stroke history)
* Severe hypoalbuminemia (albumin \<2.5 g/dL)
* Karnofsky performance status less than 60
* Overweight (body mass index \[BMI\] \>30 kg/m2)
* Exhibited drug abuse or chronic alcoholism
* Had life-threatening disease, or underwent emergent surgery
* With infection or bowel obstruction
* Pregnant or lactating
* Had received chemotherapy within 14 days of the initiation of the trial
* Had received immunosuppressive therapy or had immunological diseases recently
* Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study
* Hypersensitive to casein, fish oil, soybean, or corn oil
Factor Analysis of Unintended Initial Dissection of the Posterior Plane

To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.

Myopia is the most common eye disease in the world. Femtosecond laser small incision lens extraction (SMILE) has increasingly become the first choice in refractive surgery due to its greater biomechanical stability, less impact on the tear film and other advantages. However, because SMILE surgery is more challenging than flap-based corneal ablative surgery, young surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which will make it more difficult to extract the lenticule or even cause the retained lenticule. The purpose of this study aims to explore the potential risk factors for unintended initial dissection of the posterior plane in large samples and surgeons of different surgical volumes and different surgical habits (different angles of peripheral corneal incision) in multiple scenarios.

Eligibility Criteria:
Inclusion Criteria:

* A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
* Age ≥18 years;
* Spherical equivalent (SE) ≥ -10.0D;
* Corrected distance visual acuity (CDVA) ≥ 16/20;
* Stable myopia for at least 2 years;
* No contact lenses wearing for at least 2 weeks.

Exclusion Criteria:

* The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
* A history of eye surgery;
* The presence or history of systemic diseases.
Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer

Targeted and systematic biopsy stands as the prevalent diagnostic approach for prostate cancer. Despite its widespread use, this method is characterized by a high volume of needle biopsies. A refined approach, termed targeted and index-lesion-ipsilateral systematic biopsy, as one of targeted and regional systematic biopsy methods, aim to reduce the number of biopsy cores while maintaining an adequate positive rate. However, the absence of robust evidence necessitates further investigation. This study employs a prospective, multicenter, paired, non-inferiority design to assess the diagnostic efficacy of targeted and index-lesion-ipsilateral systematic prostate biopsy in comparison with the conventional targeted and systematic biopsy for the detection of clinically significant prostate cancer (csPCa). Eligible participants were identified as those with target lesions on prostate MRI, who subsequently underwent targeted and systematic prostate biopsies. The index lesion was defined as the one with the highest Prostate Imaging Reporting and Data System (PI-RADS) score; in cases of multiple lesions with identical PI-RADS scores, the lesion with the greatest diameter was prioritized. Post-biopsy pathological data were collected and evaluated using the International Society of Urological Pathology (ISUP) grading system, which classifies patients with a grade of 2 or higher as having csPCa. The study's primary outcome was to calculate the confidence interval for the difference in csPCa detection rates between the two biopsy methods under a paired design. This interval was then compared against a pre-specified non-inferiority margin to determine whether the targeted and index-lesion-ipsilateral systematic biopsy method is non-inferior to the standard targeted and systematic biopsy in detecting csPCa.


Eligibility Criteria:
Inclusion Criteria:

* Prostate specific antigen (PSA) \>4 ng/ml;
* Prostate Imaging-Reporting and Data System (PI-RADS) score of any lesions on prostate magnetic resonance imaging ≥4 or PI-RADS score of lesions on prostate magnetic resonance imaging = 3 and prostate specific antigen density ≥0.1ng/cm3;
* accept prostate biopsy;

Exclusion Criteria:

* Prostate specific antigen\>20ng/ml；
* the location of index lesion on prostate MRI is on the midline of the prostate and symmetrical on both sides;
* any contraindication of prostate biopsy;
* Previous prostate biopsy；
* Previous history of androgen deprivation therapy (ADT), pelvic radiotherapy, and other treatments；
* Previous history of transurethral prostatectomy (TURP)；
90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.

This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin \< 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.

The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.

Eligibility Criteria:
Inclusion Criteria:

* HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines
* Eastern Cooperative Oncology Group score 0 - 1
* Child-Pugh A - B
* Bilirubin \< 2.5 mg/dL
* Creatinine \< 2.0 mg/dL
* No prior liver-directed therapy or systemic therapy for HCC
* Solitary, unresectable HCC ≤ 3cm
* Albumin level \< 3.4 g/dL at HCC diagnosis
* Tumor anatomical location and angiosome amendable to MWA and 90Y

Exclusion Criteria:

* Pregnant women
* Concurrent malignancy
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.

This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.

Eligibility Criteria:
Inclusion Criteria:

• Non-infectious anterior uveitis

Exclusion Criteria:

* Uveitis of infectious etiology
* Previous anterior uveitis episode ≤ 4 weeks prior to baseline
* Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
* Topical corticosteroid treatment in either eye \< 48 hours prior to baseline
* Oral corticosteroid or intraorbital corticosteroid treatment in either eye \< 2 weeks prior to baseline
* Active intermediate or posterior uveitis
Inpatient Multimodal Path to RecOVEry

The goal of the proposed study is to develop and implement a comprehensive strategy to address pain management in the inpatient setting while appropriately managing pain and optimizing patient safety in the inpatient setting. This strategy involves developing a new health Information Technology tool in the Omnicell and electronic medical record, implementing a "menu" of pain management and relaxation strategies, and developing educational materials for staff and patients to change the culture of pain management.

The goal of the proposed study is to develop and implement a comprehensive strategy to address pain management in the inpatient setting while appropriately managing pain and optimizing patient safety in the inpatient setting. This strategy involves developing a new health Information Technology tool in the Omnicell and electronic medical record, implementing a "menu" of pain management and relaxation strategies, and developing educational materials for staff and patients to change the culture of pain management.

This intervention will be implemented throughout CHS hospitals, using a stepped wedge design to guide rollout. The initial pilot will be conducted in the trauma inpatient units at Carolinas Medical Center. All patients admitted to the two primary trauma units (11A and 11 Tower) during the pilot study period will be included in the evaluation.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated in facility as inpatient during the study period will be included in the analysis.

Exclusion Criteria:

* Patients not admitted to facility during the study period will be excluded from the analysis.
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths).
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Exclusion Criteria:

N/A
Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

Presently, the left ventricular lead is placed in a similar position for all patients. It is not known whether placing this lead in different positions in the heart will make the heart pump better. In this study, the investigator will collect measurements of the heart's electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that these measurements will provide the know how to develop an individualized left ventricular lead placement "prescription" for patients referred for left ventricular lead pacing.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic cardiomyopathy
* Intrinsic QRS duration \>120 milliseconds
* LV ejection fraction \<40%

Exclusion Criteria:

* Persistent atrial tachyarrhythmia
* Active cardiac ischemia
* Cerebrovascular accident within 6 months
* Surgical or percutaneous cardiac revascularization procedure within 3 months
* Under 18 years of age
* Pregnant
* Participating in a clinical study that would preclude enrollment
* Unable to provide informed consent
Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women

Healthy premenopausal women were enrolled in a diet intervention study that examined the effect of a combination EPA/DHA supplement on risk factors associated with breast cancer. In a randomized cross-over design, women consumed their habitual diet with a supplement for three menstrual cycles, had three cycles of wash-out and then consumed a low-fat diet with the same supplement. Blood, urine and nipple aspirate fluid were collected periodically over the 10 month protocol and analyzed for biomarkers associated with supplementation and future risk of breast cancer.

Non-pregnant, non-lactating women aged 18+ were recruited by way of posters, to take part in a dietary intervention study that was examining the effects of dietary fat level and fat type on risk factors associated with breast cancer. Women who were normally menstruating, consumed either their habitual diet or a low-fat diet for three menstrual cycles, along with a supplement containing 1.2 g DHA+EPA /day. This was followed by a 3-menstrual cycle washout, where the habitual diet was consumed without a supplement. Subsequently the participants consumed the other diet (either low-fat or habitual) for a further 3 menstrual cycles with the 1.2 g DHA/EPA supplement. Blood, urine and nipple aspirate fluid were collected at the beginning and end of each intervention period and analyzed for a variety of biomarkers. Diet records were collected continuously over the entire study period and periodic 7-day records examined for collection of detailed nutrition information. Anthropometry was completed at each study visit, and nutritional counselling provided throughout.

Eligibility Criteria:
Inclusion Criteria: menstruating, pre-menopausal -

Exclusion Criteria: pregnant, lactating, post-menopausal, smoking, on birth control pills

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