cyrilzakka/clinical-trials huggingface dataset:
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) \[IRE cohort\], and patients who were treated with SOC and did not receive IRE \[SOC cohort\].


Eligibility Criteria:
Inclusion Criteria:

1. Provisions of signed and dated informed consent form
2. Patient is 18 years of age and older
3. Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
4. Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
6. Patient has received 3 months of SOC per each participating institution's guidelines
7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
9. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
10. Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

Exclusion Criteria:

1. Participation in an interventional trial for pancreatic cancer during the study data collection period
2. Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
3. Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
4. Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE
Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study

The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.

Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.

This study assesses risk communication and shared decision-making in patient-clinician dyads by administering validated measures at baseline, after interacting with the tools prior to the clinic visit, and after the clinical visit (quantitative analysis); and by using observer-based methods of audio-tape recordings of their clinical encounters (qualitative analysis).

The investigator hypothesizes that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake.

Eligibility Criteria:
Inclusion Criteria:

* 5-year breast risk of 1.67% or lifetime risk of 20% according to the Gail model
* The participant understands and is willing to provide informed consent in English or Spanish
* Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital

Exclusion Criteria:

* Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
* Prior history of breast cancer
Analysis of Risk Factors for High Intraocular Pressure and Retinal Detachment Recurrence After Vitrectomy with Silicone Oil Tamponade in Retinal Detachment Patients

This study is a retrospective study. Patients who visited the ophthalmology clinic of the First Affiliated Hospital of Chongqing Medical University between September 1, 2024, and December 31, 2025, will be screened according to the inclusion and exclusion criteria mentioned below. After obtaining informed consent, clinical data of the subjects will be collected. The surgical procedure will involve "vitrectomy + retinal laser photocoagulation + retinal reattachment + silicone oil tamponade (+ cataract extraction + intraocular lens implantation)." Observation indicators will be recorded at various time points postoperatively: 1 day, 1 week, 1 month, 3 months, 6 months, and before silicone oil removal. Any emergent events occurring during the trial will be treated accordingly. Finally, data will be statistically analyzed to identify risk factors for high intraocular pressure and retinal detachment recurrence in patients with rhegmatogenous retinal detachment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosed with "rhegmatogenous retinal detachment". 2. Aged over 18 years old, with normal mental and psychological status, regardless of gender.

  3. Intraocular pressure of both eyes is less than 21 mmHg before surgery, and having no personal or family history of glaucoma.

  4. Cup - to - disc ratio (C/D) in fundus examination is less than 0.5 for both eyes.

  5. Those who understand the purpose of this study, sign the "Informed Consent Form" and have a high degree of compliance.

Exclusion Criteria:

- 1. Those with high intraocular pressure before surgery and suffering from ophthalmic diseases such as glaucoma; 3. Those with acute or chronic systemic infections and hematological diseases; 4. Those with a history of mental and psychological diseases; 5. Those with incomplete survey data or unable to cooperate with this research. 5. Those with traumatic rhegmatogenous retinal detachment; 6. Those with active ocular infectious lesions in either eye; 7. Those with severe refractive media opacity (such as corneal nebula, corneal leukoma) in the target eye, which affects imaging examinations during postoperative follow - up.

8. Those with a history of congenital structural abnormalities in the target eye; 9. Those who have undergone vitrectomy for other vitreoretinal diseases in the target eye before screening; 10. Those whom the researchers consider unfit to participate in this clinical trial.
Normalizing HPV Vaccination in Preteens With a Serious Video Game

Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States and causes genital warts and cancers in both females and males. Vaccination against HPV is recommended for routine use in those aged 11-12 years old, yet is underutilized. The study's premise is that preteens are relevant decision makers who can be motivated to initiate and complete the HPV vaccine series (assuming parental consent and provider recommendation). This study evaluates a serious video game to engage preteens in the decision to pursue HPV vaccination. The hypothesis is that preteens who are assigned to the video game will be more likely to initiate and complete HPV vaccination than preteens who are not assigned to the video game.

The aims of this pilot study are to (1) evaluate whether preteens who receive the video game have better self-reported outcomes related to knowledge of HPV and HPV vaccine, vaccination self-efficacy and decisional balance compared with preteens who do not receive the game; and (2) evaluate outcomes related to immersion in the video game and game play experiences of preteens who played the game. HPV vaccination initiation and completion data are collected from practices for both preteens who receive the game and a comparison group who do not receive the game.

This is a multiple baseline study based in primary care practices in North Carolina and conducted over 3 waves of 16 practices each wave. The goal is to recruit 160 boys and girls ages 11-12 and not vaccinated against HPV for each wave. Participants are recruited by their primary care providers to enroll in the study. Parents give consent and preteens give assent.

An original video game, Land of Secret Gardens, is created for the study. The game is a metaphor for protecting seedlings (body) with a potion (vaccine). Points to buy seeds and create the potion are earned by playing minigames. The minigames include several versions of finding secret objects in a garden shed and another involves playing a shield game with blue spikey balls (i.e., HPV) before they land on budding plants. Throughout the play, players are exposed to messaging about HPV and the benefits of the HPV vaccine.

Preteens are randomly assigned to an intervention group to play the video game or to a comparison group that will not play the game. Participants are asked to complete baseline and postintervention surveys. Measures included are scales for knowledge of HPV and HPV vaccine, vaccination self-efficacy and decisional balance about deciding to pursue HPV vaccination. Participants in the intervention group are also asked about story immersion and game play.

Eligibility Criteria:
Inclusion Criteria:

* preteens 11-12 who had not received any doses of HPV vaccination
* recruited by primary care practices in North Carolina
* parent signed HIPAA release
* willing to take baseline and postintervention surveys
* access to internet and mobile device or personal computer

Exclusion Criteria:

* preteens who had received at least one dose of HPV vaccine
Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG

The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0）

In recent years, the incidence of gastric cancer has been decreasing year by year in the world, but the incidence of adenocarcinoma of the esophagogastric junction (AEG) has shown a significant upward trend, especially in Western countries such as Europe and the United States. The prognosis of AEG is poor, therefore, it is extremely necessary to establish AEG's best diagnosis and treatment strategies to improve the long-term outcome of AEG. Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma (cT2-4a, N-/+, M0) by comparing with laparoscopic assisted.

Eligibility Criteria:
Inclusion Criteria:

* Age from over 18 to under 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
* Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to obtain R0 resection sugicall results.
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) class I to III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
* Gastric multiple primary carcinoma
* Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
* History of other malignant disease within the past 5 years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within the past 6 months
* History of cerebrovascular accident within the past 6 months
* History of continuous systematic administration of corticosteroids within 1 month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of the predicted values
Tracheobronchial Angle in Children - Three-dimensional Computed Tomography Based Measurements

Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks state that the anatomic orientation of the right main bronchus is at less acute angle to the vertical tracheal axis, although these angles tend to be similar in children younger than three years of ageThe visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway.

We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.

Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children.

Significant variations and discrepancies in the reported tracheobronchial angles are found in literature.

Various imaging modalities ranging from chest x-ray to helical computed tomography (CT) have been used for measuring the tracheobronchial angles in children and the results are varied with some studies reporting equal angles \[2016\] while others reporting right bronchial angle to be smaller than left bronchial angle \[Kubota\].

The visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway. The highest quality medical-grade (3D) images are obtained using CT data \[Uchida M\]. Computed tomography (CT) is considered the current gold standard for airway measurements as the air-tissue interface is better delineated by CT imaging \[Reinhardt\].

We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.

Eligibility Criteria:
Inclusion Criteria:

* CT scans airways

Exclusion Criteria:

* any disease that is anticipated to distort the normal shape of airways wee excluded from the study
Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma

The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma

The main purposes: to determine the overall survival (OS) of patients who have locally advanced inoperable or metastatic HER2-negative gastric and gastroesophageal adenocarcinoma treated with first-line EOX (epirubicin + oxaliplatin + capecitabine) or mDCF (docetaxel + cisplatin + leucovorin + 5fluorouracil) palliative chemotherapy regimens

The secondary purposes: to determine safety (as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0) and the progression-free survival (PFS)

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction;
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2;
* adequate renal, hepatic, and hematologic function;
* measurable or nonmeasurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible

Exclusion Criteria:

* HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+
* previous chemotherapy for metastatic or locally advanced disease
* surgery \<3 weeks before the onset of the study treatment
* congestive heart failure
* significant dysphagia that would preclude oral administration of capecitabine
* concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer)
* clinical evidence of brain metastases
Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia

One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33, pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31, dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. Clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (VAS), ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Aged 18-75 years

One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia

Exclusion Criteria:

* Pregnant
* Allergic and/or contraindicated to the study drugs
* American Society of Anesthesiologists (ASA) score III and above
* Having drug
* Alcohol addiction
* Renal failure
* Diabetes mellitus
* Epilepsy
* currently using opioids for chronic pain and/or any of the drugs studied.
Robot-Mediated Intervention for Children With Autism Spectrum Disorders

This study is being done to examine the impact of an interactive, social robotics program in helping children with autism spectrum disorders (ASD) understand emotions and how to better recognize emotions while interacting with others. Eligible families will be randomized to either the robot intervention (n=20) or a no intervention (TAU; n=20) condition for 8-14 weeks. Assessments will occur at pre- and post-intervention as well as weekly for both conditions.


Eligibility Criteria:
Inclusion Criteria:

* Child participants must be between the ages of 4 years, 0 months and 8 years, 11 months.
* Children must meet criteria for ASD or autism on the Autism Diagnostic Observation Schedule (ADOS-2; Lord et al., 2012) plus receive a clinical judgment of pervasive developmental disorder not otherwise specified (PDD-NOS) or autism by the study team.
* Children must possess sufficient expressive language skills to qualify for at least an ADOS-2 Module 2.
* Caregivers must agree to participate in the study and commit to having their child participating in the intervention to which they are randomized for approximately three months.
* Caregivers must agree to bring their child in for pre-testing and post-testing.
* Family must speak English at least 50% in the home.

Exclusion Criteria:

* Child IQ \<70 (per Stanford Binet short form).
* History of head injury, seizure disorder, severe aggression or self-injurious behavior.
* Vision impairment after correction.
* Cannot be living in foster care.
Maintenance Dosing of Vitamin D in Crohn's Disease

Vitamin D repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. High quality evidence is lacking to determine the optimal strategy to maintain adequate levels of Vitamin D levels in patients with Crohn's disease.

The investigators seek to identify patients with Crohn's disease in clinical remission who have vitamin D levels \<30 ng/ml. Subjects will undergo a 8 week lead in period and receive Vitamin D supplementation with 50,000 IU D2 weekly for 8 weeks.Participants with sufficient Vitamin D levels after 8 weeks (\>30 ng/mL) will be enrolled into the study and randomized to one of three arms: (1) placebo (2) 1000 IU/day Vitamin D3 (3) 5,000 IU/day Vitamin D3 for 22 weeks. Based on clinical experience, doses higher than the recommended doses for bone health in the general population (600-800 IU/day Vitamin D3) are needed to achieve and maintain optimal levels of Vitamin D in people with Crohn's disease.

The investigators aim to determine optimal maintenance dosing to sustain vitamin D sufficiency in people with Crohn's disease. The investigators also seek to determine demographic and disease related characteristics associated with inability to maintain sufficient levels.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Crohn's disease
2. In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4
3. 25(OH)D level \<30 ng/ml within three months of study enrollment
4. Prior 25(OH)D level \<30 ng/ml currently on repletion therapy
5. Provided written informed consent
6. 18 years of age or older
7. All maintenance therapies required to be on stable doses for 3 months.

Exclusion Criteria:

1. Unwilling to provide consent or lack capacity
2. Clinical disease activity (Harvey Bradshaw index \>4)
3. Current pregnancy or attempting to conceive
4. Hypercalcemia (must have calcium level within 6 months of enrollment)
5. Known coexisting hyperparathyroidism
6. BMI \>30 kg/m²
7. History of kidney stones
8. Subjects \<18 years of age - pediatric population with different recommended dosing than adults
9. Non-english speakers
10. Has an ileo-anal pouch or ileostomy
11. C-reactive protein greater than 2x the upper limit of normal
12. Lactose intolerant
13. Short gut syndrome
14. Renal insufficiency (CrCl \<60 ml/min)
15. Concomitant therapy with thiazide diuretics, barbiturates, digitalis or supplemental products containing vitamin D
16. Vitamin D levels \<30ng/ml at completion of lead in