cyrilzakka/clinical-trials huggingface dataset:
Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty

Bone metastases are a cause of significant morbidity in cancer patients. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death (1). These metastases frequently give rise to complications that reduce patients' quality of life. These include: pain, fractures, and decreased mobility, ultimately reducing performance status.

Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone metastases has been shown to be feasible, efficacious, and safe. However, patient reported outcomes have yet to be determined.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically proven malignancy.
2. Patients aged 18 and above.
3. Advanced cancer with bone metastasis(es) to the spine and/or pelvis
4. Symptomatic with axial pain from spinal lesions and at risk for pathological fracture, or, pathological fracture without spinal cord compromise
5. Karnofsky Performance Status (KPS) greater than or equal to 40 at the time of baseline evaluation.
6. Is planned to receive RFA and/or cementoplasty with treatment to all sites being followed for study.
7. Is able to provide worst pain score at bony metastatic site(s).
8. Patient is able and willing to fill out daily diary.
9. Patients must be able to provide informed consent prior to being enrolled to the study.

Exclusion Criteria:

1. Progressive neurological compromise
2. Pathological fracture of vertebrae with significant cortical involvement or spinal canal compromise
3. Central nervous system metastases
4. Inability to record pain score, complete diary and communicate this to study personnel.
A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System

Holter monitoring is one of the most widely used diagnostic methods to detect cardiac arrhythmias. Newer Holter monitors may provide some advantages over the more traditional ones. This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device.

The 24-hour ambulatory electrocardiography, commonly known as Holter monitoring, is a diagnostic method to correlate clinical symptoms with cardiac arrhythmias. The Holter monitor records electrical signals from the heart using electrodes attached to the chest, which are connected via cables to a digital recorder. In addition to the device to record the cardiac electrical signals, the Holter system also has a software for review and analysis of the record. The software of the Holter system has an integrated automatic analysis process to detect different sorts of heart beats, rhythms, etc, which are then validated by a technician and a physician. The success of the automatic analysis depends of the quality of the captured electrical signals, which are dependent on the appropriate attachment of the electrodes/cables to the patient body. Therefore, inappropriately attached electrodes/cables can result in electromagnetic disturbance that can interfere with the ECG signal, resulting in a very noisy record that is hard to be analysed.

Newer Holter systems that eliminate the cables and attach the recorder directly to the electrodes positioned in the patient´s chest might reduce the electromagnetic disturbance in the ECG signal capture and, therefore, improve the quality of the exam.

This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device.

Eligibility Criteria:
Inclusion Criteria:

* Any individual who has an indication of 24 hours Holter monitoring and is referred to the arrhythmia clinic of the Instituto Dante Pazzanese de Cardiologia

Exclusion Criteria:

* Refusal to provide written informed consent
Is Carotid-Vertebral Doppler Ultrasonography Necessary for Patients With Vertigo?

This study will be carried out prospectively on patients who applied to the cardiovascular surgery polyclinic and the carotid-vertebral artery doppler ultrasound due to the vascular problem. All patients will fill "Balance Disorder Scan Survey" and "Vertigo-Dizziness Imbalance Questionnaire-SS". Patients who score 1 and more are directed to the ear nose throat polyclinic and detailed differential diagnosis. Those who score 0 will be in control group.

Right and left carotid artery flow velocities, intima-media thicknesses (IMT), presence of plaque, vertebral artery flow velocities, and vertebral artery resistance indexes (RI) will be recorded in all patients. Risk factor analysis, Vertigo Symptom Scale (VSS) and Dizziness Handicap Inventory (DHI-S) questionnaires will be applied to the patients in the ENT outpatient clinic. The differential diagnosis of vertigo will be made by performing detailed balance examinations and advanced balance tests.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have a vascular problem and doppler USG.

Exclusion Criteria:

Patients with impaired cooperation, history of malignancy, presence of central nervous system pathology, presence of neurological disease affecting balance in the history, patients whose use of glasses may cause problems (epilepsy, vision loss, etc.) were excluded from the study.
Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

This study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.

This study will provide clinical information on the use of insulin lispro in continuous subcutaneous insulin infusion (CSII) in participants with type 2 diabetes. This study is designed to allow comparison of the 2 rapid-acting insulin analogs, with regard to their efficacy and safety, when used as a pump insulin therapy in this participant population. Each participant will be randomized to 1 of the 2 sequence groups in a 1:1 ratio and randomization will be stratified according to screening A1C (less than or equal to 8.0% or greater than 8.0%) and thiazolidinedione (TZD) use (yes or no). The study design includes the following periods: Screening/Randomization, Treatment Period 1 (16 weeks), and Treatment Period 2 (16 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes (per World Health Organization \[WHO\] Classification of Diabetes)
* Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months
* Have a screening A1C less than or equal to 9.0% (no lower limit for A1C)
* Have a body mass index (BMI) less than 45 kilograms/square meter (kg/m²) at screening
* Have a history of stable body weight (not varying by greater than 10% for at least 3 months prior to screening)
* For participants on oral anti-diabetes medications (OAMs): must have been on a stable dose of OAMs, labeled for use with insulin, for at least 3 months prior to study entry

Exclusion Criteria:

* Have severe insulin resistance \[require greater than 2 units/kilogram/day (U/kg/day) of insulin\]
* Are taking or have taken within the last 3 months, antihyperglycemic medication not approved for use with insulin, injectable non-insulin antihyperglycemic medications, or have a contraindication to current antihyperglycemic medication
* Have a serum creatinine greater than or equal to 2 milligrams/deciliter (mg/dL) if not on metformin; known metabolic or lactic acidosis; any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study within 48 hours prior to study entry
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intraarticular, and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
* Have had more than 1 episode of hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer

Surgical quality control is a crucial determinant of evaluating the tumor efficacy. We assess the ClassIntra grade for quality control and oncological outcomes of robotic radical surgery for gastric cancer (GC).

Gastric cancer (GC) is the fifth most common malignant tumor worldwide and the fourth leading cause of cancer-related deaths. Surgery remains the cornerstone of GC treatment, and there is a significant lack of research on iAE compared with postoperative complications. Owing to the influence of reporting and cultural acceptance, there have been issues of inadequate reporting and non-standardized practices regarding iAE reporting.

The previously reported laparoscopic results showed that the ClassIntra grade is an effective prognostic and surgical quality control index for laparoscopic radical surgery for gastric cancer therefore it could be included in routine hospital care and surgical quality control. (DOI: 10.1097/SLA.0000000000005727). Here, iAEs in patients who underwent robotic radical gastrectomy significantly correlated with the occurrence of postoperative complications and a poor long-term prognosis. Therefore, utilization and inclusion of ClassIntra grading as a crucial surgical quality control and prognostic indicator in the routine surgical quality evaluation system are recommended.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with gastric adenocarcinoma through pathology;
* Preoperative chest radiograph, abdominal ultrasonogram, and full abdominal CT examination showed no distant metastasis to the liver, lungs, or abdominal cavity;
* Patients who underwent robotic radical gastrectomy.

Exclusion Criteria:

* Intraoperatively existing distant metastases
* Neoadjuvant chemotherapy
* Missing general and video data.
Colorectal Cancer Screening With Improved Shared Decision Making

The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).

Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N\~50,000 patients.

Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).

Eligibility Criteria:
Inclusion Criteria:

* 50 to 75 years of age
* Lives in or receives care in the selected intervention or comparison (control) communities
* Average-risk for colorectal cancer
* Non-adherent to CRCS recommendation
* English-speaking
* People who consent to participate

Exclusion Criteria:

* \<50 years of age or \>75 years of age
* Not living in or receiving care in the selected intervention or comparison communities
* High-risk for colorectal cancer
* Adherent to CRCS recommendation
* Non-English speaking
* People who do not consent to participate
Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

This pilot study aims to assess the feasibility of providing immunonutrition supplementation to older burn patients (age 55 and older) and its impact on burn wound healing. Supplements containing arginine and omega 3 fatty acids have been shown to have beneficial effects on healing in other types of wounds but data within the burn population remains limited. 20 participants will be randomized into two arms, immunonutrition or conventional supplement and can expect to be on study for 3 months.

Studies performed previously in burn patients have had mixed patient cohorts with small sample sizes and these have failed to show any large improvements in wound healing. However, in older populations the investigators suspect that immunonutrition supplements may have a larger benefit to these patients as they often present with malnutrition and are more likely to struggle with delayed wound healing. In this pilot study, the investigators look to assess the impact of immunonutrition supplements the burn wound healing of adults over the age of 55 years with 1-15% total burn surface area (TBSA) partial thickness and full thickness burn injuries.

The primary outcome objective of the study will be time to complete wound closure. The secondary objectives include need for surgical grafting, length of inpatient stay, and infections including pneumonia, urinary tract infections, wound infections, and blood stream infections.

Eligibility Criteria:
Inclusion Criteria:

* Subject has partial of full thickness thermal injury of 1-15% of total body surface area (TBSA)
* Subject has an inpatient admission for their burn
* Subject or authorized decision maker understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator

Exclusion Criteria:

* Subject with inhalation injury and/or intubation
* Subject receiving immunosuppressive medications including chronic steroids, immune modulating medications, and chemotherapy prior to admission
* Subject with pre-existing severe chronic liver disease or end stage renal disease
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers

The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.

The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.

DermDx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer. The software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes.

Because the study is designed to investigate the change in the performance of the PCPs before and after seeing the device output, a single-arm study design has been used.

Eligibility Criteria:
Inclusion criteria:

* The subjects must be Primary Care Physicians who are board certified in family medicine or internal medicine.

Exclusion criteria:

* Subjects not meeting inclusion criteria.
Rice Anthocyanin Bioavailability in Humans

Aims of the project

1. To determine the rice anthocyanin content via high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS
2. To study the oral bioavailability of anthocyanins in healthy volunteers after the intake of a serving (80 g) of black rice (Venere and Artemide varieties).
3. To determine the plasma biokinetics parameters of rice anthocyanins via spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS.

To limit the interindividual variability, The protocol will be designed as a prospective, randomized, cross-over pharmacokinetic study on healthy volunteers. Participants will be randomly divided into three groups (black rice Venere, black rice Artemide and white rice/control) by an allocation software ( http://graphpad.com/quickcalcs/randomise1.cfm ) which will generate different random sequences of the treatment assignment.

Subjects will be deprived of anthocyanin-rich food sources 7 days before experimentation (wash-out period). Each volunteer will receive a complete list of anthocyanin-rich foods to be avoided, including berry fruits (i.e. blueberries, cranberries, raspberries, blackcurrants and elderberries), red/violet fruits/vegetables (i.e. grapes, cherries, pomegranates, red apples, plums, eggplants, tomatoes and peppers), red wine and other colored products (i.e. marmalade, jams and juices containing berries). Breakfast, lunch and dinner will be standardized 1 day before the experiment. Each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences:

1. 80g of black rice Venere (Group A)
2. 80g of black rice Artemide (Group B)
3. 80g of white rice (Group C)

Therefore, each subject will be involved in three experimental days. The three treatments will be separated by a 7 day wash-out period.

After an overnight fast, volunteers will consume the rice serving within 10-15 min, immediately after the first basal blood collection at 8:00 a.m. (baseline). Other blood withdrawals will be collected after 30 minutes, 1 hour, 2 hours, 3 hours.

Chemical analyses. The extraction protocols of anthocyanins from body fluids will be developed, in order to reach the maximum yield of the analytes from the samples. Plasma anthocyanins will be measured by spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS.

Eligibility Criteria:
Inclusion Criteria:

* Healthy status
* Age: 18-45
* Normal weight (BMI 18.5-24.9) who voluntarily accept to join the study, after informed consent.

Exclusion Criteria:

* \<18 Years;
* Pregnancy and lactation;
* Systemic disorders;
* Dietary supplements intake (vitamins, antioxidants, botanicals, phytochemicals)
* Abnormal hematological parameters;
* Heavy smoking and alcohol drinking;
* High-intensity physical activity.
PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)

This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG 7909) Injection to continue receiving the treatment until disease progression.


Eligibility Criteria:
Inclusion Criteria:

Immediate (within 4 weeks) prior completion of a clinical trial of PF-3512676 Injection alone or in combination with other anti-neoplastic treatment for malignancy.

Exclusion Criteria:

The patient has received any anti-neoplastic therapy since completing a prior trial with PF-3512676 Injection, or has participated in another clinical trial following participation in a trial with PF-3512676 Injection.
CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.

Study participants will be screened from and recruited on their entry into the suspected COVID-19 admission pathway at Derriford Hospital, Plymouth, UK. In addition to usual clinical care (including physical exam and observations, blood tests, nasopharyngeal swab for viral PCR testing, and chest x-ray as standard), participants will undergo focused lung ultrasound examination.

Participants who are negative for COVID-19 will be followed up to confirm their final discharge diagnoses, and clinical outcome at either 3 months post-enrolment or discharge from hospital.

Participants who are positive for COVID-19 will have regular focused lung ultrasound examination during their hospital admission in addition to usual clinical care until their treatment for COVID-19 is complete. Their discharge diagnoses and clinical outcome at either 3 months post-enrolment or discharge from hospital (whichever is later).

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Suspected or confirmed diagnosis of COVID-19
* Able to provide informed consent to study participation

Exclusion Criteria:

* Age less than 18 years
* Inability to provide informed consent at the time of study enrolment
Effect of Perioperative Factors on the Analgesia Nociception Index

The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However, many perioperative factors such as medications, position, maneuvers may influence the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid dosing has never been tested. Therefore, the aim of our study is to collect in a database all the perioperative factors and to study their influence on the ANI.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing scheduled surgery

Exclusion Criteria:

* Non sinusal rhythm
* Pace maker or defibrillator holders
* Pregnancy or feeding
* American Society of Anesthesiology physical status 4
Clinical Factors Associated Floppy Iris

This study is planned to investigate the incidence of intraoperative floppy iris and its relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1 adrenergic blocker use.

Our aim is to investigate the incidence of intraoperative floppy iris syndrome (IFIS) signs and evaluate the relationship of IFIS signs as well as complete IFIS with pseudoexfoliation, diabetes, hypertension, and alpha-1 adrenergic blocker (A1AB) use. Five-hundred patients will be included in this prospective study. Preoperatively, pupil diameter before and after dilation, presence of pseudoexfoliation, history of diabetes, hypertension, and use of any A1AB will be recorded. Intraoperative adverse events such as pupillary constriction, iris billowing, and iris prolapse from the wound will be noted. Multinomial regression analysis will be used to evaluate the relationship of IFIS signs with pseudoexfoliation, diabetes, hypertension, and A1AB usage. According to the results we will determine the incidence of IFIS in our patient population and evaluate its relationship with alpha-1 adrenergic blocker use. We will also investigate the relationship of floppy iris problems with pseudoexfoliation, diabetes, high blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with the diagnosis of cataract who were decided to have phacoemulsification

Exclusion Criteria:

* Previous history of trauma or surgery of the eye, congenital ocular disease including cataract, infection, inflammation, angle closure glaucoma, or medication (topical) that might affect the size and shape of the pupil

Only the first operated eye of each patient was included.
Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique

Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity.


Eligibility Criteria:
Inclusion Criteria:

* patients with symptoms from sacrococcygeal pilonidal sinus .

Exclusion Criteria:

* Abscess formation
* Immunodeficiency.
* Patients with congenital asymptomatic pits.
* Patient with psychiatric disease disabling surgical intervention. . Pregnant females.