cyrilzakka/clinical-trials huggingface dataset:
EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations

The objective of this pilot study is to collect preliminary data using total body scans on a new, first of its kind, FDA 510k-cleared positron emission tomography/computed tomography (PET/CT) scanner, called EXPLORER. The study will aim to recruit healthy individuals from racial/ethnic minority populations.

The aim of this pilot study is to increase the number of healthy individuals from racial/ethnic minority populations. This will advance research being conducted at EMIC by providing "controls" or comparisons to differentiate between images from patients with cancer versus healthy people of the same racial/ethnic ancestry. In addition, blood samples from participants to this study will be utilized for quantitative, genetics-based estimates of ancestry (e.g., African, Chinese, Colombian, Western European, Mexican, Vietnamese, etc.), which is especially valuable in the case of admixed individuals.

Eligibility Criteria:
Inclusion criteria:

* Men and women, 18 years of age or older
* Member of a Federally recognized racial/ethnic minority population, e.g., African American or Black; Hispanic or Latino; Asian American; Native Hawaiian or Other Pacific Islander; Native American or Alaska Native
* Willing and able to fast for at least 6 hours before and for the duration of the scan
* Willing to provide urine samples throughout scan visit
* Willing to provide blood samples for ancestry analysis
* Willing and able to lay motionless in a supine position for up to 60 minutes and for up to 20 minutes at two separate timepoints
* Willing and able to give informed consent, personal contact information (phone number, email and postal address), insurance information, and primary care physician contact

Exclusion criteria:

* No Primary Care Physician
* No health insurance
* Body weight more than 240 kg (529 pounds)
* Any known concomitant acute infection (including upper respiratory infection, genitourinary infections, etc.)
* History of metastatic or newly (last 5 years) diagnosed locally invasive cancer
* Chemotherapy in the last 5 years
* Radiation therapy in the last 3 years
* Major surgery within the last 6 months
* Pregnancy or breast-feeding
* Diabetes
* Fasting blood glucose level \> 200 mg/dL before administration of fluorodeoxyglucose (FDG)
* Prisoners
* Self-reported history of dysphoria or anxiety in closed spaces
Testing Decision Aids About Early Stage Prostate Cancer

This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:

* increase patients' perceptions of the importance of their preferences to their decision making
* increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists
* increase patients' actual engagement with their physician during the clinical encounter
* increase the concordance between patient decision making preferences and actual decision making outcomes
* increase long term satisfaction with decision on type of treatment selected
* increase patient satisfaction with their decision and the decision making process
* influence patient perception of his physician (e.g., trust) and of the diagnosis visit


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years and older
* Scheduled for a prostate biopsy to test for prostate cancer
* Ability to read and answer survey questions in English

Exclusion Criteria:

* Previous diagnosis of prostate cancer
Trevo Aspiration Proximal Flow Control Registry

This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy.

The TRAP Registry is designed to collect real-world data on the use of the TRAP technique for mechanical thrombectomy in stroke patients. Recanalization success (as assessed using a TICI Score), along with the time to recanalization and number of passes needed for success will be assessed at the conclusion of the procedure. In addition, neurologic recovery (as evaluated using the Modified Rankin Scale and National Institutes of Health Score) will be assessed at 24 hours, discharge, and 90 days after the thrombectomy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA)
* Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel
* Subjects that range in age from 18-85
* Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30
* Subjects that the operator feels may be treated with endovascular therapy
* Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better
* Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration)
* Subjects who have consented in accordance with local Institutional Review Board requirements

Exclusion Criteria:

* Absence of large vessel occlusion on neuroimaging
* Evidence of tandem occlusion on neuroimaging
* Platelet count \< 100 x 10³ cells/mm³ or known platelet dysfunction
* Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)
* Previously documented contrast allergy that is not amenable to medical treatment
* Women who are pregnant or breastfeeding at time of intervention
* Evidence of brain hemorrhage on CT and/or MRI at presenting hospital
Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies

This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice.

The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.


Eligibility Criteria:
Inclusion criteria:

* Patients aged 18 years or older at index.
* Patients with RMS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS) at the time of initiating anti-CD20 treatment.
* Newly initiated anti-CD20 treatment after March 2017 (no history of anti-CD20 therapy at any time in medical record before this date) to the latest data cutoff (November 2022).
* Patients with at least one documented IgG lab value pre- and post-anti-CD20 drug initiation.

Exclusion criteria:

* Patients with diagnosis of primary progressive multiple sclerosis (PPMS) prior to anti-CD20 treatment.
* Participated in an anti-CD20 drug clinical trial during the study period.
The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

This study is a multi-center, prospective, non-interventional (NI) study evaluating the safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in China hospitals. Each subject will be followed up overall survival (OS) time or the date of withdrawal and subjects who remain alive after study completion will have their OS time censored on the last date known to be alive. Eligible subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated until disease progress, unacceptable toxicity, withdrawal from the study at their own request, or until the final analysis for the study is performed. The NI study will capture observations that will be used for evaluating the safety profile of sunitinib, including: subject demographics, medical history and medications. Safety assessments, treatment data and any other laboratory examination results, which were done according to routine clinical practice, will be collected at all visits.

The sunitinib non-interventional (NI) study is a real world observational study which represents the usual and customary treatment of patients and being proposed to collect data systematically and to assess the safety and efficacy in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.It is designed and conducted to meet CFDA post-marketing commitments. non-probability sample

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Subjects who are willing to follow up visits within current clinical practice.
* Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)
* Unresectable (as assessed by the investigator) or metastatic disease documented on a scan
* A minimum age of 18 years

Exclusion Criteria:

* Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)
* Patients who have received at least one dosage of sunitinib treatment prior to signing informed consent form will be excluded from participating in this study.
Aerosolisation During Respiratory Procedures

Currently, a major issue within respiratory medicine is undertaking procedures that generate aerosolisation with the concern of spreading infection, such as the SARS-COV-2/COVID-19 virus. It is anecdotally reported that lung function testing and positive airways pressure devices used in clinical practice are aerosol generating procedures however the data to support this is limited. With the advent of high-speed imaging systems that can capture and quantify particle size and velocity we aim to investigate the aerosol generation in routine non-invasive positive pressure respiratory procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Healthy subjects with no active medical conditions or previous pneumothorax
* Cognitively and linguistically able to follow instructions given in English and provide informed consent

Exclusion Criteria:

* Significant respiratory, cardiac or neurological conditions or previous pneumothorax
* Smoking history greater than 10 pack years
* Acute illness at the time of assessment
* Allergies to latex, metals or local anaesthetic agents
Efficacy of Dexmedetomidine on Postoperative Analgesia

This prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. The investigators hypothesis is that the administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the plane in the erector spinae is less effective in controlling acute postoperative pain in radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.

Patients undergoing radical mastectomy are randomly assigned to receive, in addition to standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine at 0.3 mcg kg (n = 15) for the intervention group. General anesthesia was induced using anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular relaxation with cisatracurium at a dose of 0.1 mg / kg.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing radical mastectomy for pathology "breast cancer"
* Patient undergoing anesthetic technique due to erector spinae plane block
* Informed consent to perform the anesthesia technique.
* Karnofsky\> 80 points

Exclusion Criteria:

* Emergency surgery
* Patient with mental pathology that prevents pain assessment.
* Rejection of anesthetic technique.
* Patient with allergy to local anesthetics
* Patient with local infection of the puncture site for application of the erector spinae block
Glycemic Targets for Pregnant Women With GDM and T2DM

The purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a singleton gestation
* 18 years or older
* Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes

Exclusion Criteria:

* Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
* Type 1 diabetes
* Diabetic retinopathy
* Diabetic nephropathy
* Diabetic vasculopathy
A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed locally advanced rectal cancer;
* measurable disease;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

* prior treatment with bevacizumab;
* prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
* previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
* history or evidence of central nervous system (CNS) disease;
* clinically significant cardiovascular disease;
* chronic treatment with high dose aspirin (more than \[\>\] 325 milligrams per day \[mg/day\]) or non-steroidal anti-inflammatory drugs.
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).

All eligible patients will receive SB injection therapy for 6 cycles (14\~21 days for each cycle). Efficacy wll be evaluated every 3 cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years or over
2. Patients with Hepatocellular carcinoma progression (HCC) and primary liver cancer as a diagnostic imaging test (eg, X-ray, CT, scan, ultrasound) can be measured in patients with a lesion
3. Directly to standard therapy (surgery, RF ablation, TACE) is not possible, patients with advanced liver cancer. However, the standard treatment of the subject or subjects entirely voluntary participation of subjects participating at the discretion of the doctor or researcher can be deemed included in the selected target.
4. Life expectancy ≥ 5 months
5. ECOG status 0, 1, 2 patients
6. Child-Pugh classification A, B patients
7. PLT 70,000, ANC 1,000 or more patients (OT / PT \<upper normal limit x 5.0, Bilirubin \<upper normal limit x 3.0)
8. Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7 days ago
9. Patients or their legal representatives who have signed the informed consent form

Exclusion Criteria:

1. Last 4 weeks the patients who had participated in another clinical trial
2. Last 4 weeks the patients who received chemotherapy
3. Associated with hepatocellular carcinoma in patients with a history of malignant tumor
4. Hepatectomy or liver transplantation patients who received treatment.
5. Active systemic infection requiring medical treatment
6. Uncontrolled hypertension or diabetes mellitus.
7. Clinically Significant cardiac disease (myocardial infarction / angina / severe arrhythmia / congestive heart failure)
8. Autoimmune diseases (systemic lupus erythematosus: SLE / rheumatoid arthritis / myasthenia gravis) and the patients currently being treated
9. Presence or history of malignancy other than Hepatocellular carcinoma within 5 years
10. Patients who have history of allergy with this investigational drug.
11. Obvious cognitive or physical impairment that would prevent participation
12. Pregnancy, lactation period and don't using contraception earnest Patients
The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain

Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for cancer survivors with chronic neuropathic pain. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among breast cancer survivors with chronic neuropathic pain. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of stress and immune function, cognitive function, as well as brain structure and function.

The investigators will recruit 108 adult women survivors of breast cancer living with chronic neuropathic pain. All will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group MBSR program or a wait-list. All participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure several markers of immune function at four different time points: before medical treatment, after medical treatment and before randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic resonance imaging before and after participation in MBSR.

The primary outcome is pain interference. The investigators will compare the proportion of participants who report reduced pain-related disability, as measured by the Brief Pain Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain Inventory Interference score) in the interdisciplinary program in comparison to medical treatment alone.

Eligibility Criteria:
Inclusion Criteria:

* Female.
* 18 years or older.
* Completed treatment for breast cancer a minimum of 1 year prior to study enrollment.
* Have been experiencing neuropathic pain following their cancer treatment for a minimum of 6 months.
* Report pain intensity levels ≥4 (moderate to severe).

Exclusion Criteria:

* Metastatic disease or current evidence of cancer recurrence
* Pregnancy or breastfeeding
* Unable to complete questionnaires in English or French.
Prevalence of Hepatitis B in Vallés Occidental. Observational Multicentric Study

The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental. Also, describe the stage of the disease, and whether if they are under medical treatment or not.

The hepatitis B virus ( HBV ) is a global health problem . It is estimated that in the world there are about 350-400 million carriers of HBV surface antigen ( HBsAg ) 1 .

The prevalence in Spain is estimated at a 2-7 % and is considered a second intermediate prevalence.

For over 20 years, has carried out a program of primary prevention through universal vaccination against hepatitis B including it in the childhood vaccination schedule and has already been observed that in some estudi3 the prevalence has declined . For this reason , we want to evaluate what is the currently prevalence in our area of influence. There aren't recent studies to assess what is the current status of these patients ( how many , what risk factors which needs of treatment and with answer ...)

Eligibility Criteria:
Inclusion Criteria:

* Patients with HBsAg + visited in Digestive/Hepatology outpatient visits and Hepatology of the participating hospitals

Exclusion Criteria:

* Patients \< 18 aged
* Duplicity on record
An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice

This study is to investigate the effects of Fiasp®, a mealtime insulin, in patients with diabetes mellitus. The purpose of this study is to collect information about Fiasp®, which is prescribed to the participants by their doctors. Participants will administer Fiasp® as prescribed by their doctors. The study will last for about 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, age equal to or above 18 years at the time of signing the informed consent.
* Patients diagnosed with diabetes mellitus.
* Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician.

Exclusion Criteria:

* Known or suspected hypersensitivity to study product(s) or related products.
* Patients on or likely to use insulin pump therapy during the study period
* Previous participation in this study. Participation is defined as having given signed informed consent.
* Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation.
* Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start.
* Any disorder which in the opinion of the treating physician may jeopardise the patient's safety or compliance with the protocol.