cyrilzakka/clinical-trials huggingface dataset:
A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer

Pancreatic cancer progresses rapidly and has a higher death rate. Albumin-bound paclitaxel is a new generation of paclitaxel . Albumin-bound paclitaxel is recommended as a class 1A evidence treating patients with pancreatic cancer.The purpose of this study was to further observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel in the treatment of non-operative locally advanced or metastatic pancreatic cancer and to explore the prognostic factors .

This is a prospective, single-arm, observational study. After the subjects meet the inclusive and exclusive criteria, then they will receive albumin-bound paclitaxel treatment. The researchers can choose the treatment based on albumin-bound paclitaxel and choose dosage according to the patient's condition.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 -80, male or female;
2. Non-operative patients with locally advanced or metastatic pancreatic cancer diagnosed by pathology or histology (except islet cell carcinoma);
3. The patient has not received standard systematic treatment in the past, and the metastatic site has not received any local treatment, including radiotherapy, chemotherapy, surgical treatment, etc.;
4. At least one measurable lesion (CT scan length of tumor lesion is greater than 10 mm, CT scan short diameter of lymph node lesion is greater than 15 mm, scanning layer thickness is not greater than 5 mm);
5. The subjects volunteered to participate in this study and signed the informed consent form, with good compliance to follow-up.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients allergy to albumin-bound paclitaxel or its excipients
3. Patients with albumin-bound paclitaxel contraindication;
4. Doctors consider those who are not suitable for this study.
Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.

Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.

Eligibility Criteria:
Inclusion Criteria:

* relapsed/refractory CD19-positive CLL
* At least 28 days since prior treatment for CLL
* ECOG PS 0-2
* Screening laboratory values must be met

Exclusion Criteria:

* No prior anti-CD19 antibody tx
* No active, uncontrolled infection
* No prior allogeneic bone marrow transplant
* No autoimmune disease
A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20% chance that intermediate-risk prostate cancer will come back after this treatment. The purpose of this study is to find out whether giving an even higher dose (a "boost" dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure the cancer or prevent it from coming back for a longer period of time while causing few side effects.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:

  * PSA 10-20 ng/ml or
  * Gleason score = 7 or
  * Clinical stage T2b/T2c or
* Additionally, patients will be required to meet all of the following criteria:

  * Age ≥ 18
  * Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1)
  * Prostate size ≤ 80 cc
  * Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus
  * MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
  * International Prostate Symptom Score ≤ 15
  * Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Exclusion Criteria:

Patient will be excluded if they meet any one of the following criteria:

* Gleason score \>7
* PSA \>20
* Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE
* MRI findings: \>2 disease foci identifiable
* Evidence of metastatic disease on bone scan or MRI/CT
* MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.
* Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
* Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
* Contra-indications to receiving gadolinium contrast
* KPS \< 80
* Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
* Prior history of transurethral resection of the prostate
* Prior history of urethral stricture
* Prior history of pelvic irradiation
* History of inflammatory bowel disease
* Unable to give informed consent
* Unable to complete quality of life questionnaires
* Abnormal complete blood count, including any of the following:

  * Platelet count less than 75,000/ml
  * Hb level less than 10 gm/dl
  * WBC less than 3.5/ml
* Abnormal renal function tests (creatinine \> 1.5)
Lateral Arm Free Flap: a Useful Flap in the Maxillo-facial Surgeon's Therapeutic Armory, Case Series

Lateral arm free flap harvesting has been well described, it however remains underused compared to other free flaps such as radial forearm and anterolateral thigh free flap. Due to its easy harvesting, low donor site morbidity, versatility as well as useful possibilities of modifications it should be considered more often as valuable reconstruction option in head and neck defect. With this publication we want to describe the operative technique, illustrate it with postoperative pictures and describe the outcome with 8 of our cases operated at University Hospital In Lausanne, Switzerland.

The aim of this study is to be a useful tool for young surgeons and demonstrate the advantages of this useful flap in head and neck reconstructions.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* operated between 01 january 2021 and 12 december 2022
* lateral arm free flap operation for primary or secondary cervicofacial reconstruction
* written informed consent

Exclusion Criteria:

* minor patients
* no written informed consent
Innovative Biotechnological Production of Antioxidant Products

Several natural compounds have been explored as immune-boosting, antioxidant, and anti-inflammatory dietary supplements. Amongst them, hydroxytyrosol a natural antioxidant found in olive products, and endemic medicinal plants have attracted the scientific's community and industry's interest. The safety and biological activity of a standardised supplement containing 10 mg of hydroxytyrosol synthesized using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum in an open-label, single-arm, prospective clinical study were studied. The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks.

The study was designed to evaluate the safety and biological activity of the supplement Antiox-Plus: one capsule/day, 15 minutes before their main meal which contained 10 mg of HT, synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from Origanum vulgare, Sage officinalis and Crithmum maritimum. The volunteers will consume the supplement for 8 weeks. A follow-up analysis will be performed one month after the end of the supplementation period (12 weeks from the initiation of the study). During this time, the participants will consume a placebo.

The volunteers are instructed to maintain their normal dietary habits. The following measurements will be taken: A) Dietary assessment at the beginning of the study (week 0), B) Body composition analysis at the beginning (week 0) and the end of the study (week 8), C) biochemical and laboratory analysis of plasma samples at week 0, 8 and 12.

The volunteers will record their food intake for 3 days (including one day of the weekend) and will fulfil a food frequency questionnaire. Analysis of their data will be done by a certified nutritionist. Nutritional assessment will be performed using the Evexis dietary software. The Tanita Dual Frequency Body Composition Monitor "Innerscan" will be employed to measure weight, muscle mass, muscle quality score, heart rate, body fat (%), physique rating, visceral fat, metabolic age, basal metabolic rate, bone mass, body water (%) and body mass index (BMI) in the morning. Physical activity will be assessed by the Greek version of the short International Physical Activity Questionnaire (IPAQ-short).

Eligibility Criteria:
Inclusion Criteria:

* age between 25 and 65 years
* the absence of any chronic health conditions
* adequate understanding of the study

Exclusion Criteria:

* the presence of any chronic health conditions (diabetes, hypertension, dyslipidemia)
* intake of nutritional supplements over the past 60 days
* heavy smokers (≥25 cigarettes/day)
* high alcohol use (men \>14 drinks/week, women \>7 drinks/week)
Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery

The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Aged 18-35
* Symmetrical Class 2 Position B according to Winter and Pell-gregory classification
* Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index

Exclusion Criteria:

* Individuals who had systemic disease affecting bone or soft tissue metabolism
* Smokers (more than 10 cigarettes a day
* Alcohol dependent
* Systemic disease affecting bone or soft tissue metabolism
* Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection
Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects

Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate.

We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen.

Current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.

The study subject will have a brief trans-abdominal ultrasound examination.

3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes will be placed into the vagina.

It is anticipated that 6 months will be required to recruit, consent and study 25 participants.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 36 weeks pregnant
* Singleton fetus

Exclusion Criteria:

* Prisoners
A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury

To explore the cerebral protective effect of midazolam in patients with traumatic brain injury, we will collect blood samples from patients treated with or without midazolam when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h， 48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral metabolism and inflammatory response will be obtained from the blood samples or the cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical outcome and cerebral metabolism and inflammatory response will be detected with statistical method.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older;
* Hospitalized in ICU within 6 hours after the injury or after the operation;
* Traumatic brain injury is confirmed by computed tomography scan or magnetic resonance imaging, Glasgow Coma Scale is 3 to 12, and the patient should meet the diagnostic standard of severe traumatic brain injury;
* Informed consent is obtained.

Exclusion Criteria:

* Aged less than 18;
* Death is expected in 24 hours;
* History of neurological disease or history of drug abuse which may affect the outcome of the study;
* Failed to obtain Informed consent.
A Pilot Trial of Mindfulness-Based Resilience Training Among Police Officers

Successful policing requires rapid and unbiased decision-making, well-developed emotion regulation skills, and psychological resilience. However, law enforcement officers (LEOs) are frequently exposed to intensive work-related stress and trauma, and consequently, are at elevated risk of adverse mental health outcomes. These mental health issues in turn are some of the primary mechanisms underlying other- and self-directed violence among LEOs. The excessive use of force by LEOs, including unjustified shootings, frequently captures national headlines and is considered by many to be one of the most serious and divisive human rights issues in the United States. Previous research suggests that LEOs can be impacted by various factors when making rapid decisions while using firearms, including a lack of careful consideration of contextual factors and unconscious racial stereotypes. This is especially true when their cognitive and emotional resources are compromised due to factors such as stress. Similarly, key precursors to suicide among LEOs include chronic stress, exposure to trauma, alcohol misuse, and depression. The substantial personal, social, and economic costs of LEO stress, including unjustified shootings and suicide, suggest a clear need for innovative and novel prevention programs to promote well-being and reduce violence. Given its demonstrated impact on many of the precursors to self- and other-directed violence among LEOs, one possible approach is an adapted Mindfulness-Based Stress-Reduction (MBSR) program, developed specifically for LEOs. Therefore, the primary objectives of this proposal are to: (1) assess the feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments, and (2) determine the impact of an adapted MBSR program (Mindfulness-Based Resilience Training; MBRT) on precursors to other- and self-directed violence, and in promoting psychological resilience and emotion regulation among LEOs. There is promising preliminary evidence suggesting that mindfulness is an effective strategy for LEOs to decrease stress and its negative outcomes, enhance resilience and emotion regulation, and ultimately reduce other- and self-directed violence. The proposed project will test the impact of MBRT using a pilot feasibility randomized controlled trial (RCT). This research will generate important information on the feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments, and data obtained through the proposed study will build on the investigators existing work to provide support for a larger RCT examining the efficacy of MBRT in reducing violence.


Eligibility Criteria:
Inclusion Criteria:

* full-time, active status, sworn-in law enforcement officers in the Portland Metro area

Exclusion Criteria:

* previously completed MBRT or MBSR course
Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)

This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.

The duration of treatment is 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients who do not meet specific cholesterol levels as required by the study
reGional Network for Acute Myocardial Infarction

Incidence of ST-segment Elevation Myocardial Infarction (STEMI) is rising and the existing emergency medical aid system for STEMI was not enough for timely perfusion treatment. No existing research with high-quality data focuses on the characteristic of STEMI incidence and regional network construction. Aiming of Guangdong GAMI(reGional network for Acute Myocardial Infarction) project is to establish effective collaborative regional network system for STEMI patients treatment.

The project of Guangdong GAMI(reGional network for Acute Myocardial Infarction) is being conducted during 2015-2019 in eight districts with diverse economic development across southern China (Integrated care model was conducted in four regions, which mainly included community public education, non primary-PCI capable centre and referral system improvement, and inhospital green-channal optimization for primary-PCI capable centre. Other four centers were underwent usual care of acute myocardial infacrtion public and medical health service). All the ST-segment elevation myocardial infarction (STEMI) patients admitted in the hospital within 30 days from the symptom onset were enrolled. The key data of the timeline of STEMI onset and treatment were precisely recorded. Other details of STEMI treatment in hospitals such as laboratory data and medication were also collected. During the research period, actions of both optimizing the regional STEMI patients transfer and treatment to shorten the medical delay, as well as educating the public to improve their awareness of early treatment of STEMI were taken meanwhile. In addition, laboratory data, medication, and follow-up information were recorded in a database for further analysis regarding the STEMI patient treatment.

Eligibility Criteria:
Inclusion Criteria:

All adult patients who suspected diagnosis with STEMI.

Exclusion Criteria:

1. patients refused to undergo coronary angiography;
2. patients were confirmed as non-STEMI by coronary angiography or the course of STEMI over 1 month;
3. patients occurred onset STEMI during hospitalization in hospitals
Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers

To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy male or female volunteer aged 18-55 years inclusive
* Subject has a Body Mass Index (BMI) of 18.0 - 30.0 kg/m\^2 and a weight of at least 50 kg (males) or 45 kg (females)
* Subject has normal vital signs values, Electrocardiograms (ECGs) and clinical laboratory values
* Female subjects should have a negative pregnancy test or be of non-childbearing potential

Exclusion Criteria:

* Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
* Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
* Subject has an intolerance or allergy against the compound or related drugs
Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients

Hospital-acquired venous thromboembolism (HA-VTE) is one of the leading preventable causes of in-hospital mortality, but prevention of VTE in hospitalized medical patients remains challenging, as preventive measures such as pharmacological thromboprophylaxis (TPX) need to be tailored to individual thrombotic risk.

The broad objective of this project is to improve VTE prevention strategies in hospitalized medical patients by prospectively examining VTE risk factors (including mobility) and comparing existing risk assessment models.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Admitted for hospitalization \>24 hours on a general internal medicine ward
* Informed consent as documented by signature

Exclusion Criteria:

* Need for therapeutic anticoagulation (e.g., atrial fibrillation)
* Life expectancy \<30 days
* Insufficient proficiency of the German or French language
* Unwilling to provide informed consent
* Prior enrolment in the study
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)

The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.

The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.


Eligibility Criteria:
Inclusion Criteria - at screening:

* Has the patient given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject.
* Is the subject 18 years of age or above?
* Is the subject scheduled for elective resection of the rectum?
* Is a colorectal anastomosis below the peritoneal reflexion planned?

For females of childbearing potential:

* Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?
* Is the blood or urine pregnancy test negative?

Exclusion Criteria -at screening:

* Is the subject scheduled for emergency resection of the rectum?
* Does the subject suffer from inflammatory bowel diseases?
* Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
* Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
* Does the subject participate or plan to participate in another clinical trial during the trial period?

For females of childbearing potential:

• Is the subject pregnant or breast feeding?

Exclusion - peroperative

* Was an anastomosis performed differently from what was defined in the inclusion criteria?
* Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?