cyrilzakka/clinical-trials huggingface dataset:
A Study of AMG 337 in Subjects With Advanced Solid Tumors

First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years old
* Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
* Subjects with primary central nervous system (CNS) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up MRI shows no new lesions appearing
* Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Competent to sign and date an Institutional Review Board approved informed consent form
* Adequate hematologic and renal function as determined by laboratory blood and urine tests

Exclusion Criteria:

* Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug.
* Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
* History of bleeding diathesis
* Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension
* A baseline ECG QTc \> 470 ms
* Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
* Significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption
* Known positive test for HIV
* Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
* Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
* Major surgery within 30 days of study day 1
* Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor
A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer

This is a single-center phase II study designed to evaluated the efficacy and safety of fulvestrant in combination with oral vinorelbine in hormone receptor-positive advanced breast cancer

This is a single-group, single-center phase II trial. Patients with hormone-receptor-positive, Her2-negative recurrent or metastatic breast cancer who had not previously received any systemic antitumor therapy for advanced disease were treated with fulvestrant combined with oral vinorelbine as a first-line regimen. Key issues to be addressed in this study: to observe and evaluate the efficacy and safety of fulvestrant combined with oral vinorelbine in the treatment of hormone-receptor-positive and HER2-negative advanced breast cancer. Thirty patients are planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; Hormone receptor-positive
* ECOG score: 0-1, expected survival time ≥ 3months;
* Recurrence after adjuvant therapy or metastatic breast cancer and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer.
* Patients must have measurable disease according to RECIST criteria Version 1.1. Bone metastases lesions were excluded.
* The patients have adequate hematologic and organ function.

Exclusion Criteria:

* Patients with symptomatic brain metastases.
* Patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug.
* Received ≥1 standard chemotherapy regimen (excluding endocrine therapy) for advanced breast cancer.
* Participation in other clinical trials within 4 weeks before enrollment.
* Severe cardiovascular disease, including history of congestive heart failure, acute myocardial infarction within 6 months before enrollment, transmural myocardial infarction measured by ECG, uncontrolled arrhythmia, angina requiring therapy, clinically significant valvular heart disease, uncontrolled hypertension.
* Severe or uncontrolled infection.
* Any factors that affect the oral administration and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
* Active malignancy in the past 5 years (other than carcinoma in situ of the cervix or basal cell carcinoma of the skin).
* Patients who are pregnant , breastfeeding ,or refuse to use adequate contraception during the course of participation.
* Need to concurrent other cancer therapy(other than palliative care for non-target lesions).
* Other ineligible conditions according to the researcher's judgment.
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries

Post-operative, throat pain, nausea and vomiting is a common occurrence in rhinology surgeries due to the use of throat packs during the procedure. In order to optimize quality of care and patient satisfaction, the aim of this study to evaluate the incidence of post-operative, throat pain, nausea and vomiting in patients that have been packed with either conventional gauze throat packs or pharyngeal tampons.

The nose and para nasal sinuses are anatomically known to be highly vascular and a substantial amount of bleeding is expected from rhinology surgeries, ingested blood is known to be a power full emetic, and the risk aspiration of blood is present due to the fact that an endotracheal tube is not 100% effective in protecting the airway. Post-operative nausea and vomiting is a frequent problem that is encountered in surgical patients with a 4th to 6th fold increase in nasal and endoscopic sinus operations.

Posterior throat pack is an often-used in rhinology surgery, it is said to help in protecting the air way against aspiration and also helps in the reduction of post-operative nausea and vomiting, however many studies concluded that posterior throat pack is associated with higher amount of post-operative pain, nausea,, vomiting and in some rare cases even forgotten in the patient leading to mortality. However, despite poor evidence the placement of posterior throat packs is commonly practiced by surgeons and anesthetists because the possible risk of aspiration is worrisome to the latter and the former.

A conventional throat pack consists of gauze, but an alternative practice involves the pharyngeal placement of tampons. In Marais and Prescott posterior pharyngeal placement of tampons is associated with a decrease amount of post-operative throat pain, when compared to conventional gauze throat packs, however they did not compare the incidence of post-operative nausea and vomiting in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients ( above the age of 18 years)
* Admitted under Dr. Hiba Al-Reefy
* Underwent a rhinology procedure that required the use of a throat pack

Exclusion Criteria:

* Pediatric patients
* Pt who underwent a procedure without the use of throat packs
The Effect of Probiotics (L. Helveticus, B. Longum, and B. Bifidum) on Immune Function and Digestive Health

The purpose of this study is to determine if daily consumption of a probiotic in the period before, during and after academic exams will help maintain digestive and immune health and quality of life of undergraduate students.

A randomized, double-blinded, placebo-controlled trial will be used. Healthy full-time undergraduate students will be recruited from the University of Florida via flyers, emails, announcements, etc. Informed consent will be obtained and the inclusion/exclusion criteria will be reviewed to determine whether a participant qualifies for the study. All participants will be consented for the main six-week intervention and a subgroup (n=50/group) of these students will be consented to provide two stool samples.

Participants will provide saliva and stool samples (for the sub-group)during the pre-baseline week and during the week of final exams at approximately week 4. At the randomization visit, height, weight and age will be obtained. Participants will be stratified based on body mass index and randomized via sealed envelopes to one of four groups: Lactobacillus helveticus, Bifidobacterium longum ssp. Infantis, Bifidobacterium bifidum or the placebo (n=145/group). Participants will take the study provided capsule of probiotic or placebo daily for 6 weeks. Participants will receive daily questionnaires via email throughout the prebaseline week and the 6-week intervention. Daily questionnaires will ask about intake of the supplement, cold symptoms, and general health (i.e., new medications, doctor visits). Throughout the study, participants will also be asked to complete weekly questionnaires (inquiring about gastrointestinal symptoms and physical activity) and Quality of Life Questionnaires (administered during pre-baseline, final exam week and week 6 of the study).

Eligibility Criteria:
Inclusion Criteria:

To participate in the study you must:

* be 18 years of age or older.
* be a healthy full-time undergraduate at the University of Florida.
* be willing to complete daily questionnaires form via computer.
* be willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, echinacea, fish oil, vitamin E \>400% of the RDA or \>60 mg/day).
* be willing to take the probiotic capsule daily of 6 weeks.
* have had at least one cold in the last 12 months.
* have at least 1 final during the scheduled exam week.
* have daily access to the Internet.

Exclusion Criteria:

To participate in the study you must NOT:

* be a current smoker.
* have chronic allergies involving the upper respiratory tract.
* have had immunosuppressive illness or treatment within the last year.
* have received antibiotic therapy in the past two months.
USG CMBB DSA Study

Injections that freeze neck joints can be done using x-rays or ultrasound imaging, which as a newer way of guiding the needle to the right spot. This study will look at how often freezing liquid goes into a blood vessel during neck injections that freeze neck joints when ultrasound guidance is used to place the needle. When this happens, it can go undetected because it does not make the patient feel any different, however it could cause a test block to be falsely negative, leading to the wrong diagnosis. Based on previous studies, we think that this happens rarely, and the purpose of this study is to prove that conclusively

Cervical medial branch blocks (CMBB) are commonly employed for the diagnosis and management of facet-related pain. The latter constitutes the most important cause of axial neck pain and has been implicated in 40% of all cases. In addition, the upper cervical joints can also cause cervicogenic headaches, an often-debilitating condition representing up to 20% of chronic headaches3. Well-defined pain referral patterns for each joint can help operators select the appropriate injection level. While fluoroscopy has long been the imaging standard for spinal procedures, ultrasound guidance (USG) is being increasingly adopted as an alternative and presents several advantages such as the ability to identify and avoid soft tissue structures such as blood vessels during needle insertion. From a clinical perspective, avoiding blood vessels and reducing the incidence of vascular breach can lessen the occurrence of intravascular injections that are associated with false negative diagnostic blocks. Indeed, a recent study examining the safety of USG CMBB reported a lower incidence of vascular breach than previous studies that had used fluoroscopic guidance. While these findings suggested a potential benefit associated with USG, further confirmatory studies employing digital subtraction angiography (DSA), the current imaging standard to detect intravascular spread, are required. We hypothesize that USG will be associated will a lower incidence of intravascular spread during primary needle placement than has been reported with fluoroscopic guidance.

Eligibility Criteria:
Inclusion Criteria:

Consenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care.

Exclusion Criteria:

Subjects with one or more of the following characteristics will be excluded from the study:

Known bleeding disorder or coagulopathy Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents) Inability to visualize targeted structures on ultrasound Known allergy to contrast agents
Evaluating Overcoming Anxiety in Pregnancy and Postpartum as an Online Self-Directed Program

The pregnancy and postpartum periods can be joyous times in life; however, they can also be filled with challenging physical, emotional, and lifestyle changes. These changes may lead to feelings of stress, anxiety, and depression amongst new and expecting mothers, which can have negative effects on fetal and infant development (Beijers et al., 2010; Goodman et al., 2016). The impacts of increased worry about health and safety due to COVID-19 as well as future-related uncertainties, paired with social (physical) distancing, may be felt especially strongly in this population. Of concern, pregnant and postpartum women have low rates of mental health service use even prior to the pandemic (Fonseca et al., 2015). E-health (Internet) and m-health (mobile application) psychological interventions are accessible, available at reduced cost, and can be accessed within users' homes, a factor that is particularly important during the pandemic (Andrews \& Titov, 2010). In this study, the investigators will disseminate a free, online, self-directed Cognitive Behavioural Therapy program to women experiencing symptoms of anxiety during pregnancy and postpartum. This program has shown to be effective at improving symptoms of anxiety and depression when delivered in an in-person group format, and has high acceptability (Furer \& Reynolds, 2015). The investigators will transfer this program into an online format so that pregnant and postpartum users can navigate the sessions on their own, without the support of a clinician. This program contains six modules which include topics such as coping with negative thoughts, unpacking the myth of the supermom, and managing expectations during pregnancy and postpartum. Additionally, material related to COVID-19 has been added to the program to target any pandemic-related stress participants may be experiencing. The investigators will collect information about the program's feasibility, acceptability, and effectiveness, which will inform future improvements to the program. This program is expected to reduce participants' feelings of stress, anxiety, and depression, in addition to improving maternal attachment. It is anticipated that these gains will be maintained when the investigators follow-up with participants one month after program completion. This program has the potential to provide accessible and affordable mental health services to pregnant and postpartum women struggling during the pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant or within 12 months postpartum
* Age 18 or older
* Experiencing symptoms of anxiety
* Have access to a computer, tablet, or smartphone
* Have access to the Internet
* Speak English
* Manitoba resident
* Willing to provide their name, email address, home address, and phone number

Exclusion Criteria:

* Current substance use disorder
* Diagnoses of bipolar disorder or schizophrenia
* Current suicidality
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This study will assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Eligibility Criteria:
Inclusion Criteria:

* Man ≥ 18 years
* Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
* Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.

Exclusion Criteria:

* Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
* Scheduled for bilateral inguinal herniorrhaphy.
* Undergone a prior herniorrhaphy on the side scheduled for repair.
* Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
* Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
* Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
* Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.
Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients

Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.

This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves echocardiographic and clinical outcomes among HF patients with a CRT device implanted for standard indications. All patients will have measurement of electrocardiograms at a range of device settings. Patients will be randomized in a 1:1 ratio to either the active comparator arm (standard CRT programming), or the experimental arm (CRT device programmed by the information obtained by ECGs). Standard CRT programming used in this study is simultaneous biventricular (BiV) pacing with a fixed atrioventricular delay. At 6 months, control patients who were initially randomized to standard programming will have programming changed based on the ECG optimization information. Patients will be blinded to randomization. Change of LV size and function will be performed prior to randomization, and again \~6 and \~12 months following CRT implant in both subgroups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
2. Age greater than or equal 18 years
3. Pre-CRT EF less than or equal 40%
4. Patients will be receiving or have received a first-time CRT device for standard clinical indications within \~2 months of study enrollment
5. Adequate echocardiographic images for LV EF and LV ESV determination
6. On optimal medical therapy

Exclusion Criteria:

1. Patients who are pregnant or may become pregnant
2. Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
3. Patient has a His Bundle pacing lead
4. Patient has right bundle branch block (RBBB)
5. Patient is enrolled in concurrent research study that would potentially confound the results of this study
6. Premature ventricular contraction (PVC) burden greater than or equal to 10%
COVID-19 and Multiple Sclerosis Disease Modifying Therapies

The COVID-19 pandemic is a major concern for people on long-term treatments that modify the immune system function. People with multiple sclerosis (pwMS) form a large group who receive such treatments called disease modifying therapies (DMTs). Several types of DMTs with different effects on the immune system are being used for multiple sclerosis (MS). In the absence of large-scale national studies, the risk of COVID-19 among pwMS on various DMTs has not been established.

A few physician-reported registry-based studies have suggested that anti-CD20 monoclonal antibodies, such as ocrelizumab and rituximab, used in the treatment of MS can increase the risk of COVID-19. However, in our community-based COVID-19 study of a large cohort of pwMS as part of the UK MS Register, we could not demonstrate an association between DMTs and susceptibility to COVID-19. Other studies have not found any relationship between DMTs and the outcome of COVID-19 among pwMS.

To our knowledge, UK is the only country in the world that collects national data on DMT use, providing us with the opportunity to investigate the impact of DMTs on COVID-19 susceptibility and severity in a large population of pwMS. In England, no DMT is being dispensed without prior approval and specialised commissioning by the national Health Services (NHS) England \& NHS Improvement (NHSE/I). The scheme, currently implemented in over 100 NHS Trusts in England, ensures that treatment decisions are made in line with agreed commissioning policy and are evidence-based. NHSE/I also has access to Public Health England (PHE) held data on all people who have had a SARS-CoV-2 test. By identifying all pwMS on DMTs and all those who have had a test for coronavirus and collecting data on the clinical outcome of their COVID-19 from their local NHS hospitals, we would be able to establish the risk of COVID-19 and the risk of contracting the infection associated with different DMTs. The findings of the study will help MS clinical teams address the concerns of pwMS about taking DMTs during the COVID-19 pandemic and update their guidelines on the measures pwMS need to take during these unprecedented times.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Diagnosed with MS
* Received treatment with a DMT

Exclusion Criteria:

* Not fulfilling the inclusion criteria