cyrilzakka/clinical-trials huggingface dataset:
Mirdametinib + BGB-3245 in Advanced Solid Tumors

A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.


Eligibility Criteria:
Key Inclusion Criteria:

* Able to provide informed consent
* At least 18 years of age on day of signing ICF
* Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated.
* Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway
* Part 2: oncogenic mutation or genomic aberration defined below:

  * Cohort A: cutaneous melanoma harboring NRAS mutations.
  * Cohort B: non-small cell lung cancer (NSCLC) harboring a KRAS mutation.
  * Cohort C: NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutations or BRAF Fusion mutation.
* Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
* Measurable disease per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Adequate organ function and no transfusion within 14 days of first dose

Key Exclusion Criteria:

* Central Nervous System metastases, leptomeningeal carcinomatosis or untreated spinal cord compression
* History of glaucoma
* Active parathyroid disorder or history of malignancy associated hypercalcemia
* Clinically significant cardiac disease within the past 6 months of signing ICF
* History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these agents
* Severe or uncontrolled systemic disease
* Inability to swallow oral medications
* Clinically significant active infection (HIV, Hepatitis B or Hepatitis C)
* History of or ongoing Immune Thrombocytopenia (ITP), Von Willebrand disease and/or other past or present bleeding disorders
* Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
* Systemic anti-cancer therapy within 2 weeks or 5 half-lives before first dose
* Concomitant systemic or glucocorticoid therapy within 2 weeks before first dose
* Concomitant medicines that are strong CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives before first dose
* Live vaccine within 4 weeks before first dose
Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients

PICOTS:

P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations.

T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer


Eligibility Criteria:
Inclusion Criteria:

* Bilateral class I carious lesions in their occlusal pits and fissures.
* High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA)
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Disabilities.
* Systemic diseases or severe medically compromised.
* Lack of compliance.
* Evidence of severe bruxism, clenching or temporomandibular joint disorders
Alpha as a Predictive Biomarker

The investigators will use non-invasive recordings of brain activity to measure pain as a proxy to self-report. Participants will undergo testing for about 3 hours on two separate days. The testing will involve experiencing painful heat.

Neurophysiological investigations of pain have suggested that electroencephalograph (EEG) measures of peak alpha frequency might provide a means of pain assessment. In healthy subjects, increased peak alpha frequency is strongly correlated with pain self-reports after exposure to acute noxious heat. Conversely, chronic pain patients compared to healthy control display decreased peak alpha frequencies higher in alpha power. Measures of peak alpha frequency also show a negative relationship with disease duration, suggesting that peak alpha frequency may not only index ongoing pain but also disease progression. The overall aim is to determine the predictive accuracy, reliability, and specificity of EEG alpha activity in acute pain and a model of neuropathic pain in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak, read, and write English
* Between 21 and 44 years of age
* Able to understand and willing to comply with all study procedures and is available for the duration of the study
* Free of an acute or chronic pain condition
* Not history of psychiatric or neurologic condition

Exclusion Criteria:

* Unable to undergo EEG, assessed on an individual basis
* History of unstable major psychiatric disorder (self-report)
* History of chronic pain (self-report)
* More than 14 alcoholic drinks per week on average (self-report)
* Active \[within 6 months\] substance or alcohol abuse (self-report and urine toxicology)
* Use of opioids (self-report and urine toxicology)
* History of major depressive disorder (self-report)
* Pregnant or Lactating (women only), based on (self-report and urine test)
* Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
* Uncontrolled (systolic blood pressure \> 175 mmHg or diastolic blood pressure \>105 mmHg) or unstable hypertension
Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

A study to determine the feasibility and safety of individualized cancer stem cell targeted therapy based on high-throughput functional profiling of FDA/EMA-approved drugs in patients with GBM that has recurred or progressed following standards-of-care (RT, TMZ).

This protocol describes a prospective single-center phase 1 study to evaluate the feasibility and safety of a high-throughput drug sensitivity and resistance testing (HTS) platform of individualized cancer stem cells (CSC) to predict targeted therapies in patients with recurrence of GBM after standards-of-care. Secondary outcome include efficacy of drug treatment. The underlying hypotheses is that treatment of patients based on functional profiling og autologous CSCs using HTS a) is feasible within an acceptable time window for clinical translation, b) safely delay disease progression and c) increase survival. There are increasingly published literature that strongly support the importance of a targeting CSC to improve therapy and prevent tumor recurrence in GBM, as an additional strategy to improve the overall prognosis of patients.

Eligibility Criteria:
Inclusion Criteria:

* Recurrence of histologically verified glioblastoma
* Adequate biopsy to generate enough live cells to allow functional screening
* Must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Must be 18 to 70 years of age
* Adequate bone marrow, liver and heart function
* Must be competent to give consent
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice guidelines (ICH GCP), and national/local regulations.

Exclusion Criteria:

* Patients taking part in other clinical trials which could make inclusion or follow-up difficult
* Any reason why, in the opinion of the investigator, the patient should not participate
Responses to E-Cigarette Advertising

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18 years of age, is especially alarming because it is not only a critical period in development but also a time when tobacco use is established. Additionally, the tobacco industry targets individuals of this age with the hope that they will one day progress to using combustible cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the Food and Drug Administration (FDA) now has the authority to regulate EC advertisement features. The goal of the study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most popular EC brands that employ a brand, product descriptions, and modeling features were selected. Young adults who are susceptible to EC use will come into the lab and view these ads. During exposure, they will be assessed for real-time visual attention using eye-tracking, orienting responses using heart rate, and arousal using skin conductance as well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral intentions. These factors will help determine the most high impact features, which will be associated with the greatest visual attention, orienting responses, and arousal levels and changes in attitudes. Findings from this study will provide public health officials important and urgently needed information as to what advertising features are contributing to the sharp rise in the use of ECs among young adults.


Eligibility Criteria:
Inclusion Criteria:

* 18-26 years old,
* Fluent in English,
* Biochemically confirmed abstinence combusted tobacco or marijuana (eCO: exhaled carbon monoxide \<6 parts per million) at time of visit
* Reporting never trying an e-cigarette, not even a puff OR reporting having used an e-cigarette in the past but has not used in the past 30 days
* Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire

Exclusion Criteria:

* Younger than 18 years or older than 26 years
* Not fluent in English
* Not confirmed abstinent of combusted tobacco or marijuana
* Use of an e-cigarette
* Not susceptible to e-cigarette use
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.

This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.

There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.

A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has Stage IV pancreatic cancer.
2. Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
3. Patient agrees not to obtain pain medications from other physicians during the study.
4. Patient is at least 22 years of age.
5. Investigator considers the patient to be able and willing to fulfill all study requirements.
6. Patient is able to understand the study and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
2. Patient is enrolled in another clinical study.
Clinical Trials Outreach & Education

The purpose of this study is to provide education and information about clinical trials and clinical trials participation. Investigators also aim to see if education makes a difference in increasing knowledge of clinical trials and clinical trials participation.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Able to provide informed consent
* Reside in the Tampa Bay Area (Hillsborough, Pinellas, Polk or Pasco county)
Effect of Different Obturation Techniques on Postoperative Pain

This study evaluated the postoperative pain after the endodontic treatment by using three different obturation techniques. ( Cold lateral condensation (CLC), thermoplasticized solid-core carrier method (GuttaCore) and cold free-flow compation tecnique ( GuttaFlow2))


Eligibility Criteria:
Inclusion Criteria:

1. Participants between 18 - 72 years of ages,

2 Good oral hygiene,

3. Have not taken any analgesic in the last 7 days,

4. Have not taken any antibiotics in the last 7 days,

5. Positive response to both cold test (EndoIce; Coltene/Whaledent Inc, Cuyahoga ),

6. Patients diagnosed with asymptomatic irreversible pulpitis with his/her single-rooted teeth caused by a deep carious lesion,

7. Patients have single-rooted teeth requiring endodontic treatment according to the pre-prosthetic reason,

8.The presence of profusely pulp bleeding with a thick consistency, which is exposed during caries removing.

9. The periapical region was healthy in radiographic diagnosis.

Exclusion Criteria:

1. Patients who refuse to participate in this study,
2. Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications),
3. Devital teeth that have no response to pulp test,
4. The presence of advanced periodontal disease (probing depth \> 4 mm),
5. The presence of open apex,
6. The presence of calcification,
7. The presence of resorption,
8. Patients who had multiple teeth requiring endodontic treatment,
9. Patients with allergic sensitivity to materials and agents that should be used during the root canal treatment,
10. Allergic sensitivity to local anesthetics,
11. Patients who had systemic or allergic sensitivity for the NSAIDs,
12. Pregnant participants or participants in the lactation period,
13. Teeth cannot be applied to a rubber-dam.
Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study

The purpose of this study is to explore the feasibility and efficacy of a 12-week, home-based exercise program in bladder cancer patients undergoing curative intent neoadjuvant chemotherapy and RC.

The investigators will seek to recruit 20 patients diagnosed with muscle invasive localized urothelial carcinoma of the bladder who are scheduled to receive neo-adjuvant chemotherapy prior to RC from the Queen Elizabeth Health Sciences center in Halifax, Nova Scotia. Participants will be randomly allocated to standard of care treatment versus standard of care plus a multimodal, home-based program including strength and endurance exercises. Outcomes measured will include feasibility data, patient outcomes, and post-surgical complications.

Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of localized muscle invasive urothelial carcinoma of the bladder (clinical stages cT2-4a, N0-1, M0);
2. treatment plan includes the administration of cisplatin-based systemic neoadjuvant chemotherapy prior to anticipated RC (typically four, 3-week cycles of cisplatin-based chemotherapy);
3. English fluency;
4. physician approval; and
5. participant willingness to participate in a 12-week, home-based exercise intervention.

Exclusion Criteria:

1. unstable or symptomatic cardiac or pulmonary disease, musculoskeletal injury or co-morbid disease that precludes ability to exercise; and
2. significant cognitive limitations.
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer

The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens.

This is a phase 2, open-label, multicenter study to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with HER2-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens.

Each treatment cycle will be 21 days in duration. During each 21-day cycle, participants who are eligible for participation will receive poziotinib orally once daily.

All treated participants will be followed up until disease progression, death, intolerable adverse events or up to a maximum of 24 months whichever comes earlier.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically confirmed primary breast cancer with metastatic lesions.
2. Confirmed HER2 overexpression or gene-amplified tumor
3. At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine
4. Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
5. Participant is at least 18, and ≤90 years of age.
6. Adequate hematologic, hepatic, and renal function
7. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2

Exclusion Criteria:

1. Previous treatment with poziotinib prior to study participation
2. Brain metastases that are symptomatic or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 15 days of enrollment.
3. Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or investigational treatment within 15 days, except for hormone therapy, palliative therapy, or supportive therapy.
4. History of congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
5. Cardiac ejection fraction \<50%
6. History of other malignancies within the last 5 years
7. Participant is pregnant or breast-feeding.
8. Unable to take drugs orally
Hospital Based Group Intervention for Breast Cancer Patients.

INCAM-study is a multicenter, prospective, randomized controlled trial. The aim of the study is to test the effectiveness of psychoeducative intervention when offered in hospital setting as a component of routine breast cancer care. The hypotheses are; - that breast cancer patients participating in psychoeducative interventions focusing on coping will experience better health-related quality of life than those who participate in the hospital standardised psychoeducative intervention. - that coping styles are associated with the immune system.

Women operated for breast cancer often experience psychosocial problems for several years. Although, meta-analyses have clearly demonstrated that the efficacy of psychosocial support groups, little is known about the effectiveness of this intervention when offered in the hospital setting as a component of routine breast cancer care.

A few studies have found that psychological intervention reduce emotional distress and enhance immune responses,but if there is an association between coping styles and immune system is not clear.

440 breast cancer patients at two Hospital will be randomized into the study. Both Hospital have standardised psychoeducative interventions as a component of routine breast cancer care. Both Hospital will have two groups, the standardised groups and the experimental groups. Participants will answer the same standardised questionnaires before surgery,2,6,12 months and 3 and 5 years after the interventions. Blood sample will be drawn at all assessments. The questionnaires are the Hospital Anxiety and Depression Scale, the Mini-mental Adjustment to Cancer Scale, the EORTC QLQ-BR32, the Life Orientation Test-Revised.

All groups are facilitated by two nurse specialists and follow a structured program. The standardised groups consists of three weekly 2-hours sessions and the experimental groups will consists of six weekly 2-hours session. The intervention protocol has been approved by the Norwegian Committee for medical research Ethics.

Knowledge from this study will be used to develop a manual for hospital based group interventions for breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

Verified breast cancer diagnosis Age 18 years or more but under 75 years -

Exclusion Criteria:

Diagnoses of metastatic breast cancer Do not read or write Norwegian Diagnoses of mental retardation, severe or untreated psychopathology, dementia Diagnoses of any immunologic condition or disease

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Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section

The purpose of this study is to determine if giving an injection of numbing medication at the incision at the end of cesarean will help control pain AFTER cesarean delivery. This study seeks to assess pain relief with incisional infiltration of local anesthetic during cesareans performed under spinal anesthesia also using intrathecal opioids. Participants will receive the usual regimen of pain medication in spinal anesthesia. At the end of the cesarean delivery, while the participants are still under the spinal medication, participants will receive an injection, at the incision, either numbing medication (with or without epinephrine) or sterile saline. After the cesarean delivery, participants will receive, by mouth, commonly prescribed pain medications - these medications are oxycodone (an opioid/ narcotic), acetaminophen (or more commonly known as Tylenol), and ibuprofen.

The study assesses addition of subcutaneous bupivacaine with and without epinephrine to the standard intrathecal morphine/fentanyl combination given during spinal anesthesia during elective cesarean delivery on postoperative pain control as measured by postoperative usage of oral opioids and a postoperative pain assessment scale. Comparing post-op pain scores and oxycodone usage in patients who receive just intrathecal morphine to patients who receive intrathecal morphine plus subcutaneous bupivacaine .25%, to patients who receive bupivacaine .25% with epinephrine 1:200,000.

After cesarean delivery, all groups will actively control the use of post-operative pain medication by indicating to the care nurse whether or not pain medication is desired. Pain control for all groups will be the standard pain treatment: ibuprofen for mild to moderate pain and percocet (oxycodone) for severe pain.

The U.S. Food and Drug Administration (FDA) has approved bupivicaine as an anesthetic and for pain but the FDA has not approved bupivicaine to be given specifically for postoperative cesarean pain. Acetaminophen, oxycodone and ibuprofen are being used as part of routine clinical care for pain control after cesarean. Fentanyl and duramorph are being used in spinal anesthesia and are FDA approved for regional anesthesia and used for this purpose in routine clinical care.

Eligibility Criteria:
Inclusion criteria:

* elective cesarean delivery
* planned spinal anesthesia

Exclusion criteria:

* Non-English speaking
* Urgent or emergent cesarean delivery
* Active labor \[defined as: \>4cm cervical dilation or regular contractions noted on tocometer (\>2 contractions in a 10 minute period for 30 consecutive minutes)\]
* Chronic antepartum opioid use
* History of substance abuse (alcohol or drug)
* Current tobacco use
* Chronic steroid use