cyrilzakka/clinical-trials huggingface dataset:
The SHARED, Project, Lung Cancer Screening for African American Men (AAM)

This study is a single-arm pre-test post-test design with a two-month follow-up assessment. The study aims to provide support to participants in quitting smoking and accessing lung cancer screening through the combination of education interventions and patient navigation (PN)

This study is a single-arm pre-test post-test design with a two-month follow-up assessment. The study aims to provide support to participants in quitting smoking and accessing lung cancer screening through the combination of education interventions and patient navigation (PN). After participant consent the study team will administer a series of surveys to collect the participant's contact information and complete the study's pretest measures. These include a demographic survey, smoking history, lung cancer knowledge, lung screening knowledge, intention to quit/screen, informed to decide, satisfaction survey, and decision conflict survey. The study also consists of three scheduled meetings with the PN lasting up to 60 minutes. The 1st session will be held between 7-14 days after consent. The 2nd session will be held 7-14 after the 1st session and the 3rd session will be held 42-49 days after the 1st session. Additional phone calls will last 10 minutes or less and be focused on specific questions generated by study participants.

In the 1st session the PN will re-orient participant to the goals and objectives of the project and answer participant questions before starting the intervention. The 1st activity will be to show a 3 minute culturally tailored video that will explain the benefits of lung cancer screening for African American Males (AAM) using an internet-enabled device. After completion of the video, the PN will invite the participant to ask any questions that they have and the PN will offer clarifying information. The PN will review with the participant a culturally adapted shared decision-making tool. The participant will complete the posttest surveys as described abov.

In the 2nd session the PN will determine the scheduling and completion of lung cancer screening and Illinois Tobacco Quit Line (ITQL) engagement. The participant will complete the LDCT screening, navigation needs, Quitline Engagement, and decision change surveys

In the 3rd session the PN will determine scheduling, barriers and completion of lung cancer screening and Quitline engagement. The participant will complete LDCT screening check, and a Quitline engagement check

Eligibility Criteria:
Inclusion Criteria:

1. Self-identify as African American or Black males
2. Current smokers of any nicotine-containing products
3. Do not self-report a history of lung cancer symptoms
4. Speaks English

Exclusion Criteria:

1. Do not self-identify as African American males
2. Former smokers
3. Self-report a history of lung cancer symptoms
4. Do not speak English
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois

This study will help determine the relationship between impaired sleep and chronic kidney disease, specifically to determine if sleep disturbances are a risk factor for worsening kidney function.


Eligibility Criteria:
Inclusion Criteria:

* CKD subjects will be participants in a larger study, CRIC, at the University of Illinois, Chicago
* 30 Healthy controls age and gender matched to 30 CKD subjects, regular bedtimes of at least 6h/night, sedentary lifestyle

Exclusion Criteria:

* Diabetes
* Current or previous dialysis for more than 1 month
* Uncontrolled hypertension
* Heart failure
* Liver disease
* HIV
* Hemoglobin \< 10.5 g/dl
* Treatment with EProcrit, Epogen, or Aranesp
* Bone or organ transplant,
* Use of immunosuppressive drugs within past 6 months
* Current oral contraceptive use
* Current pregnancy
* Chemotherapy for malignancy within past 2 years
Cardiovascular Events in Chronic Obstructive Pulmonary Disease Patients Initiating Olodaterol or Other Long-acting beta2 Agonists

Examine the risk of cardiovascular events (cardiac arrhythmia or myocardial ischemia) or all-cause mortality in Chronic Obstructive Pulmonary Disease (COPD) patients who are new users of Olodaterol or other LABAs available for the treatment of COPD.

Purpose:

Time Perspective:

Eligibility Criteria:
Inclusion criteria:

* COPD diagnosis
* aged 40 years or older (to minimise the likelihood of including individuals who have asthma only)
* New user of olodaterol or a new user of indacaterol, salmeterol, or formoterol (not in fixed-dose combination with an inhaled corticosteroid) and have no dispensing of any LABA in the 6 months before the index date
* at least 1 year of enrolment in the electronic database before their first LABA dispensing (defined as the index LABA)
* Complete data on sex

Exclusion criteria:

none
Scapular Stabilization Exercises on the Clavicular Movement

This study was planned to indicate efficiacy of the scapular stabilization exercises on the clavicula movements.

All subjects in the study were evaluated for range of motion (Goniometer), muscle strength (Manuel Muscle Strength Test), angular displacements of clavicula during abduction and skapular plan elevation of arm (Video Analysis Method), disability of the arm (Quıck Dash Turkish). The study was applied in two groups for three times per week during 8 weeeks.

Eligibility Criteria:
Inclusion Criteria:

* Having no ınjury for lower anda upper extremites

Exclusion Criteria:

* Having ınjury for lower anda upper extremites
Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.

OBJECTIVES:

* Assess the antitumor activity of pyrazoloacridine (PZA) in chemotherapy naive patients with metastatic cutaneous or ocular melanoma.
* Determine the toxic effects of PZA in this patient population.
* Determine the pharmacokinetic profile of PZA in these patients.

OUTLINE: Patients are stratified into cutaneous or ocular melanoma treatment groups.

Patients receive pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 28-70 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive
* Bidimensionally measurable disease
* No pleural effusions or ascites
* No untreated CNS metastases
* Stable brain metastases by CT or MRI scan

  * At least 4 weeks since prior steroid therapy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* WBC at least 4,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases)

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active infection
* No known hypersensitivity to E.coli derived proteins
* No other serious medical problems
* No more than 1 primary malignancy within past 5 years, other than:

  * Nonmelanomatous skin cancer
  * Carcinoma in situ of the cervix
* No history of spinal cord compression

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy)

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed
* No other prior radiotherapy

Surgery:

* At least 2 weeks since prior surgery and recovered
Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe

The coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents.

In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases.

In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs.

Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Patients fitting classification criteria for each IMID (i.e., Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, axial spondyloarthritis or giant cell arteritis);
* Willingness to participate;
* There are no specific inclusion criteria based on IMID previous activity, treatment or known COVID-19.

Exclusion Criteria:

* Patients who refuse to participate;
* Patients who don't speak or read the local language,
* Patients unable to perform a routine blood collection during the study period
Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers

This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women ages 18 to 65 years inclusive
2. Body mass index between 18.0 kg/m\^2 and 30.0 kg/m\^2, inclusive

Exclusion Criteria:

1. Pregnant or breast-feeding women
2. Any clinically significant abnormalities observed during screening (day -21 to day -2)
3. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen, and/or positive hepatitis C antibody at the screening visit
4. History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
5. Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
6. Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
7. History of a hypersensitivity reaction to doxycycline or similar compound
8. Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
9. Previous adverse experience to any biological investigational or therapeutic agent
10. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
A Study of Nemtabrutinib (MK-1026) in China Participants With Relapsed or Refractory Hematologic Malignancies (MK-1026-005)

The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of oral nemtabrutinib in Chinese participants at least 18 years of age who have Relapsed/Refractory hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory participants with a diagnosis of B-cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) or Waldenström's Macroglobulinemia (WM) who have received no more than 4 prior standard systemic therapies. Participants must have failed or are intolerant to standard therapies and cannot be a candidate for standard salvage regimens and those with low grade lymphoma must be progressing and requiring treatment
* Must have received prior systemic treatment before joining this study
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* HBV/HCV viral load undetectable or no history of HBV/HCV
* Has adequate organ function
* Male participants agree to be abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 30 days after the last dose of the study intervention
* Female participant is not a Women of Child Bearing Potential (WOCBP) or is a WOCBP using contraception during the intervention period and for at least 30 days after the last dose of the study intervention

Exclusion Criteria:

* Has a history of prior cancer within \<3 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas
* Has active primary tumor involvement of central nervous system (CNS) disease
* Has an active infection requiring systemic therapy
* Has a known history of Human Immunodeficiency Virus (HIV) infection
* Has an uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness
* Had immunotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product ≤4 weeks prior to treatment initiation
* Has any clinically significant gastrointestinal abnormalities that might alter absorption
Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion.

This trial did not recruit patients in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)
* Performance status 0-2 (Eastern Cooperative Oncology Group)
* Patients without severe osteoporosis at study entry
* No evidence of relapse at the time of randomization
* Adequate function of bone marrow, kidney, and liver

Exclusion Criteria:

* Estrogen- and progesterone-receptor status negative or unknown
* Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
* Inflammatory breast cancer
* Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery
* History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
* Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)
* Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.
* Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.

Additional protocol defined inclusion/exclusion criteria may apply.
Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine

Migraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients' reasons for making/not making the appointment.


Eligibility Criteria:
Inclusion Criteria:

* Migraine diagnosis age 16+
* English speaking

Exclusion Criteria:

* Unable to read the questionnaire, no phone number
Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery

Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, greater than 18 years of age
* ASA Class I or II
* Ability to take oral medication in order to assess the patient's opioid regimen postoperatively
* Forefoot surgery, including bunionectomy +/- digital surgery
* For females of reproductive potential: hCG levels will be determined during the pre-operative period. Females of childbearing age require a hCG level below 5mIU/mL in order to participate in the study. hCG levels above 25 mIU/mL is considered positive for pregnancy and, as a result, the patient will not be considered eligible for inclusion in the study

Exclusion Criteria:

* Chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week
* Prescription for SSRIs, gabapentin, duloxetine within 3 days of surgery
* Systemic glucocorticoids within 1 month of study enrollment
* History of hepatitis
* History of peripheral vascular disease
* History of diabetes mellitus type 1 or 2
* Pregnancy or lactation
* Allergic to opioids
* Known allergic reactions to components of the bupivacaine injectable or other amide anesthetics; the allergen may involve preservative compounds such as methylparaben used in the preparation of amide-type agents are metabolized to PABA
* BMI \> 40
Comparative Evaluation of Two Different Radiosurgery

Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients

This is a prospective double arm phase III study to evaluate cerebral side effects following radiosurgery delivered by Gamma Knife Perfexion and Linac Based EDGE. In particular our primary objective is to evaluate rate of symptomatic radionecrosis from the two different modalities of radiosurgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 85 years
* 1 - 4 brain metastases
* Karnofsky performance status (KPS) ≥70
* RPA 1 or 2
* Histopathologically confirmation of primary solid tumor
* Estimated survival ≥ 3 months as GPA score
* Written informed consent

Exclusion Criteria:

* Prior WBRT
* Age \> 85 years
* KPS \< 70
* RPA 3
* Diagnosis of small cell lung cancer (SCLC) or Lymphoproliferative disease
* Use of Avastin for at least 2 months after radiosurgery
* Pregnant women
Ready to Read: Ready to Read: A School-Based Intervention to Promote Growth Mindset and Reading

Primary Aim/Objective: To determine if a school-based intervention promoting reading with a growth mindset framework improves student reading achievement in the intervention group compared to a wait-list comparison group of children in kindergarten through 2nd grade.

Secondary Aim/Objective: To determine if students whose parents endorse a fixed mindset with regard to student reading abilities show more improvement post-intervention than parents that endorse growth mindset.

Secondary Aim/Objective: To determine if more parents endorse growth than fixed mindset post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* all children in kindergarten through 2nd grade and their caregivers at the targeted elementary school

Exclusion Criteria:

* Less than kindergarten or above 2nd grade