cyrilzakka/clinical-trials huggingface dataset:
Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications. We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Individuals who have received a diagnosis for type 2 diabetes mellitus
* Enrolled as a patient at a participating community health center
* Individuals currently being treated with oral and/or injectable diabetes medications

Exclusion Criteria:

* Non-English speakers
* Individuals who report they do not have a cell phone
* Individuals unwilling and/or not able to provide written informed consent
* Individuals with unintelligible speech (e.g., dysarthria)
* Individuals with a severe hearing or visual impairment
* Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey
* Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant
* Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater
ITIL-168 in Advanced Melanoma

DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma.
* Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto- oncogene BRAF V600 activating mutation, targeted therapy.
* Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
* Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
* Medically suitable for surgical resection of tumor tissue
* Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow and organ function

Key Exclusion Criteria:

* History of another primary malignancy within the previous 3 years
* Melanoma of uveal, acral, or mucosal origin
* Previously received an allogeneic stem cell transplant or organ allograft
* Previously received TIL or engineered cell therapy ( eg, CAR T-cell)
* Significant cardiac disease
* Stroke or transient ischemic attack within 12 months of enrollment
* History of significant central nervous system (CNS) disorder
* Symptomatic and/or untreated CNS metastases
* History of significant autoimmune disease within 2 years prior to enrollment
* Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, or IL-2.
VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study

The purpose of this study is to determine the range of expected PRUTest values in patients in the intended use population receiving dual antiplatelet treatment with aspirin and prasugrel (Effient®), or ticagrelor (Brilinta®).

The on-drug reference range study will be performed by measuring venous blood samples in duplicate collected from patients receiving prasugrel (Effient®), or ticagrelor (Brilinta®). Subjects must be on aspirin at the doses prescribed by their treating physician.

When possible, venous blood samples may be collected in conjunction with routine laboratory testing, to minimize the number of needle sticks for the subject. Alternatively, samples may be collected separately to complete the study.

A CBC measurement must be performed for each enrolled subject from a sample collected at the time of blood draw or within ± one week and tested at a certified laboratory. Samples for PRUTest collected in conjunction with a CBC must be drawn after the PRUTest sample.

Up to 130 subjects will be enrolled in the study to facilitate collection of the minimum number of blood samples needed to determine the on-drug reference range of prasugrel (Effient®), or ticagrelor (Brilinta®).

Eligibility Criteria:
Inclusion Criteria:

* • Males and females 18 years and older

  * Able and willing to provide written informed consent.
  * Current treatment with aspirin (any dose).
  * Have a planned or scheduled percutaneous coronary intervention (PCI) with the potential to receive treatment with prasugrel (Effient®), or ticagrelor (Brilinta®) following an oral loading dose or on maintenance treatment for a minimum of seven days who may have symptomatic cerebrovascular disease (transient ischemic attack or following a thrombotic stroke) or cardiovascular disease.

Exclusion Criteria:

* • Unable to provide written informed consent.

  * Currently receiving an investigational antiplatelet agent.
  * GP IIb/IIIa therapy (ReoPro®, Integrilin®, Aggrastat®) within the past 2 weeks.
  * Received any therapy containing dipyridamole (Persantine®, Aggrenox®) within the past 2 weeks.
  * Women who may be pregnant or are of child bearing potential
Acute Cardiovascular Events Triggered by COVID-19-Related Stress

The current COVID19 pandemic has afflicted almost the whole globe. The stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psychosocial stresses.

This study is a cross sectional study that will enroll patients evaluated during the COVID19 pandemic period for acute cardiovascular events.

The onset of acute myocardial infarction (AMI) is a complex interplay of internal circadian factors and external physical and emotional triggers. These interactions may lead to rupture of an often non-occlusive vulnerable atherosclerotic coronary plaque with subsequent formation of an occlusive thrombus. Physical and emotional stresses are important triggers of acute cardiovascular events including AMI. Triggering events, internal changes, and external factors vary among different geographical, environmental, and ethnic regions. Life-style changes, pharmacotherapy, and psychological interventions may potentially modify the response to, and protect against the effects of triggering events. Certain times in the life span of different communities all around the world are prone to natural and man-made disasters that, not only have direct negative impact on human lives and state-resources, but also have indirect impact on triggering acute cardiovascular events during the time of the disaster and the period immediately after. For example, earthquakes, wars, and terrorist attacks, in addition to direct human life loss and destruction of communities, have bees associated with a surge in the number of acute MI, sudden cardiac death, ventricular tachy-arrhythmia and implantable cardiovertor defibrillators (ICD) discharges.

The current COVID-19 pandemic has afflicted almost the whole globe. The virus can directly attack the myocyte and cause various degrees of cardiac damage and cardiovascular clinical entities. However, the stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psycho-social stresses such as extreme physical effort, lock down, anger, fear, financial stress, sorrow, death of a significant person..etc.

This study is a cross sectional study that will enroll patients evaluated during the COVID-19 pandemic period for acute cardiovascular events not directory related to the virus infectivity, who voice certain and specific trigger(s) related to the pandemic impact on social life and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Acute MI (STEMI and NSTEMI).
* Sudden cardiac death
* Ventricular tachycardia
* ICD shocks.
* Stressful trigger prior to the cardiovascular event

Exclusion Criteria:

\* COVID-19 infection.
Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

This phase 2 study is designed to evaluate the safety and activity of TH-4000, a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

An open label, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
* For patients with oropharyngeal cancer, p16 status is known or can be determined
* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Acceptable laboratory results as indicated by protocol
* Acceptable cardiac function as indicated by protocol

Exclusion Criteria:

* Received prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy for recurrent or metastatic Squamous Cell Carcinoma (e.g., oral EGFR TKIs such as erlotinib, gefitinib, or afatinib)
* Family history of long corrected QT interval (QTc) syndrome
* Receiving medication that prolongs QT interval ,with a risk of causing Torsades de Pointes (TdP), unless ECG meets inclusion criteria while on a stable dose of the medication
* Family history of long QTc syndrome
* Symptomatic central nervous system (CNS) lesions, or CNS lesions that require therapy
* Radiation therapy within 2 weeks prior to the first dose of study medication
* Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
* Concurrent active malignancy requiring systemic treatment
* Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
* Pregnant or breast-feeding
Study to Investigate the Efficacy and Safety of WX-0593 in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 in patients with ALK-positive NSCLC


Eligibility Criteria:
Key Inclusion Criteria:

* ≥18 years
* Female or male
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Life expectancy of at least 12 weeks
* At least one measurable lesion
* Histologically or cytologically confirmed diagnosis of advanced or recurrent or metastatic NSCLC that is ALK-positive by grade A tertiary hospitals, and subjects should have disease progression (RECIST 1.1) or intolerance (stopping criteria according to drug insert) after 1 or 2 marketed ALK inhibitors, the patients had disease progression after ALK inhibitor should continuously have drug at least 12 weeks , and less than 3 chemotherapy regimens previously
* No brain metastasis, or asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of \> 10 mg/day or equivalent hormone) for more than 2 weeks

Key Exclusion Criteria:

* Crizotinib is the only ALK inhibitor subjects received;unmarketed ALK inhibitor received; Lorlatinib or Brigatinib received; active ingredient or generic drug of ALK inhibitors received
* HBsAg-positive and/or HBcAb positive and HBV DNA \> 1000 copies/mL, or HCV antibody-positive, or known HIV infected
Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder - 1

The purpose of this study is to test the use of High-Dose versus Regular-Dose Nicotine Patch for Nicotine Dependence in Individuals with Schizophrenia or Schizoaffective Disorder

This is a randomized double-blind placebo controlled 8 week outpatient medication clinical trial to evaluate the relative efficacy of High-Dose (42mg) versus Regular Dose (21mg) nicotine patch treatment for individuals with schizophrenia or schizoaffective disorder and nicotine dependence. It also has a placebo controlled continuation phase to examine if longer duration of treatment is more effective than a standard eight week dosing schedule. The literature supports that schizophrenics have an increased rates of smoking and are more likely to be dependent on nicotine. Nicotine gum and patches are safe and now approved for over the counter sale in the United States. High dose patch therapy is well tolerated and provides more complete nicotine replacement. This improves withdrawal symptom relief and it is hypothesized that abstinence rates from smoking will be greater in the high dose patch group. Few trials have examined the usefulness of nicotine replacement therapy in this population and preliminary evidence shows lower than expected success rates of smoking cessation with conventional treatments

Eligibility Criteria:
Inclusion Criteria:

Subjects: 100 stable outpatients with schizophrenia and schizoaffective disorder and nicotine dependence. All subjects will meet the following inclusion criteria:

* Patients who are able to provide informed consent
* Patients will meet DSM-IV diagnostic criteria for Nicotine Dependence and Schizophrenia or Schizoaffective disorder
* Patients will be stable on their current antipsychotic regimen and will be interested in treatment for both their psychiatric and nicotine dependence

Exclusion Criteria:

* Potential subjects meeting the following criteria will be excluded:
* Patients with history of clinically significant angina or unstable angina pectoris
* Patients with severe CAD or recent myocardial infarction (within last 6 months)
* Patients with evidence or history of other severe medical illness (hematologic, renal or neoplastic)
* Patients who represent a serious suicide risk, including recent suicidal behavior or attempt within the last thirty days
* Patients with history of severe skin allergies or chronic dermatoses
* Concomitant use of clonidine or bupropion
* Pregnant females
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.

The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.


Eligibility Criteria:
Inclusion Criteria:

* Men and women \> 18 years old
* Thermoablation indication of renal neoplasia, bone or lung decided during a multidisciplinary consultation meeting - Generally speaking, the indications are: (i) inoperable primary malignant tumor or secondary malignant tumor, (ii) resectable primary malignant renal and lung tumor with medical contraindication to surgery or general anesthesia
* Signature of informed consent for participation
* Affiliation to a social security scheme or French beneficiary of such a regime.

Exclusion Criteria:

* Contraindication to percutaneous thermoablation
* Renal or lung tumor up to 4 cm
* Women of childbearing age, premenopausal, non-sterilized surgically, and unwilling to use effective contraception
* Legal incapacity or legal capacity limited
* Person unlikely to cooperate in the study and / or low degree of cooperation expected by the investigator
* Person without health insurance
* Pregnant women
Traffic Safety Study at Calgary Elementary Schools

Installing specific traffic calming features designed to reduce vehicle speed and volume around schools may lead to a reduction in injury risk for child pedestrians and bicyclists, and may increase numbers of children walking and bicycling to school. Therefore, this study seeks to evaluate the effectiveness of specific built environment features at influencing traffic speed and volume, and active transportation, both immediately following installation and months later.

Background Collisions with motor-vehicles are a leading cause of severe child bicyclist and pedestrian injuries in Canada. Injury rates and severity are associated with traffic speeds and volume but may be moderated through traffic calming.

Objective To assess the association of specific traffic calming measures on changes in traffic speed and volume, and active transportation prevalence, around Calgary, Alberta, Canada elementary schools.

Design This modified stepped-wedge randomized controlled trial was conducted at a sample of public elementary schools, from July 2020 to May 2021. Schools had either traffic calming curbs or in-street signs installed at an intersection within 100 m of the main entrance. The primary outcome was speed of vehicles driving towards or away from intervention. Secondary outcomes were traffic volume driving past the intervention and counts of children using active transportation at the intervention crosswalk.

Eligibility Criteria:
Inclusion Criteria:

* No individual participants are recruited.
Metabolic Syndrome Prevalence Study

Following the first study conducted to investigate the prevalence of metabolic syndrome and its components in Turkey, it was aimed to demonstrate the change in general health condition of available patients after the period of time lapsed. This study will provide important information on the social and economic dimensions of metabolic syndrome and will contribute to development of preventive programs.

In the first METSAR-I study conducted in 2003, metabolic syndrome screening was made by two different team. Participants were visited at their addresses and informed about the research study and gave written consent. They were invited on an empty stomach for hospital visit on the day after. Pre-trained nurses completed the forms of patients during that second visit. After 11 years, a questionnaire by telephone survey will be applied to patients who participated in the METSAR-II study. The main goal is to determine the changes of metabolic syndrome population during that period.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers who participated in the METSAR-I study in 2003
* Patients who accepted to participate will be included the second follow up phase.

Exclusion Criteria:

None
Phase II Proof of Concept Study in Uncomplicated UTI

A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection
* On adequate birth control
* Normal ECG

Exclusion Criteria:

* Participated in any other trial within 30 days of visit 1
* Known or suspected allergy to investigational drug
* Narrow angle glaucoma
* Recovering from chicken pox or flu-like symptoms
* History of peptic ulcer, gastrointestinal bleeding, gastrointestinal surgery, or gastrointestinal dysfunction which could interfere with drug absorption
* Taken any drugs for within past 24 hours for symptoms associated with uncomplicated urinary tract infections
* Currently taking prohibited drugs
* Taken an antibiotic within 7 days of Visit 1
* Are ineligible to receive an antibiotic
* History of urinary retention
* History of interstitial cystitis
* History of impaired renal function
* History of impaired hepatic function
* Diagnosis or suspicion of complicated urinary tract infection or systemic infection
* History of substance abuse
Impact of the Be Well Care Well Program on Early Care Education Teachers

The study will address the following specific aims: (1) assess the impact of the BWCW program on teacher stress and physical activity, (2) Examine feasibility of collecting cortisol.


Eligibility Criteria:
Inclusion Criteria:

Teachers that meet the following criteria will be included:

1. currently employed as a teacher or assistant teacher at a participating ECE center;
2. ages 18 or older;
3. men or women;
4. able to speak, read, and write English.

Exclusion Criteria:

None
Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer

Locally advanced cervical cáncer continues to be a public health problem in emergent economies, even though treatment is very well standardized, recurrence rate is still high, making necessary to evaluate prognostic clinical and pathological factors. The aim of this study is to evaluate clinical and pathological prognostic factor in terms of treatment outcomes, disease-free survival (DFS) and overall survival (OS) in a retrospective cohort of patients with LACC treated with standard chemoradiotherapy in a reference center in México.

This is a retrospective study, the data were obtained from clinical files of cervical cancer patients with clinical stages IB2-IVA(FIGO2009) treated at the Instituto Nacional de Cancerología in Mexico City from January 2005 to December 2014.

A total of 1954 patients with LACC confirmed by pathology, clinical exams and computed tomography scan (CT) were identified.

Demographic, clinical, pathological and follow-up as well as survival status of all patients was recorded. Treatment outcome was classified as complete response if the patient had no signs of tumor activity after 6 months of finishing treatment, persistence of disease was defined if tumor could be identified after treatment or before six months of treatment termination, progression was defined if tumor growth occurred or metastatic disease appeared. Disease-free survival (DFS) was defined as the period between finishing treatment and the occurrence of relapse, which was confirmed by pathological study and/or CT. Overall survival (OS) was defined as the time period between diagnosis and death or date at last visit. Quantitative variables were described with central tendency and dispersion measures and analyzed with Student's t or Mann-Whitney U test. Normality was determined with Shapiro-Wilk's test, Chi-squared for categorical comparisons between groups, Kaplan-Meir with the log-rank test for survival analysis were performed. The multivariate analysis was performed using Cox proportional Hazard regression model. Statistically significant differences were defined as a p value \<0.05.

Statistical analyses were performed using IBM SPSS, version 23 (IBM Corp., Armonk, N.Y., USA).

Eligibility Criteria:
Inclusion Criteria:

* Patients with cervical cancer clinical stage Ib2-IVa
* Treated with concomitant Chemoradiotherapy

Exclusion Criteria:

* Rare histologies such gastric type adenocarcinoma, neuroendocrine or clear-cell carcinoma
* incomplete treatment or not treated with chemoradiotherapy
* Two primary malignancies
* Insufficient data for analysis.