cyrilzakka/clinical-trials huggingface dataset:
Bone Health Management for Women Diagnosed With Breast Cancer

The purpose of this study is to test the feasibility of the study protocol. The study protocol was designed to evaluate questions - "Do educational materials improve dual x-ray absorptiometry (DXA) screening rates for women diagnosed with breast cancer" and "Does educational materials delivered by the participant's selected choice change DXA screening rates compared to the conventional mail method?".

"Bone health management" for osteoporosis is important for women diagnosed with breast cancer. Osteoporosis can lead to bones breaking easily. Broken bones may make living independently challenging. Effective bone health management can reduce the risk of broken bones. This study will examine whether providing "osteoporosis information" to women diagnosed with breast cancer will promote their bone health management. With the current advance in technology, people are more interested in receiving information by email or smartphone text messaging. This study will also examine whether delivering osteoporosis information in different ways will change bone health management.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Is 65-75 year old on July 1st, 2015
* Lives in British Columbia (BC), Canada
* Reads and understands the information provided in English
* Was diagnosed with breast cancer prior to July 1st, 2012
* Is not receiving surgery, radiation or chemotherapy for any cancers
* Has not had breast cancer spread beyond her breast(s) and nearby lymph nodes
* Has not had screening tests after July 1st, 2012
* Is not taking medications prescribed by doctors for osteoporosis

Exclusion criteria:

* Is medically unfit for preventive care (death, cognitive impairment, nursing home admission, severe mental illness, etc), which will be determined by their family doctors
* Have terminated patient-doctor relationship with her family doctor who is indicated in our record
PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes

Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated. Treatment comprises modification of diet and in some cases taking medication. This treatment lowers undesirable events like macrosomia or premature birth. However, unitl gestational diabetes is diagnosed the fetus is exposed to increased intrauterine glucose levels. The long-term effects of a well-managed gestational diabetes on the development of the offspring is still not well understood. Therefore, the PREG - Offspring study investigates several aspects of development in children from healthy and gestational diabetes mothers until adulthood.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent provided by child and parent
* documented oral glucose tolerance test of the mother during pregnancy
* adequate management of gestational diabetes until birth

Exclusion Criteria:

* severe malformation that makes an examination impossible
* existent of coagulation disorder with increased risk of bleeding after blood sampling
AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors

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

PURPOSE: Phase I trial to study the effectiveness of AG2037 in treating patients who have advanced, metastatic, or recurrent solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced, metastatic, or recurrent solid tumor.
* Determine the safety and tolerance of this drug in these patients.
* Assess the pharmacokinetics of this drug in these patients.
* Document any antitumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AG2037 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed solid tumor

  * Advanced, metastatic, or recurrent disease
  * No curative therapy exists
* Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic:

* Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome)
* SGOT OR SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

Renal:

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

Other:

* No unstable or severe concurrent medical condition that would preclude study participation
* No sociological or familial condition that would preclude study compliance
* No psychological or addictive disorder that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 40% of bone marrow

Surgery:

* Not specified

Other:

* At least 2 weeks since prior blood transfusions
* At least 4 weeks since prior investigational agent and recovered
* No prior glycinamide ribonucleotide formyltransferase (GARFT) inhibitor
* No concurrent extradietary folate supplements
* No concurrent allopurinol
* No other concurrent anticancer or investigational agents
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients

The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* body weight 40-100kg
* diagnosed as systemic lupus erythematosus, (according to American College of Rheumatology Diagnostic Criteria,1997)
* diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months
* 24hr proteinuria ≥2g and/or active urinary sediments

Exclusion Criteria:

* receiving immunosuppressant
* receiving routine treatment of tacrolimus and leflunomide within 1 month
* receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the study
* history of allergy to tacrolimus and leflunomide
* anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed over 2 weeks before recruitment
* planning to receive kidney transplantation or in the near future or having a history of undergoing kidney transplantation
* serum creatinine (Scr) ≥3mg/dl or estimated glomerular filtration rate (eGFR) \< 30ml/min
* diabetes mellitus patients
Sleep and Immune Checkpoint Inhibitors

Sleep disturbances are prevalent in cancer patients and linked to levels of fatigue and depressive symptoms with a major impact on quality of life. A growing body of evidence links sleep disturbances with various health outcomes, including increased risk of depression, cancer, and overall mortality. Inflammation is suggested to be an underlying mechanism both driving and maintaining the symptom cluster of sleep disturbance, fatigue and depressive symptoms, as well as being bi-directionally linked to sleep. The main purpose of the present study is to investigate the prevalence of sleep disturbance and its association with psychological and physical symptoms as well as the clinical response to ICI in non-small-cell lung cancer patients (NSCLC), with a secondary aim of exploring the role of inflammation.

A total of 240 cancer patients diagnosed with advanced NSCLC, referred to treatment with ICI will be enrolled in this prospective observational study. Patients will be assessed prior to initiation of treatment (baseline) and every third subsequent week, corresponding to each treatment cycle over a period of 18 weeks. Assessments will include questionnaires, sleep diaries, actigraphy, and blood and saliva samples to examine sleep, fatigue, psychological and physical symptoms, the sleep-wake-cycle, inflammation, and cortisol. Additionally, the patients will be asked to complete a reduced questionnaire every week within the 18 weeks period, to address weekly fluctuations in sleep quality, fatigue, and mood. Treatment response is assessed after 9 and 18 weeks.

Aims:

1. To explore possible associations between sleep and the clinical response to treatment with ICI.
2. To investigate the prevalence of sleep disturbance in patients with NSCLC during treatment with ICI.
3. To prospectively assess changes in sleep parameters over the course of treatment.
4. To examine associations between sleep parameters and fatigue, depression, anxiety, and inflammation.
5. To explore possible associations between sleep, fatigue, depression, inflammatory responses and the clinical response to treatment with ICIs.

Hypotheses:

Patients with high levels of sleep disturbance (insomnia severity) will experience 1) poorer clinical response to ICI, 2) more depressive symptoms, 3) higher levels of fatigue, 4) poorer overall health-related quality of life (HRQoL), 5) higher levels of inflammation.

Eligibility Criteria:
Inclusion Criteria:

- Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria:

* Insufficient Danish proficiency
* Pre-existing confounding psychiatric illnesses
Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer

The investigators propose to build and test a supportive care software platform called Nurse AMIE (Addressing Metastatic Individuals Everyday) to be provided to metastatic breast cancer patients on Android Tablets. This program will be tested in 50 metastatic breast cancer patients within the Penn State Cancer Institute's 28 county catchment area. The company with whom the investigator will partner to develop this application is already working with multiple investigators at the institution (Webster Group).

Goals of the Nurse AMIE software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via YouTube style videos, weekly Skype calls (face to face, tablet to tablet) with a patient navigator at Penn State, and appropriate referrals to phone or in person consultations as needed. The proposed Nurse AMIE software program will allow for the provision of resources (YouTube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. This is an identified need on the part of both metastatic patients and their medical care teams. Finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

Eligibility Criteria:
Inclusion Criteria:

1. Women with metastatic breast cancer
2. ECOG performance score ≤3.
3. English Speaking
4. With sufficient vision/hearing or family support

Exclusion Criteria:

1. Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
2. Patients who are receiving any other behavioral intervention
Retrospective Analysis Assessing Clinical Risk Factors for Cardiovascular Events and Mortality and Development of a Risk Calculator in Chronic Kidney Disease Stage 5 on Dialysis

The purpose of this study is to evaluate which clinical and laboratory factors are associated with major adverse cardiovascular event (MACE) in chronic kidney disease (CKD) patients on dialysis.

The study will also establish a cardiovascular (CV) risk equation appropriate for this dialysis population.

This study is a retrospective analysis of dialysis dependent CKD patients participating in AURORA. The retrospective analysis will be performed using the AURORA study database.

AURORA was a prospective clinical trial in which dialysis patients were randomly assigned to rosuvastatin or placebo, sponsored by AstraZeneca. Patients included in the AURORA study who had end stage renal disease (ESRD) and had been treated with regular hemodialysis or hemofiltration for at least 3 months. Patients were recruited from approximately 300 centers in 25 countries.

The clinical study data is held by AstraZeneca AB, Sweden.

No formal sample size calculation was performed. The sample size is based on the available data from the AURORA study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in the AURORA study. In brief, men and women who had ESRD and had been treated with regular hemodialysis or hemofiltration for at least 3 months (patients were recruited from 280 centers in 25 countries).

Exclusion Criteria:

* The major exclusion criteria in AURORA were statin therapy within the previous 6 months, expected kidney transplantation within 1 year, and serious hematologic, neoplastic, gastrointestinal, infectious, or metabolic disease (excluding diabetes) that was predicted to limit life expectancy to less than 1 year.
* Other exclusion criteria were a history of a malignant condition, active liver disease (indicated by an alanine aminotransferase level that was more than three times the upper limit of the normal range), uncontrolled hypothyroidism, and an unexplained elevation in the creatine kinase level to more than three times the upper limit of the normal range.
Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole.

This is a non-interventional, prospective, multinational, multicentre, observational study, in which data collected are those derived from routine clinical practice via an European registry on CS: ERCUSYN.

The aim is to further document the safety and efficacy of Ketoconazole HRA administered in routine clinical practice in patients with CS.

The study operates under real clinical practice conditions, i.e. there is no treatment protocol thus.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged from 12 years or older with a diagnosis of CS
2. Patients who started ketoconazole therapy after study start
3. For patients previously treated with ketoconazole, patients must have taken their last dose at least 6 months before starting ketoconazole again in this study.
4. Written informed consent signed prior to registration of any patient data in HRA modules.

Exclusion Criteria:

1. Adrenal cortical carcinoma
2. Patients currently participating in any other trial (interventional or not) of an investigational medicine or participation in the past one month before start of ketoconazole
3. Patients who have at least one contraindication among those listed in section 4.3 of the ketoconazole SmPC
Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction

This purpose of this study is to examine the relationship between HMGB-1 and postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based cardiac rehabilitation program.

Exercise-based Cardiac Rehabilitation after acute myocardial infarction (AMI) has beneficial effects on cardiovascular functional capacity, quality of life, risk factors modification, and morbidity and mortality. Mounting evidences suggest that inflammation plays a key role both on initiation and progression of atherosclerosis. Several markers of systemic inflammation appear to be active effectors in the pathophysiology of athero-thrombotic disease leading to the occurrence of AMI.

The high mobility group box 1 (HMGB-1) is a ubiquitous nuclear protein constitutively expressed in quiescent cells, and it has been implicated in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB-1 has been recently recognized as a critical mediator of inflammatory diseases. In fact, the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response. Specifically, HMGB-1 binds to the receptor for advanced glycation end products (RAGE) and, in turns, it activates mitogen-activated protein-kinase (MAPK) and nuclear factor-κB (NF-κB).

This intracellular pathway leads to the production of several pro-inflammatory cytokines. Interestingly, increased levels of HMGB-1 have been observed in atherosclerotic lesions, suggesting that HMGB-1 might be involved in the pathophysiology of atherosclerosis.

This study was designed to investigate the relationship between HMGB-1 and strong postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based Cardiac Rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Acute Myocardial Infarction

Exclusion Criteria:

* BMI higher than 30 and lower than 18
* Residual myocardial ischemia
* Severe ventricular arrhythmias
* IIb or III degree atrio-ventricular block
* Valvular disease requiring surgery
* Pericarditis
* Severe renal dysfunction (i.e. creatinine \>2.5 mg/dl)
* Severe concomitant non-cardiac disease such as cancer
* Liver dysfunction (alanine aminotransferase/aspartate aminotransferase level \>1.5 times the upper normal limit)
* Dementia
* Any systemic disease limiting exercise
* Inability to participate in a prospective study for any logistic reason
Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria for Lung Cancer Based on Real-world Data

Eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. In order to evaluate the REC of NSCLC drug trials, this study will use deep learning methods to construct a structured real-world database of NSCLC across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety.

Restrictive eligibility criteria in cancer drug trials result in low enrollment rates and limited population diversity. Relaxed eligibility criteria (REC) based on solid evidence is becoming necessary for stakeholders worldwide. However, the absence of high-quality, favorable evidence remains a major challenge. This study presents a protocol to quantitatively evaluate the impact of relaxing eligibility criteria in common non-small cell lung cancer (NSCLC) protocols in China, on the risk-benefit profile. This involves a detailed explanation of the rationale, framework, and design of REC.

To evaluate our REC in NSCLC drug trials, we will first construct a structured, cross-dimensional real-world NSCLC database using deep learning methods. We will then establish randomized virtual cohorts and perform benefit-risk assessment using Monte Carlo simulation and propensity matching. Shapley value will be utilized to quantitatively measure the effect of the change of each eligibility criterion on patient volume, clinical efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

Patients in the database were considered to be part of the real-world cohort if they were (1) diagnosed with NSCLC according to the tenth revision of the international classification of diseases (ICD-10) code; (2) diagnosed with stage IIIB, IIIC, IV NSCLC between 1 January 2013 and 31 December, 2022; (3) had at least two documented clinical visits on or after 1 January 2013.

Exclusion Criteria:

（1）NSCLC in stage I-IIIa
Effect of Fire Suppression and Emergency Duties on Vascular Function

Firefighters are at increased risk of death from heart attacks when compared to other emergencyy service professionals whose jobs involve similar components such as emergency call-outs and shift work. In the largest analysis of cause of death amongst on-duty firefighters, firefighter deaths were classified according to the duty performed during the onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart attack) occurred during fire suppression whilst this activity represented a relatively small amount of a firefighters professional time. There was also a risk of death associated with other duties such as emergency non-fire response and physical exertion.

The investigators hypothesize that participation in active fire-fighting duties impairs blood vessel function and increases blood clot formation when compared with non-fire-fighting activities. In this study, healthy career firefighters will be assessed after three periods of duty: fire-suppression, emergency response without fire suppression and following a sedentary shift. The investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. The investigators will then perform studies placing small needles in the arm to assess blood vessel function following these duties. By undertaking this comprehensive assessment of blood, blood vessel and heart function the investigators hope to understand the mechanisms whereby the risk of a heart attack, fatal or otherwise, is posed throughout these distinct duties that firefighters undertake on a daily basis.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking healthy firefighters

Exclusion Criteria:

* Current smoker
* History of lung or ischaemic heart disease
* Malignant arrhythmia
* Systolic blood pressure \>190mmHg or \<100mmHg
* Renal or hepatic dysfunction
* Previous history of blood dyscrasia
* Unable to tolerate the supine position
* Blood donation within the last 3 months
* Recent respiratory tract infection within the past 4 weeks
* Routine medication including aspirin and NSAIDs
Biomarkers and Risk Factors for Perioperative Neurocognitive Dysfunction in Elderly Patients

Basic information and biological samples of patients were collected preoperatively and intraoperatively, and patients were divided into case and control groups by cognitive function assessment postoperatively, and risk factors and biomarkers of perioperative cognitive dysfunction were derived by analyzing and statistically processing basic information and biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal to 65 years old
* ASA classification Ⅰ\~Ⅲ grade

Exclusion Criteria:

* History of previous Craniocerebral surgery or Craniocerebral trauma
* Inability to successfully complete preoperative psychological function tests
* Those who are severely deaf, speech impaired and otherwise unable to communicate.