cyrilzakka/clinical-trials huggingface dataset:
Smoking Cessation Intervention for Thoracic Patients

The primary aim of the proposed study is to develop and assess the feasibility of delivering a smoking cessation intervention to patients undergoing lung surgery that begins before surgery and continues up to 3 months post-discharge. The secondary aim is to assess smoking cessation rates 3 months following surgery.

This is a pilot study evaluating the feasibility of a cognitive-behavioral smoking cessation plus Varenicline program, designed specifically for early stage lung cancer patients and patients with a potential lung cancer diagnosis pre and post-surgery. The study population will be approximately 80 smokers who have upcoming lung resection surgery scheduled at Massachusetts General Hospital (MGH) in Boston. A patient will be considered eligible for the intervention or control group if he or she 1) is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis, and 2) had a cigarette in the past 2 weeks, 3) is willing to make a pre-surgical quit attempt. Patients will be excluded from the control group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon/oncologist, 3) suffering from psychosis or dementia 4) is currently on Varenicline has been on Varenicline for more than 3 weeks, or 5) is otherwise unable to participate in the intervention. Patients will be excluded from the intervention group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon, 3) suffering from psychosis or dementia 4) have been taking Varenicline for longer than three weeks 5) have been taking Bupropion (for smoking cessation purposes) for more than three weeks, 6) is otherwise unable to participate in the intervention.

Eligibility Criteria:
Inclusion Criteria:

A patient is eligible if he/she:

1. Is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis
2. Smoked a cigarette in the past 2 weeks
3. Is willing to make a pre-surgical quit attempt

Exclusion Criteria:

Patients will be excluded from the intervention group if they are:

1. Non-English speaking
2. Determined medically ineligible by their surgeon
3. Suffering from psychosis or dementia
4. Have been taking Varenicline for longer than three weeks
5. Have been taking Bupropion (for smoking cessation purposes) for more than three weeks
6. Is otherwise unable to participate in the intervention.
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF. Diagnosis must be confirmed within 12 months before enrollment.
2. Subjects between 18 and 75 years of age, inclusive

Exclusion Criteria:

1. Patients who have contraindications to open heart surgery
2. Patients from an Intensive Care Unit
3. Patients with active systemic infection (sepsis)
4. Patients who have had previous ablation in the left or right atrium
5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
8. Patients with New York Heart Association Class III or IV heart failure
9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
10. Bleeding disorder history
11. Patients with a known sensitivity to anesthesia or neuromuscular block agent
12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
13. Myocardial infarction within the last three months
14. Atrioventricular (AV) block II° or III°
15. Left ventricular ejection fraction (LVEF) of less than 35%
16. Unstable angina
Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)


Eligibility Criteria:
Inclusion Criteria:

* Patients must be documented to be refractory or not candidates for current approved therapies.
* Must have an ECOG status 0-2.
* Peripheral neuropathy \< or = 2.
* Must have acceptable organ and marrow function per protocol parameters.
* No clinically significant ventricular arrythmias or ischemia.

Exclusion Criteria:

* Must not be pregnant or breastfeeding.
* Chemotherapy or radiation within 3 weeks.
* Previous radiation to \>25% of total bone marrow.
* Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.
* Primary brain tumors or active brain metastases.
* Use of any investigational agents within 4 weeks.
* Treatment with chronic immunosuppressants.
* Uncontrolled, intercurrent illness.
Trial of Health At Work Workplace Health Intervention

This pilot study will compare workplace health intervention delivered by advisors based in GP practices with normal GP care to assess the usefulness of the concept and its potential for wider use in a larger randomised controlled trial.

The aim of this pilot study is to examine the impact of H@W intervention(s) on job retention and return to work and compare outcomes with those from normal GP care. The target population for this study is people still at work but experiencing a work-related health problem as well as those off work. For the purpose of the study, short term sickness absence is defined as a period of 4 weeks or less and long term sickness absence defined as a period of 4 weeks or longer. Hypothesis

That H@W intervention in comparison to standard care:

* promotes work retention
* enables a quick and sustained return to work for those on short term sick leave (4 weeks or less)
* achieves sustained return to work for those on long term sick leave of 4 weeks or more. This could include a phased return to work.
* achieves positive outcomes which could mean leaving one job and starting another.

Eligibility Criteria:
Inclusion Criteria:

* People with work related health problems registered with GP practices in Liverpool Primary Care Trust.

Exclusion Criteria:

* People registered with GP practices outside Liverpool Primary Care Trust.
* Vulnerable adults and those considered by their GP to be unsuitable for the trial.
AZD6280 Multiple Ascending Dose Study

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Clinically significant illness within 2 weeks before the study start.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years-old at the time of consent to participate this trial
* Patients with stage I-III invasive breast cancer
* No prior anti-cancer treatment
* Felt to be a possible candidate for neoadjuvant therapy by their physician

Exclusion Criteria:

* Known to have other aggressive malignant tumor in the past 5 years.
* Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.
* There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
* The investigator determines that subjects are not appropriate to participate in the study due to other factors.
Epidemiology Controls Using Healthy Participants

The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer.

For this study, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), certain environmental exposures, your medical history, family history, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview.

You will also have around 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors associated with certain cancers. The interview and blood draw will be scheduled at the time and place of your convenience. You will not be informed of the results of any of the testing done with your samples.

There is a possibility that you might be contacted in the future about if researchers need clarification on any of information already collected. You are free to refuse any further participation if you wish.

This is an investigational study. Up to 1,500 participants will take part in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals ages 18 and over with no prior cancer
2. Willing and able to complete an administered questionnaire
3. Willing and able to donate 30 mL of blood

Exclusion Criteria:

1. Individuals with prior cancer
2. Individuals under the age of 18
Metronomic Chemotherapy in Advanced Gastric Cancer

phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer

About 80% of patients with advanced gastric cancer are diagnosed at an advanced stage with limited treatment options including systemic chemotherapy with or without radiation. Commonly used maximally tolerated dose (MTD) chemotherapy such as DCT, ECF, FOLFOX regimens induce responses in the range of 20 to 50% with median survival in the range of 10 to 12 months. Metronomic chemotherapy has been found to have more consistent anti-tumor effects through anti-angiogenic and immunomodulating effects. Preliminary clinical studies of weekly POLF have found very encouraging clinical activities and low overall toxicities in pancreatic cancer and gastric cancer. Here we conduct a formal clinical trial to determine the clinical efficacy and side effect profiles of this regimen in patients with advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

1. pathologically confirmed gastric cancer AJCC stage III or IV
2. measurable disease based on CT or endoscopy exam
3. non-surgical candidates or patients who declined surgery
4. non-radiation candidates or patients who declined radiation
5. patients who are able to sign informed consent
6. patients who are 2 weeks out and recovered from surgery
7. patients who have completed radiation to relieve obstructive symptoms
8. patient who previously received Oxaliplatin and 5-FU in other MTD regimens
9. adequate marrow function: neutrophil \>1000/ul, Hgb \>10g/dl, Plt\>50,000

Exclusion Criteria:

1. allergic to any of the drugs involved
2. concurrent malignancies
3. severe co-morbidities of heart, lungs, kidneys and bone marrow
4. severe psychological disorder
5. severe malnutrition
6. difficult to heal or unhealed wound
7. ECOG performance status equal or over 3
8. uncontrolled complications from the malignancy
9. uncontrolled CNS metastasis
10. peripheral neuropathy grade 3 or above
11. pregnancy or breast feeding
Volume CT of the Wrist and Carpus After Trauma

The purpose of this study is to evaluate whether standard volume computed tomography (CT) has impact on treatment in patients with suspicion of fractures of the wrist and carpus.


Eligibility Criteria:
Inclusion Criteria:

* Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus
* Recent trauma mechanism (within 3 days before presentation)
* Clinical suspicion of fractures of the wrist and carpus. The carpus includes all carpal bones, but does not include the metacarpal bones.

Exclusion Criteria:

* Patients who were not evaluated by a clinician before imaging was performed.
* Open fractures
* No informed consent or no prospective data collection could be obtained. Informed consent cannot be obtained in case patients do not speak or understand Dutch.
* Patients who cannot be positioned in upright position, immobilized on a spine board or transferred to the intensive care unit and cannot undergo upright CT
Renal Nerve Denervation(RDN) and Renal Function

Current studies have found the efficacy of RDN in the treatment of hypertension, however, the safety of RDN in renal function is still lacking. Therefore, the investigators are aimed to study the effect of RDN on renal function.


Eligibility Criteria:
Inclusion Criteria:

1.18\<age≤75 years; 2.clinic blood pressure ≥ 140/90 mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥ 135/85 mmHg after taking 3 or more antihypertensive drugs for more than 4 weeks; 3.essential hypertension, renal parenchymal hypertension, or hypertension patients who are willing to receive RDN ; 4.who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.

Exclusion Criteria:

* pregnant women or lactating patients;

  * identified secondary hypertension or Pseudo hypertension;

    * whose renal arteries were unsuitable for ablation

      * obvious bleeding tendency and blood system diseases;

        * malignant tumors or end-stage diseases; ⑥Severe peripheral vascular disease, abdominal aortic aneurysm; ⑦A history of the acute coronary syndrome within two weeks; ⑧acute or severe systemic infection; ⑨drug or alcohol dependence or refusal to sign informed consent.
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

Primary objective:

To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo.

Secondary objectives:

To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.


Eligibility Criteria:
Inclusion Criteria:

1. Man or woman ≥ 18 years and \< 65 years of age
2. Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997 American College of Rheumatology (ACR) or 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
3. Have moderate to severe active SLE
4. Have seropositive disease at screening
5. Subject must be at least on one or more of the treatments for SLE as listed in the protocol
6. Others as defined in the protocol

Exclusion Criteria:

1. Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal system at screening and at baseline for the organ systems that can be clinically assessed
2. Have a systemic inflammatory disease other than SLE
3. Clinically significant infection treated or needing treatment
4. Any active or recurrent viral infection that based on the Investigator´s clinical assessment makes the subject unsuitable for the study
5. Have received prior therapy blocking the interleukin-6 (IL-6) pathway
6. Others as defined in the protocol
Exogenous Toxicants and Genetic Susceptibility in ALS

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a fatal neurodegenerative disease that poses a significant burden for affected individuals and their family members. The principal objective of this epidemiologic study is to identify environmental and genetic risk factors for ALS. Of primary interest is whether environmental chemicals such as heavy metals, pesticides and organic solvents contribute to the cause of ALS. We also aim to identify genetic factors that contribute to the risk of ALS because individuals with certain genetic traits may be unable to protect against the toxic effects of chemical exposure. Other factors that may protect against the development of ALS, such as dietary antioxidants, are also under investigation. If modifiable factors affecting the risk for ALS could be identified, interventions to delay or even prevent the development of ALS could be developed.

The principal objective of this study is to identify environmental and/or genetic risk factors for amyotrophic lateral sclerosis (ALS). We are addressing this objective by conducting a case-control study of ALS in the Northern California Kaiser Permanente Medical Care Program (KPMCP). Over a four-year period, approximately 175 persons newly diagnosed with ALS will be identified and recruited through physician referrals and computerized mechanisms available within the Kaiser system. The patients with ALS will be compared to a sample of 350 age- and gender-matched persons without ALS from the same membership. Specific study aims are as follows: (1) to investigate the association of ALS with exposure to neurotoxicants including lead, other heavy metals, solvents and pesticides; (2) to determine whether inadequate oxidative defenses for protecting against free-radicals enhance the toxicity of exogenous exposures; (3) to examine the evidence for familial aggregation of neurodegenerative diseases among first-degree relatives of patients with ALS; and (4) to estimate the incidence of ALS in diverse racial and ethnic groups.

Eligibility Criteria:
Individuals with ALS within the Kaiser Permanente population of Northern California, ages 18 years and older, with first diagnosis of ALS in the years 1996-2000.

Controls are individuals who are age- and sex-matched to the patients with ALS, also from the Kaiser Permanente population.
Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis

To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Blood Glucose \>200
* potential of hydrogen (pH) \< 7.3
* Bicarbonate \< 18
* Ketonemia or Ketonuria
* Anion Gap \> or = 16

Exclusion Criteria:

* Age \< 18 years
* Pregnant
* End state renal disease (ESRD)
* Prisoners
* Patients in shock or requiring emergency surgery
* Those unwilling to consent for the trial
* Allergic to Insulin Glargine
IASLC Grading System as a Predictor for EGFR-TKI Therapy

The investigators previously validated the grading system proposed by International Association for the Study of Lung Cancer (IASLC) for invasive nonmucinous lung adenocarcinoma (LADC) for its reproducibility, prognostication function and predictive value of adjuvant chemotherapy (ACT). In this exploratory study, the investigators aimed to investigate the role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy.


Eligibility Criteria:
Inclusion Criteria:

* invasive lung adenocarcinoma patients who underwent complete resection with positive EGFR mutations in exons 18-21.

Exclusion Criteria:

* adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), invasive mucinous adenocarcinoma and other variants of adenocarcinoma
* patients with pathologic slides unavailable for re-evaluation
Evaluation of a Community Health Nurse/Peer Counselor Program to Help Low-Income Women Breastfeed Longer

This research was done to better understand how new mothers who are breastfeeding feel and the questions they have. We wanted to use ways to help new mothers to breastfeed successfully. We compared a new approach (home visits and telephone calls) to the usual care given at Johns Hopkins Hospital with strong support to new mothers from nurses, and a peer counselor (another mother with breastfeeding experience).

Healthy People 2010 included the goal of increasing breastfeeding duration to 6 months for 50% of all mothers. Other professional and national health organizations and the Health and Human Services Blueprint for Action on Breastfeeding recommend that women breastfeed exclusively for six months. Increasing breastfeeding among low-income women is a priority, as disparities exist. Only 20.1% of low-income women (on WIC) breastfeed for six months compared to 40.7 % of more affluent women. Consistent, comprehensive, culturally sensitive breastfeeding support increases duration of breastfeeding, thus offering well-documented health benefits often specifically appropriate for low-income women. Breastfeeding relates to lower formula cost, lower health care costs, and breastfeeding may be less time consuming. These cost savings can potentially offset costs of breastfeeding promotion. Facilitating breastfeeding among low-income women includes comprehensive and culturally relevant support in the hospital, during the first week postpartum, and periodic support in the mother's home. Nearly 35% of low-income women stop breastfeeding within eight days of delivery. Repeated contact with supportive persons such as peer counselors and nurses, affects the duration and exclusivity of breastfeeding practice after the immediate postpartum period. However, support for low-income women has been neglected and not made available because of generally unsubstantiated claims that it is not cost effective. The breastfeeding intervention used an enhanced traditional community health nurse/peer counselor home visit, which is no longer usual care for contemporary community health nursing practice, along with in-hospital and telephone support. The overall hypothesis was the intervention group will have improved breastfeeding outcomes and will demonstrate a net cost savings over usual care.

The consent form explained the purpose of the study; the actual number of visits and telephone calls (if randomized into the intervention group) and the data collecttion procedures. There were no identified risks for those enrolled in the study. Incentives included $105 if the participant completed each data point.

Eligibility Criteria:
Inclusion Criteria:

* breastfeeding
* low-income (WIC eligible)
* English speaking
* telephone available (includes pager or close family member)
* full-term singleton birth, with no cranio-facial abnormalities
* neonate was admitted to the normal newborn nursery (not the NICU)
* negative drug screen for mother and infant.

Exclusion Criteria:

* inability to meet the above criteria