cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Distracted Driving Campaign

The study will measure the effectiveness of a distracted driving campaign in the emergency department in teenagers, 15 to 18 years old, to determine if it changes their attitudes towards texting while driving. It will also assess previous knowledge and behaviors in this age group, regarding distracted driving and what educational tool (power point vs. videos vs. brochure) has the most impact changing the attitudes towards texting and driving.

Distracted driving is defined by the National Highway Safety Administration (NHTSA) as any activity that could withdraw a person's attention away from the primary task of driving. It includes, talking or texting on a cell phone, grooming, eating or drinking, changing radio stations, or talking to passengers. Of all these activities text messaging is by far the most alarming distraction because it requires visual, manual, and cognitive attention from the driver.

The NHTSA Research Note on distracted driving found that in 2011, 10% percent of fatal crashes were reported as distraction-affected crashes. This research also showed that teens between 15 to 19 years old are currently the largest group with distracted driving affected crashes, with 21% percent of them getting distracted while using their cell phones.

During the last few years, multiple public awareness campaigns have been launched in attempt to reduce this problem. These massive campaigns have included television, radio and internet campaigns, posters, billboards and brochures among others. Nevertheless, there are no studies assessing the success of these methods.

The research project will use visual and verbal educational tools to engage this population in order to maximize the learning process. The project will include brochures, video presentations and power point presentations. The investigators intend to test a potentially new and effective way to teach our teenagers about the dangers of distracted driving. The project primary goal is to assess if a distracting driving campaign in the emergency department is effective in changing the attitudes towards texting while driving. The investigator also intends to assess the current knowledge about distracted driving and to determine which tool (visual vs. verbal) is most effective to deliver this message.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between the ages of 15 to 18 years

Exclusion Criteria:

* Adolescents refusing to participate in the Distracted Driving Campaign.
* Adolescents visiting the emergency department with a chief complaint related to mental illness, suicide ideation or attempt, or any complaint limiting the ability to complete the questionnaire.
* Adolescents with diagnosis of developmental delay that could affect his or her ability to complete the questionnaire.
* Adolescents that do not speak English (the videos about real people who have had accidents while texting and driving found at http://www.distraction.gov/faces/index.html are available only in English.
Risk Factors Associated With Calcification of the Aortic Valve

The purpose of this study is

* to determine the degree of endothelial dysfunction and inflammation in calcific aortic valve disease associated with coronary artery disease(CAD).
* to determine whether there is relationship between calcium metabolism and calcific aortic valve disease associated with CAD.

Cardiovascular disease, mainly coronary artery disease, causes more than one half of deaths in the developed countries. Only recently, calcific aortic valve disease, was proved to belong to the family of atherosclerosis. It is associated with higher cardiovascular morbidity and mortality, the cause of which is not entirely clear. The link to significant coronary artery disease, probably, is of highest importance.

We compare groups of patients with coronary artery disease and calcific stenotic, sclerotic or intact aortic valve. The aim is to assess and compare their risk profile to verify our hypothesis that, within significant coronary artery disease, calcific aortic valve identifies a subgroup of patients with higher cardiovascular risk, assessed by endothelial dysfunction and the two year follow-up of cardiovascular events on optimally set treatment.

Further, we study the possible association of valvular calcification and calcium metabolism in patients with normal kidney function.

Eligibility Criteria:
Inclusion criteria:

* significant stenosis (more than 50% diameter stenosis) of one or more coronary arteries
* aortic sclerosis (group 1) or stenosis (AVA \< 1cm2/m2, or mean gradient ≥ 30 mmHg) (group 2) or normal aortic valve (group 3)

Exclusion criteria:

* Rheumatic heart disease (defined as aortic stenosis with commissural fusion + rheumatic mitral valve disease)
* Status post aortic valve replacement
* Congenital complex heart disease (except bicuspid aortic valve)
* Moderate to severe aortic insufficiency (grade \> 2/4)
* Marfan syndrome
* Infective endocarditis
* Hypertrophic obstruction cardiomyopathy
* Acute coronary syndrome within less than three months
* Severe heart failure, NYHA class IV
* Severe locomotion disability
* Renal failure requiring dialysis
* Significant systemic disease or other disease severely limiting the patient prognosis (e.g. known cancer, liver cirrhosis)
* Primary hyperparathyroidism
* Patient non-compliance
Preventing Intravenous Immunoglobulin-associated Adverse Reactions

In patients treated with the monoclonal antibody infliximab (Remicade®) -which binds to and blocks tumor necrosis factor alpha (TNF-alpha) - an infusomat filter is routinely used to prevent the very same early adverse events observed in individuals receiving intravenous immunoglobulins (IVIG). We recently used such a filter in a patient suffering from malaise and vomiting in the context of an IVIG substitution therapy. In this patient symptoms improved and IVIG-induced complement-activation was reduced (unpublished observation).

Based on this simple observation we hypothesize that this simple and approved filter-system may be efficient in retaining complement-activating immunoglobulin G (IgG) aggregates in IVIG-preparations. This effect may reduce complement activation - and consecutive inflammation - thereby diminishing adverse events.

In this prospective study we propose to investigate how complement activation and side effects after IVIG infusion relate in individuals receiving conventional (i.e. unfiltered) vs. filtered IVIG-preparations.

Prospective single center study with an observational phase (phase A) and a randomized intervention-phase (phase B), monitoring adverse events and complement activation after IVIG infusion. Patients would be enrolled at the Out-patient Clinic of the Division of Hematology at the Department of Internal Medicine at the University Hospital Basel (USB). Based on the number of patients receiving IVIG at the Division of Hematology of the USB we expect to be able to complete data accrual within 8-10 months.

Inclusion criteria: all patients at the Division of Hematology at the University Hospital of Basel, Switzerland after allogeneic stem cell transplant and older than 18 years which are planed for at least 2 applications of IVIG. The patients are included in this study only by informed consent.

Methods: Side effects of IVIG will be monitored by use of a standardized questionnaire distributed to the nursing staff and the patients (please see attachment). Complement activation will be monitored before and after the IVIG-infusion using standard C3, C4 and 50% complement hemolytic activity (CH50) assays. Serum levels of immunoglobulin A, immunoglobulin M and immunoglobulin G will be quantified before and after IVIG-infusion. In phase A of the study we aim at including approximately 40 patients (which would be predicted to include approximately 20 patients with clinical symptoms). In phase B we would randomize these same patients into two groups of similar sizes, the first group receiving standard unfiltered IVIG infusions, the second group receiving 0.2um filtered IVIG infusions

Eligibility Criteria:
Inclusion Criteria:

* All patients at the Division of Hematology at the University Hospital of Basel, Switzerland after allogeneic stem cell transplant and older than 18 years which are planned for at least 2 applications of IVIG. The patients are included in this study only by informed consent.

Exclusion criteria:

* if inclusion criteria not applicable
Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration

This is a study to assess the distribution, metabolism and excretion of \[14C\]AZD6765 after a single-dose intravenous administration.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a normal creatinine clearance of ≥60 mL/min
* Subjects who self-identify their race as Asian

Exclusion Criteria:

* History of any clinically significant medical, neurologic or psychiatric disease as judged by the investigator
* History of symptomatic orthostatic hypotension (ie, postural syncope)
* Subjects who have received any radiolabelled study drug within 12 months of the Screening Visit.
* Subjects who are monitored for radioactivity as part of their occupation
* Subjects who have been exposed to radiation levels above background, (eg, throughX-Ray examinations) of \>5mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1mSv per year of life.
Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis

Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.

Glenohumeral osteoarthritis causes pain, stiffness and weakness in the shoulder joint, and furthermore, it affects activities of daily living and quality of life. Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. Several studies have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments.

The ProAct trial is a Nordic multicenter randomized controlled trial. Patients with glenohumeral osteoarthritis, eligible for a TSA will be randomised to either TSA followed by usual care or exercise only. The exercise intervention consists of 12 weeks of exercise with one weekly physiotherapist-supervised exercise session.

The primary outcome will be the total the Western Ontario Osteoarthritis of the Shoulder index score at 12 months follow-up.Outcome assessment will be performed at baseline, and at 3 and 12 months and 2-, 5- and 10 years after start of surgical/non-surgical treatment.

Patients fulfilling the eligibility criteria but declining to participate in the randomised trial will be offered the option of participating in an observational cohort using the same primary end point and patient reported outcomes, but following usual clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥55-85 years
* Moderate-severe primary OA of the glenohumeral joint according to Samilson and Prieto, by measuring the lower osteophyte (32)
* Eligible for surgery with standard TSA

Exclusion Criteria:

* Surgical need for bonegraft
* Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture)
* Planned other upper extremity surgery within six months
* Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA
* Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
* Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease)
* Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test.
* Unable to communicate in the participating countries respective languages
Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis (DVT) Using Low-Molecular-Weight Heparin (LMWH) Versus LMWH Followed by Warfarin

The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.

Two studies demonstrated that out-of-hospital low-molecular-weight heparin given by twice daily subcutaneous injection without laboratory monitoring was as effective and as safe as continuous intravenous heparin given in-hospital. Innohep (tinzaparin) has been shown to be safe and effective for both the initial and long-term treatment of DVT. The Home LITE study compares long-term Innohep treatment to treatment with a combination of initial low-molecular-weight heparin followed by standard long-term warfarin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a first or recurrent episode of acute proximal vein thrombosis who are eligible for outpatient or home care during the initial therapy.

Exclusion Criteria:

* Any condition which, in the opinion of the investigator, precludes entire out-of-hospital treatment
* Presence of familial bleeding diathesis or the presence of active bleeding contraindicating anticoagulant therapy
* Receiving therapeutic heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis
* Receiving long-term warfarin treatment
* Females who are pregnant
* Known allergy to heparin, warfarin sodium, or bisulfites
* History of heparin-associated thrombocytopenia
* Severe malignant hypertension
* Hepatic encephalopathy
* Severe renal failure
* Inability to attend follow-up due to geographic inaccessibility
* Inability or refusal to give signed informed consent
* Mothers who are breast-feeding and who are unable to refuse to discontinue breast-feeding during study treatment
Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age

This study will establish the relationship between magnitude of opioid exposure and a pupillary measure referred to as PUAL (pupillary unrest in ambient light), in subjects aged 40-60. Previous investigation demonstrated that loss of PUAL was a sensitive, discriminative indicator of opioid toxicity and respiratory depression among subjects aged 20-40 years old. Population data indicate that pupil size and PUAL decline slightly with age. The investigators will explore whether PUAL proves to be a sensitive indicator of opioid exposure and respiratory depression in this older group.

Healthy volunteer subjects aged 40-60 will receive a standardized weight-based 10-minute remifentanil infusion protocol to achieve a peak estimated remifentanil effect site concentration of approximately 6 ng/mL. Pupillary measures will be taken at baseline and regular time intervals during and after the infusion, over a period of 35 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, BMI \< 35 kg/m2

Exclusion Criteria:

* current or recent opioid use
* opioid or other substance use disorder
* known or suspected OSA or sleep disordered breathing
* ischemic heart disease, heart failure or symptomatic arrhythmia history
* ocular disease or previous eye surgery
* active use of alpha adrenergic blockers, anticholinergic medications,
* active use of antidepressant or mood stabilizing medications
* active use of phosphodiesterase inhibitors
* use of stimulant or appetite suppressant medications
* active use of antihypertensive or antiarrhythmic medications
* use of topical eye medications.
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 18 years of age.
2. Prior diagnosis of CLL
3. Must have received ≥ 1 prior therapy for CLL
4. Intolerant of ibrutinib
5. Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria
6. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
7. ECOG performance status of ≤ 2.

Exclusion Criteria:

1. Ongoing AE attributed to ibrutinib therapy
2. Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199)
4. Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years.
5. Significant cardiovascular disease such as uncontrolled or symptomatic untreated arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc \> 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
6. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
7. Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.
8. CNS involvement by CLL or related Richter's transformation.
9. Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.
10. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
11. History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.
12. History of bleeding diathesis.
13. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
14. Major surgical procedure within 28 days of first dose of study drug.
15. Requires treatment with a strong CYP3A inhibitor
Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

A history of breast cancer is a risk factor for the development of endometrial pathologies, such as typical and atypical glandular hyperplasia, endometrial polyps, uterine fibroids, endometrial adenocarcinoma and uterine sarcoma, probably due to some common risk factors (eg. obesity, nulliparity). Even if ethiopathogenesis for breast cancer and endometrial pathologies is not well established, both genetic factors and hyperestrogenic state may be play a pivotal role for their development. Indeed, relative hyperestrogenism is also the main target for the treatment of breast cancer. Currently used therapies for this purpose are selective estrogen receptor (ER) modulators (SERMs), such as Tamoxifen (TAM), and third generation non-steroidal aromatase inhibitors (AIs), such as letrozole and anastrozole.

TAM has both agonist and antagonist properties, depending upon the individual target organ and circulating levels of serum estrogens: on the one hand, it blocks estrogen stimulation in breast tissue; on the other hand, TAM shows an ER agonist activity in the endometrium that is able to stimulate proliferation and, in some cases, it causes an increased risk of uterine pathologies. Women with hormone-dependent breast cancer have to use TAM for five to ten years. Many reports suggest that the risk of uterine pathologies increases with the time of administration.

Considering these elements, the primary aim of this study will be to investigate the incidence of endometrial pathologies, especially of endometrial cancer, in different groups of breast cancer women undergoing diagnostic hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* History of breast cancer treated with surgery (regardless of the adjuvant radio/chemotherapy)

Exclusion Criteria:

* Incomplete data collection
* Recurrence of breast cancer
* Any other concomitant disease
* Any pharmacological treatment (wash-out: 3 months) other than Tamoxifen or Aromatase inhibitors
* Women who switched from a therapy to another one during the study period.
Messages for Increasing Dairy Consumption

Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the recommended number of milk and milk product servings (≤2 servings per day). Given the wide range of health benefits associated with increased dietary intake of milk and milk products the objectives of this study were to conduct a prospective, 5-arm randomised controlled trial in order to test the effectiveness of a variety of messages for increasing milk and milk product consumption in men and women aged 30-50 years old. The five arms consisted of 4 messages that contained slightly different content specifically: 1) gain-framed message condition, 2) loss-framed message condition, 3) self-regulatory efficacy-enhancing message condition, 4) gain-framed and self-regulatory efficacy-enhancing message condition and 5) loss-framed plus self-regulatory efficacy-enhancing message condition. It was hypothesised that those who receive self-regulatory efficacy-enhancing information would consume more dairy than those who received messages without such information. Second, those who received gain-framed messages would consume more dairy as compared to those who received loss-framed messages. Third, those who received gain-framed messages that include self-regulatory efficacy-enhancing information would consume the most dairy in comparison to the other four conditions.


Eligibility Criteria:
Inclusion Criteria:

* Between 30 and 50 years of age
* Consume less than 2 servings of milk or milk products per day
* No health or religious reasons to avoid milk and milk products
* Regular access to the internet
* Can speak and read English

Exclusion Criteria:

* Dietary restrictions, allergies, or medical reasons for limiting dairy intake will be excluded