cyrilzakka/clinical-trials huggingface dataset:
Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer

In Europe, breast cancer is by far the most common form of cancer diagnosed in women today, accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and/or trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast cancer patients.

Unfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke, and is the most common non-malignancy cause of death. During the last two decades, RT regimens for breast cancer have changed and the doses of radiation to which the heart is exposed are now potentially lower due to new and improved RT techniques. However, there are no data on whether these new regimes decrease the risk of cardiovascular disease.

In this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and 15 years after both conventional and laser assisted breath controlled RT, and compared with cardiovascular diseases in the general female population. A further aim is to evaluate signs and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic resonance imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac biomarkers and to investigate whether these signs can predict later cardiovascular disease. The importance of traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking habits and physical activity, as registered before RT) will also be evaluated.

The study is an observational study. In 2007-2012 conventional RT was part of the common treatment regime for breast cancer, but has recently been replaced by laser assisted breath controlled RT. Thus, two cohorts of breast cancer patients treated with different modes of RT will be followed for the development of cardiovascular disease for the subsequent 15 years.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast cancer
* expected life-expectancy above 10 years

Exclusion Criteria:

* Not willing to participate
Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

The purpose of this study is to determine if Itacitinib in combination with erlotinib is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB/Stage IV or recurrent whose tumors have EGFR activating mutations.

The study consists of an open-label, safety run-in to confirm the safety of Itacitinibin combination with erlotinib in subjects with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent whose tumors have EGFR activating mutations. Subjects in the safety run-in will receive open-label Itacitinib and erlotinib.

In the second part of the study, subjects will be enrolled and randomized to receive erlotinib (open-label) and either Itacitinib or placebo in a blinded manner. The dose of Itacitinib administered will be determined from the data produced in the safety run-in phase.

Treatment will consist of repeating 21-day cycles. Subjects will take erlotinib tablets daily and Itacitinib/placebo will be self-administered daily during the entire cycle.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB, Stage IV, or recurrent (including Stage II).
* Documented evidence of an activating mutation in EGFR in tumor samples (exon 19 deletions or point mutation L858R in exon 21 or point mutations at codon 719).
* A mGPS of 1 or 2 as defined below:

  * Criteria: C-reactive protein \>10 mg/L AND albumin ≥35 g/L Score-1
  * Criteria: C-reactive protein \>10 mg L AND albumin \<35 g/L Score-2
* Radiographically measurable or evaluable disease.
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.

Exclusion Criteria:

* Known presence of the T790M mutation in EGFR in tumor samples
* Candidates for curative radiation therapy or surgery.
* Previous systemic chemotherapy for advanced disease, including EGFR inhibitor therapy, except subjects who received 1 cycle of chemotherapy while waiting to receive EGFR results, who may enroll provided that 21 days have elapsed from end of chemotherapy to the day to the baseline radiographic measurement prior to Cycle 1 Day 1.
* Distinct or suspected, or history of, pulmonary fibrosis or ILD.
* Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive indolent or Stage I malignancy without sponsor approval.
Vagus Nerve Stimulation as Treatment for Long Covid

Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. To date, fourteen patients provided evaluable data. Eight of these fulfilled the study's requirements for treatment success.

Patients who have had COVID and who fulfill criteria for chronic fatigue syndrome will sign IC and be mailed a parasym device with instructions its use after completing entry baseline questionnaires. Subjects will be called two, four and six weeks after beginning participation \[application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day\] to ask about adverse events. At the end of 6 weeks, patients will complete these questionnaires again plus one assessing their assessment of treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients had to have had COVID
* Patients have to fulfill the 1994 case definition for chronic fatigue syndrome.

Exclusion Criteria:

* BMI \> 30
A Multiple Meal Stable Iron Isotope Study in Iron Deficient Rwandese Women to Investigate the Performance of Low Phytic Acid Bean Seeds

Recent iron absorption studies with biofortified beans indicated that the currently developed beans do not provide an extra amount of iron compared to normal iron beans. This effect was ascribed to the inhibitory nature of phytic acid (PA), which is present in high concentrations. A possible solution to alleviate problems associated with the high PA concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit a good agronomic performance, were tested in a human absorption study in Switzerland and provided a higher amount of bioavailable iron compared to their parent beans with normal PA concentrations. However, the informative value of the study for the real life situation is limited due to the simple study design with a relatively large amount of isotopic label added extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron sufficient women in a non-bean consuming population. Additional investigations are necessary to verify that iron bioavailability from lpa beans is high and that their performance is better compared to common biofortified beans in a real life situation. A multiple meal randomized crossover study in Rwandese women with low iron status will be done to measure iron absorption from three different beans (lpa bean line, biofortified high iron bean, normal iron bean as a control). During the study, the subjects will receive multiple meals to reduce the amount of extrinsic label, therefore more closely simulating hypothetical dietary iron intake from lpa beans. This will also allow to avoid an overestimation of the effect of inhibitors and to minimize the influence of intra subject day to day variation. The study will be divided into two parts. In part one, two of the three bean varieties will be fed as part of composite meals over several days (morning and lunch) and in part two, the remaining bean will be administered as part of composite meals over several days (morning and lunch). Iron absorption from the three varieties will be measured and compared with erythrocyte incorporation of stable isotopic labels 14 days after test meal administration.


Eligibility Criteria:
Inclusion Criteria:

* non pregnant women, non lactating women
* 18-30 years
* \<65 kg

Exclusion Criteria:

* metabolic, chronic or gastrointestinal disease
* long term medication
* blood donation within the last 6 month
Great Saphenous Vein Electrocoagulation

Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. Endovenous electrocoagulation can selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical results has never been studied before.

Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation and radio frequency (RF) endovascular varicose vein treatment clinical results and quality of life improvement in a prospective double blind randomized controlled clinical trial.

Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising, neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical Severity Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained preoperatively, at 3 and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the Mann-Whitney test and Pearson's correlation, considering positive statistical significance when level of p \<0.05.

All patients included in the study will be preoperatively examined to evaluate the severity of venous disease, using the CEAP classification, VCSS and AVVQ. They will undergo venous DS with the aim of investigating GSV insufficiency, its caliber and depth and presence of previous thrombophlebitis.

Patients will be randomized on the day of surgery with an electronic table of random numbers:

Group 1:Electrocoagulation treatment. Group 2: Radiofrequency treatment.

Patients and outcomes assessor will be blinded to the group of endovenous treatment.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic varicose veins of the lower limbs and partial or total failure (venous reflux) of the GSV

Exclusion Criteria:

* Previous varicose vein surgery with removal of the GSV
* Pregnant women
* Patients in use of anticoagulants
* Known thrombophilia
* Presence of saphenous vein tortuosity and/or depth less then 7 mm from the skin
* GSV diameter \< 5mm and \> 12 mm
* Previous deep vein thrombosis
* Peripheral arterial disease.
Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* Smoking status of current smoker in structured field of electronic health record (EHR)
* Language listed as English in EHR
* Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP)
* PCP visit in the past 2 years
* Mobile telephone number listed in EHR

Exclusion Criteria:

* Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking
* Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
* Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.
* Past 30-day use of Massachusetts state quit-line or SmokefreeTXT programs
* Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation
* Ever had an allergy to nicotine patch
* Weight \< 100 pounds
* Unstable coronary disease
* Unstable arrhythmia
* Dementia or active psychosis or schizoaffective disorder
* Willing and able to receive and participate with a text message program for up to 12 weeks
* Unable to read English or unable to write English
Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)

The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD.

This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education) treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18 to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week baseline monitoring phase prior to randomization. Active treatment consists of weekly visits for 8 week, then maintenance treatment for 6 months. Outcome measures include pain, physical and psychosocial function and are assessed at post-treatment, 3-months, and 6-months

Eligibility Criteria:
Inclusion:

* Age \>= 18 and \<= 65
* Pain \>= 3 months duration due to temporomandibular joint disorder
* Pain due to TMD is primary if other pain conditions present

Exclusion:

* Continuous, chronic painful non-reducing disc displacement of TMJ and patient can't open mouth
* Unstable or acute severe pain from another pain condition
* Patient is pregnant
* Presence of a medical condition that contraindicates nortriptyline: angle-closure glaucoma,symptomatic orthosis
* EKG: first degree heart block or QTc \> 450 msec
* Unstable angina or a history of a myocardial infarction within the past 3 months
* Current treatment with an antidepressant which cannot be withdrawn
* Current use of a medication that interacts with nortriptyline to raise blood levels, such as selective serotonin reuptake inhibitors (e.g.,paroxetine), systemic anti-fungal agents (fluconazole), antiarrhythmics (e.g., quinidine), antipsychotics (e.g., haloperidol), and antibiotics (e.g., erythromycin).
* Presence of dementia, psychosis or other disorder of cognition that impairs ability to participate in minimal contact intervention
* Beck Depression Inventory (BDI) score \>= 35 OR BDI Item #9 (suicide item) is scored \> 1
* Patient has a terminal illness with a life expectancy of less than six months
* History of arthrotomy of temporomandibular joint
* History of allergic reaction to nortriptyline or benztropine
* History of a therapeutic trial with nortriptyline (dose \>= 100 mg for at least 3 weeks)
Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems

The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.

Internet-delivered cognitive behaviour therapy (CBT) has emerged as a promising way to administer evidence-based psychological treatments. Mild to moderate major depression has previously been found to treatable via the Internet, with the provision that minimal therapist guidance is given. However, previous research has not taken the issue of comorbidity into account. It is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially. The idea behind the proposed research is to tailor the Internet intervention according to the symptom profile. By used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules. In a randomized trial we want to compare this procedure (e.g., tailored CBT) with the standard Internet-delivered CBT. We will also include a control group in the form of a supervised online discussion group who will later receive CBT.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder
* 15 or more on MADRS-S

Exclusion Criteria:

* Severe depression (more than 35 on MADRS-S or based on interview)
* Severe psychiatric condition (e.g. psychosis or bipolar disorder)
* Changed medication during the last three months
Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent.
* No previous contact lens experience or attempt to try contact lenses (neophyte).
* Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
* Use spectacle lenses for vision correction.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* 45 years or older.
* Prior wear experience with rigid or soft contact lenses.
* Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
* History of ocular surgery/trauma within the last six months.
* Pregnant or nursing women.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Other protocol-defined exclusion criteria may apply.
REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease

Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. The investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. In this project, the investigators aim to establish a well-characterized CHD cohort with comprehensive data collection, good compliance, and an appropriate sample size. By focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (IVUS), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CAD and PCI was successfully performed.
* Presence of non-target lesions near the target lesion (more than 5mm proximal or distal), with stenosis of 20% to 50% and identifiable anatomical markers (e.g., branches, calcifications, stent edges).
* 18 to 75 years old.
* Written informed consent.

Exclusion Criteria:

* Known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset.
* Known familial hypercholesterolemia.
* Critical conditions (e.g., cardiogenic shock, acute heart failure).
* Severe renal insufficiency (eGFR \< 30 mL /(min·1.73m2)), or severe hepatic insufficiency (ALT or AST≥3 times the upper limit of normal).
* Severe underlying diseases (such as end-stage malignancies), life expectancy \< 1 year.
* Allergic to lipid-lowering medications.
* Pregnant, or trying to become pregnant, and breastfeeding women.
* Other conditions deemed unsuitable for inclusion by the researcher.
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma

Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma


Eligibility Criteria:
Main inclusion Criteria:

* written informed consent
* male and female subjects with documented diagnosis of asthma
* age 18 to 65 years
* ACT score 19 or less at screening
* treatment wih oral corticosteroids or hospital or emergency department admission due to asthma exacerbation within the past year
* subject's able to use Easyhaler inhalers and comply with study requirements

Main exclusion Criteria:

* recent (within 1 month) asthma exacerbation
* concomitant major respiratory disease which may complicate the measurement of asthma control
* \>20 pack-year history of smoking
* recent upper or lower respiratory tract infection
* pregnant or lactating female subjects
Actual Use Trial of Naproxen Sodium

An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.


Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age
* Report taking OTC analgesics for pain on at least 5 days in the last month
* Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it
* Able to read and understand English
* Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)
* Provide contact information
* Purchase the investigational product

Exclusion Criteria:

* Have participated in a trial involving OTC analgesics in the last 6 months
* They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)
* Have a history of known allergies to NSAIDs (i.e., naproxen, ibuprofen, aspirin, etc.)
* Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
* (Female subjects) are pregnant or breastfeeding