cyrilzakka/clinical-trials huggingface dataset:
Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer

Today, the majority of clinically node positive (cN+) breast cancer patients is treated with neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients are areas of controversy. Patients with a pathological complete response (pCR) of the axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND). Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques in terms of oncologic safety and impact on quality of life (QoL) is lacking.

The MINIMAX is a multicenter registry study that includes node positive breast cancer patients, who are treated with NST (chemotherapy and ± immunotherapy), in order to gain insight in the oncologic safety and impact on QoL of less and more invasive axillary staging and treatment strategies.

Patients who are included in this study will complete Patient Reported Outcome Measures (PROMs) at baseline (time of diagnosis), and 1 and 5 years after diagnosis to assess impact on QoL.

A database will be built by the Netherlands Cancer Registry. Data on patient-, tumor-, pre-NST staging-, post-NST staging- and treatment-characteristics will be retrieved from patients' records by trained data registrars of the Netherlands Comprehensive Cancer Organisation (IKNL) using electronic case report forms (eCRFs). Five-year survival and recurrence will be evaluated to determine oncologic safety.

The results will be incorporated in the national guidelines. In case of an equilibrium between less and more invasive strategies, the data of this study will at least be extremely suitable to be used in the shared decision making process.

Eligibility Criteria:
Inclusion Criteria:

* Female patient with unilateral invasive breast cancer and cN1-3
* Pathologically proven positive axillary lymph node
* Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla

Exclusion Criteria:

* Clinically node negative breast cancer before NST
* Bilateral invasive breast cancer
* Neoadjuvant endocrine therapy
* Distant metastases (including oligometastatic disease)
* History of invasive breast cancer
* Other malignancies, except for basal/squamous cell skin cancer, and in situ carcinoma of the cervix or breast
* Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)
Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve

This study is to elucidate the impact of germline mutations and clonal hematopoiesis (CHIP) on the progression of early aortic valve calcification in patients with bicuspid aortic valves. The study will be conducted over a recruitment period of one year and a follow-up observation period of two years. Considering a 2-year event rate and a 33% occurrence rate of clonal hematopoiesis, each group requires a minimum of 102 participants. Accounting for a 15% dropout rate, a total of 120 participants are needed for each group (type I error (α) = 5%, type II error (β) = 20%). Therefore, the total study population, including patients with normal aortic valve function, is set at 240 participants.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with confirmed bicuspid aortic valves based on cardiac imaging (echocardiography, CT, MRI) or surgical findings.
2. Early aortic valve calcification group: Patients aged 20-80 with moderate or greater aortic valve stenosis/regurgitation.
3. Normal functioning aortic valve group: Patients aged 20-80 with mild or less aortic valve stenosis/regurgitation.
4. Patients who understand the purpose of the study and voluntarily consent to participate.

Exclusion Criteria:

1. Patients with malignant neoplastic diseases or other conditions, such as cerebrovascular accidents, which predict survival of less than 6 months.
2. Patients with unclear presence of bicuspid aortic valves.
3. Patients with stage 3 or higher chronic kidney disease.
4. Patients with other inherited cardiac conditions.
5. Patients with cognitive impairment or hemodynamically unstable patients who have difficulty understanding the study content.
Transfusion-requirements in Septic Shock Trial

Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive care unit. The evidence that blood transfusion leads to improved outcome is limited and the blood may be harmful to some of these patients. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in these very sick patients

Background Septic patients often receive red blood cell (RBC) transfusions in the intensive care unit. The evidence that RBC transfusion leads to improved outcome is limited and the intervention may be harmful to some of these patients. In contrast, current guidelines recommend restrictive transfusion of RBC for critical ill patients without septic shock. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in patients with septic shock

Design Pragmatic, multicenter, randomised, outcome assessment-blinded trial of patients with septic shock to RBC transfusion at haemoglobin (Hb) transfusion trigger of 7 g/dl (4.4 mM) or 9 g/dl (5.6 mM), stratified by the presence of haematological malignancy and centre.

Inclusion and exclusion criteria:

To increase the validity of the trial inclusion criteria will be broad with few exclusions

Outcome measures The outcome measures will mainly be patient-important but ICU- and hospital length of stay will also be assessed

Trial size 2 x 500 patients will be needed to show a 9% absolute risk difference in 90-day mortality (baseline mortality of 45%, relative risk reduction 20% (from septic patients in the TRICC trial), alpha of 0.05 (two-sided) and a beta of 0.20 that is a power of 80% (1-beta).

An interim-analysis will be performed after 500 patients. The Data Safety and Monitoring Board (DMSC) will recommend that the trial is stopped if a group-difference in 90-day mortality with p\<0.001.

Time Line The first patient is expected to be randomised December 1st 2011 and the trial database is expected to be closed early 2014. The main manuscript will be submitted shortly thereafter.

Funding The trial is publicly funded by the Danish Strategic Research Council

Eligibility Criteria:
Inclusion Criteria:

* Patient in the ICU AND
* Fulfil the criteria for septic shock AND
* Have haemoglobin of 9.0 g/dl (5.6 mM) or less AND
* Consent obtainable from patient or proxy or national law allows delayed consent

Exclusion Criteria:

* Documented wish against transfusion OR
* Previous serious adverse reaction with blood product OR
* Acute coronary syndrome OR
* Life-threatening bleeding OR
* RBC transfusion during current ICU admission OR
* Withdrawal from active therapy or brain death OR
* Lack of informed consent (depending on national law) OR
* Acute burn injury regardless of degree and burn surface area
The Role of Impact Activity in Peripubertal Bone Accrual

Osteoporosis has been established as a major public health problem, primarily effecting women. The attainment of maximal peak bone mass is crucial in the prevention of osteoporosis, yet little is known about the specifics of bone accrual. Physical activity has been identified as an important modifiable factor controlling bone accrual. It is has been shown that increased activity during peri-pubertal years increase bone mineral content during adulthood. Thus, strategies designed to increase peak bone mass should target the peri-pubertal years of critical bone acquisition.

Hypothesis 1a: The amount of bone mineral accrued during the peri-pubertal years is greater in girls who engage in impact activity than in those who do not.

Hypothesis 1b: The positive effects of impact activity on bone accrual are maintained after cessation of the activity, resulting in greater bone mineral density in girls who participate in impact activity during a portion of the peri-pubertal years than in those who never participated in impact activity.

As above

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 10-12 will be asked to participate
Oral Contraceptive DDI Study

A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal females with a body mass index (BMI) between 18 and 32 kg/m2 (inclusive)
* Have not received any oral contraceptives during the Screening period or for at least 15 days prior to the first dose of Period 1

Exclusion Criteria:

* History of any contraindications to the combined oral contraceptive tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, hormonally-induced migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected)
* Prior exposure to sotagliflozin (LX4211)
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
* Concurrent conditions that could interfere with safety and/or tolerability measurements
* Women who are breastfeeding or are planning to become pregnant during the study
* Positive serum pregnancy test
* Have taken injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1 or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1
Effect of Symptom Management on Inflammation and Survival in Metastatic Lung Cancer

There is a growing body of evidence that implicates inflammation as a mechanism of disease progression and reduced survival in patients with advanced cancer. Elevated c-reactive protein levels have been shown to be associated with reduced performance status, specific cancer related symptoms and reduced overall survival. C-reactive protein levels are a surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer recurrence. VeriStrat® is a multivariate test which measures protein expression related to a host/tumor interaction mediated by inflammation. The investigators hope to examine the relationship between quality of life outcomes per FACT-L survey and correlate them with changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study is that the remarkable survival benefit in the Temel study is mediated by reduced inflammation with improvement of symptom control.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of stage IV non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Able to read and respond to questions in English

Exclusion Criteria:

* Small Cell Lung Cancer
The Impact of a Tobacco Control Intervention in African-American Families

The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:

1. preventing tobacco initiation in youth
2. promoting anti-tobacco socialization in the home
3. decreasing environmental tobacco smoke exposure in children
4. promoting successful cessation in parent/guardian smokers.

Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.

All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.

Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).

Eligibility Criteria:
Inclusion Criteria:

* child being of African-American ethnicity
* in a 4th grade classroom of randomized schools
* parent or guardian that 4th grade child resides with at least 50% of the time
* have access to a telephone or mobile phone

Exclusion Criteria:

* not being a child of African-American ethnicity
* not being a parent or guardian that an eligible child lives with at least 50% of the time
* not having access to a telephone or cell phone
Increasing PrEP Among African Americans in Louisville KY

This study evaluates the effectiveness of a multifaceted strategy to increase pre-exposure prophylaxis (PrEP; a medication regimen to reduce HIV risk) uptake among high risk African Americans in Louisville, KY. We will do this by 1) implementing a media campaign to raise awareness about PrEP, 2) providing PrEP education to medical personnel who can prescribe PrEP, and 3) partnering with AIDS service organizations to improve outreach and linkage to PrEP services.


Eligibility Criteria:
Inclusion Criteria:

* Between ages 18-29 years old
* Self-identifies as African American or Black
* Resident of Louisville, KY
* Member of a priority group for PrEP HIV prevention (Men who have sex with men, people who inject drugs, trans women, high risk heterosexuals, people in serodiscordant relationships).
* Not diagnosed with HIV

Exclusion Criteria:

* Older than 29 and younger than 18 years old
* Does not identify as African American or Black
* Does not reside in Louisville, KY
* Not a member of a priority group
* Diagnosed with HIV
In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol

The rates of cesarean deliveries (CD) and postpartum hemorrhage (PPH) are on the rise, with failed induction and augmentation of labor as major contributing factors. Oxytocin is commonly used for labor induction, as well as during the third stage of labor to minimize the risk of primary PPH. At delivery, it is imperative that the uterus responds effectively to parenteral oxytocin. Poor response to oxytocin following delivery is commonly due to prolonged labor with oxytocin augmentation that is known to "desensitize" the myometrium. Despite the option of several second line uterotonic agents, none of them are as effective as oxytocin in controlling PPH. Given that poor uterine muscle contraction is the root cause of both failed induction or augmentation (leading to a CD in labor) and uterine atony (leading to PPH), there is an urgent and clinically important need to investigate novel methods to enhance oxytocin-induced myometrial contractions.

Propranolol, a beta adrenergic receptor agonist, has the potential to improve myometrial contractions by virtue of its ability to inhibit catecholamine production. The investigators plan to investigate the effects of propranolol in both naive and desensitized myometrium, in order to better understand its potential role in improving labor induction and reducing the risk of PPH following oxytocin exposure during labor.

The investigators hypothesize that propranolol is likely to potentiate the action of oxytocin upon human myometrium, to ultimately help improve the success of labor induction/augmentation and treatment of PPH.

Myometrial samples will be used to investigate the effect of propranolol on uterine contractions when exposed to high and low doses of oxytocin (to simulate PPH treatment and labor induction respectively).

The tissue will also be frozen at the end of the experiment, and Western blotting will be used to investigate the effect of propranolol on the expression patterns and cellular distribution of the oxytocin receptor and beta-adrenergic receptor and their signaling pathways in desensitized myometrium.

Eligibility Criteria:
Inclusion Criteria:

* Patients who give written consent to participate in this study
* Patients with gestational age 37-41 weeks
* Non-laboring patients, not exposed to exogenous oxytocin
* Patients requiring primary Cesarean delivery or first repeat Cesarean delivery

Exclusion Criteria:

* Patients who refuse to give written informed consent
* Patients who require general anesthesia
* Patients who had previous uterine surgery or more than one previous Cesarean delivery
* Patients with any condition predisposing to uterine atony and postpartum hemorrhage, such as abnormal placentation, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, bleeding diathesis, chorioamnionitis, or a previous history of postpartum bleeding
* Emergency Cesarean section in labor
* Patients on medications that could affect myometrial contractility, such as nifedipine, labetolol or magnesium sulfate
Association of Oral Lichen Planus and Thyroid Disease

Thyroid disease is a common endocrine disorder. Oral lichen planus (OLP) is a chronic autoimmune disease that occurs on the oral mucosa in 1-2% of the general population.The purpose of this study was to determine whether there is an association between thyroid disease and oral planus lichen in the population of our patients. In the last few years, a couple of studies have been published in the world literature that have studied the possible association of these diagnoses in different populations. Most of the results showed a higher prevalence of thyroid disease in the population of lichen patients, compared with patients without lichen, although some results are contradictory. Some authors believe that the onset of OLP precedes thyroid dysfunction. In the population of Croatian patients with lichen, no research has been done to study the possible connection between these two diseases. The obtained results could help clarify whether there is a connection between these two diagnoses in the population of our lichen patients and enable earlier detection of patients with thyroid hypofunction.


Eligibility Criteria:
Inclusion Criteria:

* for test group: female patients of the Department of Oral Medicine School of Dental Medicine University of Zagreb with clinically and histopathologically confirmed oral lichen planus
* for control group: female patients of the Department of Oral Medicine School of Dental Medicine University of Zagreb, without oral lichen planus or other immune disorders; age matched to test group

Exclusion Criteria:

* male patients; female patients with immune disorders; female patients which are not age-matched to test group
Circulating Tumor Cells and Tumor DNA in HCC and NET

Background Treatment and control of cancer is associated with high costs, to patients in the form of side effects and discomfort during investigations, to society in the form of expensive drugs and studies.

Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the analysis of the CTC.

The investigators would like to with molecular biological methods predict which patients requires special monitoring and individualized therapy and explore these tests as clinical decision support.

Purpose and method

In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and digital polymerase chain reaction (PCR):

1. Identify and isolate the CTC and investigate these for tumor-specific mutations.
2. Quantify ctDNA and analyze this for specific mutations, which in the past has been found frequent in NET and HCC.
3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies.

The results are compared with the clinical data on disease course, including the effect of treatment and survival.

Subjects 40 Patients with small intestinal/unknown primary NET before treatment with somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30 patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib A blood sample will be taken prior to the start of treatment, after 1 month after start of treatment and thereafter every 3.-6. month for up to two years.

Perspectives In several cancer types molecular diagnostics have had significant influence in treatment and control strategy. The goal is in future to be able to take advantage of a so-called "liquid biopsy" as clinical decision support. The study will bring new knowledge to this growing field of research.


Eligibility Criteria:
Inclusion Criteria:

* one of the above mentioned diseases
* planed surgery, RFA, Somatostatin Analogue, Sorafenib or Everolimus treatment
* signed informed consent

Exclusion Criteria:

* age below 18, concomitant invasive cancer (not skin cancer) and planed emigration of Denmark.
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.


Eligibility Criteria:
Inclusion Criteria:

Subjects enrolled in V59P13:

* healthy subjects who have completed the V59P13 study.

Naïve subjects:

* healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).

Exclusion Criteria:

Subjects who had completed the V59P13 study:

* who received any meningococcal vaccine after the V59P13 trial;
* who have had previous confirmed or suspected disease caused by N. meningitidis;
* who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
* subjects with any serious, acute or chronic progressive disease.

Naïve subjects:

* who previously received any meningococcal vaccine;
* who have had previous confirmed or suspected disease caused by N. meningitidis;
* who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
* subjects with any serious, acute or chronic progressive disease.