cyrilzakka/clinical-trials huggingface dataset:
The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer

Breast cancer is a heterogeneous disease and can be classified into several distinctive subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER), progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2) overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its aggressive clinical behavior and insensitivity toward available targeted treatment strategies such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early relapse with metastatic disease is common and the prognosis is poor. Development Of novel treatment strategies is,therefore,needed and the study of other potential targets in TNBC,like tyrosine kinase receptors,is a topic of interest.

Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR mutation was rare in TNBC.

By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one or more limitations including:1) the study population had received heavily pretreatment; 2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR was not clear in the enrolled patients.

Here, the investigators launch a prospective clinical trial, and about 50 patients with triple-negative,EGFR positive metastatic breast cancer that have received at least second line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in the metastatic TNBC.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* ≥1 measurable or assessable lesion
* Eastern Cooperative Oncology Group(ECOG)performance status of 0-2
* adequate renal,hepatic and hematological function
* a life expectancy of \>12 weeks
* histologically proven EGFR positive metastatic TNBC

Exclusion Criteria:

* brain metastasis
Optimal Dose of a Cognitive Control Training for Depression Vulnerability

This study aims to examine the dose-response relationship of an online adaptive cognitive control training on depressive symptomatology and rumination. Participants will be randomized over six groups, each receiving a different dose (0, 1, 5, 10, 15 or 20 sessions) of a cognitive control training in remitted depressed patients. An adaptive Paced Auditory Serial Addition Task will be used as cognitive control training.

Depression is often associated with cognitive impairments and recent studies have found that for some people, these cognitive problems persist after remission of depression. These cognitive impairments could be a risk factor for recurrence of depressive episodes. Cognitive control training aims to address these cognitive impairments and decrease the risk of recurrence of depression.

One promising operationalization of cognitive control training is the adaptive Paced Auditory Serial Addition Task, but currently, it's unclear how many sessions one should complete in order to obtain cognitive- and emotional transfer effects. By comparing multiple groups with a different number of sessions (0, 1, 5, 10, 15 and 20), with measures at post (one month after baseline) and two follow-up periods (at 3 months and 6 months after baseline), this study examines the effects of an online cognitive control training on depressive vulnerability factors.

Eligibility Criteria:
Inclusion Criteria:

* History of ≥ 1 depressive episode(s)
* Currently in remission (≥ 3 months)
* Access to a computer with an internet connection

Exclusion Criteria:

* Ongoing depressive episode
* Psychotic disorder (current and/or previous)
* Neurological impairments (current and/or previous)
* Excessive substance abuse (current and/or previous)
* Use of antidepressant medication is allowed if kept at a constant level
Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp.
* Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp

Exclusion Criteria:

* Location of the treatment area

  * within 5 cm of an incompletely healed wound
  * within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate gel on the treatment area
* Lesions in the treatment areas that have

  * atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
  * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA).

The study will be a randomized, placebo-controlled, double blind clinical trial in which 250 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study outcome will be incidence of severe or invasive infections. Secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or PCR), incidence of vaso-occlusive crisis (VOC), change in height-for-age z-score, and incidence of zinc-related adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
2. Age range of 1.00-4.99 years, inclusive, at the time of enrollment
3. Weight at least 5.0 kg at the time of enrollment
4. Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion Criteria:

1. Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
2. Severe malnutrition determined by impaired growth parameters as defined by the World Health Organization (WHO) (weight for length/height or height for age z-score \<-3, using WHO growth standards)
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.


Eligibility Criteria:
Inclusion Criteria:

* Patient with LDL-C \>100 mg/dL \& on a stable dose of atorvastatin 20 mg

Exclusion Criteria:

* Pregnant or lactating women or intending to become pregnant
* Patient with sensitivity or intolerance to ezetimibe or atorvastatin
* Patient with diabetes or coronary heart disease
Reminding Patients of the Important of Colorectal Cancer Screening Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy

Colorectal cancer is the third most common cancer diagnosed and third leading cause of cancer-related deaths in the United States for both men and women. The American Cancer Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been dropping as a result of screening and early detection of cancer. In 2007, ACS reported that early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could be prevented each year if eligible patients received screening when necessary. However, despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible US patients are currently being screened.

Specific Aims

The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening. The following three areas will be investigated during this research:

1. To determine whether a communication tool provided to patients will initiate a conversation with their primary care physicians about CRC screening, especially via colonoscopy.
2. To determine whether this tool will impact referral patterns for screening, especially, although not primarily, among poor and underserved populations.
3. To determine whether differences exist in regard to patient-physician communication patterns about screening among residents and faculties in the fields of internal medicine and family practice clinics.

At the close of the investigators study, the investigators wish to organize quantifiable data demonstrating how patient-initiated prompting of primary care physicians for CRC screening increases early detection and decreases potential mortality from colorectal cancer. This data will inform a second, larger study to pursue the questions surrounding patient-initiated prompting in


Eligibility Criteria:
Inclusion Criteria:

* All patient age older than 50, exception for African American age 45 and older
Mechanical Bowel Preparation for Elective Colorectal Anastomosis

Colorectal surgery is highly associated with septic complications, therefore, multiple approaches have been used to reduce this complications, one of the most used is mechanical bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation might not be necessary.

Objective: Compare elective colorectal anastomosis with or without mechanical bowel preparation on outcomes, particularly anastomotic leak, surgical site infection, and ileum.

Materials and methods: A clinical trial was conducted including patients with colorectal pathology who underwent elective colorectal anastomosis. Patients were randomized into two groups; with mechanical bowel preparation (Group 1), and without mechanical bowel preparation (Group 2). Surgical, and non-surgical outcomes were evaluated, including anastomotic leak, surgical site infection, ileum, acute kidney injury, pneumonia, and mortality.

The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages. Inferential analysis with student's t-test, and/or Mann-Whitney's U test; chi-square distribution, and/or Fisher's exact test respectively.

Eligibility Criteria:
Inclusion Criteria:

* Entitlement to the Mexican Institute of Social Security
* Signed informed consent
* Patients with colorectal pathology who needed primary elective colorectal anastomosis
* Body mass index \>18, and \< 31

Exclusion Criteria:

* Patients who dropped out from the study or withdrew the informed consent
* Patients who did not accepted the surgical procedure
* Patients who had been submitted to surgery before entering the protocol
* Patients who need a colostomy
Brain Reaction to Treatment of Nicotine Dependence

The purpose of the study was to determine how the treatments for cigarette craving work.

Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.

PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.

Eligibility Criteria:
Inclusion Criteria:

* Heavy smoker, more than one pack per day
* Free of medical conditions or medications that affect brain activity
* Not pregnant

Exclusion Criteria:

Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.

The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
* IVF cycle attempts ≤ 2.
* Egg age ≤ 40 years.
* Planned Day 3 embryo transfer.
* At least 4 normally fertilized eggs (2PN).
* All 2PN embryos must be imaged by Eeva.
* Ejaculated sperm or sperm from the epididymis (fresh or frozen).
* Willing to comply with study protocol and procedures.
* Willing to provide written informed consent.

Exclusion Criteria:

* Planned preimplantation genetic diagnosis or preimplantation genetic screening.
* Planned "freeze all" cycle (oocytes or embryos).
* Sperm retrieved from testicular tissue.
* Abnormal uterine cavity as evaluated by standard methods.
* Gestational carrier.
* Endometriosis
* Hydrosalpinx.
* History of cancer.
* Concurrent participation in another clinical study.
Mother Daughter Bone Microarchitecture

The aim of this study is to analyze the hereditary determinism of bone microarchitecture measured at the distal radius and distal tibia from a case control-study of mother-daughter pairs.

Many factors influence the risk of osteoporosis but one of the most important is a positive family history, emphasizing the importance of genetics in the pathogenesis of osteoporosis. Till now, most genetic studies in osteoporosis have focused on the phenotype of BMD. However, areal BMD (bone quantity per unit bone area measured) does not provide information regarding bone distribution (between cortical and cancellous compartments) or bone microarchitecture (trabecular number, thickness, spacing and distribution) and cortical (thickness, porosity). We are planning to analyze the hereditary determinism of bone microarchitecture assessed non invasively with HR pQCT at the distal radius and the distal tibia in a case-control study with fractured and not fractured mothers and their daughters. Additionally, the role of the bone turnover, hormones involved in regulating bone metabolism , bone geometry measured at the proximal femur and bone strength estimated by finite element analysis (μFE)in the hereditary determinism of bone fragility will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Case mothers: postmenopausal women who have at least one bone fragility fracture confirmed by radiological examination or by a surgical report. Fragility fracture is a fracture that occurs as a result of a fall from standing height or less. Fractures of the skull, fingers and toes will be excluded.
* Control mothers: menopausal women not having suffered from bone fragility fracture.
* Daughters: Women aged 20 and older (postmenopausal or not), biological daughters of participating mothers. Several daughters from the same mother may be included.

Mothers and some daughters are recruited from the OFELY (Os des FEmmes de LYon) cohort or the FMC (Filière MédicoChirurgicale).

Exclusion Criteria:

* Adoptive daughters
* Nonmenopausal mothers
Treatment of CD20 Antibody Plus CIK for Patients With Refractory Lymphomas

To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.

Autologous CIK transfusion within 3 days post CD20 antibody treatment.

Eligibility Criteria:
Inclusion Criteria:

- diagnosed as B-cell lymphoma with CD20 positiveness, and need to therapy

Exclusion Criteria:

- to refuse the therapy and need not tolerate the therapy
Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study

The investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of seroprevalence between Spring and Fall seasons in a cohort of patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to our unit who had performed SARS-COV-2 serologic test

Exclusion Criteria:

* age \< 18
A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness

This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients who have a clinical diagnosis of schizophrenia as documented in their medical records
* Patients who, in the opinion of the investigator, have had on-going, persistent symptoms of schizophrenia for at least the last 3 months prior to enrolment
* Patients who, in the opinion of the investigator, have been prescribed adequate doses of antipsychotic treatment for at least the last 3 months
* Patient has adequate spoken local language

Exclusion Criteria:

* Acute exacerbation of schizophrenia within the last 3 months prior to enrolment
* Enrolment in an interventional study
ctDNA in Patients With Thyroid Nodules

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test can detect a cancer at a very early stage. The results of this study should help define the role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign thyroid nodules).

After the participants with thyroid nodules or other abnormalities have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to the performance of the fine needle aspiration biopsy of the thyroid. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of thyroid or other cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* presence of one or more thyroid nodules who are going to have a fine needle aspiration biopsy performed as part of their normal care.

Exclusion Criteria:

* Prior history of cancer excluding basal cell carcinoma of the skin.
Correlation of Microvascular Ophthalmic Disease With Macrovascular Coronary Artery Disease in Trinidad

Coronary artery disease (CAD) is the leading cause of death in Trinidad and Tobago. Early detection and management can help improve morbidity and mortality. Retinal artery microvascular disease has been shown to directly correlate with coronary artery disease. Retinal artery calibre screening via the Optic Coherence Tomography (OCT) will provide a non-invasive method of diagnosing CAD.

Cardiovascular disease is the number one cause of death in Trinidad and Tobago. There has been a 20.4% increase in cardiovascular deaths from 2007 to 2017(1). Prevention of non-communicable diseases decreases the burden and progression to cardiovascular disease. Prevention of death from cardiovascular disease can also be decreased by early detection, intervention and appropriate management of coronary artery disease.

Due to the burden of the cost of health care on the economy of Trinidad and Tobago, patients are required to go on a waitlist to receive specialist medical investigation such as a coronary angiogram. This investigation is only offered at one public health facility in Trinidad and Tobago, the Eric Williams Medical Sciences Complex.

Coronary artery disease is graded by a scoring system, the SYNTAX score, which is calculated based on the assessment of the complexity of coronary artery disease by coronary angiography (2). In a study done on 173 patients- the EYE-MI study, patients with the lowest retinal vascular density had a higher SYNTAX score, indicating a direct correlation between retinal artery calibre and the severity of coronary artery disease (3).

Retinal artery calibre is assessed using the Optical Coherence Tomography. It is a relatively affordable non-invasive test performed by an Ophthalmologist that allows three dimensional imaging of the retinal vasculature. It is recommended by the American Association of Ophthalmologist for assessing retinal disease (4). This test is not available in the public health care system in Trinidad and Tobago.

In a country with a Human Capital Index of 0.61 (5), and cardiovascular disease being the number one cause of death, a cheaper non-invasive tool to screen for coronary artery disease would be of benefit to the population. We postulate that there is a direct correlation between the retinal artery calibre assessed by the Optical Coherence Tomography and the severity of coronary artery disease. There are not many studies assessing this relationship and this study will promote further avenues for research into this correlation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years and over,
2. Patients who had a coronary angiogram done at the Catheterisation lab at the Eric Williams Medical Sciences Complex during the study period.

Exclusion Criteria:

1. Patients who do not give informed consent to participate in the study,
2. Patients who are acutely unwell,
3. Patients who are symptomatic for Coronary Artery Disease,
4. Patients with bilateral cataract.