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<s>[INST] Provide the recruitment status for trial id: NCT04906330 [/INST] Recruiting </s> |
<s>[INST] Provide the medical condition for trial id: NCT04906330 [/INST] Breast Cancer </s> |
<s>Trial Id: Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT Recruitment Status: Completed Trail description: The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up.
150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT). Inclusion Criteria: Clinical suspected recurrence of breast cancer
Blood glucose level less than 8,0 mmol/L Exclusion Criteria: Disqualified patients
Other malignancies
< 18 years
< 50 kg
> 90 kg
Pregnant or lactating
Patients with permanent address outside of the Region of Southern Denmark
Estimated inability to collaborate </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT01552655 [/INST] Clinical suspected recurrence of breast cancer
Blood glucose level less than 8,0 mmol/L </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT01552655 [/INST] Disqualified patients
Other malignancies
< 18 years
< 50 kg
> 90 kg
Pregnant or lactating
Patients with permanent address outside of the Region of Southern Denmark
Estimated inability to collaborate </s> |
<s>[INST] Provide description for trial id: NCT01552655 [/INST] The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up.
150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT). </s> |
<s>[INST] Provide title for trial id: NCT01552655 [/INST] Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT </s> |
<s>[INST] Provide the recruitment status for trial id: NCT01552655 [/INST] Completed </s> |
<s>[INST] Provide the medical condition for trial id: NCT01552655 [/INST] Breast Cancer Recurrent </s> |
<s>Trial Id: PERSONAL - Sleep In Breast Cancer Recruitment Status: Completed Trail description: Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals. The incidence of insomnia in cancer patients is disproportionality higher, with breast cancer patients experiencing prevalence rates ranging from 19% to 69%. The impact of insomnia on cancer patients' lives can be significant and is associated with depression, cancer-related fatigue, increased pain, reduced quality of life, decreased immunity, disease progression, and survival. To date, breast cancer studies show large variation in reported insomnia prevalence rates, and the severity of sleep complaints in these patients have been difficult to assess. Thus, these issues require further investigation using standardised and validated measures.
In this observational study, we aim to investigate the prevalence and severity of insomnia in a cohort of breast cancer patients at the Christie Hospital using the Insomnia Severity Index (ISI), a validated measure for insomnia. This study will consist of two stages. In Stage 1, patients aged 18 and over, who provide informed consent and have a diagnosis of Stage I, II or III breast cancer in the previous 12 months will be asked to complete the validated ISI. Using the ISI, participants identified as having sleeping difficulties and/or insomnia will be invited to Stage 2 of the study. In this stage, participants will be asked to track their sleep each morning for 3 weeks using a digital sleep diary downloaded onto their own smartphone. They will also be asked to complete a series of questionnaires gathering information regarding their quality of life, well-being, and health. This research will provide a better understanding of sleeping patterns, sleeping difficulties and insomnia in patients with breast cancer, and in the long-term, help us design better treatments for patients with sleeping problems. Inclusion Criteria: None Exclusion Criteria: None </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT05093426 [/INST] None </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT05093426 [/INST] None </s> |
<s>[INST] Provide description for trial id: NCT05093426 [/INST] Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals. The incidence of insomnia in cancer patients is disproportionality higher, with breast cancer patients experiencing prevalence rates ranging from 19% to 69%. The impact of insomnia on cancer patients' lives can be significant and is associated with depression, cancer-related fatigue, increased pain, reduced quality of life, decreased immunity, disease progression, and survival. To date, breast cancer studies show large variation in reported insomnia prevalence rates, and the severity of sleep complaints in these patients have been difficult to assess. Thus, these issues require further investigation using standardised and validated measures.
In this observational study, we aim to investigate the prevalence and severity of insomnia in a cohort of breast cancer patients at the Christie Hospital using the Insomnia Severity Index (ISI), a validated measure for insomnia. This study will consist of two stages. In Stage 1, patients aged 18 and over, who provide informed consent and have a diagnosis of Stage I, II or III breast cancer in the previous 12 months will be asked to complete the validated ISI. Using the ISI, participants identified as having sleeping difficulties and/or insomnia will be invited to Stage 2 of the study. In this stage, participants will be asked to track their sleep each morning for 3 weeks using a digital sleep diary downloaded onto their own smartphone. They will also be asked to complete a series of questionnaires gathering information regarding their quality of life, well-being, and health. This research will provide a better understanding of sleeping patterns, sleeping difficulties and insomnia in patients with breast cancer, and in the long-term, help us design better treatments for patients with sleeping problems. </s> |
<s>[INST] Provide title for trial id: NCT05093426 [/INST] PERSONAL - Sleep In Breast Cancer </s> |
<s>[INST] Provide the recruitment status for trial id: NCT05093426 [/INST] Completed </s> |
<s>[INST] Provide the medical condition for trial id: NCT05093426 [/INST] Insomnia, Breast Cancer </s> |
<s>Trial Id: Identification of New Prognostic Markers for Breast Cancer. Recruitment Status: Recruiting Trail description: Candidate markers have been identified thanks to an original approach developed by our research team aiming at detecting ectopic gene expression using public pan-genomic breast cancer data. The same approach had already been used and validated in lung tumors, leukemias and lymphomas. The main objective of the present research is to use tumor samples from patients in a retrospective and prospective cohort to test and validate the relevance of these prognostic markers in breast cancer. Inclusion Criteria: Adult female patients with breast cancer Exclusion Criteria: Presence of another cancer, excluding basal cell cancers or pre-neoplastic lesions of the cervix.
Subject under guardianship or subject deprived of liberty
Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.)
Male patients </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT03436069 [/INST] Adult female patients with breast cancer </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT03436069 [/INST] Presence of another cancer, excluding basal cell cancers or pre-neoplastic lesions of the cervix.
Subject under guardianship or subject deprived of liberty
Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.)
Male patients </s> |
<s>[INST] Provide description for trial id: NCT03436069 [/INST] Candidate markers have been identified thanks to an original approach developed by our research team aiming at detecting ectopic gene expression using public pan-genomic breast cancer data. The same approach had already been used and validated in lung tumors, leukemias and lymphomas. The main objective of the present research is to use tumor samples from patients in a retrospective and prospective cohort to test and validate the relevance of these prognostic markers in breast cancer. </s> |
<s>[INST] Provide title for trial id: NCT03436069 [/INST] Identification of New Prognostic Markers for Breast Cancer. </s> |
<s>[INST] Provide the recruitment status for trial id: NCT03436069 [/INST] Recruiting </s> |
<s>[INST] Provide the medical condition for trial id: NCT03436069 [/INST] Breast Cancer </s> |
<s>Trial Id: Aberrant Expression of Micro RNA for Diagnosis of Breast Cancer Recruitment Status: Unknown status Trail description: In this study we aim to:
Assess serum miRNA-373, miRNA-425-5p expression in patients with breast cancer.
Explore their correlations with breast cancer clinicopathological documented data including staging, grading and tumor receptors. Inclusion Criteria: Female age 20 years or older
documented diagnosis of breast cancer based on physical examination, imaging and histopathology
possibility of obtaining blood samples from the subject. Exclusion Criteria: All patients with prior history of exposure to chemotherapy, radiotherapy or hormonal therapy .
patients with other malignancies.
patients with chronic inflammatory diseases.
patients with missed documentation for histopathological diagnosis of breast cancer. </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT04720508 [/INST] Female age 20 years or older
documented diagnosis of breast cancer based on physical examination, imaging and histopathology
possibility of obtaining blood samples from the subject. </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT04720508 [/INST] All patients with prior history of exposure to chemotherapy, radiotherapy or hormonal therapy .
patients with other malignancies.
patients with chronic inflammatory diseases.
patients with missed documentation for histopathological diagnosis of breast cancer. </s> |
<s>[INST] Provide description for trial id: NCT04720508 [/INST] In this study we aim to:
Assess serum miRNA-373, miRNA-425-5p expression in patients with breast cancer.
Explore their correlations with breast cancer clinicopathological documented data including staging, grading and tumor receptors. </s> |
<s>[INST] Provide title for trial id: NCT04720508 [/INST] Aberrant Expression of Micro RNA for Diagnosis of Breast Cancer </s> |
<s>[INST] Provide the recruitment status for trial id: NCT04720508 [/INST] Unknown status </s> |
<s>[INST] Provide the medical condition for trial id: NCT04720508 [/INST] Breast Cancer </s> |
<s>Trial Id: What Matters Most: Choosing the Right Breast Cancer Surgery for You Recruitment Status: Completed Trail description: What Matters Most is a study that aims to determine how best to help women of lower socioeconomic status make high-quality decisions about early stage breast cancer treatments. What Matters Most will be comparing two decision aids used in the clinic visit to usual care (what normally happens in the clinic). The first decision aid (Option Grid) presents evidence-based information about lumpectomy and mastectomy in a tabular format using text only. The second decision aid (Picture Option Grid) presents evidence-based information about lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most aims to show that the interventions can reduce disparities in decision-making and treatment choice between women of high and low SES. Inclusion Criteria: Assigned female at birth;
18 years and older;
Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);
Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;
Spoken English, Spanish, or Mandarin Chinese. Exclusion Criteria: Transgender men and women;
Women who have undergone prophylactic mastectomy;
Women with visual impairment;
Women with a diagnosis of severe mental illness or severe dementia;
Women with inflammatory breast carcinoma. </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT03136367 [/INST] Assigned female at birth;
18 years and older;
Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);
Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;
Spoken English, Spanish, or Mandarin Chinese. </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT03136367 [/INST] Transgender men and women;
Women who have undergone prophylactic mastectomy;
Women with visual impairment;
Women with a diagnosis of severe mental illness or severe dementia;
Women with inflammatory breast carcinoma. </s> |
<s>[INST] Provide description for trial id: NCT03136367 [/INST] What Matters Most is a study that aims to determine how best to help women of lower socioeconomic status make high-quality decisions about early stage breast cancer treatments. What Matters Most will be comparing two decision aids used in the clinic visit to usual care (what normally happens in the clinic). The first decision aid (Option Grid) presents evidence-based information about lumpectomy and mastectomy in a tabular format using text only. The second decision aid (Picture Option Grid) presents evidence-based information about lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most aims to show that the interventions can reduce disparities in decision-making and treatment choice between women of high and low SES. </s> |
<s>[INST] Provide title for trial id: NCT03136367 [/INST] What Matters Most: Choosing the Right Breast Cancer Surgery for You </s> |
<s>[INST] Provide the recruitment status for trial id: NCT03136367 [/INST] Completed </s> |
<s>[INST] Provide the medical condition for trial id: NCT03136367 [/INST] Breast Cancer </s> |
<s>Trial Id: Comparison of Ultrasound and Breast MRI for Breast Cancer Detection Recruitment Status: Recruiting Trail description: The goal of this randomized clinical trial is to compare diagnostic results of secondary breast cancer surveillance using breast ultrasound abbreviated MRI and full protocol MRI. Inclusion Criteria: Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasive breast cancer [stage 0-3])
Women with a negative resection margin in the pathology results of the last surgical specimen from past breast cancer
Women with dense breasts with pattern C (heterogeneously dense) or D (extremely dense breasts) using AI-based Lunit INSIGHT for Mammography (version 1.1.4.3, Lunit Inc.) in the most recent mammography
Women who have not had a breast imaging test within 6 months
Women who agreed to undergo regular annual mammography, breast ultrasound, and breast MRI
If mammography, ultrasound, or breast MRI was performed within the last 1 year, the most recent test result is normal or positive (BI-RADS 1 or 2) Exclusion Criteria: Patients with symptoms related to current breast cancer or breast cancer recurrence (palpable mass, bloody or transparent nipple secretion, palpable mass in the axillary region, abnormal skin changes in the breast or nipple)
If you have been diagnosed with regional recurrence (axillary lymph nodes, supraclavicular and subclavian lymph nodes, internal mammary lymph nodes, etc.) or distant metastases
In case of bilateral total mastectomy
If women are receiving chemotherapy for cancer in other organs
Women during pregnancy or lactation
Glomerular filtration rate < 30 mL/min/1.73m2, or patients with renal insufficiency on dialysis
If women have severe claustrophobia
If women have a metal prosthesis that is not suitable for MR (e.g. breast tissue expander, etc.)
If there is a history of severe contrast agent side effects (e.g., anaphylactoid reaction, dyspnea, etc.) </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT05797545 [/INST] Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasive breast cancer [stage 0-3])
Women with a negative resection margin in the pathology results of the last surgical specimen from past breast cancer
Women with dense breasts with pattern C (heterogeneously dense) or D (extremely dense breasts) using AI-based Lunit INSIGHT for Mammography (version 1.1.4.3, Lunit Inc.) in the most recent mammography
Women who have not had a breast imaging test within 6 months
Women who agreed to undergo regular annual mammography, breast ultrasound, and breast MRI
If mammography, ultrasound, or breast MRI was performed within the last 1 year, the most recent test result is normal or positive (BI-RADS 1 or 2) </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT05797545 [/INST] Patients with symptoms related to current breast cancer or breast cancer recurrence (palpable mass, bloody or transparent nipple secretion, palpable mass in the axillary region, abnormal skin changes in the breast or nipple)
If you have been diagnosed with regional recurrence (axillary lymph nodes, supraclavicular and subclavian lymph nodes, internal mammary lymph nodes, etc.) or distant metastases
In case of bilateral total mastectomy
If women are receiving chemotherapy for cancer in other organs
Women during pregnancy or lactation
Glomerular filtration rate < 30 mL/min/1.73m2, or patients with renal insufficiency on dialysis
If women have severe claustrophobia
If women have a metal prosthesis that is not suitable for MR (e.g. breast tissue expander, etc.)
If there is a history of severe contrast agent side effects (e.g., anaphylactoid reaction, dyspnea, etc.) </s> |
<s>[INST] Provide description for trial id: NCT05797545 [/INST] The goal of this randomized clinical trial is to compare diagnostic results of secondary breast cancer surveillance using breast ultrasound abbreviated MRI and full protocol MRI. </s> |
<s>[INST] Provide title for trial id: NCT05797545 [/INST] Comparison of Ultrasound and Breast MRI for Breast Cancer Detection </s> |
<s>[INST] Provide the recruitment status for trial id: NCT05797545 [/INST] Recruiting </s> |
<s>[INST] Provide the medical condition for trial id: NCT05797545 [/INST] Breast Neoplasms, Breast Cancer </s> |
<s>Trial Id: The Effect of Breast Cancer Screening Training Recruitment Status: Active, not recruiting Trail description: The lack of knowledge of women on breast cancer and health literacy poses a major obstacle to people's breast cancer screening behaviors and beliefs. In order to increase social sensitivity and awareness on this issue; In particular, it is important to research, examine and examine how the municipalities and their employees, who are representatives of the society, evaluate breast cancer screening studies. The aim of our project is to evaluate the effect of breast cancer screening training given to women working in the municipality on health literacy, breast cancer screening belief and behavior. This study will be conducted in a randomized-controlled experimental design with women (n=120) working in a municipality in Istanbul Province between November 2022 and November 2023. Data will be obtained face-to-face using the Participant Information Form, the Health Literacy Scale and the Breast Cancer Screening Beliefs Scale. The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers. No application will be made to the control group (n=60). Follow-up evaluations of the research will be completed in the following six months. The Health Literacy Scale and Breast Cancer Screening Beliefs Scale will be re-administered to all women in the experimental and control groups at the first follow-up after three months and at the second follow-up after 6 months. The data will be analyzed with statistical methods and the effectiveness of the training will be evaluated.
When the project is concluded; The results will be presented as an article in a national or international journal, or as an oral presentation at a national or international congress. It will be ensured that breast cancer screening training given to women working in the municipality will increase their level of health literacy, have a positive effect on breast cancer screening belief and behavior, and increase their awareness and knowledge level on this subject. In the long term, widespread effects such as reducing the costs women spend on breast cancer, reducing mortality and morbidity rates, raising a conscious society, training undergraduate students involved in the project, and helping them learn by experiencing the research conducted at the national level are foreseen. Inclusion Criteria: Women aged 18 and over,
Volunteering to participate in the study,
Working in the municipality for at least 1 month and
Not having any communication problems Exclusion Criteria: Women who have any communication barrier and
Do not volunteer to participate in the study will be excluded from the study. </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT05723237 [/INST] Women aged 18 and over,
Volunteering to participate in the study,
Working in the municipality for at least 1 month and
Not having any communication problems </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT05723237 [/INST] Women who have any communication barrier and
Do not volunteer to participate in the study will be excluded from the study. </s> |
<s>[INST] Provide description for trial id: NCT05723237 [/INST] The lack of knowledge of women on breast cancer and health literacy poses a major obstacle to people's breast cancer screening behaviors and beliefs. In order to increase social sensitivity and awareness on this issue; In particular, it is important to research, examine and examine how the municipalities and their employees, who are representatives of the society, evaluate breast cancer screening studies. The aim of our project is to evaluate the effect of breast cancer screening training given to women working in the municipality on health literacy, breast cancer screening belief and behavior. This study will be conducted in a randomized-controlled experimental design with women (n=120) working in a municipality in Istanbul Province between November 2022 and November 2023. Data will be obtained face-to-face using the Participant Information Form, the Health Literacy Scale and the Breast Cancer Screening Beliefs Scale. The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers. No application will be made to the control group (n=60). Follow-up evaluations of the research will be completed in the following six months. The Health Literacy Scale and Breast Cancer Screening Beliefs Scale will be re-administered to all women in the experimental and control groups at the first follow-up after three months and at the second follow-up after 6 months. The data will be analyzed with statistical methods and the effectiveness of the training will be evaluated.
When the project is concluded; The results will be presented as an article in a national or international journal, or as an oral presentation at a national or international congress. It will be ensured that breast cancer screening training given to women working in the municipality will increase their level of health literacy, have a positive effect on breast cancer screening belief and behavior, and increase their awareness and knowledge level on this subject. In the long term, widespread effects such as reducing the costs women spend on breast cancer, reducing mortality and morbidity rates, raising a conscious society, training undergraduate students involved in the project, and helping them learn by experiencing the research conducted at the national level are foreseen. </s> |
<s>[INST] Provide title for trial id: NCT05723237 [/INST] The Effect of Breast Cancer Screening Training </s> |
<s>[INST] Provide the recruitment status for trial id: NCT05723237 [/INST] Active, not recruiting </s> |
<s>[INST] Provide the medical condition for trial id: NCT05723237 [/INST] Women's Health: Neoplasm of Breast </s> |
<s>Trial Id: Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy Recruitment Status: Completed Trail description: The aim of this trial is to investigate the effectiveness of acupuncture on quality of life in patients with breast cancer receiving chemotherapy compared to routine care. Inclusion Criteria: diagnosed breast cancer (invasive, intraductal, hormone-sensitive and not hormone-sensitive, only locoregional metastases)
current chemotherapy at Mammazentrum Hamburg with regimen FEC/DOC or EC/DOC
willingness to receive acupuncture within the next 6 month if randomized in acupuncture group
willingness to refrain from acupuncture within the next 6 month if randomized in control group
informed consent Exclusion Criteria: distant metastases
blood coagulation disorder and/or current use of anticoagulants
serious acute or chronic mental or physical disorders
clinically relevant cardiac arrhythmia symptoms
insufficient German language ability </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT01727362 [/INST] diagnosed breast cancer (invasive, intraductal, hormone-sensitive and not hormone-sensitive, only locoregional metastases)
current chemotherapy at Mammazentrum Hamburg with regimen FEC/DOC or EC/DOC
willingness to receive acupuncture within the next 6 month if randomized in acupuncture group
willingness to refrain from acupuncture within the next 6 month if randomized in control group
informed consent </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT01727362 [/INST] distant metastases
blood coagulation disorder and/or current use of anticoagulants
serious acute or chronic mental or physical disorders
clinically relevant cardiac arrhythmia symptoms
insufficient German language ability </s> |
<s>[INST] Provide description for trial id: NCT01727362 [/INST] The aim of this trial is to investigate the effectiveness of acupuncture on quality of life in patients with breast cancer receiving chemotherapy compared to routine care. </s> |
<s>[INST] Provide title for trial id: NCT01727362 [/INST] Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy </s> |
<s>[INST] Provide the recruitment status for trial id: NCT01727362 [/INST] Completed </s> |
<s>[INST] Provide the medical condition for trial id: NCT01727362 [/INST] Breast Cancer </s> |
<s>Trial Id: Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer. Recruitment Status: Unknown status Trail description: Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.
The purpose of this clinical study is to assess the ability of this novel technology to detect clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.
We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates. Inclusion Criteria: Female
Woman has read, understood and signed the inform consent form
Age: 20 years and older
Women who are asymptomatic for breast cancer
Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models
Women scheduled to undergo routine mammography and/or US or MRI screening Exclusion Criteria: Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
Women who had a lumpectomy surgery
Women who had undergone mastectomy and/or reconstruction
Women who have undergone any type of breast surgery throughout the 6 months preceding the study
Women who have had a breast biopsy performed throughout the 10 weeks preceding the study.
Women who have a fever on the day of the MIRA imaging
Women who are pregnant
Women who are breast-feeding
Women who had undergone breast reduction/augmentation </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT02009150 [/INST] Female
Woman has read, understood and signed the inform consent form
Age: 20 years and older
Women who are asymptomatic for breast cancer
Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models
Women scheduled to undergo routine mammography and/or US or MRI screening </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT02009150 [/INST] Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
Women who had a lumpectomy surgery
Women who had undergone mastectomy and/or reconstruction
Women who have undergone any type of breast surgery throughout the 6 months preceding the study
Women who have had a breast biopsy performed throughout the 10 weeks preceding the study.
Women who have a fever on the day of the MIRA imaging
Women who are pregnant
Women who are breast-feeding
Women who had undergone breast reduction/augmentation </s> |
<s>[INST] Provide description for trial id: NCT02009150 [/INST] Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.
The purpose of this clinical study is to assess the ability of this novel technology to detect clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.
We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates. </s> |
<s>[INST] Provide title for trial id: NCT02009150 [/INST] Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer. </s> |
<s>[INST] Provide the recruitment status for trial id: NCT02009150 [/INST] Unknown status </s> |
<s>[INST] Provide the medical condition for trial id: NCT02009150 [/INST] Breast Cancer </s> |
<s>Trial Id: Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Recruitment Status: Recruiting Trail description: Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (>50%) risk of future life-threatening recurrences and death. Inclusion Criteria: Age ≥18 years.
Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
Surgically resectable disease following neoadjuvant systemic treatment.
At least one of the following must be true:
Received at least 2 weeks of neoadjuvant endocrine therapy
Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination
Provide written informed consent.
Willing to return to enrolling institution for breast cancer surgery.
Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic. Exclusion Criteria: Ineligible for surgery.
History of prior malignancy <3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix). </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT04703244 [/INST] Age ≥18 years.
Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
Surgically resectable disease following neoadjuvant systemic treatment.
At least one of the following must be true:
Received at least 2 weeks of neoadjuvant endocrine therapy
Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination
Provide written informed consent.
Willing to return to enrolling institution for breast cancer surgery.
Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic. </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT04703244 [/INST] Ineligible for surgery.
History of prior malignancy <3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix). </s> |
<s>[INST] Provide description for trial id: NCT04703244 [/INST] Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (>50%) risk of future life-threatening recurrences and death. </s> |
<s>[INST] Provide title for trial id: NCT04703244 [/INST] Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer </s> |
<s>[INST] Provide the recruitment status for trial id: NCT04703244 [/INST] Recruiting </s> |
<s>[INST] Provide the medical condition for trial id: NCT04703244 [/INST] Breast Cancer, Residual </s> |
<s>Trial Id: Breast Cancer Risk Reduction: A Patient Doctor Intervention Recruitment Status: Completed Trail description: The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action. Inclusion Criteria: Patient component:
Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period
Between the ages of 40 and 74
Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White
Have no history of breast cancer are eligible to participate.
Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF Exclusion Criteria: Patient component: Women whose physicians object to their participation in the study
Physician component: No exclusion criteria for physicians </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT01830933 [/INST] Patient component:
Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period
Between the ages of 40 and 74
Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White
Have no history of breast cancer are eligible to participate.
Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT01830933 [/INST] Patient component: Women whose physicians object to their participation in the study
Physician component: No exclusion criteria for physicians </s> |
<s>[INST] Provide description for trial id: NCT01830933 [/INST] The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action. </s> |
<s>[INST] Provide title for trial id: NCT01830933 [/INST] Breast Cancer Risk Reduction: A Patient Doctor Intervention </s> |
<s>[INST] Provide the recruitment status for trial id: NCT01830933 [/INST] Completed </s> |
<s>[INST] Provide the medical condition for trial id: NCT01830933 [/INST] Breast Cancer </s> |
<s>Trial Id: VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer Recruitment Status: Completed Trail description: The purpose of this study is to determine the uptake, (semi-)quantification and localization of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue, surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW is assessed. Another purpose is to assess the abilities of three different fluorescent signal detection systems to detect the fluorescent signal pre- and intra-operatively. Inclusion Criteria: Age ≥ 18 years.
Patients with proven breast cancer (cytology, histology) who are scheduled to receive operation intervention.
Tumor size of at least 15 mm diameter according to anatomical imaging data.
Signed written informed consent.
Able to comply with the protocol.
WHO performance score 0-2. Exclusion Criteria: Other invasive malignancy.
Serious other medical conditions.
Pregnant or lactating women. (Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause).
Prior radiotherapy on the involved area.
Major surgery within 28 days before the initiation of the study.
Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Prior neo-adjuvant chemotherapy.
Breast prosthesis in target breast.
UMC Utrecht (FDOT) specific exclusion criteria
Breast is too big to fit in the biggest cup or is too small to fit in the smallest cup of the FDOT system.
Non-intact skin at time of the FDOT procedures.
Breast located skin diseases.
Piercings or tattoos located on the breast/nipple.
Contra-indication for MR procedures or claustrophobia.
Inability to lay prone positioned for the duration of the FDOT procedure (10 minutes) and MR procedure (30 minutes).
Tumor located close to the chest wall as assessed by breast imaging data. </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT01508572 [/INST] Age ≥ 18 years.
Patients with proven breast cancer (cytology, histology) who are scheduled to receive operation intervention.
Tumor size of at least 15 mm diameter according to anatomical imaging data.
Signed written informed consent.
Able to comply with the protocol.
WHO performance score 0-2. </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT01508572 [/INST] Other invasive malignancy.
Serious other medical conditions.
Pregnant or lactating women. (Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause).
Prior radiotherapy on the involved area.
Major surgery within 28 days before the initiation of the study.
Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Prior neo-adjuvant chemotherapy.
Breast prosthesis in target breast.
UMC Utrecht (FDOT) specific exclusion criteria
Breast is too big to fit in the biggest cup or is too small to fit in the smallest cup of the FDOT system.
Non-intact skin at time of the FDOT procedures.
Breast located skin diseases.
Piercings or tattoos located on the breast/nipple.
Contra-indication for MR procedures or claustrophobia.
Inability to lay prone positioned for the duration of the FDOT procedure (10 minutes) and MR procedure (30 minutes).
Tumor located close to the chest wall as assessed by breast imaging data. </s> |
<s>[INST] Provide description for trial id: NCT01508572 [/INST] The purpose of this study is to determine the uptake, (semi-)quantification and localization of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue, surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW is assessed. Another purpose is to assess the abilities of three different fluorescent signal detection systems to detect the fluorescent signal pre- and intra-operatively. </s> |
<s>[INST] Provide title for trial id: NCT01508572 [/INST] VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer </s> |
<s>[INST] Provide the recruitment status for trial id: NCT01508572 [/INST] Completed </s> |
<s>[INST] Provide the medical condition for trial id: NCT01508572 [/INST] Breast Cancer </s> |
<s>Trial Id: Cyberknife for Early Stage Breast Cancer Recruitment Status: Completed Trail description: This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given. Inclusion Criteria: Patients with stage 0, I, or II (Tis, Ti, or T2 <=3cm & NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion <= 3 cm, treated with wide excision.
Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
No involved axillary lymph nodes by routine histologic examination (H&E) of sentinel node(s) or of nodes identified from axillary dissection.
Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment. Exclusion Criteria: Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
Patients who are pregnant.
Patients who have any histologically confirmed positive axillary nodes.
Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash. </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT03946683 [/INST] Patients with stage 0, I, or II (Tis, Ti, or T2 <=3cm & NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion <= 3 cm, treated with wide excision.
Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
No involved axillary lymph nodes by routine histologic examination (H&E) of sentinel node(s) or of nodes identified from axillary dissection.
Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment. </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT03946683 [/INST] Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
Patients who are pregnant.
Patients who have any histologically confirmed positive axillary nodes.
Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash. </s> |
<s>[INST] Provide description for trial id: NCT03946683 [/INST] This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given. </s> |
<s>[INST] Provide title for trial id: NCT03946683 [/INST] Cyberknife for Early Stage Breast Cancer </s> |
<s>[INST] Provide the recruitment status for trial id: NCT03946683 [/INST] Completed </s> |
<s>[INST] Provide the medical condition for trial id: NCT03946683 [/INST] Early Stage Breast Cancer </s> |
<s>Trial Id: Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer Treatment Planning Recruitment Status: Recruiting Trail description: RadioVal will develop and implement interoperable solutions for clinical deployment of the radiomics tools, including information, training, and communication packages for clinicians and patients, as well as standard operating procedures for the integration of radiomics in clinical oncology. With this study, we will clinically validate these solutions, by looking at their reliability for precise breast cancer diagnosis, treatment recommendation and prognosis estimate, treatment response, evaluation of residual disease and outcome prediction. Inclusion Criteria: Females ≥ 18 years up to 85 years old
Individuals referred to hospitals for diagnosis of breast cancer
Availability of radiological images: 2D mammography or 2D synthetic digital tomosynthesis, ultrasound, or magnetic resonance
Availability of pathological report (surgical specimen)
Availability of (Neoadjuvant) treatment allocation (scheme, duration, benefit)
Availability of treatment response Exclusion Criteria: Patient with incomplete or low-quality data (radiological, pathological or clinical) </s> |
<s>[INST] Provide inclusion criteria for trial id: NCT05070884 [/INST] Females ≥ 18 years up to 85 years old
Individuals referred to hospitals for diagnosis of breast cancer
Availability of radiological images: 2D mammography or 2D synthetic digital tomosynthesis, ultrasound, or magnetic resonance
Availability of pathological report (surgical specimen)
Availability of (Neoadjuvant) treatment allocation (scheme, duration, benefit)
Availability of treatment response </s> |
<s>[INST] Provide exclusion criteria for trial id: NCT05070884 [/INST] Patient with incomplete or low-quality data (radiological, pathological or clinical) </s> |
<s>[INST] Provide description for trial id: NCT05070884 [/INST] RadioVal will develop and implement interoperable solutions for clinical deployment of the radiomics tools, including information, training, and communication packages for clinicians and patients, as well as standard operating procedures for the integration of radiomics in clinical oncology. With this study, we will clinically validate these solutions, by looking at their reliability for precise breast cancer diagnosis, treatment recommendation and prognosis estimate, treatment response, evaluation of residual disease and outcome prediction. </s> |
<s>[INST] Provide title for trial id: NCT05070884 [/INST] Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer Treatment Planning </s> |
<s>[INST] Provide the recruitment status for trial id: NCT05070884 [/INST] Recruiting </s> |
<s>[INST] Provide the medical condition for trial id: NCT05070884 [/INST] Breast Cancer </s> |