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Breast Fibroadenoma clinical trials

View clinical trials related to Breast Fibroadenoma.

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NCT ID: NCT06026176 Completed - Breast Neoplasms Clinical Trials

Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS

Start date: August 1, 2022
Phase:
Study type: Observational

Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD AT BPKIHS Rationale: The Study will help us to know about pattern of presentation of different breast diseases Aims and Objectives: 1. To investigate the pattern of symptoms in patients with Breast diseases 2. To assess the burden of different Breast diseases. Research Hypothesis (if relevant): N/A 1. Material & Methods: 1. Whether study involves Human/animals or both : Human 2. Population/ participants: Files of patients presenting in Surgical OPD with Breast related complaints 3. Type of study design: : Descriptive Research Design 4. Human study : Inclusion Criteria: Patients presenting in Surgical OPD with Breast and related complaints Exclusion Criteria: Those who deny consent for participation. 5. Expected sample size : 823 Sample size calculation: Mentioned in methodology 6. Control groups : N/A 7. Probable duration of study: 365 days 8. Setting: Outpatient Department 9. Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, gender, address. ii. Family History Dependent Variables: i. Clinical symptoms associated with breast disease ii. Type of breast disease (benign or malignant) Outcome measures: Primary (main outcome): All dependent variables (i) Rational for statistical methods to be employed : Retrospective Study Data will be entered in Microsoft Excel and converted it into SPSS for statistical analysis For descriptive studies, percentage, ratio, mean, SD, median will be calculated along with graphical and tabular presentations. For inferential statistics, bivariate analysis will be done using χ2 test and independent t test to find out the significant differences between dependent and independent variables at 95% confidence interval and p-value significant at <0.05. Multivariate logistic regression will be done to adjust for confounding. (ii) Ethical clearance : Ethical clearance will be obtained from Under Graduate Medical Research Protocol Review Board (UM-RPRB) of BPKIHS. (iii) Permission to use copyright questionnaire/Pro forma: Not applicable (j) Maintain the confidentiality of subject Confidentiality of the participants will be maintained. Whether available resources are adequate: Yes 1. Other resources needed: No 2. For Intervention trial: Not applicable A. Permission from Drug Controller of Nepal required/ Not required/Received/ Applied when_____ B. Safety measure C. Plan to withdraw

NCT ID: NCT04341129 Completed - Breast Cancer Clinical Trials

Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)

Start date: July 13, 2020
Phase: Early Phase 1
Study type: Interventional

Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol with ultrafast imaging using Dotarem® (Gadoterate Meglumine).

NCT ID: NCT04297007 Completed - Breast Cancer Clinical Trials

Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Start date: March 23, 2020
Phase: N/A
Study type: Interventional

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries. The primary aim of the study is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

NCT ID: NCT03715413 Completed - Breast Fibroadenoma Clinical Trials

Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia

Start date: August 15, 2018
Phase: Phase 2
Study type: Interventional

Background: Breast pain, mastalgia or mastodynia, is recognized as an organic benign breast disease. Mastalgia may be bilateral, may be in only one breast or part of one breast, and may radiate to the axilla and down the medial aspect of the upper arm. This study aimed to evaluate the additional pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia to the routine regimen treatment of mastalgia tamoxifen 10 mg daily may improve breast pain severity and quality of life. Method: Patients was randomly classified into two groups:Group A (n=13): they was received Tamoxifen 10 mg daily. Group B (n=13): they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. The following parameters were monitored: Primary outcome: VAS after injection and at interval two weeks, 1, 2 and 3 months after injection. Secondary outcome:1-Immediate complications for ex. Hematoma, neurological deficits or respiratory insufficiency (dyspnea or pneumothorax).2-Need for analgesic intake was recorded.3-Side effect of Tamoxifen as nausea, vomiting, hot flashes and dizziness.4-Quality of life (The American Chronic Pain Association's Quality of life scale).

NCT ID: NCT03470051 Completed - Breast Fibroadenoma Clinical Trials

Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology

EVALUATE
Start date: February 26, 2018
Phase:
Study type: Observational

This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.

NCT ID: NCT03022695 Completed - Breast Fibroadenoma Clinical Trials

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

HIFU
Start date: October 2013
Phase: N/A
Study type: Interventional

This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.

NCT ID: NCT02488655 Completed - Breast Fibroadenoma Clinical Trials

Treatment of Breast Fibroadenoma With FastScan HIFU

Start date: June 2015
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.

NCT ID: NCT02139683 Completed - Breast Fibroadenoma Clinical Trials

Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

Start date: January 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

NCT ID: NCT02078011 Completed - Breast Fibroadenoma Clinical Trials

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

HIFU-FA-001
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger). This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.

NCT ID: NCT02011919 Completed - Breast Fibroadenoma Clinical Trials

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

HIFU
Start date: December 2013
Phase: N/A
Study type: Interventional

This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device