cyrilzakka/clinical-trials huggingface dataset:
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers

The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.

The Research Question: In female BRCA mutation carriers, will adding DIM (100mg\*1/d, a nutritional supplement), decrease breast density in two years?

Study design: A single center single arm prospective interventional study of the use of DIM to decrease risk of breast cancer among female BRCA carriers.

Study population: Subjects will be female carriers of a BRCA mutation and have more than 10% mammographic breast density at baseline.

Intervention: DIM supplement (100mg\*1/d).

Study Time line: This will be a 2 years study. At initiation a breast mammography will be performed and eligibility assessed. Follow-up visits will occur every 4 months and quality of life questionnaires as well as adherence to DIM supplementation will be assessed. At the initiation and every 4 months blood and urine samples will be collected for Estrogen profile. At 12 and 24 months a mammography will be performed to verify changes in breast density.

Primary Endpoint: A decrease of more than 10% in breast density compared to baseline, following DIM supplementation intervention among female BRCA carriers.

Study impact: Decrease in mammographic breast density was shown to be a good marker for lower risk of breast cancer. This study has the potential to dramatically impact the management of female BRCA carriers. If we prove that by adding a food supplement breast density is decreased, we will change standard of care in these woman. In addition, the urine and blood samples collected during the study will be used for future translational research on the pathogenesis of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women who carrier the BRCA 1\\2 mutation.
* No history of breast or ovarian malignancy.
* i. Baseline mammographic breast density is more than 10% OR ii. Baseline breast MRI with density or enhancement ≤ 2.
* Age 18-70.
* Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule.
* Informed written consent must be signed according to ICH/EU GCP, before subject registration.

Exclusion Criteria:

* Women who have undergone preventive breast reduction.
* Breast imaging demonstrating a lesion suspected to be cancerous.
* Breast feeding or Pregnancy or planning to get pregnant.
* Known allergy to DIM and its ingredients.
Healing Track Clinical Trial

This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP).

The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for CBP.

This study will assess changes in pain intensity from PRT intervention compared to a standard of care (SOC) control group in adults with CBP. SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual.

The research team plans to enroll 180 participants who will be randomized into one of three groups.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 to 70
* Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force
* Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months.
* Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week).
* Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner.
* Able to use a smartphone

Exclusion Criteria:

* Back pain associated with compensation or litigation issues as determined by self-report within the past year
* Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
* Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
* Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder
* Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma

In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.

* Participants will receive radiation therapy for 6 weeks, given in daily doses, Monday through Friday, for a total of 30 treatments.
* A medical history and physical examination will be performed prior to the start of radiation treatment, weekly during the 6 weeks of radiation and after the finish of radiation performed at 3 and 6 months and then annually for 5 years.
* Hormonal function tests will be taken prior to the start of radiation treatment and after the finish of radiation treatment at 3 and 6 months, and annually for five years to assess the participants hormonal functions as they relate to the pituitary gland's function.
* A brain MRI will be performed prior to the start of radiation treatment and then performed at 3 and 6 months after radiation treatment then annually for 5 years.
* A neurocognitive exam will be performed prior to the start of radiation therapy, a limited exam 6 months after the completion of radiation therapy, and a complete exam annually for 5 years.
* Quality of Life and Emotional Well-Being Questionnaires will be done before radiation begins, 2 months after radiation treatment, 6 months after radiation treatment and then annually for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas
* Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater
* KPS of 70 or greater
* 18 years of age or older
* Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable
* Must be able to speak and comprehend English

Exclusion Criteria:

* Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
* Prior history of cranial irradiation
* Pregnancy at the time of radiation treatment
* Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers)
* Comorbid illness or reason to suggest a life expectancy of less than 5 years
Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease

Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma.

Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. This research is being done because current treatment does not help everyone with this disease. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma. Thalidomide has been shown to have activity against other cancers but is not approved by the FDA for treatment of lymphoma. Thalidomide prevents growth of new blood vessels that allow cancer cells to receive nourishment and spread. Another reason for doing the study is that researchers want to learn more about how the drug works and whether some patients respond better than others.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an expected survival period of 6 months or greater and who have been diagnosed with any stage of diffuse large B-cell lymphoma or Hodgkin's disease will be eligible to participate in this study. Final eligibility will be determined by the health professionals conducting this trial.

Exclusion Criteria:

* Women who are pregnant, lactating or who refuse to have a pregnancy test will not be eligible for this study. Also, patients with an active infection, or a history of current or previous deep vein thrombosis and/or currently receiving anticoagulant therapy for deep vein thrombosis will be excluded from participation in this study. Final eligibility will be determined by the health professionals conducting this trial.
Fast-track Discharge After Elective Cesarean Section

Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. However, several aspects need to be considered.

The aim of this project is to evaluate fast-track discharge for multiparas after elective CS concerning neonatal and maternal complications as well as the parents' sense of security and well-being.

The study is a randomized controlled trial including 142 women allocated to either 1) the intention to discharge within 28 hours followed by a home visit or 2) standard discharge after at least 48 hours after elective CS.

This study will be among the first evaluating fast-track discharge after CS in a European context. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS.


Eligibility Criteria:
Inclusion Criteria:

* Planned elective CS of multiparous women
* Singleton pregnancy
* Gestational age at least 37+0 weeks
* Prepregnancy BMI \<35

Exclusion Criteria:

* Lack of consent
* Women with no or little understanding of and ability to speak Danish
* Expected maternal or neonatal complications after delivery
Sientra Post-Approval Study

This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.


Eligibility Criteria:
Inclusion Criteria:

1. Genetic female with US residency
2. Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation
3. Agrees to Sientra study requirements

Exclusion Criteria:

1. Has an active infection anywhere in body
2. Has active cancer without adequate treatment
3. Currently pregnant or nursing
4. Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements
5. If control participant, has undergone breast implant surgery with silicone gel-filled breast implants
A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir

The purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).

This is a multicenter, observational (a study in which the investigators/ physicians observe the patients and measure their outcomes), prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study) designed to reflect routine clinical practice. Approximately 300 Hepatitis C virus (HCV) infected patients who are prescribed simeprevir by their health care provider as part of their routine HCV treatment regimen, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (\<=) 28 days will be enrolled in this and observed to evaluate the effectiveness of a simeprevir. Practice setting features will be documented at the initiation of the study by each participating site. The decision of patients to participate in this study will in no way impact upon the standard of care that they are receiving. All treatment decisions will be made at the discretion of the health care provider. Safety assessments will include assessment of adverse events, and clinical laboratory parameters (hematology, clotting tests, human immunodeficiency virus tests, chemistry, and liver function tests). The maximum study duration for each patient will be approximately 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have genotype 1 chronic hepatitis C infection
* Hepatitis C virus (HCV) ribonucleic acid (RNA) test result above the limit of quantification before initiation of simeprevir-based therapy
* Health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (\<=) 28 days will be enrolled into the study
* Prior HCV treatment must be completed more than 3 months before initiation of simeprevir-based therapy
* In the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine

Exclusion Criteria:

* Non-genotype 1 HCV infected patients
* Absolute contraindication to any component of prescribed HCV treatment per prescribing information
* Patient is currently enrolled in an interventional study
* Past use of an HCV direct-acting antiviral therapy
* Any investigational drug use within 30 days before initiation of simeprevir-based therapy
Reveal® XT Performance Trial (XPECT)

The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety.

The study is a prospective, non-randomized, multi-center international post-market study.

The study will be conducted at 20-30 centers primarily in Europe. The study will be conducted at least in Germany, Austria, Switzerland, The Netherlands, and the Czech Republic. Study centers from Canada may also participate, depending on the timelines for regulatory approval and commercial release of the Reveal® XT in this region.

It is expected that between 140 and 200 patients will be enrolled to ensure that at least 47 patients are included to assess the first primary objective and at least 60 patients to assess the second primary objective.

The primary objective is to quantify the AF detection performance of the device.

The patient population will be assessed in two separate cohorts. The first primary objective is to quantify the 24-hour AF burden accuracy in patients with more than 1% AF burden.

The second primary objective is to quantify the detection accuracy of non-arrhythmia in patients with 1% or less AF burden.

Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to provide his/her informed consent
* Patient has been implanted with a Reveal® XT
* Patient fulfills at least one of the following three additional requirements

  1. is scheduled for PV ablation or surgical rhythm control intervention, and the PV ablation or surgical intervention can be deferred until study completion or
  2. has documented frequent AF or frequent symptoms attributable to AF or
  3. has undergone PV ablation within the last 6 months and still has symptoms attributable to AF

Exclusion Criteria:

* Patient has an implanted pacemaker or ICD
* Patient has persistent or permanent AF
* Patient is allergic to adhesive ECG electrodes
* The study will interfere with a therapeutic or diagnostic procedure which is planned or expected during the study period
* Patient is participating in another study that is expected to compromise the results of this study
* Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study
* Patient is pregnant
A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer

A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis is that the instrument can measure the Brillouin light scattering spectra from the eye safely and effectively from human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 20-60
* No refractional abnormalities
* Clear enough cornea and media to permit imaging

Exclusion Criteria:

* Occludable narrow angles (without a patent peripheral iridotomy)
* Other ocular or systemic pathology, which precludes safe eye dilation
* LASIK eye surgery
* Allergies to the dilation medication
* Only one healthy eye
* Pregnant women or expected pregnancy within the timeframe of the study
* Do not or cannot understand the instructions for the imaging
* Restricted mobility
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body

The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism

This study will include patients who will undergo PRK in both eyes, for each patient each eye will be randomly allocated to one of 2 procedures:

topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other eye (group II).

Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for photoablation.

The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3 and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be compared between the two treatment modalities.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* Myopia with up to -6.5 D with or without astigmatism up to -4.75 D

Exclusion Criteria:

* anterior segment abnormalities (ie, cataracts, corneal scarring)
* basement membrane disease
* history of recurrent corneal erosions
* Schirmer's test less than 5 mm
* established or forme fruste keratoconus
* macular or retinal disease
* current use of immunosuppressive therapy
* autoimmune disease
* pregnancy, and lactation
A Casefinding and Referral System for Older Veterans Within Primary Care

Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services.

Background:

Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services.

Objectives:

Our goal is to improve care for at-risk older veterans through a comprehensive system of casefinding, assessment, referral and follow-up within the primary care setting. We hypothesize that subjects receiving this intervention will have more complete evaluation and treatment for selected geriatric conditions (i.e., falls, urinary incontinence, functional status impairments, depression, and cognitive deficits), better continuity of care, less decline in functional status, and better general health than subjects receiving usual care.

Methods:

This randomized controlled trial is being performed at the Sepulveda VA Outpatient Clinic. The study sample is composed of community-dwelling veterans aged 65 and older who are not receiving VA geriatric services. Veterans are mailed a health screening survey to identify those at risk for decline based on criteria established in pilot work. At-risk respondents who are in the intervention group receive a structured telephone assessment (casefinding) and referral to appropriate geriatric services, including a geriatric assessment and teaching clinic integrated with primary care, and telephone case management. Subjects in the control group receive usual care. Major outcome measures collected by telephone interview at baseline, 12, 24, and 36 months include functional status, self-rated health, satisfaction, and health care utilization. Medical records are reviewed for evidence of evaluation and treatment of the target conditions.

Status:

Data collection for this project was completed on September 30, 2001. The subject recruitment phase was completed in August, 1998. Collection of 36 month follow-up data has been completed for all subjects enrolled. Data analysis and preparation of publication is in press.

Eligibility Criteria:
Inclusion Criteria:

Subjects have to have a score of 4 or higher in a screening questionnaire and have been seen at clinic in the past 18 months.

Exclusion Criteria: