cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.

OBJECTIVES:

* Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma, melanoma, or sarcoma.
* Determine the 3-, 6-, and 12-month radiographic and neurologic intracranial patterns of progression (i.e., original lesions vs new lesions) in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to maximum tumor diameter (2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm).

Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter. Patients undergo MRI or CT scan at 3, 6, and 12 months after treatment or until disease progression.

All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases, unless there is documented progression or unrelenting mass effect that necessitates craniotomy.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 7.2 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma, melanoma, or sarcoma with 1-3 newly diagnosed intraparenchymal brain metastases based on contrast-enhanced MRI (CT scan acceptable if patients have a medical contraindication to MRI)
* No lesion greater than 4.0 cm in diameter and, if multiple lesions are present, no more than one greater than 3.0 cm in diameter
* No limitation on the extent of extracranial metastatic disease
* No metastases in the brain stem, midbrain, pons, or medulla
* No leptomeningeal metastases documented by MRI or CSF evaluation
* No metastases within 10 mm of optic nerve or chiasm
* No history of multiple liver metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 50,000/mm\^3
* Hemoglobin greater than 8 g/dL

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No major medical illness
* No psychoses
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior chemotherapy allowed
* Systemic chemotherapy may be continued at the discretion of investigator after completion of radiosurgery

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior cranial radiotherapy
* Prior or concurrent radiotherapy to noncranial sites allowed

Surgery:

* No prior surgical resection for brain metastases
* Prior stereotactic biopsy for diagnostic purposes allowed
Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Expansion (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment

This study will be comprised of 2 parts: 1) Part A (Multiple Ascending Dose \[MAD\]) will be conducted to evaluate the safety and tolerability of vesleteplirsen at MAD levels to determine the maximum tolerated dose (MTD), and 2) Part B will be conducted to further evaluate the vesleteplirsen doses selected in Part A. Participants enrolling in Part B will be those who completed Part A or Study 5051-102 (NCT03675126) and meet applicable eligibility criteria for Part B, as well as additional participants who meet applicable eligibility criteria for enrollment at the beginning of Part B.


Eligibility Criteria:
Inclusion Criteria for participants previously treated with Vesleteplirsen:

- Has received prior Vesleteplirsen treatment in Part A of this study or in Study 5051-102.

Exclusion Criteria for participants previously treated with Vesleteplirsen and new participants enrolling into Part B:

- Presence of other clinically significant illness, including cardiac, pulmonary, hepatic, renal, hematologic, immunologic, or behavioral disease, or infection or malignancy or any other condition that, in the Investigator's opinion, could interfere with participation in the trial.

Inclusion Criteria for treatment-naïve participants enrolling into Part B:

* Has a genetic diagnosis of Duchenne muscular dystrophy (DMD) and an out-of-frame deletion mutation of the DMD gene amenable to exon 51-skipping treatment.
* Has been on a stable dose of oral corticosteroids for at least 12 weeks prior to study drug administration and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight), or has not received corticosteroids for at least 12 weeks prior to study drug administration.
* Has stable pulmonary function (forced vital capacity \[FVC\] ≥40% of predicted and no requirement for nocturnal ventilation).

Exclusion Criteria for treatment-naive participants enrolling into Part B:

* History of hypomagnesemia within 12 weeks prior to Screening.
* Initiation or change of dosing (except for modifications to accommodate changes in weight or changes in standard of care) within 12 weeks prior to Screening for any of the following: angiotensin-converting enzyme inhibitors, angiotensin receptor-blocking agents, β-blockers, or potassium.
* Initiation or change of dosing within 12 weeks prior to Screening for over-the-counter preparations, such as herbal/nonherbal supplements, vitamins, minerals, and homeopathic preparations.
* Has a left ventricular ejection fraction (LVEF) \<40.0% based on an echocardiogram (ECHO) performed within 12 weeks prior to Screening or at the Screening Visit.
* Treatment with any exon 51-skipping therapy within 4 weeks prior to Screening, or with any experimental gene therapy for the treatment of DMD at any time.

Other inclusion/exclusion criteria apply.
Use of Bee Wax Mammary Areolae to Improve Breastfeeding

A comparative randomized intervention study is presented between a mixed strategy of use of bee wax mammary areolae. Together with the health education program for the promotion of breastfeeding by the WHO and another educational program with the aim of improving the adherence of breastfeeding to primiparous women. The use of both interventions can contribute to the adherence to exclusive maternity in 20% in the first 6 months of life, than only with the educational program.

The study provides evidence of nursing practice, thus contributing to the improvement of nursing mothers in the prevention of lesions in the nipple and care in them if they occur. Consequently, improve the rates of successful breastfeeding, as well as the quality of life of breastfeeding mothers. The study will be carried out with several groups of midwives in Health Centers, in Spain, Colombia and Mexico. The sample was calculated in 240 women who attend the midwife's controls between week 29 and 40.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women regardless of age.
* Attended in the consultation of midwives of health centers selected for the study.
* Signature of informed consent.

Exclusion Criteria:

* Atopias and dermatological problems.
* No willingness to continue breastfeeding.
* Mental diseases.
* Allergy to the products of the bee.
* No informed consent.
Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)

The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female adults at least 18 years of age.
* A DSM-IV-TR diagnosis of post-traumatic stress disorder (PTSD).
* Naïve to yoga and other meditative practices, defined as less than one hour per week for the past 6 months.
* Potential subjects receiving ongoing medical or psychological treatment are eligible, as long as treatment remains stable over the course of the study and does not include more than one hour weekly of mind-body medicine (strategies directly related to meditation and yoga).
* No more than 2 alcoholic or caffeinated drinks/day
* No illicit drug use
* Potential subjects are eligible if they have been on stable dosage (not PRN) of medication for PTSD symptoms including sleep disturbances and any medication that may influence sleep for at least 6 weeks prior to the study, and be willing to continue with same dosage for the duration of the study.
* No current substance abuse, defined as diagnosis of substance abuse or dependence disorder within the past year, and/or in/outpatient treatment for substance abuse or dependence in the past 6 weeks.
* No transcontinental travel over the course of the study.
* No night-shift or rotating shift work over the course of the study.
* Insomnia based on the American Academy of Sleep Medicine's Research Diagnostic Criteria (RDC) for insomnia due to a mental health disorder
* Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process.

Exclusion Criteria:

- Potential subjects are ineligible if pregnant.
Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study

One of the most recent advances in cataract surgery is microincisional phacoemulsification (MICS). Through small incisions of 2.0 mm and less the lens material is emulsified either bimanually or with a thin single coaxial hand-piece. The possible advantages are lower induced corneal astigmatism1, 2, possibly a lower incidence of infection due to higher resistance of the wound to deformation3 and a lower risk of complications such as iris prolapse during surgery in patients at risk such as with intraoperative floppy iris syndrome (IFIS). Additional factors that have to be taken into account are the construction and the position of the incision and the influence of the extraocular force on the wound morphology.4 Another effect that may influence the wound architecture is stromal hydration at the end of surgery.5 Wound architecture has recently been assessed6-9 using optical coherence tomography. Elkady et al.10 observed the wound architecture in MICS cases focusing on corneal thickness and the incision angle. However, none of these studies observed the effect of the wound architecture on post-operative astigmatism. Furthermore, all observations in the past have been performed in the post-operative period only and information concerning the wound architecture intra-operatively is missing. A recently launched CE-marked intra-operative OCT allows observing the wound architecture intra-operatively.

One aim of the study is to assess the influence of the intra-operative wound architecture using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to deformation of the wound and the surgically induced astigmatism in MICS and small incision cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged incision with a pre-cut should be assessed along the same line


Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract
* Age 21 and older
* written informed consent prior to recruitment

Exclusion Criteria:

* Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
* Any ophthalmic abnormality that could compromise the measurements
The Effect of Dairy and Non-dairy Breakfasts on Satiety and Post-meal Glycemia in Healthy Older Adults

This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt, cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each participant will receive every treatment in this crossover design study.

Regular consumption of dairy is associated with better body composition and lower incidences of type 2 diabetes and obesity. This may be due to dairy's ability to increase satiety and decrease post-prandial glycemia. However, most clinical studies have only investigated isolated dairy proteins (whey and casein) and the effects of whole dairy products, consumed as part of a meal, remain unclear. Additionally, the effect of dairy type and form remain to be further investigated. Therefore, this study will test the effects of dairy products when consumed with a high glycemic index breakfast on satiety and post-prandial glycemia.

Thirty healthy older males and females (60-70 years, BMI 18.5-30.0 kg/m2) will be recruited for the randomized, unblinded, crossover study. Participants will fast overnight, and at baseline will consume 1) 2% milk (250 mL), 2) soy beverage (250 mL), 3) plain 2% Greek yogurt (175 g), 4) cheddar cheese (30 g), or 5) water (250 mL - control). Treatments will be consumed along with 2 pieces of white toast with strawberry jam, except for the water control which will be consumed alone. All breakfast meals will be isocaloric and water will be given with the yogurt (75 mL) and cheese (220 mL) to compensate for fluid content. At 0 (baseline), 15, 30, 45, 60, 90, 120, 150, 180, (pre-meal period) and 210 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes. Between 180-200 minutes, an ad libitum lunch will be provided to assess food intake.

Eligibility Criteria:
Inclusion Criteria:

* Healthy BMI (18.5-30.0 kg/m2)
* Regular breakfast consumers
* Menopausal for at least 1 year (females)

Exclusion Criteria:

* Smoking
* Diabetes
* Fasting blood glucose equal to or higher than 6.0 mmol/L
* Cardiovascular disease
* Medication affecting appetite or metabolism
* Trying to lose or gain weight through a diet or exercise regime
* Lactose intolerance or allergies to study foods
* Score equal to or higher than 11 on Eating Habits Questionnaire
Development of Dysplasia in the Pelvic Pouch in Patients With Ulcerative Colitis (UC) and Risk Factors

The purpose of this study is to study development of dysplasia in the ileal mucosa among patients with Ulcerative Colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.

Objective Some of the rare complications reported in patients with an ileal pouch-anal anastomosis (IPAA) after colectomy for chronic ulcerative colitis are dysplasia and carcinoma. The supposed pathway is for the ileal pouch mucosa to go through adaptational changes then to progress through the phases of chronic pouchitis, dysplasia and subsequently to adenocarcinoma. The purpose of this study is to study development of dysplasia in the ileal mucosa among patients with Ulcerative Colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.

Methods In a cohort of 680 patients having IPAA with a median follow-up time of 18 years, 75 patients with risk factors for dysplasia were identified. Sixty-five patients were eligible for inclusion, fifty-six patients accepted to participate in the study. Patients are invited for clinical examination, endoscopy with macroscopic evaluation as well as mucosal biopsies. The biopsies are reviewed and evaluated by two independent pathologists, experienced in colonic pathology, concerning morphological changes, dysplasia and potential carcinoma Results Architectural structural changes, inflammation and reactive atypia is noted in the rectal cuff and ileal pouch. So far, none of the biopsies showed genuine dysplasia after a follow up for 18 years (Range 12-23 years). In this respect there is full agreement between the two pathologists.

Further microscopic evaluation are planned for the rest of the participating patients.

Eligibility Criteria:
Inclusion Criteria:

* UC (Ulcerative Colitis)
* IPAA
* risk factor for dysplasia

Exclusion Criteria:

* Not able to give consent
* CD (Crohns disease)
Real-life Evaluation of the Daivobet® Gel Applicator

This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Dermatologist or general practitioner has decided to initiate treatment with Daivobet® gel Applicator

Exclusion Criteria:

* Indication not within the approved labelling in France
* Contraindication for treatment with calcipotriol or betamethasone dipropionate
* Informed consent to participate in the study has not been obtained
Pulmonary Hypertension Inspiratory Training

This study is examining the effects of six weeks of inspiratory muscle strength training (IMST) on outcomes related to pulmonary hypertension. This study leverages previous cardiopulmonary exercise test (CPET) results and a pre-existing upcoming CPET to examine the effects of IMST on cardiopulmonary pressures and exercise tolerance and ability.

PH is a condition characterized by abnormally high blood pressure in the lungs (i.e., pulmonary arterial pressure), which impacts heart function and reduces exercise tolerance. This study will assess whether six weeks of a breathing exercise called IMST can improve heart and lung function as well as exercise capacity for individuals with PH.

For this study, patients will be asked to perform IMST for the six weeks prior to their next scheduled clinical standard of care assessment of their PH. The goal of this study is to determine whether IMST reduces pulmonary arterial pressure and improves exercise tolerance in individuals with PH. This study will be minimally invasive, as it simply adds a safe, well-tolerated, non-invasive respiratory training to the participants' standard of care and leverages their existing PH assessment data to evaluate the impact of IMST on PH.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PH defined by clinical guideline criteria
* Must already be scheduled for a clinical assessment of their PH within 8 weeks of enrolling in the study.
* Must have undergone an assessment of their PH in the last 18 months with no major changes in PH management or medication within that period.

Exclusion Criteria:

* Current smoker or have smoked in the last 10 years
* Unable or unwilling to undergo routine functional testing of their PH (i.e., 6-minute walk distance).
* Presence of significant cardiovascular or respiratory conditions other than PH, including but not limited to:

  * Chronic obstructive pulmonary disease
  * Severe asthma
  * Severe ischemic heart disease
  * Left-sided heart failure
* History of a major cardiovascular event, such as a myocardial infarction or stroke, within the last 6 months
* Individuals with an implanted pacemaker or other significant cardiac devices
* History of neurological, respiratory, head and neck, or thoracic surgeries, or conditions such as a collapsed lung or perforated eardrum
* Pregnant individuals or those actively trying to become pregnant
* Individuals with any of the following: chronic laryngitis, chronic bronchitis, emphysema, pneumonia, tuberculosis, chronic cough, extremely high blood pressure (\>170/100), neurological problems, scoliosis, organ transplants, HIV or other immunocompromising conditions, or autoimmune disease.
Two Schemes Response in Multiple Myeloma

Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.

The most current treatment of multiple myeloma is based on a combination of drugs, including immunomodulators, proteasome inhibitors, etc. The VTD (bortezomib, thalidomide, and dexamethasone) and TD (thalidomide and dexamethasone) regimens are commonly used as a first-line treatment due to limited resources. The study aimed to compare the proportion of favorable responses, survival, and time to the next treatment between two different treatment approaches. The investigators designed a retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.

Eligibility Criteria:
Inclusion Criteria:

* clinical records of patients who were considered eligible for transplant due to their functional status and who were given some treatment strategy comprising a combination of drugs.

Exclusion Criteria:

* Incomplete clinical records
* Clinical records of patients who abandoned treatment or could not continue with the treatment due to economic or distance issues
* Clinical records of patients who presented severe sepsis before the beginning of either treatment
Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)

This registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and imaging data (including anatomic and advanced imaging sequences obtained prior to and serially following SRS) will be archived in an online informatics platform, specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for Metastatic Tumors (CONDR - Mets).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 yo) with a pathological diagnosis of metastatic brain cancer
* Participants must have \>4 tumors felt to require stereotactic radiosurgery
* Karnofsky scale of \> 70 at the time of initial treatment
* Age \< 80

Exclusion Criteria:

* Karnofsky scale \<70
* Age \> 80
* Inability to undergo MR imaging studies