cyrilzakka/clinical-trials huggingface dataset:
us Elastography and us Doppler in Differentiating Breast Masses

The aim of this study is to compare the diagnostic performance of grey scale US , US elastography \& color Doppler US in differentiating breast masses comparable with histopathology as a gold standard.

Breast cancer is the most fre¬quently diagnosed cancer and the chief cause of cancer death among women worldwide, with an es¬timated 1.7 million cases.

Breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females .so, Its high incidence has led to research on new diagnostic imaging techniques for early diagnosis and to improve patient's mortality rate\[1\].

Application of imaging techniques together with other investigation would help clinical decision making. the most important factor in reducing mortality of certain cancers is an early diagnosis of cancer via screening based on imaging\[2\].

US is an accurate method for detection of breast masses ; however, US has a low accuracy in differentiating between benign from malignant breast masses . US could suggest a malignancy likelihood criteria of a breast mass, such as hypoechogenicity, irregular margins, microcalcifications, increased vascularity by Doppler and us elastography \[3\].

Ultrasound elastography provides a non-invasive evaluation of the "stiffness" of a lesion. Recent studies show that ultrasonographic elastogra¬phy (USE) provides higher diagnostic accuracy together with Doppler application compared with conventional B-mode ultrasonography during breast cancer diagnosis, which eventually helps to reduce false-positive results (ie, increased specificity) and therefore is useful in avoiding breast biopsy\[4\].

US elastography has been used to detect the nature of breast lesions , by measuring the tissue stiffness non invasively. It depends on tissue deformation strain that is caused by external compression. it is complementary to gray scale findings particularly in lesions with indeterminate US findings, also US elastography could be used to guide the follow up of leisons diagnosed as benign at ( FNA) fine needle aspiration.\[5\]\[6\]

Eligibility Criteria:
Inclusion Criteria:

* patients with breast masses referred to our department of diagnostic radiology for radiological assessment.

Exclusion Criteria:

Patients with purely cystic lesions on conventional breast ultrasound. Breast implant. Superficial lesions (\>5 mm deep to skin surface).
Online Study of the Effects of Sugary Drink Warning Labels on Consumption

The aim of this study is to determine the degree to which sugar-sweetened beverages (SSB) warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB purchases and consumption. 216 racially and ethnically diverse parents of children 6-11 years old will be recruited to buy snacks and beverages for four weeks via an online store that ships participants their purchases. Participants will be randomized to either 1) calorie labels (control); or 2) sugar graphic warning labels. The investigators hypothesize that sugar graphic warning labels displayed in an online store in weeks 2-4 will lead to the greatest reductions from week 1 across both primary outcomes compared to the control group that will only see calorie labels.

During this study, participants will shop in an online store created using Shopify for four weeks. In this within-participant design, the first week of shopping is baseline. Participants will then be randomized to different store interfaces for the remaining three weeks based on one of two warning label conditions: 1) calorie labels (control); or 2) sugar graphic warning labels. Participants will complete a brief survey at the start of the study to assess demographic information, information about parent and child beverage consumption, and their online shopping experiences. At the end they will complete another survey about their beverage consumption, their experience shopping in the store, whether they noticed and used the warning labels, and their ability to recall the warning label message. Participants will also be asked about their perceptions of a specific type of warning label in this final survey. Upon completion of the survey, participants will be shown a debriefing statement explaining the study purpose. After they read the information, they will be asked whether or not they consent to allow their data to be used in this study.

Eligibility Criteria:
Inclusion Criteria:

* a primary caregiver of a child 6-to-11 years old;
* \>=18 years old;
* can read and speak English;
* primary grocery shopper for their household;
* have regular Internet access; and
* report that the oldest of their children between 6 and 11 years old is consuming sugar sweetened beverages at least twelve times per month or approximately three times a week

Exclusion Criteria:

* not a primary caregiver of a child 6-to-11 years old;
* \<18 years old;
* cannot read and/or speak English;
* not the primary grocery shopper for their household;
* does not have regular Internet access; and
* does not report that the oldest of their children between 6 and 11 years old is consuming sugar sweetened beverages at least twelve times per month or approximately three times a week
Ultrasound Guidance Versus Anatomical Landmarks for CVC Catheterisation:

anatomical landmarks on the body surface were used to insert central vein catheter. However, ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority of one technique over the other.


Eligibility Criteria:
Inclusion Criteria:

* patients needing CVC

Exclusion Criteria:

* refusal of consent
Variations in Osteoarthritic Knee Laxity Between Individuals and Populations

Severe osteoarthritis of the knee is a condition associated with severe pain, disability and a loss of independence. The most definitive method of surgical treatment for this condition is total knee arthroplasty (TKA). Total knee arthroplasty aims to provide new metallic bearing surfaces within the knee, in order to alleviate the major source of pain.

Although total knee arthroplasty is an established surgical treatment option, up to 20% of patients may be dissatisfied with the outcome , and many prostheses fail over time, requiring costly revision surgery. Current understanding suggests that soft tissue balancing has a crucial role to play in the outcome of total knee arthroplasty. Instability after total knee replacement is an important cause of failure. It is not clear what the normal collateral ligament laxity should be. There is a paucity of current data on normal knee collateral ligament laxity . Nevertheless, restoring this may improve patient satisfaction with TKA and longevity. It appears that there is considerable variation between individuals, genders , and ethnic groups , when it comes to "normal" laxity. However, much of the existing data relates to healthy young volunteers , and it is not clear how this information should map against the elderly osteoarthritic population who are most likely to be in need of TKA. Recent advances in computer assisted navigation have provided surgeons with a more precise measure of knee alignment , and knee laxity .

Orthopaedic surgeons at New Cross Hospital have been utilising this technology to improve intraoperative placement of total knee replacement implants since 2015. Computer navigation is carried out using the Stryker Precision Navigation System. This system records kinematic and static measurements of knee alignment and laxity in patients just prior to the commencement of the total knee replacement procedure.

By gathering and analysing data from this machine, on the degree of laxity in osteoarthritic patients about to undergo TKA, I this study aims to gain a greater understanding of what can be considered "normal" and whether there are significant differences between individuals, and between ethnic populations in this regard. This will help future surgical decision making about how tight or loose prosthetic knee replacements should be, based on individual characteristics.


Eligibility Criteria:
Inclusion Criteria:

* All cases of TKA recorded on the 2 Stryker navigation machines based at New Cross and Cannock Chase Hospitals will be included in the study. Duplicates will be identified and removed from the case series.

Exclusion Criteria:

* Cases in which there is incomplete or inadequate kinematic data recorded in the machine database will be excluded from the study.
Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome

The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.

The investigators propose to use the adverse effects as well as the need for dose reduction as a criterion to judge tolerability of treatment.

The primary endpoint would be hematological response rate according to international myeloma working group (IMWG) response criteria for amyloidosis and neurological response rate defined by overall neuropathy limitation scale (ONLS) score.

This study expects to enroll approximately 41 subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must understand and voluntarily sign an informed consent form.
2. Older than 18 years old at the time of signing consent.
3. Meet the diagnostic criteria of POEM syndrome.
4. Must be cytotoxic treatment naive. However, previous or existing corticosteroid (prednisone or dexamethasone) or intravenous immunoglobin (IVIG) therapy is allowed.
5. Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
6. Male subjects must agree to use condoms throughout study drug therapy.

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or lactating females.
3. Any of the following laboratory abnormalities:

   Absolute neutrophil count(ANC) of\<1.0×10E9 cell/L. Platelet count\<50×10E9 cell/L. Renal failure requiring dialysis. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times of the normal upper limit.
4. Prior history of malignancies, but not including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and T1a or T1b prostate cancer.
5. Known hypersensitivity or prior history of uncontrollable side effects to dexamethasone therapy.
6. Prior use of cytotoxic drugs.
7. Subjects who are unable or unwilling to undergo antithrombotic therapy.
Arthroscopic Treatment Combine With TXA for Elbow Stiffness

This study is a prospective randomized controlled study of different arthroscopic treatments for elbow stiffness combined with tranexamic acid(TXA) injection. The patients with stiffness were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local TXA injection group and a control group (normal saline) to perform additional operations for reduction of hemorrhage. In different time periods, the quantitative and qualitative indicators including pain, functional score, range of motion, level of Hemoglobin, the circumference of the limb 10cm above and below the elbow, amount of hemorrhage, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with TXA on the treatment of reduction of hemorrhage. Determine the effectiveness of TXA.


Eligibility Criteria:
Inclusion Criteria:

Clinically diagnosed patients with elbow stiffness Young and middle-aged patients aged 18 to 60 with failed nonoperated treatment Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients No other comorbidities or medical diseases affect the surgical patients -

Exclusion Criteria:

Elderly people older than 60 years old and patients younger than 18 years old With severe comorbidities or medical diseases affect the surgical patients

-
Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment

Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common symptom whereas life-threatening anaphylaxis is rather rare. A recently published study (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients, disregarding their penicillin skin test results. In the proposed study the investigators will similarly challenge beta-lactam allergic patients, both children and adults for an extended (5 days) period of time. The study will include patients with a history of a skin rash following beta-lactam administration as well as patients who cannot provide any data on their presumed allergic reaction, disregarding their penicillin skin test results.


Eligibility Criteria:
Inclusion Criteria:

* History of skin rash following the administration of beta-lactam antibiotic
* Patients with a diagnosis of penicillin allergy who have no data on the nature of the symptoms that have eventually resulted in establishing this diagnosis

Exclusion Criteria:

* Patients in whom the rash appeared within 1 hour after the last dose of the drug
* Patients who also developed other anaphylactic symptoms
* Patients who had a life-threatening rash such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or DRESS.
* Pregnancy
The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Half of the clinics in the study will be assigned to the OPTIMIZE intervention and half will administer standard care.

African American women and their infants experience profound perinatal health disparities. The purpose of this study is to develop and evaluate the OPTIMIZE intervention, which is an integrated and comprehensive perinatal care checklist with patient navigation support, using a Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial among 600 African American women (15-45 years of age and 1st-2nd trimester of pregnancy) recruited from approximately 20 clinics affiliated with two Chicago area community health center networks that are the largest providers of perinatal care for low-income African American women in Chicago. Clinic sites will be randomized 1:1 to standard perinatal care (control arm) or standard perinatal care plus the OPTIMIZE checklist with Patient Navigation support starting from the initial prenatal visit and up through 12-weeks postpartum (intervention arm).

The study will test the central hypothesis that African American women in the OPTIMIZE intervention group will have received a greater proportion of recommended perinatal care components (prenatal care content, postpartum care content, and social determinants of health content) consistent with American College of Obstetricians and Gynecologists guidelines than African American women in the standard care group.

Eligibility Criteria:
Inclusion Criteria:

* Age 15 to 45 years
* Self-identified as Black/African American
* Pregnant or recently gave birth (less than 6 months post-delivery)
* English speaking

Exclusion Criteria:

* Cognitive impairment
* Incarceration
* Adults unable to consent
Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma

The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.

A series of anonymous questionnaires will be administered to a panel of experts. Each questionnaire administered results in a body of information that is re-presented to the experts before performing the next round. Initial brainstorming questionnaires are open in nature, and are used to generate statements that individual experts would like to see evaluated by their peers. Subsequent ranking questionnaires require that each expert rank each statement according to a pre-defined likert scale. Serial ranking questionnaires are administered electronically and continue until stopping rules are met, or the maximum number of allowed rounds is achieved (capped at three rounds for the present study).

Experts are recruited by invitation or response to open call (see eligibility criteria and url at the end of this declaration.)

Eligibility Criteria:
Inclusion Criteria:

* The expert is either a pulmonologist/respiratory disease specialist, an allergist, an endocrinologist, a paediatrician, a rheumatologist or a patient advocacy organisation representative
* All clinicians involved must manage patients on a weekly basis and have clinical experience in managing disease following oral corticosteroid withdrawal/tapering.
* Patient advocacy organization representatives must represent a relevant patient group (and provide contact information for their group)

Exclusion Criteria:

* Currently employed by a pharmaceutical company, or will have such employment in the upcoming 12 months
* Ownership in a pharmaceutical company or any other conflict of interest with the present study
Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus

The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Type Ⅱ diabetes mellitus
* Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270
* HbA1c between 7 and 11%
* Body mass index (BMI) in the range 21-40
* The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month
* Agreement with written informed consent

Exclusion Criteria:

* Type I diabetes, gestational diabetes or secondary diabetes
* Treatment with insulin(over 1month) within 3 months
* Fasting Plasma Glucose level is over 270 mg/dl
* Triglyceride level is 500 mg/dl and over
* Uncontrollable hypertension
* History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
* Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 3 times as high as upper normal limit(UNL)
* Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
* Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
* In treatment concomitant drug having severe risk drug interaction with investigational drug
* History of cancer within 5 years
* History of drug abuse or alcoholism
* Hepatitis B Antigen(HBsAg) test is positive
* Treatment systemic or inhalant corticosteroids within 1 month prior to Screening
* Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
* Fertile women who not practice contraception with appropriate methods Pregnant women or nursing mothers
* Has a contraindication to treatment investigational drug from the medical and psychogenic side
* Participated in other trial within 4 weeks Participating in other trial at present
* An impossible one who participates in clinical trial by legal or investigator's decision
PatiEnt Neuropsychological outcomeS After laseR Ablation

PatiEnt Neuropsychological outcomeS After laseR ablation

This is a multicenter sub-study that will include comprehensive neuropsychological assessment data collection done at baseline (within 1 year prior to the index LITT procedure) and at follow-up (at least 6 months from the index LITT procedure). Visual field testing will be conducted in a subset of enrolled patients. Up to 250 subjects may be enrolled at up to 15 study sites.

Eligibility Criteria:
Inclusion Criteria:

1. Patient or legally authorized representative provides written authorization and/or consent.
2. Patient is enrolled in the LAANTERN trial and had an epilepsy diagnosis without the presence of a malignant brain tumor.
3. Patient is 16 years of age or older.
4. Patient has completed a baseline comprehensive neuropsychological assessment with a neuropsychologist.

Exclusion Criteria:

1. Patient does not complete the index LITT procedure as specified in the LAANTERN registry.
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients

To investigate the effect of intercostal blockade with and without adjuvants.

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive routine procedure. It's less invasive than thoracotomy but postoperative pain is still a problem.

At Aalborg University Hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing VATS. Adding adjuvants to the blockades may prolong the effect.

The aim of this study is to investigate if intercostal nerve blockade with adjuvants (intravenous (IV) dexamethasone) will result in better pain management.

The primary plan was to evaluate the effect of adding IV dexamethasone and perineural adrenaline, but due to adverse effects, adrenaline was first reduced and later removed from the intervention (amendment protocol N-20200040 approved by the Ethics Committee of Northern Jutland on February 2nd 2021).

Eligibility Criteria:
Inclusion Criteria:

° Consecutive adult patients over 18 years of age scheduled to undergo VATS because of verified/suspected lung cancer.

Exclusion Criteria:

* Inability to understand verbal and written information.
* Preexisting chronic pain condition.
* Preoperative daily treatment with pain medication (Non-opioids, opioids, gabapentin/pregabalin).
* Previous thoracic surgery.
* Previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax.
* Pregnant women.
* Autoimmune neuromuscular diseases (sclerosis, peripheral neuromuscular disorders). General muscle weakness or atrophy.
* Hypersensitivity, allergy or intolerance to dexamethasone, bupivacaine or adrenaline.
* Preoperative epidural anaesthesia.
Conversations With Caregivers About Health and Appearance

This clinical trial is evaluating the effects of a 2-hour, small group discussion with parents and caregivers of adolescents in Oregon. We will evaluate whether parents'/caregivers' experience reductions in their disordered eating symptoms, mood symptoms, and parent-child relationship quality, relative to parent/caregiver participants in the wait list control. We will also evaluate whether the children of these parents/caregivers experience improvements in their disordered eating and mood symptoms.


Eligibility Criteria:
Inclusion criteria for parent/caregiver:

* at least 18 years old
* the primary caregiver of at least one child 12-17 years old who lives with them at least 50% of the time
* living in the state of Oregon
* can read and understand English at the 6th grade level or higher
* access to internet and private space for zoom

Inclusion criteria for the child:

* 12-17 years of age
* can read and understand English at the 6th grade level or higher