cyrilzakka/clinical-trials huggingface dataset:
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS

CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Thus, our aim is to explore the application value of CEUS LI-RADS in contrast-enhanced fusion imaging for focal liver lesions that are not visible on conventional ultrasound in high-risk patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent.

Exclusion Criteria:

Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.
Reproductive Health Survivorship Care Plan

The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life.

Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers have limited guidance on how best to manage these reproductive health late effects. The research team has generated a practical, accessible, evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their providers to address this deficit in survivorship care. This clinical trial will test if YBCS who receive the web-based SCP-R are more likely than controls to improve on at least one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and contraception.

Participants may be recruited from throughout the United States, as all study activities may be done remotely. It is not necessary to live in San Diego or visit UC San Diego to participate in the study.

YBCS who are interested in the study will be provided access to an online screening survey to determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks.

Following a one-week study run in, YBCS participants will be randomized to the SCPR intervention or control arms and receive the corresponding interventions.

All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At each time point, they will complete a web-based study questionnaire on medical and reproductive health. YBCS participants will also daily track their hot flashes via text messaging. YBCS participants will designate a healthcare provider with whom they would discuss reproductive health issues.

Designated healthcare providers will be approached to participate in the study. Those providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time point, HCP will be assessed for preparedness on managing reproductive health issues by a web-based questionnaire.

Eligibility Criteria:
Inclusion:

* Breast cancer (Stages 0-III) diagnosis
* Breast cancer diagnosis age ≤ 45 years
* ≤ 5 years since breast cancer diagnosis
* Current age 18 to 50 years
* Completed treatment with surgery, radiation and chemotherapy (if applicable)
* Able to read English
* Able to consent to the study
* Access to an Internet connection

Exclusion:

• Women who are pregnant at recruitment
Blue Light Intraocular Lenses (IOLs) and Photostress

To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery.

Exclusion Criteria:

* Age related
Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography

To test the ability of electron beam CT in evalting the coronary artery pattern in children with congenital heart disease.

To test the ability of electron beam CT in evalting the coronary artery pattern in children with congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

- TOF, DORV, TGA, CCT

Exclusion Criteria:

-
A Retrospective Assessment of OviTex PRS (OviTex)

The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.

This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction.
3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).

Exclusion Criteria:

1. Patient received a textured permanent breast implant.
2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery.

Additional prospective inclusion criteria (if applicable):

1. Patient agrees to return in-person for prospective portion including the completion of photographs.

Additional prospective exclusion criteria (if applicable):

1. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.
Implementing Inclusive Fraction Intervention Classwide

The main purpose of this study is to assess effects of a previously validated fraction intervention when it is conducted classwide on the fraction knowledge of fourth-grade students with and without math learning difficulties (MLD). The study population is 4th-grade students with MLD and without MLD. Teachers agree to be randomly assigned to two conditions. In one condition, teachers include classwide fraction intervention (CFI) in their standard math program. In the other condition, teachers conduct their standard math program without CFI. CFI is implemented 2 times per week for 20 weeks for about 30 minutes each time. Students in both conditions are tested before and after CFI ends.

The study is conducted in the Metropolitan-Nashville Public Schools. Teachers decide if they want to participate. Parents of students in their classrooms decide if they want their children to participate in the study; participation means students complete the study's pretesting and posttesting, and teachers report their test scores on a school-collected measure. Students decide if they want to participate. Teachers complete a survey, report student scores on the school-collected measure, and are observed during CFI implementation.

Each CFI session comprises 3 segments. In Segment 1 (10-12 minutes), teachers conduct that day's CFI lesson. In Segment 2 (10-12 minutes), students work in pairs, taking turns being "coach" and "player" as they explain their thinking and solution strategies taught in that day's Segment 1. Students use CFI help cards to provide constructive feedback to each other. Segment 3 (5-7 minutes) is independent practice.

The primary end-points are students' posttest fraction ordering, fraction number line estimate, fraction calculations. Secondary end-points are students' performance on more distal fraction measures. Other measures are a teacher survey describing fractions instruction and reliance on CFI procedures and their perceptions of CFI's effectiveness and feasibility, as well as CFI adherence from audio recordings and live observations of teachers implementing CFI.

Eligibility Criteria:
Inclusion Criteria:

* To enter the study, students must meet the following criteria. They must attend a Metropolitan-Nashville Public School whose principal has given permission for his/her school to participate and participate in a fourth-grade classroom whose teacher has agreed to let her/his students participate.

Exclusion Criteria:

* We exclude students with identified intellectual disability from study data collection because CFI is not designed to meet the needs of this population. There are no other exclusions.
This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =\< 35%).


Eligibility Criteria:
Inclusion Criteria:

* Patients must give written informed consent before any assessment is performed.
* Outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =\< 35%) and elevated BNP.
* Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
* Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
* Previous history of intolerance to recommended target doses of ACEIs or ARBs
* Known history of angioedema.
* Requirement of treatment with both ACEIs and ARBs.
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
* Symptomatic hypotension and/or a SBP \< 100 mmHg.
* Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula
* Serum potassium \> 5.2 mmol/L.

Other protocol-defined inclusion/exclusion criteria may apply.
Saliva-based Detection of CD44

The purpose of this study is to test the ability of OncAlert™ to screen for cancer and the reappearance of cancer. OncAlert™ was developed by Vigilant Biosciences, a collaborator in this research study. OncAlert™ is an oral rinse which is spit into a cup and sent to a laboratory for analysis. OncAlert™ is considered experimental by the FDA because it is not approved for the screening of cancer.

A noninvasive point of care salivary rinse test performed as 1) a one-time test for control subjects, 2) at pretreatment and post treatment 3,6, 12, and 18 month time points in oral cavity/oropharynx cancer patients

Eligibility Criteria:
Inclusion Criteria:

* Patient has the ability to understand and the willingness to sign a written informed consent.
* Previously untreated, measurable squamous cell carcinoma of the oral cavity or oropharynx with no evidence of distant metastasis, T1-4N0-3M0
* No prior history of treated upper aerodigestive tract cancer
* No concurrent, second, active malignancy other than oral cavity and/or oropharynx cancer
* Planned to undergo treatment with curative intent
* Able to follow up after therapy at 3, 6, 12, and 18 months after completion of therapy during routine post treatment follow up
* For control subjects: no evidence or history of upper aerodigestive tract cancer
* For control subjects: absence of any suspected or confirmed active malignancy at time of enrollment
* Patients may have had prior therapy for malignancy other than upper aerodigestive malignancy completed 2 years prior to enrollment if they have been disease free since completion of therapy
* Patient is ≥ 18 years of age.
* Both men and women of all races and ethnic groups are eligible for this trial.
* Performance Status ≤ ECOG 3
* Patient is able to gargle and spit 5 cc of saline
* Patients may be concurrently enrolled in other therapeutic or detection clinical trials

Exclusion Criteria:

* Prior completed therapy for an upper aerodigestive tract cancer within the past 3 years.
* Patient unable to gargle and spit 5 cc of saline, or anticipated to be unable to gargle and spit after completion of therapy
* Patient unable or does not intend to undergo curative therapy
* Patient with concurrent, second primary malignancy under active therapy or completed therapy within 2 years prior to enrollment.
Chinese PD-GBA Registry

The purpose of the Chinese Parkinson's disease with GBA variants Registry (CPD-GBAR) is to develop a database of patients of Parkinson's disease with Glucocerebrosidase (GBA) gene variants in mainland China.

Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. GBA gene variants such as L444P can influence the risk of developing PD and these variants have the greatest impact on PD susceptibility among all the PD related gene variants yet discovered. The investigators aim to establish a database of PD with GBA variants and characterize the clinical manifestation of these patients in mainland China.

Method:

1. Peripheral blood from patients has been tested to have GBA gene variants.
2. Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO).
3. The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with GBA gene variants.

Exclusion Criteria:

-
Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged\< 12 years with documented cow's milk protein allergy (CMPA).

Not Provided

Eligibility Criteria:
Inclusion Criteria:

* Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):

  * Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
  * Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum \[sIgE\>0,35 KUI/L\] or skin prick test \[SPT ≥ 3 mm\]) OR
  * Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
* Aged ≤12 years of age at screening.
* Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
* Written informed consent from one or both parents (depending on the local legislation) or legal representative.

Exclusion Criteria:

* Children who receive breastfeeding at study enrolment.
* Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine \[excluding eye drops\] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
* Severe anaphylactic reaction \[required ≥ 2 doses of epinephrine\] to milk or breast milk within the past 2 years;
* Existing illness that could interfere with formula acceptance or identification of allergic reactions.
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis.

The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.

With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1
* Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging
* Moderate to severe endometriosis-associated pelvic pain (EAPP)
* Adherence to screening period diary entries
* Willingness to use only standardized pain medication if needed
* Good general health (except for findings related to endometriosis)
* Normal or clinically insignificant cervical cytology not requiring further follow-up
* An endometrial biopsy performed at the screening phase without significant histological disorder
* Use of an acceptable non-hormonal method of contraception
* Willingness / ability to comply with electronic diary entry for the duration of study participation

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1)
* Hypersensitivity to any ingredient of the study treatments
* Laboratory values outside the inclusion range before randomization, and considered clinically relevant
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including elevated liver enzymes
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Undiagnosed abnormal genital bleeding
* Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator
* Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
* Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol
* Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator
* Inability to cooperate with the study procedures for any reason
* Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias)
* Hypersensitivity to any ingredient of standardized pain medication
* Wish for pregnancy during the study
* Regular use of pain medication due to other underlying diseases
* Non-responsiveness of EAPP to GnRH-a (Gonadotropin-releasing hormone agonists)
Phase I Study of Intravenous Lipotecan® (TLC388 HCl for Injection) in Patients With Advanced Solid Tumors

The purpose of this study is to find a safe and tolerable dose of Lipotecan® when administered to patients with advanced solid tumors.

Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines in vitro and anti-tumor activities in several xenograft models with human tumor cell lines. Structurally, TLC388 HCl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients defined by age ≥18 years.
* Pathologically confirmed advanced solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective
* Evaluable disease, either measurable on imaging or with informative tumor marker(s), by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

Exclusion Criteria:

* Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment. Male and female patients of childbearing potential must agree to use appropriate birth control (barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records).
* Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.
* Receipt of more than 3 prior regimens of chemotherapy.
* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to baseline. Receipt of radiotherapy to \>25 % of bone marrow. Major surgery within 4 weeks prior to baseline.
* Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors or inducers of cytochrome P450 enzymes unless approved by the Sponsor.
* Uncontrolled intercurrent illness that would jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.