cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

Ultrasound is a well-established imaging modality for the evaluation of breast disease.

The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.

SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.

Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.

The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study.
* Woman scheduled for biopsy or surgery within 1 month from the examination.

Exclusion Criteria:

* Patients who have already performed a biopsy on the lesion during investigation
* Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm)
* Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
* Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
* Pregnant or nursing female
* Patient known to have a coronary syndrome
* Unstable angina and myocardial infarction
* Acute cardiac failure, Class III/IV cardiac failure
* Severe rhythm disorders
* Acute endocarditis
* Prosthetic valves
TD-1211 IV/Oral Mass Balance Study

The purpose of this study is to determine TD-1211 is processed by the body.

This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, nonsmoking male, 18 to 50 years old, inclusive.
2. Agrees to use a highly effective method of birth control.
3. Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.
4. Willing and able to give written informed consent.

Exclusion Criteria:

1. Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
2. Hemoglobin \<14.1 g/dL or hematocrit \< 40.6% at Screening.
3. History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
4. Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]).
5. Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER- (defined by local guidelines) metastatic or inoperable, locally advance breast cancer
* Participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
* Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic scans within 28 days of Day 1 of Cycle 1
* Participants with radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or metastatic breast cancer

Exclusion Criteria:

* HER2-positive disease
* Prior treatment with fulvestrant
* Prior treatment with greater than (\>) 1 cytotoxic chemotherapy regimen or \>2 endocrine therapies for advanced or metastatic disease
Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes

The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 to 60 years
* No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
* Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
* Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
* Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
* Subjects should refrain from use of make-up on testing day
Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients

Influenza is an important public health problem. Organ transplant patients are particularly susceptible to severe disease. Also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. Therefore, improved strategies to prevent influenza in this population is an important public health concern. Standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza vaccines containing adjuvants have become available in Canada but have only limited information in transplant patients. This randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

Adult kidney transplant recipients Greater than 3 months post-transplant

Exclusion Criteria:

Has already received influenza vaccination for 2012-2013 season Egg allergy Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks Unable to provide informed consent Unable to comply with study protocol
Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa

A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).

The clinical trial identifier is PIONEER II. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe HS. HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults must have a diagnosis of HS for at least 1 year prior to Baseline.
* HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
* Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
* Subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of HS.
* Subject must have a total AN count of greater than or equal to 3 at baseline.

Exclusion Criteria:

* Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).
* Subjects on permitted oral antibiotic treatment for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit.
* Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
* If entering the study on concomitant oral analgesics for non-HS related pain:

  * Subject on opioid analgesics within 14 days prior to Baseline visit;
  * Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.

The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of BG2109 alone and in combination with add-back therapy (Estradiol 1 mg / Norethindrone Acetate 0.5 mg) for the treatment of uterine fibroids in China.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject is an 18 years and older premenopausal woman.
2. Subject's Body Mass Index ≥ 18 kg/m2.
3. Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound.
4. Subject's menstrual cycles is between 21 days and 35 days in the last 3 months.
5. Subject has clinical manifestations of heavy menstrual bleeding.
6. Subject's menstrual blood loss \>80mL for at least 2 menstrual periods assessed at screening using the alkaline hematin method.

Key Exclusion Criteria:

1. The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
2. The subject has a history of uterus surgery that would interfere with the study.
3. The subject's condition is so severe that she will require surgery within 6 months.
4. The subject have had or are currently suffering from any estrogen- dependent malignancy.
5. The subject has a significant risk of osteoporosis, or have a known history of osteoporosis or other metabolic bone disease.
Fluoroquinolone Resistance Prevalence Study

This is an exploratory study to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM).

These data may be used in subsequent studies exploring the use of prophylaxis in this patient population.

The goal of this observational study is to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM).

The main question\[s\] it aims to answer are:

* What is the prevalence of fluoroquinolone-resistant Enterobacterales (FRE) in patients undergoing autologous PBSC transplantation with dose-intense melphalan?
* Does the risk of febrile neutropenia differ in FRE carriers compared to non-carriers?

Participants will be tested for the presence of FRE before receiving fluoroquinolone prophylaxis at multiple points during the transplant course, including before chemotherapy mobilization (if used) using fluoroquinolone prophylaxis, at initial transplant hospitalization, at time of hospital discharge, and at or after day 84 after transplantation (day 0 is defined as day of HSC (hematopoietic stem cell) infusion).

FRE colonization will not be a determining factor in the use of fluoroquinolone prophylaxis during the treatment course.

This study will be open at two transplant units: Hackensack University Medical Center (HUMC) and MedStar Georgetown University Hospital (MGUH). Estimated number of subjects to be enrolled;

* HUMC: 124
* MGUH: 20

Anticipated enrollment period: 12-months with monitoring of subjects for 84 days (twelve weeks) after transplantation. Data will be analyzed over a three-month period (total study period of 18 months).

Eligibility Criteria:
Inclusion Criteria:

* Subjects \>18 yrs of age.
* Diagnosis of multiple myeloma undergoing (first or subsequent) autologous PBSC transplantation.
* Transplant conditioning with melphalan 200 mg/m2.
* PBSC cell dose of \>2x10e6 CD34+ cells/kg.
* Able to receive fluoroquinolone prophylaxis.
* Subjects must give consent for enrollment into this study.

Exclusion Criteria:

* Unwillingness to provide informed consent.
* Enrollment into a treatment protocol prescribing antibiotic prophylaxis.
* A diagnosis other than multiple myeloma.
* Receiving a conditioning regimen other than melphalan 200 mg/m2.
* Known light-chain amyloid deposition in any organ.
Apolipoprotein Polymorphisms and Risk of Coronary Heart Disease

To determine the relative risk in a defined population of angiographically demonstrated coronary artery disease due to genetic polymorphisms at the four apolipoprotein genomic regions.

BACKGROUND:

Numerous epidemiological studies have shown that the risk of coronary heart disease is strongly influenced by plasma lipid levels, especially HDL and LDL cholesterol, and their specific apolipoprotein constituents. Genetic studies have established significant heritability of these lipid components, and have also identified relatively rare major genes that result in extreme lipid values and increased risk of coronary heart disease. Geneticists have identified a number of segregating polymorphisms at the four major apolipoprotein genomic regions, using a combination of protein and DNA assays. However, in 1988 when the study was initiated, the relationship between these polymorphisms and risk of coronary heart disease had not yet been properly defined.

DESIGN NARRATIVE:

The study had a case-control design. Cases were consecutively selected from the pool of eligible Latter Day Saints Hospital patients referred for coronary angiogram. Eligibility criteria included residing in the Wasatch County or Southern Idaho counties, being healthy at the time of angiogram and having greater than 60 percent occlusion. Approximately 80-100 controls were retrospectively selected from the clinic records of the past four years. Fasting lipid profiles were defined for cases and controls in terms of total cholesterol, total triglycerides, HDL levels, LDL levels, VLDL levels, density gradient distribution of HDL-LDL subfractions, and levels of apo A-1, apo B, and apo E. The distribution of genetic polymorphisms at the four major apolipoprotein genomic regions was determined by typing all cases and controls for isoforms of apo E and apo AIV and a wide variety of DNA polymorphisms. Approximately 800 first degree relatives of cases and controls were also typed for DNA polymorphisms. Data were collected on risk factors including smoking, alcohol use, obesity, physical activity, and diet. Clinical data included medical and family history of cardiovascular disease and medication status. Multivariate statistical analysis was used to define the relative risk of coronary disease associated with segregating polymorphisms, and DNA haplotypes at these loci in conjunction with lipid profiles and risk factors. Analyses were also conducted on the extent to which the genetic segregation at these apolipoprotein genomic regions influenced the distribution of lipid profiles and whether the distribution of risk factors was influenced by the interaction of environmental risk factors such as smoking and genotypes at these regions.

Eligibility Criteria:
No eligibility criteria
Urdu Version Of ProFitMap-Neck Questionnaire In Population With Chronic Neck Pain A Reliability And Validity Study

The aim of this study is to translate or culturally adapt ProFitMap-neck into Urdu language and to investigate the reliability and validity of the ProFitMap-neck in Pakistani population having chronic neck pain. Also check it's correlation with Neck Disability Index.

As with prior suggestions, the English version of the ProFitMap-neck will be translated and culturally modified.In population having Chronic Neck Pain ProFitMap-neck will be distributed among one hundred and thirty six participants selected by a convenience sampling technique based on pre-defined inclusion and exclusion criteria.The questionnaire will be filled out by two observers on the same day to examine inter and intra-observer reliability of the final ProFitMap-neck and neck disability index. For the inter-observer evaluation, there will be a 2 hour delay between the first and second application. After 7 days, observer-1 will conduct a third assessment (re-testing) for intra-observer evaluation.The Statistical Package of Social Sciences program will be used to examine the data.

Eligibility Criteria:
Inclusion Criteria

Non-specific chronic neck pain Age 18-65 years Neck pain that isn't caused by a traumatic event

Exclusion Criteria

Neck pain due to any type of surgery Neck pain as a result of an injury Neck pain due to broken bone or dislocation Rheumatological issues Pregnant women Any Cardiovascular disorders Any Neurological problems Cord compression Insufficiency of the vertebrobasilar artery
Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

Continuous renal replacement therapies (CRRT) such as continuous venovenous hemofiltration are used to provide renal support for critically ill patients with acute kidney injury (AKI), particularly patients who are hemodynamically unstable. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how CRRT affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving CRRT.

This is a prospective, multi-center, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 16 critically ill patients receiving CRRT support. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive standard of care antibiotics which may include cefiderocol as necessary to treat any current infection.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Receiving CRRT including CVVH, CVVHD, and CVVHDF support.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding;
2. History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication);
3. A hemoglobin less than 8 gm/dl at baseline;
4. Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal;
5. Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator);
6. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies

This study is to determine the appropriate dosing regimen of GS-9820 in subjects with lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL
* Measurable lymphadenopathy
* Requires therapy

Exclusion Criteria:

* Recent history of a major non-lymphoid malignancy
* Evidence of ongoing infection
* Concurrent participation in another therapeutic clinical trial