cyrilzakka/clinical-trials huggingface dataset:
Biological Factors Associated With Subclinical Valvular Thrombosis

A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).

- The main objective is to determine whether the high residual platelet reactivity rates in patients undergoing TAVI is associated with the occurrence of clinical and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography

For the purpose of the study, platelet reactivity will be measured with the commercial kit PLT VASP/P2Y12 at baseline, 1day and 3 months postprocedure.

Secondary objectives include: -Determine the variability of platelet aggregation measured at baseline before the procedure, 1-day post-procedure and at 3-6 and 1 year follow-up.

* To determine whether the pro-thrombotic inflammatory response measured by the CD14 + and CD16 + quantification observed after TAVI is associated with the appearance of prosthetic thrombosis.
* To evaluate the Correlation of Von Willebrand factor levels and distribution of Von Willebrand multimers with the appearance of prosthetic thrombosis at baseline before the procedure, 1-day post-procedure and at 3, 6 months follow-up and 1 year.
* To determine whether the residual platelet reactivity rates in patients undergoing TAVI are associated with the occurrence of clinical events, at baseline before the procedure, 1-day post-procedure and at 3,6 months follow-up and 1 year
* To evaluate the clinical factors associated with the appearance of early prosthetic thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe symptomatic aortic stenosis who it was accepted to be treated with TAVI by a multidisciplinary team "Heat Team".
* TAVI was successfully implanted (according to Valve Academic Research Consortium II criteria) and are under treatment with double antiplatelet therapy.
* Signed informed consent to participate in this study.

Exclusion Criteria:

* Age under 18 years and pregnant or of childbearing age.
* Acute Recent stroke recent \<14 days before TAVI.
* The patients with proven allergy to aspirin, clopidogrel
* Patients that after TAVI cannot undergo a double antiplatelet regimen for 6 months due to a new post-TAVI medical indication or are anticoagulated.
* Knowledge of pregnancy or lactation Thrombocytopenia (\<50,000 platelets U / L) well documented and clinically relevant.
* The patients with documented moderate or severe hepatic insufficiency
* Severe chronic renal insufficiency with creatinine clearance \<30 ml / min.
* The patients who can not attend the follow-up visits scheduled in the study
Art for Hearts/Black Women's Hearts Paint Night

The purpose of this research study is to learn about different techniques that can be used to increase self-reflection, reduce stress, manage high blood pressure in Black women.

The researchers want to know how Black women process stress and cope with it during the pandemic, and if managing stress related through a tailored stress reduction activity/art program affect psychological and blood pressure outcomes over the course of 2 months. It is possible that this information may help people reduce their stress and get treatment for high blood pressure sooner, which can help prevent other heart problems over time.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American or black
* have a measured blood pressure (BP) of \<140/90 mmHg

Exclusion Criteria:

* Are experiencing cognitive impairment
* Report an untreated psychotic disorder, bipolar disorder, any organic brain syndromes, or substance abuse disorder that the study team believes may result in being a threat to themselves or others
* Report hospitalization for any psychiatric disorder within the past 12 months
Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer

RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.

OBJECTIVES:

* Determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer.
* Determine the objective response rate and duration of response in patients treated with this regimen.
* Determine the acute side effects of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1-3 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not undergoing local treatment receive up to 8 courses. Patients planning to undergo surgery receive up to 4 courses.

Patients are followed every 8 weeks until disease progression and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 13-28 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed penile squamous cell carcinoma

  * Locally advanced or metastatic disease

    * T3, N1-2 OR T4, N3, M1
* Measurable disease outside of any previously irradiated field
* No clinical signs of brain metastases

PATIENT CHARACTERISTICS:

Age

* 75 and under

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)
* Transaminases no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)

Renal

* Glomerular filtration rate at least 60 mL/min

Gastrointestinal

* No chronic diarrhea
* No unresolved bowel obstruction
* No chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)

Other

* No other prior or concurrent malignancy except adequately treated skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy for pain control

Surgery

* Not specified

Other

* No other concurrent experimental or anticancer therapy
Barley and Rice Mixture Effects on Blood Glucose

The purpose of this research was to investigate 5 different formulations of whole grain barley and refined white rice against a control of white bread on post-prandial glycemic response, as well as self-reported hunger/satiety in a randomized cross-over trial.

Beta-glucan-rich barley has been shown to improve glycemic response, reduce hunger and increase satiety. Nutrient-dense grain mixtures that include a new cultivar of barley (Sustagrain, Ardent Mills, LLC) with exceptionally high dietary fiber content may help individuals meet their dietary fiber needs while minimizing the rapid increase in blood glucose following the consumption of a refined grain product. The primary objective of this study was to compare the effects of five different test meals containing varying amounts of whole-grain barley and refined white rice to white bread on post-prandial blood glucose concentrations. A secondary aim was to evaluate changes in self-reported hunger and satiety following the consumption of each treatment. This study was a single-site, blinded, randomized crossover trial among 24 healthy adults. Each participant consumed the following treatments: 100% Sustagrain barley flakes, 100% Sustagrain steel cut barley , an 80/20 rice-steel cut Sustagrain barley mix, a 50/50 rice-steel cut Sustagrain barley mix, 100% rice, and white bread.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, English speaking adults;
* BMI between 18 and 30 kg/m2

Exclusion Criteria:

* History of GI malabsorption diseases, food allergy or intolerance to gluten;
* Prediabetes, and/or diabetes, and/or treatment with diabetic medications for any reason;
* Hypertension, hypothyroidism and other chronic disease that affects nutrient metabolism;
* Any women pregnant or lactating, or expecting to become pregnant during the study;
* Individuals with a history of bleeding disorders
TRACE4BUS for BI-RADS Classification

The purpose of this clinical study is to evaluate the use of the TRACE4BUS software that is proposed to support the physician in reporting the results of breast ultrasound according to the international classification standard Breast Image - Reporting and Data System (BI-RADS) of the American College of Radiology. This classification is recommended because it reduces the risk of subjective interpretations of descriptive results and prevents these results from being interpreted differently by the physician who evaluated the ultrasound examination, the physician who may have requested the examination, the patient and the patient's trusted physician (family physician or specialist). The BI-RADS classification is based on the evaluation of the shape, size, margins and other characteristics of a possible breast abnormality identified on the ultrasound image by the physician who evaluated the ultrasound examination, characteristics that are not always easy for that physician to evaluate.

The study aims to verify if the BI-RADS classification by the physician can be supported by the TRACE4BUS software. In particular, it refers to the support that the software provides to the physician who has evaluated the ultrasound examination in assigning the BI-RADS category for an abnormality of the breast found to be suspicious by the physician on the basis of qualitative characteristics (shape, size, margins, preferential orientation with respect to the skin plane, internal homogeneity/inhomogeneity, possible acoustic barrier effect, etc.). The TRACE4BUS software, trained on the basis of hundreds of ultrasound images of suspicious breast masses with a certain diagnosis of benignity or malignancy at subsequent diagnostic investigations, performs a quantitative analysis of the ultrasound characteristics of a suspicious breast mass and proposes a BI-RADS category to the physician. In any case, the physician will have complete decision-making power in the final attribution of the BI-RADS category and in the subsequent recommendations or decisions regarding the medical management of the case.

The clinical study also aims to evaluate whether the agreement between physicians in the use of this BI-RADS classification of suspicious breast masses improves with the use of the software.


Eligibility Criteria:
Inclusion Criteria:

1. Retrospective study part:

   * Availability of ultrasound-guided breast biopsy and, in case of B3 lesions at needle biopsy, the vacuum-assisted excision, or surgical specimens or a clinical follow-up outcome in at least 12 months subsequent to the biopsy.
2. Prospective study part:

   * Signed informed consent to participate in the study.

Exclusion Criteria:

1. Retrospective study part:

   * Not availability of ultrasound-guided breast biopsy and, in case of B3 lesions at needle biopsy, the vacuum-assisted excision, or surgical specimens, or a clinical follow-up outcome in at least 12 months subsequent to the biopsy. Age \< 18 or \> 89 years.
2. Prospective study part:

   * Not availability of Signed informed consent to participate in the study. Age \< 18 or \> 89 years.
Long Term Experience With Abatacept in Routine Clinical Practice

The purpose of this study is to estimate the retention rate of Abatacept over 24 months in routine clinical practice in every participating country depending on the treatment line.

Time Perspective: Other: Collection of the baseline data collected at Abatacept IV initiation, prospectively or retrospectively within maximum 3 months following the first administration. Other assessments are collected during the follow up period (maximum of 2 years by patient)

Biospecimen Retention: None Retained excepted for a local sub study (in Spain) where sample with DNA was retained

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or Female subjects of more than 18 years old
* Patients with a diagnosis of established moderate to severe active RA (as per the American College of Rheumatology revised criteria, 1987), who at their physician's discretion are treated with Abatacept according to the SmPC in Europe and the Product Monograph in Canada (initiating or already on treatment for maximum 3 months) and for whom baseline characteristics are available

Exclusion Criteria:

* Patients who are currently included in any interventional clinical trial in RA
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women

To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets


Eligibility Criteria:
Inclusion Criteria:

Non-hysterectomized, menopausal women between the ages of 35 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
Pink and Dude Chef

The purpose of the study is to evaluate an afterschool program to teach nutrition through basic cooking skills. This after school extracurricular program increases the students' confidence, knowledge, and skills for cooking as one of the first steps for dietary improvement. In addition to the life lessons students learn during this class, they gain self-confidence and become self-sufficient culinary experts that are capable of educating their siblings, parents, and social circles. This research project will test the impact this program has on nutritional knowledge, culinary efficacy, and nutritional choices made in and out of the home. The Pink and Dude Chef Afterschool Cooking Program was developed through STRIDE (Science through Translational Research in Diet and Exercise at California Polytechnic state University (Cal Poly) in San Luis Obispo, CA.

Hypothesis: Middle school students participating in the Pink and Dude Chef afterschool cooking program will increase nutritional knowledge, culinary efficacy, motivation to eat fruits and vegetables, and fruit and vegetable intake compared to an attention control group.


Eligibility Criteria:
Inclusion Criteria:

* Middle school aged child with parent willing to partcipate
* Ability to partipate in an afterschool program

Exclusion Criteria:

* Less or greater than middle school aged
An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older (Prosthetists and Prosthesis Users)
* must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)
* had a trans-tibial amputation at least 12 months prior (prosthesis users only)
* regularly use a definitive prosthesis with pin lock suspension and few or no pads (prosthesis users only)
* self-report experiencing limb volume fluctuation in the past (prosthesis users only)
* have residual limb length of at least 9 cm (prosthesis users, Aim 2 and Aim 3 only)
* walk at least 5 continuous minutes and intermittently at least 1 hour (prosthesis users, Aim 2 and Aim 3 only)
* capable of distinguishing socket sizes too large and too small to be tolerated (Prosthetists and Prosthesis Users)

Exclusion Criteria:

* Are not certified prosthetists (prosthetists only)
* neuropathy (prosthesis users only)
* reduced skin sensation (prosthesis users only)
* regular use of an assisted device (prosthesis users only)
* sores or skin breakdown on their residual limb (prosthesis users, Aim 2 and Aim 3 only)
Effect of Hibiscus Tea and Green Tea Supplements on Athletic Performance, Blood Pressure, Muscle Damage Indices and Oxidative Stress

This study evaluated effect of Hibiscus tea and green tea supplements on athletic performance, blood pressure, muscle damage indices and oxidative stress in male athletes 18-35 years old and cardiovascular disease prevention approach.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 to 35 y/o
* no history of smoking or alcohol consumption
* no taking nutritional sport supplements during the last 2 months

Exclusion Criteria:

* any injury during intervention
* any inflammatory disease during the intervention
Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.

Eligibility Criteria:
Inclusion Criteria:

* visual acuity worse than 20/40, caused by central subepithelial fibrosis

Exclusion Criteria:

* pregnancy, age less than 18 years-old or more than 80 years-old.
* diabetes, autoimmune diseases, corneal thickness less tha 400 micron.
Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)

Children who are hospitalized are especially vulnerable to the effects of tobacco use and dependence among their caregivers, and they are more likely to be exposed than children who are not hospitalized. Hospitalization is an important teachable moment for health care providers to intervene with tobacco dependent parents, and help them reduce their child's exposure, potentially improving outcomes after hospitalization, and their future health. Understanding the best way to approach and intervene with these families will provide the investigator with the necessary information to create a sustainable intervention that can be disseminated to hospitals across the country that provide pediatric care, and to ultimately make a significant improvement in the health of children.

This study is a randomized controlled trial (RCT) to determine whether the proposed bundled intervention is superior to usual care in the pediatric inpatient setting can decrease children's secondhand smoke exposure, and encourage their parents to make smoke-free home rules and quit smoking, as measured by a validated survey and biomarkers.

We have developed an intervention that bundles the best evidence for tobacco dependence treatment, including the United States Public Health Service (USPHS) guidelines, and evidence from parent-specific interventions, to create a sustainable, transferrable intervention specific to using the inpatient stay to help parents quit smoking and reduce their children's exposure. The intervention bundle includes screening for exposure, assessing readiness to quit, providing at least one brief motivational interviewing session in the hospital, dispensing nicotine replacement therapy if appropriate, providing a smoking cessation/reduction starter kit and arranging for follow up after the child is discharged.

INSPIRE specific aims:

Aim 1: To assess the efficacy of the intervention in increasing parent report of having smoke-free homes and cars 6 and 12 months after hospitalization

Aim 2: To demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels 6 and 12 months post-hospitalization

Aim 3: To assess the efficacy of the intervention in increasing parent quit rates 6 and 12 months after hospitalization

Aim 4 (Exploratory): To use implementation process measures from the RE-AIM framework to assess the extent that our intervention results in hospital-wide systems change, including automatic screening for tobacco smoke exposure and delivery of tobacco control services.

Eligibility Criteria:
Inclusion Criteria:

* Families admitted to the inpatient units of Children's Hospital Colorado
* Families with children \<17 years of age
* Families with at least one custodial parent smoker

Exclusion Criteria:

* Admitted in the hospital \< 24 hours
* Families with children in foster care
* Families with unclear custody of the child (i.e. children admitted with non-accidental trauma)
Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia

The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation vs an iron supplement in capsules in subjects with mild anemia.

The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild anemia after 8 weeks of supplementation, compared to baseline values and also aims to evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used as a comparison supplement.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed prior to inclusion in the study
* 18-55 years
* Ability to understand the nature and the purpose of the study, including possible risks and side effects
* Capability to collaborate with the investigator and meet the requirements of the entire study
* Subjects with mild anemia (with WHO hemoglobin values between 11-11.9 g/dl for women and between 11-12.9 g/dl for men)

Exclusion Criteria:

* Clinically significant abnormalities in the ECG evaluation
* Clinically significant abnormal laboratory values indicative of disease
* Known allergy or presumed hypersensitivity to the food supplement investigated (iron) and / or to the excipients of the two formulations
* History of anaphylaxis from drugs, dietary supplements or allergic reactions in general, which the investigator believed could influence the outcome of the study
* Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the study
* Taking herbal remedies and dietary supplements (including iron supplements, supplements with vitamin C, supplements with folic acid, supplements with vitamin B12, multivitamins) in the 2 weeks prior to the start of the study
* Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics
* Alcohol abuse
* Any clinical condition that in the investigator's judgment is deemed incompatible with study participation
* Women who are pregnant or breastfeeding