cyrilzakka/clinical-trials huggingface dataset:
Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities

The current health literacy (HL) pilot intervention was designed through focus groups with women in low socio-economic status (SES) communities. The primary HL issue identified was communication challenges at doctors' visits. As a unique HL intervention tailored to the participants' preferences, this intervention can serve as a model for improving HL in similar communities worldwide.

Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge. A unique HL intervention tailored to the participants' preferences was designed which consisted of three workshops conducted in municipality-sponsored women's groups in low SES Jerusalem communities. Questionnaires were completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in low SES women?

The current health literacy (HL) pilot intervention was designed through focus groups with women in low socio-economic status (SES) communities. The primary HL issue identified was communication challenges at doctors' visits. As a unique HL intervention tailored to the participants' preferences, this intervention can serve as a model for improving HL in similar communities worldwide.

Objectives include increasing the percentage of women who utilize patient-doctor communication skills, prepare for their doctor's visit, and increase their cardiovascular disease (CVD) knowledge.

In order to accomplish these objectives, a unique HL intervention tailored to the participants' preferences was designed which consisted of three workshops conducted in municipality-sponsored women's groups in low SES Jerusalem communities. This intervention consisted of a three consecutive weekly workshop conducted in women's support groups in disadvantaged communities in Jerusalem. The workshop includes women's heart health sessions, as well as sessions about how to make the most of a doctor's visit, which includes role play and teach back method practice. A self-admitted questionnaire regarding CVD and relevant HL knowledge and behaviors was completed at the beginning of the intervention, and three months after the last session.

This study answers the question of whether a three session HL workshop for women can successfully raise their CVD knowledge and awareness, as well as change behaviors of women in terms of preparing for doctor's visits.

Eligibility Criteria:
Inclusion Criteria:

* Women from Jerusalem
* Hebrew and Arabic speakers

Exclusion Criteria:

* None
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

This is a prospective, open label, parallel controlled study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

1. Female breast cancer patients at the age of \>= 18 years and \<= 65 years who received first treatment；
2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of \> 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
5. The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 90 × 10\^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.

Exclusion Criteria:

1. Known history of hypersensitivity to pyrotinib or any of it components;
2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
5. Patients with severe heart disease or discomfort who cannot be treated;
6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
7. Pregnant or lactating women;
8. Less than 4 weeks from the last clinical trial;
9. Patients participating in other clinical trials at the same time
10. The researchers think inappropriate.
Hyaluronic Acid in Acute Exacerbation of COPD - Duration Of Noninvasive Assistance

The objective of this study is to test the effect of High Molecular Weight Hyaluronic Acid (HMW-HA) on Non Invasive Ventilation (NIV) effectiveness in patients admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

The objective of this study is to test the effect of HMW-HA on NIV effectiveness in patients admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of COPD. The design is a parallel-arm, single-blind, placebo-controlled randomized clinical trial. Eighty patients, aged eighteen years or older, admitted for respiratory failure primarily due to COPD exacerbation and requiring non-invasive ventilation will be enrolled and randomized to the study treatment (active or placebo).

All patients will be treated with NIV delivered using a Hamilton C1 ventilator and medical therapy according to current guidelines (inhaled long-acting b2 agonists, inhaled long-acting anticholinergic, inhaled and systemic corticosteroids, antibiotics). Patients randomized to the active intervention group will also receive HMW-HA (Yabro® - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d., while patients randomized in the control group will receive a matching placebo. Patients will be treated until weaning or until NIV failure, defined as oro-tracheal intubation or death.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years of age or older
* Admitted for respiratory failure primarily due to COPD exacerbation
* Requiring non-invasive ventilation
* Respiratory distress, as evidenced by moderate-to-severe dyspnea and use of accessory muscles of respiration
* Hypercapnic respiratory failure
* High respiratory rate

Exclusion Criteria:

* Respiratory arrest or the need for immediate intubation
* Upper airways obstruction
* Facial trauma
* Inability to cooperate
Novel Strategies for Innovating Deceased Donor Procurement

Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. By innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. Further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. In this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Currently listed to receive a deceased donor kidney transplant
2. Able to fully understand the informed consent document
3. Recipient over the age of 18 years

Exclusion Criteria:

1. Recipients undergoing a bilateral native nephrectomy at time of transplant
2. Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant
3. Individuals who are unable to understand the informed consent document
4. Recipient under age 18 years
5. Recipients receiving desensitization protocols for high levels of donor specific antibodies
A Safety Study of LY2811376 Single Doses in Healthy Subjects

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.

This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3 period, crossover study. Part 1 will assess the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and nonchild-bearing potential women
* 20 years or older
* Body mass index between 18-32kg/m2

Exclusion Criteria:

* Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement.
* Smoke more than 10 cigarettes per day.
* Consume more than 5 cups of coffee per day.
Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis

This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.


Eligibility Criteria:
Inclusion Criteria:

- Patients are at least 6 years of age at the baseline visit. - Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics. - Patients or their guardians are able to understand and complete the study-related questionnaires. - Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable.

Exclusion Criteria:

- Patients who have a contraindication for dupilumab based on the current Summary of Product Characteristics. - Patients who have already been treated with dupilumab for more than 7 days. - Any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results. - Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study. "The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."
Multicenter Quantitative and Qualitative Study of the Determinants of Participation in a Cytomegalovirus Preventive Vaccine Study in France in Women Aged 18 to 40 Years Old.

During a vaccine clinical trial of Cytomegalovirus (CMV) vaccine, one of the participants' motivations was to prevent an infection responsible for malformations in a future child. Would their attitude towards a vaccine trial be the same in the context of a vaccine designed to protect them individually? By improving the knowledge of clinical research and determinants in women aged 18 to 40, this study could improve recruitment methods in this specific population for future vaccine trials within the CIC1408 infectious diseases and vaccinology area at Saint-Etienne University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Womens between 18 to 40 included in CMVCTORY vaccine trial

Exclusion Criteria:

* Refusal
Unilateral Neck Radiotherapy in Head and Neck Cancer

Patients with head and neck cancer typically undergo a surgical procedure to remove the lymph nodes that could contain disease on both sides of the neck. After surgery, radiotherapy is given (with or without chemotherapy) to the area that underwent surgery and both sides of the neck, even if disease was only found on one side. Giving radiotherapy to both sides of the neck commonly results in high rates of side effects, which in turn affects patient quality of life.

There is growing evidence from some other studies that support the safety of omitting radiotherapy after surgery in the side of the neck with no disease. With this study, the investigators are hoping to justify its routine use and, if successful, the standard of care could be to receive radiation on only one side of the neck instead of both sides. This could alleviate the extent of some side effects and improve patient quality of life.

Participants will be randomized into one of the following groups to receive radiotherapy as follows:

Arm 1 (Non-experimental intervention): standard intervention: Radiotherapy to both sides of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.

Arm 2 (Experimental intervention): Radiotherapy to one side of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.


Eligibility Criteria:
Inclusion Criteria:

Patients with squamous cell carcinoma of the head and neck undergoing primary surgical management are eligible to participate if they meet the following eligibility criteria:

* Age ≥18
* Primary site of disease in the oral cavity, oropharynx, larynx, or hypopharynx.
* Squamous cell carcinoma confirmed by histology.
* Bilateral modified radical or selective neck dissections carried out as part of primary surgery, with \>= 10 lymph nodes removed from the contralateral neck
* The contralateral neck is pathologically negative
* Pre-surgical FDG-PET/CT scan did not show any clinically involved contralateral neck nodes.
* Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.

Exclusion Criteria:

* Previous radiation to the head and neck area
* Pregnancy
* Other contraindications to radiation treatment (e.g. severe connective tissue disease).
A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection

The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:

* Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.
* Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression.

Cirrhosis is a chronic progressive disease caused by different etiological factors and characterized by diffuse hepatocellular degeneration and necrosis, abnormal regeneration of hepatocytes, intrahepatic neovascularization, massive proliferation of hepatic fibrotic tissues, and pseudofollicular formation. The number of patients with liver disease in China is about 300 million, and the number of deaths from cirrhosis accounts for 11% of the global deaths from cirrhosis. Its etiology is diverse, and hepatitis due to hepatophilic virus infection is still the main cause in China. A recent study by scholars on 11861 patients hospitalized for the first time due to liver cirrhosis in 50 hospitals in China showed that among the causes of liver cirrhosis in China, HBV infection accounted for 71.15% and HCV infection accounted for 8.12%. About two-thirds of patients with cirrhosis and extrahepatic organ failure suffer from sepsis. Infections increase the risk of death in patients with cirrhosis, and reports have shown that these patients are hospitalized for twice as long as patients without cirrhotic sepsis and have a hospital mortality rate of up to 50%. This study focuses on the impact of secondary infections on the clinical prognosis of cirrhosis, and proposes to establish a prospective, multicenter clinical cohort of secondary infections in cirrhosis, map infection pathogens, correlate the characteristics of the underlying immune status with the pathogen profiles of secondary infections, and set up an early warning system of secondary infection surveillance, with the aim of early prevention and early recognition of secondary infections, and improvement of prognosis for patients with liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients with viral hepatitis cirrhosis agreed to participate in the study and signed an informed consent form;
2. Any gender and age between 18-70 years old;
3. HBsAg positivity lasting more than 6 months;
4. have clinical manifestations of hepatic decompensation and portal hypertension, laboratory test results, liver imaging or endoscopy and other comprehensive diagnosis of definite cirrhosis.

Exclusion Criteria:

1. Patients with other non-hepatophilic causes of cirrhosis;
2. Patients who, in the opinion of the investigator, are not suitable for participation in the study.
Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD)

This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD.

The study will look children with ASD's response to a 7-week occupational therapy led dance program in regards to social-emotional health. This will include exploring the effect on change of social-emotional behavior in children with ASD after being exposed to dance intervention through comparing the quantitative measurements of pre- and post-assessment scores of the Developmental Profile 4 (DP-4), analysis of the qualitative measurements of pre- and post-social-emotional behaviors via child report, and analysis of qualitative observations of social-emotional behavior through reviewing video recording of dance classes. Additionally, parents' perspectives will be explored through post-interview questions to share their observations of their child's experience.

Eligibility Criteria:
Inclusion Criteria for Youth Participants

* Elementary school children ages 7-11.
* Parent/caregiver/guardian must provide proof of an Individualized Education Plan (IEP) with a Primary Eligibility of Autism.

  o Parent/caregiver/guardian must provide proof of IEP and eligibility.
* Will speak and understand English.
* Able to physically participate in the dance program without the use of adaptive equipment.
* Answer yes to the following Skillset Checklist (Per parent/caregiver/guardian report):

  * Follow 1- and 2-step instructions.
  * Follow structured activities with supervision (e.g., visual schedule, routine).
  * Previous participation in extracurricular group activities over the last 6 months - 1 year (e.g., structured sports).
  * Minimum 5-minutes of attention to task.

Exclusion Criteria:

* No IEP Primary Eligibility of Autism.
* No children participants younger than 7.
* No children participants older than 11.
A Study of JNJ-55308942 in the Treatment of Bipolar Depression

The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.


Eligibility Criteria:
Inclusion Criteria:

* Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI)
* Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
* Have a body mass index (BMI) between 18.0 and 35.0 kilograms per meter square (kg/m\^2) inclusive (BMI = weight/height\^2)
* A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test before the first dose of study intervention

Exclusion Criteria:

* Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
* Received transcranial magnetic stimulation (TMS), any transcranial electrical stimulation, including transcranial direct current stimulation (tDCS), vagal nerve stimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior to randomization
* History of moderate to severe cannabis misuse according to DSM-5 criteria within 6 months before screening
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)