cyrilzakka/clinical-trials huggingface dataset:
Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women

Background: The use of estrogen in postmenopausal (or surgically menopausal) women is a common practice. Compliance is problematic in that estimates show only 1/3 of women use hormone replacement therapy (HRT) and only 30% are compliant. Estrogen has many documented benefits including symptomatic relief of hot flashes, improvement of the dry vagina and dyspareunia. Estrogen has been found to improve bone mineral density and increase the high- density lipoprotein portion of a cholesterol panel. To improve compliance and to provide an alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste and propose to study the absorption, rate of build-up and rate of decline.

Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically postmenopausal women, not on HRT. Absorption takes place across the buccal mucosa.

Specific Aims:1) To estimate the systemic absorption of estrogen from daily use of estrogen containing toothpaste.

2) To estimate the rate of build-up of serum estrogen levels based upon daily use of toothpaste containing estrogen for eight days.

3) To estimate the rate of decline in serum estrogen levels when the use of estrogen containing toothpaste is discontinued for a week.

Methods: Fifteen women ages 35-75 who are menopausal or surgically menopausal will be identified, with exclusion based on estrogen contraindications. Subjects will have blood samples taken before, during and after an eight-day course of once-daily toothpaste that is admixed with 0.5 mg estradiol. Toothpaste shall meet strict quality control standards and instructions for uniform tooth brushing shall be provided. Serum estradiol will be determined from the samples obtained. Statistical analysis shall address absorption by comparing baseline estradiol measurements with those a few hours after use. The rate of build-up will be assessed by comparing the post-use levels of estradiol at the start of a week and at the end of the week. After a week off the estrogen, the rate of decline in serum estradiol will be calculated.

Eligibility Criteria:
Postmenopausal women or surgically menopausal women, not on hormone replacement therapy for at least 3 weeks
SET-Recovery/Healthy Home

The study conducts a community-based randomized trial comparing an adaptation of Structural Ecosystems Therapy (SET), "Healthy Home", as an enhancement of substance abuse or mental health outpatient treatment, to outpatient treatment as usual (TAU) among approximately 172 Black, Hispanic and White nonHispanic mothers enrolled in outpatient substance abuse or mental health services. The study is conducted with a community partner, Banyan Health Systems, that delivers substance abuse/mental health treatment and primary care. Data is collected at baseline and 4, 8, and 12 months postrandomization. The Specific Aims of the proposed study are to: 1) test the effectiveness of Healthy Home for improving physical and mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2) test the effectiveness of Healthy Home for improving health and mental health outcomes of children of mothers in recovery; 3) test mechanisms of action of Healthy Home (self care, environmental risk, family functioning and stigma); 4) assess implementation and sustainability factors and the relationship between fidelity and outcomes; and 5) examine the interactions of ethnicity and ethnicity related factors on outcomes. Healthy Home is a manualized, strength-based, directive and process oriented family ecosystemic home health intervention developed to address the needs of mothers and their children affected by substance abuse and other mental health disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in outpatient substance abuse or mental health treatment (or treatment for substance abuse as a co-occurring disorder) or case management for mental health or substance abuse problems,
2. have at least one child age 0-17 with whom she has at least monthly contact
3. be age 18 or above,
4. capable of giving informed consent and comprehending either English or Spanish,
5. willing and able to participate fully in the protocol

Exclusion Criteria:

Persons who do not meet the inclusion criteria listed above will be excluded.
Digital Ocular Fundus Photography in the Emergency Department: A New Application for Telemedicine?

The purpose of this study is to determine if non-dilated retinal photography in the emergency room improves the diagnosis of papilledema (optic nerve swelling) in patients with neurologic disease compared to direct ophthalmoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Presenting complaint of headache, acute focal neurologic disease, or acute visual changes
* Diastolic blood pressure \>= 120
* Age 18 or older

Exclusion Criteria:

* Unable to sit-up, not interested in participation, confused
* Age 17 or younger
Analgesic Treatment Mediated by Arcoxia (0663-093)

Allow physicians to test the efficacy of arcoxia in patients with acute pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute pain susceptible of pharmacological treatment
* Greater than 18 years of age
* Voluntary acceptance to participate in the study and signature of the informed consent form

Exclusion Criteria:

* Allergy to etoricoxib or any of its components
* Less than 18 years old
* Patient is taking anticoagulants
* Patient that already has taken any drug as analgesic
Non-technical Skills of Clinical Simulation in Physiotherapy Students

Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.

However, if we focus on physiotherapy, the use of clinical simulation is a very new field and therefore requires great research. The investigators still do not have the consistency or experience as in other health branches such as medicine or nursing, in which they have been using simulators for years for the learning of all their students.

For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients.


Eligibility Criteria:
Inclusion Criteria:

* Second year students of the Physiotherapy Degree
* They do not have clinical experience with real patients.

Exclusion Criteria:

* Not wanting to sign to participate in the study.
* Not signing the informed consent
Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor

Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~75 years old, male or female
2. Life expectancy ≥ 6 months
3. ECOG score: 0-3
4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
5. Advanced solid tumor was diagnosed by pathological or clinical physicians
6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥70 x 10\*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level
7. Signed informed consent
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion

Exclusion Criteria:

1. Expected overall survival \< 6 months
2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months
3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation

This study will update an existing health literacy intervention (decision aid) for informed consent procedures and then conduct a randomized experiment implementing the health literacy intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care. Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to usual care will increase knowledge about cancer clinical trials. Secondary outcomes include patients' ability to communicate with health care providers about trials, willingness to participate in trials, and enrollment rates for minority participants.

A previously developed and pilot tested web-based decision aid (DA) based on best practices in health literacy that is well received by minority participants and significantly improved knowledge about cancer clinical trials and decision self-efficacy will be used. This study will expand the reach of the DA and test it in a larger study in a different geographic region and center (Siteman Cancer Center). An additional benefit of conducting this work at Siteman Cancer Center is that Siteman and the Program for the Elimination of Cancer Disparities (PECaD) already institute structural changes at the system level to improve minority participation in trials. This study will activate and educate patients and will complement the system-level interventions.

By random 1:1 assignment, 180 participants will either receive:

\*Targeted, web-based decision aid (DA) about participating in cancer clinical trials.

or

\*Usual care/control-Access to the Siteman Cancer Center website about clinical trials.

Outcomes from the DA group will be compared to outcomes in a usual care/control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer in the past 6 months
* English speaking
* At least 18 years old

Exclusion Criteria:

* Past participation in a clinical trial for treatment
Children's Taste Study to Increase Vegetable Intake in Preschoolers

Studies have shown that when exposed to a variety of food and flavor options people tend to consume more than when only one item is presented. This strategy has been used to increase vegetable intake in adults and during snacktime in children. Increasing vegetable consumption in children is important because higher vegetable intake has been associated with reduced risk of disease and because vegetables can help prevent weight gain by lowering the energy density of a meal. The purpose of this study was to investigate the effects of using herb and spice blends to create flavor variety in carrots as a model vegetable in a laboratory test meal. We predict that children will consume more vegetables and that the energy density of the meal will be lower when a variety of seasoned carrots are presented in comparison to a single flavor. A secondary goal of the study was to determine other influences that may predict children's liking and intake of seasoned vegetables, such as previous exposure, infant feeding practices, and genetic bitter sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance of test meal foods
* Generally healthy

Exclusion Criteria:

* Food allergies
* Medications (prescription or OTC) that can affect taste, smell or appetite
* Medical conditions
Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

Case-series and cohort studies have shown the feasibility of reperfusion therapies in patients with ischemic stroke and COVID-19, but due to the absence of a contemporary control group of non-COVID-19 patients, small sample size or lack of long-term outcome assessment, concerns regarding safety and efficacy of these treatments remain to be clarified. Taking into account its limitations, some studies documented higher rates of endovascular treatment complications such as clot fragmentation with distal embolization and vessel re-oclusion, to be more difficult to achieve recanalization after endovascular treatment, and higher rates of any intracerebral hemmorhage.

The investigators aim is to assess in a large, multicenter and international cohort, the safety and outcomes of acute reperfusion therapies in patients with ischemic stroke and COVID-19, by comparison with a contemporary control group of patients with ischemic stroke and without COVID-19 from the same centers.


Eligibility Criteria:
1. Inclusion Criteria:

   * Consecutive ischemic stroke patients receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment) up to 24 hours since last time since well, and according to local treatment criteria
   * From 1st of March 2020 (for Chinese Centers from 1st January 2020)
2. Exclusion Criteria:

   * Patients without a PCR- or antigen test within the first 7 days after treatment
   * Patients with nosocomial SARS-CoV-2 infection after receiving acute recanalization treatment - PCR- or antigen test becoming positive more than 7 days after treatment
   * Patients with "Suspect/ probable case of SARS-CoV-2 infection" according to the World Health Organization definition
   * Symptomatic cases of SARS-CoV-2 infection with symptoms resolution more than 7 days before treatment
   * Asymptomatic cases of SARS-CoV-2 infection with treatment performed more than 10 days after first positive test for SARS-CoV-2
The Effect of Ideal Birth Environment on Birth Pain, Fear of Childbirth, Mode of Delivery and Duration of Delivery

The aim of this study was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery.

on the impact of the study. The main questions it aims to answer are Does the ideal birth environment reduce fear of childbirth? Does the ideal birth environment reduce labor pain? does the ideal birth environment affect the duration of labor? In order to evaluate the effect of the ideal birth environment on fear, pain and duration of labor, the researchers will compare the standard delivery room and women who will give birth in a room customized for women, where they have their own sheets, pillows, items that make them feel special, where medical devices are reduced, in a room where they have photos with their partner, in a room where they listen to the music they want, where they have freedom of movement. both in the experimental and control groups: In the last trimester, the Wijma birth experience A version will be applied and in the postpartum period, the Wijma B Birth experience scale will be applied again and the fear of childbirth will be evaluated. Pain in labor will also be assessed using VAS (Visceral Visual Analgesic Scale) during the latent and active phase of labor.

The birth environment filled with medical instruments increases the level of anxiety and fear in the mother.

increase, disrupting the neurohormonal relationship that ensures the normal functioning of labor and an increase in the rate of cesarean section deliveries. Also women when she does not feel safe in her environment and her baby does not feel safe, the birth process is temporary. may slow down as a result release of adrenaline (epinephrine) and noradrenaline (norepinephrine) as a result of stress and anxiety increases, creating a "fight or flight" situation in the woman. Adrenaline and noradrenaline are the main

towards the end of labor to help the fetus to expel, while towards the end of labor should be at a low level at the beginning. The woman cannot fight stress in these cases, adrenaline and noradrenaline levels increase, while oxytocin levels decrease. This one from a physiological point of view, it can cause the progression of labor to stop, the duration prolonged labor and increased cesarean section rates. In a study conducted with pregnant rats, noise and movement in the birth environment restriction has been found to negatively affect hormones involved in labor

Eligibility Criteria:
Inclusion Criteria:

18-35 years old pregnant primiparous literate

Exclusion Criteria:

Medium and high-risk pregnant women (oligohydramnios, pre-eclampsia, heart disease, diabetes, placenta previa)

* Psychiatric illness such as anxiety and depression
* Communication barrier
The Impact of a Web-based Psychoeducation Programme with a Motivational AI Chatbot on Covid-19 Vaccine Hesitancy

Vaccine hesitancy is defined as 'delay in acceptance or refusal of vaccines, despite the availability of vaccine service' and was named one of the top ten global health threats by the World Health Organization in 2019.

Our proposed study will aim to develop and evaluate the effectiveness of a Web-based psychoeducation programme to address Covid-19 vaccine hesitancy, 'AI-driven Vaccine Communicator' (including educational materials, animations of vaccine research and development, and an MI communication skills-based AI, digital assistant).

Our goal is to standardise our intervention so that it can serve as an effective toolkit for clinicians/healthcare providers to increase Hong Kong residents' motivation to vaccinate and to ensure that the programme can be adapted to viral mutations and newly developed vaccines in the medium/long term.

This study is a two-arm, single-blind pilot randomized controlled trial, and it will be adopted to evaluate the efficacy of the 'AI-driven Vaccine Communicator' relative to being self-informed about Covid-19 vaccines.

Also, to address the widespread hesitancy among Hong Kong residents toward Covid-19 vaccines, we will develop a Web-based psychoeducation programme, 'AI-driven Vaccine Communicator,' driven by artificial intelligence (AI) techniques based on the Vaccine Hesitancy Determinants Matrix Model and MI communication skills and concepts (theoretical underpinnings). After developing and piloting this programme, we will test its effectiveness among members of the population who are hesitant about Covid-19 vaccines. The programme will then be refined further and standardised to use the most relevant information and effective communication skills to promote acceptance of Covid-19 vaccines among a wider Hong Kong population. Clinicians and healthcare providers will be able to utilise our programme as a toolkit in their usual practice when working with clients who are hesitant about Covid-19 vaccines.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or above;
* Hong Kong residents;
* Show vaccine hesitancy (not taking COVID-19 vaccines or receiving involuntary COVID-19 vaccines);
* have internet access
* able to read Chinese or English. Recruitment involved social media promotion and collaborating with community organizations

Exclusion Criteria:

* People with self-reported cognitive impairments or mental disorders that might interfere with their understanding of the intervention content;
* People who currently engaged in another clinical trial in relation to Covid-19 vaccines.
Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years

The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.


Eligibility Criteria:
Inclusion criteria:

* decision to start treatment with intranasal fentanyl spray
* written informed consent

Exclusion criteria:

* criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.

This single arm study will assess the safety and effect on response rate of a combination of rituximab and chlorambucil in previously untreated participants with B-cell chronic lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of each cycle, at a dose of 375 milligrams per square meter (mg/m\^2) intravenously (IV) in Cycle 1, and 500 mg/m\^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of each cycle at a dose of 10 mg/m\^2/day per oral (PO).


Eligibility Criteria:
Inclusion Criteria:

* previously untreated participants with cluster of differentiation 20 (CD20) positive B-cell chronic lymphocytic leukemia;
* participants with progressive Binet stage B, or C requiring therapy according to National Cancer Institute (NCI) criteria;
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2.

Exclusion Criteria:

* previous treatment for Chronic Lymphocytic Leukaemia (CLL);
* known concomitant hematological malignancy;
* transformation to aggressive B-cell malignancy;
* history of severe cardiac disease;
* known hypersensitivity or anaphylactic reactions to murine antibodies.
Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial

The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent Atrial fibrillation (20\~80 years)
* LA diameter \<55mm
* patients possible to anticoagulation and anti arrhythmic drug

Exclusion Criteria:

* Structural cardiac disease
* Contraindication to brain perfusion CT
* Catheter ablation history for AF,
* Cardiac surgery for AF
* active internal bleeding
* Impossible to anticoagulation or antiarrhythmic drug
* valvular AF (MA\> GII, Mechanical valve, Mitral valve replacement)
* Patients with severe medical disease
* Expected survival \< 1year
* Severe alcoholics, drug addiction
Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan

The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future.


Eligibility Criteria:
Inclusion Criteria:

* Capable adults weigh ≥ 50 kg

Exclusion Criteria:

* Not Taiwanese
* Having received oral antibiotics, immunosuppressants, and chemotherapy drugs in the past month
* Incapacity
* Limited disposing capacity
* Mental disorders or intellectual disabilities