cyrilzakka/clinical-trials huggingface dataset:
PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients

At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. However, the value of PCI is being challenged in the era when MRI examination of brain has been popularized.

The goal of this clinical study is to compare PCI and regular brain MRI follow-up (control arm) and regular brain MRI follow-up alone (study arm) in patients with limited-stage SCLC who have received definitive radiotherapy and chemotherapy and acheived complete remission (CR) of tumor.

The main questions to answer are:

1. Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group.
2. The difference of 2-year overall survival rate between the control group and the study group.
3. Whether the patients in the study group have better overall quality of life than those in the control group.

Participants will randomly receive either PCI and regular brain MRI follow-up or regular brain MRI follow-up alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically proven diagnosis of SCLC.
* Age ≥ 18 years.
* Karnofsky performance status ( KPS) ≥80.
* The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter ≥ 1cm or PET-CT shows increased metabolism with SUV≥2.5, or proved by mediastinoscopy/EBUS/TBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC/UICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis.
* Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers).
* Good follow-up compliance;
* Fully understand this study, and voluntarily sign the informed consent form.

Exclusion Criteria:

* Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ.
* Patients who have received radical surgery (excluding biopsy).
* Patients with psychiatric history, pregnancy and lactation.
* Uncontrolled diabetes, hypertension, severe active infection.
* Patients with chronic diseases of central nervous system.
* Patients with contraindications of brain MRI examination.
* Other situations deemed unsuitable by the doctor in charge.
Antecubital Versus Femoral Approach for Adrenal Venous Sampling

Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%. Our research team is the first in the world to conduct AVS via an antecubital approach. The aim of this study is to compare the success rate and safety of AVS via antecubital and femoral approach.

Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%.How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. Our research team is the first in the world to conduct AVS via an antecubital approach. The previous study found that the success rate of AVS via this approach can reach to 88.0%, with a low incidence of complications. In this study, patients with primary aldosteronism who meet the indications of AVS will be randomly assigned to antecubital approach group and femoral approach group. Clinical, laboratory and examination data will be recorded and the success rate and safety of AVS via antecubital and femoral approach will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 60 with no limits in sex;
2. Patients with confirmed primary aldosteronism;
3. Patients or their legal representatives sign written informed consent approved by the ethics committee

Exclusion Criteria:

1. Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
2. An estimated glomerular filtration rate \<45 ml/min/1.73 m2, or serum creatinine \>176 μmol/L；
3. Patients who refuse adrenalectomy;
4. suspected of having an adrenocortical carcinoma;
5. allergy to contrast agent;
6. pregnant, nursing, or planning to become pregnant
A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers

Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.


Eligibility Criteria:
Inclusion:

* A healthy man or woman
* 18 - 50 years old
* Neither too fat, nor too thin
* Female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit.
* Female subjects must not be breast feeding and should not have been breast feeding for a month.
* Male subjects must agree to use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up.
* Subjects need to smoke 20 - 40 cigarettes a day inclusive for at least the past year and to not have tried to quit in the 3 months before the start of the study.

Exclusion:

* Any current medical or psychiatric illness
* Any history of chronic medical or psychiatric illnesses
* Previous or current alcohol or drug abuse/dependence including nicotine
* Personal or family history of prolonged QTc syndrome
Virtual Reality Pain Neuroscience Education for Middle School Students

Investigating the use of a Virtual Reality (VR) pain neuroscience education (PNE) platform with middle school students. The investigators have previously studied the use of PNE with in person educational sessions with middle school kids and video recorded sessions. This study will be looking into utilizing the VR platform for delivery of the educational information.

Potential middle school students will be contacted through fliers to local parents in the Louisville, KY area via various sports team events. The investigators have secured a meeting room space at a large reception room at Lake Forest Country Club (Louisville, KY) on August 4, 2020. Potential participants will call to schedule time for participation to allow for proper staggering of participants arriving on the day of data collection.

Research team will set up informed consent space at the entrance to the reception room and stagger participant arrival time to reduce contact with other participants. This space will be cleaned and disinfected regularly during the consenting process as new participants arrive. Once student and parent arrives they will complete informed consent and COVID-19 screening form before being allowed into research space (reception room). Each participant will be given a pen to keep during the research study and go home with also provided with hand sanitizer to use before and after. No pens will be reused with other participants. Masks will be made available for anyone that requests one, but they will not be required while at the testing location. Parents of child will be allowed to sit in waiting chair keeping 6 feet of distance from anyone else. The child research participant will be lead to a chair in the room and complete pre-test questionnaire and then they will be set-up with a Virtual Reality (VR) device (cleaned and disinfected between each use) and go through a VR educational experience (\~30 minutes) on Pain Neuroscience Education (PNE). Upon completion of the VR educational session they will complete post-test questionnaire and then be able to leave.

Eligibility Criteria:
Inclusion Criteria:

* willing to view VR educational session
* in grades 5, 6, 7, or 8.

Exclusion Criteria:

* has been through PNE educational program previously
* aversion to VR or problems with viewing VR in the past
* history of epilepsy or seizures
* eye surgery or injury within the last 6 months
* open sores or wounds around where VR googles are worn on face
* anyone who has had a concussion that has not been cleared for full activity or experiencing any post-concussion syndrome symptoms currently.
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 40-65 years of age,
3. Received a negative mammography screening result in the previous four weeks
4. Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
5. Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
6. BMI 25-40 kg/m2
7. Has access to a computer or mobile device with wireless internet
8. Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)

Exclusion Criteria:

1. Previous history or current diagnosis of breast cancer
2. Pregnancy or lactation
3. Involvement in a weight loss program
4. Major co-morbidities (e.g.,diabetes, hypertension, etc.)
5. History of disordered eating
6. Currently taking medication that may impact weight (e.g., synthroid, metformin)
Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer

A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary agreement to provide written informed consent;
2. Patients aged ≥18 years and ≤75 years with locally advanced or metastatic breast cancer diagnosed by histology or cytology，and who may benefit from monotherapy of Doxorubicin liposomes;
3. Life expectancy of at least 3 months; Eastern Cooperative Oncology Group (ECOG) performance status (PS)\<2;
4. adequate bone marrow function \[leukocyte ≥3,000/mm3, absolute neutrophil count (ANC) ≥1,500/mm3, hemoglobin ≥90g/L, and platelet count ≥90,000/mm3；
5. adequate renal function (serum creatinine ≤1.5×Institutional upper limit of normal (ULN));
6. adequate coagulation function \[prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN\];
7. adequate hepatic function \[aspartate aminotransferase (AST), alanine aminotransferase (ALT) level ≤ 2.5×ULN (or ≤5×ULN for subjects with liver metastases), and total bilirubin level ≤ 1.5×ULN (or ≤ 3×ULN for subjects with liver metastases).

Exclusion Criteria:

1. Patients with a diagnosis of severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric conditions that the researchers did not consider appropriate for inclusion;
2. With a history of myocardial infarction, unstable angina pectoris, coronary revascularization, New York Heart Association (NYHA) grade ≥Ⅱ cardiac insufficiency, severe pericardial disease, and severe unstable ventricular arrhythmia, cerebrovascular accident or transient cerebral ischemia or pulmonary embolism within 6 months before randomization;
3. Unstable brain metastases;
4. Electrocardiogram (ECG) QTC \>480ms; left ventricular ejection fraction \<50% or below the lower limit of study center value;
5. The total cumulative dose of doxorubicin was ﹥350mg/m2 before screening；
6. Persistent or active infection requiring systemic treatment;
7. Pregnancy or breast feeding;
8. Other situations that investigators consider as contra-indication for this study.
Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Adults with Chronic Disease

In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. Conducted during the 2023/2024 influenza season, the first NUDGE-FLU-CHRONIC trial demonstrated the effectiveness of behavioral nudging letters in increasing influenza vaccination rates among adults aged 18-64 years with chronic diseases in Denmark. This present study will once again investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among adults aged 18-64 years with chronic diseases including whether the effectiveness of the previously successful strategies can be confirmed during a subsequent influenza season.

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons aged 18-64 years identified as eligible for free-of-charge influenza vaccination due to a chronic condition. Subjects will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10). Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries with the exception of information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-64 years
2. Must be registered in the Danish nationwide registries as meeting at least one of the following eligibility criteria for free-of-charge influenza vaccination in the Danish public health system:

   1. Chronic lung disease
   2. Chronic cardiovascular disease other than hypertension
   3. Type 1 or type 2 diabetes mellitus
   4. Congenital or acquired immunodeficiency
   5. Impaired breathing due to muscular weakness
   6. Chronic renal or hepatic insufficiency
   7. Other chronic conditions with an increased risk of severe influenza as determined by the treating physician
3. Access to the official, mandatory Danish electronic mailbox system

Exclusion Criteria:

None
The Best Timing of Delivery in Women With GDM Study

The investigatiors aimed to conduct a well-designed RCT to firstly focus on GDM women controlled with only diet and exercise, and provide an optimize process on their timing and mode of delivery

GDM is a common complication of pregnancy and even mildly hyperglycemia could significantly affect fetal growth. Optimal delivery timing in women with GDM remains controversial. This decision process involves balancing the potential for complications that are caused by increased interventions with the benefit of avoidance of future adverse outcomes. Thus, the aim of the present trial is to explore the best management on the timing of delivery of pregnant women with GDM that controlled with only diet and exercise, which can both decrease the risk of macrosomia and the risk of cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnant women
* in vertex presentation
* GDM that is controlled with only diet and exercise
* at 37 weeks 0 days to 37 weeks 6 days of gestation
* more than 18 years old
* have no other contraindications to vaginal delivery.

Exclusion Criteria:

* prior caesarean section or myomectomy
* any known contraindications to vaginal delivery
* uncertain gestational age
* non reassuring foetal wellbeing necessitating delivery
* maternal pregnancy-related disease necessitating delivery (any hypertensive disorder, cardiac disease, renal insufficiency、immune diseases, et al.)
* placenta previa, accreta, vasa previa
* known foetal anomaly
* negative reproductive history
* ruptured membranes or known oligohydramnios (defined as AFI \< 5 or MVP \< 2 ) before 37weeks 6 days of gestation
* fetal growth restriction, defined as EFW \< 10th percentile
* known HIV positivity because of modified delivery plan
* signs of labor (regular painful contractions with cervical change) before 37weeks 6 days of gestation.
The Progressively Lowered Stress Threshold Model

Today, with the prolongation of human life, the elderly population has increased and the frequency of diseases seen in old age has increased due to this situation. The most common of these diseases is Alzheimer's disease. The Progressively Lowered Stress Threshold (PLST) is a conceptual model for reducing behavioral symptoms in individuals with dementia. In this study, it is aimed to determine the effect of interventions according to Decreased Stress Threshold Model on the level of neuropsychiatric symptoms and agitation of Alzheimer's patient and caregivers care satisfaction and life satisfaction.

Today, with the prolongation of human life, the elderly population has increased and the frequency of diseases seen in old age has increased due to this situation. The most common of these diseases is Alzheimer's disease. Alzheimer's disease is a progressive neurodegenerative disease which causes cognitive decline and various neuropsychiatric behavioral disorders and disorders in daily living activities. The emergence of these symptoms of Alzheimer's disease leads to an increase in the costs of care provided and a great distress for caregivers. In the literature, it is recommended to use nonpharmacological approaches as the first choice in the treatment of behavioral and psychological symptoms. One of the non-pharmacological approaches is the interventions according to the Progressively Lowered Stress Threshold Model. In this method, taking into account the individuality of the patient, focusing on the interaction of the Alzheimer's patient with the environment and the rearranging of the environment for the reduction of cognitive abilities, focuses on creating a less stressful environment. Since this model uses the steps of the nursing process, home visits are made. This study will be carried out with Alzheimer's patients and caregivers from Aksaray University Education and Research Hospital's Home Health Services unit. In this study, it is aimed to determine the effect of interventions according to Decreased Stress Threshold Model on the level of neuropsychiatric symptoms and agitation of Alzheimer's patient and caregivers care satisfaction and life satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above,
* Caring for moderate to mild Alzheimer's patients (test cognitive levels score is 19 and below)
* Being a close relative of the patient,
* Being the primary caregiver,
* Having volunteered to participate in the study
* There is no problem with communication

Exclusion Criteria:

* Younger than 18,
* Caring for an advanced Alzheimer's patient
* Paid caregiver
* Having a communication problem

the standardized Mini-Mental State Examination (MMSE) test cognitive levels score is above 20 points
Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)

To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI.

Objective :

To compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or knee-chest position (concord position) for cervical operation.

To identify Influence of the modified prone position (concord position) on these variables.

Method

1. To assess influence of the position change on PVI and other variables(PPV, SVV)
2. To assess PVI to predict fluid responsiveness at modified prone position

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists'(ASA) physical status 1-3
* patients who received cervical operation in modified prone position or knee-chest position

Exclusion Criteria:

* Valvular heart disease
* Congestive heart failure, reduced left ventricular function ( Ejection fraction \< 40%)
* Moderate grade of pulmonary disease
* Arrhythmia (atrial fibrillation, atrial flutter.. etc.)
* body mass index \> 30 or \< 15 kg/m2