cyrilzakka/clinical-trials huggingface dataset:
Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer

A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. age \>= 18 years old;
2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023;
3. Received CDK4/6 inhibitors(Abemaciclib, Palbociclib or Dalpiciclib) as first-line therapy for at least one cycle;
4. Complete medical history was available.

Exclusion Criteria:

1. Medical history was incomplete.
Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease

Major depressive disorder (MDD) is a chronic health condition with significant consequences for health care costs, disability, quality of life, medical morbidity, and mortality. The World Health Organization (WHO) has considered depression as the leading cause of disability, a major contributor to overall global burden of disease . The core symptoms of depression are low mood and loss of interest or enjoyment in usually pleasurable activities. Associated symptoms include disturbances to sleep and appetite, reduced energy and concentration, negative thoughts of guilt or worthlessness and suicidal ideation. The International Statistical Classification of Diseases \& Related Health Problems (ICD-10) states that for a diagnosis of depression at least five symptoms need to be present, including at least one of the core symptoms, at an intensity that causes functional impairment and for a minimum duration of 2 weeks.

Vitamin B6 (Pyridoxine) is a water-soluble compound that comprises three different pyridine derivatives, pyridoxine, pyridoxal, and pyridoxamine, of which PLP(pyridoxal phosphate) is the biologically most active form. The coenzyme PLP is an essential cofactor for amino acid decarboxylases involved in the synthesis of neurotransmitters implicated in depression, including dopamine, norepinephrine ,serotonin or 5-hydroxytryptamine (5-HT), and γ-amino butyric acid (GABA). it prevents the accumulation of neurotoxic intermediates produced during tryptophan metabolism, acting as a cofactor in the metabolism of tryptophan through the kynurenine aminotransferase and kynureninase enzymes. Inadequate intake of vitamin B6 has recently been linked to an increased risk of anxiety and depression in a cross-sectional study of over 3,000 individuals.

Eligibility Criteria:
Inclusion Criteria:

* All participants must fulfill the following inclusion criteria;

  1. Patients diagnosed newly as major depressive disorder according to DSM-5( Diagnostic and Statistical Manual ) and (APA 2013) .
  2. Aged at least 18 years of both sex .
  3. Able to give informed consent .

Exclusion Criteria:

1. Patients have Comorbidity with other psychiatric disorders .
2. Patients have chronic medical conditions , chronic debilitating or nutritional disorders .
3. for control , Patients with any psychiatric disorders .
Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®

The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children and youth who suffer from stiffness of their muscles due to a neurological problem. These injections are given into each muscles which require treatment, which often means receiving multiple injections in one session. Intramuscular injections are typically painful. Treatment can be provided unsedated and then should incorporate distraction and relaxation techniques, or can be alternatively be provided with the use of sedation.

To improve the pain experience the investigators want to assess the feasibility and impact on the pain perception when using a vibration device called the Buzzy during BoNT-A injections. The Buzzy creates a vibration that is applied over the injection site for 30 seconds before the injection and will be continued just above the injection site during the injection. The Buzzy has been shown to help reduce pain in procedures such as i.v. insertions and immunizations, but has not been tested in children and youth receiving multiple BoNT-A injections.

Children and youth who receive hypertonia treatment with non-sedated BoNT-A injection will be invited to participate in this clinical trial. The patients will be randomized to receiving the injection with the Buzzy versus the control group without the Buzzy. Both groups will still receive their typical supports that will include their choice of local anesthetic cream, relaxation and distraction techniques. Randomization will be stratified for the ability to self report.

Measures to capture the pain will include self report of pain, by using the Face Pain Scale revised (FPSr) in all participants who are able to self report. In addition all participants will be evaluated by the use of the Face, Legs, Activity, Cry and Consolability scale (FLACC scale), an observational tool validated to capture pain responses. The investigators will also include measurement of heart rate at rest, during and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Any child and youth who receives non-sedated Botulinum toxin-A injections and is interested and consenting to using the Buzzy

Exclusion Criteria:

* Patients receiving Botulinum Toxin-A injections under sedation
* Patients younger than 2 years or older than 18 years.
Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China

to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by Hepatitis B in western China

Hepatopulmonary syndrome (HPS) occurs in approximately 4%-29% of cirrhotic patients and influences mortality. China has 100 million Hepatitis B virus (HBV) carriers and Chronic HBV infection is well-recognized risk factor for cirrhosis.But little is known about the prevalence of HPS in cirrhosis patients caused by HBV in western China. The aim of this study was to investigate the HPS incidence, and the signs, symptoms, arterial blood gas, and BMP9 in the serum of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-80 years old;
2. American association of anesthesiologists(ASA) score: I-III;
3. Ability to comply with research programmes;
4. Voluntary participation in the study;
5. Has the history of HBV infection;
6. No primary cardiopulmonary disease (heart disease, emphysema, pneumonia, asthma, etc.)

Exclusion Criteria:

1. Severe heart, lung, kidney disease coexisted;
2. American association of anesthesiologists(ASA) score≥IV; forced expiratory volume at one second (FEV1) or forced vital capacity (FVC) \<70%, or FEV1 / FVC \<0.70;
3. Mental state could not cooperate
4. Absence of written informed consent.
Indian Transforming Alzheimer's Care Training (INTACT)

INTACT will utilize a group-randomized trial, to test the effectiveness of a culturally informed provider training and "dementia friendly clinic" intervention for detection and appropriate management of AI/AN patients with ADRD and MCI in 28 urban and rural clinics serving AI/ANs.

The INTACT team will conduct a group-randomized trial (GRT) to test the effectiveness of the INTACT program, a culturally informed primary care provider training and clinic level workflow intervention for detection and appropriate management of AI/AN patients with Mild Cognitive Impairment (MCI) and ADRD in 28 urban and rural clinics serving AI/ANs. The clinics are the primary unit of randomization. Within each participating clinic, PCPs who are routinely seeing AI/AN patients ages 55 years and older will be recruited for data collection at baseline and 1-year follow-up. Each clinic will be randomized either to the immediate intervention or to a wait-list control arm. Data will be collected from PCP questionnaires, Electronic Health Records (EHR) data extraction and manual medical chart reviews. At the clinic level, we will rely on EHRs to document INTACT's effect on new ADRD diagnoses. At the PCP level, we will test whether INTACT increases knowledge and confidence in dementia assessment, ADRD care, and caregiver support. Patient-level data will be collected from the EHR and by manual chart review.

Once enrolled, clinics will complete a clinic profile interview and clinic and patient population information form, PCPs will be consented and complete a baseline survey. Next the clinics will be randomized into the immediate intervention or the wait-list control arms. Data collection will be conducted at baseline and 1-year follow-up. After completing the 1-year study period, clinics in the wait-list arm will have the opportunity to receive the INTACT intervention.

Eligibility Criteria:
CLINIC Eligibility criteria

To be eligible to participate in INTACT a clinic must be:

1. A primary care clinic
2. Have at least 20 AI/AN active patients 55 years or older
3. Have an EHR system
4. Not intending to change EHR systems in the next year
5. Willing to conduct a total of 40 limited patient chart reviews to assess quality of care metrics for AI/AN patients with MCI and ADRD, staff permitting

PCP

Eligibility criteria:

To be eligible to participate in the baseline and follow-up surveys a primary care provider must be:

1. have a title of MD, DO, Nurse Practitioner, or PA, and
2. regularly provides care to AI/ANs aged 65 and older.

PATIENTS

We will only collect patient EHR data from eligible patients who:

1. Recorded as AI/AN in the EHR system
2. Active clinic patient with prevalent ADRD as of the first day of the time period each data extraction will cover
3. Age 55 or older at the start of the surveillance interval
4. At least one primary care clinic visit during the time period each data extraction will cover.

There are no exclusion criteria for the clinic, PCPs and patients.
Codeine in Sickle Cell Disease

The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.

People with sickle cell disease require oral pain medications to manage an acute pain crisis. Sometimes these individuals fail to obtain adequate pain relief with the medications prescribed for outpatient use resulting in emergency room visits and hospital admissions. Subsequently, many patients are admitted to the hospital for pain management for a few days until the pain crisis resolves. The most common medications prescribed to sickle cell individuals for outpatient use include codeine and hydrocodone containing medications (i.e. Tylenol #3™, Vicodin™, Lortab™). These medications must be broken down in the body to make the active pain reliever (morphine or hydromorphone, respectively). Some individuals may not be able to break down these medications to the active pain reliever; therefore, these individuals will likely continue to experience pain unless they take other pain medications. We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to the active pain reliever in individuals with sickle cell disease.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Sickle cell disease (HbSS)
* Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past

Exclusion Criteria:

* Renal dysfunction, serum creatinine (SCr) \> 2.0 mg/dl
* Hepatic dysfunction, AST, ALT or direct bilirubin \> 3 x upper limit of normal (ULN)
* Codeine allergy
* Medications shown to induce or inhibit CYP2D6
* Women who are pregnant or breast feeding
* Unable to provide written, informed consent
Steroid Versus Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture

To compare the efficacy of steroid injection versus topical mitomycin-C in the treatment of pediatric benign recurrent esophageal strictures. The rationale for this study is to compare the two therapeutic options in order to measure their effectiveness, in terms of improvement of Dysphagia Severity Score (DSS).

After taking approval from the Institutional Review Board of the university; and taking the informed consent from parents, patients fulfilling the inclusion and exclusion criteria will be enrolled in the study. They will be then randomly allocated into two groups; group A and group B. Patients in Group A will be treated with esophageal dilation with a CRE balloon (controlled radial expansion balloon). After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. Patients in Group B will be treated with esophageal dilation with a CRE balloon in the same manner. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Dysphagia Severity Score will be noted at start of intervention, at 2 weeks after intervention and at 6 weeks post- intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients up to 16 years of age belonging to both genders
* Patients with single esophageal stricture
* Patients with benign recurrent esophageal strictures
* Patients with any etiology for esophageal stricture including; post-corrosive, congenital, post-anastomotic and eosinophilic.

Exclusion Criteria:

* Patients unfit for anesthesia and/or hemodynamic instability
* Patients with hemostatic disorder (platelets \<50,000 or international normalized ratio \>1.5)
* Patients who have undergone esophageal surgery in last one month
* Patients with complications such as; stricture perforation, signs of air leak or mediastinitis
* Those with hypersensitivity to Mitomycin- C
* Patients with multiple strictures
Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)

The purpose of this study is to determine the efficiency of Olmesartan medoxomile (OLMETEC®) alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial blood pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment goals using this antihypertensive regimen.

α= 0.05. α's Z=1.96 β= 80%. β's Z=0.84 Estimated proportion of subjects to achieve optimal control of arterial hypertension= 83.2%

450 subjects are expected to be enrolled in the study of which 40 subjects will be enrolled in Venezuela.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years of age or older
* Essential arterial hypertension Stade I and II according to JNC VII
* Signature of Informed Consent

Exclusion Criteria:

* Secondary arterial hypertension
* Pregnant woman or during lactancy
* Recent cardiovascular disease, as heart attack, unstable angina, or procedures of coronary revascularization on the previous six months.
* Acute Coronary Failure Syndrome on the previous six months.
* Chronic Ischemic Cardiopathy Treatment.
* Cerebral Vascular Disease on the previous six months.
* Alcoholism Story or use of drugs on the two previous years.
* Hepatic Disease Story
* Chronic Renal Failure defined by a serumal creatinine higher than 2mg/dl
* Albuminuria higher than 1gr.
* Known Allergy to blockers of angiotensine II receptors.
* Neoplasmic Malignant Disease included leukemia and the lymphoma (Skin basocellular cancer is not included)
* Auto Immune Disorders as systemic erythematosus lupus.
* Non attachment to medical treatments history.
* Patients sharing some clinical investigation essay on the last 3 months.
* Congestive heart failure under previous treatment with ECA inhibitors.
* Allergy to thiazidic diuretics.
* Angioedema History
* Use of drugs that affect potassium secretion, as diuretic savers of potassium, angiotensine enzyme inhibitor, betablockers, non-steroid anti-inflammatory drugs.
* Potassium consumption orally
Clinical Performance of the AFGen1 Device Over a 7-day Period

AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.

The primary purpose of this study is to demonstrate that the ECD signal acquired by the AFGen1 device is as of adequate quality and is suitable to support its intended use for the detection of AFib.

Eligibility Criteria:
Inclusion Criteria:

1. 18+ willing to sign the consent form

Exclusion Criteria:

1. Implanted pacemakers
2. Implanted cardioverter defibrillators
3. Implanted cardiac resynchronization devices
4. Potential life-threatening arrythmias
5. Physical or mental health conditions that would prevent the person from being able to follow instruc-tions regarding participation in the study
6. Open wounds, abraded or irritated skin at the application site
7. Planned to undergo a MRI during the course of the study duration
Outcomes and Risk Factors of CPR in PICU

1. To detect the frequency and the underlying causes of cardiopulmonary arrest .
2. To detect outcome of CPR
3. To identify the associated risk factors for the different outcomes after CPR among those patients

Cardiac arrest (CA) is uncommon in children, and the epidemiology of pediatric CA is different from adults. CA Is a critical cause of death in children in the hospital especially in the pediatric Intensive care unit (PICU). CA Is reported in 2-6% of children in the PICU, which is much higher than out-of-hospital arrest (about 8 to 20 annual cases per 100,000 pediatric population .

Previous studies reported that return of spontaneous circulation (ROSC) after cardiopulmonary Resuscitation (CPR) for in-hospital CA (IHCA) is about half of these patients, and ∼30% survived to hospital discharge Previous studies had analyzed the cause and prognostic factors associated with outcomes after IHCA, which included the Initial rhythm, duration of CA and CPR, the underlying disease, and where the event attacked .

Patients in PICU are more likely to develop CA because they are more critically ill. Information on factors associated with prognosis of in-PICU CA can promote Improvement in PICU care, which means improving survival with good neurologic outcomes .

Analyzing the epidemiological variables and risk/prognostic factors of in-PICU CA is of great Importance in developing the better therapeutic strategy and deciding appropriate preventive Measure .

Probability of death on admission and a longer length Of stay in the PICU were associated with increased odds of receiving CPR. Children admitted with cardiac conditions were at significantly higher risk of receiving CPR in the PICU Compared with those Admitted with noncardiac primary diagnosis. The risk Of receiving CPR was significantly associated with age, History of preadmission CPR, also, Electrolyte Imbalances and Multi-organ Dysfunction increase risk of receiving CPR in PICU .

Eligibility Criteria:
Inclusion Criteria:

* Including Children aged 1 month to 18 years who received at least 1 minute of CPR

Exclusion Criteria:

* Exclusion of 1-Children aged below1 month and older than 18 years .
* terminal disease patients, such as malignancy
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) During Pregnancy

This pilot study aims to examine the feasibility and acceptability of adding a cardiovascular health module to the existing Nurse Family Partnership (NFP) home visitation program delivered by trained nurses in the Northern Appalachian region of Central Pennsylvania.

The Promoting Cardiovascular Health of Northern Appalachian Women During and After Pregnancy: Pilot Study is a single arm pilot study that will enroll pregnant women (\<28 weeks' gestation) participating in the NFP home visitation program in the Northern Appalachian region of Central Pennsylvania. This pilot study will include an enhanced version of the NFP standard care plan delivered by trained nurses to promote cardiovascular health among women by targeting decreased sedentary time and enhanced physical activity (and where applicable smoking cessation) during and after pregnancy. This pilot study will also examine the feasibility and acceptability of digital devices (actigraphy, digital scale, blood pressure monitor) during this same time period.

Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous pregnant woman
2. Age ≥ 18 years old
3. Enrolled in and receiving the Nurse-Family Partnership program through the Geisinger Clinic or UPMC Home Health Care of Central PA
4. English speaking
5. Women with a singleton viable pregnancy confirmed by NFP home visitors
6. Access to reliable internet service required for data collection
7. A minimum of 5 women with use of nicotine containing products (cigarette, cigar, hookah, chewing tobacco, e-cigarette, patch) within the past 3 months

Exclusion Criteria:

1. Unable or unwilling to comply with the study visits and procedures
2. Participation in a concurrent interventional study
3. Diagnosis of cancer
4. A personal history of complex congenital heart disease
5. A fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded
Cardiopulmonary Effects of Prone Position in CARDS

In coronavirus disease-2019 (COVID-19)-related ARDS (C-ARDS), especially in the severe form, increased shunt rate, impaired ventilation/perfusion ratio (V/Q), hypoxic pulmonary vasoconstriction inhibition, and increased immune microthrombosis may have similar effects on the right ventricle .The cardiopulmonary pathophysiology and outcomes of C-ARDS vary, and this variability requires monitoring to follow the diagnosis and treatment process. This study aimed to increase the treatment success of the prone position in C-ARDS and to provide a prognostic factor for survival by analyzing and monitoring heart-lung interactions. Therefore, we used transesophageal echocardiography (TEE) to evaluate the cardiopulmonary effects of prone position.

This prospective study included 30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (PP) (T0), the first hour of PP (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment. Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) was preferred right ventricular evaluations as primer outcome. Static compliance (C-stat) was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Patients diagnosed with polymerase chain reaction/computed tomography results
* Moderate/severe severity class according to the Berlin ARDS classification
* Prone position applied in the first 48 h after orotracheal intubation in treatment
* Obtaining an informed consent form

Exclusion Criteria:

* Pulmonary embolism
* Pneumothorax
* Heart valve disease
* Pregnancy
* Perforated esophageal varices
* Coagulopathy
* Esophageal stricture
* Esophageal tumor
* Neck fracture
* Thrombocytopenia
* Gastrointestinal bleeding
* Previous stomach surgery
* Previous esophageal surgery
* Esophageal perforation
Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes aged \>1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.