cyrilzakka/clinical-trials huggingface dataset:
MyChart Proxy Outreach to Parents (MyPOP)

The goal of this randomized controlled trial is to assess the extent to which different modes of contacting parents who have not yet enabled to access to their children's medical records will result in greater proxy access. The main questions the study aims to answer are:

* will outreach via text or patient portal message result in more parents having access than usual care (which is in-office suggestions to get access).
* which mode - text or portal - will get more parents access. Participants will get a text message, or a portal message through their own patient portal, or no message. The investigators will check access to see which group has increased more during the study period.

This study aims to evaluate the feasibility and impact of contacting parents/guardians of children seen in pediatric primary care practices to establish their proxy access to the EHR patient portal, called "MyChart." The primary objective of the study is to determine if directly messaging a guardian results in activation of proxy access to a child's MyChart at a higher rate compared with no specific messaging (usual care).

A secondary objective of the study is to compare messaging strategies, with one arm being a message to the guardian's patient portal, and the other text messaging.

Another secondary objective of the study is to ascertain whether sending information about activation to a guardian via text or email (as preferred) will result in self-activating their own Electronic Health Record (EHR) patient portal access.

At the conclusion of the study, the investigators will determine best-method for activation and utilize this method to invite guardians initially randomized to the usual-care arm of the study.

Eligibility Criteria:
Inclusion Criteria:

* Guardian of a child aged ≤12 years seen in one of the two identified health centers within the last 3 years with guardian status and contact information documented in the child's EHR

Exclusion Criteria:

* Preferred method of contact for guardians with no MyChart is telephone or physical letter to home
* Guardians with EHR proxy access already activated for all children in their care.
Japanese Lead Extraction Registry

Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.

Japanese Lead Extraction (J-LEX) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system until 30 days after the lead extraction. The investigators will collect the data regarding patient's background and lead characteristic, medical history, details about lead extraction procedure, lead characteristics, and outcomes. The data were anonymized in a linkable manner at each study site before they were sent. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing transvenous lead extraction in Japan.

Exclusion Criteria:

* Patients who receive open-chest surgical extraction alone.
* Patients who refused to consent.
Effect of Emotional Freedom Technique on Perceived Pain, Situational Anxiety and Satisfaction Levels During Mammography Screening.

This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxietyl and satisfaction level during mammography screening.

The randomized controlled and experimental study will be conducted with 94 women who applied to the Cancer Early Diagnosis, Screening and Education Center for mammography screening. The women in the experimental group (n=47) will be applied the Emotional Freedom Technique before mammography screening and the women in the control group (n=47) will be given routine mammography screening. The Sociodemographic Information Form, Visual Analog, Situational Anxiety Inventory, blood pressure monitor, thermometer and saturation device will be used to collect the data.

Eligibility Criteria:
Inclusion Criteria:

* Having a first mammography screening
* Knowing how to read and write,
* Having entered menopause (at least 1 year has passed since the last menstruation)

Exclusion Criteria:

* Having any cognitive or hearing problems,
* Having used painkillers before the procedure,
* Having no chronic diseases (cardiovascular, respiratory tract),
* Having a diagnosed mental illness (schizophrenia, bipolar disorder),
* Having epilepsy (as it is a contraindication for EFT applications),
Assessing Optimal XRB Initiation Points in Jail

This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.


Eligibility Criteria:
Inclusion Criteria:

* Incarcerated men able to provide written informed consent in English.\*
* Unsentenced.
* Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.
* Minimum anticipated jail stay is 4 days.
* Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).

Exclusion Criteria:

* Sentenced.
* Allergy, hypersensitivity or medical contraindication to either medication.
* Chronic pain requiring opioid pain management or other contraindicated medications.
Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis

To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria


Eligibility Criteria:
Inclusion Criteria:

* Adult premenopausal females, 18 years and older.
* Mentally competent patients that can comply with the study protocol and are able to complete and keep or study related material (patient diaries, etc.).
* Signed and dated written informed consent.
* Clinical diagnosis of BV according to Amsel criteria
* Gram stains Nugent Score ≥7 or Nugent Score 4-6 with the presence of clue cells
* Patient does not need an anti-infective treatment which would be required for specific treatment of vaginosis or to prevent the development of acute vaginitis and which may affect treatment outcome of BV.
* Negative pregnancy test at screening.

Exclusion Criteria:

* Patients with other infectious causes of vulvovaginitis (e.g. Vaginal candidiasis, Trichomonas vaginalis).
* Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical and or therapeutic response.
* Patients who received antifungal or antimicrobial therapy (systemic or intravaginal), as part of standard clinical practice, or clinical trial, within 14 days of randomization.
* Patients who are diagnosed with a chronic inflammatory disease (Rheumatoid Arthritis, psoriasis, Crohn's disease, Coeliac disease, spondyloarthritis rheumatica etc.)
* Women who are scheduled to be under treatment during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
* Pregnancy or lactation.
* Patients with known hypersensitivity to formaldehyde.
* Patients undergoing antibiotic treatment.
* Patients with acute polyarthritis, known serious cardiac, liver, kidney diseases or unstable diabetes mellitus.
* Known abnormalities of the blood circulation or of the haemopoietic system.
* Use of any investigational drug within 30 days from randomization.
* Patients who do not abstain from use of intravaginal products for at least 7 days prior to study randomization (e.g. douches, female deodorant sprays, spermicides, condoms, tampons, and diaphragms). Patients should also refrain from using intravaginal products 3 days prior to each study visit.
* Patients who do not abstain from vaginal intercourse during at least 3 days prior to each study visit.
The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.

The investigators will record 120 patients who received general anesthesia, their EEG data recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.

The electroencephalography (EEG) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) which can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear.

The relationship between frontal EEG patterns and hypnotics remain poorly understood. The investigators only can tell the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to decompose EEG with HHT and find the energy shift during general anesthesia, compare with different anesthetics.

The investigators will record 120 patients who received general anesthesia, their EEG data recorded from BIS machine for EMD analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* scheduled surgery who need general anesthesia

Exclusion Criteria:

* allergy to the BIS patch
* not suitable for general anesthesia
Actigraphs for Detection of Asymmetries

In hemiplegia quantitatively measurement of the asymmetry in the use of upper limbs could overcome the limitation of many outcome measures in which scores are dependent on the experience and training of the therapist. The main aim of this study was to determine the validity of Actigraph GXT3+ to measure asymmetry in the use of the two upper limbs during the Assisting Hand Assessment (AHA) in children, adolescents and young with hemiplegia aged 5-19 years, compared to age-matched typically developing subjects (TD).

This study aims to validate the use of Actigraphs as an evaluation tool of the upper limb asymmetry in children / adolescents and young adults with typical development or hemiplegia.

The validation involves two stages:

The first stage, carried out in the clinical setting, provides the use of Actigraphs (Actigraph GXT3+ and in a subgroup also FitBit) during the administration of clinical tests which are usually performed for the evaluation of the manual dominance in individuals with hemiplegia but also suitable for those with typical development.

This first phase will allow to compare the quantitative measures acquired by the actigraphs (e.g. the mean activity of each hand and the asymmetry index i.e. difference between the mean activities of the two arms) with those from clinical standardized measures.

The second phase, carried out in a non-clinical setting, provides the use of Actigraphs (Actigraph GXT3+ and in a subgroup also FitBit) in a subgroup of subject involved in the first phase for a week in order to measure the asymmetry index during the activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3-25 years
* Hemiplegia (experimental group) or Voluntary adhesion (control group)

Exclusion Criteria:

* movement disorders
* sensory deficits
Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata

To the investigators knowledge there is no research data published to date regarding the lower urinary tract symptoms in women with leiomyomas. The primary aims of this study are:

1. To determine prevalence of lower urinary tract symptoms in patients who present for care for symptomatic leiomyomata.
2. To compare change in lower urinary tract symptoms within treatment groups measured by the UDI-6 total before and at six months after three common treatments for symptomatic uterine fibroids including: hysterectomy, myomectomy, or uterine artery embolization.

The study proposed here will hopefully answer the question if one particular therapy is appropriate to treat fibroids and relieve lower urinary tract symptoms.

1. Uterine fibroids Uterine leiomyomas or fibroids are one of the most common conditions affecting women of reproductive age. They account for approximately a third of all hysterectomies performed. Symptoms often attributed to uterine leiomyomas include excessive menstrual bleeding, dysmenorrhea, pelvic pain, and so called "bulk symptoms," or symptoms related to pressure on adjacent organs such as ureteral obstruction, urinary frequency and urgency, rectal pressure, pelvic pressure and increasing abdominal girth. Current treatment for symptomatic uterine fibroids includes hysterectomy, myomectomy and uterine fibroid embolization.
2. Lower urinary tract symptoms Although, urinary symptoms like frequency, urgency, incontinence, and voiding dysfunction are often attributed to fibroids, the relationship between fibroids and lower urinary tract symptoms (LUTS) has been poorly studied. The public health burden of fibroids has been studied before and after radical hysterectomy, supracervical hysterectomy, and total abdominal hysterectomy.(1-3) What is missing in the literature is a comparison of traditional and non-traditional surgical fibroid techniques in a prospective fashion. Moreover, there are no studies evaluating the relationship between anatomic factors like uterine size or fibroid number or location and the presence of LUTS.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age,
* Vaginal bleeding secondary to anatomic uterine leiomyomas confirmed at the Cleveland Clinic Fibroid and Menstrual Disorders Center,
* Patients complaining of mass effect symptoms due to fibroids, and
* Patients undergoing either hysterectomy, myomectomy, or uterine artery embolization

Exclusion Criteria:

* Patients who are pregnant, or
* Diagnosis of solitary or multiple intracavitary fibroids without subserosal or intramural leiomyomas present, or
* Prior or interval anti-incontinence procedure, or
* Patients with a urinary tract infection, or
* Patients taking anti-cholinergic medications, or
* Presence of an adnexal mass, or
* Unable or unwilling to complete a follow up survey at six months following treatment
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)

The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).


Eligibility Criteria:
Inclusion Criteria:

* Patient has mild to moderate Alzheimer Disease
* Women cannot be able to get pregnant
* Patient has a reliable caregiver, who will attend all visits and answer questions about the patient

Exclusion Criteria:

* Patient lives in a nursing home or facility
* Patient has another neurological or neurodegenerative disorder
* Patient has a history of stroke
* Patient uses illicit drugs or has a history of drug/alcohol abuse
* Patient has received blood or blood derived products within 6 months
Reducing Teen Pregnancy in the Emergency Department

This study will determine the feasibility, acceptability, and potential efficacy of an emergency department-based pregnancy prevention intervention targeting sexually active adolescent female emergency department patients.

Emergency Departments (ED) care for 15 million adolescents each year. Adolescents who use the ED are at particularly high risk of unintended pregnancy. To date, no intervention has successfully increased contraception use among this high risk, hard-to-reach ED population.

In this study, the investigators will conduct a pilot randomized controlled trial of a user-informed, theory-based, personalized, interactive, pregnancy prevention text messaging intervention (Dr. Erica) to determine its feasibility, acceptability and potential efficacy. The investigators hypothesize that high risk adolescent female ED patients who receive Dr. Erica will more often initiate contraceptives than those females who receive standard discharge instructions alone.

At baseline and follow-up assessment at 3 months, participants will provide information regarding effective contraception initiation, any contraception at last intercourse, follow up with reproductive preventive health services, and contraception self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* female emergency department patient
* age 14-19 years
* sexually active with males in the past 3 months

Exclusion Criteria:

* currently using any effective form of contraception
* do not own a mobile phone with texting
* are pregnant
* are too ill for participation per the attending physician
* are cognitively impaired
* do not live locally
* do not speak English
* want to "become pregnant in the next year"
Community-acquired Pneumonia in Buskerud County in Norway

The purpose of this study is to determine the etiology of community-acquired pneumonia, to assess risk factors and to investigate potential prognostic biomarkers of serious disease and fatal outcome.

Background: This project addresses an important challenge in international medicine: Pneumonia as the leading cause of death from infection in developed countries. Purpose: (A) Determine the etiology of CAP among adult hospitalized patients- especially the occurrence of mixed infections- by systematic implementation of combined conventional and new diagnostic methods. (B) Assess risk factors of CAP, such as COPD, congestive heart failure, smoking, malignancy etc., predictive of re-admittance to hospital and mortality. (C) Examine the prognostic value of potential predictors in relation to all-cause mortality in adult patients hospitalized with CAP. Design: Prospective observational study with inclusion of 270 adult patients during a 3-year period, who all required admission for pneumonia in a community hospital setting. Clinical and biochemical data was recorded longitudinally by inclusion, at stable clinical situation and after 6 weeks, and mortality and need for re-admission within 12 months. Patients were examined systematically, using modern research methods to explore relevant microbes. At all points, blood tests were sampled for clinical-chemical analysis, DNA, RNA and immunological analyses. Application: A translational research approach with the ambitions to elucidate new pathogenic mechanisms which could lead to new diagnostic tools and treatment modalities. This will possibly lead to less drug exposure and unnecessary hospitalization both of which have positive consequences for patients and medical care costs.

Eligibility Criteria:
Inclusion Criteria:

* New infiltrate on chest X-ray and
* Fever \> 38,0 by rectal measurement

  * at least one of these additional criteria: Cough +/- expectoration, dyspnoea, respiratory chest pain, crackles or reduced respiratory sounds.
* Criteria must be present within 48 hours after admission

Exclusion Criteria:

* Patients \< 18 years
* Non infectious cause of lung infiltration (tumors, embolism)
* Bronchial obstruction (tumor, bronchiectasia)
* Hospitalised more than 48 hours or discharged within the last 2 weeks
Impact of Smoking on Salivary Interleukin (IL)-39, IL-41, IL-1β, TNF-α Levels in Periodontal Disease

The goal of this observational study is to evaluate if the measurement of salivary Interleukin (IL)-39, IL-41, IL-1Beta(β), and Tumor necrosis factor-alpha (TNF-α) levels can aid in the early diagnosis of periodontitis in patients with varying periodontal conditions, both smokers and non-smokers. The main questions it aims to answer are:

Can salivary IL-39, IL-41, IL-1β, and TNF-α levels be used as biomarkers for the early diagnosis of periodontitis? How do IL-41 and IL-39 levels correlate with smoking status in periodontal healthy and periodontitis patients? Researchers will compare the salivary biomarker levels between smokers and non-smokers to see if smoking affects these levels.

Participants will:

Provide salivary samples for biomarker analysis. Undergo a comprehensive periodontal examination to determine their periodontal status.


Eligibility Criteria:
Inclusion Criteria:

* The periodontitis groups (Non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with Stage II and III, generalized, Grade B, C periodontitis based on the consensus report of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions.
* Agreeing to participate in the study

Exclusion Criteria:

* use of oral contraceptive drugs
* use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study;
* history of excessive alcohol use;
* pregnancy or breastfeeding status;
* periodontal treatment during the last 6 months before the study.
* Not agreeing to participate in the study
* Not meeting the inclusion criteria
Prospective Randomized On-X Versus SJM Evaluation Trial

The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.

The study is a multi-centre, randomized trial that will sequentially enroll up to 500 eligible patients in each group from up to 10 participating study centres internationally to test the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

1. The patient requires an isolated mitral or isolated aortic valve replacement. (Patients undergoing coronary artery bypass and / or concomitant repair of mitral or tricuspid valves are eligible.)
2. The patient is a candidate for receipt of a mechanical heart valve.
3. The patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements.
4. The patient can be having a re-operative procedure, so long as the previous prosthetic valve is explanted and the patient does not become a double valve implantation patient.

Exclusion Criteria:

1. The patient is not a candidate to receive a mechanical heart valve.
2. The patient already has a prosthetic valve other than the valve(s) being replaced at this time.
3. The patient requires a tricuspid valve replacement.
4. The patient is enrolled in another investigative study or trial.