cyrilzakka/clinical-trials huggingface dataset:
Gestrinone and Endothelial Function in Young Women

The purpose of this study is to assess the association of hormonal implant with gestrinone in cardiovascular health outcomes in young women.

After being informed about the study, volunteers will be screened in accordance with eligibility criteria. Eligible volunteers will be invited to appear to the research institute and participate in the study. All volunteers giving the written informed consent will perform all assessments in the same day at their visit.

Eligibility Criteria:
Inclusion Criteria:

* Women;
* Between 25 and 45 years age;
* History of ≥ 1 hormonal implant with gestrinone in the last 6 months or never had used any hormonal implants.

Exclusion Criteria:

* Pregnancy;
* Menopause;
* Smoking;
* Moderate-high consumption of alcoholic beverages (above 14 drinks per week);
* Previous cardiovascular event (e.g. myocardial infarction and stroke);
* Uncontrolled psychiatric disease;
* Ventricular arrhythmia;
* Using antibiotics or corticoids;
* Regular contraceptive use (estrogen and progesterone);
* Use of illicit drugs.
Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS

The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.

Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Fine needle aspiration (FNA) provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, FNB needles are stiffer and more difficult to handle, which can complicate tissue acquisition. In addition, the superiority of histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance, tissue, obtained by FNA and processed with the new cell-block technique, may equal the diagnostic yield of histological tissue cores.

A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an adequate cytological specimen. In this study, we aim to compare the properties and merits of a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA device.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for EUS-guided tissue acquisition because of a (I) pancreatic mass lesion or (II) lymph node
* Age \> 18 years
* Written informed consent
* Lesion can be visualized with EUS and is ≥1 cm in size

Exclusion Criteria:

* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
* Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5
* Purely cystic lesions
* Previous inclusion in the current study
* Pregnancy
Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

The primary study aims are to determine the clinical, behavioural and social predictors of SMI development in youth, and to investigate whether neuroimaging can distinguish youth who will develop SMI from those who will not.

The study's secondary aims are to examine the proportions of the cohort that make transitions between the different clinical stages of risk, and to determine the proportions that have poor outcomes, defined as ongoing or increased symptoms, secondary substance misuse, poor social or role functioning, i.e., non-participation in education, or employment, and new self-harm.

Investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group; n=160), youth at risk due to a family history of a SMI (family high risk (FHR); n=40), and healthy controls (HC; n=40). From this cohort, clinical, social and cognitive data, as well as imaging data will be gathered to create a multi-layered "snapshot" of these individuals and provide full-level characterization. Investigators will use the full range of clinical and imaging data generated from this cohort to develop novel prediction algorithms incorporating key variables that predict the development of SMI.


Eligibility Criteria:
Inclusion Criteria:

* Participants will understand and sign an informed consent (or assent for minors) document in English.

Exclusion Criteria:

* meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
* IQ \< 70;
* past or current history of a significant central nervous system disorder or serious medical disorder; and
* current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.
MPOWERed Messages: Tailored Mobile Messages to Enhance Weight Loss for Teens

Obesity affects millions of American children and increases their risk of adult obesity, a myriad of serious illnesses, increased healthcare costs, and premature death. It is vital to find ways to reverse this epidemic. Multidisciplinary behavioral weight management programs offer the promise of effectively treating childhood obesity. However, participants in such programs often find it challenging to follow recommended treatment plans and frequently drop out from programs without completing them. The proposed project aims to address these problems through frequent contact with patients between office visits. This interim contact will be achieved by automatically sending tailored messages to the mobile phones of adolescents enrolled in a multidisciplinary weight management program (the MPOWER program), as an adjunct to clinic visits.

The investigators hypothesize that program participants who receive the tailored text messages will experience lower attrition rates, increased treatment adherence, and greater weight loss compared to those program participants who do not receive the messages.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 95th percentile for sex and age according to CDC growth charts
* Enrollment in the MPOWER program
* At least one parent willing and able to participate in the MPOWER program with the adolescent
* Absence of any major medical illness, disability, or moderate/severe mental disorder (e.g., liver disease, renal failure, cancer, bipolar disorder)

Exclusion Criteria:

* Presence of any major medical illness, disability, or moderate/severe mental disorder (e.g., renal failure, cancer, bipolar disorder)
* Physical, mental, or cognitive handicaps that prevent participation
* Chronic use of medications that may affect study outcomes (e.g., Diuretics, oral steroids)
* Girls who are pregnant, planning to become pregnant in the next 6 months, lactating, or within 6 months postpartum
iTBS/fMRI Study of Hierarchical Control in the PFC

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.

The Comprehensive Control Task (CCT) was designed to examine hierarchical control in a single, well-controlled factorial task. On each trial, participants view a letter surrounded by a colored shape at a particular screen location. Color cues the relevant feature, letter or location, for a block of trials. The first trial of a block requires a decision of whether the stimulus is the first position of a circular sequence (sequence start). Subsequent trials require a decision of whether the viewed stimulus follows the previous stimulus in a circular sequence (sequence 1-back). The letter sequence (T-A-B-L-E-T) and spatial sequence (Top-Bottom Right-Left-Right-Bottom Left-Top) are difficulty-matched.

Shape cues the task to perform. Squares indicate the standard baseline task, and each block begins and ends with baseline trials. Different shapes indicate sub-tasks. In Switching blocks, shape-switches (e.g. from square to circle or circle to square) cue the sequence start task. Shape-repeats cue the sequence 1-back task. In Planning blocks, triangle shapes indicate that the stimulus can be ignored (automatic "no" response). All the while, the last square-shaped stimulus must be retained as a reference for the next square-shaped stimulus. Finally, in Dual blocks, diamond shapes indicate switching (sequence start) and also planning. The reversion back to square shapes requires sequence matching to the distal, previous square.

The design is factorial with stimulus-domain x contextual control x temporal control orthogonally manipulated. Full details of the CCT have been previous described in Nee \& D'Esposito, 2016; 2017.

The focus in this study will be comparison of FPl-TMS, MFG-TMS, and S1-TMS in an interleaved fMRI-TMS-fMRI design. The logic is to test the apical status of the FPl/MFG through the extent to which TMS impacts other PFC areas and behavior.

Each experiment will begin with 1 session of the CCT with fMRI to localize PFC targets. Each participant will then perform 3 counter-balanced sessions wherein a different site will be targeted by TMS followed immediately by fMRI on the CCT.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 30
* Right-handed
* Native English speaker or fluent by the age of 6

Exclusion Criteria:

* History of psychiatric disorders
* History of neurological disorders
* Receiving medications for psychiatric or neurological disorders
* Familial history of epilepsy
* Taking any drugs or medications that are pro-epileptic
* Metal anywhere in the head excluding the mouth
* Tinnitus
* Women who are pregnant
Mitigating Pain Following Refractive Surgery

Using Contact lens following refractive procedure to reduce pain.

Patients at day 1 following the procedure will be treated with a contact lens and assessed for pain at 1,2,4 hours and 1,3,5 days.

prospective comparative study

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent bilateral Refractive surgery for myopic correction.
2. Age 18-60.
3. Evidence of an epithelial defect.
4. Patient complains of significant pain.
5. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.

Exclusion Criteria:

1. Any other anterior segment abnormality other than that associated with Refractive surgery.
2. Any abnormalities associated with the eye lids.
3. Prior laser treatment of the retina.
4. Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
5. Diagnosis of glaucoma.
6. Active diabetic retinopathy.
7. Clinically significant inflammation or infection within six (6) months prior to study.
8. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
9. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material.
10. Intolerance or hypersensitivity to topical anesthetics,
11. Specifically known intolerance or hypersensitivity to contact lenses.
12. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
13. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)

Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research (EISNER) is a multi-study research program being conducted at Cedars-Sinai Medical Center.

The principal objective of this randomized trial (referred to as "Study 1") is to assess whether coronary artery calcium (CAC) scanning provides clinical benefit thus improving patient outcomes in asymptomatic subjects with intermediate coronary artery disease (CAD) risk. Additionally, the study is designed to assess the value of combining the CAC scan with the Framingham risk score (FRS) and measurements of serum or plasma biomarkers to predict outcomes.

At baseline eligible subjects underwent a clinic visit where they were randomized 2:1 to a "scan group" which had complete cardiac risk assessment and CAC scanning or a "no scan group" which had only complete cardiac risk assessment. Both groups underwent a private counseling session with a trained nurse practitioner to review their results and receive customized health behavior suggestions based on current American Heart Association guidelines for primary prevention of heart disease.

Subjects were followed up for changes in clinical status, medication use and specific health behaviors at one year after baseline. Annually for four years, subjects were followed up for subsequent diagnostic testing, therapy, and outcomes related to their cardiac health.

At four years after baseline, all subjects (from both groups) returned for a repeat clinic visit to have a complete cardiac risk assessment and CAC scanning. Year 4 CAC scanning was performed in both the "scan group" and "no scan group".

Additional long-term followup is being conducted under a separate protocol.

Eligibility Criteria:
Inclusion Criteria:

* No symptoms of CAD
* Intermediate risk of CAD, defined as either:

  1. male with age of 55-80 years or female with age 65-80 years or
  2. male of 45-54 years and at least one CAD risk factor or female with age 55-64 years and at least one CAD risk factor

     * Risk factors include: smoking, high blood pressure, high total or LDL cholesterol, low HDL cholesterol, diabetes, family history of early CAD.)

Exclusion Criteria:

* History of CVD including heart attack, cardiomyopathy, peripheral artery disease, angina, revascularization, and CVA (stroke)
* Prior coronary calcium scan or coronary angiogram
* Pregnancy
* Required radiation badges for work (CSMC Radiation Safety ruling)
* Clinically unstable health status or significant medical co-morbidity
Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions

The study will explore whether a 3D camera data can provide a more accurate baseline measurement (compared to 2D images with manual measurement) to support better clinical decision making in referrals to tissue viability.

Chronic and non-healing wounds are a significant problem to manage in community and represent a significant workload in community nursing. The current management for non-healing wounds includes referral to the tissue viability service, using a 2 D photographic image with assessment information. This study will pilot the use of a 3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention. The introduction of 3 D measurement and monitoring of wounds will be compared with usual care. With a target recruitment of 30 patients via tissue viability, the pilot will report on the feasibility of using this outcome measure and the effectiveness of monitoring on wound closure or improvement.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a non-healing wound and be over 18 years of age the criteria for non-healing wounds is as per 5.1 on the community nursing referral criteria when considering referral of patients to tissue viability:

'would expect that the wounds are deteriorating, chronic, non-healing or static or there are problems with the dressing regime'

Patients must be willing to provide written informed consent

Patients must have a registered Sheffield General Practitioner and be referred to tissue viability for a static or deteriorating wound

Exclusion Criteria:

* Patients with circumferential leg ulcers

Patients with deep narrow sinus where the opening is less than 10mm

Wounds on the face where the image would include the eyes or distinguishing features

Patients unable to provide written informed consent.
Patient Initiated Note About Goals

This is a randomized controlled trial of the Patient-Initiated Note about Goals (PING).

The PING is a brief survey designed to elicit patients' goals, preferences, and preferred surrogate decision-maker. In the PING study, patients will be assigned to receive either a nurse-administered PING or usual care. Outcomes include PING completion, subsequent goals of care conversations with providers, and healthcare utilization.

Eligibility Criteria:
Inclusion Criteria:

* Patient referred for Annual Wellness Visit at participating clinic

Exclusion Criteria:

* Non-English speaking
Computer-Assisted Cancer Risk Behavior Counseling

To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.

Patients are randomized into one of three groups. Before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. After a patient visits with their doctor, they are called again to answer question about the visit they just had. If a patient is place into group A or B, based on their answers to the questions they are mailed a printed report before their doctor visit. The report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. Group A feedback report will emphasize the risks from diabetes and the feedback reports for Group B will emphasize things to do to protect oneself from problems from having diabetes. Participants randomized to Group C will only receive printed reports after a doctors visit. No extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Has type 2 (adult-onset) diabetes;
* Developed diabetes after the age of 21;
* Has a scheduled doctor visit about diabetes in the next few months
Carbon Ion Radiotherapy for Atypical Meningiomas

Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.

First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.

Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.

Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed atypical meningioma
* macroscopic tumor after biopsy or subtotal resection
* Simpson Grade 4 or 5
* prior photon radiotherapy to the clinical target volume (CTV) of 48-52 Gy
* beginning of study treatment no later than 12 weeks after surgery
* age ≥ 18 years of age
* Karnofsky Performance Score ≥ 60
* For women with childbearing potential, adequate contraception
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria:

* refusal of the patients to take part in the study
* previous radiotherapy of the brain
* optic nerve sheath meningioma (ONSM)
* time interval of \> 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment
* Patients who have not yet recovered from acute toxicities of prior therapies
* Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
* Pregnant or lactating women
* Participation in another clinical study or observation period of competing trials, respectively
Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study is designed to differentiate parameters of pain between randomized laterality using no touch technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery but will receive a refund of a partial payment. Patients must undergo evaluation at consultation and surgical quote is provided.

Breast augmentation in the subpectoral position has classically been associated with postoperative pain and discomfort within the first two weeks after the operation. Minimizing this pain and discomfort and ability to return to normal function soon after the operation has been the goal of numerous interventions. Minimal injury no touch dissection techniques have proven results regarding morbidity. ERBEjet is a novel dissection using a jet of local anesthetic infused saline fluid with a built in coagulation function used for dissection of soft tissues. The study is designed to randomly perform ERBEjet Breast augmentation operation unilaterally on breast augmentation and mastopexy augmentation patients undergoing traditional sub pectoral dissection technique on the contralateral side. Patient's record pain scores at regular intervals in the postoperative period. Physical examination performed by blinded practitioners assess discomfort and tenderness scores within the two weeks after the operation.

Eligibility Criteria:
Inclusion Criteria:

* silicone breast implants candidate

Exclusion Criteria:

* history of breast cancer
* inability to conform to post operative questionnaire and recovery follow up