cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening

Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country.

This pilot project will evaluate two approaches to implementing the use of a simple printed PSA screening decision-aid (DA) administered in an urban primary care clinic populated with a significant number of African-Americans. All subjects will complete a survey assessing their knowledge and attitudes about PSA screening and shared decision making (SDM), and physicians will also be briefly queried about their perceptions of the SDM process.

After the first three month implementation period we will conduct focus groups with clinic staff to guide changes and refinements to the use of DA in the clinical setting. Another three month implementation period will follow using the same methods to assess outcomes. Finally we will conduct another round of focus groups to assess the overall impact of the interventions.

Eligibility Criteria:
Inclusion criteria:

* Males ages 50-75
* Able to read and speak English
* Provide written informed consent

Exclusion criteria:

* Diagnosis of prostate cancer
* PSA testing within last 12 months
* Previous prostate biopsy
* Voiding problems as reason for clinic visit
* Visit scheduled same day or 'walk-In' patient
Meaning-Centered Psychotherapy Training for Cancer Care Providers

The purpose of this project, entitled "Meaning-Centered Psychotherapy Training for Cancer Care Providers," is to develop a multi-modal training program in Meaning-Centered Psychotherapy (MCP) for multidisciplinary cancer care clinicians who provide psycho-oncology and psychosocial palliative care services for cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinicians who provide psycho-oncology and/or psychosocial palliative care services for to patients with cancer and/or severe medical illness/disease at MSKCC, other institutions, or in the community, as per self-report.
* Completed online MCPT application form and commits to attend the two-day intensive MCPT program, complete training follow-up assessments, and participate in required follow-up training activities.
* Able to speak, read, and understand English proficiently to participate in MCPT training sessions and complete assessments.

Exclusion Criteria:

* Does not meet the criteria of an appropriate candidate for training program, as determined by review of the MCPT Application Evaluation Checklist in the opinion of the investigator.

  * Materials for the training and the training will be conducted in English only.
Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass.

The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass. Firstly, this study aims to characterize the gut microbiota in patients with valve disease treated with surgery. Secondly, it aims to evaluate microbiota and its influence on postoperative sleep.

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Chinese;
* Age, 18 to 65 years old;
* Patients undergoing heart valve surgery with cardiopulmonary bypass

Exclusion Criteria:

* Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* Body mass index exceeding 30 kg/m2
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Controling Mean Arterial Pressure Using a Closed-Loop System for Vasopressor Titration

The investigators have developed an automated vasopressor controller to improve the titration of vasopressor in order to maintain mean arterial pressure (MAP) within a narrow range and have recently shown the controller was effective in both the operating room and intensive care unit. The controller has been used recently in a case series of three patients undergoing cardiac surgery and in five patients after cardiac surgery.

The investigators want to compare now a manual to a closed-loop titration of vasopressor infusion in patients admitted in the Intensive Care unit after cardiac surgery

Perioperative hypotension and arterial pressure variability have been shown to negatively impact patient outcomes, increasing risk of stroke, kidney injury, and myocardial injury among others.

Vasopressors are usually used to rapidly correct hypotension. Vasopressor infusions are typically administered by standard infusion pump with the rate adjusted by anesthesiologists to reach a predefined target mean arterial pressure (MAP); this requires frequent changes in the infusion rate because of the almost constantly changing hemodynamic status of such patients. Because it is infeasible for human providers to pay constant attention and make second-to-second changes, management is often suboptimal (i.e. large amounts of time are spent in hypotension below the target, or well above the target with the vasopressor drip still running).

The investigators have developed an automated closed-loop vasopressor (CLV) controller to improve the titration of vasopressor (e.g:noradrenaline) in order to maintain MAP within a narrow range in the perioperative setting. The investigators have published engineering, animal and most recently, pilot,studies or case series with promising results.

In this randomized controlled trial, the investigators will compare time spent in hypotension defined as a mean arterial pressure \< 65 mmHg. They tested the hypothesis that the automated system will allow patients to spent less time during the postoperative period with a MAP \< 65 mmHg. This is thus a superiority study over a two hours study period

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Elective cardiac surgery
* French speaking patient

Exclusion Criteria:

* Uncontrolled hypertension
* Renal insufficiency (estimated glomerular filtration rate \< 30mL/min/1,73m²)
* Left ejection fraction \< 40%
* Emergency surgery
* Preoperative infection
* Preoperative cardiac arrythmia
* Pregnant women
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
* Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
* Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B \& 2C)
* Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)

Exclusion Criteria:

* Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
* Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted

Other protocol-defined inclusion/exclusion criteria apply
How to Learn Cardiopulmonary Resuscitation

the aim of the study is to evaluate two methods of teaching cardiopulmonary resuscitation in the context of chest compression quality. We will evaluate the usefulness of the application cpr feedback device (CPRMeter) for quality of chest compression.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* no medical experience

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy
VitalTraq for the Detection of CRS

The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.


Eligibility Criteria:
Inclusion Criteria:

1. Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows:

   * Axicabtagene ciloleucel
   * Lisocabtagene maraleucel
   * Brexucabtagene autoleucel
   * Idecabtagene vicleucel
   * Ciltacabtagene autoleucel
   * Obecabtagene autoleucel
   * Tisagenlecleucel
   * Blinatumomab
   * Mosunetuzumab
   * Talquetamab
   * Elranatamab
   * Teclistamab
   * Glofitamab
2. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening.
3. Able to read and understand English
4. Willing and able to provide informed consent to the study

Exclusion Criteria:

1. Receiving a non-FDA approved CAR-T or BiTE product
2. Receiving Epcoritamab
The Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders

This trial will test the efficacy of robot-enhanced interventions for developing social skills in children with Autism Spectrum Disorders (ASD). The study will compare, in an equivalence design, an innovative intervention delivered by a semi-autonomous robotic agent with standard behavioral intervention. The target group is children between 3 and 6 years old which will be randomly allocated to one of the two treatments. Each treatment will be delivered over 8 bi-weekly sessions of 45 minutes each.

Autism Spectrum Disorders (ASD) is characterized by a pattern of persistent deficits in communication and abnormal behaviors (i.e., repetitive and restrictive). Previous research has shown promising results for the use of social robots to develop social skills in ASD children. However, most of the research is based on case studies and single case experiments. Rigorous clinical data comparing robot--enhanced therapy with standard therapy is needed to establish the efficacy of this innovative intervention. The present study is an equivalence randomised clinical trial which plans to include children with a diagnosis of ASD between 3 to 6 years old. Eligible children are randomly allocated in one of two groups: (1) standard therapy, derived from applied behavior analysis (ABA) and (2) a robot--enhanced intervention in which the same treatment is delivered by a semi--autonomous robotic mediator agent (the robot acts as a mediator while the therapist is supervising the session). Both interventions are delivered over 8 bi-weekly sessions of about 45 minutes each. The present study will provide some of the first rigorous data regarding the efficacy of robot--enhanced therapy delivered by an intelligent robotic agent which require less direct input from an operator to deliver the intervention, as compared to previous research. If the results demonstrate the equivalence of the two interventions, this could open the door for the dissemination of evidence--based interventions for ASD children through the use of robotic agents.

Eligibility Criteria:
Inclusion Criteria:

* to be diagnosed using DSM-V criteria by a psychiatrist;
* the diagnostic is confirmed by the Autism Diagnostic Observation Scale (ADOS; scores are in the clinical range).
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
3. Subjects who successfully completed Study MT-1186-A01.

Exclusion Criteria:

1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication.
2. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Visit
3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Study of Tolerance to Oral Peanut

Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy

Background Peanut allergy is severe and rarely resolves.

Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy.

Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Peanut allergy defined by oral challenge

Exclusion Criteria:

* Major immunodeficiency
Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center

The primary objective of this study is to evaluate the practice patterns of rivaroxaban usage invenous-thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) in cancer patients.

The secondary objectives are to evaluate outcomes such as recurrent VTE, stroke and bleeding for cancer patients on rivaroxaban.

This retrospective descriptive study will review charts of approximately 375 cancer patients prescribed rivaroxaban from January 1, 2012 to November 7, 2016 at UT MDACC for NVAF or patients that had prior VTE and diagnosis of cancer. The list of patients prescribed rivaroxaban during the study period will be obtained from Pharmacy Informatics. We will review the eligibility of all patients on the pharmacy list who were prescribed rivaroxaban during the study time-frame. The eligible patients who meet inclusion/exclusion criteria will be identified. All available data concerning demographic, clinical parameters and rivaroxaban usage will be collected for eligible patients from Pharmacy Informatics, CS, Laboratory Informatics, and Clinical Informatics Databases.

The variables of interest include demographic information, clinical parameters (tumor type, extent of disease, clinical exam findings, and presence of comorbidities, diagnostic assessments, and treatment interventions), reason for rivaroxaban discontinuation and outcomes. The confidentiality of all patient-specific data will be maintained. By using Pharmacy Informatics and CS, we can capture most of patients prescribed rivaroxaban at the UT MDACC.This is a descriptive study and the final sample size will depend on available records for chart review from 01/01/2012 to 11/07/2016.

Eligibility Criteria:
Inclusion Criteria:

1. Age range: patient must be ≥ 18 years.
2. Male and female patients will be eligible for enrollment.
3. Patients diagnosed with deep-vein thrombosis of the lower and upper extremities, pulmonary embolism or both or with non-valvular atrial fibrillation.
4. Patients must have active malignancy defined as a diagnosis of cancer (excluding basal cell squamous cell carcinoma of the skin) within six months before enrollment, have received any treatment for cancer within the previous six months or have documented recurrent or metastatic cancer .

Exclusion Criteria:

1. Patients who are on hemodialysis
2. Patients with valvular heart disease (using a coexisting prosthetic heart valve or have a hemodynamically significant valve disease)
Comparison of Skin - Epidural and Intervertebral Distances in Sitting and Rider Position

Epidural anesthesia/analgesia can be performed under various positions. In this study, the investigators aimed to compare the intervertebral and skin-epidural distances in "the sitting" and "rider" positions with the help of ultrasonography

Complication rates in epidural intervention, which can be used for both intraoperative and postoperative analgesia are higher than peripheral blocks, especially in open abdominal surgeries. In epidural intervention, correct determination of patient position, puncture site and the distance from the skin to the epidural area (skin - epidural distance) is very important in terms of preventing complications. The location of the point where the epidural intervention will be made is aimed to be determined using the anatomical surface markings in the blind technique. However, anatomical surface markings are unreliable in pregnant or obese patients and patients with anatomical variants. The use of pre-procedure ultrasonography allows obtaining information such as midline and baseline determination, skin-epidural distance measurement, increasing the success of the intervention.

The most preferred positions for epidural interventions are sitting and lateral decubitus positions. Many modifications of these positions also exist. The rider position is used in a few centers in and out of Turkey, but there is only one clinical study related to the position.

Eligibility Criteria:
Inclusion Criteria:

• ASA (American Society of Anesthesiologists) classification I-III

Exclusion Criteria:

* Prior spinal surgery
* Spinal deformity
* Recent spinal and head trauma
* Infection in the area to be measured
* Severe hypovolemia
* Severe edema
* severe abdominal distention
* Severe pain
* Difficulty in cooperation
This Study is Mainly About Finding Incidence Among Other Factors of Thyroid Cancer in Patient with Benign Disease As MNG to Early Discover of the Malignancy to Save the Patient from Aggressive Procedure

The purpose of the present study was to evaluate the prevalence of thyroid cancer in patients who had thyroidectomy for MNG, and analyze patient-related parameters to identify type and risk factors associated with incidental thyroid malignancy.

Multinodular goiter (MNG) is a common thyroid disorder characterized by the presence of multiple nodules in the thyroid gland. It is a benign condition, but a proportion of patients with MNG have risk of developing thyroid cancer .

Thyroid carcinoma is one of the most frequent types of endocrinological cancers, and its occurrence has been on the rise globally. Total thyroidectomy is regarded as the most effective surgical treatment for MNG and is also advised for patients with diagnosed thyroid cancer.

Several studies have revealed a greater incidence of thyroid cancer in MNG. Published data regarding the prevalence of thyroid cancer within a multinodular goitre (MNG) have demonstrated a wide distribution of cancer rates, ranging from 3 to 35 percent.

Although fine-needle aspiration (FNA) is the most accurate and cost effective method of thyroid nodule evaluation, benign cytological -diagnosis is associated with false-negative. Further complicating this topic, FNA cytology may be non-diagnostic in up to 25 per cent of patients with nodular thyroid disease, and its performance in the setting of MNG presents other difficulties, including deeply located thyroid nodules that may be more challenging to aspirate as well as reliably evaluating all suspicious nodules.

Incidental thyroid cancer (ITC) is sometimes detected in the final pathological examination, the incidence of ITC after surgery varies widely in literature, ranging from 2% to 30%.

Certain risk factors, such as sex, age, history of neck irradiation, family history, calcifications observed during imaging studies, size of the thyroid tumor and thyroid-stimulating hormone (TSH) levels, may be related to ITC; however, this remains controversial. Although previous studies have focused on clinical factors related to cancer, the knowledge on pathologic characteristics of ITC is limited.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients with multinodular goiter Patients with normal thyroid function tests Patients with FNAC negative for malignancy Patients who are fit for general anesthesia

Exclusion Criteria:

* patient suspicious nodule on ultrasound imaging patients in whom distant metastases occurred preoperatively but FNAC was negative for malignancy patients with a history of thyroidectomy Patients with severe comorbid conditions with high risk for general anesthesia