cyrilzakka/clinical-trials huggingface dataset:
Impact of a Mailed Educational Reminder on Fecal Occult Blood Testing (FOBT): A Randomized Controlled Trial

The purpose of our randomized controlled trial is to determine whether mailed educational reminders would increase fecal occult blood test (FOBT) card return rates and, therefore, improve patient compliance with colonrectal cancer (CRC) screening.

We will conduct a randomized, controlled trial to evaluate the hypothesis that compliance to FOBT referrals is at least 10% greater among patients who receive mailed educational reminders on the importance of CRC screening. The study will be conducted in Veteran Affairs Medical Center and surrounding VA clinics in San Diego.

Colorectal cancer (CRC) is the third most common cancer in men and women in the United States with an estimated 147,000 new cases and more than 56,000 deaths each year. Early detection of colon cancer and removal of precancerous adenomatous polyps have been shown to reduce its morbidity, mortality and incidence. There are several recommended CRC screening tests, including fecal occult blood test (FOBT), flexible sigmoidoscopy, air-contrast barium enema, and colonoscopy. In the VA, FOBT is the predominant screening test for CRC, however patient compliance is low. Numerous studies have evaluated patient participation in CRC screening programs and FOBT card return rates, all of which have shown patient adherence was suboptimal. To date, there are no studies that have evaluated whether mailed educational reminders can improve FOBT compliance. The purpose of our randomized controlled trial is to determine whether mailed educational reminders would increase FOBT card return rates and, therefore, improve patient compliance with CRC screening.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic men and women age 50 years or older who received screening FOBT card kits from the laboratory

Exclusion Criteria:

* are less than 50 years of age
* are inpatients
* are not undergoing routine colon cancer screening
Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair

This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.

Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.

Study Procedures:

Before Surgery: The Informed Consent process will be completed prior to any data collection. Consent will be completed after explanation of each treatment group and the data to be collected. Baseline and demographic data will be collected prior to surgery:

Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff repair technique groups using REDCap software. Randomization will be stratified by gender.

Patient Visits:

Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3 months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given a pain diary to record all narcotic pain medications they consume during the 1st week post-op.

An ultrasound will be done during their 6 month, 1 year, and 2 year follow up.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-75 years old
* Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
* Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)

Exclusion Criteria:

* Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
* Patients undergoing revision rotator cuff tears will be excluded.
Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects

The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty diabetic subjects with chronic periodontitis will be divided in the following therapeutic groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group: SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing depth, clinical attachment level, bleeding on probing and suppuration. At these same periods, glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid samples from two shallow and two deep sites will be evaluated for the levels of cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus
* Clinical diagnosis of generalized chronic periodontitis
* \> 30 years old
* At least 15 teeth excluding third molars and teeth indicated to exodontia
* More than 30% of the sites with probing depth and clinical attachment level ≥ 4 mm at baseline

Exclusion Criteria:

* Pregnancy
* Lactation
* Current smoking
* Smoking within the past 5 years
* Periodontal or/and antibiotic therapies in the previous 6 months
* Regular use of mouthrinses containing antimicrobials in the preceding 2 months
* Other systemic condition that could affect the progression of periodontal disease
* Long-term use of anti-inflammatory and immunosuppressive medications
* Presence of periapical pathology
* Use of orthodontic appliances
* Multiple systemic complications of DM.
Incorporating teleCBIT Into a Hospital-Based Tic Program

This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.

Comprehensive Behavioral Intervention for Tics (CBIT) is a behavioral therapy with proven efficacy for treating persistent tic disorders (e.g., Tourette Syndrome) in youth and adults. Lack of access to a local CBIT provider prevents treatment access for many patients who could benefit from CBIT. Providing CBIT to patients in their homes via videoconferencing technology (i.e., teleCBIT) is a promising approach to increasing CBIT access. This study investigates treatment uptake, acceptability, feasibility, and clinical effectiveness of teleCBIT among pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.

Eligibility Criteria:
Inclusion Criteria:

* age 5-65, diagnosis of Tourette Syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis)
* Clinical Global Impressions - Severity Score \> 3 (i.e., "moderately ill" or worse),
* unmedicated or on stable medication treatment for tics and psychiatric problems,
* fluency in English
* a functional accessible home computer and high speed (i.e., cable/DSL) internet connection
* willingness to sign a release of information to contact a local, licensed medical or mental health provider, of whom they are currently a patient (in case of emergent safety concerns).
* Minor participants must have a parent or guardian who is fluent in English available to attend treatment and assessment sessions.

Exclusion Criteria:

* significant suicidality, (i.e., a score of \> 12 on the MINI or MINI-Kid suicidality module);
* prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care
* lack of a functional home computer with high speed (i.e., cable or DSL) internet connection;
* or, prior receipt of \>3 previous sessions of behavior therapy for tics within the past year (per self/parent report)
Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women

To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.

Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019 were reviewed to explore the correlation between early induction of labor and caesarean birth after 38 + 0 weeks. The hypothesis of the study is that induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.

Eligibility Criteria:
Inclusion Criteria:

* After 38 + 0 weeks of gestation
* low-risk pregnant primiparas
* singleton
* nulliparous
* \> 20 years old

Exclusion Criteria:

* Premature rupture of membranes
Understanding Physician Signout Risk Perception

The purpose of the study is to compare the ability of physicians and a statistical index (the Rothman score) to predict clinical deterioration over the next 24 hours. Clinical deterioration is defined as concern in change in vital signs or patient status requiring a call to the rapid response team, cardiopulmonary arrest, or transfer to the ICU.

The proposed study will ask interns, residents, and attending physicians from general internal medicine teaching teams in a large teaching hospital to make predictions about the probability of their patient having a clinical deterioration in the next 24 hours. The investigators will compare these judgments to the Rothman index.

Eligibility Criteria:
Inclusion Criteria:

* Interns, residents, attendings in the Department of Medicine, Division of General Internal Medicine, University of Pittsburgh.
* Rotating on the general medical service at the University of Pittsburgh Medical Center - Presbyterian Hospital.

Exclusion Criteria:

* None
Comparing CGM and OGTT in Relation to Iron Overload Detected by Pancreas T2* MRI in High-Risk Hematology Group

A prospective, observational, comparative study with no intervention.The objective of the study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C (Glycated Hemoglobin) and their relation to iron overload detected by T2\* MRI of the pancreas in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance and to study the different factors that may affect the glycemic control in these patients in relation to their results like the Dose of corticosteroids and chemotherapy in ALL and Hemoglobinopathies, Liver function in ALL and Hemoglobinopathies, and Serum ferritin in Hemoglobinopathies and their transfusion status. Using Validated Tools with Permission, the participants will be selected through probability (random) sampling method with expected subjects numbers ALL/L: 30-50, Thalassemia Major: 20, Sickle cell disease: 20.


Eligibility Criteria:
Inclusion Criteria:

* This study will include participants who are High-risk patients to develop glycemic abnormalities:

  1. Thalassemia major and SCD (beta cell toxicity and hepatic siderosis)
  2. ALL/L ( beta cell injury and hepatic injury due to chemotherapy, and insulin resistance due to corticosteroids)

Exclusion Criteria:

* Age \< 14 years;
* Other systemic diseases, renal disorders or malnourished;
* Patients and unwilling to participate in the study.
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Atrial fibrillation is an abnormal beating of the heart that can lead to stroke or heart failure. Structural heart diseases are conditions that affect the heart valves or heart muscle and can cause permanent heart damage if left untreated. Sometimes people have atrial fibrillation or structural heart disease and do not know it. The purpose of this study is to evaluate two devices that can predict who has or may develop atrial fibrillation or structural heart disease based on the results of an electrocardiogram.


Eligibility Criteria:
Inclusion Criteria:

* Retrospective Phase:
* Adults aged 40 or older.
* At least 1 ECG obtained during routine clinical care.
* Prospective Phase:
* AF Cohort:
* Adults aged 65 or older at the time of ECG.
* ECG obtained as part of a clinical care.
* Patient is able to identify a licensed healthcare provider to receive the results of the patch monitor.
* SHD Cohort:
* Adults aged 40 or older at the time of the ECG.
* ECG obtained as part of a clinical care between study start date and the end of study recruitment
* Patient is able to identify a licensed healthcare provider to receive the results of the echocardiogram.

Exclusion Criteria:

* Retrospective Phase:
* Patients who have previously requested that their data not be involved in any secondary use application such as a research study.
* Prospective Phase:
* AF Cohort:
* Any clinical or social factor that would prohibit completing the follow-up studies in a timely fashion.
* Patient currently admitted to the hospital (at time of consent)
* Permanent pacemaker or implanted cardiac defibrillator or implanted loop recorder.
* History of atrial fibrillation or atrial flutter.
* Cardiac surgery within 30 days prior to the index ECG
* Cardiac surgery planned within the next 6 months.
* Allergy to adhesive.
* SHD Cohort:
* Any clinical or social factor that would prohibit completing the follow-up studies in a timely fashion.
* Patient currently admitted to the hospital (at time of consent).
* History of SHD defined as any of the following: severe mitral regurgitation, severe tricuspid regurgitation, moderate or severe aortic stenosis, moderate or severe aortic regurgitation, moderate or severe mitral stenosis, left ventricular systolic dysfunction (LVEF ≤ 40%), or increased septal wall thickness \> 15 mm.
* Allergy to ultrasound gel.
The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of ATRA plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to ATRA+ high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed newly-diagnosed, treatment-naive ITP;
2. Platelet counts \<30×109/L ;
3. Platelet counts \< 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
4. Active infection;
5. Maligancy;
6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
9. Patients who are deemed unsuitable for the study by the investigator.
A Study of the Safety and Tolerability of IBI321 in Patients With Advanced Solid Tumors

This first-in-human open-label,dose-escalation study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Patients with advanced solid tumors who had failed standard treatment.
3. Male or female subjects ≥18 years and ≤75 years.
4. At least one measurable lesion per RECIST version 1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
6. Life expectancy of ≥ 12 weeks.
7. Adequate hematologic and end organ function

Exclusion Criteria:

1. Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
2. Failure to recover from adverse events from the most recent anti-tumor treatment
3. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
4. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
5. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
6. Pregnancy, lactation, breastfeeding
Releasing of Inflammatory Mediators During Retreatment of Root Canals

Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.The aim of this thesis study is to evaluate the effect of ProTaper Universal Retreatment (PTUR), Reciproc blue and XP-endo Finisher R file systems, which are used in the removal of root canal filling materials during retreatment with different motion kinetics on the release of Substance P, Calcitonin Gene-Related Peptide (CGRP), IL-6 and IL-10 inflammatory mediators in the periapical region

Seventy-five individuals with asymptomatic and chronic apical periodontitis teeth with retreatment indication were included in the study. Individuals were randomly divided into three groups according to the file system used to remove root canal filling materials (n = 25): ProTaper Universal Retreatment, Reciproc blue and XP-endo Finisher R.After the removal of the previous root canal filling materials, reshaping and disinfection of the root canals, periapical fluid samples were taken from the root tip of the teeth in all three groups. The amount of Substance P, CGRP, IL-6 and IL-10 mediators that cause pain, swelling and flare-up in periapical fluid samples were measured by ELISA test.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had single root canal treated teeth with chronic periapical lesion

Exclusion Criteria:

* Patients who are immunocompromised
* Patients under antibiotic or analgesic medication
Determining the Optimal Dose of Reactive Balance Training After Stroke

Falls in daily life are one of the most significant complications for people with stroke. Fall rates are particularly high soon after discharge from stroke rehabilitation. A new type of balance training, called reactive balance training (RBT), can reduce fall rates after discharge from stroke rehabilitation. In our previous study, RBT was implemented as part of routine care, and as a result, the dose of training was different for each participant; participants completed between one and twelve 30-minute sessions of RBT. Previous research in healthy older adults suggests that a single session of RBT is enough to lead to lasting changes in reactive balance control and reduce fall rates in daily life. It is not clear if the same is true for people with stroke, who have more severe impairments and might need a higher dose of training to achieve the same benefits.

The overall goal of this work is to determine the optimal dose of reactive balance training for people with stroke who are attending rehabilitation. This pilot study will determine the feasibility of a clinical trial to address this larger goal. People with sub-acute stroke will be randomly assigned to one of three groups: 1 session, 3 sessions, or 6 sessions of RBT. Each session will be 45 minutes long, and will occur as part of participants' routine out-patient rehabilitation. We will use our experiences with this pilot study to help design a larger study. Specifically, we will use this pilot study to answer the following questions: 1) what is the optimal sample size; 2) how long will it take to reach this sample size; 3) what outcome measures should be used; 4) how feasible is it to prescribe a specific dose of RBT to people with sub-acute stroke; and 5) what two intervention groups should be included in the larger trial?


Eligibility Criteria:
Inclusion criteria:

* Sub-acute stroke;
* Receiving out-patient rehabilitation at the Toronto Rehabilitation Institute;
* Can stand independently for \>30 seconds;
* Can walk with or without a gait aid (but without assistance of another person) for \>10 metres; and
* Living in the community.

Exclusion Criteria:

* Completed reactive balance training during in-patient rehabilitation;
* Lower-extremity amputation, weight-bearing restrictions, recent lower-extremity injury or surgery (e.g., fracture), acute back or lower-limb pain, halo, aspen collar, history of fragility fracture and/or severe osteoporosis/osteopenia, contractures that prevent neutral hip or ankle;
* Activity restrictions following cardiac event/surgery, abnormal or unstable cardiovascular responses to exercise, arterial dissection;
* Severe spasticity in the legs;
* Cognitive impairment (i.e., unable to understand the purpose of training and/or to provide informed consent); and/or
* Acute illness (e.g., vomiting, fever), extreme obesity (exceeds safety harness weight limits), colostomy bags, indwelling catheter, infection, pressure sore on pelvis or trunk.