cyrilzakka/clinical-trials huggingface dataset:
Asthma and Technology in Emerging African American Adults

The purpose of the ATHENA Project is to test a mobile health intervention to help African American young adults better manage their asthma. The program has four components: 1) a web-based, mobile asthma program delivered to participants' mobile device, 2) meetings with an asthma nurse via video conference, 3) text messaging, and 4) physical activity tracking. Participants will be randomly assigned to one or more of these components to better meet the needs of young adults with asthma.

Asthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEA; ages 18-30), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be most effective. However, face-to-face interventions are often difficult to implement, especially among emerging adults. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, the research team will use an innovative strategy to develop a mobile asthma management intervention using the most effective combination of a smart phone app delivering personalized asthma information (MES), nurse-delivered asthma education (SA), text messaging (SMS), and physical activity tracking (PAT).

The purpose of this proposal is to develop an effective mHealth intervention to improve asthma management and asthma control in AAEA. Investigators will assess the ability of multiple technologic components to assist and improve traditional asthma education. Upon completion of the study, investigators will have an empirically-supported mobile asthma management intervention to improve asthma control for AAEA.

It is hypothesized that post-intervention, participants with uncontrolled asthma will show clinically-significant improvement in asthma control and improvements in asthma management behaviors, quality of life, symptoms, adherence, and exacerbations will also be observed.

Eligibility Criteria:
Inclusion Criteria:

* African American, 18-30 years of age, uncontrolled asthma (defined by a score of less than 19 on the ACT), own or have access to a cell phone for the duration of the study, have a primary care physician (PCP)

Exclusion Criteria:

* Significant cardiopulmonary disease (including chronic obstructive pulmonary disease), a greater than 20 pack per year smoking history, developmental delay or mental illness such that participation in the program would not be possible, pregnancy
Postpartum Pain Experience and Attitudes About Opioid Prescribing

This is a prospective qualitative study of obstetric clinicians examining factors which influence their approach to postpartum pain management, their perspectives and preferences of interventions aimed at reducing opioid use, and the biases which may contribute disparities in this setting.

Opioid misuse has been declared a national emergency in the United States. More than half of hospitalized patients receive an opioid during their hospitalization. As birth is the most common reason for hospitalization, reproductive-aged individuals are particularly vulnerable to opioid exposure and are an important population for addressing the opioid epidemic. Indeed, data have demonstrated the high frequency of postpartum inpatient and outpatient opioid use, the wide variation in postpartum pain management, the lack of alignment of opioid prescribing with patient reports of pain, and the contributions of obstetric clinicians to opioid prescribing.

The opioid epidemic has a differential impact by race/ethnicity; individuals of minority race/ethnicity are less likely to receive an opioid for pain management than non-Hispanic White individuals. Notably, data show that, despite reporting higher levels of pain postpartum, minority race/ethnicity birthing individuals receive less opioid treatment as inpatients and are less frequently prescribed an opioid upon hospital discharge. A complete understanding and, ultimately improvement, of these experiences and reduction in disparities requires a deeper delve into influences which guide clinicians in their management of postpartum pain.

This investigation aims to fill an unmet need for a systematic, in-depth, and unbiased evaluation of obstetric clinicians' experience of postpartum pain management. This is a prospective qualitative study of obstetric clinicians, examining factors which influence their approach to postpartum pain management, biases which may contribute to disparities, and their perspectives and preferences of interventions to reduce opioids and improve pain control. Investigators will conduct in-depth semi-structured interviews with up to 50 obstetric clinicians, including physicians, advanced practitioners, and nurses. Aim 1 will evaluate beliefs and factors which influence clinicians' management of postpartum pain, including potential clinician-level biases which may contribute to disparities. Using the Consolidated Framework for Implementation Science, Aim 2 will evaluate clinicians' perspectives and preferences of interventions to reducing postpartum opioid prescribing and improving pain control, in order to optimize the implementation of future interventions.

Eligibility Criteria:
Inclusion Criteria:

* Practicing health care provider in obstetrics/gynecology at Northwestern Medicine

Exclusion Criteria:

* Below the age of 18 years old
Anchoring Patients Pain Scores in the Emergency Department

The proposed research will be a prospective, observational study to test the hypothesis that anchoring will affect verbal pain scores in the emergency department. There will be a small retrospective aspect to this study to obtain patient satisfaction ratings.

The investigators will evaluate a convenience sample of patients presenting to the ED with a complaint of pain. Patients will be consented for participation and will fill out a brief survey concerning the current visit in the ED. There will be two forms of the survey. Participants will be randomly assigned to one of the two survey forms. Participants will first be asked if their pain score for this visit is greater than or less than an anchor number provided. In this survey, the investigators will use 20 and 80 as our anchoring numbers. The participants will then have a follow up question asking them to estimate their pain score on a 0-100 scale. Investigators will then perform a chart review to determine patient satisfaction scores for that specific visit to determine if the anchoring effect has any input on patient satisfaction scores.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Presenting to the ED with a chief complaint of any type of pain

Exclusion Criteria:

* Under 18 years of age
* Refusal to consent
* Incarcerated patients
* Pregnant patients
* Unable to complete survey secondary to clinical instability, severe pain, or disorientation determined by a study physician
Apoptotic Changes in Gingiva Caused by Smoking

Smoking is a major environmental risk factor associated with common forms of human chronic periodontitis. The aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals. The investigators of the study suggest that smoking decrease tissue quality and increase inflammation level in gingival tissues in both healthy individuals and periodontitis patients. One possible mechanism for this is suggested to be increased apoptosis.

Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. The etiology and pathogenesis of chronic periodontitis are mostly revealed, however, the mechanism of environmental factors such as smoking yet to be clarified. Major consequences of smoking in gingival tissues are suggested to be the reduction in neutrophil and fibroblast function, decreased immunoglobulin G production, increased periodontal pathogen bacteria prevalence, difficulty in eliminating pathogens with mechanical therapy, and reduction in growth factor production. In the present study, markers of tissue destruction, matrix metalloproteinase-8 and tissue inhibitor of matrix metalloproteinase-1, hypoxia markers, vascular endothelial growth factor and hypoxia-inducible factor and apoptotic markers, bax, bcl-2, and caspase-3 were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 30 to 45,
* the existence of at least 20 functioning teeth,
* systemical health,
* no antibiotic use within 6 months,
* no periodontal therapy within 6 months,
* no pregnancy or lactation,
* no drug use, in addition; for the smokers existence of the smoking condition for at least five years.

Exclusion Criteria:

* Patients younger than 30 older than 50 years old,
* the absence of occlusion,
* drug use,
* pregnancy/lactation,
* previous antibiotic use,
* previous periodontal therapy,
* the existence of any systemical disease.
A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder

This study examines the efficacy of the medication D-Cycloserine in the reduction of obsessions and compulsions in individuals with obsessive-compulsive disorder (OCD). All study participants will receive Exposure and Response Prevention, a common form of behavior therapy for individuals with OCD. Half (50%) of the participants will be randomly assigned to the placebo condition and the other half (50%) will be randomly assigned to receive D-Cycloserine. Because all participants will receive 10 sessions of behavior therapy, all participants are expected to improve from this treatment.

The study consists of Behavior Therapy (Exposure and Response Prevention; ERP) for OCD. Specifically, it involves exposure to anxiety-provoking situations and response-prevention of any rituals. ERP has shown to be effective for many individuals with OCD.

All assessments and treatment sessions are at no cost to the patients. 50% of the patients will randomly be assigned to the D-Cycloserine (DCS) condition, and 50% of the patients will be assigned to a placebo condition. D-Cycloserine is FDA-approved for the treatment of Tuberculosis. However, recent research in other anxiety disorders has shown that D-Cycloserine plus Behavior Therapy is more effective than Behavior Therapy alone.

This treatment study has two active conditions. That is, all patients will receive Behavior Therapy and we do expect that everybody will improve from this treatment. However, it may be that those patients in the DCS condition will improve somewhat more than those in the placebo condition.

The treatment will be structured with homework and repeated assessments every 4 weeks. Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. The treatment consists of 10 sessions (twice a week) plus post-treatment and follow-up assessments at 1 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnosis for obsessive-compulsive disorder

Exclusion Criteria:

* History of psychotic disorders
* History of neurological disorders
* History of bipolar disorders
Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise

The aim of the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate essential hypertension and whose medical condition make them eligible for treatment with Telmisartan/Telmisartan+HCTZ

Exclusion Criteria:

* Pre-menopausal women who had had no birth control, who are pregnant or nursing
* Patients with advanced hepatic impairment, advanced renal impairment or both
* Patients with functional class III or IV (NYHA) congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
* Patients with any valvular disease with hemodynamic repercussion
* Patients receiving chronic administration of oral anticoagulants or digoxin
* Patients with known hypersensitivity to any component in the formulation of Micardis / MicardisPlus
* Patients with previous history of angioedema associated with ACE inhibitors
* Patients with severe, uncontrolled hypertension or any form of secondary hypertension
* Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
Evaluating ZetaMet Via Outpatient Local Intratumoral Injection Procedure to Treat Breast Cancer Bone Metastases in the Spine to Control Pain and Prevent Complications Such as Fracture

ZetaMet™ (ZetaFuse™ Bone Graft) is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. ZetaMet™ (ZetaFuse™ Bone Graft) is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ (ZetaFuse™ Bone Graft) is only for implantation into the vertebral body.

This is an open-label single-arm study. Subjects (N=10) will be recruited from up to 4 Investigational Sites in Canada. Key inclusion criteria are metastatic breast cancer to bone with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. Post-operative care will be per standard of care (SOC) at the Investigational Site. Subjects will be followed for 180 days post-treatment. If post-surgical radiation treatment is planned, it should not occur for at least 84 days post-surgery to allow for bone formation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment.
* Life expectancy of 12 months or more.
* Female patient with histologically confirmed diagnosis of primary breast cancer.
* Metastatic breast cancer to bone, with or without involvement of other sites (patients with single metastasis qualify)
* At least one lytic metastatic lesion located in the vertebral body of the spine.
* Normal spinal alignment.
* SINS ≥3 and ≤9.
* Signed and dated Informed Consent Form (ICF).
* Patient is willing and able to participate in required follow-up visits at the Investigational Site and to complete study procedures and questionnaires.

Exclusion Criteria:

* Vertebral body collapse.
* Spinal cord compression.
* Known allergy to Investigational Device materials.
* Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids).
* Current tobacco smoker or stopped smoking in past 6 months.
* Uncontrolled diabetes mellitus, HbAIC cutoff.
* An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC).
* Currently participating in any investigational trial not related to this trial.
* Any other severe acute or chronic medical condition that may interfere with the interpretation of the trial results, in the judgment of the PI, which would make the patient inappropriate for entry into this trial.
* Pregnant or planning to become pregnant during the trial.
Hyperthermia Combined Brachytherapy in CCU

The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG score. Following the completion of radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45 minutes before and during the HDR BT. Follow-up examinations were scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained from these patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with locally advanced cervical cancer FIGO stage II - III
* signed informed consent for participation in the study

Exclusion Criteria:

* patients with FIGO stage I and IV
* patients with poor performance status with contraindications for radical treatments
Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal Prolapse

Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical procedures have been suggested for it but with unsatisfactory results.To develop new surgical treatment and to provide higher quality proof for this intractable condition is of significance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ODS by defecography, coloscopy, barium enema and dynamic MRI.
* Patients should accord with Rome IV criteria.

Exclusion Criteria:

* Severe heart or other organ disease.
* test.
Effect of the Minimum Bronchial Cuff Volume of Left-sided Double-lumen Endotracheal Tube for One-lung Ventilation on the Change of the Bronchial Cuff Pressure During Lateral Positioning in Thoracic Surgery

Over-inflation of the bronchial cuff of the double-lumen tube (DLT) can cause damage to the airway mucosa and misplacement of the tube, and under-inflation may cause incomplete collapse of the non-ventilated lung and incomplete ventilation of the lung that should be ventilated. Appropriate cuff pressure is generally known to be ranged 20-30 cmH₂O, but in the study of Okubo et al., who observed the minimum bronchial cuff volume and pressure that did not cause air leakage using the method of confirming by capnography, it was possible to obtain the result that OLV was possible without air leakage even at a pressure lower than 25 cmH₂O (the generally recommended tube cuff pressure) in both men and women. In a recent study of Yamada et al., when using the capnography waveform-guided method to inflate the bronchial cuff by checking for air leakage using the capnography waveform, the bronchial cuff volume (BCV) that satisfies the air-tight seal was significantly smaller compared with a pressure-guided method to inflate the bronchial cuff with 20 cmH₂O.

The minimum bronchial cuff volume (BCVmin) at which such air leakage does not occur may vary from individual to individual. It is presumed that this is because the diameter of the left main bronchus (LMB) differs from individual to individual, which causes the variation of the gap between the diameter of the LMB and the outer diameter of the DLT mounted thereon. Moreover, the previous study revealed that the lateral positioning could increase the pressure of the bronchial cuff mounted on the LMB due to the gravity-induced morphological and conformational change of the trachea. Considering these factors, the researchers hypothesized that the change in the bronchial cuff pressure (BCP) due to a positional change might vary depending on whether the bronchial cuff was inflated, that is, the initially established BCVmin.

Therefore, in this study, the researchers tried to investigate the effect of BCVmin on the change of minimum bronchial cuff pressure (BCPmin) due to the positional change from the supine to lateral decubitus, by dividing the groups whose BCVmin is 0 ml or exceeds 0 ml.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-80 and with an American Society of Anesthesiologists (ASA) physical status of 1 or 3 who are scheduled to undergo elective video-assisted thoracoscopic surgery (VATS)

Exclusion Criteria:

A. Need for a right-sided DLT B. An intraluminal lesion in the left main bronchus C. An anatomical problem in the tracheobronchial tree D. Patients with chronic obstructive pulmonary disease with impaired lung compliance E. Patients with interstitial lung disease with severe pulmonary dysfunction F. Patients with Body mass index (BMI) ≥ 30
Community Organizing Network for Environmental Health

The Community Organizing Network for Environmental Health is a part of Community Action Against Asthma (CAAA), which, in turn is a part of the Michigan Center for the Environment and Children's Health. It is a community-based intervention research partnership between the University of Michigan, community-based organizations, and health care institutions in Detroit.

The aims of the Community Organizing Network for Environmental Health are to:

* share with community groups and organizations the findings from data collected through household and air quality research of the CAAA project;
* identify and engage existing community groups and organizations interested in working on environmental issues important to their neighborhood and community in the hopes of creating an interorganizational network (I.N.);
* work with member group of the I.N. to organize, coordinate and conduct activities to reduce physical environmental threats related to asthma; and
* increase community awareness and knowledge of factors associated with the environment and asthma through sharing of findings to community residents through presentations, annual reports, postings of websites, and community forums

Eligibility Criteria:
A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy

The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent approval
* Women must not be at risk to become pregnant during study participation
* Diagnosis of Rheumatoid Arthritis
* Active Rheumatoid Arthritis
* Current, regular use of Methotrexate, at a stable dose
* Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
* Other criteria to be reviewed by study doctor

Exclusion Criteria:

* Use of excluded medications (reviewed by study doctor)
* Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
* Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
* Evidence of tuberculosis
* Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
* Other criteria to be reviewed by study doctor