cyrilzakka/clinical-trials huggingface dataset:
Diabetes Engagement and Activation Platform

The following are hypothesized:

1. The Diabetes Engagement and Activation Platform (DEAP) can be integrated into primary care workflow to facilitate the care of patients with type 2 diabetes.
2. The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.
3. The DEAP intervention will enhance patient activation and improve type 2 diabetes self management and glucose control

Aim 1: To evaluate how primary care practices adopt and integrate DEAP into routine workflow including identification of barriers and facilitators to support acceptable, feasible, and sustainable use of the system.

* Sub-aim 1.1: Measure the proportion of clinicians and care team members who engage patients through the DEAP intervention as well as the types of patient support activities they address; assess the representativeness of participating clinicians and care team members in relation to all practice staff; and assess how they integrated DEAP into the care of type 2 diabetes patients.
* Sub-aim 1.2: Assess how practices redesign workflow, overcome barriers, and enhance facilitators in order to integrate DEAP.
* Sub-aim 1.3: Determine processes for sustaining DEAP beyond the project funding period .

Aim 2: To compare, relative to usual care, the effectiveness of the DEAP intervention.

* Sub Aim 2.1: Measure the proportion and representativeness of eligible patients who choose to enroll; access the DEAP curriculum; complete the DEAP curriculum; and contact care team members. .
* Sub Aim 2.2: Compare the change in the average glycosylated hemoglobin (primary outcome), Body Mass Index, systolic blood pressure, and type 2 diabetes (T2D) medications and patient activation (secondary outcomes) from baseline to 3 months and from 3 to 6 months for patients randomized to DEAP versus usual care.

Sub Aim 2.3: Assess the clarity, readability and acceptability of the DEAP curricula materials for T2D patients enrolled in the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 2 diabetes and A1C measure ≥ 8%;
* English speaking;
* Enrolled in the practice EHR linked patient portal.

Exclusion Criteria:

* Patients without type 2 diabetes or with type 2 diabetes who have a A1C less than or equal to 7.9%;
* Non-English speaking;
* Patients not enrolled in the practice EHR linked patient portal;
* Under 18 and over 75 years of age.
Effect of Epidural Analgesia on Regional Lung Ventilation in Parturient Women as Assessed by Thoracic Impedance

The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor.

Participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.


Eligibility Criteria:
Inclusion Criteria:

* At-term pregnancy (at least 36 weeks)
* ASA class I-II

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) Class III or more
* BMI\>35 before pregnancy
* Contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil)
* Contraindication to epidural analgesia
* Pregnancy-related complications (including pre-eclampsia)
* Respiratory system diseases
* Severe psychiatric disorders
* Twin pregnancy
* Skin lesions in correspondence to the position of the Electric impedance tomography belt
* Pacemaker or Implantable Cardioverter Defibrillator (ICD)
* Language barrier
Motivation and Methylphenidate

The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic and noradrenergic agent, onto the different components of motivation: decision-making, effort allocation and instrumental learning.


Eligibility Criteria:
Inclusion Criteria:

* weight\>= 50kg and \<=90kg
* free and informed consent
* social security affiliation
* no chronic illness
* no previous participation to a protocol wth similar tasks
* no special legal status (guardianship,trusteeship)
* no personnal or familial neurologic or psychiatric background
* no contraceptive device for a reproductive woman

Exclusion Criteria:

* inability to squeeze a handgrip
* smoking
* psychoactive substance consumption less than 3 weeks ago
* pregnant or breastfeeding woman
* hypersensitivity to methylphenidate
* hyperthyroidism
* cardiovascular or cerebrovascular disease
* respiratory, hepatic or renal failure
* glaucoma
* pheochromocytoma
* gluten intolerance or hypersensitivity
* galactosemia, glucose malabsorption syndrome, lactase deficit
* countraindicated meds (IMAO, IMAO-A, orhtosympathomimetics, alcaloids, linezolin, enzymatic inducers, psycho-active drugs)
OTIVACTO Spain Non Interventional Study

This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.

Purpose:

Study Design:

Eligibility Criteria:
Inclusion criteria:

1. Written informed consent prior to participation
2. Female and male patients = or \> 40 years of age
3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation

Exclusion criteria:

1. Patients with contraindications according to Spiolto® Respimat® SmPC
2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
3. Patients continuing Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 agonists
4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
5. Pregnancy and lactation
6. Patients currently listed for lung transplantation
7. Current participation in any clinical trial or any other non-interventional study of a drug or device
Clinical and Radiographic Outcome of Regeneration in Immature Permanent Human Teeth Using a New Scaffold

This study aimed to evaluate clinical and radiographic outcome of regeneration in immature permanent human teeth using two different types of scaffolds:

1. Collagen-hydroxyapatite scaffold (Osteon III collagen) after blood clot.
2. Conventional blood clot scaffold.


Eligibility Criteria:
Inclusion Criteria:

1. Single rooted immature permanent teeth.
2. Symptoms:

   1. Pulp necrosis either due to infection or trauma.
   2. Periapical condition; tooth should have periapical radiolucency.
3. Tooth should be restorable without the need for further post placement.
4. Age: from 6-15 years.
5. Sex: males or females.
6. Preoperative Cone beam Computed tomography is a must.

Exclusion Criteria:

* Teeth with complete root formation. 2. Teeth that are badly broken down with difficult isolation. 3. Medically compromised patients. 4. Periodontally affected teeth.
ADAPT-Altering Diet for African American Populations to Treat Hypertension

The purpose of the study is to develop a culturally appropriate DASH intervention and test the effectiveness of the intervention lower blood pressure in a group of African American participants at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).

The effectiveness of the Dietary Approaches to Stop Hypertension (DASH) diet has shown to have limited impact on blood pressure control among African Americans, which might be explained by inappropriate adaptation to African American culture and tradition. Therefore, the adequate adaptation of the DASH diet would result in blood pressure control among African-Americans. Using the nominal group technique as a part of the formative assessment, this project proposes to identify key cultural variables that impact dietary patterns for African Americans. Based on those results, a modified behavioral intervention will be developed and tested in African Americans with pre-hypertension or stage I hypertension. Primary outcomes will include change in systolic and diastolic blood pressure at six months. It is expected that this project will contribute an additional tool for physicians, patients and health care systems to improve hypertension control amongst African Americans. The specific aims for this dietary intervention are: (1) to develop a modified DASH dietary pattern that is culturally appropriate for African-Americans by using principals of formative analysis and (2) to conduct a randomized, controlled trial to determine the effectiveness of the modified DASH dietary pattern in reducing blood pressure for a cohort of African-Americans with pre-hypertension or stage I hypertension to a usual care control group.

Eligibility Criteria:
Inclusion Criteria:

* Baseline SBP 120-159 mmHg and DBP 80-95 mmHg
* Age 25 or older as of the initial screening visit
* Willing and able to participate fully in all aspects of the intervention
* Not on rigid diet
* Provide informed consent
* BMI 18.5-45 kg/m2

Exclusion Criteria:

* Regular use of anti-hypertensive drugs or other drugs that raise or lower BP (any in previous three months)
* Current use of insulin or oral hypoglycemic agents
* Use of oral corticosteroids \>5 days/month on average
* Current use of medications for treatment of psychosis or manic-depressive illness
* Use of oral breathing medications other than inhalers \> 5 days/month on average
* Use of weight-loss medications in previous 3 months
Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.

OBJECTIVES:

Primary

* To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus.

Secondary

* To evaluate the toxicity of everolimus in patients with multiple myeloma.
* To study the tumor cells and blood from patients entering this trial for laboratory correlates.

OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspirate, biopsy, and blood sample collections periodically. Samples are assessed for the following: cyclin D1, phospho-AKT, phospho-p70 S6 kinase, and phospho-S6 by western blot; checkpoint regulators PTEN, p53, pRB, and p27 by immunoblotting; p53, Rb, p16, PTEN, p27, and cyclin D1 by DNA analysis; caspases 3 and 9 by immunoblotting and Annexin/PI by flow cytometry; unknown molecular markers by protein profiling; and microvessel density.

After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma, meeting 1 of the following criteria:

  * Monoclonal protein in the serum of ≥ 1 g/dL
  * Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours
  * Measurable light chains by free light chain assay of ≥ 10 mg/dL
  * Measurable plasmacytoma
* Must have received prior therapy and have relapsed or refractory disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* ANC ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 8.0 g/dL
* Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal)
* AST ≤ 3 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Calcium \< 11 mg/dL
* No uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No HIV positivity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 weeks since prior cytotoxic chemotherapy
* At least 2 weeks since prior biologic therapy or radiotherapy
* At least 2 weeks since prior corticosteroids

  * Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma
* No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway

Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective general anesthesia requiring OTI.
* Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.
* Age ≥18 years.
* ASA I-III.
* Sufficient intellectual capacity to understand the procedure and equipment used.
* Predictors of difficult airway (Mallampatti class III or IV; thyromental distance \<6 cm, sternomental distance \<12.5 cm, interincisal distance\<4.0 cm, bite test II or III, cervical mobility \<90 ° or history of difficult intubation).
* Thyroid surgery or present pharyngolaryngeal, glottic or cervical pathology
* BMI \>30kg / m2
* Not presenting risk factors for aspiration
* Not presenting respiratory disease, coronary or cerebral vascular.
* Do not have a preoperative sore throat

Exclusion Criteria:

* Failure to meet the above criteria
* Pregnancy
* Allergy to any drug included in the protocol.
Plaque Burden Pre- Myocardial Revascularisation

The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG).

Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG.

Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.


Eligibility Criteria:
Inclusion Criteria:

* pre CABG

Exclusion Criteria:

* no consent, prior carotid intervention
Efficacy of Animated Videos to Foster Healthy Bladder Behaviors in Community Women

In daily life, women are exposed to a wide range of challenging situations that can negatively affect toileting management and long-term bladder health. Research shows that women engage in behaviors that may lead to unfavorable consequences, such as a worrying sense of bladder urgency or an awkward moment of urine leakage. The investigators surmise that consciously or unconsciously adopted behaviors influence lifelong bladder health, toileting management, and sense of self-efficacy in this arena. Adoption of research-supported behaviors that foster bladder well-being for women is dependent on women's access to learning multiple healthy behavioral strategies.

Studies on personal woman-centered strategies for toileting management and adoption of behaviors that foster bladder health are scarce in the scientific literature. The investigators have published encouraging results of an in-person study with a clinical sample using accessible and enjoyable videos about research-based bladder health behaviors, invented by the co-investigator of this study, Janis M. Miller.

We now launch an additional study of 90 community-based women of midlife age using an online survey methodology that incorporates sending study participants to the website. The study has two main objectives:

1. To determine baseline bladder health and toileting management behavior profiles in intervention-naïve community-based women as assessed by the Confident Bladder Behavior Questionnaire
2. To determine at post-intervention whether behavioral profiles of the respondents have significantly changed after being randomized into one of three groups: Group 1: who watch the animated explainer videos within the Confident Bladder website that are predominantly related to daytime conditions, Group 2: who watch the Confident Bladder website's animated explainer videos predominantly related to sleep/wake conditions and the additional tips and tricks section, and Group 3: controls who only receive access to the the Confident Bladder website at study's end after post-intervention assessments.

We will test the following hypothesis:

Viewing the Confident Bladder website will demonstrate an effect size at 2-weeks post intervention of greater than 0.5, as determined by comparing number and percentage of research-based behavioral strategies used by the Control group to the number and percentage of strategies used by the two intervention groups who were assigned to view different parts of the website.


Eligibility Criteria:
Inclusion Criteria:

* Must have a U.S. IP Address
* Must be female between age of 40 and 64
* Must be enrolled in a Study Participant Panel accessed by Qualtrics
* Must read and speak English

Exclusion Criteria:

* NonEnglish speakers/readers
* Does not consent to participate
* Does not commit to providing thoughtful and honest answers to the surveys
Cross Linking for Treatment of Corneal Infection

This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of infectious keratitis

Exclusion Criteria:

* corneal ulcer that has perforated
* corneal ulcer that has produced a descemetocele
* women who are pregnant or breastfeeding
* patients who are immunocompromised or unwilling or unable to comply with a medication regimen
Electrical Impedance Tomography of Lung in Child and Young Age

The investigator will determine a compliance of two diagnostic techniques (EIT and Body plethysmography) in collective of children and teenagers with obstructive lung disease and a matched control group.

The aim of the present study is verification of the correlation between EIT-derived data and following extracted parameters of the pulmonary function:

* forced expiratory volume in 1 second (FEV 1)
* forced vital capacity (FVC)
* relative forced expiratory volume in 1 second (FEV1/FVC)
* maximal expiratory flow (MEF 25)
* total lung capacity (TLC)
* resistance (Raw).

These findings could bring out new prospective opportunity for pulmonary function tests without cooperation.

Furthermore, the study aims to clarify whether EIT technique can be used for regional pulmonary function testing.

In addition, dynamic lung function parameter and static radiological techniques will be correlated with EIT.

Eligibility Criteria:
Inclusion Criteria:

* Patients: children and teenagers with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive brochitis, obstructive pneumonia).
* Probands: Children and Teenager of 5-18 years without known obstructive pulmonary diseases

Exclusion Criteria:

* active implants (ICD, CRT)
* metal in chest
* artificial heart valve
* children \< 5 years
* pregnant and lactating females
* Persons, who are in relationship of dependence to the investigator / sponsor
* Persons, who are not able to understand and follow the instructions of the study personnel.
* Lack of signed informed consent (by legal guardian /proband)
18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma

The purpose of this research is to evaluate the study drug, 18F FTC-146, as a positron emission tomography (PET) / computed tomography (CT) radiotracer imaging agent to evaluate tumor status in patients newly diagnosed with osteosarcoma ("bone cancer").

Primary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment tumor necrosis in newly-diagnosed and treated osteosarcoma patients.

Secondary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment pain reduction in newly-diagnosed and treated osteosarcoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy proven osteosarcoma requiring local surgical intervention.
* ECOG ≤ 2
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Chemotherapy in the past 2 months.
* Prior history of allergic reaction to 18F FTC 146.
* Pregnant or nursing
Prevalence of Chronic Obstructive Pulmonary Disease (COPD) and Eosinophilia Among Primary Care Patients

Early diagnosis and appropriate treatment for COPD subjects are both critical to minimize the progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil (specific type of white blood cell that protects body against certain kinds of germs) level is associated with increased risk of both moderate and severe exacerbations in COPD subjects. To date, there is insufficient amount of data that describes the prevalence of COPD in Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five centers located in five different Brazilian cities will provide estimation about the prevalence of COPD in primary care and will also determine the levels of eosinophils in subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to be enrolled in the study.

The study is a cross sectional (prevalence study).

Eligibility Criteria:
Inclusion Criteria:

* Adult \>= 35 years old
* At least one of the following risk factors for COPD:

  • being a current smoker (who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes) or past smoker (who has smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview); Current or past exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure \>=100 hours/year
* Capable of giving signed informed consent

Exclusion Criteria:

* Physical or mental disability to complete the study procedures
* Heart above 120 beats per minute
* Participants under treatment for tuberculosis
* Participant in current clinical trial
* Pregnancy
* Patients with one of the following contraindications to spirometry: chest surgery in the last month; abdominal surgery within the past three months; neuromuscular disease, acute coronary syndrome; retinal detachment; hospitalization for any cardiac problem in the prior 3 months.