cyrilzakka/clinical-trials huggingface dataset:
Assesment of Intermediate Vision After BIL Cataract Surgery

The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".

The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.

Participants will:

* Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)
* Have to fill in 2 questionnaires about visual functioning and spectacle independance

Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .


Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 18 years old
* Must have underwent bilateral bag in the lens cataract surgery in the University hospital Brussels at least 3 months before inclusion
* Must not meet any exclusion criteria

Exclusion Criteria:

* Prior refractive surgery (other than bag in the lens)
* Glaucoma
* Corneal opacities
* Moderate non proliferative diabetic retinopathy or worse
* Optic neuropathy
* History of uveitis
* Amblyopia
* Residual post-operative astigmatism higher than 1.5 Diopters (D)
* Best corrected visual acuity \< 1.0
* Patients unable to cooperate or sign the informed consent
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.


Eligibility Criteria:
Inclusion Criteria:

* Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.

Exclusion Criteria:

* Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.
ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus

The purpose of this study is to evaluate whether a combination of pharmacist-delivered patient engagement techniques improves disease control and medication adherence among patients with poorly-controlled diabetes compared with usual care. These engagement techniques include shared decision-making and brief negotiated interviewing and are delivered telephonically.

The US is facing a growing epidemic of type 2 diabetes. Among patients with poorly controlled diabetes, it is often not clear whether the problem is attributable to failure to appropriately intensify therapy, poor adherence to prescribed medications, unwillingness to accept new treatments or a combination of these factors. Multi-component pharmacist-delivered interventions, particularly those rooted in patient engagement, have been shown to be some of the most effective at improving adherence to chronic disease medications. Even though shared decision making and brief negotiated interviewing are complementary patient engagement techniques, the effectiveness of combining these 2 intervention approaches, especially in the management of diabetes, is unknown.

In this study of patients using at least one oral hypoglycemic therapy with poorly controlled disease, the investigators examine the impact of a shared decision making and behavioral interviewing intervention delivered telephonically by pharmacists, compared with usual care. Briefly, all patients allocated to the intervention will be mailed a patient decision aid to prime them for encounters with pharmacists. After receiving the decision aid, these patients will be asked to engage in and provide informed consent for at least 4 telephonic discussions with pharmacists about their diabetes treatment options, goals, and preferences, medication adherence, strategies for reducing adherence barriers, and the benefits of maintaining blood glucose control. The study is being conducted within a large insurer and consists of 700 patients each allocated to the intervention group and the control group. Analyses will be performed on an intent-to-treat basis.

After study completion, the investigators will also use predictive analytics to examine whether treatment response could be predicted based on patient characteristics, such as sociodemographic, clinical, medication use, and other motivational characteristics, which will provide information about which patients are most likely to benefit from the intervention.

Eligibility Criteria:
Inclusion:

* Commercially-insured beneficiaries
* Receive all medical/prescription drug benefits through Horizon
* On ≥1 one oral hypoglycemic agent
* Latest HbA1c measurement ≥ 8% (within previous 6 months)
* Provided phone number to Horizon

Exclusion:

- Currently using any insulin
Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

This pilot randomised controlled trial (RCT) aims to assess the feasibility of using a new type of risk communication intervention for people with Type 2 diabetes mellitus (T2DM) in primary care and to evaluate its potential impact on risk perceptions and self-management behaviour.

The study comprises 40 participants with T2DM randomly allocated to usual care supported by the risk communication intervention or usual care only.

Diabetes self-management, which includes self-care behaviours such as healthy eating and physical exercise, has become the cornerstone for treating type-2 diabetes mellitus (T2DM). However, although self-management education (SME) is necessary to equip patients with the knowledge, skills and attitudes required to manage their diabetes care, the most effective method to do so is still unclear.

Recent studies have shown that people with T2DM underestimated their risks of developing complications. Although behavioural processes are complex, wrong risk perceptions are a major impediment to the adoption of self-care behaviours and, as a result, an additional risk for the occurrence of adverse outcomes.

Existing risk communication interventions have shown mixed results, with many participants barely understanding the explanations of health professionals about risks and having poor recall of risk information. In this context, there is a need for better risk communication interventions.

Based on the results of recent studies investigating the risk perceptions and risk attitudes of people with T2DM, we have developed a new, tailored risk communication intervention. The objectives of this intervention are:

* To increase the awareness of risks for complications associated with type 2 diabetes.
* To encourage the adoption of recommended self-care behaviours.

The intervention has been developed in collaboration with both health professionals and patients. We have designed a pilot study to assess the feasibility of using the intervention in primary care and to evaluate its potential impact on patients' risk perceptions and self-management behaviour, in order to inform the design of a largest study (RCT to be conducted in the future)

The intervention lasts 5 minutes on average, conducted by the general practitioner (GP) during patients' routine primary care consultation. The study involves 40 participants with T2DM randomly allocated to usual care supported by the risk communication intervention or usual care only.

The research is supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Diagnosed with type-2 diabetes.

Exclusion Criteria:

* Unable to provide informed consent.
* Non-English speaker.
* Not suitable for the study according to GP.
A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)

There is clear, converging evidence from multiple prospective studies with well-diagnosed adolescents with ADHD and comparison, non-ADHD adolescents, that teen drivers with ADHD have more accidents and other adverse driving outcomes. Available research indicates parental monitoring and limit-setting for adolescent drivers is one of the most effective interventions for preventing negative driving outcomes. For children with ADHD, interventions to promote parenting capacity to effectively oversee and intervene in teen driving will likely need to be intensive and require multiple treatment components. The present proposal aims to compare the standard care for teen drivers (driver's education classes and driving practice) to the Supporting a Teen's Effective Entry to the Roadway (STEER) program, that includes a parent-teen intervention, adolescent skill building, parent training on effective adolescent management strategies, joint parent-teen negotiations sessions, practice on a driving simulator, parental monitoring of objective driving behaviors, and the targeting of safe teen driving via contingency management strategies (i.e., parent-teen contracts). To facilitate teen and parent engagement the intervention will be preceded by a motivational interview. The specific aims of the proposal are to investigate the efficacy of the STEER program relative to a standard care group in a randomized clinical trial (N=172) on measures of objective driving outcome and parenting capacity. It is hypothesized that the STEER program will result in improved outcomes relative to the standard care group at the end of intervention and 6 and 12 month follow-up assessments.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of ADHD, Combined Type
* At least 16 years old
* Has a driving Permit

Exclusion Criteria:

* No parent willing to be involved
* Seizure disorder, eating disorder, psychotic disorder, current diagnosis of substance/alcohol dependence
* Prior Driver's education class
Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults

The overall objectives are to:

1. Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the whole-body, tissue, and cellular levels.
2. Systematically compare different HIIT regimens to help identify effective "doses" of HIIT that may be optimal for improving metabolic health in obese adults.
3. Assess the ability/willingness of obese subjects to adhere to a long-term HIIT program.

Findings from these studies will greatly expand knowledge about the effects of HIIT on metabolic health, and will provide valuable information for development of programs aimed at maximizing key metabolic benefits of exercise.

If subjects are eligible for the study, they will be randomized into one of four different exercise training groups. Before training (and twice after 3 months of training) subjects will participate in a "clinical study" in which they will be required to stay overnight in the hospital. During the clinical study, the research team will perform a series of metabolic tests. Before and after the 3 months of training, the research team will assess subjects "free-living" 24h blood sugar control using a Continuous Glucose Monitor (CGM). The research team will measure several other relevant clinical markers (e.g., whole body and regional body fat assessments \[Dual Energy X-ray Absorptiometry (DEXA) and Magnetic Resonance Imager (MRI)\], hepatic lipid accumulation \[MRI analysis\], blood lipid profile, resting metabolic rate, glycated hemoglobin \[hemoglobin A1c\]). After the first 3 months of training, adherence to the subjects assigned training program will be tracked for the next 9 months (1 year of training in total). One year after initiating a training program, subjects will be asked to return to the clinic for a quick follow-up visit where the research team will complete some standard clinical assessments (e.g., body weight, body composition, blood pressure, and a blood sample).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40
* Body Mass Index: 30-40 kg/m2
* Waist circumference: 88-98cm for women and 100-110cm for men
* Glucose intolerant (i.e., 2h glucose concentration during a screening oral glucose tolerance test (OGTT)= 140-199mg/dl
* No regularly planned exercise/physical activity
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* EKG abnormalities as assessed by the cardiologist on the research team
* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism
* Pregnant or lactating
* Tobacco or e-cigarette use
Sensitivity of Basic Taste in Elderly

The purpose of this study is to identify the thresholds sensitivity of the five basic tastes in an elderly population and relate to food intake, nutritional status, age, gender and others variables.

The investigators propose a study of 300 elderly patients to characterize de sensitivity of the four basic tastes, according to the methodology of International Organization for Standardization (1985) and to identify umami taste (Mojet et al. 2001, 2003). This is a cross-sectional study. The length of the inclusion of the study will be 24 months. This study's general objective is: to characterize food intake, nutritional status and identify thresholds for the five basic tastes in an elderly population.

Eligibility Criteria:
Inclusion Criteria:

* 60 years old patient or older, who present oral feeding and the ability to express themselves to perform the sensory analysis tests will be included.

Exclusion Criteria:

* Patient with fever, flu, cold or some complication in the oral cavity will be excluded, since these factors can interfere in the perception of the tastes and those that do not present conditions to express themselves or deficits of cognition, being excluded the elderly that present result of the application of the Mini Mental under 24. In addition to those who do not agree to sign the Term of Free and Informed Consent.
Neural Activations During Imaginal Exposure in Individuals Fearful of Spiders

This study explores the brain basis of imaginal exposure, a widely used psychological treatment technique. Specifically, this study uses functional magnetic resonance imaging to examine brain areas activated during imaginal exposure, in individuals fearful of spiders. Physiological responses and subjective fear experienced during imaginal exposure are also assessed.

The primary aim of this study is to explore differences in neural activity during exposure to phobic, compared to neutral, mental imagery. The study will focus primarily on exploratory whole brain analyses, but will also include regions of interest analyses on brain areas previously associated with imaginal exposure. The experimental procedure consists of repeated exposure to mental imagery, i.e. imagery of short durations, including either highly emotion-provoking or neutral content, prompted by verbal instructions. A secondary aim is to explore the effects of repeated exposure to mental imagery, used during the experimental procedure, on subjective fear and physiological responses.

Results will elucidate if neural activity to phobic imagery differs from activity associated with the production of mental imagery per se. Findings will also increase our general understanding of the neural basis of imaginal exposure treatments.

Eligibility Criteria:
Inclusion Criteria:

* Significant fear of spiders

Exclusion Criteria:

* Current psychiatric disorder other than spider phobia
* Substance abuse
* Neurological disease
* Psychological treatment or psychotropic medication within six months
* Magnetic resonance imaging contradiction
Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery

This study is designed to determine the perceived value of continuous remote monitoring to surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether algorithms can be generated to predict risk of readmission following discharge. This initial study will be conducted through the Department of Cardiovascular Surgery.

The overall aim of this project is to determine the perceived utility and benefit to use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. The investigators also aim to determine whether machine learning algorithms can predict readmission following cardiac surgery in these patients, which the investigators believe will benefit patients in future studies.

Eligibility Criteria:
Target accrual: 100 patients

Subject population (children, adults, groups): adults undergoing coronary bypass surgery at Mayo Clinic in Rochester, MN

Inclusion Criteria:

* Patients undergoing isolated coronary artery bypass graft (CABG) surgery
* Must be undergoing the procedure at Mayo Clinic in Rochester, MN
* Must be greater than or equal to 40 years of age

Exclusion Criteria:

* Under 40 years of age
* Concomitant additional surgical procedure (e.g., CABG + valve replacement)
* Patients with implantable pacemakers/defibrillators
* Patients that find the device too uncomfortable to wear for 48 hours
Improving Arteriovenous Fistula Patency

All vascular access guidelines recommend monitoring and surveillance protocols to prevent vascular access complications in hemodialysis units.

However, in the case of second generation screening techniques which determine access blood flow measurement (QA), there is a huge controversy about it´s efficiency.

Although multiple observational studies find a decrease in the thrombosis rate and an increased primary assisted patency survival related to the use of these techniques, a recently published meta-analysis find contradictory results in the randomized controlled trials, affirming that the measurement of QA is useless in grafts and questionable in native arteriovenous fistulae (AVF).

We have designed a multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods.

The primary endpoint will be a reduction in the thrombosis rate with an increased assisted primary patency survival, and a cost effectiveness economic analysis.

As secondary endpoints we will analyze the impact over non-assisted primary patency survival and secondary patency survival.

Definition:

Multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods.

For Patient Registries:

Clinical data repository (CDR) paper notebook will contain all baseline patient characteristics and the information related to vascular access. These data will be collected by the different investigators and reviewed and included in data base by the study´s monitor.

This information will be included in a centralized computer database (SPSS 15.0 computer system) and encoded in order to preserve patients´ confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signature.
* Age between 18 and 95 years old.
* Functioning native AVF.
* Patients with end stage renal disease (ESRD) undergoing hemodialysis program for at least three months.

Exclusion Criteria:

* Coagulopathy or hemoglobinopathy of any cause.
* Hospitalization of any cause in the previous month.
* VA related complications or dysfunction in the previous three months.
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.

OBJECTIVES:

I. Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.

II. Assess the time to disease progression and overall survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed surgical stage III or IV endometrial cancer
* Any stage clear or serous papillary endometrial cancer
* Positive para-aortic lymph nodes allowed
* Tumor must be surgically reduced to 2 cm or less within 8 weeks of study

  * Must have had hysterectomy and bilateral salpingo-oophorectomy
* No recurrent disease
* No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes
* Performance status - GOG 0-2
* Absolute neutrophil count greater than 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN
* Creatinine no greater than 1.5 times ULN
* No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer
* No prior chemotherapy
* No prior radiotherapy
* See Disease Characteristics
* No more than 8 weeks since prior surgery
* No prior anticancer therapy that would preclude study