cyrilzakka/clinical-trials huggingface dataset:
The Impact of Different CSII and CGM Systems on Different Clinical Outcome Variables in Children and Adolescents With Type 1 Diabetes. An Observational Study Form the Norwegian Childhood Diabetes Registry (NCDR)

To examine the effect of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) on metabolic control, in a large population-based nationwide observational study under real life conditions.

All children and adolescents with type 1 diabetes are investigated,using annual data in 2017 from the population-based Norwegian Childhood Diabetes Registry (NCDR). HbA1c, incidence of diabetes ketoacidosis (DKA) and severe hypoglycemia (SH) are evaluated depending on the use of CSII and CGM in a linear mixed-effects and linear regression model adjusted for age, biologic gender and diabetes duration. Health-related quality of Life (HRQOL) is assessed by using the DISABKIDS diabetes specific module (DDM-10), and associations with the use of CSII, CGM, age, gender and diabetes duration are evaluated.

In Norway, all children with diabetes 0-18 years should, due to a recommendation from the national health care authority, receive their diabetes follow-up in a pediatric department. All pediatric departments participate in the NCDR reporting standardized clinical data on their patients to the NCDR, at diabetes onset and annually, until the patients reach 18 years of age. The data completeness of NCDR is high, on individual level 99 % at diabetes onset, and 98 % on the annual examinations in 2016 - 2017.

In addition, HRQOL data were collected in 2017, using the DISABKIDS diabetes specific module (DDM-10). Children 10-17 years with type 1 diabetes were invited to independently fill out the questionnaire regarding their own disease-related quality of life. All parents to children with type 1 diabetes (independent of the child's age) were invited to fill out the same questionnaire, giving a proxy evaluation of their child's quality of life.

Eligibility Criteria:
Inclusion Criteria:

All registered subjects with type 1 diabetes in the 2017 annual cohort of the NCDR

Exclusion Criteria:

None
Kazakh Version of Reflux Symptom Index

Reflux symptoms index (RSI) were developed to identify a clinical index of suspicion for laryngopharyngeal reflux (LPR) in patients with ear, nose, and throat symptoms. RSI is an efficient diagnostic tool for LPR/ It is easy to use, even for those who know little about LPR. It does not require special equipment or examinations and is inexpensive. Thus, it can be considered highly efficient and cost-effective. The study will focus on translating and testing the RSI into Kazakh language and comparing its results in healthy people and people with laryngopharyngeal reflux.


Eligibility Criteria:
Inclusion Criteria:

* Patient's informed consent;
* Age: 18-74 years old;
* No serious somatic diseases;
* Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching;
* Diagnosis: Chronic pharyngitis;
* Chronic laryngitis.

Exclusion Criteria:

* Disagreement to participate in scientific research;
* Age: under 18 and over 74;
* Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs;
* Patients with pulmonary pathologies;
* Patients with allergic manifestations (chronic or allergic rhinosinusitis and nasal polyposis);
* With diagnoses: Acute respiratory diseases;
* Patients with general neuralgic disorders;
* Pregnancy;
* Benign lesions of the vocal cords;
* Acid-suppressive therapy within 4 weeks prior to recruitment
Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients

The aim of this study are 1) to determinate the effectiveness of motor imagery or strength training in differens aspects of pain modulation. 2) evaluate the functional improvement of the hand by a motor imagery protocol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* be under 18
* any pathology which provoke pain.
Enhancing Behavior and Brain Response to Visual Targets Using a Computer Game

Participants will play a computer game that is controlled by their gaze patterns and designed to direct attention their attention to specific on-screen targets. Visual attention to targets will be rewarded. Both visual behavior and brain response will be recorded during game play.

It is hypothesized that that, over the course of the game, relative to baseline, participants will show (a) increased looking to targets, (b) decreased response time to targets, and (c) enhanced, more efficient neural response to visual cues. It is hypothesized that clinical variability will associate with visual attention and brain response.


Eligibility Criteria:
Inclusion Criteria:

* Able to participate in an eye-tracking experiment
* Able to participate in an EEG experiment

Exclusion Criteria:

* Sensory or physical impairment that would preclude completion of protocol
* Participants taking prescription medications that may affect cognitive processes
* Participants reporting significant head trauma or history of seizures
Pharmacist Role in HF Patients Transition of Care

To assess the effectiveness of pharmacist's provided education in HF patients, in improving patients' knowledge and self-efficacy, and to assess the impact of this intervention on the rate of hospital readmission and emergency visits at 30-days, 60-days and 90-days after discharge.

"Transition of care" is one of the new disciplines that pharmacists have been involved-in within the healthcare system. It is a process where a patient's care is shifting from one setting to another. During this process, transitional care is designed to ensure continuity of patient care across different sites or across different levels of care within the same facility. For example, from Intensive Care Unit (ICU) to the ward, from hospital to home, or from hospital to rehab centers. Many stakeholders are involved in this process, and coordination between them is necessary to have successful one, in addition to logistical arrangements, and patient education. Otherwise, poor communication, inadequate patient education, and lack of access to healthcare services, will produce failure of having a smooth transition and could result in negative health outcomes including complications in the patient's disease status, emergency room visits or hospital readmissions. Not only that these negative health outcomes are affecting the patient, they are also negatively affecting the healthcare spending in the United States. For instance, inadequate care coordination and management of care transitions accounted for $25 to $45 billion in wasteful spending in 2011 through preventable adverse events and hospital readmissions. Therefore, cost containment and reducing the excessive spending in healthcare is an important aim of "transition of care", secondary to improving patient outcomes.

Pharmacist's role in Transition of care:

Pharmacists have the knowledge, training and expertise to play a major role in the transition of care process. They are involved in dispensing the patient's medications at the hospital, ensuring that the patient's medication chart is updated, identify any medication discrepancy, provide medication reconciliation, medication education, patient counseling at discharge and they could follow-up with the patients after discharge to check if they filled their prescription, what side effects are they having, and monitor their adherence to their treatment plan. These pharmacist's interventions have been applied, among other approaches, by hospitals to improve the quality of their services and minimize the rate of readmissions.

Eligibility Criteria:
Inclusion Criteria:

* Admitted HF patients at WKBH
* Patients with primary or secondary diagnosis of HF
* Discharged to Home
* 18 years old or older

Exclusion Criteria:

* ≥ 90 years old
* Patients with major comorbidities such as cancer, end-stage kidney disease, and liver failure
* Patients with memory problems such as dementia and Alzheimer's disease
* Patients discharged to places other than home
* Patients who are unable to understand or follow discharge instructions
Nocebo Effect in OSA Patients With CPAP Treatment

This study is aimed to evaluate whether the information provided by health care professionals in the visits previous to start with CPAP treatment may influence the number of reported adverse effects and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.

Background: The presence of side effects in the first few weeks of treatment with CPAP is common. However, it has never been evaluated whether side effects could be related to the presence of the nocebo effect in this population.

Main objective: To assess whether the information provided by health care professionals may influence the number of reported adverse events and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.

Methodology: Unicentric randomized clinical trial that will include 80 patients over 18 years of age with a recent diagnosis of OSA and indication for treatment with CPAP. Participants will be recruited consecutively and will be randomly assigned in a 1: 1 ratio to receive usual information or more detailed information in possible adverse effects of treatment during the CPAP adaptation visit. Follow-up will be performed at 1 month and 3 months after starting CPAP treatment. Side effects and treatment compliance in each of the groups will be blindly assessed. Descriptive statistics and differences in the number of side effects and hours of compliance between the two groups will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with OSA with indication for CPAP treatment
2. To be over 18 years old
3. Sign informed consent for study participation.

Exclusion Criteria:

1. Patients previously treated with CPAP.
2. Patients with other previous treatments for OSA (surgery, mandibular advancement device, etc.)
3. Presence of any other previously diagnosed sleep disorder
4. Patients with\> 50% central sleep apnea or Cheyne-Stokes respiration
5. Diagnosis of a mental or physical condition that makes difficult to complete questionnaires
The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients

The purpose of the study is to test the feasibility mHealth dietary app + health coaching for improving primary outcomes (recruitment, retention, and adherence) and secondary outcomes (perceived stress \[ Perceived Stress Scale\], exercise self-efficacy\[Exercise Self-efficacy Scale\], vegetable intake \[Fruit, Vegetables, and Fiber Screen\] fat intake \[Lose-it Premium database\], carbohydrate intake \[Lose-it Premium database\], weight, \[Wi-Fi weight scale using the Lose-it Premium database\], and blood pressure \[Wi-Fi blood pressure cuff using the Lose-it Premium database\].

The proposed study seeks to shift the paradigm for promoting diet intake and physical activity using education and self-report to provide a powerful combination of mHealth dietary app and health coaching (set goals, provide ongoing feedback, and self-monitor behaviors). To the investigators knowledge, this is the first time a mHealth dietary app and health coaching intervention has been used in kidney transplant recipients to link real-time data for monitoring dietary intake and physical activity.

The long-term goal of this work is to enhance well-being in kidney recipients via lifestyle self-management of care for dietary intake and physical activity to ultimately prevent chronic diseases. The proposed study is important because early weight gain after kidney transplant is associated with adverse effects on the transplanted kidney function resulting in increased health care cost and poor quality of life. Interventions are needed to monitor kidney transplant recipients diet and physical activity in real-time to prevent health decline.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older men and women
* functioning KTR (not on dialysis)
* ability to speak, read, and hear English,
* possession of a smartphone capable of accessing and downloading a mHealth dietary app
* Wi-Fi or Internet access,
* greater than 3 months post-transplant (due to medication adjustments and decreased functional levels),
* not hospitalized
* capable of self-consent per capacity screening.

Exclusion Criteria:

* Participation in a weight loss program
* participation in a structured exercise program
* diagnosis of dementia.
IVPCA in the Management of Pain Following Major Intracranial Surgery

This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing intracranial surgery

Exclusion Criteria:

* Patient refusal
* Pregnancy
* Aphasia
* Respiratory failure
* Allergy/intolerance to fentanyl
* Opioids use
* History of opioid-dependent pain,
* Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
* Mental or physical limitations that would prevent patient assessment or PCA use
* Chronic painful conditions unrelated to the reason for surgery,
* Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
* Patient is unable to initiate a bolus dose of IVPCA fentanyl
Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy At the James

This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.

This retrospective / prospective study will allow us to collect and analyze the presurgical, peri-operative, and outcome data of patients who undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center, beginning February 2008 onwards.

Eligibility Criteria:
ARM A:

Inclusion Criteria:

* Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
* Ability to understand and willingness to sign the written informed consent document.
* 18 years and older

ARM B:

Inclusion Criteria:

* Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
* Ability to understand and willingness to sign the written informed consent document.
* 18 years and older
Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action

The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA).

OA is the most common rheumatic disease and the most important from the social-economic point of view because of its frequency, causing functional impairment and disability in older people, important health resource utilization and costs (drugs, physical therapies, spa therapy, surgical prothesis, early retirement).

Thermal therapy is one of the most commonly used non-pharmacological approaches for OA, but it is still being discussed and its role in modern medicine is still not clear. The action mechanisms of mud packs and thermal baths are not completely known, and it is difficult to distinguish the effects of thermal applications from the benefits that could be derived from a stay in a spa environment. Furthermore, there are no data about cost analysis of spa therapy in OA.

The aim of this study is to analyze for the first time the cost/effectiveness- cost/utility for spa therapy in comparison to conventional treatments in knee OA (one-year-follow-up)and to assess changes of some biomarkers or mediators of cartilage damage in order to identify new possible mechanisms of action of spa therapy in rheumatic diseases.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from OA of the knee according to American College of Rheumatology (ACR) criteria and to standard radiography of the knee

Exclusion Criteria:

* patients enrolled in other research protocols
* patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months
* patients affected by neoplastic diseases or in the last five years, with cardiovascular disease of recent onset, suffering from inflammatory diseases in the acute phase, serious impairment of hematopoietic, renal and hepatic systems, other inflammatory rheumatic or autoimmune disorders, or unable to complete the questionnaires and the daily diary for the collection of socio-economic data
Vahelva Respimat Regulatory Post-marketing Surveillance in Korean Patients With Chronic Obstructive Pulmonary Disease

To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with COPD in a routine clinical practice setting

Study Design:

regulatory PMS study

Eligibility Criteria:
Inclusion criteria:

* Patients who have been started on Vahelva Respimat in accordance with the approved label in Korea
* Age \>= 18 years at enrolment
* Patients who have signed on the data release consent form

Exclusion criteria:

* Patients with hypersensitivity to Vahelva Respimat or to any of the excipients.
* Patients with a history of hypersensitivity to atropine or its derivatives(e.g. ipratropium, oxitropium, glycopyrronium, clidinium, umeclidinium)
* Patients with asthma
* Current participation in other clinical trials
A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

The cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. However, there is still no clear and unified cuff leak test operation specification. A cohort study has proposed a modified method. When the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Oral endotracheal intubation and mechanical ventilation \> 36 hours
* Fulfilled the weaning criteria

Exclusion Criteria:

* The patient has a chest drainage tube and there is persistent air leak
* Abnormalities of the larynx: such as tumors or vocal cord paralysis
* The patient cannot maintain the semi-recumbent position
* Unconventional weaning, such as awake ECMO, etc
* Participated in the study during the hospitalization
* Patients or their relatives refused written informed consent
Early Diagnosis, Pathogenesis and Progression of Open Angle Glaucoma

The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991. The primary aim is the evaluation of diagnostic and prognostic validity of morphometrical, sensory and hemodynamical diagnostic procedures. No therapeutic studies are performed.

Purpose: Detection of onset and progression of structural and functional damage due to glaucoma. Determination of rate and amount of progressive change due to glaucoma. Characterisation of the relationship between structural and functional change over time. Evaluation of predictive factors for the development and progression of glaucoma.

Eligibility Criteria:
Participants:

* Patients: Primary open angle glaucoma, secondary open angle glaucoma due to PEX or MDS, glaucoma suspects including ocular hypertension
* Healthy volunteers (for cross sectional analysis only)

Inclusion Criteria:

* Open anterior chamber angle
* Best corrected visual acuity 0.7 or better
* Age between 18 and 65 years

Exclusion Criteria:

* Any eye disease other than glaucoma
* Systemic diseases with potentially ocular involvement (e.g., diabetes mellitus)
* Myopic or hyperopic refractive error exceeding 8.0 diopters
Unpacking the "Mind" and "Body" Pathways of the Antidepressant Effect of Qigong in Older Adults: A Pilot Study

The goals of the study are to explore the neurobiological mechanisms and cognitive benefits of qigong in older adults. The main research questions are:

* Does 12-week qigong training lead to significant enhancement in serum adiponectin, serum BDNF and significant reduction in salivary cortisol?
* Does 12-week qigong training bring significant improvement in global cognitive function?

Participants are older adults aged 60 or above. They were randomly assigned to qigong training, mindfulness training, physical exercise training, or wait-list which all last for 12 weeks. Their changes before and after the 12-week period in depressive symptoms, neurobiological markers, and cognitive functions are assessed.


Eligibility Criteria:
Inclusion Criteria:

* 60 years or older;
* With mild or severer levels of depressive symptoms as indicated by the Geriatric Depression Scale (GDS-8) scores of 5 or above, or Depression Anxiety and Stress Scale-21 (DASS-21) depression subscale scores of 4 or above
* Self-identified as physically stable and without life-threatening diseases.

Exclusion Criteria:

* With a history of practicing or receiving training of any form of mind-body or regular exercises (including tai chi, yoga, and qigong, or regular physical activity \> 3 times/week) during the month prior to study enrollment
* Having changed medications or the dose of medications prescribed for their health condition in the month prior to study enrollment
* With severe cognitive or language impairment as defined as a score of less than 21 on Montreal Cognitive Assessment (MoCA-5min)
* Undergoing electroconvulsive therapy, psychotherapy, or psychoeducation for a psychological or psychiatric condition
* Unable to demonstrate satisfactory standing balance.