cyrilzakka/clinical-trials huggingface dataset:
CGM - Reimagine Primary Care

To assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type I or II diabetes treated within the Reimagine Primary Care clinics.

This is a parallel randomized controlled trial. Eligible patients who consent will be randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for CGM, or (2) the control group who will follow their current standard finger-prick protocol via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and Clarity mobile apps for data capture, whereas the standard of care group will use the Contour Next mobile app for their respective readings.

The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in this study are FDA approved and commercially available.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5%
* Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider)
* Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine). • Patients 18-80 years of age

Exclusion Criteria:

* Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician)
* Patients that are not treated within the four Reimagine Primary Care clinics
* Patients less than 18 years of age, and 81 years of age and older
* Patients with a diagnosis of dementia
* If the patient is currently using a Continuous Glucose Monitor
* Patients with previous hospitalization for hypoglycemia within the last 18 months
* No access to a mobile phone to download the Dexcom or Contour Next applications
* Patients who are pregnant or planning to become pregnant over the course of their six-month participation
Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration

Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Active primary or recurrent subfoveal lesion with CNV secondary to AMD

Exclusion Criteria:

Prior treatment with any intravitreal drug in the study eye

* Prior treatment with verteporfin photodynamic therapy in the study eye
* Prior treatment with systemic bevacizumab
* Prior treatment with any intravitreal durg or verteprofin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
* Laser photocoagulation within 1 month before study entry in the study eye
* Previous participation in any clinical trial within 1 month before the entry of the study
* Subfoveal fibrosis or atrophy in the study eye
* CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathologica myopia
* Retinal pigment epithelial tear involving the macula in the study eye
* Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
* Active intraocular inflammation
* Vitreous hemorrhage in the study eye
Effect of a Mobile App on Improving Asthma Control in Patients With Persistent Asthma

mINSPIRERS_RCT aims to assess the magnitude of the effect of a mobile app for improving asthma control in adolescents and adults with persistent asthma, followed at primary and secondary care in Portugal.

INSPIRERS_RCT is a pilot randomized, multicenter superiority clinical trial regarding the effect of a mobile app together with usual care (experimental group) in comparison to usual care alone (control group) in adolescents and adults with persistent asthma. The study includes two face-to-face visits (initial visit and at 3 months), and 3 telephone interviews (1 week, 1 month and 4 months), implemented in 32 primary (General Practice) and secondary care centers (Allergy, Pediatrics, Pulmonology) in Portugal.

Eligibility Criteria:
Inclusion Criteria:

* Age between 13 and 17 years (adolescents) or and between 18 and 64 years (adults);
* Previous medical diagnosis of persistent asthma;
* Uncontrolled or partially controlled asthma according to Global Initiative for Asthma (GINA) criteria;
* Active prescription of inhaled control medication for asthma (all treatments will be accepted. There will be no change in the prescribed therapeutic regimen directly or indirectly related to participation in this study);
* Ability to use mobile app and a access (availability and use) to Android mobile devices with internet access;
* Do not currently use any mobile application for asthma management.

Exclusion Criteria:

* Patients diagnosed with chronic respiratory disease other than asthma or, diagnosed with another significant chronic disease, with possible interference with the objectives and/or evaluations of the study.
* Patients that participated in previous feasibility studies with InspirerMundi app will be excluded.
Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan

Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatient equal to or more than 20 years of age.
2. T2DM patient initiated dapagliflozin after May 1st 2016 as a second line or third line oral anti-diabetic therapy, either as add-on or switching from one to another. Or initiating dapagliflozin as adjunctive therapy for T2DM subjects treated with insulin.
3. Completed follow-up of at least 6 months regardless of continuation on dapagliflozin therapy.
4. Will provide completed and signed written informed consents.

Exclusion Criteria:

1. Subjects with a history of SGLT2 inhibitor therapy other than dapagliflozin prior to Baseline.
2. Subjects with Type 1 diabetes.
3. Treatment with other investigational drugs concurrently during the retrospective data collection period.
Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing double-lumen endotracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Patients scheduled for double-lumen endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Mallampatti scores greater than 3
* Recent sore throat
* Cervical spine disease
* History of head and neck surgery
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber

This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.

The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.

Eligibility Criteria:
Inclusion Criteria:

* Have a history of seasonal allergic rhinitis
* Have a positive (as defined in the protocol) skin prick or RAST test within 12 months prior to the screening visit

Exclusion Criteria:

* Have a clinically significant illness or disease
* Have unstable asthma
* Has participated in a clinical trial 30 days prior to the screening visit
Evaluate the Effect of Dry Needling on the Temporomandibular Joint in Subjects Who Have Suffered a Whiplash as a Result of a Traffic Accident

The transportation industry is growing rapidly and the most popular mode is overland by road. Traffic accidents are the most direct and serious risk to the lives of Western people. A large number of traffic accidents occur on the roads each year, especially those caused by motor vehicles on motorways and urban ring roads, often resulting in massive loss of life. According to the World Health Organization (WHO), 1.35 million people die each year worldwide.

Whiplash is the most common injury in motor vehicle collisions, affecting 83% of injured people.

The temporomandibular joint (TMJ) is one of the most complex joints in the human body, since in addition to performing functions in dental occlusion, it does so in the neuromuscular system.

Due to the relationship of the neck with the mandible, the main objective of the study is to determine if there is an improvement in pain and functional limitation in general by applying the dry needling technique in the temporomandibular joint musculature.


Eligibility Criteria:
Inclusion Criteria:

* Having suffered a traffic accident
* Having suffered a subsequent collision
* Having been diagnosed with whiplash in the hospital ''Fundación Jiménez Díaz (FJD)´´ emergency room in the first 72 hours after the collision.
* Age between 18-45 years, to avoid osteoarthritis and other degenerative problems.
* Minimum 3 in temporomandibular joint (TMJ) according to Visual Analog Scale (VAS)
* Consent to participate

Exclusion Criteria:

* Temporomandibular joint (TMJ) or craniofacial surgeries
* Spinal surgery
* Direct trauma in temporomandibular joint (TMJ) or prior to the accident
* Botox, silicones or any type of cosmetic surgery in the facial region.
* Problems of migraines and tension headaches (pre-accident)
* Any degenerative musculoskeletal disease (fibromyalgia, rheumatoid arthritis, osteoarthritis)
* Fear of needles
* Any neurological disorder (trigeminal neuralgia, epilepsy)
* Pregnancy
* Uncontrolled vascular or metabolic problems
Patients With Distal Radius Fracture

Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.

Distal radius fracture (DRF) affects overall health status. The International Classification of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this study was to investigate functional status and activity participation levels of DRF patients.

The patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. The evaluation of the body function and structure were done with Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic evaluations were done. Activity participation assessments were done with Push-Off Test (POT), Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical significance level was p\<0,05.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60
* Diagnosed with distal radius fracture
* Primary fixation after injury.

Exclusion Criteria:

* Bilateral distal radius fracture
* Concomitant ulna styloid fracture
* Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb
* Patients who underwent surgery that involved ipsilateral upper extremity
* Associated injuries such as nerve or tendon injuries
* Secondary procedures at follow-up
* Un-cooperated patients.
Clinical Outcomes of Cardiovascular Disease

This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Evaluate multiple examination indicators of patients at baseline, 1 year and longer, and follow up on the incidence of major cardiovascular and cerebrovascular adverse events, heart failure readmission, death, and other endpoint events.

This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Mainly including coronary heart disease, cardiomyopathy, hypertension, heart failure and other diseases, multiple examination indicators are evaluated for patients at baseline, 1 year and longer periods of time. The primary endpoints for coronary heart disease are all-cause mortality, cardiogenic death, non fatal myocardial infarction, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for cardiomyopathy are all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for hypertension are stroke, all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular and cerebrovascular adverse events. The primary endpoints for heart failure are all-cause mortality, cardiogenic death, readmission for heart failure, and major cardiovascular adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Coronary heart disease According to coronary angiography and coronary CTA, at least one coronary artery has a degree of stenosis greater than 50%.
2. Hypertension Hypertension is defined as office systolic blood pressure is ≥ 140mmHg and/or the diastolic blood pressure is ≥ 90mmHg without the use of antihypertensive drugs.
3. Heart failure There is a clear history of organic heart disease, clinical symptoms and signs of heart failure, and objective evidence of heart failure.
4. Cardiomyopathy Including defined dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.
5. Able to sign informed consent form.

Exclusion Criteria:

1. Age\<18 years old, or\>80 years old.
2. Patients with various malignant tumors.
3. Liver dysfunction (defined as ALT or total bilirubin greater than three times the upper normal limit).
4. Renal insufficiency (defined as blood creatinine exceeding 1.5 times the upper normal limit).
5. Those who have participated in other clinical studies within the past three months.
6. Individuals without legal capacity or with limited legal capacity.
7. Any situation where the researcher deems it unsuitable to participate in the clinical study.
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases

In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support national efforts to reduce serious adverse outcomes resulting from opioid abuse. This study will evaluate trends before and after the ER/LA REMS implementation for changes in mortality rates associated with prescription opioids utilizing state medical examiner databases from multiple states. Databases from 2005 through the most recent year available will be obtained.


Eligibility Criteria:
Inclusion Criteria:

* Fatalities associated with prescription opioids in several states during 2005-2015 (or later).

Exclusion Criteria:

* None
Study to Assess Breast Sensation Before and After Breast Cancer Treatment

The purpose of this study is to establish techniques for evaluating breast cutaneous sensation at baseline and following either lumpectomy or mastectomy for breast cancer.

Measuring nerve recovery and breast sensibility has been reported in a limited fashion in the past. A number of studies have assessed patients before and after breast reduction surgery using Semmes-Weinstein monofilaments and found this to be an effective technique. A limited number of studies have been done in patients undergoing mastectomy for breast cancer using these techniques. The main limitation of these existing studies is the lack of prospective measurements before surgery and through time, thus restricting the findings to isolated long-term outcomes. Additionally, no studies have compared patients undergoing mastectomy versus lumpectomy to determine the impact that surgical approach has on breast sensibility.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer
* patients that have been offered lumpectomy or mastectomy for surgical treatment
* patients with a high risk of breast cancer and are pursuing prophylactic mastectomies

Exclusion Criteria:

* metastatic malignancy of any kind
* subjects will not have breast surgery as a portion of their breast cancer care
* between 25 and 65 years old
* subjects with breast implants or a history of prior breast implants
* subjects that have had prior breast reduction surgery
* subjects who have had radiation to one of both breasts in the past
* subjects who cannot give informed consent
Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA

The comorbidity between obstructive sleep apnea (OSA) and insomnia (COMISA) is common, and associated with poorer sleep quality. CPAP adherence among COMISA patients is worst than among those with OSA only. The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months.

The comorbidity between OSA and insomnia (COMISA) is common. COMISA leads to additive impairment of quality of sleep and quality of life compared to patients with insomnia or OSA alone. Patients with COMISA demonstrate worse adherence to CPAP compared to patients with isolated OSA. The best therapeutic approach for patients with COMISA is still unclear. Hypnotics have not been tested among patients with COMISA and indication for CPAP.

The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months. In addition, the investigators will assess the effect eszopiclone on insomnia severity, quality of life, anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Insomnia;
* Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.

Exclusion Criteria:

* Craniofacial anatomical abnormalities or severe otorhinolaryngological disorders that potentially impair CPAP use;
* Use of hypnotics for more than 7 days in the last 2 months;
* Renal dysfunction (serum creatinine \>2mg/dL);
* Severe liver or cardiac dysfunction;
* Alcoholism;
* Previous CPAP or mandibular advancement device for OSA treatment in the last 12 months.
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups:

* 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod,
* 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or
* 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.

Eligibility Criteria:
Inclusion Criteria:

Patients must:

* Have relapsing remitting multiple sclerosis
* Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option.

Exclusion Criteria:

Patients with:

* History of chronic immune disease
* Crohn's disease
* Certain cancers
* Uncontrolled diabetes
* Certain eye disorders
* Negative for varicella-zoster virus IgG antibodies
* Certain hepatic conditions
* Low white blood cell count
* On certain immunosuppressive medications or heart medications
* Resting heart rate less than 45 bpm.
* Certain heart conditions or certain lung conditions
* Inability to undergo MRI scans

Other protocol-defined inclusion/exclusion criteria may apply
3D Printed Personalized Extendable Prosthesis

The goal of this type of observational study is to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma. The main question it aims to answer is:

Is 3D printed personalized extendable prosthesis replacement has a good outcome in limb salvage pediatric osteosarcoma？

Osteosarcoma is one of the most common primary malignant bone tumors in children and adolescents. In this study, the investigators try to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma.

Eligibility Criteria:
Inclusion Criteria:

* tumors of the extremities, with moderate soft-tissue invasion
* the neurovascular bundle is not invaded, and the tumor can be excised totally
* no metastatic lesions or metastases can be cured

Exclusion Criteria:

* recurrent tumors
* poorly differentiated tumors
* poor soft-tissue conditions
* neurovascular invasion around tumors
* ineffective chemotherapy with metastasis