cyrilzakka/clinical-trials huggingface dataset:
ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic

This is a implementation research study of a surgical wound tele-monitoring online tool developed at the University of Edinburgh and demonstrated in the "Tracking wound infection with smartphone technology" (TWIST) randomised control trial (NCT02704897) conducted in NHS Lothian. The study design is based on the Medical Research Council (MRC) "Guidance for developing and evaluating complex interventions".

Surgical site infection (SSI) is one of the most common complications following surgery with significant costs to patients and health systems. Earlier diagnosis and treatment of SSI can reduce its impact. The investigators have previously developed a unique remote wound surveillance tool in a University of Edinburgh research setting. The investigators have demonstrated in a previous randomised controlled trial (NCT02704897), that wound infection can be diagnosed sooner (in the first 7 days postoperatively) when this tool is used.

This 12-month implementation research study will be conducted across the general surgical departments of the Royal Infirmary of Edinburgh and the Western General Hospital (two large tertiary hospitals). Informed consent will be required from all patients prior to enrolment, with a target of 200 patients recruited.

All data during the study will be collected via online forms hosted on the ISLA care platform, self-submitted by patients based on their own concerns with their wound or prompted by a routine request to complete. These forms are based on the smartphone-delivered wound assessment model developed and delivered in the TWIST trial (based on the Center for Disease Control and Prevention (CDC) classification criteria, and the ASEPSIS model (Additional treatment, Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of Inpatient Stay)). Participants will be asked to upload at least one photograph of their wound each time they use the smartphone-delivered wound assessment tool. Participants will be sent one (1) reminder notification the following day if they have not completed a requested response.

On postoperative day 30-day, patients will be requested to complete an online questionnaire based on two validated questionnaires: Bluebelle Wound Healing Questionnaire (WHQ) and Telehealth Usability Questionnaire. Furthermore, a subset of patients will be asked to indicate their interest to take part in a separate semi-structured interview regarding their experience within the study, and views of telemedicine in routine postoperative care (target 20 patients).

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 16 years) with the capacity to provide informed consent
* Patient undergoing abdominal surgery who own a smartphone capable of accessing and completing the online response form

Exclusion Criteria:

* Any participants with self-reported impairment that would prevent use of the online questionnaires (and no alternative means for completion e.g. assistance from family or carers).
Opioid Free Anesthesia in Bariatric Surgery

This study compares the intraoperative opioid free anesthesia approach in laparoscopic bariatric surgery to a conventional opioid- based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

Since optimal analgesia for the obese patients undergoing bariatric surgeries has always been challenging, and knowing the comorbidities and physiological changes in this population, use of opioid-sparing agents during anesthesia has attracted substantial research.the use of opioids in the perioperative period in obese patients is associated with an increased risk of complications . They are especially more sensitive to the respiratory depressant effect of opioids , thus any analgesic alternative without further compromising airway tone would be a desirable choice.

Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic and sedative properties, without compromising airway tone and reflexes .

Lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to minimize postoperative pain was evaluated in one study involving obese patients undergoing bariatric surgery. Its usage was associated with an improved quality of recovery compared to placebo .

Eligibility Criteria:
Inclusion Criteria:

* Age group: 18-65 years old
* American Society of Anesthesiologists (ASA )class I and II
* Indicated laparoscopic bariatric surgery

Exclusion Criteria:

* Renal, hepatic or cardiac insufficiency
* Positive pregnancy test
* Alcohol or drug abuse
* Psychiatric disease
* History of chronic pain
* Allergy or contraindication to any of the study drugs
Aspects Associated With Sleep Quality

Evaluate the correlation among the diagnostics of sleep bruxism and sleep quality obtained from the use of smartphone application (APP-Sleep Cycle®), PSG and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson).

This study will evaluate the correlation between sleep bruxism and sleep quality diagnoses obtained using the application of the smartphone (APP-Sleep Cycle®), polysomnography and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson). Subjects (n = 40) between 19 and 60 years old will be submitted to polysomnography from January to December 2019. The questionnaires will be applied before the polysomnography, and the APP will be used together with the polysomnography. The data will be tabulated and a descriptive statistical analysis performed. Specific statistical tests will be determined after preliminary analysis of the data (α = 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);
* Adequate cognitive capacity to understand and answer the questionnaire.

Exclusion Criteria:

• Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.
Serial Changes After Drug-Coated Balloon

The study aims at evaluating the morphological changes of plaque estimated by optical coherence tomography (OCT) and Factors Influencing Plaque Healing after Drug-Coated Balloon (DCB) for de Novo Coronary Lesions.

Percutaneous coronary intervention with a drug-eluting stent (DES) is the most common mode of revascularization for coronary artery disease. However, their efficacy is limited by in-stent restenosis and stent thrombosis. Drug-coated balloon (DCB) deliver an anti-proliferative drug into the vessel wall and leave nothing behind, which is a promising technique in the treatment of coronary artery disease. Previous many studies have confirmed that DCB treatment for de Novo coronary lesions is safe and efficient. But, data about morphological changes of plaque and factors influencing plaque healing after DCB for de Novo Coronary Lesions is scarce. The study compares morphological changes of plaques evaluated by OCT between baseline and 1-year follow-up and evaluates factors influencing plaque healing. All the included patient will receive dual antiplatelet therapy (DAPT) for one month followed by clopidogrel treatment.

Eligibility Criteria:
Inclusion Criteria:

- Diagnosed as CAD underwent coronary angiography and OCT Examination.

* Patients with de novo lesion suitable for DCB treatment.
* The reference diameter of targeted artery ≥2.75mm, the length of targeted lesion ≤25mm.
* Agreed to accept DCB treatment and written the informed consent.

Exclusion Criteria:

* Patients with de novo lesion unsuitable for DCB treatment.
* In-stent restenosis, coronary dissection, coronary spam, thrombus
* left main artery disease
* Age\>80 years old
* Cardiogenic shock or stroke admission
* Severe hepatic or renal dysfunction
* Poor quality of OCT image or massive thrombus
* Disagreed to accept DCB treatment.
* Life expectancy \< 1year. Angiographic Exclusion Criteria
* After pre-dilation of targeted lesions, the patients with residual stenosis\>30%, TIMI flow \<III grade and presence of major dissection (C type or higher).
Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?

Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ages 18 or older
* Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD
* Undergoing upper endoscopy and wireless pH monitoring (standard of care)
* Erosive disease: presence of esophageal mucosal injuries documented
* Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms
* Control group: normal subjects without symptoms of GERD

Exclusion Criteria:

* Anti-reflux therapy within 7 days prior to the pH study
* Previous neck, esophagus, or stomach surgery
* Major motility disorders
* Previous neck, esophagus, or stomach cancer or radiations
Life Satisfaction and Psychopathology in Institutionalized Elderly People

The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several selfreport questionnaires and were assessed with Mini Mental State Examination. Participants attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48 sessions (16 weeks) and Participants were evaluated before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* literacy
* age above 65 years

Exclusion Criteria:

* presence of cognitive or sensorial
* impairment
Acute Dietary Nitrate in Dilated Cardiomyopathy

Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice.

Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice. This study is a randomized, double-blind placebo-controlled, crossover trial. Resting blood pressure, phlebotomy and ISWT will be performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable,
* Confirmed non-ischemic, dilated cardiomyopathy

Exclusion Criteria:

* Active musculo-skeletal conditions
* Ischemic heart disease
* Pulmonary hypertension
* COPD
* Taking vasodilators
* Diabetes mellitus
Quetiapine Compared With Placebo in the Management of Fibromyalgia

Is quetiapine more effective than other medications in the treatment of fibromyalgia.

This study is a double blind, placebo controlled, 24-week crossover design. For 12 weeks subjects receive either study medication (200mg Quetiapine) or placebo, after which they will be switched to the other treatment for an additional 12 weeks. Between treatments, subjects are required to undergo a 1-week washout where no drug is given in order to clear the effects of the first treatment. At each visit subjects will complete the following assessment: Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Beck Depression Inventory, State-Trait Anxiety Inventory, and Short Form Health Survey. Temperature, blood pressure, pulse rate, weight and waist circumference will also be recorded. Physical exams and blood tests will be performed at 1, 12, and 25 weeks

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60, inclusive
* Females of childbearing potential using reliable method of contraception AND negative urine pregnancy test.
* Widespread pain present for at least 3 months
* Widespread encompassing both sides of the body, as well as above and below the waist
* Pain in at least 11 of 18 tender points as determined by a physician

Exclusion Criteria :

* Pregnant or breastfeeding
* Use of any of the following in the 14 days prior to enrollment: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, saquinavir phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrollment
* Substance or alcohol dependence at enrollment (except in full or recovery, and except nicotine or caffeine dependence)
* Abuse of any of the following within 4 weeks of enrollment: opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen
* Medical conditions that would affect study treatment
* Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by investigator
* Involvement in the planning and conduct of the study
* Previous enrollment or randomization of treatment in the present study
* Participation in another drug trial within 4 weeks prior to enrollment in this study or longer
* Admitted to hospital for Diabetes Mellitus (DM) related illness in past 12 weeks
* Not under physician's care for DM
* Physician responsible for your DM care has indicated you DM is uncontrolled
* Physician responsible for your DM care has not approved your participation in the study
* Have not been on the same dose of DM medicine and/or diet for the 4 weeks prior to starting the study
* For thiazolidinediones (glitazones) this period should not be less than 8 weeks
* Taking insulin whose daily does on one occasion in the past 4 weeks has been more than 10% above or below your mean dose in the preceding 4 weeks
* A low white blood cell count
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.

This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \<=75 years of age;
* single organ recipients of renal allograft;
* negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.

Exclusion Criteria:

* severe gastrointestinal disease which may influence the absorption of oral drug therapy;
* severe infection, HIV or active hepatitis;
* active gastric ulcers;
* malignancy other than cured skin cancer;
* severe anemia, leucopenia or thrombocytopenia.
Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial

The investigators plan to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.

Primary Aim. Determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.

Primary hypothesis. Unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized.

Secondary Aim. Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions.

Secondary hypothesis. Unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, and bradycardia within 48 hours after major non-cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Are expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution;
2. Are ≥18 years old;
3. Are designated American Society of Anesthesiologists physical status 1-4;
4. Are scheduled for major noncardiac surgery lasting at least 1.5 hours;
5. Are expected to remain hospitalized at least one postoperative night;
6. Are expected to have general or neuraxial anesthesia.

Exclusion Criteria:

1. Have language, vision, or hearing impairments that might compromise continuous monitoring;
2. Are designated Do Not Resuscitate, hospice, or receiving end of life care;
3. Are expected to have telemetry monitoring;
4. Have previously participated in the study.
What Makes a Cup, a Cup? Generalizing Novel Words

The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

The goal of the current proposal is to identify how digital media alters the mechanisms of word learning and subsequently impacts the lexical foundation on which a child's vocabulary is built. Specifically, the proposal aims to identify the impact of digital media on 1) the processes underlying real-time word learning, and 2) the processes of language generalization and vocabulary growth. Specific Aim 1 will use a novel word learning task to test children's ability to map and retain new words within and between digital media (2D images on a tablet) and real world objects (3D objects). Specific Aim 2 will probe children's novel label generalization abilities within and between 2D and 3D modalities using a novel noun generalization task. Further, individual differences in a child's prior technology experience will be measured and used to predict overall vocabulary as well as performance within and between each task. This Clinical Trial record focuses on Specific Aim 2.

Eligibility Criteria:
Inclusion Criteria:

* between 18-30 months old

Exclusion Criteria:

* diagnosed developmental delay or disorder
* exposure to more than 25% of another language
Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease

This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease.

This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease. Children and adolescents in UZ Leuven will be evaluated according to a psychosocial and neuropsychological protocol including different psychological tests and patient questionaires.

Eligibility Criteria:
Inclusion criteria

* children and adolescents (0-18 years)
* diagnosis of neuromuscular disease
Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty

Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement

This is a double-blind randomised control trial. After informed consent, the patients who undergoes primary total knee replacement will be assigned to either control group or experimental group randomly. The effectiveness and complication will be analysed.

If the patients are not medically fit for the study (including contraindications for lidocaine), they will be excluded.

Eligibility Criteria:
Inclusion criteria:

1. Males and females, aged 50-100 years
2. The patients who undergo primary total knee replacement (performed by the same surgeon, Dr.Jiang)
3. Clear consciousness
4. No contraindication for staple removal on the post-operative day 7

Exclusion criteria:

1. Allergy to lidocaine
2. Patient with second or third degree atrio-ventricular block
3. Patients with severe Sinoatrial node block
4. Patients taking class I antiarrhythmia drugs
5. Pregnant patients
6. Patients undergoing revision total knee replacement
7. Contraindication for removal of staples on post-operative day 7