cyrilzakka/clinical-trials huggingface dataset:
Lidocaine And Neuromonitoring in Thyroid Surgery

The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo.

The use of neuromonitoring in thyroid surgery imposes a number of special demands for anaesthetic management. Such demands include avoiding muscle relaxation and local anaesthesia. Maintaining a balance between the risk of awakening during surgery and excessively deep anaesthesia in fast track surgery is an important task for the anaesthesiologist.

Mild anaesthesia in the absence of muscle relaxation increases the risk of developing laryngeal reflexes, coughing during surgery, while excessively deep anaesthesia slows down recovery after surgery and increases the risk of arterial hypotension. The frequency and duration of arterial hypotension, as well as the depth of anesthesia assessed by the Bispectral index, are independent risk factors for postoperative cardiovascular complications and long-term mortality. On the other hand, coughing in response to irritation of the endotracheal tube during recovery from anesthesia is recognized as a risk factor for respiratory and cardiovascular complications, as well as postoperative wound insufficiency.

Optimization the anesthesia by intravenous infusion of lidocaine can improve anesthesia controllability, hemodynamic stability and overall anesthesia recovery rates. Local use of lidocaine, including filling the endotracheal tube cuff with its alkalinized solution, has also been shown to be effective in reducing the frequency of laryngeal reflexes upon awakening after surgery of varying duration. However, the efficacy and safety of local use of lidocaine under neuromonitoring conditions has not been studied. Despite recommendations to avoid the local use of lidocaine for tracheal intubation, there is evidence of the safety of this technique in the absence of a negative impact on the quality of neuromonitoring.

The purpose of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo. At the same time, the investigators assume that recovery after surgery will be comparable with both local and intravenous use. Intergroup differences in arterial hypotension, depth of anesthesia and intraoperative neuromonitoring parameters will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Planned thyroid surgery
* Age\> 45 years
* Signed informed consent to participate in the study

Exclusion Criteria:

* Emergency surgery
* Redo surgery
* Contraindications for lidocaine use
* Pregnancy
* Enrolment to another randomised clinical trial within the last 30 days
Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients

This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian traditional mouth rinse (Punica granatum Pleniflora or "Golnaar" mouthrinse) on treatment of diabetic gingivitis and compare it with chlorhexidine (0.2%).

Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill other inclusion criteria, are randomly assigned to intervention or control groups. All of the patients will undergo a training panel about mouth hygiene and receive a pack of a toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2 weeks for the second evaluation and taking tooth bleaching. The demographic and general information of all participants are taken and the primary outputs (plaque index and bleeding on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the examinations are done by one trained person and patients, practitioner and statistical analyser are blind to the interventions.

Eligibility Criteria:
Inclusion Criteria:

* To have gingivitis
* Controlled diabetes mellitus \[FBS\<130mg/dl \& Glycosilated hemoglobin (A1C)\<7%\]
* Presence of gingivitis
* Having at least 20 teeth
* No history of hypersensitivity reaction
* Age between 20 to 65 years
* Agreement to participate in the study

Exclusion Criteria:

* History of hypersensitivity reaction
* Smoking
* Systemic diseases (Kidney, liver or rheumatologic diseases)
* To have a pocket depth of more than 5
* Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in the past 3 months and during the study period
Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracorporeal Shoch Wave Therapy of the Patients With Lateral Epicondylitis: a Randomized Controlled Trial

To compare the effects of Trigger Point Ischaemic Compression Massage (TPICM) and Focused Extracarporeal Shock Wave Therapy (focused ESWT) on pain level, muscle strength, Joint range of motion, functionality and quality of life in patients with lateral epicondylitis (LE) in a randomised controlled trial.

The study was planned to include at least 66 patients who presented to the sports medicine clinic of Gülhane Training and Research Hospital with lateral epicondyle pain for at least 2 months, were diagnosed with lateral epicondylitis and verbally and in writing declared that they were willing to participate in the study.

Patients participating in the study;

1. assessment of pain intensity with visual analog scale (VAS)
2. Evaluation of hand grip strength with jamar hand dynamometer
3. Isokinetic muscle strength assessment of wrist muscles with biodex isokinetic system 3
4. assessment of wrist range of motion with a manual goniometer
5. Function assessment with PRTEE-T
6. DASH questionnaire
7. SF-36 quality of life assessment will be performed before and after treatment.

inclusion criteria

1. Male and female individuals aged 18-60 years
2. being diagnosed with lateral epicondilitis
3. volunteering to participate in the study

exclusion criteria from eswt treatment

1. non-cooperation
2. presence of systemic and metabolic diseases
3. malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
4. pregnancy
5. utilization of another treatment for lateral epicondylitis during the study period
6. previous invasive treatment with steroids for lateral epicondylitis
7. any treatment for lateral epicondylitis in the last 6 months

Eligibility Criteria:
Inclusion Criteria:

1. Male and female individuals between the ages of 18-60
2. being diagnosed with lateral epicondylitis
3. volunteering to participate in the study

Exclusion Criteria:

1. non-cooperation
2. presence of systemic and metabolic diseases
3. malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
4. pregnancy
5. utilization of another treatment for lateral epicondylitis during the study period
6. previous invasive treatment with steroids for lateral epicondylitis
7. any treatment for lateral epicondylitis in the last 6 months
School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes

This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.

This pilot cluster randomized controlled trial will examine the feasibility of a school-partnered collaborative care (SPACE) model for children with type 1 diabetes (SPACE for T1D). School districts will be randomized to the intervention or control arm in a 2:1 allocation ratio. School districts randomized to the control arm in Year 1 of the study will be invited to participate in SPACE in Year 2. All children with type 1 diabetes meeting inclusion criteria in each school district will be approached to participate through their school nurse.

All research activities will be conducted using a virtual video-conferencing platform. The intervention arm will consist of four monthly virtual meetings between the child, school nurse, diabetes care and education specialist (DCES), and any other identified school-related support people. The purpose of these meetings will be to determine a shared treatment plan, make treatment recommendations, and determine progress towards meeting the child's goals. The control arm will receive usual care in the school and the clinical setting as well as monthly phone calls from the DCES to the parent to offer review of blood glucoses. No additional contact with the school will be offered.

Participants and their parents will be asked to complete surveys regarding their overall health and well-being and provide us access to their glucometer/continuous glucose monitor data. Additional information will be collected from the electronic health record (hemoglobin A1c, care utilization, referrals). At the end of study, surveys for the parent and school nurse will assess feasibility and other implementation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least 6 months
* Attend school in one of the partnered school districts
* Receive daily oversight from the school nurse for their diabetes
* Managed by the Children's Hospital of Pittsburgh Diabetes center
* Able to participate in English

Exclusion Criteria:

* Child has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires
* Child is completely independent in diabetes care in school
The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties

This study is to analyze the effects of a 5-step skin care regimen on various skin parameters such as pigmentation, and firmness and elasticity of the skin around the eyes. The 5 facial products in the regimen are a cleansing balm, a toner, a serum, a moisturizer. and an eye cream.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 35 years old and 65 years old.
* Must have fine lines and wrinkles around the eyes.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners
* Adults unable to consent
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Subjects using any topical retinoid, hydroquinone, kojic acid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
* Subjects with any facial treatments in the past 6 months and who are unwilling to withhold facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, tightening treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus

The present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial function in premenopausal women with SLE (systemic lupus erythematosus). Patients with hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast feeding women. This is a randomized, double blind, placebo controlled study.

SLE (systemic lupus erythematosus) is characterized by accelerated atherosclerosis. The risk of suffering an acute myocardial infarction among premenopausal women with SLE is 50 times higher than control women of the same age. Insulin resistance and hyperinsulinemia are frequent in SLE. Lipid metabolism in SLE, as in other insulin resistant states, is characterized by high triglycerides, low HDL-cholesterol, normal LDL cholesterol (or slightly increased) and an increase in LDL's susceptibility to oxidation.

All these alterations can produce endothelial dysfunction which is present in SLE patients. Pioglitazone is a PPAR (peroxisome proliferator activated receptor) gamma agonist that can potentially improve insulin resistance, with a positive effect on the lipid profile (lowering of triglycerides, and a discrete increase in HDL-C) and improve endothelial function.

Patients will be randomized to receive either placebo or pioglitazone 30 mg/day during a period of 12 weeks. Endothelial function will be assessed by Positron Emission Tomography (PET).

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were premenopausal women with SLE
* Older than 18 years
* Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary care hospitals

Exclusion Criteria:

* menopause
* diabetes
* thyroid dysfunction
* neurological
* hepatic
* renal or liver disease
* personal history of high blood pressure
* CHD (coronary heart disease)
* cerebrovascular events
* chronic or acute infections
* malignancy
* nor history of chronic drugs or alcohol abuse
* smoking
* pregnancy or breast-feeding
* intake of hormones or lipid-regulating drugs
Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

The purpose of this study is to determine a effect-site concentration of propofol in children 3 to 11 years effective to make a induction of general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* obtained informed consent
* children between 3 and 11 years
* healthy
* elective surgery under general anesthesia
* no premedication

Exclusion Criteria:

* body mass index for age \> 95th percentile
* chronic or acute intake of any sedative drug
* any known adverse effect to the study drugs
A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)

A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)

A Phase 1b/2, multicenter, open-label study was designed to evaluate the efficacy and safety of acalabrutinib in subjects with recurrent glioblastoma multiforme (GBM) who had progressed after one or two prior systemic treatment regimens.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age
* Histologically confirmed GBM at first or second recurrence after concurrent or adjuvant chemotherapy or radiotherapy (must have received temozolomide).
* Radiographic demonstration of disease progression by MRI following prior therapy.
* Measurable disease (bidimensional) as defined by the RANO criteria, with a minimum measurement of 1 cm in longest diameter on MRI performed within 21 days of first dose of acalabrutinib; MRI must have been obtained ≥4 weeks after any salvage surgery after first or second relapse.
* Stable or decreasing dose of corticosteroids ≥5 days before baseline MRI (at study entry).
* On a stable dose of any required therapy (such as anticonvulsant medication for subjects to be enrolled into the Phase 1b portion), for ≥3 weeks before the first dose of acalabrutinib.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Life expectancy ≥ 12 weeks.
* Completion of all prior anticancer therapy before first ACP-196 dose.
* Need to have recovered (i.e., Grade ≤1 or baseline) from AEs associated with prior cancer therapy. Note: Subjects with Grade ≤2 neuropathy or Grade

  * 2 alopecia are an exception, and may qualify for the study.

Exclusion Criteria:

* Three or more prior lines of systemic therapy for GBM.
* Prior malignancy (other than GBM), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥2 years. Any cases of prior malignancy allowed on study are to be approved by the study medical monitor.
* Significant cardiovascular disease.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Evidence of bleeding diathesis or coagulopathy.
* Requires urgent palliative intervention for primary disease
* Requires treatment with a strong CYP3A4 inhibitor..
* History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
* Breastfeeding or pregnant.
* Subjects previously treated with bevacizumab (Avastin)
Molecular Markers of Acute Kidney Injury in Elderly Deceased Donors

Scoring systems that combine donor clinical and morphological parameters to predict outcome of kidney transplantation lack enough specificity to be generally accepted. Compare to classical histology, molecular assessment of renal tissue offers unbiased and technically robust approach. In this prospective 3-months' observational study procurement biopsies in 180 brain death donors will be performed. Using microarray which detect top differently regulated genes, conventional histology, urinary AKI biomarkers, renal function and clinical variables models predicting DGF and early graft scarring (IFTA, poor graft function) in recipients will be constructed. The associations of AKI in donors with distinct fibrosis atrophy and AKI molecular signals will be found. Molecular techniques and final models may help to improve the decision-making process for the acceptance of kidneys from marginal donors but more importantly, it may help clinicians to guide less toxic immunosuppression in identified problematic grafts.

The aim is to create a prediction model of early clinical outcome (delayed graft function) based on donor and recipient clinical variables, donor eGFR, urinary AKI biomarkers, histology (glomerulosclerosis, interstitial fibrosis, vascular changes) and top differently regulated genes found in microarray of wedge procurement donor biopsy. Construct a model capable to predict early renal allograft scarring (IFTA\>2), and impaired graft function (eGFR\<45 mL/min), as early as at 3 months. Describe renal molecular changes associated with established AKI in brain-death deceased donor and with aging.

Eligibility Criteria:
Inclusion Criteria:

* All DBD (donation after brain death) donors whose kidneys will be procured by transplant team of Institute for Clinical and Experimental Medicine (IKEM) in donor hospital.
* All DBD (donation after brain death) donors whose kidneys will be procured by transplant team of Institute for Clinical and Experimental Medicine (IKEM) at IKEM.

Exclusion Criteria:

* Donors with circulatory death
* Donors with machine perfusion
* Donors with multiorgan transplantation.
Longitudinal Assessment of Transient Elastography in Cystic Fibrosis

To determine if transient elastography (TE), when combined with ultrasound (US) pattern characterization can improve the prediction of progression to a nodular pattern on US.

To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis (CF) To prospectively assess whether TE data are associated with conventional laboratory markers of hepatic fibrosis To determine the variability of TE measurements taken at different sites in the same patient

A noninvasive assessment of hepatic fibrosis is desperately needed to advance the care of children with CF significant liver disease and to provide for measurements during clinical trials. That global assessment might serve as both a predictor/descriptor of disease course but also as a critical biomarker for clinical research. FibroScan® measurement of liver stiffness has great potential to fill this void. The underlying hypothesis of this proposal is that elastography in addition to US can improved the prediction of the development of a nodular liver on US and development of portal hypertension over time in children and young adults with CF.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in CFLD NET PUSH study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers)
* Entry criteria for that study were:
* CF as determined by sweat chloride \>60 meq/l
* Pancreatic insufficiency
* Age 3-12 years old at entry
* For entry into the longitudinal follow up subjects were in one of two groups

  * A screening US pattern of nodular liver (CIR), heterogeneous increased echogenicity (HTG) or homogeneous increased echogenicity (HMG)
  * A screening US pattern of normal (NL) matched to a HTG subject (2 NL:1HTG) by age, center and pseudomonas status

Exclusion Criteria:

* Exited from the PUSH Study
* Unable / unwilling to sign consent
A Multicenter Survey Study Into Patient Experience With Mobile Apps

This multicenter prospective survey study is designed to evaluate a newly developed mobile app that will support patients with malignant pleural effusion (MPE) treated with an indwelling pleural catheter (IPC). The aim is to test the mobile app with patients with MPE and get user feedback during and at the end of the study period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with MPE and, scheduled for an indwelling pleural catheter (IPC) procedure,
* Age 18 or older

Exclusion Criteria:

* Patients without an iOS smartphone or email account
* Patients who refuse participation.
Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD

This study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.

This study is a multicenter, randomized controlled trial. According to the inclusion and exclusion criteria, patients with complex coronary artery disease undergoing elective coronary angiography will be prospectively enrolled in the study. Patients will be randomly assigned to the real-time heart team group and the conventional heart team group by block randomization. The real-time heart team group needs to conduct multidisciplinary heart team discussion during the coronary angiography process, while the traditional heart team group needs to conduct multidisciplinary heart team discussion offline and face-to-face after the coronary angiography process. Patients who are not randomized will be registered. This study will prospectively collect the patient information, heart team meeting process, clinical treatment, and clinical outcomes to evaluate the efficiency and feasibility and differences in clinical outcomes of patients under different heart team approaches.

Eligibility Criteria:
Inclusion Criteria:

1. Significant stenosis in the left main or left main equivalent with or without stenosis in one of the other vessels\[Significant stenosis is defined as: 1) a diameter stenosis of at least 50% reduction in luminal diameter by visual assessment or 2) any total occlusion (no age limitation and no exclusion of unfavorable anatomic features); Left main equivalent disease is defined as significant stenosis of the ostium of the left anterior descending and the ostium of the left circumflex.\]
2. At least 1 significant stenosis in all 3 major epicardial territories supplying viable myocardium;
3. Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.

Exclusion Criteria:

1. Less than 18 years of age;
2. Previous history of PCI or CABG;
3. Admitted for AMI, ECG and biomarker detection indicated acute stage;
4. Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment;
5. Combined with AF or severe arrhythmia;
6. Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization;
7. Rejection or exclusion of a revascularization mode (PCI or CABG);
8. Refuse to participate in the study.