cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine in Pediatric Tonsillectomy

The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.

Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.

As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.

Eligibility Criteria:
Inclusion Criteria:

* Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

* Children less than 3 years
* Children with uncorrected cardiac lesions
* Children with heart block or liver impairment
* Children with American Society of Anesthesiology Class 3 or 4.
Early Staged Consent Before Prostate Biopsy

This is a study and a novel approach to clinical trials, testing the feasibility and acceptability of two-stage consent in the context of a trial integrated into routine clinical practice. The investigator will use, as a model, a trial of a brief mind-body intervention) with guided imagery for procedural pain at the time of prostate biopsy. In the two-stage design, patients will first be approached for consent to 1) have their routinely collected clinical data used for research purposes and 2) be randomly selected to be offered an intervention to improve the experience of prostate biopsy. Only patients randomized to the experimental arm will be informed about the benefits and harms of the intervention and will sign a second consent for the experimental treatment. There will be two separate randomizations in this study, one-stage (usual informed consent) vs. two-stage consent and mindfulness intervention vs. control.


Eligibility Criteria:
Inclusion Criteria:

* All male patients that will be scheduled for standard prostate needle biopsy (first, repeat or active surveillance biopsy) under local anesthesia and potentially consented to the mindfulness study of mind-body intervention for prostate biopsy within the next 12 months.
* English fluent

Exclusion Criteria:

* Patient with prior rectal surgery or anal stricture requiring surgical intervention prior to biopsy.
* Prior prostate radiation
Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST).

In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth.

The first phase of this study will be the preparation phase. This will comprise the development of a conceptual framework and conducting a feasibility pilot study consisting of three intervention components: Motivational interviewing (MI), Oral health promotion messages (OHPm), and Storytelling (ST). The second phase of the study is the optimization phase which constitutes a factorial trial of the three selected intervention components (MI, OHPm and ST). Each component will be set at two levels: yes (the intervention is applied) vs no (the intervention is not applied).

Eligibility Criteria:
Inclusion Criteria for mother's of children enrolled in study:

* Has children between 2 and \<5 years of age
* Has children with high plaque index scores (PlI≥2 or visible plaque accumulation on maxillary anterior teeth).
* Literate and owns a mobile phone with already set-up or possibility to set-up Whats-App messenger application.
* Willing to participate in the study and receive periodic OHPm and ST videos.

Exclusion Criteria:

* Mothers of children who are not willing to cooperate and show a definite negative behavior (Rating 1 Frankel's classification).
* Mothers of children who are physically disabled or medically compromised.
* Mothers of children in need of emergency dental treatments.
Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.

Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion Criteria:

-
Effect of Muscular Relaxation and Breathing Technique on Blood Pressure in Pregnancy

Gestational hypertension is the main cause of maternal and fetal mortality, however, it has no definite effective treatment. nowadays, the stress management approaches are use for essential hypertension. So, this study aimed is study the effect of progressive muscular relaxation and breathing control technique on blood pressure during pregnancy.

this 3-groups clinical trial has been done in Mashhad Health Centers and Governmental hospitals. 60 pregnant women with systolic blood pressure less than 135 mm Hg or diastolic blood pressure more than 85 mm Hg who met inclusion criteria were assigned into three groups of progressive muscular relaxation, breathing control and control. In tow experiment groups, exercises were controlled by one day personally and the rest by CD, BP before and after interventions was controlled for 4 weeks. In control group blood pressure was measured before and after 15 minutes with no intervention.


Eligibility Criteria:
Inclusion Criteria:

* systolic blood pressure ≥ 135mmHg or
* diastolic blood pressure ≥ 85mmHg
* absence of severe preeclampsia condition
* eclampsia
* absence chronic hypertension
* gestational age 20-36w
* single pregnancy
* have not contraction or bleeding
* absence of underlying disease and mental disorders
* absence of polihydramnios
* hydatiform mole and placenta previa
* not addicted to drugs, alcohol, mood-altering medicine and cigarette
* not to use similar relaxation methods and breathing techniques during pregnancy
* reading and writing literacy
* have contact number

Exclusion Criteria:

* using antihypertensive drugs(for experimental groups)
* CBR
* bleeding
* contraction or watering during study
* deteriorating of preeclampsia to severe form
* hospitalization
* start medical treatment for experiment groups
* changing mind for continuing with study
* to be absent in one session of personal instruction for experiment groups do not exercises more than 3 sessions of relaxation and breathing control at home
* delivery during 4- week interventions and presence of symptoms such as confusion, fatigue, feeling of suffocation, pain, blurred vision during doing exercises
Orange Juice Consumption in Patients With Hepatitis C

This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C, may contribute to the treatment of patients with chronic hepatitis C.

Forty-three patients with chronic hepatitis C who were being treated with pegylated interferon combined with ribavirin, according to the Clinical Protocol and Therapeutic Guidelines for Viral Hepatitis C and Co-infections of the Brazilian Health Ministry were randomly divided into two parallel groups: (1) orange juice (n = 23), which were supplemented with orange juice (500 mL/d) for 8 weeks; (2) control group (n = 20) composed of patients that were not drinking orange juice regularly. The recruitment process began in February 2012, the intervention was carried out from May 2012 to July 2012, and the data analysis started in September 2012. The sample number took into account variances on total cholesterol with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Dourado et al., 2015). The minimum sample size should have 20 individuals per group (n = 40), considering an approximately 15% dropout rate. Primary and secondary endpoints were the reduction of total cholesterol and modification of biochemical markers, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. Assessment of the data was performed in all participants on the first and last day of the experiment. All the parameters were compared between the juice group and the control group using General Linear Model of Repeated Measures Analysis. Differences in baseline patients' characteristics between the two groups were analyzed by One-way analysis of variance (ANOVA). The LSD signed rank post-test was used to assess significant changes in parameters after the start of treatment in each group, and the differences were considered statistically significant at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Detection of circulating HCV RNA
* Negative HBV surface antigen
* Negative antibodies to HIV

Exclusion Criteria:

* Co-infection with hepatitis B virus (HBV)
* Co-infection with hepatitis A virus (HAV)
* Co-infection with human immunodeficiency virus (HIV)
* Presence of diabetes mellitus,
* Presence of ascites
* Elevation in serum ferritin levels
Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device

Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.


Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18-110 years
2. Must have a CRT-D (A biventricular pacemaker with defibrillator)
3. Last optimization of their device (CRT-D) must not have been done in the past 3 months
4. Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)

Exclusion Criteria:

1. Less than 18 years of age or greater than 110 years old.
2. Does not have a CRT-D
3. Optimization of their device has occurred in the past 3 months
4. Not on optimal medical therapy for heart failure as listed in the inclusion criteria.
Measurement of Exhaled Propofol

Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total intravenous anaesthesia with propofol is done only by experience of the anaesthetist or according to pharmacokinetic models. In this study we want to investigate if the exhaled fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled propofol will be measured with an electrochemical sensor developed by "Drägerwerk AG \& Co. KGaA". Exhaled propofol levels will be compared with the corresponding arterial serum concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol levels with the Bispectral Index (BIS).


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anaesthesiologists) classification I \& II
* Body-Mass-Index \< 35
* elective surgery with the necessity of an arterial catheter

Exclusion Criteria:

* chronic obstructive lung disease
* bronchial asthma
* smokers with more than 5 packyears
* peripheral artery occlusive disease
* diabetes mellitus
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Male or females with an age ≥ 18 years.
2. Subjects with histological- or cytological-confirmed, advanced cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists

   1. For Phase 1, only subjects HER2 or HER3 molecular/genetic alterations will be enrolled.
   2. For Phase 2a, subjects with one of the following tumor types will be enrolled:

   i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with HER2 mutation or amplification vii. Other tumors with HER2 mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial).
3. At least 1 measurable lesion for solid tumor
4. Is able to take medications orally (e.g., no feeding tube).
5. Able to agree to and sign informed consent and to comply with the protocol
6. Has adequate organ function

Exclusion Criteria:

1. Has a serious illness or medical condition(s)
2. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration
3. Impaired cardiac function or clinically significant cardiac disease
Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation

This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.

This is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary objectives are to compare the pain relief and quality of life of participants in these two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Upcoming elective foot or ankle surgery

Exclusion Criteria:

* Preoperative weakness in knee extension
* Documented neuropathy
* Previous knee surgery
* Inability to provide informed consent
"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement

Internal jugular, subclavian, or femoral veins are often used for central venous catheter (CVC) placement. Regardless of which vein is preferred, the "Seldinger" technique is used most frequently. The most commonly used method with ultrasound is the short-axis out-of-plane approach. The main problem in this method is that the correct needle tip is missed, and it causes some complications by causing posterior wall punctures. The "Syringe-free" technique is first reported by Matias et al. in adults; it is a technique that allows full real-time monitoring of the guidewire insertion into the vein without blood aspiration. It is a great advantage in CVC placement, especially with the long-axis in-plane approach. When the literature is reviewed, no study other than a 12 case study in which brachiocephalic vein catheterization related to CVC placement was performed using this technique in children was found. There is no randomized study comparing the "Syringe-free" Long-Axis In-Plane technique with the classic Short-Axis Out-of-Plane technique in pediatric patients.

This study compares these two techniques' efficacy and complication rates in critically ill children requiring CVC placement.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 3 months, younger than 15 years old
* Critical illness pediatrics

Exclusion Criteria:

* Patients younger than 3 months and older than 15 years,
* body weight less than 5000 gr,
* anatomical malformation in the neck,
* infection at the intervention site,
* thrombosis
Post Approval NovaSure Essure Labeling Study

This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.

A prospective, single arm, multi-center, post approval study that is designed to provide additional information on the safety of performing a NovaSure Impedence Controlled Endometrial Ablation System in the presence of Essure Permanent Birth Control System, following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15 clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the exclusion criteria will have the study explained to them and be invited to participate. Enrolled subjects will have baseline data collected at the time of their NovaSure procedure and will be followed for 1 month after the NovaSure procedure to be assessed for adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older and premenopausal.
* Subject's gynecological history supports the use of NovaSure endometrial ablation for the treatment of menorrhagia.
* Subject has had an Essure Permanent Birth Control System procedure.
* The Essure Confirmation Test has confirmed both bilateral tubal occlusion and satisfactory placement of the Essure micro-inserts. A written report or ECT radiologic films need to be provided by the physician who performed the ECT. If neither is available, the ECT must be repeated prior to enrollment.
* Subject is able to provide informed consent

Exclusion Criteria:

* Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.
* Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or other imaging study (e.g. congenital malformation, large fibroid or large polyp)
* Subject with any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium.
* Subject has an active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
* Subject has an intrauterine device (IUD) currently in place.
* Subject has active pelvic inflammatory disease or history of recent pelvic infection.
* Subject has undiagnosed vaginal bleeding.
* ECT unable to adequately assess bilateral tubal occlusion and proper micro-insert placement.
* Subject has uterine sound measurement greater than 10 cm.
* Subject with a uterine cavity length less than 4 cm.
* Subject with a uterine cavity width less than 2.5 cm, as determined by the width dial of the disposable NovaSure device following device deployment.
* Subject is unable to comply with the protocol and be available for follow up
* In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study.
Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery

Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that is responsible for significant morbidity and mortality.It is present when the ventricular filling is impaired as a result of delayed relaxation or decreased compliance. During Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting 20-30% of patients undergoing coronary revascularization procedures. AF is associated with significant morbidity and mortality and has been identified as a causative factor of increased length of both hospital and intensive care unit (ICU) stay after CABG surgery, resulting in increased resource utilization and medical care costs.The primary aim of this study is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective CABG or OPCAB surgery
* signed informed consent

Exclusion Criteria:

* Patients with a history of previous heart surgery and/or undergoing valvular heart surgery.
* Patients with preoperative atrial fibrillation.
* Patients in whom TEE is contraindicated.
Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4

Primary Objectives

* Determine the biodistribution of \[18F\]-C-SNAT4 in 5 healthy volunteers. Secondary Objectives
* Determine the dosimetry of \[18F\]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.
* Determine the acute toxicity of \[18F\]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.
* Determine whether uptake in \[18F\]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy.
* Determine/verify the safety profile of the \[18F\]-C-SNAT4 radiotracer, as an imaging agent in patients with lung cancer.
* Determine the time of maximal \[18F\]-C-SNAT4 radiotracer uptake post injection.


Eligibility Criteria:
Inclusion Criteria:

* ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment
* Hgb ≥ 9 g/dL (90 g/L); \< 9 g/dL (\< 90 g/L) is acceptable if Hgb corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan
* Platelet count ≥ 100 x 109/L w/o blood transfusions for 7 days preceding lab assessment
* Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert's disease
* ALT ≤ 2.5 x ULN
* AST ≤ 2.5 x ULN
* Alkaline phosphatase (AP) ≤ 3 x ULN
* If a women of childbearing potential (WCBP): negative early pregnancy test (EPT)
* Karnofsky Performance Status (KPS) ≥ 60
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Has already begun non-surgical therapy for any recurrence, prior to the first \[18F\]-C-SNAT4 PET/CT scan
* Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan.
* Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.
* History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biological composition to \[18F\]-C-SNAT4 used in study.
* Pregnant or nursing
* Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70 cm).