cyrilzakka/clinical-trials huggingface dataset:
Cryoablation of Bone Metastases From Endocrine Tumors

This study will evaluate the clinical response and safety of cone beam computed-tomography guided percutaneous cryoablation in bone metastases from thyroid, adrenal and neuroendocrine tumors in 30 patients.

Thyroid neoplasms, as well as adrenal and neuroendocrine tumors have the potential to metastasize to bone. About 3% of patients with well-differentiated thyroid carcinomas develop secondary bone lesions, while adrenal and neuroendocrine tumors have 10% and 13% bone metastases rates, respectively. Spinal metastases are associated to a worst prognosis. The progressive systemic disease, the post-operative complications, and the pre-operative neurologic impairment were associated to a worst global survival rate in the thyroid cancer. Additionally, extensive spinal instrumentation of metastatic thyroid carcinoma was associated to greater complication rates. Interventional radiology offers promising techniques for the minimally invasive approach of bone metastases. Image-guided percutaneous radiofrequency ablation and cryoablation techniques have been studied in clinical trials and are considered effective options in pain palliation of patients with bone metastatic disease. These techniques may be associated with conventional treatment, as well as radiation therapy and percutaneous embolization, avoiding major surgical interventions and its complications.

Eligibility Criteria:
Inclusion Criteria:

* patients with bone metastases from thyroid, adrenal or neuroendocrine tumor diagnosis, associated to one of the following: pain; risk fracture; risk of compression of spinal cord; hypercalcemia; performance status (ECOG) 0-3; mean life expectancy over one month;

Exclusion Criteria:

* age \< 18 years
* active anticoagulant therapy or uncorrectable coagulopathy
* pregnancy or breast feeding
A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer.


Eligibility Criteria:
General Inclusion Criteria:

* Willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blood draw
* Diagnosis of HER2+, HR+ (for cohort R1) or triple negative breast cancer (for cohort T1) as per local assessment
* Availability of an archival tumor tissue (most recent pre-treatment tumor tissue is preferred)
* Unequivocally growing tumor lesion (progressive lesion) that is accessible for resection, excision or core needle biopsy
* Discontinuation of prior anti-cancer treatment outlined below should not be longer than 4 weeks from participation in this study

Inclusion criteria for participants in the cohorts studying acquired resistance

* Participant had undergone regular monitoring for disease progression as per local practice (preferably every 3-6 months) while on most recent breast cancer therapy
* Accessible tumor lesion that newly appeared or a lesion that started to regrow while the participant was at least 6 months on therapy

Inclusion criteria for participants in the cohort studying primary resistance

* Accessible tumor lesion that continued to increase in size or a newly appearing lesion (as confirmed by routine tumor assessment) while treated for at least 4 weeks but less than 6 months on therapy

Exclusion Criteria:

* Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders)
* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
* Participant has started treatment with subsequent anti-cancer therapy
* Participants whose progressive tumor lesion that is targeted for biopsy/resection is in the bone
* Discontinuation of treatment was due to a reason other than disease progression
Oral Omega-3 for Reduction of Kidney Scar Due to Pyelonephritis in Children

Urinary tract infections (UTI) are a common and important clinical problem in childhood.Upper urinary tract infections (ie, acute pyelonephritis) may lead to renal scarring, hypertension, and end-stage renal disease.Pathogenesis of acute pyelonephritis (APN) is associated with urinary tract anatomy and function, bacterial virulence factors, the host innate immune system and production of free radicals. Oxygen-free radicals and oxidative stress play a role in renal scar formation after an APN. Oxygen-free radical scavengers and antioxidants can reduce tissue damage and renal scaring during acute pyelonephritis.we want to publish a study that indicates that antioxidant therapy with omega-3 given to children with pyelonephritis may indeed lower the risk for renal scarring.

Several studies show that omega-3 alleviated oxidative stress and inflammation.This study is a simple randomized clinical trial (RCT) evaluating the effect of omega-3 in addition to antibiotic on preventing renal scaring after acute pyelonephritis in children. This randomized clinical trial on 60 patients in 2 groups (intervention \& control) is conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis were enrolled into a clinical trial. Patients with neurogenic bladder, systemic hypertension, obstructive uropathy and high grade vesicouretera are excluded.Patients in Intervention group are administered omega-3 based on body weight in divided doses in addition to antibiotic regimens and patients in control group received antibiotic regimens without omega-3. Primary outcome is the development of renal scar by doing DMSA renal scan on the 7th day of admission and four to six months after the intervention and compared between groups.Also,measurement of urinary biomarker of acute kidney injury (NGAL) three days after antibiotic or omega-3 administration for assessing of subsequent scarring in both groups will be done . Secondary outcome is the incidence and severity of renal scarring after pyelonephritis and response to treatment between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 month to 10 years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis

Exclusion Criteria:

* neurogenic bladder,
* systemic hypertension,
* obstructive uropathy,
* High grade vesicoureteral
Vein External Support Trial

Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.


Eligibility Criteria:
Primary Inclusion Criteria:

1. Patient scheduled for on-pump CABG on clinical grounds
2. Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds
3. Native circumflex and right coronary arteries have at least one stenosis in each vessel\> 75%

Primary Exclusion Criteria:

1. Concomitant non-CABG cardiac procedure
2. Prior peripheral vascular or cardiac surgery
3. Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)
The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study

Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under PPI therapy. Studies in children are yet scarce.

This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance monitoring. All patients will have undergone conservative measures prior to initiation of PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal microbiome will be determined by 16S rDNA-based microbial community profiling by high-throughput pyrosequencing.

Data will be compared by dependent non parametric test (Wilcoxon). P-values \<0.05 will be considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

symptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy

Exclusion Criteria:

neurological impairments
Relation Between Bruxism and Cervical Function

correlation between Bruxism and Cervical function

Bruxism is defined as an unconscious oral habit of dysfunctional rhythmic pressing, clenching and grinding of the teeth when performing movements that are not part of the masticatory function that leads to occlusal trauma and it is an oral parafunctional activity it is not related to normal physiological functions, such as speech, breathing, chewing and swallowing , and/or by bracing or thrusting of the mandible , and it accelerates abnormal tooth wear, periodontal disease, and temporomandibular disorders (TMD)

Bruxism should be considered a potential protective risk factor rather than a disorder in otherwise healthy individuals. In most persons bruxism is not a disorder, it is a sign of a disorder (e.g. in individuals with obstructive sleep apnea, epilepsy , being the ending episode of respiratory arousals, so as to prevent the collapse or restore the patency of the upper airway whilst asleep) , which would classify bruxism as an attribute that decreases the chance of a negative health outcome.

There is two distinct circadian manifestations, either occurring during wakefulness or during sleep. Awake bruxism is a semivoluntary masticatory muscle activity during wakefulness that is characterized clenching or grinding tooth and/or by bracing or thrusting of the mandible

Eligibility Criteria:
Inclusion Criteria:

* Tooth-grinding or clenching .
* Sounds associated with bruxism or jaw muscle discomfort.
* Pain in the jaw, temple, ear or front of the ear and pain modified by jaw movement, function, or parafunction.

Exclusion Criteria:

* History of trauma to the face .
* History of orthodontic treatment, craniofacial anomalies, degenerative disease, or TMJ trauma .
* Any systematic joint or muscle disease and neurologic disorder. neurologic disorders (eg, trigeminal neuralgi ,neurologic disorders (eg, trigeminal neuralgi neurologic disorders (eg, trigeminal neuralgi
* Osteoarthrosis or arthritis of temporomandibular joint .
* Tumors in the head and neck area.
Work Place Health Promotion: a Change Project

The purpose of this study is to determine if intelligent physical exercise training can increase the productivity of office workers in Denmark. Effects of intervention is measured after 1 and 2 years.

The project is driven as a change project.

The investigators measure productivity as:

* Individual health
* Sick leave
* Retention at the workplace


Eligibility Criteria:
Inclusion Criteria:

* Office workers

Exclusion Criteria:

* Pregnancy
Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.

Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae.

Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with BOTOX injections in the other axilla.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years
* Persistent bilateral primary axillary hyperhidrosis
* Hidrosis interferes with daily activities of patient
* Gravimetrically minimal 50 mg spontaneous sweat production in each axilla, measured during 5 minutes in room temperature in calm condition
* signed informed consent
* patient can and shall continue the trial until the end, and will follow the instructions correcly
* women in reproductive period had a pregnancy test

Exclusion Criteria:

* Medical condition that can be dangerous by treatment with BOTOX, including myastenia gravis, Lambert-Eaton syndrome, ALS, and each other disease that can interfere with the neuromuscular function
* Secundary hyperhidrosis (for example secundary on hyperthyroid problems, lymfoma, malaria)
* Known allergy against study medication, his components, local anesthesia or iodium
* Use of aminoglycosids, curare-like products, or other products which can interfere with the neuromuscular function during the study
* Use of therapy for hyperhidrosis with Aluminium chlorid during the study
* Infection or skin disease in the area to treat
* Participation in an other therapeutic study on the same time
* Botuline toxine treatment in the last 4 months
* Women who can or who want to become pregnant
* Women in reproductive period who don't use the appropriate contraception
* Patients in a situation of which the researchers decide it can be dangerous, or can interfere with the study
Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

Eligible patients will be randomized 1:1 without stratification to bilateral continuous QL catheters with local anesthetic continuous infusion (QL block + IV patient-controlled analgesia group) or normal saline continuous infusion (IV patient-controlled analgesia group).

In the postanesthesia care unit (PACU), patients will be given intravenous boluses of hydromorphone or fentanyl as needed. Following immediate recovery from anesthesia, patients will be provided with a hydromorphone IV patient-controlled analgesia pump with standard initial settings and an option of clinician dose for breakthrough pain. IV patient-controlled hydromorphone pump settings will be titrated to comfort level (pain score\<4) by blinded clinicians.

Each of the catheters will be connected to patient controlled infusion pump running at a basal rate of 6mL/hour of 0.1% Bupivacaine or normal saline with on-demand bolus of 5 mL every 60 minutes to be started in the operating room before the surgical incision.

Opioid consumption first 72 hours or until discharge, whichever comes first will be recorded.

Pain scores during first 72 hours or until discharge, whichever comes first will be recorded with a verbal rating scale and obtained from the patient's electronic medical records.

The morning of post operative day 1 and post operative day 3 the ORSDS and QOR surveys will be completed.

Morning of the day of discharge, the overall patient satisfaction with pain management survey will be completed.


Eligibility Criteria:
Inclusion Criteria:

* Adults scheduled for elective colorectal surgery with a midline incision;
* American Society of Anesthesiologists (ASA) physical status 1-3.

Exclusion Criteria:

* Contraindication or intolerance to opioids and/or local anesthetics;
* Inability to use IV PCA system;
* History of chronic pain defined as use of opioids for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine and/or abdominal pain for more than 6 months, present most days of the weeks;
* History of neurological illness and/or neuropathy - Peripheral neuropathy, paralysis;
* Pregnancy and/or breastfeeding;
* Chronic renal failure, defined by estimated GFR \<60 ml/min;
* Chronic liver failure, defined by cirrhosis, portal hypertension, or history of variceal bleeding.
* BMI \> 35
Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

The aim of this clinical trial is to compare the rate of myopic progression in children wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design is an aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information). Myopic progression is quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6 months crossover) with double-masking. Peripheral refraction and ocular aberration will be evaluated.

Visual manipulation induced by progressive addition lenses (PALs) have been shown to inhibit eye growth and myopia development in children with up to 11% to 21% efficacy compared to single vision lenses. However, the treatment effect of PALs is statistically significant but clinically insufficient. The current study aims at investigating the use of spectacle lenses with a unique novel design for myopia control in children. This prospective one-year randomized clinical study will evaluate axial elongation and myopia progression in eyes using the novel lens design compared to those using the conventional single-vision design. It is a double-masked, cross-over study. One eye will be fitted with the study lens and the other eye will be fitted with the single-vision lens. Subjects will be asked to wear the spectacles for 6 months and the two lens designs will be swapped in the next 6 months after a wash-out period of 2 weeks. Both the subjects and examiners will not aware the lens design being used by the subjects in each phase.

Eligibility Criteria:
Inclusion Criteria:

* Myopia between 0.75 \~ - 4.50 D and with-the-rule astigmatism not more than 1.50 D
* Difference between eyes, no more than 1.25 spherical equivalent
* Best corrected visual acuity (VA) is equal to or better than 0.10 in logMAR scale (Snellen VA 6/7.5 or better)
* Eyes straight at distance and near with best subjective correction
* Willing to be randomized and wear the study spectacles according to the instructions from practitioner
* Willing to come back for follow up in the Optometry Clinic during the study period

Exclusion Criteria:

* Abnormal ocular and general health
* Prior myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
* History of rigid contact lenses (including orthokeratology lenses) wearing
* Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
* Ocular conditions which might affect the refractive error (for example, cataract, ptosis).
Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer

Conventional laparoscopic surgery (CLS) for colorectal cancer has been demonstrated to be safe and feasible and present minimally invasive benefits including faster recovery, reduced postoperative pain and shorter hospital stay, also acquiring comparable oncologic outcomes with open surgery. To achieve further minimally invasive outcomes, SILS plus one port surgery was attempted by some surgeons. Preliminary results showed that SILS+1 could achieve better minimally invasive benefits than CLS while preserving oncologic feasibility.

Till now, ERAS has been practiced in colorectal cancer surgery for approximately 20 years. Studies have proven that ERAS is safe and significantly improved the recovery course of patients during perioperative period, meanwhile, the expense could be greatly reduced.

Based on ERAS studies protocols and SILS+1 trials, investigators tried to combine SILS+1 with ERAS, hopefully to provide patients with more safe, economic, feasible and rapid surgery and perioperative strategies.


Eligibility Criteria:
Inclusion Criteria:

* Primary tumor diagnosed as adenocarcinoma confirmed pathologically by endoscopic biopsy
* cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
* Located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, the upper segment of the rectum.
* Diameter ≦ 5cm
* No severe organ dysfunction
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) score class I or II
* Written informed consent

Exclusion Criteria:

* Unsuitable for patients undergoing single incision plus one port laparoscopic surgery
* Patients with Complications caused by colorectal cancer ( bleeding , perforation, obstruction or incomplete obstruction )
* Previous abdominal surgery
* Malignant diseases within the past 5years
* Requirements of simultaneous surgery for another diseases
STUMBL Score as a Risk Stratification Tool for Management of Blunt Chest Trauma Patients

The aim of this study is to assess validity of the STUMBL score in EGYPT for complications of blunt chest trauma without multi-trauma and immediate life-threatening injuries and identify patients at risk of in- hospital mortality or ICU admission and predict survival in both Assiut \& Suez Canal University Hospitals.

The STUMBL Score (STUdy of the Management of BLunt chest wall trauma) (also referred to as the Battle score) is a clinical prediction model that was developed and externally validated in 2014 in the UK . The purpose of the model is to assist in the clinical decision-making of patients with blunt chest wall trauma (excluding those with life-threatening injuries) in the Emergency Department (ED), through the calculation of a percentage risk of complications which in turn, provides a recommended discharge disposition. The STUMBL score includes five predictors: age at attendance, number of rib fractures, chronic lung disease, use of pre-injury anticoagulants and oxygen saturation (SpO2). This is the first score to introduce clinical variables, specifically chronic lung disease and anticoagulation, in contrast to other scores which have used anatomical variables and age alone. A huge benefit of the STUMBL score is that these variables are all routinely measured in the ED. Whilst other scores exist, the STUMBL Score is the only externally validated model with excellent predictive capabilities, that can be used for adult patients of all ages with blunt chest trauma presenting to the ED, not just a specific age group or severity of injury.

Collected data will be analyzed and tabulated by using appropriate statistical methods.

Statistical analysis will be performed by the SPSS statistical software computer program version 20 (Statistical Package for Social Science), Medcalc v.11.6.and Open Epi V.3.01.

Data will be described using mean ± standard deviation (SD) and frequencies according if they are quantitative or qualitative respectively.

Parametric tests will be used in the current study if data proved to be normally distributed.

For all statistical tests, a P value less than 0.05 will be taken to indicate a significant difference.

Eligibility Criteria:
Inclusion Criteria:

* The present study will be conducted on patients of blunt chest trauma of both genders "without intently selected certain gender" and had 18 years old or more.

Exclusion Criteria:

* patients \<18 years of age
* patients with life threatening conditions
Grass Sensitisation and Allergic Rhinitis in Thai Patients

Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of grass or weed are different in various part of the world. The allergens from grass and weed has never been studied in Thailand. This study will find the major allergen from Bermuda grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In addition, the investigators will study about the cross-reactivity among these group of allergen.

To find the major allergen of grass and weed, the serum of patients will be used to bind with the allergen extract by immunoblot study.

The ELISA-inhibition will be used to study about cross-reactivity among various kinds of grass and weed.

Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis patients age 10-50 years old
* Control: healthy volunteer age 18-50 years old

Exclusion Criteria:

* Chronic illness such as cardiovascular diseases, liver diseases
* History of anaphylaxis
* Pregnancy