cyrilzakka/clinical-trials huggingface dataset:
The Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement

Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.

We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for unilateral total knee replacement
* Consent to spinal anaesthesia
* ASA Grade I to III

Exclusion Criteria:

* Patient refusal
* Mini-Mental Score \< 25 (see appendix 3)
* Allergy to bupivacaine, morphine, paracetamol, diclofenac
* Skin lesions/infection at site of injection
* Uncorrected renal dysfunction
* Coagulation disorders
* chronic pain condition other than knee pain
The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients

Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.

Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.

The main question it aims to answer is:

• Does the use of multimedia during the preoperative consent process affect the anxiety level of parents of patients undergoing orchiopexy surgery?

Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.

Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.

The patient's age, gender, known diseases, previous hospital admissions, and whether they have undergone surgery before will be recorded. The primary caregiver's age, gender, known diseases, educational status, occupation, number of children, and any additional illnesses in other children will be noted.

Patients will be randomized into 2 groups with the help of (https://www.randomizer.org/ ). The first group will be informed of the Standard Consent Form and Verbal Information during the preoperative process. In contrast, the second group will be informed of the Standard Consent Form, Verbal Information, and Multimedia. Both groups will fill out the Hospital Anxiety and Depression Scale(HADS), BECK Anxiety Inventory(BAI), and The State-Trait Anxiety Inventory (STAI) Form Tx 1-2 forms one day before the surgery and on the 7th day after the surgery to determine their anxiety levels.

Eligibility Criteria:
Inclusion Criteria:

* parents of orchiopexy patients

Exclusion Criteria:

* history of previous orchiopexy surgery
* orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection

Purposes of this study will be as follows:

1. To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
2. To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:

I. To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.

II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.

The urinary tract infection (UTI) is a common etiology of the febrile children and the acute pyelonephritis (APN) happen in 70% children with the first febrile UTI. After the first APN, the irreversible renal scarring takes place in about 40% patients. The sequela of the renal scarring includes chronic kidney disease, hypertension, the complication during the pregnancy, and even the end stage of renal diseases. Due to the progression of the pathophysiology of the pyelonephritis and the renal scarring in the past years, we understand that the inflammation is one of the important mechanisms. Therefore, there are many animal studies clarifying the role of the anti-inflammation or antioxidant to reduce the renal scarring. In our previous studies, Dr. Chiou Y.Y. and colleagues has provided the evidence that the adjunctive methylprednisolone (MPD) can decrease the risk of the renal scarring for patients with high risk APN, which was defined as inflammatory volume more than 4.6 mL on technetium-99m-labeled dimercaptosuccinic acid scan or abnormal renal ultrasonography results. Our study is the first human study demonstrating the solution for the renal scarring. However, whether this result can be applied to the whole spectrum of the UTI is still unknown. Purposes of this study will be as follows:

1. To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
2. To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:

I. To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.

II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.

According to these studies, we will provide a new and effective guideline to shorten disease course, save medical expenses, and decrease the risk for renal scarring sequela.

Eligibility Criteria:
Inclusion Criteria:

* 1week old \~ 16 years old children with UTI

Exclusion Criteria:

* Previous UTI
* Known GU tract obstruction
* Severe sepsis with vital signs change
* Antibiotics used
Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism

Currently there is no clear guidance for the treatment of moderate risk of pulmonary embolism. The aim of the study is to compare two different therapeutic modalities - standard anticoagulation versus thrombolytic treatment followed by anticoagulation in standard regimen as stated in the pulmonary embolism guidelines.

Standard treatment of moderate risk pulmonary embolism constitutes of sole anticoagulation therapy. In case of troponin positivity and/or echocardiographic findings as i.e. thrombi in RV thrombolytic therapy should be considered. The aim of this trial is to compare the two treatment modalities in their ability to reduce/predict 12 month end-point: pulmonary hypertension, right ventricular failure, exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* moderate risk pulmonary embolism as defined by the European Society of Cardiology /ESC/ guidelines
* signed informed consent

Exclusion Criteria:

* patient not willing to sigh informed consent
* absolute contraindication of thrombolysis
* inability to obtain meaningfull echocardiographic images¨
* pulmonary arterial hypertension
* known right ventricular failure
Haemodynamic Response to General Anaesthesia in Healthy Orthopaedic Patients

Continuous cardiovascular monitoring as part of management of high-risk surgical patients is widely practiced, however its role in low-risk surgical patients is unclear. Detailed monitoring of cardiovascular parameters from pre-induction stage allows clinicians to individualise anaesthetic management in the perioperative period. The investigators' aim was to investigate haemodynamic and Bispectral Index (BIS) changes in healthy patients undergoing surgery following induction of anaesthesia with propofol using a continuous non-invasive blood pressure device (LiDCOrapid™).

Recruitment Orthopaedic surgical teams, anaesthetists and theatre staff were made aware of the study that was being conducted at the investigators' institution. Prospective subjects that met the inclusion criteria were identified from the hospital operating theatre's database two weeks prior to surgery. A letter, which contained the study's objectives and methods, was sent out to all patients. Subsequently, a telephone call was made to patients one week before surgery to clarify any queries they had. Consent was obtained on the morning of surgery. All study participants provided written informed consent.

Peri-operative monitoring LiDCO™ CNAP and BIS monitoring were attached prior to induction of anaesthesia in the anaesthetic room of the operating theatre. A standardised anaesthetic technique was used for every participant, consisting of propofol induction, sevoflurane maintenance to a target BIS (40-60) and opioid analgesia with fentanyl. Participants underwent positive pressure ventilation to a tidal volume of 8ml/kg.

Measurements of the following variables were taken continuously from pre-induction to time of extubation: heart rate, mean arterial blood pressure, stroke volume, cardiac output, systemic vascular resistance and BIS. Data recorded up to 3 minutes following propofol injection was analysed to capture the post-induction period. Further measurements were taken in recovery room. The total quantity and type of fluids, drugs administered, time of tourniquet application and removal (if performed), and the duration of the operation were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the study were those aged 18-45 years undergoing elective lower limb arthroscopic procedures with an American Society of Anesthesiologists (ASA) Grade of I-II.

Exclusion Criteria:

* Patients unable or unwilling to provide valid informed consent,
* Patients undergoing regional anaesthesia,
* Patients that have contraindications to the LiDCO rapid™ CNAP monitoring (cardiac arrhythmias, aortic regurgitation and digital ischaemia) and BIS monitoring (hypersensitivity to adhesive use) and refusal of surgical, anaesthetic or operating theatre team.
Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

To see if using teriparatide for 12 months will increase Bone Mineral Density at the lumbar spine in postmenopausal women with osteoporosis


Eligibility Criteria:
Inclusion Criteria:

* Are postmenopausal women at least 55 years old and at least 2 years postmenopausal at the time of entry into the trial, and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study. In addition, women below the age of 60 years with indeterminate menopause due to premenopausal hysterectomy must have their postmenopausal status confirmed with a serum FSH level \> 30 IU/L.
* Posterior-anterior lumbar spine (L1-L4) BMD and/or femoral neck BMD measurement at least \< 2.5 standard deviation (SD) from the mean of healthy, pre-menopausal women.
* Results of lumbar BMD (L1-L4) measurement must be available. The initial lumbar spine assessment and the determination of the patient's eligibility for entry into the screening phase will be made by the individual investigator. If the L-1 vertebra cannot be analyzed due to artifact, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis.
* Normal or clinically insignificant abnormal laboratory values (as defined by the investigator) including serum calcium, 25 hydroxyvitamin D levels and alkaline phosphatase.
* Willing to be trained on and use a pen type injection delivery system on a daily basis for 12 months.

Exclusion Criteria:

* Active liver disease - liver enzymes (ALT, AST) more than three times the upper normal range, or a bilirubin of \> 2.0 mg/dl, or clinical jaundice.
* Abnormal thyroid function not corrected by therapy. Normal thyroid function will be documented by a normal TSH during screening phase
* History of active nephrolithiasis or urolithiasis in the prior 2 years. Patients with any documented history of nephro- or urolithiasis must have had an appropriate imaging procedure within the prior 6 months, such as, an intravenous pyelography (IVP), supine radiograph of the kidney ureter bladder (KUB), or renal ultrasound, which must document the absence of stones
* History of malignant neoplasms within the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease.
* Current pharmacological treatment for osteoporosis, other than calcium and Vitamin D
* History of Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption
Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment

Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus also receiving metformin.

Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of AVE2268.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening.
* HbA1c measured at visit 1 in the range of ≥ 7.0 and \< 9.0 %.
* Stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). No other antidiabetic medications are permitted for 3 months prior to enrollment.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Women of childbearing potential not protected by medically approved contraceptive method of birth control.
* BMI \>40kg/m2
* Diabetes other than type 2 diabetes.
* Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
* Presence or history of cancer within the past five years.
* Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
* Impaired hepatic tests, impaired renal function.
* History or evidence of clinically relevant renal or urological disorder.
* The investigator will evaluate whether there are other reasons why a patient may not participate.
Discrete Versus Rhythmic Gait Training

The objective of this study is to compare the effects of novel versus standard locomotor training using a robotic gait orthosis (LT-RGO) after stroke. The hypothesis is that the novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance force, may facilitate greater motor recovery compared to the use of a standard protocol.

Standard (rhythmic) robot-assisted locomotor training on a bodyweight-supported treadmill (LT-BWST) used progressively increased speed each week. Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. The novel approach of slowing down the treadmill reduced momentum. If speed had been increased (standard approach), momentum would have increased (momentum = mass \* velocity); and the resulting, passive propulsion of momentum would have diminished the role of cortical skills needed to plan, initiate, and overtly control gait. In sum, the novel protocol used a slower-than-standard treadmill speed in order to provide a window of time sufficient for the corticomotor system to process information, learn, and adjust its response to internal and external feedback (eg, proprioceptive input; therapist input) during robot-assisted LT-BWST.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke and image with hemiparesis left or right;
* No more that one ischemic or hemorrhagic stroke episode;
* 06 months post-stroke;
* Verified clinical stability on medical evaluation;
* Spasticity level I or II in the Ashworth scale;
* Score 1-2 in the Functional Ambulation Scale (FAC);
* Signed informed consent.

Exclusion Criteria:

* Dependence to perform activities of daily living before the stroke;
* Lack of clinical indications for exercises (such as cardiopulmonary instability and uncontrolled diabetes);
* Severe cognitive impairment;
* Serious psychiatric change that needs psychiatric care;
* Severe osteoporosis;
* Severe spasticity of the lower limbs, deformities or fixed contractures that prevent the achievement of movements;
* Lack of resistance or disabling fatigue;
* Body weight greater than 150 kg;
* Unstable angina or other untreated heart disease;
* Chronic obstructive pulmonary disease;
* Unconsolidated fractures, pressure sores;
* Other neurological diseases.
The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System

The objective of this study is to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA).

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone implantation of the iliac bifurcation stent graft system;
* Patients with complete medical records

Exclusion Criteria:

* Patients with ruptured aortic aneurysm;
* Patients with infected or mycotic aortic aneurysm;
* Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease
Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds

The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.

The study includes an extended follow up to 24 months.


Eligibility Criteria:
Inclusion Criteria:

* interested on soft tissue augmentation for the nasolabial folds
* moderate to severe nasolabial fold

Exclusion Criteria:

* sensitivity to anesthetics
* allergy to hyaluronic acid
* previous treatment with permanent fillers in the treated area
* recent previous aesthetic procedure in the treatment area
* infected skin areas or autoimmune diseases affecting the skin
EF Intervention in Children With Severe Congenital Heart Disease

Survival rates of children with severe congenital heart disease (CHD) have increased with ongoing medical progress over the past decades. However, many children with CHD face academic challenges during adolescence, which are associated with executive dysfunction. Executive functions (EF), higher-order cognitive processes allowing goal-directed behavior, can be particularly affected in children with CHD. To improve EF in affected children, a specific EF intervention has been developed.

The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary. This intervention is tested on its feasibility. As the intervention was built in a patient centered manner, we expect it to be feasible, showing in a high adherence rate and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Born with CHD
* Underwent cardiopulmonary bypass surgery
* No genetic syndrome detected, no known dysmorphic-syndrome
* Aged 10 to 12
* written informed consent of parents and verbal informed consent of children
* EF deficits showing in screening

Exclusion Criteria:

* Failure to provide a signed Informed Consent
* Heart surgery without cardiopulmonary bypass
* Heart surgery not performed in Switzerland
* Any genetic syndrome detected
* large cerebral lesions (stroke, HIE) or severely neurologically impaired as a result of a serious event
Longitudinal Study of Neurogenetic Disorders

The purpose of this study is to analyze patterns in individuals with hnRNP (and other) genetic variants, including their neurological comorbidities, other medical problems and any treatment. The investigators will maintain an ongoing database of medical data that is otherwise being collected for routine medical care. The investigators will also collect data prospectively in the form of questionnaires, neuropsychological assessments, motor assessments, and electroencephalography to examine the landscape of deleterious variants in these genes.

Neurodevelopmental disorders are a group of disorders in which the development of the central nervous system is disturbed. The genetic basis for many neurodevelopmental disorders has continued to expand and a recent gene called HNRNPH2 (Heterogeneous Nuclear Ribonucleoprotein H2, encoded by HNRNPH2) is one such gene that is associated with a common neurodevelopmental disorder characterized by developmental delay, intellectual disability, autism and autistic features, and tone abnormalities, among other multisystem problems.

The investigators will expand the genetic cohort to include any individual with a confirmed variant in any gene presenting with neurodevelopmental abnormalities. This is non-interventional study that examines both data previously used in clinical practice and prospective data collection in the form of questionnaires and assessments. The investigators will examine patterns of initial presentation, patterns in neurological evaluations; neurological testing including brain MRI and electroencephalography, and outcomes in individuals with genetic variants.

Genes of Focus:

hnRNPA1 hnRNPA2 hnRNPB1 hnRNPB2 hnRNPC2 hnRNPD hnRNPE1 hnRNPE2 hnRNPE3 hnRNPE4 hnRNPG hnRNPH1 hnRNP H2 hnRNPI hnRNPK hnRNPL hnRNPM hnRNPP hnRNPQ1 hnRNPQ2 hnRNPQ3 hnRNPR hnRNPU

Eligibility Criteria:
Inclusion Criteria:

* Individuals must have had whole genome/exome sequencing and have a confirmed variant in any gene.

Exclusion Criteria:

* Subjects who cannot provide genetic confirmation of a predicted deleterious variant in any gene.