cyrilzakka/clinical-trials huggingface dataset:
Gaming Open Library for Intervention in Autism at Home (GOLIAH /MICHELANGELO)

To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH). The major objective of the study is to test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the usefulness and acceptability of the gaming platform; (2) how experimental children performed using the different Imitation and JA games; and (3) whether children from the experimental group improved significantly more than children treated as usual (control group).

Background: To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH) by mapping the Imitation and Joint Attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. For the purpose of this study, 24 ASD children will be recruited (one half in Pisa and the other half in Paris). They will be divided into two groups: an Experimental group (N=14) and a Control group (N=10). The Control group will not go through the training sessions, they will participate only in the assessment sessions. All patients will be referred to treatment as usual, according to local facilities.

The protocol is organized into 3 periods (with two assessments at T0 and T6).

* During the initial stage of the protocol (T0), all the ASD children (experimental participants and controls) will be evaluated during a clinical session.
* During the rehabilitation period, only half of the children will participate in the training sessions designed to improve their imitation and joint attention capacities.
* During the final stage of the protocol (T6), all children will be evaluated again during a second clinical session.

The clinical assessments will occur at stage 0 and at stage 6. The same tools will be used for these two assessments. The improvement of children's capabilities will be measured by the progress made between stage 0 and stage 6. The investigators will be able to affirm that the training was beneficial by comparing the clinical session performance between the trained and control children.

Eligibility Criteria:
Inclusion Criteria:

* a current diagnosis of ASD confirmed by clinical assessment and the Autism Diagnostic Interview-Revised;
* an intellectual quotient ≥ 60;
* aged between 5 to 8 years.
* Inclusion in the experimental group was based on parents' motivation to follow such a heavy protocol both at home and for the one session per week at the hospital.
* Controls were matched for sex, age, IQ, study sites and treatment.

Exclusion Criteria:

* known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.
Chlorhexidine Mouthrinses and Plaque Control

The aim of the present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F).

Chlorhexidine (CLX) mouthrinse has been the gold standard as antiplaque solution.However, if its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%, the formulation of the final product may affect the effectiveness. Thus, it can be concluded from this study that 0.12% CLX alcohol base mouthrinse is significantly more effective in inhibiting plaque than the diluted 0.1% CLX non-alcohol base containing formaldehyde mouthrinse.

Eligibility Criteria:
Inclusion Criteria:

* give written informed consent before entering the study
* accept to stop tooth cleaning for a week

Exclusion Criteria:

* less than 20 teeth;
* presence of periodontal disease
* presence of factors of plaque retention (clinically unacceptable restorations, important carious, dental overlapping, removable prosthesis, faulty fixed prosthesis, orthodontic appliances),
* associated systemic diseases (diabetes, heart disorders, blood diseases, HIV infection),
* use of antibiotics or other anti-inflammatory drugs during the latest months,
* known allergy against components of mouth rinses,
* pregnancy,
* smoking
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis

The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.


Eligibility Criteria:
Postmenopausal women who have attended the 20030216 (NCT00089791) study month 36 visit will be eligible to participate if they meet the inclusion and exclusion criteria given below.

Inclusion Criteria

* Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg subcutaneous injection every 6 months
* Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit
* Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.

Exclusion Criteria

* Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted)
* Missed 2 or more investigational product doses during the 20030216 study
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
* Developed sensitivity to mammalian cell derived drug products during the 20030216 study
* Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
* Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
* Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium, or tibolone
* For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
Cognitive Behavioral vs. Interpersonal Therapy (IPT) Prevention of Depression in Adolescents

The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an interpersonal therapy program for preventing depressive symptoms in adolescents.

Hypothesis -- The cognitive-behavioral and interpersonal therapy prevention programs will be significantly better than the no-intervention control group in preventing depressive symptoms measured at post-intervention and at the 6-month follow-up. Gender differences also will be explored.

Eligibility Criteria:
Inclusion Criteria:

* All students in 9th grade Wellness classes who have parental consent

Exclusion Criteria:

* Students without parental consent
Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH

This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates.

Epidermal growth factor receptor (EGFR) signaling is critical for cancer cell proliferation, invasion, metastasis, and resistance to apoptosis.EGFR is overexpressed in many epithelial malignancies and therefore makes an attractive therapeutic target.This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates. Secondary endpoints include progress-free survival, overall survival, safety and so on.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologic or cytologic diagnosis of carcinoma of the gastroesophageal junction or esophagus;
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
* Overexpression of EGFR defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation;
* Have progressed after one chemotherapy regimen;
* Age 18-75 years old with performance status of 0 to 2

Exclusion Criteria:

* Prior targeted therapy with erlotinib, gefitinib, and so on
* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Aortic Calcification and Central Blood Pressure in Patients With Chronic Kidney Disease

Aim and background:

This study will seek to identify physiological and biochemical factors explaining and predicting a higher than expected central (aortic) blood pressure (BP) in patients with chronic kidney disease (CKD). The basic hypothesis of the study is that the degree of aortic calcification is an important component of elevated central BP, which, in turn, is important for the organ-damage and increased risk of cardiovascular disease associated with CKD.

Methods:

Adult patients with varying degrees of CKD undergoing scheduled coronary angiography (CAG) at Aarhus University Hospital will be included in this study.

During the CAG procedure, systolic and diastolic BP is determined in the ascending part of aorta by a calibrated pressure transducer connected to the fluid-filled CAG catheter.

Simultaneous with the registration of invasive aortic BP, estimation of central BP is performed using radial artery tonometry (SphygmoCor®), while a corresponding brachial BP is also measured.

Prior to the CAG, a non-contrast CT scan of aorta in its entirety will be performed to enable blinded quantification of calcification in the wall of aorta and coronary arteries.

Furthermore, echocardiography, resting BP measurement and a range of blood- and urine samples will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patient referred for planned CAG at the Department of Cardiology, Aarhus University Hospital (AUH)
* eGFR constantly either \>60 ml/min or \<60 ml/min in at least 2 separate blood-sample measurements over at least 3 months.
* Signed informed consent-form.

Exclusion Criteria:

* Antihypertensive treatment changed within the last two weeks prior to the CAG.
* Severe aortic valve stenosis (\<1 cm) as central hemodynamics may be altered
* Maximum number of patients in CKD-group already reached.
* Atrial fibrillation or other cardiac arrhythmia making radial Pulse Wave Analysis (PWA) estimations impossible.
* Known significant stenosis of a. subclavia or a. brachialis
* Bilateral arteriovenous-fistula (even if one or both of these have been surgically removed) as this may significantly affect the pulse-wave form.
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.

Primary Performance:

* The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion\* to an alternate approach comprises conversion to open, multiport laparoscopic\*\*, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.

  * Performing an extracorporeal anastomosis is not considered a conversion \*\* Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance

Primary Safety:

• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* BMI ≤ 35
* Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures
* ASA ≤ 3
* Willing and able to provide a written informed consent document
* Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years

Exclusion Criteria:

* Clinical or radiological evidence of metastatic disease
* Life expectancy less than 6 months
* Cancer of the anal canal requiring an abdominoperineal resection
* Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY)
* Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case
* Subjects undergoing both LAR/TME and right colectomy during the same operation
* Preoperative colonoscopy demonstrating synchronous colorectal cancer
* History of inflammatory bowel disease
* Subject has a known bleeding or clotting disorder
* Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Subject is contraindicated for general anesthesia or surgery
* Subject had prior incisional hernia with mesh repair
* Subject belongs to vulnerable population
* Subject is pregnant or suspected to be pregnant

Intraoperative Exclusion Criteria:

• Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure
Analgesic Additives to Epidural Bupivacaine in Normal Labor

The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.

Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased .

Recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. The ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction .

Epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia .

Studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics.

Dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .

It has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension .

Nalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of Mu-antagonist and Kappa-agonist activities. Nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses .

The analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. It has the potential to provide effective postoperative analgesia with no risk of respiratory depression .

Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years of age
* American Society of Anesthesiologists (ASA) Physical Status 2 or 3
* Full term pregnancy (\>37 gestational weeks)
* Planning vaginal delivery
* Planning epidural labor analgesia
* Vertex presentation

Exclusion Criteria:

* Patient refusal to epidural analgesia,
* Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity)
* Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine)
* hemodynamic instability, severe aortic or mitral stenosis)
* Severe pre-eclampsia,
* Breech presentations
* Antepartum hemorrhage
* Cephalopelvic disproportion
* Body mass index ≥40 kg/m2.
* Uncontrolled systemic comorbidities \[i.e., diabetes, hepatic, renal or cardiac\]
* Known or suspected fetal abnormalities
* Inability to communicate or participate in study procedures
Semirecumbent Position by Mechanical Ventilation

It's based in an observational trial in mechanical ventilated patients. The investigators assess the head of bed elevation angle in the routine treatment of the unit. The investigators decide to assess the time the patient has a semirecumbent position \>35°.

A Semirecumbent-bed position in mechanical ventilated patients is recommended in every international guidelines in order to avoiding Ventilator Associated Pneumonia (VAP). Despite being a simple and cheap measure, the literature describe a low compliance. Globally, every intensive care unit tends to use different maneuvers that help or improve compliance of this recommendation. However, there are multiple factors in daily work that hinder compliance. Before taking actions, it would be convenient to know the current state of the unit.

Investigators aim to evaluate the quality with which the recommendation is carried out in the unit in order to maintain a semirecumbent position. To conduct the Trial it will be used a device that measures continuously (every 5 minutes) the angle of the bed without giving any information to caregivers. Once patients are extubated the data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Every ventilated patients

Exclusion Criteria:

* Patients excluded are those lower that 18 years old or neurocritical patients that require flat position.
Kidney Function in Patients With Bladder Exstrophy

Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic

Exclusion Criteria:

* No
Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin

In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs) focusing specifically on this population. Evidence suggests that in obese participants, both higher dosing and duration of VTE prophylaxis with Low Molecular Weight Heparins (LMWH) may be required to achieve a therapeutic effect similar to non-obese participants.

This non-interventional study utilizes data already collected from a usual clinical practice setting in the Optum US clinical database, representing obese participants hospitalized with an acute medical condition or undergoing surgery receiving enoxaparin prophylaxis. Its aim is to compare the impact of the following enoxaparin prophylaxis strategies on the incidence of symptomatic VTE and major bleeding in the overall study population and prespecified subgroups:

* High versus conventional dose
* Extended versus conventional duration
* Combined High-Dose and Extended-Duration versus Conventional-Dose and Conventional-Duration.

The first date of enoxaparin prophylaxis will be the index date.

The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Medical Patients: Hospitalization due to:

  * Heart failure
  * Ischemic stroke
  * Respiratory insufficiency
  * Infection
  * Inflammatory diseases
  * Active cancer
* Surgical Patents: Following surgery types:

  * Orthopedic
  * Thoracic
  * Abdominal/Pelvic
* Other inclusion criteria:

  * Initiation of enoxaparin prophylaxis (index date)
  * Age ≥ 40 years
  * Body Mass Index (BMI) ≥ 30

Exclusion Criteria:

* VTE or bleeding event during or 3 months prior to index date
* Surgery within 3 months prior to and up to two days following index date
* Atrial fibrillation
* Antiplatelet or anticoagulation therapy within \[-32, -2\] days before index date
* Chronic Kidney Disease (CKD) stages IV and V, or dialysis
* Pregnancy

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Music and Feeding in NICU

The purpose of this study is to investigate the effect of classical music exposure on improved time to regain birth weight and improved feeding readiness in healthy premature infants in the NICU.


Eligibility Criteria:
Inclusion Criteria:

* • Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days

  * Parents ≥18 years of age
  * English speaking parents
  * Breastmilk as intended primary form of nutrition

Exclusion Criteria:

* Congenital anomalies affecting hearing or feeding skills
* Patients requiring HFOV or HFJV