cyrilzakka/clinical-trials huggingface dataset:
Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

This study investigates the efficacy of a single-dose of exogenous oxytocin administration on socially adaptive mirror-motor mapping in participants with Autism Spectrum Disorders. A placebo-controlled cross-over trial will be conducted: each participant will receive both a single-dose of placebo and oxytocin in two sessions separated by one week. The order of nasal spray will be randomised across participants. Mirror-motor mapping will be assessed by transcranial magnetic stimulation (TMS), a standard technique to investigate mirror system activity.

The brain's action observation network or 'mirror system' supports a variety of socio-cognitive functions, as it enables us to internally simulate and understand others' actions, emotions and intentions. Generally, mirror responses are larger upon the observation of actions accompanied by relevant information for the observer, such as direct eye contact from the actor. In other words, 'mirroring' is adaptively modulated according to the social salience of the observed actions (i.e. it is socially adaptive).

Individuals with Autism Spectrum Disorders (ASD) are known to endure difficulties with correctly recognizing eye contact as a communicative cue. Instead, they tend to experience eye contact as stressful and arousing. It is therefore hypothesized that, upon the observation of actions combined with salient gaze cues from the actor, these mirroring processes will not be adaptively modulated in participants with ASD.

As appropriate processing of eye contact is a key aspect of (non-verbal) communicative behavior, the investigator will investigate the efficacy of a single dose of intranasal oxytocin administration for enhancing socially-adaptive mirroring in ASD. Oxytocin is a neuropeptide that acts as a regulator social brain areas. On a behavioral level, it is known to enhance the saliency of observed social cues and to improve prosocial behavior. As such, it is regarded a promising intervention for alleviating the social and communicative deficits in ASD.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Young adults (between 18 - 35 y/o)
* Right-handed
* Official diagnosis of Autism Spectrum Disorders (for ASD participants)

Exclusion Criteria:

* Female
* Left-handed
* Any neuro(psycho)logical / psychiatric illness (for healthy controls)
* Motor dysfunctions of the hands / arms
* Any contradiction to TMS research as assessed with the TMS screening list: no metal objects in the body (e.g. pacemaker, coronary bypass clips, implants, medication pumps, ...), history of brain trauma in the past (e.g. meningitis, epilepsy, surgery, ...) or history of drug and/or alcohol abuse.
Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy

To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying.

Intraoperative bleeding remains a major concern during liver resection. Blood loss usually occurs during parenchymal transection and reperfusion after Pringle's maneuver. The amount of blood loss and the need for blood transfusion have a detrimental effect on the short- and long-term prognosis.

Portal triad clamping is sufficient in most situations to control bleeding during hepatectomy. However, it does not prevent backflow bleeding from hepatic veins, which may become troublesome or even hazardous. This is particularly true in tumors that are large or that have invaded into the branches of the major hepatic veins.

SHVE completely isolates the liver from the systemic circulation with the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.

The purpose of the study is to assess the risk factors for the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE and to evaluate that SHVE can improve survival in HCC patients or not.

Eligibility Criteria:
Inclusion Criteria:

* Corresponding to diagnostic standards of HCC.
* Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins.
* liver function in the Child-Pugh classification A or B.
* Age between 18\~70 years.
* Haven't taken any current treatment.
* Understanding and being willing to sigh the informed consent form.

Exclusion Criteria:

* cannot be follow-up
* severe liver, renal, or brain dysfunction
* with tumor thrombi in the main trunk of portal vein
* with tumor thrombi in the hepatic vein
* with extrahepatic metastasis
Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine

This study is aimed at evaluating single short spinal technique as a form of labour analgesia in a setting where more expensive and labor intensive techniques are not feasible.The study will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine) through a randomized control trial.

The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients experiencing normal labour.


Eligibility Criteria:
Inclusion Criteria:

* Parturients with singleton pregnancy
* Emancipated minors

Exclusion Criteria:

* Those who declined.
* Parturients with any identified complication of labour like preeclampsia, severe cardiac disease or previous operative delivery.
* Sepsis or wound at site of spinal injection.
* Allergy to any of the study drugs elicited from history.
To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125

This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a man or woman, 18 to 55 years of age, inclusive
* The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive
* The subjects must be in a good health at screening and check-in

Additional inclusion criteria for Japanese subjects:

* Subject must be a non-naturalized Japanese citizen and hold a Japanese passport
* Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens
* Subject has been living outside of Japan for no more than 10 years

Additional inclusion criteria for Caucasian subjects:

* The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The subject is a woman who is pregnant or lactating
* The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)
* The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment
* Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing

  * Additional criteria apply, please contact the investigator for more information
A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass

The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-\[ADP ribose\] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines.

Heart-lung bypass during heart surgery sometimes leads to side effects or complications after surgery.

Studies have shown that PARP inhibitors protect cells from damage due to lack of oxygen. Heart-lung bypass during heart surgery can result in cells being deprived of oxygen. INO-1001 may be able to protect these cells and reduce complications following surgery.

A total of 162 patients will be randomly assigned to either INO-1001 or placebo (sugar water). Treatment will begin on the day of heart surgery and continue for 36 hours. A total of 4 doses of INO-1001 will be given. Patients will be followed up until 30 days after surgery.

The following information will be collected: symptoms, vital signs, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.

The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
* Males and non-pregnant, non-lactating females

Exclusion Criteria:

* Subjects will be required to undergo a full medical review in order to exclude serious medical or psychological illness prior to inclusion
* History of a hypersensitivity reaction to more than three drugs or to mannitol
* Participation in any other investigational study within 30 days of the screening phase
* Known alcohol or drug abuse within the last year
* Treatment with certain restricted medications within a specified time prior to participation in the study
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 6 months to \< 12 years.
* Have clinical signs/symptoms of acute otitis media in at least one ear.
* Parent(s)/legal guardian(s) provide written informed consent.

Exclusion Criteria:

* Clinical significant other disease.
* Recent use of investigational drugs, prescription or nonprescription drugs.
Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants

To investigate the incidence, clinical characteristics and prognosis of acute ischemic and hemorrhagic cerebrovascular disease secondary to the implantation of cardiovascular implantable electronic devices, so as to provide a basis for subsequent treatment strategies and risk factor stratification.

This study intends to retrospectively collect the incidence and case characteristics of acute cerebral infarction, cerebral embolism, transient ischemic attack and cerebral hemorrhage in CIED patients admitted to the First Affiliated Hospital of Xi 'an Jiaotong University and other centers from January 2012 to September 2022. Then, the incidence of poor prognosis and related factors of patients within 3 months were followed up by telephone to provide a basis for subsequent treatment strategy and risk factor stratification.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute cerebrovascular disease secondary to cardiac electronic device implantation.
* Hospitalized from January 2012 to September 2022.

Exclusion Criteria:

* Patients were absent of cranial CT/MRI scan data.
* Patients refuse to take follow-up interviews.
Clinical Assessment of a HYDRAGLYDE® Regimen

The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.


Eligibility Criteria:
Inclusion Criteria:

* Must sign informed consent document;
* Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;
* Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add \<+0.50 D in each eye;
* Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;
* Current user of an MPS (excluding OFPM) to care for lenses;
* Willing to answer text messages on a daily basis during the study;
* Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;
* Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;
* Other protocol specific inclusion criteria may apply.

Exclusion Criteria:

* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Prior refractive surgery;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Known pregnancy or lactating;
* Other protocol specific exclusion criteria may apply.
Precision Medicine in Ischemic Stroke and Atrial Fibrillation

The overall goal of this study is to minimize morbidity due to Atrial Fibrillation (AF). The specific objective is to develop and implement a rational and personalized approach to AF risk estimation that can inform management decisions with ischemic stroke. The investigators propose to develop a clinical AF risk estimation tool in the electronic health record and to test the effectiveness of implementing a clinical AF risk estimation tool into care for use by stroke neurologists during the care of acute ischemic stroke patients at Massachusetts General Hospital. The investigators will evaluate cardiac monitoring utilization calibrated to AF risk by stroke neurologists using a custom electronic health record (EHR) notification module.

The investigators hypothesize that cardiac rhythm monitoring utilization will be positively correlated with the predicted risk of AF.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Presenting with a primary diagnosis of ischemic stroke or transient ischemic attack admitted to Massachusetts General Hospital inpatient stroke service

Exclusion Criteria:

* Patients not meeting above inclusion criteria
Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of MDS
* Adequate liver and kidney function
* Ineligible for, or refusing, allogeneic bone marrow transplant
* At least 18 years of age
* Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry

Exclusion Criteria:

* Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
* Pregnant or lactating women
* History of allergy to eggs
* Other investigational drugs within 14 days of study entry
* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
* Concomitant steroids or hormones for the treatment of neoplasms
Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer

* A prospective, observational study on clinical outcomes of surgical management of primary and metastatic colorectal cancer
* Prospective collection of tissues to explore potential biomarkers in blood and/or primary or secondary cancers and/or normal colon

Prospective project in collecting and assessing clinical outcomes data related to molecular profiling of tumors based on cancer primary or metastatic tissue or tissue from peripheral blood samples. As a future part of the project will be collected patient reported outcomes (PROs) for assessing clinical outcomes in relation to clinical pathways, patient reported results, as well as tumor profiling by molecular methods.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of colorectal cancer, primary or metastatic (liver), with a treatment intention of planned curative surgery
* Informed consent to participate
* Age ≥18

Exclusion Criteria:

* failure to provide written informed consent
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation

The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely demonstrated. The success of this procedure requires that the patient is awake and cooperative. The conditions of this intervention can be difficult to tolerate by the patient for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly the head in the stereotactic frame), stress related to the localization of the DBS. It is therefore important to improve the comfort as well as the cooperation of the patient, during implantation of the DBS electrodes, in order to optimize the conditions of the intervention. In addition to analgesia, acupuncture should allow sedation without affecting alertness and should contribute to the regulation of any vegetative reactions during the procedure. Therefore, we hypothesize that acupuncture could improve the quality of care of the patient during a DBS procedure. In practice, this is electroacupuncture that will be used in this research to maintain the stimulation of acupuncture points to an optimal level during the time of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients from both sexes aged who are \>= 18 years
* Disabling movement disorders, resistant to medical treatment, in Parkinson's patients who should benefit from a Deep Brain Stimulation in the subthalamic nucleus
* Scheduled intervention of a Deep Brain Stimulation
* Understanding of acupunctural analgesia with electrostimulation
* Signed informed consent
* Membership to a social security insurance scheme

Exclusion Criteria:

* Patients who are \>= 75 years
* History of intolerance to acupuncture
* Contraindications to local anesthesia
* Respiratory problems (asthma, COPD, ...)
* Holder of an implanted pacemaker
* Obesity with BMI \> 30
* History of motion sickness
* Unstabilized psychiatric disorders
* Impaired cognitive functions
* Pregnancy
* Breastfeeding
* Minors
* Major under a legal protection regime
Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)

A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)

This is a prospective observational study conducted to (1) characterize the patients who receive DUPIXENT® for AD in a real world setting with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD; (2) characterize real world use patterns of DUPIXENT® for AD (eg, most commonly used regimens by line of therapy, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching); (3) assess the long-term effectiveness of DUPIXENT® in AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in patients who receive DUPIXENT® for AD; and (5) collect safety data on study participants

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
* Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
* Willing and able to comply with study-related activities.
* Able to understand and complete study-related questionnaires.
* Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.

Key Exclusion Criteria:

* Patients who have a contraindication to the drug according to the country-specific prescribing information label.
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
* Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)

The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects.

The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects. Short- to medium-term outcomes will also be evaluated through follow-up.

Eligibility Criteria:
Inclusion Criteria:

* subjects with 65 years or older

Exclusion Criteria:

* no informed consent