cyrilzakka/clinical-trials huggingface dataset:
The Laryngeal Tube Suction Versus Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery

This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

Background:

For standard procedure, the endotracheal tube is used to ventilate the anesthetized patients who undergo gynecological laparoscopic surgery that increase intrabdominal pressure. Now there is a new supraglottic airway device, laryngeal tube suction (LTs) can be use instead of ETT.

Objective This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

Material and methods Prospective single blinded randomized control trial, the patients were divided into two groups, LTs group and ETT group n = 60 for each group. All patients were induced anesthesia with fentanyl 1-2 mcg/kg, propofol 2 mg/kg, vecuronium 0.1 mg/kg then maintained anesthesia with air : oxygen 30%. Respirator setting are tidal volume 10 ml/kg, I/E 1:2 adjust RR base on ETCO2 keep ETCO2 35-40 mmHg.

Results No statistical difference in demographic data between groups. PAP and ETCO2 in the LTs group were significant higher than ETT group in the first 5 and 10 minutes but no statistically significant after 10 minutes until the end of operation. No statistically significant in TV and SpO2 between groups. In ETT group MAP and HR after insertion are significant higher than LTs group, no statistically significant about postoperative complication such as sorethroat, hoarseness and nausea vomiting.

Conclusion LTs can be used in gynecological laparoscopic surgery like ETT.

Eligibility Criteria:
Inclusion Criteria:

* female age between 20-65 years
* ASA class 1-2
* elective gynecologic laparoscopic surgery
* height \< 180 cm
* BMI \< 35 kg/m2

Exclusion Criteria:

* interincisor gap \< 2.5 cm
* risk of aspiration
* history of difficult intubation
* oropharyngeal pathology
* allergy to anesthetic drug
Mental Health Services for Foster and Adopted Children

This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.

Infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. In the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. This study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care.

Children are randomly assigned to either an experimental group or to a treatment control group for 3 years. The experimental group focuses on relational issues; the control group focuses on cognitive development. Caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. Caregivers in the treatment control group receive training designed to enhance children's cognitive development. Caregivers in both groups will receive 10 home visits. Observations of children and parents are used to assess participants.

Eligibility Criteria:
Inclusion Criteria:

* Toddler placed into foster care
* Resident of Delaware and surrounding counties in Pennsylvania and Maryland

Exclusion Criteria:

* Significant medical problems
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. This enzyme helps to break down and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In people with Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because alpha-galactosidase A is not present, or is present in small quantities. The build up of glycolipid levels (also referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood with pain in the hands and feet. This trial is designed to evaluate the efficacy of a lower dose of Fabrazyme in patients who initially received 1.0 mg/kg every 2 weeks of Fabrazyme by investigating if the achieved clearance of glycosphingolipid deposits in the vascular endothelium of the kidney can be maintained at a lower dose.


Eligibility Criteria:
Inclusion Criteria:

* Have clinical manifestations of Fabry disease
* All patients have to have a plasma αGAL activity of \< 1.5 nmol/hr/mL or a documented leukocyte αGAL activity of \< 4 nmol/hr/mg
* Patient or patient's parent/guardian had to provide written informed consent prior to any study-related procedures being performed
* Patients had to be male and ≥ 16 years of age

Exclusion Criteria:

* There is evidence of renal insufficiency, as defined by serum creatinine greater than or equal to 2.2 mg/dL (194.7 μmol/L) AND/OR has an estimated glomerular filtration rate (GFR) of \<80 mL/min (using the equation derived from the Modification of Diet in Renal Disease Study (MDRD))
* Has undergone kidney transplantation or is currently on dialysis
* Has a clinically significant organic disease or an unstable condition (with the exception of symptoms relating to Fabry disease) that in the opinion of the Investigator would preclude participation in the trial
* Has participated in a study employing an investigational drug within 30 days of the start of this trial
* Patients who received prior treatment with enzyme replacement therapy for Fabry disease
* Patient was unable to comply with the requirements of the protocol
Brain Response to Serotonergic Medications in ASD

This study investigates brain response to single acute dose of citalopram, tianeptine, and placebo in males with and without autism spectrum disorder.

There is increasing evidence that the serotonin (5-HT) system is implicated in autism spectrum disorder (ASD), with the standard treatment for depression and anxiety in both the general population and ASD includes targeting the 5-HT system with selective serotonin reuptake inhibitors (SSRIs) citalopram. Some individuals with ASD have a good treatment response but others do not. Tianeptine, which has a different mechanism of action to SSRIs, is also an effective antidepressant. As it is unlikely that all individuals with ASD will respond to the same treatment, the investigators aim to conduct a pharmacological magnetic resonance imaging (phMRI) investigation to elucidate the neural mechanisms underlying the response to citalopram and tianeptine in ASD. The investigators are inviting 50 male adults with ASD and 50 male adults without ASD. Each participant receives each drug once (20 mg citalopram, 12.5 mg tianeptine, or placebo) and MRI is used to obtain measures of brain biochemistry, activity, and connectivity. The investigators also acquire data from questionnaires, electroencephalography, neurocognitive tests and blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Intelligence Quotient (IQ) above 70
* Has capacity and is capable of giving written informed consent
* Able to read, comprehend and record information written in English
* Bodyweight of \<120 kg and BMI within the range 18.5 - 33 kg/m2 (inclusive).
* Not taking medication directly affecting gamma-aminobutyric acid (GABA) neurotransmission for at least the past 4 weeks
* Not taking medication directly affecting the serotonergic system for at least the past 4 weeks
* ASD only: Diagnosis of Autism Spectrum Disorder (ICD 10-R criteria, confirmed using the Autism Diagnostic Interview (ADI) and/or ADOS) including atypical autism
* ASD only: Being recommended drug therapy for symptoms of depression and/or anxiety
* Controls only: No diagnosis of Autism Spectrum Disorder (ICD 10-R criteria, confirmed using the ADI and/or ADOS)
* Controls only: No diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or ICD 10.

Exclusion Criteria:

* Current risk of self-harm
* Acute risk of suicidality (e.g., current suicidal ideations)
* Age \< 18 years or \> 60 years old.
* Taking medication directly affecting the serotonergic system (e.g. SSRIs, Tricyclic antidepressants)
* Taking medication directly affecting GABA neurotransmission (e.g. antiepileptic drugs, and benzodiazepines)
* Taking antipsychotic medication or medication for attention deficit hyperactivity disorder (ADHD) for the past 4 weeks
* History of dependence to alcohol or substances of abuse (excluding nicotine)
* Major mental illness (e.g. psychosis), or a learning disability (mental retardation)
* Needle phobia
* Medical/genetic disorder associated with ASD
* Diagnosed and treated for hyperkinesis or Tourette's syndrome
* Allergy to food colouring
Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.

Primary objective:

* To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as booster.

Subjects aged 12 months of age and older and who are given study vaccine during routine health-care visits will be enrolled in the study.

No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed by the subject (for subjects 19 years old and above) or the parent(s) or other legal representative (for subjects under 19 years of age)
* Receipt of the first dose of IMOJEV® (on the day of inclusion) according to approved local insert paper.

Exclusion Criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure.
* Subjects who already participated in this study.
MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).

This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects

In Escalation phase: MEDI4736 and gefitinib in NSCLC subjects In Expansion phase: Subjects with EGFR mutation positive locally advanced or metastatic NSCLC will be enrolled in expansion arms. Initiation of expansion arms with the recommended dose of MEDI4736 in combination with gefitinib will be based on an adequate safety and tolerability profile of the combination from the escalation phase.

Eligibility Criteria:
Key Inclusion Criteria:

1. Provision of signed and dated, written informed consent
2. Male or female aged 18 years and older.
3. Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. In the expansion phase, histologically or cytologically confirmed locally advanced or metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and sensitive to EGFR TKIs therapy
4. a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

   * For Japan Escalation - the same as the global escalation I/E criteria except patients must be EGFR mutation positive

Key Exclusion Criteria:

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
2. Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment
3. Inadequate bone marrow reserve or organ function
Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes

The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S).

The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age \> 33 weeks and uncomplicated hyperbilirubinemia.


Eligibility Criteria:
Inclusion Criteria:

* Newborns with gestational age \>33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines

Exclusion Criteria:

* Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis)
* Liver disease
Autologous Stem Cell Therapy in Stroke

The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with sub acute/chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age18 years-80 years
* diagnosed as stroke by clinical and MRI findings

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/ Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever
* hemoglobin less than 8
* bleeding tendency
* bone marrow disorder
* left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding
Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer

This study examines the relationship among epigenetic alterations and the development and persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms, anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early stage breast cancer. The relationship among inflammatory markers and psychoneurologic symptoms will also be explored. It is hypothesized:

1. Chemotherapy triggers inflammatory activation, which in turn leads to the acquisition of genetic alterations. These alterations result in cellular changes and are modified over time.
2. Inflammatory activation and epigenetic alterations are related to the temporal development, severity, and persistence of psychoneurologic symptoms.

Advancements in breast cancer have resulted in increased survival rates; however, many women with breast cancer experience distressing symptoms. Inflammatory activation and epigenetic alterations have been associated with the etiology of cancer. To date, no investigators have considered these epigenetic processes as possible mechanisms associated with the etiology of distressing symptoms in women with breast cancer. The specific aims of this study are to examine:

1. The frequency and severity of psychoneurological (PN) symptoms (depressive symptoms, anxiety, sleep disturbances, fatigue, pain and cognitive dysfunction)and the interrelationship among PN symptoms at each time point
2. Levels of inflammation and to quantify the frequency and genome-wide location of changes in epigenetic patterns across time following chemotherapy
3. The relationship among inflammation, epigenetic changes, and the development, severity, and persistence of PN symptoms across time The study results may potentially deepen understanding regarding the biological processes underlying PN symptoms and lead to improved strategies for symptom management in women with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Diagnosed with stage I to IIIa Breast Cancer
* Scheduled to receive chemotherapy

Exclusion Criteria:

* previous cancer history
* previous chemotherapy history
* dementia
* active psychosis
Study of Phosphate Levels in Patients With Chronic Kidney Disease

The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.


Eligibility Criteria:
Main Inclusion Criteria:

* ≥ 18 years of age,
* Receiving stable maintenance hemodialysis 3 times a week
* On restricted phosphate diet at screening and throughout study
* Receiving stable dose of phosphate binder for at least 1 month
* Serum phosphate levels \>1.78 mmol/L

Main Exclusion Criteria:

* Uncontrolled hyperphosphatemia
* Hypercalcemia at screening or during washout
* Serum calcium \< 1.9 mmol/L (\<7.6 mg/dL)
* Severe hyperparathyroidism (iPTH levels \>600 ng/L)
* Pregnancy or lactation
* Iron deficiency anemia
* History of hemochromatosis or ferritin \>800 mg/L,
* Hepatitis B, hepatitis C or other significant concurrent liver disorders
* Known positivity to HIV
* Use of oral iron preparations 1 month before screening,
* Serious medical condition or uncontrolled systemic disease
Improving HIV Prevention Skills in People With Serious Mental Illnesses

This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.

People with serious mental illness (SMI) are at higher risk for contracting HIV than the general population. Although fewer people with SMI are sexually active, as compared to the healthy population, those with SMI who are sexually active tend to engage in sexual behaviors that put them at increased risk for HIV and other STDs. The onset of SMI, which often interferes with normal psychosocial development, may cause these behaviors. Additionally, SMI is frequently associated with poor judgment, affective instability, and impulsiveness. Interventions designed to reduce the risk for contracting HIV in people with SMI exist, but they have had little success. New approaches to treating this population are essential. This study will evaluate the effectiveness of motivational interviewing (MI) plus skill building (SB) exercises in reducing HIV risk behavior in people with SMI.

Participants in this 6-month, open-label study are randomly assigned to partake in SB training either alone or combined with MI. The skill building program focuses on behavioral skills training, with an emphasis on negotiating and communicating with prospective partners. Training includes information about HIV risk, including mechanisms of transmission, abstinence, and safer sex and drug use behaviors; HIV risk reduction strategies, including condom use, abstinence/safer sex negotiation skills, and reduced/safer drug use; and an opportunity to be tested for HIV if the participant has not already done so. The SB plus MI intervention (SB-MI) includes components of the SB intervention, as well as elements of MI. MI includes identifying high risk sexual and drug use behaviors related to HIV; reducing the ambivalence about making high risk behavior changes; increasing motivation to change high risk behaviors; and developing a plan to implement these changes. HIV testing may be included. Participants in both interventions report to the study site on six to seven occasions over the course of the study. The visits last between 1 and 2 hours and include both treatment and evaluation. Participants attend two follow-up visits, one 3 months after randomization, and one 6 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for a serious and persistent mental illness (as defined by the Massachusetts Department of Mental Health)
* English-speaking
* Engagement in HIV risk behavior within 3 months prior to study entry
* Ability to keep study-related appointments

Exclusion Criteria:

* Unstable mental status
Walking to School Supports

This pilot study will test the feasibility and acceptability of an enhanced individual-level intervention delivered to 4th-6th graders to increase rates of walking to/from school. Up to 8 youth who do not already walk to school will be enrolled into the intervention. The theoretically-based intervention content will be delivered over 6 weeks through family-based telephone coaching sessions, ongoing short message service (SMS) text messaging, and activities and content on the study website.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children enrolled at Benjamin Banneker school
* Parents/child dyads who completed the Phase 1 survey OR respond to recruitment attempts and express interest in walking to school. Included parent/child dyads will be:

Those who do not participate in LINC program both before and after school 4+ days per week (child); Those who live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off).

Exclusion Criteria:

* Children not enrolled at Benjamin Banneker school
* Those who participate in LINC program both before and after school 4+ days per week (child); Those who do not live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are not willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off).
* We will exclude each of the following special populations:

Adults unable to consent Prisoners Wards of the state Pregnant women may be included, but only in such capacity as parents of other children enrolled at Benjamin Banneker school
Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players

Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on objective, physiological measures of brain function and ultimately a quantification of injury severity.

The present study aims to assess neurophysiological markers of auditory and visual measures of brain function using the NeuroCatch Platform and eye-tracking technology, respectively. The current gold standard of TBI evaluation, including cognitive and balance assessments, will also be captured.


Eligibility Criteria:
Inclusion Criteria:

* Any sex, 14-25 years old inclusively
* Attending the Creative Artists Agency LLC (CAA) hockey camp in July 2019
* Able to understand the informed consent/assent form, study procedures and willing to participate in study

NeuroCatch Platform-Specific Inclusion Criteria

* Able to remain seated and focused for 6 minutes
* Normal hearing capabilities

Exclusion Criteria:

• Unable to provide informed consent

NeuroCatch Platform-Specific Exclusion Criteria

* Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
* In-ear hearing aid or cochlear implant, hearing device
* Implanted pacemaker or defibrillator
* Metal or plastic implants in skull
* Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device during hockey camp (July 7th - 13th 2019)
* Not proficient in English
* Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
* History of seizures
* Allergy to rubbing alcohol or EEG gel
* Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)