cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway

The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in children under general anesthesia.

The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and allows the patient to breathe in and out adequately under general anesthesia (GA). The ProSeal™ LMA (PLMA™) is a specialized type of LMA with a design that permits the delivery of higher pressures to help the patient breathe in and out (ventilate) and also contains a channel to suction the stomach.

Children under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the children breathing on their own through a PLMA™. Pressure support ventilation allows the patient to breathe on their own with additional help from the anesthesia machine. Pressure control ventilation allows the patient to breathe with the help of an anesthesia machine.

A child undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, children may not breathe in oxygen and carbon dioxide out adequately at this level of anesthesia and it may be beneficial to provide some level of support to enhance carbon dioxide exchange and to avoid hypoventilation.

This study will attempt to determine whether pressure support ventilation improves ventilation in children undergoing outpatient surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical classification 1,2 (Healthy or relatively healthy children)
* Subjects scheduled for outpatient surgical procedures.
* Surgical procedure anticipated to be \< 90 minutes
* Subject weight of ≤ 20 kg (44 lbs)
* Subject age of 12 months to 5 years (inclusive)

Exclusion Criteria:

* Inpatient
* ASA physical classification of 3, 4 or E (sick children)
* Risk of aspiration
* Subjects with malignant hyperthermia or family history of malignant hyperthermia
* Subjects with tracheostomies
Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation

This study is being done to evaluate whether a program called Heart to Heart, that helps patients make a more informed decision about cardiac rehab (CR), is interesting, acceptable to participants, and whether participants would recommend it to others.

This is a prospective, single-institution pilot study to evaluate the acceptability, feasibility and preliminary efficacy of a tailored Community Health Worker (CHW) led intervention to increase CR participation called H2H. Individuals hospitalized with Cardio Vascular Disease (CVD) events (aged 21 and older) will be identified and screened for eligibility from two Johns Hopkins acute care sites into the pilot study. The duration of participation for each participant is up to 6 months from baseline assessments.

All participants will complete a survey at baseline, 3-, and 6-months and will have medical record abstraction conducted performed by the Johns Hopkins (JH) research study team.

For the intervention, participants enrolled in the H2H program will complete between 4 to 8 coaching sessions with the CHW (delivered by telephone and/or video chat) who will provide tailored education, improve or engage the participant's existing social support network, and assistance with health system navigation over a 3-month period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized with cardiac events and eligible for CR at Johns Hopkins Hospital and Bayview Medical Center. CR eligibility is determined by their treating health care team .
2. Low socioeconomic status defined by Medicaid insurance, or top quartile of the area deprivation index in Baltimore city.
3. Age ≥ 21 years
4. Willing to be audio-recorded

Exclusion Criteria:

1. Formal diagnosis of dementia or cognitive impairment in the Electronic Health Record (EHR) that would prohibit completion of study activities
2. Formal diagnosis of a severe psychiatric disorders by Diagnostic and Statistical Manual (DSM-5) criteria in the EHR that would prohibit completion of study activities (e.g., schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder).
3. Systemic illness limiting longevity (e.g., advanced cancer)
4. Contraindications to CR as assessed by their health care team
5. Unwilling or unable to follow study procedures.
6. Unable to consent
7. Unable to speak or understand English. Assessments including in-depth interviews will be conducted in English.
An Extended Access Program for Perampanel

The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases:

* Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation.
* Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician.

Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment.

Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC).

The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are participating in either Study 207, Study 307, or Study 235 and who in the opinion of the treating physician, continue to benefit from treatment with perampanel (revised per Amendment 01)
* Patients who provide informed consent where applicable per local requirements.
* Female patients of childbearing potential must agree for the duration of the program and for a period of at least 1 month following last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (e.g., a double-barrier method \[condom plus spermicide, condom plus diaphragm with spermicide\])

Exclusion Criteria:

* Patients residing in countries where perampanel is commercially available for the treatment of POS
* Female patients who are lactating, pregnant, or planning to become pregnant
Nuedexta for the Treatment of Adults With Autism

Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8 weeks over subjects given placebo.

Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS).

This is a randomized placebo-controlled crossover study. The parents, neuropsychologists, clinical research coordinator (CRC) and PI will be blinded as to whether subjects are on placebo or Nuedexta.

Nuedexta will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. Patients may also remain on the once-daily dose if desired.

The study will last 44 weeks. This includes 20 weeks for study enrollment, 8 weeks of treatment/placebo, 4 weeks for washout, and a second 8 week-period of treatment/placebo followed by 4 weeks of washout.

Subjects will be randomized to 8 weeks of Nuedexta/placebo. After the 8 week follow-up visit, there will be a 4 week washout period. At week 12 (second baseline), the groups will crossover for another 8 weeks of Nuedexta/placebo. Study endpoints will be measured in the both groups at weeks 8, 12, and 20. A final study visit will occur at week 24.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 60 years of age
2. Have a collateral informant who can attend visit and answer questionnaires pertaining to participant behavior
3. Diagnosis of autistic spectrum disorder based on the Diagnostic and Statistical Manual, 4th edition, Text Revised (DSM-IV-TR) criteria, developmental history, and Autism Diagnostic Observation Schedule (ADOS); or confirmed diagnosis of autism during childhood through similar methods
4. Capable of giving informed consent, or have a legal guardian capable of giving consent on the subject's behalf; patient able to assent to participate
5. Mood issues and frontal lobe type perseveration issues
6. No medication changes within 30 days and no use of new medications during the course of the study except for non-related conditions approved by the investigators

Exclusion Criteria:

1. Clinically uncontrolled epilepsy
2. Cardiovascular conditions including cardiac or structural malformation heart failure, prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block
3. Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral palsy, head injury, or brain tumor
4. Known allergy to either dextromethorphan or quinidine
5. Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt Nuedexta
6. Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists
7. Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome
8. Pregnancy - sexually active females of childbearing potential must be on a reliable form of contraception
9. Other clinically significant abnormality on physical, neurological, laboratory, vital signs, that could compromise the study or be detrimental to the subject
Use of Virtual Reality for Overdose Management Educational Trainings

This cluster-randomized trial will compare changes in attitudes and knowledge on administering naloxone based on exposure to either a virtual reality educational training or the current standard educational trainings (e.g. on-line videos, printed information handouts) offered at local libraries. Individuals attending local library's naloxone training days will voluntarily complete an anonymous validated survey pre and post attending either the virtual reality or standard educational training.

This study will utilize a cluster-randomized trial design. Entire libraries will be randomized to either offer community members the virtual reality training or the standard educational offerings (e.g. handouts, online videos). Volunteers will be asked to complete the brief, anonymous, and validated Opioid Overdose Knowledge Scale prior to receiving an education intervention (pretest) and then again immediately after (posttest). Neither participants nor investigators will be blinded. Library patrons who do not participate in the study will be offered current standard training materials. Regardless of the library's randomization, to either virtual reality or standard training, all patrons completing pre and post test surveys will have the opportunity to view the virtual reality training or other public health department materials.

Eligibility Criteria:
Inclusion Criteria:

* Able to complete paper surveys independently
* Provide verbal consent

Exclusion Criteria:

* Unable to complete immediate post-training assessment
* Individuals under 18 years of age
* Individuals who cannot communicate in English and provide consent
Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery

The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is undergoing ambulatory surgery for:

  * in orthopedics: shoulder (arthroscopy, abutment, prosthesis), hip (prosthesis, arthrolysis), knee (osteotomy, ligamentoplasty), ankle (prosthesis, ligamentoplasty) foot (hallux valgus); removal of major or multi-site equipment;
  * digestive (cholecystectomy, hernia repair, partial gastrectomy, colectomy, cleaning);
  * in gynecology (hysterectomy, oophorectomy, mastectomy, quadrantectomy, dissection, cystoplasty, sphincter);
  * in urology (total or partial resection of the prostate);
  * ENT (thyroidectomy, tonsillectomy);
  * Neurosurgery (herniated disc);
  * Vascular (stripping varix, creating fistula).
* The patient has sufficient intellectual and cognitive capacity to use the devices
* The patient must pass the test performed during the anesthesia consultation, namely:

  * open and connect the tablet,
  * activate the measurement of the blood pressure and the measurement of the oxygen saturation,
  * be connected to a 4G network

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant
* The patient is undergoing emergency or minor surgery
* Patient has a psychological class ASA 5
* Patient is non-eligible for ambulatory surgery for medical reasons (decompensated medical pathology) or social reasons according to the criteria defined by the société française anesthésie réanimation. Person lives alone or has a geographical distance from a hospital center\> 30 km (or\> 45 min by car).
* Patient who doesn't classify for ambulatory surgery at time of discharge
Buprenorphine HIV Care Integration Project

A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.

DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.

DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.

SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.

POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.

STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)

INTERVENTON At entry subjects will be randomized to one of the following:

ARM A: Standard drug addiction counseling + buprenorphine / naloxone

ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone

The three primary outcomes are:

1. Cessation of illicit opioid use
2. Reduction in high risk behavior
3. Improved HIV therapy adherence

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Receiving or seeking outpatient HIV care
* Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine
* Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given
* Men and women age ≥ 18 years
* Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine
* Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase \<=5 X ULN, Total bilirubin \<= 2.5 x ULN

Exclusion Criteria:

* Serious medical problem
* Acute and/or severe psychiatric conditions
* High dose methadone (\>30 mg/day)
* Documented co-dependence on alcohol and/or benzodiazepines, barbiturates
* Chronic pain management requiring opioids
* Pregnancy or breast-feeding
* Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical
Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

Exclusion Criteria:

* Under 10 years of age
REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors

The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors.

The name of the study groups in this research study are:

1. REVITALIZE
2. Educational Materials

This Phase 3 randomized controlled trial will evaluate the effect of a brief, acceptance-based tele-health intervention (REVITALIZE) vs. educational materials in participants with ovarian cancer who are taking poly-ADP ribose polymerase (PARP) inhibitors.

Participants will be randomized into one of two study groups: 1) REVITALIZE or 2) Educational Materials. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, using a wireless pill bottle, and completing questionnaires.

Participation in this research study is expected to last about 7 months.

It is expected about 240 people will take part in this research study.

The National Cancer Institute is supporting this research by providing funding.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy).
* Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months.
* English-speaking.
* Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.
* ECOG performance status of 0-2.
* Willing to use a wireless pill bottle for PARP inhibitor medication.

Exclusion Criteria:

* Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist.
* Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide.
* Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures.
* Inability to complete the first questionnaire within one week of consent.
Development of Exercise Promotion Program Using a Mobile Community

This study aims to investigate the effect of a mobile community based on a smart phone application to enhance physical activities of breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Stage 0-III breast cancer

Exclusion Criteria:

* Stage IV breast cancer
* Breast cancer recurrence or metastasis
* Severe medical illness
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Researchers propose to evaluate the change in the uptake value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer.

In addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of prostate cancer
* Evidence of metastatic disease by radiologic criteria
* Bone scan within 4 weeks of starting therapy
* Creatinine within 2 weeks of registration, calculated creatinine clearance \> 60ml/min.
* Minimum life expectancy of 6 months
* Willingness to have pre-therapy PET scans performed within 2 weeks after registration and post therapy PET scan performed within 1 week after dose of Zometa (a total of 3 PET scans required)
* Calculated creatinine clearance \> 50ml/min.
* No prior Zoledronate therapy
* Patients must have disease progression despite testosterone suppression (level\<50ng/ml); progression can be by rising PSA ( at least 2 values at least 2 weeks apart) or by new lesions on scans or progression of existing lesions on CT scan.
* No concomitant systemic therapy for metastatic prostate cancer is allowed except LHRH analogue should be continued if necessary to maintain testosterone suppression.
* No concomitant radiation therapy
* Prior RT is allowed if completed at least 2 weeks prior to registration.
* Presence of measurable or evaluable disease
* If RT has been administered, disease outside the RT port is required.
* Willingness to sign informed consent.
* Registration and willingness to sign informed consent for separate PET protocol 2335 that describes the PET scan procedure.
* Patients must have good oral hygiene which includes having a recent dental evaluation

Exclusion Criteria:

* Patients who are unable to swallow
* Patients with dental cavities that are likely to need dental extraction or root canal treatment as management
HeRO Vascular Access Device Post Market Procedural Survey Protocol

Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.

Evaluation Design: This is a multi-center post market observational survey designed to collect procedural data on a minimum of 50 HeRO™ patients in the commercialization phase. Data will be collected retrospectively for patients already implanted with the HeRO™ device in the commercialization phase or prospectively for patients that receive the HeRO™ Device during the data collection period. No special patient screening, testing, or procedures are required. There is no required patient follow-up.

Subject Population: Any patients the investigator deems/deemed eligible for HeRO™ implant with complete procedural data are eligible for inclusion in this post market observational survey.

Endpoints: None

Inclusion/Exclusion Criteria: There are no formal screening criteria other than patients must have all required procedural data points available for recording on the case report form.

Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* None