cyrilzakka/clinical-trials huggingface dataset:
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

This is a feasibility study of performing repeated EEG recordings and assessment of affective states during open-label administration of BRX to women with postpartum depression. Study phases will include screening, enrollment, intervention, and follow-up. Subjects will be screened for study eligibility criteria through clinical assessments and self-report. Enrolled subjects will be admitted to the UNC Women's Hospital, where five serial EEG recordings will be obtained, along with frequent assessments of affective state, before, during, and after a 60-hour IV infusion of BRX. Follow-up procedures will include assessments of PPD and affective symptoms, as well as an exit interview with the study team. If feasibility outcomes are achieved, exploratory EEG analyses will be performed with AMICA (adaptive mixture independent component analysis), community detection, and microstate assessment. Exploratory analyses of data collected by facial expression detection software (iMotions Affectiva) are also planned.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Documented proof of full COVID-19 vaccination
* Ambulatory, female, aged 18-45
* ≤ 8 months postpartum
* Agrees to adhere to the study requirements.
* Onset of depression in 3rd trimester or within 4 weeks of delivery
* Meets DSM-V criteria for major depressive disorder with peripartum onset.
* 17-item HAM-D total score ≥20 at screening
* Stopped breastfeeding or agrees to temporarily stop for 7 days including 4 days of hospitalization and 3 days after
* No new psychotropic drugs during screening and active treatment of study
* Stable use of any current psychotropic drugs for at least 28 days prior to enrollment, with stable dosage for at least 14 days prior to enrollment
* Must be on documented contraceptive.
* Must have a caregiver or family member with them to help care for the subject's child(ren) during the infusion and to be in the room with the subject if the child(ren) are present during the infusion

Exclusion Criteria:

* Positive pregnancy test at screening or day 1
* Pregnancy that resulted in a stillbirth, termination, or child that was placed for adoption.
* Renal impairment or failure, hepatic impairment or failure, or anemia
* Untreated or inadequately treated hypothyroidism or hyperthyroidism
* Known allergy to progesterone or allopregnanolone.
* Suicide attempt at this episode
* Medical history of schizophrenia, and/or schizoaffective disorder
* Current psychotic symptoms including delusions, hallucinations, or formal thought disorder.
* Concurrent substance abuse
* Exposure to another investigational medication or device within 30 days
* Has previously participated in any study employing brexanolone or SAGE-217.
* Subject is investigative site personnel, sponsor personnel, or an immediate member of their family.
* Has received electroconvulsive therapy during current episode.
* History of seizure disorder
* On anticonvulsant agents
* On benzodiazepines
Chemotherapy-induced Circadian Rhythm Disruption

The purpose of this study is to investigate chemotherapy-induced circadian rhythm disruption through biomarkers, and the relationship between chemotherapy-induced circadian rhythm disruptions and side effects of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Those who have undergone breast cancer surgery and are waiting for chemotherapy
2. premenopausal women
3. Invasive adenocarcinoma of the breast stages I-III

Exclusion Criteria:

1. Other cancer diagnosis within the last 5 years
2. Other physical problems that can affect survival
3. Other physical problems that can affect sleep or mood ex) pulmonary disease(COPD, Asthma), GI disorder(GERD), Renal disorder(End stage renal disease), Endocrine disorder(Hypothyroidism, Acromegaly), Infectious disease(Viral, bacterial infections, HIV infections), Neurological disease(epilepsy, parkinson's disease, neuromuscular disorder, stroke, multiple sclerosis), Cardiovascular disease(Coronary heart disease), Pain, etc.
4. ECOG(Eastern Cooperative Oncology Group performance status) \>1
5. In the case of depression, anxiety disorder, sleep disorder, etc.
6. If you have worked night shifts or shifts within the past 6 months
7. Weight 40kg or less, digestive diseases, history of gastrointestinal surgery, etc.
8. If you are currently taking psychiatric drugs (antipsychotics, antidepressant, mood stabilizer, benzodiazepine, psychostimulant, beta-blocker, etc.)
9. If you have traveled on a transmeridian plane in the 3rd zone or more within the past 6 months.
Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy

The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy


Eligibility Criteria:
Inclusion Criteria:

1. patients undergoing laparoscopic or robot-assisted laparoscopic nephrectomy (total or partial)
2. patient who want intravenous PCA for postoperative pain control

Exclusion Criteria:

1. long-term use of opioid, pain reliever or tranquilizers
2. a history of DM neuritis
3. prolonged prothrombin time or activated partial thromboplastin time
4. impairment of cognitive function
5. obesity (BMI ≥ BMI 30 kg/m2)
Boostrix® Pregnancy Registry

The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with Boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively

The Registry was originally initiated on 03 May 2005, as part of a program of enhanced pharmacovigilance. Following new European Union Pharmacovigilance legislation, pregnancy registries are to be considered as post-authorization safety studies (PASS). The ongoing Registry will therefore be converted into a PASS study in Q1 2014.

Exposed pregnancies reported to the Registry before the transition into a PASS (between 03 May 2005 and Q1 2014), from which data were collected and analyzed prospectively, will also be included in the analyses.

Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.

Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births for whom the contact details of their HCP will be available) to ascertain the presence of birth defects not diagnosed before, from Q1 2014 to Q3 2019.

Eligibility Criteria:
Inclusion Criteria:

A subject will be included in the Registry if all of the following criteria are met:

* Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
* Subject is a US resident.
* A HCP is identified (name, address and phone number).
* Subject can be identified (by GSK or HCP).

Data from registered subjects will be included in the analyses if the following criterion is met:

• Pregnancy is ongoing and the outcome is unknown.

Exclusion Criteria:

Data from registered subjects will not be included in the analyses if the following criterion is met:

• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Typically, pregnancies \> 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

This study will compare a single dose of oral dexamethasone to placebo in a multicenter, randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any other routine therapy used at that center. No current standard therapy is withheld, and no additional tests or other treatments are part of the study.The primary hypothesis is that dexamethasone will be more effective than placebo in preventing hospital admission. The secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the duration of the disease when compared to placebo, and that dexamethasone will be as safe and as well tolerated as placebo.

Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the most hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence both for and against the effectiveness of corticosteroids such as dexamethasone has been published. Editorials, expert reviews, and a recent report from the Agency for Healthcare Research and Quality recommend a study such as this one.

Patients will be drawn from the emergency departments at participating medical centers in the Pediatric Emergency Care Applied Research Network, created by the Emergency Medical Services for Children program and the Maternal and Child Health Bureau of the Health Resources and Services Administration to study health problems of high acuity and high incidence in children.

Comparisons: The primary outcome (hospital admission after 4 hours of ED observation) and secondary outcomes will be compared between treatment and placebo groups.

Eligibility Criteria:
Inclusion Criteria:

* First attack of wheezing within 7 days of onset
* Age 2 months through 11 months (less than 12 months)
* Disease of at least moderate severity (RDAI score greater than or equal to 6)

Exclusion Criteria:

* Prior adverse reaction to dexamethasone
* Known heart or lung disease
* Premature birth prior to 36 weeks' gestation
* History of prior asthma or bronchodilator use
* Immune suppression or deficiency
* Trisomy 21
* Critical or life-threatening complications of bronchiolitis
* Treatment with corticosteroids within 14 days
* Known active chickenpox
* Exposure to chickenpox within 21 days
* Child sent to ED for automatic admission
Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects
* BMI 17.5 - 30.5
* Must provide informed consent

Exclusion Criteria:

* Clinically significant disease
* Narrow angle glaucoma
* Positive drug screen
A Feasibility Study of SenseGuard to Assess Airway Responsiveness During Methacholine Challenge Test (MCT)

SenseGuard (SG) is an innovative device for respiratory monitoring. At this study SG measurement will be integrated in a Methacholine Challenge Test (MCT) for monitoring changes in airway obstruction occurred during MCT in parallel to spirometry.

SenseGuard (SG) is a wireless wearable medical device intended for monitoring of patient's breathing. It allows to seamlessly monitor patient's tidal breathing, at rest or during daily activities, and to extract critical respiratory parameters, such as respiration rate (RR) and durations, ratios and variability of phases within the breath-cycle, including: inspired breath (Ti) and expired breath (Te).

The study goal is to evaluate the capability of SG to measure clinical changes in respiratory parameters.

During Methacholine Challenge Test (MCT), asthma patients demonstrate airway responsiveness due to airway obstruction. SG will be used to measure respiratory parameters during MCT in parallel to spirometry and the correlation between measurable respiratory parameters will be assessed.

Successful study results will demonstrate the capability of SG to measure changes in airway obstruction leading to future implementation of SG for monitoring of patients with respiratory diseases and improvement of their clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥18.
* Eligible for MCT procedure. The contradictions to MCT are listed as exclusion criteria.
* Provision of a signed and dated informed consent form.
* Subject who receives one of the following medications, that decrease bronchial hyperresponsiveness, is required for a washout period, before conducting the MCT: inhaled bronchodilators, oral albuterol , inhaled and oral glucocorticoids, leukotriene modifying agents, theophylline, cromolyn, and anti-histamines due to their anticholinergic effect.

Exclusion Criteria:

* Subjects who have known contradictions to MCT, including:

  * Tolerate inhalation of the challenge agents
  * Low baseline FEV1: Airflow limitations in FEV1 less than 60% predicted or 1.5L (baseline FEV1 of \< 1.5 L or \< 60% predicted).
  * Spirometry quality: inability to consistently reproduce quality spirometry
  * Cardiovascular problems: recent myocardial infarction within past three months, uncontrolled hypertension, known aortic aneurysm
  * Recent ophthalmologic surgery or patients at risk for intracranial pressure elevation.
  * Pregnancy and nursing mothers: Methacholine is a pregnancy category C drug and it is not known whether it is excreted in breast milk or is associated with fetal abnormalities. Women subjects will be asked to sign a statement, as part of the Informe Consent Form, that they are not pregnant or nursing mothers).
* Inability to provide informed consent.
* Known allergic reactions to materials used in the components of the SG, i.e., polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
GON-injection for a Sooner and Better Treatment of Cluster Headache

Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ICHD-3
* Patients have to be aged 18-65 years
* Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment
* Patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion.
* Patients should be in their cluster period for shorter than 4 weeks before inclusion.

Exclusion Criteria:

* A contraindication for treatment with steroids or verapamil
* The use of anticoagulants or known bleeding disorder.
* Use of any prophylactic medication for cluster headache
* Patients with a history of other primary headache who are currently using prophylactic medication for this headache
* Pregnancy
A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants

The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.

Key Exclusion Criteria:

* Mentally or legally incapacitated or significant emotional problems.
* Any condition that might interfere with drug absorption.
* History of sensitivity to study medication or other drug allergies.
* Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.
* Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.
* Participated in another clinical study within 28 days prior to the first dose.
* Significant laboratory abnormalities.
* Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.
Effect of Four-Week Wellness Program on Work Engagement Burnout and Sleep in a Healthcare Organization (WEBS)

The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would

1. decrease burnout
2. improve sleep and work engagement.

Researchers will compare : intervention group : participating in 4 weeks of Heartfulness Meditation with control group: receiving no intervention

Responses to the Utrecht Work Engagement Scale (UWES), Bergen Insomnia Scale (BIS) and two burnout questions will be compared between the study groups at the beginning and end of the intervention period.

The study is an 8-week single-center prospective, randomized, crossover study among healthcare workers in the WellSpan Health System. All participants were asked to answer two demographic questions and responses to the Utrecht Work Engagement Scale (UWES), and Bergen Insomnia Scale (BIS), two burnout questions were requested for a baseline. Participants were randomized to two groups. One of the groups would undergo the intervention first, which comprised receiving an orientation session regarding the study, attending at least once weekly didactic sessions on Zoom, and participating in morning and evening meditation for ten to fifteen minutes daily. The duration of the intervention period was four weeks. During this time, the control group would not be undergoing any intervention. After four weeks, both groups completed the original questionnaire again followed by a 2 week washout period. This was followed by a crossover, allowing the second group to undergo the intervention for four weeks. After four weeks, the final survey was sent to all participants again.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 and willing to participate
* Able to understand the English language as the instructions were in English

Exclusion Criteria:

* Not able to understand English language
A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
3. Male or female
4. Meet the body mass index standard
5. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of mental illness
3. Subjects with a history of cognitive impairment epilepsy
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with atrioventricular block or cardiac insufficiency
6. Subjects with a history of ischemic stroke or transient ischemic attack
7. Subjects with poor blood pressure control after medication
8. Subject with a history of substance abuse and drug abuse
9. Abnormal values in liver function
10. Allergic to drugs that may be used during the study
11. Pregnant or nursing women
12. No birth control during the specified period of time
13. Participated in clinical trials of other drugs (received experimental drugs)
14. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Diagnosis of Tuberculosis Infection in HIV Co-infected Children

Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival.

The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited.

Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children:

1. assess the agreement between the TST and blood-based diagnostic testing,
2. compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure,
3. measure the impact of age, nutritional and immune status on children's response to blood-based testing,
4. describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB.

Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in children include 1) timely institution of treatment for TB infection to prevent severe disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of childhood TB infection also prevents future contagious adult disease, thus decreasing community transmission. Blood-based diagnostic testing may also be able to identify children that are more likely to become ill following TB infection. Therefore, blood-based diagnostic testing has great potential to improve TB control and the health of HIV-infected and uninfected children, their households and communities.


Eligibility Criteria:
Inclusion Criteria:

* age less than 15 years
* completion of informed consent

Exclusion Criteria:

* less than 3 months of age
* documented anemia
* recent diagnosis of tuberculosis
* receiving treatment for tuberculosis