cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women, receiving antiretroviral drugs per SOC as prescribed by their healthcare provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk.

Prospective, single-site, open label, PK and safety study. Co-enrollment of lactating women ≥18 years of age receiving drugs of interest (DOIs) per standard of care (SOC), as prescribed by their healthcare providers, and their infants who receive maternal breastmilk ≤180 days postpartum.

To understand drug transfer into breastmilk and determine subsequent infant exposure, biological samples will be collected from lactating women (blood and breastmilk) and infants (blood). The opportunistic design of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of antiretroviral drugs, and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants. The data collected through this initiative will provide valuable PK, dosing, and safety information for drugs in this vulnerable population in order to inform public health.

Eligibility Criteria:
Inclusion Criteria Mothers/Infants:

1. Lactating women ≥18 years of age who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
2. Informed consent, according to local IRB/REB/IEC guidelines, prior to any study-related procedures.
3. If the mother is receiving more than one DOI, the mother must have taken all DOIs that she is receiving concomitantly for the 6 doses prior to sample collection.
4. Mother participant is fluent in English or Setswana.
5. Willing to provide at least 1 of the below required samples between the co-enrolled mother/infant pair:

   * Maternal breastmilk
   * Infant blood

Exclusion Criteria Mothers/Infants:

1. Any concomitant condition which, in the opinion of the participant's healthcare provider, the site principal investigator (PI), a research nurse, or designee conducting the study, would preclude participation in the study.
2. Known pregnancy of mother during sample collection.
3. Mother has pumped any breastmilk at all in between the last 6 direct infant feedings prior to sample collection.
4. Infant was fed breastmilk in any manner besides nursing at mother's breast for any of the last 6 feedings prior to sample collection.
5. Previous enrollment on this study.
Vitamin D Serum Concentrations & Supplementation in Children With Cerebral Palsy

The purpose of this study is to try to correlate vitamin D dosing and dosing adjustment with Vitamin D levels, measure affects of seizure medications on levels as well as pathologic fractures and bone density in severely cognitively impaired, non-mobile children and adolescents with CP.


Eligibility Criteria:
Inclusion Criteria:

* Recorded vitamin D supplementation dose (i.e. prescribed diet and any additional sources of vitamin D) with at least two serum vitamin D concentrations recorded in the medical chart from January 1, 2008 to June 30, 2013.
* Resident of HLCCD since 2008

Exclusion Criteria:

* No vitamin D levels recorded.
* History of hyperthyroidism or parathyroid pathology.
* Short gut syndrome that requires TPN.
* Poor medical documentation.
* Heritable disorders that affect vitamin D levels such as Pseudovitamin D deficiency rickets, Vitamin D resistant rickets, autosomal dominant hypophosphatemic rickets and X-linked hypophosphatemic rickets
Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer.

Study treatment will be given in 28-day cycles.

In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)
* HER2+ disease documented since progression of the most recent line of systemic therapy, as follows:

  * Phase 2 paclitaxel dose optimization stage:

    * HER2 amplification in a blood-based NGS assay performed at a central laboratory, or
    * HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
  * Phase 2 dose expansion stage:

    * Cohort 2A: HER2 amplification in a blood-based NGS assay performed at a central laboratory
    * Cohort 2B: No HER2 amplification by blood-based NGS assay, but HER2 overexpression/amplification by IHC and ISH (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
  * Phase 3: HER2 amplification in a blood-based NGS assay performed at a central laboratory
* History of prior treatment with a HER2-directed antibody
* Progressive disease during or after first-line therapy for locally-advanced unresectable or metastatic GEC
* Phase 2: Measurable disease according to RECIST version 1.1
* Phase 3: Measurable or non-measurable disease according to RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Life expectancy of at least 3 months, in the opinion of the investigator

Exclusion Criteria:

* Subjects with squamous cell or undifferentiated GEC
* Having received more than 1 line of prior systemic therapy for locally-advanced unresectable or metastatic disease
* Having received taxanes ≤12 months prior to enrollment, prior treatment with ramucirumab, or prior treatment with tucatinib, lapatinib, neratinib, afatinib, or any other investigational anti-HER2 and/or anti-EGFR tyrosine kinase inhibitor, or with T-DM1, T-Dxd, or any other HER2-directed antibody-drug conjugate
* Phase 2 paclitaxel dose optimization stage only: history of prior partial or total gastrectomy
* Unable to swallow pills
The Influence of Age on Dexmedetomidine Pharmacodynamic

Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects .At earlier time It was approved by the FDA only for short-time sedation during mechanical ventilation of adult patients (\<24h) in ICU. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age and gender,such as the drug sensitivity of propofol and remifentanil is increased with age,while the current study also demonstrated that gender may influence the sedate efficacy of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim to explore the right DEX dose of different Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the BIS,during the operation.The relation between BIS values and the depth of sedation for patients is also investigated.

120 patients scheduled to undergo lower extremity surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg, in the youth,and middle-aged group. The initial doses of DEX was 0.7 μg/kg,also with dose adjustment intervals of 0.05μg/kg.Sedative efficacy was defined as an OAA/S of ≤2, or an OAA/S of 3 but with an BIS value of ≤46, 26 min after the beginning of drug administration.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ patient undergoing lower extremity surgery
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.5～25

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. People who were language or hearing impaired
5. Sensory block reached to T8 or higher.
6. People who had lung infection or sleep apnea syndrome.
7. Pregnancy
8. Chronic renal failure
9. Alcohol or drug abuse
10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients

In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023.

Infective endocarditis (IE), a condition linked with significant mortality and morbidity rates, is particularly concerning for patients with prosthetic left-sided valves.

These patients face an elevated IE risk, estimated at about 1% annually in tertiary care settings, cumulatively impacting around one in every 20 patients over a decade.

In line with this, both the American Heart Association (AHA) and the European Society of Cardiology (ESC) strongly advocate for the elimination of potential dental sepsis sources at least two weeks before prosthetic valve implantation, except in urgent cases.

These guidelines, while not grounded in randomized trials, largely draw upon registry data detailing IE incidence among surgical aortic valve replacement (SAVR) patients.

In a recent study the investigators found no difference in risk of IE when comparing mandatory preoperative dental screening (MPDS) with no preoperative dental screening (NPDS).

Thus, this prospective registry-based observational before-and-after study aims to investigate the impact of different preoperative dental screening practices on the risk of IE in patients undergoing.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TAVI

Exclusion Criteria:

* None
A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have completed Phase II/III study of E0302 (E0302-J081-761, hereafter referred to as Study 761) except for those patients who discontinued the treatment of Study 761. Completed patients are defined as those who completed the treatment period of Study 761, those on 24-hour use of non-invasive positive pressure ventilation (NIPPV), or those who eventually resulted in the use of NIPPV.
2. Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign (or affix a seal) by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.

Exclusion Criteria:

1. Patients with cognitive impairment.
2. Pregnant women or women who may have a possibility of becoming pregnant.
3. Patients or their partners who are not willing to use reliable contraception.
4. Patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "Ministry of Health, Labor and Welfare (MHLW) Drug Safety Dept. Notification No. 80, Drug Safety Classification Criteria for Severity of Adverse Drug Reaction by Medicinal Products, Grade 3." However, an event due to the primary disease will be precluded).
5. Patients with malignant tumor.
6. Patients who participated in another clinical study after the completion of Study 761.
7. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
8. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
Effects of Delayed School Start Times on Sleep, Mental Health, and Academic Performance Among Norwegian Adolescents

The aim is to investigate whether later school start times have positive effects on high school students' sleep patterns, mental health and daytime functioning.

The current study is a randomized controlled study investigating whether later school start times on Mondays and Tuesdays have positive impact on high school students' sleep patterns, mental health, and daytime functioning. 1st year high school students are randomly assigned to classes starting either two hours later on Mondays and one hour later on Tuesday and ordinary school start times (8:15 ± 15 min) for the rest of the week, or to classes starting at regularly school start times (8:15 ± 15 min.) all weekdays. The students will be invited to respond to a web-based survey assessing sleep, mental health, and daytime functioning by the beginning and end of the school year. Official school grades and school absence data will be collected through the county administration for consenting students. Cognitive tests and objective sleep record through Somnofy are planned for a subgroup by the end of the 2024-25 school year. The study will last for two school years and involve two different cohorts of 1st year high school students.

Eligibility Criteria:
Inclusion Criteria:

* 1st year high school students at study preparatory program of participating schools

Exclusion Criteria:

* Parent consent not obtained/documented for participants under 16 years
Long-term Pulmonary Outcomes After Infection With Sars-CoV-2

The objective of this study is to assess the long-term outcomes after hospital admission with Covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and socioeconomic outcomes.

Patients will be invited to follow-up visits 3 and 12 months after hospitalization with COVID19.

Inclusion will take place during 2020. We expect to enroll 180 non-ICU patients and 36 ICU patients.

Eligibility Criteria:
Inclusion Criteria:

* Infection with Sars-CoV-2

Exclusion Criteria:

* Unable to attend hospital visits due to frailty or severe disease
* Unable to understand and complete questionnaires due to intellectual or language limitations / deficits
Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P)

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for preschoolers and their caregivers. The investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P).

Preschool-aged foster and other high-risk children are at increased risk for numerous negative outcomes. However, there is very limited use of evidence-based interventions for these young children. Major barriers to progress in this area include a lack of available evidence-based programs for high-risk children across the preschool years and the tendency for the few existing evidence-based interventions to be resource intensive in terms of funding and the level of staff expertise required to be implemented with fidelity. Readily scalable, evidence-based interventions for foster and other high-risk preschoolers are clearly needed to reduce the widespread disparities. The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for caregivers of preschool aged children. The investigators propose to evaluate two versions of the intervention: (a) a basic version that employs a curriculum consisting of 12 weekly psychoeducational caregiver support groups and (b) an augmented version that consists of the caregiver support groups with extended curriculum including with the addition of information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development (FIND) video coaching program. Across four waves of data collection (baseline, immediately postintervention, and 12 and 18 months postbaseline), the investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes. The investigators will conduct multivariate modeling to examine mediating mechanisms underlying the hypothesized immediate and longer- term intervention effects.

Finally, the investigators will conduct a comprehensive economic evaluation to examine the incremental costs associated with implementing the intervention and the benefits realized in the intervention conditions in terms of increased positive outcomes for children.

Eligibility Criteria:
Inclusion Criteria:

* Preschool-aged foster children
* Preschool-aged children referred to early intervention/childhood special education services

Exclusion Criteria:

* Children will be excluded from recruitment if they or their primary caregiver are not sufficiently fluent in English to complete the assessment or if it is determined that the child would not be able to complete the assessment procedures due to a severe developmental, medical, or physical disorder.
Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects

The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants.

Arms 1 \& 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Arms 1 \& 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day.

Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naïve participants with CLL/SLL.

Arms 5 and 6 of Part 2 will test 150mg TL-895 BID in combination with 240 mg navtemadlin QD in participants with relapsed/refractory and treatment naïve without 17p(del). Arm 7 will test 150mg TL-895 in combination with 240 mg navtemadlin QD in participants with relapsed/refractory CLL/SLL with 17p(del).

Every participant in this study will receive TL-895.


Eligibility Criteria:
Inclusion Criteria

* Relapsed/refractory CLL or relapsed/refractory SLL (Arms 1, 2, 5, and 7)
* Treatment naïve CLL or SLL (Arm 3, 4, and 6)
* ECOG performance status of ≤ 2
* Adequate hematologic, hepatic, and renal functions

Exclusion Criteria

* Prior treatment with any BTK or PI3K inhibitors
* History of major organ transplant
* Women who are pregnant or breastfeeding
Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers

The purpose of this study was to identify genetic, brain morphologic, and environmental biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity disorder (ADHD).

The investigators planned to recruit ADHD and healthy controls from the age of 6 to 17.

Genetic data including dopamine, norepinephrine, serotonin, neurotropic factors, glutamate-related genes will be genotyped.

Environmental disruptors including phthalate and cotinine will be analyzed. Brain MRI data including T1, diffusion tensor imaging (DTI), resting state functional MRI (rsfMRI) will be obtained.

Neuropsychological tests including continuous performance test, Stroop test, Children's color trail test, Wisconsin card sorting test will be conducted.

The investigators plan to identify biomarkers of ADHD using an integrative approach of genetic, environmental, neuroimaging and clinical data.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of attention-deficit/hyperactivity disorder confirmed using the Kiddie-Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version- Korean Version (K-SADS-PL-K).
* IQ over 70

Exclusion Criteria:

* Intelligence quotient (IQ) \< 70
* A hereditary genetic disorder
* A current/past history of brain trauma, organic brain disorder, seizure, or any neurological disorder
* Autism spectrum disorder, communication disorder, or learning disorder
* Schizophrenia or any other childhood-onset psychotic disorder
* Major depressive disorder or bipolar disorder
* Tourette's syndrome or chronic motor/vocal tic disorder
* obsessive-compulsive disorder
* A history of methylphenidate treatment lasting more than 1 year or received within the previous 4 weeks
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study

The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* An aortioiliac or iliac aneurysm
* An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
* Unwilling or unable to comply with the follow-up schedule
* Simultaneously participating in another investigative device or drug study
Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer

A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. age \>= 18 years old;
2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023;
3. Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
4. Complete medical history was available.

Exclusion Criteria:

1. Medical history was incomplete.