cyrilzakka/clinical-trials huggingface dataset:
Effects of Varying Duration of Naps on Cognitive Performance and Memory Encoding

To evaluate the nap duration that achieves maximal cognitive gain with practicality of implementation, the present work employs a within-subject design comparing nap durations of 10 minutes, 30 minutes, and 60 minutes with a no nap condition on benefits to alertness, vigilance, mood, speed of processing and memory over post-nap intervals of 5 minutes, 30 minutes, 60 minutes and 240 minutes. The effect of nap duration on memory encoding will also be examined.

Naps are a global phenomenon and a commonly adopted lifestyle countermeasure to reduce sleepiness and performance impairments. Experimental studies have also shown that naps can improve cognitive functioning and enhance memory and mood. However, the implementation of naps is highly varied amongst individuals, and it remains uncertain what duration of naps achieves the greatest cognitive benefit. Given the potential for naps to boost productivity in societies such as ours where insufficient nocturnal sleep is prevalent and where work hours are long, an investigation of the optimal nap duration is warranted.

Previous studies suggest that the benefits of brief naps (5-15 minutes) occur immediately after the nap and last a limited period (1-3 hours). Longer naps (\>30 minutes) are more likely to produce some temporary decrements due to sleep inertia but have the potential to improve cognitive performance for a more sustained period. These findings need to be strengthened through replication and extended to include memory measures that are evaluated over a longer post-nap testing period. To evaluate the nap duration that achieves maximal cognitive gain with practicality of implementation, the present work employs a within-subject design comparing nap durations of 10 minutes, 30 minutes, and 60 minutes with a no nap condition on benefits to alertness, vigilance, mood, speed of processing and memory over post-nap intervals of 5 minutes, 30 minutes, 60 minutes and 240 minutes. The effect of nap duration on memory encoding will also be examined.

The investigator's findings are expected to inform theoretical models of sleep and cognition and will aid in the design of practical lifestyle strategies to alleviate sleepiness and improve cognitive performance that may be adopted in an everyday context to boost societal well-being and productivity.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged from 21 - 35 years and who have an average sleep duration of 6-6.5 h are eligible for this study.

Exclusion Criteria:

* Participants who have an average sleep duration of less than 6 h or more than 6.5 h, who report sleep apnea symptoms, who report drinking more than 5 cups of caffeinated drinks a day, who have a BMI greater or equal to 30, or report elevated depression or anxiety symptoms will be excluded.
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

To purpose of this study is to assess the safety and tolerability of intravenous (IV) tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia (CAP).

This is a multicenter, open-label study evaluating the safety and efficacy of tigecycline in the treatment of Japanese subjects with CAP. Subjects with clinical signs and symptoms of CAP who meet the eligibility requirements will be considered for enrollment. Qualifying subjects will be assigned to receive tigecycline via IV administration for 7 to 14 consecutive days. The exact duration of administration of the study drug will be at the discretion of the investigator, based on the subject's condition. Subjects will be followed for safety until the test-of-cure (TOC) assessment 10 to 21 days after the last dose of therapy, and for efficacy until TOC assessment.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized Japanese descent subjects known or suspected to have CAP with a severity that requires IV antibiotic treatment.
* Chest radiograph within 48 hours before the first dose of IV test article showing the presence of a new infiltrate.
* The presence of fever or hypothermia within 24 hours before the first administration of test article, and of at least two signs/symptoms of CAP within 24 hours before the first administration of test article.

Exclusion Criteria:

* Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
* Hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of safety and efficacy of tigecycline.
* Known or suspected hypersensitivity to tigecycline or tetracyclines, or contraindication for these antibiotics.
Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factor receptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung, and head and neck. Blockade of the EGFR results in inhibition of multiple downstream pathways, leading to slowed tumor growth. In addition, these inhibitors may enhance anti-tumor immune responses through uncharacterized mechanisms. While producing significant responses in many settings, EGFR inhibitors also result in significant skin toxicity (rash) in a high percentage of patients. Multiple studies have correlated the presence and severity of rash with clinical response. Unfortunately, severe rash can often lead to dose delays, reductions, or even discontinuation of EGFR inhibitors, thus limiting their efficacy. The mechanism of both the rash and its correlation with tumor response is poorly understood. Skin biopsies display a robust leukocyte infiltrate, but a systematic analysis of the type of infiltrating leukocytes, activation state, or homing receptor expression has not been performed. Chemokines and chemokine receptors control leukocyte trafficking to the skin and other tissue sites, and defined receptor profiles for skin-, gut-, and lung-homing leukocytes are well established. In this study, the investigators propose to evaluate the homing phenotype of leukocytes from peripheral blood and skin biopsies of patients receiving EGFR inhibitors. The investigators will use RNA microarrays to evaluate the expression of chemokines and other key genes regulated in skin during treatment. The investigators will utilize in vitro methods to investigate effects of EGFR inhibitors on imprinting of T cell tissue-specific homing receptors. The investigators will examine correlations among the pathologic data, clinical findings, and tumor response. If validated, peripheral blood evaluation could potentially be used as a predictive indicator for patients receiving EGFR inhibitors. This study may also identify novel targets for limiting skin toxicity while receiving EGFR inhibitors, thus allowing maximal dosing and clinical response from these agents.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible if they have histologically proven adenocarcinoma, are planning to or currently undergoing treatment with an anti-EGFR (epidermal growth factor receptor) therapy, and are 18 years of age or older.

Exclusion Criteria:

* None
The Efficacy of TBCT Compared to ERP in the Treatment of OCD Patients, by the Assessment of Magnetic Resonance.

This is a sample made up of ninety-six adult individuals of both sexes to be divided into three groups: the experimental group of thirty-two patients with OCD who will be undergone Trial-Based Cognitive Therapy; the gold standard, with thirty-two people with OCD subject Exposure and Response Prevention and the control group of thirty-two healthy individuals. Interviews and therapeutic intervention occur in private practices researchers or medical schools accredited by UESPI.

Experimental group: Will be eligible adults of both sexes with educational level equal to or higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed according to criteria DSM-IV (APA, 1994). It is going to be excluded patients who had previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.

OBJECTIVES

Evaluate the effectiveness of Trial-Based Cognitive Therapy (TBCT) compared to Exposure and Response Prevention (ERP) in the treatment of OCD patients, by neuroimaging tests such as MRI.

1. Describe the neuroanatomical profile of the sample participants before and after the psychotherapeutic intervention by MRI;
2. Compare the profile neuroanatomical between the experimental group and the control group by MRI;
3. Identify possible neuroanatomical differences in the participating sample of pre and post-treatment, both among individuals and among psychotherapeutic intervention groups;
4. To investigate associations between the results of MRI scans and indexes the scales currently used to assess severity of OCD.

Eligibility Criteria:
Inclusion Criteria:

* Will be eligible adults of both sexes with educational level equal to or higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed according to criteria DSM-IV

Exclusion Criteria:

* It is going to be excluded patients who had previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.
Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS 681257 for reduction of plasma Lipoprotein(a) \[Lp(a)\] levels in participants with hyperlipoproteinemia(a) and established cardiovascular disease (CVD).


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of CVD defined as documented coronary artery disease, stroke, or peripheral artery disease
* Lp(a) plasma level ≥ 60 mg/dL
* Must be on standard-of-care preventative therapy for other than elevated Lp(a) CVD risk factors

Key Exclusion Criteria:

* Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/TIA
* Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis
* Heart failure New York Heart Association (NYHA) class IV
Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 to 3
* 18 years of age or older
* Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium
* Scheduled for surgery in supine position
* Given written informed consent

Exclusion Criteria:

* Participants in whom a difficult intubation is expected due to anatomical malformations
* Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
* Participants known or suspected to have a (family) history of malignant hyperthermia
* Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medications used during surgery
* Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium
* Female participants who are pregnant or breast-feeding
* Females participants of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), intrauterine device (IUD), abstinence\]
* Participants who had already participated in a Org 25969 trial including Protocol 19.4.305
* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305
Expanded Access Protocol for Patients With Eosinophilic Esophagitis

This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.

Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months. Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic visits.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥12 years of age at the time of informed consent
2. Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents
3. Confirmed medical history of EoE
4. Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options
5. Willing and able to adhere to the treatment regimen and visit schedule

Exclusion Criteria:

1. Have known contraindication, hypersensitivity, or intolerance to corticosteroids
2. Have signs and symptoms of adrenal suppression or hypercorticism
3. Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
4. Have current alcohol or drug abuse in the opinion of the Investigator
5. Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program
6. Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program
Prevention of Developmental Delay and Xylitol (PDDaX) Study

The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children.

Additionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes).

The researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Child born during the PPaX trial
* Enrollment age between 4-8 years old
* Parental or legal guardian consent obtained
* Willing to undergo 3 neurodevelopmental tests
* Willing to travel to BCMF for neurodevelopmental assessment
* Assent by the pediatric subject for participation in the study

Exclusion Criteria:

* Parent or legal guardian cognitively unable to provide consent
* Child unwilling to provide assent to participate in the study
A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.

Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria

Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
* Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
* After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
* After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
* Able to tolerate rescue medication with acetaminophen
* Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

* Pregnancy, lactation
* OA of Kellgren-Lawrence grade 4
* OA pain in the contralateral knee requiring medication (OTC or prescription)
* History of OA of either Hip or Hands
* History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
* History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
* History of Drugs or Alcohol abuse within the previous year
* Symptomatic peripheral vascular disease of the study leg
* Any musculoskeletal condition
* Skin disease at the application site
* Active asthma requiring periodic treatment with systemic steroids
* Known history of positive HIV, hepatitis C virus, or HBsAg
* Uncontrolled hypertension
* History of myocardial infarction, thrombotic events, stroke etc.
* Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
Peer-enhanced Intervention to Support Teen Weight Loss

The purpose of this study is to determine whether adding a peer-based intervention based on an outward bound model is more effective than a standard behavioral weight intervention for helping adolescents lose weight.

The prevalence of overweight in children and adolescents has increased significantly during the last two decades. While there are empirically supported weight management interventions for school age children, treatment findings with overweight adolescents are not as consistent. A potential limitation of weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment. We have promising findings from a pilot study that involves adding an innovative peer-based intervention (peer-based skills training; PBST) to cognitive- behavioral weight management treatment for adolescents. The purpose of the proposed study is to expand the pilot by: 1) increasing our sample size, 2) assessing weight loss over a longer time period, and 3) evaluating the role of psychosocial variables, as well as physical activity and diet, in mediating treatment outcome. It is hypothesized that overweight adolescents randomized to cognitive-behavioral treatment with peer enhancement will demonstrate greater weight loss at long term follow-up than adolescents randomized to cognitive-behavioral treatment with exercise.

One hundred and fifty adolescents between the ages of 13 and 16 years and 20% and 90% overweight will be randomized to one of two treatment conditions: 1) Cognitive-Behavioral Weight Loss Treatment with Peer-Based Skills Training (CBT+PBST) or 2) Cognitive-Behavioral Weight Loss Treatment with Exercise (CBT+EXER). Measures of height, weight, physical activity, diet, and psychosocial functioning will be obtained at baseline, end of treatment, 12 months, and 24 months after randomization. A between-groups t-test will be conducted to evaluate group differences in change in percent overweight between baseline and 24-month follow-up. Hierarchical linear modeling will be used to assess the pattern of weight loss for the two treatment groups across four time points: baseline, end of treatment, 12 month, and 24 month follow-up. Effects of treatment on psychosocial measures will be analyzed using mixed analysis of variance with treatment condition as the between subjects factor and a within subject factor of time. Finally, a series of regression analyses will be conducted to evaluate the role of psychosocial variables, physical activity, and diet, as mediators of treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents 13-16 years old
* 20-90% overweight with reference gender and age
* At least 1 parent who can participate
* English speaking
* Agree to study participation and random assignment
* Be available for long-term follow-up

Exclusion Criteria:

* Current involvement in another weight loss program
* Unable to adhere to prescribed dietary plan and physical activity due to medical condition
* Unable to understand intervention materials
* In treatment for or diagnosed with psychiatric disorder
The Registry of Oncology Outcomes Associated with Testing and Treatment

This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.

This is a master observational trial (MOT). Anyone who has been diagnosed with advanced cancer is eligible as long as they are a candidate for treatment. Each patient will receive testing and treatment as determined by patient in consultation with physician. ROOT will proceed in two directions: (1) Validation Cohorts. These patients will demonstrate the ability of the MOT to prospectively collect data using the same protocol and related documents, standardized data elements and processes, and accepted scientific endpoints; and (2) Analysis Cohorts. The modular nature of the study allows collection of RWD ranging from diagnosis only to the full treatment course of the of the patient. Patients are grouped to allow focused data collection or a specific analysis. Analysis cohorts can be created from patients already enrolled in ROOT or be defined prospectively. Because of the ongoing advancements of molecular based oncology, this trial allows a detailed focus on molecular testing as part of any cohort.

Data is reported by the group that is most qualified to provide this information and is proved, at point of care, using standardized data elements and processes. Physicians will report diagnosis, molecular characteristics, staging, disease burden, significant comorbidities, treatment response, and medical decision making. Molecular testing (reports and details) will be requested from testing laboratories. Any diagnostic films will be received digitally from the location the study was performed. Research staff assist in data entry and providing physicians needed data as part of the regular workflow to allow point-of-care reporting.

The Validation Cohorts and Analysis Cohorts may run sequentially or in parallel with each other.

Eligibility Criteria:
Inclusion Criteria:

* Patient or representative provides written informed consent
* Patient is diagnosed with advanced malignancy
* Patient is willing to be treated for this malignancy according to a plan determine by them and their physician
* patient will be willing to have regular follow up visits as part of their standard of care

Exclusion Criteria:

* patient is not a candidate or does not desire any treatment for their disease