cyrilzakka/clinical-trials huggingface dataset:
Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

The purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery.

Spinal fusion surgery to correct scoliosis causes severe postoperative pain in adolescents and pediatric patients. Thus, appropriate control of postoperative pain has a significant impact on postoperative recovery, patient satisfaction and reduction of hospital stay. Although pain control was achieved through only opioids, the importance of multimodal analgesia has recently been emphasized as opioid addiction and side effects increase.

Acetaminophen is recommended as a key factor in multimodal analgesia and previous studies performed in adult spine surgery showed that intravenous administration of acetaminophen reduced the postoperative pain and opioid consumption. In addition, acetaminophen is a drug widely recognized for safety in adolescents and pediatric patients and has a fast and predictable analgesic effect. Therefore, the purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery. Thus the specific aim of this trial the investigators will determine is;

1. The decrease in postoperative analgesic requirement following IV acetaminophen
2. The decrease in intensity of postoperative pain following IV acetaminophen
3. The quality of recovery including self-reported recovery, physical and functional recovery and length of stay
4. The preemptive analgesic effect of IV acetaminophen

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-3
* patients undergoing spinal fusion surgery

Exclusion Criteria:

* patients who refuse to participate in this study
* patients unable to communicate due to mental impairment or developmental delay
* patients allergic to acetaminophen or its additives or who are contraindicated in acetaminophen administration for other reasons
* patients with existing liver diseases or dysfunction (i.e. active hepatitis, clinically relevant chronic liver conditions, elevated liver enzymes)
* patients who are judged ineligible by the medical staff to participate in the study for other reasons
Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography

This pilot research trial studies the effects of dexamethasone in patients with non-small cell lung cancer that has not responded after previous treatment. Drugs such as dexamethasone can affect how tumors grow and respond to treatments. Imaging tests, such as fluoro-L-thymidine (FLT) positron emission tomography , use a small amount of radioactive substance to show changes in tumor cells. Studying the effects of dexamethasone on lung tumors using FLT positron emission tomography may help doctors plan better treatments.

PRIMARY OBJECTIVES:

I. To evaluate the effect of dexamethasone (Dex) treatment in patients with relapsed non-small cell lung cancer (NSCLC) using 3'-fluorothymidine (FLT) positron emission tomography (PET) as measured by changes in tumor maximum standardized uptake value (SUVmax).

SECONDARY OBJECTIVES:

I. Assess the reversibility of Dex-mediated changes in tumor FLT retention following the withdrawal of Dex.

II. Measure tumor Glucocorticoid Receptor alpha expression (GRα) from recent patient biopsy samples.

III. Analyze blood samples obtained during imaging to determine serum Dex concentration and for senescence markers in circulating tumor cells.

OUTLINE:

Patients receive dexamethasone orally (PO) twice daily (BID) on days 1-5. Patients undergo 3 fluorothymidine F-18 (18F)-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically proven advanced non-squamous NSCLC. Patients may have newly diagnosed recurrent progressive or refractory disease which may be localized or wide spread.
* No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear progression in that lesion (greater than 20% increase in longest diameter).
* Life expectancy of greater than 4 weeks
* Absolute neutrophil count \>= 1,000/mcL (measured within 2 weeks of registration)
* No history of human immunodeficiency virus (HIV) or active infections
* No history of diabetes
* No surgery in the last 2 weeks prior to study enrollment
* Has not received Dex or another corticosteroid in over 4 weeks prior to enrollment
* Ability to understand and the willingness to sign a written informed consent document
* Agreed to FLT-PET imaging and signed consent and eligible FLT-PET protocol 2006-127
* Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State University

Exclusion Criteria:

* Patients must have measureable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques (computed tomography \[CT\], magnetic resonance \[MR\] or PET); lesions in the previously irradiated area can be considered as measureable lesions as long as there has been an increase of at least 10 mm when compared to measurements obtained after completion of radiation
Neurofeedback to Aid Vets' Memory

Military deployment is associated with increased risk of mild cognitive impairment (MCI). Combat stress related memory deficits has been well documented. Mild cognitive impairment such as memory deficits are the most common and earliest symptoms of Alzheimer's disease and related dementia (ADRD). The complaints about declined memory are common in healthy and cognitively intact civilian older adults, but less understood in aging Veterans. Brain training strategies to enhance cognitive skills and especially memory processes are unmet needs in aging Veterans who are at additional risk for MCI induced by ADRD. Since currently there is no effective drug treatment to stop cognitive decline, non-invasive brain training to boost memory functions in older Veterans is an increasingly attractive option to attenuating decline in memory.

The proposed project is poised to investigate state-of-art neurofeedback (NF; biofeedback of brain activity) training for self-modulation of neural plasticity to boost memory performance in Veterans. The recent advance of NF with Brian-Computer Interface (BCI) has provided a novel way to examine brain functions and plasticity. Thus far, there have been limited applications that have developed effective experimental and clinical paradigms for rehabilitation in Veterans. Historically, brainwave patterns during memory task performance have been analysed offline, a methodology which does not allow real-time NF modulation and training. The central hypothesis guiding this research is that optimal memory-related brainwave patterns of a Veteran can be trained. The online NF allows maximization of brainwave patterns associated with healthier memory states.

The development of efficient NF paradigms to augment memory performance is an important first step for the application of this nonpharmacologic intervention to improve combat Veterans' memory functions and potential for treating MCI due to mild TBI or pain. The pilot work will start with wider range of Veterans using state-of-the-art wearable wireless brain-computer interface headset, which is affordable and can be easily set up in VAMCs and eventually in remote assessment settings. This innovative, cognitive neuroscience based, nonpharmacologic intervention serves to revolutionize the diagnosis and treatment of combat Veterans who are at risk for degenerative dementia.

Eligibility Criteria:
Inclusion Criteria:

* Veterans age 60 and older

Exclusion Criteria:

* Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazapines
Evaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression

The goal of this project is to conduct a pilot study to test the utility of a Natural Language Processing (NLP) clinical messaging tool to improve the reach and the quality (fidelity and competency) of coaches providing behavioral activation (BA) strategies through a mobile mental health app called Personalized Real-time Intervention for Motivational Enhancement (PRIME). This study will improve the reach of clinicians by using a NLP-powered messaging tool, which will ensure fidelity to the BA model and clinicians will have access to real-time clinical information about their patients to guide more targeted treatment (competence). If successful, PRIME could operate as a cost effective tool for clinicians to extend their reach and an accessible treatment for the population of those struggling with depression.


Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Read and speak English
* PHQ-9 score of 5 or greater or indicate that their depressive symptoms are interfering with their daily functioning (Item 10 of the PHQ-9 \> 2).
* To be consistent with the NIMH RDoC initiative, we will assess for co-morbid problems (substance abuse, anxiety, and psychosis), but will not exclude participants with psychiatric comorbidities
* Must own a mobile device on iOS or Android platforms that either Wi-Fi or 3G/4G ready;

Exclusion Criteria:

* Under 18
* Cannot read or speak in English
* Cannot attain suitable mobile device
Breaking up Sedentary Time in Rheumatoid Arthritis

This study will verify the effects of breaking up sitting time with short bouts of light intensity walking on vascular function in women with rheumatoid arthritis.

Women diagnosed with rheumatoid arthritis will participate in this randomized crossover trial. In one of the experimental sessions, the participants will remain 4-h on uninterrupted sitting, and in another day they will perform 3-min light intensity walk every 30 min to break up the sitting position. Vascular function will be assessed before and after each intervention using the following devices/techniques: a) transcranial Doppler ultrasound to assess the middle cerebral artery blood flow velocity at baseline and in response to CO2 breathing (5% CO2 mixture for 3 min), and to repeated sit-to-stand transitions; b) a multi-frequency linear transducer (7-12 MHz) attached to a high-resolution ultrasound machine to assess femoral artery dilation after reactive hyperemia (i.e., flow-mediated dilation); c) a laser Doppler probe attached to the skin surface of the right shin in order to quantify the Laser Doppler flux at baseline and during reactive hyperemia. Additionally, healthy age- and body mass-matched women will be recruited and will only perform the pre-intervention tests.

Eligibility Criteria:
Inclusion Criteria:

* Adult women diagnosed with RA
* From the Rheumatology Clinic at the Liverpool University Hospitals NHS Foundation Trust
* Aged 18-60 yr
* Non-smoker for at least 6months
* Able to provide written informed consent.

Exclusion Criteria:

* Cannot readily read and understand English.
* Currently smoking or within last 6 months.
* Alcohol consumption \>14units per week.
* Symptoms of or established cardiovascular disease (except hypertension)
* Previous stroke or myocardial infarction.
* History of diabetes or respiratory disease or chronic kidney disease.
* Musculoskeletal impairment/disability precluding physical activity
* Unstable medication (change in medication within the 3 months)
* Aged \<18 or \> 60 yr
* Currently pregnant
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV

The purpose of this study is to evaluate the first web-based cessation program developed expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care with a primary outcome of 3 month point-prevalence abstinence.

Positively Smoke Free on the Web is the first web-based cessation program developed expressly for people living with HIV (PLWH) who smoke tobacco. It is a resource that is ready for clinical use, but its feasibility and efficacy have yet to be studied. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) in a cohort of 69 PLWH smokers, and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care (total N = 138) with a primary outcome of 3 month point-prevalence abstinence.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmation of HIV infection
* Montefiore Medical Center Infectious Disease Clinic patient
* Current tobacco user
* Affirmed motivation to quit within the next 6 months
* Have home access to the Internet
* Read above 4th grade level (by REALM)
* Willingness to grant informed consent and undergo randomization

Exclusion Criteria:

* Pregnant or breastfeeding women
* People with contraindications to nicotine replacement therapy
* People currently receiving other tobacco treatment
* Spouses, partners, and/or roommates of current study participants
Head Elevation During Pre-oxygenation Can Delay Desaturation Time

This study is a randomized-controlled trial study comparing the association between several degree of head elevation and conventional position during pre-oxygenation to desaturation time in patients undergo endotracheal intubation with general anesthesia

Preoxygenation anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation with head elevation 20°, 30° and 45° and conventional position to the time of desaturation before endotracheal intubation in patients undergoing general anesthesia. This was a randomized clinical trial of 56 patients, divided into four groups (conventional or 0° head elevation group, 20° head elevation group, 30° head elevation and 45° head elevation group). All subject was preoxygenated for 3 minutes with 100% oxygen. Induction of anesthesia was started with fentanyl, propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes. There was a significant difference in mean desaturation time among the four groups (p = 0.011). The most significant different was in 45o head elevation group (p \< 0.05). . In patients undergoing general anesthesia, pre-oxygenation with head elevation 20°, 30° and 45° slows down the time for desaturation before endotracheal intubation compared to the conventional position. The 45° head elevation has the best result.

Eligibility Criteria:
Inclusion Criteria:

* undergo endotracheal intubation with general anesthesia for elective surgery
* aged 18-60 years old
* ASA physical status 1-2 preoperatively

Exclusion Criteria:

* Patients with difficult airway, cardiopulmonary disease, anemia, grade II obesity, pregnant, history of hypersensitivity to induction agents
* Patients did not give consent to follow the study
Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function

The objectives of the current study are to evaluate the efficacy and safety of HX106 in healthy adults with subjective memory complaints for improving neurocognitive functions and to find the changes of brain using magnetic resonance imaging and their associations with the neurocognitive function enhancement.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60 years old,
* Global Deterioration Scale score (GDS) of 2
* One or more symptoms of subjective memory impairment
* High school or higher levels of education.

Exclusion Criteria:

* Current pregnancy or breast-feeding
* Evidence of neurologic or medical conditions
* Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV),
* One or more major depressive episode during last 12 months
* Mini-mental status examination score of 24 or less
* Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
* Intelligence quotient less than 80
* Any history of head trauma involving loss of consciousness or seizure
* Contraindications to magnetic resonance imaging (MRI)
* Use of psychotropics in last 3 months
* Use of oral contraceptive medication
* Participation in other clinical trials during the study period that might affect the outcome of the present study.
Innovations in Placental Metabolism and Association With Antioxidants and Nutrients in Diabetes and Gestational Obesity

This research project aims to investigate, in an innovative way, the molecular pathophysiology of gestational complications induced by maternal obesity and gestational diabetes mellitus (GDM). These complications have an immediate impact on obstetric outcomes - such as pre-eclampsia and intrauterine growth restriction - as well as long-term consequences for the health of the mother and child. This proposal aims to advance the understanding of the relationship between subclinical maternal and placental inflammation with dietary components through a prospective cohort of pregnant women. To this end, a prospective cohort of pregnant women will be conducted with four follow-up waves: 13th-20th (baseline), 24th-28th, 32nd-36th gestational weeks and at the time of delivery. Retrospective data referring to the first trimester of pregnancy will be obtained from the medical records. Pregnant women will be invited to participate in the study by registering at the prenatal service. Women who start prenatal care with less than 13 weeks of gestation will be registered, for capture in the 2nd consultation. The initial sample calculation is 120 volunteers. Maternal blood samples will be collected at 2 times: 2nd trimester appointment and 3rd trimester appointment. Placental and umbilical cord blood samples will be collected immediately after delivery. Dietary consumption during pregnancy will be assessed by 2 24-hour recalls at each visit (1 in person and 1 by telephone). The identification of functional biomarkers in maternal blood and placenta will serve for prognostic purposes of gestational complications such as Gestational Diabetes Mellitus. The identification of dietary factors associated with obesity and gestational diabetes mellitus and associated complications will provide information that will serve as a basis for nutritional guidelines for pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years;
* Free from chronic non-communicable diseases such as high blood pressure and type 2 diabetes mellitus, except obesity;
* Free from infectious diseases;
* Carrying a single fetus;
* Intention to deliver at Maternity School-Federal University of Rio de Janeiro

Exclusion Criteria:

* Smokers;
* With low weight in early pregnancy (BMI \< 18.5 kg/m²). They will be verified by interview, before the signing the informed consent form.
Assessing Manual Acupuncture's Impact on Mucositis From Nasopharynx Cancer Radiotherapy: A Visual Analogue Scale (VAS) and Quality of Life Study

The goal of this clinical trial is to learn if acupuncture can play a role in reducing pain and improving the quality of life of post-radiotherapy nasopharyngeal cancer mucositis patients. The main questions it aims to answer are:

- Do manual acupuncture and medication therapy affect pain intensity as measured by the visual analogue scale (VAS) in patients with oral mucositis compared with sham manual acupuncture and medication?

Participants will receive acupuncture therapy 2 times a week for 3 weeks

This is a clinical trial study to evaluate the role of acupuncture in pain relief and improving the quality of life of nasopharyngeal cancer patients with post-radiotherapy mucositis. Participants were 30 men/females with mucositis in post-radiotherapy nasopharyngeal cancer aged 19-59 years. They will be divided into 2 groups: (1) verum acupuncture and (2) sham acupuncture. Acupuncture is scheduled 2 times per week for 3 weeks. Research assessment on pain scale and improvement in quality of life

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been proven by anatomical pathology examination to have a diagnosis of Nasopharyngeal Cancer.
* Subjects with adult Nasopharyngeal Cancer aged 19 years - 59 years.
* Nasopharyngeal Cancer Patients, who underwent bilateral Head and Neck radiotherapy.
* Patients diagnosed with mucositis.
* Willing to participate in the research until completion by signing an informed consent.

Exclusion Criteria:

* Nasopharyngeal Cancer patients who have distant metastases (based on the Tumor Node Metastasis (TNM) classification with the presence of metastases (M1)).
* Subjects who still smoke and consume alcohol to date.
* Patients have contraindications for manual acupuncture, namely the use of anti-coagulant drugs, the presence of infection or wounds at the puncture site, emergency conditions, and pregnancy.
* There is a history of allergy to stainless steel materials.
* Patients with blood clotting disorders; Platelets \<50,000/μL, Absolute Neutrophil Count (ANC) \<1000/mm3, patients undergoing anticoagulant therapy with International Normalized Ratio (INR) \>2.47
Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia

We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.

The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery

Exclusion Criteria:

* increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs
Self-Determination Theory and Motivational Interviewing

Self-Determination Theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes.

Participants would be randomly allocated into either the intervention group or the usual care group from baseline to 3 months follow-up. The intervention is based on integrated self-determination theory and motivational interviewing.

Eligibility Criteria:
Inclusion Criteria:

* patients with schizophrenia and Type 2 Diabetes
* between 20 years old to 80 years old
* can communicate in Chinese langue

Exclusion Criteria:

* can not communicate well
* have neurocognitive disorders