cyrilzakka/clinical-trials huggingface dataset:
Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects

Study Design

* Randomized, double-blind, placebo-controlled, escalating single-dose design.
* Six ascending dose cohorts
* In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control).
* Primary Objective
* to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.

Secondary objectives:

* to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
* to compare the PK of HM10460A in Japanese and Caucasian subjects.
* to assess the relationship between the serum concentration of HM10460A and absolute neutrophil count (ANC).
* to assess the relationship between the serum concentration of HM10460A and CD34+ cell counts in the blood.
* To assess the immunogenicity potential of HM10460A by measuring binding antibodies (bAb) and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a single subcutaneous dose of HM10460A.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18 - 29.9 kg/m2
* have not used tobacco or nicotine containing products for at least 3 months prior to dosing
* be able to remain abstinent throughout the study.

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* positive urine drug/alcohol testing
* Positive for HIV, HBsAg, HCV ab
* History of anaphylactic reaction to medicine or environmental exposure
Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).
* At least 18 years of age.
* Female.
* Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Cognitive impairment.
* History of abdominal surgery precluding free flap donor site.
* Allergy or intolerance to bupivacaine or "amide" anesthetics.
* Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.
* Pregnant or breastfeeding.
Probiotics and Influenza Vaccination Response

Assess efficacy of oral ingestion of a probiotic product on immune function in a population of healthy adult men and women in a clinical vaccination study.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 16 - 65 y and healthy
* Self-reported regular Dutch eating habits as assessed by questionnaire (3 main meals per day)
* No influenza vaccination in 2022
* Non-smokers
* BMI 18.5-28
* Adherence to habitual diet
* no changes during study period
* Signed informed consent

Exclusion Criteria:

* Recent vaccination
* Acute or chronic illness (e.g., diabetes mellitus)
* Gastrointestinal disorders (e.g., inflammatory bowel disease)
* Acute gastroenteritis in the past 2 months
* Immunodeficiency disorder
* Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies)
* Unexplained weight loss or weight gain of \> 3 kg in the 3 months prior to pre-study screening
* Alcohol or drug abuse
* Mental status that is incompatible with the proper conduct of the study
* History of cancer
* Use of immune boosting supplements within 4 weeks before screening To be extended \& specified in protocol phase
Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Neck Pain

Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue.


Eligibility Criteria:
Inclusion Criteria:

* chronic nonspecific neck pain
* age between 20 and 40 years,
* either sex
* symptoms lasting longer than three months

Exclusion Criteria:

* Pregnancy
* Spinal surgeries
* spinal deformities
* visual or auditory issues
* ongoing physical or medical treatment for cervical or low back pain
Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with Malignant Pleural Mesothelioma.


Eligibility Criteria:
Inclusion Criteria:

* Inapplicable for radical operation
* Not received prior systemic chemotherapy
* Performance status: 0-1

Exclusion Criteria:

* Having a history of sensitivity to platinum agent, folic acid or vitamin B12
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder

The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.


Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis
* Age 9-12y
* Native German speaker

Exclusion Criteria:

* Allergy against fish and fish products
* IQ below 85
* Objections against pork gelatine
Self-Management in African Americans With Diabetes and Hypertension

The primary aim of the study is to design a group-based, culturally appropriate self-management skills training intervention for disadvantaged African-Americans with both diabetes and hypertension and to compile an intervention Manual of Operations (MOO). The investigators are developing an intervention to assist individuals in reducing weight and hemoglobin A1c.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus (HgA1c\>7%), requiring the patient to take at least one tablet per day or one insulin injection per day and a diagnosis of hypertension (130/80) requiring them to take at least one medication per day;
* Participants must identify themselves as African-American;
* Participant resides in or proximal to the North Lawndale neighborhood;
* Secure written permission from their physician to engage in moderate physical activity. This set of participants may be at high risk for cardiac disease and this exclusion avoids putting them at undue risk;
* BMI ≥ 25. Participant must be overweight because the main goal of our intervention is weight loss of 5% or more of initial body weight.

Exclusion Criteria:

* Diet-controlled diabetes;
* Hypertension controlled with lifestyle modification only;
* Endstage renal disease, stroke with paresis, congestive heart failure (NYHA class 3 or 4), or other major endorgan complication of diabetes;
* Comorbid conditions limiting probable life span to \<4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
* Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
* Unable to give informed consent;
* Are under the age of 18-While type-2 diabetes and hypertension are increasing in those under the age of 18, adolescent medicine is a separate specialty area from adult medicine. Interventions should be targeted specifically toward this age group to take into consideration the specific emotional and psychological needs of adolescents;
* Alcoholism as measured by the CAGE.screener for alcohol abuse.
Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma

The study's chief objective is to observe the evolution of cellular (in terms of expression of transmembrane transporters and their transcriptional regulators) and viral resistance (in terms of development of mutations in the HIV genome that may confer resistance to future treatment for HIV) in HIV-infected patients with lymphoma.

The study team will take two or three tubes of blood on three occasions during the course of chemotherapy. The total amount of blood required for this research project is 64mL (approximately 4 tablespoons).

This will allow better understanding of the changes that take place in the blood and the HIV virus itself. It is hoped that this will provide new insights that may aid the understanding and treatment of HIV patients with lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements.
* Documented HIV-1 infection.
* Diagnosis of lymphoma (with the exclusion of the five subjects that will be controls).
* On cART or about to start cART as part of clinical routine care before the initiation of chemotherapy.

Exclusion Criteria:

- Receiving anti-tuberculosis treatment.
Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study

This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.

Time-Restricted Eating (TRE) is a form of caloric restriction through daily prolonged fasting that has been shown to lead to weight loss, improved glucose regulation, and suppression of inflammation. Non-alcoholic fatty liver disease (NAFLD) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. The only current treatment for NAFLD is weight loss. In the proposed study, the investigators aim to test the hypothesis that TRE will add additional benefit in the treatment of NAFLD on top of standard of care diet and lifestyle modifications.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and \< 65 years old
* Must provide signed written informed consent and agree to comply with the study protocol
* BMI \>25 kg/m²
* Baseline liver fat content of at least 10% as measured by MRI-PDFF

Exclusion Criteria:

* Unclear etiology of liver disease
* Competing etiologies for hepatic steatosis
* Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:
* Positive hepatitis B surface antigen
* Positive hepatitis C virus RNA
* Suspicion of drug-induced liver disease
* Alcoholic liver disease
* Autoimmune hepatitis
* Wilson's disease
* Hemochromatosis
* Primary biliary cholangitis or primary sclerosing cholangitis
* Known or suspected hepatocellular carcinoma
* Current or recent history (\<5 years) of significant alcohol consumption. For men, significant consumption is defined as \>30g of alcohol per day. For women, it is defined as \>20g of alcohol per day.
* Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded.
* Reduction in weight by ≥ 5% within the prior 90 days
* Current fasting for ≥ 12 hours per day on the majority of days each week
* Pregnant females
* Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain
* Inability to perform MRI-PDFF and/or study as defined below
* Inability to medically perform prolonged fasting (i.e. insulin regimen)
LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)

The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.

Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of the tumor prior to initiating radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with radiographic evidence of suggestive of a primary high-grade glioma
2. Brain MRI with contrast demonstrates an enhancing mass within 60 days prior to registration. Patient must be deemed a candidate for LITT from MRI by Neurosurgery in order to be eligible.
3. History and physical including neurological exam within 30 days prior to registration
4. Karnofsky performance status ≥50% within 30 days prior to registration
5. Age ≥ 18 years old
6. Patients must have signed an approved informed consent
7. Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
8. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

Exclusion Criteria:

1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation
2. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:

   * History or presence of serious uncontrolled ventricular or significant arrhythmias.
   * Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
3. Infratentorial tumor or evidence of leptomeningeal spread
4. Inability to undergo a MRI
5. Pregnant or breast-feeding women
Modified Story Memory Technique (mSMT) in Persons With TBI

The current RCT is designed to:

1. test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
2. assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other
3. evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
4. evaluate the long-term effects of the treatment protocol.

To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).

Outcome measures will assess objective memory abilities, everyday memory abilities and patterns of cerebral activation during learning. A long-term follow-up assessment will be conducted, designed to measure the impact of the mSMT 3 months following treatment completion. Alternate forms will be utilized wherever available.

Eligibility Criteria:
Inclusion Criteria:

* I am between the ages of 18-65.
* I have had a Traumatic Brain Injury at least one year ago.
* I can read and speak English fluently.
* I have difficulties with learning and memory skills.

Exclusion Criteria:

* I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications.
* I have had a prior stroke or neurological injury/disease other than a traumatic brain injury.
* I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
* I have unstable or uncontrolled seizures.
* I have a significant alcohol or drug abuse history.
Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic

This study aims to evaluate the effect of Virtual Reality (VR) as a distraction method to help those patients undergoing trigger points therapy to reduce anxiety and increase patient satisfaction. Half of the participants will wear VR gear, meanwhile the other half will be in control group, which will not wear VR headset, only the normal care.

trigger points can cause a wide range of pain symptoms; pain in the anterior shoulder and down the arm, headache pain, back pain, hip pain, knee pain, frozen shoulder pain, and other symptoms. Local anesthetic injections and lidocaine injections are common "wet" needling treatments for trigger points injections. The proposed mechanism by which trigger points injections alleviate pain is based on mechanical disruption of the taut bands of muscle with palpation based needling. During injections, patients may feel an intensified pain and a twitch response.

Distraction has been proved to be an effective tool in pain management, and it can also be used for a variety of medical procedures. By engaging in assigned tasks, pain and anxiety are assumed to be lessened throughout the procedure, while leaving patients less occupied by pain stimuli. . An immersive virtual environment may be preferable to medications such as sedatives, due to side effects and prolonged discharge from procedure suite. Occasionally, medications may not even be available in a busy interventional pain suite. At the UCD pain clinic, we do not offer sedating medications for bedside procedures like trigger point injections. By wearing VR headset, patients may feel less tense, anxious, and painful during trigger point injections.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old, who are referred to UC Davis Pain Medicine Clinic and are candidates for trigger point injections, are English speaking and can understand oral and written instructions

Exclusion Criteria:

* Patients who have high risk of motion sickness, seizure disorder, visual/hearing impairment, prisoners or are pregnant are not eligible for this study.
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion

The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.

Parenteral nutrition (PN) has been widely and successfully used in the pediatric population for more than 40 years, the most serious and significant life-threatening complication today continues to be parenteral nutrition-associated cholestasis(PNAC). Parenteral nutrition-associated cholestasis is indeed the most worrisome complication because it is difficult to treat and may progress to eventual cirrhosis and liver failure namely parenteral nutrition-associated liver disease (PNALD).

Two types of lipid emulsions are currently used for adult as well as pediatric patients: one lipid emulsions prepared from soybean oil that are composed of long-chain triacylglycerols (LCTs), and the other lipid emulsions composed of 50% medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion (20%) of polyunsaturated fatty acids(PUFAs)and 60% monounsaturated fatty acids (MUFAs). So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.

Eligibility Criteria:
Inclusion Criteria:

* Infants of both genders
* Hospitalized
* The parent of the infant agreed to participate by signing an informed consent form
* Infants admitted hospital within 72 hours after birth(gestational age\<37 weeks)
* Birth weight \<= 2000g
* No PN support contraindications
* Parenteral nutrition for 14 days or more
* The parent of the infant is to sign an informed consent form prior to enrollment

Exclusion Criteria:

* Receiving PN before screening
* Enteral nutrition(EN)caloric\>10%
* Obstruction jaundice
* Suspected or identified biliary tract atresia
* Neonatal hepatitis
* Infants with liver markers \>2 times normal levels
* Infants with renal markers \>2 times normal levels
* Congenital metabolic situations
* Identified as having major chromosomal disease
* Cytomegaoviyns(CMV), virus hepatitis and syphilis infection
* Congenital or acquired immune deficiency
Prevention of Postpartum Depression in Low-Income Women

This study will determine whether a prevention program reduces the incidence of postpartum depression in pregnant women who receive public assistance and are at risk for postpartum depression.

The impact of major depression in the postpartum period is profound, with considerable emotional pain for the new mother as well as disturbances in infant development. Unfortunately, few preventive interventions have been developed or systematically tested to reduce the risk of postpartum depression. An area of even greater neglect is the development of such an intervention for financially disadvantaged women who are at high risk for postpartum depression and for the disturbances associated with postpartum depression. This study will develop a psychosocial intervention for financially disadvantaged pregnant women at risk for postpartum depression.

Participants are randomly assigned to receive either the "Life at Home with a New Baby" intervention or care as usual. Women who receive the intervention join a counseling group in which information about mother-baby relationships is shared. This information is reinforced with a follow-up "booster" session after the infant is born. Participants are assessed at baseline, after the booster session (for the intervention condition) or after 2 weeks postdelivery (for the care as usual condition), and at 3 months postpartum. Depression levels and social adjustment are measured at baseline and 2 weeks after delivery. Functional status is also measured. A self-report questionnaire is completed by the mothers to measure parental distress, parent/child dysfunctional behavior, and difficult child interactions. At 3 months postpartum, a brief standardized interview is used to assess the presence of a depressive disorder.

Eligibility Criteria:
Inclusion criteria:

* Receive public assistance
* At risk for postpartum depression
* Pregnant women between 23-32 weeks gestation