cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a)

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-65 inclusive and weighing ≥ 50 kg at the time of informed consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI \< 35.0 kg/m2
* Subjects must have Lp(a) ≥ 75 nanomoles/liter nmol/L (30 mg/dL) at Screening

Exclusion Criteria:

* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
* Treatment with another Study Drug, biological agent, or device within one-month of screening
* Regular use of alcohol within 6 months of Screening
* Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
* Smoking \> 10 cigarettes a day
* Considered unsuitable for inclusion by the Principal Investigator
Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea

The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* both parents ethnically Japanese, or one parent Japanese and the other east-Asian
* PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and \<80% of apneas and hypopneas are obstructive
* cNEP collar fits and is well-tolerated

Key exclusion Criteria:

* BMI \>34
* abnormalities in neck structure
* sleep disturbance other than obstructive sleep apnea
* serious medical illness
* pregnancy
Responsible Side Effects Management in Oncology

Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.

Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's reported by patient with the ones recognised by the oncologist, and vice versa, during antineoplastic treatment.

Eligibility Criteria:
Inclusion Criteria:

all cancer patients receiving systemic antineoplastic treatment, ECOG 0-2

Exclusion Criteria:

age \<18, \>75; other active and severe comorbidities; no solid cancer; IUC patients
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.


Eligibility Criteria:
Inclusion Criteria:

* Female Patients Over 18 Years Old
* Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
* Signed Informed Consent Form (ICF)

Exclusion Criteria:

* Patients With LDL-C Below 90 mg/dL
* Pregnant Or Breast Feeding
* Diabetes Mellitus
* Or Any Clinically Relevant Organ Disfunction
Alleviation of Common Cold Symptoms

Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health care system billions of dollars annually. This double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory throat sprays against placebo and against a throat spray taken in conjunction with 325mg of aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants having common cold symptoms lasting less than two days were enrolled and given treatment to administer at home. Various common cold symptoms were assessed and measured via clinically validated self-assessment scales. Participants were screened for influenza and COVID-19 before enrollment and were excluded if found positive.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy adults with cold symptoms including sore throat who do not meet any of the exclusion criteria listed below,
* who rate their sore throat at least a 3 on a 10-point scale,
* who have had a sore throat for less than 48 hours by the time they complete the intake clinical trial manager (CTM) assessment.

Exclusion Criteria:

* Sore throat for more than 2 full days at the time of intake CTM assessment
* Fever or development of fever during the course of the trial
* Positive COVID-19 test or influenza test at clinical trial administrator (CTA) visit
* Likelihood of strep throat (to be determined by physician PI to the best of their ability)
* Less than 2 doses of the coronavirus (COVID-19) vaccine
* Any allergies to eggs, milk, or aspirin
* Females who are pregnant or test positive for pregnancy at the CTA visit
* Any chronic disease such as asthma, hypertension, post-nasal drip, gastroesophageal reflux disease (GERD), cardiopulmonary obstructive disorder (COPD), diabetes, cancer, HIV
* Any history of allergy in the last 14 days for which they took medication
* Anyone with fever above 101 or who has taken medication other than birth control in the last 30 days
* Anyone taking an Angiotensin Converting Enzyme (ACE) inhibitor
* Participation in another clinical trial within the last 6 months or during this trial
* Anyone who smokes
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Participant or guardian health proxy must provide informed consent before any study assessment is performed.
* Male or female participants aged ≥ 12 years.
* Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval.
* Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization.

Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.

Exclusion Criteria:

* Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
* Presence of severely impaired renal function defined by estimated creatinine clearance \< 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening.
* In the opinion of the investigator, unlikely to survive for \> 24 hours from randomization.
* Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
* Currently receiving ECMO.
* Participant may not be sharing a ventilator, or co-ventilating, with any other patient.
* Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization.
* Treatment with a JAK inhibitor within 30 days of randomization.
* Participants who are on long-term use of antirejection or immunomodulatory drugs.
* Pregnant or nursing (lactating) women.
Continuous Local Anesthesia Versus Continuous Femoral Nerve Bloc After Total Knee Arthroplasty: Impact on Mean Discharge Aptitude Delay

This study aims at comparing continuous local anesthesia and femoral nerve bloc for total knee arthroplasty in terms of post-operative recovery.


Eligibility Criteria:
Inclusion Criteria:

* Total knee arthroplasty
* Age \> 18 years with social security covering.
* Written informed consent

Exclusion Criteria:

* Age \< 18 years
* ASA Physical Status \> III
* Body weight \< 50 kg
* Latex or silver allergy.
* Loco-regional anesthesia contraindication
* Chronic anticoagulant, corticoid or pain treatment.
* Rivaroxaban or enoxaparin contraindication
* Communication issues
* Patient under guardianship
* Pregnant or breast-feeding patient
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment

The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female subjects aged 18 to 70 years, with hepatic impairment conforming to Child-Pugh class A, B or C
* Healthy subjects to the extent possible matched to the first four hepatically impaired subject in each Child-Pugh class with regard to age (approximately ± 10 years), body weight (approximately ± 20%) and gender

Key Exclusion Criteria:

* History of esophageal and gastric variceal bleeding within past 6 months
* Primarily cholestatic liver diseases
* Active alcoholic hepatitis
* Stable encephalopathy of \>= Stage 2
* Presence of severe ascites or edema
* Presence of hepatopulmonary or hepatorenal syndrome
* Positive for HCV, unless HCV RNA is undetectable
Abequolixron (RGX-104) and Durvalumab in Lung Cancer

Non-Small Cell Lung Cancer (NSCLC) is one of the deadliest types of cancer. In lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. Neoadjuvant therapy may have advantages such as, it may be more tolerable prior to surgery, earlier treatment may be more efficacious, and it can provide an indication of treatment response. Neoadjuvant treatment can provide pre- and post-treatment specimens for correlative analysis to better understand mechanisms of action and resistance.

This pilot study will investigate the effects of neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist, in subjects with NSCLC who are scheduled to undergo surgical resection as part of their standard of care.

The purpose of this study is to study how well using a combination of durvalumab, platinum doublet chemotherapy (carboplatin/abraxane or carboplatin/pemetrexed), and abequolixron treats non-small cell lung cancer before surgery. Durvalumab (a type of immunotherapy) and platinum doublet chemotherapy are drugs that are individually approved for use during the treatment of cancer. FDA (Food and Drug Administration) has not approved the combined use of these drugs in treating non-small cell lung cancer. Abequolixron is not FDA approved for the treatment of cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent obtained to participate in the study and

   HIPAA authorization for the release of personal health information.
2. Age ≥ 18 years at the time of consent.
3. Histologically or cytologically confirmed non-small cell lung cancer for which surgical resection

   would be standard of care.
4. ECOG Performance Status of 0-1
5. Body weight of \> 40 kg
6. Is able to swallow and retain oral medication.

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 3 weeks
2. Concurrent enrollment in another clinical study unless it is an observational (non-interventional)

   clinical study or during the follow-up period of an interventional study.
3. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment with the

   exception of those mentioned in this protocol. Concurrent use of hormonal therapy for noncancer-

   related conditions (e.g., hormone replacement therapy) is acceptable.
4. Lack of full recovery from a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
5. History of allogenic organ transplantation.
PET/CT to Image Hypoxia in Head and Neck Tumours

Patients with head and neck cancer will be imaged with PET scan and CT scan in order to determine areas of the tumour that are hypoxic.

It is hypothesized that PET /CT will provide information on hypoxia of the tumors and tumor regions in head and neck cancer patients.

Patients with head and neck cancer greater than 3 cm will imaged with PET scan and CT scan in order to determine areas of the tumour that are hypoxic. Following surgical removal, samples of the tumour will be evaluated for the expression of hypoxia genes. The preoperative imaging will be compared to the "gold standard" measures of hypoxic response at the level of gene transcription and a new hypoxia marker with the hypoxyprobe detection system (pimonidazole).

Hypothesis: FDG/PET visualization of glycolysis combined with CT visualization of blood flow will correlate with cellular response to hypoxic stress in head and neck tumors and intra-tumor regions. Measurement of relative levels of mRNAs encoding hypoxia response genes will be performed in cells microdissected from the surgical samples. Good correlation between imaging signals and direct molecular measures of hypoxic response in primary human tumors will provide information necessary to develop treatment strategies that employ targeted, increased radiation to hypoxic tumors.

Pimonidazole is an exogenous nitro-imidazole marker, which can be detected through immunohistochemical analysis of frozen sections. It detects cellular hypoxia upon becoming reduced in cells with low oxygen tension, a property that can be detected through antibody mediated detection of the reduced form. It has also shown to reliably and specifically stain hypoxic regions within the tumor, and to correlate well with patient prognosis and treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* All patients with head and neck tumours (\>3cm diameter) without bone involvement.

Exclusion Criteria:

* Known allergy to contrast agents
* Poor kidney function (serum creatinine level \> 2.0 mg/dL or 177 mmol/L)
* Pregnancy
* Breast-feeding
* Unable to lie supine
* Patient who were biopsied or operated upon within the past month.
* Patient who were treated with chemotherapy or radiation within the past month.
* Tumors that were obscured by artifacts (e.g. tooth fillings) in CT scans.
Complementary or Alternative Medicine Practices Used by Women at Increased Risk for Breast Cancer

RATIONALE: Increasing knowledge about the complementary or alternative medicine practices used by women who are at increased risk for breast cancer may provide useful information for planning breast-cancer-prevention strategies.

PURPOSE: Clinical trial to determine how many women who are at increased risk for breast cancer use complementary or alternative medicine.

OBJECTIVES: I. Determine the prevalence of complementary or alternative medicine (CAM) practices among adult women who are enrolled in the Risk Assessment Clinic at the National Naval Medical Center Breast Care Center and are found to be at increased risk for developing breast cancer. II. Correlate the use of CAM with individual risk for breast cancer. III. Define the types of CAM practices used by this study population. IV. Identify reasons why this study population is using CAM.

OUTLINE: Patients are stratified according to prevalence of complementary and alternative medicine practices (enteral/parenteral vs psychologic/neurologic). Patients complete a Personal Risk Assessment form, pre-test/post-test knowledge questionnaires, and a survey questionnaire.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within approximately 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Enrolled in the Risk Assessment Clinic (RAC) of the National Naval Medical Center and found to be at increased risk for breast cancer based on at least one of the following: Estimated risk of at least 1.7% for developing breast cancer over the next 5 years, as determined by the Breast Cancer Risk Assessment Tool (BCRAT) Prior history of lobular carcinoma in situ or ductal carcinoma in situ Family history of breast or ovarian cancer consistent with autosomal dominant pattern of inheritance or empirically elevated risk of breast cancer based on a single first- or second-degree relative with breast or ovarian cancer Must have attended the RAC education session within past 3-6 months Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior cancer except ductal carcinoma in situ or basal cell carcinoma Able to read and understand English

PRIOR CONCURRENT THERAPY: Not specified
Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses

Title: Reducing malnutrition and helminthic infectious disease among primary school children by the school nurses: School-based non-randomized study in a developing country

Introduction: Globally, malnutrition alone with the infectious disease a widespread problem among primary school (5 to 12 years) children. Infectious diseases such as worm infestations are aggravated with nutritional disorders which most often lead to anemia and several complications. The prevalence of malnutrition and intestinal worm infestation/ helminthic infection is still high and the awareness level of those issues is immensely poor. However, there are limited studies that evaluated the impact of increasing health awareness by the development of the Health Awareness Program for Primary School Children (HAPSC) which is conducted by the experimentally placed school nurse in Bangladesh.

Objective: To increase health awareness and knowledge towards reducing malnutrition and intestinal worm infestation by implement and evaluate the impact of the Health Awareness Program for Primary School children (HAPSC) in Bangladesh.

Methods:

Design: A prospective, open-label, parallel-group (1:1), cluster non-randomization controlled trial (NRCT)

Site and sample: School children from four primary schools in the rural areas of North Matlab at Chandpur district at Chittagong division in Bangladesh.

Duration: The duration of this study is from August 2021 to March 2024 (32nd months).

Outcome variables:

Primary: changes in malnutrition among primary school children. Secondary: Evaluate and reduce the prevalence of intestinal worm infestation, increase awareness and knowledge regarding malnutritional and intestinal worm infestation, improvement of health behavior (eating and hygiene), frequency of school absent days, and health-related quality of life.

Conclusion: Health education by the health professional in the school setting may be an effective method for improving health behavior, and increasing awareness and knowledge levels about malnutrition and intestinal worm infestation from early childhood.


Eligibility Criteria:
Inclusion Criteria:

* The primary school children who are studying in class 1 to class 5 among male, female or others gender.
* The children's parents or legal guardians would like to give consent and are willing to participate in the study.
* Those, who will be agreed to receive health check-ups, answer questionnaires and are willing to give the sample for laboratory investigation.
* Who will stay in the same school and area till study completion.

Exclusion Criteria:

* The child is absent from school during the health checkup periods (at baseline) due to severe illness or without any reason and information.
* Who does not want to give consent and is not willing to participate.
* Who does not want to share their information and does not want to give the sample for laboratory investigations.
S100B Protein and Postoperative Cognitive Dysfunction

Primary aim of this study is to evaluate the association between postoperative cognitive dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic radical prostatectomy.

The neurocognitive assessment protocol will design to evaluate general cognitive function and identify patients with cognitive dysfunction. Neuropsychological tests of all patients will conduct on the one day prior to surgery, the seventh day after surgery, and the 3rd month after surgery, respectively. According to a consensus statement, cognitive function will assess using a battery of seven neuropsychological tests: Rey Auditory Verbal Learning Test (delayed recall), Trail Making Test (Parts A and B), Digit Span Test (forward and backward), and Grooved Pegboard Test (dominant and non-dominant hands). To determine a normal reference value of cognitive functions, a group of 20 healthy individuals appropriately selected with respect to sex, age and education level without any significant mental or somatic disorders and without operation were recruited as a control group. To determine the cognitive dysfunction, baseline score or time measurement were subtracted from test score and the difference was divided by the standard deviation of the score in the control group. The result was called the Z score. Z score was calculated for each test and, POCD was defined as a Z score greater than 1.96 in at least two of the seven tests, and/or a combined Z score greater than 1.96.

Serum levels of S100B protein will obtain from venous blood samples collected before surgery, after anesthesia induction, at 30 min and 24 h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* over 50 years old
* scheduled for robotic-assisted laparoscopic radical prostatectomy
* the body mass index ranged from 18 kg/m2 to 25 kg/m2
* American Society of Anesthesiologists class I, II or III

Exclusion Criteria:

* Patients with previous neurological deficit (symptomatic stroke, hemorrhage, transient ischemic attack)
* other neurologic disorders (epilepsy, trauma, intra- or extracranial malignancy)
* psychiatric diseases (schizophrenia, or depressive disorder)
* alcoholism or any other drug dependence
* serious hearing or visual impairment