cyrilzakka/clinical-trials huggingface dataset:
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer


Eligibility Criteria:
Inclusion Criteria:

* Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
* Subjects must have Fitzpatrick Skin Type I, II, III or IV.
* Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion Criteria:

* Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
* Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
* Subjects must not have significantly tanned skin.
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects

The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.

This study is an open-label, randomized, cross-over design with three single-dose treatment periods and a washout of at least 10 days in between each treatment visit. The study period consists of 5 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose treatment), Visit 3 (second single-dose treatment), Visit 4 (third single-dose treatment) and Visit 5 (follow-up).

Target subject population is healthy male Japanese subjects aged 20-45 years. Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male, 20 to 45 years of age (inclusive).
* Body mass index (BMI) ≥ 18.5 and ≤ 25 (kg/m2).
* Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical findings). Hemoglobin level must be ≥ the lower limit of study centre reference range. 12-Lead ECG with QT interval corrected for heart rate using Fridericia's formula (QTcF) should be \> 340 msec and \< 450 msec.
* No habitual use of drug(s) and tobacco/nicotine-containing products for a minimum of 3 months prior to first dosing.
* Subjects must be willing and able to give written informed consent by signing an Institutional Review Board (IRB)-approved Informed Consent Form prior to admission to this study and follow the restrictions and procedures outlined for the study.

Exclusion Criteria:

* Past history of psychological or physical disorder which may affect the objectives of this study, in the opinion of the PI.
* An individual who has abnormal laboratory values (ie, suggesting hepatic, renal, cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate current or past medical history for participation based on the decision of the PI.
* A history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
* Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months prior to first admission day.
* Have serum (or plasma) EPA and/or DHA concentrations exceeding the upper limit of reference range for the "fatty acids profile, four-fraction" test, determined at Visit 1.
Manuka Honey Sinus Rinse Study

A trial investigating the effect of a sinus rinse in people with CF

People with with CF often have bacterial infection in their air ways. There is great interest in the different types of bacteria found within these infections.

This clinical trial looks at whether a novel sinus rinse device (that incorporates manuka honey) could help clear infection or reduce the amount and/or types of bacteria found within the upper airway. This study assesses the changes in the Sino-Nasal Outcome Test (SNOT-22) scores along with any changes in quality of life, before and after the use of a sinus rinse device for 30 days.

In addition to this, the amount and types of bacteria found in nasal swabs, the sinus rinse solution, and sputum samples, before and after using the sinus rinse device will be investigated. Sputum samples will also be monitored for changes in composition before and after using the sinus rinse.

Eligibility Criteria:
Inclusion Criteria:

* The patient is willing and able to give informed consent.
* The patient must be ≥ 18 years.
* The patient must have an established diagnosis of CF (one or more of the following) Sweat chloride \>60mEq/L Presence of two CF causing mutations.
* The patient must have chronic symptoms of rhinosinusitis according to the criteria of the European Position Paper on Rhinosinusitis (appendix A).
* The patient scores greater ≥ 7 on their SNOT-22 questionnaire.

Exclusion Criteria:

* The patient has ever tested positive for the bacteria Mycobacterium tuberculosis.
* The patient is currently using a nasal rinse protocol.
* The patient has undergone sinus surgery within 6 months.
* The patient suffers from nasal bleeding.
* The patient is currently undergoing systemic antibiotic therapy for infective exacerbation.
* The patient is using overnight oxygen via nasal cannula.
* The patient is participating in another clinical trial or has done so within the last 30 days.
* The patient has a known allergy to bee products.
* The patient has an objection to the use of bee products
Tecovirimat Intravenous Treatment for Orthopox Virus Exposure

* To provide a therapeutic option for patients not able to take the oral formulation of TPOXX (e.g., cannot swallow, vomiting) and who have confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) orthopox virus infections OR who have a significant vaccinia adverse reaction (as defined in the protocol) resulting from vaccinia vaccination, secondary transmission, or other exposure;
* To collect data on the safety of TPOXX IV (tecovirimat injection, 10 mg/mL).


Eligibility Criteria:
Inclusion Criteria:

1. Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection.

   Note: Patients with a negative orthopox virus diagnostic test but with epidemiological and clinical evidence of an orthopox viral infection, especially those with evidence of clinical disease progression, may be included. Primary/Treating physician may consult with sponsor's Subject Matter Expert; OR Have developed a significant vaccinia adverse reaction (e.g., eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure;
2. Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility;
3. Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting);
4. Is available for clinical follow-up for duration of the treatment and follow-up period;
5. Females of childbearing potential must use a highly effective method of contraception during treatment and for 30 days after the last dose of drug. Male patients with a female partner of childbearing potential must use an acceptable method of contraception and refrain from donating sperm during treatment and for 30 days after the last dose.

Exclusion Criteria:

1. Hypersensitivity to tecovirimat;
2. Unable or unwilling to cooperate with the requirements of the protocol;
3. Breastfeeding women: Nursing mothers will be counseled that tecovirimat has not been studied in breast-feeding women. Women who choose to continue breastfeeding will not be enrolled in this protocol. However, if a patient elects to stop breastfeeding for the duration of the study until 30 days after the last dose of the TPOXX IV, she may be enrolled.
Inter-relationship Between Vitamin D Requirements and Calcium Intake in Older Adults

This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial (RCT) aims to examine the impact of various levels of habitual calcium intake on dietary vitamin D requirements in older adults stratified by calcium intake. This will provide new data on the impact of different levels of calcium intake, ranging from low/moderate to high, on winter serum 25(OH)D levels, and their utilization and catabolism in adults.

The aim of this study is to perform a randomised controlled vitamin D3 intervention study in apparently healthy, free-living adults (aged 50+ y) to investigate whether different levels of habitual calcium intake, ranging from low-moderate to high, influence serum 25(OH)D concentrations and indices of vitamin D activation and catabolism during winter, when vitamin D intake is adequate versus inadequate.

This research will provide new data and scientific understanding in relation to the impact of different levels of dietary calcium intake on vitamin D requirements in the older adult population. As such, this new data will inform dietary reference values for vitamin D.

Eligibility Criteria:
Inclusion Criteria:

Consenting white men and women aged ≥ 50 y

Exclusion Criteria:

* Unwilling to discontinue consumption of vitamin D-containing supplements 4 wks before the initiation of the study and throughout the study.
* Planning to take a winter vacation (during the course of the 15-wk intervention) to a location at which either the altitude or the latitude was predicted to result in significant cutaneous vitamin D synthesis from solar radiation (e.g., a winter sun coastal resort or a mountain ski resort)
* Use of tanning facilities of any type.
* Pregnancy or planning to become pregnant during the study
* A severe medical illness,
* hypercalcaemia,
* Known intestinal malabsorption syndrome,
* Excessive alcohol use,
* Taking medications known to interfere with vitamin D metabolism
Intrathecal Dexmedetomidine Vs Epinephrine

Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients
* aged 18-55 years
* presenting for scheduled primary or secondary cesarean section
* candidates for single shot spinal anesthesia singleton pregnancy

Exclusion Criteria:

* patient refusal of spinal anesthetic
* if patient is not a candidate for spinal anesthesia due to history of coagulopathy, elevated intracranial pressure, infection at site of injection, etc.
* emergency cesarean section
* preexisting motor or sensory deficit
* suspected pre-eclampsia
* patient receiving combined spinal-epidural as anesthetic technique
* BMI \> 40
Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject)
* Fixed home/place of residence and can be reached by telephone
* On a stable dose of antipsychotic medications
* Able to swallow capsules

Exclusion Criteria:

* Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
* Treated with clozapine in past 30 days
* Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
* History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
* Uncontrolled hypertension
* History of thyroid disorder that has not been stabilized on thyroid medication
* Glaucoma
* Pregnant or nursing
* Subject has received an investigational product or participated in a clinical study within 30 day
Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients

Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine bark extract.

Objective: The main objective of present study is surveying the effect of French maritime pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the first human study in the world.

Method: this is double-blind, randomized controlled trial. Block randomization are used. Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for assessment of clinical status of patients and Nutric questionnaires for assessment of nutritional status filled out at the base line, 5th day and the end of study. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked by phone within 28 days of the start of the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th day of intervention are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.

Randomization:

investigators randomly assign eligible patients on enrolment (1:1) to either the control group or the intervention group. Randomization is stratified by site and a randomization list of unique patient identifiers is generated by the study statistician using a computer-generated random block size. The classification is based on age (18 to 40 and 40 to 65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using quadruple blocks.

Eligibility Criteria:
Inclusion Criteria:

* Admission in ICU due to TBI2
* 18 year ≤ age ≤ 65 year
* GCS score ˃ 8
* Stable hemodynamic and metabolic status in the first 24 to 48 hours
* Having enteral nutritional support
* Fill out the informed consent form by the patient or first-degree relatives of the patient

Exclusion Criteria:

* Pregnancy and lactation
* Morbid obesity: BMI ≥ 40
* Failure to start enteral nutrition in the first 24-48 hours
* Suffering from autoimmune disorders and HIV/Aids
* Suffering or having History of cancer and any liver failure
* Receiving positive inotropic medications including Dopamine, Dobutamine and Epinephrine
* Severe and active bleeding
* Suffering from Sepsis
* Having history of known food allergies
Automated Screen for Fetal Aneuploidy

The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old and can provide informed consent;
2. Subject has a viable singleton or twin pregnancy;
3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
4. Subject is planning to undergo chorionic villus sampling and/or amniocentesis for the purpose of genetic analysis of the fetus because of a suspected fetal chromosomal anomaly based on cell-free DNA test results, standard serum screening result, or fetal ultrasound abnormality.
5. OR the subject has already undergone chorionic villus sampling and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.

Exclusion Criteria:

1. Subject (the mother) has known aneuploidy;
2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.
SEDentary Lifestyle, Mortality and Major Adverse Clinical Outcomes in Chronic KIDney Disease

The goal of this study is to learn if a simple home exercise program can benefit patients with advanced chronic kidney disease. There is also an observational part of the study without an exercise program.

The study will record patients' mortality, cardiovascular events, emergency department visits, hospital stays, need for dialysis and 6 minutes walking distance. Also maximal oxygen uptake, quality of life and bone fractures are recorded and blood tests and X-rays analyzed. The prospective observational part of the study will investigate the link between cardiovascular and kidney health as well as exercise capacity and adverse outcomes.

The prevalence of chronic kidney disease (CKD) and patients on maintenance dialysis is increasing, and affected patients are at elevated risk of premature death and adverse cardiovascular events.

Frailty is a term used to describe aging related attenuation of physical, mental, psychological and cognitive performance. Frailty is common in patients with CKD. Frailty is associated with increased mortality, hospitalization and falls in both the general population and in CKD.

Treatment of frailty is challenging due to its multidimensional nature and the old age and comorbidity of the affected patients. In spite these challenges, physical rehabilitation and training programs have been shown to successfully improve the prognosis of patients with CKD.

The investigators hypothesize that marked frailty is associated with a weak prognosis in spite renal replacement therapy and kidney transplantation. Because advanced predialysis stage CKD carries a high risk of adverse events and kidney transplants available are scarce, it is imperative to identify those elderly CKD stage 5 patients that benefit from initiating renal replacement therapy and those who are unlikely to benefit to avoid futile intensive treatment when it does not improve prognosis or quality of life. The investigators expect that the progression of frailty may up to a point be hindered using a simple physical exercise program that can be produced cost effectively to aid a large number of patients.

The trial aims to examine the benefits of an individual physical training education program in advanced CKD. In addition to the controlled trial setting the study examines the association between measures of frailty, physical and psychological capability assessed at study inclusion (baseline) and incident hospitalization, mortality, renal replacement therapy (RRT) and major adverse cardiovascular events during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age \>40 years
* Estimated glomerular filtration rate \< 20ml/min/1.73m2 (CKD stage 4-5)
* Informed consent from the patient is received

Exclusion Criteria:

* Maintenance dialysis dependency before inclusion
* Pregnant women
* Patient's lack of commitment to follow-up
* Chronic or acute clinical condition with a prognosis less than 6 months
* Amputated lower limbs
Hepatitis C Virus and the Humoral Immune System

The purpose of this study is to measure specific chemokines, antibodies, and antibody-producing B cells in the blood of patients with hepatitis C virus (HCV) infection. Our hypothesis is that changes in chemokine levels affect the development of an effective immune response against HCV.

The long-term goal of our research is to understand why immune complexes (ICs) are produced in patients infected with HCV, and whether these complexes affect virus interaction with target cells. We have found that many patients infected with HCV have an increased frequency of circulating B cells, but no evidence that the increased B cells are activated of proliferating. One possible mechanism for such an increase would be a change in levels of chemokines that influence B cell localization and trafficking. Our studies are aimed at testing the following hypotheses:

1. One hypothesis is that HCV infection results in increased levels of specific cytokines and chemokines that may affect the motility and localization of immature and mature B cells. An alternative model is that HCV infection leads to chronic antigenic stimulation of B lymphocytes, and that the abnormalities of B cell function associated with HCV infection reflect this chronic antigenic stimulation.
2. A second hypothesis is that autoantibodies and immune complexes present in HCV patient serum contribute to the persistence and spread of viral infection.

To test these hypotheses, we are measuring levels of chemokines, the frequency of circulating B cells (mature resting B cells, mature activated B cells, memory B cells, and immature B cells), and the levels and components of ICs in the blood of HCV-infected patients. Controls include healthy volunteers and patients with chronic liver disease unrelated to HCV infection. No interventions in patient care are planned. When patients elect to undergo standard antiviral therapies under the supervision of their hepatologists, we will study the outcomes of therapy (no virologic response, partial or transient virologic response, sustained virologic response) to determine whether any of the observed alterations in chemokine levels, B cell frequency or activation, or immune complex levels correlate with the patient's response to antiviral therapy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, no liver disease
* Chronic infection with hepatitis C virus
* Other chronic liver disease unrelated to hepatitis C virus
* Subjects in all groups must have sufficiently healthy veins to allow blood collection.

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigators, precludes the patient's participation