cyrilzakka/clinical-trials huggingface dataset:
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions

To compare the safety and efficacy of Perrigo's product to an FDA approved product, and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions


Eligibility Criteria:
Inclusion Criteria:

1. Males or non-pregnant females aged 18 months or older.
2. Must have a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
3. Must have a positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
4. Must have a positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
5. Must have a Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
6. Must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, and be able to complete the study.
7. Must be in general good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesion(s), that might interfere with the study evaluations.

Exclusion Criteria:

1. Subjects who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
2. Presence of any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
3. Presence of bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
4. Presence of secondarily infected bite or puncture wound.
5. Presence of systemic signs or symptoms of infection (fever defined as an oral temperature greater than 101°F or 38.3°C).
6. Requirement for surgical intervention for treatment of the infection prior to study entry.
7. Presence of cutaneous herpes simplex infections.
8. Use of any topical corticosteroid, topical antibiotic, or topical antifungal, on the secondarily infected target lesion, within 48 hours prior to Visit 1/Day 1.
9. Use of systemic antibiotics or systemic corticosteroids within 7 days of Visit 1/Day 1.
10. Primary or secondary immunodeficiency.
11. Diagnosed Diabetes Mellitus (controlled or uncontrolled).
12. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments.
13. History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study medication.
14. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
15. Subjects who, in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

The purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.

The purpose of the study is to examine the clinical effects of lozenges containing three extracellular matrix-degrading enzymes on dental plaque accumulation and removal, prevention of gingivitis, and oral microbiome composition after professional tooth cleaning, as compared to a placebo lozenge without enzymes. Two different concentrations of the enzymes will be tested, to investigate a potential dose-dependent effect of the enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral mucosa. The null hypothesis is that treatment with enzyme-containing lozenges does not affect plaque accumulation as compared to a placebo control.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy males and females ≥18 years of age.
* Able to read, sign and receive a copy of the signed informed consent form.
* Have at least 20 natural teeth.

Exclusion Criteria:

* Clinically visible active caries lesions and/or periodontitis.
* Significant oral soft tissue pathology based on a visual examination.
* History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
* History of allergies to ingredients in the test product.
* Self-reported as pregnant or nursing.
* Self-reported serious medical conditions.
* Antibiotic or anti-inflammatory medication within 30 days of screening visit.
* Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures.
* Acute sinusitis or severe oral-pharyngeal infections.
To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers

A Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inhibitor Itraconazole and the CYP2C19 Inhibitor Fluconazole on the Pharmacokinetics of a 25 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg. 2. Female subjects of non-childbearing potential. 3. Have a calculated creatinine clearance (CrCL) \>50 mL/min using the Cockcroft-Gault formula.

Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese. Asian (ie, China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable. 3. Current or past history of central serous retinopathy or retinal vein thrombosis,intra-ocular pressure \>21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Gastric Acid Suppression and Probiotic Colonization

Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.

All activities will be related to research. Participants will be randomized to receive either over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey data, serum, and stool samples will be collected at weeks -2, 0, and 4.

The intervention medication and probiotics have a very low side effect profile and are available over the counter. All data collection methods are non-invasive.

Elucidation of the effects of acid suppression on probiotic colonization will allow us to better understand the utility of probiotics use by individuals on acid suppression medications.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers ages 18 years and ≤ 75 years.
* Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.

Exclusion Criteria:

* Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity
* Previous abdominal surgery
* Currently pregnant or nursing
* Had H. Pylori Infection
* Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia
* Currently consuming herbs or probiotics
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma

The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.

By enrolling patients with nasopharyngeal carcinoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography （DSA） for nasopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of nasopharyngeal carcinoma based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except nasopharyngeal carcinoma
2. History of coagulation disorders or anemia
A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with heterozygous familial hypercholesterolemia diagnosed by genetic confirmation or clinical diagnosis criteria.
* Stable on pre-existing, lipid-lowering therapies (statins with or without ezetimibe) for at least 4 weeks with no planned medication or dose change for the duration of study participation.
* Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 70 mg/dL in patients with history of Atherosclerotic Cardiovascular Disease (ASCVD) or Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL in patients without history of Atherosclerotic Cardiovascular Disease (ASCVD).
* Fasting triglycerides ≤ 400 mg/dL.
* Body weight ≥ 40kg.

Key Exclusion Criteria:

* Subjects with homozygous FH (clinically or by genotyping).
* Receipt of LDL apheresis within 12 months prior to the first dose of Investigational product.
* Receipt of Lomitapide or Mipomersen within 5 months prior to the first dose of Investigational product.
* Prior use of PCSK9 inhibitors.
* Creatine kinase (CK) \>3 times of the upper limit of normal (ULN).
* Aspartate Aminotransferase (AST) ≥ 2 x ULN.
* Estimated Glomerular Filtration Rate (eGFR)≤ 30 mL/min/1.73m\^2.
* Thyroid-Stimulating Hormone (TSH)\> 1.5 x ULN or \<1 x LLN.
* Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c\> 8.5%).
* Subjects with untreated or active chronic hepatitis B or active hepatitis C virus infections.
Assessment of Pain Monitoring With ANI/NIPE Monitor Program in Pediatric Cardiac Surgery Postoperative.

The main objective is to assess correlation between ANI/NIPE values and external evaluation COMFORT B scale during painful medical cares and during said comfort medical cares in intubated children admitted in pediatric intensive care unit postoperative of cardiac surgery with extracorporeal circulation.

ANI/NIPE monitors is a continuous noninvasive measurement of the parasympathetic tone, as a component of the autonomous nervous system. It uses the tiny variations of heart rate induced by each respiratory cycle (natural or induced) to quantify parasympathetic tone (respiratory sinus arrhythmia).

Developed in surgical units, the ANI monitor has rarely been studied in pediatrics (only 2 publications, and only concerning peroperative measures). The NIPE monitor has only been available since 2014. Nevertheless, adult surveys and fundamental scientific publications on heart rate variations suggest that these monitors can evaluate pain on a continuous way. No study has been led in pediatric intensive care units.

In our study, a continuous blinded monitoring will be set up as soon as patients' admittance for all eligible subjects. We will study, for children in cardiac post-surgery, ANI/ NIPE values and COMFORT B values during both painful and non-painful cares to determine correlation between those values. We will analyze a posteriori the ANI/NIPE values, through a standardized protocol, to recount the sequence of care and to determine discrepancies in drug consumption. Data gathering will be made in the first 48h after admittance in Pediatric Intensive Care Units (PICU). Patients will not be followed after leaving PICU.

Eligibility Criteria:
Inclusion Criteria:

* ventilated children admitted in PICU postoperative of cardiac surgery with extracorporeal circulation, consent of the parental control, children benefiting from social security system

Exclusion Criteria:

* Heart rhythm disorder, use of heart rhythm disorder treatments, use of active pacemaker, which make ANI/NIPE values impossible to interpret
Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation

The investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). No further follow up was conducted.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 1-12 years undergoing MRI studies

Exclusion Criteria:

* Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations
A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping

This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Subjects with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive hysterectomy with lymph node mapping.
* Subjects with FIGO Clinical Stage IA cervical cancer ≤ 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping. Subjects with clinical Stage IA1 cervical cancer without lympho vascular space involvement (LVSI) and negative margins on cone biopsy are not to be included.
* Subjects with negative nodal status (N0)
* Subjects with negative metastatic involvement (M0).

Exclusion Criteria:

* Have had prior dissection and/or radiation in pelvis.
* Advanced cervical or endometrial cancer, T3/T4 lesions
* Diagnosis of cervical cancer with a tumor size greater than 2 cm.
* Locally advanced or inflammatory cervical or uterine cancer
* Metastatic cervical or uterine cancer.
* Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
* Known allergy or history of adverse reaction to Blue dye (Isosulfan blue) or triphenylmethane.
* Hepatic dysfunction defined as MELD Score \> 12.
* Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl.
* Subjects who have participated in another investigational study within 30 days prior to surgery.
* Pregnant or lactating subjects.
* Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
Far Infrared Treatment for Alzheimer's Disease

Alzheimer's disease is a progressive and fatal brain disease. This study will investigate the use of far infrared radiation treatment for the disease.

Alzheimer's destroys brain cells, causing problems with memory, thinking and behaviour severe enough to affect work, lifelong hobbies or social life. Alzheimer's gets worse over time and it is fatal.

Alzheimer's, which has no current cure, is the most common form of dementia. It is hereby postulated that far infrared radiation of the central nervous and endocrine systems will help with the management of the disease and possibly cure the disease.

Eligibility Criteria:
Inclusion Criteria:

* People with Alzheimer's disease

Exclusion Criteria:

* None
Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

Using of low concentrate sodium tetradecyl sulfate for sclerotherapy of telangiectasias should be no less effective than hypertonic glucose, and have a comparable frequency of adverse events.

For sclerotherapy of telangiectasias are used detergents. These are aggressive substances, which have a high frequency of adverse events. According to histological studies the safest concentration for the treatment of telangiectasias is less than that specified in the official instructions. The concentration of sodium tetradecyl sulfate 0.15% was effective and did not cause any adverse reactions in the treatment of telangiectasias from 0.8 to 1 mm in diameter. Small telangiectases (0.5 mm or less) require the treatment with the less aggressive sclerosing agent. Perhaps, the sodium tetradecyl sulfate 0.15%, 0.1% or even 0.05% and hypertonic glucose may be more effective and safe in this situation.

Eligibility Criteria:
Inclusion Criteria:

* women over 18
* single primary or secondary telangiectasias unrelated to the reticular veins
* signed informed consent to participate in the study

Exclusion Criteria:

* telangiectasias associated with reticular veins
* diabetes mellitus
* pregnancy or lactation
* malignant neoplasms
* inability or unwillingness of the patient to wear compression stockings
* hypersensitivity to one of the drugs
* concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena, known hereditary thrombophilia.
* period after treatment of alcoholism
* reception of oral contraceptives
* sedentary lifestyle
Fecal Microbiota Alterations in Steroid Refractory Active Colitis Ulcerosa

Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients suffering from this disorder. This study proposal aims at investigating changes in the intestinal microbiota that can predict a therapy refractory course of ulcerative colitis (UC) and may be used to identify high risk patients in an early phase of their disease.

The Investigators suggest that certain alterations in the intestinal microbiota are at least in part responsible for the inability of some patients to response to steroid therapy and probably also for the failure to other immunosuppressive therapies. Certain pathobionts have the capability to stimulate the mucosal immune system, thereby leading to chronic inflammation. On the other hand, commensals are necessary for repair processes in the mucosa and are providing metabolites that are used as an energy source for the colonic epithelium. An increase in pathobionts in combination with a lack of certain commensals might therefore maintain colonic inflammation despite immunosuppressive therapy with systemic steroids in patients with UC.

The investigators therefore plan to investigate the intestinal microbiota in UC patients before and 4 weeks after a systemic corticosteroid therapy and correlate potential alterations of the microbiota to the therapeutic response. Other factors like concomitant UC treatment, disease severity, disease extent and environmental factors will also be correlated to changes in the microbiota.

In the subgroup of patients not responding to steroids and requiring a rescue therapy with infliximab or a calcineurin Inhibitor, the predictive value of microbiota alterations will also be investigated.

If certain bacterial taxa can predict a steroid refractory and an unfavorable disease course, the results of this study will help in identifying possible microbiota based biomarkers for an individualized treatment approach in UC patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* Active ulcerative colitis with a Lichtiger score ≥4
* Patient scheduled for steroid therapy with systemic steroids (prednisolone or methylprednisolone) at standard dosing and patients who started steroid therapy not longer than 48 hours prior to the study inclusion.
* Written informed consent
* Established or suspected diagnosis of ulcerative colitis or indeterminate colitis

Exclusion Criteria:

* No follow up possible
* Bacterial intestinal infections (C. difficile, Salmonella, EHEC, Campylobacter, Shigella, Yersinia), parasitic or viral infection causing acute infectious diarrhea at baseline.
* Diagnosis of Crohn´s disease
* Planned initiation or discontinuation of probiotic therapy between baseline and follow up visit