cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties

The overall objective of this study is to assess how the use of the drug may shift the skin microbiome and skin biophysical properties. Specifically, the study objectives were to assess the following:

* How the drug affects the skin microbiome compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.
* How the drug affects the skin physical properties compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
* Male and female 18 years of age and older.
* Participants must have clinical diagnosis of moderate to severe rosacea.
* Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
* Have 2 nodules or less.

Exclusion Criteria:

* Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
* Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
* Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index

The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate OSA (5≤ AHI \<30)
* BMI ≤ 45
* Age ≥ 18
* Men \& Women

Exclusion Criteria:

* AHI ≥ 30
* BMI \>45
* Current use of steroids or anti-inflammatory medication
* Diagnosis of insulin dependent diabetes
* Diagnosis of autoimmune disorder
* Shiftwork
* Current use of CPAP
MRI Markers of Cartilage Damage in Knee With Osteoarthritis

The objectives of this study are: to identify and develop techniques to minimize precision errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if results from newly-identified MRI techniques in measuring cartilage changes and structure can be reproduced.

The development of a disease modifying osteoarthritis drugs (DMOADs) is currently limited by the inability to detect and monitor early cartilage damage that would be amenable to treatment. There is growing interest within the pharmaceutical and research community to use Magnetic Resonance Imaging (MRI) to identify biochemical and structural changes in the cartilage extra cellular matrix that occur early in the disease process. Although these techniques have been validated in small studies at single sites, multi-center evaluation of accuracy and precision, needed to apply these techniques to clinical trials of DMOADs, has not been performed. To address this need, the primary objective for this protocol is to identify and develop techniques to minimize systematic errors that decrease precision of MRI evaluation of knee cartilage, and to assess the reproducibility of the newly identified MRI techniques in measuring the cartilage morphometry and structure. Successful completion of this project may establish a multi-center imaging network in Pennsylvania for MRI evaluation of potential disease modifying osteoarthritis drugs (DMOADs) therapy.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be \>18 years old;
* Participants must have a KL score between 0 and 3;
* Participants must have clearance to use protocol specified equipment: 3T MRI with parallel imaging capability and phased array knee coil (minimum 4 elements);
* Participant had no change of treatment occur within the last 6 months;
* Participants have no plans of changing to a different treatment within the next 3 months;
* Participant must provide a study-specific signed informed consent form.

Exclusion Criteria:

* Patients with contraindication to 3T MRI: Claustrophobia, Implanted metal or medical device that is not approved for MRI scanning at 3T, pregnancy, inability to tolerate relative immobility for 1 hour;
* Patients with prior knee surgery or trauma of the knee;
* Patients with KL score of 4.
A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)

The objectives of this trial are to:

* Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus placebo following one week of treatment in subjects undergoing photorefractive keratectomy (PRK).
* Evaluate the potential of diquafosol to accelerate corneal wound healing/re-epithelialization following PRK.


Eligibility Criteria:
Inclusion Criteria:

* between age 18 - 45 years old
* candidate for bilateral PRK

Exclusion Criteria:

* dry eye disease
* any corneal pathologies
* previous corneal or intraocular surgeries
Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant

The objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant

Thirty-four patients with ASA classification I-II, who required oroendotracheal tube intubation, were studied in this prospective, double-blinded, randomized, clinical trial. Anesthesia was induced using fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg. Patients were randomly assigned to one of the two groups to receive either rocuronium 0.6 mg/kg or saline intravenously. The Mcgrath® VL intubation was initiated after 90s, when the patients were fully relaxed. The primary outcome was to compare tracheal intubating conditions between two groups. The secondary outcomes were the success rate in the first attempt intubation, time to intubation, the required propofol dose for intubation and anesthetic complications. Statistical analyses were performed using the R program version 2.14.2. The level of statistical significance was set at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old.
* ASA class I-II.
* Elective surgery required general anesthesia with oroendotracheal intubation

Exclusion Criteria:

* Suspected or known difficult airway.
* Patient with risk of aspiration with required of rapid sequence induction .
* Plan remained intubation.
* Allergic to drugs used in the study.
* Renal or hepatic disease.
Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes

The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.

Trampoline accidents are increasing since a few years. In Rennes hospital, pediatric emergencies are experiencing a subjective increase in admissions for trampoline trauma with increasingly early ages and severe trauma. The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.

In parallel, retrospective data analysis will be performed on the same data during the year 2008, to compare with a period before the explosion of trampoline sales.

Eligibility Criteria:
Inclusion Criteria:

* Child from 2 to 16 years old
* Childs admitted in emergencies unit for a trauma
* Parents not opposed in their child's participation to the study

Exclusion Criteria:

* Child under 2 years old (before learning to walk)
* Single wounds and head injuries not related to sports activities (Fall from a bed or from its height, simple wound with sharp objects)
Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery

Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer treatment. The purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with local rectal cancer, which is within 12cm from anus.
2. Male, 20-65 years old.
3. IIEF-5 score\> 21.
4. No obvious abnormal in external genitalia, testis, epididymis and spermatic cord.
5. Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.
6. Signed informed consent.
7. Recently take no drugs affecting sexual function (such as androgen replacement drugs, PDE5i and Chinese patent medicine, etc.).

Exclusion Criteria:

1. Suffering hypertension or diabetes.
2. In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery.
3. Patient's partner is trying to conceive during the trial period.
4. Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
5. Geographically inaccessible for follow-up visits required by protocol or want to other treatment.
Study of Glycogen Storage Disease Expression in Carriers

The purpose of the study is to determine whether carrier status for any type of glycogen storage disease (GSD) predisposes the carrier to GSD markers, like high cholesterol, by testing blood, urine, and saliva samples.

Subjects will be asked to contribute about a teaspoon of blood, 1 oz of urine, and 2 tablespoons of saliva samples in the morning before they have had anything to eat. The blood and urine samples will be tested for the markers of GSD, while the saliva sample will be used for genetic testing. Subjects' height and weight will also be measured.

Subjects will also be asked to fill out a questionnaire about symptoms common to full GSD expression that they may have experienced, as well as if they are currently on any medication to control their cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* parents and other family members of patients undergoing treatment for GSD at the University of Florida

Exclusion Criteria:

* pregnant females
Bioavailability of Pepper Carotenoids in Humans

- list item one, Peppers

We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific aims of this study are: 1) to determine blood response kinetics of lutein following multiple doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We will feed 16 healthy man and women (50 - 65 y, females were at least one year post menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood samples up to 21 days to determine blood response kinetics of xanthophylls following multiple doses of pepper dishes.

- list item one, Peppers

Epidemiological data show that carotenoids and ß-C are health promoting when taken at physiologic levels in foods. However, human absorption and metabolism of carotenoids contained in various food matrices has not been studied well. It is important to investigate the characteristics of absorption and disposal kinetics after eating carotenoid rich foods in order to gain a basic understanding of the biological characteristics of lutein, zeaxanthin, and other carotenoids in food sources.

We propose to evaluate bio absorption of pepper carotenoids in a 2-phase research study: phase 1 will utilize red bell-pepper and phase 2 will utilize non-pungent green jalapeno pepper. The pepper will be provided as a dish in a meal. We will feed 16 healthy man and women (50 - 70 y, females were at least one year post menopause), each with red pepper (phase 1) and/or green jalapeno pepper (phase 2) for \~ 4 days and donate blood samples up to 21 days. Volunteers will be randomly assigned to one of the following two phases: phase 1 and phase 2.

The study will provide us the information on the bioavailability of pepper carotenoids.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* GI track problems
Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age

The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA).


Eligibility Criteria:
Inclusion Criteria:

* SGA children.

  * Treated with GH at least 36 months.

Exclusion Criteria:

* Patients treated with GH for other indications (not SGA).
Early Detection of Malnutrition in Oncology Patients and Elderly Patients

The project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the Czech Republic.

The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of malnutrition in oncology patients and hospitalised patients patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

The main goal of the project is the early detection of malnutrition in oncology patients and hospitalised patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

Another goal of the project will be the creation of a unified diagnostic proposal process and methodological material for determining malnutrition. This process will then be designed as the standard of nursing practice for patients with an oncological diagnosis and for persons older than 65 years such that, so that an adequate nutritional intervention is started in time, which will lead to a higher tolerance of demanding treatment and thus to increase the quality of life.

The project will include testing the procedure on a sample of approx. 1,500 oncological and 500 geriatric patients.

The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0000282.

Eligibility Criteria:
Inclusion Criteria:

Cohort Oncological patients:

* 18+
* an oncological diagnosis
* a survival prognosis of at least 3 months

Cohort Patients older than 65 years:

* 65+
* hospitalization at least 14 days or longer

Exclusion Criteria (both cohorts):

* not agreeing to participate in the project
Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy

OBJECTIVES: I. Evaluate the efficacy of interferon beta and thalidomide in male patients with adrenoleukodystrophy who show evidence of brain inflammatory response and are receiving concurrent glyceryl trierucate and glyceryl trioleate (Lorenzo's oil).

II. Evaluate the progress of the disease and possible side effects of the medication in these patients.

PROTOCOL OUTLINE: This is randomized, double blind, placebo controlled study. Patients are randomized to receive beta interferon and thalidomide placebo (arm I), thalidomide and beta interferon placebo (arm II), or placebo for both beta interferon and thalidomide (arm III). Patients receive interferon beta by subcutaneous injection and thalidomide orally. All patients are maintained on glyceryl trierucate and glyceryl trioleate (Lorenzo's oil) therapy.

Patients are followed at 3, 6, and 12 months and then may be followed every 6 months thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Adrenoleukodystrophy (ALD) diagnosis based on history and examination, MRI, and biochemical assay

Clinical evidence of rapidly progressive phase of cerebral ALD must include 2 or more of the following during the preceding year:

Significant and progressive impairment of school performance Significant loss of cognitive function leading to an IQ of 75 or less Progressive impairment of the ability to understand spoken words Progressive impairment of vision Progressive deterioration of handwriting Progressive difficulty in walking Progressive impairment in speech articulation, and vocabulary Progressive weakness of one or more limbs

Must have MRI abnormalities characteristic of cerebral ALD, especially evidence of the breakdown of the blood-brain barrier using gadolinium contrast medium and magnetization transfer technique Evidence of brain white matter inflammatory response Must not meet criteria for bone marrow transplantation Not in an apparent vegetative state --Prior/Concurrent Therapy-- Concurrent glyceryl trierucate and glyceryl trioleate (Lorenzo's oil) therapy required --Patient Characteristics-- Effective contraception required of all patients
Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome

In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 60 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. The investigators will examine short and long-term complications through follow-up with clinical assessment as well as patient-reported outcome measures including pain, cosmetic appearance, and overall patient satisfaction. Furthermore, the investigators will study the difference in surgical stress response between the two methods measured from a variety of different biomarkers before and after the operation. A cost-effective analysis will be conducted for the robotic and open procedure.

Ventral hernias occur in up to 25% of the population. They are diverse in severity ranging from small umbilical hernias to large abdominal wall defects that may result in loss of domain. Approximately one-third are incisional hernias. Incisional hernias are usually more complex due to complications from previous surgery. The procedure may be complicated as a result of intraabdominal bowel adhesions and adhesions within the hernial sac. These factors cause discomfort and may complicate the repair. Ventral hernias may be repaired either through a minimally invasive laparoscopic procedure or an open approach. The laparoscopic repair was introduced in the 1990s and in 2003 the first robotic-assisted procedure was described in a porcine model. In 2012 the first series of robotic repairs were reported in humans. Due to the superior flexibility of the robotic instruments, there is a substantial interest in harnessing the advantages of the robotic platform. Because robotic repair differs in several technical aspects from the open approach, it is important to determine whether the short and long-term results differ between the two procedures. Furthermore, it remains unresolved whether the robotic procedure is able to provide comparable outcomes to the open repair when assessed for quality-of-life outcome measures. These questions are important to address in order to determine the most appropriate surgical options for individual patients.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18
* ASA 1-3
* Clinical and radiologic diagnosis of midline ventral hernia
* Eligible to surgery according to a preoperative anaesthetic assessment
* Informed consent
* Able to understand written and oral Danish language

Exclusion Criteria:

* Incarcerated ventral hernia requiring emergency surgery
* Pregnancy
* Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of analgesics (paracetamol, NSAID, opiates etc).
* Current cancer diagnosis
* History of psychiatric or addictive disorder that prevents the patient from participating in the trial
* Co-existing inflammatory disease
* Co-existing immunological disease that requires medication of any kind
* BMI \>40 kg/m2
Impact of Sperm DNA Integrity on Artificial Reproductive Treatment (ART)

The purpose of this study is to establish a new criteria with which to judge the quality of sperm samples submitted for artificial reproductive treatments. It is believed that this type of testing can compliment the traditional semen analysis to better drive patient care.


Eligibility Criteria:
Inclusion Criteria:

* needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria:

* severly oligozoospermic patients
Duration Between Drainage and Ureteroscopic Lithotripsy

This study will be conducted to compare early (seven days) versus delayed (14-21 days) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection.

All the study participants will be monitored during the early post-operative period for post-operative pain and complications. The rate and grade of reported complications will be determined according to modified Dindo-Clavian grading system. After ensuring safe status for discharge, all patients will be reassessed at the outpatient department after 4 weeks by NCCT to assess stone free status.

Eligibility Criteria:
Inclusion Criteria:

1. Obstructing ureteral or renal stone \<20 mm.
2. Associated clinical evidence of acute upper urinary tract infection based on systemic inflammatory response syndrome (SIRS).

Exclusion Criteria:

1. History of endoscopic instrumentation to the urinary tract in the last 4 weeks prior to presentation.
2. Bilateral obstructed kidneys necessitating bilateral drainage.
3. Associated emphysematous pyelonephritis or perinephric abscess.
Management of Acute Heart Failure: Contribution of Ultrasound Daily "in Bed Patient" Adjustment on Therapy With Impact Measure on re Hospital Rate During 30 Days

Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and reproducible estimation of filling pressures with an evaluation of mitral inflow and the inferior vena cava, allow a more reliable estimate of the true blood volume of the patient and thus lead to a therapeutic adjustment more suitable.

This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30 days and mortality, less alteration of biological parameters myocardial, kidney and liver.


Eligibility Criteria:
Inclusion Criteria:

The patient or his representative must be given free and informed consent and signed consent.

* The patient must be affiliated or beneficiary of a health insurance plan.
* The patient is available for a follow-up 6 months.
* The patient is of age or older (\>) 18.
* Patients hospitalized for acute heart failure who received at least 40mg of furosemide IV.
* Patient with impaired LVEF \<50%.
* Patient with Nt-proBNP values\> 1200pg / ml.

Exclusion Criteria:

* The subject takes part in another study.

  * The subject is exclusion period determined by a previous study.
  * The subject is under judicial protection.
  * The subject or his representative refuses to sign the consent.
  * It is not possible to give the subject or his representative informed information.

Non-inclusion criteria for those diseases or conditions associated (s) interfere (s):

* The patient is pregnant or is breastfeeding.
* The patient is already included in a surveillance program (PRADO, OSICAT).
* Patient with a mechanical or biological mitral prosthesis.
* History of mitral stenosis.
* severe valvular surgery with maturity in months (\<30 days).
* chronic renal impairment on dialysis.
* High grade AV block (AVB and BAV3 2/1).
* Hypertrophic cardiomyopathy.
* Cardiogenic shock.
* Contraindications to furosemide.