cyrilzakka/clinical-trials huggingface dataset:
Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application

The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.

Central venous catheters are increasingly used to provide long-term venous access, e.g. after failure of the primary arteriovenous fistula, and they are the first choice in case of an acute need for extracorporeal therapy. Microbial adhesions and biofilm formation have been implicated in serious infections associated with the use of indwelling catheters.

In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.

The clinical study described below aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections.

Eligibility Criteria:
Inclusion Criteria:

* central venous catheter placement
* Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
* Anticipated duration of dialysis therapy less than or equal to 30 days
* Age between 18 and 85 years
* Written informed consent

Exclusion Criteria:

* Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection
* Known pregnancy
A Comparison of Two Nebulisers for Sputum Induction

Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways.

However, the procedure can be slightly uncomfortable for patients. This study aims to assess the differences in participants' tolerability of sputum induction, by comparing two different nebulisers when performing the procedure.

This is a single centre, crossover study to compare the use of two nebulisers in the sputum induction procedure. 54 participants with stable asthma or COPD will be recruited and will attend 2 visits, at least 48 hours apart. Differences in the quality and quantity of samples and the time taken to produce a sample will be described. The main purpose is to explore the optimum device to perform the procedure, whilst protecting the safety of participants and maximising their comfort.

If participants are unable to produce a sputum sample after completion of the induction procedure, physiotherapy techniques may be performed. This is an exploratory objective to establish whether these techniques may help in the event of unsuccessful procedures.

Eligibility Criteria:
Inclusion Criteria:

* Have an ability to provide fully informed consent.
* Have a diagnosis of asthma or COPD.
* Male or female.
* Age between 18 to 75 years.

Exclusion Criteria:

* Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value.
* Have an exacerbation of asthma or COPD within the 30 days prior to the first visit.
* Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit.
* Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study.
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy

This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.


Eligibility Criteria:
Key Inclusion Criteria:

* Completed study drug treatment in parent study (VX18-445-109); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study

Key Exclusion Criteria:

* History of study drug intolerance in parent study

Other protocol defined Inclusion/Exclusion criteria may apply.
Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home

Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life.

Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.

Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.

Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.

The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age with diagnosed endometriosis (histology, imaging, clinical symptomatology) and/or adenomyosis.
* Women with at least 2 consecutive days per month of endometriosis-related pelvic-perineal pain of moderate to severe intensity (NS ≥ 4):

  * Women without amenorrhea: pain around the onset of menstruation.
  * Women with amenorrhea: most intense pain of the month.

Exclusion Criteria:

* Pregnant or nursing women.
* Women participating, or who have participated, in a clinical interventional study within 30 days prior to inclusion.
* Women with severe visual, auditory or cognitive impairment, color blindness, photosensitivity, epilepsy or motion sickness.
* Women whose pain is occasional and not present at each menstrual period.
* Women who have previously received virtual reality treatments.
* Women under judicial protection, guardianship, curatorship, protective mandate.
Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars

This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.

This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.

Patients will be offered the opportunity of enrolling in the trial before their surgery. If they qualify and agree to participate they will sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) form.

The surgical defect should be closed primarily, with the minimal scar length being 3cm. The scar will be randomized into 3 equal thirds, each third will randomly receive either: no treatment, 595nm PDL, or 595/1064nm Multiplex laser. A total of 3 laser treatments will be performed over a period of 3 weeks (one treatment session performed every week), and the patient will come in for a final follow up visit, for a final assessment of the scar using the Patient and Observer Scar Assessment Scale (POSAS) system.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin types 1-3
* Suture line should be at least 3 cm long

Exclusion Criteria:

* The patient should not be receiving any alternate systemic, topical or intralesional treatment of the scars during the study
* Pregnant or lactating females
* Fitzpatrick skin type 4-6
* A history of keloids or hypertrophic scars
Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32mg and Dilatrend Tablet 25mg

The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.

Healthy male subjects are administrated multiple-dose over the period I and II (Crossover) of dilatrend SR capsule 32mg and dilatrend tablet 25mg.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 35aged in healthy male
* Body Weight more than 50kg, and within 20% of ideal body weight(IBW).

  * IBW(kg) = {height(cm)-100}\*0.9
* Have not any congenital or chronic disease and medical symptoms.
* Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
* Agreement with written informed consent

Exclusion Criteria:

* Subject has hypersensitivity reaction or clinically significant history about carvedilol or investigator drug.
* Clinically significant cardiovascular system, respiratory system, liver, kidney, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease, otorhinolaryngologic diseases and so on.
* Hypotension(SBP \< 105mmHg or DBP \< 65mmHg), Hypertension(SBP \> 150mmHg or DBP \> 100mmHg)
* Heart rate \< 50times/minute
* Active liver disease or AST, ALT \> 1.5\*upper limit of normal range
* Creatinine clearance \< 80mL/min
* Subject has a disease affecting drug's ADME or gastrointestinal surgery.
* Subject with symptoms of injured or acute disease within 28days before the first IP administration.
* Subject has a history of drug abuse or a positive reaction for drug abuse at the screening test for urine.
* Taking ETC medicine including oriental medicine within 14days before the first IP administration or Taking OTC medicine within 7days
* Subject takes an abnormal meal which affect the ADME of drug.
* Previously participate in other trial within 90days.
* Previously make whole blood donation within 60days or component blood donation within 30days before the first IP administration.
* Continued to be taking caffeine(caffeine \> 5cup/day), drinking(alcohol \> 21unit/week, 1unit = 10g = 12.5mL of pure alcohol) or during clinical trials can not be drunk or severe heavy smoker(cigarette \> 10cigarettes/day).
* Subject with positive reaction about serum test(HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
* Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result.
The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

Evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using Fitostimoline in addition to or without other topical devices available on the market.

Three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.


Eligibility Criteria:
Inclusion Criteria:

* None previous therapies for anal fissure
* Symptomatic anal fistula
* Signing of informed consent
* age \>18 years old

Exclusion Criteria:

* Patients unable to complete the questionnaire and with a legal guardian.
* Patients with concomitant abscess/fistula
* Pregnant women
Coronary Sinus Pressure and Microvascular Disease

MACCHUS is a randomized, single-center, controlled, cross-over interventional study in which coronary artery resistances will be measured at baseline and during temporary occlusion of the coronary sinus.

The aim of this study is to test whether an increase in coronary sinus pressure leads to a change in coronary microvascular resistances in patients with angina pectoris and with an indication to measurement of microvascular function as per clinical guidelines.

All patients with a clinical indication for the assessment of microvascular function will be invited to participate and will sign the informed consent at least 24 hours before the study. Patients with an index of microvascular resistances \>25 (i.e. evidence of microvascular dysfunction) will undergo study-specific procedures in the same session (i.e. no additional invasive procedure is required for the study).

Study-specific procedures include the repetition of the assessment of microvascular resistances at rest and during coronary sinus occlusion. Coronary sinus occlusion will be achieved by inflating a balloon sized to \~70% of the diameter of the coronary sinus. Since the implantation of a coronary sinus reducer is a therapeutic option for this type of patients, also this procedure (inflation of an undersized balloon in the coronary sinus) provides clinically relevant information (sizing of the vessel, effect on microvascular resistances and feasibility of the intervention).

The primary goal of the study is to study the effect of coronary sinus occlusion on microvascular resistances at rest and during hyperemia.

Eligibility Criteria:
Inclusion Criteria:

* Chronic coronary syndrome (including patients with anginal equivalents).
* Reversible ischemia on non-invasive testing, indication to cardiac catheterization;
* Indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication; only those with evidence of pure or mixed microvascular disease (index of microvascular resistances (IMR)\>25 will proceed into the study);
* Willingness to participate and ability to understand, read and sign the informed consent;
* Age\>18 years

Exclusion Criteria:

* Previous CABG with patent grafts to the left anterior descending coronary
* Epicardial coronary disease (FFR \<0.80 with evidence of a focal stenosis) in the left anterior descending territory
* Severe valvular heart disease
* Any cardiomyopathy; pulmonary or renal disease
* Inability to provide informed consent
* Any disease reducing life expectancy
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 years or above
* Patients scheduled for elective total knee replacement

Exclusion Criteria:

* Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH)
* Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)
* Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy

For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared.

It was aimed to investigate whether routine cystoscopy with carbon dioxide is a safer and faster method for the evaluation of lower urinary tract injuries compared to standard saline cystoscopy. In addition, with this study, it will be studied whether bladder bleeding or intra-bladder masses can be evaluated more quickly and clearly.

Eligibility Criteria:
Inclusion Criteria:

1. laparoscopic hysterectomy for benign reasons planned patients
2. The operation will be performed in our hospital
3. Reporting preoperative endometrial and cervical samplings as benign
4. After discharge, control examinations will be carried out in our hospital.

Exclusion Criteria:

1. Abdominal, robotic or vaginal hysterectomies
2. malignant reporting of preoperative cervical and endometrial samplings
3. Patients do not want to participate in the study
The Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables

This study will aim to compare ankylosing spondylitis (AS) participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur

Ankylosing spondylitis (AS), a common type of spondyloarthropathy, is a chronic inflammatory disease that affects spinal joints, and adjacent soft tissues such as sacroiliac joints, tendons, and entheses (1). Inflammation of the spinal structures and progressive changes in the surrounding tissue is largely responsible for decreased physical function and mobility in participants with AS (2).

It is unknown how these parameters of AS participants with AMSI (smaller than 5 cm) are affected compared to AS participants with normal modified Schober index (NMSI, bigger than 5 cm). In addition, it is unclear which demographic characteristics and variables predispose AMSI to occur.

This study will aim to compare AS participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur

Eligibility Criteria:
Inclusion Criteria:

* Participants who meet the modified New York criteria for AS
* Participants over 18 years

Exclusion Criteria:

* Participants with other concomitant rheumatic diseases (such as fibromyalgia, rheumatoid arthritis, etc.),
* Participants with cognitive or psychiatric disorders,
* Participants with neuromuscular or orthopedic diseases
Ambient Light Levels in the Kindergarten and Schools and the Relation to Refractive Development

Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained elongation of the eye globe There are number of theories concerning the environmental effect on the emmetropization process, most are related to childhood exposure to outdoor activity, near work and sleep with night light. Studies in lab animals found an association between intensity of ambient lighting and myopia development.

In this study, the investigators will examine the ambient light in kindergarten and schools and their relation to refractive error. Diurnal luminance in kindergarten and school class room will be measured and correlated to biometric measures such as refraction, axial length and keratometry.


Eligibility Criteria:
Inclusion criteria

* Every child that have been studying in the same class for the last 6-12 months (kindergarten and school respectively).

Exclusion criteria

* Noncooperative child or parents.
* Ocular surgery.
* Ocular genetic disease.
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease

People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.


Eligibility Criteria:
Inclusion Criteria:

Females, aged 9-21 years, in the following groups:

* CKD (defined as estimated glomerular filtration rate between 90 ml/min/1.73m2 and 15 ml/min/1.73m2, as calculated by the Schwartz formula)
* ESRD (eGFR \< 15 ml/min/1.73m2, or receiving chronic dialysis \[peritoneal or hemodialysis\])
* Status-post kidney transplant

Exclusion Criteria:

* Within first 3 months post kidney transplant
* Within 3 months of kidney rejection episode
* Hypersensitivity to active substances or excipients of Gardasil vaccine
Combined Bleaching Technique: Efficacy and Tooth Sensitivity

The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).

This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .

After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.

Eligibility Criteria:
Inclusion Criteria:

* Upper and lower anterior teeth without restorations;
* Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).

Exclusion Criteria:

* Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
* Presence of non-carious lesions, such as abfraction, erosion and abrasion;
* Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
* Use of fixed orthodontic appliances;
* Presence of tooth sensitivity classified as equal to or greater than mild;
* Presence of severe dental dimming;
* Presence of parafunctional habits;
* Presence of any oral pathology;
* Smokers;
* pregnant and lactating women