cyrilzakka/clinical-trials huggingface dataset:
Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study

The objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be included.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 years of age or older, in good general and oral health, except gingivitis.
2. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
3. Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
4. A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
5. A mean gingival index ≥ 1.75 according to the Modified Gingival Index.
6. A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
7. Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
8. Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
9. Absence of fixed or removable orthodontic appliance or removable partial dentures.

Exclusion Criteria:

1. History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
2. History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject.
3. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
4. Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
5. Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
6. Current or history of alcohol or drug abuse.
7. Self reported pregnancy or lactation (this is an exclusion criterion due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure

Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.

During the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. The obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. Their success rate was evaluated only in pilot companies supported studies. We do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (QoL); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. The new methods bring also new complications which were not yet relevantly and objectively documented.

In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation

Eligibility Criteria:
Inclusion Criteria:

* female sex
* age 18 and more
* subscribed informed consent
* objective symptoms of prolapse-POP-Q 3 and more according to ICS standards
* compliance of the patient

Exclusion Criteria:

* patients with evidence of malignant lesion in small pelvis
* history of radiotherapy in small pelvis
* patients suffering from any form of PID within inclusion process
* pregnancy
* lactation
* total eversion of uterus and vagina
* serious internal disorders
* history of recto- or vesico-vaginal fistula
* history of rejection of any artificial material
* symptoms of primary genuine stress urinary incontinence
* patients who were not able to subscribe the informed consent
* patients, who couldn´t be reached for further follow-up
Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy

Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL) with nephrostomy placement and double J stent and PCNL with double J placement only without nephrostomy.

Measurement of complications in and comparison between two groups of patients undergoing upper pole PCNL. First group consists of patients left with nephrostomy and double J stent and the second group includes patients left with double J stent only without nephrostomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing upper pole percutaneous nephrolithotomy older than 18 years of age and willing to participate

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients unwilling to participate in the study
* Patients that nephrostomy tube placement was a prerequisite at the end of the procedure
Safety and Efficacy of URS Stents in the Treatment of Ureteral Stricture

A prospective observational study aimed to assess the efficacy and safety of Allium ureteral stent long-term indwelling in the treatment of ureteral stricture.


Eligibility Criteria:
Inclusion Criteria:

1. Benign diseases: UPJ, ischemic injury caused by surgical separation, endoscopic surgery injury, heat injury by laser lithotripsy, infection (chronic inflammation, tuberculosis), peri-ureteral fibrosis caused by endometriosis, ureteral anastomotic stenosis after renal transplantation, ureteral fistula, multiple polyps;
2. Malignant diseases: ureteral anastomotic stricture after urinary diversion, stricture caused by compression of abdominal and/or pelvic tumors, stricture caused by urinary tract tumors, stricture caused by radiotherapy for colon or cervical cancer, ureteral fistula

Exclusion Criteria:

1. Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter)
2. Colon resection surgery patients -
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27

The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.

The goal is to evaluate the effect of the double maintenance dose of clopidogrel versus single dose in patients with proven coronary and with BMI ≥ 27 kg.m-2 1 - Biologically: study and compare the respective effects of the double dose and single dose of clopidogrel on platelet aggregation.

2 - Clinically: to study and compare the cardiovascular events and adverse effects depending on the dose of clopidogrel.

Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* Old (e) of more than 20 years
* BMI ≥ 27kg.m-2
* Patients hospitalized for acute coronary syndrome (Whatever the ST segment and troponin dosage)
* Patients with proven coronary candidates for treatment with Clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days)

Exclusion Criteria:

* Patients unwilling.
* Patient participating in another study.
* Patients with cardiogenic shock
* Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
* Patients scheduled for surgery in less than 6 months
* ischemic stroke older than 6 weeks.
* History of hemorrhagic stroke (any time)
* Patients on or candidates for AVK
* Patients with a different anti ADP (ticlopidine, prasugrel)
* Patients with an indication against clopidogrel (side effects, bleeding ...)
* Thrombocytopenia \< 100000/mm3
* anemia (Ht \< 30%)
* Thrombocythaemia (Ht \> 52%)
* Pregnancy
Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)

Three sexual health clinical services across Australia and their associated pathology testing laboratories are implementing a new management program for gonorrhoea infection. The services are implementing the use of gonorrhoea drug resistance testing as part of routine clinical and laboratory practice, where drug resistance test results are provided to clinicians quickly to guide choice of antibiotic therapy. Clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone.

This study aims to demonstrate the feasibility of a new approach to antibiotic stewardship based on individually tailored antibiotic prescribing. Three sexual health clinical services in New South Wales Australia with high caseloads of gay and bisexual men will adopt a new management practice for gonorrhoea infection involving provision of tailored antibiotic therapy by clinicians at the time of gonorrhoea diagnosis and treatment, guided by the results of resistance testing. The services are implementing the use of gonorrhoea drug resistance testing as part of routine clinical and laboratory practice, where drug resistance test results are provided to clinicians quickly to guide choice of antibiotic therapy. This differs from existing practice where the prolonged turn-around times for drug resistance testing results mean clinicians must prescribe drug therapy without knowing these results. This can lead to increasing levels of drug resistance to ceftriaxone.

The drug resistance test used in the new program detects genetic material (nucleic acids). It was developed and validated in Australia and is as accurate as existing culture-based drug resistance testing but provides quicker results. Patients treated presumptively at their first clinic visit will be treated with standard of care ceftriaxone. However, for cases treated at the return visit, clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone. This will preserve ceftriaxone for situations where it must be used as the only effective drug available. Established patient follow-up procedures at clinical services will confirm that treatment has been successful.

Quantitative data from the clinical and laboratory services in the study will be used to assess the proportion of all cases treated with ceftriaxone. The cure rate in gonorrhoea cases within the new management program versus standard care will also be assessed which will help illustrate the impact of the new management program.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with gonorrhoea infection at the return visit

Exclusion Criteria:

* Patients for whom ciprofloxacin is contraindicated
Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD

Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use. Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.

See above.

Eligibility Criteria:
Inclusion Criteria:

* 1) 13-18 years old;
* 2) Presenting to LCC/HH for evaluation or treatment;
* 3) Report having experienced IPV in their lifetime, including: CSA, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
* 4) Have a memory of the incident(s);
* 5) Five or more DSM-IV PTSD symptoms;
* 6) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.

Exclusion Criteria:

* 1) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
* 2) Actively suicidal or homicidal;
* 3) Reports active psychotic disorder
Developing and Testing the Effect of Online Interactive Videos in Improving Low Anterior Resection Syndrome.

This study aims to develop and test the effect of online interactive videos in improving LARS.


Eligibility Criteria:
Inclusion Criteria:

1. Stage I-III rectal cancer.
2. Patients already know their condition.
3. Aged 20 years and older.
4. Consciously communicate in Mandarin or Taiwanese.
5. Agreed with the interview and had signed the permit.

Exclusion Criteria:

1. Recurrent rectal cancer.
2. Stage IV rectal cancer.
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children

The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged \>= 3 months to \< 5 years in Egypt.


Eligibility Criteria:
Inclusion Criteria:

* Age: \>= 3 months and \< 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
* Signs, symptoms, and conditions:
* One of the functional or general signs of otalgia, conjunctivitis, fever AND EITHER
* Paradise's criteria, OR
* Spontaneous otorrhoea of less than 1 day.
* Onset of signs and symptoms of acute otitis media within 3 days prior to diagnosis of acute otitis media by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 2-3 days after initiation of treatment.
* Written informed consent obtained from parent(s) or Legally Acceptable Representative prior to study start.

Exclusion Criteria:

* Hospitalised during the diagnosis of acute otitis media or during treatment,
* Otitis externa, or otitis media with effusion,
* Presence of a transtympanic aerator,
* Systemic antibiotic treatment received for a disease other than acute otitis media in the 3 days prior to enrolment,
* Receiving antimicrobial prophylaxis for recurrent acute otitis media,
* Provision of antibiotic by the ear nose and throat specialist at the enrolment visit, prior to the sampling of the middle ear fluid by tympanocentesis or spontaneous otorrhoea,
* Patients on antibiotics for acute otitis media who are clinically improving.
* Child in care.
Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients.

Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe keratoconjunctivitis sicca defined by:
* Staining of the cornea ≥ grade III according to the Oxford scale
* OSDI value ≥ 12
* Age between 18 and 90 years
* Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months

Exclusion criteria:

* Pregnancy (excluded with a pregnancy test in patients of childbearing potential)
* Children and young people up to the age of 18
* Eye surgery in the past 6 months
* Simultaneous participation in another study
* Regular use of eye drops, with the exception of tear substitutes
* Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months
Probing TBS-induced Neural Plasticity and Associated Effects on Learning

Recent animal research indicates that excitatory brain stimulation opens a time window of increased neural plasticity that permits remodeling of neural representations. Repetitive transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by reducing proactive interference but human research is missing. Therefore, it is the aim of this study to investigate the effects of intermittent theta-burst stimulation (iTBS), a potent form of excitatory brain stimulation, on associative memory. Twenty right handed healthy participants will receive 3 minutes of iTBS or sham stimulation of the left lateral parietal cortex after memorizing a set of 20 face-word associations. Recall capacity will be tested directly before and after stimulation. Participants will then learn a new combination of associations using the same set of stimuli, followed by an evaluation of their recall capacity. It is hypothesized that iTBS compared to sham stimulation will reduce recall capacity directly after the stimulation but increase recall capacity of the newly learned associations due to reduced proactive interference. This study may not only pave the way towards a new understanding of the mechanism of action of brain stimulation, but can also help in developing new treatment strategies for neuropsychiatric disorders.


Eligibility Criteria:
Inclusion Criteria:

* education level of primary six or above
* right-handedness
* normal or corrected-to-normal vision

Exclusion Criteria:

* seizures in medical history
* current or past psychiatric disorders or severe internal or neurological illness
* common TMS exclusion criteria
* substance abuse or dependence
* intake of medication that is known to affect the excitation threshold
A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency

The purpose of this study is to measure the evidence-based intervention's (EBIs) impact on patient safety and efficiency, to assess the EBIs implementation by measuring acceptability, appropriateness, cost, fidelity, penetration, and sustainability and to identify the facilitators and barriers that influence the degree of implementation of these EBIs.


Eligibility Criteria:
Inclusion Criteria:

* new, significant abnormal anemia (Hgb \>1g/dl below normal, with normal white cells and platelets) or decreased estimated glomerular filtration rate (eGFR) (\<60 ml/min/1.73m2 ) seen in one of the University of Texas Physicians (UTP) adult primary care clinics.

Exclusion Criteria:
Multifocal Lens Design Evaluation

The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Sign written Informed Consent document.
* Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
* Be presbyopic with a spectacle add ≥ 0.50 diopter.
* Currently wearing soft contact lenses at least 5 days a week.
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* Eye injury or surgery within 12 weeks of enrollment in this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.
* Binocular visual acuity worse than 20/25.
* Corrected by monovision.
* Other protocol-defined exclusion criteria may apply.
Mixed Strain H. Pylori Infection in Patients Who Have Problems With Eradication of H. Pylori

The purpose of this study is to determine whether mixed H. pylori strain infection is the reason for eradication failure during treatment of H. pylori infection. The investigators present the results got from extensive sampling of biopsy samples taken from individuals diagnosed with H. pylori connected disease. The investigators were looking for individuals that were not able to eradicate H. pylori although they had susceptibility testing tailored antibiotic therapy. On their control visit after 2 months they presented again with H. pylori although at their first visit they had H. pylori isolated from biopsy sample sensitive to all antibiotics prescribed. Multi Locus Sequence Typing (MLST) was used to prove the sequence type of H. pylori and E test was used to determine susceptibility of H. pylori to antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* People who have H. pylori sensitive to all antibiotics before therapy and and do not eradicate H. pylori after appropriate antibiotic therapy.

Exclusion Criteria:

* People who did not eradicate H. pylori because of primary resistance to antibiotics.