cyrilzakka/clinical-trials huggingface dataset:
Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections

Nosocomial infections caused by multi-drug-resistant (MDR) and extensively drug-resistant (XDR) Gram-negative pathogens represent a major threat worldwide. The increasing trend of multi-drug resistance in Gram-negative bacteria (MDR-GNB) poses a particularly acute challenge to health systems especially in critically ill patients.

Patients in intensive care units (ICUs) have encountered an increasing emergence and spread of antibiotic-resistant pathogens. In Saudi Arabia mainly MDR-GNB such as Acinetobacter Baumannii, Pseudomonas Aeruginosa, Klebsiella Pnemoniae and Enterobacter are observed in ICUs.

Polymyxins are the last line therapy in the treatment of infection caused by these MDR-GNB. Colistin is the most widely used polymyxin antibiotic, it is administered as inactive prodrug colistimethate sodium (CMS) that is hydrolyzed to an active moiety of colistin base activity (CBA). It acts as cationic detergent and damages bacterial cytoplasmic membrane causing leaking of intracellular substances and then cell death.

During the first years of their use, polymyxin-associated neurotoxicity occurred in patients with an incidence as high as 27% following parenteral administration. However, other retrospective clinical trials have not exposed neurotoxicity to be a major concern. On the other hand, nephrotoxicity is by far the most common and dose-limiting side effect associated with parenteral polymyxins, with incidence rates in patients as high as 60%. Despite the high incidence of colistin induced nephrotoxicity, in 2012, the World Health Organization (WHO) reclassified polymyxins as critically important for the management of MDR-GNB infection, renewing the interest in these antibiotics.

To the best of our knowledge no study compared the efficacy and safety of both dosing strategies in critically ill patients. Moreover, there is still a lack of evidence on the efficacy and safety of both dosing strategies in obese patients. Therefore, this study aims at comparing the efficacy and toxicity of both strategies in colistin dosing (the fixed dose and the weight-based dosing) in obese patients and non- obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 18 years old.
* Patients who will be treated with CMS for MR GNB infections.
* Patients who are admitted to the ICUs.

Exclusion Criteria:

* Known hypersensitivity to colistin.
* Pregnant and lactating women.
* Patients who are treated with colistin for \< 24 hours.
* Patients with myasthenia gravis or concomitant anesthetics or neuromuscular blocking drugs.
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial

Objectives:

to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children.

Methods:

A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their salivary level of mutans streptococci species, and lactobacillus at the baseline and three weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion simplified oral hygiene index were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* age from 8 to 9
* parents signed the consent form they attended morning session for brushing

Exclusion Criteria:

* medical compromised children
* parents did not sign the consent form Did not attend morning session
A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test.

The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

Eligibility Criteria:
Inclusion Criteria:

* Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period
* Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
* Patient with an average frequency of micturition of 8 or more times per 24-hour period
* Written informed consent has been obtained

Exclusion Criteria:

* Patients without experience of urge incontinence before informed consent
* Patients given a clear diagnosis of stress incontinence
* Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)
* Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis
* Patients with a previous history of recurrent urinary tract infection
* Patients complicated with or with a history of bladder tumor or prostatic tumor
* Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease
* Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period
* Patients with an indwelling catheter or practicing intermittent self-catheterization
* Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia
* Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period
* Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or \< 50 bpm
* Patients with polyuria exceeding 3000 mL in mean daily urine volume
* Patients meeting any of the following in the examinations

  * Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee
  * Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)
  * Patients with a blood creatinine level ≥ 2.0 mg/dL
Comparison of the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD

Prospective, randomized, subject/evaluator-masked post market clinical study at up to 2 sites at Gemini eye clinic in Czech Republic. Randomization will be done by the eye surgeon. The purpose of this post market clinical trial is to compare the safety and efficacy of Ophtesis Bio 3% with a similar 3% sodium hyaluronate OVD in routine cataract surgery.

The purpose of this clinical study is to evaluate the performance of the Ophtesis Bio 3%. The primary endpoint is the rate of intraocular pressure (IOP) spikes of 30 mmHG or greater at the 7-day postoperative visit. The secondary endpoint will be the rate of user acceptance evaluated using the surgeon questionnaire at the surgery day visit. Other key endpoints will include IOP and IOP change from baseline at the 7-day postoperative visit, rate of inflammation measured using Slip Lamp at the 7-day postoperative visit, and rates of serious and/or device-related adverse events. Number of Subjects/eyes: Up to 296 eyes will be enrolled to achieve approximately 148 operated eyes per group.

Eligibility Criteria:
Inclusion Criteria:

* Cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes
* Clear intraocular media, other than cataract
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
* Use of systemic or ocular medications that may affect IOP
* Known steroid responder
* Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
* Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial
Assessing the Implementation and Feasibility of the SMART-MR

The objective of the proposed pilot study is to assess the feasibility and implementation of the SMART-MR program, an integration of stress management, general resilience, and moral resilience skills, with frontline staff who provide direct patient care at The Ottawa Hospital (TOH).

Many of the sources of stress facing healthcare workers during the COVID-19 pandemic involve difficult ethical trade-offs that give rise to moral distress. Moral distress has personal consequences for healthcare workers, notably for their mental health, and wider consequences for the organization and health system as a whole as it negatively affects quality of care, patient satisfaction, and the recruitment, retention and satisfaction of staff. Moral resilience refers to the capacity of an individual to sustain or restore their integrity in response to moral adversity and has been raised as a potential way to mitigate moral distress.

The Stress Management and Resilience Training (SMART) program is one of the few evidence-based interventions designed to build resilience in healthcare workers. The SMART program is a brief, neuroscience-based intervention, typically delivered in a single 90-minute session. The structured program teaches self-care skills by developing intentional attention and the ability to reframe potentially stressful situations more quickly.

Recently, a modified version of the existing SMART program, SMART-Moral Resilience (SMART-MR), has been developed with an additional focus on reducing moral distress and building moral resilience for healthcare workers. The synergy of general resilience strategies with focus on the moral/ethical dimensions of clinical practice offer clinicians specific skills to address ethical challenges. We believe implementing the SMART-MR program with frontline staff during the COVID-19 pandemic is warranted. Therefore, we plan to pilot this innovative intervention at TOH to assess its feasibility and implementation.

Eligibility Criteria:
Inclusion Criteria:

• full-time or part-time TOH staff who provide direct patient care, including: attending physicians, nurses, allied health, social workers and spiritual care providers

Exclusion Criteria:

• TOH staff members who do not provide direct patient care
Bacterial Vaginosis Screening at IUD Insertion

A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no inference can be made about the possible influence of IUD insertion and presence to the development of upper genital tract infection . Consequently, with the current literature, it would be difficult to make an argument for screening and treatment for BV prior to IUD insertion. This study will help us determine whether women with an IUD develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In addition, in those women with BV, we are looking to see if they develop more significant problems with the IUD, than those who do not have BV. Overall, this will help us determine whether all women should be screened for BV prior to IUD insertion.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.

Exclusion Criteria:

* pregnancy
* a previous history of ectopic pregnancy or pelvic inflammatory disease
* HIV positive or immunocompromised
* unable to understand English
* unable to give informed consent
Evaluation of Histamine H3 Receptor Radioligand [11C]AZ12807110 and Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration

The purpose of this study is to investigate features of radioligand \[11C\]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female volunteers between 20 to 45 years with suitable veins for cannulation or repeated venipuncture (pilot panel)
* Female must be of non-child bearing potential (pilot panel)
* BMI between 18 to 30 30 kg/m2
* Normal MRI scan
* Provision of signed, written and dated informed consent

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
* History of severe allergy or hypersensitivity or ongoing allergy or hypersensitivity
* Healthy volunteer suffers from claustrophobia
The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

This study evaluates the effects of an inhaled blend of essential oils on fatigue scores among women who have hypothyroidism. Half of the participants will receive an essential oil blend to inhale daily for two weeks while the other half will serve as controls and inhale a carrier oil.

The inhalation of certain essential oils has been found to increase stamina and reduce fatigue among athletes but have not been evaluated for the purpose of reducing fatigue among women who experience fatigue as a result of a hypothyroid condition.

The essential oils used in this study are inhaled mid-afternoon, the time in which women with hypothyroidism typically experience the lowest levels of energy during the day, otherwise known as the "afternoon slump." The essential oil is administered during this time to evaluate both the immediate effects on fatigue as well as the overall effects, with measurements at the end of both the first and second week of the study.

Fatigue is measured on a multi-dimensional scale, a validated instrument that measures not only physical fatigue but also emotional and mental fatigue.

Eligibility Criteria:
Inclusion Criteria:

* female
* diagnosed with hypothyroidism
* otherwise healthy

Exclusion Criteria:

• history of thyroid cancer
Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients

Patients with COPD have lower capability of activating their muscles. At the cortical level, force production is not only controlled by contralateral primary motor cortex but also by ipsilateral motor cortex. The aim of this study is to determine whether ipsilateral areas are functionally impaired in COPD.

Chronic obstructive pulmonary disease (COPD) patients exhibit not only respiratory symptoms but also a peripheral muscular weakness. This weakness is characterized by a loss in strength, harmful for the patients' life quality and vital prognosis (Swallow et al., 2007). Even if many studies have enlightened damages at a peripheral level, the muscular atrophy itself cannot totally explain the loss in force (Menon et al., 2012). Furthermore, the contractile properties of COPD muscles fibres are preserved (Debigare et al., 2003). Consequently, peripheral muscle weakness cannot only be explained by peripheral factors and central structures must be investigated.

At the central level, it is admitted that force production is controlled by the activation of contralateral motor areas. In COPD, these areas were found to be less activated than in controls during force production (Alexandre et al., 2014). However, recent studies bring the evidence that ipsilateral motor areas are also mobilized to cope demand during such task. The activation of ipsilateral areas is possible through inter hemispheric pathways, as the corpus callosum. Recently, the integrity of the corpus callosum have been linked to the capability of activating the ipsilateral motor cortex (Chiou et al., 2014) during force production. This is of concern knowing that several studies reported white matter lesions in the brain of COPD patients (Dodd et al, 2012) and more precisely in regions containing the corpus callosum (Lahousse et al., 2013).

Therefore, we hypothesize that COPD patients have a lower capability of activating their ipsilateral motor cortex during force production compared to controls.

Eligibility Criteria:
Inclusion Criteria:

* Health insurance
* Patients : COPD Gold II-IV

Exclusion Criteria:

* Pregnant women
* Seizures
* Unable to give written consent
* Metalic object above shoulders
* Dermatological issue concerning surface electrodes
* Caffeine consumption \> 4 coffee / day
* Neurological disorders
* Opioid-based treatment
* Patients : recent exacerbation (\< 4 weeks)
* Patients : rehabilitation in previous 1 year
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Eligibility Criteria:
Inclusion Criteria:

* patients having cataract surgery

Exclusion Criteria:

* Uncontrolled glaucoma or intraocular hypertension;
* Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
* A history of chronic or recurrent ocular inflammatory disease;
* Uncontrolled diabetes mellitus and diabetic retinopathy ;
* Patients with sight in a single eye;
* Iris atrophy in the eye to be operated;
* Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
* Known or suspected allergy or hypersensitivity to any component of study medication;
* A history or any other evidence of severe systemic disease
Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to bone tissue death.

PURPOSE: This laboratory study is looking at risk factors for bone tissue death in young patients with acute lymphoblastic leukemia treated on clinical trial CCG-1882.

OBJECTIVES:

* Identify possible pharmacogenetic risk factors for avascular necrosis (AVN) in pediatric patients who received intensive therapy for acute lymphoblastic leukemia on clinical trial CCG-1882.
* Compare whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin D receptor C/C start site genotype are more common among patients who developed AVN than among patients who did not.

OUTLINE: This is a retrospective, cohort, multicenter study. Patients are stratified according to gender and treatment regimen on clinical trial CCG-1882 (augmented vs regular Berlin-Frankfurt-Munster).

DNA is extracted from slides of blast samples that were previously obtained from patients treated on clinical trial CCG-1882. DNA genotyping is performed, and genotypes (proportion of population with variant alleles or frequency of variant alleles) are compared between patients who did and did not develop avascular necrosis.

PROJECTED ACCRUAL: A total of 671 tissue samples from patients (294 females and 377 males) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia (ALL)

  * Has diagnostic ALL blast sample slides available for DNA extraction
* Previously treated on clinical trial CCG-1882

PATIENT CHARACTERISTICS:

Age

* 10 and over at diagnosis

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers

Single center, randomized, double-blind, placebo-controlled, adaptive sequential ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of single doses of deferiprone administered by intravenous infusion to healthy males and females. A bioavailability comparison will be included.


Eligibility Criteria:
Main Inclusion Criteria:

1. Healthy adult males or females, at least 18 years old but not older than 50 years.
2. Body weight at least 60kg.
3. Body Mass Index (BMI) ≥ 18.50 and ≤ 30.00 kg/m2
4. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, ECG, vital signs, physical examination.
5. Non or ex-smoker (someone who has completely stopped smoking 6 months before study start)
6. For females, negative result on a serum pregnancy test.

Main Exclusion Criteria:

1. Absolute neutrophil count (ANC) \<1.5x10\^9/L.
2. History or presence of hypersensitivity to deferiprone or any related products.
3. History or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
4. Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
5. Any history of tuberculosis (TB) or prophylaxis for TB.
6. Suicidal tendency, history of seizures, head trauma with coma or craniotomy/trepanation, state of confusion or relevant psychiatric disease.
7. Inadequate venous access in either arm.
8. Presence of out-of-range cardiac interval or clinically significant ECG abnormalities (PR \<110 msec or \> 220 msec, QRS \<60 msec or \>119 msec, QTcB \> 450 msec for males and \>460 msec for females).
9. Use of acetaminophen, acetylsalicylic acid (ASA), or non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 7 days before study start.
10. Use of any enzyme-modifying drugs, including strong inhibitors of P450 (CYP) enzymes such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals OR strong inducers of CYP enzymes such as: barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, and St. John's wart within 28 days prior to study start.
11. Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse.
12. Had a clinically significant illness during the 28 days prior to study start.
13. Receipt of an investigational product in another clinical trial within 28 days prior prior to study start.
14. Enrolment in a previous cohort of this study.