cyrilzakka/clinical-trials huggingface dataset:
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia

Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.

The most frequent complications of long term TCVC are catheter related blood steam infections(CRBSI)often caused by microorganisms located in the biofilm formed on the inner surface of the TCVC after a short time. CRBSI may be lifethreatening, will need long term intravenous broad spectrum antibiotic therapy possibly combined with intraluminal antibiotic lock therapy. In spite of this CRBSI may often lead to the premature removal of the TCVC.

Several methods to prevent the occurrence of intraluminal microbial colonization have been investigated with no single method standing out as the optimal one.

There is a need for a simple and safe method of reducing the occurrence of CRBSI in immunocompromised children receiving chemotherapy for malignant diseases. Various catheter lock solutions in stead of using heparin have been investigated in experimental models. Taurolidine is a chemically modified amino acid with broad spectrum antimicrobial activity in vitro. It is claimed to prevent the formation of luminal biofilm in TCVCs in a CVC model and it has been demonstrated to eradicate infected CVC in a three reports with a total of 18 patients.

In a 24 months study of routine use of Taurolidine 1,25%/Sodium-Citrate 4% (TaurolockTM) a reduction of gram-positive CVC associated infections was demonstrated. The findings were not statistically significant due to relatively few patients.

There is a need of a larger study with more patients receiving Taurolock for locking the TCVC between use in order to test for a significant reduction of the occurrence of CRBSI. Furthermore there is a need for an in vivo demonstration of the reduction of biofilm formation in TCVCs locked with taurolock compared with TCVCs locked with heparin.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-17 years with malignant disease requiring a tunneled central venous catheter.

Exclusion Criteria:

* No written consent from child or parents
Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT

Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and American College of Sports Medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional MRI outcomes in 88 cognitively-impaired persons with MS. This study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common MS-related cognitive impairment) and improving brain health in persons with MS.


Eligibility Criteria:
All participants will:

* Be between the ages of 18-65
* Have a clinically definite MS diagnosis based on established criteria
* Be fully-ambulatory based on Expanded Disability Status Scale (EDSS) scores between 0-4.0
* Demonstrate slowed CPS based on initial SDMT scores at least 1 SD below the regression-based normative score for healthy controls (i.e., 16th percentile)
* Be relapse-free and will not have acutely taken corticosteroids for at least 30 days (i.e., relative neurologic stability)
* Not have a history of major depressive disorder, schizophrenia, bipolar disorder I or II, or substance-abuse disorders.
* Not be taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines).
* Be right-handed
* Have corrected vision better than 20/80
* Not have known/diagnosed cardiovascular, metabolic, or renal disease. Individuals with known/diagnosed cardiovascular, metabolic, or renal disease who are asymptomatic will be included only with a physician's approval.
* Demonstrate scores on the Mini-Mental State Examination (MMSE) of 21 or higher (no decisional impairment)
* Be on a stable disease-modifying therapy regimen (i.e., at least 6 months prior to study enrollment).
* Have a low risk for contraindications for MRI based on not having metal (e.g., non-MRI compatible aneurysm clips, metal shards in the body or eyes, or recently placed surgical hardware) or electronic devices (e.g., pacemaker, cochlear implant) within the body.
* Not be pregnant
* Not be engaging in ≥ 150 min of moderate-to-vigorous physical activity (i.e., not meeting public health guidelines for physical activity) per week
* Not be actively engaging in cognitive rehabilitation, or participating in regular brain fitness activities
* Demonstrate systolic blood pressure values of \< 200 mmHg or diastolic blood pressure values \< 110 mmHg at rest
Sequence of Radiation and Targeted Therapy in Brain Metastases

The investigators conducted a single institutional, retrospective cohort study to demonstrate the appropriate treatment strategy of upfront intracranial radiotherapy or upfront targeted therapy in patients with brain metastases, including an assessment of its feasibility and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Had histologically proven primary cancer.
* Had newly diagnosed brain metastases in contrast-enhanced MRI.
* Brain metastases focus should be measurable.
* All the patients should safely receive radiotherapy and/or systematic tyrosine kinase inhibitors.
* Karnofsky performance score (KPS) ≥60 or KPS ≥40, but only caused by brain metastases.

Exclusion Criteria:

* Patients with prior intracranial local treatments, such as surgery and radiotherapy without dose prescription in detail
* Patients with leptomeningeal metastases at first diagnosis.
* Had synchronous or metachronous malignancies that might affect survival.
* Had severe systemic diseases, abnormal conditions that might lead to incoordinate behavior during the implementation of clinical measures.
* Had incomplete sociodemographic and/or clinicopathologic baseline data
Color Synbiotics Study

This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study
* Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
* Parents' or legal guardian's written informed consent

Exclusion Criteria:

* Exclusion criteria for run-in period (visit 1, screening) are:
* Being weaned before inclusion (introduction of any other foods other than formula or human milk)
* Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
* Medical condition for which a special diet other than standard (non hydrolised) cow's milk-based infant formula is required
* Known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
* Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks prior to entry into the study
* Received Inactivated Poliovirus Vaccine (IPV) or Rotavirus Vaccine (RV) prior to entry into the study
* Gastroenteritis or diarrhoea in the last two weeks prior to entry into the study
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
Sculptra for Décolletage Crepiness and Wrinkling

The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.


Eligibility Criteria:
Inclusion Criteria:

* Female volunteer
* Aged from 40-70 years on the day of screening
* No known medical conditions that may interfere with study participation
* Moderate to severe crepiness and wrinkling of the décolletage
* Willingness to not use any products on their décolleté for the duration of the study
* Read, understand, and sign informed consent forms
* Willingness to sign photography release form
* Willing and able to comply with all follow-up requirements
* Willingness to undergo a series of three Sculptra injections, 2-3 months apart, in their décolletage

Exclusion Criteria:

* Any significant skin disease at treatment area
* Any medical condition which could interfere with the treatment
* Inability or unwillingness to follow the treatment schedule
* Inability or unwillingness to sign the informed consent
* History of poor wound healing
* History of keloid formation
* History of HIV, hepatitis, immuno-compromised
* Pregnant or lactating
* Previous use of deep chemical peels on the treatment area
* Previous injections of Sculptra in the décolletage
* Known hypersensitivity to Sculptra or any of its ingredients
* Previous laser or light based treatments to the treatment area 6 months prior to the screening visit
Validity Reliability of The Dubousset Functional Test in Stroke Patients

Increased muscle tone, decreased normal range of motion, and functional impairments may result in decreased load on the affected limb, deviations in gait patterns, balance and coordination disorders in individuals with stroke.

In the literature, there are many scales that evaluate balance and functional performance in stroke. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of stroke. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in stroke patients.

While the ambulation ability is completely lost in some patients after stroke, impaired balance reactions and increased postural oscillations cause an increase in the fear of falling and the risk of falling in stroke patients. These disturbances cause stroke patients to make more effort to balance while standing. Balance assessment performed in individuals with stroke determines the risk of falling and is important in preventing complications that may develop due to loss of balance.

Dubousset Functional Test (DFT); A conceptually practical four-component assessment test has been proposed by Dr. Jean Dubousset to assess the functional capacity of adult individuals. The validity of the test was made in individuals with spinal deformity. DFT; It consists of four components: getting up from a chair without arms and walking 5 meters forward and backward, descending and climbing steps, transition from standing to sitting on the ground, and the dual task test in which the individual walks while counting down from 50 at the same time. In the literature, there are many scales that evaluate balance and functional performance in stroke. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of stroke. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in stroke patients

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,

  * Getting a diagnosis of stroke,
  * Not having cooperation and communication problems
  * To be able to walk 10 m independently with or without device

Exclusion Criteria:

* Have a neurological or orthopedic problem other than stroke that will affect functionality and balance
* Individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.
Dengue Effectiveness Study in the Philippines

This is an observational study that aims to determine the effectiveness of a tetravalent dengue vaccine (CYD-TDV) when given through a community-based immunization program against hospitalized and /or severe virologically confirmed dengue.

This is a matched case-control study. Cases will be children who are admitted with a clinical suspicion of dengue at the study hospitals and were eligible to have received the dengue vaccine during the mass immunization. The outcome of interest is hospitalized and/or severe virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. Each case will be matched to two controls who were also eligible to have received the dengue vaccine and lives in the same area as the case. Cases and controls will be matched by age and sex.

Eligibility Criteria:
Inclusion Criteria:

CASE-CONTROL STUDIES

* For a suspected case to be enrolled in the study, he/she should:

  * Provide signed informed consent and assent (as applicable)
  * Be within the age group eligible to receive the dengue vaccine at the time of mass vaccination (i.e. no condition that would have made him/her ineligible for dengue vaccination)
  * Be admitted in any of the participating hospitals for suspected dengue
  * Have ≤5 days history of fever.
  * For the case to be included in the analysis, the participant must meet all the inclusion criteria above plus have virologically-confirmed dengue infection by RT-PCR
* For controls to be recruited into the study, he/she should:

  * Provide signed informed consent and assent (as applicable)
  * Be age and sex-matched to the case
  * Be from the same community as the matched case
  * Be eligible to have received dengue vaccine during the community-based dengue immunization campaign in 2017 (i.e. no condition that would have made him/her ineligible for dengue vaccination)
  * Have had no episode of clinically-diagnosed or laboratory-confirmed dengue fever from the start of the community -based dengue immunization campaign to the focal time (the date of onset of dengue fever in the matched case)
  * Should not have been previously recruited as a control.

Exclusion Criteria:

• Any subject whose parent/guardian refuse to provide informed consent and/or assent.

* In addition, the following conditions automatically exclude children from the dengue mass immunization:

  * Children \<9 years or adults older than 45 years of age
  * Anyone who is allergic or has had an allergic reaction to a prior dose or to any component of the dengue vaccine
  * Recipient of blood product in the last 3 months
  * Immunocompromised individuals, due to but not limited to genetic defects, HIV infection, or therapies that affect the immune system such as high-dose corticosteroids or chemotherapy
  * Recipient of any vaccine within the past month
  * History of bleeding disorder
  * Pregnant or breastfeeding women
  * Enrolled in dengue vaccine Phase 3 clinical study
Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?

The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.

The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires a chronic indwelling Foley catheter for at least 3 days.
* Catheters will not remain indwelling greater than 30 days at a time
* Patient is more than 18 years of age
* Patient is able to give informed consent
* Patient is able to attend follow-up sessions

Exclusion Criteria:

* Patient is less than 18 years of age
* Patient is pregnant
* Patient with a known allergy to silicone
* Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
* Patient unable to accommodate the catheter
* Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated.
* Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
* Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
* Patient is unable to feel and/or communicate their symptoms
* Informed consent is unable to be obtained
* Patient is unable or unwilling to comply with the study follow-up schedule
* Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
* Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study
Treat-to-target Prednisolon Taper in Patients with Polymyalgia Rheumatica

Polymyalgia rheumatica (PMR) has an incidence of approximately 1000/10\^6 for persons more than 50 years. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to taper prednisolone as fast as possible. Systematic treatment strategies (treat-to-target) is the most important improvement of disease management for other rheumatic diseases such as rheumatoid arthritis in the last decades. Thus, the purpose is to investigate benefits and harms associated with a nurce led systematic prednisolone taper strategy at the department of rheumatology compared to individual treatment by discretion of the general practitioner. It is a 1-year open label randomised trial with a 1-year extension in 120 treatment naïve patients with PMR.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with PMR according to the EULAR criteria for PMR.
* No sign of GCA on ultrasonography of the temporal and axillary arteries.
* Age over 50 years.
* Danish spoken and written language skills sufficient to fill out questionnaires.

Exclusion Criteria:

* Peroral, intraarticular or intramuscular application of glucocorticoids within the last month.
* Previous prednisolone treatment for GCA/PMR.
* Unable to give consent.
* Symptoms of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances).
* Active malignant cancers within the last 5 years (except basal cell carcinoma).
* Other inflammatory rheumatic diseases (eg. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritits, gout).
* Uncontrolled diseases (eg severe active asthma, cardiac disease with NYHA class IV)
Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses

The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.

Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This cartridge is used as lens delivery system for foldable lens implantation while doing cataract surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating would be useful for smooth delivery of intraocular lens.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 60
* Senile cataract
* Nuclear Sclerosis grade I and grade II

Exclusion Criteria:

* Inherent zonular weakness
* Shallow anterior chamber
* PXF
* Traumatic cataract
* Uveitis and Complicated cataract
* Dense PSCC and PPC
Internet-based Cognitive Behavioural Treatment for Chronic Back Pain

The aim of this study was to investigate whether an Internet-based cognitive behavioural intervention would have an effect on the symptoms of chronic back pain.

All participants were screened in a live, structured interview before inclusion. It´s a experimental design with a treatment and a control group measured before and after a treatment period.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-65 years
* access to the Internet
* having been in contact with a physician
* back pain of chronic nature
* in current employment or on short-term sick leave(not longer than 6 months)

Exclusion Criteria:

* wheelchair user
* surgical treatment planned
* history of cardiovascular treatment
* severe depression
HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission.

The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation.

This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.

Conducted in Lima Peru, 20 HIV-1 and HSV-2 seropositive women with CD4 counts greater than 200 and on no antiretroviral therapy were randomly assigned to receive valacyclovir 500 mg bid or placebo for the first 8 weeks of the study. After these 8 weeks, a 2-week washout period followed, which was then followed by the alternative regimen for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old woman,
* Documented HIV-1 seropositive,
* CD4 count greater than 200,
* Not on HIV antiretroviral therapy,
* HSV-2 seropositive as determined by Focus EIA (IN \>3.5)
* Not intending to move out of the area for the duration of study participation.
* Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.
* Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment.

Exclusion Criteria:

Women who meet any of the following criteria are not eligible for this study:

* Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;
* Planned open label use of acyclovir, valacyclovir, or famciclovir
* Known medical history of seizures
* Known renal failure, serum creatinine \>2.0mg/dl
* Hematocrit \< 30 %