cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine in Treating Children With Refractory Solid Tumors

Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Estimate the maximum tolerated dose of gemcitabine in children and adolescents with refractory solid tumors.

II. Assess the toxicity of gemcitabine in this patient population. III. Determine the pharmacokinetic profile of gemcitabine in male and female children and adolescents.

IV. Assess the antitumor activity of gemcitabine within a phase I study.

OUTLINE: This is a dose escalation study.

Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at week 4 and then every 6 months until death.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant solid tumor Confirmation made at original diagnosis
* No bone marrow involvement
* Refractory to conventional therapy and other therapies of higher priority according to CCG Phase I/II Priority List

PATIENT CHARACTERISTICS:

* Age: 1 to 21
* Performance status: 0-2
* Life expectancy: At least 2 months
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 100,000/mm3 (transfusion independent)
* Hemoglobin at least 10 g/dL (transfusions allowed)
* Bilirubin no greater than 1.5 times normal
* AST less than 2.5 times normal
* Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope GFR at least 70 mL/min
* No seizure disorder Not pregnant or nursing
* Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* At least 2 weeks since prior cytokine therapy and recovered
* No prior bone marrow transplantation
* No more than 3 prior combination or single agent chemotherapy regimens
* At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered
Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis

To give expanded access to intrathecal autologous MSC-NP treatment to patients with progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell trial.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS as defined by the McDonald criteria
* Diagnosis of primary progressive or secondary progressive MS
* Patients will be 18 years or older
* Significant disability shown by an Expanded Disability Status Score (EDSS, \[5\]) ≥4.5 that was not acquired within the last 12 months \*(Patients with moderate to severe cerebellar dysfunction who have an EDSS of \<6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included. This is because EDSS scores are heavily related to muscle strength and not balance or coordination and most accurately reflect paraparesis. Also there are patients with MS who have disabling upper limb coordination dysfunction but EDSS scores of better than 6.5 who are not suitable for the Phase II study but may benefit from this therapy).
* Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the last six months and no significant change in EDSS (1 point or more) in the last 12 months
* Does not qualify for the inclusion/exclusion criteria of our Phase II stem cell trial. For example, patients with EDSS \>6.5 or MS symptom onset and/or duration of disease \>15 years

Exclusion Criteria:

* All patients who have had any prior stem cell treatments, including HSCT
* Pregnant or nursing mothers or any woman intending to become pregnant in the next three years
* Use of systemic chemotherapeutic or anti-mitotic medications within three months of study start date due to the possibility of interference with bone marrow procedure
* History of central nervous system infection or immunodeficiency syndromes due to increased risk of CNS infection
* Patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the PI.
* Patients who have not tried available therapies for their progressive MS
Characteristic of Play: Comparison Between Children With Development Coordination Disorder ( DCD) and Children With Typical Development

There will be found differences in the issue of characteristic of play between Children with Development Coordination Disorder and Children with Typical Development.


Eligibility Criteria:
Inclusion Criteria:

* Children with proper( age expected) intelligence and IQ level
* Study in regular education system
* The DCD diagnosis must be confirmed by a pediatrician

Exclusion Criteria:

* Score above 9 in the Movement Assessment Battery test for Children
* Score below 3.83 in Children Activity Scale for Parents
* routinely take medication
* any physical limitations
* neurologic and/or muscle disease
* any significant hearing and/ or vision limitations
The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy

The aim of this study will be to evaluate the effect of FES on stimulation of the anterior tibial group by using the WalkAide foot drop stimulator on improving walking and balance abilities in children with hemiplegic CP.

The aim of this study will be to evaluate the effect of FES on improving walking and balance abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for lower limb, balance and gait training. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to FES by using the WalkAide foot drop stimulator. Patients' evaluation will be carried out before and after training to assess walking ability and balance performance.

Eligibility Criteria:
Inclusion Criteria:

* Their weight should be less than 40 kg.
* The spasticity degrees of the affected lower limb will range between grades (1, 1+ \& 2) according to Modified Ashworth Scale (MAS).

Those children functioning scores at Gross Motor Function Classiﬁcation System (GMFCS) Levels I and II.

* They can walk 10 min conditionally without an orthosis.
* Ought to be intellectually skilled and ready to comprehend and take after directions.
* They will have neither serious nor recurring medical complications.
* Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
* No serious hip \& knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
* Peroneal nerve and the proximal leg muscles ought to be in place.
* They ought to have no significant issues influencing balance other than spasticity.

Exclusion Criteria:

* Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
* Children with visual, auditory or perceptual deficits.
* Children with surgical interference for the lower limb.
* Children with seizures or epilepsy.
* Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
* Children with pacemakers or other diseases that are contraindicated by electrical stimulation.
Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.

A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma between the two groups and the quality of life of the patients is assessed, given that none of them has a drain

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Conservative surgery for breast cancer with associated axillary lymphadenectomy

Exclusion Criteria:

* Mastectomy
* History of axillary surgery or ipsilateral axillary radiotherapy
* ASA 4 patients. (ASA 3 patients selected)
* Lack of adequate cognitive capacity and/or signed informed consent
* Pregnancy
Whole Body Washing With Chlorhexidine for the Eradication of MRSA

The purpose of this study is to determine whether whole body washing with chlorhexidine in combination with mupirocine nasal ointment is effective in the eradication of meticillin-resistant Staphylococcus aureus (MRSA).

The number and rate of infections due to meticillin-resistant Staphylococcus aureus (MRSA)is increasing world wide. Patients who are colonized with MRSA are the main source for further distribution. In addition colonization with MRSA is a precondition for infection.

Whole body washing with antiseptic solutions as part of eradication strategies for MRSA has been widely used. However, there is insufficient evidence to support use of topical antimicrobial therapy for eradicating of MRSA because treatment with antiseptic solution has never been compared to placebo.

Comparison: The efficacy of whole body washing in the control of MRSA was studied in a randomized, placebo-controlled, double-blinded clinical trial. The study treatment consisted of five days of whole body washing either with 4% chlorhexidine solution (verum) or with placebo. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9 and 30 days after treatment by swabs taken from several body site.

Eligibility Criteria:
Inclusion Criteria:

* persons who are colonized with MRSA, i.e. one or more cultures from any body site yielded MRSA

Exclusion Criteria:

* ongoing systemic or local antimicrobial treatment directed against MRSA
* hypersensitivity to mupirocin or chlorhexidine
* pregnancy
* previous enrolment
Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection

The aim of this clinical trial is to determine whether a novel combination antibiotic treatment (vancomycin/daptomycin + beta-lactam) is superior to the standard antibiotic treatment (vancomycin/daptomycin) for hospitalised adults with Methicillin Resistant Staphylococcus aureus bacteraemia. The hypothesis is that the addition of beta-lactam antibiotics (these are antibiotics from the penicillin family) to the standard therapy will lead to more efficient bacterial killing and hence lead to faster clearance of bacteria from the blood stream and other areas of infection, thereby reducing the risk of the spread of infection and death.

The study design is an investigator-initiated, multi-centre, open-label, randomised controlled trial. This will include 440 participants diagnosed with Methicillin Resistant Staphylococcus aureus bacteraemia recruited over a period of 4 years (July 2015 - June 2019) from within Infectious Diseases inpatient units across 21 hospital sites including 18 from within Australia and 3 located in Singapore. Participation will be voluntary and subject to informed consent. The participants will be randomised 1:1 to either the standard therapy group or combination therapy group. The combination therapy will include a treatment of intravenous beta-lactam for the first 7 days of treatment, in addition to the standard treatment (either vancomycin or daptomycin). The primary outcome measure will be complication-free survival 90 days post randomisation.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years.
2. ≥1 set of blood cultures positive for MRSA
3. Able to be randomized within 72 hours of blood cultures being collected.
4. Likely to remain as inpatient for 7 days following randomization

Exclusion Criteria:

1. Previous type 1 hypersensitivity reaction to ß-lactams
2. Polymicrobial bacteraemia (not counting contaminants)
3. Previous participation in the trial
4. Known pregnancy
5. Current β-lactam antibiotic therapy which cannot be ceased or substituted
6. Participant's primary clinician unwilling to enrol patient
7. Moribund (expected to die in next 48 hours with or without treatment)
8. Treatment limitations which preclude the use of antibiotics Note that we are NOT planning to exclude participants with renal failure.
Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer

The main object of this trial is to offer treatment of recombinant endostatin ( Sulijia) combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) , disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.

Recombinant endostatin injection Sulijia is a new type of recombinant protein drugs inhibiting tumor angiogenesis developed by a group of Chinese scientists and clinician. It is expressed in E. coli which Consists of 184 amino acids. It appears to be better than NP chemotherapy alone in terms of efficacy in phase I/II trials for advanced NSCLC. In this study, a randomized, double-blind, Placebo plus NP as control, multi-center phase III trial was designed to evaluate the safety and efficacy of Sulijia plus NP in the treatment of advanced NSCLC patients. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), DCR (disease control rate) and safety as the secondary end-point. A total of 560 patients have been recruited.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18 to 70 years old;
2. Patients with histological confirmed stage IV NSCLC;
3. According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter \>=10mm by spiral CT, PET-CT, with the largest diameter \>=20mm by ordinary CT and MRI;
4. general condition ECOG performance scale (PS) 0-1;
5. Life expectancy of more than 3 months;
6. No major organ dysfunction and laboratory indicators should meet the following requirements: absolute neutrophil count \> 1.5\*10\^9/L, platelet count\> 90\*10\^9/L, hemoglobin\> 9g/dL; liver function: serum bilirubin was less than 2\* maximum normal value; ALT and AST were less than 2.5\*maximum normal value; BUN, Cr within 80% of normal range;
7. Patients could understand the circumstances of this study and those who have signed the informed consent form.

Exclusion Criteria:

1. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time;
2. Patients who have uncontrolled brain metastasis;
3. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer;
4. Pregnant or lactating women;
5. Severe infected patients;
6. Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure;
7. Patients who have vein thrombus;
8. Patients who have psychiatric illness;
9. Patients who are allergic to E. coli preparation;
10. Researchers believe that those who do not fit.
Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial

Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of Chile were invited to participate. Oral health education component was given to children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. The experimental group was treated with fluoride varnish every six months while the control group received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of Caries Incident Cases, increment dmft index

Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of Chile were invited to participate. Oral health education component was given to children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. The experimental group was treated with fluoride varnish every six months while the control group received placebo applications. A trained, calibrated dentists blinded to treatment arm performed a visual-tactile dental assessment at 6, 12, 18 and 24 months. The number of incidents children with caries were recollected as the number of caries during the follow-up visits.

Nº of participant/ centres: 277 preschoolers (2 to 3 years) of 28 public preschools in non-fluoridated areas.

Main outcome: Number of Caries Incident Cases, increment dmft index

Eligibility Criteria:
Inclusion Criteria:

* Children between 24 an 47 months, free of caries, preschooler of a public centre and living in a non-fluoridated community.

Exclusion Criteria:

* Children compromised medically, or with developmental or learning disabilities, or with a temporary residence or with dental developmental anomalies.
Frailty and Mortality in Older Old With Severe Aortic Stenosis

BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with poor prognosis, the most frequent cause of heart surgery in the elderly and associates high health costs. No variables have been identified as determinants of morbidity and mortality of these patients and there are not algorithms developed for treatment decision-making in this particular population. The FS as a functional reserve indicator could be a prognostic and interventional treatment tolerance marker, and should be included in the selection of patients for surgical treatment. The FS and cardiovascular disease (CVD) share biological substrates among which an inflammatory state associates poor prognosis.

OBJECTIVES .- To evaluate the effectiveness of the diagnosis of FS to characterize the prognosis of elderly patients with severe symptomatic AS representative of clinical practice. In addition, to examine the contribution of an inflammatory state to the relationship of FS with the prognosis of severe, symptomatic AS.

METHODS .- Prospective study during 12 months of 200 patients \> 74 years old with severe symptomatic AS. During the index visit the main clinical characteristics will be recorded and in addition we will perform a comprehensive geriatric assessment, FS assessmet according to Fried et al criteria (strength, walking speed, physical activity, fatigue, unintentional weight loss) and determination of inflammatory markers (C-reactive protein and interleukin-6). During follow-up, measures of functional impairment (basic and instrumental activities of daily living, walking speed and timed set up \& go test), hospitalizations, death and quality of life will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Severe aortic stenosis
* 75 years or older
* Ambulatory

Exclusion Criteria:

* Life expectancy lower than one year
* Severe cognitive decline
* Previous intervention on aortic valve
Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis

The aim of this prospective observational study is to evaluate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis.

The aim of this prospective study is to collect data on patients with liver cirrhosis and to investigate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis. If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status \[RFH-NPT\], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. Renal injury was measured using conventional and novel serum biomarkers (serum creatinine, cystatin-C, neutrophil gelatinase-associated lipocalin, kidney injury molecule 1, and interleukin-18. Sarcopenia was evaluated using skeletal muscle index on abdominal computed tomography. Frailty was measured using Liver Frailty Index. The research database will be updated to include data on patients' disease outcomes and follow-up care.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* aged over 20 years

Exclusion Criteria:

* serum creatinine \>1.5 mg/dL
* on dialysis
* liver transplant
Kubota Glass Parameter Refinement Study

Length of the eye will be measured in subjects exposed to various stimulus characteristics using an electronic spectacle which presents illuminated targets to the eye. The results will be analyzed to determine which stimulus characteristics may be most beneficial for use in the device.

Axial length measurements will be taken before and after two-hour monocular exposure to various stimulus characteristics using an electronic spectacle which presents illuminated defocus targets to the retina. Areas of investigation include the dioptric amount of defocus, the intensity of illumination, the spectrum of illumination, and the shape of the illumination target. The transient axial length results will be analyzed to determine which stimulus characteristics may be most beneficial for slowing myopic eye growth.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
* Sign written Informed Consent (and the California Bill of Rights, if applicable).
* Ages 8-24 (inclusive) and able to understand and assent to participation
* Have need of optical correction for myopia, from -1.00 to -5.00 diopters (D).
* Have a refractive astigmatism of less than -1.00 D.
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better.
* Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria:

* Not able or willing to provide informed consent and assent
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Currently enrolled in an ophthalmic clinical trial
* Pregnant or lactating or expect to become pregnant during the trial
* Evidence of systemic or ocular abnormality, infection or disease
* Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye
* Habitually uncorrected anisometropia ≥ 2.00
* Subjects who have undergone corneal refractive surgery
* Use of a treatment for myopia progression within the past 6 months, including atropine, specialized spectacle lenses, orthokeratology, specialized soft contact lenses