cyrilzakka/clinical-trials huggingface dataset:
Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients

Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of the lung cancer population. The prognosis of these patients has improved over the years due the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The brain, however, remains one of the major sites of failure. Patients with brain metastasis suffer from a variety of neurological, cognitive and emotional difficulties that are known to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI) can prevent or delay the development of brain metastasis, and as such can improve neurological disease-free survival and consequently health-related quality of life. But survival is short, and toxicities are real, as PCI in itself can also induce adverse effects. The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to the lack of formal and systematic evaluation in patient populations expected to have short survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated yet.

Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs and benefits of this therapy should be investigated properly, to allow for well-informed treatment choices.


Eligibility Criteria:
Inclusion Criteria:

* UICC stage III A or III B (without malignant pleural or pericardial effusion) non-small cell lung cancer
* Whole body PDG-PET scan before the start of therapy available: no distant metastasis.
* CT or preferably MRI of the brain before the start of radical therapy available; no brain metastasis.
* Platinum-based chemotherapy is mandatory.
* Radical local therapy: concurrent or sequential chemotherapy and radiotherapy with or without surgery.
* Radiotherapy dose without surgery to at least biological equivalent of 60 Gy.
* No prior cranial irradiation.sufficient proficiency in Dutch language
* sufficient proficiency in Dutch language
* MRI (and not CT scan) pre-PCI

Exclusion Criteria:

* none
Using Artificial Intelligence-platform on Plaque Control and Periodontal Treatment Outcome in Patients With Periodontal Disease-Preliminary Results

The aim of this study was to evaluate the long-term effectiveness of an AI dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. This randomized controlled trial included experimental group: AI group (EG-A), AI-humanized group (EG-B) and control group(CG), respectively.

The EG-A and EG-B received AI dental monitoring intervention by taking mouth image at home once a week for six month.

Baseline and follow-up surveys were used to collect the data in periodontal index, periodontal preventive behavior and motivation.

A randomized experimental design was used. Patients with periodontal disease whose aged 35-65 years were recruited through department of Periodontics in Kaohsiung Medical University Hospital.

Each group was expected for 100 per group, patients will be randomized into each group. G\*Power (version 3.1.9.4) was used for power analysis.

All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month follow-ups.

Each patients will be diagnosed periodontal disease by dentist and have more than 16 functional teeth.

Each patients will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35-65 years old
* Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
* More than 16 functional teeth

Exclusion Criteria:

* Have received periodontal treatment within 3 months
* Patient has disease related to periodontal disease (ex. Drug-related excessive gum growth or blood clotting problems, pregnancy, mental illness)
* Disability patients
Neutrophil Gelatinase-Associated Lipocalin: Biomarker of Acute Kidney Injury After Cardiac Surgery

The following objectives were used for comparison: 1)primary objective: Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery.

All patients aged greater than 18 years undergoing elective cardiac surgery for coronary artery bypass grafting and / or valve replacement, in need of cardiopulmonary bypass and with the prospect of minimum hospital length stay of 48 hours in ICU, will be candidates for participation in this study.

Criteria for exclusion Patients with IRA before hospitalization in the ICU; Patients with estimated glomerular filtration (MDRD formula simplified) less than 30 ml / min; Patients transplanted kidney; Patients with chronic renal failure on dialysis; Patients anuric the admission in the ICU; Refusal to participate in the study.

Definition of IRA:

IRA will be defined according to the new proposal of AKIN (Acute Kidney Injury Network) (awaiting publication): abrupt elevation (48 hours) of serum creatinine in value greater than or equal to 0.3 mg / dL or an increase of 50% compared to baseline or reduction of urinary volume to 0.5 ml / kg / h for more than 6 hours (Annex 1).

Laboratory Investigations Samples of urine will be collected before surgery, after 2, 4, 6, 12, 24, 48, 72 and 96 hours after the end of the CEC for determination of creatinine and urinary NGAL (normalization of NGAL for excretion urinary creatinine).

The serum creatinine is measured before surgery and daily during the first 4 days after surgery for the diagnosis of IRA. If the time of CEC exceed 2 hours, the first sample of urine after the end of the CEC will be considered as "sample 2 hours".

Quantification of NGAL Samples of urine will be centrifuged (5 min at 2000 rpm) and frozen at -20 ° C for later determination of NGAL by method of ELISA (Kit commercial AntybodyShop, Denmark).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged greater than 18 years undergoing elective cardiac surgery for coronary artery bypass grafting and/or valve replacement
* In need of cardiopulmonary bypass and with the prospect of minimum hospital length stay of 48 hours in ICU

Exclusion Criteria:

* Patients with IRA before hospitalization in the ICU
* Patients with estimated glomerular filtration (MDRD formula simplified) less than 30 ml/min
* Patients transplanted kidney
* Patients with chronic renal failure on dialysis
* Patients anuric the admission in the ICU
* Refusal to participate in the study.

Definition of IRA:

IRA will be defined according to the new proposal of AKIN (Acute Kidney Injury Network) (awaiting publication): abrupt elevation (48 hours) of serum creatinine in value greater than or equal to 0.3 mg / dL or an increase of 50% compared to baseline or reduction of urinary volume to 0.5 ml / kg / h for more than 6 hours
Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children

Childhood obesity is one of the most critical and accelerating health challenges throughout the world. It is a major risk factor for developing varus/valgus misalignments of the knee joint. The combination of misalignment at the knee and excess body mass may result in increased joint stress and damage to articular cartilage. A training programme, which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion. Despite the large number of guidelines for muscle strength training and neuromuscular exercises that exists, most are not specifically designed to target the obese children and adolescent demographic.

The purpose of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically designed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age: 10 -18 years
* BMI greater than the 97th percentile
* Availability: can participate in two exercises session per week for a period of 12 weeks

Exclusion Criteria:

* Present syndromes
* Chronic joint diseases, osteoarthritic surgery or
* Neuro-motor diseases
Clinical Evaluation of Fractional Bi-Polar RF for Symptoms of SUI and Vulvovaginal Atrophy

Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy

The objective of this trial is to evaluate the safety and efficacy of the MorpheusV Applicator for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate in the study.

  * Female subjects, 35 and 75 years of age at the time of enrolment with primary and moderate to severe symptoms of SUI, who had scored at least 6 out of 12 according to severity index developed by Sandvik
  * She has produced a leak during the bladder "cough" stress test.
  * 18 out of 27 for the Stress Incontinence Questions and were confirmed as having predominant SUI on the Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
  * General good health confirmed by medical history and skin examination of the treated area.
  * The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.

Exclusion Criteria:

* - Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
* Current or history of cancer, or premalignant condition in the treatment area.
* Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* Pregnancy and nursing.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
* Any surgery in treated area within 3 months prior to treatment.
* Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
* Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
Treatment of Patients With Nocturia (Non-PK Study)

The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female 50 years or older
* Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria:

* CHF
* Diabetes
* Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency
* Incontinence
* Illness requiring steroids
* Current or past urologic malignancy
* Nephrotic Syndrome
* Unexplained pelvic masses
* Urinary bladder neurological dysfunction
* Urinary bladder surgery or radiotherapy
* Sleep Apnea
* Pregnant or breast feeding
Correlation Between Visual Field Defects on FORESEE HOME and on Optical Coherence Tomography in Choroidal Neovascularization Subjects

The FORESEE HOME is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee HOME demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.


Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed with CNV
* Did not perform more then 4 anti- VGEF injections
* VA with habitual correction better then 6/45 in the study eye
* Ability to understand instructions
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following DMEK Using Ultra-high Resolution OCT

Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss of endothelial cells, thickening of Descemet's membrane and deposition of extracellular matrix in the form of guttae. This result in failure of the endothelium to support corneal deturgescence leading to corneal edema. Affected patients complain about blurred vision at early stages of the disease which can progress to blindness. The pathophysiology of the disease is still unclear, but several studies point towards a genetic susceptibility. Additional risk factors that have been identified are female sex, smoking and older age.

While for a long time penetrating keratoplasty (PKP) was the only therapy available for affected patients, in the recent years less invasive methods such as descemet's membrane endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane and the endothelium is removed and replaced with the corresponding parts from a donor's cornea. For FECD, this brings the advantage that only the diseased part of the cornea is replaced. Graft detachment has been identified as the main complication following DMEK.

In the investigators' study, an ultra high resolution OCT system will be used to detect graft detachment in patients with FECD after DMEK. With this technique, even small detachments can be visualized. The area of graft detachment will be evaluated at predefined time points after surgery and correlated to visual acuity. A follow-up of one year will be performed in order to investigate the predictive value of graft adherence status at several time points for visual outcome.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years scheduled for primary DMEK because of Fuchs' Endothelial Dystrophy

Exclusion Criteria:

* Any disease inhibiting OCT acquisition; such as blepharospasm, severe tremor or immobility
* Any previous intraocular surgery other than cataract extraction
* Previous clinically significant ocular trauma in the study eye, as judged by the investigator
* Pregnancy, planed pregnancy, or lactating
* Appointment of a custodian
* Progressive retinal disease
* History or presence of glaucoma
A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele or phenotypically similar nonsense allele.

Up to 16 patients will be enrolled in the trial; up 4 patients will be homozygotes to G542X, and the remaining patients will be compound heterozygotes with G542X or phenotypically similar nonsense mutation and any Class 1 or Class 2 mutation.

Each patient will receive 5 escalating doses as follows:

* 0.3 mg/kg per day SC
* 0.75 mg/kg per day SC
* 1.5 mg/kg per day SC
* An individualized dose, as high as 3.0 mg/kg per day SC, based upon the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests
* ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid


Eligibility Criteria:
Patients must meet the following criteria to participate in this study:

1. Males and females age 18 years and above in Germany and Israel; in countries where permitted, males and females age 16 years and above
2. A confirmed diagnosis of nmCF with a documented G542X or phenotypically similar nonsense mutation, homozygote, or compound heterozygote with one of the specified mutations. For heterozygotes, one mutation has to be G542X or phenotypically similar nonsense mutation, and the second mutation could be and Class 1 or Class 2 mutation. Patients with one G542X or phenotypically similar nonsense allele and a second allele that is not in the above list may be potentially allowed but only after discussion on a case by case basis with and written approval from the Sponsor.
3. Documented SCC ≥ 60 mEq/L
4. FEV1 ≥ 40% predicted normal for age, gender and height at Screening (Knudson Equation)
5. Body Mass Index (BMI) of 19.0 to 30.0 kg/m2 (inclusive).

Patients with any of the following characteristics/conditions will not be included in the study:

1. Participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study
2. History of any organ transplantation
3. Major surgery within 180 days (6 months) of Screening
4. Patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides
5. Known allergy to any aminoglycoside
6. Patients with any abnormality at ENT screening, that indicates the presence of a vestibular toxicity associated with prior exposure to aminoglycosides.
7. Dizziness Handicap Inventory (DHI)-H score at screening \>16
8. Patients receiving CFTR modulators within 2 months of study treatment
First Line Chemotherapy for Advanced Cancer

The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.

Eligibility Criteria:
Inclusion Criteria:

* Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
* Adult patients \>=18 years of age
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
* At least have one measurable disease(according to RECIST)
* Adequate bone marrow,renal and liver function

Exclusion Criteria:

* Previous chemotherapy for advanced/metastatic disease
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.

This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers.

This is a prospective, single masked, comparative, mono-therapeutic trial evaluating three fluoroquinolone agents that are approved and marketed for the treatment of conjunctivitis. Approximately 120 patients who have corneal ulcers greater than 2 mm but less than 6 mm in size who meet all other inclusion criteria will be enrolled into this study. Patients will be randomized in a 2:1:1 ratio to receive besifloxacin 0.6% ophthalmic suspension, gatifloxacin 0.5% ophthalmic solution, or moxifloxacin 0.5% ophthalmic solution.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be between the ages of 18-90 years of age.
2. Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
3. Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
4. Patients must have corneal ulcer present in only one eye.
5. Patients must agree not to wear contact lenses while on study.

Exclusion Criteria:

1. Patients with multifocal ulcers.
2. Signs of any other viral or fungal infection.
3. Treatment with antibiotics within 14 days of study entry.
4. Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period.
5. Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%).
6. Contact lens only with no spectacles available.
7. Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
8. Participation in any investigational study within the past 30 days.
9. Pregnant women, minors, or those not able to consent for themselves.
Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.

The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the forced expiratory volume at one second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the 6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or catheterization.

Eligibility Criteria:
Inclusion Criteria:

* IPF according to ATS/ERS 2011's criteria
* Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)

Exclusion Criteria:

* Patients with a significant disease other than IPF. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
* Pregnant or nursing women.
* Non-pulmonary fibrosis
* treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function