cyrilzakka/clinical-trials huggingface dataset:
Crizotinib in ALK Rearranged Non-small-cell Lung Cancer

This is a multicenter, observational, retrospective cohort study aimed at assessing the efficacy and safety of crizotinib in ALK positive NSCLC treated in real life setting.

Primary efficacy objective:

To assess the efficacy of crizotinib in real life setting

Secondary objectives:

1. To evaluate the therapeutic response to crizotinib-based treatment
2. To identify additional biomarkers selectively present in the ALK positive population
3. To assess the safety of crizotinib (250 mg/bid) in the treatment of NSCLC in real life setting

Non-small-cell Lung Cancer (NSCLC) remains the leading cause of cancer death in Western Countries. Identification of anaplastic lymphoma kinase (ALK) gene rearrangements reinforced the role of targeted therapies in lung cancer. The EML4-ALK fusion gene is detected in 3-7% of patients with adenocarcinomas of the lung and is associated with specific clinical pathological features, including young age, absent or minimal smoking history and adenocarcinoma histology. However, such clinical features do not properly select patients for ALK inhibitors (ALK-Is) and, consequently, molecular testing is mandatory. Indeed, current guidelines recommend to test ALK rearrangements at diagnosis all patients with advanced lung adenocarcinoma, due to immediate therapeutic implications.

Eligibility Criteria:
Inclusion Criteria:

* 1. Males and Females aged 18 years with diagnosis of advanced or metastatic NSCLC
* 2. Former participation in the Italian NPU program between December 2010 - April 2013 or receiving crizotinib according to 648 legislative Decrete from April 2013 to February 2015 and thereafter in clinical practice up to December 31st, 2017.
* 3. Ascertained compliance to the Crizotinib therapy as prescribed by the relevant physician
* 4. ALK rearrangement report including details of method and cutoff used for ALK testing
* 5. Data on prior therapies
* 6. Data on toxicity
* 7. Data on crizotinib therapy efficacy including response to the therapy and survival
* 8. Data on site of metastases
* 9. Availability of archival tissue (not mandatory)
* 10. Signed Informed Consent for alive and contactable patients

Exclusion Criteria:

* 1. Lack of clinical data
* 2. No evidence of ALK rearrangemement
* 3. Early death defined as fatal outcome within 30 days since the first crizotinib dose
* 4. Absence of any radiological assessment
* 5. No data on crizotinib efficacy including survival
Comparison of LASIK and SBK

The objective of the study is to compare clinical outcomes from LASIK and SBK using FDA-approved laser technology on the same patient

Patients undergoing bilateral refractive surgery on the same day will have one eye randomized to LASIK and the fellow eye assigned to SBK treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients deemed to be suitable candidates for bilateral LASIK surgery

Exclusion Criteria:

* Patients who desire monovision correction rather than bilateral distance correction
Oropharyngeal Airway and Airway Complications

Laryngeal Mask Airway has been used in paediatric anaesthesia since the 1990's. Clinical practice in paedeatric anaesthesia for Laryngeal Mask Airway removal varies and there is no standard of care.

In children removing the Laryngeal Mask Airway under deep inhalational anaesthesia has some advantages compared to awake, but may be associated with higher rate of complications when Laryngeal Mask Airway is removed in supine compared to lateral position. On the other hand deep anaesthesia may cause airway obstruction due to reduction in tone of upper airway muscles in some patients. An oropharangeal airway may prevent this. This aspect had not been studied before and represent a gap in literature.

Study Hypothesis:

Airway complications associated with Laryngeal Mask Airway removal under deep anaesthesia are same with or without insertion of an oral airway. Alternate hypothesis is that airway complications be less if an air way is inserted at the end of anaesthesia.

Objective:

The present study was designed to observe any difference in immediate complication after removal of LMA in supine head down position under deep anaesthesia with or without insertion of an oro-pharyngeal airway. Airway complications that we will observe are desaturation \<92%, stridor, excessive secretions, laryngospasm, retching, vomiting, coughing, trauma to the soft tissues and damage to the teeth.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients aged 2-10 years undergoing surgery where anaesthesia with LMA is considered appropriate.

Exclusion Criteria:

* Patients undergoing surgery involving soiling of the airway
* Patients with conditions associated with higher incidence of gastrooseophageal reflux
* Presence of active upper respiratory tract infection (URI)
* Emergency Surgery
Knee Brace and Biomechanical Footwear in the Treatment of Knee Osteoarthritis.

This study investigates the effects of unloader knee brace, biomechanical footwear device and exercise therapy on pain, physical function and quality of life in patients with knee osteoarthritis. The aim is to find more effective treatment strategies to delay or prevent heavy knee replacement surgeries.

The aim of this study is to investigate the effects of exercising, and using a knee brace and exercising, and using of biomechanical footwear device on clinically important symptoms, physical function and quality of life in patients with osteoarthritis of the knee. The hypothesis is that the groups of using knee brace and biomechanical footwear can alleviate pain, improve physical function and quality of life more efficiently, than the group doing home exercises only.

The subjects (n = 120) will be randomized into three groups mentioned above, after which they will start to do exercises, or to use a knee brace and do exercises, or to use biomechanical footwear at home according to the instructions for 4 months. Physical function, symptoms and quality of life will be measured before and after 4-month intervention. In addition, at 12-month time point follow-up surveys will be addressed with regard to symptoms and quality of life, as well as to cost-effectiveness of the study.

Eligibility Criteria:
Inclusion Criteria:

* moderate or severe knee pain (\>40mm on a VAS scale 0-100mm)
* radiographic knee osteoarthritis (Kellgren-Lawrence grades 1-3)
* age between 45 and 70 years

Exclusion Criteria:

* inflammatory joint disease
* acute (\<6 months) knee trauma
* arthroscopic surgery in the past six months
* a planned knee replacement surgery or other planned surgical treatment of the knee
* knee injections in the past 3 months
* superficial wounds at the knee area
* arterial insufficiency
* severe varicosities
* impaired vision
* postural difficulties
* body-mass index (BMI) \>35kg/m2
* fibromyalgia
* rheumatoid arthritis or other active rheumatoid inflammatory disease.
FEAST Perinatal Support Program Intervention

Latino individuals face an elevated risk of adverse health outcomes during pregnancy, impacting both the birthing parent and the baby with potential long-term chronic health conditions. While promoting a healthy diet during pregnancy is a promising strategy, interventions targeting dietary behaviors have yielded mixed results and lack widespread dissemination in communities in need. Collaborating with community-based organizations could enhance cultural relevance, build trust with Latino families, and improve program reach and effectiveness. Food Education Access Support Together (FEAST) is a community-based program that promotes healthy eating, well-being, and health equity for diverse, under-resourced urban populations in Los Angeles. The newly developed FEAST Perinatal Support Program (PSP) aims to support individuals through pregnancy and postpartum by providing dietary psychoeducation, skill-building, and social support, with an additional component of grocery gift cards to address food access barriers. This study proposes a randomized controlled pilot trial to assess the feasibility and preliminary efficacy of the FEAST PSP in enhancing dietary outcomes, overall health, and socio-cognitive precursors, in pregnant individuals. The study will enroll 40 pregnant adults (\>70% Latino) randomly assigned to one of two different groups: core PSP with a $15 gift card for healthful fresh food (PSP+giftcard) and a waitlist control group. Pre- and post-intervention assessments will include questionnaires, dietary recalls, physical measurements, and interviews to evaluate program perceptions. Specific aims include evaluating program feasibility and acceptability (i.e., reach, retention, and participant perceptions) and determining preliminary efficacy on changing socio-cognitive and behavioral aspects of diet, self-reported health, and cardiometabolic risk factors. The project aligns with goals of improving health outcomes in Latino families in Southern California and supports FEAST's strategic objectives for improving health and wellness of individuals during pregnancy and throughout the lifespan. The findings will inform program refinement and future NIH grants for rigorous evaluation of the FEAST PSP.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant
* Speak and read English
* First pregnancy
* Eligible for Electronics Benefit Transfer (EBT) and/or Women, Infants, and Children (WIC) benefits

Exclusion Criteria:

* Inability to attend in-person sessions
Ibuprofen and Renal Function in Premature Infants

Purpose of the study:

1. To evaluate renal function maturation within the first month of life in very premature infants.
2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.

Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication. However, experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants.

Purpose of the study:

1. To evaluate renal function maturation within the first month of life in very premature infants.
2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.

Population:

At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording of mother and child history, and associated therapies prone to alter renal function should allow to improve the use of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Gestational Age = 27 to 31 weeks
* Postnatal age \< 48 hours
* Parental Consent Obtained

Exclusion Criteria:

* Renal malformation
* Urinary tract infection
* Renal Failure
* Pulmonary Hypertension at echocardiography
Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

Almost 50% of all children have at least 1 episode of noisy breathing before the age of 2 years and almost 25% of these children have more episodes of noisy breathing. The lack of an objective technique for diagnosing noisy breathing children often leads to overrated diagnosis of "wheezing", whereas there may be other noisy breathing phenotypes, like "rattling", that don't favor from the same therapeutic treatment. Presumably, different underlying pathophysiological mechanisms are involved with different biomarker profiles characteristic for different phenotypes. The goal of this study is to optimize the diagnosis of noisy breathing infants and toddlers. Children will be followed for a treatment period of 6 weeks and will visit the paediatrician 3 times (week 0, 3 and 6). During the consultations breath sound analysis will be performed and a breath sample and a nasal mucus will be collected to analyse biomarker profiles. Both methods for diagnosing noisy breathing infants are non-invasive and will be compared to the standard procedure of the paediatrician which consists of auscultation and palpation of the chest. An objective and non-invasive method for diagnosing noisy breathing infants and toddler will pave the way for more cost-effective and personalized prescription of therapies which will increase the quality of life of children with noisy breathing.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of noisy breathing ("wheezing" or "rattling")

Exclusion Criteria:

* born before pregnancy week 37
* congenital or genetic conditions (Down syndrome, Klinefelter's syndrome, ...)
* acquired chronic respiratory diseases (bronchopulmonary dysplasy, lung fibrosis, ...)
Comparison on Outcomes of Four IOLs in Patients With Cataracts

The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into 4 groups. Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into group A (TECNIS PCB00 IOL), Group B (HumanOptics Diff-Aay IOL), Group C (TECNIS Symfony ZXR00 IOL) and group D (ZEISS AT LISA tri 839MP IOL). Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

Eligibility Criteria:
Inclusion Criteria:

* age-related cataract with myopia≤-6.0D and over 0.0D
* axial length≤26mm and corneal astigmatism≤1.5D
* well-cooperation of finishing preoperative examinations
* completion of all follow-up visits

Exclusion Criteria:

* previous eye diseases that affect vision including keratopathy, glaucoma, uveitis, amblyopia, fundus diseases, etc.
* patients with decreased cognitive ability, unable to cooperate with preoperative examination, or suffering from severe anxiety, depression and mental illness
* serious complications during operation, including corneal injury, iris injury, expelling choroidal hemorrhage, posterior capsule rupture, etc
* serious postoperative complications, including displacement of intraocular lens, macular edema, endophthalmitis, etc
* follow-ups less than 3months
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)

The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.

Evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer's disease along with a number of epidemiological studies suggests that non-steroidal anti-inflammatory drugs (NSAIDs) may slow the rate of cognitive deterioration. We have selected two such drugs for a therapeutic trial: rofecoxib and naproxen. The trial employs a double-blind parallel design with three primary treatment groups: rofecoxib, naproxen and placebo. A total of 320 patients will be enrolled in the trial and randomized to the three groups. Stable use of cholinesterase inhibitors, estrogen, low dose aspirin, and vitamin E will be allowed. Patients with inflammatory diseases that might respond to the study medications will be excluded.

The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAScog). The attainment of significant endpoints will be examined as a secondary outcome measure. Other secondary measures include the CDR sum-of-boxes, Neuropsychiatric Inventory, the Quality of Life-AD and the ADCS pharmacoeconomic scale. The influence of HLA-DR (Human Leukocyte Antigen) genotype on clinical progression and response to treatment will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* NINCDS/ADRDA criteria for probable AD
* MMSE between 13 and 26, inclusive
* Stable medical condition for 3 months
* Screening visit
* Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam, and clinical laboratory tests
* Supervision available for administration of study medications; caregiver/informant to accompany patient to all scheduled visits
* Fluent in English or Spanish
* Age greater than or equal to 55 years old
* Modified Hachinski of less than or equal to 4
* CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion
* Able to complete baseline assessments
* 6 years of education or work history sufficient to exclude mental retardation
* Able to ingest oral medication

Exclusion Criteria:

* Hypersensitivity to aspirin or NSAID
* Active peptic ulcer disease within 5 years
* Renal insufficiency with creatinine greater than 1.5
* Clinically significant liver disease
* Poorly controlled hypertension
* Congestive heart failure
* Bleeding ulcer
* Active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director)
* Inflammatory diseases (including crystal arthropathy, rheumatoid arthritis, systemic lupus, erythematosus, Sjogren's syndrome, inflammatory bowel disease)
Ultrasound-guided Approach Combined With Pressure Measurement Technique to Thoracic Paravertebral Block

Posterolateral thoracotomies are among the most painful procedures of surgery and may cause severe postoperative chest pain and impaired respiratory performance. Paravertebral block (PVB) is an established method of administering postoperative analgesia for thoracic procedures. PVB blocks the somatic and sympathetic nervous systems and is placed by injecting a local anesthetic (LA) into the paravertebral space where the nerve and its branches are located after exiting the intervertebral foramen. But previous study showed 5-10% of failure rate in PVB using ultrasound machine. Pressure measurement during needle advancement could improve reliability of correct needle placement. When the needle tip reaches paravertebral space, there is a sudden lowering of pressures due to respiratory cycle. Therefore, sensitivity and specificity could be improved and correct needle placement become objective and reproducible when PVB using ultrasound is combined with pressure measurement during needle advancement.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective thoracotomy
* ASA status 1,2

Exclusion Criteria:

* Inability to provide adequate informed consent
* Any contraindication to the placement of thoracic paravertebral catheters
* Unstable vertebral and transverse process fractures
* Any chronic painful conditions or preoperative opioid use Any chronic painful conditions or preoperative opioid use
* Coagulation abnormalities or expectation to be on therapeutic anticoagulants postoperatively
* Allergy to any of the drugs/agents used in study protocol
* Altered mental status or emergency surgery
* Comorbid conditions such as sepsis, unstable angina, congestive heart failure
Variation of Cerebral Blood Flow in Anterior Cerebral and Basilar Artery in Neonates and Infants in Genreal Anesthesia With Caudal Block

With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and the basilar artery (BA) after the caudal block changes.


Eligibility Criteria:
Inclusion Criteria:

* opened big fontanella
* infraumbilical surgery

Exclusion Criteria:

* cardiac or cerebral disease
* prior operation on vertebra, heart or head/brain
* malforamtion of head or vertebra
* closed fontanella
* contraindication for caudal block (von-Willebrand-Syndrome, haemophilia,...)
The Effect of Free Weight Resistance Training and Body Composition on Cognition

This study, titled The Effect of Free Weight Resistance Training (FWRT) on Cognitive Function Explored through Eye Tracking, will be a randomized double-blind clinical trial aimed at evaluating how FWRT influences cognitive processing in healthy young adults. Eye-tracking technology will be used to measure reading metrics and DXA scans will be used to measure body composition before and after a 10-week FWRT intervention.

Participants will be randomly assigned to either an experimental group, which will undergo a 10-week FWRT program, or a control group. This study will provide insights into the potential benefits of free weight resistance training on the cognitive performance of text processing tasks.


Eligibility Criteria:
Inclusion Criteria:

* University students between the ages of 18 and 30.
* Healthy individuals with no recent participation (last six months) in physical training programs.
* Normal or corrected-to-normal vision.

Exclusion Criteria:

* Physical or health limitations that prevent participation in a resistance training program.
* Current involvement in other physical training programs.
* Visual impairments that cannot be corrected with glasses or contact lenses.
Safety and Efficacy of DLBS1033 in Healthy Subjects

The objective of this study are:

1. To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject
2. To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject

This study is a 2-arm, randomized, double-blind, placebo controlled, cross-over study with a fixed dose regimen. The study will involve twenty (20) healthy subjects. The study will be a comparative study of safety and efficacy of DLBS1033 with placebo. Each study period will consist of 14 days treatment with a 2-week wash-out period in between. The evaluation of safety parameters will be performed at Day 1 (baseline), 7, and 14; while the efficacy parameters will be performed at Day 1, 2, 7, and 14.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 - 50 year-old at screening
* Having good and stable health judged on the basis of medical history, physical examination, and routine laboratory
* Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study

Exclusion Criteria:

* Participating in other clinical trial within 4 weeks prior to screening
* Had a major surgical procedure or dental procedure within 4 weeks prior to screening
* History of any of the following medical conditions: haemophilia, past medical history of haemorrhagic stroke, acid peptic disease, easy bruising and frequent external bleeding
* Any other known current medical condition, which is judged by the investigator could jeopardize subject's health or interfere with the study evaluation
* Being on regular medication(s), including traditional medicine(s)
* Pregnant or lactating women (urinary pregnancy test will be applied to women subjects during screening and just before treatment in each periods)