cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of Famitinib Malate in Patients With Solid Tumor

Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Famitinib in patients with solid tumor

1. To evaluate the safety and tolerability of Famitinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
2. To determine the pharmacokinetic profile of Famitinib and its metabolites .
3. To assess preliminary antitumor activity .
4. To determine preliminary dose and regimen for phase II study .

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed advanced or metastatic solid tumor，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
* no standard therapy protocol available according to patients'condition
* both sex, age 18 to 65
* ECOG 0-1
* Life expectancy more than 3 months
* ALT,AST,TB≤1.5(UNL),normal serum creatinine level, normal electrolyte or can be corrected by medication
* Subjects receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery
* Understand and agree to sign informed consent form.

Exclusion Criteria:

* Peripheral neuropathy ≥ Grade 2(according to NCI-CTC 3.0)
* Preexisting uncontrolled hypertension defined as more than 140/90 mmHg by using single agent therapy, \>Grade 1 (NCI-CTCAE 3.0 ) myocardial ischemia, arrhythmia,cardiac function insufficiency
* PT, APTT, TT, Fbg abnormal(PT\>16s,APTT\>43s,TT\>21s,Fbg\<2g/L), or have hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
* Active peptic ulcer
* Previously medication include sunitinib
* More than 4 weeks since the last clinical trial
* Pregnant or lactating women
* Women of childbearing age do not take effective contraceptive measures
* Allergies, or known allergy history to components of the drug
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

* 18 years or older
* Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation;
* Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal.
* Signed and dated the informed consent form prior to investigation procedures;
* Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.

Exclusion Criteria:

* Pure aortic insufficiency
* Requires emergency surgery
* Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
* Left ventricular ejection fraction of ≤ 25%
* Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery
* Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis
* Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring.
* Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery
* Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser
* Disease limiting life expectancy to less than 12 months
* Pregnant or lactating
* Currently participating in another drug or device clinical investigation;
* Documented blood diatheses
* Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal
* Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery
* Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation
* Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
* Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
* Documented hyperparathyroidism
Feasibility Study of the Vedera KXS for Treatment of Keratoconus

The objective of this investigation is to evaluate the feasibility, safety and efficacy of the Vedera KXS for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or glasses.


Eligibility Criteria:
Inclusion Criteria:

1. 14 years of age or older
2. Presence of central or inferior steepening on the Pentacam map
3. Axial topography consistent with keratoconus
4. I-S ratio \> 1.5 on the Pentacam map or topography map
5. BSCVA worse than 20/20 (\<53 letters on ETDRS chart)
6. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction
7. Signed written informed consent
8. Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

1. Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme.
2. A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
3. Corneal pachymetry \<400 microns at diameter to be treated.
4. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

   1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
   2. Clinically significant corneal scarring in the treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the treatment.
5. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
6. Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing.
7. Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome

The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.

Enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care

Intervention group: The neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life.

Control group: The neonates enrolled in this group will receive standard care according to standard unit protocol

Eligibility Criteria:
Inclusion Criteria:

* Gestation age ≥ 37 week
* Cephalic presentation
* Singleton pregnancy
* Age \< 2 hours
* Baby delivered through meconium stained amniotic fluid
* Presence of respiratory distress (DOWNE's score ≥4)

Exclusion Criteria:

* Major congenital malformation
* Antenatal diagnosed CHD
* Hydrops fetalis
* Air leaks before enrolment
Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana

The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities.


Eligibility Criteria:
Inclusion Criteria:

* Has PE class the semester during Hoosier Sport-
* Parent provides informed consent

Exclusion Criteria:

* Answer yes to any question on the Physical Activity Readiness for Everybody (PARQ+)
Integrated Analysis in Recovery After Exercise With and Without Hydration.

This study aims to evaluate post-exercise recovery in healthy young men submitted to a prolonged exercise protocol of submaximal intensity with or without water intake, from the integrated analysis of autonomic (heart rate variability indices), cardiovascular outcomes (systolic blood pressure, diastolic blood pressure and heart rate) and respiratory (oxygen saturation and respiratory frequency). In addition, it will also be evaluated whether the proposed model is able to estimate the number of individuals undergoing hydration that have better recovery.


Eligibility Criteria:
Inclusion Criteria:

* Include healthy and male individuals, age between 18 and 25 years and physically active.

Exclusion Criteria:

* Volunteers with at least one of the following characteristics will be excluded: smoking, use of drugs that influence the autonomic activity of the heart, alcoholics, people with known metabolic and/or endocrine disorders, and sedentary individuals, insufficiently active and very active.
Modified Release Posaconazole in Patients With Cystic Fibrosis

A prospective single center observational cohort of patients with cystic fibrosis to determine whether adequate serum levels of posaconazole, after administration of the newer modified release once daily oral formulation, can be achieved.

Use of antifungals has increased in people with cystic fibrosis. Aspergillus is the dominant fungal pathogen in this patient population and thus far, voriconazole has been used first line. Apart from recurrent and chronic lung infections, people with cystic fibrosis can also have problems with their gastrointestinal tract and absorption, and can develop chronic liver disease. As a consequence, they are at high-risk for not achieving adequate antifungal levels, which may be due to altered oral bioavailability, and they may be more susceptible to hepatic toxicities.

This study will evaluate the use of the newer modified release, once daily formulation of posaconazole in people with cystic fibrosis to identify if there is any difference in the bioavailability of the drug due to the effect of cystic fibrosis on the gastrointestinal tract. This newer formulation of once daily posaconazole is approved by the Therapeutic Goods Administration (TGA) and available on the Pharmaceutical Benefits Scheme (PBS) since March 2015. The newer formulation has the potential to overcome one of the major challenges with antifungals in cystic fibrosis; oral bioavailability. Posaconazole also appears to have reduced hepatotoxicity. This study will focus on the safety and tolerability of the drug, as well as pharmacological and microbiological endpoints.

20 eligible participants will be enrolled and have a

* Pre-treatment sputum will be collected as standard of care.
* Posaconazole serum levels will be taken at days 2, 5 and 7. (Day 5 and 7 as standard of care).
* renal and liver function assessed whilst on treatment as standard of care.
* followed up for 30 days to assess tolerability and monitor for the development of liver toxicity

Eligibility Criteria:
* Albe to provide written informed consent
* Greater than 18 years of age or older
* Have a diagnosis of cystic fibrosis
* To commence as part of their standard of care the newer modified release oral formulation of posaconazole to treat Aspergillus
* Able to provide a pre-treatment sputum collected for fungal culture as part of standard of care
* Have been prescribed a loading dose of 300mg bd for 1 day of the modified release posaconazole tablet followed by 300mg daily.

Exclusion Criteria:

* • Known azole hypersensitivity
Erector Spinae Plane, Paravertebral Versus Intercostal Nerve Block for VATS Surgery

The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains controversial. 105 patients scheduled to undergo video-assisted thoracic surgery under general anesthesia will be included. Patients will be randomly allocated to receive ultrasound-guided ESP blocks on T4 and T6 levels (Group ESPB, n = 35),PVB (Group PVB, n = 35) after the anesthesia induction and turning the patient in the lateral position or (Group ICNB, n=35) with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .

Standard general anesthesia was applied Patients will be randomly allocated to receive single shot of ESP blocks (Group ESPB), Paravertebral blocks (Group PVB) or (Group ICNB )at T4 and T6 levels according to a random number list that will be generated by a computer and will be stored in sealed envelopes. An independent experienced anesthesiologist will perform the first two blocks or surgeon will perform the third one through the thoracoscope according to the random number. The study coordinator, attending anesthesiologist, data collection resident and the patients will be all blinded to the treatment group assignment. All blocks will be applied on patient's back in a lateral position. Postoperative analgesia regimen consisted of a continuous infusion of iv iboprofen and morphine as a second rescue drug. Demographic data, past medical history, surgical and anesthetic data will be documented. Postoperative pain scores, consumption of analgesia and quality of recovery will be recorded to evaluate the analgesic effect.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients
* Thoracic surgery

Exclusion Criteria:

* Coagulation defect
Effectiveness of Orthokeratology in Decreasing Myopic Progression in a Young Adult Population Enrolled in a Professional Optometric Curriculum

The high prevalence of myopia - especially in Asian countries - is well documented, as are the sight-threatening complications of high or degenerative myopia. Retinal detachment, glaucoma, vitreal degeneration and focal retinal changes occur secondary to the progressive axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at night and change the corneal topography to correct low to moderate amounts of myopia. This same axial elongation has also been shown to occur in young adults with high near demands, however to our knowledge, there are no studies examining the effect of ortho-k lenses in this population. Our project seeks to investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in subjects between the ages of 21-30. Results will help elucidate what role these specialty lenses may have in the management of the myopic patient throughout their development, as well as what potential they have in prevention of associated degenerative changes.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be in the incoming first year optometry class, with a myopic prescription between -0.50D and -5.00D in at least one eye with refractive astigmatism \<1.50D. Visual acuity must be at least logMAR 0.10 (Snellen 20/25) or better at baseline examination in both eyes. Ocular examination must not reveal any strabismus, ocular pathology or contraindications for orthokeratology lens wear. Subjects must be in good general health with no systemic conditions that might impact their ocular health or refractive error. They must be willing to sleep a minimum of six hours per night. Finally, subjects must be willing and able to present to clinic for all necessary follow-up care.

Exclusion Criteria:

* Prescription falls outside the refractive guidelines, have a history of any type of trauma or ocular surgery, have a history of prior experience with myopia control treatment, are amblyopic or if they are current gas permeable lens wearers. They will be discontinued from the study if they are non-compliant with the treatment protocol or do not achieve a desirable subjective result,
Oxytocin in Adolescents With Autism Spectrum Disorders

This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.

Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills, quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with the use of oxytocin.

Individuals with ASD have impaired social interaction, repetitive and disruptive behaviors. Oxytocin has been described to improve those skills and studies suggest that administration can reduce repetitive behaviors as well as enhance social interaction and communication deficits.

This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.

Instruments:

1. Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification.
2. Evaluation of repetitive behavior: Repetitive Behavior Scale (RBS): Consists of 43 items divided into six subscales: stereotyped behavior, self-harm behavior, compulsive behavior, ritualistic behavior, behavior monotonous and restricted behavior. This scale is able to measure the presence and severity of repetitive behaviors as common in individuals on the autism spectrum.
3. Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
4. Multidimensional Student's Life Satisfaction Scale (MSLSS)

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 11 years 11 months and 17 years 11 months
* Autism spectrum disorder according to DSM V
* ADI \> 10
* WISC \> 70
* CARS \> 30

Exclusion Criteria:

* Female
* presence of genetic and neurological syndromes
* changes in drugs or in any intervention during the study
Prognostic Factors , Morbidity and Mortality in Patients With Neuromuscular Disorders Admitted in ICU

Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary failure and cardiomyopathy affect prognosis.The investigators aim to establish predictive factors for mortality and morbidity in Intensive care unit (ICU ) and to describe the long term follow up after ICU discharge.

Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary failure and cardiomyopathy affect prognosis. Little is known about morbidity and mortality of patients with muscular dystrophies admitted in intensive care unit (ICU).The investigators aim to describe the spectrum of patients with muscular dystrophies admitted in ICU , to establish predictive factors for ICU mortality and morbidity and to describe the long term follow up after ICU discharge.

Eligibility Criteria:
Inclusion Criteria:

* admitted in ICU
* Duchenne muscular dystrophy
* Becker muscular dystrophy
* LGMD
* Steinert disease
* Pompe disease
* FSHD
* metabolic disease
* mitochondrial disease
* congenital myopathy
* others neuro-muscular diseases

Exclusion Criteria:

* brain injury
* minor patient
Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation

Investigators seek to propose a non-drug therapeutic alternative, namely a mindfulness meditation protocol based on virtual reality training in order to induce progressive modifications of various indicators of craving.

The study hypothesis is that the practice of mindfulness meditation in a virtual reality environment reduces the craving induced by cues and stress and therefore ultimately smoking relapse.

The main objective of the protocol will be to demonstrate that mindfulness meditation can reduce long-term relapse (continuous cessation (\> 30 days) of smoking cessation).

The participants will be randomized into two groups: the experimental group will perform six virtual reality sessions in a multisensory cabin at the rate of one session per week; the control group will be prescribed the gold standard treatment (nicotine patches and chewing gum).

Participants will be seen again at three and six months to assess whether or not there has been a smoking relapse.


Eligibility Criteria:
Inclusion Criteria:

* Any patient consuming 10 to 40 cigarettes per day
* Woman or man aged 18 to 75 inclusive
* Substance use disorder according to the DSM5 classification
* Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person
* Having signed the informed consent form after having received written information.

Exclusion Criteria:

* Disabling cognitive disorders
* Patient under 18 or over 75 years old.
* Patient with a psychological disorder or a psychiatric pathology requiring specialized follow-up
* Patient with addiction to another product.
* Cardiological pathologies that could compromise the participation of patients, detected by an ECG (only for patients who will be randomized in the experimental group).
* Advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor
* Pregnant or breastfeeding woman
* Simultaneous participation in another trial
* Employee of the investigator or of the clinical trial site
* Patients protected by law
* Patients who do not speak the French language
* People not covered by state health insurance
* Patients who in the opinion of the investigator are unable to complete the questionnaires
* Patient claustrophobic or anxious about using the cabin
* Patient allergic to a molecule present in nicotine substitutes