cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration

The objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
2. Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
3. Patients must be age 50 or older

Exclusion Criteria:

1. Patients who have received prior treatment with any investigational new drug or device for wet AMD in the study eye within 24 weeks of the screening visit.
2. Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
3. Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
4. Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
5. Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
6. Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
7. Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.
Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.

The duration of treatment is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 50 years or older with rheumatoid arthritis.

Exclusion Criteria:

* History of gastrointestinal malabsorption or inflammatory bowel disease
* History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.
Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments

This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment.

This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of single-cell molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment. In this way, it is possible to study how the mutational profile varies under therapeutic pressure and identify any alterations responsible for resistance. It will thus be possible to define a panel of new molecular markers to be included in the diagnostic routine to identify early patients refractory/resistant to treatment with FLT3 inhibitors and thus improve the therapeutic approach of these patients.

Eligibility Criteria:
Inclusion Criteria:

* FLT3 mutated

Exclusion Criteria:

* Respoder to therapy
Treatment With SU11248 in Patients With Neuroendocrine Tumors

To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.
* Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
* ECOG performance status 0 or 1

Exclusion Criteria:

* Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
* Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.
Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer

This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer histologically or cytologically proven
* Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or panitumumab
* Age\> 18 years
* Presence of at least one measurable target by RECIST
* Life expectancy\> 3 months
* Satisfactory biological functions (renal, hepatic and hematologic)
* Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the Act of August 9, 2004
* Patient has signed, after informing the informed consent form

Exclusion Criteria:

* Patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing
* Patient with another pathology deemed incompatible with the entry in the protocol
* Prior treatment in metastatic
* Patients taking antiepileptic
* Allergic reaction or intolerance to irinotecan
* Heart failure , kidney , bone marrow , liver or respiratory
* Higher bilirubin 1.5 times the upper limit of normal
* Significant psychiatric or neurological abnormality
* Infectious syndrome requiring treatment with antibiotics or antiviral long-term
* Patients with chronic inflammatory bowel disease and / or bowel obstruction
* Contraindication Association St. John's wort and yellow fever vaccine
* Against Heart indication 5-FU
* Concurrent treatment with a drug test , participation in a clinical trial within \<30 days
* Patient refused to sign the consent
Frequency and Type of Genetic Abnormalities Found in Antenatal Corpus Callosum Malformation

Corpus callosum malformation (CCM) is the most frequently detected cerebral defect diagnosed in the prenatal setting. The most common CCM is corpus callosum agenesis (CCA) which is found in 2 to 3% of patients presenting with intellectual disability.

When CCM is diagnosed, the risk of chromosomal disorder is estimated to be 16%, be it aneuploidy such as trisomy 18, trisomy 13 or mosaic trisomy 8, or a chromosome structure anomaly, copy number variation or more complex rearrangement In France, since 2013 oligoarray-based comparative genomic hybridization (aCGH) analysis is performed in the prenatal period for most malformations after approval by a multidisciplinary prenatal diagnosis ethics committee (Centre Pluridisciplinaire de Diagnostic Prénatal, CPDPN) . However, to date only a few studies have been published which report recurrent Copy Number Variations (CNV) associated with CCM and estimate the risk for a chromosomal disorder, thus making counseling difficult in this context of prenatal diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Prenatal diagnosis of corpus callosum malformation, isolated or not, between 01/01/2013, and 31/05/2018
* Fetal DNA available
* Mother's informed consent obtained

Exclusion Criteria:

* No amniocentesis performed
* Refusing to participate
A Trial to Learn More About an Experimental Gene Therapy Called Bidridistrogene Xeboparvovec (SRP-9003) as a Possible Treatment for Limb Girdle Muscular Dystrophy 2E/R4

This is a multicenter, global study of the effects of a single systemic dose of SRP-9003 on beta-sarcoglycan (β-SG) gene expression in participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4). This study will consist of both ambulatory participants (Cohort 1) and non-ambulatory participants (Cohort 2).


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1, only ambulatory participants:

  * Able to walk without assistive aid
  * 10-meter walk test (10MWT) \<30 seconds
  * NSAD ≥25
* Cohort 2, only non-ambulatory participants:

  * 10MWT ≥30 seconds or unable to perform
  * PUL 2.0 entry scale score ≥3
* Participants must possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic β-SG DNA gene mutations
* Able to cooperate with muscle testing
* Participants must have adeno-associated virus serotype rh74 (AAVrh74) antibody titers \<1:400 (that is, not elevated) as determined by AAVrh74 antibody enzyme-linked immunosorbent assay.

Exclusion Criteria:

* Left ventricular ejection fraction \< 40% or clinical signs and/or symptoms of cardiomyopathy
* Forced vital capacity ≤40% of predicted value and/or requirement for nocturnal ventilation
* Diagnosis of (or ongoing treatment for) an autoimmune disease and on active immunosuppressant treatment
* Presence of any other clinically significant illness or medical condition (other than LGMD2E/R4)

Other inclusion/exclusion criteria apply.
Efficacy Comparison Between Primary Care Physicians' Independent Auscultation and AI-assisted Auscultation for Congenital Heart Disease Screening in Patient-enriched Populations: a Randomized Controlled Trial

In recent years, the application of artificial intelligence (AI) in the healthcare domain has witnessed a significant surge, with deep learning emerging as a potent force in the medical field. Deep learning algorithms possess the remarkable ability to automatically extract intricate features and patterns, thereby facilitating highly accurate heart sound recognition. Drawing on this technological advancement, Professor Sun Kun and his research team from Xinhua Hospital, in collaboration with numerous centers spanning across China, have been diligently investigating the development and application of AI-assisted heart sound recognition for congenital heart disease (CHD) screening.

Utilizing electronic stethoscopes to meticulously collect heart sounds, and harnessing AI algorithms to analyze extensive datasets comprising heart sounds from both children diagnosed with CHD and those who are healthy, the system has been trained to adeptly differentiate between normal and pathological murmurs. The current iteration of the system boasts an impressive accuracy and sensitivity rate of 90%.

This study is designed as a randomized controlled trial (RCT) to be conducted at Shanghai Xinhua Hospital and Qinghai Provincial Women and Children's Hospital. The primary objective is to demonstrate the superiority of AI-assisted primary care physicians in identifying CHD over primary care physicians working independently. This will be achieved by conducting a comparative analysis of the performance of AI-assisted physicians versus their unassisted counterparts, thereby substantiating the model's practical applicability. Through an ongoing process of refinement and widespread application, this pioneering research endeavors to empower a diverse range of medical professionals, including general practitioners, child health physicians, and non-cardiovascular specialists, with the transformative capabilities of AI-assisted electronic auscultation. The ultimate goal is to elevate the standard of pediatric care across the nation.


Eligibility Criteria:
Inclusion Criteria:

* Age between 0 to 18 years, with no gender restrictions.
* Children who consent to undergo echocardiography to determine the presence or absence of congenital heart disease.
* Voluntary participation in this study and signing of an informed consent form.

Exclusion Criteria:

* Age greater than 18 years.
* Children who are unable to undergo echocardiography or who do not cooperate with auscultation.
* Participants who cannot provide informed consent or are unwilling to comply with study requirements to provide medical data for further analysis and research.
TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histologically confirmed non-small cell lung cancer
* Stage IV or IIIB
* Measurable disease by RECIST
* ECOG performance status of 0-1
* Adequate liver and renal function
* Adequate bone marrow reserve

Exclusion Criteria:

* History of bone marrow transplantation or stem cell support
* Pregnant or lactating women
Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

The postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. Dexamethasone is known to effective for the prevention of postoperative sore throat. The combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated.

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for urologic surgery under general anesthesia
* ASA I-III

Exclusion Criteria:

* Patients with recent sore throat
* Patients with neck surgery
* Patients with anticipated difficult airway
* Patients with Mallampati grade 3
* Patients with severe cardiovascular or pulmonary disease
* Patients with allergic history to dexamethasone or paracetamol
* Patients with liver function disorder
* Patients with liver disease
Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.

Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.

Prospective clinical study in ICU with brain injured ventilated patients eligible to extubation.

Identification of clinical and biological criteria associated with failure of extubation.

Elaboration of a prognostic score of extubation failure of brain injured patients, based on criteria previously identified with multivariate analysis.

Failure of extubation is defined by the need of re-intubation or the need for non-invasive ventilation within 48 hours or more after extubation.

Eligibility Criteria:
Inclusion Criteria:

* Adult brain injured patients ventilated eligible to discontinuation of mechanical ventilation
* Stable respiratory and hemodynamic conditions
* Ventilated patients for more than 48 hours
* Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%, positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥ 7mL/kg
* Therapeutic extubation

Exclusion Criteria:

* • Status epilepticus

  * Cerebrospinal infection
  * Patients under 15 years old
  * Mechanical ventilation of \< 48 h
  * Spinal cord injury
  * Withdrawal of life support
Total Contact Soft Cast in Diabetic Foot Ulcers

To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.

This study will evaluate whether the use of a total contact soft cast with or without a removable cam boot is as effective in healing diabetic foot ulcers as more commonly used offloading methods.

The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be:

* Unna boot from MPJs to just below the knee,
* Sterile Kerlix from MPJs to just below the knee
* Sterile 4 inch Kling wrap from the MPJs to just below the knee,
* Four inch coban from MPJs to just below the knee, and
* Ace wraps from MPJs to just below the knee

Removable diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use diabetic cam boot then surgical shoe or regular shoe would be options.

Eligibility Criteria:
Inclusion Criteria:

- Any adult with a diabetic foot ulcer

Exclusion Criteria:

* Allergy to Calamine or Zinc oxide
* Inability to have leg wrapped
* Inability to be seen weekly or as needed
* Unable or unwilling to consent
* Prisoners
* Persons lacking capacity to consent
The Role of Reactive Thrombocytosis in Children With Pneumococcal Infection

Thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with infections. Streptococcus pneumoniae (S. Pneumoniae) is the most common pathogen. In this study, the investigators investigated the associations of clinical profiles and thrombocytosis and evaluated platelet counts, leukocyte counts and CRP levels as predictors of hospitalization days in patients with S. pneumoniae infection.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients diagnosed with pneumococcal infection.

Exclusion Criteria:

* Patients with automatic discharge.
Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms

To maximize implementation potential of pain self-management in the VA, alternative delivery methods are needed to provide Veterans with education and support needed to self-manage their pain, without requiring additional resources from healthcare teams. A novel and promising approach is a peer coaching model, in which Veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other Veterans with pain.

The investigators' goal is to test the effectiveness of a peer coaching model among Veterans. The investigators are examining feasibility for implementation alongside effectiveness, to shorten the timeline to implementation.

Aim 1 (primary aim): To compare 6-month (primary endpoint) and 9-month (sustained effects) effects of peer-supported chronic pain self-management versus controls on overall pain (intensity and function).

Hypothesis 1: Veterans in the peer support arm will experience reduced overall pain compared to controls.

Aim 2 (secondary aim): To compare 6- and 9-month effects of peer-supported chronic pain self-management versus controls on self-efficacy, social support, pain coping, patient activation, health-related quality of life, and health service utilization.

Hypothesis 2: Veterans in the peer support arm will experience greater self-efficacy, social support, pain coping, patient activation, and health-related quality of life, and lower health service utilization, compared to controls.

Aim 3 (pre-implementation aim): To explore facilitators and barriers to implementation of peer support for chronic pain, intervention costs, and fidelity to the model.

Eligibility Criteria:
Inclusion Criteria:

* have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for 3 months
* have at least moderate pain severity, defined by pain 5 on a 0 (no pain) to 10 (worst pain imaginable) scale
* indicate willingness to engage in phone or in-person contact on a regular basis with another Veteran

Exclusion Criteria:

* if the electronic medical record indicates a diagnosis of a psychotic disorder (e.g., International Classification of Diseases (ICD) ICD-9 codes 295-295.9 for schizophrenia)
* current substance dependence (e.g., ICD-9 codes 304-304.9)
* severe medical conditions precluding participation (e.g., New York Heart Association Class III or IV heart failure, ICD-9 codes 428-428.9 )
* if the eligibility screener given to prospective participants reveals active suicidal ideation severe hearing or speech impairment
* pending surgery for a musculoskeletal condition (e.g., back surgery)
Effectiveness of Music Intervention on Anxiety and Physiological Responses in Critical Ill Patient

Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in Intensive Care Unit (ICU) is still unknown. The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU. This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety. Agitation Sedation Scale, sleep quality and physical parameters were selected to collect as secondary outcomes.There was no significant difference between the groups at baseline. The results of this study support that music can reduce anxiety and agitation levels in ICU's patient. Nurses can incorporate this intervention into the daily care in order to reduce the discomfort of patients.

Background:Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in ICU is still unknown.

Objectives: The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU.

Methods: This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety measured by Visual Analog Scale. Richmond Agitation Sedation Scale, Richards-Campbell Sleep Scale and their physical parameters were selected to collect the secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or older and staying in an intensive care unit.
* Patients within 24 hours of admission (Acute Physiology And Chronic Health Evaluation, APACHE II score) ≦25 points.
* Can express their intentions by writing or shaking their heads.
* Can communicate in Mandarin, Taiwanese, Hakka or English.
* After explaining the purpose of the research, agree to participate and fill out the consent form.

Exclusion Criteria:

* Dementia or mental illness are recorded